Guideline for the reporting of harms in randomized trials: interpretation of Harms 2022_Chinese Journal of Evidence-Based Medicine

Authors：

LI Binyan ¹ , WANG Liqiong ^1,2 , DUAN Yanshan ^1,2 , WANG Yu ^1,2 , TU Jianfeng ^1,2 , SHI Guangxia ^1,2 ,  LIU Cunzhi ^1,2

1. College of Acupuncture-Moxibustion and Tuina Beijing University of Chinese Medicine, Beijing 100029, P. R. China;
2. International Acupuncture and Moxibustion Innovation Institute, Beijing 100029, P. R. China;

Corresponding?author：

LIU Cunzhi, Email: lcz623780@126.com

Keywords：

Harms; Reporting guideline; Interpretation; CONSORT; Randomized controlled trial

DOI：

10.7507/1672-2531.202306157

Video：

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An intervention with clinical application must be effective and safe, therefore, when evaluating interventions, the benefit-harm ratio should be considered, and only those interventions with more benefits than harms have application value. To evaluate the benefits and harms of an intervention evidence of both benefits and harms should be reported in clinical trials. To promote better reporting of harms in randomized controlled trials, the CONSORT group had added an entry on harms in the 2001 version of the CONSORT statement, and then in 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated, the reporting of harms is still inadequate. The CONSORT group has updated《Better reporting of harms in randomized trial: an extension of the CCONSORT statement.》, published《CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials》. This article presents and explains the Harms 2022, with the aim of helping researchers better understand and use the statement, with a view to improving the reporting quality of harms in clinical trials.

Citation： LI Binyan, WANG Liqiong, DUAN Yanshan, WANG Yu, TU Jianfeng, SHI Guangxia, LIU Cunzhi. Guideline for the reporting of harms in randomized trials: interpretation of Harms 2022. Chinese Journal of Evidence-Based Medicine, 2024, 24(3): 339-347. doi: 10.7507/1672-2531.202306157 Copy

