Print-based self-help interventions for smoking cessation

  • Review
  • Intervention

Authors


Abstract

Background

Many smokers give up smoking on their own, but materials giving advice and information may help them and increase the number who quit successfully.

Objectives

The aims of this review were to determine: the effectiveness of different forms of print-based self-help materials, compared with no treatment and with other minimal contact strategies; the effectiveness of adjuncts to print-based self help, such as computer-generated feedback, telephone hotlines and pharmacotherapy; and the effectiveness of approaches tailored to the individual compared with non-tailored materials.

Search methods

We searched the Cochrane Tobacco Addiction Group trials register. Date of the most recent search April 2014.

Selection criteria

We included randomized trials of smoking cessation with follow-up of at least six months, where at least one arm tested a print-based self-help intervention. We defined self help as structured programming for smokers trying to quit without intensive contact with a therapist.

Data collection and analysis

We extracted data in duplicate on the participants, the nature of the self-help materials, the amount of face-to-face contact given to intervention and to control conditions, outcome measures, method of randomization, and completeness of follow-up.

The main outcome measure was abstinence from smoking after at least six months follow-up in people smoking at baseline. We used the most rigorous definition of abstinence in each trial, and biochemically validated rates when available. Where appropriate, we performed meta-analysis using a fixed-effect model.

Main results

We identified 74 trials which met the inclusion criteria. Many study reports did not include sufficient detail to judge risk of bias for some domains. Twenty-eight studies (38%) were judged at high risk of bias for one or more domains but the overall risk of bias across all included studies was judged to be moderate, and unlikely to alter the conclusions.

Thirty-four trials evaluated the effect of standard, non-tailored self-help materials. Pooling 11 of these trials in which there was no face-to-face contact and provision of structured self-help materials was compared to no intervention gave an estimate of benefit that just reached statistical significance (n = 13,241, risk ratio [RR] 1.19, 95% confidence interval [CI] 1.04 to 1.37). This analysis excluded two trials with strongly positive outcomes that introduced significant heterogeneity. Six further trials without face-to-face contact in which the control group received alternative written materials did not show evidence for an effect of the smoking self-help materials (n = 7023, RR 0.88, 95% CI 0.74 to 1.04). When these two subgroups were pooled, there was no longer evidence for a benefit of standard structured materials (n = 20,264, RR 1.06, 95% CI 0.95 to 1.18). We failed to find evidence of benefit from providing standard self-help materials when there was brief contact with all participants (5 trials, n = 3866, RR 1.17, 95% CI 0.96 to 1.42), or face-to-face advice for all participants (11 trials, n = 5365, RR 0.97, 95% CI 0.80 to 1.18).

Thirty-one trials offered materials tailored for the characteristics of individual smokers, with controls receiving either no materials, or stage matched or non-tailored materials. Most of the trials used more than one mailing. Pooling these showed a benefit of tailored materials (n = 40,890, RR 1.28, 95% CI 1.18 to 1.37) with moderate heterogeneity (I² = 32%). The evidence is strongest for the subgroup of nine trials in which tailored materials were compared to no intervention (n = 13,437, RR 1.35, 95% CI 1.19 to 1.53), but also supports tailored materials as more helpful than standard materials. Part of this effect could be due to the additional contact or assessment required to obtain individual data, since the subgroup of 10 trials where the number of contacts was matched did not detect an effect (n = 11,024, RR 1.06, 95% CI 0.94 to 1.20). In two trials including a direct comparison between tailored materials and brief advice from a health care provider, there was no evidence of a difference, but confidence intervals were wide (n = 2992, RR 1.13, 95% CI 0.86 to 1.49).

Only four studies evaluated self-help materials as an adjunct to nicotine replacement therapy, with no evidence of additional benefit (n = 2291, RR 1.05, 95% CI 0.88 to 1.25). A small number of other trials failed to detect benefits from using additional materials or targeted materials, or to find differences between different self-help programmes.

Authors' conclusions

Standard, print-based self-help materials increase quit rates compared to no intervention, but the effect is likely to be small. We did not find evidence that they have an additional benefit when used alongside other interventions such as advice from a healthcare professional, or nicotine replacement therapy. There is evidence that materials that are tailored for individual smokers are more effective than non-tailored materials, although the absolute size of effect is still small. Available evidence tested self-help interventions in high income countries; further research is needed to investigate their effect in contexts where more intensive support is not available.

Résumé scientifique

Les méthodes utilisant des imprimés d’autosupport pour le sevrage tabagique

Contexte

De nombreux fumeurs arrêtent de fumer d'eux-mêmes, mais des documents donnant des conseils et des informations pourraient les aider et augmenter le nombre de ceux qui réussissent à arrêter.

Objectifs

Les objectifs de cette revue étaient de déterminer : l'efficacité de différentes formes d’outils imprimés d’autosupport, en comparaison à l'absence de traitement et à d'autres stratégies de contact minimal; l'efficacité d’ajouts aux outils imprimés d’autosupport, comme la rétroaction générée par ordinateur, les lignes d'assistance téléphonique et la pharmacothérapie ; et l'efficacité des approches adaptées à l'individu par rapport aux documents standardisés non adaptés.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre d'essais cliniques du groupe Cochrane sur le tabagisme. Date de la recherche la plus récente : avril 2014.

Critères de sélection

Nous avons inclus des essais randomisés sur le sevrage tabagique avec un suivi d’au moins six mois et où un groupe au moins avait expérimenté une intervention à base d’imprimés d’autosupport. Nous avons défini l'autosupport comme un programme structuré à destination de fumeurs essayant de se sevrer sans suivi intensif par un thérapeute.

Recueil et analyse des données

Nous avons extrait en double les données sur les participants, la nature des documents d'autosupport, la quantité de contact face-à-face pour le groupe d’intervention et pour le groupe de contrôle, les mesures de résultats, la méthode de randomisation et l'exhaustivité du suivi.

Le principal critère de jugement était l'arrêt du tabac après un suivi d'au moins six mois chez des personnes qui fumaient au départ. Nous avons utilisé la définition la plus rigoureuse de l'abstinence dans chaque essai et les taux validés biochimiquement lorsqu'ils étaient disponibles. Lorsque c'était approprié, nous avons effectué une méta-analyse au moyen d'un modèle à effets fixes.

Résultats principaux

Nous avons identifié 74 essais qui remplissaient les critères d'inclusion. De nombreux rapports d'études n'incluaient pas suffisamment de détails pour juger du risque de biais pour certains domaines. Vingt-huit études (38 %) ont été jugées à risque élevé de biais pour un ou plusieurs domaines mais le risque global de biais dans toutes les études incluses a été jugé modéré, et peu susceptible de modifier les conclusions.

Trente-quatre essais ont évalué l'effet de documents d'autosupport standardisés non personnalisés. Le regroupement de 11 de ces essais, dans lesquels il n'y avait pas de contact en face-à-face et où la fourniture de documents d'autosupport structurés était comparée à l'absence d'intervention, a donné une estimation de bénéfice qui atteint juste le seuil de significativité statistique (n = 13 241, risque relatif (RR) 1,19, intervalle de confiance (IC) à 95 % 1,04 à 1,37). Cette analyse a exclu deux essais aux résultats très positifs et qui introduisaient une hétérogénéité significative. Six essais supplémentaires sans contact en face-à-face et dans lesquels le groupe contrôle avait reçu d'autres documents écrits n’ont pas montré de preuves d'un effet des documents d'autosupport sur le tabagisme (n = 7 023, RR 0,88, IC à 95 % 0,74 à 1,04). Lorsque ces deux sous-groupes ont été combinés, il n'y a plus eu de preuves du bénéfice des documents standard structurés (n = 20 264, RR de 1,06, IC à 95 % 0,95 à 1,18). Nous n'avons pas trouvé de preuve d'un bénéfice de la fourniture de documents d'autosupport standard quand il y avait une brève entrevue avec tous les participants (5 essais, n = 3 866, RR 1,17, IC à 95 % 0,96 à 1,42), ou des conseils donnés en face à face pour tous les participants (11 essais, n = 5 365, RR 0,97, IC à 95 % 0,80 à 1,18).

Trente-et-un essais proposaient des documents adaptés aux caractéristiques de chaque fumeur, avec un groupe témoin qui soit ne recevait pas de documents, soit des documents adaptés à leur stade de changement ou standardisés. La plupart des essais ont envoyés des documents plus d’une fois. Le regroupement de ces études a montré un avantage en faveur des documents adaptés (n = 40 890, RR 1,28, IC à 95 % 1,18 à 1,37) avec une hétérogénéité modérée (I² = 32 %). Les preuves sont les plus solides pour le sous-groupe de neuf essais dans lesquels les documents adaptés ont été comparés à l'absence d'intervention (n = 13 437, RR de 1,35, IC à 95 % 1,19 à 1,53), mais elles montrent également une plus grande utilité des documents adaptés par rapport aux documents standard. Une partie de cet effet pourrait être due à l’entrevue ou à l'évaluation supplémentaire requise pour obtenir des données individuelles, étant donné que le sous-groupe de 10 essais où le nombre de contacts a été apparié n'a détecté aucun effet (n = 11 024, RR de 1,06, IC à 95 % 0,94 à 1,20). Dans deux essais portant sur une comparaison directe entre les documents adaptés et de brefs conseils donné par un professionnel de santé, il n'y avait aucune preuve d'une différence, mais les intervalles de confiance étaient larges (n = 2992, RR 1,13, IC à 95 % 0,86 à 1,49).

Seules quatre études évaluaient les documents d'autosupport en complément de la thérapie de substitution nicotinique, sans aucune preuve de bénéfice supplémentaire (n = 2 291, RR 1,05, IC à 95 % 0,88 à 1,25). Un petit nombre d'autres essais n'a pas réussi à détecter de bénéfices liés à l'utilisation de documents supplémentaires ou ciblés, ni à trouver de différence entre différents programmes d'autosupport.

Conclusions des auteurs

Les imprimés d'autosupport standardisés augmentent le taux de sevrage par rapport à l'absence d'intervention, mais cet effet est probablement faible. Nous n'avons pas trouvé de preuve qu'ils présentent un bénéfice supplémentaire lorsqu'ils sont utilisés en plus d'autres interventions telles que les conseils d'un professionnel de santé ou le traitement de substitution nicotinique. Il y a des preuves que les documents adaptés à chaque fumeur sont plus efficaces que ceux qui sont standardisés, bien que l’ampleur d'effet absolue reste limitée. Les preuves disponibles évaluaient les interventions d'autosupport dans des pays à revenus élevés ; des recherches supplémentaires sont nécessaires pour étudier leur effet dans des contextes où un soutien plus intensif n'est pas disponible.

Plain language summary

Do printed self-help materials containing information about how to give up smoking help people to quit

Background

We reviewed the evidence that printed materials giving structured advice about how to stop smoking help people to quit. We looked for trials of any type of printed self-help material which gave structured support and advice about quitting. We also included materials in audio or video format but we did not include internet programmes or other formats. Trials had to include people who smoked, but they did not need to be currently trying to give up. We were interested in the number of people who were not smoking at least 6 months from the time when materials were provided. Some trials mailed materials on more than one occasion. Some trials gathered information about smoking history and habits in order to provide materials which were individually tailored to the characteristics of the smoker (tailored materials). In some trials, there was no face-to-face contact, and the materials were the only support. Other trials gave everyone advice and were designed to test whether there was any additional benefit from providing written materials.

Study characteristics

This evidence is current to April 2014. We identified 74 studies. Most of them took place in North America or Europe and were conducted in adults. Most studies did not require that people wanted to quit smoking in order to join. Although some studies were judged to be at possible risk of bias, mainly because the papers did not report the methods in detail, this did not affect the overall conclusions from the review.

Key results

Based on 11 studies with over 21,000 participants, there was evidence of a small benefit of printed non-tailored structured self-help materials when provided without any other contact. The likelihood of quitting was increased by about 20%. If self help was compared to even a brief pamphlet about smoking (6 studies), there was no evidence of additional benefit from structured materials. When self-help materials were provided in addition to brief face-to-face contact (5 studies) or advice (11 studies), there was no longer any evidence of additional benefit compared to the effect of contact or advice alone.

We found 31 trials which provided written materials that were individually tailored. Some studies compared these to no materials and some to non-tailored materials. There was evidence based on 9 studies with over 13,000 participants that tailored materials were of more benefit than no materials. There was also weaker evidence from an additional 22 studies that tailored materials were of more benefit than non-tailored materials.

Conclusions

The size of benefit from self-help materials is small, with only about 1 additional successful quitter expected from 100 people receiving materials with no other support. Studies of this type often sent materials to people who were not trying to quit, and the number of successful quitters was low. Most studies also took place in countries where more intensive support was available for people wanting to quit (for example, counselling). People were more likely to make successful quit attempts when they had face-to-face support, but in these studies giving materials did not help increase success further. People who choose to use materials may find them helpful, especially if more intensive support is not available to them, but people who want to quit should be encouraged to seek more intensive support if it is available.

Résumé simplifié

Les imprimés d'autosupport contenant des informations sur les moyens d'arrêter de fumer aident-t-ils les gens à arrêter ?

Contexte

Nous avons examiné les preuves concernant le fait que des brochures donnant des conseils structurés sur la façon d'arrêter de fumer aident les gens à le faire. Nous avons recherché des essais sur tout type d’imprimés d'autosupport donnant un soutien et des conseils structurés sur le sevrage. Nous avons également inclus des documents audio ou vidéo mais nous n'avons pas inclus les programmes Internet ou d'autres formats. Les essais devaient inclure des personnes qui fumaient, mais il n’était pas nécessaire qu’elles soient actuellement en train d’essayer d'arrêter. Nous nous sommes intéressés au nombre de personnes qui ne fumaient pas au moins 6 mois après la distribution des documents. Dans certains essais, des documents étaient envoyés à plusieurs reprises. Certains essais avaient recueilli des informations sur les antécédents de tabagisme et les habitudes afin de fournir des documents adaptés aux caractéristiques individuelles des fumeurs (documents personnalisés). Dans certains essais, il n'y avait pas de contact en face-à-face, et les imprimés étaient le seul soutien. Dans d'autres essais, des conseils étaient donnés à tout le monde et les essais étaient conçus de façon à évaluer s’il existait un quelconque bénéfice supplémentaire à fournir des documents écrits.

Les caractéristiques de l’étude

Ces preuves sont à jour en avril 2014. Nous avons identifié 74 études. La plupart d'entre elles ont été réalisées en Amérique du Nord ou en Europe, et chez l'adulte. L’entrée dans la plupart des études n’était pas conditionnée par le fait que les personnes désiraient arrêter de fumer. Bien que certaines études aient été considérées comme présentant un risque potentiel de biais, principalement parce que les articles ne rapportaient pas les méthodes en détail, cela n'a pas affecté les conclusions générales de la revue.

Résultats principaux

L’étude de 11 études totalisant plus de 21 000 participants montrait l’existence d’un petit bénéfice en faveur des imprimés d’autosupport structurés non personnalisés lorsque ceux-ci étaient fournis sans autre contact. La probabilité d'arrêt du tabac était augmentée d’environ 20 %. Si l'autosupport était comparé ne serait-ce qu’à une brève brochure sur le tabagisme (6 études), il n'y avait aucune preuve de bénéfice supplémentaire en faveur des documents structurés. Lorsque la documentation d'autosupport était fournie en sus d’une brève entrevue (5 études) ou de conseils oraux (11 études), il n'y avait alors plus aucune preuve de bénéfice supplémentaire par rapport à l'effet du contact ou des conseils seuls.

Nous avons trouvé 31 essais qui fournissaient des documents écrits personnalisés. Certaines études comparaient ces documents à l'absence de matériaux et certaines à la distribution de documents standardisés non adaptés. Il y avait des preuves fondées sur 9 études totalisant plus de 13 000 participants que les documents adaptés étaient plus bénéfiques que l'absence de matériaux. Il y avait également des preuves plus faibles d’après 22 autres études que les documents adaptés apportaient plus de bénéfices que des documents standardisés non adaptés.

Conclusions

L'ampleur du bénéfice des documents d'autosupport est de faible envergure, avec seulement environ 1 sevrage efficace supplémentaire attendu pour 100 personnes recevant des documents sans autre soutien. Les études de ce type envoyaient souvent les documents à des personnes qui n'essayaient pas, à ce moment-là, d'arrêter de fumer, et le nombre de ceux qui réussissaient était faible. La plupart des études ont aussi été menées dans des pays où un soutien plus intensif était disponible pour les personnes souhaitant arrêter de fumer (par exemple, le counselling). Les patients étaient plus susceptibles de faire des tentatives de sevrage réussies lorsqu'ils avaient une prise en charge en face à face, mais dans ces études la fourniture de matériaux n'a pas permis d’accroître davantage la réussite. Les personnes qui choisissent d'utiliser des documents peuvent les juger utiles, en particulier si aucun soutien plus intensif n'est disponible pour eux, mais les personnes qui veulent arrêter de fumer devraient être encouragées à rechercher un soutien plus intensif s'il est disponible.

Notes de traduction

Traduit par: French Cochrane Centre 7th August, 2014
Traduction financée par: Ministère du Travail, de l'Emploi et de la Santé Français

Laienverständliche Zusammenfassung

Hilft gedrucktes Selbsthilfematerial mit Informationen zur Raucherentwöhnung Rauchern, mit dem Rauchen aufzuhören?

Hintergrund

Wir haben die Evidenz dafür überprüft, dass Druckerzeugnisse mit strukturierter Beratung Rauchern bei der Entwöhnung helfen. Wir suchten nach Studien jeder Art über gedrucktes Selbsthilfe-Material mit strukturierter Hilfestellung und Beratung zur Raucherentwöhnung. Wir schlossen auch Material in Audio- oder Videoformaten ein, aber keine Internetprogramme oder sonstige Formate. Die Studien mussten Raucher einschließen, die nicht unbedingt bemüht waren, sich das Rauchen abzugewöhnen. Uns interessierte, wie viele Personen mindestens 6 Monate nach dem Zeitpunkt, an dem sie das Material erhielten, nicht mehr rauchten. In manchen Studien wurde mehrfach Material zugesendet. In einigen Studien wurden Angaben zur Raucherhistorie und den Rauchgewohnheiten erhoben, um individuell auf die Merkmale des Rauchers zugeschnittene Unterlagen bereitstellen zu können (individuell zugeschnittene Unterlagen). In manchen Studien gab es keinen persönlichen Kontakt und die Unterlagen waren die einzige Hilfestellung. In anderen Studien wurden alle Teilnehmer beraten und ihr Design war darauf ausgerichtet zu prüfen, ob die Bereitstellung von schriftlichen Unterlagen zusätzlichen Nutzen bringt.

Studienmerkmale

Die Evidenz ist auf dem Stand von April 2014. Wir identifizierten 74 Studien. Die meisten fanden in Nordamerika oder Europa statt und wurden an Erwachsenen durchgeführt. In den meisten Studien war für die Teilnahme nicht Bedingung, mit dem Rauchen aufhören zu wollen. Zwar wurde bei einigen Studien erachtet, dass sie möglicherweise ein Risiko für Bias darstellten, da insbesondere die Aufsätze keine Details über die Methode enthielten; dies beeinträchtigte jedoch nicht die Gesamtschlussfolgerungen des Reviews.

Hauptergebnisse

Basierend auf 11 Studien mit über 21.000 Teilnehmern gibt es Evidenz für einen geringen Nutzen von gedruckten, nicht individuell abgestimmten, strukturierten Selbsthilfematerialien, wenn sie ohne jeglichen anderweitigen Kontakt bereitgestellt werden. Die Wahrscheinlichkeit, mit dem Rauchen aufzuhören, stieg um rund 20 %. Wenn die Selbsthilfe mit einem kurzen Merkblatt über das Rauchen verglichen wurde (6 Studien), gab es keine Evidenz für zusätzlichen Nutzen aus strukturierten Materialien. Wurde das Selbsthilfe-Material zusätzlich zu einem kurzen persönlichen Kontakt (5 Studien) oder einer Beratung (11 Studien) bereitgestellt, gab es keine Evidenz mehr für einen zusätzlichen Nutzen im Vergleich zur alleinigen Wirkung des Kontakts oder der Beratung.

Wir fanden 31 Studien, in denen schriftliches, individuell zugeschnittenes Material bereitgestellt wurde. Einige Studien verglichen dies mit überhaupt keinem Material und andere mit nicht individuell zugeschnittenen Materialien. Basierend auf 9 Studien mit über 13.000 Teilnehmern gibt es Evidenz, dass individuell zugeschnittenes Material nutzbringender war als kein Material. Ferner ergaben weitere 22 Studien eine schwächere Evidenz dafür, dass der Nutzen von individuell zugeschnittenem Material größer ist als der von nicht individuell zugeschnittenem Material.

Schlussfolgerungen

Der Nutzen von Selbsthilfe-Material ist gering und von 100 Personen, die Material ohne sonstige Unterstützung erhalten, ist nur von ungefähr einer Person zu erwarten, dass sie sich das Rauchen erfolgreich abgewöhnt. Bei Studien dieser Art wurde oft Personen Material zugesandt, die nicht bemüht waren, sich das Rauchen abzugewöhnen, und die Anzahl der Personen, die sich das Rauchen erfolgreich abgewöhnten, war gering. Die meisten Studien fanden zudem in Ländern statt, in denen intensivere Unterstützung für Personen bereitsteht, die sich das Rauchen abgewöhnen wollen (zum Beispiel Beratung). Die Teilnehmer machten mit höherer Wahrscheinlichkeit einen erfolgreichen Entwöhnungsversuch, wenn sie persönliche Unterstützung erhielten, aber in diesen Studien trug die Bereitstellung von Material nicht dazu bei, den Erfolg zu vergrößern. Diejenigen, die Materialien benutzen möchten, finden sie vielleicht hilfreich, besonders wenn ihnen keine intensivere Unterstützung zur Verfügung steht, aber Raucher, die sich das Rauchen abgewöhnen möchten, sollten ermutigt werden, intensivere Unterstützung in Anspruch zu nehmen, falls sie verfügbar ist.

