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间隔性生活事件是随机试验结果异质性的一个重要决定因素:一种新颖、简单的评估方法。

Interval life events are an important determinant of heterogeneity in outcomes in a randomised trial: a novel, simple method of assessment.

机构信息

Medicine, Weill Cornell Medical College, New York City, New York, USA

Statistics and Data Science, Cornell University, Ithaca, New York, USA.

出版信息

BMJ Open. 2024 Jul 30;14(7):e074623. doi: 10.1136/bmjopen-2023-074623.

DOI:10.1136/bmjopen-2023-074623
PMID:39079918
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11337663/
Abstract

OBJECTIVE

Although life events are clearly important to health, most of the scientific focus has been on baseline life events that occur prior to a study. Life events that occur after enrolment, that is, interval life events, have had almost no attention. The aim of this analysis of data was to develop a method for measuring interval life events that could be used in clinical trials and other longitudinal studies.

DESIGN

Small Changes and Lasting Effects (SCALE) was a 12-month weight-loss randomised controlled trial (RCT). This was an analysis of the SCALE follow-up data.

SETTING

Healthcare networks, outpatient clinics and community churches in the South Bronx and Harlem areas of New York City.

PARTICIPANTS

Overweight black and Latino adults. This analysis focuses on the 330 of the 405 patients who had >4 weeks of follow-up with at least one perceived stress score (PSS).

INTERVENTION

The SCALE RCT was published elsewhere and involved positive affect and self-affirmation to increase behaviour change.

OUTCOME

5% weight loss.

FOLLOW-UP: Over 12 months, up to 27 follow-ups were conducted that evaluated interval life events, eating and physical activity behaviour, weight and perceived stress. During these follow-ups, participants were asked two open-ended questions to capture interval life events. The interval life events were qualitatively coded into categories. The interval life events categories were compared with interval monthly measures of perceived stress using the 4-item PSS scale.

RESULTS

During the interval follow-ups for the RCT, 70.6% of the 330 patients reported at least one interval life event, which occurred during a median of 15 follow-ups (95% CI: 5 to 24). The median number of interval events was 2 (95% CI: 0 to 8): 30.6% reported their own illness; 22%, death or bereavement; 21.8%, illness in the family and 13.1%, family conflicts. The mean perceived stress score (PSS-4) assessed over the year of follow-up was 3.2±2.7. Mean perceived stress (PSS-4) increased, especially for interval financial events, major conflict with a partner and unemployment, but by less for deaths, family illness and family conflict. Participants with the most interval life events had the greatest increase in interval perceived stress (p<0.0001). Of note, neither high baseline perceived stress (PSS-10 >20) nor baseline depression (Patient Health Questionnaire-9 >10) were associated with higher interval life events (p>0.05); but those with lower social support had more events. However, those with either depression or stress had higher interval stress responses. Most participants had neither baseline nor interval events, and the percentage with both was small so that baseline events did not predict subsequent perceived stress.

CONCLUSIONS

This method provides a straightforward method of assessing interval life events, by asking two open-ended questions, that can be coded in a simple categorical framework. Such events can affect outcomes in longitudinal studies and trials in part by increasing perceived stress. This framework moves beyond the events identified as important in the 1950s and recognises that specific life events may have significantly different life impacts in different individuals.

TRIAL REGISTERATION NUMBER

NCT01198990; Post-results.

摘要

目的

尽管生活事件对健康显然很重要,但大多数科学研究的重点都集中在研究前发生的基本生活事件上。入组后发生的生活事件,即间隔期生活事件,几乎没有得到关注。本数据分析旨在开发一种可用于临床试验和其他纵向研究的测量间隔期生活事件的方法。

设计

小变化和持久影响(SCALE)是一项为期 12 个月的减肥随机对照试验(RCT)。这是对 SCALE 随访数据的分析。

地点

纽约市南布朗克斯和哈莱姆地区的医疗保健网络、门诊诊所和社区教堂。

参与者

超重的黑人和拉丁裔成年人。本分析重点关注 405 名患者中的 330 名,他们的随访时间超过 4 周,至少有一次感知压力评分(PSS)。

干预措施

SCALE RCT 已在其他地方发表,涉及积极的情感和自我肯定,以增加行为改变。

结果

体重减轻 5%。

随访

在 12 个月的时间里,进行了多达 27 次随访,评估了间隔期生活事件、饮食和身体活动行为、体重和感知压力。在这些随访中,参与者被要求回答两个开放式问题,以捕捉间隔期生活事件。将间隔期生活事件定性编码为不同类别。使用 4 项 PSS 量表,将间隔期生活事件类别与每月间隔期感知压力测量结果进行比较。

结论

该方法通过询问两个开放式问题,提供了一种简单的评估间隔期生活事件的方法,可以在简单的分类框架中进行编码。此类事件可能会通过增加感知压力,对纵向研究和试验的结果产生影响。该框架超越了 20 世纪 50 年代确定的重要事件,并认识到特定的生活事件可能会对不同个体产生显著不同的生活影响。

试验注册号

NCT01198990;试验后注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1726/11337663/bdae273ffc36/bmjopen-14-7-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1726/11337663/88d9e285eb26/bmjopen-14-7-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1726/11337663/837d4445b29f/bmjopen-14-7-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1726/11337663/35b0d2a6a7be/bmjopen-14-7-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1726/11337663/bdae273ffc36/bmjopen-14-7-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1726/11337663/88d9e285eb26/bmjopen-14-7-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1726/11337663/837d4445b29f/bmjopen-14-7-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1726/11337663/35b0d2a6a7be/bmjopen-14-7-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1726/11337663/bdae273ffc36/bmjopen-14-7-g004.jpg

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