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

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

Journal of Epidemiology & Community Health ◽

10.1136/jech-2017-210052 ◽

2018 ◽

Vol 72 (10) ◽

pp. 944-950 ◽

Cited By ~ 5

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.

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Does tension applied in kinesio taping affect pain or function in older women with knee osteoarthritis? A randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-041121 ◽

2020 ◽

Vol 10 (12) ◽

pp. e041121

Author(s):

Yago Tavares Pinheiro ◽

Germanna Medeiros Barbosa ◽

Hilmaynne Renaly Fonseca Fialho ◽

César Augusto Medeiros Silva ◽

Jaciara de Oliveira Anunciação ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Knee Osteoarthritis ◽

Older Women ◽

Controlled Trial ◽

Secondary Outcome ◽

Group Differences ◽

Control Group ◽

Kinesio Taping ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectiveTo analyse the short-term effects of kinesio taping (KT) with tension (KTT) or without tension (KTNT) in older women with knee osteoarthritis (KOA), and compare them to controls who did not receive KT.DesignRandomised controlled trial.SettingUniversity physiotherapy school clinic.ParticipantsForty-five older women (fifteen participants per group) with 66.8 (±5.6) years and clinical diagnosis of KOA were assessed pre, post and 3 days after intervention.InterventionsParticipants were randomly allocated to KTT, who received two simultaneous applications of KT with tension on the knee and rectus femoris; KTNT, who received the same application as the KTT group, but without tension and a control group that attended a class on KOA.Primary and secondary outcome measuresPrimary outcome was pain intensity and secondary outcomes were knee-related health status, functional capacity, muscle strength and global rating of change.ResultsNo between-group differences were observed in pain after the first intervention (KTT vs KTNT: mean difference (MD), −1.8 points; 95% CI −4.2 to 0.5; KTT vs control: MD, −1.2 points; 95% CI −3.6 to 1.2; KTNT vs control: MD, 0.66 points; 95% CI −1.7 to 3.0) or 3 days later (KTT vs KTNT: MD, −1.3 points; 95% CI −3.7 to 1.0; KTT vs control: MD, 0.13 points; 95% CI −2.2 to 2.5; KTNT vs control: MD, 1.4 points; 95% CI −0.9 to 3.8). The lack of between-group differences was also found for secondary outcomes.ConclusionThe short-term use of KT with or without tension in older woman with KOA had no beneficial effects on pain and function. These findings call into question the clinical use of KT as a non-pharmacological therapy for this population.Trial registration numberNCT03624075.

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Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study

BMJ Open ◽

10.1136/bmjopen-2017-019350 ◽

2018 ◽

Vol 8 (3) ◽

pp. e019350 ◽

Cited By ~ 1

Author(s):

Susanne van de Hei ◽

Steven McKinstry ◽

George Bardsley ◽

Mark Weatherall ◽

Richard Beasley ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Vitamin C ◽

Feasibility Study ◽

Common Cold ◽

Controlled Trial ◽

Secondary Outcome ◽

Pcr Analysis ◽

Control Group ◽

The Common ◽

Randomised Controlled

ObjectiveTo determine the feasibility of a randomised controlled trial (RCT) of rhinothermy for the common cold.DesignOpen label, randomised, controlled feasibility study.SettingSingle-centre research institute in New Zealand recruiting participants from the community.Participants30 adult participants with symptoms of a common cold, presenting within 48 hours of the onset of symptoms.InterventionsParticipants were randomly assigned 2:1 to receive either 35 L/min of 100% humidified air at 41°C via high flow nasal cannulae, 2 hours per day for up to 5 days (rhinothermy), or vitamin C 250 mg daily for 5 days (control).Primary and secondary outcome measuresThe primary outcome was the proportion of screened candidates who were randomised. Secondary outcomes included: proportion of randomised participants who completed the study; modified Jackson scores from randomisation to 10 days after initiation of randomised regimen; time until feeling ‘a lot better’ compared with study entry; time until resolution of symptoms or symptom score at 10 days postrandomisation; proportion of organisms identified by PCR analysis of nasal swabs taken at baseline; the patterns of use of the rhinothermy device; estimated adherence of the control group; and rhinothermy device tolerability.ResultsIn all 30/79 (38%, 95% CI 27% to 50%) of potential participants screened for eligibility were randomised. Rhinothermy was well tolerated, and all randomised participants completed the study (100%, 95% CI 88% to 100%). The reduction from baseline in the modified Jackson score was greater with rhinothermy compared with control at days 2, 3, 4, 5 and 6, with the maximum difference at day 4 (−6.4, 95% CI −9.4 to −3.3). The substantial clinical benefit threshold for modified Jackson score was a 5-unit change.ConclusionsThis study shows that an RCT of rhinothermy compared with low-dose vitamin C in the treatment of the common cold is feasible.Trial registration numberACTRN12616000470493; Results.

