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496 results for “randomised controlled trials”
MiRoR7-P1- Disagreements in risk of bias assessment for randomised controlled trials included in more than one Cochrane systematic reviews: a research on research study using cross-sectional design
<p>dataset referring to </p> <p><strong>Disagreements in risk of bias assessment for randomised controlled trials included in more than one Cochrane systematic reviews: a research on research study using cross-sectional design</strong></p> <p> </p> <p> </p> <p>Lorenzo Bertizzolo<sup>1</sup>, Patrick M Bossuyt<sup>2</sup>, Ignacio Atal<sup>1, 5</sup>, Philippe Ravaud<sup>1, 3-6</sup>, Agnès Dechartres<sup>7</sup></p> <p> </p> <p><sup>1</sup> INSERM, U1153 Epidemiology and Biostatistics Sorbonne Paris Cité Research Center (CRESS), Methods of therapeutic evaluation of chronic diseases Team (METHODS), Paris, F-75004 France; Paris Descartes University, Sorbonne Paris Cité, France.</p> <p><sup>2</sup> Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, Netherlands.</p> <p><sup>3</sup> Centre d’Épidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP (Assistance Publique des Hôpitaux de Paris), Paris, France.</p> <p><sup>4</sup> Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.</p> <p><sup>5</sup> Cochrane France, Paris, France</p> <p><sup>6</sup> Columbia University, Mailman School of Public Health, Department of Epidemiology, New York, USA</p> <p><sup>7</sup> Sorbonne Université, INSERM, Institut Pierre Louis de Santé Publique, Département Biostatistique, Santé Publique et Information Médicale, AP-HP, Hôpitaux Universitaires Pitié Salpêtrière – Charles Foix, Paris, France</p>
Data relating to Clyne et al. Quality, scope and reporting standards of randomised controlled trials in Irish Health Research: an observational study
<p>Data relating to the study reported in the paper "Quality, scope and reporting standards of randomised controlled trials in Irish Health Research: an observational study".</p>
Data and analysis supplement for: Functional imagery training versus motivational interviewing for weight loss: a randomised controlled trial of brief individual interventions for overweight and obesity.
<p>This submission provides the data and code for analyses reported in our publication.</p>
DATASET OF "Impact of short-acting vs. standard anaesthetic agents on obstructive sleep apnoea: a randomised, controlled, triple-blind trial"
<p>Sleep apnoea is associated with negative outcomes following general anaesthesia. Current recommendations suggest using short-acting anaesthetic agents in preference to standard agents to reduce this risk, but there is currently no evidence to support this. This randomised controlled triple-blind trial tested the hypothesis that a combination of short-acting agents (desflurane-remifentanil) would reduce the postoperative impact of general anaesthesia on sleep apnoea severity compared with standard agents (sevoflurane-fentanyl). Sixty patients undergoing hip arthroplasty under general anaesthesia were randomised to anaesthesia with desflurane-remifentanil or sevoflurane-fentanyl. Respiratory polygraphy was performed before surgery and on the first and third postoperative nights. The primary outcome was the supine apnoea-hypopnoea index on the first postoperative night. Secondary outcomes were the supine apnoea-hypopnoea index on the third postoperative night, and the oxygen desaturation index on the first and third postoperative nights. Additional outcomes included intravenous morphine equivalent consumption and pain scores on postoperative days 1, 2 and 3. Pre-operative sleep study data were similar between groups. Mean (95%CI) values for the supine apnoea-hypopnoea index on the first postoperative night were 18.9 (12.7–25.0) and 21.4 (14.2–28.7) events.h<sup>-1</sup>, respectively, in the short-acting and standard anaesthesia groups (p=0.64). Corresponding values on the third postoperative night were 28.1 (15.8–40.3) and 38.0 (18.3–57.6) events.h<sup>-1</sup> (p=0.34). Secondary sleep- and pain-related outcomes were generally similar in the two groups. In conclusion, short-acting anaesthetic agents did not reduce the impact of general anaesthesia on sleep apnoea severity compared with standard agents. These data should prompt an update of current recommendations.</p>
Dataset supplementing the article A randomised controlled trial of Losartan as an anti-fibrotic agent in non-alcoholic steatohepatitis