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2.	張宏偉, 劉建平. 臨床試驗中的結局指標及效應測量. 中醫雜志, 2007, 48(8): 696-698.
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4.	雷翔, 鄭文科, 王輝, 等. 淺談臨床試驗中不良事件記錄欠佳的原因和改善方法. 中國新藥雜志, 2014, 23(11): 1260-1263.
5.	Moskowitz A, Andersen LW, Holmberg MJ, et al. Identification, collection, and reporting of harms among non-industry-sponsored randomized clinical trials of pharmacologic interventions in the critically ill population: a systematic review. Crit Care, 2020, 24(1): 398.
6.	Phillips R, Hazell L, Sauzet O, et al. Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ Open, 2019, 9(2): e024537.
7.	Costello R, Patel R, Humphreys J, et al. Patient perceptions of glucocorticoid side effects: a cross-sectional survey of users in an online health community. BMJ Open, 2017, 7(4): e014603.
8.	Leporini C, De Sarro G, Russo E. Adherence to therapy and adverse drug reactions: is there a link. Expert Opin Drug Saf, 2014, 13(Suppl 1): S41-S55.
9.	Birnbaum HG, White AG, Reynolds JL, et al. Estimated costs of prescription opioid analgesic abuse in the United States in 2001: a societal perspective. Clin J Pain, 2006, 22(8): 667-676.
10.	Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 276(8): 637-639.
11.	Moher D, Schulz KF, Altman DG, et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol, 2001, 1: 2.
12.	Ioannidis JPA, Evans SJW, tzsche PCG, et al. 更好地報告隨機試驗中的危害: CONSORT聲明擴展版. 中國循證醫學雜志, 2006, (9): 682-689.
13.	Junqueira DR, Phillips R, Zorzela L, et al. Time to improve the reporting of harms in randomized controlled trials. J Clin Epidemiol, 2021, 136: 216-220.
14.	周慶輝, David M, Sally H, 等. CONSORT2010說明與詳述: 報告平行對照隨機臨床試驗指南的更新. 中西醫結合學報, 2010, 8(8): 701-741.
15.	Junqueira DR, Zorzela L, Golder S, et al. CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials. BMJ, 2023, 381: e073725.
16.	陳紀言, 張宇輝, 肖文良, 等. 海博麥布治療原發性高膽固醇血癥的有效性和安全性: 多中心、隨機、雙盲、安慰劑平行對照Ⅲ期臨床研究. 中國循環雜志, 2022, 37(7): 708-714.
17.	Correll CU, Davis RE, Weingart M, et al. Efficacy and safety of lumateperone for treatment of schizophrenia: a randomized clinical trial. JAMA Psychiatry, 2020, 77(4): 349-358.
18.	樊星硯, 熊殷, 王亦凡, 等. 阿托品治療近視研究進展. 中國醫藥工業雜志, 2021, 52(9): 1161-1168.
19.	Sampaio-Junior B, Tortella G, Borrione L, et al. Efficacy and safety of transcranial direct current stimulation as an add-on treatment for bipolar depression: a randomized clinical trial. JAMA Psychiatry, 2018, 75(2): 158-166.
20.	張萍, 張崇凡. 隨機臨床試驗報告統一標準聲明2022擴展版建議的清單條目翻譯和解讀. 中國循證兒科雜志, 2023, 18(2): 142-147.
21.	Goldacre B, Drysdale H, Dale A, et al. COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time. Trials, 2019, 20(1): 118.
22.	Zaman K, Bandyopadhyay AS, Hoque M, et al. Evaluation of the safety, immunogenicity, and faecal shedding of novel oral polio vaccine type 2 in healthy newborn infants in Bangladesh: a randomised, controlled, phase 2 clinical trial. Lancet, 2023, 401(10371): 131-139.
23.	Albany C, Dockter T, Wolfe E, et al. Cisplatin-associated neuropathy characteristics compared with those associated with other neurotoxic chemotherapy agents (Alliance A151724). Support Care Cancer, 2021, 29(2): 833-840.
24.	Koren MJ, Sabatine MS, Giugliano RP, et al. Long-term efficacy and safety of evolocumab in patients with hypercholesterolemia. J Am Coll Cardiol, 2019, 74(17): 2132-2146.
25.	任明, 商洪才, 張伯禮, 等. 臨床試驗中不良事件的管理. 中國臨床藥理學雜志, 2008, 24(5): 452-454,457.
26.	Hulshof TA, Zuidema SU, Gispen-de Wied CC, et al. Run-in periods and clinical outcomes of antipsychotics in dementia: a meta-epidemiological study of placebo-controlled trials. Pharmacoepidemiol Drug Saf, 2020, 29(2): 125-133.
27.	He J, Chen J, Miao M, et al. Efficacy and safety of low-dose interleukin 2 for primary Sj?gren syndrome: a randomized clinical trial. JAMA Netw Open, 2022, 5(11): e2241451.
28.	駱曉艷, 高志剛, 李永成, 等. 天津市6周齡-5歲兒童國產13價肺炎球菌多糖結合疫苗疑似預防接種異常反應主動和被動監測評價. 中國疫苗和免疫, 2022, 28(5): 591-594.

