Yes / Randomised controlled trials of non-pharmacological interventions in children's therapy are rare. This is, in part, due to the challenges of the acceptability of common trial designs to therapists and service users. This study investigated the acceptability of participation in cluster randomised controlled trials to therapists and service users. A national electronic survey of UK occupational therapists, physiotherapists, speech and language therapists, service managers, and parents of children who use their services. Participants were recruited by NHS Trusts sharing a link to an online questionnaire with children's therapists in their Trust and with parents via Trust social media channels. National professional and parent networks also recruited to the survey. We aimed for a sample size of 325 therapists, 30 service managers, and 60 parents. Trial participation was operationalised as three behaviours undertaken by both therapists and parents: agreeing to take part in a trial, discussing a trial, and sharing information with a research team. Acceptability of the behaviours was measured using an online questionnaire based on the Theoretical Framework of Acceptability constructs: affective attitude, self-efficacy, and burden. The general acceptability of trials was measured using the acceptability constructs of intervention coherence and perceived effectiveness. Data were collected from June to September 2020. Numerical data were analysed using descriptive statistics and textual data by descriptive summary. A total of 345 survey responses were recorded. Following exclusions, 249 therapists and 40 parents provided data which was 69.6% (289/415) of the target sample size. It was not possible to track the number of people invited to take the survey nor those who viewed, but did not complete, the online questionnaire for calculation of response rates. A completion rate (participants who completed the last page of the survey divided by the participants who completed the first, mandatory, page of the survey) of 42.9% was achieved. Of the three specified trial behaviours, 140/249 (56.2%) therapists were least confident about agreeing to take part in a trial. Therapists (135/249, 52.6%) reported some confidence they could discuss a trial with a parent and child at an appointment. One hundred twenty of 249 (48.2%) therapists reported confidence in sharing information with a research team through questionnaires and interviews or sharing routine health data. Therapists (140/249, 56.2%) felt that taking part in the trial would take a lot of effort and resources. Support and resources, confidence with intervention allocation, and sense of control and professional autonomy over clinical practice were factors that positively affected the acceptability of trials. Of the 40 parents, twelve provided complete data. Most parents (18/40, 45%) agreed that it was clear how trials improve children's therapies and outcomes and that a cluster randomised trial made sense to them in their therapy situation (12/29, 30%). Using trials to evaluate therapy interventions is, in principle, acceptable to therapists, but their willingness to participate in trials is variable. The willingness to participate may be particularly influenced by their views related to the burden associated with trials, intervention allocation, and professional autonomy. / The study was funded and supported by the UK Occupational Therapy Research Foundation, a division of the Royal College of Occupational Therapists, as part of the 2018–2021 Research Priority Grant.

La Société Européenne de Cardiologie recommande pour les patients insuffisants cardiaques, en plus de la prise en charge médicamenteuse et interventionnelle, une prise en charge de type « éducation du patient » pour améliorer leur qualité de vie. En France, des programmes multidisciplinaires d’éducation du patient en hôpital ont mesuré leurs effets sur les ré-hospitalisations, la mortalité et le taux de participation des patients aux programmes. Certaines études internationales ont mesuré l’effet de programmes éducatifs délivrés par des équipes hospitalières multidisciplinaires, d’autres ont recruté des patients en soins primaires, mais les programmes étaient conduits par des infirmières ou des assistants des médecins généralistes. Ce type de programme ne reflète pas la situation actuelle en France où la plupart des patients sont suivis en ambulatoires par leurs médecins généralistes. Il semblait nécessaire de connaître plus précisément l'effet de programmes d'éducation du patient délivrés par les médecins généralistes auprès de leurs propres patients. L’objectif principal de l’étude ETIC (Education thérapeutique des patients insuffisants cardiaques) était d’évaluer si un programme d’éducation des patients insuffisants cardiaques délivré par leurs médecins traitants et suivis en médecine générale, améliorait leur qualité de vie. Cette étude interventionnelle, contrôlée, randomisée en grappes, a inclus 241 patients insuffisants cardiaques chroniques suivis par 54 médecins généralistes pendant 19 mois. Les médecins généralistes du groupe intervention ont été sensibilisés pendant 2 jours au programme d’éducation du patient et entrainés à adapter leurs propres objectifs d'éducation aux attentes du patient. Plusieurs séances d'éducation ont été simulées au cours de la formation des médecins. La 1re séance comportait un bilan éducatif explorant le mode de