ObjectiveTo evaluate the reporting quality of systematic reviews (SRs)/meta-analyses on acupuncture focusing on literature screening results and explore the influencing factors of the complete reporting.MethodsPubMed, EMbase, CNKI, WanFang Data, and VIP databases were searched to collect SRs/meta-analyses on acupuncture from inception to December 31st, 2019. Two reviewers independently screened literature, extracted data and evaluated the reporting quality of literature screening results of SRs/meta-analyses on acupuncture based on PRISMA statement. Logistic regression model analysis was applied to explore the influencing factors of the complete reporting rate of literature screening results. Statistical analysis was performed by using Excel 2016 and SPSS 16.0 software.ResultsA total of 1 227 SRs/meta-analyses were included. Only 62.3% SRs fully reported the four parts of literature screening results. The parts with a low reporting rate included the number of studies assessed for eligibility (73.2%) and the reasons for exclusions at each stage (67.0%). And the reporting rate of the literature screening flowchart was also low (63.6%). The reporting rate of literature screening results in Chinese SRs was lower than that in English SRs, and there was significantly statistical difference (P<0.001). Multivariate logistic regression analysis showed that the type of published journal, publication year, pages of article and the number of searched databases were correlated with the complete reporting rate of literature screening results (P<0.001).ConclusionsThe complete reporting rate of the literature screening results of SRs on acupuncture is low, especially in Chinese SRs. The complete reporting rate of literature screening results is significantly higher for SRs published after PRISMA statement, in SCI journals, with longer length and more searched databases.
ObjectiveTo evaluate the reporting quality of clinical randomized controlled trials (RCTs) published in five Chinese psychiatric journals from 2016 to 2020 and to compare the reporting quality with that from 2004 to 2008. MethodsRCTs in five Chinese psychiatric journals were collected through a computerized search of the CNKI, WanFang Data, and CBM databases and manual searches of paper journals, all with a search timeframe from 2016 to 2020. The CONSORT 2010 statement and two extensions (CONSORT extension for abstracts and CONSORT harms extension) were used to evaluate the RCTs. The criteria for reporting quality were the evaluation score, reporting proportion, and compliance proportion. The reporting quality of RCTs in the past 5 years was compared by year group. In addition, the RCT reporting quality from 2004 to 2008 was compared with that from 2016 to 2020. ResultsIn total, 226 RCTs were included. There was no statistically significant difference in the total evaluation score or abstract score from 2016 to 2020 (F=0.54, P=0.71; H=1.49, P=0.83). However, there were statistically significant differences in the harm scores from 2016 to 2020 (H=10.78, P=0.03). Further analysis of the items revealed statistically significant differences in the reporting proportion of items 16 and 19 (Fisher’s=8.61, P=0.04; χ2=11.63, P=0.02) and no significant differences in the other items (P>0.05). The reporting proportion of defined primary and secondary outcome indicators, allocation concealment, randomization implementation, outcomes and estimation, generalization, trial registration, and flow chart was <10% in each year. There was a statistically significant difference in the compliance proportion of RCT reporting quality from 2016 to 2020 versus 2004 to 2008 (39.54%±8.92% vs. 34.76%±9.16%, t=6.60, P<0.001). ConclusionThe reporting quality of RCTs in five Chinese psychiatric journals from 2016 to 2020 is better than that from 2004 to 2008. However, the reporting quality of RCTs within the latter 5 years still have reporting deficiencies in important items, and many aspects still are needed to be improved and enhanced.
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 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 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 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.
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 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.
ObjectivesTo evaluate the reporting quality of domestic and foreign randomized controlled trials (RCTs) on acupuncture for dry eye based on Consolidated Standards of Reporting Trials Expand Statement 2010 (CONSORT 2010) and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA).MethodsCNKI, VIP, CBM, WanFang Data, PubMed, EMbase and The Cochrane Library databases were electronically searched to collect RCTs of acupuncture for dry eye at home and abroad from inception to February 2020. The reporting quality of the selected literature was evaluated with the items in the CONSORT and STRICTA, respectively.ResultsA total of 69 Chinese literatures and 8 English literatures were included. The average reporting rate of all items of CONSORT in Chinese and English literatures was 41.4% and 56.4%, respectively. The missing items of Chinese literature report primarily focused on the sections of “methodology”, “results”, and “other information”. The Chinese and English literature report rate was relatively close in terms of the literature report rate of STRICTA, and both were relatively complete in the description of acupuncture intervention.ConclusionsThe reporting quality of RCTs of acupuncture treatment for dry eye in China and abroad is generally low. Further improving the relevant reporting quality according to the CONSORT statement 2010 and STRICTA 2010 is urgent.
Objective To evaluate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine published inChinese Journal of Integrated Traditional and Western Medicine, and to analyze changes. Methods We searched CNKI to collect RCTs published inChinese Journal of Integrated Traditional and Western Medicine (CJITWM) in 2014. Reporting quality of RCTs was evaluated by using CONSORT 2010 checklist, the methodological quality and ethics requirements were also analyzed. The changes of quality was also analyzed by comparing with those of 2004. Results A total of 80 RCTs were included. The top three interventions were Chinese patent medicine, decoction, acupuncture. Items with high reporting rate (>80%) included abstract, participants, randomization sequences and informed consent. Items with reporting rate of 50% to 80% including introduction, interventions, harms and funding, and others were all less than 50%. Among them, the reporting quality of title, trial design, outcomes, sample size, type of randomization, allocation concealment, blinding, numbers analyzed, outcomes and estimation, generalizability, interpretation, registration and protocol was less than 10%. Compared with those of 2004, the quality of reporting, methodology, and ethics has all increased. Significant progress was made in items of structured summary, background and objectives, collecting participants, adverse reactions, quality control standards of TCM interventions, diagnostic evaluation criteria of TCM, follow-up, funding, ethical approval and informed consent. But small progress was made in randomization, allocation concealment and implementation, sample size, blinding and ITT. There has been no participant flow. Conclusion The quality of reporting, methodology, and ethics of RCTs published inChinese Journal of Integrated Traditional and Western Medicine have made some progress, however, trial design, outcomes selection, estimation of sample size, randomization, blinding, registration and participant flow are still needed to be further improved.