Information provision for people with multiple sclerosis

  • Review
  • Intervention

Authors


Abstract

Background

People with multiple sclerosis (MS) are confronted with a number of important uncertainties concerning many aspects of the disease. Among others, these include diagnosis, prognosis, disease course, disease-modifying therapies, symptomatic therapies and non-pharmacological interventions. It has been shown that people with MS demand adequate information to be able to actively participate in medical decision making and to self-manage their disease. On the other hand, it has been found that patients’ disease-related knowledge is poor. Therefore, guidelines have recommended clear and concise high-quality information at all stages of the disease. Several studies have outlined communication and information deficits in the care of people with MS and, accordingly, a number of information and decision support programmes have been published.

Objectives

To evaluate the effectiveness of information provision interventions for people with MS that aim to promote informed choice and improve patient-relevant outcomes.

Search methods

We searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Specialised Register which contains trials from CENTRAL (The Cochrane Library 2013, Issue 6), MEDLINE, EMBASE, CINAHL, LILACS, PEDro and clinical trials registries (12 June 2013) as well as other sources. In addition, we searched PsycINFO, trial registries, and reference lists of identified articles. We also contacted trialists.

Selection criteria

Randomised controlled trials, cluster randomised controlled trials and quasi-randomised trials comparing information provision for people with MS or suspected MS (intervention groups) with usual care or other types of information provision (control groups) were eligible.

Data collection and analysis

Two review authors independently assessed the retrieved articles for relevance and methodological quality, and extracted data. Critical appraisal of studies addressed the risk of selection bias, performance bias, attrition bias and detection bias. We contacted authors of relevant studies for additional information.

Main results

Ten randomised controlled trials involving a total of 1314 participants met the inclusion criteria and were analysed. The interventions addressed a variety of topics using different approaches for information provision in different settings. Topics included disease-modifying therapy, relapse management, self-care strategies, fatigue management, family planning and general health promotion. The interventions contained decision aids, educational programmes, self-care interventions and personal interviews with physicians. All interventions were complex interventions using more than one active component, but the number and extent of the intervention components differed markedly between studies. The studies had a variable risk of bias. We did not perform meta-analyses due to marked clinical heterogeneity. All four studies assessing MS-related knowledge (524 participants; moderate-quality evidence) detected significant differences between groups as a result of the interventions indicating that information provision may successfully increase participants’ knowledge. There were mixed results from four studies reporting effects on decision making (836 participants; low-quality evidence) and from five studies assessing quality of life (605 participants; low-quality evidence). There were no adverse events in the six studies reporting on adverse events.

Authors' conclusions

Information provision for people with MS seems to increase disease-related knowledge, with less clear results on decision making and quality of life. There seem to be no negative side effects from informing patients about their disease. Interpretation of study results remains challenging due to the marked heterogeneity of the interventions and outcome measures.

Résumé scientifique

Diffusion d'informations chez les patients atteints de sclérose en plaques

Contexte

Les patients atteints de sclérose en plaques (SEP) font face à de nombreuses incertitudes concernant de nombreux aspects de la maladie. Entre autres, celles-ci comprennent le diagnostic, le pronostic, l'évolution de la maladie, les traitements modificateurs de l'évolution de la maladie et les interventions non pharmacologiques. Il a été démontré que les patients atteints de SEP demandent des informations adéquates pour pouvoir participer activement à la prise de décision médicale et gérer eux-mêmes leur maladie. D'un autre côté, il a été constaté que les connaissances sur la maladie chez les patients sont faibles. Par conséquent, les directives préconisent des informations de haute qualité qui soient claires et concises, ceci à tous les stades de la maladie. Plusieurs études ont souligné l'insuffisance de la communication et des informations dans la prise en charge des patients atteints de SEP et, en conséquence, un certain nombre de programmes d'information et de soutien à la prise de décisions ont été publiés.

Objectifs

Évaluer l'efficacité des interventions fournissant des informations aux patients atteints de SEP qui visent à promouvoir un choix éclairé et à améliorer les résultats relatifs au patient.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre spécialisé du groupe Cochrane sur la sclérose en plaques et les maladies rares du système nerveux central qui contient des essais dans CENTRAL ( La Bibliothèque Cochrane 2013, numéro 6), MEDLINE, EMBASE, CINAHL, LILACS, PEDro et dans les registres d'essais cliniques (12 juin 2013) ainsi que dans d'autres sources. De plus, nous avons effectué des recherches dans PsycINFO, les registres d'essais et les références bibliographiques des articles identifiés. Nous avons également contacté des investigateurs.

Critères de sélection

Les essais contrôlés randomisés, les essais contrôlés randomisés en cluster et quasi-randomisés, comparant la diffusion d'informations aux patients atteints ou suspectés être atteints de SEP (groupes d'intervention) par rapport aux soins habituels ou à d'autres types de diffusion d'informations (groupes témoins) étaient éligibles.

Recueil et analyse des données

Deux auteurs de la revue ont indépendamment évalué les articles identifiés afin de juger leur pertinence et la qualité méthodologique et ont extrait les données. L'analyse critique des études portait sur le risque de biais de sélection, le biais de performance, le biais d'attrition et le biais de détection. Nous avons contacté les auteurs des études pour obtenir des informations supplémentaires.

Résultats principaux

Dix essais contrôlés randomisés portant sur un total de 1 314 participants remplissaient les critères d'inclusion et ont été analysés. Les interventions portaient sur une variété de thèmes à l'aide de différentes approches pour fournir des informations dans différents contextes. Les thèmes incluaient le traitement modificateur de l'évolution de la maladie, la prise en charge de la rechute, les stratégies d'autonomie, le contrôle de la fatigue, la planification familiale et la promotion de la santé en général. Les interventions comprenaient des aides à la prise de décision, des programmes éducatifs, des interventions relatives à l'autonomie personnelle et des entretiens personnels avec les médecins. Toutes les interventions étaient des interventions complexes utilisant plus d'un composant actif, mais le nombre et l'étendue des composants de l'intervention différaient considérablement entre les études. Les études présentaient un risque de biais variable. Nous n'avons pas réalisé de méta-analyse en raison de l'hétérogénéité clinique prononcée. Les quatre études évaluant les connaissances relatives à la SEP (524 participants; preuves de qualité moyenne) ont détecté des différences significatives entre les groupes suite aux interventions, ce qui indique que la diffusion des informations pourrait accroitre avec succès les connaissances des participants. Quatre études indiquaient des résultats mitigés sur les effets de la prise de décision (836 participants; preuves de faible qualité) et cinq études indiquaient également des résultats mitigés sur la qualité de vie (605 participants; preuves de faible qualité). Il n'y avait pas d'effet indésirable dans les six études rapportant les effets indésirables.

Conclusions des auteurs

La diffusion des informations aux patients atteints de SEP semble accroitre les connaissances relatives à la maladie, avec des résultats moins précis sur la prise de décision et la qualité de vie. Informer les patients concernant leur maladie semble ne pas apporter d'effets secondaires négatifs. L'interprétation des résultats des études reste difficile en raison de la forte hétérogénéité des interventions et des mesures de résultats.

Plain language summary

Information provision to help people with Multiple Sclerosis make informed decisions

People with multiple sclerosis (MS) are confronted with many uncertainties in all phases of the disease. For example, the significance of a diagnosis for the future disease course remains unclear as up to one third of people will experience a benign disease course with little or even no disability progression. Uncertainty is also present for the effects and adverse effects of pharmacological and non-pharmacological therapies. People with MS want to receive accurate, recent and relevant information in order to make informed choices on all relevant disease-related decisions and also on personal life planning decisions. For this, balanced information is a prerequisite. It has been shown that disease knowledge is poor in people with MS. Therefore, people with MS should receive interventions that provide information on all aspects relevant for them.

We reviewed whether interventions aimed at providing information for people with MS increase knowledge and improve decision making and quality of life in people with MS. We looked for relevant studies in the medical literature in June 2013 and identified 10 studies that involved a total of 1314 participants. The studies evaluated a variety of approaches including the provision of written information or decision aids, educational programmes and personal information. The methodological quality of the studies varied. Topics included disease-modifying therapy, relapse management, self-care strategies, fatigue management, family planning and general health promotion. The four studies assessing the level of knowledge showed that information may successfully increase patients’ knowledge (moderate quality evidence). There were mixed results from four studies reporting on the effects on decision making (low quality evidence) and from five studies assessing quality of life (low quality evidence). As the studies and the interventions used differed markedly, and the quality of the evidence for our outcomes was not high, the results do not allow for a clear conclusion about the effectiveness of information provision interventions for people with MS.

Laički sažetak

Pružanje informacija oboljelima od multiple skleroze koje im mogu pomoći u donošenju odluka

Osobe s multiplom sklerozom suočavaju se s mnogim pitanjima u svim fazama bolesti. Primjerice, značaj dijagnoze za budući tijek bolesti i dalje je nejasan jer će jedna trećina bolesnika imati benignu bolest s blagom ili nikakvom progresijom onesposobljenosti. Dvojbe postoje i kad je riječ o učincima i štetnim učincima farmakoloških i ne-farmakoloških terapija. Osobe s multiplom sklerozom žele primiti točne, nove i važne informacije kako bi mogle donijeti informirane odluke o svim pitanjima koja trebaju odlučiti kad je u pitanju njihova bolest i kad trebaju planirati osobni život. Stoga je ključno uravnoteženo informiranje bolesnika. Već je pokazano kako oboljeli od multiple skleroze imaju malo znanja o svojoj bolesti. Stoga bi tim bolesnicima trebalo omogućiti intervencije tijekom kojih će dobiti informacije o svim pitanjima koja su im važna.

Cochrane sustavni pregled analizirao je da li intervencije kojima je cilj pružanje informacija oboljelima od multiple skleroze povećavaju znanje o bolesti i poboljšavaju odlučivanje i kvalitetu života oboljelih od multiple skleroze. Pretražena je literatura objavljena do lipnja 2013. kako bi se pronašla relevantna literatura i pronađeno je 10 kliničkih studija u kojima je bilo uključeno ukupno 1314 ispitanika. Studije su istražile niz pristupa, uključujući pružanje pisanih informacija ili pomagala za odlučivanje, edukacijskih programa i osobnih informacija. Metodološka kvaliteta tih studija bila je nedosljedna. Teme intervencija uključivale su terapiju usmjerenu na bolest, liječenje relapsa, strategije za samoliječenje, liječenje umora, planiranje obitelji i opću promociju zdravlja. Četiri studije koje su istražile razinu znanja pokazale su da pružanje informacija može uspješno poboljšati znanje pacijenata o bolesti (dokazi umjerene kvalitete). Različite rezultate dale su četiri studije koje su opisale učinke informativnih intervencija kojima je cilj pospješiti donošenje odluka (dokazi niske kvalitete) i pet studija u kojima je procijenjen utjecaj dobivenih informacija na kvalitetu života.

Budući su se studije i ispitane intervencije značajno razlikovale, i kvaliteta dokaza ili ishoda nije bila visoka, rezultati ne dopuštaju jasne zaključke o učinkovitosti intervencija za pružanje informacija oboljelima od multiple skleroze.

Bilješke prijevoda

Prevoditelj:: Croatian Branch of the Italian Cochrane Centre

Résumé simplifié

Diffusion d'informations pour aider les patients atteints de sclérose en plaques à prendre des décisions éclairées

Les patients atteints de sclérose en plaques (SEP) font face à de nombreuses incertitudes dans toutes les phases de la maladie. Par exemple, l'importance d'un diagnostic pour l'évolution future de la maladie reste incertaine car jusqu'à un tiers des patients ressentiront une évolution bénigne de la maladie avec peu, voir aucune, progression d'incapacité. Une incertitude existe également sur les effets indésirables des traitements pharmacologiques et non-pharmacologiques. Les patients atteints de SEP souhaitent recevoir des informations pertinentes, précises et récentes afin d'effectuer des choix éclairés pour toutes les décisions relatives à la maladie et à la planification de la vie personnelle. Pour cela, une information objective est une condition préalable. Il a été démontré que les connaissances sur la maladie sont faibles chez les patients atteints de SEP. Par conséquent, les patients atteints de SEP devraient recevoir les interventions fournissant des informations sur tous les aspects qui leurs sont pertinents.

Nous avons examiné si les interventions visant à fournir des informations aux patients atteints de SEP accroissaient les connaissances et amélioraient la prise de décision et la qualité de vie chez les patients atteints de SEP. En juin 2013, nous avons recherché des études pertinentes dans la littérature médicale et identifié 10 études qui portaient sur un total de 1 314 participants. Les études évaluaient diverses approches, y compris la diffusion d'informations écrites ou des aides à la prise de décision, les programmes éducatifs et les informations personnelles. La qualité méthodologique des études variait. Les thèmes incluaient le traitement modificateur de l'évolution de la maladie, la prise en charge de la rechute, les stratégies d'autonomie, le contrôle de la fatigue, la planification familiale et la promotion de la santé en général. Les quatre études évaluant le niveau de connaissances montraient que l'information pourrait accroitre avec succès les connaissances des patients (preuves de qualité modérée). Quatre études indiquaient des résultats mitigés sur les effets de la prise de décision (preuves de faible qualité) et cinq études indiquaient également des résultats mitigés sur la qualité de vie (preuves de faible qualité). Étant donné que les études et les interventions utilisées différaient considérablement et que la qualité des preuves pour nos critères de jugement n'était pas élevée, les résultats ne permettent pas d'apporter de conclusions définitives concernant l'efficacité des interventions fournissant des informations aux patients atteints de SEP.

Notes de traduction

Traduit par: French Cochrane Centre 6th August, 2014
Traduction financée par: Financeurs pour le Canada : Instituts de Recherche en Santé du Canada, Ministère de la Santé et des Services Sociaux du Québec, Fonds de recherche du Québec-Santé et Institut National d'Excellence en Santé et en Services Sociaux; pour la France : Ministère en charge de la Santé

எளியமொழிச் சுருக்கம்

மல்டிபிள் ஸ்கலரோசிஸ் கொண்ட மக்கள் தகவலறிந்த முடிவுகளை எடுக்க தகவல் வழங்குதல்

மல்டிபிள் ஸ்கலரோசிஸ் (எம்எஸ்) கொண்ட மக்கள், நோயின் அனைத்து நிலைகளிலும் பல நிலையாமைகளை எதிர்கொள்ள வேண்டி இருக்கும். உதாரணத்திற்கு, எதிர்காலத்தில் நோயின் போக்கை குறிப்பிடும் ஒரு அறுதியீடு தெளிவற்றதாக இருக்கும், அதெனில் மூன்றில் ஒரு பங்கு மக்கள் கடுமையிராத நோயின் போக்கோடு, சிறிது அல்லது எந்த இயலாமையும் தீவிரமடையாமல் அனுபவிக்க கூடும். மருந்தியல் மற்றும் மருந்தியல் அல்லாத சிகிச்சைகளின் விளைவுகள் மற்றும் தீங்கு விளைவுகளுக்கும் உறுதியற்ற நிலை உள்ளது. தொடர்புடைய அனைத்து நோய்-சம்மந்தமான முடிவுகளுக்கும் மற்றும் தனிப்பட்ட வாழ்க்கையை திட்டமிடும் முடிவுகளுக்கும் தகவலறிந்த தேர்வுகளின் படி முடிவு செய்யும் பொருட்டு துல்லியமான, சமீபத்திய மற்றும் தொடர்புடைய தகவல்களை பெற எம்எஸ் கொண்ட மக்கள் வேண்டுகின்றனர். இதற்கு, ஒரு சீரான தகவல் ஒரு முற்படு தேவையாகும். எம்எஸ் கொண்ட மக்களில், நோய் பற்றிய அறிவு குறைவாக உள்ளது என்று காட்டப்பட்டுள்ளது. ஆதலால், எம்எஸ் கொண்ட மக்கள், அவர்களுக்கு தொடர்புடைய அனைத்து அம்சங்களிலும் தகவல் அளிக்க கூடிய சிகிச்சை தலையீடுகளை பெற வேண்டும்.

