Cole Judith A, Gillespie Paddy, Smith Susan M, Byrne Molly, Murphy Andrew W, Cupples Margaret E
Department of General Practice and Primary Care, Queen's University Belfast, Dunluce Health Centre, 1 Dunluce Avenue, Belfast BT9 7HR, UK.
BMC Res Notes. 2014 Oct 15;7:725. doi: 10.1186/1756-0500-7-725.
Patient reported outcome measures (PROMs) are used to evaluate lifestyle interventions but little is known about differences between patients returning valid and invalid responses, or of potential for bias in evaluations. We aimed to examine the characteristics of patients who returned valid responses to lifestyle questionnaires compared to those whose responses were invalid for evaluating lifestyle change.
We conducted a secondary data analysis from the SPHERE Study, a trial of an intervention to improve outcomes for patients with coronary heart disease in primary care. Postal questionnaires were used to assess physical activity (Godin) and diet (DINE) among study participants at baseline and 18 month follow-up. Three binary response variables were generated for analysis: (1) valid Godin score; (2) valid DINE Fibre score; and (3) valid DINE Total Fat score. Multivariate analysis comprised generalised estimating equation regression to examine the association of patients' characteristics with their return of valid responses at both timepoints.
Overall, 92.1% of participants (832/903) returned questionnaires at both baseline and 18 months. Relatively fewer valid Godin scores were returned by those who left school aged <15 years (36.5%) than aged 18 and over (50.5%), manual workers (39.5%) than non-manual (49.5%) and those with an elevated cholesterol (>5 mmol) (34.7%) than those with a lower cholesterol (44.4%) but multivariate analysis identified that only school leaving age (p = 0.047) was of statistical significance.Relatively fewer valid DINE scores were returned by manual than non-manual workers (fibre: 80.8% v 86.8%; fat: 71.2% v 80.0%), smokers (fibre: 72.6% v 84.7%; fat: 67.5% v 76.9%), patients with diabetes (fibre: 75.9% v 82.9%; fat: 66.9% v 75.8%) and those with cholesterol >5 mmol (fat: 68.2% v 76.2%) but multivariate analysis showed statistical significance only for smoking (fibre: p = 0.013; fat: p = 0.045), diabetes (fibre: p = 0.039; fat: p = 0.047), and cholesterol (fat: p = 0.039).
Our findings illustrate the importance of detailed reporting of research methods, with clear information about response rates, respondents and valid outcome data. Outcome measures which are relevant to a study population should be chosen carefully. The impact of methods of outcome measurement and valid response rates in evaluating healthcare requires further study.
患者报告结局指标(PROMs)用于评估生活方式干预措施,但对于返回有效和无效回答的患者之间的差异,或评估中的潜在偏差知之甚少。我们旨在研究与那些回答无效的患者相比,对生活方式问卷返回有效回答的患者的特征。
我们对SPHERE研究进行了二次数据分析,该研究是一项旨在改善初级保健中冠心病患者结局的干预试验。在基线和18个月随访时,使用邮政问卷评估研究参与者的身体活动(戈丁量表)和饮食(DINE量表)。生成了三个二元反应变量进行分析:(1)有效的戈丁量表得分;(2)有效的DINE量表纤维得分;(3)有效的DINE量表总脂肪得分。多变量分析包括广义估计方程回归,以研究患者特征与两个时间点有效回答返回情况之间的关联。
总体而言,92.1%的参与者(832/903)在基线和18个月时都返回了问卷。15岁之前离校的人返回的有效戈丁量表得分(36.5%)相对少于18岁及以上离校的人(50.5%),体力劳动者(39.5%)少于非体力劳动者(49.5%),胆固醇升高(>5 mmol)的人(34.7%)少于胆固醇较低的人(44.4%),但多变量分析确定只有离校年龄(p = 0.047)具有统计学意义。体力劳动者返回的有效DINE量表得分相对少于非体力劳动者(纤维:80.8%对86.8%;脂肪:71.2%对80.0%),吸烟者(纤维:72.6%对84.7%;脂肪:67.5%对76.9%),糖尿病患者(纤维:75.9%对82.9%;脂肪:66.9%对75.8%)以及胆固醇>5 mmol的人(脂肪:68.2%对76.2%),但多变量分析仅显示吸烟(纤维:p = 0.013;脂肪:p = 0.045)、糖尿病(纤维:p = 0.039;脂肪:p = 0.047)和胆固醇(脂肪:p = 0.039)具有统计学意义。
我们的研究结果说明了详细报告研究方法的重要性,包括关于回复率、受访者和有效结局数据的清晰信息。应仔细选择与研究人群相关的结局指标。结局测量方法和有效回复率在评估医疗保健中的影响需要进一步研究。