<p>These data supplement the article A randomised controlled trial of Losartan as an antifibrotic agent in non-alcoholic steatohepatitis.</p> <p>Stuart McPherson, Nina Wilkinson, Dina Tiniakos, Jennifer Wilkinson, Alastair Burt, Elaine McColl, Deborah D. Stocken, Nick Steen, Jane Barnes, Nicola Goudie, Stephen Stewart, Yvonne Bury5, Derek Mann, Quentin M. Anstee, Christopher P. Day.</p> <p>Use is free for academic purposes, provided the aforementioned article is appropriately cited.</p> <p>The data consists of anonymised csv data files, described in DataDictionaryFELINE.csv, the final protocol and a blank copy of the case report forms used (both pdf).</p>
Tenofovir-lamivudine-dolutegravir Combination as Second-line ART: a Randomised Controlled Trial
ClinicalTrials.gov study NCT03991013. IPD Sharing: YES. Countries: 1. Publications: 4.
Data from: A village doctor-led mobile health intervention for cardiovascular risk reduction in rural China: cluster randomised controlled trial
Open the record for dataset details and reuse information.
Tramadol effects on physical performance and sustained attention during a 20-min indoor cycling time-trial: A randomised controlled trial
<p>Objectives: To investigate the effect of tramadol on performance during a 20-min cycling time-trial (Exper- iment 1), and to test whether sustained attention would be impaired during cycling after tramadol intake (Experiment 2). Design: Randomized, double-blind, placebo controlled trial. Methods: In Experiment 1, participants completed a cycling time-trial, 120-min after they ingested either tramadol or placebo. In Experiment 2, participants performed a visual oddball task during the time-trial. Electroencephalography measures (EEG) were recorded throughout the session. Results: In Experiment 1, average time-trial power output was higher in the tramadol vs. placebo condition (tramadol: 220 W vs. placebo: 209 W; p < 0.01). In Experiment 2, no differences between conditions were observed in the average power output (tramadol: 234 W vs. placebo: 230 W; p > 0.05). No behavioural differences were found between conditions in the oddball task. Crucially, the time frequency analysis in Experiment 2 revealed an overall lower target-locked power in the beta-band (p < 0.01), and higher alpha suppression (p < 0.01) in the tramadol vs. placebo condition. At baseline, EEG power spectrum was higher under tramadol than under placebo in Experiment 1 while the reverse was true for Experiment 2. Conclusions: Tramadol improved cycling power output in Experiment 1, but not in Experiment 2, which may be due to the simultaneous performance of a cognitive task. Interestingly enough, the EEG data in Experiment 2 pointed to an impact of tramadol on stimulus processing related to sustained attention. Trial registration: EudraCT number: 2015-005056-96.</p>
Study protocol and data dictionary: Effectiveness of a GP delivered medication review in reducing polypharmacy and potentially inappropriate prescribing in older patients with multimorbidity in Irish primary care: a cluster randomised controlled trial (SPPiRE study)
<p><strong>Methods</strong></p> <p><strong>Study design and participants</strong></p> <p>The methods for the SPPiRE cluster RCT have been described in the trial protocol (21). This study is reported in line with the CONSORT 2010 cluster RCT checklist (22), see Appendix 1, and was approved by the Irish College of General Practitioners Research Ethics Committee. In brief, SPPiRE was a pragmatic two arm cluster RCT, with the intervention delivered to GP clusters and analysis of outcomes at the patient level. Information about the trial was publicised through a variety of GP research, teaching and training networks throughout Ireland. Eligible practices expressing an interest were formally invited. Practices were eligible to participate if they had at least 300 registered patients aged ≥65 years (based on the need to identify a sufficient number of eligible participants) and used either of the two Irish GP practice management systems (PMS) with over 80% national cover; this enabled use of a SPPiRE patient finder tool which was developed and embedded into these systems. Practices were excluded if they were currently involved in a medication management or prescribing trial or if they were unable to recruit at least five participants.