Anmerkungen zur Übersetzung

Koordination durch Cochrane Schweiz

Резюме на простом языке

Помогают ли печатные материалы для самопомощи, содержащие информацию о том как бросить курить, действительно бросить курить

Актуальность

Мы рассмотрели доказательства того, что печатные материалы, дающие структурированные советы о том, как бросить курить, помогают людям бросить курить. Мы провели поиск испытаний, исследующих любой тип печатных материалов в качестве самопомощи, которые представляли структурированную поддержку и советы по отказу от курения. Мы также включили материалы в аудио или видео формате, но не включили интернет-программы или другие форматы. Испытания должны были включать курильщиков, но они не обязательно должны были при включении пытаться бросать курить. Для нас представляло интерес число людей, которые не курили, по меньшей мере 6 месяцев с момента, когда им были предоставлены материалы. В некоторых клинических испытаниях материалы выслали курильщикам более чем один раз. Некоторые испытания собирали информацию об истории курения и привычках курильщиков, чтобы предоставить материалы, которые были составлены индивидуально с учетом особенностей курильщика (адаптированные материалы). В некоторых испытаниях, не было контакта лицом к лицу, и материалы были единственной поддержкой. В других испытаниях давали совет каждому, и они были так спланированы, чтобы проверить, есть ли какая-либо дополнительная польза от предоставления письменных материалов.

Характеристика исследований

Эти доказательства актуальны по 28 апреля 2014 года. Мы нашли 74 исследования. Большинство из них были проведены в Северной Америке или Европе у взрослых. Большинство исследований не требовали, чтобы люди хотели бросить курить, чтобы присоединиться к исследованию. Хотя некоторые исследования были признаны имеющими возможный риск смещения, в основном, потому что в статьях не сообщали детали методов, это не повлияло на общие выводы обзора.

Основные результаты

На основе 11 исследований с более чем 21 000 участников, получены доказательства незначительной пользы печатных, индивидуально не адаптированных структурированных материалов для самопомощи, при их предоставлении без какого-либо контакта. Вероятность отказа от курения была увеличена примерно на 20%. Если самопомощь сравнивали с краткой брошюрой о курении (6 исследований), не было доказательств дополнительной пользы от структурированных материалов. Когда материалы самопомощи были предоставлены в дополнение к краткому взаимодействию лицом к лицу (5 исследований) или советам (11 исследований), не было каких-либо доказательств дополнительной пользы по сравнению с влиянием только взаимодействия или советов.

Мы нашли 31 испытание, которые представили письменные материалы, которые были индивидуально подобраны (адаптированы). Некоторые исследования сравнивали их с отсутствием каких-либо материалов, а некоторые - с не адаптированными материалами. Были доказательства, основанные на 9 исследованиях с более чем 13 000 участников, что адаптированные материалы давали больше пользы, чем отсутствие каких-либо материалов. Были также более слабые доказательства из дополнительных 22 исследований, что адаптированные материалы давали больше пользы, чем не адаптированные материалы.

Выводы

Величина пользы от материалов для самопомощи мала: ожидается только лишь 1 дополнительный успешный бросивший курить из 100 человек, получающих материалы без каких-либо других видов поддержки. Исследования такого типа часто посылали материалы людям, которые не пытались бросить курить, и число успешных отказов от курения было низким. Большинство исследований также проходили в странах, где более интенсивная поддержка была доступна для людей, желающих бросить курить (например, консультирование). Курильщики были более склонны предпринимать успешные попытки бросить курить, когда они имели поддержку лицом к лицу. Но в этих исследованиях предоставление материалов не способствовало дальнейшему увеличению успеха. Люди, которые решили использовать материалы, могут найти их полезными, особенно если им не доступна более интенсивная поддержка, но люди, которые хотят бросить курить, должны быть стимулированы вести поиск более интенсивной поддержки, если она доступна.

Заметки по переводу

Перевод: Джамалбеков Алмаз Рысбекович. Редактирование: Зиганшина Лилия Евгеньевна. Координация проекта по переводу на русский язык: Cochrane Russia - Кокрейн Россия (филиал Северного Кокрейновского Центра на базе Казанского федерального университета). По вопросам, связанным с этим переводом, пожалуйста, обращайтесь к нам по адресу: lezign@gmail.com

Streszczenie prostym językiem

Czy drukowane materiały z zakresu samopomocy zawierające informacje jak rzucić palenie pomagają ludziom zerwać z nałogiem.

Wstęp

Dokonano przeglądu danych naukowych na to, że materiały drukowane zawierające usystematyzowane porady jak zaprzestać palenia pomagają ludziom w zerwaniu z nałogiem. Szukano badań na temat dowolnego rodzaju poradników, które dostarczały usystematyzowanego wsparcia i porad jak zaprzestać palenia. Włączono także materiały w formacie audio oraz wideo, jednak zrezygnowano z programów internetowych lub innych formatów. Badania musiały obejmować osoby palące, jednak niekoniecznie te, które w danej chwili próbują zaprzestać palenia. Zwrócono uwagę na liczbę osób, które zaprzestały palenia na co najmniej 6 miesięcy od chwili dostarczenia im materiałów. W niektórych badaniach materiały wysyłano więcej niż jeden raz. Niektóre badania gromadziły informacje na temat przebiegu nałogu oraz zwyczajów z nim związanych w celu dostarczenia materiałów, które były indywidualnie dopasowane do charakterystyki palacza (dopasowane materiały). W niektórych badaniach nie występował kontakt twarzą w twarz, a materiały były jedyną formą wsparcia. W innych badaniach udzielano porad wszystkim i zaprojektowano je tak, aby zbadać czy występowała jakaś dodatkowa korzyć z dostarczania materiałów pisemnych.

Charakterystyka badania

Dane są aktualne do kwietnia 2014. Zidentyfikowano 74 badania. Większość z nich została zrealizowana w Ameryce Północnej lub Europie i przeprowadzano je wśród dorosłych. W większości badań nie wymagano, aby uczestnicy chcieli rzucić palenie. Chociaż uznano, że w przypadku części badań występuje ryzyko błędu systematycznego, głównie ze względu na brak szczegółowego opisu metod, nie wpłynęło to na wnioski ogólne przeglądu.

Główne wyniki

W oparciu o 11 badań w których wzięło udział 21 000 uczestników, stwierdzono dowody na to, że występuje niewielka korzyść związana z udostępnieniem usystematyzowanych materiałów pisemnych niedopasowanych do indywidualnej osoby, bez innych form wsparcia. Prawdopodobieństwo zaprzestania palenia wzrosło o ok. 20%. Porównując materiały samopomocy z nawet najkrótszymi broszurami na temat palenia (6 badań) nie stwierdzono dowodów na dodatkowe korzyści wynikające z dostarczenia usystematyzowanych materiałów. Jeśli materiały samopomocy dostarczono jako dodatek do kontaktu twarzą w twarz (5 badań) lub poradnictwa (11 badań), nie stwierdzono dodatkowej korzyści w porównaniu z efektem samej porady lub poradnictwa.

Znaleziono 31 badań, w których materiały drukowane były indywidualnie dostosowywane. Niektóre z badań porównywały je do sytuacji, w której nie dostarczono żadnych materiałów, a inne do materiałów, które nie zostały dostosowane indywidualnie. Na podstawie danych z 9 badań, w których wzięło udział 13 000 uczestników, stwierdzono, że materiały dostosowane indywidualnie przynosiły większe korzyści w porównaniu z niestosowaniem jakichkolwiek materiałów drukowanych wspomagających rzucenie palenia. Stwierdzono również na podstawie słabszych danych z dodatkowych 22 badań, że materiały dostosowane indywidualnie przynosiły większe korzyści niż materiały niedostosowane do indywidualnego użytkownika.

Wnioski

Korzyść wynikająca ze stosowania materiałów do samopomocy jest mała - szacuje się, że jedynie 1 palacz rzuci palenie na 100 osób którym dostarczono materiały bez innych form wsparcia. W tego typu badaniach często wysyłano materiały osobom, które nie próbowały zerwać z nałogiem, a liczba osób którym udało się zaprzestać palenia była niewielka. Ponadto większość badań była prowadzona w państwach, w których dostępne były bardziej intensywne formy wsparcia dla osób pragnących zerwać z nałogiem (przykładowo: pomoc psychologa). Istniało większe prawdopodobieństwo, że badanym udało się skutecznie zerwać z nałogiem, jeśli mieli zapewnione wsparcie twarzą w twarzą, jednak w badaniach tych dostarczenie materiałów nie wiązało się z dalszym zwiększeniem skuteczności. Osoby, które zdecydowały się na wykorzystanie materiałów mogą stwierdzić, że są one pomocne, zwłaszcza, jeśli nie mają dostępu do bardziej intensywnych form wsparcia, jednak osoby pragnące zaprzestać palenia należy zachęcać do szukania bardziej intensywnej formy wsparcia, o ile jest dostępna.

Uwagi do tłumaczenia

Tłumaczenie: B. Matulewicz, Redakcja: Małgorzata Bała

Summary of findings(Explanation)

Summary of findings for the main comparison. Print-based self help compared to no materials for smoking cessation
  1. 1 Control group success rate based on average across studies. Low rate reflects intervention in participants not selected on basis of motivation to quit. All studies conducted in high income countries.
    2 Majority of studies at high or unclear risk of bias but no evidence of differential effect based on risk of bias
    3 Lower confidence interval close to no effect
    4 All but one study at high or unclear risk of bias. One study at low risk of bias was small with wide confidence intervals

Print-based self help compared to no materials for smoking cessation
Patient or population: People who smoke, not selected for interest in quitting smoking
Settings: Community - materials provided without personal contact
Intervention: Print-based self help materials
Comparison: No materials
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
No materials Print-based self help materials
Abstinence - non-tailored self-help
Follow-up: 6+ months
Moderate risk population1 RR 1.19
(1.04 to 1.37)
13241
(11 studies)
⊕⊕⊕⊝
moderate 2.3
No evidence of effect detected in other studies where the controls received other materials (n = 6), or where all participants had personal contact (n = 5) or brief advice (n = 11).
50 per 1000 60 per 1000
(52 to 69)
Abstinence - individually tailored self-help
Follow-up: 6+ months
Moderate risk population1 RR 1.35
(1.19 to 1.53)
13437
(9 studies)
⊕⊕⊕⊝
moderate 4
Similar effect also detected in 22 other studies where the controls received non-tailored materials, but effect may be partially due to additional contacts.
50 per 1000 68 per 1000
(60 to 76)
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

The World Health Organization has identified tobacco use as the leading behavioural risk factor for preventable premature death (WHO 2012). Globally, tobacco smoking is currently estimated to cause the death of about five million tobacco users a year, but this is expected to rise to over eight million within the next 20 years. More than 80% of these deaths are projected to occur in low- and middle- income countries (WHO 2012). The adverse health effects from tobacco use include cardiovascular disease, respiratory disease and cancer.

Behavioural strategies to aid smoking cessation range from very brief interventions, such as advice from a physician, to intensive multi-component programmes. There is good evidence for the effectiveness of brief, therapist-delivered interventions, such as physician advice (Stead 2013a), and for the additional effect of more intensive behavioural interventions, such as group therapy (Stead 2005), individual counselling (Lancaster 2005) and telephone counselling (Stead 2013b). However, a major limitation of therapist-delivered behavioural interventions is that they reach only a small proportion of smokers. Most successful quitters give up on their own (Lee 2007). Methods to support otherwise unaided quit attempts therefore have the potential to help a far greater proportion of the smoking population. This is especially the case in lower income countries, where more intensive cessation support may not be available.

The aim of self-help interventions is to provide some of the benefits of intensive behavioural interventions without the need to attend treatment sessions. Such materials can be disseminated and used on a much wider scale than therapist-delivered treatment. They therefore represent a bridge between the clinical approach to smoking cessation oriented towards individuals, and public health approaches that target populations (Curry 1993). Self-help programmes were first developed as written materials, primarily delivered in print, but other formats such as videos or audiotapes have also been used. New technologies enable delivery of information and support via the internet and mobile phones; these self-help formats are evaluated in separate Cochrane reviews (Civljak 2013; Whittaker 2012).

Previous reviews and versions of this review have found evidence of a small but significant effect of print-based self-help interventions. However, new theories and technologies have led to continued interest and research in this field, in particular the ability to tailor materials based on individual characteristics through computer-based algorithms. Such personalization is the focus of most new research in this field.

The aim of this review is to summarize existing evidence for the older (print-based, video, and audiotape) forms of self-help interventions in promoting smoking cessation.

Objectives

The aims of this review were to determine: the effectiveness of different forms of print-based self-help materials, compared with no treatment and with other minimal contact strategies; the effectiveness of adjuncts to print-based self help, such as computer-generated feedback, telephone hotlines and pharmacotherapy; and the effectiveness of approaches tailored to the individual compared with non-tailored materials.

Methods

Criteria for considering studies for this review

Types of studies

Randomized controlled trials with a minimum follow up of six months, where at least one arm consisted of a print-based self-help intervention without repeated face-to-face therapist contact. We included trials where allocation to treatment was by a quasi-randomized method but, where appropriate, we used sensitivity analysis to determine whether their inclusion altered the results.

Types of participants

Any smokers except pregnant smokers and adolescent smokers. Interventions in pregnant smokers (Lumley 2004) and in adolescent smokers (Grimshaw 2006) have been evaluated in separate Cochrane reviews.

Types of interventions

We defined self-help interventions as any manual or programme to be used by individuals to assist a quit attempt not aided by health professionals, counsellors or group support. This review primarily covers written materials, but information could also have been provided via audio or videotape or similar medium. Interventions designed to be delivered via the internet, or via mobile phone, are covered in separate reviews (Civljak 2013; Whittaker 2012). Materials could be aimed at smokers in general, could target particular populations of smokers, for example different ages or ethnic groups, or could be tailored to individual smoker characteristics. Brief leaflets on the health effects of smoking were not included - they were considered to be a control intervention if compared to a more substantial manual. Interventions with a single session of minimal face-to-face contact for the purpose of supplying the self-help programme materials were regarded as self help alone. Where a face-to-face meeting included discussion of the programme contents we categorized this as brief advice in addition to self-help materials. We excluded interventions that provided repeated sessions of advice in addition to self-help materials. Telephone counselling or hotlines as adjuncts to self-help materials are covered in a separate Cochrane review (Stead 2013b).

Types of outcome measures

We use sustained abstinence, or two-point prevalence, where available. We included studies using either self report of cessation alone or biochemically validated cessation.

Search methods for identification of studies

We identified trials included in previous reviews and meta-analyses, and searched the Cochrane Tobacco Addiction Review Group Specialized Register of controlled trials for additional studies, using the terms 'self-help', 'manual*' or 'booklet*' or pamphlet* in the title or abstract, or as a keyword (Appendix 1). The most recent search of the Register was in April 2014. At the time of the search the Register included the results of searches of: the Cochrane Central Register of Controlled trials (CENTRAL), issue 3, 2014; MEDLINE (via OVID) to update 20140321; EMBASE (via OVID) to week 201413 and PsycINFO (via OVID) to update 20140317. See the Tobacco Addiction Group Module in the Cochrane Library for full search strategies and a list of other resources searched.

Data collection and analysis

Two authors extracted data. Information extracted included details of the intervention, population recruited, method of randomization, completeness of follow-up, way in which cessation was defined and whether self-reported cessation was validated.

We summarized individual study results as a risk ratio, 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 method to estimate a pooled risk ratio with 95% confidence intervals (Greenland 1985). The amount of statistical heterogeneity between trials was estimated using the I² statistic (Higgins 2003). Values between 30 to 60% may suggest moderate heterogeneity, and values over 75% represent considerable heterogeneity (Higgins 2011).

We categorized trials according to the amount of face-to-face contact provided to both treatment and comparison intervention groups, according to whether or not any written materials were given to the comparison group, and according to whether the material was individually tailored. The comparison tables included:

  • Non-tailored self-help materials versus no treatment or a leaflet only, without face-to-face contact

  • Non-tailored self-help materials versus no treatment or a leaflet only, with face-to-face contact

  • Non-tailored self-help materials and brief advice versus brief advice alone

  • Individually tailored materials versus no materials

  • Individually tailored versus standard or stage-matched materials

  • Self-help materials plus nicotine replacement therapy (NRT) versus NRT alone

Any trials comparing self help to individual counselling were covered in a Cochrane review of individual counselling (Lancaster 2005). Self help versus group counselling has been covered in the Cochrane review of group therapy for smoking cessation (Stead 2005). Self help plus NRT versus self help alone is a test of the efficacy of NRT and is covered in the Cochrane review of NRT (Stead 2012).

Comparison tables also addressed enhancements and adjuncts to self help, namely:

  • Tailored self-help programmes versus non-tailored programmes, or no intervention controls

  • Targeted materials versus standard materials

  • Provision of additional materials

  • Different self-help programmes or different media formats (audiotapes, video) compared to each other

We define as tailored materials those that make use of participant characteristics to provide individualized programmes. We also include in this category interventions providing individual written feedback in addition to standard materials. We define targeted materials as those tailored for a broadly defined category of smoker, for example, women with young children, older smokers, or smokers in a particular stage of change (Kreuter 2000).

The use of proactive telephone counselling or provision of telephone hotlines as an adjunct to self-help materials is now evaluated in a separate Cochrane review (Stead 2013b), so trials which only compare these interventions are no longer included here.

Results

Description of studies

For the present update of the review we identified 285 potentially relevant records new to the Tobacco Addiction Group Specialised Register since the last update; six new studies met the inclusion criteria (Figure 1). The review now includes 74 trials of self-help methods. One study with a factorial design was treated as two studies for data entry (Killen 1997; Killen 1997 +NP). Thirty-four of the included studies compared standard self-help materials to no intervention or provided standard materials as an adjunct to advice. The other trials compared targeted or tailored self-help methods or compared other variations of programmes. Some trials used multiple interventions, testing the effect of different types of information, or the effect of increasing amounts of material. Trials of self-help materials were carried out in a range of settings. In some the materials were provided without face-to-face contact or any additional motivating strategy. Some studies tested the use of materials for people who had called quitlines; self-help materials were the main form of support offered, or were evaluated as an adjunct to counselling (Strecher 2005). In healthcare settings, self-help materials were more frequently used as an adjunct to brief advice to quit. Some studies described as being tests of self-help materials included relatively high levels of face-to-face support, though less than in formal counselling programmes. The smokers recruited to trials ranged from those who had already succeeded in quitting for 48 hours (Killen 1990), to those with no interest in quitting (Dijkstra 1999), but in most cases an interest in quitting was not a selection criterion.

Figure 1.

Flow diagram for update

The content and format of the self-help programmes were varied. The most frequently used approach was the American Lung Association (ALA) Freedom from smoking in 20 days cessation manual and A lifetime of freedom from smoking maintenance manual. Most other programmes were not named or described fully. Materials have tended to become more complex over time and to incorporate more techniques from behaviour therapy approaches. Most recent studies have used computerized expert systems to provide tailored materials judged to be relevant to the characteristics of each smoker, using baseline data. We specified that materials should contain a structured programme for quitting. When it was not clear whether the materials provided met these criteria, we performed sensitivity analysis to determine the effect of including or excluding these trials.

Further details on each of the included studies can be found in the Characteristics of included studies table. Details of 73 studies excluded at full text stage can be found in the Characteristics of excluded studies table. The most common reasons for listing studies as excluded were that self-help materials were used as the control and that follow-up was too short, typically only one month.

Non-tailored self-help materials compared to no intervention (Comparisons 1 & 2)

Non-tailored materials without face-to-face contact

We identified 19 trials in which non-tailored self-help materials were sent to smokers without any personal contact. In 13 of these the comparison control group was not sent any materials (Cuckle 1984; Ledwith 1984; Lando 1991; Gritz 1992; Pallonen 1994; Curry 1995; Humerfelt 1998; Dijkstra 1999; Schofield 1999; Becona 2001a; Becona 2001b; Lennox 2001; Willemsen 2006). In the other six the control group received a brief leaflet (Davis 1984; Cummings 1988; Orleans 1991; Lichtenstein 2000; Lichtenstein 2008; Parekh 2014). In 11 trials, participants responded to promotion of smoking cessation programmes or volunteered for a trial. One of these only recruited smokers who were not planning to quit in the next six months (Dijkstra 1999). Two studies sent unsolicited materials to smokers in Health Maintenance Organisations (Curry 1995; Gritz 1992). One sent either tailored or non-tailored letters from a physician to general practice patients who had answered a questionnaire about smoking behaviour (Lennox 2001); we compare the standard letter to the non-intervention control in this comparison. One study addressed smoking, diet, physical activity and weight so only a subgroup of participants smoked; the control group received information on other health behaviours (Parekh 2014). One study sent a booklet and a personally addressed letter from a consultant to smokers or recent quitters discharged from hospital (Schofield 1999). Three studies targeted factors which might motivate interest in quitting. One of these used a community survey to identify young (30-45) male smokers with reduced FEV1 or asbestos exposure. The intervention consisted of self-help materials accompanied by a letter from a respiratory physician, which drew attention to the individual's higher risk of smoking-related lung disease and advised quitting (Humerfelt 1998). The other two recruited households via utility bill enclosure offering radon testing, and provided a leaflet (Lichtenstein 2000) or video (Lichtenstein 2008) that highlighted the synergistic impact of radon and smoking and advised on quitting or not smoking indoors. The comparison groups received a standard leaflet about the risks of radon that did not emphasise quitting. All the studies used a single mailing of materials except Becona 2001a and one arm of Becona 2001b which sent six weekly mailings, Pallonen 1994 which sent stage of change-based manuals at six-monthly intervals, and Parekh 2014 in which one intervention arm received a second assessment and mailing after three months.

