The University of New Mexico, United States.
Cardiff University, Wales, United Kingdom.
Contemp Clin Trials. 2014 Mar;37(2):234-41. doi: 10.1016/j.cct.2014.01.005. Epub 2014 Jan 24.
There is often wide variability in the reported effects of complex behavioral interventions. Effectiveness can vary across studies, sites, and providers. A factor that has been insufficiently considered is the fidelity of the behavioral treatment that was provided. Low quality practice could be likened to partial doses of a vaccine or antibiotic: the right idea but insufficient strength. Using motivational interviewing (MI) as an example, the authors describe three quality conditions that should be present for a study to be regarded as a trial of a complex behavioral intervention: (1) The treatment should clearly contain the components that are theoretically or empirically related to its efficacy; (2) providers should be trained to an adequate and specified criterion of proficiency before treating trial patients; and (3) the fidelity of treatment should be documented by reliable coding of practice throughout the study and reported in a manner that permits comparison with skill levels in other trials. The authors also discuss bona fide intervention failures despite strong clinical trial methodology, offering recommendations for future outcome research.
复杂行为干预措施的报告效果常常存在很大差异。有效性可能因研究、地点和提供者而异。一个尚未充分考虑的因素是所提供的行为治疗的保真度。低质量的实践可以比作疫苗或抗生素的部分剂量：想法正确但力度不足。作者以动机性访谈 (MI) 为例，描述了三个质量条件，对于一项研究被视为复杂行为干预措施的试验，这些条件应该存在：(1) 治疗应明确包含与疗效理论或经验相关的成分；(2) 在治疗试验患者之前，应按照足够和规定的熟练标准对提供者进行培训；(3) 通过在整个研究过程中对实践进行可靠编码来记录治疗的保真度，并以允许与其他试验中的技能水平进行比较的方式报告。作者还讨论了尽管有强大的临床试验方法，但仍存在真正的干预失败的情况，并为未来的结果研究提出了建议。
