Dataset Information

Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform.

ABSTRACT: Background. This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP). Methods. All records of acupuncture RCTs registered in the ICTRP have been collected. The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs). Results. A total of 453 records, found in 11 registries, were examined. Methodological details were insufficient in registration records; there were 76.4%, 89.0%, and 21.4% records that did not provide information on randomization methods, allocation concealment, and blinding respectively. The proportions of adequate randomization methods, allocation concealment, and blinding were only 107 (23.6%), 48 (10.6%), and 210 (46.4%), respectively. The methodological design improved year by year, especially after 2007. Additionally, methodology of RCTs with ethics approval was clearly superior to those without ethics approval and different among registries. Conclusions. The overall methodological design based on registration records of acupuncture RCTs is not very well but improved year by year. The insufficient information on randomization methods, allocation concealment, and blinding maybe due to the relevant description is not taken seriously in acupuncture RCTs' registration.

SUBMITTER: Gu J

PROVIDER: S-EPMC3945025 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform.

Gu Jing J Wang Qi Q Wang Xiaogang X Li Hailong H Gu Mei M Ming Haixia H Dong Xiaoli X Yang Kehu K Wu Hongyan H

Evidence-based complementary and alternative medicine : eCAM 20140212

Background. This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP). Methods. All records of acupuncture RCTs registered in the ICTRP have been collected. The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs). Resul ...[more]

PMID: 24688591

Similar Datasets

Project description:IntroductionThe advent of the coronavirus disease 2019 (COVID-19) pandemic has led to the development of vaccines against severe acute respiratory syndrome coronavirus 2. Prospective evidence regarding safety for pregnant people and their developing fetuses is lacking. The aim of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to estimate the relative risk of obstetric, neonatal, and infant outcomes by comparing participants vaccinated against COVID-19 during pregnancy to a reference group of people enrolled in the Pregistry International Pregnancy Exposure Registry (PIPER) who remained unvaccinated during pregnancy.MethodsThe C-VIPER and the PIPER are international, non-interventional, real-world cohort studies. Participants receiving a COVID-19 vaccine during pregnancy will be matched in the analyses by country and gestational age at enrollment to unvaccinated individuals. Self-enrolled and self-consented participants complete online questionnaires at enrollment, during pregnancy, and for 12 months after the delivery of a live infant. Where possible, outcomes are verified by medical records. The study aims to recruit at least 500 pregnancies for each approved or authorized vaccine and will last for 5 years for each product.ConclusionsBy collecting data for each vaccine brand, the C-VIPER will be able to determine individual safety profiles. The study design allows for analysis of the effects of exposure to COVID-19 vaccines during specific etiologically relevant periods of gestation. Although the sample size may be too small to detect associations with rare outcomes, the study will be used to generate hypotheses for future research. Ultimately, the C-VIPER should provide data that will allow pregnant people and their healthcare providers to make informed decisions about COVID-19 vaccination.Clinical trial registrationClinicalTrials.gov NCT04705116. Registered on 12 January, 2021. EU PAS EUPAS39096. Registered on 20 January, 2021.

Project description:ObjectiveTo provide a comprehensive review of registered COVID-19-related randomised controlled trials (RCTs) in mainland China and evaluate the transparency of reporting through comparison of registrations, protocols and full reports.DesignSystematic review of trial registrations and publications.Data sourcesInternational Clinical Trials Registry Platform, Chinese Clinical Trial Registry, ClinicalTrials.gov, the ISRCTN registry and EU Clinical Trial Register were accessed on 1 February 2022. Publications were searched in PubMed, Embase, Cochrane Library, Google Scholar, CNKI.net and Wanfangdata from 10 February 2022 to 12 February 2022.Eligibility criteriaEligible trials were COVID-19 related RCTs carried out in mainland China. Observational studies, non-randomised trials and single-arm trials were excluded.Data extraction and synthesisTwo reviewers independently extracted data from registrations, publications and performed risk of bias assessment for trial reports. Information provided by registrations and publications was compared. The findings were summarised with descriptive statistics.ResultsThe number of eligible studies was 415. From these studies 20 protocols and 77 RCT reports were published. Seven trials published both protocol and RCT full report. Between registrations and publications, discrepancy or omission was found in sample size (7, 35.0% for protocols and 47, 61.0% for reports, same below), trial setting (13, 65.0% and 43, 55.8%), inclusion criteria (12, 60.0% and 57, 74.0%), exclusion criteria (10, 50.0% and 54, 70.1%), masking method (9, 45.0% and 35, 45.5%) and primary outcome or time frame of primary outcome measurement (14, 70.0% and 51, 66.2%). Between protocols and full reports, 5 (71.4%) reports had discrepancy in primary outcome or time frame of primary outcome measurement.ConclusionsDiscrepancy among registrations, protocols and reports revealed compromised transparency in reporting of COVID-19-related RCTs in mainland China. The importance of trial registration should be further emphasised to enhance transparent RCT reporting.

Dataset Information

Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform.

Publications

Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets