Telephone counselling for smoking cessation

  • Review
  • Intervention

Authors


Abstract

Background

Telephone services can provide information and support for smokers. Counselling may be provided proactively or offered reactively to callers to smoking cessation helplines.

Objectives

To evaluate the effect of proactive and reactive telephone support via helplines and in other settings to help smokers quit.

Search methods

We searched the Cochrane Tobacco Addiction Group Specialised Register for studies of telephone counselling, using search terms including 'hotlines' or 'quitline' or 'helpline'. Date of the most recent search: May 2013.

Selection criteria

randomized or quasi-randomised controlled trials in which proactive or reactive telephone counselling to assist smoking cessation was offered to smokers or recent quitters.

Data collection and analysis

One author identified and data extracted trials, and a second author checked them. The main outcome measure was the risk ratio for abstinence from smoking after at least six months follow-up. We selected the strictest measure of abstinence, using biochemically validated rates where available. We considered participants lost to follow-up to be continuing smokers. Where trials had more than one arm with a less intensive intervention we used only the most similar intervention without the telephone component as the control group in the primary analysis. We assessed statistical heterogeneity amongst subgroups of clinically comparable studies using the I² statistic. We considered trials recruiting callers to quitlines separately from studies recruiting in other settings. Where appropriate, we pooled studies using a fixed-effect model. We used a meta-regression to investigate the effect of differences in planned number of calls, selection for motivation, and the nature of the control condition (self help only, minimal intervention, pharmacotherapy) in the group of studies recruiting in non-quitline settings.

Main results

Seventy-seven trials met the inclusion criteria. Some trials were judged to be at risk of bias in some domains but overall we did not judge the results to be at high risk of bias. Among smokers who contacted helplines, quit rates were higher for groups randomized to receive multiple sessions of proactive counselling (nine studies, > 24,000 participants, risk ratio (RR) for cessation at longest follow-up 1.37, 95% confidence interval (CI) 1.26 to 1.50). There was mixed evidence about whether increasing the number of calls altered quit rates but most trials used more than two calls. Three studies comparing different counselling approaches during a single quitline contact did not detect significant differences. Of three studies that tested the provision of access to a hotline two detected a significant benefit and one did not.

Telephone counselling not initiated by calls to helplines also increased quitting (51 studies, > 30,000 participants, RR 1.27; 95% CI 1.20 to 1.36). In a meta-regression controlling for other factors the effect was estimated to be slightly larger if more calls were offered, and in trials that specifically recruited smokers motivated to try to quit. The relative extra benefit of counselling was smaller when it was provided in addition to pharmacotherapy (usually nicotine replacement therapy) than when the control group only received self-help material or a brief intervention.

A further eight studies were too diverse to contribute to meta-analyses and are discussed separately. Two compared different intensities of counselling, both of which detected a dose response; one of these detected a benefit of multiple counselling sessions over a single call for people prescribed bupropion. The others tested a variety of interventions largely involving offering telephone counselling as part of a referral or systems change and none detected evidence of effect.

Authors' conclusions

Proactive telephone counselling aids smokers who seek help from quitlines. Telephone quitlines provide an important route of access to support for smokers, and call-back counselling enhances their usefulness. There is limited evidence about the optimal number of calls. Proactive telephone counselling also helps people who receive it in other settings. There is some evidence of a dose response; one or two brief calls are less likely to provide a measurable benefit. Three or more calls increase the chances of quitting compared to a minimal intervention such as providing standard self-help materials, or brief advice, or compared to pharmacotherapy alone.

Resumen

Asesoramiento telefónico para el abandono del hábito de fumar

Antecedentes

Los servicios telefónicos pueden proporcionar información y apoyo a los fumadores. El asesoramiento puede ser proporcionado proactivamente o ser ofrecido reactivamente a quienes llaman a las líneas de ayuda para el abandono del hábito de fumar.

Objetivos

Evaluar el efecto del apoyo telefónico proactivo y reactivo a través de líneas de ayuda y en otros contextos para ayudar a los fumadores a abandonar el hábito.

Métodos de búsqueda

Se realizaron búsquedas en el registro especializado del Grupo Cochrane de Adicción al Tabaco (Cochrane Tobacco Addiction Group) para obtener estudios de asesoramiento telefónico, mediante el uso de términos de búsqueda que incluyeron "hotlines" o "quitline" o "helpline". Fecha de la búsqueda más reciente: mayo de 2013.

Criterios de selección

ensayos controlados aleatorios o cuasialeatorios en los que se ofrecía asesoramiento telefónico proactivo o reactivo para ayudar a abandonar el hábito de fumar a los fumadores o a quienes abandonaron el hábito de fumar recientemente.

Obtención y análisis de los datos

Un revisor identificó y extrajo los datos de los ensayos, y un segundo revisor los verificó. La medida de resultado principal fue el cociente de riesgos para la abstinencia de fumar después de al menos seis meses de seguimiento. Se seleccionó la medida más rigurosa de abstinencia y se utilizaron las tasas validadas bioquímicamente cuando estuvieron disponibles. Se consideró que los participantes perdidos durante el seguimiento continuaron como fumadores. Cuando los ensayos tenían más de un brazo con una intervención menos intensiva, en el análisis primario se utilizó solamente la intervención más similar sin el componente telefónico como grupo control. La heterogeneidad estadística entre los subgrupos de los estudios clínicamente comparables se evaluó mediante la estadística I². Los ensayos que incluyeron a quienes llaman a líneas telefónicas de abandono se consideraron por separado de los estudios que reclutaron pacientes en otros contextos. Cuando fue apropiado, los estudios se agruparon mediante un modelo de efectos fijos. En el grupo de estudios que reclutaron pacientes en contextos diferentes a las líneas telefónicas de abandono se utilizó una metarregresión para investigar el efecto de las diferencias en el número planificado de llamadas, la selección para la motivación y la naturaleza de la condición control (autoayuda solamente, intervención mínima, tratamiento farmacológico).

Resultados principales

Setenta y siete ensayos cumplieron los criterios de inclusión. Algunos ensayos se consideraron con riesgo de sesgo en algunos dominios, pero en general los resultados no se consideraron con alto riesgo de sesgo. Entre los fumadores que establecieron contacto con líneas de ayuda, las tasas de abandono fueron mayores en los grupos asignados al azar a recibir sesiones múltiples de asesoramiento proactivo (nueve estudios, > 24 000 participantes, cociente de riesgos [CR] para el abandono al seguimiento más largo 1,37; intervalo de confianza [IC] del 95%: 1,26 a 1,50). Hubo pruebas mixtas acerca de si el aumento del número de llamadas alteró las tasas de abandono, pero la mayoría de los ensayos utilizó más de dos llamadas. Tres estudios que compararon diferentes enfoques de asesoramiento en una sesión única no detectaron diferencias significativas. De tres estudios que probaron la provisión de acceso a una línea telefónica de asistencia, dos detectaron un efecto beneficioso significativo y uno no.

El asesoramiento telefónico que no se inició mediante llamadas a las líneas de ayuda también aumentó el abandono (51 estudios, > 30 000 participantes, CR 1,27; IC del 95%: 1,20 a 1,36). En una metarregresión que controló por otros factores se calculó que el efecto fue ligeramente mayor cuando se ofrecieron más llamadas, así como en los ensayos que incluyeron específicamente a fumadores motivados a intentar abandonar el hábito. El efecto beneficioso relativo adicional del asesoramiento fue más pequeño cuando se proporcionó como agregado al tratamiento farmacológico (generalmente tratamiento de reemplazo de nicotina) que cuando el grupo control solamente recibió material de autoayuda o una intervención breve.

Otros ocho estudios fueron demasiado diferentes para contribuir al metanálisis y se analizan por separado. Dos compararon intensidades diferentes del asesoramiento y ambos detectaron un efecto de respuesta en relación con la dosis; uno de los estudios detectó un efecto beneficioso de las sesiones de asesoramiento múltiples sobre una llamada única en los pacientes a los que se les había prescrito bupropión. Los otros probaron diversas intervenciones que incluyeron principalmente asesoramiento telefónico como parte de una derivación o cambio de sistemas y ninguno detectó pruebas de efecto.

Conclusiones de los autores

El asesoramiento telefónico proactivo ayuda a los fumadores que buscan asistencia a través de las líneas telefónicas de abandono. Las líneas telefónicas de abandono proporcionan a los fumadores una importante forma de acceder al apoyo, y el asesoramiento a través de llamadas posteriores mejora su utilidad. Existen pruebas limitadas sobre el número óptimo de llamadas. El asesoramiento telefónico proactivo también ayuda a los pacientes que lo reciben en otros contextos. Hay algunas pruebas de un efecto de respuesta en relación con la dosis; una o dos llamadas breves tienen menores probabilidades de proporcionar un efecto beneficioso cuantificable. Tres o más llamadas aumentan las probabilidades de abandonar el hábito de fumar en comparación con una intervención mínima como proporcionar materiales estándar de autoayuda, asesoramiento breve o en comparación con farmacoterapia sola.

Plain language summary

Is telephone counselling effective as part of a programme help people stop smoking?

Background: People trying to quit smoking can be helped with medication or by face-to-face behavioural support such as counselling and group therapy.
Objectives: We wanted to to find out whether support was also effective when it was provided by telephone.
Search methods: The most recent search for evidence was in May 2013. We identified 77 controlled trials with a total of almost 85,000 participants.
Results:This review identified trials evaluating the effect of any type of telephone counselling. We included trials where the participants had called helplines offering support for people trying to quit smoking (quitlines). We also included trials where people had received telephone calls from counsellors or other healthcare providers. Some of these compared telephone support with very minimal support such as self-help leaflets, and others looked at whether adding telephone calls was more helpful than just face-to-face support, or just providing a smoking cessation medication such as nicotine replacement therapy (NRT). Some trials only recruited people who were trying to stop smoking, whislt others offered support even if people were not actively planning to quit. Trials had to be randomized, and to follow up participants for at least six months.

A small number of trials were judged to be at risk of bias but we did not think that the overall results were likely to be biased. Trials in quitline populations were more likely to be unable to contact everyone for follow-up and generally relied on participants' self report of not smoking, rather than checking using biochemical tests. Trials used a wide range of numbers and lengths of calls, and there was some variation between the results of different trials which means that we cannot be certain that all types of counselling have the same effect.

Twelve trials involving over 30,000 people tested the effect of additional telephone calls from a counsellor for people who had called a quitline. When we pooled their results there was evidence that people receiving call-back counselling were more likely to have stopped smoking than those only sent self-help materials or given brief advice and support during the initial call. Calls increased the relative success by between 25% and 50%, but since the proportion quitting in the control groups was quite low this was equivalent to an absolute increase of only 2 to 4 percentage points.

Fifty-one trials involving over 30,000 people tested the effect of telephone counselling for people who had not called a quitline, some of whom might not have been actively planning to quit. Overall when pooled these showed a small benefit of the telephone calls, increasing the relative success by between 20% and 36%, equivalent to an absolute increase of 2 to 3 percentage points. In an analysis that took into account different characteristics of the trials (metaregression) there was evidence that offering a larger number of calls, and having participants who were interested in trying to quit, increased the effect. Trials which tested the additional benefit of telephone counselling for people who were using a smoking cessation medication had a slightly smaller relative benefit, but since people in these studies were benefitting from the medication the absolute benefit from adding telephone calls was about the same. Two trials that compared different numbers of calls detected a benefit of more calls compared to a single contact.

Six other trials tested other uses of telephone counselling including systems for referral of smokers to support. We did not pool these and none of them showed clear evidence of an effect.

Streszczenie prostym językiem

Czy poradnictwo telefoniczne będące częścią programu antynikotynowego jest skuteczne i pomaga w zaprzestaniu palenia?

Wprowadzenie:Osobom próbującym rzucić palenie można pomóc przy użyciu leków lub dzięki bezpośredniemu wsparciu behawioralnemu, takiemu jako poradnictwo lub sesje terapii grupowej.
Cele:Celem przeglądu było sprawdzenie czy wsparcie behawioralne jest skuteczne również w formie poradnictwa telefonicznego.
Metody identyfikacji danych naukowych: Ostatnie wyszukiwanie danych przeprowadzono w maju 2013 roku. Zidentyfikowano 77 badań klinicznych z grupą kontrolną, w których wzięło udział łącznie 85 tys. uczestników.
Wyniki: W przeglądzie zidentyfikowano badania oceniające efekt jakiegokolwiek typu poradnictwa telefonicznego. Wzięto pod uwagę badania, w których uczestnicy korzystali z infolinii oferujących wsparcie dla osób próbujących rzucić palenie tytoniu. Do przeglądu włączono również badania, w których z uczestnikami telefonicznie kontaktowali się terapeuci lub inni świadczeniodawcy. W niektórych badaniach porównywano poradnictwo telefoniczne z minimalnymi formami wsparcia, takimi jak broszury z informacjami z zakresu samopomocy. W innych badaniach sprawdzano czy dodanie interwencji telefonicznych było bardziej pomocne niż wsparcie jedynie w postaci kontaktu bezpośredniego, lub wyłączne stosowanie nikotynowej terapii zastępczej (NTZ). Do niektórych z badań rekrutowano wyłącznie osoby, które próbowały zaprzestać palenia, z kolei w innych oferowano wsparcie nawet jeśli uczestnicy nie próbowali aktywnie rzucić palenia. Badania musiały być przeprowadzone z losowym przydziałem do grup (randomizacja), a obserwacja uczestników musiała trwać co najmniej 6 miesięcy.

Uznano, że niewielka liczba badań obarczona została ryzykiem błędu systematycznego, ale autorzy uważają, że nie jest prawdopodobne aby wyniki w całości były obarczone błędem systematycznym. W badaniach obejmujących uczestników korzystających z poradnictwa telefonicznego częściej nie udawało się skontaktować ze wszystkimi badanymi w celu sprawdzenia efektu i w nich z reguły opierano się na zgłoszeniu niepalenia przez uczestnika, a nie na potwierdzeniu za pomocą testów biochemicznych. W badaniach używano zróżnicowanej liczby oraz czasu trwania połączeń telefonicznych. Wyniki poszczególnych badań różniły się, co oznacza, że nie jest pewne czy wszystkie rodzaje poradnictwa wykazują ten sam efekt.

W dwunastu badaniach, w których udział wzięło ponad 30 tys. osób, oceniano efekt dodatkowych porad telefonicznych wykonanych przez terapeutę do osób, które zadzwoniły na infolinię antynikotynową. Po zsumowaniu wyników tych badań stwierdziliśmy, że są dane wskazujące, że osoby otrzymujące telefony zwrotne od terapeuty częściej zaprzestawały palenia niż osoby, którym wysyłano jedynie materiały samopomocy lub którym udzielano krótkich porad i wsparcia w trakcie początkowych rozmów telefonicznych. W porównaniu z grupą kontrolną porady telefoniczne powodowały zwiększenie częstości pomyślnego rzucenia palenia od 25% do 50%. Jednak ze względu na mały odsetek osób rzucających palenie w grupach kontrolnych, różnica (zwiększenie w kategoriach bezwzględnych) wyniosła jedynie od 2 do 4 punktów procentowych.

W 51 badaniach obejmujących ponad 30 tys. osób oceniano efekt poradnictwa telefonicznego u osób, które nie dzwoniły na infolinię antynikotynową, spośród których część mogła nie planować aktywnego zerwania z paleniem. Kiedy zsumowaliśmy wyniki okazało się, że jest niewielka korzyść będąca efektem porad telefonicznych, a zwiększenie częstości pomyślnego zerwania z paleniem względem grupy kontrolnej wyniosło od 20% do 36%, co jest równoważne bezwzględnemu zwiększeniu od 2 do 3 punktów procentowych. W analizie uwzględniającej różne cechy badań (metaregresja) stwierdzono, że oferowanie większej liczby porad telefonicznych oraz obecność uczestników chcących zerwać z nałogiem wiązały się ze zwiększeniem efektu terapeutycznego. W badaniach, w których sprawdzano dodatkowe korzyści poradnictwa telefonicznego u osób stosujących leki wspomagające rzucenie palenia, wykazano nieco mniejszą korzyść względem grupy kontrolnej. Ze względu na to, że u uczestników korzyść pochodziła też ze stosowania farmaceutyków, bezwzględna korzyść z dodatkowych rozmów telefonicznych była zbliżona do innych badań. W dwóch badaniach, w których porównano różne liczby rozmów telefonicznych, wykazano korzyść wynikającą z większej liczby rozmów w porównaniu z pojedynczą rozmową.

W innych sześciu badaniach analizowano inne formy poradnictwa telefonicznego, w tym systemy przekierowujące osoby palące do ośrodków wsparcia. Żadne z tych badań nie przyniosło jednoznacznych danych wskazujących na efekt tych interwencji. Nie sumowano wyników dla tych interwencji.

Uwagi do tłumaczenia

Tłumaczenie: Bartłomiej Matulewicz Redakcja: Sylwia Sroka, Małgorzata Bała

Ringkasan bahasa mudah

Adakah kaunseling melalui telefon berkesan sebagai sebahagian daripada program untuk membantu orang berhenti merokok?

Latar belakang: Mereka yang cuba untuk berhenti merokok boleh dibantu dengan ubat-ubatan atau kaedah sokongan tingkah laku bersemuka seperti kaunseling dan terapi berkumpulan.
Objektif: Kami ingin mengetahui sama ada kaedah sokongan turut berkesan apabila ia dilakukan melalui telefon.
Kaedah Carian : Carian bukti terkini diperoleh adalah pada Mei 2013. Kami mengenal pasti 77 kajian terkawal dengan jumlah peserta hampir 85,000 orang.
Keputusan: Kajian ini mengenalpasti kesan bagi sebarang jenis kaunseling yang dibuat melalui telefon. Kami mengambilkira kajian yang mana para peserta telah menghubungi talianhayat yang menawarkan sokongan bagi mereka yang cuba untuk berhenti merokok (talian berhenti merokok). Kami juga mengambilkira kajian yang mana peserta telah menerima panggilan telefon daripada kaunselor atau petugas kesihatan yang lain. Sebahagian daripadanya membandingkan sokongan melalui telefon dengan sokongan minima yang lain seperti risalah bantu diri, dan ada yang melihat sama ada panggilan telefon tambahan lebih membantu berbanding sokongan yang berbentuk bersemuka, atau dengan menyediakan ubat pemberhentian merokok seperti terapi penggantian nikotin (NRT). Beberapa kajian hanya memasukkan peserta yang cuba untuk berhenti merokok, manakala yang lain menawarkan sokongan walaupun kepada orang yang tidak bercadang untuk bersungguh-sungguh berhenti. Kajian harus dijalankan secara rawak, dan harus menilai semula keberkesanan dalam kalangan peserta sekurang-kurangnya untuk tempoh enam bulan.

Sejumlah kecil kajian telah dinilai sebagai mempunyai risiko berat sebelah namun kami tidak merasakan ia mempengaruhi keputusan keseluruhan. Kajian-kajian dalam kumpulan talian berhenti merokok lebih berkemungkinan untuk menghadapi masalah tidak dapat menghubungi semula peserta dan secara amnya bergantung kepada peserta untuk melaporkan sama ada telah berhenti merokok, berbanding memeriksa menggunakan ujian biokimia. Kajian-kajian telah menggunakan pelbagai bilangan dan tempoh panggilan, dan terdapat beberapa variasi antara keputusan kajian-kajian yang berbeza yang menyebabkan kami tidak dapat mengesahkan yang semua jenis kaunseling mempunyai kesan yang sama.

Dua belas kajian yang melibatkan lebih dari 30,000 peserta mengkaji kesan panggilan telefon tambahan oleh kaunselor ke atas mereka yang telah menelefon talian berhenti merokok. Apabila kami mengumpulkan keputusannya terbuktilah bahawa mereka yang menerima panggilan semula kaunseling lebih cenderung untuk berhenti merokok berbanding mereka yang diberi risalah bantu diri atau yang diberikan nasihat ringkas dan sokongan semasa panggilan pertama. Panggilan telefon telah meningkatkan kejayaan secara relatif antara 25% hingga 50%, tetapi kerana peratusan yang berhenti merokok dalam kumpulan kawalan adalah agak rendah, peningkatan sebenar hanya bersamaan dengan 2 hingga 4 mata peratus.

Lima puluh satu kajian yang melibatkan lebih dari 30,000 peserta menguji kesan kaunseling melalui telefon untuk orang yang tidak menelefon talian berhenti merokok, dengan sesetengah daripada mereka mungkin tidak bercadang secara bersungguh-sungguh untuk berhenti. Apabila keputusan ini dikumpulkan, ia menunjukkan manfaat kecil daripada panggilan telefon, meningkatkan kejayaan relatif antara 20% hingga 36%, bersamaan dengan peningkatan mutlak sebanyak 2 hingga 3 mata peratus. Dalam analisis yang mengambil kira ciri-ciri berbeza kajian (regresi meta), terdapat bukti yang mencadangkan panggilan telefon yang lebih banyak, dan mempunyai peserta yang berminat untuk berhenti merokok, akan meningkat keberkesanannya. Kajian yang melihat manfaat tambahan bagi kaunseling melalui telefon untuk mereka yang telah menggunakan ubat berhenti merokok pula mempunyai manfaat relatif yang sedikit lebih kecil, tetapi kerana peserta dalam kajian ini mendapat manfaat dari ubat-ubatan, faedah mutlak daripada menambah panggilan telefon adalah lebih kurang sama. Dua kajian yang membandingkan jumlah bilangan panggilan yang berbeza mendapati lebih manfaat diperoleh dengan panggilan berbilang kali daripada panggilan tunggal.

Enam kajian lain menilai kegunaan lain kaunseling melalui telefon iaitu termasuk sistem rujukan sokongan untuk perokok. Kami tidak pula mengumpulkannya dan tiada satu pun daripadanya yang menunjukkan bukti-bukti kesan yang jelas.

Catatan terjemahan

Diterjemahkan oleh Irfan Mohamad (Universiti Sains Malaysia). Disunting oleh Norhayati Mohd Noor (Universiti Sains Malaysia). Untuk sebarang pertanyaan berkaitan terjemahan ini sila hubungi irfankb@usm.my Untuk sebarang pertanyaan berkaitan suntingan ini, sila hubungi hayatikk@usm.my

Resumen en términos sencillos

¿El asesoramiento telefónico es efectivo como parte de un programa para ayudar a los pacientes a dejar de fumar?

Antecedentes: Los pacientes que tratan de abandonar el hábito de fumar pueden ser ayudados con medicación o a través del apoyo conductual presencial como el asesoramiento y la terapia grupal.
Objetivos: Se deseó determinar si el apoyo también fue efectivo cuando se proporcionó por teléfono.
Métodos de búsqueda: La búsqueda de pruebas más reciente fue en mayo de 2013. Se identificaron 77 ensayos controlados con casi 85 000 participantes.
Resultados: Esta revisión identificó los ensayos que evaluaron el efecto de cualquier tipo de asesoramiento telefónico. Se incluyeron los ensayos en los que los participantes habían llamado a líneas de ayuda que ofrecían apoyo a los pacientes que intentaban dejar de fumar (líneas telefónicas de abandono). También se incluyeron los ensayos en los que los pacientes habían recibido llamadas telefónicas de asesores u otros profesionales sanitarios. Algunos de los ensayos compararon el apoyo telefónico con apoyo mínimo como volantes de autoayuda, y otros analizaron si el agregado de llamadas telefónicas fue más útil que el apoyo presencial solamente, o solo la administración de medicación para el abandono del hábito de fumar como el tratamiento de reemplazo de nicotina (TRN). Algunos ensayos solamente incluyeron a pacientes que intentaban dejar de fumar, mientras que otros ofrecieron apoyo aunque los pacientes no planificaban activamente el abandono del hábito. Los ensayos debían ser aleatorios y realizar el seguimiento de los participantes durante al menos seis meses.

Un escaso número de ensayos se consideró con riesgo de sesgo, aunque no se consideró probable que los resultados generales estuvieran sesgados. Los ensayos con poblaciones de pacientes que llamaron a una línea telefónica de abandono tuvieron mayores probabilidades de no poder establecer contacto con todos los pacientes para el seguimiento y, en general, dependieron del autoinforme de los participantes de que no fumaban, en lugar de verificarlo mediante pruebas bioquímicas. Los ensayos utilizaron una gran variedad de números y duraciones de las llamadas y hubo alguna variación entre los resultados de diferentes ensayos, lo que significa que no es posible tener la certeza de que todos los tipos de asesoramiento tienen el mismo efecto.

Doce ensayos con más de 30 000 pacientes probaron el efecto de llamadas telefónicas adicionales de un consejero a los pacientes que habían llamado a una línea telefónica de abandono. Cuando se agruparon los resultados hubo pruebas de que los pacientes que recibieron una nueva llamada de asesoramiento tuvieron más probabilidades de haber dejado de fumar que los que solamente recibieron materiales de autoayuda o asesoramiento y apoyo breves durante la llamada inicial. Las llamadas aumentaron el éxito relativo entre el 25% y el 50%, aunque debido a que la proporción que abandonó el hábito en los grupos control fue muy baja, lo anterior fue equivalente a un aumento absoluto de solo 2 a 4 puntos porcentuales.

