真实世界的数据和证据在疼痛研究:在当前实践方法的定性系统回顾。

IF 3.4 Q2 NEUROSCIENCES
Jan Vollert, Bethea A Kleykamp, John T Farrar, Ian Gilron, David Hohenschurz-Schmidt, Robert D Kerns, Sean Mackey, John D Markman, Michael P McDermott, Andrew S C Rice, Dennis C Turk, Ajay D Wasan, Robert H Dworkin
{"title":"真实世界的数据和证据在疼痛研究:在当前实践方法的定性系统回顾。","authors":"Jan Vollert,&nbsp;Bethea A Kleykamp,&nbsp;John T Farrar,&nbsp;Ian Gilron,&nbsp;David Hohenschurz-Schmidt,&nbsp;Robert D Kerns,&nbsp;Sean Mackey,&nbsp;John D Markman,&nbsp;Michael P McDermott,&nbsp;Andrew S C Rice,&nbsp;Dennis C Turk,&nbsp;Ajay D Wasan,&nbsp;Robert H Dworkin","doi":"10.1097/PR9.0000000000001057","DOIUrl":null,"url":null,"abstract":"<p><p>The use of routinely collected health data (real-world data, RWD) to generate real-world evidence (RWE) for research purposes is a growing field. Computerized search methods, large electronic databases, and the development of novel statistical methods allow for valid analysis of data outside its primary clinical purpose. Here, we systematically reviewed the methodology used for RWE studies in pain research. We searched 3 databases (PubMed, EMBASE, and Web of Science) for studies using retrospective data sources comparing multiple groups or treatments. The protocol was registered under the DOI:10.17605/OSF.IO/KGVRM. A total of 65 studies were included. Of those, only 4 compared pharmacological interventions, whereas 49 investigated differences in surgical procedures, with the remaining studying alternative or psychological interventions or epidemiological factors. Most 39 studies reported significant results in their primary comparison, and an additional 12 reported comparable effectiveness. Fifty-eight studies used propensity scores to account for group differences, 38 of them using 1:1 case:control matching. Only 17 of 65 studies provided sensitivity analyses to show robustness of their findings, and only 4 studies provided links to publicly accessible protocols. RWE is a relevant construct that can provide evidence complementary to randomized controlled trials (RCTs), especially in scenarios where RCTs are difficult to conduct. The high proportion of studies reporting significant differences between groups or comparable effectiveness could imply a relevant degree of publication bias. RWD provides a potentially important resource to expand high-quality evidence beyond clinical trials, but rigorous quality standards need to be set to maximize the validity of RWE studies.</p>","PeriodicalId":52189,"journal":{"name":"Pain Reports","volume":null,"pages":null},"PeriodicalIF":3.4000,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2d/2d/painreports-8-e1057.PMC9891449.pdf","citationCount":"2","resultStr":"{\"title\":\"Real-world data and evidence in pain research: a qualitative systematic review of methods in current practice.\",\"authors\":\"Jan Vollert,&nbsp;Bethea A Kleykamp,&nbsp;John T Farrar,&nbsp;Ian Gilron,&nbsp;David Hohenschurz-Schmidt,&nbsp;Robert D Kerns,&nbsp;Sean Mackey,&nbsp;John D Markman,&nbsp;Michael P McDermott,&nbsp;Andrew S C Rice,&nbsp;Dennis C Turk,&nbsp;Ajay D Wasan,&nbsp;Robert H Dworkin\",\"doi\":\"10.1097/PR9.0000000000001057\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The use of routinely collected health data (real-world data, RWD) to generate real-world evidence (RWE) for research purposes is a growing field. Computerized search methods, large electronic databases, and the development of novel statistical methods allow for valid analysis of data outside its primary clinical purpose. Here, we systematically reviewed the methodology used for RWE studies in pain research. We searched 3 databases (PubMed, EMBASE, and Web of Science) for studies using retrospective data sources comparing multiple groups or treatments. The protocol was registered under the DOI:10.17605/OSF.IO/KGVRM. A total of 65 studies were included. Of those, only 4 compared pharmacological interventions, whereas 49 investigated differences in surgical procedures, with the remaining studying alternative or psychological interventions or epidemiological factors. Most 39 studies reported significant results in their primary comparison, and an additional 12 reported comparable effectiveness. Fifty-eight studies used propensity scores to account for group differences, 38 of them using 1:1 case:control matching. Only 17 of 65 studies provided sensitivity analyses to show robustness of their findings, and only 4 studies provided links to publicly accessible protocols. RWE is a relevant construct that can provide evidence complementary to randomized controlled trials (RCTs), especially in scenarios where RCTs are difficult to conduct. The high proportion of studies reporting significant differences between groups or comparable effectiveness could imply a relevant degree of publication bias. RWD provides a potentially important resource to expand high-quality evidence beyond clinical trials, but rigorous quality standards need to be set to maximize the validity of RWE studies.</p>\",\"PeriodicalId\":52189,\"journal\":{\"name\":\"Pain Reports\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2023-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2d/2d/painreports-8-e1057.PMC9891449.pdf\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pain Reports\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1097/PR9.0000000000001057\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"NEUROSCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain Reports","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1097/PR9.0000000000001057","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"NEUROSCIENCES","Score":null,"Total":0}
引用次数: 2

