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丹麦肺癌筛查试验中,心理社会状况、社会人口统计学和吸烟状况是否会影响对照组参与者的失访?一项嵌套观察性研究。

Did psychosocial status, sociodemographics and smoking status affect non-attendance in control participants in the Danish Lung Cancer Screening Trial? A nested observational study.

机构信息

The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark

The Primary Health Care Research Unit, Region Zealand, Copenhagen, Denmark.

出版信息

BMJ Open. 2020 Feb 20;10(2):e030871. doi: 10.1136/bmjopen-2019-030871.

Abstract

OBJECTIVES

We investigated if psychosocial status, sociodemographics and smoking status affected non-attendance in the control group in the randomised Danish Lung Cancer Screening Trial (DLCST).

DESIGN AND SETTING

This study was an observational study nested in the DLCST. Due to large non-attendance in the control group in the second screening round we made an additional effort to collect questionnaire data from non-attenders in this group in the third screening round. We used a condition-specific questionnaire to assess psychosocial status. We analysed the differences in psychosocial status in the third and preceding rounds between non-attenders and attenders in the control group in multivariable linear regression models adjusted for sociodemographics and smoking status reported at baseline. Differences in sociodemographics and smoking status were analysed with χ tests (categorical variables) and t-tests (continuous variables).

PRIMARY OUTCOME MEASURE

Primary outcome was psychosocial status.

PARTICIPANTS

All control persons participating in the third screening round in the DLCST were included.

RESULTS

Non-attenders in the third round had significantly worse psychosocial status than attenders in the scales: 'behaviour' 0.77 (99% CI 0.18 to 1.36), 'self-blame' 0.59 (99% CI 0.14 to 1.04), 'focus on airway symptoms' 0.22 (99% CI 0.08 to 0.36), 'stigmatisation' 0.51 (99% CI 0.16 to 0.86), 'introvert' 0.56 (99% CI 0.23 to 0.89) and 'harms of smoking' 0.35 (99% CI 0.11 to 0.59). Moreover, non-attenders had worse scores than attendees in the preceding screening rounds. Non-attenders also reported worse sociodemographics at baseline.

CONCLUSIONS

Non-attenders had a significantly worse psychosocial status and worse sociodemographics compared with attenders. The results of our study contribute with evidence of non-response and attrition driven by psychosocial status, which in turn may be influenced by the screening intervention itself. This can be used to adjust cancer screening trial results for bias due to differential non-attendance.

TRIAL REGISTRATION NUMBER

Clinicaltrials.gov Protocol Registration System (NCT00496977).

摘要

目的

我们研究了在丹麦肺癌筛查试验(DLCST)的对照组中,心理社会状况、社会人口统计学和吸烟状况是否会影响不参加筛查。

设计和设置

这是一项嵌套在 DLCST 中的观察性研究。由于对照组在第二轮筛查中有大量的不参加者,我们在第三轮筛查中对这组不参加者进行了额外的问卷调查。我们使用特定于疾病的问卷来评估心理社会状况。我们在多变量线性回归模型中分析了对照组中第三轮和前两轮的不参加者与参加者之间心理社会状况的差异,这些模型调整了基线时报告的社会人口统计学和吸烟状况。社会人口统计学和吸烟状况的差异用卡方检验(分类变量)和 t 检验(连续变量)进行分析。

主要结局指标

主要结局是心理社会状况。

参与者

所有参加 DLCST 第三轮筛查的对照组人员均被纳入研究。

结果

与参加者相比,第三轮的不参加者在以下量表中表现出更差的心理社会状态:“行为”0.77(99%CI 0.18 至 1.36),“自责”0.59(99%CI 0.14 至 1.04),“关注气道症状”0.22(99%CI 0.08 至 0.36),“污名化”0.51(99%CI 0.16 至 0.86),“内向”0.56(99%CI 0.23 至 0.89)和“吸烟危害”0.35(99%CI 0.11 至 0.59)。此外,不参加者在前几轮筛查中的得分也比参加者差。不参加者在基线时的社会人口统计学状况也较差。

结论

与参加者相比,不参加者的心理社会状态更差,社会人口统计学状况更差。我们的研究结果提供了证据,证明不参加者的心理社会状态和不参加率受到了影响,而这反过来又可能受到筛查干预本身的影响。这可以用于调整癌症筛查试验结果,以消除因不同的不参加率而导致的偏差。

试验注册号

Clinicaltrials.gov 方案注册系统(NCT00496977)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4efa/7044926/11f5374f791a/bmjopen-2019-030871f01.jpg

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