Interpretation of reporting checklist (CONSORT-ROUTINE 2021) for trials using cohorts and routinely collected data_Chinese Journal of Evidence-Based Medicine

Authors：

LU Cuncun ¹ , ZHANG Qiang ¹ , LEI Chao ¹ , DENG Xiuxiu ² , XUN Yangqin ³ , QIAO Meng ¹ , XIE Yanming ¹ ,  WANG Zhifei ¹

1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;
2. Department of Gastroenterology, Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, P. R. China;
3. Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;

Corresponding author：

WANG Zhifei, Email: wzhftcm@163.com

Keywords：

CONSORT-ROUTINE checklist; Randomized controlled trial; Reporting guideline; Routinely collected data

DOI：

10.7507/1672-2531.202203024

Video：

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In recent years, the number of randomized controlled trials using cohorts and routinely collected data (e.g., electronic health records, administrative databases, and health registries) has increased. Such trials can ease the challenges of conducting research and save cost and time. Accordingly, to standardize such trials and increase the transparency and completeness of research reports, an international panel of experts developed the CONSORT-ROUTINE (2021) reporting guideline. The reporting guideline was published in 2021 in the BMJ. To help understand and formally apply the reporting guideline and improve the overall quality of this type of study, the present paper introduced and interpreted the development process and reporting checklist of the CONSORT-ROUTINE.

Citation： LU Cuncun, ZHANG Qiang, LEI Chao, DENG Xiuxiu, XUN Yangqin, QIAO Meng, XIE Yanming, WANG Zhifei. Interpretation of reporting checklist (CONSORT-ROUTINE 2021) for trials using cohorts and routinely collected data. Chinese Journal of Evidence-Based Medicine, 2022, 22(6): 731-738. doi: 10.7507/1672-2531.202203024 Copy

