Huibers Marcus J H, Bleijenberg Gijs, Beurskens Anna J H M, Kant I Jmert, Knottnerus J André, van der Windt Daniëlle A W M, Bazelmans Ellen, van Schayck Constant P
Department of Epidemiology, Maastricht University, The Netherlands.
Fam Pract. 2004 Apr;21(2):213-8. doi: 10.1093/fampra/cmh219.
Although the randomized controlled trial is widely accepted as the best design to investigate new interventions, conducting a trial in primary care may present researchers with many methodological problems.
Our aim was to present an alternative trial design to overcome internal validity and recruitment problems.
In a randomized controlled trial, fatigued employees absent from work were selected among the population of an occupational health service in the South of The Netherlands. Patients randomly assigned to the experimental condition received cognitive behavioural therapy by a research GP near their home address, whereas patients in the control group received no intervention. We describe our considerations for building an alternative design. Research GPs and patients were recruited separately for the study. The pre-randomization design was applied.
Nine research GPs performed all the interventions. Seventy-six experimental patients and 75 control patients were selected for study participation. Of these, only six patients in the experimental group and seven patients in the control group withdrew from the study at some point during follow-up.
Results suggest that recruitment and randomization procedures in the alternative design served their purpose well. The alternative design proposed here might have several advantages compared with conventional trial procedures. However, our design is not widely applicable and there are ethical aspects involved that should be considered. Researchers should address their creativity when trying to minimize the problems they may encounter in designing a study.
尽管随机对照试验被广泛认为是研究新干预措施的最佳设计，但在初级保健中开展试验可能会给研究人员带来许多方法学问题。
我们的目的是提出一种替代试验设计，以克服内部效度和招募问题。
在一项随机对照试验中，从荷兰南部一家职业健康服务机构的人群中选取缺勤的疲劳员工。随机分配到试验组的患者由离家较近的研究全科医生提供认知行为疗法，而对照组患者不接受任何干预。我们描述了构建替代设计的考量因素。研究全科医生和患者分别为该研究招募。采用随机前设计。
9名研究全科医生实施了所有干预措施。76名试验组患者和75名对照组患者被选入研究。其中，试验组只有6名患者和对照组只有7名患者在随访期间的某个时间点退出了研究。
结果表明，替代设计中的招募和随机程序很好地实现了其目的。与传统试验程序相比，这里提出的替代设计可能有几个优点。然而，我们的设计并非广泛适用，并且涉及一些伦理方面的问题需要考虑。研究人员在试图最小化研究设计中可能遇到的问题时应发挥创造力。
