OBJECTIVE: To evaluate the report quality of Chinese and English randomized controlled trials (RCTs) of acupuncture based on the CONSORT statement and STRICTA checklist. METHODS: The Chinese and English RCTs of acupuncture published from January 1, 2015 to December 31, 2019 were searched in 7 databases including PubMed. The report quality of the included RCTs was evaluated with the CONSORT 2010 statement and STRICTA checklist. RESULTS: A total of 506 Chinese RCTs and 76 English RCTs were included. According to the CONSORT statement, in Chinese RCTs, the items with report rate less than 50% accounted for 78.38% of all items, and the report rate of 25 items, such as background and reason, study design, outcome index, and sample size, was less than 10%. In English RCTs, the items with report rate less than 50% accounted for 35.14% of all items, and 5 items had a report rate of less than 10%. The difference of the report rate of 15 items, such as background, reason and study design, was more than 50% between Chinese and English RCTs. The report rate of all items of STRICTA checklist was relatively high in both Chinese and English RCTs. In Chinese RCTs, the items with report rate less than 50% accounted for 29.41% of all items, which included acupuncture rationale and depth of insertion. In English RCTs, only two items had a report rate less than 50%, which were acupuncture rationale, setting and context of treatment. The report rate of five items, including needle retention time, frequency and duration of treatment sessions, details of other interventions administered to the acupuncture group, setting and context of treatment, and precise description of the control or comparator in Chinese RCTs, were higher than in English RCTs. CONCLUSION The report quality of Chinese acupuncture RCT needs to be improved urgently, and corresponding measures should be taken to further standardize the writing and reporting of acupuncture clinical research.
Humans ; Acupuncture Therapy ; Checklist ; Randomized Controlled Trials as Topic/standards*

BACKGROUND: The therapeutic evidence collected from well-designed studies is needed to help manage the global pandemic of the coronavirus disease 2019 (COVID-19). Evaluating the quality of therapeutic data collected during this most recent pandemic is important for improving future clinical research under similar circumstances. OBJECTIVE: To assess the methodological quality and variability in implementation of randomized controlled trials (RCTs) for treating COVID-19, and to analyze the support that should be provided to improve data collected during an urgent pandemic situation. SEARCH STRATEGY: PubMed, Excerpta Medica Database, China National Knowledge Infrastructure, Wanfang, and Chongqing VIP, and the preprint repositories including Social Science Research Network and MedRxiv were systematically searched, up to September 30, 2020, using the keywords "coronavirus disease 2019 (COVID-19)," "2019 novel coronavirus (2019-nCoV)," "severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2)," "novel coronavirus pneumonia (NCP)," "randomized controlled trial (RCT)" and "random." INCLUSION CRITERIA: RCTs studying the treatment of COVID-19 were eligible for inclusion. DATA EXTRACTION AND ANALYSIS: Screening of published RCTs for inclusion and data extraction were each conducted by two researchers. Analysis of general information on COVID-19 RCTs was done using descriptive statistics. Methodological quality was assessed using the risk-of-bias tools in the Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0). Variability in implementation was assessed by comparing consistency between RCT reports and registration information. RESULTS: A total of 5886 COVID-19 RCTs were identified. Eighty-one RCTs were finally included, of which, 45 had registration information. Methodological quality of the RTCs was not optimal due to deficiencies in five main domains: allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, and selective reporting. Comparisons of consistency between published protocols and registration information showed that the 45 RCTs with registration information had common deviations in seven items: inclusion and exclusion criteria, sample size, outcomes, research sites of recruitment, interventions, and blinding. CONCLUSION The methodological quality of COVID-19 RCTs conducted in early to mid 2020 was consistently low and variability in implementation was common. More support for implementing high-quality methodology is needed to obtain the quality of therapeutic evidence needed to provide positive guidance for clinical care. We make an urgent appeal for accelerating the construction of a collaborative sharing platform and preparing multidisciplinary talent and professional teams to conduct excellent clinical research when faced with epidemic diseases of the future. Further, variability in RCT implementation should be clearly reported and interpreted to improve the utility of data resulting from those trials.
COVID-19/virology* ; Humans ; Pandemics ; Randomized Controlled Trials as Topic/standards* ; SARS-CoV-2/drug effects*

