Structured template for planning and reporting on the implementation of real world evidence studies (STaRT-RWE): an interpretation_Chinese Journal of Evidence-Based Medicine

Authors：

CAO Xue , MENG Xiangran , WANG Xin , QIN Yuning , WANG Mengqi ,  LIU Jia

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;

Corresponding author：

LIU Jia, Email: marie_liujia@sina.cn

Keywords：

Real world; Structured data; Reporting guidance; STaRT-RWE

DOI：

10.7507/1672-2531.202312132

Video：

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Structured template and reporting tool for real world evidence (STaRT-RWE) was developed by a team led by professor Shirley V Wang of Brigham and Women's Hospital, Harvard Medical School, which is to plan and report on the implementation of real world evidence (RWE) studies on the safety and efficacy of treatments. The template, published in the journal BMJ in January 2021, has been endorsed by the International Society of PharmacoEpidemiology and the Transparency Initiative promoted by the International Society of Pharmacoeconomics and Outcome Research. This article interprets its entries to promote the understanding and application of STaRT-RWE by domestic scholars engaged in real world study, and help to improve the transparency, repeatability and accuracy of RWE research.

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2.	王雯, 谭婧, 任燕, 等. 重新认识真实世界数据研究: 更新与展望. 中国循证医学杂志, 2020, 20(11): 1241-1246.
3.	费宇彤, 柴倩云, 夏如玉, 等. 真实世界临床研究证据分级的思考与初步探索. 中国循证医学杂志, 2022, 22(10): 1206-1211.
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5.	金鑫瑶, 郑文科, 张俊华, 等. 推进真实世界研究的透明化. 世界中医药, 2019, 14(12): 3106-3110.
6.	廖星, 章轶立, 谢雁鸣. 真实世界研究标准: RECORD清单和GRACE清单的解读. 中国中药杂志, 2015, 40(24): 4734-4738.
7.	王雪, 乌兰其其格, 杨悦. 美国应用真实世界证据辅助医药产品监管决策的研究. 中国药事, 2020, 34(9): 1057-1062.
8.	Wang SV, Pinheiro S, Hua W, et al. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies. BMJ, 2021, 372: m4856.
9.	Wang SV, Schneeweiss S, Berger ML, et al. Reporting to improve reproducibility and facilitate validity assessment for healthcare database studies V1. 0. Value Health, 2017, 20(8): 1009-1022.
10.	Langan SM, Schmidt SA, Wing K, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ, 2018 Nov 14: 363: k3532.
11.	European Medicines Agency. ENCePP checklist for study protocols (revision 4). 2018.
12.	Sterne JA, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ, 2016, 355: i4919.
13.	Dreyer NA, Bryant A, Velentgas P. The GRACE checklist: a validated assessment tool for high quality observational studies of comparative effectiveness. J Manag Care Spec Pharm, 2016, 22(10): 1107-1113.
14.	US Food and Drug Administration. Guidance for industry and FDA staff: best practices for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data. 2013.
15.	Rentsch CT, Beckman JA, Tomlinson L, et al. Early initiation of prophylactic anticoagulation for prevention of coronavirus disease 2019 mortality in patients admitted to hospital in the United States: cohort study. BMJ, 2021, 372: n311.
16.	Schneeweiss S, Rassen JA, Brown JS, et al. Graphical depiction of longitudinal study designs in health care databases. Ann Intern Med, 2019, 170(6): 398-406.
17.	Khambholja K, Gehani M. Use of structured template and reporting tool for real-world evidence for critical appraisal of the quality of reporting of real-world evidence studies: a systematic review. Value Health, 2023, 26(3): 427-434.
18.	ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf, 2008, 17(2): 200-208.
19.	European Medicines Agency. Guidance for theformat and content of the protocol of non-interventional post-authorisation safety studies (2012). 2021.
20.	Gatto NM, Reynolds RF, Campbell UB. A structured preapproval and postapproval comparative study design framework to generate valid and transparent real-world evidence for regulatory decisions. Clin Pharmacol Ther, 2019, 106(1): 103-115.
21.	NEST Coordinating Center. National evaluation system for health technology coordinating center(NESTcc) dataquality framework (2020). 2020.
22.	Gatto NM, Campbell UB, Rubinstein E, et al. The structured process to identify fit-for-purpose data: a data feasibility assessment framework. Clin Pharmacol Ther, 2022, 111(1): 122-134.
23.	Wang SV, Sreedhara SK, Schneeweiss S, et al. Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions. Nat Commun, 2022, 13(1): 5126.
24.	Wang SV, Schneeweiss S. Assessing and interpreting real-world evidence studies: introductory points for new reviewers. Clin Pharmacol Ther, 2022, 111(1): 145-149.
25.	聂晓璐, 雷毅, 尉耘翠, 等. 《使用非结构化电子健康数据开展真实世界比较效果和安全性研究的报告规范》要点解读及思考. 中国食品药品监管, 2021(11): 47-55.
26.	Wang SV, Pottegård A, Crown W, et al. Harmonized protocol template to enhance reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR task force. Pharmacoepidemiol Drug Saf, 2023, 32(1): 44-55.

