Predictors of Effective Scaling: A Meta-Epidemiological Study of Bias in Early-Stage Studies to Prevent Chronic Disease

项目概要/摘要 开发既有效又可扩展的行为干预措施是一个主要的 行为科学领域的挑战。许多行为干预在其早期表现出希望， 测试，只是在一个更大的，更有力的评估中失败。这种常见模式（即初始 承诺然后失败）浪费宝贵的资源和时间。本提案的目的是调查 在发展公共卫生行为方面的初步、早期研究（例如试点、可行性研究） 注意在早期阶段测试中引入的内部和外部偏见。本研究将 利用已开发的搜索策略和现有资源，开展一系列元流行病学研究， 针对成年人体力活动和饮食行为的行为干预评论。在这些评论中， 行为干预与已发表的早期研究和已发表的，更有力的试验， 相同/类似的干预措施将被系统编码，以确定是否存在外部和内部有效性偏倚。 将运行荟萃回归模型，以了解早期研究中每种偏倚的存在/不存在， 影响干预措施更大迭代的效果大小和重要性。该项目的目标是告知 未来的身体活动和饮食/营养行为干预研究，提高其效率，并最终， 行为干预研究对解决慢性非传染性疾病的有效性。目标1是 确定成人体力活动和饮食样本中外部效度偏差的流行程度和影响 干预措施。目标2是对目标1的主要/资深作者进行定性访谈，以更好地了解 早期研究和更有效研究之间确定差异/相似性的原因。通过 该项目的执行将获得以下内容：广泛的技能，系统审查，元分析 技术、元流行病学方法、定性研究过程和科学交流 包括同行评审的出版物，科学报告，导师同行评审，以及起草博士后 补助金申请拟议的F31研究意义重大，因为拟议研究的结果将确定 导致功效良好的试验成功和不成功的扩展的特征，可能增加 行为干预发展的速度。这项研究是创新的，因为它将是第一个 确定成人体力活动和饮食中外部和内部偏见的流行程度和影响 行为干预。

PROJECT SUMMARY/ABSTRACT Developing behavioral interventions that are both effective/efficacious and that can be scaled is a major challenge in the field of behavioral science. Many behavioral interventions demonstrate early promise in their testing, only to fail to be effective during a larger, more well-powered evaluation. This common pattern (i.e. initial promise then fail) wastes valuable resources and time. The objective of this proposal is to investigate the role of preliminary, early-stage studies (e.g. pilot, feasibility studies) in the development of public health behavioral interventions with attention to internal and external biases introduced during early stage testing. This study will capitalize on developed search strategies and established resources to conduct a series of meta-epidemiological reviews of behavioral interventions targeting adult physical activity and dietary behaviors. In these reviews, behavioral interventions with a published early-stage study and a published, more well-powered trial of the same/similar intervention will be systematically coded for the presence of external and internal validity biases. Meta-regression models will be run to understand how the presence/absence of each bias in early-stage studies, influences the effect size and significance of larger iterations of the intervention. This project’s goal is to inform future physical activity and diet/nutrition behavioral intervention studies, increasing their efficiency and ultimately, the effectiveness of behavioral intervention research to address chronic, non-communicable disease. Aim 1 is to identify the prevalence and impact of external validity biases in a sample of adult physical activity and diet interventions. Aim 2 is to conduct qualitative interviews with lead/senior authors from Aim 1 to better understand the reasons for identified differences/similarities between early-stage and more well-powered studies. Through the execution of this project the following will be gained: extensive skills in systematic-review, meta-analytic techniques, meta-epidemiological methods, qualitative research processes, and scientific communication including peer-reviewed publication, scientific presentation, mentor peer-reviewed, and a drafted post-doctoral grant application. The proposed F31 study is significant because findings from the proposed study will identify characteristics that lead to successful and unsuccessful scaling of well-powered trials, potentially increasing the speed of behavioral intervention development. This study is innovative because it will be among the first to establish the prevalence and impact of external and internal biases in adult physical activity and dietary behavioral interventions.