Dataset Information

The quality of reporting in randomized controlled trials of acupuncture for knee osteoarthritis: A cross-sectional survey.

ABSTRACT: To assess the reporting quality of acupuncture trials for knee osteoarthritis (KOA), and explore the factors associated with the reporting.Three English and four Chinese databases were searched from inception to December 2016 for randomized control trials testing effects of acupuncture for knee osteoarthritis. We used the standard CONSORT (2010 version), CONSORT Extension for Non-Pharmacological Treatments, and STRICTA for measuring the quality of reporting. Using pre-specified study characteristics, we undertook regression analyses to examine factors associated with the reporting quality.A total of 318 RCT reports were included. For the standard CONSORT, ten items were substantially under-reported (reported in less than 5% of RCTs), including specification of important changes to methods after trial commencement (0.6%), description of any changes to trial outcomes (0.0%), implementation of interim analyses and stopping guidelines (0.6%), statement about why the trial ended or was stopped (1.6%), statement about the registration status (4.4%), accessibility of full trial protocol (4.7%), implementation of randomization (4.7%), description of the similarity of interventions (3.5%), conduct of ancillary analyses (3.8%) and presentation of methods for additional analyses (4.4%). Four of the STRICTA items were under-reported (reported in less than 10% of RCTs), including description of acupuncture style (8.5%), presentation of extent to which treatment varied (1.3%), statement of practitioner background (7.2%) and rationale for the control (9.1%). For CONSORT Extension, the reporting was poor across all items (reported in less than 10% of trials). Trials including authors with expertise in epidemiology or statistics, published in English, or enrolling patients from multiple centers were more likely to have better reporting.The reporting in RCTs of acupuncture for KOA was generally poor. To improve the reporting quality, journals should encourage strict adherence to the reporting guidelines.

SUBMITTER: Jia P

PROVIDER: S-EPMC5896985 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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The quality of reporting in randomized controlled trials of acupuncture for knee osteoarthritis: A cross-sectional survey.

Jia Pengli P Tang Li L Yu Jiajie J Liu Jiali J Kang Deying D Sun Xin X

PloS one 20180412 4

<h4>Objective</h4>To assess the reporting quality of acupuncture trials for knee osteoarthritis (KOA), and explore the factors associated with the reporting.<h4>Method</h4>Three English and four Chinese databases were searched from inception to December 2016 for randomized control trials testing effects of acupuncture for knee osteoarthritis. We used the standard CONSORT (2010 version), CONSORT Extension for Non-Pharmacological Treatments, and STRICTA for measuring the quality of reporting. Usin ...[more]

PMID: 29649270

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Project description:ObjectiveTo assess risk of bias and to investigate methodological issues concerning the design, conduct and analysis of randomised controlled trials (RCTs) testing acupuncture for knee osteoarthritis (KOA).MethodsPubMed, EMBASE, Cochrane Central Register of Controlled Trials and four major Chinese databases were searched for RCTs that investigated the effect of acupuncture for KOA. The Cochrane tool was used to examine the risk of bias of eligible RCTs. Their methodological details were examined using a standardised and pilot-tested questionnaire of 48 items, together with the association between four predefined factors and important methodological quality indicators.ResultsA total of 248 RCTs were eligible, of which 39 (15.7%) used computer-generated randomisation sequence. Of the 31 (12.5%) trials that stated the allocation concealment, only one used central randomisation. Twenty-five (10.1%) trials mentioned that their acupuncture procedures were standardised, but only 18 (7.3%) specified how the standardisation was achieved. The great majority of trials (n=233, 94%) stated that blinding was in place, but 204 (87.6%) did not clarify who was blinded. Only 27 (10.9%) trials specified the primary outcome, for which 7 used intention-to-treat analysis. Only 17 (6.9%) trials included details on sample size calculation; none preplanned an interim analysis and associated stopping rule. In total, 46 (18.5%) trials explicitly stated that loss to follow-up occurred, but only 6 (2.4%) provided some information to deal with the issue. No trials prespecified, conducted or reported any subgroup or adjusted analysis for the primary outcome.ConclusionThe overall risk of bias was high among published RCTs testing acupuncture for KOA. Methodological limitations were present in many important aspects of design, conduct and analyses. These findings inform the development of evidence-based methodological guidance for future trials assessing the effect of acupuncture for KOA.