எம்எஸ் கொண்ட மக்களுக்கு, அந்நோய் பற்றிய அறிவை அதிகரிக்கவும், முடிவெடுத்தல், மற்றும் வாழ்க்கைத் தரத்தை மேம்படுத்தவும் தகவல் அளிப்பதை நோக்கமாக கொண்ட சிகிச்சை தலையீடுகளை நாங்கள் திறனாய்வு செய்தோம். ஜூன் 2013-ல், மருத்துவ இலக்கியத்தில் தொடர்புடைய ஆய்வுகளை நாங்கள் கண்டு, மொத்தம் 1314 பங்கேற்பாளர்கள் சம்பந்தப்பட்ட 10 ஆய்வுகளை அடையாளம் கண்டோம். எழுத்து பூர்வ தகவல் அல்லது முடிவு சாதன கலங்கள், விளக்கக் கல்வி திட்டங்கள் மற்றும் தனிப்பட்ட தகவல்கள் அளிப்பது உள்ளிட்ட பல்வேறு அணுகுமுறைகளை ஆய்வுகள் மதிப்பீடு செய்தன. ஆய்வுகளின் செயல் முறையியல் தரம் மாறுபட்டு இருந்தது. நோய்-மாற்றும் சிகிச்சை, மறுவீழ்வு மேலாண்மை, சுய-பராமரிப்பு உத்திகள், அயர்ச்சி மேலாண்மை, குடும்பக் கட்டுப்பாடு மற்றும் பொது ஆரோக்கிய உயர்வு ஆகியவை தலைப்புகளில் அடங்கும். தகவல், நோயாளிகளின் நோய் பற்றிய அறிவை வெற்றிகரமாக அதிகரிக்கக் கூடும் என்று நோய் பற்றிய அறிவின் நிலையை மதிப்பிட்ட நான்கு ஆய்வுகள் காட்டியது (மிதமான தர சான்று). முடிவெடுத்தலின் மீதான விளைவுகளை அறிக்கையிட்ட நான்கு ஆய்வுகள் மற்றும் வாழ்க்கை தரத்தை மதிப்பிட்ட ஐந்து ஆய்வுகளிலிருந்து கலவையான முடிவுகள் (குறைந்த தர சான்று) இருந்தன. ஆய்வுகள் மற்றும் பயன்படுத்தப்பட்ட சிகிச்சை தலையீடுகள் குறிப்பிடும்படியாக மாறுபட்டு இருந்தபடியால் மற்றும் எங்களின் விளைவுகளின் மேலான ஆதாரத்தின் தரம் உயர்வாக இல்லாத படியாலும், எம்எஸ் கொண்ட மக்களில், தகவல் வழங்கும் சிகிச்சை தலையீடுகளின் திறன் பற்றிய ஒரு தெளிவான முடிவிற்கு வர கண்டுப்பிடிப்புகள் அனுமதிக்கவில்லை.

மொழிபெயர்ப்பு குறிப்புகள்

மொழி பெயர்ப்பாளர்கள்: சிந்தியா ஸ்வர்ணலதா ஸ்ரீகேசவன், தங்கமணி ராமலிங்கம், ப்ளசிங்டா விஜய், ஸ்ரீகேசவன் சபாபதி.

Laienverständliche Zusammenfassung

Informationsbereitstellung für Menschen mit Multipler Sklerose, um informierte Entscheidungen zu treffen

Menschen mit Multipler Sklerose (MS) sind mit zahlreichen Unsicherheiten während aller Krankheitsphasen konfrontiert. Zum Beispiel bleibt die Bedeutung der Diagnose für den zukünftigen Krankheitsverlauf unklar, da bis zu einem Drittel der Menschen einen harmlosen Krankheitsverlauf erleben werden, mit geringer oder sogar keiner fortschreitenden Behinderung. Unsicherheit besteht ebenfalls über die positiven und unerwünschten Wirkungen von pharmakologischen und nicht pharmakologischen Therapien. Menschen mit MS wollen korrekte, aktuelle und relevante Informationen erhalten, um eine informierte Wahl zu treffen bei allen relevanten, krankheitsbezogenen Entscheidungen und auch Entscheidungen der persönlichen Lebensplanung. Voraussetzung dafür sind ausgewogene Informationen. Es wurde nachgewiesen, dass Menschen mit MS wenig über die Erkrankung wissen. Deshalb sollten sie Interventionen erhalten, die zu allen für sie bedeutsamen Aspekten informieren.

Wir überprüften, ob Interventionen, die darauf ausgerichtet waren, Menschen mit MS Informationen zur Verfügung zu stellen, die Kenntnisse der Betroffenen steigern und die Entscheidungsfindung und die Lebensqualität verbessern. Wir suchten im Juni 2013 nach entsprechenden Studien in der medizinischen Literatur und identifizierten 10 Studien, die insgesamt 1314 Teilnehmer umfassten. Die Studien evaluierten eine Vielzahl von Ansätzen, einschließlich der Bereitstellung schriftlicher Informationen oder Entscheidungshilfen, Bildungsprogrammen und persönlichen Informationen. Die methodische Qualität der Studien variierte. Die Themen umfassten krankheitsmodifizierende Therapie, Rückfall-Management, Selbstversorgungsstrategien, Fatigue-Management, Familienplanung und generelle Gesundheitsförderung. Die vier Studien, die den Kenntnisstand bewerteten, zeigten, dass Informationen das Wissen der Patienten erfolgreich steigern können (moderate Qualität der Evidenz). Es gab unterschiedliche Ergebnisse aus vier Studien, die über den Einfluss auf die Entscheidungsfindung berichteten (niedrige Qualität der Evidenz) und aus fünf Studien, die die Lebensqualität untersuchten (niedrige Qualität der Evidenz). Da sich die Studien und die untersuchten Interventionen deutlich unterschieden und die Qualität der Evidenz für unsere Endpunkte nicht hoch war, erlauben die Ergebnisse kein eindeutiges Fazit zur Alltagswirksamkeit der Bereitstellung von Informationen für Menschen mit MS.

Anmerkungen zur Übersetzung

C. Meiling, R. Oltman, freigegeben durch Cochrane Deutschland.

Summary of findings(Explanation)

Summary of findings for the main comparison. 
  1. 1Serious risk of bias, 2Serious inconsistency, 336-Item Short Form Health Survey, 4HAQUAMS: Hamburg Quality of Life Questionnaire in Multiple Sclerosis.

Information provision for people with multiple sclerosis
Patient or population: People with multiple sclerosis
Settings: Hospital and primary care, MS regional centres
Intervention: Information provision
OutcomesEffects of the information provision for people with multiple sclerosisNo of Participants
(studies)
Quality of the evidence
(GRADE)
Knowledge
Four different self-reported questionnaires
All four studies reported significant differences between groups in favour of the intervention groups.524
(4 studies)
⊕⊕⊕⊝
moderate 1
Decision making
Different self-reported measures and instruments
One study (Köpke 2009) reported a significant difference for active roles in decision making in favour of the intervention group.In one study (Prunty 2008) there were no significant differences between groups at follow-up for decisional conflict, decision self-efficacy, and decision certainty. However, mean changes between baseline and follow-up significantly differed between groups for all three measures. In two studies no differences were found for measures of decision making: "realised role preferences" (Kasper 2008) and decisional conflict (Köpke 2013).836
(4 studies)
⊕⊕⊝⊝
low 1,2
Quality of life
SF-363 and HAQUAMS4
Two studies reported significant differences in favour of the intervention groups for different subscales of the SF-36: 3 of 8 subscales (physical, mental health, general health) in Ennis 2006 and 2 of 8 subscales (mental health, vitality) in O´Hara 2002. The other three studies found no differences between groups.605
(5 studies)
⊕⊕⊝⊝
low 1,2
Adverse events
Different adverse effects used
Six studies assessed this outcome reporting no adverse events.765
(6 studies)
-
Assessment followed the GRADE Working Group's categories using GRADEpro software (version 3.6):
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

Description of the condition

Multiple sclerosis (MS) is an inflammatory and degenerative disorder of the central nervous system leading to damage of myelin and axons. It usually starts in early adult life, typically in the third decade (Compston 2008). Prevalence rates vary between geographical areas with the highest rates of 120 to 180 per 100,000 people reported for Northern Europe, North America and Australia (Multiple Sclerosis International Federation 2010). In most people, the early disease course is characterised by inflammation causing relapses, that is episodes of neurological dysfunction that usually recovers partially or in total. Relapses can lead to a number of clinical presentations ranging from mild sensory dysfunctions to severe symptoms (for example loss of vision or paraplegia). However, over time neurodegeneration seems to be more important than inflammation leading to progression of disability. About 10% to 15% of people with MS have a primary progressive disease course. As the cause and mechanisms of the disease remain mostly unexplained (Compston 2008), uncertainty remains a constant feature of the disease (Heesen 2011; NCC-CC 2004). Individual disease courses and prognoses are variable and hard to predict, with about one third of people remaining relatively unaffected by the disease that is experiencing a 'benign' course (Degenhardt 2009; Ramsaransing 2006). A number of so called disease-modifying drugs (DMDs) for example interferons, glatiramer acetate and natalizumab have been licensed for clinical isolated syndromes, relapsing-remitting and secondary progressive MS aiming to reduce relapses rates and slow down disease progression. However, so far interventions are only partially effective and long-term effects remain unclear (Ebers 2010; Freedman 2008; Shirani 2012). Furthermore, DMDs are expensive and have regular adverse effects (Filippini 2003) resulting in low treatment adherence (Bruce 2010). The effectiveness of DMDs in progressive disease courses remains unknown. So far there are no DMDs available for primary progressive disease courses.

As MS disease courses can differ between individuals, their information needs may also vary. Taking into account a variety of upcoming DMD options and therefore the rapidly increasing complexity of treatment options, the availability of well-developed, unbiased up-to-date information is increasingly necessary to enable informed treatment choices (Heesen 2011).

Apart from DMD choices, people with MS have to make decisions on relapse therapies. Options range from high-dose intravenous or oral steroids to watchful waiting (Burton 2012; Köpke 2004) as well as symptomatic therapies and non-pharmacological therapies.

Uncertainty remains concerning diagnostic tests. Diagnostic criteria for MS are based on experts’ consensus without a clear gold standard to evaluate new diagnostic tests (Schäffler 2011). Despite the limited specificity of diagnostic tests in MS, a ‘hit hard and early’ treatment approach is increasingly promoted by experts and pharmaceutical stakeholders (Freedman 2009). This is likely to result in over-diagnosis and over-treatment (Schäffler 2011; Whiting 2006).

These multiple uncertainties pose a challenge for the medical decision making process between people with MS and their healthcare providers (Heesen 2011). It has been shown that most people with MS have a need for sufficient information and they claim autonomous roles in decision making (Heesen 2004), although there may be cultural differences (Giordano 2008). This contrasts with the poor disease-related knowledge among people with MS (Giordano 2010; Heesen 2004). Several studies have outlined communication and information deficits in the care of people with MS (Heesen 2003; Solari 2007; Vickrey 2000; Wollin 2000) as well as differences between patients and physicians concerning perception of disease severity (Rothwell 1997), risk perception (Heesen 2010) and perception of involvement in the decision process (Kasper 2011; Pietrolongo 2013). Therefore, MS management guidelines have acknowledged the need for balanced information and patient participation in MS decision making (NCC-CC 2004). In 2007 the European Union published a 'Code of Good Practice' on the rights of people with MS (EMSP 2007), demanding the provision of clear and concise high-quality information, from diagnosis onwards, to empower people with MS to self-manage their disease as far as possible.

Description of the intervention

Various information tools have been developed for people with MS. Despite a large amount of available information, for example on the Internet, comprehensibility, up-to-dateness, relevance, accuracy, validity and the efficacy of this information have rarely been studied (Heesen 2011). Available education and information materials include patient information handouts and booklets provided by pharmaceutical companies, charities and self-help groups. Other sources of information, for example on CD, DVD or websites, are becoming increasingly important. Furthermore, information technologies commonly referred to as Web 2.0 systems (podcasts, blogs and social networks), smart phones and pocket PC technologies might be used to provide MS patient information. For this review we aimed to include studies assessing the effects of interventions providing information about MS to people with MS. The information may be provided in different formats such as printed materials, educational programmes, lectures, audiovisual aids, computer programmes or websites, decision support tools and personal information, or combinations of any of these.

How the intervention might work

Accurate and unbiased information may help to prevent unrealistic expectations for example concerning disease courses and effects of therapies. In order to express preferences and to be involved in decision making, people with MS need sufficient and appropriate information that allows them to make informed decisions together with their physicians (Coulter 1999; Heesen 2011). Therefore, information provision may not only directly influence patients’ knowledge but also positively affect, for example, psychological outcomes, quality of life, sense of control and health services utilisation (Heesen 2012). Treatment choices and adherence or discontinuation of treatment may become more rational and economical. Moreover, positive effects on the disease course could be expected as information provision can lead to more effective disease management strategies (Heesen 2007).

Why it is important to do this review

Recently Mulley et al (Mulley 2012) called for higher sensitivity towards patients' preferences in medicine claiming that not taking into account patients' preferences and not addressing these preferences through providing adequate information and counselling is an important shortcoming of modern medicine comparable to other medical misdiagnoses. With the growing availability of various treatment options for MS, it seems increasingly important for patients to have access to adequate information in order to make informed choices. In this context, it is imperative to evaluate the effectiveness of different information strategies. The best evidence for the efficacy of interventions that aim to provide patients with information should come from large, well-conducted randomised controlled trials or from meta-analyses of these. A systematic review is therefore required to identify all trials in this area and to summarise the existing evidence. Despite the wide range of approaches to information provision, a systematic review summarising the findings of relevant studies in MS has not been conducted. A number of systematic reviews have addressed the different forms of information provision for patients, health professionals and caregivers in other conditions. For example, a recent Cochrane review (Forster 2012) that included 21 trials indicates that information provision to people following stroke may have positive effects on knowledge, patient satisfaction and depression. The results showed that active information provision had a greater benefit compared with passive information provision at least in some outcome measures. Another Cochrane review (Stacey 2011) that included 86 trials showed that decision aids are effective in increasing knowledge and may also positively influence decision making. However, this review included only one study (Kasper 2008) addressing MS patients.

Objectives

  1. To evaluate the effectiveness of information provision interventions for people with MS that aim to promote informed choice and improve patient-relevant outcomes.

  2. To evaluate the components and the developmental processes of the complex interventions used.

  3. To highlight the quality and quantity of research evidence available and to set an agenda for future research.

Methods

Criteria for considering studies for this review

Types of studies

Randomised, cluster randomised, or quasi-randomised trials of information provision interventions provided with the intention of improving the outcome of patients compared to (optimised) standard care were included. Trials comparing two different strategies of information provision were also included.

