Introduction

The Salford Lung Studies (SLS) were real-world randomised controlled trials set within UK primary care that assessed the effectiveness and safety of initiating once-daily fluticasone furoate/vilanterol versus continuing usual care in patients with chronic obstructive pulmonary disease or asthma. Data were collected for a relatively short period, limiting the study of long-term outcomes. To broaden the capture of SLS patients’ data, we undertook the Extended SLS (Ext-SLS), aiming to better understand the patient disease journey and the effects of treatment in a real-world setting, through collection of patient-level data. Here, we present study design information and the challenges and learnings gathered in creating the Ext-SLS.

Methods

The Ext-SLS was intended to augment the SLS by collecting retrospective and prospective (up to 10 years from consent) primary and secondary care electronic health record (EHR) data and patient questionnaires. After ethics approval, general practitioners (GPs) obtained consent from SLS patients remotely (mean 3.2 years post-SLS completion). To facilitate GPs identifying eligible patients, a novel EHR-based approach flagged SLS patients who were alive and registered with their original GP. An automated system sent consent forms/questionnaires to patients. Medical data were collected via EHRs; primary care data were extracted from GPs’ systems whilst secondary care data were sourced from the UK NHS.

Results

Of the 75 GP sites from the SLS, 35 (47%) declined Ext-SLS participation leaving 4158 potentially eligible patients; 1169 (28%) patients were excluded as GPs could not confirm them as SLS participants or due to incapacity. Of 2989 patients invited, 1189 (40%) consented.

Conclusions

Developing an EHR-based trial extension was achieved, with reasonable consent rates amongst invited patients. The resulting Ext-SLS is a unique and valuable research resource. Leveraging EHRs and technology reduced GP burden, facilitating participation. Initiation of extension studies prior to study close-out may help increase GP and patient participation.

中文翻译：

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从扩展研究到现实世界有效性试验的主要经验：扩展索尔福德肺研究

介绍

索尔福德肺研究 (SLS) 是在英国初级保健机构开展的真实世界随机对照试验，评估了在慢性阻塞性肺病或哮喘患者中开始每日一次糠酸氟替卡松/维兰特罗与继续常规治疗的有效性和安全性。数据的收集时间相对较短，限制了对长期结果的研究。为了扩大 SLS 患者数据的采集范围，我们开展了扩展 SLS (Ext-SLS)，旨在通过收集患者级别的数据，更好地了解患者的疾病旅程和治疗效果在现实世界中的情况。在这里，我们介绍了研究设计信息以及在创建 Ext-SLS 过程中收集到的挑战和经验教训。

方法

Ext-SLS 旨在通过收集回顾性和前瞻性（从同意起最多 10 年）初级和二级保健电子健康记录 (EHR) 数据和患者问卷来增强 SLS。在伦理学批准后，全科医生 (GP) 远程获得了 SLS 患者的同意（SLS 完成后平均 3.2 年）。为了便于全科医生识别符合条件的患者，一种新的基于 EHR 的方法标记了存活并在其原始全科医生处登记的 SLS 患者。自动化系统向患者发送同意书/问卷。通过 EHR 收集医疗数据；初级保健数据来自全科医生的系统，而二级保健数据来自英国 NHS。

结果

在 SLS 的 75 个 GP 站点中，35 个 (47%) 拒绝了 Ext-SLS 参与，留下 4158 名可能符合条件的患者；1169 名 (28%) 患者被排除在外，因为 GP 无法确认他们是 SLS 参与者或由于无能力。在受邀的 2989 名患者中，1189 名 (40%) 同意。

结论

开发了基于 EHR 的试验扩展，并在受邀患者中获得了合理的同意率。由此产生的 Ext-SLS 是一种独特而有价值的研究资源。利用 EHR 和技术减轻了全科医生的负担，促进了参与。在研究结束之前启动扩展研究可能有助于增加全科医生和患者的参与。