Non-tailored materials with brief contact

We identified five trials in which non-tailored self-help materials were given personally to participants, but not in the context of formal advice to stop smoking. In one study the control group were given health education materials without a specific focus on tobacco use, and the intervention group was intended to receive a single telephone call (Resnicow 1997). In the other studies the controls received no intervention (Prue 1983; Campbell 1986; Fortmann 1995; Betson 1998). Three studies recruited in outpatient clinics (Prue 1983; Campbell 1986; Betson 1998); the last of these probably included some telephone contact for the self-help group, although the extent of this is unclear. In one trial (Fortmann 1995) volunteers were recruited who had quit for 24 hours before randomization in a factorial design with a nicotine gum/no gum condition. Since there was no interaction between the gum and self-help conditions the nicotine arms have been collapsed for entry in the analysis. All these participants were offered a US$100 incentive to quit for six months.

Non-tailored materials and advice versus advice alone

Eleven trials assessed non-tailored self-help materials as an adjunct to brief advice about stopping smoking given by a healthcare worker. In three of these trials some written materials were given to the control group. In one study (Lando 1988) both arms were also prescribed nicotine gum and instructed in its use. Advice was given by a doctor alone in six studies, and by a doctor, nurse or both in four. In one study student nurses advised two smokers each, one before and one after training to deliver a self-help manual (Davies 1992). In one trial (Hollis 1993) self-help participants had additional advice from a nurse as well as a physician message. In a study of physician advice (Thompson 1988) which used a complete factorial design some smokers received structured advice with or without materials, and some received brief advice - we have combined the two levels of advice. Kottke 1989 randomized physicians to a workshop with or without a supply of self-help materials for patients.

We did not identify any trials that directly compared standard self-help materials with brief advice.

Tailored self-help materials (Comparisons 3 & 4)

Thirty-one trials used materials tailored according to the characteristics of individual smokers. Only two of these had any face-to-face contact as part of the baseline intervention (Lipkus 1999; Meyer 2012). Four recruited people who had called a quitline. In Borland 2003 only those callers seeking written materials without counselling were recruited. In Borland 2004 some had brief counselling prior to recruitment, and in Strecher 2005 and Sutton 2007 all participants received counselling during their initial call. Just under half the remaining studies included volunteers who were likely to have been seeking help to quit. Fifteen recruited a mix of people, some of whom were not interested in immediate quit attempts (Curry 1995; Velicer 1999; Lennox 2001; Prochaska 2001a; Prochaska 2001b; Aveyard 2003; Etter 2004; Prochaska 2004; Prochaska 2005; de Vries 2008; Schumann 2008; Meyer 2012; van der Aalst 2012; Gilbert 2013; Parekh 2014), and one trial specifically recruited people not interested in quitting (Dijkstra 1999). Four trials evaluated multiple risk factor interventions so only a subgroup of participants were smokers (Prochaska 2004; Prochaska 2005; de Vries 2008; Parekh 2014).

Nine studies compared tailored materials to no intervention (Dijkstra 1998b; Prochaska 2001a; Prochaska 2001b; Etter 2004; Prochaska 2004; Prochaska 2005; Meyer 2008; Schumann 2008; Hoving 2010). Some of the 19 trials testing the incremental effect of tailoring over standard materials confounded the tailoring with additional contact, so we grouped the trials according to whether or not the number of mailings was matched. Ten trials matched contacts (Burling 1989; Owen 1989; Velicer 1999; Becona 2001a; Lennox 2001; Strecher 2005; Velicer 2006; Sutton 2007; de Vries 2008; van der Aalst 2012). Of the trials with additional contact, some provided the same materials initially but then provided additional tailored materials to the intervention group, so we distinguished between six where all materials were tailored (Curry 1991; Prochaska 1993; Curry 1995; Aveyard 2003; Borland 2003; Gilbert 2013) and three where materials were only partially tailored (Ledwith 1984; Dijkstra 1999; Borland 2004). Two studies tested tailored materials as an adjunct to advice (Lipkus 1999; Meyer 2012). One study compared a placebo tailored intervention (tailoring was not actually conducted, but materials were constructed to suggest it had been) with a standard, non-tailored intervention (Webb 2013).

The method used for obtaining information, the theoretical basis for tailoring materials and the number of contacts varied, and are reported in more detail in the Characteristics of included studies table. Eleven studies tailored materials based only on information provided at baseline (Ledwith 1984; Owen 1989; Curry 1995; Dijkstra 1998a; Lennox 2001; Aveyard 2003; Strecher 2005; Sutton 2007; de Vries 2008; Hoving 2010; van der Aalst 2012), whereas the others sent further materials based on further assessments. Of those interventions that reported the theoretical basis for their tailoring, stage of change was by far the most common model used, with 14 interventions modelling material on this theory (Pederson 1983; Velicer 1999; Lennox 2001; Prochaska 2001a; Prochaska 2001b; Aveyard 2003; Borland 2003; Etter 2004; Prochaska 2004; Prochaska 2005; Velicer 2006; Meyer 2008; Schumann 2008; Meyer 2012). One study tailored materials based on social cognitive and perspectives of change theories (Sutton 2007) and two based their intervention on the I-Change model (Dijkstra 1998a; Hoving 2010). The majority of tailored interventions provided materials at multiple time points.

Self-help and nicotine replacement therapy (NRT) compared to NRT alone (Comparison 5)

Two studies tested non-tailored self-help materials as an adjunct to nicotine replacement (Fortmann 1995; Lando 1988). Both have been included in the relevant subgroup of the comparisons above, but are also compared directly here. Both studies used nicotine gum. We excluded a further study from this comparison because both groups received written materials, which we classified as self help (ICRF 1994).

Two studies tested tailored/targeted self-help materials as an adjunct to NRT. One study, published as an abstract (Orleans 2000), used a guide targeted for older smokers and seven age-tailored computer-generated mailings as an adjunct to nicotine patch. The control group received a fact sheet on patch-assisted quitting. One study tested a single tailored letter as an adjunct to stage-based manuals, and nicotine patch for people identified as ready to quit (Velicer 2006).

Other enhancements or adjuncts to self-help materials (Comparison 6)

Additional written materials

Four studies examined the effect of further mailings of non-tailored materials. In one, smokers who had succeeded in quitting for 48 hours were given an initial module booklet, How to cope with the urge to smoke without smoking (Killen 1990). The control group received no further intervention. The self-selecting group then chose a further seven modules on avoiding smoking in specific high-risk situations. The final group were sent a random selection of modules at weekly intervals. These factors were crossed with a nicotine gum or placebo condition. Since no interaction was reported we have collapsed the gum conditions and combined the self-selected and random module groups. Another trial compared a Quit Kit with five-day cessation plan against a staged correspondence course (Owen 1989). In the third, the American Lung Association (ALA) Freedom from smoking in 20 days manual used in conjunction with a televised programme and additional maintenance newsletters was compared to manual and programme alone (McFall 1993). In one trial the materials were mailed six months after the quit kit (Cuckle 1984).

Additional video

One trial (Killen 1997) tested a video as an additional component. The factorial design also tested the effect of nicotine patches, and since there was evidence for an interaction between the NRT and the self-help condition the patch and placebo arms have been entered separately.

Materials targeted at particular populations of smokers

Five trials compared a manual targeted at a particular population to a standard one. Davis 1992 compared a programme intended for mothers with young children with ALA or National Cancer Institute (NCI) materials. Orleans 1998 compared a guide addressing the quitting needs and barriers of African-American smokers with a standard guide, mailed to smokers calling the NCI Cancer Information Service. Prochaska 1993 provided manuals tailored to the smoker's stage of change compared to standard materials. Another trial of manuals tailored for older smokers was excluded as no long-term follow-up has been reported (Rimer 1994). Nollen 2007 compared culturally sensitive to standard materials for African-American smokers who also received nicotine patches and two phone calls.

Comparisons between different types of self-help material

We identified eight trials that compared different types of self-help materials that were neither tailored nor personalized, or delivered over different time periods (Glasgow 1981; Omenn 1988; ICRF 1994; Berman 1995; Becona 2001b; Sykes 2001; Clark 2004; Smith 2004). In two of these, three different sets of materials were compared (Glasgow 1981; Omenn 1988). ICRF 1994 compared a standard 16-page booklet with a larger manual containing more information about quitting with the use of a nicotine patch. Berman 1995 compared two types of materials for smokers volunteering for heart health screening and cessation. Becona 2001b compared a manual with a weekly mailing of six booklets, both based on the same cognitive behavioural approach. Sykes 2001 compared a cognitive behavioural programme consisting of a handbook, reduction cards, a progress chart and an audiotape, which summarized the programme and provided relaxation music, with a leaflet developed by the UK Health Education Authority, both used as an adjunct to a single introductory session in a group format. Clark 2004 compared a handout listing internet sites providing useful resources to standard self-help materials. Smith 2004 compared materials produced by the Canadian Cancer Society; a 44-page booklet or a single page advice pamphlet. These were tested in a factorial design along with two different intensities of telephone counselling (which are collapsed in this review).

Risk of bias in included studies

Allocation

Only 11 study reports provided full descriptions of randomization and allocation concealment methods that we judged to have low risk of bias (BTS 1983; ICRF 1994; Schofield 1999; Lennox 2001; Aveyard 2003; Borland 2004; Smith 2004; Velicer 2006; Sutton 2007; Schumann 2008; Gilbert 2013). The majority of studies did not explicitly describe the way in which the randomization sequence was generated or concealed until patient enrolment. In many of the studies there was no face-to-face contact with participants and the likelihood of biased allocation was probably low. In four studies (Campbell 1986; Pederson 1983; Davis 1992; Meyer 2008) a pseudo-random method of allocation by day or week of attendance was used, and one study (Hollis 1993) used numbers in the patient record. One study shuffled questionnaires (Borland 2003) and another used the pre-printed colour on the questionnaire to determine allocation (Hoving 2010). One study randomized physicians to intervention groups (Kottke 1989) and two randomized households (Lichtenstein 2000; Lichtenstein 2008). Three studies randomized by recruitment site (Berman 1995; Resnicow 1997; Meyer 2012). In some of these studies we judged that the method of generating the allocation could have led to selection bias in the recruitment or assignment of patients. Excluding studies where we judged there could be a risk of bias due to an inadequate method of allocation does not alter the conclusions from any meta-analysis.

Blinding

In this update, we assessed performance and detection bias based on blinding of participants and personnel and on whether biochemical validation was used. Forty-two studies provided detail of blinding, biochemical validation and/or description of similar intensity interventions that led us to judge them to be at low risk of bias in this domain. Fourteen studies described procedures which we judged to place the results at high risk of bias in this domain (Prue 1983; Cuckle 1984; Dijkstra 1998a; Orleans 1998; Owen 1989; Lando 1991; Davies 1992; Curry 1995; Resnicow 1997; Becona 2001a; Becona 2001b; Etter 2004; Willemsen 2006; Meyer 2012; Gilbert 2013), and the remainder did not provide sufficient detail with which to judge, and hence were judged to be at unclear risk of performance and detection bias.

Biochemical validation of all self reports of quitting, or sufficient data to adjust quit rates for the level of misreport in a sample, were available in 23 studies (Glasgow 1981; BTS 1983; Cuckle 1984; Campbell 1986; Harackiewicz 1988; Omenn 1988; Burling 1989; Kottke 1989; Curry 1991; Orleans 1991; Davies 1992; Hollis 1993; ICRF 1994; Fortmann 1995; Killen 1997; Humerfelt 1998; Schofield 1999; Becona 2001a; Lennox 2001; Sykes 2001; Clark 2004; Nollen 2007; Webb 2013). In three cases quitting was confirmed by a significant other (Prue 1983; Cummings 1988; Davis 1992). Amongst those that did not report fully biochemically verified quit rates, 15 studies (Pederson 1983; Prue 1983; Janz 1987; Thompson 1988; Owen 1989; Lando 1991; Resnicow 1997; Orleans 1998; Dijkstra 1999; Lipkus 1999; de Vries 2008; Hoving 2010 (GP arms only); Gilbert 2013; Meyer 2012; Parekh 2014 (single arms only)) used self-reported abstinence at a single follow-up point. In the other studies without validation, participants classified as nonsmokers had either reported sustained abstinence, or been abstinent at one or more points prior to the final follow-up.

Incomplete outcome data

Some reports give quit rates based only on those people contacted at follow-up. In this review we have followed the methods of the Cochrane Tobacco Addiction Review Group in reporting analyses based on the total number randomized wherever possible, with drop-outs and participants lost to follow-up classified as smokers. In population-based studies it has been argued that it may be pessimistic, and introduce bias, to classify all drop-outs as continuing smokers if those data are missing at random (Velicer 1999). We have noted in the Risk of Bias table the number of drop-outs by group, and whether the data used in this review included all randomized participants. Where the proportion of drop-outs was high and differed across treatment conditions we performed sensitivity analyses to assess whether excluding drop-outs would affect the conclusions. It should be noted that if the proportion of drop-outs is similar across conditions, including losses as treatment failures does not affect the risk ratio. The large majority of included studies reported sufficiently similar losses to follow-up across arms that we judged them to be at low risk of attrition bias. Fourteen did not provide sufficient detail with which to judge, and three reported data on loss to follow-up that led us to place the study at high risk of bias in this domain: one in which less than half of participants were followed up (Nollen 2007); one in which loss to follow-up was differential (41% difference) between intervention and control arms (Cuckle 1984); and one in which only participants who provided data at final follow-up were reported in the paper (de Vries 2008).

Measures of abstinence

Studies reported a range of measures of abstinence. A minimum period of follow-up of six months was required for inclusion in the review, but 47/74 (63.5%) followed up participants for 12 months or more. Thirty-three of these required abstinence to have been sustained for a period. Trials that used strict criteria for self-reported sustained abstinence, with validation at one or more follow-up points, tended to report lower quit rates for both experimental and comparison interventions. In minimal contact programmes, obtaining saliva samples for biochemical validation was often reported to be a problem. Participants may have declined to provide samples for reasons unrelated to their smoking status. Validated quit rates may therefore be particularly low, and are likely to underestimate success rates if all those for whom samples are not available are classified as smokers. Measures using abstinence from the first follow-up may underestimate the long-term effect of having access to the self-help materials, which may prompt a quit attempt some time after they were supplied. Trials with long follow-up which only use point prevalence abstinence rates may show a trend of increasing quit rates as more smokers make attempts over time.

Figure 2 shows risk of bias judgements for each included study.

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Effects of interventions

See: Summary of findings for the main comparison Print-based self help compared to no materials for smoking cessation

Trials varied in the amount of face-to-face advice or counselling given to both experimental and comparison interventions, and in whether or not control materials were given to smokers in the comparison group. In considering the effects of self help, we grouped trials by these categories. In Comparison 1 we calculated a pooled risk ratio (RR) separately for each level of personal contact with subgroups for the type of control. In Comparison 2 we used the same trial data and pooled all subgroups in order to estimate an overall pooled RR from all trials comparing self help to no self help.

Non-tailored self-help materials compared to no intervention (Comparisons 1 & 2)

Non-tailored materials without face-to-face contact

There were 13 trials with a total of over 15,500 participants where standard non-tailored self-help manuals or materials were provided by post, and control groups did not receive any materials. There was substantial heterogeneity (I² = 71%) attributable to the inclusion of two trials conducted in Spain (Becona 2001a; Becona 2001b) that showed very strong effects (Analysis 1.2). Both trials enrolled treatment-seeking smokers, and those in the control group knew they would be offered treatment after six months, a possible disincentive to make an unaided quit attempt. Quit rates were also very high in the intervention groups (16% and 25%). We have therefore excluded these studies from this meta-analysis and calculated a pooled estimated effect for the other 11 trials amongst which there was no evidence of heterogeneity (I² = 0%). Amongst these trials the control quit rate ranged from 1% to 11%, with an average of 5%, and the intervention quit rate ranged from 2% to 10%. The pooled risk ratio favoured self-help interventions, although the confidence interval (CI) only narrowly excluded 1.0 (n = 13,241, risk ratio (RR) 1.19, 95% CI 1.04 to 1.37, Analysis 1.1.1/ 2.1.1).

Six trials in which the controls received some form of written materials did not show any trend towards a benefit of more structured materials, with the pooled risk ratio for this subgroup being less than 1.0 (n = 7023, RR 0.88, 95% CI 0.74 to 1.04, Analysis 1.1.2/ 2.1.2). If these two subgroups are pooled there is no longer evidence for a benefit of structured materials, (n = 20,264, RR 1.06, 95% CI 0.95 to 1.18).

Non-tailored materials with brief contact

In the group of five trials in which the materials were delivered in person rather than by post there were almost 4000 participants, and an average control group quit rate of 9%. There was no evidence of heterogeneity and we failed to find evidence for a significant effect of self-help materials given with face-to-face contact whether or not controls received some written materials (n = 3866, RR 1.17, 95% CI 0.96 to 1.42, Analysis 1.3).

Non-tailored materials and advice versus advice alone

There were 11 trials with a total of over 5,000 participants in which self-help materials were tested as an adjunct to face-to-face advice from a healthcare provider. There was little heterogeneity and we did not find evidence that the additional self-help materials significantly increased quit rates (n = 5365, RR 0.97, 95% CI 0.80 to 1.18, Analysis 1.4). Whether or not the control group received materials did not affect the estimate. The control group quit rates ranged from 2% to 25% with an average of 7%. As would be expected, this is higher than the rates seen in control groups that received no intervention.

Overall effect of non-tailored self-help, alone or as adjunct to advice

When we pooled 32 trials of self-help materials compared to no self help, irrespective of level of contact and support common to the control group, there was no evidence of an effect and little heterogeneity (n = 29,495, RR 1.06, 95% CI 0.98 to 1.16, I² = 23%, Analysis 2.1, Figure 3). (Note: the estimate excludes Becona 2001a and Becona 2001b, and Betson 1998 contributes data to two subgroups.)

Figure 3.

Forest plot of comparison: 2 Self-help vs no self-help, pooling all studies, outcome: 2.1 Long term abstinence.

Tailored self-help materials (Comparisons 3 & 4)

Based on nine studies, participants receiving tailored self-help materials had higher quit rates than those receiving no materials at all (n = 13,437, RR 1.35, 95% CI 1.19 to 1.53, I² = 0%, Analysis 3.1.1). Control group quit rates were 4 to 7%. Estimates were largely based on sustained but self-reported abstinence with the exception of Prochaska 2005, which only reported point prevalence quit rates.

In other trials of tailored materials the control groups received standard self-help materials. The subgroup of ten trials in which the intervention and control groups were matched for number of contacts did not detect a benefit (n = 11,024, RR 1.06, 95% CI 0.94 to 1.20) with some evidence of heterogeneity (I² = 50%), largely contributed by Becona 2001a where there was a significant effect of weekly feedback reports. One trial (Sutton 2007) included some recent quitters for whom the effect of intervention was smaller, but restricting inclusion to those still smoking at enrolment had little impact on the pooled estimate. Velicer 1999 showed an almost significant effect based on numbers randomized. Excluding drop-outs from the denominators increased the estimated effect a little because more people were lost from the expert system intervention groups. This trial also tested different numbers of tailored versus non-tailored mailings, but did not detect a consistent dose response effect (data not shown).

Amongst the six studies where tailored materials were compared to a non-tailored control, but with the effect potentially confounded by the increased contact, results were consistent. Although none of these studies individually had statistically significant results, the pooled estimate suggested a small benefit of the intervention (n = 11,379, RR 1.32, 95% CI 1.09 to 1.61, Analysis 3.1.3). In the group of three studies where only the additional materials were tailored, there was also evidence of benefit (n = 2787, RR 1.72, 95% CI 1.25 to 2.37, Analysis 3.1.4). Two studies that tested tailored materials as an adjunct to physician advice detected a benefit of the materials (n = 1839, RR 1.68, 95% CI 1.19 to 2.37, Analysis 3.1.5).

One study (Webb 2013) detected a benefit of 'placebo tailoring' (n = 424, RR 1.98, 95% CI 1.18 to 3.31), suggesting that the actual content of the tailored message may be less important than the perception that it is individualised.

If the differences in the details of tailoring and amount of contact are taken to be of limited importance, and all 31 studies are pooled, there is only modest statistical heterogeneity (I² = 32%) and there is evidence of an overall benefit from tailored materials (n = 40,890, RR 1.28, 95% CI 1.18 to 1.37, Analysis 3.1, Figure 4). The estimate remains almost unchanged if we exclude the nine trials in Analysis 3.1.1 where there was a no-intervention control (n = 27,453, RR 1.24, 95% CI 1.13 to 1.36, I² = 48%). Additional sensitivity analysis removing the study using placebo tailoring makes little difference to either result. This supports a conclusion both that tailored materials increase the number of quitters and that they do so more than standard materials.

Figure 4.

