An assessment of methodological quality of multi-center randomized controlled trials of stroke treatments conducted in Chinese Mainland_West China Medical Journal

Authors：

 HE Sha , ZHANG Tian , SUN Wei , QIU Zhi

Department of Rehabilitation Medicine, Guizhou Orthopaedics Hospital, Guiyang, Guizhou 550001, P. R. China;

Corresponding?author：

HE Sha, Email: 756178245@qq.com

Keywords：

Stroke; Randomized controlled trial; Methodological quality; Outcome measure

DOI：

10.7507/1002-0179.202004491

Video：

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Objective To evaluate the current status and trend of methodological quality of multi-center randomized controlled trials (RCTs) of stroke treatments in Chinese Mainland.Methods Multi-center RCTs of stroke treatments conducted in Chinese Mainland published in Chinese or English language from January 2000 to December 2019 were retrieved from seven databases including PubMed, Cochrane Central Registry of Controlled Trials, Embase, China Biology Medicine, China National Knowledge Infrastructure, Chinese Science and Technique Journals Database, and Wanfang Database. The basic information was collected. Methodological items were referred to the Cochrane Collaboration’s tool for assessing risk of bias. The definitions of Wade were used to assess the outcome measure.Results A total of 90 multi-center RCTs were included, of which 39 were published from 2000 to 2009, and 51 were published from 2010 to 2019. The total number of trials published from 2010 to 2019 was 1.31 times of that published from 2000 to 2009. The research subjects were ischemic stroke patients in 58.9% (53/90) of the RCTs, intracerebral hemorrhage patients in 14.4% (13/90) of the RCTs, and ischemic stroke patients as well as hemorrhagic stroke patients in 26.7% (24/90) of the RCTs. There were 55.6% (50/90) drug trials, and 44.4% (40/90) non-drug trials. There were statistically significant differences in the loss of visit report (P=0.005), primary and secondary outcome indicators report (P=0.027), and adverse reaction report (P=0.007) between the two periods; there was no statistically significant difference in reported adequate randomized methods (P=0.341), allocation concealment (P=0.611), blindness (P=0.551), used intentionality analysis (P=0.573), or follow-up time (P=0.061) between the two periods.Conclusion In the past 20 years in Chinese Mainland, the quality of stroke treatment RCTs improves slowly, and more attention should be paid to develop the RCTs of true randomization, blinding, and better patient outcome measures.

Citation： HE Sha, ZHANG Tian, SUN Wei, QIU Zhi. An assessment of methodological quality of multi-center randomized controlled trials of stroke treatments conducted in Chinese Mainland. West China Medical Journal, 2020, 35(6): 673-678. doi: 10.7507/1002-0179.202004491 Copy

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2.	Kasner SE. Clinical interpretation and use of stroke scales. Lancet Neurol, 2006, 5(7): 603-612.
3.	Liu M, Counsell C, Sandercock P. Report of randomized controlled trials identifified in the Chinese literature vs. MEDLINE. JAMA, 1998, 280(15): 1308-1309.
4.	He S, Wu S, Zeng Q, et al. Assessment of methodological quality and outcome measures of acute stroke randomized controlled trials in China in recent 15 years. J Evid Based Med, 2012, 5(3): 174-182.
5.	中華醫學會神經病學分會, 中華醫學會神經病學分會腦血管病學組. 中國急性缺血性腦卒中診治指南2018. 中華神經科雜志, 2018, 51(9): 666-682.
6.	中華醫學會神經病學分會, 中華醫學會神經病學分會腦血管病學組. 中國缺血性腦卒中和短暫性腦缺血發作二級預防指南2014. 中華神經科雜志, 2015, 48(4): 258-273.
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8.	劉鳴, 吳波, 袁強. 我國急性腦卒中臨床試驗療效判斷方法分析. 中國循證醫學雜志, 2004, 4(3): 164-166.
9.	Wade DT. Measurement in neurological rehabilitation. Oxford, England: Oxford University Press, 1992: 682-686.
10.	全國降纖酶臨床再評價研究協作組. 降纖酶治療急性腦梗死的臨床再評價—多中心前瞻性隨機雙盲對照研究. 中華神經科雜志, 2000, 33(5): 263-267.
11.	全國降纖酶臨床再評價研究協作組. 降纖酶治療急性腦梗死的臨床再評價(II). 中華神經科雜志, 2005, 38(1): 11-16.
12.	Liu X, Wang L, Wen A, et al. Ginsenoside-Rd improves outcome of acute ischaemic stroke - a randomized, double-blind, placebo-controlled, multicenter trial. Eur J Neurol, 2012, 19(6): 855-863.
13.	Zhang S, Wu B, Liu M, et al. Acupuncture efficacy on ischemic stroke recovery: multicenter randomized controlled trial in China. Stroke, 2015, 46(5): 1301-1306.
14.	Zhao JW, Su YY, Zhang Y, et al. Decompressive hemicraniectomy in malignant middle cerebral artery infarct: a randomized controlled trial enrolling patients up to 80 years old. Neurocrit Care, 2012, 17(2): 161-171.
15.	Peng B, Ni J, Anderson CS, et al. Implementation of a structured guideline-based program for the secondary prevention of ischemic stroke in China. Stroke, 2014, 45(2): 515-519.
16.	Juszczak E, Altman DG, Hopewell S, et al. Reporting of multi-arm parallel-group randomized trials: extension of the CONSORT 2010 statement. JAMA, 2019, 321(16): 1610-1620.
17.	何俐, 韓釗, 劉鳴, 等. 我國神經疾病防治性研究隨機對照試驗現狀的初步分析. 中華神經科雜志, 1999, 32(2): 92-94.
18.	Charles P, Giraudeau B, Dechartres A, et al. Reporting of sample size calculation in randomised controlled trials: review. BMJ, 2009, 338: b1732.
19.	Luengo-Fernandez R, Paul NL, Gray AM, et al. Population-based study of disability and institutionalization after transient ischemic attack and stroke: 10-year results of the Oxford Vascular Study. Stroke, 2013, 44(10): 2854-2861.
20.	Stinear CM, Lang CE, Zeiler S, et al. Advances and challenges in stroke rehabilitation. Lancet Neurol, 2020, 19(4): 348-360.