Types of participants

Patients of all ages with a diagnosis of any course of MS or in the diagnostic process (that is with suspected MS or clinically isolated syndrome) were considered for inclusion. The criteria of diagnosis were any established diagnostic criteria (for example Schumacher (Schumacher 1965), Poser (Poser 1983), McDonald (Polman 2005) or McDonald 2010-revised (Polman 2011)) as used in the original studies.

Types of interventions

Any intervention or group of interventions providing disease specific information provided with the intention of improving the outcome of patients was considered for inclusion. In the case of multi-faceted interventions, information provision had to be the main or one of the main components of the intervention. Interventions which covered information on general disease issues, drug therapies, other (non-drug) therapies, or combinations of these, were eligible for inclusion. Information was expected to be provided by:

  1. information leaflets, booklets, manuals or pamphlets;

  2. educational programmes or lectures;

  3. audiovisual aids like videos, tape recordings, computer programmes or websites;

  4. Web 2.0 systems including podcasts, social networks or other information technologies such as smart phones;

  5. decision support tools; and

  6. personal information (e.g. house visits or telephone calls).

We expected some interventions (for example educational programmes) to be designed as complex interventions, that is comprising more than one of the components outlined above. Following the ‘framework for design and evaluation of complex interventions’ (Campbell 2000; Campbell 2007; Craig 2008), it may not be possible to extract the effective or ineffective components of the interventions. Control interventions could be either standard care or optimised standard care, for example providing standard information in a structured way.

Types of outcome measures

Primary outcomes

As primary outcomes we considered:

  • disease-related ('risk') knowledge measured by any type of instrument used in the included studies (e.g. questionnaire or interview);

  • measures of (shared) decision making e.g. the OPTION scale (Elwyn 2005), the Shared Decision Making Questionnaire (SDM-Q) (Simon 2006), or the Decisional Conflict Scale (O'Connor 1995).

Secondary outcomes

Further outcomes were:

  • a quality of life measure e.g. MSQOL-54 (Vickrey 1997) or Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) (Gold 2001);

  • measures of informed choice e.g. the Multimodal Measure of Informed Choice (MMIC) (Marteau 2001);

  • psychological status measures e.g. Hospital Anxiety and Depression Scale (HADS) (Airlie 2001);

  • treatment choices (e.g. invasive, less invasive, no treatment); and

  • treatment compliance.

We also considered:

  • satisfaction with the information received and with the decisional process;

  • hospital admissions and use of healthcare services;

  • measures of activities of daily living (ADLs);

  • coping e.g. Coping Orientation to the Problems Experienced (Goretti 2009);

  • disability e.g. Expanded Disability Status Scale (EDSS) (Kurtzke 1983));

  • role preferences e.g. Control Preference Scale (CPS) (Degner 1997)); and

  • adverse events, as suggested by the Cochrane Consumers and Communication Review Group (CCCRG 2008).

Furthermore, reporting of process-related outcomes (for example qualitative data) was assessed using the CReDECI criteria (Möhler 2012) to allow for analysis and deeper understanding of the (complex) interventions used. Data on patient or consumer involvement and their perception of the intervention were extracted.

Search methods for identification of studies

No language restrictions were applied to the search.

Electronic searches

The Review Group's Trials Search Co-ordinator searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Trials Register (12 June 2013), which contains trials from the following sources:

1. Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 6);

2. MEDLINE (PubMed) (1966 to 12 June 2013);

3. EMBASE (Embase.com) (1974 to 12 June 2013);

4. CINAHL (EBSCOhost) (1981 to 12 June 2013);

5. LILACS (BIREME) (1982 to 12 June 2013);

6. PEDro (1990 to 12 June 2013);

7. Clinical trials registries (http://clinicaltrials.gov).

The keywords used to search for trials for this review are listed in Appendix 1.

Information on the Group's Trials Register and details of the search strategies used to identify trials can be found in the 'Specialised Register' section within the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group module.

Additionally, the authors searched PsycINFO (OvidSP) (1967 to 3 August 2013) (Appendix 2).

Searching other resources

  1. We checked trial and dissertation registers (Appendix 3) as well as reference lists of published reviews, and retrieved articles for unpublished or ongoing trials.

  2. We also contacted experts in the field to identify unpublished or ongoing studies.

Data collection and analysis

Selection of studies

Two review authors (SK, AG) independently examined the titles and abstracts of citations obtained from the search and independently assessed articles for inclusion according to the above criteria. Disagreements were resolved by discussion. One review author who was not involved in the primary study being assessed checked inclusion of the primary studies in which authors of the review were involved.

Data extraction and management

We designed and piloted a data extraction form using a standardised data collection form based on the Consumers and Communication Group's data extraction template and entered data in the current version of RevMan 5 (Review Manager 2013). Two review authors (SK, AG) independently extracted the data from the included studies using the standardised form and checked for accuracy. One review author not involved in the primary study checked data extraction for the primary studies in which authors of the review were involved. We extracted data for characteristics of participants, baseline data, interventions, duration of intervention, length of follow-up, outcome measures and adverse events. For dichotomous data, we extracted the number in each treatment group and the numbers experiencing the outcome of interest. For each outcome measure, we extracted data for every participant assessed. To allow for an intention-to-treat (ITT) analysis, we extracted the data irrespective of compliance and whether or not the participant was subsequently deemed ineligible or otherwise excluded from treatment or follow-up. If ITT data were not available in the publications, we retrieved 'on-treatment' data or the data of those who completed the trial. We did not mask study names. In the case of disagreement, a third review author (CH) was brought into the process to reach consensus. We aimed to collect any supplementary (for example qualitative) data produced as process evaluations to allow for deeper understanding of the complex interventions (Craig 2008) in the included studies and their components using the CReDECI criteria (Möhler 2012) as a framework. Where necessary, we contacted study authors for additional information and data.

Assessment of risk of bias in included studies

Assessment of risk of bias followed the guidance in the Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2 (Higgins 2011). Two review authors (SK, AG) independently assessed and scored studies’ risk of bias in order to identify any potential sources of systematic bias through selection bias, performance bias, attrition bias and detection bias. For primary studies in which authors of the review were involved, one review author not involved in the primary study assessed the risk of bias. As recommended in the Cochrane Handbook for Systematic Reviews of Interventions, we used a two-part tool, addressing six domains (sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other issues). The first part described what had been reported in the study. In the second part a judgement concerning the related risk of bias was assigned for each entry by asking for the adequacy of the study in relation to the entry. The domains of sequence generation, allocation concealment (avoidance of selection bias) and selective outcome reporting (avoidance of reporting bias) were addressed in the tool by a single entry for each study. Blinding of participants, staff and outcome assessors (avoidance of performance bias and detection bias) was considered separately for objective outcomes and subjective outcomes. Although initially planned, we did not consider incomplete outcome data (avoidance of attrition bias) separately for different lengths of follow up (shorter and longer follow-up) as this was present in only one trial (Prunty 2008). The quality of evidence for the three main outcomes (knowledge, decision making and quality of life) was assessed with the criteria proposed by the GRADE working group (Guyatt 2011) using the GRADEpro software (version 3.6) and is presented within the Summary of findings for the main comparison.

Measures of treatment effect

As we detected clinical heterogeneity (see below), the study results were presented in a narrative form. We extracted the data as reported in the Characteristics of included studies table. If meta-analyses become feasible in future updates, we will analyse treatment effects as described in the protocol (Köpke 2010).

Unit of analysis issues

For each study we assessed whether individuals or groups of individuals were randomised together (in clusters) to the same intervention, whether individuals underwent more than one intervention, or whether there were multiple observations for the same outcome.

Dealing with missing data

Numbers and types of missing data related to participants’ dropping out are described in the Characteristics of included studies table. As no meta-analysis was performed and we had no indication of data not missing at random, we did not perform imputation of missing data or sensitivity analyses.

Assessment of heterogeneity

We analysed and presented the studies separately. To consider clinical heterogeneity, we analysed all studies in terms of participants, interventions and outcomes. Due to apparent clinical heterogeneity, we did not perform meta-analyses and we did not assess statistical heterogeneity. If data become available in future updates, we will consider both clinical heterogeneity and statistical heterogeneity as described in the protocol (Köpke 2010).

Assessment of reporting biases

In order to minimise the risk of publication bias, we performed comprehensive searches in multiple databases, including searching for unpublished studies. Due to the small number of included trials, we did not analyse trials data using a funnel plot to investigate the likelihood of overt publication bias.

Data synthesis

Due to clinical heterogeneity we did not perform meta-analyses and the results are presented in a narrative form as we were unable to identify a feasible way to synthesise the included studies. Results are listed according to the study endpoints.

Subgroup analysis and investigation of heterogeneity

Due to the small number of included studies, there were insufficient data to perform subgroup analyses as originally planned.

Sensitivity analysis

Due to the narrative presentation of results, we did not perform sensitivity analyses. If meta-analyses become feasible in future updates, we will categorise and analyse interventions separately as described in the protocol (Köpke 2010).

Results

Description of studies

See Characteristics of included studies, Characteristics of excluded studies, and Characteristics of studies awaiting classification.

Results of the search

We screened a total of 2943 abstracts for inclusion (Figure 1; Table 1) and assessed 31 publications in full text. Ten publications fulfilled the eligibility criteria (Ennis 2006; Kasper 2008; Köpke 2009; Köpke 2013; Kos 2007; O´Hara 2002; Prunty 2008; Shinto 2008; Solari 2010; Young 1986). We did not identify any ongoing studies but one unpublished study is awaiting classification (Rotstein 2012).

Figure 1.

Study flow diagram.

Table 1. Search results
  1. ISTP, Index to Scientific & Technical Proceedings. WHO, World Health Organization. UMIN, University hospital Medical Information Network.

Source Date Searched

Records retrieved

(excluding duplicates)

Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group RegisterSearched 12 June 20131307
PSYCINFO (Ovid SP) Searched 3 August 2013117
ISI Web of Science with ISTP Conference ProceedingsSearched 12 June 20131
Meta Register of Controlled TrialsSearched 12 June 20131119
WHO International Clinical Trials RegistrySearched 12 June 201336
Canadian Theses and DissertationsSearched 12 June 2013255
Australian Digital Theses Program via TroveSearched 12 June 201390
UMIN Japan Trial RegisterSearched 12 June 20139
Forward and backward tracking of included articles and relevant systematic reviewsSearched 12 June 20139
TOTAL after rejecting duplications2943

Included studies

We included 10 randomised controlled trials (RCTs) with a total of 1314 participants (Ennis 2006; Kasper 2008; Köpke 2009; Köpke 2013; Kos 2007; O´Hara 2002; Prunty 2008; Shinto 2008; Solari 2010; Young 1986) in this review. We found pronounced clinical heterogeneity in terms of the definitions of interventions and the outcomes assessed. Therefore, we did not determine statistical heterogeneity and we did not perform meta-analyses. Thus, the study results were presented in a narrative format.

Settings and participants

All but three studies (Kasper 2008; Kos 2007; Prunty 2008) were hospital-based (mostly out-patient departments). In Prunty 2008 the participants were recruited from members of regional MS societies, in Kos 2007 either through the national MS society or by treating neurologists, whereas in Kasper 2008 the participants were recruited from different locations including primary and hospital care. Three studies were carried out in Germany (Kasper 2008; Köpke 2009; Köpke 2013), two in the UK (Ennis 2006; O´Hara 2002), two in the USA (Shinto 2008; Young 1986), one in Australia (Prunty 2008), one in Belgium (Kos 2007) and one in Italy (Solari 2010); see Characteristics of included studies. The mean patient age ranged from 31 to 51 years across studies. Most participants were women (more than 60% overall). In Prunty 2008, only women participated due to the target of the intervention. Levels of disability were mentioned in all but three studies (O´Hara 2002; Prunty 2008; Young 1986) and were moderate overall. More than 50% of patients had 12 or more years of education; level of education was not reported in two studies (Ennis 2006; Prunty 2008). All patients had a confirmed MS diagnosis (Ennis 2006; Kasper 2008; Köpke 2009; Köpke 2013; Kos 2007; O´Hara 2002; Prunty 2008; Shinto 2008; Solari 2010; Young 1986) or a clinically isolated syndrome (Kasper 2008; Köpke 2013). Two studies included only relapsing-remitting patients (Köpke 2013; Shinto 2008). Most studies excluded patients with cognitive impairment. One study did not report any exclusion criteria (Young 1986).

Duration of follow-up

Study follow-up ranged from one month (Prunty 2008; Young 1986) to two years (Köpke 2009) (Figure 2).

Figure 2.

Overview of the intervention components.

Description of interventions

In all studies the information was provided using one or more components (see Figure 2). In four studies patients participated in an educational program: in Ennis 2006 the 'OPTIMISE' program aimed to provide knowledge, skills and confidence to undertake health-promoting activities; in Köpke 2009 and Köpke 2013, besides a four-hour educational program, participants received a preparatory booklet on the topics of the intervention that is relapse management (Köpke 2009) or diagnosis, prognosis and early MS therapy (Köpke 2013). In Köpke 2009 participants were also offered a prescription of oral corticosteroids. In Kos 2007 the participants took part in four two-hour education sessions during four weeks, each consisting of information provision followed by an interactive component.

In Kasper 2008 and Prunty 2008 patients received a decision aid. In Kasper 2008 this comprised a “comprehensive evidence-based MS patient information booklet about immunotherapy options and an interactive worksheet"; in Prunty 2008 the decision aid consisted of an information booklet containing an exercise sheet that aimed to "help women consider their personal values and those of their partners" on family planning ('motherhood choice'). In three studies (O´Hara 2002; Shinto 2008; Young 1986) patients received personal information and a booklet on self-care strategies (O´Hara 2002), information on specific aspects related to MS (Shinto 2008) or steroid medication (Young 1986). In Solari 2010 the patients received information on different aspects of MS including diagnosis and drug therapy during a personal interview with a physician and using a navigable CD and a take-home booklet.

Development

Two interventions (Ennis 2006; Köpke 2009) were based on psychological theories: Ennis 2006 stated that “the group setting provides opportunity for development of self-efficacy (Bandura 1977) through vicarious experiences and verbal persuasion from other people with MS”. In Köpke 2009 the program was based on the protection motivation model (Boer 1996; Rogers 1975) "applied to decisional autonomy" with the curriculum derived from the "practical oriented approach" (Meyer 1983). Four studies (Kasper 2008; Köpke 2013; Prunty 2008; Solari 2010) used as their theoretical background international standards (Campbell 2000; Coulter 1999; Elwyn 2006), and also pre-studies investigating patients’ needs and feasibility tests (Heesen 2004; Kasper 2006; Solari 2007). Two studies (Kos 2007; O´Hara 2002) did not mention underlying theories but performed pre-studies. O´Hara 2002, reported a 'pragmatic approach' (O'Hara 2000) based on previous publications of patients' needs (Robinson 1996) and pre-studies (O'Hara 2000). In two studies (Shinto 2008; Young 1986) the intervention was based on clinical practice with no theoretical basis mentioned.

