种族和民族对旨在改善外周动脉疾病患者身体健康状况的动机性访谈干预的调节作用：一项试点随机试验的二次分析。
完整摘要 · 中文译文
背景：在一项试点随机试验中，对于外周动脉疾病（PAD）患者，面对面或电话动机性访谈（MI）在3个月时在增加6分钟步行距离（主要结局）和降低体重（次要结局）方面比一款智能手机应用程序更有效。关于与健康社会决定因素（SDOH）相关的干预异质性，目前所知甚少。 目的：本研究旨在探索SDOH是否与MI对步行距离和体重减轻的干预效果相关，并产生干预异质性假设。 方法：通过社区渠道招募堪萨斯州威奇托的社区居民，并筛查PAD。获得同意的参与者被随机分配至MI组（n=16）或应用程序组（n=13）。使用调查工具测量SDOH、人口统计学特征和不良童年经历，并评估其与6分钟步行距离变化和体重减轻的关联。使用Wilcoxon和Kruskal-Wallis非参数检验，对SDOH分层之间的中位变化进行双重差分（DiD）比较。 结果：对于6分钟步行距离，“其他”种族和族裔参与者的前测-后测变化显著大于非西班牙裔白人参与者（DiD=44.0米，95% CI 19.2-164.2；P=.004），其他SDOH的DiD均不显著。在拥有大学或更高教育程度者（48.8米，95% CI 28.0-61.4）和未婚个体（40.4米，95% CI 0.5-56. 0）、与家人同住者（55.7米，95% CI 30.5-199.5）、每周与家人或朋友交谈及见面3次或以上者（46.4米，95% CI 17.2-69.4），以及无未满足日常需求者（46.5米，95% CI 7.6-67.1）。对于体重减轻，我们未观察到与任何SDOH相关的显著DiD。然而，在我们观察到6分钟步行距离显著增加的每一个SDOH分层中，均观察到显著的中位体重减轻。在另外5个SDOH分层中也观察到显著的体重减轻：男性个体、家庭收入低于30,000美元、从未在军队服役、在职状态以及无压力。体重减轻和步行距离的改善在方向和幅度上跨SDOH分层高度一致。 结论：本项先导研究首次探索了潜在的SDOH相关干预效应修饰及异质性。步行距离与种族和民族之间的显著关联提示了潜在的效应修饰。两项结局在同一SDOH分层中均观察到显著的前测-后测改善。尽管样本量较小，但两项结局及所有SDOH分层间高度一致的证据为潜在干预疗效及异质性提供了信心。我们的发现与已确立的SDOH与外周动脉疾病患者一般功能之间的关联一致，提示可能的介导途径为健康素养和社会支持。未来的干预措施应考虑异质性，以针对社会处境不利的外周动脉疾病患者，从而缩小差距并最大化获益。 试验注册：ClinicalTrials.gov NCT03694652；https://clinicaltrials.gov/ct2/show/NCT03694652。 国际注册报告标识符（IRRID）：RR2-10.2196/30295。
完整摘要 · 英文原文
BACKGROUND: In a pilot randomized trial, face-to-face or telephone motivational interviewing (MI) was more efficacious than a smartphone app after 3 months for increasing 6-minute walk distance (primary outcome) and reducing body weight (secondary outcome) in patients with peripheral artery disease (PAD). Little is known about intervention heterogeneity related to social determinants of health (SDOH). OBJECTIVE: This study aimed to explore whether SDOH are associated with the MI intervention effects on walking distance and weight loss and generate intervention heterogeneity hypotheses. METHODS: Community dwellers in Wichita, Kansas, were recruited through community outlets and screened for PAD. Consented participants were randomly assigned to MI (n=16) or an app (n=13). Survey instruments were used to measure SDOH, demographics, and adverse childhood experiences, which were assessed for their associations with 6-minute walk distance change and weight loss. Difference-in-differences (DiD) comparisons of median changes between SDOH strata were conducted using Wilcoxon and Kruskal-Wallis nonparametric tests. RESULTS: For 6-minute walk distance, pretest-posttest changes were significantly greater among participants of "other" race and ethnicity than among non-Hispanic White participants (DiD=44.0 m, 95% CI 19.2-164.2; P=.004), and no DiDs for other SDOH were significant. Significant median pretest-posttest increases in walking distance were observed in those with a college or higher educational attainment (48.8 m, 95% CI 28.0-61.4), unmarried individuals (40.4 m, 95% CI 0.5-56.0), those living with family (55.7 m, 95% CI 30.5-199.5), those who talked to and saw family or friends 3 or more times a week (46.4 m, 95% CI 17.2-69.4), and those without unmet daily needs (46.5 m, 95% CI 7.6-67.1). For weight loss, we did not observe significant DiDs with any SDOH. However, a significant median weight loss was observed in every SDOH stratum where we observed a significant increase in 6-minute walk distance. Significant weight loss was also observed in 5 additional SDOH strata: male individuals, household income below US $30,000, never served in military, employed status, and no stress. The improvements in weight loss and walking distance were highly consistent in both direction and size across SDOH strata. CONCLUSIONS: This pilot study was the first to explore potential SDOH-related intervention effect modification and heterogeneity. The significant association between walking distance and race and ethnicity suggested a potential effect modification. Significant pretest-posttest improvements in both outcomes were found in the same SDOH strata. The highly consistent evidence across both outcomes and all SDOH strata provided confidence in potential intervention efficacy and heterogeneity despite the small sample size. Our findings were consistent with established associations between SDOH and general functions in patients with PAD, suggesting likely mediation pathways through health literacy and social support. Future interventions should consider heterogeneity to target socially disadvantaged patients with PAD to bridge disparities and maximize benefits. TRIAL REGISTRATION: ClinicalTrials.gov NCT03694652; https://clinicaltrials.gov/ct2/show/NCT03694652. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/30295.