Patient education in the management of coronary heart disease

Lindsey Anderson; James PR Brown; Alexander M Clark; Hasnain Dalal; Henriette Knold K Rossau; Charlene Bridges; Rod S Taylor

doi:10.1002/14651858.CD008895.pub3

Educación del paciente en el tratamiento de la cardiopatía coronaria

Declaraciones de intereses de los autores

Versión publicada: 28 junio 2017 Historial de versiones

https://doi.org/10.1002/14651858.CD008895.pub3

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Resumen

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Antecedentes

La cardiopatía coronaria (CC) es la causa única más frecuente de muerte a nivel mundial. Sin embargo, con la disminución de las tasas de mortalidad por CC, un número cada vez mayor de pacientes vive con esta afección y pueden necesitar apoyo para controlar sus síntomas y mejorar su pronóstico. La rehabilitación cardíaca es una intervención compleja y multifacética que tiene como objetivo mejorar los resultados de salud de las personas con CC. La rehabilitación cardíaca consiste en tres modalidades básicas: educación, entrenamiento con ejercicios y apoyo psicológico. Esta es una actualización de una revisión sistemática Cochrane publicada anteriormente en 2011, que tiene como objeto investigar el impacto específico del componente educativo de la rehabilitación cardíaca.

Objetivos

1. Evaluar los efectos de la educación del paciente comparada con la atención habitual sobre la mortalidad, la morbilidad, la calidad de vida relacionada con la salud (CdVRS) y los costos de la asistencia sanitaria en pacientes con CC.

2. Explorar a nivel de estudio las variables predictivas de los efectos de la educación del paciente en los pacientes con cardiopatía coronaria (p.ej., intervención individual versus grupal, momento con respecto al evento cardíaco índice).

Métodos de búsqueda

Se actualizaron las búsquedas de la revisión Cochrane anterior, mediante la búsqueda en el Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials) (CENTRAL) (Cochrane Library, número 6, 2016), MEDLINE (Ovidio), Embase (Ovidio), PsycINFO (Ovidio) y CINAHL (EBSCO) en junio de 2016. También se hicieron búsquedas en tres registros de ensayos, revisiones sistemáticas anteriores y en las listas de referencias de los estudios incluidos. No se aplicaron restricciones de idioma.

Criterios de selección

1. Ensayos controlados aleatorizados (ECA) en los que el principal objetivo de la intervención fue la educación impartida como parte de la rehabilitación cardíaca.

2. Estudios con un mínimo de seis meses de seguimiento y publicados en 1990 o más tarde.

3. Adultos con diagnóstico de cardiopatía coronaria.

Obtención y análisis de los datos

Dos autores de la revisión examinaron de forma independiente todas las referencias identificadas para su inclusión, sobre la base de criterios de inclusión anteriores. Un autor extrajo las características del estudio de los ensayos incluidos y evaluó su riesgo de sesgo; un segundo autor de la revisión verificó los datos. Dos autores de la revisión independientes extrajeron los datos de los resultados en un formulario de recopilación estandarizado. Para las variables dicotómicas, se calcularon los cocientes de riesgos (CR) y los intervalos de confianza (IC) del 95% para cada resultado. Se exploró la heterogeneidad entre los estudios incluidos, tanto cualitativa como cuantitativamente. Cuando fue apropiado y posible, los resultados de los estudios incluidos se combinaron en cada resultado para dar una estimación global del efecto del tratamiento. Dado el grado de heterogeneidad clínica que se observó en la selección de los participantes, las intervenciones y los comparadores entre los estudios, se decidió que era apropiado agrupar los estudios utilizando modelos de efectos aleatorios. Se planeó realizar análisis de subgrupos y metanálisis estratificado, análisis de sensibilidad y metarregresión para examinar los modificadores potenciales del efecto del tratamiento. Se utilizó el enfoque de Clasificación de Recomendaciones, Desarrollo y Evaluación (GRADE) para evaluar la calidad de las pruebas y el perfilador GRADE (GRADEpro GDT) para crear tablas de resumen de conclusiones.

Resultados principales

Esta revisión actualizada incluyó un total de 22 ensayos que asignaron al azar a 76 864 personas con cardiopatía coronaria a una intervención educativa o a un comparador de "ninguna educación". Se incluyeron nueve nuevos ensayos (8215 personas) para esta actualización. Se consideró que la mayoría de estudios incluidos tuvieron bajo riesgo de sesgo en la mayoría de los dominios. La "dosis" educacional varió desde una sesión de 40 minutos más una llamada de seguimiento de 15 minutos, hasta una estancia de cuatro semanas en una residencia con sesiones de seguimiento de 11 meses. Los grupos de control recibían la atención médica habitual, que consistía normalmente en la remisión a un cardiólogo ambulatorio, a un médico de atención primaria o a ambos.

No se encontraron diferencias en el efecto de las intervenciones basadas en la educación sobre la mortalidad total (13 estudios, 10 075 participantes; 189/5187 (3,6%) versus 222/4888 (4,6%); riesgo relativo (RR) de efectos aleatorios 0,80, IC del 95%: 0,60 a 1,05; evidencia de calidad moderada). Rara vez se comunicaron las causas individuales de mortalidad, y no se pudo comunicar resultados separados para la mortalidad cardiovascular o la no cardiovascular. No hubo evidencia de una diferencia en el efecto de las intervenciones basadas en la educación sobre el infarto de miocardio (IM) mortal o no mortal (2 estudios, 209 participantes; 7/107 (6,5%) versus 12/102 (11,8%); efectos aleatorios RR 0,63, IC del 95%: 0,26 a 1,48; evidencia de muy baja calidad). Sin embargo, hubo alguna evidencia de una reducción con la educación en los eventos cardiovasculares mortales y/o no mortales (2 estudios, 310 estudios; 21/152 (13,8%) versus 61/158 (38,6%); efectos aleatorios RR 0,36, IC del 95%: 0,23 a 0,56; evidencia de baja calidad). No hubo evidencia de una diferencia en el efecto de la educación sobre la tasa de revascularizaciones totales (3 estudios, 456 participantes; 5/228 (2,2%) versus 8/228 (3,5%); efectos aleatorios RR 0,58, IC del 95%: 0,19 a 1,71; evidencia de muy baja calidad) u hospitalizaciones (5 estudios, 14 849 participantes; 656/10048 (6,5%) versus 381/4801 (7,9%); efectos aleatorios RR 0,93, IC del 95%: 0,71 a 1,21; evidencia de muy baja calidad). No hubo evidencia de una diferencia entre los grupos para el síndrome de abstinencia por todas las causas (17 estudios, 10 972 participantes; 525/5632 (9,3%) versus 493/5340 (9,2%); efectos aleatorios RR 1,04, IC del 95%: 0,88 a 1,22; evidencia de baja calidad). Aunque algunas puntuaciones en el dominio de la calidad de vida relacionada con la salud (CVRS) fueron más altas con la educación, no hubo evidencia consistente de superioridad en todos los dominios.

Conclusiones de los autores

No se encontró ninguna reducción de la mortalidad total, en las personas que recibieron educación impartida como parte de la rehabilitación cardíaca, en comparación con las personas de los grupos de control (evidencia de calidad moderada). No hubo mejoras en los infartos de miocardio mortales o no mortales, revascularizaciones totales u hospitalizaciones, con educación. Hubo alguna evidencia de una reducción de los eventos cardiovasculares mortales o no mortales con la educación, pero esto se basó sólo en dos estudios. También hubo alguna evidencia que sugieren que las intervenciones basadas en la educación pueden mejorar la calidad de vida de los seres humanos. Nuestros hallazgos apoyan las actuales directrices clínicas nacionales e internacionales de que la rehabilitación cardíaca para las personas con CC debe ser integral e incluir intervenciones educativas junto con ejercicios y terapia psicológica. Se necesita más investigación definitiva sobre las intervenciones educativas para personas con CC.

