Quality of reporting on randomized controlled trials of acupuncture for stroke rehabilitation.
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ABSTRACT: Background
Results from clinical studies on acupuncture for stroke rehabilitation are contradictory. The reason for the inconsistent findings especially lie in the transparency and accuracy of randomized controlled trials (RCTs) reports. This study aims to analyze the quality of reporting and its correlates in RCTs on acupuncture for stroke rehabilitation.Methods
Quality of reporting for included papers was assessed against a subset of criteria adapted from the CONSORT 2010 statement and STRICTA. An overall quality score (OQS) and a combined key methodological index score (MIS) was calculated for each trial. Then, factors associated with OQS and MIS were identified.Results
A total of 15 RCTs were included in full text. The median OQS based on the CONSORT statement and STRICTA was 8 and 12, respectively. The significant predictors for CONSORT OQS was funding source, for STRICTA was year of publication. With regard to the MIS, no variable was associated with improved methodological quality.Conclusions
Our study found that the overall quality of reporting on RCTs of acupuncture for stroke rehabilitation was general or good. But some items' reporting was found where information was insufficient or inadequate in most studies which needed substantial improvement.
SUBMITTER: Zhuang L
PROVIDER: S-EPMC4030573 | biostudies-literature | 2014 May
REPOSITORIES: biostudies-literature
Publications
Quality of reporting on randomized controlled trials of acupuncture for stroke rehabilitation.
Zhuang Lixing L He Jun J Zhuang Xun X Lu Liming L
BMC complementary and alternative medicine 20140507
<h4>Background</h4>Results from clinical studies on acupuncture for stroke rehabilitation are contradictory. The reason for the inconsistent findings especially lie in the transparency and accuracy of randomized controlled trials (RCTs) reports. This study aims to analyze the quality of reporting and its correlates in RCTs on acupuncture for stroke rehabilitation.<h4>Methods</h4>Quality of reporting for included papers was assessed against a subset of criteria adapted from the CONSORT 2010 state ...[more]
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Project description:ObjectiveTo assess the reporting quality of acupuncture trials for knee osteoarthritis (KOA), and explore the factors associated with the reporting.MethodThree 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.ResultsA 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.ConclusionsThe reporting in RCTs of acupuncture for KOA was generally poor. To improve the reporting quality, journals should encourage strict adherence to the reporting guidelines.
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Project description:BackgroundCognitive impairment is one of the common sequelae after stroke, which not only hinders the recovery of patients but also increases the financial burden on families. In the absence of effective therapeutic measures, acupuncture treatment has been widely used in China to treat post-stroke cognitive impairment (PSCI), but the specific efficacy is unclear. Therefore, this review aimed to evaluate the true efficacy of acupuncture treatment in patients with PSCI.MethodsWe searched eight databases [PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, China Biomedical Literature Database (CBM), China Science and Technology Journal (VIP) database, the China National Knowledge Infrastructure (CNKI) database, and Wan fang database] from the inception to May 2022 for randomized controlled trials (RCTs) related to acupuncture treatment combined with cognitive rehabilitation (CR) for PSCI. Two investigators independently used a pre-designed form to extract valid data from eligible RCTs. The risk of bias was assessed through tools provided by the Cochrane Collaboration. The meta-analysis was implemented through Rev Man software (version 5.4). The strength of the evidence obtained was evaluated using GRADE profiler software. Adverse events (AEs) were collected by reading the full text and used to evaluate the safety of acupuncture treatment.ResultsThirty-eight studies involving a total of 2,971 participants were included in this meta-analysis. Overall, the RCTs included in this meta-analysis were poor in methodological quality. The combined results showed that acupuncture treatment combined with CR showed significant superiority compared to CR alone in terms of improving cognitive function [Mean Difference (MD) = 3.94, 95% confidence intervals (CI): 3.16-4.72, P < 0.00001 (MMSE); MD = 3.30, 95%CI: 2.53-4.07, P < 0.00001 (MoCA); MD = 9.53, 95%CI: 5.61-13.45, P < 0.00001 (LOTCA)]. Furthermore, the combination of acupuncture treatment and CR