Objective To assess the reporting quality of systematic reviews/meta-analyses related to interventions published in Chinese Journal of Evidence-Based Medicine by PRISMA guidelines, and to analyze its influencing factors. Methods The systematic reviews/meta-analyses related to interventions were searched in the Chinese Journal of Evidence-Based Medicine from its inception to 2011. The quality of the included reviews was assessed in accordance with the PRISMA checklist. Based on the degree of conformity with each criterion of PRISMA, the reviews were scored as “1”, “0.5” or “0” orderly. The data were put into Excel, and the Meta-analyst software was used for statistical analysi. Results Among all literature in the volume 11 (95) of the Chinese Journal of Evidence-Based Medicine from 2001 to 2011, a total of 379 studies were included, and the number of publication showed a yearly rising trend. The PRISMA scale score ranged from 8.5 to 26 (X±SD) was 19.97±3.15. Among all studies, 25 (6.60%) scored 21-27 points, which were regarded as the complete reporting; 226 (59.63%) scored 15-21 points, regarded as relatively complete reporting; and 128 (33.77%) scored less than 15 points, regarded as serious lack of information. The results of stratified analysis showed that, both the issue of PRISMA and fund support could improve the reporting quality, with a significant difference (Plt;0.05); and authors more than 3, authors from universities, and authors from more than 2 institutions could improve the reporting quality, but without a significant difference (Pgt;0.05). Conclusion The overall reporting quality of systematic reviews/meta-analyses related to interventions published in the Chinese Journal of Evidence-Based Medicine is poor, and it is influenced by the factors of protocol and registration, risk of bias across studies, other analyses, and fund support, which have to be taken seriously. The reasonable utilization of the PRISMA checklist will improve the reporting quality of systematic reviews/meta-analyses.
Objective To assess the methodological quality of systematic reviews or meta-analyses of intervention published in the Chinese Journal of Evidence-Based Medicine, so as to provide evidence for improving the domestic methodological quality. Methods The systematic reviews or meta-analyses of intervention published from 2001 to 2011 were identified by searching the Chinese Journal of Evidence-Based Medicine. The methodological quality of included studies was assessed by AMSTAR scale. The Excel software was used to input data, and Mata-Analyst software was used to conduct statistical analysis. Results A total of 379 studies were included. The average score of AMSTAR was 6.15±1.35 (1.5-9.5 point). Just some items of AMSTAR scale were influenced by the following features of included studies: publication date, funded or not, number of author, author’s unit, and number of author’s unit. The total AMSTAR score of studies published after 2008 was higher than those published before 2008 (P=0.02), but the improvement of methodological quality was limited. While the total AMSTAR score of studies published by 3 or more than 3 authors were higher than those published by 2 or less than 2 authors (P=0.04). Conclusion The methodological quality of the included studies published in the Chinese Journal of Evidence-Based Pediatrics is uneven. Although the methodological quality improves somewhat after the publication of AMSTAR scale, there is no big progress, so it still needs to be further improved.
Objective To evaluate reporting and methodological quality of systematic reviews or meta-analyses in nursing field in China. Methods CNKI database was searched for systematic reviews or meta-analyses in nursing field from the establishment date to December 2011. Two reviewers independently identified the literature according to inclusion and exclusion criteria, and then extracted the data using Excel software. The PRISMA and AMSTAR checklists were used to assess reporting characteristics and methodological quality, respectively. Results A total of 63 systematic reviews or meta-analyses involving 21 systematic reviews and 42 meta-analyses were identified. These articles were published on 13 journals such as The Chinese Nursing Research, the Chinese Journal of Nursing, and the Chinese Journal of Evidence-Based Medicine. The deficiencies of methodological quality mainly contained literature search, heterogeneity handling, recognition and assessment of publication bias. In addition, the deficiencies of reporting characteristics were reflected on incomplete reporting of literature search, quality assessment, risk of bias and results (some studies lacked forest plot, estimated value of pooled results, 95%CI or heterogeneity). Conclusion As a whole, the included reviews and meta-analyses have more or less flaws with regard to the quality of reporting and methodology based on the PRISMA and AMSTAR checklists. Focusing on the improvement of reporting and methodological quality of systematic review or meta-analysis in nursing field in China is urgently needed in order to increase the value of these studies.