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Rehabilitation nursing for motor functional recovery of acute ischaemic stroke: study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-037391 ◽

2020 ◽

Vol 10 (9) ◽

pp. e037391

Author(s):

Jianmiao Wang ◽

Yuanyuan Chen ◽

Yuping Zhang ◽

Mei Li ◽

Jingfen Jin

Keyword(s):

Randomised Controlled Trial ◽

Ischaemic Stroke ◽

Outcome Measures ◽

Functional Recovery ◽

Acute Ischaemic Stroke ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Functional Impairments ◽

Randomised Controlled

IntroductionStroke is the second-leading cause of death and disability in the world, and patients with stroke often suffer from functional impairments and need rehabilitation. Notably, there is much evidence that rehabilitation can lead to better mortality and morbidity outcomes. The evidence for the effectiveness of rehabilitation nursing, however, is limited. Thus, this study seeks to explore whether rehabilitation nursing is not inferior to usual rehabilitation for motor functional recovery in patients with acute ischaemic stroke.Methods and analysisWe will conduct an assessor-blinded parallel randomised controlled trial of patients who meet the inclusion criteria after stratification by weighted corticospinal tract lesion load. The experimental group will receive rehabilitation nursing by trained and qualified nurses (seven consecutive days, two sessions per day, 30 min each session). The control group will receive usual rehabilitation provided by therapists (seven consecutive days, two sessions per day, 30 min each session). The primary outcome measures are the Motor Assessment Scale, the Fugl-Meyer Assessment and the Action Research Arm Test. The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale. Primary and secondary outcome assessment will be performed before and after the intervention, and secondary outcome be assessed at 4 and 12 weeks follow-up. We will recruit 224 patients within a period of 12–18 months from a hospital in southeastern China.Ethics and disseminationThe study was approved by the Human Research Ethics Committee from the corresponding author’s hospital (approval Number is Ethical Review Study No. 2018 - 112). Peer-reviewed journals and presentations at national and international conferences will be used to disseminate the results.Trial registration numberNCT03702452.

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

BMC Public Health ◽

10.1186/s12889-020-09878-w ◽

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.

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SOLACE: A Psychosocial Stigma Protection Intervention to Improve the Mental Health of Parents of Autistic Children—A Feasibility Randomised Controlled Trial

Journal of Autism and Developmental Disorders ◽

10.1007/s10803-020-04498-0 ◽

2020 ◽

Vol 50 (12) ◽

pp. 4477-4491 ◽

Cited By ~ 1

Author(s):

Annemarie Lodder ◽

Chris Papadopoulos ◽

Gurch Randhawa

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Feasibility Trial ◽

Secondary Outcome ◽

Control Group ◽

Autistic Children ◽

Self Compassion ◽

Group Interviews ◽

Randomised Controlled

AbstractThis study presents findings from a feasibility trial, testing an 8-week psychosocial stigma protection intervention (SOLACE) designed to improve the mental health of parents of autistic children. Seventeen parents were stratified then randomly assigned to either SOLACE (n = 9) or control group (n = 8). Retention and adherence rates were excellent with minimal missing data suggesting SOLACE had good acceptability and feasibility. Quantitative analysis revealed that mental health scores had significantly improved for those who took part in SOLACE compared to no significant changes for control group participants. In addition, changes in secondary outcome measures (e.g. stigma, self-esteem and self-compassion) were in favour of SOLACE. Focus group interviews revealed that SOLACE was acceptable to parents. Results suggest that a full randomised controlled trial is warranted.

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

10.1101/2021.08.16.21261782 ◽

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)

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

BMJ Open ◽

10.1136/bmjopen-2020-036799 ◽

2020 ◽

Vol 10 (5) ◽

pp. e036799 ◽

Cited By ~ 1

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.

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Prospective economic evaluation of an electronic discharge communication tool: analysis of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-019139 ◽

2017 ◽

Vol 7 (12) ◽

pp. e019139 ◽

Cited By ~ 3

Author(s):

Laura K Sevick ◽

Maria-Jose Santana ◽

William A Ghali ◽

Fiona Clement

Keyword(s):

Economic Evaluation ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Communication Tool ◽

Randomised Controlled ◽

The Cost ◽

Discharge Communication

ObjectiveTo complete an economic evaluation within a randomised controlled trial (RCT) comparing the use of an electronic discharge communication tool (eDCT) compared with usual care.SettingPatients being discharged from a single tertiary care centre’s internal medicine Medical Teaching Units.ParticipantsBetween January 2012 and December 2013, 1399 patients were randomised to a discharge mechanism. Forty-five patients were excluded from the economic evaluation as they did not have data for the index hospitalisation cost; 1354 patients contributed to the economic evaluation.InterventioneDCT generated at discharge containing structured content on reason for admission, details of the hospital stay, treatments received and follow-up care required. The control group was discharged via traditional dictation methods.Primary and secondary outcome measuresThe primary economic outcome was the cost per quality-adjusted life year (QALY) gained. Secondary outcomes included the cost per death avoided and the cost per readmission avoided.ResultsThe average transcription cost was $C22.28 per patient, whereas the estimated cost of the eDCT was $C13.33 per patient. The cost per QALY gained was $C239 933 in the eDCT arm compared with usual care due to the very small gains in effectiveness and approximately $C800difference in resource utilisation costs. The bootstrap analyses resulted in eDCT being more effective and more costly in 29.2% of samples, less costly and more effective in 29.2% of samples, less effective and more costly in 23.9% of samples and finally, less costly and less effective in 17.7% of samples.ConclusionsThe eDCT reduced per patient costs of the generation of discharge summaries. The bootstrap estimates demonstrate considerable uncertainty supporting the finding of neutrality reported in the clinical component of the RCT. The immediate transcription cost savings and previously documented provider and patient satisfaction may increase the impetus for organisations to invest in such systems, provided they have a foundation of eHealth infrastructure and readiness.Trial registration numberNCT01402609.

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

BMJ Paediatrics Open ◽

10.1136/bmjpo-2018-000341 ◽

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.

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