scholarly journals The association between registration status and reported outcomes in physiotherapy randomised controlled trials

2020 ◽  
Vol 27 (3) ◽  
pp. 1-15
Author(s):  
Christopher Ellaway-Barnard ◽  
Hannah Killick ◽  
Guy Peryer ◽  
Jane L Cross ◽  
Toby O Smith
Keyword(s):  
Randomised Controlled Trials ◽  
Multivariate Analyses ◽  
Trial Registration ◽  
Selective Reporting ◽  
Controlled Trials ◽  
Included Trial ◽  
Clinical Trial Registration ◽  
Registration Status ◽  
Registration Number ◽  
Randomised Controlled

Background/Aims Clinical trial registration has been proposed as a method of mitigating selective reporting in scientific research. It remains unknown whether trial registration is associated with reported outcomes in physiotherapy trials. This study aimed to analyse the association between registration status and outcome (the rejection or acceptance of a primary null hypothesis) for physiotherapy randomised controlled trials. Methods All randomised controlled trials reporting a physiotherapy intervention in publications listed in PubMed between 1 January 2017 and 30 June 2017 were included. Trial registration was determined based on the reporting of a registration number in the primary article or by identifying trials through trial registries. Results Of the 291 trials analysed, 176 (60.5%) were registered; 115 (39.5%) were not. There was no significant association between trial registration and outcome on multivariate analyses (Odds Ratio 1.65; 95% Confidence Interval (0.92–2.96); P=0.09). Only 22% of trials were prospectively registered. Conclusions Registration status and trial outcome are not associated in randomised controlled trials of physiotherapy interventions. The rate of physiotherapy trial registration remains low.

scholarly journals A survey of instructions to authors in surgical journals on reporting by CONSORT and PRISMA

2012 ◽  
Vol 94 (7) ◽  
pp. 468-471 ◽  
Author(s):  
S Shantikumar ◽  
J Wigley ◽  
W Hameed ◽  
A Handa
Keyword(s):  
Systematic Reviews ◽  
Randomised Controlled Trials ◽  
Trial Registration ◽  
Controlled Trials ◽  
Clinical Trial Registration ◽  
Journal Citation Reports ◽  
Randomised Controlled ◽  
The Uk ◽  
Meta Analyses ◽  
Surgical Journals

INTRODUCTION Guidance has been published on how best to report randomised controlled trials (Consolidated Standards of Reporting Trials – CONSORT) and systematic reviews (Preferred Reporting Items for Systematic Reviews and Meta-Analyses – PRISMA). The aim of this study was to establish to what extent surgical journals formally endorse CONSORT and PRISMA in the respective reporting of randomised controlled trials and systematic reviews. METHODS Overall, 136 surgical journals indexed in Journal Citation Reports® were studied. Author guidelines were scrutinised for the following guidance: conflict of interests (COI), the Uniform Requirements for Manuscripts (URM), clinical trial registration, CONSORT and PRISMA. RESULTS The frequency of guidance endorsement was found to be as follows: COI 82%, URM 62%, trial registration 32%, CONSORT 29% and PRISMA 10%. Journals with a higher impact were more likely to adopt trial registration, CONSORT and PRISMA. Journals with editorial offices in the UK were more likely to insist on disclosure of COI and to endorse CONSORT. CONCLUSIONS Guidelines produced to improve publication practice have not been implemented widely by surgical journals. This may contribute to an overall poorer quality of published research. Editors of surgical journals should uniformly endorse reporting guidance and update their instructions to authors to reflect this.

scholarly journals Determining the Feasibility of Ambulance-Based Randomised Controlled Trials in Patients with Ultra-Acute Stroke: Study Protocol for the “Rapid Intervention with GTN in Hypertensive Stroke Trial” (RIGHT, ISRCTN66434824)

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Sandeep Ankolekar ◽  
Gillian Sare ◽  
Chamila Geeganage ◽  
Michael Fuller ◽  
Lynn Stokes ◽  
...  
Keyword(s):  
Acute Stroke ◽  
Functional Outcomes ◽  
Randomised Controlled Trials ◽  
Controlled Trial ◽  
Trial Registration ◽  
Controlled Trials ◽  
Stroke Study ◽  
Registration Number ◽  
Randomised Controlled ◽  
The Uk

