背景:行为干预通常很复杂,在多个层面运作,跨设置,并采用一系列行为改变技术。收集和报告初始试验和干预可行性的关键指标对于决定进行大规模试验至关重要。关于可行性指标的报告程度以及这种情况可能随着时间的推移而发生的变化尚不清楚。这项研究的目的是(1)对2020年之前发表的与肥胖有关的行为试点/可行性研究中的可行性指标的报告进行历史范围审查,以及(2)描述报告的可行性指标的数量和类型的趋势在三个时间段内发表的研究:1982-2006,2011-2013和2018-2020。
方法:搜索在线数据库(PubMed,Embase,EBSCOhost,WebofScience)进行了与肥胖相关的健康行为试点/可行性研究,直至2020年12月31日发表,并随机抽样了600项研究,三个时间点(1982-2006年、2011-2013年和2018-2020年)中的每一个都有200个,包含在这次审查中。可行性指标的存在/不存在,包括招聘,保留,参与者的可接受性,出席,合规,和忠诚,为每项研究确定/编码。采用单变量逻辑回归模型来评估可行性指标报告随时间的变化。
结果:总共确定了16,365篇独特文章,其中6873篇进行了审查,以得出600项研究的最终样本。对于总样本,428项(71.3%)研究提供了招聘信息,595(99.2%)提供了保留信息,219(36.5%)报告了定量可接受性结果,157(26.2%)报告了定性可接受性结果,199(33.2%)报告出勤率,187(31.2%)报告参与者合规,23(3.8%)报告了成本信息,85例(14.2%)报告了治疗结果的真实性.与早期集团(1982-2006)相比,晚期组(2018-2020年)的研究更有可能报告招聘信息(OR=1.60,95CI1.03-2.49),可接受性相关的定量(OR=2.68,95CI1.76-4.08)和定性(OR=2.32,95CI1.48-3.65)结果,依从性结果(OR=2.29,95CI1.49-3.52),和保真度结果(OR=2.13,95CI1.21,3.77)。
结论:行为试点/可行性研究中的可行性指标报告随着时间的推移有所改善,但是可行性的关键方面,比如忠诚,在大多数研究中仍未报告。鉴于行为干预试点/可行性研究在转化科学领域的重要性,有必要改进可行性指标的报告。
BACKGROUND: Behavioral interventions are often complex, operate at multiple levels, across settings, and employ a range of behavior change techniques. Collecting and reporting key indicators of initial trial and intervention feasibility is essential to decisions for progressing to larger-scale trials. The extent of reporting on feasibility indicators and how this may have changed over time is unknown. The aims of this study were to (1) conduct a historical scoping
review of the reporting of feasibility indicators in
behavioral pilot/feasibility studies related to obesity published through 2020, and (2) describe trends in the amount and type of feasibility indicators reported in studies published across three time periods: 1982-2006, 2011-2013, and 2018-2020.
METHODS: A search of online databases (PubMed, Embase, EBSCOhost, Web of Science) for health behavior pilot/feasibility studies related to obesity published up to 12/31/2020 was conducted and a random sample of 600 studies, 200 from each of the three timepoints (1982-2006, 2011-2013, and 2018-2020), was included in this
review. The presence/absence of feasibility indicators, including recruitment, retention, participant acceptability, attendance, compliance, and fidelity, were identified/coded for each study. Univariate logistic regression models were employed to assess changes in the reporting of feasibility indicators across time.
RESULTS: A total of 16,365 unique articles were identified of which 6873 of these were reviewed to arrive at the final sample of 600 studies. For the total sample, 428 (71.3%) studies provided recruitment information, 595 (99.2%) provided retention information, 219 (36.5%) reported quantitative acceptability outcomes, 157 (26.2%) reported qualitative acceptability outcomes, 199 (33.2%) reported attendance, 187 (31.2%) reported participant compliance, 23 (3.8%) reported cost information, and 85 (14.2%) reported treatment fidelity outcomes. When compared to the Early Group (1982-2006), studies in the Late Group (2018-2020) were more likely to report recruitment information (OR=1.60, 95%CI 1.03-2.49), acceptability-related quantitative (OR=2.68, 95%CI 1.76-4.08) and qualitative (OR=2.32, 95%CI 1.48-3.65) outcomes, compliance outcomes (OR=2.29, 95%CI 1.49-3.52), and fidelity outcomes (OR=2.13, 95%CI 1.21, 3.77).
CONCLUSIONS: The reporting of feasibility indicators within behavioral pilot/feasibility studies has improved across time, but key aspects of feasibility, such as fidelity, are still not reported in the majority of studies. Given the importance of
behavioral intervention pilot/feasibility studies in the translational science spectrum, there is a need for improving the reporting of feasibility indicators.