1. 盧存存, 楊豐文, 柯立鑫, 等. 系統評價再評價優先報告條目解讀. 中國循證兒科雜志, 2018, 13(3): 236-240.
2. 張宏偉, 劉建平. 臨床試驗中的結局指標及效應測量. 中醫雜志, 2007, 48(8): 696-698.
3. Hodkinson A, Kirkham JJ, Tudur-Smith C, et al. Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension. BMJ Open, 2013, 3(9): e003436.
4. 雷翔, 鄭文科, 王輝, 等. 淺談臨床試驗中不良事件記錄欠佳的原因和改善方法. 中國新藥雜志, 2014, 23(11): 1260-1263.
5. Moskowitz A, Andersen LW, Holmberg MJ, et al. Identification, collection, and reporting of harms among non-industry-sponsored randomized clinical trials of pharmacologic interventions in the critically ill population: a systematic review. Crit Care, 2020, 24(1): 398.
6. Phillips R, Hazell L, Sauzet O, et al. Analysis and reporting of adverse events in randomised controlled trials: a review. BMJ Open, 2019, 9(2): e024537.
7. Costello R, Patel R, Humphreys J, et al. Patient perceptions of glucocorticoid side effects: a cross-sectional survey of users in an online health community. BMJ Open, 2017, 7(4): e014603.
8. Leporini C, De Sarro G, Russo E. Adherence to therapy and adverse drug reactions: is there a link. Expert Opin Drug Saf, 2014, 13(Suppl 1): S41-S55.
9. Birnbaum HG, White AG, Reynolds JL, et al. Estimated costs of prescription opioid analgesic abuse in the United States in 2001: a societal perspective. Clin J Pain, 2006, 22(8): 667-676.
10. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 276(8): 637-639.
11. Moher D, Schulz KF, Altman DG, et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol, 2001, 1: 2.
12. Ioannidis JPA, Evans SJW, tzsche PCG, et al. 更好地報告隨機試驗中的危害: CONSORT聲明擴展版. 中國循證醫學雜志, 2006, (9): 682-689.
13. Junqueira DR, Phillips R, Zorzela L, et al. Time to improve the reporting of harms in randomized controlled trials. J Clin Epidemiol, 2021, 136: 216-220.
14. 周慶輝, David M, Sally H, 等. CONSORT2010說明與詳述: 報告平行對照隨機臨床試驗指南的更新. 中西醫結合學報, 2010, 8(8): 701-741.
15. Junqueira DR, Zorzela L, Golder S, et al. CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials. BMJ, 2023, 381: e073725.
16. 陳紀言, 張宇輝, 肖文良, 等. 海博麥布治療原發性高膽固醇血癥的有效性和安全性: 多中心、隨機、雙盲、安慰劑平行對照Ⅲ期臨床研究. 中國循環雜志, 2022, 37(7): 708-714.
17. Correll CU, Davis RE, Weingart M, et al. Efficacy and safety of lumateperone for treatment of schizophrenia: a randomized clinical trial. JAMA Psychiatry, 2020, 77(4): 349-358.
18. 樊星硯, 熊殷, 王亦凡, 等. 阿托品治療近視研究進展. 中國醫藥工業雜志, 2021, 52(9): 1161-1168.
19. Sampaio-Junior B, Tortella G, Borrione L, et al. Efficacy and safety of transcranial direct current stimulation as an add-on treatment for bipolar depression: a randomized clinical trial. JAMA Psychiatry, 2018, 75(2): 158-166.
20. 張萍, 張崇凡. 隨機臨床試驗報告統一標準聲明2022擴展版建議的清單條目翻譯和解讀. 中國循證兒科雜志, 2023, 18(2): 142-147.
21. Goldacre B, Drysdale H, Dale A, et al. COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time. Trials, 2019, 20(1): 118.
22. Zaman K, Bandyopadhyay AS, Hoque M, et al. Evaluation of the safety, immunogenicity, and faecal shedding of novel oral polio vaccine type 2 in healthy newborn infants in Bangladesh: a randomised, controlled, phase 2 clinical trial. Lancet, 2023, 401(10371): 131-139.
23. Albany C, Dockter T, Wolfe E, et al. Cisplatin-associated neuropathy characteristics compared with those associated with other neurotoxic chemotherapy agents (Alliance A151724). Support Care Cancer, 2021, 29(2): 833-840.
24. Koren MJ, Sabatine MS, Giugliano RP, et al. Long-term efficacy and safety of evolocumab in patients with hypercholesterolemia. J Am Coll Cardiol, 2019, 74(17): 2132-2146.
25. 任明, 商洪才, 張伯禮, 等. 臨床試驗中不良事件的管理. 中國臨床藥理學雜志, 2008, 24(5): 452-454,457.
26. Hulshof TA, Zuidema SU, Gispen-de Wied CC, et al. Run-in periods and clinical outcomes of antipsychotics in dementia: a meta-epidemiological study of placebo-controlled trials. Pharmacoepidemiol Drug Saf, 2020, 29(2): 125-133.
27. He J, Chen J, Miao M, et al. Efficacy and safety of low-dose interleukin 2 for primary Sj?gren syndrome: a randomized clinical trial. JAMA Netw Open, 2022, 5(11): e2241451.
28. 駱曉艷, 高志剛, 李永成, 等. 天津市6周齡-5歲兒童國產13價肺炎球菌多糖結合疫苗疑似預防接種異常反應主動和被動監測評價. 中國疫苗和免疫, 2022, 28(5): 591-594.

Chinese Journal of Evidence-Based Medicine

Guideline for the reporting of harms in randomized trials: interpretation of Harms 2022

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