</p> <p>Eligible patients were aged ≥65 years and prescribed ≥15 repeat medicines. A repeat medicine was defined as any unique item with a World Health Organisation Anatomical Therapeutic Chemical code on the patient’s current repeat prescription. Patients were excluded if they had been recruited into a practice that was unable to recruit at least four other participants, they were judged by their GP as unable to give informed consent or they were unable to attend the practice for a face to face medication review, (e.g. nursing home residents and house bound patients). Recruited GPs ran the SPPiRE patient finder tool and screened the generated list to ensure only eligible patients were invited. Practices who identified more than 40 eligible patients were supported in selecting a random sample of 30 patients to invite. All recruited practices and patients gave fully informed consent and baseline data was collected prior to practice allocation, to reduce the likelihood of selection bias.</p> <p><strong>Randomisation and masking</strong></p> <p>Recruited practices were allocated to intervention or control groups by minimisation using Minimpy software (23) by the trial statistician (FB) who had no knowledge of participating practices. Minimisation variables included practice size (number of GP sessions per week, 0-14, 14-28 and 28 or more) and location (urban, rural or mixed). Considering the nature of the intervention, it was not possible to blind GPs or patients to the intervention, however to reduce the risk of detection bias the two primary outcome measures; the number of repeat medicines and whether a PIP was present were assessed by an independent blinded pharmacist (MF).</p> <p><strong>Procedures</strong></p> <p>Intervention GPs received unique login details to the SPPiRE website where they had access to five training videos and a template for performing the SPPiRE medication review. The training videos provided background information on multimorbidity and polypharmacy, PIP, eliciting patient treatment priorities and conducting a brown bag medication review. GPs were instructed to book a double appointment and to ask their patients to bring all their medicines in to the medication review visit with them. The SPPiRE medication review process had two main components; gather and record information and then to discuss and agree changes with their patient based on the recorded information, with a focus on deprescribing medicines that were potentially inappropriate, figure 1. The website provided suggested treatment alternatives for identified PIP but all treatment decisions were ultimately at the discretion of the individual GP, based on their clinical judgement and their patients’ individual priorities.</p> <p>Control GPs delivered usual care during the six to twelve month study period. At the time of intervention delivery there was no structured chronic disease management programme in Irish primary care and many patients with multimorbidity attended multiple hospital specialists. In Ireland, the majority of people aged ≥70 years of age have access to free GP visits and medicines with some prescription charge co-payments. In the 65 – 69 year old age category a lower proportion have access to both free GP visits and prescription medicines. Access to specialists and diagnostics in secondary care is free for the entire population.</p> <p><strong>Outcomes</strong></p> <p>The two primary outcomes were the number of repeat medicines and the proportion of patients with any PIP, from a list of 34 pre-specified indicators (see Appendix 2). A series of secondary prescribing related outcome measure were pre-specified to allow a more in depth analysis of the effect of the intervention on prescribing. These were:</p> <ul> <li>The number of medicines stopped and started</li> <li>The proportion of patients with a reduction in significant polypharmacy (defined as ≥15 repeat medicines)</li> <li>The number of PIP</li> <li>The proportion of patients with a high risk PIP (see Appendix 2)</li> <li>The proportion of patients with any reduction in PIP</li> </ul> <p>Secondary patient reported outcomes measures were included to capture the effectiveness of the intervention from the patients’ perspective. These were:</p> <ul> <li>Health related Quality of life (EQ5D-5L)(24)</li> <li>Revised Patients' attitudes towards deprescribing (rPATD) (25)</li> <li>Multimorbidity Treatment Burden Questionnaire (MTBQ) (26)</li> </ul> <p>Health care utilisation data was collected to assess the effect of the intervention on health care usage and for the trial’s economic evaluation.