Healthcare Professionals' Perceptions about the Implementation of Shared Decision-Making in Primary Care: A Qualitative Study from a Virtual Community of Practice.

Background: The incorporation of shared decision making (SDM) is a central part of empowerment processes, as it facilitates greater activation on the part of patients, increasing the likelihood of them gaining control over their healthcare and developing skills to solve their health problems. Despite these benefits, there are still difficulties in the implementation of SDM among healthcare professionals due to internal and external factors related to the context and health systems. Aim: To explore primary care professionals (PCPs)' perceptions of the SDM model, based on their preconceptions and experience in clinical practice. Methods: A framework analysis was conducted on qualitative data derived from a virtual community practice forum, within a cluster-randomized clinical trial developed in the e-MPODERA project. Results: The most important points in the opinions of the PCPs were: exploring the patients' values, preferences and expectations, providing them with and checking their understanding of up-to-date and evidence-based health information. The analysis revealed three themes: determinants of the implementation process of SDM, lack of consistency and dilemmas and benefits of PCP active listening, motivation and positive expectations of SDM. Discussion: In our initial analysis, we examined the connections between the categories of the TDC model and its application in the primary care context. The categories related to the model reflect the theoretical understanding of professionals, while those related to perceptions of its application and use show certain discrepancies. These discrepancies could indicate a lack of understanding of the model and its real-world implications or insufficient commitment on the part of professionals or the organization to ensure its effective implementation. Conclusions: Specific targeted training that addresses knowledge, attitudes and practice may resolve the aforementioned findings.

Antecedentes: La incorporación de la toma de decisiones compartida (TDC) es una parte central del empoderamiento del paciente, ya que facilita una mayor activación, ganar control sobre la atención que recibe y desarrollar habilidades para resolver sus problemas de salud. A pesar de estos beneficios, todavía existen dificultades para implementar la TDC entre los profesionales sanitarios debido a factores internos de los propios profesionales y externos, relacionados con el contexto y los sistemas sanitarios. Objetivo: Explorar en el foro de una comunidad virtual de práctica (CVdP) las percepciones de los profesionales de atención primaria (PAP) sobre el modelo de TDC en función de sus ideas preconcebidas y su experiencia en la práctica clínica. Métodos: Se realizó un análisis de marco desde un abordaje cualitativo de las intervenciones hechas por los PAP en el foro de una CVdP. Esta CVdP se implementó dentro de un ensayo clínico aleatorizado por grupos desarrollado en el proyecto e-MPODERA. Resultados: Los aspectos más importantes relacionados con la TDC desde la perspectiva de los PAP incluyeron: explorar los valores, preferencias y expectativas de los pacientes, proporcionarles información actualizada y basada en la evidencia, y comprobar su comprensión. En el análisis posterior, tres categorías emergieron como los temas más relevantes: determinantes de la implementación del TDC, falta de consistencia y dilemas, y beneficios de la escucha activa de los PAP, motivación y expectativas positivas de la TDC. Discusión: En nuestro análisis inicial, examinamos las conexiones entre las categorías del modelo de TDC y su aplicación en el contexto de atención primaria. Las categorías relacionadas con el modelo reflejan la comprensión teórica de los profesionales, mientras que las relativas a las percepciones de su aplicación y uso muestran ciertas discrepancias. Estas discrepancias podrían indicar una falta de comprensión del modelo y de sus implicaciones en el mundo real o un compromiso insuficiente por parte de los profesionales o de la organización para garantizar su aplicación efectiva. Conclusión: Una formación específica que aborde los conocimientos, las actitudes y la práctica puede resolver los hallazgos mencionados.

Exploring value creation in a virtual community of practice: a framework analysis for knowledge and skills development among primary care professionals.

BACKGROUND: Healthcare professionals traditional education reflects constraints to face the complex needs of people with chronic diseases in primary care settings. Since more innovative and practical solutions are required, Virtual Community of Practices (vCoP) seem to better respond to learning updates, improving professional and organizational knowledge. However, little is known about the value created in vCoPs as social learning environments. The objective of this project was to explore the value creation process of a gamified vCoP ("e-mpodera vCoP") aimed at improving the knowledge and attitudes of primary healthcare professionals (PCPs) (nurses and general practitioners) to the empowerment of people with chronic conditions. METHODS: A framework analysis assessed the value creation process using a mixed methods approach. The framework provided awareness about knowledge and usefulness in a learning community through five cycles: (1) immediate value, (2) potential value, (3) applied value, (4) realized value, and (5) reframing value. Quantitative data included vCoP analytics such as logins, contributions, points, badges, and performance metrics. Qualitative data consisted of PCPs' forum contributions from Madrid, Catalonia, and Canary Islands over 14 months. RESULTS: A total of 185 PCPs had access to the e-mpodera vCoPs. The vCoP showed the dynamic participation of 146 PCPs, along 63 content activities posted, including a total of 3,571 contributions (including text, images, links to webpages, and other files). Regarding the value creation process, the e-mpodera vCoP seems to encompass a broad spectrum of value cycles, with indicators mostly related to cycle 1 (immediate value - activities and interactions) and cycle 2 (potential value - knowledge capital); and to a lesser extent for cycle 3 (applied value - changes in practice) and for cycle 4 (realized value - performance improvement). The presence of indicators related to cycle 5 (reframing value), was minimal, due to few individual redefinitions of success. CONCLUSION: To reach a wider range of value possibilities, a combination of learning objectives, competence framework, challenged-based gamified platform, and pathway model of skill development seems crucial. However, additional research is required to gain clearer insights into organizational values, professionals' lifelong educational needs in healthcare, and the long-term sustainability of performance improvement. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02757781. Registered on 02/05/2016.

A Virtual Community of Practice to Improve Primary Health Care Professionals' Attitudes Toward Patient Empowerment (e-MPODERA): A Cluster Randomized Trial.

PURPOSE: We aimed to evaluate the effectiveness of a virtual community of practice (vCoP) in improving primary health care professionals' (HCPs') attitudes toward empowering patients with chronic disease. METHODS: We conducted a cluster randomized controlled trial. Practices were units of randomization, and primary HCPs and patients were units of analysis. Sixty-three practices in Madrid, Catalonia, and the Canary Islands were randomly allocated to the intervention or control groups. Randominzation of practices was performed after HCP and patient recruitment. The patients and statistician were anonymized to group allocation; it was not possible to anonymize HCPs. The intervention was a 12-month multicomponent tailored vCoP built on the Web 2.0 concept and focused on skills toward patient empowerment. The primary outcome was Patient-Provider Orientation Scale (PPOS) score at baseline and at 12 months. The secondary outcome was the Patient Activation Measure (PAM) score. RESULTS: A total of 321 HCPs and 1,921 patients were assessed. The intervention had a positive effect on PPOS total score (0.14 points higher in the vCoP arm; 95% CI, 0.03-0.25; P = .011) and the PPOS Sharing subscale (0.3 points higher in the vCoP arm; 95% CI, 0.15-0.44; P < .001). No effect was found for the PPOS Caring subscale, and no significant differences were found for PAM scores. CONCLUSIONS: A vCoP led to a minor increase in the PPOS Sharing component and the total score but not in the Caring component. However, considerable uncertainty remains, given the observed attrition and other limitations of the study. Further research is needed on the effectiveness of the vCoP model and on how to improve HCP engagement.VISUAL ABSTRACT.

Cross-cultural validation of the patient-practitioner orientation scale among primary care professionals in Spain.

BACKGROUND: In recent decades, many self-report instruments have been developed to assess the extent to which patients want to be informed and involved in decisions about their health as part of the concept of person-centred care (PCC). The main objective of this research was to translate, adapt and validate the Patient-Practitioner Orientation Scale (PPOS) using a sample of primary care health-care professionals in Spain. METHODS: Baseline analysis of PPOS scores for 321 primary care professionals (general practitioners and nurses) from 63 centres and 3 Spanish regions participating in a randomized controlled trial. We analysed missing values, distributions and descriptive statistics, item-to-scale correlations and internal consistency. Performed were confirmatory factor analysis (CFA) of the 2-factor model (sharing and caring dimensions), scale depuration and principal component analysis (PCA). RESULTS: Low inter-item correlations were observed, and the CFA 2-factor model only obtained a good fit to the data after excluding 8 items. Internal consistency of the 10-item PPOS was acceptable (0.77), but low for individual subscales (0.70 and 0.55). PCA results suggest a possible 3-factor structure. Participants showed a patient-oriented style (mean = 4.46, SD = 0.73), with higher scores for caring than sharing. CONCLUSION: Although the 2-factor model obtained empirical support, measurement indicators of the PPOS (caring dimension) could be improved. Spanish primary care health-care professionals overall show a patient-oriented attitude, although less marked in issues such as patients' need for and management of medical information.