Tailored self-help materials: Long-term abstinence

Tailored materials directly compared to brief advice

Meyer 2008 and Meyer 2012 both allowed a direct comparison between mailed tailored materials and brief advice from a health care provider combined with provision of stage matched manuals. No difference was detected, though confidence intervals were wide (n = 2992, RR 1.13, 95% CI 0.86 to 1.49, Analysis 4.1).

Self-help materials plus nicotine replacement therapy (NRT) compared to NRT alone (Comparison 5)

The four trials that specifically examined self-help materials in addition to NRT did not show any evidence of an additional benefit from the materials over the relatively high quit rates achieved by use of NRT (n = 2291, RR 1.05, 95% CI 0.88 to 1.25, I² = 0%, Analysis 5.1). The control group quit rate was over 20% in three of the four studies. There was no difference in results between the two trials using standard materials and the two that tailored materials. One study relevant to this category was excluded because follow-up was too short (Strecher 2005b). This study compared an internet-based tailored programme to internet-based non-tailored material for smokers who had purchased nicotine patch and logged on to use the behavioural support programme. In this large study the difference between continuous abstinence rates was significant after 12 weeks (23% versus 18%). It is not known whether this advantage would have been maintained had there been longer follow-up.

Other enhancements or adjuncts to self-help materials (Comparison 6)

Additional written materials

Pooled results from four trials of additional written materials failed to detect a significant benefit (RR 1.01, 95% CI 0.87 to 1.17, Analysis 6.1.1). One of the trials (Cuckle 1984) did not send further materials until six months after the initial 'quit kit', but excluding this does not affect the estimate.

Additional video

The trial that used a video as an adjunct to written materials (Killen 1997) did not detect a significant overall benefit (n = 424, RR 0.72, 95% CI 0.41 to 1.28, Analysis 6.1.2). There was a non-significantly lower quit rate in the active nicotine patch group amongst those who received the video as well as written materials.

Materials targeted at particular populations of smokers

Five trials of materials targeted at specific populations failed to show evidence for a significant benefit compared to standard materials (n = 3101, RR 1.11, 95% CI 0.90 to 1.37, Analysis 6.1.3). In two of the studies, callers to quitlines were given telephone counselling before being sent materials (Davis 1992; Orleans 1998 (in which the counselling was also tailored)), and in one, all participants received nicotine replacement therapy (Nollen 2007). These common components may have contributed to the success in quitting in all groups and limited the potential to detect effects of small differences in adjunct materials.

Comparisons between different types of self-help material

We did not perform meta-analysis of this heterogeneous group of trials. Two small trials each compared three variants of materials (Glasgow 1981, n = 88; Omenn 1988, n = 243); neither detected statistical differences in quit rates between any conditions. A trial with 1686 participants also found no significant difference in outcome between those given a longer or a shorter booklet when used in conjunction with either a nicotine or placebo patch and nurse support (ICRF 1994). Berman 1995 compared two types of materials for 348 smokers volunteering for heart health screening and cessation. There were no significant differences in any measure of quitting. Clark 2004 (n = 171) did not detect the hypothesized benefit of a list of internet resources over standard material. The results favoured the standard materials but with wide confidence intervals. A study comparing weekly mailings to a single manual detected no significant difference at six or 12 months (Becona 2001b, n = 482). There was no evidence of a difference between a 44-page booklet or a pamphlet when used as adjuncts for motivated quitters receiving an extended telephone counselling session and one of two intensities of follow-up counselling (Smith 2004, n = 632). One trial (Sykes 2001, n = 260) showed a statistically significant effect after six months with a more than three-fold increase in the odds of quitting using a cognitive behavioural self-help programme compared to a standard leaflet, with both used as an adjunct to a single introductory session in a group format. This was not sustained at 12-month follow-up (Marks 2002).

Discussion

Summary of main results: self help in different contexts

In this review, we defined self-help materials as those providing structured approaches to smoking cessation. Using this definition, there was moderate evidence that such materials, used on their own and compared with no intervention, marginally but significantly increased the number of people able to quit smoking (Summary of findings for the main comparison). The confidence in this result was somewhat limited by potential risk of bias due to inadequate reporting, but this was judged to be unlikely to affect confidence in the direction of the effect.

In trials in which mailed materials were compared with a no-intervention control, the quit rate increased by 20%. This result just reached statistical significance as the confidence interval around this estimate just excluded 1.0. The results of most of these trials were reasonably consistent, but we excluded two trials (both by the same authors) from the pooled estimate because they were the source of significant heterogeneity: these two trials showed benefits for self-help materials. None of the other trials had significant results for the outcome used in this review. While it is probable that there was a small effect of the materials compared to no treatment, this corresponds to an absolute difference in quit rates of about 1% at best (Number needed to treat = 100). This effect was lost if we included trials where controls received some alternative written materials about the health effects of smoking.

There was no evidence of a significant effect when the materials were handed out with face-to-face contact but without advice about smoking cessation. In this comparison there were four trials without, and one with, materials for the control group. The trial contributing the greatest weight (Fortmann 1995) only included smokers who had successfully quit for 24 hours, and where some smokers were additionally receiving nicotine gum - excluding gum groups did not affect the summary outcome. However this trial design was testing the effectiveness of self-help materials in preventing relapse, not in motivating a quit attempt or aiding immediate success.

Another Cochrane systematic review has shown that physician advice increases quitting compared to no advice or usual care (Stead 2013a). The present review suggests that providing additional self-help materials in addition to advice from a healthcare professional does not improve the outcome. This set of comparisons includes 11 trials with over 5000 participants. The upper limit of the 95% confidence interval for the pooled estimate of an effect is a risk ratio of 1.18, but when calculated as an absolute difference, the increase in quit rates would be no more than 1%. Russell's widely quoted study of the effects of advice from doctors in primary care (Russell 1979), suggested that the addition of a leaflet along with a warning of follow-up produced an incremental benefit. This effect was not consistently replicated in later studies. Russell's trial was not included in the present review, as the information leaflet was not substantial enough to qualify as self help. However, its inclusion in a sensitivity analysis did not alter the conclusions.

There is similarly little evidence of an effect for self-help materials in addition to nicotine replacement therapy (NRT). There have been other trials using personally tailored materials instead of standard materials combined with nicotine gum or patch (Shiffman 2000; Shiffman 2001; Strecher 2005b). They report only short follow-up and are therefore not included in this review, but combining tailored materials with NRT may be a promising field for further research.

One reason that it may be difficult to show efficacy for standard self-help programmes is the level of 'contamination'. Materials encouraging smokers to quit and giving tips are already relatively widely disseminated, so that smokers in a control arm who are motivated to try to give up may well have access to the same kinds of materials that experimental group smokers have been given. On the other hand, there may be more fundamental reasons why behavioural interventions are more effective when delivered by face-to-face contact. Killen has suggested, for example, that the self-regulatory skills required to withstand the urge to smoke may be better learnt, rehearsed and retained under direct supervision from a therapist than through the simple modelling offered by self-help materials (Killen 1997). Strecher has suggested that the length of generic self-help manuals and pamphlets may discourage effective use of materials (Strecher 1994). Meade 1989 suggested that self-help materials may be too advanced for many readers and that comprehension can be improved by adjustment of the reading grade level. Tailored materials may have the potential to address these issues.

Enhancing self-help programmes

One of the main criticisms of traditional self-help materials is that they do not take account of individual characteristics and problems in dealing with smoking cessation. This could account for the failure of self-help materials to match the effect of counselling delivered individually or in groups. Tailoring materials to individuals' habits and motivations is an attractive theoretical approach to enhancing the efficacy of such materials. In this review, individually tailored materials appeared to be effective compared to no self-help intervention. One limitation of the conclusions on the benefit of tailoring compared to standard materials is that in a number of studies the tailoring is confounded with additional contact. The small number of studies where contacts were matched had heterogeneous outcomes. One of these studies tested different number of contacts without detecting a dose response effect, but the tailored materials tended to outperform the standard ones whatever the number of contacts. We are inclined to the view that contact or assessment alone is unlikely to contribute much to the impact of tailoring, and has to form part of the tailoring process. Under this assumption, pooling all studies of tailored materials versus standard materials can be justified and the evidence suggests not only that they are more effective than no intervention, but also that they are more effective than standard materials. It should be noted though that even large individual studies have mostly failed to detect statistically significant long-term effects, and the absolute increase in quit rates attributable to the use of tailored materials is still small. Two of the authors of studies included in this meta-analysis are cautious about the effects of some types of tailoring. Aveyard is sceptical about the benefit of the expert system tailoring based on the transtheoretical ('stages of change') model (TTM) as implemented in their trial in unselected smokers (Aveyard 2003). Borland (Borland 2003) also concluded that tailoring using the TTM did not improve quit rates for smokers calling a quitline. However in a second trial using an improved system of tailoring this group did detect an improvement over standard materials (Borland 2004).

It remains unclear which elements of personalizing information to individual smokers may be important, and which theories should inform the tailoring of materials (Skinner 1999; Strecher 1999). The authors of a study using personalization as a placebo for individualized tailoring whilst manipulating expectancies suggest that the non-specific effects of tailoring may be relevant (Webb 2005). Another study amongst students who were told they were evaluating messages to be used in self-help materials suggested that both personalizing and feedback might contribute to the effect of tailored materials (Dijkstra 2005). Although three of the largest studies have been conducted by Prochaska and colleagues, other groups have also shown similar sizes of effect. In one study where tailoring did not appear beneficial the intervention materials were very brief and did not give much information about how to quit. The authors have discussed a number of explanations for this negative finding (Reiter 2003). In considering whether and how to tailor materials it appears to be important to consider the broad characteristics of the population who will be targeted. Callers to a quitline are likely to require advice geared to making their quit attempt successful rather than the motivational elements which may be appropriate to a broader population-based intervention. One group of researchers has noted that, whilst tailoring based on the transtheoretical model typically generates a large proportion of unique materials for smokers in contemplation, preparation, action, and maintenance, even if only normative data is used, the variability in materials is much smaller for smokers in precontemplation (Schumann 2008b). Absolute increases in quit rates depend to some extent on the population recruited to the intervention. In one of the largest studies (Velicer 1999), which recruited 85% of identified smokers in a Health Maintenance Organisation, there was a 1.5% to 3% increase in six-month sustained abstinence at 18 months compared to standard materials, depending on assumptions about the smoking status of smokers lost to follow-up. This is similar to the average absolute increase in quit rate of 1% to 3% when all tailored trials are pooled.

Offering tailored interventions depends on the ability to obtain baseline data. This may be difficult, and introduces a delay if printed materials are being mailed, though data from a study new to this update suggests that placebo tailoring may be effective in the absence of data with which to actually tailor the intervention (Webb 2013 ). Newer formats for providing self-help support may have greater potential for providing relevant and timely interventions. Although the evidence from trials is not yet optimal, using the internet to provide individually tailored information and support may avoid the limitations of traditional self-help materials (Civljak 2013). Using mobile phones to deliver text message based interventions also shows promise for supporting people who are making quit attempts (Whittaker 2012).

Methodological considerations

Our conclusions about the effect of self-help materials are based on an intention-to-treat analysis in which all randomized participants are included whether or not they received the intended intervention. A number of studies reported subgroup analyses showing that quit rates were higher amongst those who made more use of the programme. However, we cannot assume that this is a causal relationship, since it may be that those prepared to read a manual were those already most motivated and equipped to quit successfully. Tailored materials may produce a benefit because they are more appealing and readable so that more people use them.

We also make the assumption that participants who cannot be reached for follow-up or who decline further participation are all still smoking. It has been argued that in minimal contact population-based studies participants may be unreachable for reasons unrelated to their smoking status, and that the assumption that they are all smokers leads to unnecessarily conservative quit rates (Hall 2001; Prochaska 2001a). Prochaska, Velicer and colleagues distinguish between those lost to follow-up and those who withdraw from the trial. We have used numbers randomized in our primary analysis, but conducted a sensitivity analysis of the effect of using numbers followed up as the denominator. This of course increases the average quit rates in both intervention and control groups, but since drop-out rates are typically quite similar across study arms it has only a small impact on the estimate of the relative effect. It has no effect on the conclusions about tailoring.

A continued role for print-based self help?

It is well recognized that the majority of ex-smokers state that they have given up without the aid of a formal cessation programme. As Fisher and colleagues have pointed out (Fisher 1993) 'they have quit amongst a substantial array of health education messages, encouragement from health professionals ...changes in norms related to smoking ... and the experience gained from their own prior quit attempts'. Information is an important part of individual participation in all forms of health care, and the provision of written and other forms of information to smokers has important face validity. However, the effects of providing standardized self-help materials are modest at best. Smokers who seek help are likely to benefit more from brief advice or counselling, or from tailored materials.

This being said, Fisher's quotation is illustrative of a landscape in which legislative and individual support is available to help people who wish to quit. Though smokers wishing to quit are likely to benefit more from intensive interventions than from self-help, this is only relevant where these more intensive interventions are available. The studies included in this review overwhelmingly represent a population with access to more intensive stop-smoking support (of the 73 included studies, 72 were conducted in high income countries according to the World Bank definition; the one outlier was conducted in Hong Kong). In addition, studies in this review tended to include participants regardless of whether or not they wanted to quit smoking (only three of the 20 studies in our primary analyses focused on smokers who wished to stop). This review, therefore, can inform decisions as to whether print-based self-help should be used in developed countries, but paradoxically it can not tell us about the population who these interventions are now most likely to benefit - people motivated to quit who do not have other support available. By 2020, the World Health Organization estimates that there will be over 6 million tobacco related deaths in developing countries a year. In light of this, even a very modest effect size could have significant public health impact when applied at a population level. Further research, conducted outside of Western Europe, North America, and Australia, is therefore needed to determine if print-based self-help interventions still have a role to play.

Authors' conclusions

Implications for practice

Access to information, in understandable formats, is important for individuals who smoke, as it is for those with other kinds of medical problem. This review examined the specific effect of materials which aimed to provide a structured approach to smoking cessation beyond simple information. Such materials may provide a very small increase in quitting compared to no intervention. We did not find evidence that self-help materials produce incremental benefits over other minimal interventions such as advice from a healthcare professional, or nicotine replacement therapy. There is increasing evidence that materials that are tailored for individual smokers are more effective than no intervention, and more effective than non-tailored materials, although the absolute increase in quit rates is still small.

Implications for research

Almost all included studies were conducted in high income countries; future research should examine the effects of print-based self-help in contexts where more intensive support may not be available. In addition, future research in this field is likely to focus on ways of further individualizing self-help materials, delivered in a variety of formats.

Acknowledgements

Our thanks to Sue Curry, Paul McDonald and Saul Shiffman for their comments, and to Ann Varady, Joe Rossi, Christine Edwards, Neal Boyd, Virginia Rice and Tracy Orleans for providing additional data from published or unpublished trials.

Data and analyses

Download statistical data

Comparison 1. Non-tailored self help vs no self help, pooled by amount of contact
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Neither group had face-to-face contact (long term abstinence)1720264Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.95, 1.18]
1.1 Control group given no materials1113241Risk Ratio (M-H, Fixed, 95% CI)1.19 [1.04, 1.37]
1.2 Control group given leaflet/pamphlet67023Risk Ratio (M-H, Fixed, 95% CI)0.88 [0.74, 1.04]
2 Neither group had face-to-face contact (Becona studies only)2924Risk Ratio (M-H, Fixed, 95% CI)11.32 [5.27, 24.31]
2.1 Control group given no materials2924Risk Ratio (M-H, Fixed, 95% CI)11.32 [5.27, 24.31]
3 Both groups had face-to-face contact (long-term abstinence)53866Risk Ratio (M-H, Fixed, 95% CI)1.17 [0.96, 1.42]
3.1 Control group given no materials42712Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.86, 1.35]
3.2 Control group given leaflet/pamphlet11154Risk Ratio (M-H, Fixed, 95% CI)1.42 [0.98, 2.04]
4 Both groups had face-to-face contact with advice (long term abstinence)115365Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.80, 1.18]
4.1 Control group given no materials83581Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.73, 1.16]
4.2 Control group given leaflet/pamphlet31784Risk Ratio (M-H, Fixed, 95% CI)1.13 [0.79, 1.60]
Analysis 1.1.

Comparison 1 Non-tailored self help vs no self help, pooled by amount of contact, Outcome 1 Neither group had face-to-face contact (long term abstinence).

Analysis 1.2.

Comparison 1 Non-tailored self help vs no self help, pooled by amount of contact, Outcome 2 Neither group had face-to-face contact (Becona studies only).

Analysis 1.3.

Comparison 1 Non-tailored self help vs no self help, pooled by amount of contact, Outcome 3 Both groups had face-to-face contact (long-term abstinence).

Analysis 1.4.

Comparison 1 Non-tailored self help vs no self help, pooled by amount of contact, Outcome 4 Both groups had face-to-face contact with advice (long term abstinence).

Comparison 2. Non-tailored self help vs no self help, pooling all studies
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Long-term abstinence3229495Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.98, 1.16]
1.1 No contact/No materials for control1113241Risk Ratio (M-H, Fixed, 95% CI)1.19 [1.04, 1.37]
1.2 No contact/Leaflet for control67023Risk Ratio (M-H, Fixed, 95% CI)0.88 [0.74, 1.04]
1.3 Face-to-face contact/No materials for control42712Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.86, 1.35]
1.4 Face-to-face contact/Leaflet for control11154Risk Ratio (M-H, Fixed, 95% CI)1.42 [0.98, 2.04]
1.5 Advice/No materials for control83581Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.73, 1.16]
1.6 Advice/Leaflet for control31784Risk Ratio (M-H, Fixed, 95% CI)1.13 [0.79, 1.60]
Analysis 2.1.

Comparison 2 Non-tailored self help vs no self help, pooling all studies, Outcome 1 Long-term abstinence.

Comparison 3. Tailored self-help materials
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Long-term abstinence3140890Risk Ratio (M-H, Fixed, 95% CI)1.28 [1.18, 1.37]
1.1 Individually tailored materials versus no materials913437Risk Ratio (M-H, Fixed, 95% CI)1.35 [1.19, 1.53]
1.2 Individually tailored versus standard or stage-matched materials (matched for number of contacts)1011024Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.94, 1.20]
1.3 Individually tailored initial and additional materials versus standard or stage-matched single mailing611379Risk Ratio (M-H, Fixed, 95% CI)1.32 [1.09, 1.61]
1.4 Individually tailored additional materials versus standard or stage-matched single mailing32787Risk Ratio (M-H, Fixed, 95% CI)1.72 [1.25, 2.37]
1.5 Individually tailored materials as an adjunct to advice21839Risk Ratio (M-H, Fixed, 95% CI)1.68 [1.19, 2.37]
1.6 Placebo tailoring versus standard1424Risk Ratio (M-H, Fixed, 95% CI)1.98 [1.18, 3.31]
Analysis 3.1.

Comparison 3 Tailored self-help materials, Outcome 1 Long-term abstinence.

Comparison 4. Tailored materials versus brief advice
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Long-term abstinence22992Risk Ratio (M-H, Fixed, 95% CI)1.13 [0.86, 1.49]
Analysis 4.1.

Comparison 4 Tailored materials versus brief advice, Outcome 1 Long-term abstinence.

Comparison 5. Self help plus NRT vs NRT alone
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Long-term abstinence42291Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.88, 1.25]
1.1 Non-tailored materials2825Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.73, 1.24]
1.2 Tailored materials21466Risk Ratio (M-H, Fixed, 95% CI)1.13 [0.89, 1.43]
Analysis 5.1.

Comparison 5 Self help plus NRT vs NRT alone, Outcome 1 Long-term abstinence.

Comparison 6. Other enhancements/adjuncts to self-help materials
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Long-term abstinence11 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 Additional written materials44085Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.87, 1.17]
1.2 Additional video2424Risk Ratio (M-H, Fixed, 95% CI)0.72 [0.41, 1.28]
1.3 Targeted materials versus standard materials53101Risk Ratio (M-H, Fixed, 95% CI)1.11 [0.90, 1.37]
Analysis 6.1.

Comparison 6 Other enhancements/adjuncts to self-help materials, Outcome 1 Long-term abstinence.

Appendices

Appendix 1. CRS search strategy

#1 (self-help OR selfhelp OR manual* OR booklet* OR pamphlet*):TI,AB,MH,EMT,KW,KY,XKY
#2 (leaflet* or letter* or video*):TI,AB,MH,EMT,KW,KY,XKY
#3 #1 OR #2

What's new

Last assessed as up-to-date: 10 April 2014.

DateEventDescription
7 May 2014New citation required but conclusions have not changedJH-B added as author. Review title changed from 'Self-help interventions for smoking cessation'
7 May 2014New search has been performedUpdated with six new studies. Summary of Findings table added. Risk of Bias domains added.

History

Protocol first published: Issue 2, 1998
Review first published: Issue 4, 1998

DateEventDescription
28 January 2009New search has been performedUpdated with ten new studies for Issue 2, 2009. No major changes to results
29 October 2008AmendedConverted to new review format.
28 April 2005New citation required and minor changesUpdated for issue 3, 2005 with 9 new studies. Most used tailored interventions and strengthen the evidence that tailored materials are more useful than standard ones.
10 April 2002New citation required and minor changesUpdated for issue 3, 2002 with 10 new studies. Most used tailored interventions and strengthen the evidence that tailored materials are more useful than standard ones.
13 October 1999New search has been performedUpdated for issue 1, 2000 with 4 new trials.

Contributions of authors

TL and LS jointly undertook data extraction and drafting of review. JHB and LS undertook data extraction and drafting of this update, with oversight from TL. LS conducted searches for trials.