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Resumen en términos sencillos

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Educación para personas con enfermedades coronarias

Pregunta de la revisión

¿Cuáles son los efectos de la educación del paciente administrada como parte de la rehabilitación cardíaca, comparada con la atención habitual sobre la mortalidad, la morbilidad, la calidad de vida relacionada con la salud (CdVRS) y los costos de la asistencia sanitaria en pacientes con cardiopatía coronaria (CC)?

Antecedentes

La cardiopatía coronaria (CC) es la causa única más frecuente de muerte a nivel mundial. Sin embargo, ahora viven más personas con CC y pueden necesitar apoyo para controlar sus síntomas y reducir el riesgo de problemas futuros, como los ataques cardíacos. La educación es un elemento común de la rehabilitación cardíaca, que tiene por objeto mejorar la salud y los resultados de las personas con enfermedades cardíacas. Esta es una actualización de una revisión publicada por última vez en 2011.

Fecha de la búsqueda

Se hicieron búsquedas hasta junio de 2016.

Características de los estudios

Se buscaron en la literatura científica los ensayos controlados aleatorizados (experimentos en los que se asignan al azar a los participantes a uno de dos o más grupos de tratamiento) que examinaron la efectividad de los tratamientos con educación, en comparación con la ausencia de educación, en pacientes de todas las edades con CC.

Se incluyeron nueve nuevos ensayos que implicaron a 8215 personas con enfermedad coronaria que compararon la educación del paciente con la ausencia de educación. Se incluyó un total de 22 ensayos que estudiaron a 76.864 personas con enfermedades cardíacas, la mayoría de las cuales habían sobrevivido a un ataque cardíaco y se habían sometido a una cirugía de derivación cardíaca o angioplastia (un procedimiento que abre los vasos bloqueados que suministran sangre al músculo cardíaco).

Fuentes de financiación de los estudios

Dieciséis estudios informaron sobre fuentes de financiación; seis no informaron sobre fuentes de financiación. Un estudio fue financiado por un patrocinador industrial, cuatro por compañías de seguros de salud y 11 por fuentes gubernamentales o públicas.

Resultados clave

Los resultados de esta actualización son similares a los de la última versión de revisión (2011). La educación de los pacientes, como parte de un programa de rehabilitación cardíaca, no contribuye a reducir el número de muertes, de nuevos ataques cardíacos, de derivaciones cardíacas ni de angioplastias, ni de ingreso en un hospital por problemas relacionados con el corazón. Hay alguna evidencia de que con las intervenciones basadas en la educación se producen menos eventos relacionados con el corazón y se mejora la calidad de vida relacionada con la salud. No se comunicaron las causas de muerte individuales, por lo que no se pudo determinar cuántas personas de los estudios murieron por causas relacionadas con el corazón u otras causas de muerte.

Aunque en la actualidad no hay información suficiente para comprender plenamente los beneficios o los daños de la educación de los pacientes para las personas con enfermedades cardíacas, estos hallazgos apoyan ampliamente las guías actuales de que los pacientes con cardiopatía deben recibir rehabilitación integral que incluya educación. Se necesitan estudios de investigación adicionales para evaluar las formas más eficaces clínicamente y con respecto al coste de proporcionar una educación a personas con cardiopatía.

Calidad de la evidencia
En general, la evidencia se evaluó como de calidad muy baja a moderada.

Authors' conclusions

Implications for practice

Our findings provide limited evidence in support of the use of educational interventions for people with coronary heart disease (CHD). Given the uncertainty of the evidence of effect and the moderate (at best) quality of evidence for all outcomes, educational interventions for people with CHD should only be considered as part of a comprehensive programme that includes exercise and psychological support. This is in accordance with current evidence and international guidelines for secondary prevention and cardiac rehabilitation (Anderson 2016; BACPR 2012; Balady 2007; NICE 2007; NICE 2013; Richards 2017).

Implications for research

Given the heterogeneity in educational interventions seen in the included studies, this review reflects current uncertainty about the optimal approach of offering education to people with CHD. Further studies with longer durations and follow‐up periods are needed to compare the content and intent of individual educational interventions and their relative impact on reducing risk factors, changing patient behaviour and preventing unnecessary hospital re‐admissions and emergency department visits by people with CHD. Studies also need to assess the relative costs and benefits of different methods and approaches of delivering the educational content by comparing group versus individual delivery, face‐to‐face versus self help manuals, as well as exploring new technologies for delivering educational content. Studies should also include under‐represented groups (e.g. people aged over 65 years, ethnic minorities or people from lower socio‐economic settings) to increase the generalisability of outcomes to the wider population of people with CHD.

Research methods should not only be well designed, but also include a parallel qualitative process evaluation to assess fidelity and quality of delivery and to better understand patients' expectations and needs. Such studies should be conducted in the context of a multi‐interventional approach to secondary prevention and rehabilitation and report sufficient information to enable replication of the interventional approach.

Improved reporting, including participant characteristics (e.g. diagnoses), and the content, dose and mode of delivery of educational intervention, is needed. This would enable future reviews to stratify outcomes according to the range of CHD populations or types of cardiac rehabilitation interventions to help better understand the optimal approach for delivering education to these patient groups.

Summary of findings

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Summary of findings 1. Patient education for the management of coronary heart disease

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
Patient education for the management of coronary heart disease
Patient or population: patients with coronary heart disease Settings: Centre or home‐based Intervention: Patient education
	Assumed risk	Corresponding risk
	Control	Patient education
Total mortality at the end of the follow‐up period No of deaths Follow‐up: median 18 months	Study population		RR 0.80 (0.60 to 1.05)	10075 (13 studies)	⊕⊕⊕⊝ Moderate¹
	46 per 1000	37 per 1000 (28 to 48)
	Moderate population
	43 per 1000	34 per 1000 (26 to 45)
Fatal and/or non‐fatal MI at the end of the follow up period Follow‐up: median 33 months	Study population		RR 0.63 (0.26 to 1.48)	209 (2 studies)	⊕⊝⊝⊝ very low² ³ ⁴
	118 per 1000	74 per 1000 (31 to 174)
	Moderate population
	106 per 1000	67 per 1000 (28 to 157)
Other fatal and/or non‐fatal cardiovascular events Follow‐up: median 21 months	Study population		RR 0.36 (0.23 to 0.56)	310 (2 studies)	⊕⊕⊝⊝ low² ⁴
	386 per 1000	139 per 1000 (89 to 216)
	Moderate population
	324 per 1000	117 per 1000 (75 to 181)
Total revascularisations (including CABG and PCI) Follow‐up: median 36 months	Study population		RR 0.58 (0.19 to 1.71)	456 (3 studies)	⊕⊝⊝⊝ verylow² ³ ⁴
	35 per 1000	20 per 1000 (7 to 60)
	Moderate population
	33 per 1000	19 per 1000 (6 to 56)
Hospitalisations (cardiac‐related)at end of follow up period Follow‐up: median 12 months	Study population		RR 0.93 (0.71 to 1.21)	14849 (5 studies)	⊕⊝⊝⊝ very low¹ ² ⁵
	79 per 1000	74 per 1000 (56 to 96)
	Moderate population
	141 per 1000	131 per 1000 (100 to 171)
All cause withdrawal at follow‐up Follow‐up: median 12 months	Study population		RR 1.04 (0.88 to 1.22)	10972 (17 studies)	⊕⊕⊝⊝ low² ⁶ ⁷
	92 per 1000	96 per 1000 (81 to 113)
	Moderate population
	70 per 1000	73 per 1000 (62 to 85)
HRQoL Various HRQoL measures Follow‐up: median 12 months	Not measurable	Not measurable	Not measurable	4393 (13 studies)	⊕⊕⊕⊝ moderate²	HRQoL in intervention > HRQoL in comparator, in then 9/99 domains

