Collier Sue, Harvey Catherine, Brewster Jill, Bakerly Nawar Diar, Elkhenini Hanaa F, Stanciu Roxana, Williams Claire, Brereton Jacqui, New John P, McCrae John, McCorkindale Sheila, Leather David
Respiratory Research and Development, GlaxoSmithKline UK Ltd, Uxbridge, UK.
Global Clinical Safety & Pharmacovigilance, Safety Evaluation and Risk Management, GlaxoSmithKline UK Ltd, Uxbridge, UK.
Pharmacoepidemiol Drug Saf. 2017 Mar;26(3):344-352. doi: 10.1002/pds.4118. Epub 2016 Nov 1.
The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records.
The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications.
The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected.
Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.
索尔福德肺部研究（SLS）项目包含两项III期实用性随机对照试验，旨在利用电子健康记录，生成关于在常规初级保健中每日一次治疗哮喘和慢性阻塞性肺疾病有效性的证据。
本研究的目的是描述和讨论安全监测方法以及索尔福德肺部研究中确保患者安全所面临的挑战。还讨论了对安全监测流程和基础设施的改进。研究结果不在本文范围内。慢性阻塞性肺疾病研究的结果最近已发表，对安全结果的更深入探讨将是未来出版物的主题。
索尔福德肺部研究使用了一个链接数据库系统，从索尔福德和南曼彻斯特的初级保健机构、两家大学医院以及其他国家数据库中获取相关数据。对患者数据进行整理和分析，以创建每日摘要，用于提醒专业安全团队注意潜在的安全事件。参与研究的全科医生站点和药房的临床研究团队在常规会诊期间也记录安全事件。随着时间的推移，对安全监测流程的信心使该方法得以改进和简化，同时不影响患者安全或数据的及时收集。信息技术基础设施还允许收集安全信息的更多详细内容。
索尔福德肺部研究中多个数据源的整合可能提供比标准随机对照试验中通常收集的更全面的安全信息。应用索尔福德肺部研究的安全监测方法原则可以促进未来实用性随机对照试验的安全监测流程，并产生重要的补充安全和有效性数据。© 2016作者 药物流行病学与药物安全 由约翰·威利父子有限公司出版
