ObjectivesTo assess the methodological quality of clinical practice guidelines of cervical cancer in China published from 2014 to 2018.MethodsCNKI, WanFang Data, CBM, VIP, Medlive.cn, the National Guideline Clearinghouse, PubMed, The Cochrane Library and EMbase were searched for cervical cancer clinical practice guidelines published in China from January 1st, 2014 to December 31st, 2018. Four reviewers searched and selected the literature independently according to the inclusion and exclusion criteria and assessed the methodological quality of the included guidelines by using AGREE Ⅱ.ResultsA total of 9 guidelines were included. The average score for each area was: scope and purpose 75.47%, stakeholders’ involvement 35.09%, the rigor of development 43.70%, clarity of presentation 87.74%, applicability 80.76%, and editorial independence 0%.ConclusionsThe quality of cervical cancer clinical practice guidelines in China requires further improvement.
Objective To evaluate the quality of Chinese literatures on the methodology of D-dimer diagnostic test. Method We searched CNKI (1994 to 2006) and CBM (1978 to 2006) for articles involving the diagnostic tests of D-dimer for coagulation disorders. Result A total of 63 relevant articles were retrieved and 7 were included in our review. Only one of these provided useful data on two two table for the evaluation of diagnostic accuracy. Conclusions Few studies on the diagnostic tests of D-dimer have been performed and publ ished in China, all of poor quality. Further studies should focus on clinical diagnostic sensitivity and specificity, so as to provide more valuable information for readers.
Objectives To explore the quality of the reporting of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for chronic fatigue syndrome (CFS).Methods We searched the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library, Issue 4, 2006), PubMed, EMbase, the Chinese Biomedical Database (CBMdisc), VIP Information, and China National Knowledge Infrastructure (CNKI) (from establishment to February 2007). We also checked the reference lists of included studies. The quality of the reporting of RCTs was assessed using the 22-item checklist of the CONSORT Statement and other self-established criteria. Results Thirty-eight RCTs were included. The word “randomization” was not present in any of the trials, and only 17 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial, the estimation of the necessary sample size, the methods of allocation concealment and blinding, participant flow chart, ITT analysis, and ancillary analyses. Some authors misunderstood the diagnostic criteria and inclusion criteria, some selected inappropriate control interventions, and some did not clearly describe their statistical methods or used incorrect methods. All 38 trials reported positive outcomes, few reported adverse effects. No report included a general interpretation of the new trial’s results in the context of current evidence in their discussion section, and none mentioned the limitations of the study, the clinical and research implications or the external validity of the trial findings. Conclusion The overall reporting quality of RCTs of TCM for CFS is poor. Defects are found in each section of the reports. Researchers and journal editors should learn and use the principles and methods of evidence-based medicine—especially the use of a transparent prospective clinical trial register and the CONSORT Statement—to improve the design, conduct and report TCM trials.
ObjectiveTo investigate the methodological and reporting quality of clinical trials involving Xiaoyao San for chronic fatigue syndrome. MethodsWe searched PubMed, CBM, CNKI, VIP and WanFang Data to identify randomized controlled trials (RCTs) about Xiaoyao San for chronic fatigue syndrome. The methodological and reporting quality of included RCTs was respectively evaluated according to the assessment tool of risk of bias of the Cochrane Handbook 5.1.0 and the CONSORT 2010 statement, combined with complementary assessment by the characteristic indicators of traditional Chinese medicine (TCM). The methodological and reporting quality of included case series study was respectively assessed by the methods recommended by the Britain's National Institute for Clinical Excellence (NICE) and the STROBE statement. ResultsA total of 27 clinical trials were included, involving 11 RCTs and 16 case series studies. According to the assessment tool of risk of bias of the Cochrane Handbook, 54.5% of the RCTs performed proper random method, 9.1% conducted allocation concealment and blinding, 72.7% selected intention-to-treat (ITT) analysis without the report of loss to follow-up, and no RCT existed selective reports. Corresponding to the characteristic indicators of TCM, 54.5% of the RCTs did not conduct TCM syndrome diagnosis, the curative effect standard of TCM syndrome was discrepant, and no RCT was multi-center study. The CONSORT 2010 statement indicated that no RCT explained sample size estimation, implementation details of randomization, flow diagram of participant, use of ITT and clinical trial registration. According to the items recommended by Britain's NICE, 6.25% of the case series studies were multi-center, 81.25% did not report clear inclusion and exclusion criteria, and no case series study performed continuous patient recruitment and stratification analysis of outcome. The STROBE statement indicated that no case series study reported research design, sample size, flow chart, bias, limitations and generalizability. ConclusionThe quality of clinical trials about Xiaoyao San for chronic fatigue syndrome is still low in methodological and reporting aspects. It is suggested that the future clinical trials should be conducted with references of CONSORT statement and STROBE statement, to propel the modernization and internationalization of TCM.