¹ 95% CIs include both no effect and appreciable benefit (i.e. CI < 0.75) ² Blinding of outcome assessors was poorly described in over 50% of included studies; bias likely ³ 95% CIs include both no effect, appreciate benefit and appreciable harm (i.e. CI < 0.75 and > 1.25) ⁴ The point estimate is likely to be imprecise due to very low event rates ⁵ I² > 40%; heterogeneity may be important ⁶ 95% CIs include both no effect and appreciate harm (i.e. CI > 1.25) ⁷ Evidence of funnel plot asymmetry therefore publication bias likely

Background

Description of the condition

Coronary heart disease (CHD) is the largest cause of death globally. In 2105, an estimated 8,8 million people died from CHD worldwide (WHO 2017). In the United Kingdom (UK), an estimated 2.3 million people live with CHD, and in 2014, the condition accounted for around 69,000 deaths (15% of male deaths and 10% of female deaths), and 3.4% of all inpatient episodes in men and 1.4% in women (BHF 2015). Most cardiovascular diseases can be prevented by addressing behavioural risk factors such as smoking, unhealthy diet and obesity, physical inactivity and harmful use of alcohol. Indeed, through early detection strategies, advanced medical treatment, lifestyle changes and risk factor reductions, UK age‐standardised CHD death rates declined by 73% for all ages, and 81% for those dying before the age of 75, between 1974 and 2013 (BHF 2015). Nonetheless, with falling CHD mortality rates, an increasing number of people live with CHD and may need support to manage their symptoms and improve prognosis.

Description of the intervention

Based on evidence from previous meta‐analyses and systematic reviews, exercise‐based cardiac rehabilitation following a cardiac event is a Class I recommendation from the American College of Cardiology/American Heart Association (Balady 2011; Kulik 2015) and the European Society of Cardiology (ESC 2012; ESC 2016; Smith 2011). Many definitions of cardiac rehabilitation have been proposed. The following definition encompasses the key concepts of cardiac rehabilitation: “The coordinated sum of activities required to influence favourably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions, so that the patients may, by their own efforts, preserve or resume optimal functioning in their community and through improved health behaviour, slow or reverse progression of disease” (BACPR 2012). Cardiac rehabilitation is a complex intervention that may involve a variety of therapies, including exercise, risk factor education, behaviour change, psychological support, and strategies that are aimed at targeting traditional risk factors for cardiovascular disease. Cardiac rehabilitation is an essential part of contemporary heart disease care and is considered a priority in countries with a high prevalence of CHD.

Patient education is defined as "the process by which health professionals and others impart information to patients that will alter their health behaviours or improve their health status" (Koongstvedt 2001). Self‐management education programmes are designed to allow people with chronic conditions to take an active part in managing their own condition (Foster 2007). They are complex behavioural interventions which target patient education and promote self‐care behaviour and risk‐factor modification and aim to improve health outcomes and decrease the incidence of complications for patients by supporting, not replacing, medical care (Walker 2003). This in turn may lead to reduced hospitalisations and medical appointments and an associated reduction in costs, both to the patient and the healthcare system (Ferri 2007). Educational interventions within cardiac care increase patients’ knowledge and facilitate behaviour change (Ghisi 2014). Educational interventions in cardiac care have been shown to increase physical activity, and lead to healthier dietary habits and smoking cessation, although any related improvement in response to cardiac symptoms, medication compliance or psychosocial well‐being is more equivocal (Ghisi 2014).

The delivery of patient education programmes can vary substantially, and may be classroom‐ or home‐based, group or individual, tailored or generic. Common topics include nutrition, exercise, risk factor modification, psychosocial well‐being, and medications (Ghisi 2014). Duration, frequency and ongoing maintenance or re‐inforcement also varies between programmes. Some programmes are developed according to validated educational theory and by trained professionals who are part of an interdisciplinary team, whilst others are delivered by peers. Some programmes may use adjunctive written materials or videotapes that supplement clinical consultations, while Internet‐ and mobile phone‐based applications may be used to deliver educational material and messages to patients (Neubeck 2009). Telephone follow‐up is increasingly used by healthcare providers to reach patients more frequently and in their own environment without the burden of a clinic visit (Phillips 2014).

Both the American College of Cardiology/American Heart Association and the European Society of Cardiology recognise education as an important component of comprehensive cardiac rehabilitation programmes and give a Class I recommendation that patients with non‐ST‐elevation acute coronary syndromes (ACS) and individuals with very high cardiovascular disease risk, should be educated about appropriate cholesterol management, blood pressure, smoking cessation, and lifestyle management (Amsterdam 2014; ESC 2016; Perk 2012). Exercise and psychological interventions are the subject of recent Cochrane systematic review updates (Anderson 2016; Richards 2017). Whilst these reviews have considered trials that have included education as a co‐intervention, this review update specifically focuses on the impact of the educational component of cardiac rehabilitation for patients with CHD.

Why it is important to do this review

Two meta‐analyses of education for people with CHD were published in the 1990s (Dusseldorp 1999; Mullen 1992). Mullen 1992 demonstrated a significant reduction in mortality associated with patient education (weighted average effect size 0.24 standard deviation units, 95% CI 0.14 to 0.33), which translated into a 19% improvement in mortality. The average effects for morbidity (re‐infarction and re‐hospitalisation) were not found to be significant. However, one randomised controlled trial (RCT) was excluded from analysis because it was an outlier as it demonstrated a large positive effect size (Rahe 1979). Dusseldorp 1999 investigated the co‐interventions of health education and stress management and concluded that these programmes yielded a mean reduction of 34% in cardiac mortality and a 29% reduction in re‐infarction. A Cochrane Review was subsequently published in 2011 which identified 13 RCTs randomising a total of 68,556 participants (Brown 2011). Brown 2011 incorporated new evidence and addressed concerns relating to the generalisability of the results of the two earlier meta‐analyses to the wider CHD population, and their applicability to policy formation, improved medical treatment of people with CHD, and the changing provision of cardiac rehabilitation services. Brown 2011 did not find evidence that education reduced total mortality, cardiac morbidity, revascularisation or hospitalisation compared to control, while there was some evidence to suggest that education may improve health‐related quality of life (HRQoL) and reduce overall healthcare costs. A more recent systematic review investigated the impact of education on patients’ knowledge and health behaviour change in people with CHD (Ghisi 2014), but to our knowledge, there have been no other recent meta‐analyses which have updated the evidence on the effect of education delivered as part of cardiac rehabilitation, on mortality, morbidity and HRQoL in this population.

