Reporting and Methodological Quality of Randomised Controlled Trials in Vascular and Endovascular Surgery

Purpose We aimed to investigate association between bibliometric parameters, reporting and methodological quality of vascular and endovascular surgery randomised controlled trials. Methods The most recent 75 and oldest 75 randomised controlled trials published in leading journals over a 10-year period were identified. The reporting quality was analysed using the CONSORT statement, and methodological quality with the Intercollegiate Guidelines Network checklist. We used exploratory univariate and multivariable linear regression analysis to investigate associations. Findings Bibliometric parameters such as type of journal, study design reported in title, number of pages; external funding, industry sponsoring and number of citations are associated with reporting quality. Moreover, parameters such as type of journal, subject area and study design reported in title are associated with methodological quality. Conclusions The bibliometric parameters of randomised controlled trials may be independent predictors for their reporting and methodological quality. Moreover, the reporting quality of randomised controlled trials is associated with their methodological quality and vice versa.

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A systematic review of randomised controlled trials of psychosocial interventions for acute mental health inpatients

British Journal of Mental Health Nursing ◽

10.12968/bjmh.2018.0023 ◽

2021 ◽

Vol 10 (3) ◽

pp. 1-17

Author(s):

Laura D Wainwright ◽

Gillian Haddock ◽

Charlotte Dunster-Page ◽

Katherine Berry

Keyword(s):

Quality Of Life ◽

Methodological Quality ◽

Randomised Controlled Trials ◽

Social Care ◽

Psychosocial Interventions ◽

Controlled Trials ◽

Patient Functioning ◽

Electronic Search ◽

Randomised Controlled

Background/Aims Inpatient wards provide an opportunity to intervene with medical, psychological and social care to contain distress and prevent future relapse. However, they have been criticised for an over-reliance on medication and risk management with limited psychosocial interventions. The aim of this study was to investigate clinical trials of psychosocial interventions for inpatients to identify interventions that are effective at improving quality of life, symptoms or patient functioning. Methods An electronic search of six databases was conducted for papers published from 1806 up until February 2017. A total of 18 randomised controlled trials was identified in which outcomes for symptoms, quality of life or functioning were reported. Results Overall, 15 trials showed a statistically significant result for at least one outcome. Seven categories were identified from the 18 studies, at least one in each category was found to be effective for symptoms, quality of life or functioning. The majority were effective (15 out of 18). Conclusions Given that the methodological quality was generally low and number of randomised controlled trials were small, it is difficult to draw definitive conclusions. Recommendations include more and repeated trials using rigorous methods of testing and reporting.

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Acupuncture for Amnestic Mild Cognitive Impairment: A Meta-Analysis of Randomised Controlled Trials

Acupuncture in Medicine ◽

10.1136/acupmed-2015-010989 ◽

2016 ◽

Vol 34 (5) ◽

pp. 342-348 ◽

Cited By ~ 23

Author(s):

Min Deng ◽

Xu-Feng Wang

Keyword(s):

Cognitive Impairment ◽

Mild Cognitive Impairment ◽

Methodological Quality ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Scientific Journal ◽

Adjunctive Treatment ◽

Controlled Trials ◽

Randomised Controlled

Objective Mild cognitive impairment (MCI) is a pre-dementia state; 5–10% of cases per year will evolve into dementia. MCI can be amnestic (AMCI) or non-amnestic. AMCI is associated with a higher risk of progression. In recent years, interest in acupuncture as a potential treatment for AMCI has grown. The aim of this meta-analysis was to estimate the clinical effectiveness and safety of acupuncture for AMCI. Methods Randomised controlled trials (RCTs) of acupuncture versus medical treatment for AMCI were identified using the following databases from inception to July 2015: PubMed; Medline; CENTRAL; Chinese Scientific Journal Database; The Chinese Acupuncture Trials Register; China National Knowledge Infrastructure (CNKI); and Wanfang database. Data were extracted from RCTs meeting the inclusive criteria according to Cochrane methods. Meta-analyses were conducted using Rev Man V.5.3 software. Results Five trials involving 568 subjects were included. Meta-analysis showed that participants receiving acupuncture had better outcomes than those receiving nimodipine with greater clinical efficacy rates (odds ratio (OR) 1.78, 95% CI 1.19 to 2.65; p<0.01), mini-mental state examination (MMSE) scores (mean difference (MD) 0.99, 95% CI 0.71 to 1.28; p<0.01), and picture recognition score (MD 2.12, 95% CI 1.48 to 2.75; p<0.01). Meta-analysis also showed acupuncture in conjunction with nimodipine significantly improved MMSE scores (MD 1.09, 95% CI 0.29 to 1.89; p<0.01) compared to nimodipine alone. Three trials reported adverse events. Methodological quality of the included studies was judged to be generally poor. Conclusions Acupuncture appears effective for AMCI when used as an alternative or adjunctive treatment; however, caution must be exercised given the low methodological quality of included trials. Further, more rigorously designed studies are needed.