significantly improved patients' self-care ability compared to CR alone [MD = 8.66, 95%CI: 5.85-11.47, P < 0.00001 (MBI); MD = 5.24, 95%CI: 3.90-6.57, P < 0.00001 (FIM)]. Meanwhile, subgroup analysis showed that MMSE scores were not sufficiently improved in the comparison of electro-acupuncture combined with CR versus CR alone (MD = 4.07, 95%CI: -0.45-8.60, P = 0.08). However, we also observed that electro-acupuncture combined with CR was superior to the use of CR alone in improving MoCA and MBI scores in patients with PSCI [MD = 2.17, 95%CI: 0.65-3.70, P = 0.005 (MoCA); MD = 1.74, 95%CI: 0.13-3.35, P = 0.03 (MBI)]. There was no significant difference in the occurrence of adverse events (AE) between acupuncture treatment combined with CR and CR alone (P > 0.05). The certainty of the evidence was rated low level because of flaws in the study design and considerable heterogeneity among the included studies.ConclusionThis review found that acupuncture treatment combined with CR may have a positive effect on improving cognitive function and self-care ability in PSCI patients. However, our findings should be treated with caution owing to the existence of methodological quality issues. High-quality studies are urgently required to validate our results in the future.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022338905, identifier: CRD42022338905.
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Project description:BackgroundThe evidence of Acupuncture combined with speech rehabilitation training for post-stroke dysarthria is insufficient and there is no consensus on its efficacy.MethodsWe searched seven Chinese and English medicine databases for randomized controlled trials (RCTs) from their inception to November 2019. The primary outcome measure was the clinical response rate, assessed with the Frenchay Dysarthria Assessment (FDA) tool. We assessed risk of bias using the Cochrane risk-of-bias tool. We used GRADE to assess the certainty of evidence (CoE).ResultsThirty studies were included in this systematic review, 23 of which were pooled in meta-analysis. Acupuncture combined with speech rehabilitation training is likely beneficial for was response rate (n = 1685; RR = 1.37; 95% CI [1.29, 1.46], P < 0.01, I 2 = 34%; 17 studies, low CoE) compared to speech rehabilitation treatment alone.ConclusionThe combination of acupuncture and speech rehabilitation training may improve total response rate of stroke patients with dysarthria. However, more RCTs with rigorous study design and validated outcome measures are needed to confirm the evidence.
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Project description:BackgroundThis study was designed to assess the quality of reporting on randomized controlled trials (RCTs) of scalp acupuncture for the treatment of stroke.MethodsThe following 8 databases were systematically investigated from their inception to December 2015: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, National Institute of Informatics Scholarly and Academic Information Navigator, National Digital Science Library, Korean Traditional Knowledge Portal, and Korean Studies Information Service System. RCTs utilizing scalp acupuncture as an intervention for stroke were selected, and the quality of reports was assessed based on the Consolidated Standards of Reporting Trials 2010 statement (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture 2010 (STRICTA). For each study, the overall quality score (OQS) of 13 CONSORT items, a combined key methodological index score (MIS) of 5 CONSORT items, and the OQS of 17 STRICTA items were measured.ResultsThe original reports of 63 RCTs were ultimately obtained, and the median CONSORT OQS was 7 (minimum 2, maximum 11). Particularly, the items 'trial design', 'sample size', 'ancillary analyses', and 'harms' had a positive rate of less than 10%. The median MIS was 1 (minimum 0, maximum 5), with 'allocation concealment and implementation' and 'intent-to-treat analysis (ITT) analysis' having a positive rate of less than 10%. The median STRICTA OQS was 11 (minimum 6, maximum 14), and only the items 'sample size' and 'intent-to-treat analysis' were reported, with a positive rate of less than 10%. The mean CONSORT OQS increased by approximately 0.81 for each 5-year period in which manuscripts were published (95% confidence interval: 0.43 to 1.19; p < 0.001). No variable was significantly associated with MIS in the ordinal regression model.ConclusionThe quality of reports on RCTs investigating scalp acupuncture treatment for stroke was moderate to low. Furthermore, reporting of some items was either insufficient or inadequate in the majority of studies. In order to improve and standardize the quality of RCTs investigating scalp acupuncture for stroke, CONSORT and STRICTA guidelines should be utilized more frequently.