The American College of Cardiology/American Heart Association and the European Society of Cardiology recognise education as an important component of comprehensive cardiac rehabilitation programmes and give a Class I recommendation that people with non‐ST‐elevation ACS and those with very high cardiovascular disease risk should be educated about appropriate cholesterol management, blood pressure, smoking cessation, and lifestyle management (Amsterdam 2014; ESC 2016; Perk 2012).

This update aimed to use additional RCT evidence published since the 2011 Cochrane Review to re‐assess the effectiveness of education compared with usual care on mortality, risk of hospital admission, myocardial infarction, revascularisation, HRQoL and healthcare costs in people with CHD.

Objectives

To assess the effects of patient education delivered as part of cardiac rehabilitation, compared with usual care on mortality, morbidity, health‐related quality of life (HRQoL) and healthcare costs in patients with CHD.
To explore the potential study level predictors of the effects of patient education in patients with CHD (e.g. individual versus group intervention, timing with respect to index cardiac event).

Methods

Criteria for considering studies for this review

Types of studies

To reflect contemporary coronary heart disease (CHD) practice we included randomised controlled trials (RCTs) published after 1990.

Types of participants

We included studies where participants were adults (aged ≥ 18 years):

who had experienced a myocardial infarction (MI);
who underwent revascularisation (coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) or coronary artery stenting); or
who had angina pectoris or CHD defined by angiography.

We excluded studies of education programmes which included participants who:

had received heart valve surgery;
suffered from heart failure;
were heart transplantation recipients;
were implanted with cardiac‐resynchronisation therapy; or
were implanted with defibrillators.

Types of interventions

We identified RCTs where patient education was the primary intention of the cardiac rehabilitation intervention with a follow‐up period of at least six months. We excluded studies of cardiac rehabilitation where exercise or psychological intervention were the primary focus for investigation. These latter components of cardiac rehabilitation have been investigated in recently updated Cochrane Reviews of exercise‐based cardiac rehabilitation (Anderson 2016) and psychological cardiac rehabilitation interventions for people with CHD (Richards 2017).

For the purposes of this review, patient education was defined as the following:

instructional activities organised in a systematic way involving personal direct contact between a health professional and CHD patients with or without significant others: e.g. spouse, family member;
delivered as an inpatient, or outpatient in a community‐based intervention setting or programme;
included some form of structured knowledge transfer about CHD, its causes, treatments or methods of secondary prevention; and
delivered in a face‐to‐face format, in groups or on a one‐to‐one basis. We also included alternative interactive methods of educational delivery such as 'telehealth' (telephone, e‐mail, Internet and teleconference between educator and patient).

We included only study interventions that met all the above criteria.

We excluded general information provision, which is not organised in a systematic way (e.g. written guidance given to a patient on leaving the cardiac care unit or personal communication with a healthcare provider), which was considered to be usual care.

Given the multifaceted nature of cardiac rehabilitation we excluded studies where exercise and psychological therapies, or both, were provided and patient education was not stated to be a primary intervention.

We particularly sought studies designed to assess the independent effect of education (e.g. patient education plus usual care versus usual care alone; patient education, usual care and exercise versus usual care and exercise alone; patient education, usual care and psychological intervention versus usual care and psychological intervention alone).

Types of outcome measures

The aim of the review was to include studies that reported event data (e.g. mortality, cardiovascular events). We excluded studies that only measured alternative outcomes such as changes in smoking, diet, blood pressure or effect of education on patient knowledge. We elected not to include these alternative surrogate outcomes because we considered event rates to be more significant.

Primary outcomes

Total mortality.
Cardiovascular mortality.
Non‐cardiovascular mortality.
Fatal and/or non‐fatal myocardial infarction (MI).
Other fatal and/or non‐fatal cardiovascular events.

Secondary outcomes

Total revascularisations (including coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)).
Hospitalisations (total number of cardiac‐related patient admissions in the follow‐up period following the intervention).
Withdrawals.
Health‐related quality of life (HRQoL, using validated measures e.g. Short Form Health Survey SF‐36, Sickness Impact Profile, Nottingham Health Profile).
Adverse events.
Healthcare costs and cost‐effectiveness.

We excluded any study that did not measure one or more of these outcomes.

Search methods for identification of studies

Electronic searches

We searched the following databases on 30 June 2016:

CENTRAL Issue 6, 2016 (in the Cochrane Library);
MEDLINE (Ovid) 1946 to June week 3 2016;
Embase (Ovid) 1980 to 2016 week 26;
PsycINFO (Ovid) 1806 to June week 3 2016; and
CINAHL (EBSCO) 1937 to 30 June 2016.

The search strategies were designed with reference to those used previously (Brown 2011). We searched the databases using a strategy combining selected MeSH terms and free text terms relating to patient education and CHD, with filters applied to limit to RCTs. We used the Cochrane sensitivity‐maximising RCT filter for MEDLINE, and for Embase, terms recommended in the Cochrane Handbook were applied (Lefebvre 2011). Adaptations of this filter were applied to CINAHL and PsycINFO. We translated the MEDLINE search strategy for use in the other databases using the appropriate controlled vocabulary as applicable. We imposed no language or other limitations and gave consideration to variations in terms used and spellings of terms in different countries so that studies would not be missed by the search strategy because of such variations. See Appendix 1 for details of the search strategies used.

Ongoing trials were identified from searching the following trial registries in May 2016:

UK Clinical Trials Gateway (https://www.ukctg.nihr.ac.uk/)
ClinicalTrials.gov (https://clinicaltrials.gov)
ICTRP WHO International Clinical Trials Registry Platform (http://apps.who.int/trialsearch/)

Search results reporting was conducted in accordance with PRISMA (Moher 2009). A flow diagram is included, which provides information about the number of studies identified, included and excluded, and reasons for exclusions (Figure 1).

Figure 1

PRISMA flow diagram

Searching other resources

Reference lists of all eligible trials, systematic reviews and meta‐analyses were searched for additional studies. Attempts were made to contact all study authors to obtain relevant information not available in the published manuscript.

Data collection and analysis

Selection of studies

Titles and abstracts of studies identified by the search strategy were screened by two independent review authors (LA, RST) and obviously irrelevant studies were discarded. The full‐text reports of all potentially relevant abstracts were obtained (LA) and assessed independently for eligibility (LA, RST). Any disagreement was resolved by discussion. Excluded studies and reasons for exclusion are detailed in the Characteristics of excluded studies table.

Data extraction and management

One review author (LA) extracted study characteristics of included RCTs using a standardised data collection form which had been piloted on two RCTs included in the review. Data on patient characteristics (e.g. age, sex, CHD diagnosis) details of the intervention (including duration, frequency and delivery), description of usual care and length of follow‐up were extracted. A second author (HKR) checked all extracted data for accuracy. Two independent review authors (LA, HKR) extracted outcome data onto a standardised collection form. If data were presented numerically (in tables or text) and graphically (in figures), the numeric data were used because of possible measurement error when estimating from graphs. Any discrepancies were resolved by arbitration. One review author (LA) transferred extracted data into Review Manager 5.3 (RevMan 2014), and a second author (RST) checked data for accuracy against the systematic reviews.

If there were multiple reports of the same study, we assessed the duplicate publications for additional data. We extracted outcome results at all follow‐up points post‐randomisation. We contacted study authors where necessary to provide additional information.

