Summary
Therapeutic patient education programmes on heart failure have been widely proposed for many years for heart failure patients, but their efficiency remains questionable, partly because most articles lack a precise programme description, which makes comparative analysis of the studies difficult. To analyse the degree of precision in describing therapeutic patient education programmes in recent randomized controlled trials. Three major recent recommendations on therapeutic patient education in heart failure inspired us to compile a list of 23 relevant items that an ‘ideal’ description of a therapeutic patient education programme should contain. To discover the extent to which recent studies into therapeutic patient education in heart failure included these items, we analysed 19 randomized controlled trials among 448 articles published in this field from 2005 to 2012. The major elements required to describe a therapeutic patient education programme were present, but some other very important pieces of information were missing in most of the studies we analysed: the patient’s educational needs, health literacy, projects, expectations regarding therapeutic patient education and psychosocial status; the educational methodology used; outcomes evaluation; and follow-up strategies. Research into how therapeutic patient education can help heart failure patients will be improved if more precise descriptions of patients, educational methodology and evaluation protocols are given by authors, ideally in a standardized format.
Résumé
L’efficience des programmes d’éducation thérapeutique (ETP) dans l’insuffisance cardiaque (IC) est encore discutée ; la description insuffisamment précise des programmes dans la plupart des articles rend plus difficile l’analyse comparative des études. Analyser le degré de précision dans la description des programmes d’ETP issus d’études randomisées récentes. En s’inspirant de trois recommandations internationales récentes sur l’ETP dans l’IC, nous avons constitué une liste de 23 critères de précision qu’une description idéale d’un programme d’ETP devrait comporter. Pour vérifier si ces critères étaient présents dans la littérature récente (2005–2012), nous avons analysé 19 études randomisées contrôlées portant sur l’ETP dans l’IC. Bien que la plupart des éléments descriptifs des programmes d’ETP soient présents, nous avons repéré des lacunes d’information dans les études concernant les besoins d’éducation des patients, leur litéracie en santé, leurs attentes vis-à-vis de l’ETP, leurs projets et leur statut psycho social. La description de la méthodologie éducative, comme celle de l’évaluation des résultats font souvent défaut, ainsi que les stratégies de suivi. La recherche sur l’efficience de l’ETP dans l’IC pourrait être améliorée si la description des patients, des méthodologies pédagogiques, d’évaluation et de suivi utilisées étaient décrites de façon plus complète et plus précise. Une standardisation des critères de précision des études pourrait s’avérer utile.
Background
Heart failure (HF) is a very common and severe heart disease that affects 2–4% of the population, according to the World Health Organization (WHO), with a growing annual incidence , a poor prognosis and an estimated survival rate of 30% at 5 years. Important clinical and psychosocial repercussions, high costs and high hospitalization rates (> 175,000 days of hospitalization in France in 2008 ) are significant consequences. Beyond the availability of new, sophisticated therapies, HF patient education has proven its efficacy in reducing hospitalizations and even, as demonstrated in recent publications, all causes of mortality .
There is growing evidence that patient education in ‘HF self-care’ decreases HF morbidity and mortality , lowers hospital readmission rates and improves quality of life . In fact, patient education programmes (called therapeutic patient education [TPE] since the 1998 WHO report) on HF have been widely proposed for many years for HF patients, in many formats and in various settings. Despite proof of the efficacy of TPE, its use in HF is less frequent than expected. Studies on TPE in HF show different effects and outcomes, making it difficult to draw conclusions about its efficacy and efficiency. The efficiency of TPE programmes is particularly questionable, as the large variety of programmes differ from one another in format and educational strategies ; this is also largely due to the lack of a precise description of the programmes and intervention procedures in most articles. Several authors have recognized that this lack makes reproducibility of the initial publication and appropriation of the educational programme by other clinicians problematic. Hence, comparative analysis of ‘positive’ and ‘negative’ studies is particularly difficult.
According to Austin , ‘the published descriptions of educational interventions could be improved and provided in a standardized format so that the evidence can be systematically assessed’. This lack of description concerns not only studies on TPE in the field of HF; it has already been highlighted for publications on other chronic diseases .
Taking into account this observation and those in the literature , we analysed the principal publications on TPE in the field of HF, to identify the main elements that allow evaluation of the methodology used, as recommended in evidence-based medicine, and to facilitate ownership of the TPE programme, in negative and positive trials. Then, we analysed the key points that would improve the description of a TPE programme and its evaluation, making study comparison easier and helping to identify in the studies on TPE in HF (and in other chronic diseases and conditions) the efficiency factors that are important for future research.
Methods
Starting in March 2012, we based our work on three recent major recommendations on TPE in the HF field:
- •
‘state of the science: promoting self-care in persons with heart failure: a scientific statement from the American Heart Association’ ;
- •
‘therapeutic education in patients with chronic heart failure: proposal for a multiprofessional structured programme, by a French Task Force under the auspices of the French Society of Cardiology’ ;
- •
‘self-care management of heart failure: practical recommendations from the Patient Care Committee of the Heart Failure Association of the European Society of Cardiology’ .