</p> <p>Outcomes were collected at baseline and at six months after intervention delivery. Patient reported measures were collected by postal questionnaires. Data for all other measures including prescribed medicines, medical and investigations history and healthcare utilisation were collected by participating GPs and submitted to the study manager (CMC). This was a deviation from the original protocol, which indicated this data would be collected by the research team. This deviation related to changes in data protection and national health research regulations during the study period, which precluded research team access to the patients’ full clinical record.</p> <p><strong>Adverse events</strong></p> <p>Information on adverse events such as mortality, ED presentations and hospital admissions was collected at follow up. Given the deprescribing approach of the intervention a safety protocol for identifying and reporting any suspected adverse drug withdrawal events (ADWEs) was developed. An ADWE is defined as either recurrence of the condition for which the drug was prescribed (e.g. recurrence of angina after stopping a beta blocker) or a physiologic reaction to drug withdrawal (e.g. SSRI withdrawal syndrome) (27, 28). Although discontinuing medicines in older people has been demonstrated to be safe (29), given the paramount importance of the principle of “do no harm” in research ethics a vigorous and detailed method was established to ensure that any potential ADWEs precipitated by deprescribing in a SPPiRE medication review were captured. Intervention GPs were asked to report any possible ADWE following the SPPiRE medication review. The Naranjo ADR probability scale (30) has been adapted in other studies to assess the likelihood a reaction is related to drug withdrawal (27, 28). This tool was further adapted for SPPiRE and used to make an assessment on the causality of the ADWE. To ensure the patient perspective was included, self-reported possible ADWEs were also collected from patient follow up questionnaires. </p> <p> </p> <p><strong>Sample size</strong></p> <p>As outlined in the trial protocol (21), the study was designed with 90% power to detect a 20% reduction in the proportion with PIP and a mean difference of one medicine between intervention and control groups (based on a mean of 17.4 medicines SD (2.6)) and the sample size inflated to incorporate the effects of clustering (using an ICC of 0.025). The sample size was recalculated when it became apparent during early recruitment that it would not be possible to recruit clusters with an average of 15 participants, as was initially planned in the protocol. An average cluster size of eight was anticipated which inflated the original sample size from 30 practices (450 patients) to 50 practices (400 patients).</p> <p><strong>Statistical analysis</strong></p> <p>Descriptive statistics were used to describe baseline characteristics of recruited practices and participants. All analyses were conducted under the intention-to-treat principle and those lost to follow up had their baseline data carried forward. The primary analysis was carried out using multi-level modelling. The first primary outcome measure, number of repeat medications, was assessed using mixed effects Poisson regression with the individual as the unit of analysis and the practice included as the random effect to control for the effects of clustering and results presented using incidence rate ratios (IRR) and 95% confidence intervals (CI). The baseline number of medicines, GP size (number of GP sessions per week) and GP location (urban/rural) were included in the analysis as fixed effects. The second outcome measure, proportion of patients with a PIP, was analysed in a similar manner using mixed effects logistic regression, including PIP at baseline, GP size and location, and results presented using odd ratios (OR) and 95% CIs. A number of pre-specified sensitivity analyses were conducted; complete case analysis, per protocol analysis and including “presence of a repeat prescribing policy” as a covariate. All secondary outcomes were analysed in a similar manner to the primary outcomes, using appropriate mixed effects regression methods (i.e. linear, logistic, Poisson).</p> <p> </p> <p>Note: Version 3 (published 28 April 2025) updates Version 2 by removing Participant GP1P4 following consent withdrawal. This version should be used for all future analyses.</p> <p> </p>
