Data supporting "Effect of pedometer-based walking interventions on long-term health outcomes: prospective 4-year follow-up of two randomised controlled trials using routine primary care data."

PACE-Lift and PACE-UP are two primary care randomised trials of effective 12-week pedometer-based walking interventions. Results from the 1-year follow-ups and 3-year (PACE-UP) and 4-year (PACE-Lift) have already been published. These data relate to further analyses of both datasets, looking at health outcomes from participants’ routine primary care records.PACE-Lift recruited 60-75 year olds from three general practices in Berkshire and Oxfordshire from October 2011 to October 2012. Ethical approval was granted by Oxfordshire Research Ethics Committee for up to 12-month follow-up (11/H0606/2). Further ethical approval for 4-year follow-up and primary care download was later granted (14/SC0352). There was a control arm and one intervention arm who received the 12-week PACE-Lift walking intervention.PACE-UP recruited 45-75 year olds from seven general practices in South West London from October 2012 to November 2013. Ethical approval was granted by London Hampstead Research Ethics Committee, including substantial amendments for the 3-year follow-up and subsequent primary care data download. There was a control arm and two intervention groups who both received the 12-week PACE-UP walking intervention, one group by post and the other with additional practice nurse support. These two intervention groups are combined in the current dataset.Permission was sought from participants in both studies to access data from their primary care records for up to four years after randomisation.We identified a priori particular long-term health outcomes in primary care records: non-fatal cardiovascular events, total cardiovascular events (cardiovascular deaths plus non-fatal cardiovascular events), new onset type 2 diabetes, new depression episodes, injurious falls and fractures. We also collected information on the number of primary care consultations and baseline prevalence of prior cardiovascular disease, diabetes and depression.The dataset available includes variables listed below. There are restrictions on the availability of the data for this study due to the signed consent agreements around data security, which only allow access to external researchers for research monitoring purposes for both trials. Requestors wishing to access the trial data for the purposes of replicating or checking our analysis should contact the SGUL RDM service at [e-mail] availableDemographics: sex, age, intervention groupPrimary care outcomes: Length of follow-up (up to four years). Baseline cardiovascular disease, diabetes and depression. New cardiovascular events, new diagnoses of diabetes, new episodes of depression, falls, fractures and number of consultations during follow-up.

PACE-Lift与PACE-UP为两项基于计步器的12周有效步行干预的初级保健随机试验。两项试验的1年随访结果，以及PACE-UP的3年随访、PACE-Lift的4年随访结果均已发表。本数据集对应两项试验数据集的进一步分析，旨在基于受试者的常规初级保健病历探究其健康结局。
PACE-Lift于2011年10月至2012年10月期间，在伯克郡（Berkshire）与牛津郡（Oxfordshire）的3家全科诊所招募了60~75岁的受试者。该研究的12个月以内随访方案已获得牛津郡研究伦理委员会的伦理批准（审批号：11/H0606/2）。后续针对4年随访及初级保健病历下载的补充伦理申请亦获得批准（审批号：14/SC0352）。该试验设置对照组与1个干预组，干预组受试者接受为期12周的PACE-Lift步行干预方案。
PACE-UP于2012年10月至2013年11月期间，在伦敦西南部的7家全科诊所招募了45~75岁的受试者。该研究的伦理批准由伦敦汉普斯特德研究伦理委员会出具，审批涵盖了3年随访及后续初级保健数据下载的重大修订内容。该试验设置对照组与2个干预组，两组受试者均接受为期12周的PACE-UP步行干预方案：一组通过邮寄方式完成干预，另一组则额外获得全科护士的支持。本数据集中将上述两个干预组合并为一组。
两项试验均已获得受试者知情同意，允许在随机化后最长4年内调取其初级保健病历数据。
我们预先在初级保健病历中确定了若干长期健康结局指标：非致命性心血管事件、总心血管事件（心血管死亡合并非致命性心血管事件）、新发2型糖尿病、新发抑郁发作、创伤性跌倒及骨折。同时我们还收集了初级保健就诊次数，以及基线时既往心血管疾病、糖尿病与抑郁的患病率数据。
本公开数据集包含如下所列变量。鉴于两项试验均签署了涉及数据安全的知情同意协议，本研究的数据使用存在限制：仅允许外部研究人员出于研究监测目的访问相关数据。若有申请方希望获取试验数据以重复或验证本研究的分析结果，请联系SGUL RDM服务团队，邮箱地址为[e-mail]。
可用变量
人口统计学信息：性别、年龄、干预组
初级保健结局指标：随访时长（最长4年）、基线心血管疾病、糖尿病与抑郁状态、新发心血管事件、新发糖尿病诊断、新发抑郁发作、跌倒、骨折，以及随访期间的就诊次数。