使用常规收集的卫生数据开展药物流行病学研究报告规范（RECORD-PE）及解读

中国药物警戒 ›› 2019, Vol. 16 ›› Issue (3): 144-148.

• 药物警戒中多数据源的利用专栏 • 上一篇下一篇

使用常规收集的卫生数据开展药物流行病学研究报告规范（RECORD-PE）及解读

胡方圆, 叶小飞, 许金芳, 郭晓晶, 贺佳^*

第二军医大学卫生勤务学系卫生统计学教研室,上海 200433

收稿日期:2019-02-21 修回日期:2020-06-28 出版日期:2019-03-20 发布日期:2019-04-17
通讯作者: 贺佳,女,教授·博导,药物流行病学及新药评价的统计分析。E-mail：hejia63@yeah.net
作者简介:胡方圆,男,硕士, 药物流行病学。
基金资助:
国家自然科学基金（81703296）：药品不良反应监测中多重性检验和低频数膨胀问题的研究; 上海市自然科学基金（18ZR1449500）：疾病风险评分模型研究及在药品不良反应主动监测中的应用; 上海市第四轮公共卫生三年行动计划重点学科建设项目循证公共卫生与卫生经济学(15GWZK0901); 上海市卫计委优秀青年医学人才培养计划（2018YQ47）

Interpretation of the Guidance for Reporting of Pharmacoepidemiology Studies Conducted Using Observational Routinely Collected Health Data: RECORD-PE Statement

HU Fangyuan, YE Xiaofei, XU Jinfang, GUO Xiaojing, HE Jia^*

Department of Medical Statistics, Faculty of Medical Services, Second Military Medical University, Shanghai 200433, China

Received:2019-02-21 Revised:2020-06-28 Online:2019-03-20 Published:2019-04-17

摘要/Abstract

摘要： 常规收集的卫生数据在药物流行病学研究中发挥着越来越重要的作用。根据STROBE声明拓展而来的RECORD声明是目前利用常规收集卫生数据进行研究的主要指南,但RECORD声明并不完全适用于药物流行病学研究,RECORD-PE（RECORD for Pharmacoepidemiology）声明在RECORD声明基础上,针对药物流行病学研究扩展了15个条目。本文对RECORD-PE进行了详细解读,并给出了相应的实例,便于我国学者更好地掌握RECORD-PE声明并进行利用。

关键词: 常规收集的卫生数据, 药物流行病学, RECORD-PE声明, 指南

Abstract: Routinely collected data plays more and more important role in pharmacoepidemiology studies. Current available guidance for routinely collected data is the REporting of studies Conducted using Observational Routinely collected health data(RECORD) statement based on Strengthing the Reporting of OBservational studies in Epidemiology(STROBE) statement, but the RECORD statement is not fully suitable for pharmacoepidemiology studies. This study interprets each of the new items of the RECORD-PE (RECORD for Pharmacoepidemiology research) statement extended from the RECORD statement using related examples. We hope this interpretation will give scholars a better understanding and use of the RECORD-PE statement.

Key words: routinely collected health data, pharmacoepidemiology, RECORD-PE statement, guidelines

中图分类号:

R994.11

胡方圆, 叶小飞, 许金芳, 郭晓晶, 贺佳. 使用常规收集的卫生数据开展药物流行病学研究报告规范（RECORD-PE）及解读[J]. 中国药物警戒, 2019, 16(3): 144-148.

HU Fangyuan, YE Xiaofei, XU Jinfang, GUO Xiaojing, HE Jia. Interpretation of the Guidance for Reporting of Pharmacoepidemiology Studies Conducted Using Observational Routinely Collected Health Data: RECORD-PE Statement[J]. Chinese Journal of Pharmacovigilance, 2019, 16(3): 144-148.