These recommendations inspired us to compile a list of the most relevant items (precision criteria), identified on a clinical and educational basis, that an ‘ideal’ description of a TPE programme should contain ( Table 1 ). Our proposed list of precision criteria for studies on TPE in HF derives from a written consensus between all the authors. The list has 23 key items divided into four sections: patient characteristics; competencies that the patients are expected to acquire; intervention modalities; and evaluation and outcomes measures.
| Patient characteristics (using interview, questionnaires, educational diagnosis, etc.) | Age, sex, ethnicity, socioeconomical status |
| Family status | |
| Clinical status (weight, BMI, BP, blood chemistry, HF severity, treatment, number/duration of hospitalizations), aetiology, co-morbidities | |
| Educational profile, cognitive status, culture and values, health literacy | |
| Educational needs related to HF (prior knowledge, health belief, self-care behaviour, practice, preventive behaviours, record keeping, etc.), patient’s perception of TPE usefulness | |
| Existence of patient’s personal project | |
| Psychosocial status (depression, anxiety, self efficacy) | |
| Educational aims of the TPE programme | Knowledge (disease, treatment, etc.) |
| Self management: daily self care and monitoring, salt and food restriction, crisis management | |
| Physical activity | |
| Better use of medical resources | |
| Quality criteria of the TPE programme | TPE strategy/format (face-to-face, group teaching, group and face-to-face, with or for family members, web/telephone) |
| Educational techniques used, educational theories on which the educational techniques are based (oral presentation, video, CAI, problem-based learning, interactive teaching, group discussion, ‘Photolangage’, role-play, metaplan, motivational interviewing, outside activities, food preparation, cooking, reading food labels) | |
| Educational tools used (notebook and tools for educational diagnosis, DVD, CAI, CD, telephone, diagrams, slides, flipcharts, games, pill boxes, coloured stickers, empty boxes, diet games, food cards, etc.); tools used by the patient (booklets, notebooks, newsletters, cards with warning symptoms, action plans, handbooks, patient’s health records, etc.) | |
| Involvement of lay patients and patient associations with conception and validation of the TPE programme and educational tools | |
| TPE programme duration | |
| Educators’ typology (cardiologists, general practitioners, nurses, pharmacists, dieticians, physiotherapists, etc.) and their training in TPE methodology | |
| Location of the educational process (hospital, CHF centres, ambulatory settings, community settings, primary health care, home visits, pharmacy) | |
| Evaluation methodology and outcomes measures | Outcomes (number of hospital readmissions, improvement in NYHA symptoms, reduction in mortality, health costs, cost-effectiveness of the TPE programme) |
| Behavioural changes, self-care and self-monitoring (self weighing, checking ankles, sodium restriction, physical activity, compliance with medications and treatment, following an action plan when symptoms worsen, diuretic self adjustment, etc.) | |
| Knowledge acquired by the patient (knowledge of HF, knowledge of treatment, etc.) | |
| Psychosocial status and social functioning (depression, anxiety, QOL, family support, communication with the physician, etc.) | |
| Patient adherence to the TPE programme, patient and educator satisfaction with the TPE programme | |
The first section (seven items) focuses on patient characteristics. Beyond the usual description of a patient population (mean age, sex ratio, clinical status, etc.), it addresses cognitive and cultural characteristics, the educational needs of the patient in relation to HF and ‘health literacy’, defined as ‘the ability to read and understand prescriptions, medication instructions, appointment cards and health materials, and to process and understand basic health information and services in order to function successfully in the patient role and to make effective health decisions’ .
The second section (four items) describes the educational aims and/or topics of the TPE programme, in the fields of knowledge, self-management, healthy behaviours and psychological and social functioning.
The third section (seven items) lists the quality criteria concerning the intervention characteristics: programme format; programme size; educational techniques; educational materials; educators; TPR settings and the theories on which the interventions are based.
The fourth section (five items) contains the criteria related to measurement of outcomes (clinical, educational, psychosocial and economical) and TPE programme follow-up (duration and type).
Then, in order to find out to what extent recent studies on TPE in HF included these items, we analysed literature available on PubMed, the Cochrane central database, PsycINFO, ScienceDirect, Refdoc, EM-consulte and Scopus. For each database, we used the same search strategy in the fields keywords/title/abstract: (‘heart failure’ or ‘myocardial failure’ or ‘heart decompensation’) and (‘patient education’ or ‘self care’ or ‘self management’ or ‘self-administration’ or ‘self-monitoring’ or ‘self-medication’ or ‘education programme’). Limits were: ‘randomized controlled trial’ [article type] and ‘2005–2012′ [publication date].
After eliminating duplicate studies (23% of the total number of studies), we identified 448 articles published between 2005 and 2012, and from these we selected 49 articles that met the following eligibility criteria: written in English or French; and related to TPE programmes in HF (in which the educative intervention, aimed at patients and their family, was described in detail). We excluded studies in which patient education methodology was not described clearly.
As pointed out by the recommendations of American Heart Association , convincing arguments regarding the effects of TPE in HF should emerge from high-quality randomized controlled trials (RCTs). For this reason, we decided to restrict our analysis to the 22 RCTs among the 49 studies. We excluded one RCT in which TPE was not the main intervention, one RCT that did not report final data and one RCT where the TPE was strictly limited to a teaching intervention that was too short (< 1 hour) to be considered as a TPE programme, according to Jourdain et al. . Finally, we limited our analysis to 19 RCTs ( Fig. 1 ).