vie et les habitudes alimentaires, l'activité physique, les activités de loisirs, les projets et les ressources des patients. Les patients bénéficiaient de 4 séances d’éducation tous les 3 mois pendant 12 mois puis d’une séance d’éducation de synthèse au 19e mois de suivi. Le critère d’évaluation principal était la qualité de vie mesurée par une échelle de qualité de vie générique, la MOS 36-Item Short Form Health Survey (SF-36), et par une échelle de qualité de vie spécifique de l’insuffisance cardiaque, le Minnesota Living with Heart Failure Questionnaire (MLHFQ). La moyenne d’âge des patients était 74 ans (± 10.5), 62% était des hommes, et leur fraction d’éjection ventriculaire gauche moyenne était de 49.3% ± 14.3%. A la fin du suivi, le score MLHFQ moyen dans les groupes intervention et témoin étaient respectivement 33.4 ± 22.1 versus 27.2 ± 23.3; p = 0.74, intra-cluster coefficient [ICC] = 0.11. A la fin du suivi, la moyenne des scores SF-36 mental et physique dans les groupes intervention et témoin étaient respectivement 58 ± 22.1 versus 58.7 ± 23.9 (p = 0.58, ICC = 0.01) et 52.8 ± 23.8 versus 51.6 ± 25.5 (p = 0.57, ICC = 0.01). Le nombre de patients insuffisants cardiaques à fraction d’éjection conservée (ICFEp) était de 93 (80.9%) dans le groupe intervention et de 94 (74.6%) dans le groupe témoin (p = 0.24). Une étude exploratoire a été réalisée pour décrire les traitements prescrits dans la population de cette étude : évaluation de l’adhésion des médecins généralistes aux recommandations pour les patients à fraction d’éjection réduite (ICFEr) et description des traitements prescrits aux patients ICFEp. Le programme d’éducation du patient délivré dans le cadre de l’étude ETIC, n’a pas fait la preuve d’une amélioration de la qualité de vie des patients. D’autres recherches sont nécessaires pour améliorer la qualité de vie de ces patients. Les stratégies et les méthodes d’éducation restent un champ de recherche à développer. / The European Society of Cardiology guidelines recommend non-pharmacological management to improve patients’ quality of life. In France, patient education programs delivered by hospital multidisciplinary teams in outpatient clinics have been assessed for their impact in patients with heart failure (HF). Some international studies assessed patient education interventions for heart failure patients recruited in the hospital. These programs were delivered by hospital multidisciplinary teams. Others have recruited patients with heart failure in primary care but the patient education programs were delivered by nurses or general practitioner assistants. This does not reflect the situation of the majority of patients in France, most of whom are ambulatory and cared for by general practitioners (GPs). Therefore, more evidence is needed on the effect of patient education programs delivered by GPs. As GPs are the doctors closest to patients, we hypothesized that their patient education could improved the HF patients quality of life. The ETIC (Education thérapeutique des patients insuffisants cardiaques) trial aimed to determine whether a pragmatic education intervention in general practice could improve the quality of life of patients with chronic heart failure (CHF) compared with routine care. This cluster randomised controlled clinical trial included 241 patients with CHF attending 54 general practitioners (GPs) in France and involved 19 months of follow-up. The GPs in the intervention group were trained during an interactive 2-day workshop to provide a patient education program. Several patient education sessions were simulated during the 2-day workshop. Patients had a further four education sessions, at 4, 7, 10 and 13 months, followed by an overview session at 19 months. The primary outcome was patients’ quality of life, as measured by the MOS 36-Item Short Form Health Survey (SF-36), a generic instrument, and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The mean age of the patients was 74 years (± 10.5), 62% were men and their mean left-ventricular ejection fraction was 49.3% (± 14.3). At the end of the follow-up period, the mean MLHFQ scores in the Intervention and Control Groups were 33.4 ± 22.1 versus 27.2 ± 23.3 (p = 0.74, intra-cluster coefficient [ICC] = 0.11). At the end of the follow-up period, SF-36 mental and physical scores in the Intervention and Control Groups were 58 ± 22.1 versus 58.7 ± 23.9 (p = 0.58, ICC = 0.01) and 52.8 ± 23.8 versus 51.6 ± 25.5 (p = 0.57, ICC = 0.01), respectively. Patients with heart failure with preserved ejection fraction (HFpEF) in the intervention group and in the control group were respectively: 93 (80.9%) and 94 (74.6%) (p = 0.24). A comprehensive data set of this trial was used to assess the prescription behaviour of GPs: GP’s guideline adherence for pharmacotherapy of heart failure with reduced ejection fraction (HFrEF) patients and to describe pharmacotherapy of HFpEF patients. Conclusions Patient education delivered by GPs to elderly patients with stable heart failure in the ETIC program did not demonstrate an improvement in their quality of life compared with routine care. Further research on improving the quality of life of elderly patients with CHF in primary care is needed. Patient education strategies and methods, as well as relevant tools and adapted criteria used to assess them, remain a field of research to develop. This area of investigation will be the following of this work.