Cincuenta y un ensayos con más de 30 000 pacientes probaron el efecto del asesoramiento telefónico en pacientes que no habían llamado a una línea telefónica de abandono, de los cuales algunos quizás no hayan planificado activamente el abandono del hábito. En general, al agrupar estos datos se observó un efecto beneficioso pequeño de las llamadas telefónicas, lo que aumentó el éxito relativo entre el 20% y el 36%, equivalente a un aumento absoluto de 2 a 3 puntos porcentuales. En un análisis que consideró diferentes características de los ensayos (metarregresión) hubo pruebas de que ofrecer un mayor número de llamadas y tener participantes interesados en intentar abandonar el hábito aumentó el efecto. Los ensayos que probaron el efecto beneficioso adicional del asesoramiento telefónico en pacientes que recibían medicación para el abandono del hábito de fumar tuvieron un efecto beneficioso relativo ligeramente más pequeño, pero debido a que los pacientes de estos estudios obtenían efectos beneficiosos con la medicación, el efecto beneficioso absoluto del agregado de las llamadas telefónicas fue aproximadamente el mismo. Dos ensayos que compararon números diferentes de llamadas detectaron un efecto beneficioso al realizar más llamadas en comparación con un único contacto.

Otros seis ensayos probaron otros usos del asesoramiento telefónico, incluidos sistemas para la derivación de los fumadores para recibir apoyo. Estos ensayos no se agruparon y ninguno mostró pruebas claras de un efecto.

Notas de traducción

La traducción y edición de las revisiones Cochrane han sido realizadas bajo la responsabilidad del Centro Cochrane Iberoamericano, gracias a la suscripción efectuada por el Ministerio de Sanidad, Servicios Sociales e Igualdad del Gobierno español. Si detecta algún problema con la traducción, por favor, contacte con Infoglobal Suport, cochrane@infoglobal-suport.com.

Summary of findings(Explanation)

Summary of findings for the main comparison. Interventions for callers to quitlines - effect of additional proactive calls for smoking cessation
  1. 1 Low control rate reflects lower end of range evident in trials; 4/12 had control rates < 5%. High control rate likely to be applicable for people also using pharmacotherapy
    2 Estimated effect not sensitive to inclusion of studies judged at risk of bias
    3 Heterogeneity evident; two UK studies had point estimates suggesting no effect of intervention.

Interventions for callers to quitlines - effect of additional proactive calls for smoking cessation
Patient or population: callers to quitlines
Intervention: additional proactive calls
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Additional proactive calls
Smoking cessation
self reported abstinence (majority)
Follow-up: 6+ months
Study population RR 1.38
(1.28 to 1.49)
30182
(12 studies)
⊕⊕⊕⊝
moderate 2,3
 
76 per 1000 1 105 per 1000
(97 to 113)
Low
50 per 1000 1 69 per 1000
(64 to 75)
High
150 per 1000 1 207 per 1000
(192 to 224)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 2 Proactive telephone counselling for smokers not calling quitlines

Summary of findings 2. Proactive telephone counselling for smokers not calling quitlines
  1. 1 Based on crude average of events/total, with participants lost to follow-up assumed to be smoking. Interquartile range in trials 6-20%. Higher baseline cessation rates typical amongst motivated populations receiving pharmacotherapy and some support Relative addtional benefit of telephone intervention may be smaller in this setting.
    2 Effect estimate not sensitive to exclusion of studies without biochemical validation of abstinence.
    3 In subgroup analyses, evidence of effect was clear when the control group received usual care, or brief advice or face to face counselling. Effect smaller and less certain when all participants received pharmacotherapy.

Proactive telephone counselling for smokers not calling quitlines
Patient or population: smokers not calling quitlines
Intervention: proactive telephone counselling
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Proactive telephone counselling
Cessation at longest follow-up - All trials, subgroups by amount of control group support
Self reported abstinence (majority)
Follow-up: 6+ months
97 per 1000 1 123 per 1000
(116 to 132)
RR 1.27
(1.2 to 1.36)
30246
(51 studies)
⊕⊕⊕⊝
moderate 2,3
 
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

Behavioural and pharmacological interventions help people to quit smoking. Behavioural approaches range from brief advice from a physician to intensive specialist counselling (Lancaster 2005a; Stead 2005; Stead 2008). Support can be given in individual counselling sessions (Lancaster 2005a) or in group therapy (Stead 2005) where clients can share problems and derive support from one another. Standard self-help materials have at best a small effect helping quitting while those tailored to the characteristics of individuals are more likely to be effective (Lancaster 2005b). Telephone counselling may supplement face-to-face support, or substitute for face-to-face contact as an adjunct to self-help interventions or pharmacotherapy. Counselling may be helpful in planning a quit attempt, and helping prevent relapse during the initial period of abstinence (Brandon 2000). Although intensive face-to-face intervention increases quit rates, there are difficulties in delivering it to large numbers. Telephone counselling may be a way of providing individual counselling more cheaply. Telephone contact can be timed to maximise the level of support around a planned quit date, and can be scheduled in response to the needs of the recipient.

Telephone counselling can be proactive or reactive (Lichtenstein 1996). In a proactive approach the counsellor initiates one or more calls to provide support in making a quit attempt or avoiding relapse. This can be offered as part of an intervention including face-to-face counselling, or provided as an adjunct to a mailed self-help programme, or to pharmacotherapy. Reactive counselling in contrast is available on demand to people calling specific services; quitlines, helplines or hotlines. These services take calls from people who smoke, or their friends and family (Zhu 2006). These telephone services may offer information, recorded messages, personal counselling or a mixture of components (Ossip-Klein 2003; Anderson 2007). They may provide a regional or national service. They are often advertised in conjunction with population-wide campaigns such as No-Smoking Days. Helplines may also be provided on a smaller scale for a specific project or population. When contact is initiated by the client, any counselling during a call is reactive. In some services, people may be enrolled in a formal programme, with further proactive calls from counsellors (Zhu 1996; Zhu 2000a; Anderson 2007; Cummins 2007a). Hotlines have the potential to provide access to information for large numbers of people. Some services have reported reaching substantial proportions of the target population (Ossip-Klein 1991; Platt 1997). They have the potential to reach under-served populations such as ethnic minorities (Zhu 2000a) or younger people (Gilbert 2005; Chan 2008). A further development of hotlines uses computers and expert systems to provide a menu of automated responses (Burke 1993; Schneider 1995; Ramelson 1999).

Telephone-based services may be specific to smoking, as for example the California Smokers' Helpline (Zhu 2000a), the Quitlines in Australia (Borland 2001) or in the UK (Owen 2000), or they may be embedded in broader health information services such as the Cancer Information Service in the USA (La Porta 2007). They may also be provided as part of an integrated smoking cessation support service (e.g. Glasgow 1991). Access to hotlines or the opportunity to register to receive calls from a counsellor may also be offered as a part of a cessation programme including pharmacotherapy.

Controlled evaluation of reactive helplines has been limited by a reluctance among providers to refuse support to those requesting help. Evaluations usually compare variants in service rather than including a no-intervention control (e.g. Thompson 1993; Orleans 1998). Proactive services have been more widely evaluated because they can more easily be compared with a minimal intervention. For example, Zhu 2002 used an innovative approach for evaluating the benefit of the counselling component for callers to a quitline. Because the number of requests for counselling sometimes exceeded the quitline's capacity, all callers at these times were sent a self-help pack and invited to call back. Counselling capacity could then be equitably allocated by randomizing some callers to a group who were contacted proactively, whilst the control group were counselled only if and when they called back.

Objectives

The review evaluated the effect of telephone support to help smokers quit, including proactive or reactive counselling, or the provision of other information to smokers calling a helpline.

We tried to address the following questions:

  • Do telephone calls from a counsellor increase quit rates compared to other cessation interventions alone?

  • Do telephone calls from a counsellor increase quit rates compared to pharmacotherapy alone?

  • Does an increase in the number of telephone contacts increase quit rates?

  • Do differences in counselling protocol related to the type or timing of support lead to differences in quit rates? (There were limited data to address this question)

  • Does the availability of a reactive helpline increase quit rates?

Methods

Criteria for considering studies for this review

Types of studies

randomized or quasi-randomized controlled trials, with the unit of allocation individual participants, group, intervention site or geographical area.

Types of participants

Smokers or recent quitters. The definition of recent quitters was that used by the trial recruitment protocols, or by the participants themselves. We excluded trials that exclusively recruited quitters or were focused on telephone counselling as an intervention for relapse, as they fall within the scope of a separate Cochrane review on preventing relapse (Hajek 2009). We included trials recruiting exclusively teens or pregnant women but we considered them as a potential source of heterogeneity in meta-analyses. There are separate Cochrane reviews for these population groups (Lumley 2004; Grimshaw 2006).

Types of interventions

Provision of proactive or reactive telephone counselling to assist smoking cessation, to any population. We excluded studies if the contribution of the telephone component could not be evaluated independently of face-to-face counselling. We included studies which combined telephone counselling with self-help materials as the effect of self-help materials alone is limited (Lancaster 2005b).

Types of outcome measures

Smoking cessation at least six months after the start of intervention. We excluded trials with shorter follow-up.

Search methods for identification of studies

We identified studies from the Tobacco Addiction Group Specialised Register using the MeSH term 'hotlines' or free-text terms telephone* OR phone* OR quitline* OR helpline. See Appendix 1 for the full search strategy. At the time of the search in May 2013 the Register included the results of searches of the Cochrane Central Register of Controlled trials (CENTRAL), 2013, Issue 6; MEDLINE (via OVID) to update 20130329; EMBASE (via OVID) to week 201313; PsycINFO (via OVID) to update 20130401. See the Tobacco Addiction Group module in the Cochrane Library for full search strategies and list of other resources searched.

Data collection and analysis

We identified controlled studies where an intervention arm included telephone contact. One author (LS) extracted data from included studies and a second author (TL) checked them. We recorded the following information in the Characteristics of included studies table and in the Risk of bias in included studies table:

  • The country and setting of the trial

  • The method of recruitment to the study

  • The method of randomization and allocation concealment

  • Details of participants, including whether they were selected according to motivation to quit, and their age, gender and average baseline cigarette consumption

  • Description of intervention and control, including the schedule of telephone contacts

  • Definition of smoking abstinence used for the primary outcome, including timing of longest follow-up and whether quit status was based on recent behaviour (point prevalence abstinence, e.g. in past seven days) or on abstinence for an extended period since a quit date or a previous follow-up (continuous or sustained abstinence)

  • Description of method of any biochemical validation or other method used to confirm self-reported quitting

  • Description of numbers lost to follow-up by treatment condition

In the Characteristics of excluded studies table, we describe studies not meeting the inclusion criteria because of short follow-up, or use of an intervention that combined telephone and face-to-face counselling, or because they were uncontrolled evaluations of helplines.

Assessment of risk of bias

Items in the 'Risk of bias' table were judged to be at low, unclear, or high risk of bias.
The quality of the procedure for sequence generation was judged to be at low risk of bias if an acceptable method for generating a randomization sequence was described, at unclear risk if the study was described as 'random' but no further information given, and at high risk if based on, for example, record number.
The quality of the allocation concealment was judged to be at low risk if the group to which a participant was to be allocated remained unknown to investigators and participant until enrolment was complete.

Choice of outcome and treatment of missing data

The primary outcome was the number of quitters at the longest follow-up, using the strictest measure of abstinence reported. We preferred sustained and biochemically validated abstinence to point prevalence and/or self-reported quitting. If a less strict definition of quitting seemed more appropriate for showing an effect of the intervention on recovery from lapses or relapses, we planned a sensitivity analysis.

Where possible and appropriate we used as denominators the number randomized to each condition, with losses to follow-up assumed to be continuing smokers. We noted any exceptions in the 'Risk of bias' table for a study. Population-based studies typically have relatively high loss to follow-up because of change of address or disconnected telephones. Non-reponse might be independent of both treatment condition and smoking status, although possibly associated with other variables such as age or socio-economic status. Drop-out might be related to smoking status but not to treatment condition. Imputing as smoking all those missing, irrespective of, for example, whether they could not be contacted, or declined to respond, may not be appropriate. For individual studies it is possible to use analysis methods such as generalised estimating equations (GEE) for imputing missing data (Hall 2001). We noted whether studies that explored alternative assumptions about missing data reported any impact on the conclusions. When proportions lost are similar across conditions, and trial arms are balanced, the choice of denominator does not alter the relative effect, although the percentage quit and the absolute difference between conditions will be conservative.

Data synthesis

We summarised individual study results as a risk ratio (RR), calculated as: (number of quitters in intervention group/ number randomized to intervention group) / (number of quitters in control group/ number randomized to control group). Where appropriate we performed meta-analysis using a Mantel-Haenszel fixed-effect model to estimate a pooled risk ratio with 95% confidence intervals (Greenland 1985). When trials had more than one arm with a less intensive intervention we used only the most similar intervention without a telephone component as the control group in the primary analysis. We considered pooling of study results if both the intervention and control arms were sufficiently similar across trials. We assessed statistical heterogeneity between trials using the I² statistic which describes the percentage of total variation between studies that is due to heterogeneity rather than chance (Higgins 2003). We used threshold values of 50% and 70% as suggesting moderate and substantial heterogeneity respectively.

We also ran a meta-regression in STATA to test the association of intensity - defined as maximum number of calls -, motivation (binary: Yes/No), and type of baseline support (minimal/brief/adjunct to pharmacotherapy) with effect size. The effect size was summarised using the (natural) logarithm of the risk ratio per trial with weights given by the standard error of the logarithm of the risk ratio. All three independent variables were used with intensity defined as the maximum number of calls allowed in the intervention arm of the trial and included as a continuous variable while the other two were categorical (two and three categories respectively). We fitted these trial characteristics in a univariate meta-regression to test for association and also all of them in a single multivariate meta-regression model to estimate independent associations with the intervention.

Subgroup analysis and investigation of heterogeneity

We did not combine proactive and reactive approaches to counselling, so studies that provided access to a telephone helpline but did not call participants form a separate category. In earlier versions of this review we noted heterogeneity between studies of proactive telephone counselling, which was not explained by using subgroups based on the amount of support given for the control group. Lichtenstein 2002a has suggested that studies recruiting smokers who call quitlines should be considered separately. These studies share the characteristics that participants were actively seeking support at the time of their call, and that telephone counselling was the primary intervention. We therefore distinguish between trials in quitline callers and in other populations.

We expected differences between the relative effect of telephone support depending on whether it was being tested as the main intervention to aid cessation, or as an extra part of a multicomponent cessation programme. Therefore a priori we treated as separate subgroups those studies in which telephone counselling was the most intensive component of a minimal contact intervention and studies in which telephone counselling was assessed as an adjunct to face-to-face counselling. Where results of studies differed within the broad groupings described above we considered the following possible explanations: the difference between the intensity of the counselling based on the number of calls, the counselling strategy used, and the characteristics of the participants, in particular their motivation to quit or stage of change at baseline.

Results

Description of studies

Seventy-seven controlled studies met the criteria for inclusion in the review, with a total of almost 85,000 participants, and a median trial size of 820. Only six studies had fewer than 100 participants (Brown 1992; Osinubi 2003; Duffy 2006; Ebbert 2007; Cossette 2011; McClure 2011), whilst six studies, all involving callers to quitlines, had more than 3,000 (Zhu 1996; Zhu 2002; Rabius 2004; Hollis 2007; Rabius 2007; Joyce 2008)

Most trials were conducted in North America (60). Eight were in Australia (Brown 1992; Borland 2001; Borland 2003; MacLeod 2003; Borland 2008; Young 2008; Girgis 2011; Tzelepis 2011), two in Spain (Miguez 2002; Miguez 2008), three in the UK (Aveyard 2003; Gilbert 2006; Ferguson 2012), one in Hong Kong (Abdullah 2005), one in Norway (Hanssen 2009), and two in Germany (Metz 2007; Flöter 2009). Participants were predominantly older adults with an average age typically in the 40s. One study recruited teenagers (Lipkus 2004), one young people aged 18 to 24 (Sims 2013), and three recruited older people aged over 50 (Rimer 1994), over 60 (Ossip-Klein 1997), or over 65 (Joyce 2008). Three recruited pregnant women (McBride 1999b; Stotts 2002; McBride 2004) and a further five recruited only women (McBride 1999a; Solomon 2000; McClure 2005; Solomon 2005; Flöter 2009). Four predominantly recruited men (Osinubi 2003; Abdullah 2005; An 2006; Sorensen 2007a). One was culturally tailored for Chinese, Korean and Vietnamese smokers (Zhu 2012) and one recruited Arabic smokers in Australia (Girgis 2011).

Most of the studies were trials of proactive calls from a counsellor, or from an automated interactive voice response system (IVR) (Velicer 2006, IVR only, Reid 2007 IVR with counsellor follow-up in case of need). Only five assessed interventions that did not involve a counsellor contacting a participant (Ossip-Klein 1991; McFall 1993; Thompson 1993; Orleans 1998; Sood 2009). Twelve studies recruited participants who had phoned a quitline, but the intervention evaluated the addition of further proactive contacts (Zhu 1996; Borland 2001; Zhu 2002; Borland 2003; Rabius 2004; Smith 2004; Gilbert 2006; Hollis 2007; Rabius 2007; Ferguson 2012; Zhu 2012; Sims 2013). One study recruited proactively to quitline counselling (Tzelepis 2011). Three studies recruited participants in healthcare settings and referred them to services provided by quitlines, involving proactive counselling for those following through referral (Duffy 2006; Ebbert 2007; Borland 2008). Ellerbeck 2009 repeatedly mailed primary care patients an offer of free pharmacotherapy and tested two levels of disease management including proactive calls, or no contact. One study offered either a proactive or reactive service as covered benefit (Joyce 2008). Additional details are in the Characteristics of included studies table.

The number, duration and content of the telephone calls was variable. The potential number of calls ranged from one to twelve (Solomon 2005) and in some studies was flexible. The length of calls was also varied; a duration of 10 to 20 minutes was common, although the initial call might be longer. The call schedule could be spaced over weeks or months. Amongst studies that did not recruit participants on the basis of their willingness to make a quit attempt, the content was typically individualised to enhance motivation in those undecided about quitting or to support a quit attempt where appropriate. Counselling was most commonly provided by professional counsellors or trained healthcare professionals. One trial used trained postgraduate students (Aveyard 2003). Three trials used trained peer counsellors, in one case survivors of childhood cancer (Emmons 2005), and in the other two, women ex-smokers (Solomon 2000; Solomon 2005).

We grouped trials into three broad categories: trials of interventions for smokers who contacted a helpline, trials assessing the effect of providing access to a helpline, and trials that offered support proactively in other settings. Finally there are eight trials (Miller 1997; Hennrikus 2002; Roski 2003; Swan 2003; Katz 2004; Halpin 2006; Girgis 2011; Smith 2013) that do not fit into any of these categories, so are considered individually.

1 Trials of interventions for people calling helplines

Fifteen trials recruited people who had phoned helplines/quitlines. We distinguished between trials where the intervention involved further proactive contact by the counsellor, and those that tested different interventions at the initial call. Twelve studies tested proactive calls back to people who had initiated the contact with the quitline. The number of calls varied, with three studies comparing more than one schedule. There were small differences in the support for the control group. In one trial, all participants had brief counselling during their initial call (Borland 2001), in three, some control group participants received some counselling (Zhu 2002; Borland 2003; Gilbert 2006). Ferguson 2012 was a factorial trial comparing proactive counselling to standard support which included further contact by email, letter or text, and the offer of proactive calls. Participants were also randomized to an offer of nicotine replacement therapy (NRT). In the others the control group received self-help materials (Zhu 1996; Rabius 2004; Smith 2004; Hollis 2007; Rabius 2007; Zhu 2012; Sims 2013).

Three trials compared different interventions at the time a participant called the helpline; Sood 2009 compared counselling at the initial call to mailed self-help materials only. Thompson 1993 and Orleans 1998 compared different counselling interventions provided during the initial call; Thompson 1993 compared a counselling approach based on the stage of change model to the provision of more general information; Orleans 1998 compared counselling and materials targeted at African-American smokers to standard advice and materials.

2 Trials providing access to a helpline

Two studies assessed the impact of offering reactive counselling by providing access to a helpline/quitline/hotline. One randomized counties to hotline access or not, and followed up smokers who were planning to stop and had registered for a smokers' self-help project (Ossip-Klein 1991). One combined newsletter mailings and hotline access compared to no follow-up support for smokers who had registered for a self-help televised cessation programme (McFall 1993). Joyce 2008 compared four different levels of benefit for Medicare beneficiaries aged 65 or older. The most intensive intervention offered a choice of accessing either a reactive hotline or multisession proactive counselling, along with self-help materials and coverage of nicotine patch with a small co-payment. Other arms offered coverage of brief provider counselling with or without coverage of pharmacotherapy, and usual care.

3 Trials of proactive counselling, not initiated by calls to quitlines

There were 51 trials in this category that were judged to have sufficient common features to consider pooling their results. There were some differences in the intensity of the telephone component, the amount of cessation support that was common to both the control and intervention groups, and the populations recruited.

3.1 Studies with minimal intervention controls

There were 30 studies in this subgroup. In 22 studies (Orleans 1991; Lando 1992; Prochaska 1993; Rimer 1994; Curry 1995; Ossip-Klein 1997; McBride 1999a; McBride 1999b; Lichtenstein 2000; Prochaska 2001; Miguez 2002; Aveyard 2003; Lipkus 2004; Abdullah 2005; Emmons 2005; McClure 2005; Sorensen 2007a; Lichtenstein 2008; Miguez 2008; Graham 2011; McClure 2011; Tzelepis 2011) proactive telephone counselling calls were the only form of personal contact in the cessation intervention. The control groups generally had mailed self-help materials but Graham 2011 provided access to a cessation website. In six studies in healthcare settings the telephone intervention was an adjunct to usual care that involved at most a brief smoking intervention (Stotts 2002; Duffy 2006; Rigotti 2006; Hanssen 2009; Holmes-Rovner 2008; Young 2008). In two further studies that recruited participants through healthcare systems, advice and support were part of usual care but not all participants had clinic visits; the telephone counselling was delivered independently of any clinic visit rather than being an adjunct to a specific episode of care (Lipkus 1999; An 2006). Pharmacotherapy was not systematically offered to all intervention participants in any of the above trials but in two there was greater use of pharmacotherapy by intervention participants (McClure 2005; An 2006). In McClure 2005 all participants could enrol in the Free & Clear phone-based support programme which could also provide access to pharmacotherapy; this was used more by intervention than control groups. An 2006 encouraged the use of NRT or bupropion for intervention group participants making a quit attempt and this increased their use, although pharmacotherapy was available to all participants as part of their usual care.

3.2 Studies with brief intervention/counselling controls

Eleven trials incorporated what we judged to be more substantial face-to-face advice for all participants, but without systematic use of pharmacotherapy (Ockene 1991; Brown 1992; Osinubi 2003; McBride 2004; Chouinard 2005; Metz 2007; Ebbert 2007; Reid 2007; Borland 2008; Flöter 2009; Cossette 2011). The support common to all participants ranged from a single information session and the provision of a self-help manual (Brown 1992); usual prenatal care including provider advice and self-help materials (McBride 2004); assessment, advice or brief counselling from a physician (relevant arms of Ockene 1991; Borland 2008) or hygienist/dentist (Ebbert 2007); advice from an occupational physician to consult a personal physician (Osinubi 2003); inpatient nurse counselling (Chouinard 2005; Reid 2007; Cossette 2011); or multisession group counselling (Metz 2007; Flöter 2009).

3.3 Studies of counselling added to pharmacotherapy

Eleven trials provided telephone counselling as an adjunct to pharmacotherapy. In eight trials there was a systematic offer or provision of NRT (Ockene 1991; Lando 1997; Reid 1999; Solomon 2000; MacLeod 2003; Fiore 2004; Solomon 2005; Velicer 2006). Swan 2010 provided varenicline. Boyle 2007 recruited health maintenance organisation (HMO) members who were filling a prescription for any cessation medication and Ellerbeck 2009 offered free medication four times over two years. The support common to all participants in other trials ranged from: access to a web site (Swan 2010); physician advice and offer of free nicotine gum (relevant arms of Ockene 1991); provision of free nicotine patch after a primary care visit (Fiore 2004); three sessions of physician advice and free nicotine patch (Reid 1999); a single 90-minute session, a free prescription for nicotine patch and access to a helpline (Lando 1997); or provision of free nicotine patch (two-week supply only) but no face-to-face contact (MacLeod 2003; Solomon 2000; Solomon 2005; Velicer 2006). Velicer 2006 provided nicotine patch to participants meeting criteria for readiness to make a quit attempt; 86% received some during the study.

3.4 Telephone counselling intensity

The number of calls and the period over which they were delivered in this group of 52 studies was very varied. A summary is given in the following table.