1. Wu SM, Wu B, Liu M, et al. Stroke in China: advances and challenges in epidemiology, prevention, and management. Lancet Neurol, 2019, 18(4): 394-405.
2. Kasner SE. Clinical interpretation and use of stroke scales. Lancet Neurol, 2006, 5(7): 603-612.
3. Liu M, Counsell C, Sandercock P. Report of randomized controlled trials identifified in the Chinese literature vs. MEDLINE. JAMA, 1998, 280(15): 1308-1309.
4. He S, Wu S, Zeng Q, et al. Assessment of methodological quality and outcome measures of acute stroke randomized controlled trials in China in recent 15 years. J Evid Based Med, 2012, 5(3): 174-182.
5. 中華醫學會神經病學分會, 中華醫學會神經病學分會腦血管病學組. 中國急性缺血性腦卒中診治指南2018. 中華神經科雜志, 2018, 51(9): 666-682.
6. 中華醫學會神經病學分會, 中華醫學會神經病學分會腦血管病學組. 中國缺血性腦卒中和短暫性腦缺血發作二級預防指南2014. 中華神經科雜志, 2015, 48(4): 258-273.
7. Higgins JPT, Thomas J, Chandler J, et al. Cochrane handbook for systematic reviews of interventions version 6.0 (updated July 2019). Cochrane, 2019. [2020-02-01]. https://training.cochrane.org/handbook/current.
8. 劉鳴, 吳波, 袁強. 我國急性腦卒中臨床試驗療效判斷方法分析. 中國循證醫學雜志, 2004, 4(3): 164-166.
9. Wade DT. Measurement in neurological rehabilitation. Oxford, England: Oxford University Press, 1992: 682-686.
10. 全國降纖酶臨床再評價研究協作組. 降纖酶治療急性腦梗死的臨床再評價—多中心前瞻性隨機雙盲對照研究. 中華神經科雜志, 2000, 33(5): 263-267.
11. 全國降纖酶臨床再評價研究協作組. 降纖酶治療急性腦梗死的臨床再評價(II). 中華神經科雜志, 2005, 38(1): 11-16.
12. Liu X, Wang L, Wen A, et al. Ginsenoside-Rd improves outcome of acute ischaemic stroke - a randomized, double-blind, placebo-controlled, multicenter trial. Eur J Neurol, 2012, 19(6): 855-863.
13. Zhang S, Wu B, Liu M, et al. Acupuncture efficacy on ischemic stroke recovery: multicenter randomized controlled trial in China. Stroke, 2015, 46(5): 1301-1306.
14. Zhao JW, Su YY, Zhang Y, et al. Decompressive hemicraniectomy in malignant middle cerebral artery infarct: a randomized controlled trial enrolling patients up to 80 years old. Neurocrit Care, 2012, 17(2): 161-171.
15. Peng B, Ni J, Anderson CS, et al. Implementation of a structured guideline-based program for the secondary prevention of ischemic stroke in China. Stroke, 2014, 45(2): 515-519.
16. Juszczak E, Altman DG, Hopewell S, et al. Reporting of multi-arm parallel-group randomized trials: extension of the CONSORT 2010 statement. JAMA, 2019, 321(16): 1610-1620.
17. 何俐, 韓釗, 劉鳴, 等. 我國神經疾病防治性研究隨機對照試驗現狀的初步分析. 中華神經科雜志, 1999, 32(2): 92-94.
18. Charles P, Giraudeau B, Dechartres A, et al. Reporting of sample size calculation in randomised controlled trials: review. BMJ, 2009, 338: b1732.
19. Luengo-Fernandez R, Paul NL, Gray AM, et al. Population-based study of disability and institutionalization after transient ischemic attack and stroke: 10-year results of the Oxford Vascular Study. Stroke, 2013, 44(10): 2854-2861.
20. Stinear CM, Lang CE, Zeiler S, et al. Advances and challenges in stroke rehabilitation. Lancet Neurol, 2020, 19(4): 348-360.

West China Medical Journal

An assessment of methodological quality of multi-center randomized controlled trials of stroke treatments conducted in Chinese Mainland

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