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2.	Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2): e1000217.
3.	Caulley L, Catalá-López F, Whelan J, et al. Reporting guidelines of health research studies are frequently used inappropriately. J Clin Epidemiol, 2020, 122: 87-94.
4.	Glasziou P, Meats E, Heneghan C, et al. What is missing from descriptions of treatment in trials and reviews. BMJ, 2008, 336(7659): 1472-1474.
5.	Hoffmann TC, Oxman AD, Ioannidis JP, et al. Enhancing the usability of systematic reviews by improving the consideration and description of interventions. BMJ, 2017, 358: j2998.
6.	刘佳利, 唐立, 孙鑫. 详细报告干预措施, 提高系统评价可用性. 中国循证医学杂志, 2018, 18(1): 92-95.
7.	Caulley L, Cheng W, Catalá-López F, et al. Citation impact was highly variable for reporting guidelines of health research: a citation analysis. J Clin Epidemiol, 2020, 127: 96-104.
8.	卢存存, 柯立鑫, 汤昊, 等. 中文期刊发表的氨甲环酸Meta分析的报告质量与方法学质量评价. 中国循证医学杂志, 2021, 21(11): 1332-1338.
9.	da Costa BR, Juni P. Systematic reviews and meta-analyses of randomized trials: principles and pitfalls. Eur Heart J, 2014, 35(47): 3336-3345.
10.	Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c869.
11.	魏旭煦, 刘岩, 胡嘉元, 等. 多臂平行对照随机临床试验报告规范: CONSORT2010声明扩展版. 中国循证医学杂志, 2021, 21(2): 231-240.
12.	Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med. 2017, 167(2): 112-121.
13.	卢存存, 杨楠, 柯立鑫, 等. 社会和心理学干预随机对照试验的报告规范(2018)解读. 中国循证儿科杂志, 2019, 14(1): 74-77.
14.	Karanatsios B, Prang KH, Verbunt E, et al. Defining key design elements of registry-based randomised controlled trials: a scoping review. Trials, 2020, 21(1): 552.
15.	Kwakkenbos L, Imran M, McCall SJ, et al. CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration. BMJ, 2021, 373: n857.
16.	Imran M, Kwakkenbos L, McCall SJ, et al. Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). BMJ Open, 2021, 11(4): e049093.
17.	Mathes T, Klaßen P, Pieper D. No differences were found between effect estimates from conventional and registry-based randomized controlled trials. J Clin Epidemiol, 2019, 105: 80-91.
18.	Simera I, Moher D, Hoey J, et al. A catalogue of reporting guidelines for health research. Eur J Clin Invest, 2010, 40(1): 35-53.
19.	Kwakkenbos L, Imran M, McCord KA, et al. Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data. BMJ Open, 2018, 8(8): e025266.
20.	Nascimento DP, Ostelo RWJG, van Tulder MW, et al. Do not make clinical decisions based on abstracts of healthcare research: a systematic review. J Clin Epidemiol, 2021, 135: 136-157.
21.	张春芳, 孔燕. 结构式摘要的形成、发展及现状——兼谈医学论文摘要的英译. 医学与哲学(人文社会医学版), 2011, 32(9): 77-79.
22.	Dombkowski KJ, Costello LE, Harrington LB, et al. Age-specific strategies for immunization reminders and recalls: a registry-based randomized trial. Am J Prev Med, 2014, 47(1): 1-8.
23.	Hofmann R, James SK, Jernberg T, et al. Oxygen therapy in suspected acute myocardial infarction. N Engl J Med, 2017, 377(13): 1240-1249.
24.	Dregan A, van Staa TP, McDermott L, et al. Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records. Stroke, 2014, 45(7): 2066-2071.
25.	van Velzen P, Ter Riet G, Bresser P, et al. Doxycycline for outpatient-treated acute exacerbations of COPD: a randomised double-blind placebo-controlled trial. Lancet Respir Med, 2017, 5(6): 492-499.
26.	Marino M, Bailey SR, Gold R, et al. Receipt of preventive services after Oregon's randomized medicaid experiment. Am J Prev Med, 2016, 50(2): 161-170.
27.	Courtright KR, Madden V, Gabler NB, et al. Rationale and design of the Randomized Evaluation of Default Access to Palliative Services (REDAPS) trial. Ann Am Thorac Soc, 2016, 13(9): 1629-1639.
28.	Burbach JP, Verkooijen HM, Intven M, et al. RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study): study protocol for a randomized controlled trial. Trials, 2015, 16: 58.
29.	Erlinge D, Omerovic E, Fröbert O, et al. Bivalirudin versus heparin monotherapy in myocardial infarction. N Engl J Med, 2017, 377(12): 1132-1142.
30.	Gale C, Modi N, Jawad S, et al. The WHEAT pilot trial-WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: a multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial. BMJ Open, 2019, 9(9): e033543.
31.	Hemkens LG, Saccilotto R, Reyes SL, et al. Personalized prescription feedback using routinely collected data to reduce antibiotic use in primary care: a randomized clinical trial. JAMA Intern Med, 2017, 177(2): 176-183.
32.	Liebschutz JM, Xuan Z, Shanahan CW, et al. Improving adherence to long-term opioid therapy guidelines to reduce opioid misuse in primary care: a cluster-randomized clinical trial. JAMA Intern Med, 2017, 177(9): 1265-1272.
33.	Lundh A, Lexchin J, Mintzes B, et al. Industry sponsorship and research outcome: systematic review with meta-analysis. Intensive Care Med, 2018, 44(10): 1603-1612.
34.	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.
35.	郑晨思, 刘保延, 房繄恭. 基于注册登记研究的随机对照试验研究现状分析. 中医杂志, 2020, 61(12): 1054-1058.
36.	Li G, Sajobi TT, Menon BK, et al. Registry-based randomized controlled trials- what are the advantages, challenges, and areas for future research. J Clin Epidemiol, 2016, 80: 16-24.
37.	Medicines and Healthcare Products Regulatory Agency. Guidance and regulation. Available at: https://www.gov.uk/search/guidance-and-regulation.
38.	von Niederhäusern B, Guyatt GH, Briel M, et al. Academic response to improving value and reducing waste: a comprehensive framework for INcreasing QUality In patient-oriented academic clinical REsearch (INQUIRE). PLoS Med, 2018, 15(6): e1002580.