Objective To assess the reporting quality of noninferiority and equivalence randomized controlled trials (RCTs) related to Traditional Chinese Medicine (TCM). Methods The noninferiority and equivalence RCTs related to TCM were searched, and the quality of the included RCTs was identified in accordance with the extended version of CONSORT statement which refers to the reporting standard of noninferiority and equivalence RCTs. Results A total of 13 noninferiority and equivalence RCTs were included. Except for the common questions of RCTs in reporting quality, some contents related to noninferiority and equivalence trials in reporting were not enough: a) The title of RCTs did not reflect the most important content of the literature; b) The introduction of background was quite simple. The rationale about noninferiority and equivalence trials, and the effectiveness of positive control were not clearly defined; c) All literatures did not indicate whether the subjects, interventions and outcomes in the noninferiority and equivalence trials were identical or similar to those in previous trials of defining the effectiveness of control treatment; d) Most literatures did not define the critical value of noninferiority and equivalence, and did not estimate the sample size; e) Only half of literature described the statistical methods of noninferiority test and equivalence test; and f) Some literature had mistakes in noninferiority and equivalence conclusion. Conclusion The researchers still need deeper understanding of the theoretical basis of noninferiority and equivalence trials. The reference to the extended version of CONSORT statement, which refers to the reporting standard of noninferiority and equivalence RCTs, is helpful for researchers to identify the key points of the design, performance and reporting of the noninferiority and equivalence RCTs, to lay stress on the related contents of noninferiority and equivalence trial reporting, and to radically improve the reporting quality of such clinical trials.
Objective While reporting of adverse drug reactions (ADR) and adverse drug events (AE) following Chinese medicine injection (CMI) is becoming more common, the reporting quality is of concern. Methods A checklist about the reporting quality of ADR/AE was set up, and the ADR/AE reporting of Herba Houttuyniae injection was chosen as an example. Electronic databases Chinese Journal Net (CJN) (1994-2009) and Chinese Science and Technological Journal Net (VIP) (1989-2009) were searched for target literature. Results Based on our search strategy, 210 articles were included, with 175 articles reporting single or several cases of ADR/AE following Herba Houttuyniae injection (type I report). There were 7 reports from regional or national ADR monitoring centers (type II report), and 28 summary reports from a single hospital or medical center (type III report). All 210 papers mentioned ‘adverse effect,’ ‘safety’ or related meaning words in their titles, but 199 articles did not have abstract. Patient demographic characteristics were not fully reported in these articles. In type I articles, only 97 cases (43.11%) mentioned whether patients had or did not have a history of allergies, while 128 cases (56.89%) in Type II papers and Fourteen (50%) type III papers, did not mention allergic history of patients. Only three articles (3/210, 1.43%), all of them type I, mentioned the syndrome type in Chinese medicine. None of the papers gave clear indications of the type and grade of ADR/AE of patients. Most papers did not report details of the CMI procedure, such as the drug company, product serial number, or the drug’s validity period. Data about the occurrence time and management of ADR/AE was also inadequately reported. Conclusion and recommendations The current reporting format of ADR/AE in clinical CMIs is not standardized. Much fundamental information of ADR/AE following CMI is therefore missing. A standard reporting format for ADR should be developed, and should include the following: 1) a title mentioning adverse effects and safety; 2) a structured abstract including adequate information about the patient and the disease treated, the drug used, the specific ADR/AE, physician response to the ADR/AE, and result of management; 3) demographic characteristic of the patients (gender, age, etc.); 4) clinical characteristics of patients (disease, syndrome, etc); 5) allergic history of patients; 6) diagnosis and syndrome based on Chinese medicine theory; 7) detailed information about the Chinese materia medica intervention (the manufacturer of the drug, series number, valid dates, dosage, route of administration, menstruum, dripping speed, etc.); 8) concomitant drug use; 9) time and symptoms of ADR/AE; 10) type and grading of ADR/AE; 11) physiological systems affected by ADR/AE; 12) specific treatment and prognosis for ADR/AE; 13) evidence of the cause and effect of ADR/AE; 14) any other possibility of ADR/AE. Also, a ADR/AE registration system should be established.