Co-Design Process of a Virtual Community of Practice for the Empowerment of People with Ischemic Heart Disease.

INTRODUCTION: Virtual Communities of Practices (vCoP) offer patients the possibility to interact and share tools and knowledge necessary for their empowerment. This paper describes the co-design process of a vCoP for the empowerment of people with ischemic heart disease (IHD). METHODS: We used a modified experience-based design approach to co-design the vCoP in collaboration with people with IHD and health professionals consisting of two phases: exploratory and development phase. Data collection techniques included listening labs, workshops, and online participation. RESULTS: Twenty-five people with IHD and ten health professionals participated. Experiences and needs for empowerment in IHD were identified in the exploratory phase allowing for the development of a Patient Journey Map. In the development phase, people with IHD prioritized needs to be addressed by the vCoP content framework in addition to content proposals. DISCUSSION: The Patient Journey Map helped to easily visualize the empowerment needs of people with IHD and it might be transferable for the development of other people-centred interventions. The co-design process also allowed the development of training materials adapted to the priorities of people with IHD. CONCLUSION: A people-centred co-design process of a vCoP may facilitate the empowerment of people with IHD.

Effectiveness and cost-effectiveness of a virtual community of practice to improve the empowerment of patients with ischaemic heart disease: study protocol of a randomised controlled trial.

INTRODUCTION: Virtual Communities of Practice (VCoP) or knowledge-sharing virtual communities offer ubiquitous access to information and exchange possibilities for people in similar situations, which might be especially valuable for the self-management of patients with chronic diseases. In view of the scarce evidence on the clinical and economic impact of these interventions on chronic conditions, we aim to evaluate the effectiveness and cost-effectiveness of a VCoP in the improvement of the activation and other patient empowerment measures in patients with ischaemic heart disease (IHD). METHODS AND ANALYSIS: A pragmatic randomised controlled trial will be performed in Catalonia, Madrid and Canary Islands, Spain. Two hundred and fifty patients with a recent diagnosis of IHD attending the participating centres will be selected and randomised to the intervention or control group. The intervention group will be offered participation for 12 months in a VCoP based on a gamified web 2.0 platform where there is interaction with other patients and a multidisciplinary professional team. Intervention and control groups will receive usual care. The primary outcome will be measured with the Patient Activation Measure questionnaire at baseline, 6, 12 and 18 months. Secondary outcomes will include: clinical variables; knowledge (Questionnaire of Cardiovascular Risk Factors), attitudes (Self-efficacy Managing Chronic Disease Scale), adherence to the Mediterranean diet (Mediterranean Diet Questionnaire), level of physical activity (International Physical Activity Questionnaire), depression (Patient Health Questionnaire), anxiety (Hospital Anxiety Scale-A), medication adherence (Adherence to Refill Medication Scale), quality of life (EQ-5D-5L) and health resources use. Data will be collected from self-reported questionnaires and electronic medical records. ETHICS AND DISSEMINATION: The trial was approved by Clinical Research Ethics Committee of Gregorio Marañón University Hospital in Madrid, Nuestra Señora de Candelaria University Hospital in Santa Cruz de Tenerife and IDIAP Jordi Gol in Barcelona. The results will be disseminated through workshops, policy briefs, peer-reviewed publications, local/international conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03959631). Pre-results.

Acceptability and feasibility of a virtual community of practice to primary care professionals regarding patient empowerment: a qualitative pilot study.

BACKGROUND: Virtual communities of practice (vCoPs) facilitate online learning via the exchange of experiences and knowledge between interested participants. Compared to other communities, vCoPs need to overcome technological structures and specific barriers. Our objective was to pilot the acceptability and feasibility of a vCoP aimed at improving the attitudes of primary care professionals to the empowerment of patients with chronic conditions. METHODS: We used a qualitative approach based on 2 focus groups: one composed of 6 general practitioners and the other of 6 practice nurses. Discussion guidelines on the topics to be investigated were provided to the moderator. Sessions were audio-recorded and transcribed verbatim. Thematic analysis was performed using the ATLAS-ti software. RESULTS: The available operating systems and browsers and the lack of suitable spaces and time were reported as the main difficulties with the vCoP. The vCoP was perceived to be a flexible learning mode that provided up-to-date resources applicable to routine practice and offered a space for the exchange of experiences and approaches. CONCLUSIONS: The results from this pilot study show that the vCoP was considered useful for learning how to empower patients. However, while vCoPs have the potential to facilitate learning and as shown create professional awareness regarding patient empowerment, attention needs to be paid to technological and access issues and the time demands on professionals. We collected relevant inputs to improve the features, content and educational methods to be included in further vCoP implementation. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02757781 . Registered on 25 April 2016.

