scholarly journals Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e036799 ◽  
Author(s):  
David Blanco ◽  
Sara Schroter ◽  
Adrian Aldcroft ◽  
David Moher ◽  
Isabelle Boutron ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Review ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomised Trials ◽  
Randomised Controlled ◽  
The Impact ◽  
Completeness Of Reporting

ObjectiveTo evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.DesignRandomised controlled trial (RCT).SettingBMJ Open’s quality improvement programme.Participants24 manuscripts describing RCTs.InterventionsWe used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.OutcomesThe primary outcome is the number of adequately reported items (0–8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.ResultsManuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.ConclusionsWe demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.Trial registration numberNCT03751878.

scholarly journals Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Intellectual Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

scholarly journals Triaging and Referring In Adjacent General and Emergency Departments (the TRIAGE trial): a cluster randomised controlled trial

2021 ◽  
Author(s):  
Stefan Morreel ◽  
Hilde Philips ◽  
Diana De Graeve ◽  
Koenraad G Monsieurs ◽  
Jarl Kampen ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Predictive Values ◽  
Randomised Controlled

Objectives: To determine the effectiveness and safety of a tool diverting low urgency patients eligible for primary care from an emergency department (ED) to the adjacent general practitioner cooperative (GPC). Methods: Unblinded, randomised controlled trial with weekends serving as clusters (three intervention clusters for each control). The intervention was nurse-led triage using a new tool assigning patients to either ED or GPC. During intervention weekends, patients were encouraged to follow this assignment while it was not communicated to the patients during control weekends (they remained at the ED). The primary outcome was the proportion of patients assigned to and handled by the GPC during intervention weekends. The trial was randomised for the secondary outcome: the proportion of patients assigned to the GPC during intervention and control weekends. Additional outcomes were association of these outcomes with possible confounders (study tool parameters, nurse, and patient characteristics), proportion of patients referred back to the ED by the GPC, hospitalisations, and performance of the study tool to detect primary care eligible patients (with the opinion of the treating physician as the gold standard). Results: In the intervention group, 838/6374 patients (13.3%, 95% CI 12.5 to 14.2) were assigned to the GPC (secondary outcome), in the control group 431/1744 (24.7%, 95% CI 22.7 to 26.8). In the intervention group, 599/6374 patients (9.5%, 95% CI 8.8 to 10.3) experienced the primary outcome which was influenced by the chosen MTS presentational flowchart, patient's age, and the nurse. 24/599 patients (4.0%, 95% CI 2.7 to 5.9) patients were referred back to the ED of which three were hospitalised. Positive and negative predictive values of the studied tool during intervention weekends were 0.96 (95%CI 0.94 to 0.97) and 0.60 (95% CI 0.58 to 0.62). Out of the patients assigned to the GPC, 2.4% (95% CI 1.7 to 3.4) were hospitalised. Conclusions: ED nurses using a new tool safely diverted 9.5% of the included patients to primary care. ClinicalTrials.gov Identifier: NCT03793972 Funding: Research Foundation, Flanders (FWO)

scholarly journals Using laxatives and/or enemas to accelerate the diagnosis in children presenting with acute abdominal pain: a randomised controlled trial study protocol

2018 ◽  
Vol 2 (1) ◽  
pp. e000341
Author(s):  
Marjolijn E W Timmerman ◽  
Monika Trzpis ◽  
Paul M A Broens
Keyword(s):  
Abdominal Pain ◽  
Randomised Controlled Trial ◽  
Acute Appendicitis ◽  
Acute Abdominal Pain ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Adequate Treatment ◽  
Randomised Controlled

IntroductionMany children with acute abdominal pain and suspicion of appendicitis are diagnosed with constipation. Nevertheless, it can be difficult to differentiate between acute constipation and acute appendicitis because of similar symptoms and lack of diagnostic criteria. Consequently, constipation is often missed despite repeated consultations at the emergency department. We hypothesise that the diagnostic process can be improved and adequate treatment accelerated by supporting faecal evacuation in children with acute abdominal pain.Methods and analysisAn unblinded randomised controlled trial including children aged between 5 years and 18 years with acute abdominal pain and suspicion of acute appendicitis. Children who do not have a definitive diagnosis after the first consultation and who need to return for a second consultation will be randomised. The intervention group will receive laxatives and enemas, while the control group will receive no medication. If, after the second consultation, still no diagnosis is established, and a third consultation is needed, then the intervention group will receive only laxatives, and the control group will again not receive medication. The primary outcome will be the differences in abdominal pain scores obtained with FACES Pain Rating Scale and the visual analogue scale at first, second and possibly third consultation. The secondary outcome will be the number of consultations needed to reach final diagnosis.Ethics and disseminationLaxatives and enemas have proven to be safe and effective treatments for constipation in children. Adverse events are therefore not expected, however, should they occur, then the child concerned shall be properly followed and treated until the event is over. The local Medical Research Ethics Committee approved of this study and waived the otherwise mandatory insurance for human test subjects.Trial registration numbersPre-results: CCMO NL44710.042.12 andEudraCT 2013-000498-56.