Background. Time from acute stroke to enrolment in clinical trials needs to be reduced to improve the chances of finding effective treatments. No completed randomised controlled trials of ambulance-based treatment for acute stroke have been reported in the UK, and the practicalities of recruiting, consenting, and treating patients are unknown.Methods. RIGHT is an ambulance based, single-blind, randomised controlled trial with blinded-outcome assessment. The trial will assess feasibility of using ambulance services to deliver ultra-acute stroke treatments; a secondary aim is to assess the effect of glyceryl trinitrate (GTN) on haemodynamic variables and functional outcomes. Initial consent, randomisation, and treatment are performed by paramedics prior to hospitalisation. Patients with ultra-acute stroke (≤4 hours of onset) are randomised to transdermal GTN (5 mg/24 hours) or gauze dressing daily for 7 days. The primary outcome is systolic blood pressure at 2 hours. Secondary outcomes include feasibility, haemodynamics, dependency, and other functional outcomes. A nested qualitative study is included.Trial Status. The trial has all relevant ethics and regulatory approvals and recruitment started on February 15, 2010. The trial stopped recruitment in December 2011 after 41 patients were recruited.Trial Registration. The trial registration number is ISRCTN66434824 and EudraCT number is 2007-004766-40.

scholarly journals How do financial (dis)incentives influence health behaviour and costs? Protocol for a systematic literature review of randomised controlled trials

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024694
Author(s):  
Brittany Humphries ◽  
Andrew Irwin ◽  
Michael Zoratti ◽  
Feng Xie
Keyword(s):  
Financial Incentives ◽  
Randomised Controlled Trials ◽  
Cochrane Collaboration ◽  
Published Data ◽  
Controlled Trials ◽  
Comprehensive Overview ◽  
Clinical Trial Registries ◽  
Patient Health ◽  
Registration Number ◽  
Randomised Controlled

IntroductionIn this era of rising healthcare costs, there is a growing interest in understanding how funding policies can be used to improve health and healthcare efficiency. Financial incentives (eg, vouchers or access to health insurance) or disincentives (eg, fines or out-of-pocket costs) affect behaviours. To date, reviews have explored the effects of financial (dis)incentives on patient health and behaviour by focusing on specific behaviours or geographical areas. The objective of this systematic review is to provide a comprehensive overview on the use of financial (dis)incentives as a means of influencing health-related behaviour and costs in randomised trials.Methods and analysisWe will search electronic databases, clinical trial registries and websites of health economic organisations for randomised controlled trials. The initial searches, which were conducted on 13 January 2018, will be updated every 12 months until the completion of data analysis. The reference lists of included studies will be manually screened to identify additional eligible studies. Two researchers will independently review titles, abstracts and full texts to determine eligibility according to a set of predetermined inclusion criteria. Data will be extracted from included studies using a form developed and piloted by the research team. Discrepancies will be resolved through discussion with a third reviewer. Risk of bias will be assessed using the Cochrane Collaboration tool.Ethics and disseminationEthics approval is not required since this is a review of published data. Results will be disseminated through publication in peer-reviewed journals and presentations at relevant conferences.PROSPERO registration numberCRD42018097140

Reporting Characteristics and Risk of Bias in Randomised Controlled Trials of Acupuncture Analgesia Published in Pubmed-Listed Journals

2017 ◽  
Vol 35 (4) ◽  
pp. 259-267 ◽  
Author(s):  
Xiuxia Li ◽  
Rong Wang ◽  
Xiue Shi ◽  
Zehao Chen ◽  
Yuanqing Pan ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Reporting Quality ◽  
Cochrane Collaboration ◽  
Risk Of Bias ◽  
Acupuncture Points ◽  
Controlled Trials ◽  
Acupuncture Analgesia ◽  
Clinical Trial Registration ◽  
Pubmed Database ◽  
Randomised Controlled

Background Acupuncture analgesia has been evaluated by a number of randomised controlled trials (RCTs); however, a systematic summary of reporting quality of RCTs in this specific field is lacking. Objective To examine the reporting characteristics and risk of bias of RCTs of acupuncture analgesia indexed in the PubMed database. Methods A PubMed search of RCTs of acupuncture analgesia was conducted through November 2015. The Cochrane Collaboration Risk of Bias Tool was used to assess the risk of bias of each trial. Results 206 articles were identified across 59 journals (impact factor 0.4–20), of which 56% of articles and 86% of journals were Science Citation Index (SCI)-indexed. Nearly half of the articles were published in China. The next most represented countries of origin were the UK (22%) and USA (21%). Of the included trials, postoperative pain was the most prevalent phenotype, and manual acupuncture was the most frequently applied type of stimulation (46%). A total of 12% of articles reported on analgesic mechanisms. The most frequently used acupuncture points were LI4, ST36, PC6, SP6 and Shenmen. The overwhelming majority of trials were considered to be at high risk of bias (84%). Furthermore, 79% of trials enrolled <50 participants per treatment arm. Conclusions RCTs of acupuncture analgesia indexed in PubMed journals generally exhibited poor reporting of methodological and treatment details. Future studies should provide more information regarding clinical trial registration, blinding of participants (including sham procedures where applicable) and outcome assessors, as well as the training and qualification of acupuncturists.