Content and delivery
Content

Different information topics were addressed as part of the interventions (see Table 2) with six studies including information on MS in general (Kasper 2008; Köpke 2009; Köpke 2013; O´Hara 2002; Prunty 2008; Solari 2010), eight studies information on drug therapies (Kasper 2008; Köpke 2009; Köpke 2013; Kos 2007; O´Hara 2002; Prunty 2008; Solari 2010; Young 1986), seven on non-drug therapies (Kasper 2008; Köpke 2009; Köpke 2013; Kos 2007; O´Hara 2002; Shinto 2008; Solari 2010) and four including information of general interest for people with MS (Ennis 2006; Kos 2007; O´Hara 2002; Shinto 2008).

Table 2. Intervention components
  1. n.r.: not reported. CAM: complementary and alternative medicine.

  Disease information Drug therapies Non-drug therapies General information
Ennis 2006n.r.n.r.n.r.Sessions on “Health promoting activities”
1. Exercise and physical activity
2. Lifestyle adjustment/fatigue management
3. Stress management
4. Nutritional awareness
5. Responsible health practices.
Kasper 2008MS basicsImmunotherapy options.Very shortly addressed.No
Köpke 2009Evidence on relapsesRelapse therapy (corticoids)CAM discussed during educational sessionNo
Köpke 2013MS basics: pathology, relapses, progression, disease courses, natural course, prognosis.Therapy options for early MS focusing on immunotherapy, but also on other options including CAMCAM included in the brochure (information provided by author on request)No
Kos 2007n.r.Pharmacological treatmentDiet, cooling, assistive devices, and energy saving methods.Regular sleep, exercise, relaxation, adaptation of home or work environment.
O’Hara 2002An introduction to MS (Included in the information booklet; Information provided by Dr. De Souza on request).Medication, Therapists and Therapies (included in the information booklet; information provided by Dr. De Souza on request).Diet (included in the information booklet; information provided by Dr. De Souza on request).Coping with the emotional impact of MS; Support from friend and family; Rest; Working (information included in the information booklet; information provided by Dr. De Souza on request).
Prunty 2008General background information about MS; psychosocial impact of MS regarding parenting; effect of MS on fertility, pregnancy, labour, delivery, miscarriage, child-rearing, pregnancy, and course of MS; MS in the post-natal period.Evidence about the safety of different medications during conception and pregnancyn.r.n.r.
Shinto 2008n.r.Therapies for fatigue; mood; cognitive problems; bowel and bladder problems.Nutrition; vitamins, minerals, and herbs.Exercise; stress.
Solari 2010MS basics, diagnosis, time after diagnosis, emotions, having a childRelapse therapies and disease-modifying drugs.Definition of CAM reported only in the Glossary (information provided by author on request).n.r.
Young 1986n.r.Information on methylprednisolone (drug action,usage, side effects, danger signs)n.r.n.r.
Delivery

In two studies (Kasper 2008; Prunty 2008) patients were sent decision aids by postal mail. In O´Hara 2002 participants were assigned by a health professional to either group or one on one sessions. Sessions were conducted either at participants’ homes or in local therapy centres on two occasions during one month and each session lasted between one and two hours. In Solari 2010 the interviewing physician was a neurologist or trainee neurologist experienced in MS. Five physicians (one at each centre) were trained during one day in the personal interview and CD navigation. The physician and patient went through the topics of the CD guided by patient preferences. The booklet was presented to each patient at the end of the interview. In Young 1986, a physician and a nurse gave the oral presentation with no information available on the structure of the presentation nor on the training of providers. In Köpke 2009 the patient received a 40-page preparatory information brochure two weeks before the program, which was a structured four-hour education program with 10 participants each (plus their partners or close relatives who were also invited). Mostly, two educators held the program: a nurse and a specially trained patient with MS. In Köpke 2013 10 participants with their partners or close relatives were invited per session. The programme was led by one 'non-medical' person from the study centre and was based on structured presentation materials and moderation cards. Training of the provider was not reported. In Ennis 2006 eight weekly three-hour education sessions in small groups of approximately eight participants per group were held within a hospital. Sessions were delivered by healthcare professionals, as appropriate (occupational therapist, physiotherapist, dietician and MS nurse). The number and training of providers were not reported. In Kos 2007 four weekly two-hour education sessions were held by 'four different therapists' with no further information provided. In Shinto 2008, besides usual care, patients received eight visits from a specialised MS nurse over a period of six months. None of the studies provided information using 'Web 2.0 systems' (podcasts, social networks or smart phones).

Control groups

Three studies included control interventions that were similar in size to the active intervention (Kasper 2008; Köpke 2013; Kos 2007) and four provided some information (Köpke 2009; O´Hara 2002; Prunty 2008; Young 1986). In the other studies (Ennis 2006; Shinto 2008; Solari 2010) no intervention was offered to the control group (usual care). Characteristics of usual care were not reported in any of these studies.

Methods of data collection

In all included studies most of the primary and secondary outcomes were assessed using self-reported measures (questionnaires or scales) some of which had been validated in the target language and population.

Excluded studies

We excluded 21 studies as they did not meet the inclusion criteria relating to main outcomes, participants or the type of intervention (see Characteristics of excluded studies).

Risk of bias in included studies

We contacted the first or senior authors of all but one (Kos 2007) study and asked them to provide further information on methodological details not reported in the publications. All authors responded to our requests with all but one author able to provide further information. Overall, two studies (Kasper 2008; Köpke 2013) were of high methodological quality. All the others had at least some risk of bias (Characteristics of included studies; Figure 3; Figure 4).

Figure 3.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 4.

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

Allocation

Sequence generation was adequate in all studies. Allocation concealment was adequate in seven studies (Kasper 2008; Köpke 2009; Köpke 2013; O´Hara 2002; Prunty 2008; Shinto 2008; Solari 2010), inadequate in Ennis 2006, and unclear in Kos 2007 and Young 1986.

Blinding

Blinding of participants was performed in two studies (Kasper 2008; Köpke 2013). As far as blinding of assessors was concerned, we considered as adequate those studies in which outcomes were patient-reported that is by a questionnaire or (telephone) interview; seven studies (Ennis 2006; Kasper 2008; Köpke 2013; Kos 2007; O´Hara 2002; Prunty 2008; Shinto 2008; Solari 2010) were considered as adequate.

Incomplete outcome data

Attrition bias was present in two studies (Kos 2007; Prunty 2008) with more than 20% of dropouts at follow-up.

Selective reporting

Three studies (Kasper 2008; Köpke 2013; Solari 2010) were adequate in reporting. Reported data from Köpke 2009 differed to some extent from the data in the trial registration. For the other studies (Ennis 2006; Kos 2007; O´Hara 2002; Prunty 2008; Shinto 2008; Young 1986) no protocol was available.

Other potential sources of bias

In six studies (Ennis 2006; Köpke 2009; Kos 2007; Shinto 2008; Solari 2010; Young 1986) there was a potential contamination between groups.

Effects of interventions

See: Summary of findings for the main comparison

See Summary of findings for the main comparison .

Primary outcome measures

Knowledge

Four studies (Köpke 2013; Prunty 2008; Solari 2010; Young 1986) assessed the first pre-specified primary endpoint using different instruments (Table 3). All reported significant differences between groups in favour of the intervention group (IG) (524 participants; moderate-quality evidence). In Köpke 2013 there was a significant difference between groups two weeks after the intervention. Scores for 'good knowledge', defined as more than 11 questions of a possible 19 answered correctly, were reported for 57/88 (64.8%) patients in the IG and 23/90 (25.6%) in the control group (CG) (P < 0.001). Mean knowledge was 12.3 ± 2.5 in the IG and 10.2 ± 2.3 in the CG (P < 0.001). In Prunty 2008 there was a significant difference between groups for mean knowledge after the intervention (6.3 ± 2.2 in the IG versus 4.6 ± 1.9 in the CG of 10 possible points; mean difference 1.7; P = 0.01). In Solari 2010 there was a significant difference between groups at one month. Scores within the highest tertile were reported for 36/60 (60%) patients in the IG and 15/60 (25%) in the CG (odds ratio (OR) 4.5, 95% CI 2.1 to 9.8; P < 0.001). In Young 1986 a significant difference was reported for knowledge about steroid therapy after the intervention (14.5 ± 2.5 versus 10.9 ± 2.6 of 17 possible points; mean difference 3.6; P < 0.015).

Table 3. Summary of outcomes assessed
  1. PO: Primary outcome measure; SO: secondary outcome measure.

    CPS: Control Preference Scale; DCS: Decisional Conflict Scale: DSES: Decision Self-Efficacy scale; MMIC: Multi-Dimensional Measure of Informed Choice; HAQUAMS: Hamburg Quality of Life Questionnaire in Multiple Sclerosis; MSKQ: Multiple Sclerosis Knowledge Questionnaire; PBMS: Planned Behavior in MS questionnaire.

  Knowledge Decision Making Quality of Life
Ennis 2006Not assessedNot assessedSF-36 (SO)
Kasper 2008Not assessed

Realised role preferences (CPS) (PO)

Degree of decision progress (Self-developed questionnaire) (SO)

Not assessed
Köpke 2009Not assessed

Active role in decision on relapse treatment (Self-developed questionnaire) (SO)

Satisfaction with the decision (Self-developed questionnaire) (SO)

HAQUAMS (SO)
Köpke 2013Self-developed questionnaire (part of the PO)

Informed choice (MMIC) (PO)

Autonomy preferences (CPS) (SO)

Decision autonomy (Self-developed questionnaire based on CPS) (SO)

Decisional conflict (DCS) (SO)

Satisfaction with the decision (Self-developed questionnaire) (SO)

Decision process (PBMS) (SO)

HAQUAMS (SO)
Kos 2007Not assessedNot assessedNot assessed
O’Hara 2002Not assessedNot assessedSF-36 (SO)
Prunty 2008Self-developed questionnaire (PO)

Decisional Conflict (DCS) (PO)

Decision self-efficacy (DSES) (PO)

Decision Certainty (Self-developed questionnaire) (PO)

Not assessed
Shinto 2008Not assessedNot assessedSF-36 (PO)
Solari 2010MSKQ (part of PO)Not assessedNot assessed
Young 1986Self-developed questionnaire (PO)Not assessedNot assessed

Decision making

Four studies (Kasper 2008; Köpke 2009; Köpke 2013; Prunty 2008) assessed our second pre-specified primary endpoint using different measures and instruments (Table 3) (836 participants; low-quality evidence). In Kasper 2008 no changes were found between groups for 'realised role preferences', assessed as congruency of role preferences at baseline compared to the decision roles used within the consultations, assessed with the Control Preference Scale (CPS). No differences between groups were found with approximately 50% of participants in both groups showing congruency between role preferences and the roles used. In both groups patients reported that they were significantly more decided after the intervention with no differences between groups (P = 0.42, no numbers reported). In Köpke 2009 more patients in the IG reported an active role in decision making after the intervention: IG 93 (69%), CG 74 (42%); difference 27% (95% CI 16% to 37%; P < 0.001) assessed as a secondary outcome measure. In Köpke 2013 decisional conflict did not differ between groups or within groups for the two measurement points (before the intervention and after 12 months) for all subscales. Overall, more than two thirds of the patients preferred more active than collaborative roles without significant differences between groups and between time points. Overall, 70 (IG) and 72 (CG) decisions on DMDs were reported during the 12 months of follow-up. In both groups most decisions were reported to be solely or mostly driven by the patient or were shared between patients and physicians, with no differences between groups. In Prunty 2008, at follow-up there were no significant differences between groups for decisional conflict, decision self-efficacy and decision certainty. However, mean changes between baseline and follow-up significantly differed between groups for all three measures: decisional conflict (P = 0.001), decision self-efficacy (P = 0.002) and decision certainty (P = 0.047).

Secondary outcomes measures

Informed choice

Only Köpke 2013 assessed informed choice, using the Multidimensional Measure of Informed Choice (MMIC) (Marteau 2001), showing significant differences between groups with 50 of 85 (58.8%) in the IG compared to 18 of 89 (20.2%) in the CG showing informed choice (difference 38.6%, 95% CI 24.1% to 53.1%; OR 0.18, 95% CI 0.09 to 0.35; P < 0.001).

Quality of life

Five studies reported results on quality of life, three using the Short Form (SF)-36 (Ennis 2006; O´Hara 2002; Shinto 2008) and two using the HAQUAMS (Köpke 2009; Köpke 2013) (605 participants; low-quality evidence). In Shinto 2008 the SF-36 was the primary endpoint whereas in Ennis 2006 and O´Hara 2002 it was assessed as a secondary endpoint. In Köpke 2009 and Köpke 2013 the HAQUAMS questionnaire was used to control for adverse events of the intervention. In Ennis 2006 significant differences between groups were reported for changes from baseline to 8 weeks after the programme for the SF-36 subscales for physical health (IG +8.1 ± 14.8 versus CG +2.8 ± 19.3; P = 0.03), mental health (IG +5.7 ± 22.9 versus CG -8.6 ± 13.0; P < 0.01), and general health (IG +10.1 (SD not reported) versus CG -1.2 ± 18.0; P < 0.01). No significant changes were observed for the other five subscales of the SF-36. In O´Hara 2002 significant changes between baseline and 6 months follow-up were reported for two subscales of the SF-36: mental health (IG +3.7, 95% CI 0.4 to 7.0 versus CG -1.2, 95% CI -4.3 to 1.9; P = 0.04) and vitality (IG +1.5, 95% CI -2.7 to 5.7 versus CG –4.21, 95% CI –7.92 to –0.51) with no significant differences for the other subscales. In Shinto 2008 there were no significant differences between the IG (education group) and the CG for mean changes between baseline and follow-up in all scales of the SF-36. In Köpke 2009, for the HAQUAMS total score a slight improvement in both groups was reported with no significant difference between groups for changes in quality of life between baseline and two years of follow-up. Also, in Köpke 2013 there were no differences in changes in quality of life between groups.

Anxiety and depressive symptoms

Five studies (Köpke 2013; Kos 2007; Prunty 2008; Shinto 2008; Solari 2010) assessed anxiety or depressive symptoms using different instruments, none of them as a primary endpoint. In Köpke 2013, using the HADS as a measure of adverse events, subscale mean scores for anxiety and depression were low and no significant differences were found between groups and between time points. Kos 2007 reported "no significant changes [...] in both groups" for the Mental Health Inventory (MHI) (Ritvo 1997) without providing data. In Prunty 2008 there were no differences between groups after the intervention for anxiety (State-trait anxiety inventory (STAI)) or depression (Center for Epidemiologic Studies Depression scale (CESD) (Radloff 1977)). In Shinto 2008 no significant difference was reported between groups for the Beck Depression Inventory (BDI) (P = 0.76). In Solari 2010 anxiety and depression, measured using the HADS, were comparable in both groups at baseline and follow-up.

Adverse events

In Ennis 2006, Prunty 2008 and Shinto 2008 no adverse events were detected. Köpke 2009 and Köpke 2013 found no differences in changes in health-related quality of life or disability status between groups suggesting that the programs had no negative side effects. In Solari 2010 no serious adverse events (admission to psychiatric ward, suicide attempt or death) were recorded by the Independent Data and Safety Monitoring Committee. No adverse events were assessed in O´Hara 2002 and Young 1986. Kasper 2008also did not assess adverse events although the authors discussed that "previous findings indicate that MS patients are capable of coping with the uncertainty of scientific evidence without becoming emotionally distressed or experiencing therapeutic nihilism”.

