Objective To assess the methodological quality of clinical guidelines and consensus of lupus nephritis, to collect the recommendations of each guideline, and to provide references for clinical decision-making. Methods PubMed, CNKI, and CBM databases and related websites such as NGC, NICE, GIN, SIGN, and Medive were electronically searched from January 2012 to December 2020 to collect the clinical guidelines and expert consensus for lupus nephritis. After consistency evaluation by four evaluators, the methodological quality of the included guidelines or expert consensus was evaluated using AGREE Ⅱ. The relevant recommendations, evidence level, and recommended strength of each guideline in treating lupus nephritis were summarized. Results A total of eight guidelines and two consensus statements were included. Among them, eight guidelines or consensus statements were level B (generally recommended guidelines), and two were level C (non-recommended guidelines). Relevant recommendations mainly gave the corresponding treatment scheme according to the pathological type of lupus nephritis. Conclusion The methodological quality of lupus nephritis guideline formulation in China needs to be improved. The included guidelines and consensus can provide reference for clinical decision-makers. However, higher-quality clinical practice guidelines for the Chinese population are needed to be developed in the future.
Objective To evaluate the methodological and reporting quality of randomized controlled trials involving traditional Chinese medicine in the treatment of cholelithiasis. Methods We searched CNKI (1994 to 2007), CMCC (1994 to 2007), VIP (1989 to 2007), MEDLINE (1966 to April 2007) and The Cochrane Library (Issue 4, 2006). Data from randomized controlled trials (RCTs) and quasi-RCTs were extracted by two reviewers independently. The methodological quality of included trials was assessed by using the quality assessment criteria recommended by The Cochrane Collaboration, and the reporting quality was assessed by using the CONSORT for TCM checklist. Results Seventeen studies including 16 RCTs and one quasi-RCT were included. The methodological and reporting qualities of included studies were generally low. All studies were graded C. The highest score evaluated by the CONSORT for TCM checklist was 18. Conclusion The quality of RCTs and quasi-RCTs involving traditional Chinese medicine for cholelithiasis is generally low, with a high risk of biases. The reporting of these trials is also incomplete, which would affect a reader’s understanding and evaluation of the validity, importance and applicability of the study results. Therefore, new randomized controlled trials of high quality are required to provide reliable evidence.
The study appeared the comparison between CONSORT and CENT, and promoted the combination with GRADE and N-of-1 trial. Our objective is to further develop the method of N-of-1 trial and to widely use it in clinical researches of some diseases.
ObjectivesTo evaluate the methodological and reporting quality of clinical guidelines and consensus for esophageal cancer.MethodsDatabases including PubMed, EMbase, Web of Science, CBM, WanFang Data and CNKI were electronically searched and major guideline websites such as GIN, NICE, NGC and Yimaitong were also searched to collect guidelines and consensus for esophageal cancer from inception to August 2018. Two reviewers independently screened the literatures and extracted data according to the inclusion and exclusion criteria and then evaluated the quality of the included guidelines using the AGREE II and RIGHT instruments.ResultsA total of 26 esophageal cancer guidelines and consensus were included. The mean scores for each domain of AGREE II was 49.63% for scope and purpose, 25.16% for stakeholder involvement, 23.42% for rigor of development, 49.25% for clarity of presentation, 16.91% for applicability, and 21.07% for editorial independence. The item with the highest reporting rate among the RIGHT evaluation items was 5 (84.62%), followed by 1a (80.77%), 1c (65.38%), 13a (65.38%), and 4 (61.54%), and the remaining items were all reported below 50%. Results of subgroup analysis showed that the guidelines and consensus developed based on the evidence-based medicine method had higher average scores in the six domains of AGREE II and the RIGHT score than the guidelines and consensus developed based on expert opinions or reviews. The foreign guidelines and consensus had higher average scores in the three domains of AGREE II (formulation rigor, clarity, editorial independence) and the RIGHT score than the domestic guidelines.ConclusionsThe methodological and reporting quality of the guidelines and consensus on esophageal cancer is low, with the guidelines and consensus in China even lower, requiring further improvement. It is suggested that the guideline developers should refer to the standards such as AGREE II and RIGHT to develop high-quality guidelines and promote their application, so as to better guide the standardized diagnosis and treatment of esophageal cancer.