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Methodological quality of randomised controlled trials in burns care. A systematic review

Burns ◽

10.1016/j.burns.2009.04.031 ◽

2009 ◽

Vol 35 (7) ◽

pp. 956-961 ◽

Cited By ~ 20

Author(s):

Stefan Danilla ◽

Jason Wasiak ◽

Susana Searle ◽

Cristian Arriagada ◽

Cesar Pedreros ◽

...

Keyword(s):

Systematic Review ◽

Methodological Quality ◽

Randomised Controlled Trials ◽

Controlled Trials ◽

Randomised Controlled

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The methodological quality of cluster randomised controlled trials for managing tropical parasitic disease: a review of trials published from 1998 to 2007

Transactions of the Royal Society of Tropical Medicine and Hygiene ◽

10.1016/j.trstmh.2009.01.015 ◽

2009 ◽

Vol 103 (5) ◽

pp. 429-436 ◽

Cited By ~ 9

Author(s):

Russell J. Bowater ◽

Sally M.E. Abdelmalik ◽

Richard J. Lilford

Keyword(s):

Methodological Quality ◽

Randomised Controlled Trials ◽

Controlled Trials ◽

Parasitic Disease ◽

Cluster Randomised ◽

Randomised Controlled ◽

Tropical Parasitic Disease

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Evidence for the Efficacy of Ultra-High Diluted Homoeopathic Medicines in the Management of Influenza-Like Illness: A Narrative Review

Homœopathic Links ◽

10.1055/s-0040-1715602 ◽

2020 ◽

Vol 33 (04) ◽

pp. 257-262

Author(s):

Anupam Mukherjee ◽

Neeti Sinha ◽

Joy Kumar Dey ◽

Arun Bhargav Jadhav

Keyword(s):

Clinical Trials ◽

Placebo Group ◽

Significant Role ◽

Methodological Quality ◽

Randomised Controlled Trials ◽

Narrative Review ◽

Controlled Trials ◽

Jadad Scale ◽

Randomised Controlled

Abstract Introduction In view of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the rise in cases of influenza-like illness (ILI), there is urgent need of developing and scientifically establishing treatment strategies. Homoeopathy has been used effectively in various pandemics for a long-time showing potential of combating such outbreaks effectively. This study aims at evaluating the methodological quality of the clinical trials conducted with a motive of assessing the efficacy of homoeopathy in management of ILI. Methods The randomised clinical research manuscripts from various databases were included for the narrative review. In this study, the Jadad scale was applied as an assessment tool with the criteria of randomisation, blinding and withdrawals to evaluate the methodological quality of the selected randomised controlled trials. Results The seven randomised controlled trials fulfilling the inclusion criteria evaluated on Jadad scale lay between the ranges of 2 to 5 with a mean score of 3.71 implicating the efficacy of homoeopathy in ILI. Six studies showed significant role of homoeopathy in the faster recovery of ILI symptoms. One trial, however, reported no noticeable difference in intergroup (treatment and placebo group) improvement but distinct intragroup comparison was observed. Conclusion It was concluded from this narrative review that homoeopathy has significant role in faster recovery of ILI symptoms in comparison to placebo group, and it can be employed as a potential treatment strategy in the recurrent pandemics of ILI and the currently prevailing coronavirus disease 2019 (COVID-19) crisis. It is suggested that more clinical trials with standard methodology should be conducted in this regard.

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Status, reporting completeness and methodological quality of pilot randomised controlled trials in acupuncture: protocol for a systematic review

BMJ Open ◽

10.1136/bmjopen-2021-052528 ◽

2021 ◽

Vol 11 (12) ◽

pp. e052528

Author(s):

Yajun Zhang ◽

Hantong Hu ◽

Xiaoyu Li ◽

Jiali Lou ◽

Xiaofen He ◽

...

Keyword(s):

Systematic Review ◽

Methodological Quality ◽

Randomised Controlled Trials ◽

Biomedical Literature ◽

Cochrane Library ◽

Controlled Trials ◽

Publication Trends ◽

Pilot Trials ◽

Randomised Controlled

IntroductionTo date, there has been a lack of knowledge about the status, reporting completeness and methodological quality of pilot trials in the acupuncture field. Thus, this systematic review protocol aims to: (1) investigate publication trends and aspects of feasibility evaluated in acupuncture pilot trials; (2) identify the proportion of acupuncture pilot trials that lead to definitive trials and (3) assess the reporting completeness and methodological quality of pilot trials in acupuncture.Methods and analysisStudies of acupuncture pilot randomised controlled trials published from 2011 to 2021 will be retrieved in seven databases in January 2022, including PubMed, Web of Science, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Database and Chinese Biomedical Literature Database. The methodological quality and reporting completeness of all included studies will be assessed using the risk of bias 2.0 tool (RoB 2) and the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials, respectively. For the primary analysis, publication trends, aspects of feasibility and the proportion of pilot trials that lead to definitive trials will be analysed. A quantitative analysis of the methodological quality and reporting completeness of the included trials will be implemented by calculating the percentage of items reported in each domain of RoB 2 and CONSORT. The secondary analysis will adopt a regression analysis to identify factors associated with the reporting completeness.Ethics and disseminationEthical approval is not required for this study. This study is planned to be submitted to a peer-reviewed academic journal.

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