1. Glasziou P, Altman DG, Bossuyt P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet, 2014, 383(9913): 267-276.
2. Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2): e1000217.
3. Caulley L, Catalá-López F, Whelan J, et al. Reporting guidelines of health research studies are frequently used inappropriately. J Clin Epidemiol, 2020, 122: 87-94.
4. Glasziou P, Meats E, Heneghan C, et al. What is missing from descriptions of treatment in trials and reviews. BMJ, 2008, 336(7659): 1472-1474.
5. Hoffmann TC, Oxman AD, Ioannidis JP, et al. Enhancing the usability of systematic reviews by improving the consideration and description of interventions. BMJ, 2017, 358: j2998.
6. 刘佳利, 唐立, 孙鑫. 详细报告干预措施, 提高系统评价可用性. 中国循证医学杂志, 2018, 18(1): 92-95.
7. Caulley L, Cheng W, Catalá-López F, et al. Citation impact was highly variable for reporting guidelines of health research: a citation analysis. J Clin Epidemiol, 2020, 127: 96-104.
8. 卢存存, 柯立鑫, 汤昊, 等. 中文期刊发表的氨甲环酸Meta分析的报告质量与方法学质量评价. 中国循证医学杂志, 2021, 21(11): 1332-1338.
9. da Costa BR, Juni P. Systematic reviews and meta-analyses of randomized trials: principles and pitfalls. Eur Heart J, 2014, 35(47): 3336-3345.
10. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c869.
11. 魏旭煦, 刘岩, 胡嘉元, 等. 多臂平行对照随机临床试验报告规范: CONSORT2010声明扩展版. 中国循证医学杂志, 2021, 21(2): 231-240.
12. Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med. 2017, 167(2): 112-121.
13. 卢存存, 杨楠, 柯立鑫, 等. 社会和心理学干预随机对照试验的报告规范(2018)解读. 中国循证儿科杂志, 2019, 14(1): 74-77.
14. Karanatsios B, Prang KH, Verbunt E, et al. Defining key design elements of registry-based randomised controlled trials: a scoping review. Trials, 2020, 21(1): 552.
15. Kwakkenbos L, Imran M, McCall SJ, et al. CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration. BMJ, 2021, 373: n857.
16. Imran M, Kwakkenbos L, McCall SJ, et al. Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). BMJ Open, 2021, 11(4): e049093.
17. Mathes T, Klaßen P, Pieper D. No differences were found between effect estimates from conventional and registry-based randomized controlled trials. J Clin Epidemiol, 2019, 105: 80-91.
18. Simera I, Moher D, Hoey J, et al. A catalogue of reporting guidelines for health research. Eur J Clin Invest, 2010, 40(1): 35-53.
19. Kwakkenbos L, Imran M, McCord KA, et al. Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data. BMJ Open, 2018, 8(8): e025266.
20. Nascimento DP, Ostelo RWJG, van Tulder MW, et al. Do not make clinical decisions based on abstracts of healthcare research: a systematic review. J Clin Epidemiol, 2021, 135: 136-157.
21. 张春芳, 孔燕. 结构式摘要的形成、发展及现状——兼谈医学论文摘要的英译. 医学与哲学(人文社会医学版), 2011, 32(9): 77-79.
22. Dombkowski KJ, Costello LE, Harrington LB, et al. Age-specific strategies for immunization reminders and recalls: a registry-based randomized trial. Am J Prev Med, 2014, 47(1): 1-8.
23. Hofmann R, James SK, Jernberg T, et al. Oxygen therapy in suspected acute myocardial infarction. N Engl J Med, 2017, 377(13): 1240-1249.
24. Dregan A, van Staa TP, McDermott L, et al. Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records. Stroke, 2014, 45(7): 2066-2071.
25. van Velzen P, Ter Riet G, Bresser P, et al. Doxycycline for outpatient-treated acute exacerbations of COPD: a randomised double-blind placebo-controlled trial. Lancet Respir Med, 2017, 5(6): 492-499.
26. Marino M, Bailey SR, Gold R, et al. Receipt of preventive services after Oregon's randomized medicaid experiment. Am J Prev Med, 2016, 50(2): 161-170.
27. Courtright KR, Madden V, Gabler NB, et al. Rationale and design of the Randomized Evaluation of Default Access to Palliative Services (REDAPS) trial. Ann Am Thorac Soc, 2016, 13(9): 1629-1639.
28. Burbach JP, Verkooijen HM, Intven M, et al. RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study): study protocol for a randomized controlled trial. Trials, 2015, 16: 58.
29. Erlinge D, Omerovic E, Fröbert O, et al. Bivalirudin versus heparin monotherapy in myocardial infarction. N Engl J Med, 2017, 377(12): 1132-1142.
30. Gale C, Modi N, Jawad S, et al. The WHEAT pilot trial-WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: a multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial. BMJ Open, 2019, 9(9): e033543.
31. Hemkens LG, Saccilotto R, Reyes SL, et al. Personalized prescription feedback using routinely collected data to reduce antibiotic use in primary care: a randomized clinical trial. JAMA Intern Med, 2017, 177(2): 176-183.
32. Liebschutz JM, Xuan Z, Shanahan CW, et al. Improving adherence to long-term opioid therapy guidelines to reduce opioid misuse in primary care: a cluster-randomized clinical trial. JAMA Intern Med, 2017, 177(9): 1265-1272.
33. Lundh A, Lexchin J, Mintzes B, et al. Industry sponsorship and research outcome: systematic review with meta-analysis. Intensive Care Med, 2018, 44(10): 1603-1612.
34. 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.
35. 郑晨思, 刘保延, 房繄恭. 基于注册登记研究的随机对照试验研究现状分析. 中医杂志, 2020, 61(12): 1054-1058.
36. Li G, Sajobi TT, Menon BK, et al. Registry-based randomized controlled trials- what are the advantages, challenges, and areas for future research. J Clin Epidemiol, 2016, 80: 16-24.
37. Medicines and Healthcare Products Regulatory Agency. Guidance and regulation. Available at: https://www.gov.uk/search/guidance-and-regulation.
38. von Niederhäusern B, Guyatt GH, Briel M, et al. Academic response to improving value and reducing waste: a comprehensive framework for INcreasing QUality In patient-oriented academic clinical REsearch (INQUIRE). PLoS Med, 2018, 15(6): e1002580.

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