参考文献

[1] Public Policy Committee, International Society of Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practice (GPP)[J]. Pharmacoepidemiol Drug Saf, 2016, 25(1):2-10.
[2] 中国药学会药物流行病学专业委员会. 中国药物流行病学研究方法学指南[J]. 药物流行病学杂志, 2019, 28(1):5-9.
[3] N rgaard M, Johnsen S P.How can the research potential of the clinical quality databases be maximized? The Danish experience[J]. J Intern Med, 2016, 279(2):132-40.
[4] Benchimol E I, Smeeth L, Guttmann A, et al.The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement[J]. PLoS Med, 2015, 12:e1001885.
[5] Langan S M, Schmidt S A, Wing K, et al.The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE)[J]. BMJ, 2018,363:k3532.
[6] Vandenbroucke J P, von Elm E, Altman D G, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration[J]. PLoS Med, 2007, 4(10):e297.
[7] 詹思延. 第三讲:如何报告观察性流行病学研究-国际报告规范STROBE解读[J]. 中国循证儿科杂志, 2010, 5(3):223-227.
[8] 聂晓路,彭晓霞. 使用常规收集卫生数据开展观察性研究的报告规范-RECORD规范[J]. 中国循证医学杂志, 2017, 17(4):475-487.
[9] Benchimol E I, Manuel D G, To T, et al.Development and use of reporting guidelines for assessing the quality of validation studies of health administrative data[J]. J Clin Epidemiol, 2011, 64:821-829.
[10] Hemkens L G, Benchimol E I, Langan S M, et al.The reporting of studies using routinely collected health data was often insufficient[J]. J Clin Epidemiol, 2016, 79:104-111.
[11] Tubiana S, Blotière P O, Hoen B, et al.Dental procedures, antibiotic prophylaxis, and endocarditis among people with prosthetic heart valves: nationwide population based cohort and a case crossover study[J]. BMJ, 2017, 358:j3776.
[12] Martinez C, Suissa S, Rietbrock S, et al.Testosterone treatment and risk of venous thromboembolism: population based case-control study[J]. BMJ, 2016,355:i5968.
[13] Ueda P, Svanstr m H, Melbye M, et al. Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study[J]. BMJ, 2018, 363:k4365.
[14] Gomm W, von Holt K, Thomé F, et al. Association of Proton Pump Inhibitors With Risk of Dementia: A Pharmacoepidemiological Claims Data Analysis[J]. JAMA Neurol, 2016, 73(4):410-6.
[15] Huerta C, Abbing-Karahagopian V, Requena G, et al. Exposure to benzodiazepines (anxiolytics, hypnotics and related drugs) in seven Europeanelectronic healthcare databases: a cross-national descriptive study from the PROTECT-EU Project[J]. Pharmacoepi-demiol Drug Saf, 2016, Suppl 1:56-65.
[16] Gollwitzer S, Kostev K, Hagge M, et al.Nonadherence to antiepileptic drugs in Germany: A retrospective, population-based study[J]. Neurology, 2016, 87(5):466-72.
[17] Korhonen P, Heintjes E M, Williams R, et al.Pioglitazone use and risk of bladder cancer in patients with type 2 diabetes: retrospective cohort study using datasets from four European countries[J]. BMJ, 2016, 354:i3903.
[18] Inghammar M, Svanstr m H, Melbye M, et al. Oral fluoroquinolone use and serious arrhythmia: bi-national cohort study[J]. BMJ, 2016, 352:i843.
[19] Jun M, James M T, Manns B J, et al.Alberta Kidney Disease Network.The association between kidney function and major bleeding in older adults with atrial fibrillation starting warfarin treatment: population based observational study[J]. BMJ, 2015, 350:h246.
[20] Wong A Y, Root A, Douglas I J, et al.Cardiovascular outcomes associated with use of clarithromycin: population based study[J]. BMJ, 2016, 352:h6926.
[21] Potteg rd A, Friis S, Stürmer T, et al. Considerations for Pharmacoepidemiological Studies of Drug-Cancer Associations[J]. Basic Clin Pharmacol Toxicol, 2018, 122(5):451-459.
[22] Douglas I J, Langham J, Bhaskaran K, et al.Orlistat and the risk of acute liver injury: self controlled case series study in UK Clinical PracticeResearch Datalink[J]. BMJ, 2013, 346:f1936.
[23] Miettinen O S.The need for randomization in the study of intended effects[J]. Stat Med, 1983, 2(2):267-71.
[24] Axelsson K F, Nilsson A G, Wedel H, et al.Association Between Alendronate Use and Hip Fracture Risk in Older Patients Using Oral Prednisolone[J]. JAMA, 2017, 318(2):146-155.
[25] Lau W C, Chan E W, Cheung C L, et al.Association Between Dabigatran vs Warfarin and Risk of Osteoporotic Fractures Among Patients With Nonvalvular Atrial Fibrillation[J]. JAMA, 2017, 317(11):1151-1158.
[26] Huybrechts K F, Hernández-Díaz S, Straub L, et al.Association of Maternal First-Trimester Ondansetron Use With Cardiac Malformations and Oral Clefts in Offspring[J]. JAMA, 2018, 320(23):2429-2437.
[27] Patorno E, Glynn R J, Levin R, et al.Benzodiazepines and risk of all cause mortality in adults: cohort study[J]. BMJ, 2017, 358:j2941.
[28] Whitaker H.The self controlled case series method[J]. BMJ, 2008 , 337:a1069.
[29] Whitaker H J, Farrington C P, Spiessens B, et al.Tutorial in biostatistics: the self-controlled case series method[J]. Stat Med, 2006, 25(10):1768-1797. doi:10.1002/sim.2302
[30] Schmidt M, Hallas J, Friis S.Potential of prescription registries to capture individual-level use of aspirin and othernonsteroidal anti-inflammatory drugs in Denmark: trends in utilization 1999-2012[J]. Clin Epidemiol, 2014, 6:155-168.
[31] Larsen T B, Skj th F, Nielsen P B, et al. Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study[J]. BMJ, 2016, 353:i3189.
[32] Shin J Y, Park M J, Lee S H, et al.Risk of intracranial haemorrhage in antidepressant users with concurrent use of non-steroidal anti-inflammatory drugs: nationwide propensity score matched study[J]. BMJ, 2015, 351:h3517.

使用常规收集的卫生数据开展药物流行病学研究报告规范（RECORD-PE）及解读

Interpretation of the Guidance for Reporting of Pharmacoepidemiology Studies Conducted Using Observational Routinely Collected Health Data: RECORD-PE Statement

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