Project description:ObjectiveThe Consolidated Standards of Reporting Trials (CONSORT) recommends reporting adverse events (AEs) and dropouts (DOs) with their definitions. The purpose of this study was to identify how AEs and DOs were reported in randomized controlled trials of therapeutic exercise for knee osteoarthritis (OA).MethodsData sources were the Cochrane Library, Embase, PubMed, and CINAHL. Databases were searched to identify randomized controlled trials of therapeutic exercise for knee OA published from January 1, 1980, through July 23, 2020. Researchers independently extracted participant and intervention characteristics and determined whether a clear statement of and reasons for AEs and DOs existed. The primary outcome was exercise-related harm. Physiotherapy Evidence Database (PEDro) scoring described study quality and risk of bias. Descriptive and inferential statistics characterized results. Meta-analysis was not performed due to data heterogeneity.ResultsOne hundred and thirteen studies (152 arms) from 25 countries were included, with 5909 participants exercising. PEDro scores ranged from 4 to 9. Exercise intensity was not specified in 57.9% of exercise arms. Fifty studies (44.2%) included an AE statement and 24 (21.2%) reported AEs, yielding 297 patients. One hundred and three studies (91.2%) had a DO statement. Sixteen studies (15.5%) provided reasons for DOs that could be classified as AEs among 39 patients, yielding a 13.1% increase in AEs. Thus, 336 patients (6.0%) experienced exercise-related harm among studies with a clear statement of AEs and DOs. A significant difference existed in misclassification of DOs pre- and post-CONSORT-2010 (12.2% vs 3.1%; $\chi^{2}_{1} = 21.2$).ConclusionsIn some studies, the reason for DOs could be considered AEs, leading to potential underreporting of harm. Improvements in reporting of harm were found pre- and post-CONSORT-2010. Greater clarity regarding AE and DO definitions and therapeutic exercise intensity are needed to determine safe dosing and mode of therapeutic exercise for knee OA.ImpactMore adherence to the CONSORT statement is needed regarding reporting of and defining of AEs, DOs, and therapeutic exercise intensity; however, despite this, therapeutic exercise seems to be associated with minimal risk of harm.

Project description:ObjectivesAlthough many trials have assessed the effect of acupuncture on knee osteoarthritis (KOA), its efficacy remains controversial. Sham acupuncture techniques are regarded as representative control interventions in acupuncture trials and sometimes incorporate the use of sham devices (base units) to support a non-penetrating needle. To achieve successful blinding, these trials also use acupuncture base units in the verum acupuncture group. Base units are not used in real-world clinical settings. We aimed to assess the effect sizes of verum and sham acupuncture for KOA in sham-controlled trials with or without base units.MethodsA total of 10 electronic databases for randomized controlled trials (RCTs) comparing the efficacy of verum manual acupuncture and sham acupuncture for the treatment of KOA were searched for articles published before April 12, 2022. The primary outcome was pain intensity, and the secondary outcomes included physical function. The first assessment after the end of treatment was chosen for analysis. Effect sizes are reported as standardized mean differences (SMDs) with 95% confidence intervals (95% CIs). The risk of bias was assessed using the Cochrane risk of bias tool, and publication bias was evaluated using a funnel plot and Egger's test. The quality of evidence for estimates was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach.ResultsFifteen RCTs were included. There was generally a low risk of bias except for the difficulty in blinding acupuncture therapists (performance bias). Compared to verum acupuncture in sham-controlled trials using base units, verum acupuncture in sham-controlled trials without base units was more effective for improving pain (SMD -0.56, 95% CI -1.09 to -0.03) and function (SMD -0.73, 95% CI -1.36 to -0.10) in KOA. The quality of evidence for network estimates was moderate to low due to the risk of bias and imprecision.ConclusionThese findings suggest that verum acupuncture in different types of sham-controlled trials has different effect sizes for KOA. Because base units are not used in clinical settings, the results of verum acupuncture in sham-controlled trials with base units need to be interpreted carefully.Systematic review registrationhttps://www.researchregistry.com/browse-the-registry#registryofsystematicreviewsmeta-analyses/registryofsystematicreviewsmeta-analysesdetails/6269f962606c5e001fd8790c/, identifier reviewregistry1351.

Dataset Information

The quality of reporting in randomized controlled trials of acupuncture for knee osteoarthritis: A cross-sectional survey.

Publications

The quality of reporting in randomized controlled trials of acupuncture for knee osteoarthritis: A cross-sectional survey.

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