Baker R, Shiels C, Stevenson K, Fraser R, Stone M
Department of General Practice and Primary Health Care, University of Leicester.
Br J Gen Pract. 2000 Aug;50(457):655-6.
In a randomised trial of the implementation of guidelines for asthma and angina, we sent questionnaires that included a request for consent to collect data from the patient's clinical records to 5069 patients in 81 general practices. Of these 3429 (67.6%) responded, of whom 335 (9.8% [95%, CI = 8.8%-10.8%]) refused consent. We conclude that consent should always be sought unless a research ethics committee has waived this requirement for pressing reasons.
在一项关于哮喘和心绞痛指南实施情况的随机试验中,我们向81家普通诊所的5069名患者发送了问卷,问卷中包括请求患者同意从其临床记录中收集数据。其中3429名患者(67.6%)做出了回应,其中335名(9.8%[95%,置信区间=8.8%-10.8%])拒绝同意。我们得出结论,除非研究伦理委员会因紧迫原因免除了这一要求,否则应始终寻求患者的同意。