Declarations of interest

None known.

Sources of support

Internal sources

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

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

External sources

  • NHS Research & Development Programme, UK.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Aveyard 2003

MethodsSetting: 65 general practices, UK
Recruitment: volunteers from random selection of smoking patients, not selected for motivation
Participants2471 smokers, 1373 in relevant arms, >80% in precontemplation or contemplation, 10-14% in preparation.
54% F, av. age 41, av. cpd 20
InterventionsNo face-to-face contact.
1. Standard S-H materials, single mailing
2. S-H manual based on Transtheoretical (SoC) model, expert system letter tailored on baseline questionnaire. Further questionnaires at 3m & 6m for additional letters (approx 50% received 3 letters).
OutcomesAbstinence at 12m, sustained for 6m
Validation: saliva cotinine < 14.2 ng/ml
Notes2 vs 1, tailored S-H vs standard S-H
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomization using minimization to balance SoC, addiction and socio-economic status.
Allocation concealment (selection bias)Low riskBaseline questionnaires were read optically and data transferred automatically to the Access database that performed the minimization.
Blinding (performance bias and detection bias)
All outcomes
Low riskInterventions of similar intensity. 12m 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 risk24% of S-H and 24% control lost to follow up. Included in ITT analysis here, sensitivity analyses allowing for differential drop-out did not change findings

Becona 2001a

MethodsSetting: community, Spain
Recruitment: community volunteers, mainly in contemplation or preparation SoC
Participants300 smokers;
48% F, Av. age 37, av. cpd 26
Interventions1. No intervention. Treatment offered after 6m follow up
2. Standard S-H pamphlets, 6 mailed weekly with personalized letter
3. As 2 with individual feedback based on weekly reports + 2 additional 1 page reports.
OutcomesAbstinence at 6m or 12m, sustained since initial quit.
Validation: CO < 9ppm
Notes2 vs 1 , S-H vs control, excluded from MA comparison 2 due to heterogeneity. Quit rates 16% vs 0% at 6m
3 vs 2, 12m outcome, tailored materials
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomization method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
High riskWait list control (control group participants told treatment would be delayed)
Incomplete outcome data (attrition bias)
All outcomes
Low risk<10% lost to follow-up, included in ITT analyses

Becona 2001b

MethodsSetting: community, Spain
Recruitment: smokers interested in quitting within 6m
Participants724 smokers; 42% F, av. age 37, av. cpd 26
Interventions1. Waiting List control (only followed for 6m)
2. S-H Manual
3. S-H brochures sent weekly
OutcomesAbstinence at 12m (30 day PP) or 6m (7 day PP)
Validation: CO at 12 m
Notes3+2 vs 1, S-H vs control, 6m follow up. Excluded from MA comparison 2 due to heterogeneity.
2 vs 3 comparison between materials, not included in MA
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomization method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
High riskWaiting list control
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAll randomized participants included in ITT analysis, but number followed up not reported

Berman 1995

MethodsSetting: multi-ethnic community, USA
Recruitment: via schools, smokers interested in health screening and cessation
Participants348 smokers; 51% F, av.age 37
InterventionsAll participants received cardiovascular health screening and educational materials.
1. Freedom from Smoking for you and Your Family or Spanish equivalent. Minimally tailored message at completion of 3m telephone follow up and tailored letter (Group class offered after 6m follow up)
2. How to Double your Quitting Power and Spanish equivalent.
OutcomesAbstinence at 6m, continuous (other outcomes also reported, no differences in findings)
Validation: attempted unsuccessfully at 12m
NotesNo non-S-H control so does not contribute to main analysis. No differences at any time point or definition of abstinence.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomized by school using coin toss
Allocation concealment (selection bias)High riskParticipants were enrolled proactively after randomization so potential for selection bias. Fewer participants in control (179) than experimental (267) conditions
Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation attempted but very few participants provided samples; however, interventions of similar intensity and differed only by content so differential misreport judged unlikely
Incomplete outcome data (attrition bias)
All outcomes
Low risk218 (62.6%) reached at 12m follow up

Betson 1998

MethodsSetting: government outpatient clinic, Hong Kong
Recruitment: smokers aged < 65
Participants865 smokers; 92%M, 49% smoking >10 cpd
Interventions1. No intervention
2. S-H materials (Chinese translation of American Cancer Society booklet)
3. Physician advice (1min, based on 4As)
4. Physician advice and S-H booklet
OutcomesAbstinence at 1 yr (sustained from 3m)
Validation: poor response to request for urine specimen so data based on self report
Notes2 vs 1, S-H with face-to-face contact
4 vs 3, S-H as adjunct to advice
Full paper provided by Professor Lam.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskTable of random numbers used to allocate questionnaires to four groups placed in sealed numbered envelopes
Allocation concealment (selection bias)Unclear risk'Every doctor was given a set of sealed envelopes'. There was considerable imbalance in numbers in each group, unclear whether this was due to randomization procedure or selection bias.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskAbstract only, unclear if participants aware of what other arm received but within comparisons in this review, interventions varied by intensity
Incomplete outcome data (attrition bias)
All outcomes
Low risk36% lost to follow up, included in ITT analysis

Borland 2003

MethodsSetting: Quitline, Australia
Recruitment: smokers seeking materials or counselling
Participants1578 smokers, 1050 in relevant arms; 54% F, modal age 30-49, av. cpd 23
Interventions1. Standard S-H Quit pack based around SoC
2. Additional tailored letters at baseline, and at 3m and 6m based on mailed assessments
3. Additional proactive TC (not incl in this review)
Some participants in all groups received brief reactive counselling before enrolment
OutcomesAbstinence at 1 yr (sustained for 9m)
Validation: none
Notes2 vs 1, tailored S-H vs standard S-H.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk'Shuffling questionnaires'
Allocation concealment (selection bias)Unclear risk'no opportunity for interviewers to influence choice of condition' so bias judged unlikely
Blinding (performance bias and detection bias)
All outcomes
Low riskSelf-reported outcomes from participants not blinded to treatment condition, but as no personal contact and similar levels of intensity, considered low risk for differential misreport
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up 78.9% for 1. 76.9% for 2. Losses included in ITT analysis. Excluding losses would marginally lower effect size

Borland 2004

MethodsSetting: Quitline, Australia
Recruitment: Callers wanting written S-H materials
Participants772 baseline smokers (baseline quitters not included in this review); 54% F (all participants), approx 47% aged < 30, av.cpd 19
Interventions1. Standard S-H quit pack
2. Additional tailored letters, based on assessment phone calls. Av number 5.7 (SD 4.6)
OutcomesAbstinence at 12m (sustained for 6m)
Validation: none
Notes2 vs 1, tailored S-H vs standard S-H. No control for effect of multiple contact
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated ID numbers, even numbers allocated to intervention
Allocation concealment (selection bias)Low riskID number generated after agreement to participate obtained
Blinding (performance bias and detection bias)
All outcomes
Low riskBlinding not possible because of nature of the intervention, but "participants in each condition [did] not know about the other condition unless they specifically asked ... (none did)". No blinding or validation of smoking status, but because of low-contact nature of intervention, differential misreport of smoking unlikely
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up 71.3%% for 1. 63.8% for 2. Losses included in ITT analysis. Excluding losses would lower effect size

BTS 1983

MethodsSetting: Hospital chest clinics and inpatient wards, UK
Recruitment: Patients with smoking-related conditions
Participants748 smokers (in relevant arms); av age 49, av cpd 24
Interventions1. Brief advice to quit from a physician
2. Advice and S-H booklet containing information and advice
3. Same as 2. plus placebo chewing gum (not included in this review)
4. Same as 2. plus nicotine gum (not included in this review)
OutcomesSustained abstinence 6-12m (2m PP)
Validation: venous carboxyhaemoglobin and thiocyanate
Notes2 vs 1, S-H vs control.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCentrally generated, 'each physician initially received a balanced block of 12 treatments'
Allocation concealment (selection bias)Low riskNumbered envelopes, opened after eligibility assessed
Blinding (performance bias and detection bias)
All outcomes
Unclear riskBiochemical validation, but possible performance bias in that physicians handing out leaflets were not blind to treatment condition and this may have impacted advice, insufficient detail reported with which to judge
Incomplete outcome data (attrition bias)
All outcomes
Low risk48 withdrawals reincluded in this analysis but has no impact on effect size

Burling 1989

MethodsSetting: Veterans Administration Medical Centre, USA
Recruitment: VA employees
Participants58 smokers; av age 44, av cpd 27
Interventions1. American Cancer Society and ALA pamphlets about smoking, a telephone hotline, and a stop-smoking contest which gave vouchers for a draw, for each day when expired CO < 8ppm.
2. As 1 + use of a computer to enter data on smoking behaviour and smoke a cigarette through a filter attached to the computer; this produced an individualized nicotine fading programme, explained in an accompanying manual.
OutcomesAbstinence at 6m
Validation: CO < 8ppm
Notes2 vs 1, tailored S-H vs standard S-H.
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 (performance bias and detection bias)
All outcomes
Low riskInterventions of similar intensity, biochemical validation
Incomplete outcome data (attrition bias)
All outcomes
Low risk4 drop-outs reincluded in denominators for this review

Campbell 1986

MethodsSetting: Two chest clinics in Scotland, UK
Recruitment: Smokers attending outpatient clinic (unselected)
Participants1206 smokers referred for chest radiography; 44% aged > 50
Interventions1. S-H. 13 page booklet.
2. No treatment control
OutcomesAbstinence at 1 yr (self report of no smoking for 6m)
Validation: expired CO < 10ppm, non-attenders classified as smokers.
NotesFace-to-face contact but no advice
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskQuasi-random (interventions alternated fortnightly)
Allocation concealment (selection bias)High riskAll smoking patients attending were eligible so potential for selection bias probably low, but there was an imbalance in age distribution between groups
Blinding (performance bias and detection bias)
All outcomes
Low riskControl group unlikely to know what intervention group was receiving, same amount of personal contact, biochemical validation used
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up 74.5% intervention, 74.1% control, losses included in ITT analysis

Clark 2004

MethodsSetting: Lung cancer screening centre, USA
Recruitment: smokers enrolled in a screening study 1 yr previously
Participants171 smokers; 21% in precontemplation, 29% F, av age 57, 46% smoked 11-20 cpd
Interventions1. List of internet cessation resources, 10 sites with brief descriptions.
2. S-H manuals Clearing the Air and Quit Smoking Action Plan
OutcomesAbstinence at 12m (7 day PP)
Validation: CO
NotesComparison between S-H interventions. Not in MA. Authors' hypothesis was that 1. would be superior. OR 0.44, 95% CI 0.12 to 1.43
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 (performance bias and detection bias)
All outcomes
Low riskBiochemical validation, interventions of similar intensity so bias judged to be unlikely
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber lost to follow up not reported but all included in ITT analysis

Cuckle 1984

MethodsSetting: Community exposed to a 15min tv programme with offer of a smoking quit kit, UK
Recruitment: Random sample of individuals requesting a kit
Participants4492 smokers randomized. Results based on 2117 (47%) who replied to a baseline and follow-up questionnaire.
Interventions1. Control - letter apologising for shortage of kits
2. Quit Kit
3. Quit Kit and additional material 6m later.
OutcomesAbstinence at 12m
Saliva cotinine from 66% of quitters. Quit rates corrected by the disconfirmation rate found for each group
Notes2 vs 1, S-H vs control. 3 vs 2, additional materials
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk'One-third were chosen at random as controls and did not receive a kit'
Allocation concealment (selection bias)Unclear riskNo details given, but no personal contact so selection bias unlikely
Blinding (performance bias and detection bias)
All outcomes
High riskControl group would have expected to receive quit kit and then told there was a shortage so did not get them, could introduce performance bias
Incomplete outcome data (attrition bias)
All outcomes
High riskLow response rate in a population-based study so only participants who replied to baseline questionnaire and follow-up questionnaire were included. Response rate to baseline questionnaire was 70% in control group compared to 39% for those receiving a kit.

Cummings 1988

MethodsSetting; Stop smoking hotline, USA
Recruitment: Callers who accepted offer of a stop smoking booklet and who agreed to follow up
Participants1895 smokers; 65% F, av age 42, av cpd 28, 89% had made at least 1 prior quit attempt
InterventionsFirst 4 groups received similar length (+/- 50 pages) and format booklets, differing in precise instructions
1. High structure (day by day plan) recommending 'cold turkey' quitting
2. High structure recommending gradual reduction
3. Low structure (menu of exercises), gradual reduction
4. Low structure, 'cold turkey'
5. Control booklet, 15 pages stressing health effects of smoking
OutcomesAbstinence from 1m-6m, self report by telephone interview with blinded assessors.
No biochemical validation, confirmation by a significant other used
Notes1-4 vs 5 in main analysis
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 (performance bias and detection bias)
All outcomes
Low riskConfirmation by significant other, booklets similar length so differential misreport unlikely
Incomplete outcome data (attrition bias)
All outcomes
Low riskAnalyses based on participants reached at 1m and 6m follow up, 89% of those randomized. Drop-out rates similar in all groups.

Curry 1991

MethodsSetting: HMO, USA
Recruitment: Advertisement for study in HMO magazine
Participants1217 smokers; av age 44, av cpd 25
InterventionsFactorial design
1. S-H programme, Breaking Away
2. S-H and up to 3 sets of personalized feedback based on baseline questionnaire and progress reports (intrinsic motivation)
3. S-H and incentives including a prize draw for returning progress reports (extrinsic motivation)
4. S-H and intrinsic and extrinsic motivation
OutcomesSustained abstinence at 12m (7-day at 3m and 12m)
Validation: Saliva cotinine <= 10 ng/ml at 12m for abstainers in locality. Correcting for disconfirmation rates did not affect sustained abstinence numbers.
Notes4&2 vs 3&1 for effect of personalized feedback (tailoring). Extrinsic motivation did not increase quit rates. Aim was to increase use of materials.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomized, stratified by gender and cpd, no other information
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnclear if control group participants knew nature of intervention conditions. Biochemical validation
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo information on number lost, all randomized participants included in ITT analysis

Curry 1995

MethodsSetting: HMO, USA
Recruitment: Smokers identified via a telephone survey of health behaviour in a random sample of HMO members (unselected)
Participants1137 smokers; 53% F, av age 41, av cpd 17
InterventionsNo face-to-face contact
1. Control - no materials
2. S-H booklet (Breaking Away) with units to complete, relevant to all stages of readiness to quit.
3. As 2 plus feedback based on computer analysis of initial survey. Included a hand-written form, and a list of relevant parts of booklet.
4. As 3 plus up to 3 counsellor-initiated phone calls (not included in this review)
OutcomesSustained abstinence 3m-12m
Validation: saliva cotinine requested but not obtained for all participants. Disconfirmation rates not significantly different between groups.
Notes12m rather than 21m follow up used for comparability with other studies. Author confirmed numbers quit
2 vs 1 in S-H vs control, 3 vs 2 in effect of tailoring
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 (performance bias and detection bias)
All outcomes
High riskControl group aware that they may be receiving materials or phone calls, which they did not - could introduce performance bias. "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

Davies 1992

MethodsSetting: Community, Ottawa, Canada
Recruitment: Each of 156 nursing students recruited 2 non-hospitalized smokers (selected)
Participants307 smokers; Av age 36, av cpd 20
Interventions1. List of community resources, delivered during a home visit by a nursing student
2. Time to Quit (TTQ) S-H booklet + list of community resources, delivered by a nursing student following training in the TTQ programme.
OutcomesAbstinence at 9m
Validation: saliva cotinine <100ng/ml
NotesIt is unclear what advice was given to the control group. Marginal to include since S-H confounded by student training, but does not affect 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 (performance bias and detection bias)
All outcomes
High riskNurses knew would receive more training after delivering control condition and before meeting with intervention participants, introducing likelihood of performance bias
Incomplete outcome data (attrition bias)
All outcomes
Low riskParticipants lost to follow up reincluded as smokers for MA, 28% lost to follow-up, similar across groups

Davis 1984

MethodsSetting: Local communities with Lung Associations, USA
Recruitment: Media advertisements for American Lung Association (ALA) S-H materials
Participants1237 smokers who completed a questionnaire and paid a refundable deposit.
InterventionsNo face-to-face contact
1. ALA leaflets (8 leaflets including 2 brief cessation brochures Me Quit Smoking? Why? and Me Quit Smoking? How?
2. Leaflets and maintenance manual A Lifetime of Freedom from Smoking
3. Cessation manual Freedom from Smoking in 20 days.
4. Cessation and maintenance manuals
OutcomesSustained abstinence at 12m (PP at all 5 follow-up points), self report in telephone interview
Validation: none
Notes2+3+4 vs 1, S-H vs leaflet 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 (performance bias and detection bias)
All outcomes
Low riskNo biochemical validation used but no personal contact, interventions all similar intensity so differential misreport judged unlikely
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo information on number lost, all randomized participants included in ITT analysis.

Davis 1992

MethodsSetting: Community, USA
Recruitment: Advertisements for the Cancer Information Service hotline
ParticipantsWomen smokers with children under 6 calling hotline. Results based on 630/873 (72%) of those recruited who were followed up at 6m.
Interventions1. Quitting Times, a S-H guide developed to meet the special needs of women smokers with young children. 65 pages in magazine format
2. ALA Freedom from Smoking for You and Your Family
3. National Cancer Institute Clearing the Air
OutcomesAbstinence at 6m (7-day PP)
Validation: no biochemical validation. Confirmation by surrogate. Those refusing to give a surrogate were classified as smokers
NotesDoes not contribute to main analysis, 1 vs 2&3, impact of targeting to population
All 3 guides covered similar topics, no significant differences were found between any of them.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk'Preassigned list randomized by day of week'
Allocation concealment (selection bias)Low riskCounsellors who recruited participants during calls were blinded to the S-H guide that would be received
Blinding (performance bias and detection bias)
All outcomes
Low riskAll groups received S-H so similar levels of intensity. "Follow-up interviews were conducted by trained interviewers who were blinded regarding subject assignment.... Surrogate interviews were conducted to verify the smoking status of those who reported that they had quit smoking..."
Incomplete outcome data (attrition bias)
All outcomes
Low risk72% of participants reached at follow up, similar for all three groups. Analyses based on those reached.

de Vries 2008

MethodsSetting: Community, Netherlands
Recruitment: Telephone recruitment for a multiple risk factor health promotion intervention
Participants156 smokers amongst 2827 participants of whom 1331 (47%) responded at T4. Baseline all participants; 55% F, av age 49
Interventions1. Printed tailored letters on smoking as an identified risk factor (other targets were physical activity, nutrition) (Half group had action planning component in 3rd letter)
2. Printed generic letters
OutcomesAbstinence at 9m (not defined)
Validation: none
NotesEffect of tailoring. Numbers of smokers at baseline and quitters provided by author
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomized, method not described
Allocation concealment (selection bias)Unclear riskDetails not given
Blinding (performance bias and detection bias)
All outcomes
Low riskNo biochemical validation but interventions of similar intensity, differential misreport judged to be unlikely
Incomplete outcome data (attrition bias)
All outcomes
High riskOnly baseline smokers who responded to follow-up survey included in analysis

Dijkstra 1998a

MethodsSetting: Community, Netherlands
Recruitment: Newspaper adverts, not selected by level of motivation to quit
Participants1546 smokers; 59% F, av age 40, av cpd 20.3
InterventionsNo face-to-face contact
1. Letter with information on positive outcomes of quitting (OC)
2. Letter with information on skills for quitting (SE)
3. Letter with outcomes and skills information (BO)
All letters were computer-generated, 4-7 page reports, personalized and tailored from baseline questionnaire
4. No information (CO)
Outcomes12m sustained abstinence at 14m, self report by postal questionnaire
Validation: None, participants were told that a sample would be tested for CO levels
Notes1&2&3 vs 4 in tailored materials since 2014. Previously in main comparison.
Results are sensitive to the outcome used, PP do not differ
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 (performance bias and detection bias)
All outcomes
High riskNo biochemical validation used, control group knew other participants receiving an intervention
Incomplete outcome data (attrition bias)
All outcomes
Low risk64% responded at 14m, no difference across groups. Attrition predicted by perceived pros of quitting and intention to quit but did not differ between groups. Denominator in meta-analysis based on all randomized.

Dijkstra 1999

MethodsSetting: Community, Netherlands
Recruitment: Newspaper adverts for smokers not planning to quit in next 6m (unmotivated volunteers)
Participants843 smokers not planning to quit; 63% F, av age 42, av cpd 22
InterventionsNo face-to-face contact
1. Three tailored letters (MT)
2. Single tailored letter (ST)
3. S-H manual, 48 page colour (SHG)
4. No intervention (CO)
OutcomesAbstinence at 6m (7-day PP), self report by postal questionnaire
Validation: none
Primary outcome for trial was SoC and intention to quit
Notes3 vs 4 in S-H vs control. 1&2 vs 3 in effect of tailoring
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 (performance bias and detection bias)
All outcomes
Unclear riskUnclear if control group knew intervention arms receiving additional information, no biochemical validation
Incomplete outcome data (attrition bias)
All outcomes
Low risk89% responded at 6m. Attrition predicted by yrs smoking and group. Denominator used in MA includes all randomized

Etter 2004

MethodsSetting: Community, Switzerland
Recruitment: Mailing to population registers (not selected)
Participants2934 smokers aged 15+; 74% precontemplators, 40% tried to quit in previous yr, 51% F, av age 36, av cpd 20
Interventions1. Tailored 8 page letter + SoC-matched booklets. At 2m, 4m, 12m repeat questionnaire to initiate further letter.
2. No intervention
OutcomesAbstinence at 24m (in maintenance stage, quit for > 6m). 4w and 7-day abstinence also reported.
Validation: none
NotesTailored S-H vs nothing. Approx half of group 1. recvd 1 letter only.
Effect at 6m (Etter Arch Int Med 2001) not sustained at 24m. Relative difference smaller if shorter term abstinence used.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomization: 'list of random numbers'
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
High risk"...members of the control group received a letter indicating that they had been attributed to that group...", no validation, intervention intensity higher than control group
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow up 14.0% in 1 and 10.7% in 2. All non-responders included in ITT analysis.