Assessment of risk of bias in included studies

One review author (LA) assessed the risk of bias in included studies using Cochrane's recommended tool, which is a domain‐based critical evaluation of the following core risk of bias items: the quality of random sequence generation and allocation concealment, description of withdrawals, blinding of outcome assessment, and presence of selective reporting (Higgins 2011). We also assessed three further quality criteria: whether the study groups were balanced at baseline, if the study groups received comparable care (apart from the educational component of the intervention), and whether an intention‐to‐treat analysis was undertaken. The criteria used for assessing these last three risk of bias domains are as follows.

Groups balanced at baseline

Low risk of bias: the characteristics of the participants in the intervention and control groups at baseline is reported to be comparable or can be judged to be comparable in terms of likely main prognostic factors.
Uncertain risk of bias: it is not reported whether the participants' characteristics in the two groups are balanced at baseline and there is inadequate information reported to assess this.
High risk of bias: there is evidence of substantive imbalance in the baseline characteristics of the intervention and control groups with regard to likely major prognostic factors.

Intention‐to‐treat analysis

Low risk of bias: the trial reports that the analyses were conducted according to an intention‐to‐treat analysis, and includes all the principles of such an analysis, e.g. keeping participants in the intervention groups to which they were randomised, regardless of the intervention they actually received; and measures outcome data on all or the majority of participants (i.e. > 80% of those randomised) or includes imputation of all missing data in the analysis, using appropriate methodology, e.g. multiple imputation.
Uncertain risk of bias: it is unclear if the trial has performed an intention‐to‐treat analysis.
High risk of bias: the trial does not include an intention‐to‐treat analysis, or there is a substantive loss of outcome data (e.g. > 20%) and analyses are performed according to imputation methods known to create bias such as last observation carried forward.

Groups received comparable treatment (except exercise)

Low risk of bias: all co‐interventions were delivered equally across intervention and control groups.
Uncertain risk of bias: there was insufficient information to access whether co‐interventions were equally delivered across groups.
High risk of bias: the co‐interventions were not delivered equally across intervention and control groups.

All risk of bias assessments were checked by a second review author (HKR) and any discrepancies were resolved by arbitration. Details of the assessments of risk of bias for each included trial are shown in the Characteristics of included studies table.

Measures of treatment effect

For dichotomous variables, risk ratios (RR) and 95% confidence intervals (CI) were derived for each outcome. If any continuous variables had been reported, mean differences and 95% CI would have been calculated for each outcome.

Unit of analysis issues

In accordance with Section 9.3.1 of the Cochrane Handbook for Systematic Reviews of Intervention (Higgins 2011), we ensured that the analysis was appropriate to the level at which randomisation occurred. All studies included in this review were simple parallel group RCTs, and so there were no issues relating to unit of analysis.

Dealing with missing data

We contacted investigators or study sponsors to verify key study characteristics and obtain missing numerical outcome data where possible (for example when a study is identified as an abstract only). Had this not been possible, and the missing data were thought to introduce serious bias, we planned to explore the impact of including such studies on the overall assessment of results by a sensitivity analysis.

Assessment of heterogeneity

We explored heterogeneity amongst included studies qualitatively (by comparing the characteristics of included studies) and quantitatively (using the Chi² test of heterogeneity and I² statistic). We used a threshold of I² greater than 50% for both dichotomous and continuous outcomes to determine the statistical model to be used for meta‐analysis.

Assessment of reporting biases

The funnel plot and the Egger test were used to examine small study bias (Egger 1997).

Data synthesis

We processed data in accordance with Cochrane Handbook for Systematic Reviews of Interventions guidance (Deeks 2011). Where appropriate and possible, results from included studies were combined for each outcome to give an overall estimate of treatment effect. Given the degree of clinical heterogeneity seen in participant selection, interventions and comparators across studies, we decided it was appropriate to pool studies using random‐effects modelling.

With the exception of total mortality, the review did not identify sufficient data to allow stratified meta‐analysis at different common follow‐up timings (e.g. 6 or 12 months post‐randomisation). Instead, we pooled studies at their longest follow‐up unless otherwise stated.

Summary of findings table

Two independent review authors (LA, RST) used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to interpret result findings and used GRADEpro GDT 2014 to import data from Review Manager to create a 'Summary of findings table'. We created a 'Summary of findings' table using the following outcomes: total mortality, fatal and/or non‐fatal MI, total revascularisations, other fatal and/or non‐fatal cardiovascular events, hospitalisations, withdrawals and HRQoL. We used the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness and publication bias) to assess the quality of a body of evidence as it relates to the studies that contribute data to the meta‐analyses for the prespecified outcomes. We used methods and recommendations described in Section 8.5 and Chapter 12 of the Cochrane Handbook for Systematic Reviews of Interventions using GRADEpro GDT 2014 software (Higgins 2011). We justified all decisions to downgrade the quality of studies using footnotes, and made comments to aid readers' understanding of the review where necessary.

Subgroup analysis and investigation of heterogeneity

As stated in the protocol, we planned to undertake subgroup analysis and stratified meta‐analysis, sensitivity analysis and meta‐regression to examine potential treatment effect modifiers. We intended to test the following a priori hypotheses that there may be differences in the effect of education on total mortality and withdrawal across particular subgroups:

CHD case mix (MI‐only trials versus other trials).
Dose and nature of structured patient education. Assessed on the basis of the number and nature of education sessions e.g. extent of training of who delivers the education, a healthcare professional, or specific educational training, whether feedback or re‐inforcement were given (i.e. literature, audiovisual follow‐up material).
Method of structured educational delivery (one‐to‐one versus group versus combination).
Theoretical versus no theoretical basis to educational intervention.
Involvement of significant others (e.g. spouse, family member) in the education.
Timing of the education following the index event.
Length of the educational intervention.
Follow‐up period (≤ 12 months versus > 12 months).

For this update we also tested the following predictors of total mortality and withdrawal using univariate meta‐regression:

mean age of participants;
percentage of male participants;
type of cardiac rehabilitation (education only versus education plus e.g. exercise or psychological intervention);
study location (continent); and
setting (centre versus home).

Due to poor reporting, we were unable to examine the association of dose of education or timing following the index event, with the risk of total mortality or withdrawal.

Sensitivity analysis

We undertook a sensitivity analysis to examine the effect of risk of bias (low risk in ≥ five items versus < five items) and year of publication (before 2000 versus 2000 or later) of included studies on total mortality and withdrawal.

We decided it was appropriate to pool studies using random‐effects modelling, due to the clinical heterogeneity seen in participant selection, interventions and comparators across studies. However, we undertook a sensitivity analysis to examine the effect on the pooled data of conducting a fixed‐effect or a random‐effects model. The results of the random‐effects model are reported as default in the text, while the results from both models for all outcomes are reported in Table 1.