Objective To evaluate the reporting quality of randomized controlled trials (RCTs) in seven military medical journals. Methods Seven journals in 2007, including Medical Journal of Chinese People’s Liberation Army, Journal of South Medical University, Journal of Second Military Medical University, Journal of Third Military Medical University, Journal of Fourth Military Medical University, Bulletin of the Academy of Military of Medical Sciences and Academic Journal of PLA Postgraduate Medical School, were handsearched. We identified RCTs labeled “random” and assessed the quality of these reports using the Consolidated Standards for Reporting of Trials (CONSORT) statement. Results We identified 99 RCTs, but found an incorrect randomized method was used in 6 RCTs. According to the items in the CONSORT statement in 93 RCTs, 62 (66.7%) RCTs described baseline demographic and clinical characteristics in each group. Sixteen (17.2%) RCTs mentioned the method of random sequence generation, with 5 (5.4%) using a computer allocation. Only 1 RCT had adequate allocation concealment. Only 9 (9.7%) RCTs used blinding, with 2 mentioning blinding, 1 using single blinding and 6 described as double-blind (2 were correct). Zero (0%) reported the sample size calculation and 1 RCT reported the intention-to-treat (ITT) analysis. Conclusion The reporting quality of RCTs in seven journals is poor. The CONSORT statement should be used to standardize the reporting of RCTs.
Objective To evaluate the reporting quality of randomized controlled trials (RCTs) on acupuncture for acute ischemic stroke. Methods Six databases including The Cochrane Central Register of Controlled Trials (CENTRAL, Issue 4, 2005), MEDLINE (1966 to December 2005), EMbase (1984 to December 2005), China National Knowledge Infrastructure (CNKI, 1994 to December 2005), China Biomedicine Database disc (CBMdisc, 1980 to December 2005), VIP (a full text issues database of China, 1989 to December 2005) were searched systematically. Handsearch for further references was conducted. Language was limited to Chinese and English. We identified 74 RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).Results In regard to the items in the CONSORT statement, 54 (73%) RCTs described baseline demographic and clinical characteristics in each group. Twenty-six (35%) mentioned the method of generating the random sequence, with 4 (5%) using a computer allocation. Only 6 (8%) RCTs had adequate allocation concealment, with 5 RCTs using sealed opaque envelopes and 1 RCT using centralized computer allocation. Only 8 (11%) RCTs used blinding, including 5 described as double-blind. Four (5%) RCTs reported the sample size calculation and 5 (7%) RCTs reported that an intention-to-treat (ITT) analysis. In regard to the items in STRICTA , only 4 (5%) RCTs reported the numbers of needles inserted. In 35 (47%) RCTs the needle type was reported, but only 26 (35%) mentioned the depths of insertion. Only 1 (1%) RCT mentioned the length of clinical experience and 6 (8%) RCTs reported the background of the acupuncture practitioners, but none stated the duration of their training.Conclusion The reporting quality of RCTs of acupuncture for acute ischemic stroke was low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture.
