Aspectos organizativos de los ensayos clínicos en atención primaria

Abstract

Objective To identify health professionals concerns on the organisational issues of a randomised clinical trial. Design A qualitative cross-sectional,descriptive study. Setting Primary Care Area 11, Madrid, Spain. Participants Tweenty-four doctors and nurses from 4 primary care teams. Method Three planning meetings with researchers. Design of an anonymous self-administered questionnaire to collect researchers’ perceptions on design, method, and organisation during the implementation of a clinical trial. Results The prestige of being involved in a multi-centre nationwide project, the training sessions offered, a primary care research topic, a working team model of doctor and nurse, and the support provided by team from the 11th Area, were the main organizational incentives. Lack of time, increased clinic workload, and methodological difficulties are discouraging issues. 79.2% (19/24) of the researchers returned the questionnaire. 94.7% (18/19) considered themselves highly motivated. 84.2% (16/19) of researchers, the time required to complete recruitment was reasonable. The 57.9% (13/19) spent 20-25 minutes collecting data at the interview. Cooperation between doctors and nurses had been effective for 68.4% (13/19) of researchers. 89.4% (17/18) considered that support from the Area 11 organisers was useful. Conclusions Organisational barriers for implementation are: complexity of data collection at the recruitment interview, design and methodological issues too unrealistic for a primary care setting, and lack of time and extra workload at consultations. The factors that make organisation easier are: having a high level of motivation, sharing workload with other professionals, and support provided by organisers of the trial.