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Project description:BackgroundGood radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer.MethodsWe searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting.ResultsWe found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria.ConclusionThere is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.
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Project description:ObjectiveThe purpose of this study was to evaluate the rehabilitation effects of four common interventions (BA: body acupuncture, SA: scalp acupuncture, TA: tongue acupuncture, SLT: speech and language training) used singly or in combination with language function in patients with post-stroke aphasia (PSA).DesignWe systematically searched PubMed, EMBASE, Cochrane Library, Ovid, Web of Science, CNKI, VIP, and Wanfang from inception to 4 April 2022. Only randomized controlled trials that met the eligibility criteria were included. The risk of bias of studies included was assessed using the RoB-2 tool. The effects of different interventions for PSA patients were analyzed and ranked according to the surface under the cumulative ranking (SUCRA) analysis.ResultsA total of 69 RCTs were included, including 5097 total participants. According to the results of the SUCRA curves, TA ranked highest in improving overall efficacy (SUCRA = 86%) and oral expression score (SUCRA = 86%). BA + TA ranked highest in increasing the comprehension score (SUCRA = 74.9%). BA + SA ranked highest in improving aphasia patients' repetition (SUCRA = 89.2%) and denomination scores (SUCRA = 93%).ConclusionsResults of our network meta-analysis and SUCRA ranking showed that tongue acupuncture, body acupuncture + tongue acupuncture, and body acupuncture + scalp acupuncture seem to offer better advantages than other interventions for improving the language function in PSA patients. Moreover, it is noteworthy that our results are limited to the Chinese population, since all eligible studies are from China. Future well-designed studies with larger sample sizes and more ethnic groups are required to further verify these findings.
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Project description:BackgroundMedical therapy has become an increasingly important intervention owing to improvements in the multidisciplinary care for pituitary adenomas (PAs). This study aimed to assess the reporting quality of randomized controlled trials (RCTs) on PAs pharmacotherapy.MethodsRCTs evaluating the efficacy of pharmacotherapy in PAs published in English between January 1, 1974, and December 31, 2022, were searched for and collected from PubMed and MEDLINE. The 2010 Consolidated Standards for Test Reports (CONSORT) statement-based 28 items overall quality score (OQS) was used to evaluate the overall quality of each report.ResultsTwenty-seven related RCTs including 1816 patients were retrieved. The median OQS score was 12 (range, 6-19) on a scale of 0 to 28. Important items, such as background, objectives, participants, interventions, and outcomes, were sufficiently reported in 100% (27/27) of the articles. Statistical methods were adequately described in 93% (25/27) of patients. However, RCTs underreported identification as randomized trials in the title (3/27, 11%), sample size, allocation concealment, implementation, ancillary analysis method, and Diagram and Ancillary analyses (1/27, 4%). The OQS of published RCTs has significantly increased since 2010 (P = .012). The multivariate final model showed significant associations between higher OQS and publication since 2010 and enrollment of more than 100 patients.ConclusionsThe overall reporting quality of RCTs on pharmacotherapy in PAs was poor, based on the 2010 CONSORT statement. However, we noticed an improvement in the OQS over the years and identified the factors associated with a better report. Increased effort is necessary to raise awareness of these issues among writers, readers, reviewers, and editors.
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