Maximum no. of callsWithin 4 weeksWithin 3 monthsWithin 6 monthsOver longer period/ other
Single call Fiore 2004; Miguez 2008   
2 calls Lando 1992; Lipkus 1999; Lichtenstein 2000; Lichtenstein 2008; Ellerbeck 2009 (moderate intensity arm, up to 2 after each offer of pharmacotherapy) Ossip-Klein 1997; Stotts 2002 (in late pregnancy) Rimer 1994 
3 calls Ebbert 2007; Flöter 2009 Ockene 1991; Curry 1995; McBride 1999a; Reid 1999; Lipkus 2004; Abdullah 2005 Prochaska 2001; Aveyard 2003 McBride 1999b (part, during pregnancy)
4 calls Young 2008 Lando 1997; Reid 2007 (average 2 automated and 2 counsellor) Prochaska 1993; McClure 2005; Tzelepis 2011 (if not setting TQD) Orleans 1991
5 calls  MacLeod 2003; Osinubi 2003; Metz 2007; Graham 2011; Swan 2010  Rigotti 2006 (4 in pregnancy and 1 postpartum)
6 calls Brown 1992; Tzelepis 2011 (if setting TQD) Miguez 2002; Chouinard 2005; Sorensen 2007a; Borland 2008; Holmes-Rovner 2008; Ellerbeck 2009 (high intensity arm, up to 6 after each offer of pharmacotherapy); Cossette 2011; Emmons 2005 McBride 1999b (part) & McBride 2004 (3 during pregnancy & 3 postpartum)
7 or more  Solomon 2000; An 2006 Boyle 2007 (up to 9, average 5); Duffy 2006 (9-11); (Hanssen 2009 (9); (Velicer 2006 (up to 10 automated calls); (Solomon 2005 (up to 12); McClure 2011 (up to 12, also covering depression & physical activity). 

The average number of calls, where reported, is typically considerably smaller than the maximum available. For studies where the intervention involved a process of referral to proactive support from another source (e.g. An 2006; Ebbert 2007; Borland 2008; Young 2008; Ellerbeck 2009), the proportion of participants reached and accepting counselling was small, but those accepting intervention generally had multisession support

3.5 Recruitment and motivation of participants

We attempted to categorise this set of 51 trials according to whether or not they selected participants with an interest in stopping smoking, or whether they were non-selective or designed to reach a wider population of smokers.  Of the 16 trials in the ‘Selected’ subgroup, 11 recruited from the general population using advertisements for smokers planning to or interested in quitting (Orleans 1991; Brown 1992; Rimer 1994; Ossip-Klein 1997; Solomon 2000; Miguez 2002; MacLeod 2003; Solomon 2005; Miguez 2008; Swan 2010; Graham 2011). Two recruited during healthcare visits (Fiore 2004; Reid 1999); Lando 1997 and Boyle 2007 recruited HMO members, and An 2006 mailed invitations to patients of Veterans Administration Medical Centers.

There were 35 trials in which motivation or interest in quitting was not an explicit entry criterion. Many recruited people in healthcare settings and the level of motivation to quit as assessed by stage of change at baseline, or other measures, was often high. Four recruited pregnant women (McBride 1999b; Stotts 2002; McBride 2004; Rigotti 2006); 14 recruited people during healthcare visits including in family practices, dental practices and hospitals (Ockene 1991; Osinubi 2003; Chouinard 2005; Duffy 2006; Ebbert 2007; Hanssen 2009; Metz 2007; Reid 2007; Borland 2008; Holmes-Rovner 2008; Young 2008; Flöter 2009; Cossette 2011; Girgis 2011); seven others recruited via healthcare system records (Lipkus 1999; Prochaska 2001; Aveyard 2003; McClure 2005; Velicer 2006; Ellerbeck 2009; McClure 2011). Of the other miscellaneous methods Lichtenstein 2000 and Lichtenstein 2008 recruited smokers in households that were offered free radon testing kits, Lipkus 2004 recruited teens approached in shopping malls, Abdullah 2005 recruited smoking parents of children in a birth cohort study, Emmons 2005 recruited smokers from a cohort study of childhood cancer survivors, and Sorensen 2007a recruited union members. Prochaska 1993 advertised for community volunteers, irrespective of quitting interest. In three trials contact was initiated with smokers who had not been specifically recruited to a trial (Lando 1992; Curry 1995; McBride 1999a).

4. Other studies

We identified eight other studies where we judged the nature of the main intervention or the conditions compared to be so distinctively different to any other included studies that they are described separately rather than being pooled.
Two studies (Roski 2003; Katz 2004) used telephone counselling as a core component of a system-level intervention. Roski 2003 investigated providing access to a telephone counselling referral service as a means to increase healthcare providers' adherence to clinical practice guidelines. Participant smoking outcomes were assessed but telephone counselling was not offered to all eligible smokers in intervention clinics. Katz 2004 also tested an intervention based on clinical practice guidelines. The intervention was implemented in primary care clinics and included training intake clinicians in giving brief advice, recording smoking status as a vital sign, and offering telephone counselling for smokers willing to set a quit date. NRT was also offered to heavier smokers. Girgis 2011 tested the offer of referral to counselling for Arabic smokers identified at primary care visits.
Halpin 2006 compared different benefit designs for tobacco treatment. The control group was given coverage for pharmacotherapy only. One intervention group had coverage for telephone counselling and pharmacotherapy (bupropion or NRT, USD 15 co-payment) whilst the other had pharmacotherapy coverage only if enrolled for telephone counselling. Participants were not required to take up any treatment during the study period. Hennrikus 2002 was a cluster-randomized study in workplaces that compared the provision of telephone counselling, a group format programme, or a choice of programme format.
Two studies (Miller 1997; Swan 2003) did not have a no-telephone support control and compared interventions with different numbers of calls. Miller 1997 assessed the effect of increasing the amount of telephone follow-up after an inpatient counselling intervention. Swan 2003 compared two intensities of behavioural support, both of which involved telephone contact without face-to-face support, for smokers also randomized to one of two doses of bupropion.

Smith 2013 tested the addition of a medication adherence counselling component to standard four-session counselling in a factorial trial which also compared two durations of free NRT and a combination of patch and gum versus patch alone.

Risk of bias in included studies

A summary of the evaluation of risk of bias for each study is shown in Figure 1.

Figure 1.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Allocation

All included studies described treatment allocation as random, but the majority did not give sufficient details about the method for generating the sequence. Seventeen (22%) gave sufficient detail to be judged at low risk; (Swan 2003; Aveyard 2003; Rabius 2007; Rigotti 2006; Velicer 2006; Reid 2007; Borland 2008; Young 2008; Ellerbeck 2009; Ferguson 2012; Sood 2009; Swan 2010; Graham 2011; Sims 2013; Tzelepis 2011; Zhu 2012; Smith 2013). Five (6%) were judged to be at high risk of bias (Zhu 1996; Orleans 1998; Borland 2003; MacLeod 2003; Gilbert 2006).

Eleven trials used cluster randomization, six of which contributed to a meta-analysis. In two of these, households were the unit of randomization, and about 54% of households contained more than one smoker (Lichtenstein 2000; Lichtenstein 2008). The reported intraclass correlation was small. Borland 2008 randomized general practitioners. The reported odds ratio that adjusted for clustering and other factors was similar to that generated by the crude data. Lando 1997 randomized by orientation session attended. Chouinard 2005 randomized clusters of two to six participants. Ebbert 2007 randomized by dental practice. Excluding these studies did not alter any meta-analysis findings. The other five were not pooled with other studies in a meta-analysis. In one, participants were given access to a hotline according to county of residence so that the availability of a hotline could be advertised in the intervention counties (Ossip-Klein 1991), another randomized four workplaces to each of six conditions, (Hennrikus 2002). Joyce 2008 randomized areas within states to different Medicare benefits. The other two randomized clinics to different organisational support systems (Roski 2003; Katz 2004).

Methods for concealing the allocation were also poorly reported. Nineteen (25%) reported sufficient detail to be judged at low risk (Miller 1997; Swan 2003; Aveyard 2003; Borland 2003; Katz 2004; Smith 2004; Abdullah 2005; Chouinard 2005; Gilbert 2006; Rigotti 2006; Velicer 2006; Reid 2007; Borland 2008; Sood 2009; Ellerbeck 2009; Swan 2010; Tzelepis 2011; Ferguson 2012; Zhu 2012). Five (6%) were judged to be at high risk of bias due to lack of concealment (Zhu 1996; Orleans 1998; MacLeod 2003; Ebbert 2007; Girgis 2011). In total seven studies were potentially at risk of selection bias because of the way the sequence was generated and concealed. Because of the small number of studies with clear information, not all of which contributed to a meta-analysis, we did not conduct any sensitivity analyses based on this domain.

Incomplete outcome data

All studies reported the numbers randomized to each group, so that we could use these in the meta-analysis. Most studies reported findings based on treating all drop-outs as smokers although some did not note the number lost to follow-up who were assumed to be continuing smokers. Many also reported complete case analyses (excluding drop-outs), or used methods for imputing missing data. In most cases this had little impact on the relative effect, because numbers lost were similar across conditions. We did not identify any studies where using complete cases or using adjusted estimates of quit rates would have changed the relative effect enough to alter the conclusions of a meta-analysis.

Definitions of abstinence

Many trials reported both short-term point prevalence (seven-day or 24-hour) abstinence and sustained abstinence, at one or more follow-ups. We were able to use long-term sustained abstinence, or abstinence at both the longest and earlier follow-ups as the outcome for 43/77 (56%) trials. For the remainder the outcome was based on point prevalence abstinence at the longest follow-up. Length of longest follow-up ranged from six months from start of intervention in 24 trials, to 30 months (Velicer 2006) or 12 months postpartum (McBride 2004). One trial reported both self-reported continuous abstinence and validated seven-day abstinence (Abdullah 2005). We used the validated outcome; this gave a larger effect favouring the intervention group. We include one trial based on preliminary 12-month data for 75% of the original cohort (Rimer 1994).

Validation of self-reported abstinence

The studies in quitline callers typically did not attempt to use biochemical verification of self-reported quitting. Two tested a local convenience sample (Zhu 1996; Rabius 2004). Ferguson 2012 reported carbon monoxide (CO) validated rates although only 52% of self-reported quitters provided samples.
Studies in other settings were more likely to require biochemical verification of all self-reported abstinence. Ossip-Klein 1991, Lando 1992 and Aveyard 2003 measured cotinine levels. Lando 1997, Miguez 2002, Fiore 2004 and Rigotti 2006 measured CO levels. Chouinard 2005 used a mixture of CO and cotinine assessments. Miller 1997 and Ellerbeck 2009 tested for cotinine but allowed family member verification of some self reports. Some other studies attempted biochemical verification but did not report validated abstinence (Orleans 1991; Brown 1992; Thompson 1993; Curry 1995; McBride 1999a; McBride 1999b; Reid 1999; Solomon 2000; Hennrikus 2002; Katz 2004; Lipkus 2004; McBride 2004; McClure 2005). Stotts 2002 validated abstinence at an early follow-up.
One trial in teens reported particularly high (45% to 55%) misreport rates in both groups; some admitted smoking in the seven days before returning the sample (Lipkus 2004). Studies relying on self-reported abstinence are coded as being at high risk of detection bias in the 'Risk of bias' tool, but the likelihood of differential misreporting leading to a biased estimate or treatment effect is small.

Effects of interventions

See: Summary of findings for the main comparison Interventions for callers to quitlines - effect of additional proactive calls for smoking cessation; Summary of findings 2 Proactive telephone counselling for smokers not calling quitlines

1 Trials of interventions for people calling helplines

1.1 Effect of additional proactive support

Twelve studies (N = 30,182) that compared an intervention involving multisession proactive counselling with a control condition providing self-help materials or brief counselling at a single call showed evidence of a benefit from the additional support. With the addition of three new studies published since the last update (Ferguson 2012; Zhu 2012; Sims 2013) the heterogeneity increased markedly (from I² = 57% to I² = 71%). The pooled risk ratio (RR) was almost unchanged; 1.38 (95% confidence interval (CI) 1.28 to 1.49, Figure 2, Analysis 1.1). Because of the heterogeneity we also conducted a sensitivity analysis, pooling using a random-effects model; this gave a very similar estimate (RR 1.41, 95% CI 1.20 to 1.66). The three studies with the largest weights in the meta-analysis all detected significant effects, as did three other studies, suggesting that there is a benefit from these types of interventions in many settings but perhaps not all. We examined the characteristics of the three studies in which the point estimates suggested no effect of counselling (Gilbert 2006; Ferguson 2012; Sims 2013). The first two were conducted in the UK whereas all others were done in North America (8) or Australia (2). In the earliest UK trial (Gilbert 2006), the authors thought that the unstructured counselling might have explained the lack of effect, but in the second a more structured protocol was used. In both cases the control groups would have received some support at the original call as well as mailed or emailed materials The context of the UK healthcare system may contribute to the difference, since there is a well-developed Stop Smoking Service with access to support and medication. Ferguson 2012 also failed to detect an effect of offering free nicotine replacement therapy (NRT), in a factorial design. The other study with a point estimate suggesting no effect, although with wide confidence limits, Sims 2013 was conducted in young adults, for whom there is limited evidence for any effective interventions (Villanti 2010).

Figure 2.

Comparison 3. Interventions for callers to quitlines. Cessation at longest follow-up

In the main analysis we pooled more than one intensity of intervention into the treatment arms of four studies (Zhu 1996; Smith 2004; Hollis 2007; Rabius 2007). Using only the more intensive interventions in the two trials that reported outcomes for two different interventions (Zhu 1996; Hollis 2007) marginally increased the pooled effect size (data not shown). Smith 2004 did not detect a difference between groups receiving two or six follow-up calls after an initial 50-minute session, and results have not been reported separately. Rabius 2007 tested six different intervention formats, varying the number of calls, their duration and the use of brief booster calls at four and eight weeks after counselling. There was no clear dose response effect; five brief counselling calls plus boosters were no less effective than the standard American Cancer Society protocol of five longer calls and boosters

Using only the Hollis 2007 trial data for intervention and control arms that were not offered NRT also had minimal impact on the pooled effect since NRT increased quit rates in all behavioural conditions. Direct comparison between the more and less intensive interventions tested in two trials showed marginally significant differences in favour of the more intensive intervention in one (Zhu 1996, RR 1.32, 95% CI 1.01 to 1.74), but not in the other (Hollis 2007, RR 1.05 95% CI 0.89 to 1.23, data not shown).

1.2 Comparisons between different types of support at initial call

One study (Sood 2009) compared reactive counselling to mailed self-help materials alone. All participants in the intervention group had counselling at the time of their call and had the option to get repeated support. No effect of the intervention was detected (N = 490; RR 0.96; 95% CI 0.71 to 1.30).

Two studies compared different reactive support for helpline callers during a single session. They failed to detect a significantly increased benefit from either counselling and materials designed for African-Americans (Orleans 1998) or stage-based counselling designed for blue-collar workers (Thompson 1993) compared to standard support. Quit rates in these trials were from 15% to 20% for point prevalence rates at six months. In the first of these trials, extended follow-up for early enrollers found some evidence that quit rates were higher after 12 months in the experimental group.

(Relative effects for all three studies are displayed but not pooled in Analysis 2.1).

2 Trials providing access to a helpline

In one trial (Ossip-Klein 1991), provision of a hotline was associated with an increase in quit rates from 4.0% amongst smokers sent self-help materials only, to 6.6% amongst smokers in areas where an advertised hotline was provided in addition to materials. This difference was statistically significant using the unit of allocation (the county) as the unit of analysis.

In a second trial (McFall 1993), smokers who had enrolled to be sent materials for a self-help programme with a televised component were randomized to receive follow-up newsletters and access to a helpline for six months. Although the intervention combined a helpline and written materials, quit rates were non-significantly lower in the intervention than control condition after 24 months.

In a third trial (Joyce 2008), enrollees for a Medicare Stop Smoking Programme were randomized to different benefits. The intervention was access to a quitline that offered the choice of a reactive hotline with prerecorded messages and ad hoc counselling, or a proactive service, in addition to coverage for the nicotine patch. The control group had pharmacotherapy coverage only. The quitline significantly increased quitting at 12 months, from 15.8% to 19.3% (RR 1.22, 95% CI 1.07 to 1.39).

(Relative effects for all three studies are displayed but not pooled in Analysis 3.1).

3 Trials of proactive counselling, not initiated by calls to quitlines

3.1 Overall effect of counselling

There were 51 trials (N = 30,246) in this comparison. (Ockene 1991 contributed different data to two subgroups making a total of 52 in the analysis). The pooled effect suggested a modest benefit of proactive telephone counselling (RR 1.27; 95% CI 1.20 to 1.36) with moderate heterogeneity (I² = 42%) (Figure 3, Analysis 4.1). Our prespecified categories based on the intensity of support common to the control and intervention groups did not fully explain the heterogeneity, nor was heterogeneity reduced by excluding the trials amongst teenagers or pregnant women.

Figure 3.

Comparison 4. Interventions for smokers not calling quitlines - subgroups by baseline support. Cessation at longest follow-up

In 30 trials (N = 19,134) telephone counselling was the main component of a cessation intervention and the control group had only self-help materials or very brief support. In this subgroup the effect estimate was similar to that for all 51 trials (RR 1.34; 95% CI 1.22 to 1.46) and with slightly more evidence of heterogeneity (I² = 55%).

In the group of 11 trials (N = 3520; part of Ockene 1991; Brown 1992; Osinubi 2003; McBride 2004; Chouinard 2005; Ebbert 2007; Metz 2007; Reid 2007; Borland 2008; Flöter 2009; Cossette 2011), where the telephone support followed on from a face-to-face intervention, the point estimate and confidence intervals were again broadly similar and there was low heterogeneity (I² = 5%, RR 1.41; 95% CI 1.20 to 1.66)

In the 11 trials (N = 7592) where counselling was used as an adjunct to the systematic use or offer of NRT (part of Ockene 1991; Lando 1997; Reid 1999; Solomon 2000; MacLeod 2003; Fiore 2004; Solomon 2005; Velicer 2006; Boyle 2007; Ellerbeck 2009) or varenicline (Swan 2010), there was a relatively small and just statistically significant effect without evidence of heterogeneity (I² = 0%, RR 1.14; 95% CI 1.03 to 1.27). This analysis does not include Swan 2003 which compared two levels of telephone support for people prescribed bupropion, because there was no non-telephone control. In this trial the intervention did aid cessation (see details below) and including it would make the pooled estimate significant.

3.2 The effect of counselling intensity

A second subgroup analysis of the same 51 trials explored the impact of the number of calls, using three categories; two or fewer sessions; three to six sessions, or seven or more. We initially analysed these categories within the grouping by control condition used above, but since the pattern of results was largely consistent we simplified the comparisons (Analysis 5.1).

There were nine trials (N = 6274) in the lowest intensity category: Lando 1992; Rimer 1994; Ossip-Klein 1997; Lipkus 1999; Lichtenstein 2000; Stotts 2002; Fiore 2004; Lichtenstein 2008 and Miguez 2008 all provided one or two calls. There was moderate heterogeneity (I² = 45%) and no significant effect was detected (RR 1.07; 95% CI 0.91 to 1.26).

Thirty-four trials (N = 19,736) offered between three and six sessions. There was low heterogeneity (I² = 30%) and a significant effect showing evidence of a benefit of counselling (RR 1.32; 95% CI 1.23 to 1.42).

Nine trials (N = 4480) offered seven or more sessions (Solomon 2000; Solomon 2005; Duffy 2006; Velicer 2006; An 2006; Boyle 2007; Hanssen 2009; Ellerbeck 2009; McClure 2011) (Solomon 2000 did not specify a set number of calls, but the average provided was seven). There was a benefit (RR 1.29; 95% CI 1.11 to 1.50) but clear heterogeneity (I² = 60%) attributable in part to the large effect of An 2006. The effect seen in this study might have been increased by the effect of counselling on increasing use of pharmacotherapy in the intervention group. If this study is excluded, the lower bound of the confidence interval is 0.99. Another source of clinical heterogeneity was that five of the trials (Solomon 2000; Solomon 2005; Velicer 2006; Boyle 2007; Ellerbeck 2009) offered counselling as an adjunct to pharmacotherapy; in a post hoc subgroup these studies did not show evidence of an effect when pooled. The influence of the control condition is examined further in section 3.3 below. A further source of heterogeneity was that Velicer 2006 used an automated voice response system to provide tailored but prerecorded support.

We had no strong a priori rationale for the choice of cut points, although the 1 to 2 call group predominantly captured trials with 'brief' interventions. Because the categories were not prespecified we also conducted a meta-regression analysis in STATA 11.2 using the maximum number of planned calls for each study as a measure of intensity. In a univariate analysis there was no evidence that a larger number of planned calls increased the effect.

We also considered whether including the 12 trials of proactive counselling for quitline callers in their intensity subgroups would alter these conclusions. This confirmed the benefit of more intensive interventions (data not shown). Two of the quitline trials included a test of a brief intervention, and when these were included in the one- or two-session categories the estimate just reached significance, although the relative effect was small. One of these trials offered a single session lasting 50 minutes (Zhu 1996) and the other a session of 30 to 40 minutes followed by a second briefer call, with tailored self-help materials (Hollis 2007). These were considerably longer than the sessions used in the other 1 to 2 session trials, suggesting that their results might not be generalisable outside the quitline setting or to interventions with a small number of short calls.

3.3 The effect of motivation

A third subgroup analysis for the 51 trials explored the effect of motivation (Analysis 6.1). Sixteen studies (N = 10,612) specifically recruited smokers who wanted to make a quit attempt, including most of the studies where pharmacotherapy was common to both intervention and control. Thirty-five studies (N = 19,634) did not state that participants were included on the basis of motivation, although relatively high proportions may have been interested in quitting. The effect sizes and confidence intervals in the two subgroups were similar, although there was less heterogeneity in the 'unselected' subgroup.

3.4 Results of a meta-regression

We also explored the combined effects of differences in baseline support, maximum number of calls and motivation in a meta-regression (Stata 11.2). In univariate analyses none of these significantly moderated the effect size. However in a multivariate model incorporating all three factors, each was significant in the model. Controlling for other factors, selection for motivation, and increasing number of calls were associated with similar impacts on the effect increasing the RR by around 20% (number of calls increasing from 2 to 7, as this was treated as continuous). In this same analysis, telephone counselling as an adjunct to pharmacotherapy had a reduced effect when compared to telephone counselling versus self help or as an adjunct to brief intervention or counselling (difference of 30% and 40% on the RR respectively).

4. Other studies

Eight other studies were judged too dissimilar for pooling. Two studies compared different intensities of telephone support. Miller 1997 compared a hospital-based intervention followed by a single call with an intensive intervention in which participants could receive up to four calls after discharge from hospital. The more intensive intervention increased the continuous one-year quit rate from 14% to 19%, a difference which just reached statistical significance (P = 0.05). Swan 2003 compared two intensities of telephone support as an adjunct to bupropion. This study found a significant benefit of the Free & Clear programme which offered a telephone assessment and counselling intervention with four brief prescheduled follow-up calls, compared to the Zyban Advantage Plan which included a single scripted call (N = 1524, RR 1.31, 95% CI 1.12 to 1.54). These two studies provide further evidence that higher numbers of calls are associated with greater benefit.

Smith 2013 failed to detect any additional benefit of a counselling component to increase adherence to the NRT which was provided to all participants who received counselling from the Wisconsin Tobacco Quit Line. Thirty-day abstinence at six months was 36.7% with adherence counselling and 37.5% without. This six-arm factorial trial also compared two-week and six-week courses of NRT, and patch alone versus patch and gum. Although the effect of pharmacotherapy is not within the scope of this review, we note that the combination of NRT types for either course duration increased abstinence rates over two weeks of nicotine patch alone, but six weeks of patch did not significantly improve abstinence over two weeks.

Roski 2003 and Katz 2004 evaluated system-level interventions for changing the organisation of care for smoking cessation, with telephone counselling being the main method for providing cessation support. Roski 2003 failed to detect any benefit of introducing a smoker registry and referral system on cessation rates. Few of the smokers surveyed at the participating clinics reported using any counselling services, and only 25% to 30% of eligible smokers were estimated to have been referred. Katz 2004 tested an intervention to implement clinical practice guideline recommendations including the offer of telephone counselling and/or NRT; this showed a significant increase in sustained abstinence at six months (10.9% versus 3.8%, adjusted odds ratio 3.4, 95% CI 1.8 to 6.3).

Girgis 2011 tested the offer of referral to counselling for Arabic smokers identified at primary care visits. Take-up was low with only a quarter of intervention participants receiving one call and only eight completing all six sessions. Quit rates did not differ significantly but the direction of effect favoured the control group (8.4% abstinent at 12 months) over the intervention (11.3% abstinent).

Halpin 2006 compared benefit designs. There was no significant difference between groups; the quit rate at six months was 19% in the group given access to pharmacotherapy, 18% for the group who could access pharmacotherapy if enrolled for telephone counselling (24% accessed TC), and 13% for those who could access either (only 8% enrolled in counselling).

Hennrikus 2002 compared the offer of telephone counselling or group programmes or a choice in a workplace setting. Programmes were offered three times, and the primary evaluation was based on all smokers irrespective of participation. No difference in six-month sustained quit rates was detected at 24-month follow-up, although point prevalence quit rates favoured the telephone condition. Quit rates for programme participants were also similar. Incentives increased participation but did not appear to increase cessation rates.

Discussion

This review considers telephone services for delivering behavioural counselling and support both proactively and reactively. Interventions studied in trials range from brief contact with the potential to motivate a quit attempt to intensive support for smokers already engaged in quitting.