Treatment choices and compliance

Five studies reported treatment choices (Kasper 2008; Köpke 2009; Köpke 2013; Solari 2010). In Kasper 2008 there were no significant differences between groups for patients starting, changing or stopping DMDs during follow-up for both groups of patients with and without a DMD at baseline. In Köpke 2009, relapse therapies, assessed as a primary endpoint, differed significantly between groups. In the IG relapse therapies were less invasive with 78% of relapses treated with oral corticosteroids or without corticosteroids compared to 56% in the CG (difference = 22%, 95% CI 11% to 31%). In Köpke 2013 there were no significant differences for patients with a DMD. Kos 2007 reported "no significant changes in medication use occurred during the study", without giving data. In Solari 2010 there were no differences between groups for patients who did not change (CG 86.5% versus IG 88.9%), switched (CG 5% versus IG 2.8%) or stopped DMD (CG 8% versus IG 8%). Young 1986 assessed 'compliance' by asking participants about 'how each patient was taking the medication', showing that in both groups all patients reported taking the medication correctly.

Other outcome measures

Role preferences

In Kasper 2008, Köpke 2013 and Solari 2010 no differences were reported between groups at baseline and post-intervention for role preferences, using the CPS.

Satisfaction

Satisfaction with the information and with the decisional process was assessed in three studies (Kasper 2008; Köpke 2009; Köpke 2013). In all the studies this outcome did not show any difference between groups after the intervention.

Resource use

Only three studies reported resource use, hospital admissions and use of healthcare service. In Köpke 2009 the median numbers of visits to physicians and mean numbers of telephone calls to physicians significantly differed between groups, with less calls and visits reported for the IG. In Köpke 2013 and Solari 2010 the groups did not differ in terms of physician contacts, hospital admissions and other resource use. Furthermore, Köpke 2009 and Köpke 2013 reported that a detailed economic evaluation was to be published separately, with no publication available at present.

Activities of daily living

Only O´Hara 2002 reported measures of activities of daily living (ADL), assessed by the Barthel Index, with no significant differences between groups for changes from baseline to follow-up, although in the CG a significant deterioration was found whereas in the IG the ADL levels remained stable.

Coping

Kos 2007 assessed self efficacy using the Multiple Sclerosis Self-Efficacy (MSSE) Scale with "no significant changes [...] in both groups" but without providing data.

Disability

See Characteristics of included studies for levels of disability at baseline. In Köpke 2009 and Köpke 2013 disability (assessed with the United Kingdom Disability Scale (UNDS) (Heesen 2007a)) was used as a safety measure. In these studies there was no difference between groups at any time point.

Process-related results

Reporting (CReDECI)

Findings for the reporting of process-related results, using the CReDECI checklist (Möhler 2012), are described in Table 4. In summary, almost all studies gave information about the development stage of the interventions. Shinto 2008 reported only one of the six possible items included in this domain (item 2: Description of all components of the intervention). Only four studies reported information on the feasibility and piloting stage (Kasper 2008; Köpke 2013; Kos 2007; Prunty 2008). For the introduction of the intervention and evaluation stage, only two studies (Kasper 2008; Solari 2010) reported information on half of the items. Overall, most studies reported insufficient information on processes.

Table 4. Evaluation of the included studies using the CReDECI checklist
  1. NA: not applicable.

(A)
  Ennis 2006 Kasper 2008 Köpke 2009 Köpke 2013 Kos 2007
Development
Item 1Yes, p.790: Self-efficacy theoryYes, p.1347Yes, p.97: Protection Motivation TheoryYes, Theory of Planned Behavior (Ajzen 1985)No
Item 2Yes, p.786Yes, p.1347, table 1Yes, p.97-98, table 1Yes, table 1 and textYes, p.997
Item 3(Yes), p.786 (Ref. 2, 5)(Yes), p.1347(Yes), p.97-98(Yes)No
Item 4(Yes), p.786 (theory and practice)Yes, table 1Yes, p.97-98Yes(Yes) p.997
Item 5NoYes, p.1347, table 1Yes, p.97-98YesYes, p.997
Item 6NoNo(Yes), p.97-98: oral corticoid prescription fitted to GermanyNoNo
Feasibility and piloting
Item 7NoYes, p.1347 (Ref. 12, 13)NoYesYes (Ref. 23)
Item 8NoYes, p.1347 (Ref. 12, 13)NoYes (partially)Yes (Ref. 23)
Evaluation
Item 9No, p.785: Control group continued with their present
level of care
Yes, p.1347Yes, p.98YesYes
Item 10NANANoNoNA
Item 11NoYes, table 1Yes, table 1YesNo
Item 12NoYes, p.1349/50No (Note: implementation study published: Köpke 2012)Yes(Yes, table 4)
Item 13NoNoNoNoNo
Item 14NoYes, p.1349/50NoYes(Yes), p.1001/02
Item 15NoNoNoNoNo
Item 16NoNo(Yes), p.99 (planned)(Yes, planned)No
(B)
  O'Hara 2002 Prunty 2008 Shinto 2008 Solari 2010 Young 1986
Development
Item 1Yes, “self-care”, p.121 (Ref. 6)Yes, p.109/10NoYes, p.1394No
Item 2Yes, p.121Yes, p.110Yes, p.491/92, table 1Yes, p.1394-96Yes, p.27
Item 3(Yes), p.121 (Ref. 6)(Yes), p.110No(Yes), p.1394 (Ref. 11)(Yes), p.27
Item 4NoNoNoYes, p.1394 (literature review and Ref. 12)(Yes), p.27
Item 5Yes, p.121Yes, p.109No(Yes), p.1393/94No
Item 6Yes, p.121NoNoNoNo
Feasibility and piloting
Item 7NoYes, p.110No(Yes), p.1394No
Item 8No(Yes), p.110NoNoNo
Evaluation
Item 9YesYesNo, p.492: “standard medical care”No, p.1404: “usual care regarding MS diagnosis disclosure”Yes, p.27
Item 10NANANoNoNA
Item 11NoNo, but Decision Aid available on request (p.110)Yes, p.491, table 1(Yes), p.1394No
Item 12NoNoNoYes, p. 1399: ongoing study mentioned (Ref. 15, Borreani 2011 published)No
Item 13NoNoNoYes, p.1397/98No
Item 14NoNoNo(Yes), p. 1399: ongoing study mentioned (Ref 15, Borreani 2011)No
Item 15NoYes, p.114No(Yes), p. 1399: ongoing study mentioned (Ref 15, Borreani 2011)No
Item 16NoNoNo(Yes), p. 1400/1No

Consumer involvement

In six studies consumers were involved in the development and provision of the intervention. Kasper 2008, Köpke 2009 and Köpke 2013 referred to the same two pre-studies that investigated patients’ needs and provided feasibility testing of intervention components (Heesen 2004; Kasper 2006). In Köpke 2009 MS patients were involved in the development of the programme and also as educators providing the educational program together with a health professional. In Kasper 2008 MS patients were involved in the development of the information brochure. In O´Hara 2002 consumers were involved in a pre-study (O'Hara 2000) and in the development of the educational booklet (Robinson 1996). Prunty 2008 involved consumers in a pre-study (Prunty 2008a). Also the decision aid was piloted in 20 women with MS who commented on its readability, balance and usefulness and gave feedback on its content. In Solari 2010 MS patients (and health professionals) were involved in qualitative studies conducted before and after the trial (Borreani 2011; Solari 2007) to discuss the design and content as well as the evaluation of the intervention components.

Perception of the intervention

Four studies (Köpke 2013; Prunty 2008; Solari 2010; Young 1986) assessed how patients (or health professionals, or both) perceived the intervention. Using their own instruments, Kasper 2008 found that IG patients rated the information as significantly more helpful for decision making than CG patients who received standard information (P < 0.001). IG patients also reported they felt better informed (P < 0.001), got important questions more adequately answered (P < 0.01), and were better supported in finding their preferred role (P < 0.05) compared to CG patients. In Köpke 2013 two in-depth interviews and two focus group meeting were conducted with participants from both groups at one study centre 15 to 18 months after the intervention. From the interviews it emerged that both IG and CG participants were satisfied with the intervention, but they were only able to recall parts of the intervention content and the main goal. Participants from both groups described the group situation as particularly helpful to discuss the program's content and to learn about other participants’ experiences. The relevance of dealing with uncertainty and the relevance of the program to support decision making were particularly emphasised by the IG participants. In Prunty 2008 20 MS patients and 15 neurologists who were involved in the piloting of the decision aid provided generally positive feedback (Prunty 2008a). Solari 2010 performed a qualitative study after the trial (Borreani 2011) to assess the experiences of trial participants, using semi-structured interviews with participants and focus group meetings with participating physicians. MS patients' experiences with the intervention were positive as they felt that it enhanced their understanding of their disease. Physicians who conducted the intervention were also positive in their overall evaluation but noted initial difficulties in using the information CD. All participants considered the combination of personal interview, CD navigation and take-home booklet essential, but urged a more flexible scheduling of the personal interview. In a subsequent implementation study (Giordano 2014) the aims were to assess the effectiveness of the intervention in clinical practice and to compare the whole information aid (personal interview with navigation through the website plus take-home materials) with the take-home booklet and website component alone. The results showed that the entire information aid was not superior to the booklet and website alone, and that both were comparable in efficacy to the intervention arm of Solari 2010.

Discussion

This review has summarised RCTs investigating the effectiveness of information provision for people with multiple sclerosis (MS) aimed at enhancing informed choice. As we detected marked clinical heterogeneity between the 10 included studies, we were unable to perform meta-analyses. Therefore, we also refrained from categorising interventions although this was originally planned in the study protocol.

Summary of main results

This review includes a total of 10 trials involving 1314 participants with MS. The interventions differed for many aspects. Although all interventions included information provision as at least one of the main intervention components, the interventions' main goals differed between studies. Whereas most trials aimed at increasing knowledge, informed choice and adequate decision making, others were concerned with increasing compliance (Young 1986) or uptake of a certain behaviour (Ennis 2006; Kos 2007; O´Hara 2002). Control interventions also differed between studies ranging from 'usual care' to control interventions comparable in size to the active intervention. In one trial (Shinto 2008) assessing the effectiveness of a naturopathic intervention, information was only provided as a 'time and attention' control group. All interventions were complex interventions using more than one active component but the number and extent of the intervention components differed markedly between studies (Figure 2). Also, endpoints were inconsistent between trials (Table 3) with only four trials each assessing the pre-defined primary endpoints of knowledge or decision making, or both. All studies reporting knowledge (Köpke 2013; Prunty 2008; Solari 2010; Young 1986) detected significant differences between groups as a result of the intervention, indicating that information may successfully increase participants’ knowledge. Still, it is not possible to judge the overall magnitude of the effect as different instruments were used and knowledge was only assessed in the short term. Also, the relevance of the knowledge gained cannot be quantified. For the four trials assessing decision making (Kasper 2008; Köpke 2009; Köpke 2013; Prunty 2008) the picture is even less clear. Of all four studies, only Köpke 2009 found significant differences between groups for active roles in decision making whereas the other studies found no significant differences for 'realised role preferences' (Kasper 2008), decision self-efficacy and decision certainty (Prunty 2008) or decisional conflict (Prunty 2008; Köpke 2009). As different instruments were used at different time points, interpretation is difficult and a general impact on the quality of decision making cannot be concluded from these results. There is no consistent effect concerning quality of life, which was assessed in five studies (Ennis 2006; Köpke 2009; Köpke 2013; O´Hara 2002; Shinto 2008). Of these one assessed this outcome as a primary outcome measure (Shinto 2008) whereas in two other studies (Ennis 2006; O´Hara 2002) it was used as one of various outcome measures, with all trials using the SF-36. The trials by Köpke et al (Köpke 2009; Köpke 2013) used the HAQUAMS as a safety measure. In three trials there were no differences between groups at follow-up but O´Hara 2002 and Ennis 2006 showed significant differences in favour of the intervention for different subscales of the SF-36, again providing inconclusive results. The same applies for all other outcomes. The results must be interpreted with particular care as there are only few studies reporting on each of the outcome categories, and most of them were assessed as secondary endpoints. For most outcomes, including satisfaction and activities of daily living (ADL), no differences were detected. Two further results should be noted. First, Köpke 2013 found a highly significant effect on 'informed choice' as a primary outcome, although this result was mainly based on the marked between-group difference concerning disease-related knowledge. Second, the primary endpoint in Köpke 2009 addressing the application mode of corticoid relapse therapies showed a significant difference towards less invasive therapy choices. Due to the lack of sufficient data, we cannot make assumptions about cost comparisons or cost effectiveness. The in-depth analysis of the complex interventions used (Table 4) revealed poor and inconsistent reporting of relevant criteria to allow for comparison of the complex interventions. As interventions that aim to provide information to patients will mostly be complex interventions the syntheses will always present important methodological challenges, which should be acknowledged by authors of primary studies and systematic reviews.

Overall completeness and applicability of evidence

Taking into account the needs of people with MS for adequate patient information, and the multitude of available information programmes and materials, the number of studies included in this review is surprisingly small. As pointed out above, we found marked variation between studies concerning the content and delivery format of the interventions, which might be seen as an indicator for the diversity of programs currently offered to people with MS. We were unable to retrieve sufficient data to make meaningful statements about the primary and key secondary endpoints as less than half of the studies addressed these endpoints and when they did they used different instruments. The generalisability and applicability of the results to different countries and healthcare systems seems limited as the studies were conducted in only six different countries, predominantly European countries. Although there is obviously a need for rigorously developed and conducted studies on patient information in MS, currently there is no ongoing RCT evaluating a patient information intervention in MS. However, there is an ongoing bi-national mixed methods study that aims to develop adequate ways to present evidence-based patient information to MS patients based on current Cochrane reviews (Hill 2012), which may provide valuable insights into questions raised within this review and inform further RCTs in the field. Moreover, there is clearly a lack of interventions addressing people with progressive MS as most studies have solely or mainly addressed people with relapsing-remitting MS.

Quality of the evidence

The methodological quality differed between studies, with only two studies having a low risk of bias. All trials used adequate sequence generation for randomisation. Concerning allocation concealment, three studies used unclear (Kos 2007; Young 1986) or inadequate (Ennis 2006) methods. As could be expected from interventions based on (group) provision of patient information, blinding of participants and staff was not achieved in most studies, with only Kasper 2008 and Köpke 2013 succeeding in blinding patients by the use of comparable control interventions. However, all but one study (Köpke 2009) applied blinded outcome assessment. In all but two studies (Kos 2007; Prunty 2008) no important attrition rates were detected. We were unable to assess the possibility of selective outcome reporting in six trials due to missing pre-published study protocols or study registrations (Ennis 2006; Kos 2007; O´Hara 2002; Prunty 2008; Shinto 2008; Young 1986). From the remaining four studies, only Köpke 2009 had an unclear risk of bias in this domain due to missing results for three pre-planned outcome measures. Apart from Kasper 2008, we could not rule out risk of contamination between groups for all other studies.

Validity of outcome measures

Apart from the problem of being faced with different outcome measures for primary and key secondary endpoints, the validity of the measures was not always reported or had not been assessed, especially for knowledge and decision making measures. There were as many instruments assessing knowledge as there were studies. Only Solari 2010 used a formally validated instrument, the Multiple Sclerosis Knowledge Questionnaire (MSKQ) (Giordano 2010), which had been validated in Italian MS patients. Most consistently, validity was present for measures of quality of life. In Ennis 2006, O´Hara 2002 and Shinto 2008 the quality of life instrument used was the well-established SF-36, whereas Köpke 2009 and Köpke 2013 used the HAQUAMS, which has been validated in German MS patients (Gold 2001).