scholarly journals O32: TRANSPARENCY IN SURGICAL RANDOMISED CONTROLLED TRIALS: CROSS-SECTIONAL, OBSERVATIONAL STUDY

2021 ◽  
Vol 108 (Supplement_1) ◽  
Author(s):  
JA Helliwell ◽  
B Shelton ◽  
H Mahmood ◽  
R Blanco-Colino ◽  
JE Fitzgerald ◽  
...  
Keyword(s):  
Data Sharing ◽  
Randomised Controlled Trials ◽  
Conflicts Of Interest ◽  
Trial Registration ◽  
Controlled Trials ◽  
Cross Sectional ◽  
Research Waste ◽  
Funding Sources ◽  
Randomised Controlled ◽  
Personal Conflicts Of Interest

Abstract Introduction Randomised controlled trials (RCT) often provide the scientific basis on which commissioning and treatment decisions are made. It is essential that their results and methods are reported transparently. The aim of this study was to explore transparency with respect to trial registration, disclosure of funding sources, conflicts of interest (COI), and data sharing. Method This was a cross-sectional review of surgical RCTs. Data were extracted from RCTs in ten high-impact journals published in the years 2009, 2012, 2015, and 2018. Outcomes of interest were the incidence of reported trial registration, disclosure of funding sources, disclosure of investigator COI, and presence of a statement of data sharing plans. Result A total of 475 were eligible for analysis. Trial registration was present in 73 (67%) studies in 2009, 137 (84%) in 2012, 111 (89%) in 2015 and 110 (93%) in 2018. Funding statements were provided in 55%, 65%, 69.4%, and 75.4% of manuscripts, respectively. Conflicts of interest statements were provided in 49.5%, 89.1%, 94.6%, and 98.3% of manuscripts, respectively. Data sharing statements were present in only 15 (3.2%) RCTs. Eleven of these were in studies published most recently in 2018. Conclusion Trial registration, presence of funding statements, and disclosure of personal conflicts of interest in surgical RCTs have improved rapidly over the last 10 years. In contrast, disclosure of data sharing plans is exceptionally low. This may contribute to research waste and represents an essential target for improvement. Take-home message Trial registration, presence of funding statements, and disclosure of personal conflicts of interest in surgical RCTs have improved rapidly over the last 10 years. In contrast, disclosure of data sharing plans is exceptionally low. This may contribute to research waste and represents an essential target for improvement.

Effectiveness of school-based physical activity programmes on cardiorespiratory fitness in children: a meta-analysis of randomised controlled trials

2017 ◽  
Vol 52 (19) ◽  
pp. 1234-1240 ◽  
Author(s):  
Diana P Pozuelo-Carrascosa ◽  
Antonio García-Hermoso ◽  
Celia Álvarez-Bueno ◽  
Mairena Sánchez-López ◽  
Vicente Martinez-Vizcaino
Keyword(s):  
Physical Activity ◽  
Cardiorespiratory Fitness ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Healthy Children ◽  
Physical Activity Interventions ◽  
School Based ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTo conduct a meta-analysis of randomised controlled trials aimed at testing whether school-based physical activity programmes improve cardiorespiratory fitness (CRF) in children.DesignSystematic review with meta-analysis.Data sourcesUsing keywords, we performed a computerised search in five databases: MEDLINE, EMBASE, CINAHL, Web of Science and SportDiscus.Eligibility criteria for selecting studiesStudies that assessed the effectiveness of school-based physical activity programmes on improving CRF in children (3–12 years old). We selected interventions that included an additional physical activity programme and not only a physical activity educational component. The reference lists of selected full-text articles and systematic reviews were also searched for relevant studies. Pooled effect size (Hedges′ g) was calculated assuming a random-effects model.ResultsTwenty trials with 7287 healthy children aged 3–12 years were included in the meta-analysis. School-based physical activity interventions with aerobic games and activities were associated with a significant small increase in CRF (Hedges′ g=0.22; 95% CI 0.14 to 0.30; p<0.001). Based on subgroup analysis, the increase in CRF was significant in girls (Hedges′ g=0.25; 95% CI 0.13 to 0.37; p<0.001), but not in boys (Hedges′ g=0.02; 95% CI −0.10 to 0.14; p=0.731).SummaryModerate quality evidence supports the effectiveness of school-based physical activity interventions on improving CRF in children.Trial registration numberProtocol PROSPERO registration number CRD42016050173.