Interventions for callers to quitlines

This update of the review continues to provide evidence of a benefit from providing proactive telephone counselling for smokers who initiate contact with quitlines (Summary of findings for the main comparison). Compared to smokers who have only a single contact with the quitline, and are either sent self-help materials or receive brief counselling or both, those who are randomized to one or more additional calls increase their chance of quitting by approximately 25% to 50%. This estimate remains almost unchanged after the inclusion of three new trials contributing over 5,000 participants to this update in 2013. Seven out of 12 trials in this meta-analysis had statistically significant effects including the three that cumulatively contribute 55% of the weight (Zhu 2002; Hollis 2007; Rabius 2007). Two trials, both conducted in the UK (Gilbert 2006; Ferguson 2012) had lower quit rates in the intervention group and these contribute to statistical heterogeneity in the meta-analysis. We have still chosen to present a pooled estimate because most of the trials show evidence of benefit. In a sensitivity analysis we also pooled using a random-effects model and the effect size was similar and the confidence interval (CI) was not much wider. Because the trials in this area have been so large, the estimated effect size, although statistically significant, is small. In an exploratory analysis we pooled the trial outcomes expressed as risk differences to estimate the absolute increase in quit rates attributable to the additional counselling. Risk differences may be much more heterogeneous than risk ratios if trials have very different definitions of abstinence. In this group of 12 trials the definitions of smoking cessation were relatively similar, with seven having final follow-up at around 12 months, of which six required an extended period of self-reported abstinence. Only one used biochemical validation (Ferguson 2012), which is not judged to be necessary in large population-based studies (SRNT 2002). The quit rate in the control groups ranged from 1.5% (Smith 2004) to 12%, or 17% when free nicotine replacement therapy (NRT) was also offered (Hollis 2007). The intervention group quit rates ranged from 5% (Smith 2004) to 14%, or 21% when NRT was offered (Hollis 2007). Despite the variation in quit rates, pooling trial outcomes expressed as risk differences showed the same level of heterogeneity as for risk ratios, and the estimated absolute increase in quit rates was 3% (95% CI 2% to 4%). The three trials added in this update have not altered this estimate. These estimates are based on treating all people lost to follow-up as continuing smokers. Excluding losses to follow-up from all conditions, reducing the total numbers by about 35%, would increase the estimate of absolute effect, but only by a percentage point.

All these trials provided multisession counselling, with a variety of schedules. Evidence for a dose response effect is unclear, with Zhu 1996 suggesting a benefit from additional calls, but neither Smith 2004 nor Hollis 2007 detecting differences between two different protocols. The most detailed investigation, Rabius 2007, suggested that fewer shorter calls could be as effective as more and longer ones. They observed that "The finding that different protocols generally yielded similar outcomes may be because they all contained the same basic elements and because those with five or more sessions had similar completion rates". If only a minority of participants are willing to accept all sessions, differences between more and less intensive protocols will have little impact.

One trial (Sood 2009) compared reactive counselling for quitline callers with a control condition of mailed self-help materials only. No difference was detected, although the upper confidence interval was 1.30. Because the counselling was reactive, with no further contact initiated by a counsellor, we did not pool it with the trials discussed above. It is not clear how many further calls to the quitline the intervention group participants subsequently made. Whilst this study fails to support the benefit of reactive helplines, it does not exclude the possibility of an effect.

Interventions for people not calling quitlines

Proactive telephone counselling may also be offered to people who have not contacted quitlines, but are being offered cessation support in other settings (Summary of findings 2). These people may or may not be motivated to make a quit attempt when recruited. There is also evidence of benefit from telephone counselling under these conditions. Estimates from pooling studies suggested a 20% to 36% increase in quitting. Based on a control group quit rate of 10% this is equivalent to an absolute increase of 2 to 3 percentage points. There was only a moderate level of heterogeneity, and this was not explained by considering subgroups of trials based on the amount of support common to both intervention and control groups. In the largest subgroup of studies this consisted of mailed self-help materials but some trials included brief face-to-face advice and some offered pharmacotherapy to all participants. The telephone intervention was associated with significantly higher quit rates in each subgroup, but the estimate was smaller and less certain when participants had access to pharmacotherapy.

In the subgroup by intervention intensity, the effect was small and the confidence interval did not exclude no effect when the intervention consisted of only one or two calls. This analysis used the maximum possible number of calls as the measure of intervention intensity. Alternative measures include the average number of calls delivered, which is generally considerably lower than the number intended, and the total contact time. These process measures are less consistently reported. Unless there were particular problems with contacting participants, the planned number of calls is probably a reasonable measure of the 'dose' of support provided for those who were receptive to the intervention. In a meta-regression there was evidence that the amount of support relative to the control condition, the total number of calls and whether participants were selected for motivation to quit at the time of recruitment may all have had some influence on the effect size. Offering more calls, and having participants who were motivated to make a quit attempt increased the estimated effect, but using pharmacotherapy made the additional effect of counselling smaller. This finding is consistent with the results of a separate Cochrane review of behavioural interventions as adjuncts to pharmacotherapy (Stead 2012) which also found a relatively small, although clinically important, benefit from increasing the amount of behavioural support. Studies that offered pharmacotherapy, with or without behavioural support, to all participants and evaluated the additional effect of telephone counselling were eligible for inclusion in both reviews. That review found that in a post hoc subgroup of trials in which all contact was by telephone, there was a clearer benefit of the telephone counselling over and above the pharmacotherapy. In this review some trials provided both pharmacotherapy and face-to-face support to all participants, and in these the addition of the telephone component did not show such a clear effect.

A recent meta-analysis (Tzelepis 2011b) distinguished between trials which proactively recruited participants and those with reactive recruitment. The seven trials they classified as active recruitment (Curry 1995; McBride 1999a; Lichtenstein 2000; Prochaska 2001; Aveyard 2003; Abdullah 2005; Lichtenstein 2008) were all in our subgroup of studies that did not select participants of the basis of motivation to quit. We also found a benefit of intervention in this group.

Completeness, applicability and quality of the evidence

Rigorous evaluation of reactive services (quitlines, hotlines or helplines) has been difficult because of a reluctance to undertake randomized trials that would require callers who sought help to be refused support. This review restricted formal inclusion to randomized or quasi-randomized trials. A single large trial provides the main evidence that hotlines are beneficial (Ossip-Klein 1991). In this study use of the hotline was relatively high: 36% of the intervention participants called the hotline for recorded messages of support, and 8.7% spoke to counsellors. The hotline appeared most effective for those people who enrolled face-to-face, despite the fact that telephone enrollees made more use of the service. There is much more evidence about the benefit of counselling once smokers have called a telephone-based service. One study was able to evaluate the impact of the proactive counselling element of a helpline by capitalising on the constraints on capacity at certain times (Zhu 2002). One recent study (Sood 2009) did allocate callers to immediate reactive counselling, or self help only. This study did not detect an effect of the counselling; the evidence of a relationship between the number of calls and the effect suggests that it may be important to engage callers into a multisession protocol as used by most quitlines, at least in North America (Cummins 2007a)

Agreements and disagreement with other studies or reviews

The 2008 update of the US Clinical Practice Guideline ‘Treating Tobacco Use and Dependence’ (Fiore 2008) supports the use of proactive telephone counselling and quitline counselling. The meta-analysis on quitline counselling gives an estimated odds rate of 1.6 (95% CI 1.4 to 1.8, table 6.16), consistent with the estimate in this review. The guideline also identifies a benefit of adding quitline counselling to pharmacotherapy (OR 1.3, 95% CI 1.1 to 1.6, table 6.17). The six studies that contributed to this analysis are all included our analysis 4.1.3, and show a similar effect, but we pool a further five studies resulting in a smaller estimate.

The US Community Preventive Services Taskforce has issued updated guidance on quitline interventions based partly on the last version of this review (Stead 2009). In addition to supporting the effectiveness of quitline interventions, this evaluated interventions to increase the use of quitlines. It recommends (1) mass-reach health communication interventions tagged with the quitline number (2) offers of free evidence-based tobacco cessation medications to eligible callers; and (3) quitline referral interventions for healthcare systems and providers.

A recent meta-analysis (Tzelepis 2011b) distinguished between trials which proactively recruited participants and those with reactive recruitment, showing benefits in each subgroup. The seven trials they classified as active recruitment (Curry 1995; McBride 1999a; Lichtenstein 2000; Prochaska 2001; Aveyard 2003; Abdullah 2005; Lichtenstein 2008) were all in our subgroup of studies that did not select participants of the basis of motivation to quit. We also found a benefit of intervention in this group.

Uncontrolled evaluations have followed up quitline users in a number of places (e.g. Miller 2003; Abdullah 2004; Helgason 2004; Willemsen 2008) and typically report encouraging quit rates. Estimates of the proportion of smokers that call a quitline have varied by country; 6% in Scotland (Platt 1997); 3.6% in Australia (Miller 2003); 4% in England (Owen 2000). Although estimates of a reach of 4% to 6% of the smoking population over a year are encouraging, they are likely to be at the upper end of what can be expected, even with the help of mass media campaigns. In the USA the average usage ranges from 0.01% to 4.28% across states, with the states that spent the most on quitlines services having the highest use (Cummins 2007a). Quitlines may help reduce disparities in access to cessation support (Miller 2009a; Zhu 2011).

Promotion of quitlines by mass media antismoking campaigns helps to attract callers (e.g. Farrelly 2007; Mosbaek 2007; Miller 2009b; Farrelly 2011; CDC 2012, Community Preventive Services Taskforce), and the use of targeted advertising may increase calls from specific minority or underserved groups (Cummings 1989; Pierce 1992; Cummings 1993; Owen 2000; Zhu 2000a; Cummins 2007b; Maher 2007). There are a number of models for quitlines, using various methods to provide initial support for callers and pass them to specialist counsellors where requested and available (Ossip-Klein 2003). Callers do not necessarily ask for or want counselling, and services can increase population quitting just by mailing self-help materials, even though the effect of this minimal intervention may not be large (Lancaster 2005b). Using the telephone contact to collect sufficient data to provide tailored materials may be a useful strategy for enhancing the effect of self-help materials (Borland 2004; Lancaster 2005b). One strategy that has been used in a pilot project for increasing access to treatment for underserved populations is to provide a cellular phone, allowing smokers to receive proactive counselling (Lazev 2004).

In North America a third of quitlines distribute free NRT (Cummins 2007a). Evaluations suggest that this increases call volume, and pre-post comparisons also suggest that quit rates are increased (e.g. An 2006a; Cummings 2006; Fellows 2007; Tinkelman 2007; Bush 2008; Campbell 2008; Miller 2009a; Davis 2013; Zawertailo 2013).

Telephone-based services can provide support for users of medications such as NRT, varenicline or bupropion. One trial in this review (Fiore 2004) tested the Committed Quitters® programme as an adjunct to free nicotine patch therapy, but did not detect an additional benefit of the single counselling call even though this was supported by tailored self-help materials. One short-term randomized trial (Shiffman 2000) failed to detect an effect of a single telephone call after the target quit date compared to mailed, tailored self-help materials alone for purchasers of nicotine gum. In both trials the lack of effect may be attributed to the insufficient dose of the telephone component. Another trial compared multiple to single calls for users of bupropion, and there was a clear benefit of the four-call protocol (Swan 2003). Support provided by pharmaceutical companies may also be underused. In their trial of proactive calls as an adjunct to nicotine patch, Lando and colleagues noted that fewer than 1% of participants called the company helpline, whether they were scheduled to receive calls or simply encouraged to call the helpline themselves (Lando 1997). It may be possible to use brief proactive calls to encourage use of quitline services (Boyle 2004b; Holtrop 2005).

Telephone counselling may also have a role in increasing the appropriate use of pharmacotherapy. In a trial with one of the largest effects, part may be attributable to the greater use of pharmacotherapy amongst those receiving counselling even though NRT and bupropion were also available in the usual care condition (An 2006). Increased use of pharmacotherapy was also noted in the intervention groups in Emmons 2005. A study of callers to the California Smokers' Helpline provides useful information about the acceptability of a telephone referral service as an adjunct to pharmacotherapy (Zhu 2000). Participants in this follow-up study all planned to use NRT and had a pre-quit counselling session. Those who chose to receive further counselling were more likely to attempt to quit, and to remain nonsmokers for up to a year. Seventy-nine per cent of participants continued with counselling, and 26% of these stayed quit for a year. Of the 21% who had only a single session of counselling, 16% quit. More than half the smokers had called the helpline as a requirement for obtaining free NRT, and the high uptake of further behavioural support suggests that it was popular as an adjunct to pharmacotherapy. However a recent UK trial which failed to show a benefit of additional calls, also failed to detect a benefit of offering free NRT (Ferguson 2012).

Quitlines may exert an impact beyond that which can be measured by quit rates amongst callers. They may have a symbolic role, emphasising the importance of smoking cessation (Wakefield 2000), and may increase the number of smokers making a quit attempt each year because of awareness generated by the campaigns to promote them (Ossip-Klein 2003). Their availability may alter provider behaviour and encourage referral (Boldemann 2006).

Telephone-based support systems are increasingly well established as part of comprehensive tobacco treatment initiatives (Borland 2006; Lichtenstein 2007; McAfee 2007). The US Department of Health & Human Services has introduced a single national quitline number allowing access to the National Network of Tobacco Cessation Quitlines (Anon 2005). The North American Quitline Consortium promotes and supports evidence based quitline services in the USA, Canada and Mexico. The European Network of Quitlines had 30 member quitlines in 2010. There is also a Global Quitline Network. Other countries where national or state quitlines are known to be established include Australia (Miller 2003), New Zealand (Wilson 2005), United Kingdom (Gilbert 2006), Sweden (Helgason 2004), Italy (Pizzi 2009) Hong Kong (Abdullah 2005), Korea (Myung 2008) and Iran (Heydari 2011). The evaluation of systems that encourage and facilitate healthcare providers to refer people to specialist quitline services for extended support is an important area of current research (Perry 2005; Winickoff 2006; Sherman 2008; Wolfenden 2008). Possible future developments include the use of direct mail or 'cold calling’ to initiate contact with smokers (Van Deusen 2007; O'Connor 2008; Tzelepis 2011b, Vidrine 2011).

Authors' conclusions

Implications for practice

Proactive telephone counselling aids smokers who seek help from quitlines. Telephone quitlines provide an important route of access to support for smokers, and call-back counselling enhances their usefulness. There is limited evidence about the optimal number of calls. Proactive telephone counselling also helps people who receive it in other settings. There is some evidence of a dose response; one or two brief calls are less likely to provide a measurable benefit. Three or more calls increase the chances of quitting compared to a minimal intervention such as providing standard self-help materials, or brief advice, or compared to pharmacotherapy alone.

Implications for research

Further research on ways to combine face-to-face counselling with telephone follow-up to support quit attempts and reduce relapse rates may be useful. Research on reactive helpline services which compares different counselling protocols and different schedules of call-back sessions may also lead to improved outcomes.

Acknowledgements

Elaine Harkness assisted with data extraction in the first version of this review. Hitomi Kobayashi translated a paper from Japanese. We would like to acknowledge the helpful suggestions of Ed Lichtenstein and Corinne Husten on both the original version of the review and the update in 2006. Additional data were provided by Vance Rabius and Jennifer McClure, and other authors confirmed or clarified data. Data from Flöter 2009 were extracted by Carole Clair.

Data and analyses

Download statistical data

Comparison 1. Interventions for callers to quitlines - effect of additional proactive calls
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Cessation at longest follow-up1230182Risk Ratio (M-H, Fixed, 95% CI)1.38 [1.28, 1.49]
Analysis 1.1.

Comparison 1 Interventions for callers to quitlines - effect of additional proactive calls, Outcome 1 Cessation at longest follow-up.

Comparison 2. Interventions for callers to quitlines - comparison of different support during a single call
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Cessation at longest follow-up3 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 Reactive counselling vs self-help materials1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 Stage-based counselling versus general information1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.3 Tailored counselling versus standard counselling1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 2.1.

Comparison 2 Interventions for callers to quitlines - comparison of different support during a single call, Outcome 1 Cessation at longest follow-up.

Comparison 3. Offer of counselling via quitlines/helplines/hotlines
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Long term cessation3 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 Hotline and self-help materials compared to self help only1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 Hotline and self-help materials for cessation maintenance compared to nothing1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.3 Reactive or proactive counselling vs provider counselling1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 3.1.

Comparison 3 Offer of counselling via quitlines/helplines/hotlines, Outcome 1 Long term cessation.

Comparison 4. Interventions for smokers not calling quitlines - subgroups by baseline support
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Cessation at longest follow-up - All trials, subgroups by amount of control group support5130246Risk Ratio (M-H, Fixed, 95% CI)1.27 [1.20, 1.36]
1.1 Self-help or minimal intervention control3019134Risk Ratio (M-H, Fixed, 95% CI)1.34 [1.22, 1.46]
1.2 Adjunct to brief intervention or counselling113520Risk Ratio (M-H, Fixed, 95% CI)1.41 [1.20, 1.66]
1.3 Adjunct to pharmacotherapy117592Risk Ratio (M-H, Fixed, 95% CI)1.14 [1.03, 1.27]
Analysis 4.1.

Comparison 4 Interventions for smokers not calling quitlines - subgroups by baseline support, Outcome 1 Cessation at longest follow-up - All trials, subgroups by amount of control group support.

Comparison 5. Interventions for smokers not calling quitlines - subgroups by intensity: 1-2, 3-6, >6 calls
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Cessation at longest follow-up5130490Risk Ratio (M-H, Fixed, 95% CI)1.28 [1.20, 1.36]
1.1 Two sessions or fewer96274Risk Ratio (M-H, Fixed, 95% CI)1.07 [0.91, 1.26]
1.2 3-6 sessions3419736Risk Ratio (M-H, Fixed, 95% CI)1.32 [1.23, 1.42]
1.3 7 sessions or more94480Risk Ratio (M-H, Fixed, 95% CI)1.29 [1.11, 1.50]
Analysis 5.1.

Comparison 5 Interventions for smokers not calling quitlines - subgroups by intensity: 1-2, 3-6, >6 calls, Outcome 1 Cessation at longest follow-up.

Comparison 6. Interventions for smokers not calling quitlines - subgroups by motivation
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Long-term cessation5130246Risk Ratio (M-H, Fixed, 95% CI)1.28 [1.20, 1.36]
1.1 Selected for motivation/ interest in quitting1610612Risk Ratio (M-H, Fixed, 95% CI)1.30 [1.19, 1.42]
1.2 Not selected by motivation3519634Risk Ratio (M-H, Fixed, 95% CI)1.26 [1.16, 1.38]
Analysis 6.1.

Comparison 6 Interventions for smokers not calling quitlines - subgroups by motivation, Outcome 1 Long-term cessation.

Appendices

Appendix 1. Specialised Register Search Strategy

Searched using CRS (Cochrane Register of Studies software)

#1 MeSH DESCRIPTOR Hotlines
#2 (telephone* OR phone* OR quitline* OR helpline):TI,XKY,MH,EMT,KW
#3 (quitline* OR helpline):AB
#4 ((telephone* NEAR counsel*) OR (phone NEAR counsel*)):AB
#5 #1 OR #2 OR #3 OR #4

MH - MeSH descriptor. EMT - Embase descriptor. KW & XKY - other keywords including those assigned as part of Tobacco addiction group coding

Appendix 2. Results of metaregression

Iteration 1: tau^2 = 0
Iteration 2: tau^2 = .02026029
Iteration 3: tau^2 = .02388132

Meta-analysis regression No of studies = 53
tau^2 method reml
tau^2 estimate = .024

Successive values of tau^2 differ by less than 10^-4 :convergence achieved
------------------------------------------------------------------------------
| Coef. Std. Err. z P>|z| [95% Conf. Interval]
-------------+----------------------------------------------------------------
ncall | .0391682 .0180095 2.17 0.030 .0038703 .0744661
mot | .2027618 .0980317 2.07 0.039 .0106233 .3949003
bs1 | .3163723 .107551 2.94 0.003 .1055761 .5271684
bs2 | .4042524 .1463426 2.76 0.006 .1174261 .6910786
_cons | -.2535906 .151252 -1.68 0.094 -.5500392 .0428579
------------------------------------------------------------------------------

ncall = number of calls, continuous variable
mot = motivation, 1 = selected
bs1 = baseline support level 1, 1 = self-help or minimal intervention control
bs2 = baseline support level 2, 1 = brief intervention or counselling control

What's new

DateEventDescription
23 October 2013AmendedInformation added to ongoing studies tables.

History

DateEventDescription
20 June 2013New citation required but conclusions have not changedTwelve new studies added, no major change to conclusions. Additional author JHB.
20 June 2013New search has been performedSearches updated
12 May 2009New search has been performedUpdated for issue 3, 2009. Nineteen new studies, no change to conclusions, strengthened evidence of effect overall and for some subgroups.
4 August 2008AmendedConverted to new review format.
11 April 2006New citation required but conclusions have not changedUpdated for Issue 3, 2006. Twenty two new studies, studies of relapse prevention now excluded. Comparisons reorganised, additional subgroup analyses.
14 October 2002New citation required but conclusions have not changedUpdated for Issue 1, 2003. Four new trials, of which 3 contribute to meta-analysis. No major changes to conclusions

Contributions of authors

LS and TL contributed to developing the protocol, extracting data and writing the review. RP became an author from issue 1 2003 and extracted data, assisted with the meta-regression. and contributed to updating the text. JH-B became an author from 2013 and contributed to extracting data and updating the text.

Declarations of interest

None known

Sources of support

Internal sources

  • National Institute for Health Research (NIHR) School for Primary Care Research, UK.

  • Department of Primary Care Health Sciences, University of Oxford, UK.

External sources

  • NHS Research & Development Programme, UK.

Characteristics of studies

Characteristics of included studies [author-defined order]

Abdullah 2005

MethodsSetting: Parents of children in a birth cohort study, Hong Kong
Recruitment: active; by mail, current smokers, not selected for motivation
Participants903 current smokers with young children (49 recent quitters not included here); 84% M, > 50% aged 36 - 45, 91% smoked ≤ 20/day
Interventions1. Single mailing of stage-matched S-H (either preparation/action or contemplation/precontemplation)
2. As 1, plus 20 - 30 mins of TC at time of enrollment by trained nurse counsellor. Hotline number, further counselling at 1m & 3m
OutcomesAbstinence at 6m, validated 7-day PP. (Unvalidated self-reported continuous abstinence also reported).
Validation: CO < 9ppm or urine cotinine < 100 mmol/mol
NotesComparisons 4 - 6. Effect on self-reported continuous abstinence was non-significant
Average duration of counselling 38 mins over 3 contacts
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Low riskNumbered sealed opaque envelopes
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Independent interviewer...was unaware of subjects' group allocation... All respondents who reported they were not smoking during the preceding 7 days were invited to attend the research centre for biochemical validation."
Incomplete outcome data (attrition bias)
All outcomes
Low riskLosses to follow-up 11% intervention/ 4% control. Included as continuing smokers

An 2006

MethodsSetting: 5 Veterans Administration medical centres, USA
Recruitment: by mail, planning to quit in next 30 days
Participants821 smokers interested in quitting (excludes 16 deaths, 1 withdrawal); 91% M, av. age 57, av. cigs/day 26. 26% had > 7d abstinence in previous year, 44% ever use of bupropion, 82% ever use NRT
Interventions1. Mailed S-H and standard care; opportunity for intervention during routine health care and referral to individual or group cessation programmes. NRT & bupropion avail on formulary
2. As 1, plus proactive TC, modified California helpline protocol, 7 calls over 2m, relapse-sensitive schedule. NRT & bupropion available, could be mailed directly after screening & primary provider approval for bupropion
OutcomesAbstinence at 12m (sustained from 6m, 7-day PP also reported)
Validation: none
NotesComparisons 4 - 6. TC increased use of pharmacotherapies (86% vs 30% reported use at 3m). Effect greater for sustained quitting than PP. 72% completed 3 or more calls. Mean (SD) 7.7 (4.1) including courtesy calls, relapses, repeat attempts. Mean (SD) duration of total contact 123 (71) mins.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low riskLosses to follow-up included as smokers, 16 deaths excluded

Aveyard 2003

MethodsSetting: 65 general practices, UK
Recruitment: active; volunteers from random selection of smoking patients, not selected for motivation
randomization: centralised, minimisation to balance SoC, addiction and SES
Participants2471 smokers (2058 in relevant arms); > 80% in precontemplation or contemplation, 10 - 14% in preparation, 54% F, av. age 41, av. cigs/day 20
Interventions1. Standard S-H materials, single mailing
2. S-H manual based on Transtheoretical model, expert system letter tailored on baseline questionnaire. Further questionnaires at 3m & 6m for additional letters (approx 50% received 3 letters).
3. As 2, plus proactive TC after receipt of each questionnaire (max 3 calls). Designed as reminders, scripted, delivered by trained postgraduate students.
OutcomesAbstinence at 12m, (reported sustained for 6m)
Validation: saliva cotinine < 14.2 ng/ml
NotesComparisons 4 - 6. 3 vs 2. Sensitivity analysis 3 vs 2+1. 66% received 1st phone call, 36% 2nd, 31% 3rd.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCentralised randomization procedure, with minimisation to balance SoC, addiction and SES
Allocation concealment (selection bias)Low riskCentralised
Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk12m PP "was confirmed with salivary cotinine, so that we had unconfirmed and confirmed prevalence of quitting." Confirmed figures used in analysis.
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up 24% in group 1, 31% in 2 & 3. All included as smokers. Sensitivity analysis allowing for differential drop-out did not change findings.