scholarly journals Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e033842 ◽  
Author(s):  
Xiaochang Zhang ◽  
Xiao Hu ◽  
Jixiang Ma ◽  
Puhong Zhang ◽  
Yuan Li ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Salt Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Cluster Randomised ◽  
The Difference ◽  
Randomised Controlled

IntroductionSalt intake in China is twice the upper limit recommended by the WHO, and nearly 80% of salt is added during cooking. This study will develop a package of salt reduction interventions targeting home cooks and evaluate its effectiveness and feasibility for scale-up.Methods and analysisA cluster randomised controlled trial design is adopted in this study, which will be conducted in six provinces covering northern, central and southern China. For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member) will be selected in each cluster for evaluation. In total, 780 home cooks and 780 adult family members will be recruited. The home cooks in the intervention group will be provided with the intervention package, including community-based standardised offline and online health education and salt intake monitoring. The duration of the intervention will be 1 year. The primary outcome is the difference between the intervention and control group in change in salt intake as measured by 24 hours urinary sodium from baseline to the end of the trial. The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).Ethics and disseminationThe study has been approved by The Queen Mary Research Ethics Committee (QMERC2018/13) and Institutional Review Board of the Chinese Center for Disease Control and Prevention (No. 201801). The study findings will be disseminated widely through conference presentations and peer-reviewed publications and the general media.Trial registration numberChiCTR1800016804.

scholarly journals Impact of Compression Therapy on Cellulitis (ICTOC) in adults with chronic oedema: a randomised controlled trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029225 ◽  
Author(s):  
Elizabeth Webb ◽  
Teresa Neeman ◽  
Jamie Gaida ◽  
Francis J Bowden ◽  
Virginia Mumford ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Lower Limb ◽  
Controlled Trial ◽  
Intervention Group ◽  
Prophylactic Antibiotic ◽  
Compression Therapy ◽  
Control Group ◽  
Supporting Evidence ◽  
Randomised Controlled ◽  
The Impact

IntroductionCellulitis represents a significant burden to patients’ quality of life (QOL) and cost to the healthcare system, especially due to its recurrent nature. Chronic oedema is a strong risk factor for both an initial episode of cellulitis and cellulitis recurrence. Expert consensus advises compression therapy to prevent cellulitis recurrence in individuals with chronic oedema, however, there is little supporting evidence. This research aims to determine if the management of chronic oedema using compression therapy effectively delays the recurrence of lower limb cellulitis.Methods and analysisA randomised controlled trial with cross-over will be used to assess the impact of compression therapy on clinical outcomes (time to next episode of cellulitis, rate of cellulitis-related hospital presentations, QOL and leg volume). Using concealed allocation, 162 participants will be randomised into the intervention (compression) or control (no compression) group. Randomisation will be stratified by prophylactic antibiotic use. Participants will be followed up at 6 monthly intervals for up to 3 years or until 45 episodes of cellulitis occur across the cohort. Following an episode of recurrent cellulitis, control group participants will cross-over to the intervention group. Survival analysis will be undertaken to assess the primary outcome measure of time to cellulitis recurrence. The hypotheses are that compression therapy to control lower limb chronic oedema will delay recurrent lower limb cellulitis, reduce the rate of associated hospitalisations, minimise affected limb volume and improve the QOL of this population.Ethics and disseminationEthics approval has been obtained from the ethics committees of all relevant institutions. Results will be disseminated through relevant peer-reviewed journal articles and conference presentations.Trial registration numberACTRN12617000412336; Pre-results. The ICTOC trial is currently in progress. Participant recruitment started in May 2017 and is expected to continue until December 2019.