: Enzobiotics –A Novel Therapy For Elimination Of Uremic Toxins In Ckd Patients (EETOX Study)–Multicentric Double-Blinded Randomised Controlled Trial
<p>Supplementary file for <strong>: </strong><strong>Enzobiotics –A Novel Therapy For </strong><strong>Elimination Of Uremic Toxins In Ckd Patients (EETOX Study)–Multicentric Double-Blinded Randomised Controlled Trial</strong></p>
Data from: Effect of information about the benefits and harms of mammography on women's decision making: the InforMa randomised controlled trial
<p>Background:</p> <p>In Spain, women invited to breast screening are not usually informed about potential harms of screening. The objective of the InforMa study is to assess the effect of receiving information about the benefits and harms of breast screening on informed choice and other decision making outcomes, in women approaching the age of invitation to mammography screening.</p> <p>Methods:</p> <p>Two-stage randomised controlled trial. In the first stage, 40 elementary territorial units of the public healthcare system were selected and randomised to intervention or control. In the second stage, women aged 49-50 years were randomly obtained. The target sample size was 400 women. Women in the intervention arm received a decision aid (DA) with detailed information on the benefits and harms of screening. Women in the control arm received a standard leaflet that did not mention harms and recommended accepting the invitation to participate in the Breast Cancer Screening Program (BCSP). The primary outcome was informed choice, defined as adequate knowledge and intentions consistent with attitudes. Secondary outcomes included decisional conflict, worry about breast cancer, time perspective, opinions about the DA, and participation in the BCSP.</p> <p>Results:</p> <p>In the intervention group, 23.2% of 203 women made an informed choice compared to only 0.5% of 197 women in the control group (p < 0.001). Attitudes and intentions were similar in both study groups with a high frequency of women intending to be screened, 82.8% vs 82.2% (p=0.893). Decisional conflict was significantly lower in the intervention group. No differences were observed in confidence in the decision, anxiety, and participation in BCSP.</p> <p>Conclusions:</p> <p>Women in Spain lack knowledge on the benefits and harms of breast screening. Providing quantitative information on benefits and harms has produced a considerable increase on knowledge and informed choice, with a high acceptance of the informative materials.</p>
Replication data for: "Effectiveness of iso-inertial resistance training on eccentric and concentric power, physical performance, and risk of falls in physically active middle-older adults: a randomised controlled trial"
<p>Replication data for: "Effectiveness of iso-inertial resistance training on eccentric and concentric power, physical performance, and risk of falls in physically active middle-older adults: a randomised controlled trial"</p> <p>This folder contains 4 files:</p> <p>1) Database that contains the values for concentric and eccentric power measured with both iso-inertial and gravitational systems (Dataset_power.xlsx)</p> <p>2) Database that contains the values for the Short Physical Performance Battery (SPPB) and Get Up and Go (GUG) test (Dataset_SPPB_GUG.xlsx)</p> <p>3) R Software script used to analyse file 1 (Iso-inertial analysis_power.R)<br> <br>4) R Software script used to analyse file 2 (Iso-inertial analysis_SPPB_GUG.R)</p>
Data from: Safety and efficacy of BCG re-vaccination in relation to COVID-19 morbidity in healthcare workers: A double-blind, randomised, controlled, phase 3 trial
<p>Morbidity and mortality attributable to COVID-19 is devastating global health systems and economies. Bacillus Calmette Guérin (BCG) vaccination has been in use for many decades to prevent severe forms of tuberculosis in children. Studies have also shown a combination of improved long-term innate or trained immunity (through epigenetic reprogramming of myeloid cells) and adaptive responses after BCG vaccination, which leads to non-specific protective effects in adults. Observational studies have shown that countries with routine BCG vaccination programs have significantly less reported cases and deaths of COVID-19, but such studies are prone to significant bias and need confirmation. To date, in the absence of direct evidence, WHO does not recommend BCG for the prevention of COVID-19. This project aims to investigate in a timely manner whether and why BCG-revaccination can reduce infection rate