Borland 2001

MethodsSetting: community, Australia
Recruitment: callers to a quitline
Participants998 smokers interested in quitting; 52% F, 37% aged 15 - 29, 26% aged 30 - 39, av. cigs/day 23
Interventions1. Proactive call-back TC following initial call to quitline: Multiple calls, first pre-quit, quit, then according to need. Up to 6m. Mailed materials
2. Control: Mailed materials
Both groups also received the standard motivational counselling in response to their first call.
OutcomesAbstinence at 12m (sustained for 9m)
Validation: none
NotesComparison 1. Average number of calls 2.8, 67% received 1 or more. 20% refused call-back or wanted to initiate the calls, further 7% did not receive any.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up 37% intervention, 30% control. All participants included as smokers in the meta-analysis

Borland 2003

MethodsSetting: community, Australia
Recruitment: callers to a quitline
Participants1578 smokers; 54% F, modal age 30 - 49, av. cigs/day 23
Interventions1. Standard S-H Quit pack based around SoC
2. Additional tailored letters at baseline, and at 3m & 6m based on mailed assessments
3. As 2, plus proactive cognitive behavioural stage-base TC, calls at negotiated times, ˜10 - 15 mins. Usually over 2 - 3 wks, could extend further.
Some participants in all groups received brief reactive counselling before enrolment
OutcomesAbstinence at 12m (sustained for 9m)
Validation: none
NotesComparison 1. 3 vs 2, sensitivity analysis 3 vs 2+1.
68% received calls, av. 4.8 for those receiving any, 23% received ≥ 7.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskAllocation by shuffling questionnaires
Allocation concealment (selection bias)Low riskAuthor states "no opportunity for interviewers to influence choice"; baseline characteristics balanced, likelihood of bias judged low.
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up 21% in 1, 23% in 2, 26% in 3. All participants included as smokers in the MA

Borland 2008

MethodsSetting: general practice, Australia
Recruitment: 45 participating GPs recruiting patients who smoked
Participants1039 smokers, not selected for motivation but ˜80% had previously tried to quit; 55% F, av.age: 41, av cigs/day 17
Interventions1. Referral: Smokers with any interest in quitting referred by fax to Victorian Quitline. Proactive contact attempted with up to 2 pre-quit and 4 post-quit sessions typically using relapse-sensitive schedule. Internet support available as an alternative (4.4% reported use)
2. In-practice support, could include external referral if this was clinical preference
All participants given guideline-based assessment of readiness to quit and offer of pharmacotherapy if appropriate
OutcomesSustained abstinence at 12m (≥1m at 3m and ≥10m at 12m)
Validation: none
NotesNew for 2009 update. Comparisons 4 - 6, TC as adjunct to face-to-face intervention. 30.5% of referral group used call-back service. McKay-Brown discusses GP retention and participant recruitment problems. Reported analysis adjusts for age, gender and nicotine dependence and controls for clustering. Adjusted OR is 3.08 (1.02 to 9.28) compared to 2.81 (1.09 to 7.29) using crude data in MA
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCluster-randomized by GP (1:2 ratio). Computer allocation before GPs attended education session for their assigned intervention
Allocation concealment (selection bias)Unclear riskInitially concealed but 13 referral (30%) and 11 (42%) control GPs failed to recruit participants. Allocation not blind at time of recruitment of individual participants so further selection bias possible. Measured characteristics at baseline were similar
Blinding of outcome assessment (detection bias)
All outcomes
High risk"Three- and 12-month questionnaires were administered...by trained interviewers who were blind to treatment condition until after the outcome data were collected." However, reliant on self-reported outcomes from participants not blinded to treatment condition.
Incomplete outcome data (attrition bias)
All outcomes
Low risk33% lost in referral condition, 39% in control, all included as smokers in MA. Excluding losses does not affect MA

Boyle 2007

MethodsSetting: Health Maintenance Organisation, USA
Recruitment: proactive recruitment of members filling a prescription for cessation medications (motivated)
Participants1329 HMO members; 58% F, av.age 47, 66% smoked > pack/day
InterventionsAll participants had filled a prescription. Almost 95% used; ˜51% only bupropion, 26% only NRT, remainder both
1. No further intervention
2. Proactive call to offer counselling, up to 9 calls, given choice of structured course or unstructured format
OutcomesAbstinence at 12m (repeated 7-day PP at 3m & 12m)
Validation: none
NotesNew for 2009 update. Comparisons 4 - 6. 49% of intervention group reached, 36% of those declined, 31% of total accepted counselling. Average no of calls 5. There was no evidence of a greater relative effect in those reached or those accepting counselling
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, stratified by presence of chronic disease. Method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High risk"The follow-up survey was conducted by the Data Collection Center within the Health Partners Research Foundation, using staff not involved in the intervention." However, reliant on self-reported outcomes from participants not blinded to treatment condition.
Incomplete outcome data (attrition bias)
All outcomes
Low risk˜33% lost to follow-up, balanced across groups, included in MA as smokers

Brown 1992

MethodsSetting: community, Australia
Recruitment: advertising for smokers interested in cessation
Participants45 smokers attending an information evening on smoking cessation; 62% F, av. age 40, av. cigs/day 23
Interventions1. S-H manual
2. S-H manual and proactive TC; 6 calls at 1, 2, 4, 6, 8, 10 wks which asked about use of manual, and gave additional information about any techniques or skills proving difficult
OutcomesAbstinence at 12m (7-day PP)
Validation: Saliva samples collected but not apparently tested - 1 participant refusing to provide a sample was classified as smoking.
NotesComparisons 4 - 6, effect of TC compared to S-H and single information session alone
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskSaliva samples collected but not apparently tested.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo details given

Chouinard 2005

MethodsSetting: Canada
Recruitment setting: Inpatients with cardiovascular disease (myocardial infarction, angina, congestive heart failure) or peripheral vascular disease, unselected by motivation
Participants168 past-month smokers; 27% M, av.age 56, 60% in preparation or action SoC
Interventions1. Counselling by research nurse (1x, 10 - 60 mins, av. 40 mins, based on Transtheoretical Model, included component to enhance social support from a significant family member), 23% used pharmacotherapy.
2. As 1, plus telephone follow-up, 6 calls over 2m post-discharge, 29% used pharmacotherapy
3. Usual care cessation advice (not used in review)
OutcomesAbstinence at 6m (sustained at 2m & 6m)
Validation: Urine cotinine or CO
NotesNew for 2009 update. Comparisons 4 - 6, TC as adjunct to face-to-face counselling. 75% received 6 calls
TC as adjunct to face-to-face counselling.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster-randomized in groups of 3 - 6 "to prevent contamination between groups", method not described
Allocation concealment (selection bias)Low risk"Individuals not familiar with the study were in charge of the randomization procedure which included inserting the information into envelopes that were sealed and would be opened by the investigator only at the time of recruitment."
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used
Incomplete outcome data (attrition bias)
All outcomes
Low risk4 deaths (3 in Grp 1, 1 in Grp 2) and 3 not meeting follow-up criteria excluded from MA denominators. Other losses to follow-up included.

Cossette 2011

Methods

Setting: Specialised cardiac hospital, Canada

Recruitment: all smokers who were hospitalised were asked to participate by the study nurse (not selected by motivation)

Participants

40 current daily smokers with cardiovascular disease, 40% F, av.age 57. Most in preparation stage

Therapists: nurse specialised in smoking cessation

Interventions

All participants had 1 or more sessions with the study nurse during hospitalisation. Conditions differed after discharge.

Intervention: 6 phone calls by study nurse at wks 1, 2, 3, 4, 8, 12. If needed additional phone calls could be arranged between 3 and 6m postdischarge. At wk 3 appointment with the study nurse if asked by participant

Control: referral to a national quitline or a community centre for smoking cessation

Pharmacotherapy: NRT, bupropion or varenicline were suggested during hospitalisation and follow-up

Outcomes

Self-reported abstinence at 6m

Validation: only for 1 participant

NotesNew for 2013 update. Analysis 4.1.2, adjunct to counselling
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot specified, but generated by a centre for randomized controlled trials
Allocation concealment (selection bias)Unclear riskOpaque sealed envelopes
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskHigh loss to follow-up but missing data similar in both groups and analyses are ITT, participants lost to follow-up considered smokers

Curry 1995

MethodsSetting: Health Maintenance Organisation, USA
Recruitment: active; smokers identified via a telephone survey of health behaviour in a random sample of HMO members, not selected for motivation
Participants1137 smokers, 479 in relevant arms, not selected by motivation to quit; 52% F, av. age 41, av. cigs/day 17
Interventions1. Control - no materials or counselling
2. S-H booklet (Breaking Away)
3. As 2, plus feedback based on computer analysis of initial survey.
4. As 3, plus proactive TC; up to 3 calls at 2, 6, 10 wks
OutcomesAbstinence at 12m, from 3m - 12m
Validation: saliva cotinine requested but not obtained for all self-reported quitters. Disconfirmation rates (cut off > 20ng/ml) not significantly different between groups.
NotesComparisons 4 - 6. 4 vs 3, effect of TC compared to S-H and feedback alone. Over ⅔ completed 3 calls, rates did not differ by SoC
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk"Collecting saliva cotinine...was challenging because participants had neither explicitly volunteered for a study of smoking behavior nor requested treatment for smoking cessation... nearly one fourth of those contacted refused to provide a sample." Higher disconfirmation in control group but difference was not significant.
Incomplete outcome data (attrition bias)
All outcomes
Low risk88% provided data at all 3 &12m. No difference in response rates across groups. Missing counted as smoking in MA

Duffy 2006

MethodsSetting: ENT clinics at 4 hospitals, USA
Recruitment: Patients with head & neck cancer who screened positive for smoking, alcohol problem or depression, not selected for motivation
Participants89 current smokers used in MA, out of 184 trial participants who also included 26 quit within last month and 21 within last 6m . Demographics are for all participants; 16% F, av.age 57
Interventions1. Proactive counselling; 9 - 11 CBT-based calls from trained nurses, linked to use of CBT workbook. Smokers with problem drinking or depression received counselling for these too
2. Enhanced usual care with assessment and referral
OutcomesAbstinence at 6m (sustained)
Validation: none
NotesNew for 2009 update, in comparisons 4 - 6
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given. Smokers were a higher proportion of the intervention than control groups, and a higher proportion of those randomized than those who refused, raising possibility of selection bias
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk22 in total (including non-smokers) lost to follow-up, evenly distributed. Losses appear to have been included as smokers.

Ebbert 2007

MethodsSetting: 8 dental practices, USA
Recruitment: Patients screened by questionnaire at routine hygiene appointments, not selected for motivation
Participants82 smokers (60 intervention, 22 control). No baseline data for controls
Interventions1. Control: Brief counselling (10 mins) from hygienist, reinforced by dentist
2. As 1 plus faxed referral to quitline, proactive counselling, 45 mins baseline, 20 mins at 1w & 2w, further calls if requested.
OutcomesAbstinence at 6m (PP)
Validation: none
NotesNew for 2009 update. Comparisons 4 - 6, TC adjunct to face-to-face intervention
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster-randomized by practice, method not described
Allocation concealment (selection bias)High riskHygienists who recruited patients after screening not blind, large difference in numbers recruited, not possible to establish baseline similarity
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo description of number lost at follow-up

Ellerbeck 2009

MethodsSettng: Primary care patients, 50 rural practices, Kansas, USA
Recruitment: smoking patients not selected for motivation, but 67% of those eligible enrolled, only 8.7% in precontemplation stage of change
Participants750 smokers of >10 cigs/day, 59% F, av. age 47, av. cigs/day 24, 61% contemplation, 30% preparation
Interventions

All participants mailed an offer of free pharmacotherapy every 6m, 4 times in total. Nicotine patch 21 mg for 6 wks or bupropion SR (150 mg twice daily) for 7 wks

1. Control. No other contact.

2. Moderate intensity disease management: up to 2 calls from counsellor in each cycle encouraging uptake of pharmacotherapy, newsletter mailings & periodic progress reports with counselling suggestions faxed to physician.

3. High intensity disease management, up to 6 calls at approx 1, 3, 6, 9, 12 wks from start of each cycle.

Outcomes

Abstinence at 24m (PP). Study also reported analysis based on combination of effects at all follow-up points. Sustained abstinence not a suitable outcome since no quit date and repeated intervention.

Validation: attempted saliva cotinine (< 15 ng/ml) by mail at 12 & 24m. Proxy report used at 24m for non-returners. Rate of validation similar across groups.

Notes

New for 2013 update. Participants could have multiple courses of pharmacotherapy; 23%, 33%, 23%, 12%, and 9% of participants requested 0, 1, 2, 3, or 4 courses. Disease management conditions increased use in first cycle and reduced it later. 41% of cycles used bupropion & 59% patch. Over 24 months average number of calls 3.6 in 2. and 8.2 in 3. Fewer calls in later cycles.

No evidence of effect based on PP, but some evidence of benefit when all follow-ups taken into account.

Comparisons 4 - 6. For analysis 5.1, classified on basis of average calls; moderate in 3 - 6 sessions, high in 7+ subgroups.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"computer generated random-number table" in blocks of 24
Allocation concealment (selection bias)Low risk"To conceal allocation, we placed these cards in sequentially numbered, opaque, sealed envelopes."
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used
Incomplete outcome data (attrition bias)
All outcomes
Low riskDifferential rates of loss to follow-up (1: 22.0%; 2: 31.3%; 3: 31.1%). Participants lost to follow-up counted as smokers but sensitivity analysis shows no significant difference in analysis outcome if excluding those lost to follow-up.

Emmons 2005

MethodsSetting: Childhood Cancer Survivors Study cohort, USA
Recruitment: Smokers contacted via telephone to assess eligibility and enrol, not selected for motivation
Participants794 smokers (excludes 2 deaths in control); 47% F, av. age 31, av. cigs/day 12
Interventions1. S-H control. Mailed manual (Clearing the Air) & letter from study physician
2. Peer counselling. Up to 6 calls in 7m period, by trained cancer survivor. Motivational, tailored to SoC. Free NRT available. Individually tailored materials before 1st call & other materials during intervention.
OutcomesAbstinence at 12m (7-day PP)
Validation: none (warning that samples might be requested)
NotesComparisons 4 - 6. No data on average number of calls. Longer-term follow-up, assessed at 2 - 4 years, reported in Emmons 2009. Not used in MA - sustained rates not reported. PP rates increased from 12m and remained higher in counselling group (20.6% vs 17.6%, P < 0.0003)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBogus pipeline procedure used, no further details provided
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk19% lost in intervention vs 24% in control at 12m. all included as smokers in MA. Excluding losses does not affect MA

Ferguson 2012

Methods

Setting: English Quitline

Recruitment: Callers to the NHS Smoking Helpline from any location in England

Participants2591 smokers aged 16 or older, motivated to quit in 4 days - 4 wks. 45% M; av.age 38; 47% smoking 11 - 20 cigs/day
Interventions

1. Standard telephone support (after call, further support by email, letter or text message, offer of proactive contact)

2. As 1 plus additional proactive telephone support (up to 2 calls pre-quit date, 1 call on quit date, then calls at 3, 7, 14 and 21d post-quit date).  Structured call content using MI template (except for 7 and 14d calls).

3. As 1 plus offer of free NRT

4. As 2 plus offer of free NRT

Outcomes

Prolonged abstinence at 6m (allowing grace period of up to 5 cigs smoked). 7d PP also recorded.

Validation: exhaled CO < 10ppm

Notes

New for 2013 update. Previously listed under ongoing studies as Coleman 2009.

1+3 vs 2+4 in Comparison 1. No difference in cessation outcomes between participants offered NRT and those not offered NRT.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"computer generated random number sequence"
Allocation concealment (selection bias)Low riskSubjects allocated via central computerised system
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation rates used.
Incomplete outcome data (attrition bias)
All outcomes
Low riskHigh rates of drop-out but similar across groups (standard 43%, proactive 45%). Drop-outs counted as smokers, "this conservative supposition could possibly mask variation...and we explored this possibility by trying alternative associations between missingness and smoking status. This analysis did not change our findings."

Fiore 2004

MethodsSetting: Primary care patients, 16 clinics, USA
Recruitment: Clinic attenders willing to accept treatment
Participants961 smokers of ≧10 cigs/day. (643 in relevant arms, a further 908 were allowed to select treatment. Demographic details based on 1869); 58% F, av. age 40, av. cigs/day 22
Interventions(Self-selected group of factorial trial not included in MA)
1. Nicotine patch, 22 mg, 8 wks incl tapering.
2. As 1, plus Committed Quitters programme, single TC session and tailored S-H.
3. As 2, plus individual counselling, 4 x 15 - 25 min sessions, pre-quit, ˜TQD, next 2 wks (not used in this review)
OutcomesContinuous abstinence at 1 year (no relapse lasting 7 days, also PP)
Validation: CO, cut-off not specified. 2 discordant
NotesComparisons 4 - 6, 2 vs 1, TC as adjunct to pharmacotherapy
69% of those randomized to group 2 enrolled in CQ programme
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemically validated cessation
Incomplete outcome data (attrition bias)
All outcomes
Low risk19% lost at 1 year, no difference by condition.

Flöter 2009

Methods

Setting: Germany

Recruitment: 21 prevention or rehabilitation clinics

Participants527 hospitalised female smokers ≥1 cig during the 30 days preceding hospitalisation. Av.age 35.9, motivation to quit not required.
Interventions

1. 3 face-to-face courses (60 mins each) in groups during clinic hospitalisation featuring CBT and MI

2. As 1, plus 3 proactive phone calls (10 mins duration) post-discharge in a structured and directive style

3. As 2, but calls delivered in non-directive style

Outcomes

30 day PP at 6m

Validation: none

NotesNew for 2013 update. Intervention arms combined in comparisons 4 - 6.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod not described
Allocation concealment (selection bias)Unclear riskMethod not described
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcome with participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber lost to follow-up unclear (conflicting data available)

Gilbert 2006

MethodsSetting: Quitline, UK
Recruitment: quitline callers who engaged in counselling
Participants1457 smokers planning quit attempt within 2 wks; 66% F, av. age 39, av. cigs/day NS
Interventions1. Standard QUIT information pack & counselling at initial contact.
2. As 1, plus offered 5 proactive calls, starting TQD if possible, 2 in wk 1, 1 in wks 2 & 4. Client-centred.
OutcomesAbstinence at 12m (sustained for 6m, also PP)
Validation: none
NotesComparison 1. 26% received no additional calls, 42% had 4+ calls, 31% had 1 - 3 calls
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskPseudo-random by day of week
Allocation concealment (selection bias)Low riskRecruiters blind so concealment judged adequate
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk37% lost to follow-up in both groups. Missing counted as smoking in MA

Girgis 2011

Methods

Setting: Australia

Recruitment: Arabic-speaking GPs in 29 practices in southwest Sydney

Participants

407 Arabic smokers, aged 18 - 65.

52% F, av. age 29, av. cigs/day 19

Interventions

1. Offer of free referral by GP to proactive telephone counselling provided by bilingual psychologist. If accepted offer, participants called by counsellor for 20 min initial session. If prepared to quit, called again on quit date, 1, 3, 6 wks and 3m after specified quit date. If not ready to set quit date, assigned "less intensive schedule." Mailed quit kit and materials in Arabic and English. 

2. Usual care

Outcomes

1d PP at 6 and 12m

Validation: none

NotesNew for 2013 update. Low uptake: 101 of 213 participants agree to receive call, 46 receive at least one call, 8 completed all calls. Described narratively in 'other studies' section.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot specified
Allocation concealment (selection bias)High risk"From each participating GP, we recruited a consecutive sample of patients of Arabic background aged 18-65 years during a specified 4-week period, irrespective of their smoking status" using an "unobtrusive mark visible to only the GP to convey group randomization" on the baseline questionnaire. Suggests allocation not concealed.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo biochemical validation but research assistants conducting follow-up blind to assignment, low uptake of actual contact suggests risk of differential misreport low.
Incomplete outcome data (attrition bias)
All outcomes
Low riskSignificantly more participants in intervention group lost to follow-up at 12m than control (45% vs 34%), all drop-outs counted as smokers in ITT analysis

Graham 2011

Methods

Setting: USA

Recruitment: US residents searching for stop-smoking advice on a major internet search engine who clicked on a link to www.quitnet.com, assumed to be motivated

Participants2005 adult smokers of 5 or more cigs/day. 51.1% F, av.age 35.9, av.cpd 20, av. FTND 5.0. 1326 contribute to this review
Interventions

1. Free 6m access to www.quitnet.com (interactive commercial cessation website)

2. As 1 + up to 5 sessions of proactive telephone counselling for 3m; counsellors had access to www.quitnet.com info and encouraged participants’ use of it; counsellors sent individual emails after counselling sessions to reinforce key points

3. Control: access to static, info only (non-interactive) version of the content on QuitNet (not used in this review)

Outcomes

Multiple 30-day PP (at 3, 6, 12 and 18m).

Validation: none

NotesNew for 2013 update. 2 versus 1 in comparisons 4 - 6. Use of 18m single PP outcome would not have shown any effect of intervention; quit rates were higher and similar across conditions
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"random numbers table…stratified by sex and baseline motivation to quit"
Allocation concealment (selection bias)Unclear riskMethod not specified
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcome measure from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
High riskParticipants missing data counted as smokers. Sustained PP data not available for 46% EI, 49% EI+P 49% and 43% BI. Difference due to differential rate of follow-up at 3m. Authors state: "The lower follow-up assessment rate among EI+P participants at 3 months may have been owing to ‘telephone fatigue’...Telephone counselling was providing within the first 3 months of the study, which was the only assessment period for which higher loss to follow-up was observed. If present, this bias could have attenuated the effectiveness of the combined intervention."

Halpin 2006

MethodsSetting: Health Maintenance Organisation, USA
Recruitment: Health plan members without current smoking cessation benefit, recruited for a study giving access to coverage
Participants388 smokers; 66% F, 67% age 40+, 84% smoked less than a pack/day
Interventions1. Coverage for TC and pharmacotherapy (bupropion or NRT, USD15 co-pay)
2. Coverage for TC; coverage for pharmacotherapy (bupropion or NRT, USD15 co-pay) only if enrolled in TC
3. Coverage for pharmacotherapy only (control)
OutcomesAbstinence at 6m (PP)
Validation: none
NotesNot included in MA, results discussed separately, alongside trials for TC as adjunct to pharmacotherapy
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low riskNumber lost to follow-up not described, all participants included in analyses

Hanssen 2009

MethodsSetting: Hospital/community, Norway
Recruitment: Inpatients with diagnosis of myocardial infarction, not selected for motivation
Participants133 daily smokers amongst 288 participants. Demographics not given for smoking subgroup
Interventions1. Usual care; outpatient visit at 6 - 8 wks and primary care follow-up
2. Structured but individualised proactive TC addressing lifestyle issues including smoking, diet and exercise. Nurse-initiated calls at 1, 2, 3, 4, 6, 8, 12, 24 wks post-discharge. Smoking not explicitly addressed at each call. Reactive phone support line available 6 hrs/wk
OutcomesAbstinence at 6, 12 and 18m (assumed PP, not defined). Primary trial outcome was health-related quality of life
Validation: none
Notes18m follow-up data added in 2013. Comparisons 4 - 6. Smoking was addressed as part of a multicomponent intervention. TC as adjunct to brief/minimal intervention
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized by computer-generated list
Allocation concealment (selection bias)Unclear riskSequence in sealed opaque envelopes but not stated to be numbered. Fewer control group participants raises possibility of selection bias so not classified as low risk
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low riskAt 18m, losses amongst baseline smokers 29% in 1, 30% in 2 . Losses reincluded as smokers in this MA

Hennrikus 2002

MethodsSetting: 24 worksites, USA
Recruitment: Baseline survey to identify smokers.
Participants2402 smokers at baseline survey; 38 - 48% in precontemplation, 50 - 64% F, av age 36 - 40 (large between-company variations in prevalence and smoker characteristics).
InterventionsFactorial design, 6 conditions: Incentives for participation and cessation/no incentive crossed with telephone, group or choice of programme format.
Telephone counselling: 3 - 6 sessions + mailed ALA S-H materials.
Group therapy: 13 sessions.
Each programme offered 3 times over approx 18m
OutcomesAbstinence at 24m, sustained for 6m, & 7-day PP
Validation: saliva cotinine from a sample. No correction for misreporting
NotesCluster-randomized, and no other trial compared TC to group so not used in MA, reported narratively
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster-randomized by company, 4/condition, method not described
Allocation concealment (selection bias)Unclear riskIndividuals recruited from baseline survey so selection bias less likely
Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk"a randomly selected sample of employees who reported on the 24-month survey that they had not smoked or used nicotine-containing products in the previous 7 days were contacted by telephone and asked to provide saliva samples to test for cotinine," but no correction made based on results from biochemical validation.
Incomplete outcome data (attrition bias)
All outcomes
Low riskResults based on respondents only. Does not contribute to MA

Hollis 2007

MethodsSetting: Quitline, Oregon, USA
Recruitment: callers to quitline
Participants4500 smokers willing to make a quit attempt; 60% F, av. age 41, av.cigs/day 22
InterventionsFactorial design; 3 levels of counselling, +/- offer of nicotine patch (5 wk supply, 80% accepted, option for 3 wks more, 25 - 28% requested)
1. Brief counselling (usual care), 15 mins + referral information & tailored S-H
2. Moderate TC: 30 - 40 min MI, brief call to encourage use of community services, tailored S-H.
3. Intensive; as 2, plus offer of up to 4 further calls (Free & Clear)
OutcomesAbstinence > 30 days at 12m
Validation: none
Notes2&3 +/- NRT combined vs 1 in comparison 1. First included as Hollis 2005 based on unpublished abstract. Offer of NRT increased mean number of calls and contact time. 1 session, 20 mins in brief no-NRT, 2.9 sessions, 60 mins in Intensive + NRT
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk69% reached at 12m. Losses assumed smoking in main analysis, sensitivity analyses reported.