scholarly journals Triaging and referring in adjacent general and emergency departments (the TRIAGE trial): A cluster randomised controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0258561
Author(s):  
Stefan Morreel ◽  
Hilde Philips ◽  
Diana De Graeve ◽  
Koenraad G. Monsieurs ◽  
Jarl K. Kampen ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Triage System ◽  
Predictive Values ◽  
Randomised Controlled

Objectives To determine whether a new triage system safely diverts a proportion of emergency department (ED) patients to a general practitioner cooperative (GPC). Methods Unblinded randomised controlled trial with weekends serving as clusters (three intervention clusters for each control). The intervention was triage by a nurse using a new extension to the Manchester Triage System assigning low-risk patients to the GPC. During intervention weekends, patients were encouraged to follow this assignment; it was not communicated during control weekends (all patients remained at the ED). The primary outcome was the proportion of patients assigned to and handled by the GPC during intervention weekends. The trial was randomised for the secondary outcome: the proportion of patients assigned to the GPC. Additional outcomes were association of these outcomes with possible confounders (study tool parameters, nurse, and patient characteristics), proportion of patients referred back to the ED by the GPC, hospitalisations, and performance of the study tool to detect primary care patients (the opinion of the treating physician was the gold standard). Results In the intervention group, 838/6294 patients (13.3%, 95% CI 12.5 to 14.2) were assigned to the GPC, in the control group this was 431/1744 (24.7%, 95% CI 22.7 to 26.8). In total, 599/6294 patients (9.5%, 95% CI 8.8 to 10.3) experienced the primary outcome which was influenced by the reason for encounter, age, and the nurse. 24/599 patients (4.0%, 95% CI 2.7 to 5.9) were referred back to the ED, three were hospitalised. Positive and negative predictive values of the studied tool during intervention weekends were 0.96 (95%CI 0.94 to 0.97) and 0.60 (95% CI 0.58 to 0.62). Out of the patients assigned to the GPC, 2.4% (95% CI 1.7 to 3.4) were hospitalised. Conclusions ED nurses using a new tool safely diverted 9.5% of the included patients to primary care. Trial registration ClinicalTrials.gov Identifier: NCT03793972

scholarly journals Slip-resistant footwear reduces slips among National Health Service workers in England: a randomised controlled trial

2021 ◽  
pp. oemed-2020-106914 ◽  
Author(s):  
Sarah Cockayne ◽  
Caroline Fairhurst ◽  
Gillian Frost ◽  
Mark Liddle ◽  
Rachel Cunningham-Burley ◽  
...  
Keyword(s):  
National Health Service ◽  
Randomised Controlled Trial ◽  
Health Service ◽  
Incidence Rate ◽  
National Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomised Controlled

ObjectivesAssess the effectiveness of 5* GRIP-rated slip-resistant footwear in preventing slips in the workplace compared to usual footwear (control group).MethodsA multicentre, randomised controlled trial; 4553 National Health Service (NHS) staff were randomised 1:1 to the intervention group (provided with 5* GRIP-rated slip-resistant footwear) or the control group. The primary outcome of incidence rate of self-reported slips in the workplace over 14 weeks was analysed using a mixed-effects negative binomial model. Secondary outcome measures included incidence rate of falls from a slip, falls not from a slip, proportion of participants reporting a slip, fall or fracture and time to first slip and fall.Results6743 slips were reported: 2633 in the intervention group (mean 1.16 per participant, range 0 to 36) and 4110 in the control group (mean 1.80 per participant, range 0 to 83). There was a statistically significant reduction in slip rate in the intervention group relative to the control group (incidence rate ratio (IRR) 0.63, 95% CI 0.57 to 0.70, p<0.001). Statistically significant differences, in favour of the intervention group, were observed in falls from a slip (IRR 0.51, 95% CI 0.28 to 0.92, p=0.03), the proportion of participants who reported a slip (OR 0.58, 95% CI 0.50 to 0.66, p<0.001) or fall (OR 0.73, 95% CI 0.54 to 0.99, p=0.04) and time to first slip (HR 0.73, 95% CI 0.67 to 0.80, p<0.001).ConclusionsThe offer and provision of 5* GRIP-rated footwear reduced slips in NHS staff in the workplace.Trial registration numberISRCTN33051393.

scholarly journals Effects of training on quality of peer review: randomised controlled trial