Potential biases in the review process

Due to our comprehensive search strategy, we are confident that publication bias is unlikely. Two review authors independently performed selection of studies and data extraction, and analyses were undertaken and differences were resolved by consensus and by consulting a third person when necessary. A major point of concern could be that four of the 10 studies were from our own groups. To minimise bias, all results from these studies were checked by a third review author who was not involved in the primary study. Therefore, we believe that bias within the review process has been avoided.

Agreements and disagreements with other studies or reviews

So far, there is no other (systematic) review assessing the effectiveness of information provision in people with MS. The suggested positive effect on knowledge has been shown before for other diseases, for example stroke (Forster 2012), diabetic kidney disease (Li 2011) and rheumatoid arthritis (Riemsma 2003). A recent Cochrane review on information provision for stroke patients (Forster 2012) found that effects on some psychological outcomes as well as quality of life were more likely if the information was provided actively as opposed to passive information provision, that is if the intervention did not include a 'subsequent systematic follow-up or reinforcement procedure'. In our review, due to the narrative synthesis of results we refrained from such a subgroup analysis, with probably only two studies using 'passive' approaches (Kasper 2008; Young 1986). There are two recent reviews with some overlap with our results. Demaille-Wlodyka 2011 analysed 11 studies in a non-systematic review on "\'therapeutic patient education' for MS patients and Plow 2011 summarised 27 interventions reported in 34 papers in a scoping review on 'self-management education' interventions for MS patients. Both reviews found that the interventions were diverse and often poorly described and the study quality was often rated as poor. Although our review uses stricter and more focused inclusion criteria, we were not able to perform a quantitative synthesis due to the marked heterogeneity of the included interventions with as many intervention approaches as there were studies. Therefore, as already concluded by Plow 2011, there is a need for a standardised description of studies in order to be able to compare and delineate intervention approaches. We have used the CReDECI checklist (Möhler 2012), which showed overall poor reporting of elements of the complex interventions used within the included studies (Table 4).

Authors' conclusions

Implications for practice

Our results provide some evidence that information provision for people with MS can increase disease-related knowledge and may have a positive impact on decision making and quality of life. There seem to be no negative side effects from informing patients. Health behaviour, resource use and improved health have rarely been addressed as endpoints and a clear effect on these endpoints has only been demonstrated in Köpke 2009, who found a marked decrease in the number and invasiveness of corticoid therapies as a result of the intervention. Still, due to the marked heterogeneity of the interventions and outcome measures, it is not possible to give clear recommendations for specific methods of information provision. Of course information provision is an ethical requirement to enable patients to make informed decisions.

Implications for research

As our review leaves most questions unanswered, there are important implications for research. The development and evaluation of future interventions should be based on recent methodological requirements as for example provided by the MRC framework (Craig 2008). This includes rigorous planning and pre-studying of the intervention, which should also be clearly theory-based. There should be a pre-planned and transparently reported evaluation of the process to allow for better understanding and replication of interventions. Furthermore, outcomes should be clearly linked to the aim of the interventions with surrogate outcomes and including knowledge as well as outcomes that are important to patients such as successful decision making and adequate disease-related measures for example relapse rates, disability or disease progression. Outcome measures should be assessed using instruments with proven validity for the actual study population. In view of our results, this seems especially important for the assessment of disease-related knowledge. For patient important outcomes there should be more discussion about what would be the most relevant and feasible outcome measures.

Acknowledgements

We wish to acknowledge the contributions of consumer reviewers Michaela Beier (DMSG Hamburg) and Roswitha Kiers (MS-Network Hamburg). We also thank the Cochrane group and the external peer reviewers for their helpful comments.

Data and analyses

Download statistical data

This review has no analyses.

Appendices

Appendix 1. Keywords used to search MS Group Register

education OR "patient education" OR "education* method*" OR "education* material*" OR "education* program*" OR (information AND coping) OR "patient information*" OR "health information*" OR "information* method*" OR leaflet* OR lecture* OR "communications media" OR "information sheet*" OR "patient guidance" OR brochure* OR pamphlet* OR counselling OR "patient counselling" OR "telephone call*" OR "web site*" OR website* OR (teaching AND computer*) OR (audiovisual AND information) OR "decision making" OR "shared decision making" OR "informed choice" OR "decision support" OR advice OR "Health Education" OR "Consumer Health Information" OR "Decision Making" OR "Decision Support Techniques" OR "Informed Consent" OR "Communication" OR "Patient Participation" OR "Self Care" OR "Health Status Indicator*" OR "Drug Information Services" OR "Information Dissemination" OR "Access to Information"

Appendix 2. PsycINFO (Ovid-SP)

multiple sclerosis.mp. OR exp Multiple Sclerosis/ OR optic neurit*.mp. OR acute disseminated encephalomyelitis.mp. OR exp Encephalomyelitis/ OR myelooptic neuropathy.mp. OR myelitis.mp. OR exp Myelitis/ OR neuromyelitis optica.mp. OR Encephalomyelitis.mp. OR clinically isolated syndrome.mp. OR transverse myelitis.mp. OR devic disease.mp. OR devics.mp. OR demyelinating disease.mp. OR demyelinating disorder.mp. OR adem.mp.

AND

patient participation.mp. OR client participation.mp. OR exp Client Participation/ OR decision making.mp. OR exp Decision Making/ OR communication.mp. OR exp Communication/ OR exp Counseling/ OR counseling.mp. OR decision support technique*.mp. OR decision support systems.mp. OR exp Decision Support Systems/ OR informed consent.mp. OR exp Informed Consent/ OR health education.mp. OR exp Health Education/ OR consumer education.mp. OR exp Consumer Education/ OR client education.mp. OR exp Client Education/ OR patient education.mp. OR consumer health information.mp. OR health education.mp. OR exp Health Education/ OR drug information.mp. OR drug education.mp. OR exp Drug Education/ OR information dissemination.mp. OR exp Information Dissemination/ OR access to information.mp. OR patient information.mp. OR information method.mp. OR leaflet*.mp. OR lecture*.mp. OR communications media.mp. OR exp Communications Media/ OR information sheet.mp. OR patient guidance.mp. OR brochure*.mp. OR pamphlet*.mp. OR exp Counseling/ OR counselling.mp. OR telephone call*.mp. OR website*.mp. OR exp Internet/ OR exp Websites/ OR exp Teaching/ or teaching.mp. OR exp Education/ OR education.mp.

AND

exp Clinical Trials/ OR clinical trial*.mp. OR controlled clinical trial*.mp. OR crossover procedure.mp. OR cross over stud*.mp. OR crossover design.mp. OR double blind.mp. OR single blind.mp. OR exp Random Sampling/ OR random*.mp.

mp. [mp=title, abstract, heading word, table of contents, key concepts]

Appendix 3. List of trial and dissertation registers

  1. Meta Register of Controlled Trials (http://www.controlled-trials.com/mrct) (includes ISRCTN Register; Action Medical Research; Medical Research Council (UK); National Health Service Research and Development Health Technology Assessment Programme (HTA); National Institutes of Health (NIH) - randomised trial records held on NIH ClinicalTrials.gov website; The Wellcome Trust; UK Clinical Trials Gateway))

  2. WHO International Clinical Trials Registry Platform Search Portal (http://apps.who.int/trialsearch/) (includes Australian New Zealand Clinical Trials Registry; Chinese Clinical Trial Register (ChiCTR); Clinical Trials Registry - India (CTRI); German Clinical Trials Register (DRKS); Iranian Registry of Clinical Trials (IRCT); ISRCTN Register; Japan Primary Registries Network; The Netherlands National Trial Register (NTR); Pan African Clinical Trial Registry (PACTRI); Sri Lanka Clinical Trials Registry (SLCTR))

  3. ISI Web of Science with ISTP Conference Proceedings (http://apps.isiknowledge.com/ )

  4. UMIN Japan Trial Register (http://www.umin.ac.jp/ctr/)

  5. Australian Digital Theses Program (http://adt.caul.edu.au/)

  6. Canadian Theses and Dissertations (http://www.collectionscanada.ca/thesescanada/index-e.htm

History

Protocol first published: Issue 10, 2010
Review first published: Issue 4, 2014

DateEventDescription
10 September 2010AmendedThe section "Declarations of interest" has been updated.

Contributions of authors

SK and CH initially planned the study. SK and AG have extracted and interpreted data and have written the review. AS, FK, and CH have contributed to data analysis and have substantially commented on draft versions.

Declarations of interest

SK has been involved in three of the 10 included studies.

AS was a board member for Biogen-idec and Novartis. She has received speaker honoraria from Genzyme and Merck Serono. Also she has been involved in one of the 10 included studies.

FK has nothing to declare.

CH has received speaker honoraria, travel reimbursements and research grants from Bayer Healthcare, Biogen Idec, Merck Serono, Genzyme, Sanofi-Aventis, Teva, and Novartis. Also he has been involved in three of the 10 included studies.

AG was involved in one of the 10 included studies.

Sources of support

Internal sources

  • University Medical Centre Hamburg, Institute for Neuroimmunology and Clincal MS Research (inims), Hamburg, Germany.

  • University of Hamburg, Unit of Health Sciences, Germany.

External sources

  • National Multiple Sclerosis Society (NMSS), USA.

    Research Grant for SK

Differences between protocol and review

We have mostly adhered to the protocol with the main difference being that we did not perform meta-analyses due to marked clinical heterogeneity. For the same reason, we did not categorise interventions, as initially planned, and did not perform subgroup analyses. Instead of using the planned category 'counselling methods' as a possible intervention component, we used 'personal information' as this seemed a more appropriate term.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ennis 2006

Methods

Randomised controlled trial

Study period: "Over a period of two years", dates not reported

Participants

Country: UK
Location: MS clinic at a regional "neuroscience centre"

Number of participants: 64

Age, mean (SD), years: 45 (9) in IG, 46 (8) in CG

Female: 63% in both groups

Level of disability: EDSS 0-3: 22% in IG, 23% in CG; EDSS 3.5-6: 69% in IG, 74% in CG; EDSS 6.5-7: 9% in IG, 3% in CG

Education: not reported

Inclusion criteria: Confirmed diagnosis of MS (Poser criteria [Poser 1983]) with at least 6 months disease duration; EDSS 1.0-7.0; Age 18-65; "Desire for health promotion education"

Exclusion criteria: "Clinically significant cognitive deficit"

Interventions

Intervention group

"OPTIMISE programme" aiming to provide knowledge, skills and confidence to undertake health-promoting activities.

Structure: Eight weekly three-hour education sessions in small groups of approximately 8 participants per group held within the hospital.

Content: Education addressed "participants’ individual needs" in supporting informed decision making regarding health-promoting activities including five subjects based on published work (Marge 1988; Pender 1987).

  1. Exercise and physical activity

  2. Lifestyle adjustment/fatigue management

  3. Stress management

  4. Nutritional awareness

  5. Responsible health practices.

Each subject was provided with a theory session ("outlining the rationale for undertaking the health promotion activity and the interaction between the activity and living with multiple sclerosis") and its "practical implications to consider" together with "practical sessions" to increase self-efficacy (Bandura 1977).

The 8 sessions were:

1. Introductory session; 2.-6. the five subjects; 7. exercise and physical activity, 8. a final session "which summarises the course for spouses/family members/ friends and focuses on planning longer term goals".

The sessions were delivered by "relevant health care professionals (occupational therapist, physiotherapist, dietician and multiple sclerosis nurse specialist)" supplemented with written material.

Co-intervention: All participants in the intervention group received a "general health check" at the beginning of the study with physical examination and routine bloods tests followed by "discussion regarding the use of screening services and a review of family and social history" with 19 (59%) receiving subsequent “medical interventions”.

Control group

Usual care (no description given).

Outcomes

Primary outcome

  • Health Promoting Lifestyle Profile II (HPLP) (Walker 1987) administered at baseline and post intervention (two months afterwards)

Secondary outcomes

  • Self-Rated Abilities for Health Practices Scale (SRAHP) (Becker 1993) administered at baseline and post intervention (two months afterwards)

  • SF-36 administered at baseline and post intervention (two months afterwards)

Adverse events

  • Reported ("No adverse incidents were recorded for the duration of the study"), but assessment method unclear

NotesNumber and training of providers were not reported
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"The procedure involved placing 40 small pieces of paper with the letter A printed on them and 40 pieces with the letter B into a large envelope. Following a thorough shake of the envelope, and under the observation of an independent colleague, pieces were picked out individually and the sequence recorded."
Allocation concealment (selection bias)High riskRandomisation list known to receptionist who performed randomisation
Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and personnel not blinded to group allocation
Blinding of outcome assessment (detection bias)
All outcomes
Low risk At the point of data entry the researcher was blinded to a subject’s group”
Incomplete outcome data (attrition bias)
All outcomes
Low risk3 dropouts in the intervention group (8.8%), none in the control group
Selective reporting (reporting bias)Unclear riskNo protocol found
Other biasUnclear riskPossible contamination between groups

Kasper 2008

Methods

Randomised controlled trial

Study period: October 2004 to February 2006

Participants

Country: Germany
Location: Multiple locations including primary and hospital care

Number of participants: 297

Age, mean (SD), years: 43 (12) in IG; 43 (10) in CG

Female: 69% in IG; 78% in CG

Level of disability: Mean UNDS score (SD): 10 (7.0) in IG, 9.2 (5.8) in CG

Education: >11 years: 53% in IG; 52% in CG

Inclusion criteria: Confirmed diagnosis of MS (self-reported) or clinical isolated syndrome (self-reported) (information provided by authors on request), considering a decision on immunotherapy, age ≥ 18

Exclusion criteria: "Patients with cognitive impairment having problems in following a telephone conversation"; "patients who had already participated in studies on informed decision making"

Interventions

Intervention group

Provision of "comprehensive evidence-based MS patient information booklet about immunotherapy options and an interactive worksheet." Not stated how the booklet was provided. On request, authors reported that it was sent by postal mail.

Basis:

  • "International standards for the development of evidence-based decision support tools" (Elwyn 2006; Coulter 1999)

  • "Preliminary studies investigating patients’ needs and the feasibility of the methods" (Heesen 2004; Kasper 2006)

  • UK Medical Research Council framework for development and evaluation of complex interventions (Campbell 2000)

Content of the booklet:

  • Basics on risk communication and MS

  • Discussion of benefits and adverse effects of "all available immunotherapy options giving numerical data if possible" using "pictograms of 100 human stick figures"

  • Information structured for disease courses on three difficulty levels

  • Additional worksheet providing decision criteria "for each aspect of the decision" with the possibility to "allocate weights to the different criteria out of a given limited amount"

Control group

Standard information material on immunotherapy as supplied by the German MS self-help organisation (DMSG), comparable in size to the information booklet (80 pages), without a worksheet. Authors reported on request: Provision of CG material also by postal mail

Outcomes

Primary outcome

  • "Achievement of role preferences" defined as consistency between role preference at baseline and reported role after the consultation with physician Assessment via telephone interviews using the Control Preference Scale (CPS, Degner 1997)

Secondary outcomes

  • Treatment choice i.e. immunotherapy 6 months after randomisation (self-reported during telephone interview)

  • Measures of the decision process

    • Participants' attitude towards immunotherapy assessed at baseline, after the intervention and after the decision encounter using a 10-point Likert scale ranging from -5 (in no case immunotherapy) to +5 (in any case immunotherapy)

    • Stage of progress in the decision assessed at baseline, after the intervention and after the decision encounter using a scale ranging from 0% (I am still completely undecided) to 100% (I have made my decision)

  • Participants' evaluation of interventions and decision making assessed using 5-point Likert scales

Adverse events

  • Not assessed

Notes
  • Authors contacted about inclusion criteria. Authors replied that there had been a reporting error as not only people with a "a confirmed diagnosis of MS" were included (as stated in the inclusion criteria), but also people with a clinical isolated syndrome

  • Adverse events discussed: "Previous findings indicate that MS patients are capable of coping with the uncertainty of scientific evidence without becoming emotionally distressed or experiencing therapeutic nihilism."