and/or disease severity in health care workers during the SARS-CoV-2 outbreak in South Africa. </p> <p>These objectives will be achieved with a blinded, randomised controlled trial of BCG revaccination versus placebo in exposed front-line staff in hospitals in Cape Town. Observations will include the rate of infection with COVID-19 as well as the occurrence of mild, moderate or severe ambulatory respiratory tract infections, hospitalisation, need for oxygen, mechanical ventilation or death. HIV-positive individuals will be excluded. Safety of the vaccines will be monitored. A secondary endpoint is the occurrence of latent or active tuberculosis. Initial sample size and follow-up duration is at least 500 workers and 52 weeks. Statistical analysis will be model-based and ongoing in real time with frequent interim analyses and optional increases of both sample size or observation time, based on the unforeseeable trajectory of the South African COVID-19 epidemic, available funds and recommendations of an independent data and safety monitoring board. The study will be supported by a novel 3D lung organoid model of SARS-CoV-2 infection system that can mimic the cascade of immunological events after SARS-CoV-2 infection to determine and analyse the contribution of cellular components to the impact of BCG revaccination in this study.</p> <p>Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with highly feasible endpoints that can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would lead to immediate dissemination of the results, vaccination of the control group and outreach to the health authorities to consider BCG vaccination for all qualifying health care workers.</p>
The upper airway volume effects produced by Hyrax, Hybrid-Hyrax and Keles Keyless expanders: a single-centre randomised controlled trial
<p>Datasets for all analyses in the paper.</p>
Randomised controlled trials in schools
<p><strong>Dr Martina Ferracane </strong>and <strong>Dr Fiammetta Menchetti</strong> presented on the open science best practice from the randomised controlled trial (RCT) conducted by seven doctoral and post-doctoral researchers from the European University Institute and University of Florence in 2021-2022. The RCT involved around 1000 students from different high schools in Italy with the objective to measure the impact of certain creative digital course on students’ interest in STEM and on certain skills including creativity and grit. The webinar focused first on the process implemented to data protection, including the protocol followed for data gathering and data processing with full respect of GDPR, and illustrated the steps needed for an objective and transparent data analysis. Finally, it showcased how the data will be made available for reproducibility.</p>
Data sets from "How amenable is type 2 diabetes treatment for precision diabetology? A meta-regression of glycaemic control data from 174 randomised trials"
<p>The two data sets (in CSV format) contain the complete infomation to reproduce the analyses from the paper "How amenable is type 2 diabetes treatment for precision diabetology? A meta-regression of glycaemic control data from 174 randomised trials" which will be published in Diabetologia.</p> <p>The data set "Data_LogSD.csv" contains the data for the primary analysis of the Log(SD) as given in the main paper, the data set "Data_LogSD_BL_CORR.csv" contains the data for the analysis of the baseline-corrected Log(SD) as given in the electronic supplementary material.</p>
Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial
ClinicalTrials.gov study NCT01638416. IPD Sharing: UNDECIDED. Countries: 5. Publications: 4.
Assessing the Efficacy of Enhanced Versus Standard 3D Training Models in Laparoscopic Skills Acquisition: A Randomised Controlled Trial
ClinicalTrials.gov study NCT06184854. IPD Sharing: YES. Countries: 1. Publications: 1.
The ENIGMA II Trial:Nitrous Oxide Anaesthesia and Cardiac Morbidity After Major Surgery: a Randomised Controlled Trial
ClinicalTrials.gov study NCT00430989. IPD Sharing: NO. Countries: 1. Publications: 5.
A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
ClinicalTrials.gov study NCT00696657. IPD Sharing: Not stated. Countries: 14. Publications: 1.
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These curated guides explain access requirements, typical timelines, costs, and reuse considerations for widely used research datasets.
Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.