1. 刘建平. 临床干预试验与真实世界研究方法. 中国中西医结合杂志, 2019, 39(11): 1303-1304.
2. 王雯, 谭婧, 任燕, 等. 重新认识真实世界数据研究: 更新与展望. 中国循证医学杂志, 2020, 20(11): 1241-1246.
3. 费宇彤, 柴倩云, 夏如玉, 等. 真实世界临床研究证据分级的思考与初步探索. 中国循证医学杂志, 2022, 22(10): 1206-1211.
4. 施秀青, 阎思宇, 黄桥, 等. 真实世界研究: 弥合临床实践指南与临床决策之间的距离. 协和医学杂志, 2023, 14(4): 859-867.
5. 金鑫瑶, 郑文科, 张俊华, 等. 推进真实世界研究的透明化. 世界中医药, 2019, 14(12): 3106-3110.
6. 廖星, 章轶立, 谢雁鸣. 真实世界研究标准: RECORD清单和GRACE清单的解读. 中国中药杂志, 2015, 40(24): 4734-4738.
7. 王雪, 乌兰其其格, 杨悦. 美国应用真实世界证据辅助医药产品监管决策的研究. 中国药事, 2020, 34(9): 1057-1062.
8. Wang SV, Pinheiro S, Hua W, et al. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies. BMJ, 2021, 372: m4856.
9. Wang SV, Schneeweiss S, Berger ML, et al. Reporting to improve reproducibility and facilitate validity assessment for healthcare database studies V1. 0. Value Health, 2017, 20(8): 1009-1022.
10. Langan SM, Schmidt SA, Wing K, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ, 2018 Nov 14: 363: k3532.
11. European Medicines Agency. ENCePP checklist for study protocols (revision 4). 2018.
12. Sterne JA, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ, 2016, 355: i4919.
13. Dreyer NA, Bryant A, Velentgas P. The GRACE checklist: a validated assessment tool for high quality observational studies of comparative effectiveness. J Manag Care Spec Pharm, 2016, 22(10): 1107-1113.
14. US Food and Drug Administration. Guidance for industry and FDA staff: best practices for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data. 2013.
15. Rentsch CT, Beckman JA, Tomlinson L, et al. Early initiation of prophylactic anticoagulation for prevention of coronavirus disease 2019 mortality in patients admitted to hospital in the United States: cohort study. BMJ, 2021, 372: n311.
16. Schneeweiss S, Rassen JA, Brown JS, et al. Graphical depiction of longitudinal study designs in health care databases. Ann Intern Med, 2019, 170(6): 398-406.
17. Khambholja K, Gehani M. Use of structured template and reporting tool for real-world evidence for critical appraisal of the quality of reporting of real-world evidence studies: a systematic review. Value Health, 2023, 26(3): 427-434.
18. ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf, 2008, 17(2): 200-208.
19. European Medicines Agency. Guidance for theformat and content of the protocol of non-interventional post-authorisation safety studies (2012). 2021.
20. Gatto NM, Reynolds RF, Campbell UB. A structured preapproval and postapproval comparative study design framework to generate valid and transparent real-world evidence for regulatory decisions. Clin Pharmacol Ther, 2019, 106(1): 103-115.
21. NEST Coordinating Center. National evaluation system for health technology coordinating center(NESTcc) dataquality framework (2020). 2020.
22. Gatto NM, Campbell UB, Rubinstein E, et al. The structured process to identify fit-for-purpose data: a data feasibility assessment framework. Clin Pharmacol Ther, 2022, 111(1): 122-134.
23. Wang SV, Sreedhara SK, Schneeweiss S, et al. Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions. Nat Commun, 2022, 13(1): 5126.
24. Wang SV, Schneeweiss S. Assessing and interpreting real-world evidence studies: introductory points for new reviewers. Clin Pharmacol Ther, 2022, 111(1): 145-149.
25. 聂晓璐, 雷毅, 尉耘翠, 等. 《使用非结构化电子健康数据开展真实世界比较效果和安全性研究的报告规范》要点解读及思考. 中国食品药品监管, 2021(11): 47-55.
26. Wang SV, Pottegård A, Crown W, et al. Harmonized protocol template to enhance reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR task force. Pharmacoepidemiol Drug Saf, 2023, 32(1): 44-55.

Chinese Journal of Evidence-Based Medicine

Latest ArticlesStructured template for planning and reporting on the implementation of real world evidence studies (STaRT-RWE): an interpretation

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