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

1.	卢存存, 杨丰文, 柯立鑫, 等. 系统评价再评价优先报告条目解读. 中国循证儿科杂志, 2018, 13(3): 236-240.
2.	张宏伟, 刘建平. 临床试验中的结局指标及效应测量. 中医杂志, 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, 郑文科, 王辉, 等. 浅谈临床试验中不良事件记录欠佳的原因和改善方法. 中国新药杂志, 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. 更好地报告随机试验中的危害: CONSORT声明扩展版. 中国循证医学杂志, 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.	周庆辉, David M, Sally H, 等. CONSORT2010说明与详述: 报告平行对照随机临床试验指南的更新. 中西医结合学报, 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.	陈纪言, 张宇辉, 肖文良, 等. 海博麦布治疗原发性高胆固醇血症的有效性和安全性: 多中心、随机、双盲、安慰剂平行对照Ⅲ期临床研究. 中国循环杂志, 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.	樊星砚, 熊殷, 王亦凡, 等. 阿托品治疗近视研究进展. 中国医药工业杂志, 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.	张萍, 张崇凡. 随机临床试验报告统一标准声明2022扩展版建议的清单条目翻译和解读. 中国循证儿科杂志, 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, 张伯礼, 等. 临床试验中不良事件的管理. 中国临床药理学杂志, 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 Sjögren syndrome: a randomized clinical trial. JAMA Netw Open, 2022, 5(11): e2241451.
28.	骆晓艳, 高志刚, 李永成, 等. 天津市6周龄-5岁儿童国产13价肺炎球菌多糖结合疫苗疑似预防接种异常反应主动和被动监测评价. 中国疫苗和免疫, 2022, 28(5): 591-594.

1. 卢存存, 杨丰文, 柯立鑫, 等. 系统评价再评价优先报告条目解读. 中国循证儿科杂志, 2018, 13(3): 236-240.
2. 张宏伟, 刘建平. 临床试验中的结局指标及效应测量. 中医杂志, 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, 郑文科, 王辉, 等. 浅谈临床试验中不良事件记录欠佳的原因和改善方法. 中国新药杂志, 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. 更好地报告随机试验中的危害: CONSORT声明扩展版. 中国循证医学杂志, 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. 周庆辉, David M, Sally H, 等. CONSORT2010说明与详述: 报告平行对照随机临床试验指南的更新. 中西医结合学报, 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. 陈纪言, 张宇辉, 肖文良, 等. 海博麦布治疗原发性高胆固醇血症的有效性和安全性: 多中心、随机、双盲、安慰剂平行对照Ⅲ期临床研究. 中国循环杂志, 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. 樊星砚, 熊殷, 王亦凡, 等. 阿托品治疗近视研究进展. 中国医药工业杂志, 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. 张萍, 张崇凡. 随机临床试验报告统一标准声明2022扩展版建议的清单条目翻译和解读. 中国循证儿科杂志, 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, 张伯礼, 等. 临床试验中不良事件的管理. 中国临床药理学杂志, 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 Sjögren syndrome: a randomized clinical trial. JAMA Netw Open, 2022, 5(11): e2241451.
28. 骆晓艳, 高志刚, 李永成, 等. 天津市6周龄-5岁儿童国产13价肺炎球菌多糖结合疫苗疑似预防接种异常反应主动和被动监测评价. 中国疫苗和免疫, 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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