Holmes-Rovner 2008

MethodsSetting: 5 hospitals, Michigan, USA
Recruitment: Inpatients with acute coronary syndrome, not selected for motivation
Participants525 patients including 136 who smoked at admission and could be followed up. Smoker demographics not given.
Interventions1. In-hospital care according to American College of Cardiology Guideline Applied to Practice quality improvement (QI) programme including written discharge contract.
2. Heart After-Hospital Recovery Planner (HARP), 6 session telephone coaching, 15 - 30-min weekly sessions initiated 0 - 4 wks postdischarge. Pharmacotherapy encouraged for cessation. Intervention could address multiple behaviours.
OutcomesAbstinence at 8m ("remained quit for the period")
Validation: none
NotesComparisons 4 - 6. Data on smoking outcomes provided by authors from in Press paper by Holtrop et al.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskBlocked randomization, method not described
Allocation concealment (selection bias)Unclear riskChange in methodology from randomization at recruitment/consent to randomization after baseline interview due to initial imbalance in numbers. Data collectors were blind to group
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk15 people whose smoking status not confirmed and 15 losses to follow-up excluded because group not stated. ITT analysis said not to alter results

Joyce 2008

MethodsSetting: 7 states, USA
Recruitment: Smokers responding to mailings and media coverage of new service for Medicare beneficiaries
Participants7354 smoking Medicare beneficiaries aged 65+ (4295 contribute to review), ˜60% F, ˜69% contemplation, 30% preparation
InterventionsTrial of 4 levels of Medicare benefit. All participants mailed a S-H kit
1. Usual care (not used in MA)
2. Provider counselling benefit; up to 4 sessions of 3 - 10 mins of stage-based counselling (not used in MA)
3. As 2 plus Pharmacotherapy benefit; nicotine patch or bupropion for USD 5 co-pay, up to 2 x 12 wk courses
4. Quitline benefit; choice of a reactive hotline with prerecorded messages/ad hoc counselling, or a proactive helpline of up to 5 calls per 12-wk cycle, up to 2 cycles in the year. Also S-H manual and coverage for nicotine patch for USD 5 co-pay
OutcomesAbstinence at 12m (7-day PP)
Validation: none
NotesMain comparison 4 vs 3, which had similar levels of self-reported use of any pharmacotherapy (60% vs 63.4%). Participants were not called unless they enrolled, so treated as trial of quitline availability, estimated effect displayed in Analysis 3
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster-randomized, states divided into quarters balancing smoking prevalence & aged, restricted randomization to different conditions
Allocation concealment (selection bias)Unclear riskParticipants unaware of programme differences when enrolling and allocation determined by address. Low enrolment in one condition does not seem to have been due to bias.
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk25% lost to follow-up at 12m, absolute differences between groups small. Main analysis includes losses as smokers

Katz 2004

MethodsSetting: 8 primary care clinics, USA
Recruitment: smokers attending for non-emergency visits
Participants1141 smokers (> 1 cig/day) 56% F, age 43/40, median cigs/day 20/15
Interventions1. Intervention based on AHRQ guidelines. Training in brief advice for intake clinicians, vital signs stamp. People willing to set TQD offered proactive TC (2 calls, pre- & post-TQD) by trained nurse, smokers of > 10 cigs/day offered NRT
2. Control. Information about guidelines, no specific advice on counselling.
OutcomesSustained abstinence at 2m & 6m
Validation: saliva cotinine. Poor response, similar return & misreport rates. Validated sustained rates not reported.
NotesTC part of a multicomponent intervention, not included in MA. Study also included a baseline assessment. Data from smokers recruited during implementation period used here.
29% used NRT in intervention versus 11% in control.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster-randomized by clinic, method not described
Allocation concealment (selection bias)Low riskParticipants enrolled by completing an exit interview with researcher.
Blinding of outcome assessment (detection bias)
All outcomes
High risk"Because of the poor return rate of saliva specimens for cotinine analysis and the possibility of nonresponse bias for reasons unrelated to smoking status, we used self-reported abstinence as the primary outcome at both the 2- and 6-month assessments."
Incomplete outcome data (attrition bias)
All outcomes
Low risk4 - 8% lost to follow-up

Lando 1992

MethodsSetting: community, Minnesota, USA
Recruitment: from 4 groups of previously identified smokers
Participants1827 smokers, not selected by motivation to quit; 50% F, av. age 47, av. cigs/day 22
Interventions1. Proactive TC, 2 calls over 3 wks. Offered S-H materials
2. No intervention, contacted at follow-up only
OutcomesAbstinence at 18m (no puff, > 3m and validated abstinent at 6m)
Validation: Saliva cotinine <10 ng/ml at 6m
NotesComparisons 4 - 6.
High level of cotinine disconfirmation. 70% agreed to second call.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskMinimal contact intervention, likelihood of bias small but since control group participants were not contacted at baseline and a large number of intervention group participants could not be reached, impossible to compare baseline characteristics
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo biochemical validation at 18m. At 6m, validated abstinence rates "considerably lower" than self report.
Incomplete outcome data (attrition bias)
All outcomes
Low riskOnly a sample of intervention and control participants were selected for follow-up. Of this sample 91% reached at 18m in both groups. Numbers followed up used as denominator in MA

Lando 1997

MethodsSetting: Health Maintenance Organisation, USA
Recruitment: physician referral and HMO clinic newsletters
Participants509 smokers of > 20 cigs/day, motivated to quit; 56% F, av. age 42, av. cigs/day 28
InterventionsAll participants received prescriptions for free nicotine patch (Prostep), 22 mg for a maximum of 6 wks plus 2 wks 11 mg. Proactive vs Reactive
Attended 90-mins group orientation session describing study, use of patch, behavioural information, set quit date. Standard written materials with patch included description of a toll-free telephone help line.
1. No further support
2. Orientation session included encouragement to call toll-free number and a registration card
3. Additional proactive TC, 4 10 - 15-min calls (approx 1, 4, 7 - 9, 12 wks from quit date). Reinforced success or negotiated a new quit date
OutcomesAbstinence at 12m (from quit date)
Validation: CO at 6m. 96% of quitters were confirmed.
NotesComparisons 4-6, 3 vs 1+2, effect of proactive TC compared to contact & quitline alone. (1 & 2 combined since fewer than 1% called quitline and no difference between quit rates). Participants who did not return questionnaires at 2, 5, 8, 12 wks were called by telephone.
Average number of calls completed 3.76
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster-randomized, method not described
Allocation concealment (selection bias)Unclear riskAllocation by orientation session attended; participants did not know condition in advance so risk of selection bias probably low
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemically validated quit rates
Incomplete outcome data (attrition bias)
All outcomes
Low risk82% response rate at 12m, no difference between groups, missing treated as smoking

Lichtenstein 2000

MethodsSetting: community, USA
Recruitment: active; via electric utility mailing to identify households with smokers and low radon concentrations
Participants1006 smokers in 714 households (651 in relevant arms); av. cigs/day 20
Interventions1. Standard Environmental Protection Agency leaflet on risks of radon (this arm not used in review)
2. Pamphlet highlighting risk of smoking in low concentrations of radon, with tips for quitting, or not smoking indoors
3. Pamphlet as 2, plus up to 2 brief (mean about 6 mins) proactive TC sessions
OutcomesAbstinence at 12m (sustained at 3m, 12m)
Validation: none
NotesComparisons 4 - 6. 3 vs 2, effect of TC versus S-H alone
Cluster randomization, 54% of smokers lived with another smoker. Intraclass correlation coefficient for sustained abstinence was .010. Analyses did not correct for this. 82% received at least 1 call, 40% > 1. Mean (SD) duration 10.4 (5.4) in for 1st call, 5.8 (4.9) for 2nd.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized by household, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk80% of households reached at 3 & 12m, no difference across conditions. Missing treated as smoking

Lichtenstein 2008

MethodsSetting: Community, USA
Recruitment: active; via electric utility mailing with offer of radon test kit to identify households with smokers.
Participants1364 households with 1821 smokers, ˜18 cigs/day
InterventionsFactorial design crossing +/- brief phone counselling with 15-min video S-H materials. All households given A Citizens Guide to Radon and letter tailored to results of radon level test
1. 1 - 2 calls after receipt of radon test results. Clarified risk and encouraged quitting or no smoking in house. Second call scheduled if interest
2. No calls
OutcomesAbstinence at 12m, sustained at 3 & 12m
Validation: none
NotesComparisons 4 - 6. Results of analyses accounting for clustering of multiple smokers in households reported to yield results generally consistent with simple analyses.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskResponding households sequentially randomized to 4 conditions subject to stratification on radon test status
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk83% of households completed 12m assessment, 76% completed both 3 & 12m

Lipkus 1999

MethodsSetting: Health centre, USA
Recruitment: from telephone survey of patients
ParticipantsLow-income African-American smokers, 266 randomized, 160 followed up, 107 in relevant arms. Unselected by motivation; 52% F, 49% aged > 50
Interventions1. Physician prompts attached to chart (included other screening tests). Providers trained to use 4As (Ask/ Advise/ Assist/ Arrange follow-up) model. Only received if participants visited doctor
2. As 1, plus 1 mailing of tailored print communication around birthday
3. As 2, plus proactive TC; 1 or 2 (for women also due other screening), stage-based, barriers and reasons for quitting, approx 6 mins.
OutcomesAbstinence 16m after last intervention, 30-day quit
Validation: none
NotesComparisons 4 - 6. 3 vs 2, TC without face-to-face contact; physician advice was not an integral part of the intervention - participants not required to have visited the doctor or received advice during the intervention period.
Provider compliance reported to be 48%
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk38% loss to follow-up primarily due to disconnected phone numbers. Reported rates based on numbers followed up. Authors report that an analysis with missing treated as smoking did not alter findings

Lipkus 2004

MethodsSetting: community, USA
Recruitment: proactive in shopping malls
Participants412 teen smokers (aged 15 - 18, smoked in past 7 days); 51% F, 56% aged ≥ 17, av cigs/day 10, 21% contemplation
Interventions1. S-H, 2 booklets for teen smokers & video
2. as 1, plus proactive TC, 3 calls (12 - 15 mins) using MI and problem solving
OutcomesAbstinence at 8m (7-day PP at 4m & 8m)
Validation method: Saliva cotinine ≤ 10 ng/mL at 4m only. Low response, high failure to confirm. Abstinence based on self report only
NotesComparisons 4 - 6. TC as adjunct to targeted S-H. 72% received at least 1 call, 52% at least 5, 36% at least 3.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described, stratified by SoC
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskBiochemical validation done but final outcome figures based on self report only. High failure to confirm and low response rate.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk46% Int & 51% Cont reached at both follow-ups. Losses included as smokers.

MacLeod 2003

MethodsSetting: community, Australia
Recruitment: Community volunteers
Participants854 smokers interested in quitting; 51% F, av. age 42, av. cigs/day 24
Interventions1. Free 2-wk supply of nicotine patch by mail, instructed to purchase further supply. 14 or 21 mg depending on body weight.
2. As 1. + 5 proactive TC sessions at 1, 2, 3, 6 & 10 wks. 20-min session 1, 10 min others. Toll-free hotline, S-H materials.
OutcomesAbstinence at 6m (90-day continuous)
Validation: none, warning of CO test only.
NotesComparisons 4 - 6, TC as adjunct to NRT
Average number of calls 4.7. 9% of participants called hotline
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk'randomized' by shuffling folders each day after participants to be included were listed
Allocation concealment (selection bias)High riskPotential for bias since allocation sequence not fixed in advance. Baseline characteristics similar across groups
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"To minimise misleading reports of abstinence, a bogus pipeline technique was used, with the possibility of carbon monoxide breath testing mentioned in the consent form and at the 3- and 6-month monitoring calls."
Incomplete outcome data (attrition bias)
All outcomes
Low risk17% lost in NRT only, 15% in + counselling. Missing treated as smoking in MA

McBride 1999a

MethodsSetting: Health Maintenance Organisation, USA
Recruitment: active; health survey of women following a cervical smear (pap) test
Participants580 F current smokers, not selected for motivation to quit; av. age 36, av. cigs/day 13
Interventions1. Usual care - no smoking cessation intervention
2. Mailed cessation kit, letter personalised to SoC and quit motivation, proactive TC, 3 counselling calls (13 - 15 min) 2 wks after mailing then monthly. Motivational- & stage-based.
OutcomesAbstinence at 15m (7 day at 6m & 15m), telephone interview
Validation: saliva cotinine < 20 ng/ml, quit rates not corrected, low level of misreport
NotesComparisons 4 - 6. Effect of TC and S-H materials compared to no intervention
Counsellor discussed smoking and cervical cancer but not individual's pap results. > 80% received at least 1 call, 60% all 3.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not stated, stratified on test result
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation, quit rates not corrected but low level of misreport and "no differences between the two groups in the proportion of women who returned samples, the proportion confirmed/disconfirmed, or the confirmation rate."
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up at 15m 20% in Int, 18% in Cont. Losses included as smokers.

McBride 1999b

MethodsSetting: 2 Health Maintenance Organisations, USA
Recruitment: pregnant women who had booked a prenatal appointment, by mail
Participants897 pregnant smokers & recent quitters (44% already quit) not selected for motivation to quit; av. age 28, av. cigs/day 15 before pregnancy, 5 if still smoking
Interventions1. S-H booklet only
2. Prepartum intervention: 3 proactive TC calls av 8½ mins, approx 2 wks after S-H mailing, and 1m & 2m later. Tailored letter, S-H book. After 28-wk follow-up sent relapse prevention kit.
3. Pre- & postpartum intervention: as 2, plus 3 calls within first 4m postpartum, av 7.7 mins. 3 newsletters
OutcomesAbstinence at 12m postpartum (7 day PP)
Validation: Saliva cotinine requested by mail, < 20 ng/mL. Self-reported rates used in analyses, no difference in confirmation rates between groups
NotesComparisons 4 - 6. 3+2 vs 1, effect of TC versus S-H only
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used, not reported: "since there were no between-group differences in the proportion of saliva samples returned or the proportion confirmed, the primary trial outcomes were based on self-reported smoking status."
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up 13% at 12m, not different by group, losses included as smokers

McBride 2004

MethodsSetting: Army Medical Centre, USA
Recruitment: pregnant women at first prenatal visit
Participants583 pregnant F current smokers and recent quitters (390 in relevant arms); av. age 24
Interventions1. Usual care - provider advice and S-H guide
2. As 1, plus 6 proactive TC calls, 3 in pregnancy, 3 postpartum within 4m + late pregnancy relapse prevention kit
3. Partner-assisted intervention, not used in this review
OutcomesAbstinence at 12m postpartum (PP at all 4 follow-ups)
Validation: Saliva cotinine request, incomplete return, rates based on self report.
NotesComparisons 4 - 6, effect of TC as adjunct to brief advice
Effect at 6m not sustained longer term. Mean number of calls received 5
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described, stratified by smoking status
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBiochemical validation conducted but not used in outcome data. "Saliva return rates did not differ by condition at either follow-up," but rates of return low and level of misreport not specified.
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up higher in Int (22%) than Cont (16%). Losses included as smokers

McClure 2005

MethodsSetting: Health Maintenance Organisation, USA
Recruitment: women with an abnormal cervical smear or colposcopy
Participants275 F smokers, not selected for motivation to quit; av. age 33, av. cigs/day 14
Interventions1. Usual care, S-H, contact details for Free & Clear, a covered benefit
2. As 1, plus up to 4 x 15-min proactive TC calls over 6m.
OutcomesAbstinence at 12m (PP)
Validation: Cotinine saliva strip test, but judged over-conservative so self report used. Relative effect not altered
NotesComparisons 4 - 6. Effect of TC versus S-H only
82% completed all 4 calls, 90% 3 or 4. Mean duration 16 mins
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBogus pipeline for short follow-up, biochemical validation at 12m. Results from saliva strip test judged overly conservative, hence self report used in final outcome data, but relative effect not altered.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo information on numbers not reached at follow-up. All participants included in analysis

McClure 2011

Methods

Setting: Pacific Northwest, USA

Recruitment: members of large regional health plan identified through automated records

Participants52 adults with evidence of smoking in last year, depression in last 2 years, and without high levels of physical activity. 67% F; av.age 44.5; av. cigs/day 10.6; av. FTND 2.37
Interventions

1. Intervention: usual care + phone-based Step Up proactive counselling program (1 motivational call, 9 weekly CBT calls and 2 follow-up ‘booster calls’ according to participant need)

2. Control: usual care treatment for depression, smoking and physical activity (incl. S-H material and referral information for phone-based smoking cessation programme)

Outcomes

7-day PP at 6m, 3m also recorded

Validation: none

Notes

New for 2013 update. Analyses 4 - 6. Pilot study of an intervention also addressing physical activity and depression

Number abstinent not provided and hence extrapolated from percentages given

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"randomly assigned," stratified by baseline antidepressant use". Method of sequence generation not specified
Allocation concealment (selection bias)Unclear riskMethod not specified
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcome, participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low riskParticipants lost to follow-up counted as smokers, similar numbers lost in each group (4/27 intervention, 2/25 control)

McFall 1993

MethodsSetting: community, USA
Recruitment: Registrants for a S-H TV programme who received manual or watched at least 1 programme
Participants1745 smokers; 70% F, 23% age 18 - 30, 40% age 31 - 45, 30% 45 - 64
Interventions1. TV programme and S-H manual (ALA Freedom From Smoking in 20 Days)
2. As 1, plus 10 newsletters over 6m following programme with details of hotline with taped messages and counsellors
OutcomesAbstinence at 24m (7-day)
Validation: none
NotesEffect of access to hotline combined with S-H materials for maintenance of cessation. Estimated effect displayed in comparison 3
Use of the hotline was low - only 7% called and spoke to a counsellor
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk24% lost in maintenance condition, 27% in control. MA includes only responders; Including losses would give less conservative effect.

Metz 2007

MethodsSetting: 13 rehabilitation centres, Germany
Recruitment: recent smokers having rehabilitation, not formally selected for motivation
Participants290 smokers; 41% F, av. age 47, av cigs/day 15, control group significantly more dependent
InterventionsAll participants had inpatient group therapy of 7 x 60-min sessions. ˜26% abstinent at discharge
1. Telephone boosters; 5 x ˜10-min proactive calls over 10 wks from female psychologists (not original therapist)
2. No boosters
OutcomesAbstinence at 12m (PP)
Validation: none
NotesComparisons 4 - 6, effect of TC as adjunct to intensive support
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, 1:2 ratio, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk17/316 randomized to I excluded, no contact postdischarge. Differential drop-out from remainder, 17% Int, 40% Cont. No detected differences in characteristics of drop-outs. Sensitivity analyses excluding losses to follow-up removes significance

Miguez 2002

MethodsSetting: community, Spain
Recruitment: volunteers interested in quitting
Participants200 smokers; 38% F, av. age 35, av cigs/day 28
Interventions1. Proactive TC, 6 x weekly 10-min calls. 4 on motivation & cessation, 2 on maintenance, + S-H
2. S-H only. Personalised intro letter, manual & 6 similar mailing with self-monitoring and self-evaluation forms
OutcomesAbstinence at 12m (not even a puff since quitting)
Validation: CO at 12m
NotesComparisons 4 - 6. 10-year follow-up reported in 2008, not used in MA.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo information on numbers not reached at follow-up. All participants included in analysis

Miguez 2008

MethodsSetting: Community, Spain
Recruitment: volunteers interested in quitting
Participants228 smokers of ≥10 cigs/day; 46% F, av. age 37, av. cigs/day 27, 44% had prior year quit attempt
Interventions1. Mailed S-H programme; 6 weekly manuals, quit date intended to be set at end of wk 4
2. As 1. + single proactive 5-10 min counsellor call in wk 4, to increase motivation & adherence
OutcomesAbstinence at 12m (sustained since end of treatment)
Validation: none ('bogus pipeline' warning)
NotesComparisons 4 - 6.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Telephone interviews were conducted by a trainer interviewer who was blind with respect to the group to which each subject was assigned. To improve the reliability of these self-reports of smoking status, all follow-up questionnaires and interviews commenced with a reminder that the subject might at some point be asked to undergo a carbon monoxide test."
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskMissing data treated as failure, no statement of numbers lost to follow-up

Miller 1997

MethodsSetting: Hospitals, USA
Recruitment: Inpatient smokers (excl those with no intention of quitting, or wishing to quit unaided)
Participants1942 smokers (excludes deaths); 49% F, av. age 51, av cigs/day 20
InterventionsAll groups received standardised physician advice
1. Intensive intervention: 30-min nurse face-to-face counselling, proactive TC, 4 at 48 hrs postdischarge, 7, 21, 90 days, optional session for relapsers
2. Minimal: 30-min counselling + 1 phone call at 48 hrs
3. Usual care (not used in review)
OutcomesAbstinence at 12m (sustained at 3m, 6m, 12m)
(Paper also reports 12m PP confirmed and self-reported cessation rates)
Validation: saliva cotinine < 15 ng/ml, or family member verification
NotesEffect of additional telephone follow-up. Not pooled. Intensive intervention was significantly better than usual care for confirmed PP 12m abstinence, other differences not significant
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Low risk"Nurses opened sealed envelopes in front of patients".
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation; verification by family member used when biochemical validation not possible.
Incomplete outcome data (attrition bias)
All outcomes
Low riskNumber lost to follow-up not specified, all randomized participants, excluding 82 deaths, included in analyses

Ockene 1991

MethodsSetting: Primary care clinics, USA
Recruitment: clinic attenders, not selected for interest in quitting
Participants1223 smokers (excludes deaths and 237 who did not receive intervention); 57% F, av. age 35, av. cigs/day 23
Interventions2 x 3 factorial design, physician intervention +/- follow-up
(a) AO: Physician advice only
(b) CI: Physician-provided patient-centered counselling, written agreement and schedule follow-up, letter.
(c). CI+NCG: as (b), plus informed of availability of free nicotine gum.
1. Follow-up counselling by psychologist or health educator, 3 calls (1, 2, 3m) approx 10 mins, behavioural recommendations. Letters
2. No follow-up
OutcomesAbstinence at 6m (7-day); (3m sustained abstinence rates not given by condition)
Validation: none
NotesComparisons 4 - 6, 1 vs 2, AO and CI effect of TC in addition to physician intervention. NCG arm in pharmacotherapy adjunct, both pooled in intensity and motivation subgroup analyses. 12m abstinence rates reported in Ockene 1994 but not given by follow-up condition
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskAllocated prior to physician encounter
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk19% lost to follow-up, higher in telephone follow-up group. All included as smokers in analysis

Orleans 1991

MethodsSetting: Health Maintenance Organisation, USA
Recruitment: Largely through publicity in HMO magazine
Participants2021 smokers of 3+ cigs/day, wanting to quit (1412 in relevant arms); 63% F, av. age 44, av. cigs/day 26
Interventions1. S-H manual, Quit Kit and ALA Lifetime of Freedom from Smoking
2. Same materials as 1, plus 2 copies of a social support guide.
3. Same as 2, plus proactive TC (6, 18, 34, 60 wks) from a counsellor and invitation to call a quit line
4. Control - Referral guide
OutcomesAbstinence at 16m for > 6m, by blinded telephone interview.
Validation: Saliva cotinine < 10 ng/ml, or thiocyanate < 2400 umol/l for gum users. Self-report rates reported in analyses
NotesComparisons 4 - 6. 3 vs 1+2, effect of telephone counselling compared to S-H materials alone. (No significant difference between 1 and 2)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described, stratified by living alone/not, advice to quit in last 12m/not and nicotine content of cig.brand
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation in sample at 16m; "to improve the veracity of smoking  self-report, all follow-up questionnaires and interviews began with a reminder that the subjects might be asked for a saliva specimen for nicotine assessment, creating a sort of “bogus pipeline”"
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up 6% at 16m, did not differ across treatment groups. Analyses based on respondents; including losses would marginally increase estimated effect

Orleans 1998

MethodsSetting: community, USA
Recruitment: African-American smokers calling the NCIS telephone counselling line in response to targeted campaign
Participants1422 African-American smokers; 64% F, av. age not stated, 62% in 20 - 39 age group, median cigs/day 20
InterventionsReactive, for callers to quitline
1. Tailored TC and tailored 36-page Pathways to Freedom guide. Guide used African-American models and addressed specific obstacles. Personalised quitting plan.
2. Standard NCIS telephone counselling and standard guide Clearing the Air
OutcomesAbstinence at 6m, 7-day PP
Validation: none
(12m abstinence also assessed in sample of 445 smokers and there were significant differences; 15.0% vs 8.8% using ITT.)
NotesComparison 2, between 2 types of counselling. Also included in Cochrane Self-help review since effects of counselling and S-H materials cannot be separated.
Median call length 19 mins (interdecile range 10 - 28 min) for tailored, 13 min (8 - 23) for standard
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskPseudo-randomized by last digit of caller's contact phone number
Allocation concealment (selection bias)High riskPotential for selection bias but unlikely given low contact
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk37% lost to follow-up at 6m. No differential drop-out, losses included as smokers.