ObjectiveTo evaluate the reporting quality of randomized controlled trials (RCTs) on acupuncture for neck disorder. MethodsThree databases including CENTRAL (Issue 3, 2010), MEDLINE and EMbase from January 2006 to December 2010 were searched electronically, and only English articles were included. A manual search for further references was conducted from those references initially identified. We identified 14 RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). ResultsFinally 14 RCTs were included. Regarding the CONSORT statement, 9 (64.3%) RCTs described the baseline demographic and clinical characteristics in each group. Only 7 (50.0%) studies mentioned how the random sequence was generated. Only 6 (42.9%) RCTs had adequate allocation concealment, with 4 RCTs which described the concealment in detail. Only 8 (57.1%) RCTs used blinding, including 2 described as double-blind. Only two (14.3%) RCTs reported how the sample size was calculated. Corresponding to the items in STRICTA, 5 (35.7%) RCTs reported the numbers of needles inserted. The others just indicated the acu-points. The needle type, model and the thickness of needles were reported in 12 (85.7%) RCTs, but only 4 (28.6%) mentioned the depths of insertion. There were only 4 RCTs (28.6%) that reported the background of the acupuncture practitioners and the duration of their training. ConclusionThe RCTs of acupuncture for neck disorder meeting the criteria for the CONSORT statement and STRICTA still have room for improvement. Promoting the use of the CONSORT statement and STRICTA should help to improve the reporting quality of acupuncture related research, and hence to elucidate the scientific understanding of acupuncture.
ObjectiveTo assess the methodological and reporting quality of systematic reviews/Meta-analyses (SRs/MAs) of transurethral procedure for benign prostatic hyperplasia (BPH). MethodWe electronically searched databases including PubMed, The Cochrane Library (Issue 12, 2014), Sciverse, CNKI, VIP and WanFang Data from inception to December 2014 to collect SRs/MAs of transurethral procedure about BPH. Two reviewers independently screened literature and assessed the methodological and reporting quality of included SRs/MAs by AMSTAR and PRISMA checklists. ResultsA total of 33 SRs/MAs were included. The results of qualitative analysis showed that:the main methodological weakness of included SRs/MAs included the lack of protocol, disappropriate conclusion formulation, the lack of publication bias assessment, and the lack of stating the conflict of interest. The average score of AMSTAR scale was 6.27±2.14. There were 11 items in PRISMA checklist with coincidence rate over 80%, 8 items between 50% to 80%, and 8 items less than 50%. ConclusionThe methodological and reporting quality of SR/MA of transurethral procedure for BHP is low, and that may decrease the reliability and value of results from SRs/MAs in the field. Future SRs/MAs should strictly follow the related reporting guidelines in order to improve the methodological and reporting quality, so as to provide more reliable evidence for clinical decision.
ObjectiveTo provide references for scientific selection of different tools/guidelines by comprehensively collecting international and national tools/guidelines for assessing reporting quality and methodological quality of animal experiments, comparing them in development foundation, application scope, and aims. MethodsPubMed, EMbase, CNKI, VIP and WanFang Data were searched up to July 2014, to collect tools/guidelines for reporting quality and methodological quality of primary animal experiments. We extracted data from included guidelines/tools, including the number of items, development foundation, disease models, application scope, and assessment focus. Then descriptive analysis was conducted. ResultsA total of 32 studies were finally included, of which, 6 were for reporting quality and 26 for methodological quality. The item number of the included tools/guidelines ranged from 2 to 54. Seven tools/guidelines applied score system to assess methodological quality. Fifteen tools/guidelines were designed for specific disease models. Nineteen tools/guidelines were suitable for assessing preclinical drug studies, and 4 were designed to assess environmental toxicology research. ConclusionAlthough many tools for assessing methodological quality of animal experiments have been published so far, SYRCLE's risk of bias tool is the only one that is used to assess internal validity of animal experiments at present. Besides, although the ARRIVE guidelines and GSPC are not official mandatory reporting criteria at present, they are acknowledged by many researchers as efficient reference checklists and writing guidelines for writing and publishing animal experiments. We recommend the application of SYRCLE's risk of bias tool, ARRIVE guidelines and GSPC, in order to efficiently improve research design, implementation, reporting, differentiation, and evaluation of animal experiments, promote the development of animal experiments, and to promote full application and translation of scientific achievements.