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Table 1. Results of sensitivity analysis for fixed‐effect versus random‐effects models

Outcome or subgroup	Studies	Participants	Effect estimate (random‐effect) RR (M‐H, random, 95% CI)	Effect estimate (fixed‐effect) RR (M‐H, fixed, 95% CI)
1.1 Total mortality at the end of the follow up period	13	10,075	0.80 [0.60, 1.05]	0.80 [0.66, 0.97]
1.1.1 Studies with 12 months or less follow‐up	6	4063	0.78 [0.35, 1.78]	0.87 [0.56, 1.36]
1.1.2 Studies with more than 12 months follow‐up	7	6012	0.78 [0.60, 1.02]	0.79 [0.64, 0.97]
2.1 Myocardial Infarction at the end of the follow‐up period	2	209	0.63 [0.26, 1.48]	0.59 [0.25, 1.38]
2.2 Total revascularisations	3	456	0.58 [0.19, 1.71]	0.58 [0.20, 1.69]
2.3 Other fatal and/or non‐fatal cardiovascular events	2	310	0.36 [0.23, 0.56]	0.36 [0.23, 0.56]
3.1 Cardiac hospitalisations at end of follow‐up period	5	14,849	0.93 [0.71, 1.21]	1.02 [0.90, 1.15]
4.1 All cause withdrawal or drop‐out at follow‐up	17	10,972	1.04 [0.88, 1.22]	0.98 [0.88, 1.10]
4.1.1 Studies with 12 months or less follow‐up	10	4960	1.18 [0.93, 1.49]	1.18 [0.94, 1.49]
4.1.2 Studies with more than 12 months follow‐up	7	6012	0.98 [0.80, 1.20]	0.92 [0.81, 1.05]

Results

Description of studies

Results of the search

We identified 3918 records through our electronic database search. After de‐duplication, 2749 titles and abstracts were screened for inclusion, of which 2639 were excluded. We identified two additional records from searching the citations of publications identified as meeting our inclusion criteria, and a further 10 studies listed on trial registries. We retrieved and assessed 122 full text reports for eligibility and subsequently excluded 84 publications. Sixteen studies were ongoing and five were determined as awaiting classification because the full text was not available and authors did not respond to repeated requests for study information. In total, we included an additional nine randomised controlled trials (RCTs) (17 publications) to the 13 RCTs (24 publications) from the 2011 review, totaling 22 RCTs (41 publications). Details of the exclusion process and reasons for exclusion are summarised in a PRISMA flow diagram (Figure 1) and in the Characteristics of excluded studies table.

Included studies

The previous version of this review (Brown 2011) included 13 RCTs (24 publications) (Clark 1997; Clark 2000; Clark 2009; Cupples 1994; Esposito 2008; Hanssen 2007; Lie 2009; Lisspers 1999; P.RE.COR Group 1991; Peikes 2009; Pogosova 2008; Southard 2003; Tingström 2005). We included an additional nine RCTs for this update (16 publications, 8215 participants) (Chow 2015; Cohen 2014; Dracup 2009; Furuya 2015; Jorstad 2013; Melamed 2014; Mooney 2014; Moreno‐Palanco 2011; Park 2013). We included a total of 22 studies reporting data for a total of 76,864 participants in this update.

Details of included studies are listed in the Characteristics of included studies table. Seventeen studies compared education‐only interventions with a comparator and five studies reported on an education plus counselling or behaviour change intervention (Dracup 2009; Hanssen 2007; Lie 2009; Lisspers 1999; Peikes 2009). No studies included interventions which comprised exercise as a co‐intervention.

Eleven studies were undertaken in Europe (Cohen 2014; Cupples 1994; Hanssen 2007; Jorstad 2013; Lie 2009; Lisspers 1999; Melamed 2014; Mooney 2014; Moreno‐Palanco 2011; P.RE.COR Group 1991; Tingström 2005); six were performed in the USA (Clark 1997; Clark 2000; Clark 2009; Esposito 2008; Peikes 2009; Southard 2003); and one each in Russia (Pogosova 2008), Australia (Chow 2015), South America (Furuya 2015) and Asia (Park 2013) and one was undertaken in sites in USA, Australia and New Zealand (Dracup 2009). Fourteen studies were multicentre RCTs (Clark 1997; Clark 2000; Clark 2009; Cohen 2014; Cupples 1994; Dracup 2009; Esposito 2008; Jorstad 2013; Melamed 2014; Mooney 2014; P.RE.COR Group 1991; Peikes 2009; Southard 2003; Tingström 2005); and eight were single centre RCTs (Chow 2015; Furuya 2015; Hanssen 2007; Lie 2009; Lisspers 1999; Moreno‐Palanco 2011; Park 2013; Pogosova 2008).

Sixteen studies reported sources of funding; six did not report funding sources (Clark 1997; Esposito 2008; Lie 2009; Melamed 2014; Moreno‐Palanco 2011; Pogosova 2008). One study was funded by an industrial sponsor (Jorstad 2013), four by health insurance companies (Chow 2015; Cohen 2014; Lisspers 1999; Peikes 2009) and 11 by government or public sources (Clark 2000; Clark 2009; Cupples 1994; Dracup 2009; Furuya 2015; Hanssen 2007; Mooney 2014; P.RE.COR Group 1991; Park 2013; Southard 2003; Tingström 2005).

Most trials were relatively small in sample size (median 454 participants, range: 63 to 46,606). Two large trials (Esposito 2008; Peikes 2009) contributed 85% (65,008 participants) of all included participants.

The median duration of trial intervention was six months (range 1 to 36 months) with median follow‐up of 12 months (range 6 to 60 months).

The case mix of participants recruited to the included trials varied considerably; six studies recruited mixed populations of people with CHD (Chow 2015; Clark 1997; Clark 2000; Clark 2009; Melamed 2014; Pogosova 2008); four studies recruited participants with myocardial infarction (MI) or angina (Cohen 2014; Jorstad 2013; Mooney 2014; Park 2013); and the remaining studies recruited participants post‐revascularisation (Furuya 2015; Lie 2009; Lisspers 1999); with coronary heart disease (CHD) or heart failure (Esposito 2008; Peikes 2009; Southard 2003); MI (Hanssen 2007; P.RE.COR Group 1991); acute coronary syndromes (ACS) (Dracup 2009; Moreno‐Palanco 2011); angina (Cupples 1994); or MI or post‐revascularisation (Tingström 2005).

The mean age of trial participants ranged from 51.0 to 72.8 years. Although all but two trials included women (20 studies, 91%), only 25% of participants recruited were women.

The two largest studies (65,008 participants) (Esposito 2008; Peikes 2009) included some participants who were outside the scope of this review (i.e. trialists considered people with congestive cardiac failure and diabetes). However, participants with CHD contributed 69% and 61% respectively, to these studies. Both studies reported hospitalisation, health‐related quality of life (HRQoL) and cost data. Only hospitalisation data from Esposito 2008 contributed to the meta‐analysis, and these data were reported separately for participants with CHD (Esposito 2008). Southard 2003 included participants with cardiac failure as well as those with CHD.

Four studies involved group sessions (Clark 1997; Clark 2000; Pogosova 2008; Tingström 2005); 12 involved individual education sessions (Chow 2015; Cohen 2014; Cupples 1994; Dracup 2009; Esposito 2008; Hanssen 2007; Lie 2009; Melamed 2014; Moreno‐Palanco 2011; Mooney 2014; Park 2013; Peikes 2009); three used both group and individual sessions (Lisspers 1999; P.RE.COR Group 1991; Southard 2003); one study compared group and individual approaches (Clark 2009); and one study did not report on the mode of teaching (Jorstad 2013). Eighteen studies involved face‐to‐face sessions (Cohen 2014; Dracup 2009; Clark 1997; Clark 2000; Clark 2009; Cupples 1994; Esposito 2008; Furuya 2015; Jorstad 2013; Lie 2009; Lisspers 1999; Melamed 2014; Moreno‐Palanco 2011; Mooney 2014; P.RE.COR Group 1991; Park 2013; Pogosova 2008; Tingström 2005); three were reliant on telephone contact (Esposito 2008; Hanssen 2007; Peikes 2009); three used face‐to‐face sessions as well as telephone follow‐up (Furuya 2015; Mooney 2014; Park 2013); one involved interactive use of the Internet (Southard 2003); and one used text messages via a mobile phone (Chow 2015). The educational intervention was delivered by a wide variety of personnel, with nine interventions delivered by nurses (Cohen 2014; Dracup 2009; Esposito 2008; Furuya 2015; Hanssen 2007; Jorstad 2013; Lie 2009; Mooney 2014; Moreno‐Palanco 2011); four by trained educators (Clark 1997; Clark 2000; Clark 2009; Tingström 2005); three by physicians (Melamed 2014; P.RE.COR Group 1991; Pogosova 2008), and one each by a care co0ordinator (Peikes 2009), case manager (Southard 2003), and a researcher (Furuya 2015). The person delivering the intervention was not described in one study (Park 2013). The intensity of the education programme varied substantially from just one 40 minute face‐to‐face session plus a 15 minute follow‐up call (Dracup 2009) to a four‐week residential stay reinforced with 11 months of nurse‐led follow‐up sessions (Lisspers 1999). Description of the educational content of the programmes was mostly brief and lacked detail. Table 2 summarises educational interventions.

