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2型糖尿病筛查的心理影响:嵌入ADDITION(剑桥)随机对照试验的对照试验和比较研究。

Psychological impact of screening for type 2 diabetes: controlled trial and comparative study embedded in the ADDITION (Cambridge) randomised controlled trial.

作者信息

Eborall Helen C, Griffin Simon J, Prevost A Toby, Kinmonth Ann-Louise, French David P, Sutton Stephen

机构信息

General Practice and Primary Care Research Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge CB2 0SR.

出版信息

BMJ. 2007 Sep 8;335(7618):486. doi: 10.1136/bmj.39303.723449.55. Epub 2007 Aug 30.

DOI:10.1136/bmj.39303.723449.55
PMID:17761995
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1971192/
Abstract

OBJECTIVE

To quantify the psychological impact of primary care based stepwise screening for type 2 diabetes.

DESIGN

Controlled trial and comparative study embedded in a randomised controlled trial.

SETTING

15 practices (10 screening, five control) in the ADDITION (Cambridge) trial in the east of England.

PARTICIPANTS

7380 adults (aged 40-69) in the top fourth for risk of having undiagnosed type 2 diabetes (6416 invited for screening, 964 controls).

INTERVENTIONS

Invited for screening for type 2 diabetes or not invited (controls), incorporating a comparative study of subgroups of screening attenders. Attenders completed questionnaires after a random blood glucose test and at 3-6 months and 12-15 months later. Controls were sent questionnaires at corresponding time points. Non-attenders were sent questionnaires at 3-6 months and 12-15 months.

MAIN OUTCOME MEASURES

State anxiety (Spielberger state anxiety inventory), anxiety and depression (hospital anxiety and depression scale), worry about diabetes, and self rated health.

RESULTS

No significant differences were found between the screening and control participants at any time-for example, difference in means (95% confidence intervals) for state anxiety after the initial blood glucose test was -0.53, -2.60 to 1.54, at 3-6 months was 1.51 (-0.17 to 3.20), and at 12-15 months was 0.57, -1.11 to 2.24. After the initial test, compared with participants who screened negative, those who screened positive reported significantly poorer general health (difference in means -0.19, -0.25 to -0.13), higher state anxiety (0.93, -0.02 to 1.88), higher depression (0.32, 0.08 to 0.56), and higher worry about diabetes (0.25, 0.09 to 0.41), although effect sizes were small. Small but significant trends were found for self rated health across the screening subgroups at 3-6 months (P=0.047) and for worry about diabetes across the screen negative groups at 3-6 months and 12-15 months (P=0.001).

CONCLUSIONS

Screening for type 2 diabetes has limited psychological impact on patients. Implementing a national screening programme based on the stepwise screening procedure used in the ADDITION (Cambridge) trial is unlikely to have significant consequences for patients' psychological health.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN99175498 [controlled-trials.com].

摘要

目的

量化基于初级保健的2型糖尿病逐步筛查的心理影响。

设计

嵌入随机对照试验的对照试验和比较研究。

地点

英格兰东部ADDITION(剑桥)试验中的15家医疗机构(10家筛查机构,5家对照机构)。

参与者

7380名40至69岁的成年人,其未确诊2型糖尿病的风险处于前四分之一(6416人受邀参加筛查,964人为对照)。

干预措施

受邀参加或未受邀参加2型糖尿病筛查(对照组),纳入对筛查参与者亚组的比较研究。参与者在随机血糖检测后以及3至6个月和12至15个月后完成问卷调查。对照组在相应时间点收到问卷。未参与者在3至6个月和12至15个月收到问卷。

主要观察指标

状态焦虑(斯皮尔伯格状态焦虑量表)、焦虑和抑郁(医院焦虑抑郁量表)、对糖尿病的担忧以及自我健康评分。

结果

在任何时间,筛查组和对照组参与者之间均未发现显著差异——例如,初始血糖检测后状态焦虑的均值差异(95%置信区间)为-0.53,-2.60至1.54;3至6个月时为1.51(-0.17至3.20);12至15个月时为0.57,-1.11至2.24。初始检测后,与筛查呈阴性的参与者相比,筛查呈阳性的参与者报告的总体健康状况显著较差(均值差异为-0.19,-0.25至-0.13)、状态焦虑更高(0.93,-0.02至1.88)、抑郁更高(0.32,0.08至0.56)以及对糖尿病的担忧更高(0.25,0.09至0.41),尽管效应量较小。在3至6个月时,筛查亚组间自我健康评分存在小但显著的趋势(P=0.047);在3至6个月和12至15个月时,筛查阴性组对糖尿病的担忧存在小但显著的趋势(P=0.001)。

结论

2型糖尿病筛查对患者的心理影响有限。基于ADDITION(剑桥)试验中使用的逐步筛查程序实施全国性筛查计划不太可能对患者的心理健康产生重大影响。

试验注册

Current Controlled Trials ISRCTN99175498 [controlled-trials.com]

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