Osinubi 2003

MethodsSetting: occupational health service, USA
Recruitment: asbestos-exposed workers and retirees attending medical screening, not selected for motivation
Participants58 smokers; 93% M, av. age 52, av.cigs/day 22
InterventionsAll participants received brief physician advice at screening
1. Enrolment in Free & Clear, proactive TC, 5 calls, hotline access, pharmacotherapy available
2. Instructions to obtain support from personal physician, S-H materials & resources
OutcomesAbstinence at 6m, 30 day PP, telephone
Validation: none
NotesComparisons 4 - 6
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskSealed envelopes, not stated if opaque and numbered
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk32% lost to follow-up comparable across groups, losses included as smokers

Ossip-Klein 1991

MethodsSetting: 10 counties, USA
Recruitment: Media advertising, local sign-ons, brochures.
Participants1813 smokers planning to quit within 3m; av. age 43, av. cigs/day 28
Therapists (hotline): ex-smoker counsellors
InterventionsReactive
1. ALA S-H manuals.
2. as 1, plus materials promoting 24-hr hotline with daytime access to counsellors.
OutcomesAbstinence at 18m, sustained from 3m.
Validation: by significant other for 90% of claims, saliva cotinine for 52% of claims. Cotinine-validated rates used.
NotesThe authors report a range of analyses based on alternative measures of smoking status and using logistic regression to allow for cluster randomization. The higher quit rate in the hotline counties was consistent in all analyses. 36% called hotline, 8.7% spoke with counsellors. Estimated effect displayed in comparison 3
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMatched pairs of counties assigned to condition in a restricted procedure to minimise media spill-over.
Allocation concealment (selection bias)Unclear riskParticipant recruitment not linked to county assignment so selection bias unlikely
Blinding of outcome assessment (detection bias)
All outcomes
Low riskSelf-reported abstinence verified by significant other and/or saliva cotinine
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow-up over 90% at all points and did not differ by condition

Ossip-Klein 1997

MethodsSetting: community, USA
Recruitment: Advertising for S-H cessation for over 60 yr-olds
Participants177 smokers aged ≥ 60, planning to quit in next 3m; 61% F, av. cigs/day 25
Interventions1. S-H manual (Clear Horizons), access to 24-hr hotline, 2 letters of support and hotline reminders
2. As 1, plus proactive TC, 2 calls at 4 & 8 wks. Counsellors followed structured format to provide strategies based on SoC.
OutcomesAbstinence at 6m (7-day PP)
Validation: no biochemical. Significant others only. Refusals and non-confirmations classified as smokers.
NotesComparisons 4 - 6. 42% had called hotline and 17.5% spoken to counsellor by 6m.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskValidation by significant other, number refused/misreported not specified.
Incomplete outcome data (attrition bias)
All outcomes
Low risk97% reached at 12m

Prochaska 1993

MethodsSetting: community, USA
Recruitment: Advertisements for volunteers to test S-H materials, not selected for motivation
Participants756 smokers (12% precontemplation, 58% contemplation, 30% preparation) (378 in relevant arms); 62% F, av. age 43, av. cigs/day 27
Interventions1. ALA S-H manuals
2. Tailored manuals - 5 covering precontemplation, contemplation, action, maintenance, relapse. Participants sent manual for their SoC and subsequent ones.
3. Interactive - in addition to tailored manuals, sent personally tailored reports in response to questionnaires
4. Proactive TC - short (15-min) calls at 0, 1m, 3m, 6m. Materials as in 3.
OutcomesSustained abstinence at 18m (12m & 18m)
Validation: none. Participants asked for names of significant others but these not contacted
NotesComparisons 4 - 6. 4 vs 3, TC vs S-H alone. Numbers randomized to groups and quit rates as shown in graphs obtained from authors.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described, stratified by SoC
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Bogus pipeline" approach; names of significant others asked for but not contacted.
Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition at each assessment averaged 4.1% - 7.1% across all treatment conditions, not significantly different. 70% provided data at every assessment. MA uses numbers randomized, sensitivity analysis does not alter conclusions

Prochaska 2001

MethodsSetting: Managed care organization, USA
Recruitment: active; smokers identified by survey of members. 85% recruited to a study, unselected for motivation to quit
Participants1447 smokers (723 in comparisons used); 38% were precontemplators, 56% F, av. age 38, av. cigs/day 20
Interventions1. Assessment only (completed questionnaires on 4 occasions)
2. Expert System S-H. Tailored 2 - 3 page report at 0, 3m, 6m and SoC matched manual
3. As 2, plus proactive TC, short calls at 0, 3m, 6m. Similar to Prochaska 1993 protocol but more emphasis on alternative targets for those unwilling to set quit date.
4. As 3, plus computer-scheduled cig reduction.
OutcomesAbstinence at 18m, sustained for 6m. (Other measures of abstinence also reported)
Validation: None
NotesComparisons 4 - 6. 3 vs 2, TC vs S-H alone. Other arms compared in Self-help review
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low riskGreater loss to follow-up in TC (44%) than S-H (38%). Denominators here include losses to follow-up and refusals. Author analysis suggests this treatment of missing data is biased, but sensitivity analysis excluding losses & refusals does not alter our MA conclusions.

Rabius 2004

MethodsSetting: Quitline, USA
Recruitment: callers to quitline
Participants3522 smokers willing to make a quit attempt within 2 wks
(≤ 25/ > 25): 61%/67% F, av.age 22/44, av. cigs/day 24/18
Interventions1. 3 American Cancer Society S-H booklets
2. As 1, plus offer of 5 proactive TC calls, 2 before TQD, 3 within 2 wks
OutcomesAbstinence at 6m (sustained). Only people abstinent at 3m followed at 6m.
Validation: none for most, small local sample tested, no responders disconfirmed, 4/19 did not attend (reported in McAlister 2004)
NotesComparison 1. 58% did not complete more than 1 session of counselling (McAlister paper)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Low riskSmall local sample biochemically tested, no responders disconfirmed.
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up 50% in Int, 55% in Cont (from McAlister paper). Differed by age - higher loss in younger participants. All losses treated as smokers

Rabius 2007

MethodsSetting: National Cancer Society quitline, USA
Recruitment: Callers to NCIS, interested in quitting
Participants6322 smokers; 70% F, av. age 43, median cigs/day 20
Interventions¼ allocated to S-H control, remainder into 3 x 2 factorial design
Counselling conditions:
1. 5 sessions, 210 mins (35 - 45 min calls 10 - 14 days pre-quit, 2 - 3 days pre-quit, 1 - 2 days, 6 - 9 days, 13 - 16 days post-quit)
2. 3 sessions with 105 mins counselling (As 1 omitting 1st & last sessions)
3. 5 sessions with 50 mins counselling (Schedule as 1, 10 mins duration)
Booster conditions: 2 x 15-min calls at 4 & 8 wks after last counselling call
OutcomesAbstinence at 7m postrandomization (PP)
Validation: none
NotesAll interventions pooled vs control in comparison 1, results of different intensities discussed in more detail in text
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random number sequence without stratification
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up ˜50%, similar in all groups. Analysis includes losses as smokers.

Reid 1999

MethodsSetting: community, Canada
Recruitment: community volunteers
Participants396 smokers interested in quitting within 30 days, smoking ≥ 15 cigs/day; 48% F, av. age 38, av. cigs/day 23 - 24
Interventions1. Nicotine patch (15 mg x 8 wks, 10 mg x 2 wks, 5 mg x 2 wks) free, physician advice (x 3 15-min, 2 wks before, 4 wks, 12 wks after quit date)
2. As 1, plus proactive TC, nurse counsellors, stage-based, 3 sessions at 2, 6, 13 wks.
OutcomesAbstinence at 12m (PP)
Validation: CO, but self-reported rates reported. Only 1 disconfirmation
NotesComparisons 4 - 6, effect of adjunct TC compared to NRT and counselling alone.
Similar counselling scripts to Orleans 1991
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized using table of random numbers, stratified by gender and nicotine dependence
Allocation concealment (selection bias)Unclear riskConcealment unclear but physician blind to allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low risk'Bogus pipeline' procedures used for early follow-ups; proportion of participants who provided breath samples did not differ between two groups; only one misreport identified; adjustment of abstinence rates for validation did not affect conclusions.
Incomplete outcome data (attrition bias)
All outcomes
Low risk15% lost/dropped out in each groups, included as smokers

Reid 2007

MethodsSetting: tertiary care cardiac hospital, Canada
Recruitment: inpatients with CHD, not explicitly selected by motivation, 90% of eligible enrolled
Participants100 smokers; 32% F, av. age 54, 48% quit attempt in previous year
InterventionsAll participants received in-hospital brief counselling, access to NRT, S-H materials
1. Interactive Voice Response (IVR) system contacted participants 3, 14 & 30 days post-hospital discharge. Patients identified as needing support contacted by nurse counsellor for up to 3 x 20-min sessions over 8 wks
2. Usual care
OutcomesAbstinence at 1 year (PP)
Validation: none
NotesComparisons 4 - 6, mean 2.1 IVR calls completed, 46% received at least 1 counselling call, mean 1.8, so total calls categorised as 4
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"mediated through the Clinical Epidemiology Unit’s data centre, using a computer generated randomization list" Block size 6
Allocation concealment (selection bias)Low risk"Research staff were unaware of the treatment allocation prior to randomization"
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk˜15% lost to follow-up, similar between groups. 1 Cont death excluded, others included

Rigotti 2006

MethodsSetting: Prenatal care services, USA
Recruitment: Pregnant women in a managed care plan or referred by a care provider, not selected by motivation
Participants442 pregnant women smoking at least 1 cig in previous 7 days; av. age 29, av. cigs/day 21 prior to pregnancy, 10 at recruitment, 84% planned to quit
InterventionsAll participants received brief counselling at enrolment call & mailed a pregnancy-tailored S-H booklet
1. Proactive counselling, up to 90 mins during pregnancy & 15 mins postpartum & targeted written materials
2. Usual care
OutcomesAbstinence 3m postpartum (sustained at end of pregnancy & 3m)
Validation: saliva cotinine ≤ 20 ng/mL
NotesComparisons 4 - 6. Mean of 5 calls received, 4 in pregnancy, av. 68 mins in total.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"computer-generated randomization list arranged in balanced blocks of 4 and stratified by referral source"
Allocation concealment (selection bias)Low risk"... the application revealed the next assignment only after the smoker had consented to participate in the study"
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation; those who failed biochemical validation or did not provide a sample counted as smokers
Incomplete outcome data (attrition bias)
All outcomes
Low risk21 miscarriages excluded. 33% Int, 28% Cont lost to follow-up, included as smokers.

Rimer 1994

MethodsSetting: community, USA
Recruitment: volunteers from American Association for Retired Persons
Participants1867 smokers aged 50 - 75 (12m data based on 1391, 1225 in relevant arms) interested in finding out about quitting; 63% F, av age 61, av cigs/day 27
Interventions1. Standard S-H manual (not included in this review)
2. S-H manual tailored for older smokers (Clear Horizons)
3. Tailored manual and 2 x 10-15-min proactive TC at 4 - 8 wks and 16 - 20 wks. Also access to a quitline
OutcomesAbstinence at 12m.
Validation: none
NotesComparisons 4 - 6. 3 vs 2. Preliminary 12m results used.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk˜75% reached at 12m with no treatment group differences in follow-up rate

Roski 2003

MethodsSetting: 40 clinics, USA
Recruitment: smokers identified by survey
Participants3436 smokers identified by survey, 2729 followed up, 1664 in relevant arms
InterventionsAccess to proactive service
1. Financial incentives for clinical performance targets
2. As 1, plus smoker registry allowing referral to proactive TC for smokers ready to quit; 7 calls over 2m.
(Control arm not included in review)
OutcomesAbstinence at 6m for 7 days
Validation: none
NotesDoes not contribute to MA. Test of providing TC to increase provider adherence to guidelines. Most of the smokers surveyed did not report use of counselling services
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster-randomized by clinic, method not stated
Allocation concealment (selection bias)Unclear riskSmokers identified by survey, selection bias unlikely
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk80.5% response to telephone survey, no difference by condition

Sims 2013

Methods

Setting: Wisconsin, USA

Recruitment: young adult callers to the Wisconsin Tobacco Quit Line (WTQL)

Participants410 smokers age 18 to 24 years, smoked at least 1 cig in past 30 days and motivated to quit. 58% F; av.age 21.3 years, av. cigs/day 15
Interventions

1. S-H only, stage-based booklets

2. S-H + up to 4 proactive cessation counselling calls over 4 - 6 wks via the WTQL

Outcomes7-day PP at 6m (1m & 3m also reported)
NotesNew for 2013 update.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskList of random numbers
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskFollow-up interviewers unaware of assignment
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk53% not followed in Int, 50% in Cont. Missing treated as smoking. Responder analysis did not change results

Smith 2004

MethodsSetting: 10 communities, Canada
Recruitment: Volunteers calling a quitline
randomization: centralised, stratified by community, sequential envelope, random sequence
Participants632 smokers intending to quit; 61% F, av. age 42, 61% had prior use of NRT
InterventionsFactorial design comparing 2 intensities of TC and 2 types of S-H (collapsed in this review):
1. 50-min proactive TC, quit date set, 2 calls at 2 & 7 days post TQD
2. As 1, plus 4 further calls at 14, 21, 35, 40 days
3. Control: S-H only
OutcomesAbstinence at 12m, sustained at 3m & 6m follow-ups, also PP.
Validation: none
NotesAll TC arms compared to S-H only control in comparison 1.
Results not reported by factorial groups; "no significant interactions or main effects at any follow-up" no data from authors, estimate used in test of intensity. Findings sensitive to choice of outcome, control PP rates increase over time.
76% received at least 1 call, 22% of intensive condition received all calls, 56% of minimal condition received both calls
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, stratified by community, method not described
Allocation concealment (selection bias)Low risk"opening next in a series of envelopes' after enrolment"
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk30% not available at 12m, no difference across 5 groups, missing treated as smoking

Smith 2013

MethodsSeting: Quitline, USA
Recruitment: Quitline callers, motivated
Participants987 smokers, > 10 cigs/day, willing to set quit date within 30 days: av. age 42, av. cigs/day 21
Interventions

Factorial trial testing medication adherence counselling, 2 vs 6 wks NRT, and nicotine patch alone vs patch + gum.

All participants received the same standard TC: 4 sessions over 4 wks.

Medication adherence counselling involved additional content at each call assessing and addressing adherence

Outcomes

Abstinence at 6m (30-day PP). 7-day PP also reported

Validation: none

NotesNew for 2013. Not included in any meta-analysis as tested adjuncts to TC not the efficacy of TC. Results reported narratively.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskList of randomized numbers
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAssessors independent of quitline
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk24% lost at 6m follow-up, no difference across treatment groups

Solomon 2000

MethodsSetting: community, USA
Recruitment: volunteers for free nicotine patch trial
Participants214 F smokers, > 4 cigs/day, intending to quit in next 2 wks; av. age 33, av cigs/day 24
Interventions1. Free nicotine patch (dose based on smoking level) for up to 10 wks.
2. Free patch plus proactive TC from F ex-smoker, 7 hrs training. Calls for up to 3m, starting pre-quit, quit day, day 4, average 7.
OutcomesAbstinence at 6m (7 days at 3m & 6m)
Validation: CO ≤ 8ppm.
7% - 12% disconfirmation rate. Participants who did not provide samples remained classified as quitters
NotesComparisons 4 - 6. Intervention participants received an average of 7 calls. 95% received at least 1. Participants could call Nicoderm support line, 21% of control vs 8% of intervention did so.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskBiochemical validation but 7% - 12% disconfirmation rate. Differential rates of return at 6m (59% of self-reported quitters in intervention group and 67% in control). Participants who did not provide samples classified as quitters.
Incomplete outcome data (attrition bias)
All outcomes
Low risk˜27% lost in both groups, included as smokers

Solomon 2005

MethodsSetting: community, USA
Recruitment: volunteers for free nicotine patch trial
Participants330 female smokers > 4 cigs /day, intending to quit in next 2 wks; av. age 34, av. cigs/day 24
Interventions1. Free nicotine patch (dose based on smoking level) for up to 10 wks.
2. Free patch plus proactive TC from F ex-smoker, 7 hrs training. Calls for up to 4m, up to 12m, starting pre-quit, quit day, day 4
OutcomesAbstinence at 6m (30 days at 3m & 6m)
Validation: none
NotesComparisons 4 - 6, replication of Solomon 2000 with more extended telephone contact.
Average number of calls 8.2, average duration 10 min
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk13% lost to follow-up in both groups, included as smokers

Sood 2009

MethodsSetting: ALA Quitline, USA
Recruitment: Quitline callers
Participants990 callers; 62% F, av.age 43, av. cigs/day 22
Interventions1. Reactive counselling
2. Mailed S-H materials (Freedom from Smoking)
OutcomesAbstinence at 12m (PP)
Validation: Saliva cotinine only for convenience sample, refusals not recoded
NotesTest of different interventions for people calling a quitline. Comparison 2
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number list created by independent statistician
Allocation concealment (selection bias)Low riskEnrolment & assignment by researchers independent of helpline staff. Concealment until assigned
Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk"Interviewer assessing outcomes was blinded"; biochemical validation in a convenience sample (16/28 agreed); participants who did not agree to biochemical validation but self-reported abstinence counted as abstinent
Incomplete outcome data (attrition bias)
All outcomes
Low risk47% loss to follow-up, similar across groups, included as smokers.

Sorensen 2007a

MethodsSetting: Workplaces, USA
Recruitment: members of LIUNA (construction workers union), included non-smokers
Participants231 smokers completed baseline survey. Demographics for all participants followed up; 94% M, av. age 40
Interventions1. Proactive counselling; up to 6 calls over 3m (fruit & veg consumption also addressed), tailored feedback report & tip sheets, NRT offered to those interested in quitting.
2. Control; Nothing during programme, targeted materials at study end.
OutcomesAbstinence at 6m (7-day PP)
Validation: none
NotesComparisons 4 - 6. Baseline denominators confirmed by author
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk18% - 20% lost, assumed smokers

Stotts 2002

MethodsSetting: antenatal clinics, USA
Recruitment: pregnant continuing smokers
Participants269 pregnant smokers at wk 28; av. age 28, approx 50% smoked < 60 cigs/wk
InterventionsAll participants had received brief counselling and 7 mailed S-H booklets in early pregnancy.
1. 20 - 30-min MI-based proactive TC call in 28th - 30th wk of pregnancy, tailored letter, 2nd call.
2. No further contact.
OutcomesAbstinence or 'a few puffs' at 6m postpartum
Validation: none postpartum, cotinine at wk 34
NotesComparisons 4 - 6. The common intervention in early pregnancy was not treated as face-to-face contact within the trial. 55% received complete intervention
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThough no biochemical validation postpartum, cotinine in subsample at wk 34; no differences between experimental and control groups; "the urine samples appeared not to have been collected in a systematically biased manner." Level of misreport and refusal not specified.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk39% lost at follow-up in both groups, assumed to be smoking

Swan 2003

MethodsSetting: Group Health Co-operative, USA
Recruitment: volunteers for a trial of medication
Participants1524 smokers ≥ 10 cigs/day; 57% F, av. age 45, av. cigs/day 23, 44% history of depression
InterventionsProactive
Factorial design, 300 mg/day and 150 mg/day bupropion doses collapsed. Prescription was mailed. No face-to-face contact during enrolment or treatment.
1. Free & Clear proactive TC (4 brief calls), access to quitline & S-H materials
2. Zyban Advantage Program (ZAP) tailored S-H materials, single telephone call after TQD, access to Zyban support line
OutcomesAbstinence at 12m (7-day PP)
Validation: none
NotesCompares different intensity of TC. No dose/behavioural treatment interaction at 12m so bupropion arms collapsed.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskrandomization procedure built into study database
Allocation concealment (selection bias)Low riskProcedure ensured concealment
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up at 12m 17% Int, 12% Cont, treated as smokers

Swan 2010

Methods

Setting: community, Idaho and Washington, USA

Recruitment: community advertising, physician referral, and quitline callers

Participants1202 adult current smokers of at least 10 cigs/day in past year and 5 cigs/day in past week, motivated to quit. 66.9% F; av.age 47.3; av.cigs/day 19.7; av.FTND 4.9
Interventions

All participants received: 12-wk course of varenicline; 5 - 10-min orientation call; S-H materials; access to toll-free support line for ad hoc calls

1. Telephone counselling. Proactive; from quitline counsellor using MI techniques; max 5 calls.

2. Web programme with standardised content and interactive tools modelled on those used in phone intervention.

3. 1+2. Phone counsellors had access to info participants entered online.

Outcomes

Abstinence at 6m (30-day PP) (abstinence at 3m, 7-day PP also reported)

Validation: None

Notes

New for 2013 update. Number abstinent not provided, estimated from percentages given in published report

TC and TC+web had similar outcomes so pooled 1 + 3 vs 2 in comparisons 4 - 6 (adjuncts to pharmacotherapy).

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Group assignment was randomly allocated using an automated algorithm built into the study database"
Allocation concealment (selection bias)Low riskCentral computerised allocation, see above
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcome measure used from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low riskParticipants lost to follow-up counted as smokers in ITT analysis; equal losses between groups (103 Web, 107 Phone, 100 Web + phone)

Thompson 1993

MethodsSetting: Workplace and community, USA
Recruitment: Callers to a hotline, initially from 4 workplaces, targeting blue-collar workers, widened to general community to meet targets. Callers gave oral consent and baseline assessment of smoking characteristics prior to randomization
Participants382 (341 smokers, 41 recent quitters). Majority in contemplation or action SoC, 24% 'blue-collar', 59% F, av. age 41, av. cigs/day 18 - 22
Interventions1. Callers to hotline received general information based on fact sheets, and sent S-H material.
2. Callers were given information based on stage, and encouraged to take next step in cessation process. Script tailored to blue-collar workers using focus groups`
OutcomesAbstinence at 6m (PP) (subset followed to 12m)
Validation: saliva samples sought but not tested. Surrogates asked to confirm status
NotesComparison 2, between stage-based and non-specific brief counselling
The stage-model counselling was based on the approach used by the NCIS. Kinne 1991 gives data about call rates from original target worksites. Average call length 34 min for stage-based, 20 min for standard
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
Low riskSaliva samples sought but not tested; surrogates asked to confirm status.
Incomplete outcome data (attrition bias)
All outcomes
Low risk17% lost to follow-up at 6m, no significant difference between groups, included as smokers

Tzelepis 2011

Methods

Setting: Community, New South Wales, Australia

Recruitment: Active telephone recruitment (cold-calling) of NSW residents, motivation to quit not required

Participants1562 adult daily smokers. 50% M, av.cigs/day 19.4, av.age 45.
Interventions

1. Six proactive counselling calls for smokers willing to quit within 1m, 4 for those not willing using MI techniques. Those who relapsed and set new quit date within a month offered additional 5 calls; those relapsed but did not set quit date offered a call in 1m. Those initially not willing to quit who became motivated to quit offered additional 5 support calls. Standard S-H materials

2. S-H materials only

Outcomes

Prolonged abstinence at 13m (for 12m with 1m grace period). Other prolonged and PP rates at 4, 7, 13m also reported

Validation: none

NotesNew for 2013 update. Analyses 4 - 6. 7.8% of control group called quitline during study period. No 13m outcomes showed significant effects although earlier time points did.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"random number generator"
Allocation concealment (selection bias)Low risk"computer assisted telephone interview used a random number generator created by an independent programmer to allocate the smoker"
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcome measure used, participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskParticipants lost to follow-up counted as smokers; similar numbers in both groups (163 intervention, 154 control (21% and 19% respectively))

Velicer 2006

MethodsSetting: Community, USA
Recruitment: Proactive approach to smokers at Veterans Administration Medical Centre. Passive consent via mail then phone screening, not selected for motivation
Participants2054 smokers (1009 in relevant arms); 23% F, av age 51, 40% precontemplators, 40% contemplators, 20% preparers
Interventions1. Stage-based S-H manuals; participants sent manual for current stage and next stage. (not used in this review)
2. As 1. plus 6-wk nicotine patch if in appropriate stage, reassessed for NRT eligibility at 6 & 10m. (not used in this review)
3. As 2. plus 1 expert system written feedback report
4. As 3. plus regular automated TC (prerecorded voice files tailored to responses). People receiving NRT had weekly calls in month 1, biweekly in month 2, then monthly to month 6. People not receiving NRT had monthly calls. Participants could also initiate calls
OutcomesAbstinence at 30m, sustained for 6m
Validation: none
NotesComparisons 4 - 6, 4 vs 3 for proactive TC. In NRT eligible groups 350 (67%) received NRT at baseline and 448 (86%) received NRT at some point, so classified as adjunct to pharmacotherapy, and in > 6 call category
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-based random number generator
Allocation concealment (selection bias)Low riskAllocation done after completion of survey. randomized participants who did not return consent form are excluded from further analyses
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk39% lost incl 8% refused by 30m, no significant differences between groups. Different treatments of missing data reported not to have altered pattern of results.