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Randomisation was carried out [...] using computer generated random numbers."
Allocation concealment (selection bias)Low risk

"Randomisation was carried out by concealed allocation...". No further information

Author information on request: External person had randomisation list and send out pre-packed envelopes with information material to IG and CG participants

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"Participants [...] were not told whether the information they received was standard information or the newly developed DA."
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"To preserve blinding assessors explicitly asked patients not to refer to details of the information material."
Incomplete outcome data (attrition bias)
All outcomes
Low risk14 (9.4%) dropouts in the intervention group, 5 in the control group (3.4%)
Selective reporting (reporting bias)Low riskAdditional endpoints as stated in the study registration not reported in the publication (e.g. control beliefs)
Other biasLow risk 

Kos 2007

Methods

Randomised controlled trial

Study period: not reported

Participants

Country: Belgium
Location: Community-based participants recruited "by flyers and personal invitation through the Belgian National MS Society and on referral by the treating neurologist"

Number of participants: 51

Age, mean (SD), years: 43 (9) in IG; 45 (10) in CG

Female: 71% in IG; 65% in CG

Level of disability: Mean (SD) Multiple Sclerosis Functional Composite (MSFC) score : 0.13 (0.6) in IG, -0.16 (0.7) in CG

Education, mean (SD), years: 13.4 (2.8) in IG; 13.6 (2.9) in CG

Inclusion criteria: MS diagnosis, living in community, high impact of fatigue (score ≥ 3 on the fatigue subscale of the Guy’s Neurological Disability Scale, Sharrack 1999), able to walk ≥ 100 m, no rehabilitation programme within the last two years, no energy management programme in the past, not under psychiatric treatment for depression

Exclusion criteria: Cognitive impairment defined as PASAT score adjusted for education lower than the 10th percentile (PASAT score of 35)

Interventions

Intervention group

Participation in "Multidisciplinary fatigue management programme (MFMP)".

Basis: Multiple Sclerosis Council for Clinical Practice Guidelines on management strategies for fatigue (MS Council for Clinical Practice Guidelines 1998).

Structure: "Each session started with information provided by the instructor, followed by an interactive part, in which participants discussed the strategies they used and planned in the near future." "The MFMP was instructed by four different therapists, who stimulated participants to try out the discussed strategies" (not more information on instructors provided).

Content: Information and interactive parts on pharmacological treatment, diet, informing and involving the social environment, regular sleep, exercise, relaxation, cooling, assistive devices, adaptation of home or work environment, and energy saving methods. "No structured homework was planned in the sessions."

Control group

"Placebo intervention" programme of same frequency and duration with topics "that were interesting enough to avoid dropouts and did not concern themes directly related to fatigue (ie, car adaptations and driving abilities, communication skills, lift techniques for back protection and general information about MS).

Outcomes

Primary outcome

Secondary outcomes

  • Fatigue severity: Fatigue Severity Scale (FSS; Krupp 1989) administered at baseline, 3 weeks and six months after the intervention

  • Self-efficacy: Multiple Sclerosis Self-Efficacy Scale (MSSE; Schwartz 1996) administered at baseline, 3 weeks and six months after the intervention

  • Perceived disease impact: Participation and Autonomy Scale (IPA; Cardol 1999) administered at baseline, 3 weeks and six months after the intervention

  • Depression, anxiety, behavioural control, positive affect: Mental Health Inventory (MHI; Ritvo 1997) administered at baseline, 3 weeks and six months after the intervention

Adverse events

  • Not assessed

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Matched pairs were composed [...]. The identity number of every subject was written down on a paper and put in an envelope together with the other pair member. An independent research assistant separated each pair and divided the individuals over two groups (group A or group B) by random draw."
Allocation concealment (selection bias)Unclear riskAlthough described as "random draw" between matched pairs, it remains unclear how this could result in different group sizes (IG n=28, CG n= 23)
Blinding of participants and personnel (performance bias)
All outcomes
High risk"Due to the nature of the intervention, blinding of participants was not possible."
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Group allocation was kept concealed for data analysis."
Incomplete outcome data (attrition bias)
All outcomes
High risk4 (14.3%) dropouts in the intervention group; 7 (30.4%) in the control group. Intention-to-treat analysis only for primary outcome (MFIS)
Selective reporting (reporting bias)Unclear riskNo protocol available
Other biasUnclear riskPossible contamination between groups

Köpke 2009

Methods

Randomised controlled trial

Study period: May 2003 to June 2004

Participants

Country: Germany
Location: two MS clinics located at a University Hospital (Hamburg) and a General Hospital (Osnabrück), and one neurologist’s practice (Herborn)

Number of participants: 150

Age, mean (SD), years: 37 (7) in IG; 39 (8) in CG

Female: 82% in IG; 73% in CG

Level of disability: Mean UNDS score (SD): 7.2 (5.9) in IG;  8.6 (6.4) in CG

Education: >11 years: 49% in IG;  58% in CG

Inclusion criteria: Physician-confirmed diagnosis of MS (self-reported) with at least one relapse during the past 12 months or at least two relapses during the past 24 months; No major cognitive deficit; Age ≥18

Exclusion criteria: "History of steroid sensitivity and/or pregnancy"

Interventions

Intervention group

  • Education program on relapse management

Basis: Protection motivation model (Rogers 1975; Boer 1996) applied to decisional autonomy. Curriculum based on the practical oriented approach of education (Meyer 1983).

Content: Structured 4-h education program. Topics included personal experiences, relapses, relapse therapy, oral corticosteroid therapy, relapse management options and reflection. Methods used were Power Point presentations, work sheets, individual and group work and guided discussions.

Structure: Ten participants with their partners or close relatives were invited per session. Two educators held the program: a nurse and a specially trained person with MS. At one centre (Herborn), the MS-practice nurse carried out the training alone. After the program, treating physicians of participants were sent a fax informing them about their patients’ inclusion in the study together with brief study information.

  • Educational booklet

Two weeks before the program, participants received a 40-page educational booklet summarising the evidence on relapses and relapse management, based on the principles of evidence-based patient information [Steckelberg 2005]. Not stated how the booklet was provided. On request, authors reported that it was sent by postal mail.

  • Corticosteroid prescription

Participants were offered a prescription of 30 tablets of 100 mg methylprednisolone given to participants after the program if requested.

Control group

CG participants received a 2-page standard information leaflet on relapse treatment including information about the option of oral corticosteroid therapy.

Outcomes

Primary outcome

Proportion of relapses with oral corticoid therapy or without corticoid therapy within 2 years of follow-up

Secondary outcomes

Time to initiation of corticosteroid treatment, location and invasiveness of corticoid treatment, and costs

Further outcomes comprised perceived decision autonomy, quality of life, and disability status assessed at baseline and at 2-year follow-up

Adverse events

Adverse events of corticosteroid treatment and of the overall intervention which included: changes in quality of life and disability status over two years

NotesAccuracy of primary endpoint unclear as self-reported by patients. Blinded neurologists rated relapses after follow-up from case report files
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Computer generated randomisation lists"
Allocation concealment (selection bias)Low risk"By external central telephone. Participants were stratified by study centre and drawn consecutively using three separate randomisation lists"
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and educators not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskAssessors were not blind to participants’ allocation. To minimise bias, assessment was carried out using standardised questionnaires. One author supervised assessors regularly
Incomplete outcome data (attrition bias)
All outcomes
Low risk6 (7.8%) dropouts in the intervention group; 7 (9.5%) in the control group
Selective reporting (reporting bias)Unclear riskThree secondary endpoints were not reported: time to initiation of corticoid treatment ("not able"), cost ("will be published separately", although not yet published) and protection motivation (not mentioned in the publication)
Other biasUnclear riskPossible contamination between groups; self-reporting of the MS relapses by participants; participants in the IG were older than in the CG (63 versus 53 years)

Köpke 2013

Methods

Randomised controlled trial

Study period: May 2009 to October 2010

Participants

Country: Germany
Location: 6 academic MS centres

Number of participants: 192

Age, mean (SD), years: 37 (10) in IG; 37 (10) in CG

Female: 74% in IG; 75% in CG

Mean UNDS score (SD): 4.1(3.9) in IG;  5.1 (4.7) in CG

Education: >11 years: 57% in IG; 47% in CG

Inclusion criteria: Self-reported confirmed or possible relapsing-remitting MS within the last two years; Age between 18 and 60

Exclusion criteria: Major cognitive deficit; Primary or secondary progressive MS

Interventions

Intervention group

  • Education program on diagnosis, prognosis, and early therapy.

Basis: The 4-hour program was based on preparatory work and pre-studies, and followed the MRC framework on complex interventions (Craig 2008) as well as principles of risk communication and evidence-based patient information (Bunge 2010).

Content: The curriculum followed the "theory of planned behavior" (Ajzen 1985). The programme comprised the presentation of knowledge on MS, on relevant aspects of clinical epidemiology (e.g. study designs of prognostic studies, measures of diagnostic accuracy etc.). The best available evidence regarding diagnostic testing in MS, prognosis of MS, and early MS DMD was presented using Power Point presentations, exercises, decision trees, group work and guided discussions.

Structure: Ten participants with their partners or close relatives were invited per session. The programme was led by one "non-medical" person from the study centre based on structured presentation materials and moderation cards.

  • Educational booklet.

Two weeks before the education programme, IG participants received a 57-page educational booklet containing relevant methodological information and information on the recent evidence on diagnosis, prognosis and early therapies in MS. Presentation followed the principles of evidence-based patient information (Bunge 2010).

Control group

  • MS-specific stress management programme.

Participants in the CG took part in a 4-hour MS-specific stress management programme led by a specially trained psychologist. The programme was based on an existing programme focusing on "patients’ experience with management of stress and anxieties", aiming to "enhance participants’ resources as well as stress coping strategies".

  • Standard information

Two weeks before the programme a 5-page information leaflet with information on diagnosis, prognosis, and early therapy as provided on the web site of the German MS society was sent to the participants.

Outcomes

Primary outcome

  • Informed choice using the “Multi-Dimensional Measure of Informed Choice” (MMIC, (Marteau 2001) assessed at 6-month follow-up

Secondary outcomes

  • Control beliefs using the German version of the Control Beliefs Questionnaire (Lohaus 1989; Otto 2011) assessed two weeks before the intervention and after 12 months

  • Autonomy preferences (using the CPS) assessed 2 weeks before, 2 weeks and 12 months after the intervention

  • Decision autonomy and satisfaction with the decision assessed during the 3 months preceding the telephone interviews at 3, 6, 9 and 12 months

  • Decisional conflict administering the German version of the Decisional Conflict Scale (Buchholz 2011) 2 weeks before the intervention and after 12 months

  • Anxiety and depression administering HADS before randomisation, 2 weeks and 12 months after the intervention

  • DMD status assessed before randomisation and at 3, 6, 9 and 12 months)

  • Disease related resource use assessed during the telephone interviews at three, six, nine, and 12 months

Adverse events

Disease progression and health-related quality of life

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Computer-generated randomisation lists."
Allocation concealment (selection bias)Low risk"Concealed allocation of participants by external central telephone."
Blinding of participants and personnel (performance bias)
All outcomes
Low risk"Participants were blinded to study groups as they were not informed about the 'active' intervention." Trainers could not be blinded, but "had no role in data assessment or management."
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Outcomes were assessed via blinded telephone calls and
mailed questionnaires."
Incomplete outcome data (attrition bias)
All outcomes
Low risk2 (2%) dropouts in the intervention group, 5 in the control group (5%)
Selective reporting (reporting bias)Low risk 
Other biasUnclear riskPossible contamination between groups

O´Hara 2002

Methods

Randomised controlled trial

Study period: June 1996 to February 1999

Participants

Country: UK, London
Location: Centre for Research and Rehabilitation at Brunel´s University Osterley Campus in West London

Number of participants: 183

Age, mean (SD), years, range: 52(11), 28–79 in IG; 50(10), 30–81 in CG

Female: 71% in IG, 68% in CG

Level of disability (%): Not reported

Education: At least secondary: 79% in IG; 78% in CG

Inclusion criteria: Diagnosis of MS confirmed by general practitioner

Exclusion criteria: None

Interventions

Intervention group

Basis: No theoretical basis mentioned. "Pragmatic approach" (O'Hara 2000) based on previous publications of patients' needs (Robinson 1996) and own pre-studies (O'Hara 2000).The self-care programme primarily comprised a discussion of self-care strategies supported by an information booklet developed for the study in line with consumer priorities (Robinson 1996).

Structure: Participants were contacted by telephone, by a health professional and an appointment was made to discuss individually self-care strategies and to introduce the information booklet. The health professional assigned patients to either group or one to one sessions. Sessions were conducted either at participants’ homes or in local therapy centres. The discussions lasted between 1 and 2 hours and were conducted on two occasions, over a one month period. The format of the discussions focused on "individuals’ interests and concerns rather than on covering all the information contained in the booklet".

Content: Topics in the booklet covered physical, social, and psychological (e.g. strategies to cope with stress) "domains of life".

Control group:

Patients were under the care of their family doctor (general practitioner), some were receiving advice or information from MS Society branches (or other charities) on how to deal with their MS. None of those entering the research study were receiving regular input from a health care practitioner (information provided by Dr. De Souza on request).

Outcomes

Primary endpoint

  • Mobility scale (De Souza 1999) assessed at baseline and follow-up

  • Standard Day Dependency Record (SDDR; Lawson 1985) administered at baseline and follow-up

  • SF-36 administered at baseline and follow-up

  • Barthel Index assessed at baseline and follow-up

Adverse events

Not assessed

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"An independent person not involved in the study randomised each participant using random number tables, with odd/even number allocation to intervention/control group, with random draw"
Allocation concealment (selection bias)Low risk"Each random number was written on paper and sealed in an opaque envelope prior to the start of the study. An independent person held the envelopes and had no contact with the assessors. The health professionals administering the intervention received the sealed envelopes from the independent person, in groups of ten, following the baseline assessments. Names of participants were written on the outside of the envelopes and then the envelopes were opened to reveal their assignment to control or intervention. Information concerning the intervention and the assessments were stored separately. The blind code was broken after the final follow-up assessments had occurred. Evidence for the success of the blinding was not gathered"
Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients not blinded, personnel unclear
Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo blinding of outcome assessment reported, but as self-administered questionnaires were used, outcome measurement was not likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias)
All outcomes
Low risk7 (8.7%) withdraw participation and were lost to follow-up in the intervention group; 7 (6.8%) withdraw participation and were lost to follow-up in the control group
Selective reporting (reporting bias)Unclear riskNo protocol available. Information provided by Dr. De Sousa on request: The protocol (PCD/A2/27) was held for the duration of the study until three years after by the NHS R&D committee and was available in the public domain. However, this repository is no longer active
Other biasUnclear risk

Probable selection bias due to recruitment via "voluntary group members".

