对心血管疾病高危人群进行生活方式干预的随机对照试验的反应偏倚：一项横断面分析。
Response bias to a randomised controlled trial of a lifestyle intervention in people at high risk of cardiovascular disease: a cross-sectional analysis.
机构信息
Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College Londonz, 10 Cutcombe Road, London, SE5 9RJ, UK.
Department of Biostatistics, Institute of Psychiatry, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.
出版信息
BMC Public Health. 2018 Sep 4;18(1):1092. doi: 10.1186/s12889-018-5939-y.
BACKGROUND
Research evaluating lifestyle interventions for prevention of cardiovascular disease (CVD) may not reach those most at risk. We compared the response rate to a randomised controlled trial (RCT) of a lifestyle intervention by CVD risk, ethnicity and level of deprivation.
METHODS
Primary care patients with a QRisk2 score ≥ 20% were invited to participate in a RCT of an intensive lifestyle intervention versus usual care. This cross-sectional analysis compares anonymised data of responders and non-responders with multiple logistic regression, using adjusted odds ratios (AORs) for QRisk2 score, ethnicity, Index of Multiple Deprivation (IMD 2010) quintile, age and sex.
RESULTS
From 60 general practices, 8902 patients were invited and 1489 responded. The mean age was 67.3 years and 21.0% were female. Of all patients invited, 69.9% were of white ethnic background, 13.9% ethnic minority backgrounds and 16.2% had no ethnicity data recorded in their medical records. Likelihood of response decreased as QRisk2 score increased (AOR 0.82 per 5 percentage points, 95% CI 0.77-0.88). Black African or Caribbean patients (AOR 0.67; 95% CI 0.45-0.98) and those with missing ethnicity data (AOR 0.55; 95% CI 0.46-0.66) were less likely to respond compared to participants of white ethnicity, but there was no difference in the response rates between south Asian and white ethnicity (AOR 1.08; 95% CI 0.84-1.38). Patients residing in the fourth (AOR 0.70; 95% CI 0.56-0.87) and fifth (AOR 0.52; 95% CI 0.40-0.68) most deprived IMD quintile were less likely to respond compared to the least deprived quintile.
CONCLUSIONS
Evaluations of interventions intended for those at high risk of CVD may fail to reach those at highest risk. Hard to reach patient groups may require different recruitment strategies to maximise participation in future trials. Improvements in primary care ethnicity data recording is required to aid understanding of how successfully study samples represent the target population.
TRIAL REGISTRATION
ISRCTN, ISRCTN84864870. Registered 15 May 2012, https://doi.org/10.1186/ISRCTN84864870 .
背景
评估生活方式干预预防心血管疾病（CVD）的研究可能无法覆盖到那些风险最高的人群。我们比较了 CVD 风险、种族和贫困程度对生活方式干预随机对照试验（RCT）应答率的影响。
方法
对 QRisk2 评分≥20%的初级保健患者进行邀请，参与一项强化生活方式干预与常规护理的 RCT。这项横断面分析使用 QRisk2 评分、种族、多因素剥夺指数（IMD 2010）五分位数、年龄和性别调整后的比值比（AOR），比较了应答者和未应答者的匿名数据。
结果
从 60 家普通诊所共邀请了 8902 名患者，有 1489 名患者应答。平均年龄为 67.3 岁，21.0%为女性。所有受邀患者中，69.9%为白人，13.9%为少数族裔，16.2%的患者医疗记录中没有种族数据记录。应答率随 QRisk2 评分的增加而降低（每增加 5 个百分点的 AOR 为 0.82，95%CI 0.77-0.88）。与白人参与者相比，黑非洲裔或加勒比裔患者（AOR 0.67；95%CI 0.45-0.98）和无种族数据记录的患者（AOR 0.55；95%CI 0.46-0.66）应答的可能性较低，但南亚裔和白种人之间的应答率没有差异（AOR 1.08；95%CI 0.84-1.38）。居住在第四（AOR 0.70；95%CI 0.56-0.87）和第五（AOR 0.52；95%CI 0.40-0.68）最贫困 IMD 五分位数的患者应答的可能性低于最不贫困五分位数的患者。
结论
评估针对 CVD 高危人群的干预措施可能无法覆盖到风险最高的人群。难以接触到的患者群体可能需要不同的招募策略，以最大限度地提高未来试验的参与度。需要改善初级保健种族数据记录，以帮助了解研究样本在多大程度上代表目标人群。
试验注册
ISRCTN，ISRCTN84864870。2012 年 5 月 15 日注册，https://doi.org/10.1186/ISRCTN84864870。
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