Objective To identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems. Methods Eleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method，described outcome, side effects, and follow up etc. were analyzed. Results In the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method，934 (65.96%) had baseline comparison，828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria，finally only 89 (6.29%) reported side effects. Conclusions Although the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.
Objective To assess the quality of randomized controlled trials (RCTs) on acupuncture for treating acute migraine attacks. Methods With the searching terms of acupuncture and migraine, the Cochrane Controlled Trials Register (CCTR), PubMed, MEDLINE, EMbase, CBM, CMCC, CNKI and VIP were searched. The reports quality of the included trials, including the quality of methodology, diagnostic criteria, inclusion/exclusion criteria, acupuncture/control interventions, outcome measures, observing time, and adverse effects reports, was evaluated. Results A total 23 RCTs involving 2645 patients were included, of which only 3 RCTs were of high quality with Jadad scores equal to or more than 4. At present, only a few high quality trials on treating acute attacks of migraine with acupuncture had been reported at home and abroad. The international recognized diagnostic criteria and common evaluation methods had not been used generally, and the design of control was kind of irrational. Conclusion Based on current clinical reports, acupuncture may be effective in the management of acute migraine attacks, but some relevant proof is still required. The further domestic studies should be designed strictly following the international recommended diagnosis and evaluation criteria of migraine, and rational control methods as well.
Objective To evaluate the reporting quality and influencing factors of patient-reported outcome (PRO) data in randomized controlled trials (RCTs) of lung cancer. Methods RCTs of lung cancer with PRO as either primary or secondary endpoints were searched from PubMed, EMbase, Medline, CNKI, Wanfang Data, and VIP databases between January 1, 2010 and April 20, 2024. Reporting quality of included RCTs were assessed based on the CONSORT-PRO extension. Descriptive statistics and bivariate regression analysis were used to describe the reporting quality and analyze the factors influencing the reporting quality. Results A total of 740 articles were retrieved. After screening, 53 eligible RCTs of lung cancer with 22 780 patients were included. The patients were mainly with non-small cell lung cancer (84.91%), with the median sample size of the included studies was 364.0 (160.5, 599.5) patients. The primary PRO tool used was the EORTC QLQ-C30 (60.38%). There were 52 (98.11%) studies whose PRO measured the domain of "symptom management of cough, dyspnea, fatigue, pain, etc.", and 45 (84.91%) studies measured "health-related quality of life". Multicenter studies accounted for 84.91%, and randomized non-blind trials accounted for 62.26%. PRO was used as the primary endpoint in 33.96% of the studies and as secondary endpoints in 66.04%. The reliability and validity of the PRO tools were explicitly mentioned in 11.32% and 7.55% of the studies, respectively. The average completeness of reporting according to the CONSORT-PRO guidelines was 60.00%, ranging from 25.00% to 93.00%. The main factors affecting the completeness of CONSORT-PRO reporting included sample size and publication year. For every increment in sample size, the completeness of reporting increased by 27.5% (SE=0.00, t=2.040, P=0.046). Additionally, studies published after 2018 had a 67.2% higher completeness of reporting compared to those published in or before 2018 (SE=17.8, t=–3.273, P=0.006). Conclusion The study reveals that the overall reporting quality of PRO in lung cancer RCTs is poor. Particularly, the reporting of PRO measures reliability and validity, PRO assumptions, applicability, and handling of missing data need further improvement. Future research should emphasize comprehensive adherence to the CONSORT-PRO guidelines.