Fortmann 1995

MethodsSetting: Community, USA
Recruitment: Smokers identified via a random telephone survey, (volunteers)
Participants1044 smokers able to quit for 24 hours; av age 40, av cpd 20
InterventionsAll participants were offered an incentive of US$100 for quitting for 6m
1. Nicotine gum 2mg (NG)
2. S-H materials
3. NG and S-H materials
4. Monetary incentive only
OutcomesAbstinence at 12m (PP)
Validation: CO < 9ppm, salivary cotinine < 20ng/ml
Notes2&3 vs 1&4 in S-H vs control. 3 vs 2 for effect of S-H materials added to gum
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomized in a 2X2 factorial design, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation. 12% of self-reported nonsmokers refused confirmation. Follow up and confirmation rates did not differ by conditions. Does not appear that control participants were aware of the nature of the intervention.
Incomplete outcome data (attrition bias)
All outcomes
Low risk6.2% failed to complete telephone interviews.

Gilbert 2013

Methods

Setting: General practices, UK

Recruitment: Identified via GP records, mailed proactively

Participants6697 current smokers aged 18-65, 56% F, av. age 45, av. cpd 18 (excl. 5.4% non-daily smokers). 47% not planning to quit within 6 months
Interventions

1. Standard, non-tailored NHS 'Stop smoking start living' booklet and computer tailored

advice report based on information obtained through baseline assessment questionnaire; letter from GP; follow-up assessment via mail at 1 month; additional tailored mailing

2. Standard, non-tailored NHS 'Stop smoking start living' booklet

Outcomes

3 month sustained abstinence at 6 months

Validation: none

Notes214 participants excluded post randomization for valid reasons
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"blocked randomisation codes were generated externally and given to an independent administrator in sealed envelopes upon receipt of completed questionnaires"
Allocation concealment (selection bias)Low risk"Participants were accepted into the study before knowledge of the next assignment in the sequence in order to minimise selection bias. Each study participant randomised received the treatment corresponding to the next free study number in the randomised sequence."
Blinding (performance bias and detection bias)
All outcomes
High riskNo biochemical validation, participants aware of what other condition was receiving. "Participants were told that they would be sent some information about quitting, and could be randomly selected to receive additional information based on their answers in the questionnaire."
Incomplete outcome data (attrition bias)
All outcomes
Low risk27% lost intervention, 24% lost control, no significant differences in predictors of drop-outs between groups, authors conducted sensitivity analysis with alternative assumptions about dropouts

Glasgow 1981

MethodsSetting: Community, USA
Recruitment: media advertisements
Participants88 smokers (40 in S-H conditions)
InterventionsFactorial trial of 3 different S-H materials, with or without additional group support
1. Danaher & Lichtenstein manual
2. Pomerleau & Pomerleau manual
3. I Quit Kit
OutcomesAbstinence at 6m
Validation: CO < 15ppm
Notes3 different S-H conditions and no strong hypothesis about direction of treatment difference between D&L and P&P so not used in the MA of different programmes. No statistical difference between quit rates. Also included in group therapy review.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk'Randomly assigned', method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation used, all groups received material (difference in content only)
Incomplete outcome data (attrition bias)
All outcomes
Low risk3/88 lost to follow up, group not specified so not included as smokers.

Gritz 1992

MethodsSetting: HMO, USA
Recruitment: Members of HMO agreeing to participate in a Preventive Health Behavior Study and completing a baseline survey (unselected - not informed that focus of study was on smoking)
Participants1396 F smokers; av age 38, 42% smoked 15-24 cpd
InterventionsNo face-to-face contact, 5 follow-up interviews in 2 yrs
1. S-H programme mailed in 6 weekly instalments. Manuals were tailored to the concerns of female smokers and addressed weight gain, social support, stress and coping mechanisms.
2. Control - no materials - same schedule of follow-up phone calls
OutcomesSustained abstinence at 1m, 6m, 12m & 18m.
Validation: saliva cotinine < 15ng/ml, but due to low success in obtaining samples, unadjusted rates used. No difference in disconfirmation rates between intervention and control groups.
NotesThe strictest measure of abstinence extracted gives the lowest P value for the difference between the groups; all other measures give a smaller difference in quit rates.
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 (performance bias and detection bias)
All outcomes
Low riskControl group participants not aware of nature of intervention, participants did not know study was aimed at smoking cessation. Biochemical validation conducted, not used due to low success in obtaining samples, but no difference in disconfirmation between groups suggesting differential misreport unlikely.
Incomplete outcome data (attrition bias)
All outcomes
Low risk12.7% lost to follow up at 18m. Number in each group at baseline not stated so losses not included as smokers in MA. Similar losses across groups so no effect on estimate

Harackiewicz 1988

MethodsSetting: University campus health centre/medical centre, USA
Recruitment: Smokers applying for free cessation programme.
Participants98 smokers in relevant arms; 61% F, av age 35, av cpd 27 for all trial participants
InterventionsAll received advice from a doctor or nurse to quit by using the written materials, which were different for each group
1. S-H manual employing intrinsic motivation approach (Stopping smoking on your own with Nicorette), and nicotine gum
2. S-H manual employing extrinsic motivation approach (The Doctor's program for stopping smoking with Nicorette), and nicotine gum
3. Intrinsic motivation S-H manual only
4. Control - short booklet only, with no motivational element
OutcomesSustained abstinence at 12m, (3m-12m)
Validation CO < 8ppm at each visit, saliva thiocyanate < 10mg/dl at 3m & 6m. 2 subjects reclassified as smokers.
Notes3 vs 4 for S-H compared to control. 1 & 2 not used.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk'Randomly assigned', method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation, groups differed in intervention contact but not in intensity
Incomplete outcome data (attrition bias)
All outcomes
Low risk22/197 trial participants who did not attend any follow up & excluded from analyses; 'drop-out rates did not differ according to condition'. Other losses assumed to be smoking

Hollis 1993

MethodsSetting - HMO, USA
Recruitment - Smokers visiting primary care physicians (unselected)
Participants2707 smokers (1383 in relevant arms) who received provider advice; av age 40, av cpd 18
InterventionsAll received 30-second quit smoking advice from physician.
1. Self-quit training from a nurse or health counsellor who showed a video, gave a choice of S-H manuals + quit kit. One follow-up phone call.
2. Group referral
3. Choice of group referral or a S-H kit.
4. Control - provider advice and 2-page pamphlet from nurse.
OutcomesAbstinence at 12m (3m & 12m PP)
Validation: Saliva cotinine. Subjects not providing samples counted as smokers.
Notes1 vs 4, comparison of S-H with control
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskPseudo-randomization (two random digits in health record number) of smokers receiving provider advice. More allocated to control than each other condition
Allocation concealment (selection bias)High riskAllocation was not concealed but no evidence of selection bias; baseline characteristics similar.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnlcear if participants knew nature of what other groups were receiving. Biochemical validation. 55% of reported quitters provided saliva sample, no difference by group.
Incomplete outcome data (attrition bias)
All outcomes
Low risk14% lost to follow up at 12m; response rates did not differ significantly across treatment groups, all participants included in analysis.

Hoving 2010

Methods

Setting: Community, Netherlands

Recruitment: 75 general practices (passive recruitment via questionnaire in waiting room), 65 pharmacies (15 passive, 50 active recruitment)

Participants

1019 (545 pharmacy, 474 GP), motivated to quit within 6m, smoked in last 7 days before baseline assessment

56% F, av age 45, av cpd 22

Interventions

All participants completed baseline questionnaire.

1. Mailed 5-7 page tailored letter, using same tailoring as Dijkstra 1998a, based on I-Change model

2. Thank you letter only

Outcomes

Continuous abstinence from baseline at 3 and 12 months in pharmacy group, 6 months in GP group

Validation: none

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk‘Randomised based on the colour coding on their questionnaire (blue for experimental group, yellow for control group)’
Allocation concealment (selection bias)High riskAllocation would not be concealed if anyone was aware of the significance of colour
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot specified
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskOnly experimental losses to follow-up reported (63/256 pharmacy, 42/220 GP), unclear how many participants were lost in the control group

Humerfelt 1998

MethodsSetting: Community, Norway
Recruitment: From participants in a community survey of men aged 30-45 who had increased risk of obstructive lung disease or lung cancer
Participants2610 M with reduced FEV1 and/or occupational asbestos exposure; av age 37, av cpd 16
Interventions1. Mailed S-H pamphlet, 15 pages, emphasizing behavioural modification techniques in smoking cessation and recommending an early quit date, accompanied by a letter from a respiratory physician advising of the high risk status established by the survey.
2. No intervention
OutcomesAbstinence at 15m (PP)
Validation: subjects in 1 geographical area invited for CO measurement (CO < 10ppm)
NotesFor the MA number of quitters has been adjusted for the validated rate found in the sample who were tested (63% in expt/67% in control). Subjects who stopped smoking prior to receiving materials were included. The authors give 12m sustained abstinence rates of 5.6% vs 3.5% but these rates are based on self report by responders.
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 (performance bias and detection bias)
All outcomes
Low riskControl group not aware of intervention received by intervention group, biochemical validation conducted in subset of participants and no significant difference in misreport detected (1 intervention; 2 control)
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow up higher in the intervention group (17%) than control (8%). The probability of responding to the follow-up questionnaire was inversely related to the baseline cpd consumption in the intervention but not in the control group. Losses included as smokers.

ICRF 1994

MethodsSetting: Primary care, UK
Recruitment: Patients registered with practice invited to join
Participants1686 smokers (over 15 cpd)
Interventions2x2 factorial design:
1. Nicotine patch and 16 page Health Education Authority (HEA) pamphlet
2. Placebo patch and HEA pamphlet
3. Nicotine patch and 46 page booklet with more detailed information on cessation with the use of patches
All participants seen once by a doctor and x4 by a nurse.
OutcomesSustained abstinence at 12m
Validation: salivary cotinine or expired CO
NotesComparison between different S-H materials. Not used in a MA. No clinical or statistically significant difference between the materials in either patch condition.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom allocation of study numbers to intervention groups
Allocation concealment (selection bias)Low riskSequential allocation of study numbers and precoded packages
Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation, similar levels of intensity across interventions
Incomplete outcome data (attrition bias)
All outcomes
Low riskOnly early abstainers were followed up at at 6 & 12m. 9.2% lost to follow-up at 12 weeks. All losses included as smokers.

Janz 1987

MethodsSetting: Two outpatient medical clinics, USA
Recruitment: All smokers attending and giving informed consent for a study of health practices (unselected)
Participants250 smokers; av age 46, av cpd 24
Interventions1. Control - no intervention - clinic physicians not aware of study (not included in review)
2. Advice from physician and brief consultation from a nurse
3. As 2 and the Step-by-Step Quit Kit.
OutcomesAbstinence at 6m (ascertainment by telephone by independent interviewer)
Validation: none
Notes3 vs 2 for effect of S-H as adjunct to advice. The graphed percentages are based on numbers followed up. It has not been possible to obtain data from the authors.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskPseudo-random assignment of half-day clinic sessions to expt or control (control does not contribute to this review). Within expt clinics participants randomized to manual or no manual condition, method not described.
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Low riskNo biochemical validation but interventions tested in this review included same amount of face to face contact and self-report collection procedures designed to minimize misreport (research personnel made clear that they had no relationship to healthcare team and responses were confidential)
Incomplete outcome data (attrition bias)
All outcomes
Low risk39 (16%) lost to follow up at 6m. 'Drop-out rates did not vary significantly across study groups'. Losses not given by group so not included in MA

Killen 1990

MethodsSetting: Community, USA (Stanford Stop Smoking Project)
Recruitment: Media advertisements for volunteers for S-H relapse prevention research programme (selected). To be eligible for randomization had to have quit for 48 hours unaided. (Quit validated by CO < 9ppm)
Participants1218 smokers who had quit for 48 hours; av age 43, av cpd 25
Interventions4x3 factorial design crossing gum and S-H conditions:
Nicotine gum (2mg) conditions: Adlib schedule, whenever strong need to smoke/ Fixed schedule (1 piece per hour for at least 12h/day)/ Placebo gum/ No gum
S-H intervention was based on 16 specially written modules. All participants were given the first How to cope with the urge to smoke without smoking booklet. Then randomized to: Self selected - chose 7 more to receive in weekly mailings/ Random - sent 7 modules at random/ No modules - no further contact
OutcomesAbstinence at 12m (no smoking in 7 days prior to follow up)
Validation: By saliva cotinine, except for participants who had moved away.
Notes'No module' condition received booklet judged to be S-H, so only used for effect of additional materials.
Uncollapsed data sought. Reported that no difference by module condition.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomized, fully crossed factorial design, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Low riskTreatment condition blinded, biochemical validation used
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber lost to follow up not described. All surviving participants included in MA

Killen 1997

MethodsSetting: community, USA
Recruitment: advertisements
Participants424 smokers; 50% F, av age 42-47, av cpd 24
Interventions2x2 factorial design. All participants received S-H materials designed to help develop self-control skills
1. S-H and placebo patch
2. S-H and nicotine patch (21mg)
3. As 1. and video, watched during initial office visit, and for use at home
3. As 2. and video
OutcomesSustained abstinence (6m and 12m)
Validation: Saliva cotinine < 20ng/ml
NotesTest of additional materials. Since there was evidence of an interaction between nicotine and video conditions, the nicotine arms are entered separately using a dummy study
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomized in a 2X2 fully crossed factorial design, method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnclear if participants not receiving video knew other participants were (and viewing it in a group), biochemical validation used
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber lost to follow up not specified, but all participants included in denominators

Killen 1997 +NP

MethodsDummy study to enter results of Killen 1997 arms with nicotine patch
Participants 
Interventions 
Outcomes 
Notes 

Kottke 1989

MethodsSetting: Family practices, USA
Recruitment: Physicians recruited for trial. Target population all patients seen during month (unselected)
Participants66 physicians, 1653 smoking patients; '2/3rds female, av age slightly over 40 yrs, just under one pack/day'
Interventions1. Physicians attended 6 hour workshop
2. Physicians attended workshop and given copies of 'Quit and Win' for their patients
3. Physicians received no support, but were asked to advise patients during the study period
OutcomesAbstinence at 1 yr
Validation: Serum cotinine
Notes2 vs 1, effect of self-help in addition to advice from a trained physician. Including 3. in control group does not affect results. (RR for trial becomes 1.02 rather than 0.99).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskCluster randomized by physician not smoker, method not described, potential for imbalance in patient characteristics but number patients per physican low
Allocation concealment (selection bias)High riskResearchers attempted to contact all patients seen by physicians during one month
Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation used, as cluster randomized by physician seems unlikely control group participants would know what other participants were offered
Incomplete outcome data (attrition bias)
All outcomes
Low riskOver 87% of smokers identified at baseline were reach at 1 yr, similar across groups.

Lando 1988

MethodsSetting: Family practice or pulmonary specialists, USA
Recruitment: Physicians' patients wishing to use nicotine gum as a cessation aid
Participants304 smokers; 62% F, av age 42, av cpd 31
Interventions1. Nicotine gum (NG) and expt S-H materials emphasizing behavioural strategies, as well as correct use of gum
2. NG and control pamphlet Danger: the facts about smoking (American Cancer Society).
OutcomesAbstinence at 12m
Validation: proportion asked to provide saliva for thiocyanate, 5 discrepant, 2 in S-H, 3 in control, but not clear if these were at 6 or 12m so self-reported outcome used
NotesIn main comparison with advice and leaflet for control, and comparison of NG+SH vs NG 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 (performance bias and detection bias)
All outcomes
Low riskBiochemical validation conducted but not used, but similar levels of intensity and physicians blind to pamphlet condition so differential misreport judged to be unlikely
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo mention of number lost to follow up

Lando 1991

MethodsSetting: Community cardiovascular risk factor screening programme, USA
Recruitment: Smokers identified from screening programme who agreed to take part
Participants570 smokers; approx 50% F, av age 42, av cpd 20
InterventionsNo face-to-face contact.
1. S-H Quit for Good materials (NCI)
2. S-H Quit and Win materials - a more extensive and structured programme
3. Wait-list control
OutcomesAbstinence 7m after randomization (but only 3-4m after receipt of materials)
Validation: none
NotesBoth 1 and 2 treated as S-H programmes. There was no difference in results between them. Both expt and control subjects likely to have been exposed to simultaneous community Quit and Win contests. Author notes that a number of participants quit between randomization and receipt of materials. This study is also included in the Quit and Win review (Cahill 2008).
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; there were significant differences between intervention & control for sex and education, and higher confidence in quitting among controls
Blinding (performance bias and detection bias)
All outcomes
High riskWait list control
Incomplete outcome data (attrition bias)
All outcomes
Low risk25 lost to follow up, of which 13 were in control groups. Denominators are those followed up.

Ledwith 1984

MethodsSetting: Community, Scotland UK
Recruitment: Newspaper advertisements for a smoker's advice centre
Participants1839 smokers responding to offers of advice on stopping smoking
InterventionsNo face-to-face contact.
1. No advice control
2. S-H leaflet with standard letter
3. S-H leaflet and offer of individual advice by returning a questionnaire
OutcomesAbstinence at 12m (for 10m or more - based on self report)
Validation: attempt to obtain saliva for thiocyanate but not complete, data based on self report only.
Notes2 vs 1, S-H. 3 vs 2, effect of tailored advice. Only 34% returned baseline questionnaire to initiate tailored component.
No information about contents of leaflet. Borderline whether this counts as a structured S-H programme.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk'Assigned at random', method not described
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Low riskThough attempts to get biochemical validation were unsuccessful, control group was unaware of other treatment assignments and no face-to-face contact was given, hence differential misreport judged to be unlikely
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk16% lost to follow up. Non-respondents included as smokers.

Lennox 2001

MethodsSetting: General practice, Scotland UK
Recruitment: smokers in general practices who returned questionnaires
Participants2610 smokers; no demographic details
InterventionsNo face-to-face contact.
1. Tailored letter from physician. 4 pages, based on SoC, decisional balance and other indicators from questionnaire.
2. Untailored letter from physician. Same format, included specific behavioural advice on quitting
3. Control, letter acknowledging questionnaire
OutcomesAbstinence at 12m. (24m data reported but PP so does not represent a more conservative measure)
Validation: saliva cotinine
Notes2 vs 3 , S-H no contact. 1 vs 2, tailoring
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random numbers
Allocation concealment (selection bias)Low risk'After the questionnaires were returned, we randomised the participants to the groups'. No participant contact, low risk of selection bias.
Blinding (performance bias and detection bias)
All outcomes
Low riskSimilar intervention intensities, no face-to-face contact, and biochemical validation used
Incomplete outcome data (attrition bias)
All outcomes
Low risk22% loss to follow up, similar across groups, non-responders counted as smokers.

Lichtenstein 2000

MethodsSetting: Community, USA
Recruitment: via electric utility mailing to identify households with smokers and low radon concentrations
Participants1006 smokers in 714 households; av cpd 20
InterventionsNo face-to-face contact.
1. Standard Environmental Protection Agency leaflet on risks of radon
2. Pamphlet highlighting risk of smoking in low concentrations of radon, with tips for quitting, or not smoking indoors
3. as 2. + up to 2 brief proactive telephone calls.
All groups got standard letter with radon results.
OutcomesAbstinence at 12m, sustained at 3 & 12m
Validation: none
Notes2 vs 1, S-H vs other control. 3 contributes to telephone counselling review (Stead 2013b).
Cluster randomization, 54% of smokers lived with another smoker. Intraclass correlation for sustained abstinence was .010. Analyses did not correct for this.
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 (performance bias and detection bias)
All outcomes
Low riskSelf-reported outcomes from participants not blinded to treatment condition, but the arms included in this analysis were similar levels of intensity with no personal contact, so differential misreport judged unlikely
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: via electric utility mailing with offer of radon test kit to identify households with smokers
Participants1364 households with 1821 smokers, ˜18 cpd
InterventionsFactorial design crossing +/- brief phone counselling with video S-H materials. All households given A Citizens Guide to Radon and letter tailored to results of radon level test
1. Video, 15min, explaining risk of smoking & radon combination, encouraging quitting and/or household smoking bans.
2. No video
OutcomesAbstinence at 12m, sustained at 3 & 12m
Validation: none
NotesResults of analyses accounting for clustering of multiple smokers in households reported to yield results generally consistent with simple analyses. We were unable to get data for arms with and without phone counselling so the collapsed data contributes to comparisons 1.1.2 & 2.1.2
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskResponding households sequentially randomized to 4 conditions subject to stratification on radon test status; no true randomization sequence used
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Low riskSelf-reported outcomes from participants not blinded to treatment condition, but all received phone counselling and some S-H, so performance and detection bias judged to be unlikely
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
Participants266 randomized, 160 followed up; Low income African-American smokers, unselected by motivation, 52% F, 49% aged > 50
Interventions1. Physician prompts attached to chart (included other screening tests). Providers trained to use 4As model
2. As 1 +mailing of tailored print communication around birthday
3. As 2, + TC
OutcomesAbstinence 16m after last intervention, 30 day quit
Validation: none
Notes2 vs 1, tailored S-H adjunct to advice. (3 vs 2 in telephone counselling review)
Reported rates based on numbers followed up, not randomized.
Provider compliance reported to be 48%
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomized, method not stated
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnclear if participants aware what other participants were receiving, no biochemical validation, self-help group has more communication than control
Incomplete outcome data (attrition bias)
All outcomes
Low risk40% loss to follow up, largely due to disconnected phone numbers, 'loss to follow-up did not appear to be a function of any demographic, psychosocial of smoking pattern, nor was it a function of the intervention smokers received'. Losses not included as smokers.