Based on the internationally-recognized Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA), the reported quality of randomized controlled trials (RCTs) of acupuncture for cancer pain during last 10 years were evaluated. The RCTs of acupuncture for cancer pain were searched by computer. The English databases included PubMed and EMbase while the Chinese databases included CNKI, Wanfang, VIP and SinoMed. The publication date of the literature was from March 2009 to March 2019. As a result, 22 Chinese RCTs and 13 English RCTs were included. According to the CONSORT statement, among the Chinese studies, 1 RCT reported primary and secondary outcomes, 8 RCTs reported randomization, none of RCTs reported allocation concealment and blind method, and 4 RCTs reported baseline data; among the English studies, 8 RCTs reported primary and secondary outcomes, 8 RCTs reported randomization, 6 RCTs reported described allocation concealment, 7 RCTs reported blind method, and 13 RCTs reported baseline data. According to the STRICTA statement, among the Chinese studies, 17 RCTs reported the name of acupoints, 6 RCTs reported depth of insertion, 17 RCTs reported acupuncture response sought, and none of RCTs reported the qualifications of acupuncturists; among the English studies, 12 RCTs reported the name of acupoints, 7 RCTs reported depth of insertion, 8 RCTs reported acupuncture response sought, and 7 RCTs reported the qualifications of acupuncturists. The Chinese RCTs have more detailed description of acupuncture intervention and theory, but not enough attention is paid to methodological description such as randomization, blindness, data analysis. On the other hand, the English RCTs have better description of methodology, but the description of theory and details of acupuncture is relatively weak. It is concluded that more efforts were needed to further improve the clinical trial design according to the CONSORT statement and STRICTA statement to improve the quality of clinical evidence.
Acupuncture Therapy ; Cancer Pain ; therapy ; Humans ; Neoplasms ; complications ; therapy ; Randomized Controlled Trials as Topic ; standards

The CLASS group's vision carries out "research, standardization and promotion of new technologies for laparoscopic gastric cancer surgery, cooperation, mutual benefit, hand in hand to the international academic frontier, leading the scientific development of minimally invasive surgery for gastric cancer in China, and benefiting people's health with high-level clinical research". In the past ten years, CLASS group has become a pioneering force in promoting the progress of laparoscopic surgery for gastric cancer in China. The successful implementation of the CLASS - 01 trail has created a new standard in the clinical research of minimally invasive gastrointestinal surgery and cultivated a high - level surgical clinical research team all over the country. After the successful CLASS - 01 trial, the trials from CLASS - 02 to - 05 has been successfully implemented, CLASS - 06 to - 10 series are in an orderly advancement. On the tenth anniversary of the establishment of the CLASS group, we would like to thank the help from peer, review the development process, look forward to future cooperation, and work together to create a new situation of minimally invasive surgery.
China ; Gastrectomy ; methods ; standards ; Humans ; Laparoscopy ; standards ; Minimally Invasive Surgical Procedures ; Randomized Controlled Trials as Topic ; Stomach Neoplasms ; surgery

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials. At the same time, in order to improve the reporting quality of randomized controlled trials, CONSORT standards should be adopted in the preparation of research reports and submissions.
China ; Humans ; Materia Medica ; Medicine, Chinese Traditional ; Publications ; Randomized Controlled Trials as Topic ; standards

To evaluate the intervention effects of randomized controlled trials (RCT) involved in theoretical efficacy and actual clinical outcome (effectiveness). Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) is a tool to help researchers make decisions in study design which is consistent with the intended purpose of their trial which can be used in the design of RCT to balance the internal validity and external validity. The role of PRECIS has been gradually recognized in the practice of designing clinical trials. To ensure that the design choices are concordant with the intention and the facilitation of use set by patients, clinicians and policy makers, a new PRECIS-2 tool has been developed by mangy international team experts under modification and upgrading the existing PRECIS. The PRECIS-2 tool mainly focuses on trial design choices which determining the applicability of a trial. PRECIS-2 has nine domains, with each of them intends to help the researchers consider the consequences of that design decision in terms of the applicability of the results under particular setting. The purpose of this paper is to introduce the development, basic principle, characteristics and application of PRECIS-2 for the designers and decision makers when working on clinical trials.
Communication ; Decision Making ; Humans ; Randomized Controlled Trials as Topic/methods* ; Research Design/standards*

The Western China Gastric Cancer Collaboration (WCGCC) was founded in Chongqing, China in 2011. At the early stage of the collaboration, there were only about 20 centers. While now, there are 36 centers from western area of China, including Sichuan, Chongqing, Yunnan, Shanxi, Guizhou, Gansu, Qinghai, Xinjiang, Ningxia and Tibet. During the past few years, the WCGCC organized routinely gastric cancer standardized treatment tours, training courses of mini-invasive surgical treatment of gastric cancer and the clinical research methodology for members of the collaboration. Meanwhile, the WCGCC built a multicenter database of gastric cancer since 2011 and the entering and management refer to national gastric cancer registration entering system of Japan Gastric Cancer Association. During the entering and collection of data, 190 items of data have unified definition and entering standard from Japan Gastric Cancer Guidelines. Nowadays, this database included about 11 872 gastric cancer cases, and in this paper we will introduce the initial results of these cases. Next, the collaboration will conduct some retrospective studies based on this database to analyze the clinicopathological characteristics of patients in the western area of China. Besides, the WCGCC performed a prospective study, also. The first randomized clinical trial of the collaboration aims to compare the postoperative quality of life between different reconstruction methods for total gastrectomy(WCGCC-1202, ClinicalTrials.gov Identifier: NCT02110628), which began in 2015, and now this study is in the recruitment period. In the next steps, we will improve the quality of the database, optimize the management processes. Meanwhile, we will engage in more exchanges and cooperation with the Chinese Cochrane Center, reinforce the foundation of the clinical trials research methodology. In aspect of standardized surgical treatment of gastric cancer, we will further strengthen communication with other international centers in order to improve both the treatment and research levels of gastric cancer in Western China.
Cancer Care Facilities ; China ; Clinical Protocols ; standards ; Clinical Trials as Topic ; methods ; standards ; Databases, Factual ; statistics & numerical data ; trends ; Education, Medical, Continuing ; Gastrectomy ; methods ; Humans ; Minimally Invasive Surgical Procedures ; education ; Organizational Objectives ; Organizations ; statistics & numerical data ; trends ; Outcome Assessment (Health Care) ; Prospective Studies ; Quality of Life ; Randomized Controlled Trials as Topic ; Registries ; statistics & numerical data ; Research Design ; standards ; Retrospective Studies ; Stomach Neoplasms ; epidemiology ; therapy