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Table 2. Educational content of programs in included studies

Study ID	Description of Intervention	Theoretical basis	Tailored	Duration	One‐to‐one	Group	Face‐ to‐face	Telephone	Internet	Notes
Chow 2015	Text message‐based prevention program delivering regular semi‐personalised messages providing advice, motivation, and information to improve diet, increase physical activity, and encourage smoking cessation	NR	Y	4 messages per week for 24 weeks	Y	N	N	Y (text messages)	N	Content for each participant was selected using a prespecified algorithm dependent on key baseline characteristics
Clark 1997	*PRIDE	Y	Y	Once weekly for 4 weeks		Y	Y			Taught by health educator. Videotape and workbook aids
Clark 2000	*PRIDE	Y	Y	Once weekly for 4 weeks		Y	Y			Taught by health educator. Videotape and workbook aids
Clark 2009	*PRIDE	Y	Y	Once weekly for 6 weeks	Y	Y	Y			3 groups (self‐directed and group intervention and a control)
Cohen 2014	"House of Education" with individualised consultations with e.g. smoking cessation nurse	NR	Y	At least 6 sessions in 12 months	Y	N	Y	N	N	Consultations content was individualised according to a patient’s risk factors
Cupples 1994	Practical tailored advice on cardiovascular risk factors and appropriate health education	NR	Y	3 times a year for 2 years	Y		Y			Delivered at home by health visitor
Dracup 2009	Patients received education on ACS, anticipated emotional issues and social factors that could affect delay	Y	Y	55 mins (40 min face‐to‐face plus 15 min follow‐up call)	Y	N	Y	N	N	Delivered by a nurse with expertise in cardiology
Esposito 2008	Predesigned scripts to provide education on various aspects of care, geared to personalised clinical goals	NR	Y	Average 1.1 contacts per month for 18 months	Y		Y	Y		Nurse case manager, primarily by telephone but also face‐to‐face
Furuya 2015	Three booklets and three telephone follow‐up calls aimed at helping patient understand his cardiac condition, PCI and how to cope with CAD	Y	N	2 face to face sessions and 3 telephone calls over 16 weeks	Y	N	Y	Y	N	The first booklet was discussed with participants before undergoing PCI procedure
Hanssen 2007	Individualised education from a menu of topics to be covered	Y	Y	6 months (8 sessions in total)	Y			Y		Structured element and an on‐call element
Jorstad 2013	Outpatient clinic visits to a cardiovascular nurse	NR	Y	6 months (4 sessions)	NR	NR	Y	N	N	Nurse‐coordinated: provided general lifestyle advice, and individual counselling
Lie 2009	A psycho‐educative intervention. Structured information and psychological support	NR	N/S	2 visits (1 hour each)	Y		Y			Critical care nurse, home based
Lisspers 1999	Health education and achievement of behavioural change	NR	Y	4 week residential then 11 month one‐to‐one individual sessions	Y	Y	Y			Trained nurses (personal coaches). Seminars, lectures, discussion and skills sessions
Melamed 2014	Lesson materials consisted of a patient brochure, teaching cards and curriculum poster/wall chart set	NR	N	NR	Y	N	Y	N	N	Patients were given an exercise diary to enable them to document their daily physical activity
Mooney 2014	Education intervention aimed at reducing total prehospital delay time	Y	Y	6 months (1 face‐to‐face session, 1 telephone call and one reinforcement letter at 6 months)	Y	N	Y	Y	N	Research nurses used preprinted flip charts and prescriptive scripts as educational aids
Moreno‐Palanco 2011	Health education on the meaning of patients' disease and the importance of treatment	NR	NR	3 years (at least 5 sessions)	Y	N	Y	N	N	Each visit consisted of a nursing intervention and a medical assessment
P.RE.COR Group 1991	Education and counselling on management of cardiovascular risk factors and exercise	NR	Y	1 group session, 1 individual session with cardiologist	Y	Y	Y			Multidisciplinary input to group. Cardiologist tailors therapy
Park 2013	Psycho‐educational intervention comprising tailored face‐to‐face education and telephone‐delivered health coaching	NR	Y	12 weeks (6 sessions)	Y	N	Y	Y	N	Patients made choices about risk factors they wanted to lower and participated in goal setting
Peikes 2009	Variable ‐ nurse provision of patient education	NR	NR	1 to 2.5 times a month for an average of 30 months	Y			Y		15 different programs, majority telephone, one‐to‐one
Pogosova 2008	Structured program addressing different risk factors in each session	Y	NR	6 sessions (twice weekly, 90 min)		Y	Y
Southard 2003	Modular internet sessions, Interactive multiple choice and self tests followed by feedback	NR	NR	Once weekly for 6 months (at least 30 min)	Y	Y			Y	Communication with case manager and online discussion group
Tingström 2005	Problem based rehabilitation to teach a planned curriculum	Y	NR	13 sessions over 1 year		Y	Y			Trained facilitator

PRIDE = Problem Identification, Researching one's routine, Identifying a management goal, Developing a plan to reach it, Expressing one's reactions and Establishing rewards for making progress.

Y = Yes; N = No; NR = not reported

Excluded studies

We excluded 84 full text publications because they did not meet the inclusion criteria for this review (see Characteristics of excluded studies). Seven studies were not RCTs, 13 studies had follow‐up periods of less than six months, three studies included populations who were irrelevant for this Review, 36 studies investigated interventions that were not relevant to this Review, six included inappropriate comparators and 19 studies did not report outcomes that were relevant to this Review.

Ongoing studies

The details of 16 ongoing studies that appear to meet the inclusion criteria for this Review are presented in Characteristics of ongoing studies (ACTRN12613000395730; ACTRN12613000793718; ACTRN12616000426482; Brewer 2015; Dwinger 2013; IRCT201307162621N13; ISRCTN15839687; Kärner 2012; Lai 2016; Lynggaard 2014; NCT01028066; NCT01275716; NCT01925079; NCT02185391; NTR2388; Shah 2011).

Studies awaiting classification

The details of five studies that are awaiting classification are presented in Characteristics of studies awaiting classification.. One study was published in the IIOAB Journal, but we were not able to access any of this journal's web pages (Gao 2011). We were unable to find the full text or trace the authors of the remaining four studies ( Licina 2010; Soliman 2013; Vona 2009; Xiaolin 2012).