摘要

使用常规收集的健康数据(真实世界数据,RWD)生成用于研究目的的真实世界证据(RWE)是一个不断发展的领域。计算机化的搜索方法,大型电子数据库,以及新型统计方法的发展,允许对其主要临床目的之外的数据进行有效的分析。在这里,我们系统地回顾了疼痛研究中RWE研究使用的方法。我们检索了3个数据库(PubMed、EMBASE和Web of Science),寻找使用回顾性数据源比较多组或治疗的研究。该协议在DOI:10.17605/OSF.IO/KGVRM下注册。共纳入65项研究。其中,只有4项比较了药物干预,而49项调查了外科手术的差异,其余的研究了替代或心理干预或流行病学因素。大多数39项研究在初步比较中报告了显著的结果,另外12项研究报告了可比较的有效性。58项研究使用倾向分数来解释群体差异,其中38项使用1:1的案例:对照匹配。65项研究中只有17项提供了敏感性分析来证明其研究结果的稳健性,只有4项研究提供了可公开访问的协议链接。RWE是一种相关的结构,可以为随机对照试验(rct)提供补充证据,特别是在rct难以进行的情况下。较高比例的研究报告了组间的显著差异或可比较的有效性,这可能意味着存在一定程度的发表偏倚。RWD为扩大临床试验以外的高质量证据提供了潜在的重要资源,但需要制定严格的质量标准,以最大限度地提高RWE研究的有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Real-world data and evidence in pain research: a qualitative systematic review of methods in current practice.

Real-world data and evidence in pain research: a qualitative systematic review of methods in current practice.

The use of routinely collected health data (real-world data, RWD) to generate real-world evidence (RWE) for research purposes is a growing field. Computerized search methods, large electronic databases, and the development of novel statistical methods allow for valid analysis of data outside its primary clinical purpose. Here, we systematically reviewed the methodology used for RWE studies in pain research. We searched 3 databases (PubMed, EMBASE, and Web of Science) for studies using retrospective data sources comparing multiple groups or treatments. The protocol was registered under the DOI:10.17605/OSF.IO/KGVRM. A total of 65 studies were included. Of those, only 4 compared pharmacological interventions, whereas 49 investigated differences in surgical procedures, with the remaining studying alternative or psychological interventions or epidemiological factors. Most 39 studies reported significant results in their primary comparison, and an additional 12 reported comparable effectiveness. Fifty-eight studies used propensity scores to account for group differences, 38 of them using 1:1 case:control matching. Only 17 of 65 studies provided sensitivity analyses to show robustness of their findings, and only 4 studies provided links to publicly accessible protocols. RWE is a relevant construct that can provide evidence complementary to randomized controlled trials (RCTs), especially in scenarios where RCTs are difficult to conduct. The high proportion of studies reporting significant differences between groups or comparable effectiveness could imply a relevant degree of publication bias. RWD provides a potentially important resource to expand high-quality evidence beyond clinical trials, but rigorous quality standards need to be set to maximize the validity of RWE studies.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Pain Reports
Pain Reports Medicine-Anesthesiology and Pain Medicine
CiteScore
7.50
自引率
2.10%
发文量
93
审稿时长
8 weeks
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信