Acupressure for Respiratory Allergic Diseases: A Systematic Review of Randomised Controlled Trials

2017 ◽  
Vol 35 (6) ◽  
pp. 413-420 ◽  
Author(s):  
Yaqun Liang ◽  
George Binh Lenon ◽  
Angela Wei Hong Yang
Keyword(s):  
Randomised Controlled Trials ◽  
Symptomatic Relief ◽  
Allergic Diseases ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
Registration Number ◽  
Nasal Drop ◽  
Randomised Controlled ◽  
Unclear Risk

Objective To evaluate the effects and safety of acupressure for the management of respiratory allergic diseases by systematically reviewing randomised controlled trials (RCTs). Methods A total of 13 electronic English and Chinese databases were searched until July 2017. Two authors extracted data and evaluated risk of bias independently. Review Manager V.5.3 was employed for data analysis. Results The literature search identified 186 papers, of which only four of met the inclusion criteria: two for allergic rhinitis (AR) and two for asthma. High and unclear risk of bias existed across all the included studies. The findings demonstrated that acupressure greater effects on the relief of nasal symptoms of AR compared with 1% ephedrine nasal drop plus thermal therapy. With either Western medicine or Chinese herbal medicine as a cointervention, one study indicated that acupressure plus salbutamol was led to a significantly greater improvement of pulmonary function for patients with asthma compared with salbutamol only. However, the remaining two studies indentified no significant differences in any outcome measures between the two groups. Conclusions No reliable conclusions regarding the effects of acupressure on AR and asthma could be drawn by this review due to the small number of available trials with significant heterogeneity of study design and high/unclear risk of bias. Further, more rigorously designed RCTs are needed. Acupressure seems safe for symptomatic relief of AR and asthma, although larger studies are required to be able to robustly confirm its safety. Trial registration number ACTRN12617001106325; Pre-results.

scholarly journals Do mobile device apps designed to support medication adherence demonstrate efficacy? A systematic review of randomised controlled trials, with meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e032045 ◽  
Author(s):  
Laura Catherine Armitage ◽  
Aikaterini Kassavou ◽  
Stephen Sutton
Keyword(s):  
Systematic Review ◽  
Medication Adherence ◽  
Effect Size ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Behaviour Change Techniques ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesTo estimate the efficacy of app-based interventions designed to support medication adherence and investigate which behaviour change techniques (BCTs) used by the apps are associated with efficacy.DesignSystematic review of randomised controlled trials (RCTs), with meta-analysis.SettingMedline/PubMed, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Embase and Web of Science were searched from 1990 to November 2018 for RCTs conducted in any healthcare setting.ParticipantsStudies of participants of any age taking prescribed medication for any health condition and for any duration.InterventionAn app-based intervention delivered through a smartphone, tablet computer or personal digital assistant to help, support or advise about medication adherence.ComparatorOne of (1) usual care, (2) a control app which did not use any BCTs to improve medication adherence or (3) a non-app-based comparator.Primary and secondary outcome measuresThe primary outcome was the pooled effect size of changes in medication adherence. The secondary outcome was the association between BCTs used by the apps and the effect size.ResultsThe initial search identified 13 259 citations. After title and abstract screening, full-text articles of 83 studies were screened for eligibility. Nine RCTs with 1159 recruited participants were included. The mean age of participants was >50 years in all but one study. Health conditions of target populations included cardiovascular disease, depression, Parkinson’s disease, psoriasis and multimorbidity. The meta-analysis indicated that patients who use mobile apps to support them in taking medications are more likely to self-report adherence to medications (OR 2.120, 95% CI 1.635 to 2.747, n=988) than those in the comparator groups. Meta-regression of the BCTs did not reveal any significant associations with effect size.ConclusionsApp-based medication adherence interventions may have a positive effect on patient adherence. Larger scale studies are required to further evaluate this effect, including long-term sustainability, and intervention and participant characteristics that are associated with efficacy and app usage.Prospero registration numberPROSPERO Protocol Registration Number: CRD42017080150.

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