Risk of bias in included studies

Several studies did not report sufficient methodological detail to enable assessment of potential risk of bias. Details of random sequence generation, concealment of random allocation and blinding were the most frequent poorly reported parameters. Risk of bias results are summarised in Figure 2 and Figure 3.

Figure 2

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

Figure 3

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

Allocation

Sixteen studies were judged to provide evidence of adequate random sequence generation (Chow 2015; Cohen 2014; Clark 1997; Clark 2000; Clark 2009; Cupples 1994; Furuya 2015; Hanssen 2007;Jorstad 2013; Lie 2009; Mooney 2014; Moreno‐Palanco 2011; Park 2013; Peikes 2009; Southard 2003; Tingström 2005). Fourteen studies reported adequate concealment methods (Chow 2015; Clark 1997; Clark 2009; Cohen 2014; Cupples 1994; Furuya 2015; Hanssen 2007; Jorstad 2013; Lie 2009; Melamed 2014; Mooney 2014; Moreno‐Palanco 2011; Peikes 2009; Tingström 2005).

Blinding

Due to the nature of the educational intervention, it was not possible to blind education providers or trial participants. We investigated evidence to ascertain if those collecting, assessing or analysing outcome data were blinded to group allocation. Blinding of this nature was confirmed in 10 studies (Chow 2015; Cohen 2014; Clark 1997; Clark 2000; Clark 2009; Cupples 1994; Dracup 2009; Furuya 2015; Jorstad 2013; Moreno‐Palanco 2011).

Incomplete outcome data

Sixteen studies clearly stated withdrawal or numbers lost to follow‐up (Table 3). Overall, 11.3% of participants in intervention groups and 11.5% of control group participants were lost to follow‐up. Most authors failed to assess participants who were lost to follow‐up for systematic differences when compared to those who completed the study.

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Table 3. All‐cause withdrawal or drop‐out at follow‐up

Study ID		Number randomised	Number lost at follow‐up*	Notes
Chow 2015	Intervention	352	33	20 excluded from analysis, 9 unable to contact, 4 died
Chow 2015	Control	358	25	21 excluded from analysis, 3 unable to contact, 1 died
Clark 2000	Intervention	309	51	36 withdrew, 14 died, 1 data missing
Clark 2000	Control	262	42	33 withdrew, 8 died, 1 data missing
Clark 2009	Intervention	201	37	Self‐directed program; 33 withdrew, 4 died
	Intervention	190	24	Group format; 19 withdrew, 5 died
	Control	184	23	15 withdrew, 8 died
Cohen 2014	Intervention	251	48	6 did not meet inclusion criteria, 7 died, 23 follow‐up refusal, 10 lost to follow‐up, 2 in another protocol
Cohen 2014	Control	251	36	4 did not meet inclusion criteria, 7 died, 13 follow‐up refusal, 12 lost to follow‐up
Cupples 1994	Intervention	342	92	45 defaulted, 47 died; 21 defaulted at 2 years
Cupples 1994	Control	346	109	44 defaulted, 65 died; 25 defaulted at 2 years
Dracup 2009	Intervention	1777	197	89 lost to follow‐up, 41 withdrawn, 67 died
Dracup 2009	Control	1745	238	94 lost to follow‐up, 69 withdrawn, 75 died
Furuya 2015	Intervention	34	4	4 unable to contact by telephone at follow‐up (90 participants were originally randomised (45 in each group), but 24 participants were excluded immediately after randomisation as they were indicated for surgery or enrolled in another study)
Furuya 2015	Control	32	2	2 did not return for 6 month follow‐up
Hanssen 2007	Intervention	156	55	40 withdrew, 7 died, 8 missing data
Hanssen 2007	Control	132	38	21 withdrew, 7 died, 10 missing data
Jorstad 2013	Intervention	375	23	9 did not receive intervention, 3 died, 2 had early discontinuation of intervention, 9 had incomplete data
Jorstad 2013	Control	379	35	12 were excluded from the study, 10 died, 1 lost to follow‐up, 7 didn't attend 12 month follow‐up, 5 had incomplete data
Lie 2009	Intervention	101	8	6 withdrew, 2 medical exclusions
Lie 2009	Control	102	10	5 withdrew, 5 medical exclusions
Melamed 2014	Intervention	202	21	"patients were exclude (for example, because of missed training appointments)"
Melamed 2014	Control	205	19	"patients were excluded (for example, because of missed training appointments)"
Mooney 2014	Intervention	972	35	14 withdrew, 21 died
Mooney 2014	Control	972	27	10 withdrew, 17 died
Moreno‐Palanco 2011	Intervention	121	3	3 lost to follow‐up, 0 died
Moreno‐Palanco 2011	Control	126	5	5 lost to follow‐up, 0 died
P.RE.COR Group 1991	Intervention	60	0	Counseling program without exercise
	Intervention	61	0	Comprehensive cardiac rehabilitation
	Control	61	0	Usual care
Park 2013	Intervention	31	3	3 withdrew, 0 died
Park 2013	Control	32	2	2 withdrew, 0 died
Southard 2003	Intervention	53	4	Reasons for drop‐out stated: relocation, dietary intervention instead, psychiatric diagnosis, loss of interest
Southard 2003	Control	51	0
Tingström 2005	Intervention	104	3	7 lost to follow‐up: 2 died, 5 did not attend
Tingström 2005	Control	103	4	7 lost to follow‐up: 2 died, 5 did not attend
Combined results	Intervention	5692	641	11.3%
Combined results	Control	5341	615	11.5%

* All causes of drop out from follow0up included (including mortality)

Selective reporting

We compared the reported outcomes in the results sections to the outcomes described in the methods of published papers. No attempt was made to identify original study protocols and compare these to reported outcomes. Only one study demonstrated selective reporting by not reporting the results of a HRQoL measure (Southard 2003).

Other potential sources of bias

Baseline balance

Eighteen studies had a good balance of subject baseline characteristics between intervention and control groups. Four studies demonstrated a statistically significant imbalance between groups at baseline (Clark 2000; Dracup 2009; Mooney 2014; Peikes 2009). There were differences in baseline disease symptoms and weight in Clark 2000. Peikes 2009 highlighted 11 differences in 255 baseline characteristics compared between groups, which they qualified as "less than the expected number of statistical significant differences than would be observed by chance (Peikes 2009). In Dracup 2009, there were differences in baseline body mass index, gender (with more females in the experimental group than control, P = 0.02), and insurance for ambulance use. In Mooney 2014, there were some significant differences between characteristics and prognostic factors of the two groups at baseline including age.

Intention‐to‐treat analysis

Fifteen studies analysed results on an intention‐to‐treat basis (Chow 2015; Cohen 2014; Clark 2000; Clark 2009; Cupples 1994; Esposito 2008; Hanssen 2007; Lie 2009; Lisspers 1999; Mooney 2014; Moreno‐Palanco 2011; P.RE.COR Group 1991; Peikes 2009; Southard 2003; Tingström 2005). In most cases, this involved analysing those participants remaining at follow‐up according to initial randomisation. Clark 1997 did not present intention‐to‐treat data, but presented data for participants who had attended at least one of the four intervention sessions.

Comparative care

We specifically sought to investigate the impact of education. However, in addition to education (the primary intervention), participants appeared to receive other co‐interventions such as exercise or psychological therapy in a number of studies. It was unclear how much of these co‐interventions were received by control group participants, posing potential for performance bias (Dracup 2009; Esposito 2008; Hanssen 2007; Lisspers 1999; Park 2013; Peikes 2009; Southard 2003).