Association of glycaemia with perceived threat of illness in patients with type 2 diabetes.

BACKGROUND: It is essential to reach glycaemic control in patients with diabetes mellitus to prevent reduced life expectancy and morbidity related to complications. The aim of this study was to determine whether glycaemic control is associated with the perception of illness in type II diabetes mellitus. METHODOLOGY: Illness perception was assessed in a sample of 242 diabetics attending a Family Health Centre in Chile using the Brief Illness Perception Questionnaire (BIPQ). We considered well-controlled individuals to have glycated haemoglobin below 7%, and we assessed association with the BIPQ score. The data were analysed by logistic regression. RESULTS: The total BIPQ score was significantly higher (more negative perception) in non-controlled individuals; the most significant differences were found in the following dimensions: consequences (p=0.0003), personal control (p=0.0392), identity (p=0.0006) and emotional affection (p=0.018). The dimensions of timeline, treatment control, concern and coherence showed no differences between the groups. The mean age of well-controlled subjects was significantly higher than the age of non-controlled diabetics. Well-controlled patients had been diagnosed with diabetes for significantly fewer years than had those that were not. CONCLUSIONS: Perceiving illness as more negative (BIPQ score >37) is highly associated with being a non-controlled diabetic, with more consequences over their daily life, less control over the disease and a higher number of attributable symptoms. When control variables are considered, a negative perception of diabetes has an adjusted OR of 2.14 (CI 95% 1.17-3.92) to have glycated haemoglobin above 7%.

Percepción en enfermedades crónicas: validación lingüística del Illness Perception Questionnaire Revised y del Brief Illness Perception Questionnaire para la población española / Perception in chronic illnesses: linguistic validation of the revised Illness Perception Questionnaire and the Brief Illness Perception Questionnaire for a Spanish population

Objetivo: Obtener versiones adaptadas para la población española de una versión específica del Illness Perception Questionnaire Revised (IPQ-Re) y el Brief Illness Perception Questionnaire (BIPQ), conceptual y lingüísticamente equivalentes a los originales. Diseño: Adaptación cultural de cuestionarios: validación lingüística. Emplazamiento: Cinco equipos de atención primaria y un hospital de tercer nivel. Participantes: Se seleccionó un equipo investigador multidisciplinario. Se realizó un estudio piloto en 30 pacientes con enfermedades crónicas (hipertensión, diabetes mellitus tipo 2, cardiopatía isquémica estable, asma, enfermedad pulmonar obstructiva crónica o artrosis). Método: Se procedió en 3 fases: I) doble traducción, II) estudio piloto y III) doble retrotraducción. Se realizaron 3 reuniones de consenso, una en cada fase y otra con uno de los autores del cuestionario original. En esta última se conoció el BIPQ, una versión reducida del IPQ-R. Se decidió incluir su validación realizando una doble traducción, doble retrotraducción y consenso en ambas etapas. Resultados: Fase I) La mayoría de ítems del IPQ-Re no planteó problemas de traducción. Fase II) En el estudio piloto se detectaron algunas dificultades para la autoadministración y la comprensión de algunos ítems. Se decidió disponer de entrevistadores entrenados, introducir cambios en el vocabulario y formato del cuestionario y adaptar una versión específica con menor cantidad de ítems, que solventaba gran parte de las dificultades encontradas. Fase III) Las retrotraducciones fueron muy similares al cuestionario original. El proceso de traducción-retrotraducción del BIPQ no presentó dificultades. Conclusiones: Tras la validación lingüística del IPQ-Re y del BIPQ, se obtuvieron versiones conceptual y lingüísticamente equivalentes a los cuestionarios originales(AU)