BMJ ◽  
2004 ◽  
Vol 328 (7441) ◽  
pp. 673 ◽  
Author(s):  
Sara Schroter ◽  
Nick Black ◽  
Stephen Evans ◽  
James Carpenter ◽  
Fiona Godlee ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Review ◽  
Controlled Trial ◽  
Control Group ◽  
Group Score ◽  
The Difference ◽  
Randomised Controlled ◽  
Quality Instrument

AbstractObjective To determine the effects of training on the quality of peer review.Design Single blind randomised controlled trial with two intervention groups receiving different types of training plus a control group.Setting and participants Reviewers at a general medical journal.Interventions Attendance at a training workshop or reception of a self taught training package focusing on what editors want from reviewers and how to critically appraise randomised controlled trials.Main outcome measures Quality of reviews of three manuscripts sent to reviewers at four to six monthly intervals, evaluated using the validated review quality instrument; number of deliberate major errors identified; time taken to review the manuscripts; proportion recommending rejection of the manuscripts.Results Reviewers in the self taught group scored higher in review quality after training than did the control group (score 2.85 v 2.56; difference 0.29, 95% confidence interval 0.14 to 0.44; P = 0.001), but the difference was not of editorial significance and was not maintained in the long term. Both intervention groups identified significantly more major errors after training than did the control group (3.14 and 2.96 v 2.13; P < 0.001), and this remained significant after the reviewers' performance at baseline assessment was taken into account. The evidence for benefit of training was no longer apparent on further testing six months after the interventions. Training had no impact on the time taken to review the papers but was associated with an increased likelihood of recommending rejection (92% and 84% v 76%; P = 0.002).Conclusions Short training packages have only a slight impact on the quality of peer review. The value of longer interventions needs to be assessed.

Effects of golf training on cognition in older adults: a randomised controlled trial

2018 ◽  
Vol 72 (10) ◽  
pp. 944-950 ◽  
Author(s):  
Hiroyuki Shimada ◽  
Sangyoon Lee ◽  
Masahiro Akishita ◽  
Koichi Kozaki ◽  
Katsuya Iijima ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Training Group ◽  
Community Dwelling ◽  
Secondary Outcome ◽  
Control Group ◽  
Logical Memory ◽  
Randomised Controlled

BackgroundAlthough research indicates that a physically active lifestyle has the potential to prevent cognitive decline and dementia, the optimal type of physical activity/exercise remains unclear. The present study aimed to determine the cognitive benefits of a golf-training programme in community-dwelling older adults.MethodsWe conducted a randomised controlled trial between August 2016 and June 2017 at a general golf course. Participants included 106 Japanese adults aged 65 and older. Participants were randomly assigned to either a 24-week (90–120 min sessions/week) golf-training group or a health education control group. Postintervention changes in Mini-mental State Examination (MMSE) and National Centre for Geriatrics and Gerontology-Functional Assessment Tool scores were regarded as primary outcome measures. Secondary outcome measures included changes in physical performance and Geriatric Depression Scale (GDS) scores.ResultsA total of 100 participants (golf training, n=53; control, n=47) completed the assessments after the 24-week intervention period. The adherence to the golf programme was 96.2% (51/53 participants). Analysis using linear mixed models revealed that the golf training group exhibited significantly greater improvements in immediate logical memory (p=0.033), delayed logical memory (p=0.009) and composite logical memory (p=0.013) scores than the control group. However, no significant changes in MMSE, word memory, Trail Making Test or Symbol Digital Substitution Test scores were observed. In addition, no significant changes in grip strength, walking speed or GDS were observed.ConclusionsGolf-based exercise interventions may improve logical memory in older adults, but no significant changes in other cognitive tests. Further follow-up investigations are required to determine whether the observed effects are associated with delayed onset of mild cognitive impairment or Alzheimer’s disease in older adults.Trial registration numberUMIN-CTR UMIN000024797; Pre-results.

scholarly journals Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e032799 ◽  
Author(s):  
Titus Beyuo ◽  
Emma Lawrence ◽  
Elizabeth S Langen ◽  
Samuel A Oppong
Keyword(s):  
Randomised Controlled Trial ◽  
Health Outcomes ◽  
Magnesium Sulfate ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
University Of Michigan ◽  
Clinical Trial Registry ◽  
Randomised Controlled ◽  
Study Participants

IntroductionHypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysisThis study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and disseminationEthical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration numberPan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).

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