Unexplained difference in number of participants between groups (diff. 23 although randomisation in blocks of 10)

Prunty 2008

Methods

Randomised controlled trial

Study period: March  to November 2005

Participants

Country: Australia
Location: Community-based women with MS in New South Wales and Victoria

Number of participants: 194

Age, mean (SD), years: 32 (4) in IG; 31 (6) in CG

Female: 100%

Level of disability: Not reported

Education: Not reported

Inclusion criteria: Women with MS; ages 20-40; currently undecided about motherhood; literate in English

Exclusion criteria: Not reported

Interventions

Intervention group

Printed decision aid (DA) called "Motherhood choice".

Basis: No theoretical basis given. Content and structure based on literature search and Ottawa Decision Support Framework and the C.R.E.D.I.B.L.E. criteria (Stacey 2011).

Content: General background information about MS; psychosocial impact of MS regarding parenting; effect of MS on fertility, pregnancy, labour, delivery, miscarriage, child-rearing, pregnancy, and course of MS; evidence about the safety of different medications during conception and pregnancy; MS in the post-natal period; breastfeeding; commonly asked questions, etc.

The DA included patient stories; options that women may consider; exercises to consider personal values.

Co-intervention: Patients in the IG were telephoned 2 weeks after receiving the DA to "ensure they had read and understood the DA, to answer questions and to screen for distress". Telephone conversations did not exceed 20 min.

Control group: There is no standard care in terms of information provided to patients with MS about having children. Patients receive information differently, from different health professionals, whether that be their neurologist, GP, support centre (e.g. MS Society), or by gathering information online. Some do not know to ask questions about this issue either, and the information received will vary based on where they have gotten it from and that person’s own bias (information provided by Dr. Prunty on request).

Outcomes

Primary outcomes

  • Knowledge assessed before and after the intervention

  • Decisional Conflict (O'Connor 1995) before and after the intervention

  • Decision self-efficacy (O'Connor 1995b) before and after the intervention

  • Decision Certainty before and after the intervention

Secondary outcomes

  • Depression (Center for epidemiologic studies depression scale, CESD [Radloff 1977]) and Anxiety (State-trait anxiety inventory, STAI) before and after the intervention

  • Direction of the decision ("balance") before and after the intervention

Adverse events

None reported.

NotesReported results for balance not interpretable
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Random numbers corresponding to intervention versus control were generated using the Excel Bernoulli function and linked to participant identification numbers."
Allocation concealment (selection bias)Low risk"[...] These numbers were linked to a series of consecutive participation numbers (1, 2, 3, 4, 5, etc) by an independent researcher (LS) who was not involved in the recruitment of patients. The randomisation numbers were concealed electronically (akin to opaque envelopes). Once participants had returned their assessment and their consent form, they were assigned the next available subject number; and then the allocation code was broken to determine which group they had been allocated to" (information provided by Dr Prunty on request)
Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and personnel obviously not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBlinding of outcome assessment not reported, but as self-administered questionnaires were used, outcome measurement was not likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias)
All outcomes
High risk27 (25.7%) drop-outs in the intervention group; 28 (31.4%) in the control group
Selective reporting (reporting bias)Unclear riskNo protocol found
Other biasUnclear riskProbable selection bias due to exclusive recruitment through MS societies

Shinto 2008

Methods

Randomised controlled trial

Study period: not reported

Participants

Country: USA, Portland (Oregon)
Location: MS Center of Oregon at Oregon Health & Science University

Number of participants: 45

Age, mean (SD), years: 43(9) in Education Group; 39(10) in Naturopathic Group; 46(8) in CG

Female: 86% in Education Group; 93% in Naturopathic; 81% in CG

Mean EDSS score (SD): 2.6 (1.2) in Education Group; 2.6 (1.1) in Naturopathic Group; 2.6 (1.2) in CG

Education: College diploma or degree: 50% in Education Group; 40% in Naturopathic Group; 64% in CG

Inclusion criteria: Definite MS (Poser criteria [Poser 1983]); relapsing–remitting course of MS; Expanded Disability Status Score (EDSS) ≤6

Exclusion criteria: Corticosteroids or relapse within 30 days of enrolment; "serious medical problems" (e.g., cancer, uncontrolled diabetes mellitus, congestive heart failure, severe psychiatric disorder); pregnancy; or "recent visits to a complementary and alternative medicine practitioner"

Interventions

Particpants were randomised to three groups:

Education sessions. (Note: This group was implemented as a “time and attention” control, the number of visits and time spent with the nurse matched the "active" naturopathic intervention.There was no overlap with the information provided in the naturopathic intervention).

Basis: No theoretical basis given.

Content: Educational pamphlets published by the National MS Society on fatigue; mood; cognitive problems; bowel and bladder problems; exercise; stress; nutrition; vitamins, minerals, and herbs.

Structure: Eight visits over a period of six months with a nurse that specialised in MS care plus usual care. At each visit, the participant received an educational pamphlet published by the National MS Society containing information about MS. The nurse instructed each participant that the intent of the session was to focus on the information contained within the pamphlets. If participants had questions about other aspects of their care, such as advice on medications, specific interventions for MS-related symptoms, or alternative therapies, the nurse instructed the subjects to contact their physicians for answers to these types of questions.

Naturopathic intervention. (Note: This group was the "active" intervention to be assessed by this study).

Basis: No theoretical basis given. Pre-study applying a survey and a delphi panel to determine "the best naturopathic treatment model" (Shinto 2004)

Structure: Eight visits with a naturopath over a period of six months following plus usual care.

Content: The naturopathic intervention included oral dietary supplement, intramuscular vitamin B12 once a week based on four diet levels. Four-day "Diet Recall" documentation were completed prior to each visit to the naturopath.

Control group: Usual care (no description given). Participants in all arms were allowed to continue their conventional treatment for MS, including disease-modifying therapies and prescription symptomatic therapy.

Outcomes

Primary outcome

  • Quality of life (SF-36) assessed at baseline and 6-month follow-up

Secondary outcomes

  • Fatigue (Modified Fatigue Impact Scale [Fisk 1994]) assessed at baseline and 6-month follow-up

  • Depression (Beck Depression Inventory [Beck 1961]) assessed at baseline and 6-month follow-up

  • Cognition (Stroop test [Perret 1974] and Paced Auditory Serial Addition Test [PASAT]-3 [Gronwall 1977]) assessed at baseline and 6-month follow-up

  • Neurologic impairment (EDSS plus Multiple Sclerosis Functional Composite [MSFC, Rudick 2002]) assessed at baseline and 6-month follow-up

Adverse events

Safety was measured by "comprehensive metabolic panel, complete blood count with differential, and adverse event reports." Unclear if assessed for all participants

NotesFor this review, only the education and the control group will be considered
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated randomisation schedule (information provided by Dr Shinto on request)
Allocation concealment (selection bias)Low riskAllocation by external centre after inclusion of patients (information provided by Dr Shinto on request)
Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and personnel not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Patients were instructed not to disclose their treatment intervention to the neurologists and research assistants performing end-of-study assessments." An evaluation at the end of the study suggested successful blinding (93%)
Incomplete outcome data (attrition bias)
All outcomes
Low riskNone dropout both in the intervention and control group
Selective reporting (reporting bias)Unclear riskNo protocol or further information other than in the publication (information provided by Dr Shinto on request)
Other biasUnclear riskPossible contamination between groups

Solari 2010

Methods

Randomised controlled trial

Study period March 2008 to June 2009

Participants

Country: Italy

Location: Five Italian tertiary MS care centres

Number of participants: 120

Age, mean (SD), years, range: 34(9), 17–60 in IG; 36(9), 22–56 in CG

Female: 73.3% in IG; 63.3% in CG

Median EDSS score (range): 2 (0–5) in IG; 2 (0–6) in CG

Education: College diploma or degree: 13.3% in IG; 25.0% in CG

Inclusion criteria: All patients aged 18 years or above referred for possible MS diagnosis

Exclusion criteria: "Prior MS diagnosis disclosure, overt cognitive impairment, history of overt psychiatric disease, and substance abuse".

Interventions

Intervention group

The study intervention consisted of a personal interview with a physician using a navigable CD, and presentation of a take-home booklet at the end of the interview.

Basis

No theoretical basis given. On request authors reported that they followed the MRC framework on complex interventions (Craig 2008). Content and structure based on "comprehensive literature review" and pre-study ("focus groups with patients and clinicians") (Solari 2007) The CD and booklet were developed in Italian by a multidisciplinary panel through an iterative process of review and revision in collaboration with patients with MS."

Structure

The interview was scheduled 1–15 days after diagnosis disclosure (mean time between disclosure and interview 11.6 days (SD 7.3)). Patients' significant other were also invited if requested by the patient. The interviewing physician (not the person who communicated the diagnosis or followed the patient) was a neurologist or trainee neurologist experienced in MS. Five physicians (one at each centre) were trained during one day in the personal interview and CD navigation. Physician and patient went through the topics of the CD guided by patient preferences. Topics raised by the patient were discussed. "At the end of the interview the interviewing physician completed an interview report which was included in the patient case report form."

Content

CD: The CD has 8 sections: MS basics, diagnosis, time after diagnosis, therapies, emotions, having a child, FAQs, and glossary. The CD contains animations, visual aids and a background comment, explaining the text and illustrations. The Emotions section contains a link to an 8-minute movie.

Interview: see above.

Booklet: The 90-page take-home booklet had eight chapters, a glossary (36 pages), and a section for patient notes with the first seven chapters matching the CD sections in title and content. Chapter eight reports findings of a preliminary study. Selected references/links are given at the end of each chapter.

Control group: Usual practice (no description given).

Outcomes

Primary outcome

  • Composite of disease knowledge (MS Knowledge Questionnaire, MSKQ [Giordano 2010]) and satisfaction with care (section 2 of COSM-R (Comunicazione medico-paziente nella Sclerosi Multipla, revised version, Solari 2010b) assessed at 1-month postal follow-up and six-month follow-up

Secondary outcomes

  • MSKQ assessed at 1-month postal follow-up and six-month follow-up

  • COSM-R section 2 assessed at 1-month postal follow-up and six-month follow-up

  • HADS assessed at baseline, 1-month postal follow-up and six-month follow-up

  • CPS assessed at baseline and six-month follow-up

  • Physician consultations (over six months)

  • Disease-modifying therapies 8over six months)

  • Switching care centre (over six months)

Serious adverse events ("monitored by an Independent Data and Safety Monitoring Committee")

  • Admission to psychiatric ward

  • Suicide attempt

  • Death

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Allocation sequences (1:1 ratio) were computer-generated in permuted blocks of four, stratified by centre."
Allocation concealment (selection bias)Low riskAt baseline, after MS diagnosis disclosure, the investigator faxed patient eligibility characteristics to the randomisation unit. The allocation was faxed back to the investigator who informed the patient, who also received a contact diary
Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and personnel not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBlinding of outcome assessment not reported, but as self-administered questionnaires were used, outcome measurement was not likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias)
All outcomes
Low risk5 (8.4%) dropouts in the intervention group; 3 (5%) in the control group
Selective reporting (reporting bias)Low risk"Switching care centre" not included in the study registration
Other biasUnclear riskPossible contamination between groups

Young 1986

  1. a

    CG, Control Group

    CPS, Control Preference Scale

    EDSS, Expanded Disability Status Scale

    HADS, Hospital Anxiety and Depression Scale

    IG, Intervention Group

    MS, Multiple Sclerosis

    SF-36, 36-Item Short Form Health Survey

    UNDS, United Kingdom Disability Scale

Methods

Randomised controlled trial

Study period: not reported

Participants

Country: USA; Baltimore (Maryland)
Location:Johns Hopkins University Hospital, Baltimore

Number of participants: 18 participants were enrolled, but it is unclear how many were randomised

Age, mean (SD), years, range: 39 (8), 28-52 in IG, 39 (7), 28-50 in CG

Female: 75% in IG, 62.5% in CG

Level of disability: not reported

Education: not reported

Inclusion criteria: MS patients beginning steroid therapy

Exclusion criteria: not reported

Interventions

Intervention group

  • physician and nurse led oral presentation

  • patient information booklet

Basis: No information provided on theoretical background. Intervention based on clinical experience.

Structure: No information given, training of educators not reported.

Content: Information on methylprednisolone (drug action, usage, side effects, danger signs).

Control group

Physician and nurse led oral presentation

Co-interventions:

Review of correct answers after baseline test.

Methylprednisolone prescribed at 2 mg/kg and given on alternate days.

Outcomes

Primary outcome

  • Knowledge on steroid therapy assessed before and after the intervention

Secondary outcome

  • Compliance

Adverse events

  • Not mentioned

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Randomization was done per patient via coin flip program on an computer" (information provided by Dr Brooks on request)
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskInformation provided by Dr Brooks on request: Patients were given information booklet per randomisation above after the pre-test.

Pre-test done by Nurse Specialist or Nurse Assistant post discussion by MD with patient.

At one month clinic visit, due to the business of the clinic, the staff were assumed to not know who had information booklet and who did not
Blinding of outcome assessment (detection bias)
All outcomes
Low riskInformation provided by Dr Brooks on request: Post-test was part of intake during triage before full chart review for that encounter. Pre-test and post-test were completed by each patient without RN or Nurse Assistant input
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskUnclear how many patients were randomised, results for 18 patients given
Selective reporting (reporting bias)Unclear riskNo protocol found
Other biasUnclear riskPossible contamination between groups

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
  1. a

    ,

Berger 2005Not primarily information provision, but counselling
Bombardier 2008Information provision only optional
Bombardier 2013Information provision only optional
Burgess 2012Patients with Chronic Fatigue Syndrome, not MS
Christopherson 2006Information provision only optional
Cosio 2011Not information provision
Dlugonski 2012Not primarily information provision
Finlayson 2011Not information provision
Forman 2010Not primarily information provision
Garber 2002Only 2 patients of 41 with multiple sclerosis, no separate data for participants with multiple sclerosis available
Ghahari 2010Only 78% of participants with multiple sclerosis, no separate data for participants with multiple sclerosis available
Hill 2012No randomised-controlled trial
Mattioli 2012Not primarily information provision
McAuley 2007Not primarily information provision, but advice
McClurg 2011Main intervention abdominal massage, both groups received "advice"
Miller 2011Only information about individual disease status and appointment planning
Moss-Morris 2012Not primarily information provision
Möller 2010Not primarily information provision
Rigby 2008Not primarily information provision
Ward 2004Only 40% of participants with multiple sclerosis, no separate data for participants with multiple sclerosis available
Wassem 2003Information provision only optional

Characteristics of studies awaiting assessment [ordered by study ID]

Rotstein 2012

Methods

Randomised controlled trial

Study period: not reported

ParticipantsCountry: Canada; Toronto
Location: St. Michael's Hospital, Toronto
Interventions"Physician-designed video" on Chronic Cerebrospinal Venous Insufficiency (CCSVI) or Canadian television documentary video on CCSVI
Outcomes

Primary outcome: "Desire for CCSVI surgery" assessed with a questionnaire before and after watching the videos

Secondary outcomes unclear

NotesOnly published as conference abstract

Ancillary