Objective: To obtain adapted versions for the Spanish population of a specific version of the Revised Illness Perception Questionnaire Revised (IPQ-Re) and the Brief Illness Perception Questionnaire (BIPQ), conceptually and linguistically equivalent to the original questionnaires. Design: Cultural adaptation of questionnaires: linguistic validation. Setting: Five primary care centres and a tertiary hospital. Participants: A multidisciplinary team was selected. A pilot study was performed on 30 people with chronic diseases (hypertension, diabetes mellitus, stable ischaemic heart disease, asthma, chronic obstructive pulmonary disease or osteoarthritis). Method: The project proceeded in 3 phases: I) Double forward-translation, II) Pilot study and III) Double back-translation. Three consensus meetings were held, one in each phase. Another meeting was held with one of the authors of the original questionnaire, where we knew about a short version, the BIPQ. It was also included in the study. Double forward and back-translations were performed and consensus was reached in both stages. Results: Phase I) The majority of IPQ-Re items did not raise problems of translation. Phase II) In the pilot study we detected that patients found some difficulties in connection with the comprehension and self administration of some items. Therefore it was decided to employ trained interviewers, to introduce changes in the IPQ-Re format and vocabulary and to adapt a specific version with fewer items that solved most of these difficulties Phase III) Back-translations were very similar to the original version. The BIPQ forward and back-translation process caused no difficulties. Conclusions: After lingüistic validation, IPQ-Re and BIPQ versions conceptually and lingüistically equivalent to original instruments were obtained(AU)

[Perception in chronic illnesses: linguistic validation of the revised Illness Perception Questionnaire and the Brief Illness Perception Questionnaire for a Spanish population]. / Percepción en enfermedades crónicas: validación lingüística del Illness Perception Questionnaire Revised y del Brief Illness Perception Questionnaire para la población española.

OBJECTIVE: To obtain adapted versions for the Spanish population of a specific version of the Revised Illness Perception Questionnaire Revised (IPQ-R(e)) and the Brief Illness Perception Questionnaire (BIPQ), conceptually and linguistically equivalent to the original questionnaires. DESIGN: Cultural adaptation of questionnaires: linguistic validation. SETTING: Five primary care centres and a tertiary hospital. PARTICIPANTS: A multidisciplinary team was selected. A pilot study was performed on 30 people with chronic diseases (hypertension, diabetes mellitus, stable ischaemic heart disease, asthma, chronic obstructive pulmonary disease or osteoarthritis) METHOD: The project proceeded in 3 phases: I) Double forward-translation, II) Pilot study and III) Double back-translation. Three consensus meetings were held, one in each phase. Another meeting was held with one of the authors of the original questionnaire, where we knew about a short version, the BIPQ. It was also included in the study. Double forward and back-translations were performed and consensus was reached in both stages. RESULTS: Phase I) The majority of IPQ-R(e) items did not raise problems of translation. Phase II) In the pilot study we detected that patients found some difficulties in connection with the comprehension and self administration of some items. Therefore it was decided to employ trained interviewers, to introduce changes in the IPQ-R(e) format and vocabulary and to adapt a specific version with fewer items that solved most of these difficulties Phase III) Back-translations were very similar to the original version. The BIPQ forward and back-translation process caused no difficulties. CONCLUSIONS: After lingüistic validation, IPQ-R(e) and BIPQ versions conceptually and lingüistically equivalent to original instruments were obtained.

Interprofessional education about shared decision making for patients in primary care settings.

With an increasingly complex array of interventions facing healthcare professionals and patients, coupled with a potentially diverse number of professionals operating within the primary care team, the adoption of shared decision making (SDM) - with or without patients' decision aids - in an interprofessional manner is essential to ensure the highest quality of care for patients. In this article, we propose a framework for interprofessional education about SDM targeted to primary care settings. Five areas of knowledge and skills were agreed to be essential for all relevant stakeholders for interprofessional education in SDM to be successful: understanding the concept of SDM; acquiring relevant communication skills to facilitate SDM; understanding interprofessional sensitivities; understanding the roles of different professions within the relevant primary care group; and acquiring relevant skills to implement SDM. We suggest a series of teaching methods for the aforementioned areas, using principles from adult learning.

Knowledge and adherence to antihypertensive therapy in primary care: results of a randomized trial.

OBJECTIVES: To evaluate the efficacy of a healthcare education program for patients with hypertension. METHODS: A multicenter, prospective, cluster-randomized trial was conducted. Randomization was by primary care center; 18 of 36 urban primary care centers in Barcelona and its metropolitan area were randomized to the intervention group (IG) and 18 to the control group (CG). The study sample consisted of patients with hypertension (n=996; 515 in the IG and 481 in the CG) receiving outpatient treatment with antihypertensive drugs. The intervention consisted of personalized information by a trained nurse and written leaflets. Questionnaires on knowledge and awareness of hypertension and its medication, treatment adherence, healthy lifestyle habits, systolic and diastolic blood pressure, and body mass index were assessed at each visit, with a 12-month follow-up. An intention-to-treat analysis was applied. RESULTS: Knowledge of hypertension increased by 27.8% in the IG and by 18.5% in the CG, while that of medication increased by 10.1% in the IG and 5.5% in the CG. Treatment adherence measured by the Morisky-Green test increased by 9.6% (95% CI: 5.5-13.6) in the IG and 8.8% (95% CI: 4.9-12.6) in the CG. There were no differences in adherence on the other tests used. No differences were observed between the IG and CG in clinical variables such as blood pressure or BMI at the end of the trial. CONCLUSIONS: The educational intervention had no significant impact on patients' adherence to the medication.