Objective To investigate the reporting quality of randomized controlled trials (RCT) on laparoscopic surgery for treating colorectal disease in three SCI indexed. Methods We electronically retrieved the Ovid MEDLINE(R) from 1950 to present with Daily Updates for RCTs on laparoscopic surgery published in Diseases of the Colon amp; Rectum, International Journal of Colorectal Disease, or Colorectal Disease. The revised CONSORT statement and additional surgical items were adopted to assess the reporting quality. One point was assigned for each full description of an item, 0 for no description, and 0.5 for a partial description. Results A total of 20 RCTs were included and 8 RCTs were excluded. Their reporting quality was low. The average scores for the following items were relatively lower, 0.150 for settings where data collected; 0.250 for sample size estimation; 0.500 for sequence generation of randomization; 0.325 for allocation concealment; 0.150 for implementation; 0.475 for measurement of outcome; 0.150 for participant flow chart; 0.450 for adverse events; 0.450 for external validity; 0.400 for financial conflicts of interest; 0.250 for perioperative pharmacological treatment; 0.075 for perioperative nonphamacological treatment; 0.000 for participation of a trial methodologist; 0.350 for surgeon’s experience (years or position). Items with the lower scores were mainly in the methods and results section and surgical items. Conclusions The reporting quality of laparoscopic RCTs in these journals is low. Colorectal surgeons should rigorously evaluate reports in these journals before they apply to them in clinical practice.
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.
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.
Objectives To assess the quality of clinical practice guidelines for primary hepatic carcinoma published in 2016 and 2017 in China. Methods CNKI, WanFang Data, CBM and VIP databases were searched for clinical practice guidelines for primary hepatic carcinoma in China. The search date was from Jan. 1st, 2016 to Jan. 1st, 2018. Four researchers independently selected literatures and extracted data according to the inclusion and exclusion criteria. The Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ) was utilized to assess the methodological quality of the guidelines. Results A total of 7 guidelines were included. The average scores of six domains for these guidelines were: 65.1% for scope and purpose, 39.4% for stakeholders’ involvement, 64.3% for rigor of development, 55.6% for clarity of presentation, 61.8% for applicability and 6.1% for editorial independence. Conclusions The quality of clinical practice guidelines for primary hepatic carcinoma in China is relative high, of which the recommendations are of great value in clinical practice, yet still required to be improved in some ways.
Objective To explore the quality of the reporting of randomized controlled trials (RCTs) published in the Chinese Journal of Integrated Traditional and Western Medicine from 1999 to 2004. Methods A manual search was performed and the 22 checklists of CONSORT statement and other self-established criteria were applied. Results Six volumes and 72 issues were checked. There were 1 874 clinical trials of which 1288 (68.73%) RCTs were identified in 2 765 articles. Randomization methods were described in 630 (48.92%) RCTs which showed there was more significant difference than the RCTs published in 1998 (Plt;0.001).In the 1288 RCTs, placebo control was reported only in 21 trials (1.63%) and endpoint measurements were reported in 114 trials (8.85%). Seven trials (0.55%) mentioned the estimation of sample size. None mentioned randomization concealment. Blinding was reported in 54 trials (4.2%) and P value was reported in 9 trials (0.70%).Flow chart was not mentioned in any trials. Compliance was reported in 2 trials (0.16%), and only one trial (0.08%) reported negative results. Ancillary analysis was used in 33 trials (2.57%). 10 trials are multi-centre RCTs. None of the trials reported the approval of ethics committee. Informed consent was reported in 3 trials (0.24%). Acknowledgements were mentioned in 3 trials (0.24%). Syndrome types defined by traditional Chinese medicine (TCM) were reported in 163 trials (12.66%). The criteria of intervention quality control was mentioned in 2 trials (0.15%). Double dummy was used in 8 trials (0.63%) and outcome measurement of TCM was reported in 258 trials (20.04%). All Items reported in RCTs were of low quality. Conclusions The quality of reporting of RCTs published in the Chinese Journal of Integrated Traditional and Western Medicine from 1999 to 2004 has been improved, but it does not meet the CONSORT statement.
ObjectivesTo compare and analyze existing pharmaceutical economic evaluations quality assessment instruments, and to provide suggestions on how to choose the most appropriate instrument.MethodsPubMed, EMbase, ScienceDirect, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect studies on existing pharmaceutical economic evaluations quality assessment instruments from inception to December, 2017. Two reviewers independently screened literature, extracted data and analyzed studies in terms of items, design methods, scopes and characteristics.ResultsTwelve original checklists with good reliability and validity were found. The first quality assessment method was designed in 1987 and the latest one was published in 2013. The number of checklist items ranged from 11 to 61.ConclusionThere is no consolidated method for assessing the quality of pharmaceutical economics evaluations. Evaluators can choose appropriate evaluation tools according to the purpose, type and operability of evaluation.