Gaul Charly, Malcherczyk Annett, Schmidt Thomas, Helm Jürgen, Haerting Johannes
Klinik für Neurologie, Universitätsklinikum Essen, Essen, Germany.
Med Klin (Munich). 2010 Feb;105(2):73-9. doi: 10.1007/s00063-010-1016-4. Epub 2010 Feb 20.
Difficulties in recruiting patients for clinical trials lead to increasing costs, and prolonged implementation of evidences into medical practice. Knowledge about motivation and barriers in potential participants would be helpful to develop successful recruitment strategies. Currently, no systematic research of determining factors affecting the decision to participate in clinical studies is available from German samples.
After been given details about a potential participation in a clinical or diagnostic study in nine study centers, patients were recruited for an additional structured questionnaire survey concerning motivation and barriers to participation.
62 patients were included into the survey. 95.1% did not have any experience with clinical studies before. 66.1% met the physician explaining the study and asking for informed consent for the first time. Despite this, 96.6% judged the physician to be competent. Family and friends were important for decision-making about the participation in a study. Gender was only of marginal influence. The majority of patients (91.4%) expected advantages of the study for their own. 88% of the patients denominated potential advantages for other patients as an additional motivator. The possibility of adverse events was inferior for patients in decision-making about participation in a clinical trial.
Physicians recruiting patients for clinical studies should be well prepared about details of the study and should have adequate time for an introductory conversation in a quiet environment. Including relatives into the introductory conversation may enhance the motivation and therefore the success of recruitment. Potential advantages of a participation for the own treatment and additionally for other patients should be highlighted. Possible side effects should be explained in a realistic manner.
招募患者参与临床试验存在困难,这导致成本增加,且将证据应用于医学实践的时间延长。了解潜在参与者的动机和障碍有助于制定成功的招募策略。目前,尚无来自德国样本的关于影响参与临床研究决策的决定因素的系统研究。
在九个研究中心向患者详细介绍了参与临床或诊断研究的可能性后,招募患者进行关于参与动机和障碍的额外结构化问卷调查。
62名患者纳入调查。95.1%的患者此前没有任何临床研究经验。66.1%的患者是首次见到解释研究并要求获得知情同意的医生。尽管如此,96.6%的患者认为医生有能力。家人和朋友对参与研究的决策很重要。性别影响很小。大多数患者(91.4%)期望研究对自己有益。88%的患者将对其他患者的潜在益处视为额外的激励因素。在参与临床试验的决策中,患者对不良事件可能性的担忧较低。
招募患者参与临床研究的医生应充分准备好研究细节,并应有足够时间在安静环境中进行介绍性谈话。让亲属参与介绍性谈话可能会增强动机,从而提高招募成功率。应强调参与对自身治疗以及对其他患者的潜在益处。应实事求是地解释可能的副作用。