[Composite endpoints in clinical trials]. / Variables de resultado combinadas en los ensayos clínicos.

Composite endpoints are often used in clinical trials, especially in the cardiovascular area. Decreases in sample size requirements, ability to assess the net effect of an intervention and to avoid bias in presence of competing risk are the most cited advantages for their use. However, there is a risk of misinterpretation when heterogeneity among components with respect to either importance, number of events or magnitude of treatment effect exist. In the following review we present a conceptual discussion about the rationale and interpretation of such variables. Also, a user's friendly guide to interpret the results of clinical trials based on composite endpoints is presented. We also present an empirical study that provides evidence of the use of misleading composite endpoints in cardiovascular clinical trials.

Variables de resultado combinadas en los ensayos clínicos / Composite endpoints in clinical trials

Las variables de resultado combinadas en los ensayos clínicos son un recurso metodológico usado con frecuencia, especialmente en los estudios cardiovasculares. Las motivaciones más importantes para su utilización son aumentar la potencia estadística del estudio, valorar el beneficio neto de una intervención y evitar una interpretación errónea del resultado en presencia de riesgos competitivos. Sin embargo, su interpretación puede ser problemática si hay heterogeneidad entre los componentes en cuanto a su importancia, la frecuencia de eventos o el efecto de la intervención. En la discusión que sigue se presenta un revisión conceptual de los problemas del uso y la interpretación de las variables de resultado combinadas en ensayos clínicos, especialmente los cardiovasculares. Se presenta además una sencilla guía de interpretación de los resultados de los estudios que utilizan variables de resultado combinadas a partir de la cual se puede valorar nuestra confianza en dichos resultados. Finalmente, se presenta un estudio empírico sobre cuál ha sido el uso real de variables de resultado combinadas potencialmente problemáticas en ensayos clínicos cardiovasculares

Composite endpoints are often used in clinical trials, especially in the cardiovascular area. Decreases in sample size requirements, ability to assess the net effect of an intervention and to avoid bias in presence of competing risk are the most cited advantages for their use. However, there is a risk of misinterpretation when heterogeneity among components with respect to either importance, number of events or magnitude of treatment effect exist. In the following review we present a conceptual discussion about the rationale and interpretation of such variables. Also, a user's friendly guide to interpret the results of clinical trials based on composite endpoints is presented. We also present an empirical study that provides evidence of the use of misleading composite endpoints in cardiovascular clinical trials

Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials.

OBJECTIVE: To explore the extent to which components of composite end points in randomised controlled trials vary in importance to patients, the frequency of events in the more and less important components, and the extent of variability in the relative risk reductions across components. DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Cardiovascular randomised controlled trials published in the Lancet, Annals of Internal Medicine, Circulation, European Heart Journal, JAMA, and New England Journal of Medicine, from 1 January 2002 to 30 June 2003. Component end points of composite end points were categorised according to importance to patients as fatal, critical, major, moderate, or minor. RESULTS: Of 114 identified randomised controlled trials that included a composite end point of importance to patients, 68% (n=77) reported complete component data for the primary composite end point; almost all (98%; n=112) primary composite end points included a fatal end point. Of 84 composite end points for which component data were available, 54% (n=45) showed large or moderate gradients in both importance to patients and magnitude of effect across components. When analysed by categories of importance to patients, the most important components were associated with lower event rates in the control group (medians of 3.3-3.7% for fatal, critical, and major outcomes; 12.3% for moderate outcomes; and 8.0% for minor outcomes). Components of greater importance to patients were associated with smaller treatment effects than less important ones (relative risk reduction of 8% for death and 33% for components of minor importance to patients). CONCLUSION: The use of composite end points in cardiovascular trials is frequently complicated by large gradients in importance to patients and in magnitude of the effect of treatment across component end points. Higher event rates and larger treatment effects associated with less important components may result in misleading impressions of the impact of treatment.