ObjectiveTo systematically review the methodological quality of Chinese clinical practice guidelines (CPGs) for diagnosis and management of diabetic foot.MethodsCNKI, WanFang Data, VIP, CBM, Yimaitong databases, website of Diabetes Branch of Chinese Medical Association, website of Chinese Integrative Medicine Association and website of Peripheral Vascular Disease Professional Committee of Chinese Society of Microcirculation were electronically searched to collect relevant CPGs from inception to May, 2020. Four researchers independently evaluated the CPGs methodological quality by using AGREEⅡ tool.ResultsA total of 10 Chinese CPGs for diabetes foot were included. The standardized mean scores for various fields were 75.74% for scope and purpose, 36.58% for stakeholder involvement, 28.61% for rigor of development, 86.30% for clarity and presentation, 43.47% for applicability, and 9.44% for editorial independence. ConclusionsThere are merely a small quantity of diabetic foot guidelines in China, and the methodological quality is insufficient. Therefore, more attention should be focused on the establishment of guidelines in the future, so as to further improve the quality of Chinese diabetic foot guidelines.
ObjectiveTo investigate the reporting and methodological quality of systematic reviews/ meta-analyses conducted by hospital pharmacists in China, so as to improve the quality of systematic reviews/ meta-analyses in this field. MethodsThe literatures were retrieved from CNKI, WanFang Data, VIP, CBM, CMCI, PubMed, EMbase, The Cochrane Library from the establishment date to March 17th, 2016. According to the inclusive and exclusive criteria, authors independently screened and extracted the published information. Reporting and methodological quality of included reviews were evaluated by PRIMSA statements and AMSTAR checklists. Data analysis was conducted by using Excel 2013 software and SPSS 20.0 software. ResultsOne thousand and eighteen systematic reviews/ meta-analyses were included, including 871 Chinese literatures and 147 English literatures. The average score of PRIMSA was 18.41±2.84, and the average score of AMSTAR was 7.38±1.28. The main problems of PRIMSA were structured summary, objectives, protocol and registration, additional analyses and funding. The main problems of AMSTAR were priori design, status of publication and list of studies (included and excluded). Univariate analysis showed that some factors could improve the quality of methodology and reporting, including studies in English (P<0.000 1), published after checklists' (P<0.000 1), hospital in higher-level (P<0.000 1), illuminating the funding or interest conflict (P<0.000 1). Pearson analysis indicated that linear correlation were detected between PRISMA scores and AMSTAR scores (P<0.000 1), as well as citations and AMSTAR scores (P=0.045). ConclusionEvidenced-based pharmacy in hospital has developed rapidly, the quality of methodology and reporting have increaseed year by year, but further improvement should be considered in different aspects. The methods to evaluate the clinical application of these systematic reviews/ meta-analyses should be developed in the future.
目的 系统评价可作为将基础生命科学研究从实验室转化到人体研究和健康保健措施的工具。对动物研究的系统评价是否系统且不存在偏倚，目前尚不知。 方法 我们检索了MEDLINE、EMBASE、已知系统评价的参考文献（1996~2004）并联系相关专家，至少检索一个对公众开放的数据库全面收集基础科学文献的引文，均未设定语言限制。我们从中纳入那些在动物身上测量实验室参数或在活体动物身上给予治疗以评价疗效研究的系统评价，并将其与在实验室中研究人体或动物组织、细胞系统或器官标本以进一步了解疾病机理体外研究的系统评价进行比较。 结果 动物研究的系统评价通常缺少如定义供检验的假设（9/30，30％）；文献检索不设语言限制（8/30，26.6％）；评价发表偏倚（5/30，16.6％）、研究的真实性（15/30，50％）和异质性（10/30，33.3％）；及使用Meta分析用于定量合成（12/30，40％）等方法学特征。与体外研究的系统评价相比，动物研究的系统评价更多地限定了研究问题（96.6％ vs. 80％，P=0.04）、综合检索了多个数据库（60％ vs. 26.6％，P=0.01）、评价了研究质量（50％ vs. 20％，P=0.01）及探讨了研究异质性（33.3％ vs. 2.2％，P=0.001），因此更少出现偏倚。 结论 在各类系统评价中，方法学质量问题的出现频率似乎存在一定的梯度：虽然与人体临床试验的系统评价相比，整体动物研究的系统评价质量明显较差，但其仍优于体外研究的系统评价。在系统评价动物研究时，有必要更严格。