Young 2008

MethodsSetting: General practices, Australia
Recruitment: Patients attending for routine consultations, not selected for motivation
Participants318 smokers; 53% F, av.age ˜37, modal cigs/day 11 - 20, 56% in contemplation/precontemplation.
Interventions1. GP offered referral; telephone call from a nurse trained in cessation within 3 days. 5A's counselling framework. If willing to make a quit attempt mailed quit kit, encouraged to buy NRT, phoned again on TQD, 1 wk, 3 wks.
2. Usual care (GPs given quit kits to distribute to patients)
OutcomesAbstinence at 12m (PP)
Validation: none
NotesComparisons 4 - 6. We classified control as minimal intervention (4.1.1) rather than brief intervention, MA not sensitive to classification. Referral was to a research nurse not to a dedicated quitline. 5 control participants received intervention, analysed with controls as ITT.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuestionnaires randomly ordered and coded prior to delivery to the practice by selecting sequential numbers from a computer generated random number list.
Allocation concealment (selection bias)Unclear riskPatients (including non-smokers) completed the precoded questionnaire before the consultation. GP identified allocation from unobtrusive marks on questionnaire, could not influence allocation. But unclear whether selection bias by recruiters, given imbalance in numbers
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk31% Int, 41% Cont lost to follow-up, included as smokers

Zhu 1996

MethodsSetting: Quitline, USA
Recruitment: callers to a quitline
Participants3030 smokers calling smokers' helpline and were ready to quit in next wk; 57% F, av. age 36, av. cigs/day 20
Interventions1. S-H materials only
2. S-H materials and 50-min pre-quit TC
3. As 2, plus up to 5 further sessions TC at 1,3, 7, 14 & 30 days
OutcomesAbstinence at 13m, sustained for 12m
Validation: Cotinine < 10 mg/nl in a convenience sample.
NotesComparison 1; 2 & 3 vs 1. 3 vs 2 in effect of multiple sessions
Approx 65% of single session & 67% of multisession group received some counselling. Multisession participants received 4 calls on average.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskPseudo-random, according to last 2 digits of telephone number
Allocation concealment (selection bias)High riskPotential for selection bias but unlikely given low contact
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation in a convenience sample. Disconfirmation rate not used to correct data, but refusal and misreport rates similar in all groups.
Incomplete outcome data (attrition bias)
All outcomes
Low risk12% - 16% lost to follow-up at 13m, included as smokers

Zhu 2002

MethodsSetting: Quitline, USA
Recruitment: callers to a quitline
Participants3282 smokers calling quitline, ready to quit within 1 wk & wanting counselling; 56% F, av. age 38, av. cigs/day 20
Interventions1. S-H pack, motivational materials, counselling provided if smoker made contact to request it.
2. S-H as 1, plus prequit and up to 6 post-quit calls within 3m. Included quitting history, motivation, self efficacy, social support, planning, relapse prevention
OutcomesAbstinence at 13m, sustained for 12m
Validation: none
NotesComparison 1. Authors also analysed subgroups of control who did and did not seek counselling. 32% of Cont and 72% of Int group received counselling
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskrandomized, method not described. 60/40 split. Only randomized when counselling demand exceeded capacity
Allocation concealment (selection bias)Unclear riskNo details given
Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition
Incomplete outcome data (attrition bias)
All outcomes
Low risk˜30% lost to follow-up at 13m in both groups, included as smokers

Zhu 2012

  1. a

    AHRQ: Agency for Healthcare Research and Quality
    ALA: American Lung Association
    CBT: cognitive behavioural therapy
    CO: carbon monoxide
    F: female
    FTND: Fagerström Test for Nicotine Dependence
    HMO: health maintenance organization
    hrs: hours
    ITT: intention-to-treat (analysis)
    m: months
    M: male
    MA: meta-analysis
    MI: motivational interviewing
    NCIS: National Cancer Information Service
    NRT: nicotine replacement therapy
    PP: point prevalence
    SES: socio-economic status
    S-H: Self-help materials
    SoC: Stage of Change
    TC: Telephone counselling
    TQD: Target quit date

Methods

Setting: Quitline, USA

Recruitment: callers to a quitline

Participants2278 Chinese-, Korean- and Vietnamese-speaking daily smokers, ready to quit within 1m; 90% M; aged 18 - 75 (approx. 45% 25 - 44 and 45% 45 - 64); av.cigs/day 15.6
Interventions

1. S-H pack, culturally-tailored translated into Chinese, Korean and Vietnamese

2. S-H pack + proactive TC; Social Learning Theory; MI; CBT techniques. 30 - 40 min, pre-quit, up to 5 relapse prevention calls (10 - 15 min) 0, 3, 7, 14, 30 days

Outcomes

Prolonged abstinence at 7m post-intervention, 1m grace period immediately postquit

Validation: none (but saliva samples collected)

NotesNew for 2013 update. Number abstinent at 6m not specified; data used in meta-analysis calculated back from percentages.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"randomly assigned…using blocks of 20 to keep a balance of language and sex…Random assignment tables for each strata were created using SAS 9.2."
Allocation concealment (selection bias)Low risk"The allocation was done by the computer so that staff were blinded to group assignment until the intake call"
Blinding of outcome assessment (detection bias)
All outcomes
Low riskSelf-reported outcomes but saliva samples collected. No statistically significant differences in saliva sample return rates at 7m btwn intervention and control groups and btwn self-reported quitters and non-quitters.
Incomplete outcome data (attrition bias)
All outcomes
Low riskSimlar rate of dropouts in both groups (18% in 1, 16% in 2). Participants lost to FU included as smokers in outcome data.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
  1. a

    CI: confidence interval
    m: month(s)
    IVR: interactive voice response
    NRT: nicotine replacement therapy
    S-H: self help
    TC: telephone counselling
    TQD: target quit date

Ahijevych 1995Pilot study with 12 wks follow-up, after which the advice and control groups were offered the intervention. The intervention was 4 x weekly mailings and telephone calls from a lay facilitator. No participants in any group (n = 64) quit smoking.
Alonso-Perez 2007Not a fully randomized trial. Smokers assigned to behavioural condition by clinic attended.
Amos 1995Not a controlled trial. Callers to a workplace helpline set up in conjunction with a non-smoking policy were followed up. 16% of smokers reported they had quit 3m later, 28% of those who had tried to quit. It was estimated that between 3 and 3.3% of smokers in the company had called in the first 3m.
An 2008Intervention was to increase clinic referrals to a quitline. No smoking outcomes.
Balanda 1999Callers to a helpline were randomized to 1 of 2 S-H materials. No counselling was given. Follow-up only 1m after receipt of materials. There was no difference in cessation rates between the booklet groups. Overall 16% of 515 respondents reported 7-day abstinence at 1m.
Best 1977Allocation not stated to be random. Telephone follow-up compared to group behavioural treatment with aversive smoking only. Abstinence rates were lower for the telephone group.
Bliksrud 2002Not a randomized trial.
Bock 2008All participants received brief TC calls. Intervention was a face-to-face motivational interview
Borland 1989Not a controlled trial. Evaluation of calls to a helpline.
Borland 2004All participants called a quitline, test of different S-H materials. Included in Cochrane review of S-H (Lancaster 2005b).
Boyle 2004bIntervention for smokeless tobacco use, not smoking.
Boyle 2008Intervention for smokeless tobacco use, not smoking.
Brandon 2000Focus on preventing relapse. See Cochrane review on relapse prevention (Hajek 2009).
Brunner-Frandsen 2010Intervention condition included intensive face-to-face counselling as well as telephone contact.
Buchanan 2004Multicomponent intervention, only 12 wks follow-up
Burns 2010Not randomized; historical and non-equivalent controls.
Bush 2012Evaluated a counselling component to address cessation related weight concerns. Will be evaluated in Cochrane review of interventions for preventing weight gain after smoking cessation (Farley 2012).
Carlin-Menter 2011Only 3 months follow-up
Carlini 2008Intervention to increase re-enrolment in quitline services. No smoking outcomes
Carlini 2012Intervention was IVR to re-engage relapsed smokers, no cessation outcomes.
Carreras 2007Not a randomized trial. Compared intensive counselling delivered face-to-face or by telephone
Conway 2004Focus on preventing relapse. See Cochrane review on relapse prevention (Hajek 2009).
Cooper 2004Trial identified from a paper reporting secondary outcomes. Compared 3 levels of behavioural intervention in a primary care setting. Full results have not been published and not available.
Cummings 1988Callers to a helpline were randomized to one of 4 different S-H programmes or an information control. No counselling was given. There was no difference in outcome between any of the S-H booklets or the control, with sustained abstinence rates of 4% - 8% at 6m.
Cummings 1989Does not measure smoking cessation. Assesses impact of a media campaign to get women smokers with young children to call a quit line. Call rates compared in media markets with and without a campaign. Campaign increased call rates 10 times compared to control markets. Proportion of calls from target group also increased. Cost per caller estimated at USD 61.
Cummings 2006Not a randomized trial. Evaluated impact of free NRT as adjunct to telephone support.
Cummings 2010Not a randomized trial. Evaluated impact of different amounts of free NRT as adjunct to telephone support.
Cummings 2011All participants eligible for same telephone counselling intervention; test of different amounts of NRT.
Curry 2003Telephone component cannot be evaluated independently of face-to-face counselling.
Danaher 2011Study of smokeless tobacco users only.
Davis 1992All participants were women with young children who called a hotline and received same stage-based counselling. They were randomized to receive 3 different S-H guides. See Cochrane review of S-H (Lancaster 2005b)
De Azevedo 2010Telephone component cannot be evaluated independently of face-to-face counselling. The intervention included in-hospital motivational interviewing as well as post-discharge telephone contact, and was compared to usual care.
DeBusk 1994Telephone component cannot be evaluated independently of face-to-face counselling. The intervention included in-hospital physician advice and counselling by a nurse as well as post-discharge telephone contact, and was compared to usual care.
Decker 1989Not random or pseudo-random. Interventions ran sequentially. Participants receiving mailed materials had access to a hotline.
Dent 2009Single telephone call was the brief intervention control for a 3-session group-based pharmacist-conducted intervention.
Dubren 1977Recent quitters were randomized to access to recorded messages, not a counsellor. Short follow-up (4 wks).
Gies 2008Only 3m follow-up. Comparison between 1 and 4 telephone follow-ups as adjunct to face-to-face counselling. 19 participants per group.
Glasgow 2009Intervention aimed at reduction in cigarette use for people not wishing to attempt cessation.
Gordon 2010Telephone component cannot be evaluated independently of face-to-face counselling delivered by dental practitioner.
Gritz 2012Intervention used cell phone. Will be evaluated in Cochrane review of mobile phone-based interventions for smoking cessation (Whittaker 2012)..
Hackbarth 2006Insufficient detail in abstract to include, no full report identified.
Han 2010Study of 2 different frequencies of telephone counselling for high blood pressure, including smoking cessation counselling. Smoking cessation not reported as an outcome, unclear if smoking cessation measured.
Hasuo 2004Telephone component cannot be evaluated independently of face-to-face counselling. The intervention included in-hospital counselling by a nurse.
Hebert 2011Only 3m follow-up
Hokanson 2006Telephone component cannot be evaluated independently of face-to-face counselling and offer of pharmacotherapy.
Holtrop 2005The purpose of the telephone call was to encourage participants to enrol in quitline services
Johnson 1999Telephone component cannot be evaluated independently of face-to-face counselling. The intervention included in-hospital counselling by a nurse. Quasi-random design.
Joseph 2011Complex intervention; all participants received telephone counselling.
Killen 2008Main intervention component was face-to-face support. Telephone contact in both arms.
Koffman 1998Three worksites allocated to different interventions. No way to distinguish variation due to worksite from effect of intervention.
Lando 1996Previously included, recruited only recent quitters so now covered in Cochrane review of relapse prevention (Hajek 2009)
Leed Kelly 1996The intervention included 1 session of face-to-face counselling with telephone follow-up. Results, which did not show any intervention effect, are given in Bobo 1998.
Lichtenstein 2002bNo long-term outcomes yet reported.
Lindinger 2012Not randomized. Compared participants accepting proactive calls to those choosing only 1 session.
Little 2009Systems change intervention; trained dental staff in to assess, advise and refer to telephone counselling.
Mahabee-Gittens 2008Quitline referral confounded with brief advice, only 3m follow-up.
Manfredi 1999The intervention included the opportunity of a motivational telephone call following provider advice and S-H components. Follow-up was only 5 - 8 wks.
Manfredi 2011Smoking status not measured.
Mayer 2010Trial of a relapse prevention intervention; participants were abstinent at time of randomization.
McAfee 2008All participants had same quitline counselling.
McBride 2002The focus of the intervention was on genetic susceptibility feedback. Effect of telephone support cannot be evaluated independently.
Mermelstein 2003Compares 2 telephone-based interventions for preventing relapse following group therapy. Now included in Cochrane relapse prevention review (Hajek 2009)
Miller 2009aTrial of NRT as opposed to telephone support; same telephone support intervention offered to both groups.
Morris 2011All participants received telephone counselling and NRT, test of additional group counselling.
Ockene 1992Telephone support could not be evaluated independently of combined intervention.
Owen 2000Not a controlled trial. Survey of callers to UK quitline. Conservatively assuming that non-responders at 1 year were continuing smokers and assuming 20% of reported successes would fail biochemical validation gave an adjusted quit rate of 15. 6% (95% CI 12.7% to 18.9%).
Parker 2007Trial in pregnant women.
Partin 2006Telephone intervention purpose was to assess smoking status, interest in making another quit attempt, quit challenges, and treatment preferences, not to assist cessation per se.
Patten 2011Intervention was telephone counselling for nonsmokers wanting to help a smoker. Outcome was calls by smoker to quitline, not cessation.
Peng 2011Short follow-up.
Peterson 2009School as unit of randomization. Telephone counselling confounded by other school-based initiatives.
Platt 1997Not a controlled trial. A panel sample of callers to the Scottish Smokeline was followed up for 1 year. 607 (71% of original sample) were reached. The quit rate was 23.6%, 8.2% reported not smoking for > 80% of the previous year. It was estimated that 5.9% of the adult smokers in Scotland called during the year.
Prue 1983The amount and timing of telephone contact is unclear. The main component was a S-H programme, compared to a waiting list control. Total of 40 participants.
Racelis 1998Intervention addressed multiple risk factors, number of smokers enrolled not specified.
Ratner 2004Telephone support could not be evaluated independently of face-to-face counselling.
Reid 1999bNot a controlled trial. Followed 258 nicotine patch purchasers who enrolled for support program of 4 calls from a trained nurse counsellor. 36% quit rate at 8m.
Ringen 2002Not randomized. Smokers chose intensity of support.
Rodgers 2005Intervention used mobile phone (including text messaging). To be covered by separate Cochrane review (Whittaker 2012).
Rothemich 2010Systems change intervention; referral to quitline was only 1 component.
Schiebel 2007Small (n = 39) feasibility study in Emergency Department. Very low rate of follow-up especially for sustained abstinence outcome (2/39 reached at both follow-ups).
Schneider 1995Evaluated a telephone support system. All smokers recruited had access to the interactive programme. Random subsets were selected for access to messages about nicotine gum, sent a reminder to call, or sent a user's manual.
Segan 2011Study of phone counselling for relapse prevention.
Sherman 2008Abstinence data given only for intervention group.
Shiffman 2000Follow-up 12 wks. At this point there was no evidence that the addition of a single proactive call 2 days after the TQD increased cessation rates over 6 mailings of tailored materials.
Simon 1997Telephone component cannot be evaluated independently of face-to-face counselling. The intervention included brief counselling and NRT.
Simon 2003Telephone component cannot be evaluated independently of face-to-face counselling. The intervention included in-hospital nurse counselling as well as post-discharge telephone contact, and was compared to a minimal intervention.
Sivarajan 2004Telephone component could not be evaluated independently of combined intervention.
Sorensen 2007bTelephone intervention was a 10-min reminder call, 2m after face-to-face advice to quit prior to surgery. Outcomes combined with an arm given reminder at a face-to-face meeting.
Stevens 1993Telephone component cannot be evaluated independently of face-to-face counselling. The intervention included in-hospital physician advice and counselling by a nurse as well as post-discharge telephone contact, and was compared to usual care.
Stoltzfus 2011Not a controlled trial. Pre-test/post-test study of different referral methods.
Strong 2012All participants had same basic counselling intervention. Test of a mood management component.
Sutton 2007All participants had same counselling intervention. Test of tailored written materials, see Cochrane self-help review (Lancaster 2005b).
Szklo 2010Not an evalution of counselling; compared 2 strategies to encourage calls to a Quitline.
Taylor 1990Telephone component cannot be evaluated independently of face-to-face counselling. The intervention included in-hospital physician advice and counselling by a nurse as well as post-discharge telephone contact, and was compared to usual care.
Terazawa 2001Telephone component could not be evaluated independently of combined intervention.
Terry 2011Not randomized; comparison of work-based intervention programmes.
Toll 2010Only 3m follow-up.
Urso 2003Only 12 wks follow-up.
Van der Meer 2010All participants received telephone counselling. Test of a mood management component.
Vidrine 2006Intervention used mobile phone (including text messaging). To be covered by separate Cochrane review (Whittaker 2012).
Wadland 1999Not randomized. The treated groups were recruited by different means and given different interventions both of which included telephone counselling by nurses or counsellors.
Wadland 2001Only 3m follow-up.
Wadland 2007Trial of methods for clinic referral to quitline support. No quitting outcomes.
Walker 2011aRecruitment via quitline, but test of providing samples of NRT.
Walker 2011bRecruitment via quitline, but test of nicotine-free cigarettes as an adjunct to NRT.
Warner 2011Comparison of physician-provided general help to quit smoking with intervention primarily aimed at facilitating quitline use. Both groups had same access to quitline.
Westman 1993Telephone component cannot be evaluated independently of face-to-face counselling.
Wetter 2007Only 12 wks follow-up.
Willemsen 2008Uncontrolled evaluation. Quitline callers followed up at 1 year.
Wolfenden 2008aQuitline component was part of a comprehensive intervention including face-to-face support.
Zanis 2011Only 12 wks follow-up.
Zawertailo 2013Not randomized; uses a concurrent matched control.
Zhu 2000Not an RCT. All participants called the California Smokers' Helpline and received 1 session of counselling and planned to use NRT. Those who chose to receive further counselling were compared to those who did not.

Characteristics of studies awaiting assessment [ordered by study ID]

Zhu 2004

Methodsrandomized trial in California Smokers Helpline
Participants1101 pregnant smokers seeking assistance
InterventionsSubjects were randomized to telephone counseling or self help. Those in the self-help group received a quit kit of written materials, including the American Cancer Society booklet for pregnant smokers. Those in the treatment group received the quit kit plus up to 7 counselling calls (1 pre-quit, up to 6 follow-up).
OutcomesCessation at 3rd trimester (30 day abstinence)
NotesResults presented only as an abstract

Characteristics of ongoing studies [ordered by study ID]

Argyropoulou 2005

Trial name or titleSmoking cessation: data for two years from two different interventions
Methods9 wk open-label bupropion phase 300mg daily and NRT for 3 wks combined with behavioural support; smokers randomised in 2 groups, follow-up for 3, 6, 12 and 24 m
Participantsno information
InterventionsGroup A: 7 wkly one to one counselling sessions; Group B: telephone counselling
OutcomesPPA abstinence and continuous abstinence ?
Starting date 
Contact information 
Notes 

Asfar 2010

Trial name or titleEfficacy of Tobacco Quitline for Cancer Survivors
MethodsRCT
Participants950 childhood cancer survivors recruited nationally
InterventionsCounsellor-initiated vs. participant-initiated tobacco Quit Line with adjunctive nicotine replacement therapy (NRT) in both groups.
OutcomesCessation at 1 year
Starting dateOctober 2008
Contact information 
Notes 

Berndt 2012

Trial name or titleSmoking Cessation among Patients with Coronary Heart disease
Methods2 or more arms, randomised
Participants≥ 18 yrs and stable cardiac condition after admitted with coronary heart disease at cardiac wards and smoked ≥ 5 cigs/week prior to hospital admission
InterventionsFollow-up measurements 6 months and 12 months after the baseline measurement.
OutcomesPrimary: PP abstinence (PPA) from smoking after 6 and 12 m. PPA is considered to be the most sensitive and valid measure of smoking cessation.
Starting date15 October 2009
Contact information 
Notes 

Buller 2012

Trial name or titleReal e Quit (REQ)
Methodsrandomised pretest-posttest trial with 12- and 26-week follow-up
ParticipantsYoung adult smokers (< 30; n = 3310)
InterventionsOnline cessation programme with tailored counselling, e-cards for social support, quitting testimonials, and a cessation blog compared against a self-help booklet and telephone quit line
OutcomesAbstinence at 12 and 26 weeks
Starting date 
Contact information 
NotesQuitline was control condition so may not be eligible for inclusion

Cummins 2012

Trial name or titleSmoking Cessation in Hospitalized Smokers
Methodsrandomised; open label; NRT at discharge and proactive telephone counselling post hospital discharge, 12-m cessation rates of hospitalised smokers (2 x 2 factorial design)
Participantshospitalised ≥ 24hrs, ≥ 18 yrs; ≥ 6 CPD
InterventionsGenders Eligible for Study:
OutcomesAccepts Healthy Volunteers:
Starting dateAugust 2011
Contact information 
Notes 

Duffy 2012

Trial name or titleTobacco Tactics Website for Operating Engineers (BCBSM-OE)
Methodsclustered randomised control, open label
ParticipantsOperating Engineers Local 324 Education Center routine training attendants; ≥ 18 yrs; smoking in the past month, and interested in participating in quit programme
Interventionsintervention: Tobacco Tactics website; control: state supported 1-800 quit-now telephone hotline
OutcomesPrimary: quit rate at 30 d and 6 m follow-up; 7d PP abstinence; also assess ability to quit at all, no. quit attempts, CPD
Starting dateJanuary 2010
Contact information 
Notes 

Humfleet 2012

Trial name or titleReaching and Treating Lesbian, Gay, Bisexual, and Transgender (LGBT) Cigarette Smokers
Methodsrandomised, open label, factorial (4 arm)
Participants≥ 18 yrs; identify as LGBT
Interventions1) self help manual, 2) mail-based self-help + internet-based smoking treatment, 3) self-help manual + telephone counselling, 4) self-help manual + internet-based Intervention + telephone counselling
OutcomesPrimary: smoking status at 3, 6 and 12 m post enrolment
Starting dateFebruary 2008
Contact information 
Notes 

Lambart 2012

Trial name or titleEvaluating a Telemedicine Smoking Cessation Program in Rural Primary Care Practices
Methodsrandomised, open label,
Participants≥ 18 yrs; smoking for ≥ 1 yr
Interventions1) Telemedicine smoking cessation programme vs 2) Telephone quitline smoking cessation programme
OutcomesPrimary: 7d PP abstinence at 3, 6, and 12 m; secondary: prolonged abstinence at 3, 6, and 12 m
Starting dateJune 2009
Contact information 
Notes 

Reid 2011

Trial name or titleRandomised trial of an automated telephone follow-up system for smoking cessation in smokers with CHD
MethodsRCT
Participantshospitalised with CHD at University of Ottawa Heart Institute; ≥ 5 CPD
Interventions1) Standard care (in hospital nurse counselling and NRT) 2) IVR (interactive voice-response) group: standard care + IVR
OutcomesPrimary: self reported continuous abstinence at 26 and 52 wks post hospital discharge
Starting date 
Contact information 
NotesConference abstract report

Richey 2012

Trial name or titleEvaluating a Telephone-Based Smoking Cessation Program Among People in the Military (The AFIII Study)
MethodsRandomized controlled trial
ParticipantsAdult smokers who are Armed Forces Active Duty personnel, retirees, Reservist, National Guard and family member healthcare beneficiaries
InterventionsProactive versus reactive smoking quit line with adjunctive nicotine replacement therapy (NRT) in both groups.
OutcomesCessation at 1 year
Starting dateApril 2008
Contact information 
Notes 

Rogers 2011

Trial name or titleTelephone Care Coordination for Smokers in VA Mental Health Clinics (TeleQuit MH)
Methodsnon-randomised, open label
ParticipantsSmokers who are referred from Mental Health Clinics in VA VISNs 1 and 3
InterventionsTelephone Care Coordination and Telephone Care Coordination with state Quitline
OutcomesPimary: long-term smoking abstinence (30-day PP abstinence) and the rate of program adoption by mental health providers and patients ; 6 months post enrolment; secondary: 30-day PP abstinence at 2 m (EOT), quit attempt rate (2 and 6 m post enrolment), rate of use of cessation medications (2 and 6 m post enrolment), quarterly VA site-level performance rates on the VA tobacco performance measures
Starting dateNovember 2009
Contact information 
Notes 

Schuck 2011

Trial name or titleEvaluation of a Smoking Cessation Intervention for Parents
MethodsRandomized controlled trial
ParticipantsSmoking parents, enrolled through children's primary schools
InterventionsProactive telephone counselling (up to seven counsellor-initiated telephone calls based on cognitive-behavioural skill building and Motivational Interviewing, distributed over a period of three months) or a control condition
OutcomesSustained abstinence, 7-day point prevalence abstinence and 24-hours point prevalence abstinence at 3 & 12 months
Starting date 
Contact information 
Notes 

Sherman 2008a

Trial name or titleTeleQuit Smoking Cessation Program
MethodsTeleQuit trial, VHA study. randomised by week to either proactive or reactive approach, and to multisession or S-H
ParticipantsVeterans Administration smoking patients
InterventionsCare providers gave brief counselling and provided electronic referral to TeleQuit
OutcomesCessation at 6 months
Starting date 
Contact information 
NotesConference abstract reports preliminary results from the 12 Los Angeles sites, 60 sites in total.

Zwar 2010

Trial name or titleQuit in General Practice: a cluster randomised trial of enhanced in-practice support for smoking cessation
MethodsCluster randomised trial
ParticipantsDaily smokers presenting to general practitioners
Interventions1) Quit with Practice Nurse 2) Quitline referral 3) GP usual care
OutcomesCessation at 3 and 12 months
Starting date 
Contact information 
Notes