McFall 1993

MethodsSetting: community, USA
Recruitment: during a TV cessation programme
ParticipantsSmokers who registered and received the manual or reported viewing at least 1 part of programme
Interventions1. TV programme and ALA FfS
2. Maintenance; as 1. and 10 newsletters over following 6m
OutcomesAbstinence at 12m. (24m data reported but PP with increase over time so does not represent a more conservative measure. RR similar)
Validation: none
Notes2 vs 1. effect of additional materials
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 (performance bias and detection bias)
All outcomes
Unclear riskUnclear if participants aware what other participants were receiving, no biochemical validation, maintenance group has more communication than control
Incomplete outcome data (attrition bias)
All outcomes
Low risk24% lost in maintenance condition, 27% in control. MA includes responders; Including losses would give less conservative effect.

Meyer 2008

MethodsSetting: Primary health care centres, Germany
Recruitment: smoking patients attending practices during 3 study weeks
ParticipantsSmokers, unselected for motivation; 48% F, av age 34, av cpd 16
Interventions1. Assessment only control
2. Up to 3 letters individually tailored to SoC. First used baseline assessment, 3m & 6m depended on further assessment. Stage-matched S-H manuals
3. Brief physician advice & S-H manuals
OutcomesAbstinence at 24m (sustained for 6m)
Validation: none
NotesAnalyses in paper allowing for clustering give slightly larger estimates than use of crude numbers quit. Different assumptions about losses to follow up did not substantially alter any results. Abstinence rates increased over time in all groups. Prolonged abstinence at all follow ups is very low, not used here. 63% got 3 letters, 21% got 2 and 17% only 1.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskQuasi-random & clustered based on time of attendance. Fixed sequence of assessment-only, tailored letters, advice. At least 2 weeks between each study week.
Allocation concealment (selection bias)High riskCondition known at time of recruitment. All patients screened so recruitment bias should have been avoided, no evidence of difference in baseline characteristics
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo validation but practice team, practitioner and follow-up interviewers all blinded, however unclear if control participants were aware what intervention participants were receiving
Incomplete outcome data (attrition bias)
All outcomes
Low risk56% of letters & 64% of control reached at 24m. Different approaches to missing data did not alter conclusions.

Meyer 2012

Methods

Setting: 151 general practices, Germany

Recruitment: smoking patients attending practice

Participants

3215 patients (113 excluded) age 18+ who reported any tobacco smoking within last six months.

44% F, av. cpd not stated, av. age 41, 38% precontemplators

Interventions

1. Brief advice from practitioner (10 mins) + stage of change specific S-H manuals

2. Two individually tailored computer-generated letters based on stage of change, plus S-H manuals as per 1

3. 1+2

Outcomes

Abstinence at 12m, self-reported as prolonged for previous 6m

Validation: None

Notes3 vs 1 used as test of individually tailored S-H as adjunct to advice. 2 vs 1 in analysis 4.1, direct comparison of tailored materials and advice
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskCluster-randomized by practice. Practices randomly assigned prior to recruitment. Authors note, "randomization was seriously undermined by obviously different mechanisms of patient selection for each study condition."
Allocation concealment (selection bias)High riskPractices not blind to condition when patients recruited, and differential recruitment rates by condition.
Blinding (performance bias and detection bias)
All outcomes
High riskSee above.
Incomplete outcome data (attrition bias)
All outcomes
Low risk30% drop-out in group 1, 21% group 2, 29% group 3. Authors report sensitivity analyses regarding assumptions about participants lost to follow-up showed "same patterns of results."

Nollen 2007

MethodsSetting: hospital, USA
Recruitment: smokers visiting hospital, interested in quitting in next 6m
Participants500 African-American smokers; 60% F, av age 43, av cpd 20
InterventionsAll participants received 8w nicotine patch and 2 phone calls
1. Standard materials; ALA FfS + How to Quit video
2. Culturally sensitive guide Pathways to Freedom: Winning the Fight against Tobacco and Harlem Health Connection's Kick-It video (40 min) targeted for African-Americans
OutcomesAbstinence at 6m (30 day PP)
Validation: CO < 10ppm
NotesStudy ID was Ahluwalia 1999 until publication of full report. Minor change to results. Comparison between targeted and untargeted materials. Significantly more participants used the targeted materials (68.8% vs 59.6%) but no difference detected in salience or perceived materials
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomization codes computer-generated by study statistician in blocks of 20
Allocation concealment (selection bias)Unclear riskDescribed as investigator blind but no explicit statement
Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation used, interventions of similar intensity
Incomplete outcome data (attrition bias)
All outcomes
High risk66% lost to follow up at 6m, included in ITT analysis, no evidence of differential loss by group.

Omenn 1988

MethodsSetting: Single worksite (13,000 workers, 9 employers), USA
Recruitment: worksite volunteers
Participants243 with preference for a S-H programme
Interventions(Only S-H format conditions considered in this review)
1. Multiple component programme
2. Relapse prevention programme
3. Minimal treatment programme (American Cancer Society's Quitter's Guide, 7-day plan)
OutcomesAbstinence at 12m
Validation: saliva cotinine ≦ 35 ng/ml
NotesComparison between S-H materials; not in MA. No clinical or statistically significant differences between quit rates in the 3 groups.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk'nurses at aid stations using randomized assignment lists generated by research centre, within preference for format'
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation, interventions of similar intensities
Incomplete outcome data (attrition bias)
All outcomes
Low riskAt least 89% followed up in each arm, non-respondents counted as smokers

Orleans 1991

MethodsSetting: HMO, USA
Recruitment: Largely through publicity in HMO magazine
Participants2021 smokers; 63% F, av age 44, av cpd 26
Interventions1. Free & Clear, 28 page guide incorporating nicotine fading and standard behavioural abstinence and relapse prevention techniques. Also a Quit Kit and ALA A Lifetime a Freedom from Smoking
2. Same materials as 1. plus 2 copies of a social support guide to be given to 'allies'.
3. As 2. + TC +quitline
4. Control - Referral guide describing available S-H guides and local resources, plus NCI Clearing the Air
OutcomesAbstinence at 16m for over 6m, by blinded telephone interview.
Validation: Saliva cotinine < 10ng/ml, or thiocyanate < 2,400 umol/l for gum users.
Notes1+2 vs 4, effect of S-H alone. (3 assessed in TC review)
By 16m, 59% of participants in the control group reported that they had used an additional treatment method.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomized, method not stated, 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 (performance bias and detection bias)
All outcomes
Low riskAll arms included in this review received written material of similar levels of intensity. Biochemical 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 a Cancer Information Service telephone counselling line in response to targeted campaign
Participants1422 African-American smokers; av age not stated, 62% in 20-39 age group, median cpd 20
Interventions1. 36 page Pathways to Freedom guide and tailored TC. Guide used African-American models and addressed specific obstacles
2. Standard guide Clearing the Air and standard NCI TC
OutcomesAbstinence at 6m, 7-day PP, telephone questionnaire (12m abstinence also assessed in sample of 445 smokers)
Validation: none
NotesTest of population targeting. Counselling was also different for the 2 groups.
At 12m there were significant differences (15.0% vs 8.8% for sample selected for follow up)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomized by last digit of caller's contact phone number; risk of bias probably low
Allocation concealment (selection bias)Low riskPresumably recruited before phone number and thus allocation known, so risk of bias probably low
Blinding (performance bias and detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition, intervention includes personal contact with tailoring in one group
Incomplete outcome data (attrition bias)
All outcomes
Low risk37% lost to follow up at 6m. No differential drop out, MA includes non-responders as smokers.

Orleans 2000

MethodsSetting: community, USA
Recruitment: smokers aged > 65 using nicotine patch
Participants720 smokers; 'mostly F', av age 72, av cpd 22
InterventionsAll participant had filled a prescription for nicotine patch
1. Clear Horizons guide for older smokers + 7 personalized tailored computer-generated mailings over 6m.
2. Fact sheet on patch-assisted quitting
OutcomesAbstinence at 12m, ?7-day PP
Validation: ?none (Limited information in abstract)
NotesFollow-up rates supplied by N Boyd. Considered with other studies testing S-H adjuncts to pharmacotherapy, not with other tailored studies. 'Tailored messages were based on past research identifying the factors associated with general quitting success and with patch assisted quitting among older smokers'. Not based on individual characteristics.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomized, method not stated
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Unclear riskLimited information in abstract, unclear if biochemical validation used
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow up 21% expt, 23% control, not significantly different. Non-responders included as smokers.

Owen 1989

MethodsSetting: community, Australia
Recruitment: advertisements for smokers wishing to quit
Participants208 smokers; av age 42, av cpd 28
Interventions1. 'Quit Kit' along with apology that course full. Kit included a 5-day cessation plan
2. S-H programme in 4 mailed parts
3. As 2. but personalized with additional text, based on registration form. Option to send for additional materials
OutcomesAbstinence at 9m (PP)
Validation: some cotinine assays, but no correction for a possible 15% misreport level.
NotesIntervention 1 meets criteria for basic S-H, so 2 vs 1 for effect of additional materials and 3 vs 2 for effect of personalized materials.
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 (performance bias and detection bias)
All outcomes
High riskControl group (1) received notice course was full, could introduce performance bias by artificially decreasing control group quit rates
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk12% lost to follow up at 9m, similar between groups. Non-respondents included as smokers

Pallonen 1994

MethodsSetting: Community cardiovascular risk factor study, Finland
Recruitment: Male smokers identified via survey
Participants165 M smokers who were classified as precontemplators or contemplators according to the SoC model; av age 52, av cpd 19
Interventions1. SH. Five 10-20 page S-H manuals matched to SoC, mailed after each 6m assessment.
2. Usual care and annual telephone assessment
OutcomesSustained abstinence at 2 yrs (2 PP)
Validation: none
NotesIncluded in main analysis although targeted materials. Ns are smokers for whom complete follow-up data were available
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomized in 2:1 ratio, but prepared smokers in treatment condition then offered clinic so groups were not balanced by SoC
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnclear if control participants knew nature of intervention, no biochemical validation, different intensities of intervention
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk37% lost to follow up by 2 yrs and not reincluded in MA as group not given. Authors report sensitivity analysis of effect of excluding people with incomplete follow up and state that bias is not introduced

Parekh 2014

Methods

Setting: 21 general practices, Australia

Recruitment: Letters to patients identified via practice records

ParticipantsApproximately 400 people who completed a baseline health behaviour questionnaire and were not non smokers (˜14% of participants). Aged 18-70, had consulted in previous 6 months. 69% F av.age 46.9 (all participants)
Interventions

1. Single Intervention: Feedback on combined health score and personalised computer tailored advice (addressing smoking, diet, physical activity, and BMI), plus one page health promotion information sheets for each behaviour that did not meet national guidelines

2. Dual intervention: As per 1, plus additional assessment and computerised feedback at 3 months

3. Dual control: As per 1 but without combined health score, and addressing other health behaviours (immunization, protection behaviour, non smoking policies in home, screening; none of the items in 1.)

4. As per 3, plus additional assessment and computerised feedback at 3 months

OutcomesAbstinence at 12m, self reported
NotesMultiple risk factor intervention, only a minority of participants were smokers. Intervention tailored to health risks, smoking materials not individually tailored. Numbers of smokers at baseline and follow-up estimated from percentages. Dual and single arms combined in comparison 1.1.2/2.1.2.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk“permuted block procedure stratified by GP”
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Low risk“participants were blinded to the group to which they were randomized”
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDropouts only reported for all participants, not for smokers

Pederson 1983

MethodsSetting: Respiratory specialist outpatient clinic, USA
Recruitment: All smokers attending (unselected)
Participants75 smokers; av age 52, av cpd 25
Interventions1. Advice to quit, and effects of smoking on present health, from respiratory specialist
2. Advice and S-H manual, Break the Smoking Habit: A behavioral program for giving up cigarettes (Pomerleau & Pomerleau)
OutcomesAbstinence at 6m, (self report of no smoking for 3m via telephone interview)
Validation: none
NotesDue to quasi-random allocation a sensitivity analysis of the effect of excluding this study is reported in the discussion.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskQuasi-random assignment by week of attendance, possibility of baseline differences
Allocation concealment (selection bias)High riskNot concealed so risk of bias although all eligible patients at a clinic supposed to be recruited thus avoiding selection bias
Blinding (performance bias and detection bias)
All outcomes
Low riskNo biochemical validation but self-report not given to physician, control group not aware of intervention content, and equal amounts of physician contact in both groups, so differential misreport judged to be unlikely
Incomplete outcome data (attrition bias)
All outcomes
Low risk5 lost in expt, 1 in control, included as non-responders in MA

Prochaska 1993

MethodsSetting: Community, USA
Recruitment: Advertisements for volunteers to test S-H materials
Participants756 smokers (93 precontemplation, 435 contemplation, 228 preparation) (569 in relevant arms); av age 43, av cpd 27
Interventions1. Standard S-H. ALA FfS, A Lifetime of Freedom from Smoking, 50 most often asked questions ...
2. Targeted manuals - 5 covering precontemplation, contemplation, action, maintenance, relapse. Participants sent manual for their SoC and subsequent ones, except for relapse which was sent following an assessment at which relapse occurred.
3. Tailored Interactive - in addition to manuals, sent personalized reports in response to questionnaires
4. Counsellor telephone calls - same as 3. with short calls at 0,1,3,6m (not included in this review)
OutcomesSustained abstinence at 18m (12m and 18m)
Validation: none. Participants asked for names of significant others but these not contacted
Notes2 vs 1 targeting, 3 vs 2 tailoring
Ns randomized 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 stated, stratified by SoC
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Low risk"Bogus pipeline" approach; names of significant others asked for but not contacted. Similar intensities across interventions (all received manuals)
Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition at each assessment averaged 5.5%, not significantly different across conditions. Non-respondents included as smokers in MA

Prochaska 2001a

MethodsSetting: Managed care organisation, USA
Recruitment: Smokers identified by survey of members. 85% recruited to a study
Participants1447 smokers (967 at 18m follow up); 56% F, av age 38, av cpd 20
Interventions1. Assessment only (completed questionnaires on 4 occasions)
2. Expert System. Tailored 2-3 page report at 0,3,6m, and SoC-matched manual
3. As 2+ TC
4. As 3 + computer for scheduled cig reduction.
OutcomesAbstinence at 18m, sustained for 6m (Other measures of abstinence also reported)
Validation: None
Notes2 vs 1, tailoring. 3 contributes to telephone counselling review. 4 not included
Arm 2 is also evaluated in Velicer 1999 results
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 (performance bias and detection bias)
All outcomes
Unclear riskSelf-reported outcomes from participants not blinded to treatment condition, treatment more intensive than control and no information on blinding reported
Incomplete outcome data (attrition bias)
All outcomes
Low riskMA includes losses to follow up and refusals. Author analysis suggests ITT analysis is biased. A sensitivity analysis (comparison 99) tests impact on outcome

Prochaska 2001b

MethodsSetting: Community, USA
Recruitment: random digit dialling. 80% of smokers reached recruited
Participants4144 smokers (2571 at 24m follow up); 55% F, av age 41, av cpd 20
Interventions1. Assessment only (questioned at 6m intervals)
2. Expert System. See Prochaska 2001a
OutcomesAbstinence at 24m, sustained for 6m (Other measures of abstinence also reported)
Validation: none
Notes2 vs 1, tailoring
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 (performance bias and detection bias)
All outcomes
Unclear riskNo information on blinding provided, no validation, interventions different levels of intensity so differential misreport judged possible
Incomplete outcome data (attrition bias)
All outcomes
Low riskSimilar rates of loss to follow up but slightly higher refusal in expt. Non-respondents included as smokers in MA. A sensitivity analysis (comparison 99) tests impact on outcome

Prochaska 2004

MethodsSetting: Community, USA
Recruitment: Parents of 9th grade students in a separate study, at risk for one of the targeted health behaviours
Participants711 smokers from total of 2460 participants; 75% F (full sample), av age 43 (full), av CPD 18, 41% precontemp, 41% contemplators, 18% preparation
Interventions1. Assessment only (completed questionnaires on 3 occasions)
2. Expert System. Tailored 3-5 page report at 0,6 & 12m and manual
OutcomesAbstinence at 24m, sustained for 6m (Other measures of abstinence also reported)
Validation: none
Notes2 vs 1, tailoring
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 (performance bias and detection bias)
All outcomes
Unclear riskNo information on blinding provided, no validation, interventions different levels of intensity so differential misreport judged possible
Incomplete outcome data (attrition bias)
All outcomes
Low riskSlightly higher loss to follow up in Intervention (45% than control (40%). All participants included in this MA

Prochaska 2005

MethodsSetting: Community, USA
Recruitment: primary care patients proactively recruited by phone, at risk for one of the targeted health behaviours
Participants1211 smokers from total of 5407 participants; 70% F (full sample), av age 45 (full), av cpd 17, 31% precontemp, 46% contemplators, 23.5% preparation
Interventions1. Assessment only (completed questionnaires on 3 occasions)
2. Expert System. Tailored 3-5 page report at 0,6 & 12m and manual
OutcomesAbstinence at 24m, PP
Validation: none
Notes2 vs 1, tailoring. Sustained abstinence also an outcome; 'same pattern of results' but details not reported. Number of smokers by group at baseline not reported. Data requested.
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 (performance bias and detection bias)
All outcomes
Unclear riskTelephone assessors blinded but unclear if participants knew nature of other arm, no validation, interventions different levels of intensity so differential misreport judged possible
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk35% loss to follow up at 24m. Insufficient data to include non-respondents in MA but no interaction between missing data and intervention.

Prue 1983

MethodsSetting: Veterans Administration Medical Centre outpatients clinic, USA
Recruitment: Smokers referred to smoking treatment programme who could not attend clinic sessions (selected)
Participants40 smokers (likely to be predominantly M); av age 45, av cpd 32
Interventions1. S-H programme (Pomerleau & Pomerleau) preceded by brand fading schedule. There were also telephone calls from psychologists.
2. Wait list control
OutcomesPP abstinence at 6m follow up (wait list treated after 6m)
Validation: significant other only
NotesThis is a minimal contact programme rather than a strict S-H one, marginal for inclusion; very small impact on MA effects
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomized, method not described, unbalanced group size
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
High riskWait list control, performance bias possible
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll participants included in analyses, but number lost to follow-up not reported

Resnicow 1997

MethodsSetting: Predominantly African-American community in USA
Recruitment: In healthcare, church and public housing settings. Presented as 'health promotion' not smoking cessation.
Participants650 smokers recruited in treatment channels and 504 in control channels who completed follow-up interviews. (Attrition similar between groups)
av age 45, av cpd 16
Interventions1. S-H kit including Kick It guide, video and aids. Bi-monthly mailings and single booster telephone call
2. Health education materials not exclusively addressing smoking, and a cholesterol education video
OutcomesPP at 6m
Validation: none
NotesLess than a third of intervention group received telephone call. A post hoc analysis reported significantly higher quit rates amongst call than no call group.
Multivariate analysis controlling for intracluster correlation gives OR of quitting in treatment group as 1.36, 95% CI 0.87 to 2.11, compared to OR 1.42 95% CI 0.98 to 2.04 from figures used in MA
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster randomized stratified by type of site, prior to recruitment of smokers. Method of sequence generation not reported
Allocation concealment (selection bias)High riskAllocation known at time of recruitment, unclear that this introduced high risk of bias; all participants received smoking cessation materials
Blinding (performance bias and detection bias)
All outcomes
High riskNo biochemical validation and differential levels of contact between groups (including additional phone call), differential misreport judged possible
Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition similar between treatment (7.5%) and control (6.8%) conditions. Non-respondents did not differ on baseline characteristics; not included in MA denominators.

Rice 1994

MethodsSetting: hospital clinic, USA
Recruitment: By health professional and self referral
Participants406 smokers with a cardiovascular health problem
Interventions1. S-H materials Smokeless 6 booklet programme and individual nurse counselling
2. S-H materials and group meetings
3. S-H alone. Prompted to open envelope containing booklets on same schedule as other groups met
4. Advice to quit from nurse only
OutcomesAbstinence at 12m
Validation; saliva thiocyanate tested but rates not corrected for misreport
Notes3 vs 4, S-H vs control. 1&2 not used in this review
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomized, method not stated. Stratified by sex, smoking history and history of cardiovascular incident.
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
Unclear riskBiochemical validation conducted but not reported; unclear if participants knew what other arms were receiving; arms involved differing levels of intensity
Incomplete outcome data (attrition bias)
All outcomes
Low risk8% did not provide data at final follow-up and counted as smokers in final analysis; 12 died before follow-up and were not included in final outcome figures
Other biasUnclear riskDifferential non-participation by experimental group assignments

Schofield 1999

MethodsSetting: hospital, Australia
Recruitment: Smokers discharged from hospital, (unselected)
Participants2465 smokers or recent quitters. Excludes 1693 randomized but lost at 12m follow up. No differential drop out, 59% followed up in each arm. No demographic data
Interventions1. S-H 31 page SoC-based booklet + personally addressed letter from consultant stating health risks and urging to quit
2. Usual care
OutcomesAbstinence at 12m, and at 6m
Validation: urine cotinine ≦ 50ng/ml or CO ≦ 8ppm for sample. Refusers (22% in each group) classified as smokers.
NotesS-H, no contact. Authors report a benefit for subgroup for whom quitting highly relevant for diagnosis
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomized: 'alternately allocated to intervention or control conditions by computer'
Allocation concealment (selection bias)Low riskSmokers were identified at time of admission and allocation was determined at that time. Mailing of materials done by medical records office.
Blinding (performance bias and detection bias)
All outcomes
Low riskControl group does not appear to have been aware of intervention condition, and biochemical validation used
Incomplete outcome data (attrition bias)
All outcomes
Low riskSome people discovered to be ineligible at follow up and excluded. Loss to follow up 41% identical in each group. MA based on eligible respondents.