OBJECTIVETo evaluate and compare the reports' qualities of acupuncture randomized controlled trials (RCTs) conducted in China before and after the implementation of two guidelines, i.e., the Consolidated Standards of Reporting Trials (CONSORT) statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).

METHODSProportions of studies that reported CONSORT and STRICTA items were compared for the years before and after implementation of these two guidelines. In addition, the total score of each item's reporting were calculated and reported differences during different date ranges were compared.

RESULTSFor CONSORT items (maximum score 8), there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined (2.5±0.6) and 2004-2005 and 2009-2010 combined (3.0±0.9; difference 0.4, 95% confidence interval, 0.3 to 0.6, P<0.01). For STRICTA items (maximum score 17), there was evidence that a slight improvement in reporting between 1994-1995 and 1999-2000 combined (8.6±2.1) and 2004-2005 and 2009-2010 combined (10.1±1.8; difference 1.5, 95% confidence interval, 1.1 to 1.9, P<0.01).

CONCLUSIONQuality of reporting for RCTs of acupuncture treatment conducted in China have generally improved since the introduction of the STRICTA and CONSORT guidelines.

The application of placebo acupuncture in randomized controlled trials in the past 10 years (2004-2014) in foreign countries was systematically reviewed to summarize the design of placebo acupuncture; according to category of diseases, advantages and disadvantages were analyzed to explore an ideal placebo acupuncture set. By retrieval in PubMed, EMBASE and OVID databases, the clinical study literature which met the inclusion criteria was searched, and the category of diseases, design of placebo acupuncture and clinical efficacy were analyzed. Totally 29 articles were included. The pain was the leading disease in category of diseases; the most commonly used application of placebo acupuncture design was telescopiform sliding blunt needle, accounting for 45. 16%; the treatment locations were non-acupoints mostly; in the needling depth, approximately 60. 00% selected non-penetrating needling and 26. 67% selected superficial needling; 28 articles indicated that acupuncture and placebo acupuncture had clinical effects, accounting for 96. 55%; 37. 93% of articles indicated acupuncture was superior to placebo acupuncture and 37. 93% of articles indicated acupuncture was not superior to placebo acupuncture. It is concluded that the design of placebo acupuncture should consider multiple factors, including main symptoms, operability, security, blinding and specific effects, and the objective indices should be selected for outcome evaluation.
Acupuncture Therapy ; instrumentation ; methods ; standards ; Humans ; Internationality ; Needles ; Placebo Effect ; Randomized Controlled Trials as Topic ; standards

PURPOSE: Supraglottic airway devices have been widely utilized as an alternative to tracheal intubation in various clinical situations. The rotation technique has been proposed to improve the insertion success rate of supraglottic airways. However, the clinical efficacy of this technique remains uncertain as previous results have been inconsistent, depending on the variable evaluated. MATERIALS AND METHODS: We systematically searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials in April 2015 for randomized controlled trials that compared the rotation and standard techniques for inserting supraglottic airways. RESULTS: Thirteen randomized controlled trials (1505 patients, 753 with the rotation technique) were included. The success rate at the first attempt was significantly higher with the rotation technique than with the standard technique [relative risk (RR): 1.13; 95% confidence interval (CI): 1.05 to 1.23; p=0.002]. The rotation technique provided significantly higher overall success rates (RR: 1.06; 95% CI: 1.04 to 1.09; p<0.001). Device insertion was completed faster with the rotation technique (mean difference: -4.6 seconds; 95% CI: -7.37 to -1.74; p=0.002). The incidence of blood staining on the removed device (RR: 0.36; 95% CI: 0.27 to 0.47; p<0.001) was significantly lower with the rotation technique. CONCLUSION: The rotation technique provided higher first-attempt and overall success rates, faster insertion, and a lower incidence of blood on the removed device, reflecting less mucosal trauma. Thus, it may be considered as an alternative to the standard technique when predicting or encountering difficulty in inserting supraglottic airways.
Device Removal ; Humans ; Intubation, Intratracheal/instrumentation/*methods/standards ; *Laryngeal Masks ; Randomized Controlled Trials as Topic ; Reference Standards ; Risk ; *Rotation