Schumann 2008

MethodsSetting: Community, Germany
Recruitment: from participants in a general population health examination survey
Participants847 smokers (exsmokers in study not included here); 46% F (full sample), av age 44 (full), av cpd 15. Controls more likely to be in preparation (32 % vs 20%) & with past yr quit attempt
Interventions1. Assessment only (completed questionnaires on 3 occasions)
2. Expert System. Tailored 3-4 page letter and 8-26 page SoC matched booklet at 0,3 & 6m
OutcomesAbstinence at 24m, sustained 18m follow up (other measures of abstinence also reported)
Validation: none
NotesTailoring. 67% got 3 letters, 21% 2, 13% only 1. 72% reported reading some of materials.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskEach participant was assigned a unique computer-generated random number between 0 and 1, the data file was sorted by ascending random numbers, and participants were then consecutively assigned to the 3 study conditions.’
Allocation concealment (selection bias)Low riskNo opportunity to alter allocation or exclude
Blinding (performance bias and detection bias)
All outcomes
Low riskThough no biochemical validation, written contact only, participants in control group do not appear to have known of intervention, and all participants engaged in long term questionnaires re: smoking status, so differential misreport judged unlikely
Incomplete outcome data (attrition bias)
All outcomes
Low riskSomewhat greater loss in intervention (34%) than control (27%). MA includes lost as smokers. Authors report GEE gave similar results.

Smith 2004

MethodsSetting: 10 communities, Canada
Recruitment: Volunteers intending to quit
Participants632 smokers (423 in relevant arms); 61% F, av age 42, 61% had prior use of NRT
InterventionsFactorial design comparing 2 intensities of TC and 2 types of print materials:
1. Booklet (Canadian Cancer Society [CCS] One step at a Time, 44 pages)
2. Pamphlet (CCS How to Quit Smoking, single page)
TC conditions collapsed, booklet-only control group not used in review
OutcomesAbstinence at 12m, sustained at 3m & 6m follow ups
Validation: none
NotesNo non-S-H control, comparison between materials. Results not reported by group; 'no significant interactions or main effects'.
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 riskCentralized, sequential envelopes
Blinding (performance bias and detection bias)
All outcomes
Low riskSelf-reported outcomes from participants not blinded to treatment condition, but no difference in personal contact between intervention arms so differential misreport judged unlikely
Incomplete outcome data (attrition bias)
All outcomes
Low risk'Collapsing across telephone counseling groups, significantly more participants receiving print only were available for follow-up at 12 months (73%) than those receiving telephone counselling (62%). Those not available for follow-up were considered smokers for the intention-to-treat analyses.'

Strecher 2005

MethodsSetting: community, USA
Recruitment: telephone callers to NCI Cancer Information Service, interested in quitting
Participants1978 smokers; 70% F, av age 41, 46% smoked > pack/day, FTND 5.9
InterventionsAll participants received approx 15min of telecounselling.
Control: Single untailored 24 page booklet (Clearing the Air)
Intervention 1: Single 8 page tailored booklet, addressing motives and barriers cited by smoker
Intervention 2: Single untailored 24 page booklet (Clearing the Air) 2: Multiple tailored materials (booklet, 2 newsletters, letter), 5m, 8m, 12m. Tailored on baseline data
Intervention 3: Single untailored 24 page booklet (Clearing the Air) 3: Multiple retailored materials (same components and schedule as 2, used data from 5m follow up for retailoring)
OutcomesAbstinence at 12m (7day PP, but had also reported abstinence at 5m follow up)
Validation: none
NotesTo derive numbers quit, assumed equal numbers in each condition. 2+3+4 vs 1 in tailored vs untailored. Slightly more evidence of effect when comparing multiple to single (3+4 vs 1+2), and also for retailored materials amongst subgroup who were quit at 5m
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 (performance bias and detection bias)
All outcomes
Low riskThough no biochemical validation, all participants received same telecounselling and were unaware of other treatment conditions, so risk judged to be low
Incomplete outcome data (attrition bias)
All outcomes
Low riskOnly respondents at 5m eligible for 12m follow up. 56% loss at 12m (but includes those smoking at 5m), no difference by condition. Losses included as smokers.

Sutton 2007

MethodsSetting: Community, UK
Recruitment: Callers to UK Quitline (smokers planning to quit in next 30 days or quit in last  14 days)
Participants1506 including 344 (23%) recent quitters; 66% F, av age 38, av cpd 21
InterventionsAll participants received telephone counselling and QUIT information pack
1. Standard letter
2. Tailored 3 page letter (based on social cognitive theory and perspectives on change model. Aimed to encourage & support smokers. Medium or high dependence smokers advised to talk to their GP about cessation products)
OutcomesAbstinence at 6m, self-reported as sustained for 3m
Validation: none
NotesTailoring. Subgroup of baseline smokers showed larger effect of intervention, but still not significant
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk‘Randomization was effected by dividing days randomly within each of a series of consecutive 56-day blocks into two equal sets, with allocation to group depending on which day the participant called the Quitline.’
Allocation concealment (selection bias)Low risk‘Randomization was carried out by a member of the research team who had no direct contact with the counsellors or the participants. Counsellors were unaware of which condition the participant was allocated to and would have remained blind unless the participant had happened to mention during a subsequent telephone conversation that they had or had not received a tailored letter.’
Blinding (performance bias and detection bias)
All outcomes
Low riskThough no biochemical validation, participants received same telephone counselling and both received one off written material, so risk of differential misreport judged to be low
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow up nonsignificantly higher in control (24.4%) than intervention (20.8%). Losses treated as smoking

Sykes 2001

MethodsSetting: cessation clinic, UK
Recruitment: community volunteers interested in quitting
Participants260 smokers, high proportion low SES; 64% F, av age not stated; av cpd 25
Interventions1. Quit for Life. Cognitive behavioural manual, audiotape. Gradual reduction pre-quit day, stresses psychological addiction.
2. Stopping Smoking Made Easier. leaflet, SoC-based, abrupt quit
OutcomesAbstinence at 12m (Sykes 2001 reports 6m)
Validation: CO < 9ppm
NotesComparison between S-H materials. Does not contribute to MA. 1 yr data from Marks 2002.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster randomized by orientation group attended, method not described
Allocation concealment (selection bias)Unclear riskAlthough potential for selection bias 'the receptionist was unaware of which intervention each group of participants would receive'.
Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation and similar intensity of interventions
Incomplete outcome data (attrition bias)
All outcomes
Low risk15% loss to follow up at 1 yr, similar across groups

Thompson 1988

MethodsSetting: HMO, USA
Recruitment: consecutive attenders (unselected)
Participants379 smokers (in relevant arms); av cpd not stated, 68% smoked > 15 cpd
InterventionsComplete factorial design of 3 interventions:
A - Physician advice - structured and interactive, 3-5 mins
B - S-H materials (NCI Calling it Quits and Why do you Smoke, and a personalized follow-up letter.
C - referral to group cessation classes
Control - brief advice only
OutcomesAbstinence at 8-9m by telephone survey
Validation: none
NotesA+B & B vs A & Control in S-H + advice vs advice only
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk'physician used a randomized folder placed in the patient chart', unclear when and how randomization schedule generated
Allocation concealment (selection bias)Unclear riskParticipants enrolled before visiting physician so selection bias by physician avoided
Blinding (performance bias and detection bias)
All outcomes
Low riskThough no biochemical validation, participants never aware that smoking cessation was study target so risk of performance bias and differential misreport judged to be low
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk8% lost of follow up, but not clear by what arm and not included in final analyses

van der Aalst 2012

Methods

Setting: Community, Belgium and the Netherlands

Recruitment: Subgroup of participants enrolled in lung cancer screening trial, identified via population registry

Participants

1284 current smoking male participants of lung cancer screening trial, 50-75 years old, smokers of > 15 cpd for > 25 years or > 10 cpd for > 30 years

100% M, av. age 57, av. cpd 18, 55% not planning to quit within 6 months

Interventions

1. Computer-tailored smoking cessation advice via mail (one-off), only sent to participants who completed questionnaire after randomization

2. Standard brochure (35 page "Smoking cessation, why and how")

Outcomes

Continuous abstinence at 2 years (prolonged and PP also reported)

Validation: none

NotesParticipants had to return questionnaire before receiving tailored brochure – only 23% did so (147/642). In that subset, quit rates were slightly higher (14.3% prolonged as compared to 12.5% in total intervention group), but still less than control group and no sig. difference.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot specified
Allocation concealment (selection bias)Unclear riskNot specified
Blinding (performance bias and detection bias)
All outcomes
Low riskNot blinded but at assessment, majority of participants unaware of which are they had been assigned to; differential misreport judged to be unlikely
Incomplete outcome data (attrition bias)
All outcomes
Low risk84% intervention and 85% control followed up at 2 years

Velicer 1999

MethodsSetting: Managed care organisation, USA
Recruitment: Smokers identified by survey of members. 85% recruited to study
Participants2882 smokers in a managed care organisation; av age 38, av cpd 20
Interventions1. Interactive expert system, generated 2-4 page reports based on SoC model, and stage-based manuals. 4 different levels of contact - 1,2,3 or 4 occasions at 3m intervals
2. Stage-based manuals only, same 4 levels of contact
OutcomesAbstinence at 18m, sustained for 6m (Other measures of abstinence also reported)
Validation: None
Notes1 vs 2, tailoring. There was no evidence of a dose response to the number of contacts in either condition, and expert system conditions were better than stage-based at each contact level so these are collapsed 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 (performance bias and detection bias)
All outcomes
Low riskNot blinded or biochemically validated, but given similar intensity of both conditions, performance bias and differential misreport judged to be unlikely
Incomplete outcome data (attrition bias)
All outcomes
Low riskAuthors report numbers refusing follow up and numbers not reached. The size and significance of the results is sensitive to whether or not those lost to follow up or refusing to respond are included in the denominator as continued smokers, see sensitivity analysis 99. Including all non-responders in denominator gives a more conservative estimate and is used in the MA

Velicer 2006

MethodsSetting: Community, USA
Recruitment: Proactive approach to smokers at Veterans Administration Medical Centre
Participants2054 smokers (1031 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 on
2. As 1. plus 6w nicotine patch if in appropriate stage, reassessed fro NRT eligibility at 6 & 10M
3. As 2. plus one expert system feedback report (see Prochaska trials)
4. As 3. plus regular automated telephone counselling
OutcomesAbstinence at 30m, sustained for 6m
Validation: none
Notes3 vs 2 for tailored adjunct to targeted S-H. In NRT groups 350 (67%) received NRT at baseline and 448 (86%) received NRT at some point
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 (performance bias and detection bias)
All outcomes
Low riskSelf-reported outcomes from participants not blinded to treatment condition, but intensity did not differ substantially by condition so differential misreport judged to be unlikely
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. Sensitivity analyses in comparison 999

Webb 2013

Methods

Setting: Community, USA

Recruitment: Community volunteers

Participants424 current smokers of ≥ 5 cpd, 57% F, av. age 42, av. cpd 19.7
Interventions

Both groups received two priming phone calls explaining benefits of intervention and encouraging use of materials. In intervention, priming call explicitly stated materials were tailored.

1. 4 self-help booklets with placebo tailoring, covering cigarette smoking, cessation and relapse prevention, based on cognitive behavioural techniques

2. 4 standard self-help booklets covering same materials

Outcomes

1 month sustained abstinence at 6m

Validation: CO ≤ 8 ppm for locals

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot specified
Allocation concealment (selection bias)Unclear riskNot specified
Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation used and interventions of similar intensities
Incomplete outcome data (attrition bias)
All outcomes
Low risk29% lost intervention group, 25% lost control

Willemsen 2006

  1. a

    4As: Ask, Advise, Assist, Arrange
    ALA FfS: American Lung Association Freedom from Smoking programme
    av: average (mean)
    CI: confidence interval
    CO: carbon monoxide
    cpd: cigarettes per day
    expt: experimental
    F: female
    HMO: Health Maintenance Organization
    ITT: intention to treat
    m: month(s)
    M: male
    MA: meta-analysis
    min: minute(s)
    NCI: National Cancer Institute
    NRT: nicotine replacement therapy
    OR: odds ratio
    PP: point prevalence abstinence
    ppm: parts per million
    SES: socio-economic status
    S-H: self-help
    SoC: Stage of Change
    TC: telephone counselling
    w: week(s)
    yr: year(s)

MethodsSetting: Community, Netherlands
Recruitment: Smokers identified from a market research database, willing to participate in the evaluation of an ‘information aid’
Participants1014 smokers 'intending to quit'; 46% F, modal age 35-44, modal cpd 18-22, 86% daily smokers
Interventions1. Mailed Decision Aid; Starter’s kit including information about all major available treatment methods, classified into known effective & unknown. Samples of materials, and information on how to obtain them. Video with descriptions of quitting experiences.
2. No intervention
OutcomesSustained abstinence at 6m (quit for more than ˜4m)
Validation: none
NotesS-H vs control. Aid had no effect on prolonged abstinence outcome used in MA but there was an effect on PP abstinence. Aim of intervention was to increase use of efficacious aids, but it had no effect. Authors note aid 'did not contain any concrete self-help information that the smokers might have put into practice'.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomized, method not stated
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
High riskParticipants in control group aware it was a trial of self-help materials, and never received materials, which could have artificially lowered control group quit rate
Incomplete outcome data (attrition bias)
All outcomes
Low risk11.8% lost at 6m, intervention participants more likely to be missing at 2w but not 6m follow up. Losses included as smokers.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
  1. a

    ALA: American Lung Association
    NCI: National Cancer Institute
    m: month(s)
    S-H: self help
    w: week(s)

Armitage 2008aFollow-up only 2m.
Armitage 2008bFollow up only 1m. Intervention borderline for inclusion.
Arnold 2009Follow-up only 1m.
Balanda 1999Follow up only 1m after provision of one of two S-H guides to quitline callers. No differences between groups found.
Bansal-Travers 2010Only 1 month follow-up; all participants received NRT and counselling
Brandon 2000Only recent quitters recruited. Included in Cochrane review of relapse prevention.
Brandon 2004Only recent quitters recruited. Included in Cochrane review of relapse prevention (Hajek 2009).
Brandon 2012Relapse prevention intervention
Brown 1992Both arms received S-H materials. Test of telephone counselling, included in Cochrane review of telephone counselling (Stead 2013b).
Burling 2000Evaluated an internet-based intervention. Previously included in review but not in a meta-analysis. Falls within scope of separate Cochrane protocol ( Koshy 2008)
Carré 2008Short follow-up; not primarily directed at cessation.
Conway 2004Intervention targeted at relapse prevention. See Edwards 1999
Curry 1988Compares S-H materials with a relapse prevention approach to abstinence-based approach. Now included in relapse prevention review (Hajek 2009)
Dijkstra 1998bFollow up only 4m (6w from last contact for multiple tailored letters condition).
The study compared combinations of tailored letters and a S-H guide for a population of smokers not planning to quit.
Dijkstra 2001Follow up only 3m. Compares different types of information in S-H materials.
Dijkstra 2005Not a structured S-H intervention, outcome is 'quitting activity' at 4m. Participants were students recruited to evaluate smoking cessation messages.
Dijkstra 2006Outcome is change in stage, not abstinence.
Dijkstra 2009Field study testing function of disengagement beliefs. Numbers abstinent not reported.
Edwards 1999The intervention was directed at relapse prevention in female naval recruits required to quit smoking during basic training. Included in review of relapse prevention interventions (Hajek 2009).
Emmons 2013Doesn't test S-H; S-H served as control for more intensive intervention
Etter 2007Intervention provided information about additives in cigarettes, focus on motivating rather than assisting quitting.
Garcia 2000Trial of group therapy-based interventions. S-H manuals provided in addition to group therapy in order to test effect of therapist contact. Included in Cochrane Group therapy review (Stead 2005).
Gritz 1988No control group.
Hall 2003Smoking cessation was not an outcome.
Jeffery 1982No long-term follow up. The control was a group programme.
Jeffery 1990Compared the offer of a S-H programme at a nominal cost with the same programme for a US$60 payment, refundable if successful. There was a very low recruitment rate to the incentive programme (9 participants, 0.09% of households randomly assigned to receive the incentive option).
Johs 2003No long- term follow up.
Jordan 1999Only 3m follow up planned. Compared an internet-based programme with an ALA printed manuals, 54 participants.
Kreuter 1996Intervention provided single page of cessation information for participants who were smokers (22%) and interested in quitting. Not a S-H intervention by the criteria for this review. (Neither standard nor enhanced feedback increased quit rates over control)
Kreuter 2012Print materials not designed as S-H; intention to increase number of people taking up referrals to specialist service
Lenert 2004Not randomized; used consecutive series of participants.
Lipkus 2004S-H was the control condition.
McBride 1999The intervention included 3 proactive telephone calls in addition to provision of S-H materials.
No effect of the intervention was found.
McDonald 2003Unpublished study, insufficient data to include
McDonnell 2011Doesn't test S-H; S-H served as control for more intensive intervention
McMahon 2000Tested incentives and social support as adjuncts to self-help. Included in Cochrane review of support (Park 2004)
Meade 1989Compared smokers' ability to understand materials written at different grade levels. Cessation was not an outcome.
Moore 2002Participants were pregnant women.
Murphy 2005Only 3m follow up, and marginal to classify as S-H intervention; provided information on access to pharmacotherapy and cessation support
Naughton 2012Doesn't test S-H; S-H served as control for more intensive intervention
O'Hara 1993Follow up only 3w after receipt of materials
Ossip-Klein 1991Both arms received S-H materials. Test of hotline availability, included in Cochrane review of Telephone Counselling (Stead 2013b).
Ossip-Klein 1997Both arms received S-H materials. Test of telephone counselling, included in Cochrane review of Telephone Counselling (Stead 2013b).
Pallonen 1998Intervention targeted for adolescents. Two S-H computer-based interventions were compared. Included in a Cochrane review of cessation interventions for adolescents and young people (Grimshaw 2006).
Pederson 1981Although this is described as a trial of behavioural S-H manuals, the treatment conditions included an introductory and 2 further group meetings.
Rimer 1994No long-term follow up data reported in full.
Russell 1979The leaflet used as an adjunct to physician advice did not meet study criteria for a structured S-H intervention. Smokers given the leaflet were also warned that they would be followed up. The study found a non-significant increase in the quit rate amongst patients who were given the leaflet in addition to advice, but including it would not alter the results of the MA, which found no effect of materials as an adjunct to advice.
Sallis 1986Only 2m follow up then wait list control offered treatment.
Senesael 2013Multiple risk factor intervention recruiting only 7 smokers. Unclear if smoking intervention met inclusion criteria.
Shi 2013Doesn't test S-H; S-H served as control for more intensive intervention
Shiffman 2000Only 6w follow up. Tested materials tailored to individual smokers, in addition to nicotine gum, compared to gum and standard written materials.
Shiffman 2001Only 6w follow up. Tested materials tailored to individual smokers, in addition to nicotine patches, compared to patches and standard written materials.
Sims 2013Doesn't test S-H; S-H served as control for more intensive intervention
Song 2012Relapse prevention intervention
Stanczyk 2013Web-based intervention
Strecher 1994Did not meet review criteria for S-H materials. Compared health letters tailored to individual recipient's smoking behaviour with no intervention (Study 2) or a standardized health letter from a physician (an adaptation of NCI Quit for Good pamphlet addressing general benefits of and barriers to quitting smoking) (Study 1). Study 1 had less than 6m follow up.
Strecher 2000Participants were pregnant women.
Strecher 2005bShort follow up
Strecher 2008Did not meet review criteria for S-H materials; Web-based programme.
Te Poel 2009Web-based intervention
Travis 2004Short follow up; S-H was an adjunct to telephone counselling.
Travis 2009Only 3 months follow-up
Ussher 2011Uncontrolled evaluation
Webb 2005Smoking status was not a measured outcome.
Webb 2007Smoking status was not a measured outcome.
Webb 2008Only 3 months follow-up
Webb 2009Only 3 months follow-up.
Webb 2010Outcomes included risk perceptions, readiness to quit smoking, and smoking-related knowledge, not smoking cessation.
Weissfeld 1991'Self-help' condition received several individual counselling sessions.
Wetter 2011All groups received multiple group counselling sessions
Willemsen 1995Not a randomized trial.
Windsor 1989All groups received the same S-H intervention, differed on additional support or incentives.
Zhu 1996All arms received S-H materials. Test of telephone counselling, included in Cochrane review of Telephone Counselling (Stead 2013b).

Ancillary