DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary care by Stefan Neuner-Jehle, Katharina Tabea Jungo, Sven Streit, Sven Trelle, Nicolas Rodondi, Carole Elodie Aubert, Kristie Rebecca Weir, Enriqueta Vallejo-Yagüe, Samantha Chan, Marie Roumet, Pascal Juillerat, Sofia Carolina Zambrano Ramos, Jennifer Inauen, Angela Edith Schulthess-Lisibach, Renata Vidonscky Lüthold, Clémentine Tombez, Martina Zangger, Flurina Jenal, Yvonne Mattmann, Christof Bieri, Michaela Barbier

“…This protocol describes a study to evaluate the effectiveness of a PPI deprescribing intervention in comparison to usual care in the Swiss primary care setting.Design An open-label, cluster randomised controlled trial.Setting Swiss primary care settings.Participants Included participants will be adults with inappropriate PPI treatment and will be recruited by general practitioners (GPs). …”
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Tailored exercise and manual therapy versus standardised exercise for patients with shoulder subacromial pain: a feasibility randomised controlled trial (the Otago MASTER trial) by J Haxby Abbott, Daniel C Ribeiro, Zohreh Jafarian Tangrood, Gisela Sole, Ross Wilson

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Effects of manual osteopathic interventions on psychometric and psychophysiological indicators of anxiety, depression and stress in adults: a systematic review and meta-analysis of randomised controlled trials by Darren J Edwards, Jerry Draper-Rodi, Danny Miller, Josh Hope-Bell, Andrew MacMillan, Tom C Gordon

“…Objectives To evaluate whether osteopathic and related manual interventions improve adult mental health (depression, anxiety, stress) and psychophysiological measures (eg, heart rate variability, skin conductance).Design Systematic review and meta-analysis of randomised controlled trials (RCTs).Data sources PubMed, MEDLINE (Ovid), Scopus, Cochrane, and AMED, searched through September 2024.Eligibility criteria English-language RCTs with ≥30 participants investigating osteopathic or related manual therapies (eg, myofascial release, high-velocity low-amplitude thrusts) delivered by qualified practitioners, compared with no treatment or sham, and reporting immediate postintervention mental health or psychophysiological outcomes.Data extraction and synthesis Full-text screening, risk-of-bias assessment and data extraction were conducted independently by multiple reviewers using a standardised Joanna Briggs Institute (JBI) Extraction Form. …”
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Effects of a social participation-focused virtual reality intervention for community-dwelling stroke survivors with physical disabilities: a randomised controlled trial protocol by Janita Pak Chun Chau, Suzanne Hoi Shan Lo, Vivian Wing Yan Lee, Kai Chow Choi, Alexander Yuk Lun Lau, David R Thompson, Eddie Chi Fai Kwok

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Peripherally inserted central catheters versus implanted port catheters in patients with breast cancer: a post hoc analysis of the PICCPORT randomised controlled trial by Anton Utas, Stefanie Seifert, Knut Taxbro

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Laparoscopic Versus Robotic Ventral Hernia Repair With Intraperitoneal Mesh: A Systematic Review and Meta-Analysis Comparing the Perioperative Outcomes Randomised Controlled Trials by Anurag Singh, Wei H. Toh, Nada Elzahed, Goldie Khera, Mirza K. Baig, Andrei Mihailescu, Muhammad S. Sajid

“…ObjectiveThe objective of this meta-analysis is to compare the perioperative surgical outcomes and cost-effectiveness of robotic ventral hernia repair (RVHR) versus laparoscopic ventral hernia repair (LVHR) with intraperitoneal mesh.MethodsRandomised control trials (RCTs) reporting perioperative outcomes and costs in patients undergoing RVHR versus LVHR were selected from medical electronic databases and meta-analysis was conducted in accordance with the guidelines of the Cochrane Collaboration using statistical software RevMan version 5.ResultsFour RCTs on 337 patients reporting perioperative outcomes and cost comparison were included. …”
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Qualitative evaluation of the Rehabilitation Exercise and psycholoGical support After COVID-19 InfectioN (REGAIN) randomised controlled trial (RCT): ‘you are not alone’ by Gordon McGregor, Susanne Finnegan, Martin Underwood, Joyce Yeung, James Mason, Peter Heine, Nigel Edwards, Julie Bruce, Kate Seers, Harbinder Kaur Sandhu, Helen Atherton, Sharisse Alleyne, Katie Booth, Ranjit Lall, Vivien P Nichols, Stuart Ennis, Scott McGuire, Rachel Potter, Jessica Smith, Chen Ji, Shilpa Patel, Henry Nwankwo, Kate Evans, Susie Hennings, Alastair Canaway, Grace Lobley, David Mcwilliams, Christina Jones, Emma Padfield, David Montgomery, Beatriz Lara, Becky Haley, Francesca Denton, Bartholomew Sheehan, Mariam Ratna, Elaine Fairbrother, Zoe Noakes, Bogdan Zutic, Lee Austin, Tom Forsyth, Anne Bush, Alan Bush, Patrick Sawdon, Jonathon Prosser, Lee Tompkins, Jonathon Guck, Danielle Hale, Juwairia Said, Georgie Ray, Rowena Williams, Gail Evans, Thillini Hettiarachchi, Abeesh Panicker

“…Background This qualitative evaluation was embedded in the Rehabilitation Exercise and psycholoGical support After COVID-19 InfectioN (REGAIN) study, a randomised controlled trial (RCT) for those with post-COVID-19 condition (‘long COVID’) after hospital admission for COVID-19, comparing weekly home-based, live online supervised group exercise and psychological support sessions with ‘best practice usual care’ (a single session of advice).Objective To increase our understanding of how and why the REGAIN programme might have worked and what helped or hindered this intervention.Design A qualitative evaluation which utilised interviews with participants and practitioners delivering the intervention. …”
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Economic evaluation of tranexamic acid for the treatment of acute gastrointestinal bleeding: a cost-effectiveness analysis using data from the HALT-IT randomised controlled trial by Ian Roberts, Vipul Jairath, Alec Miners, Jack Williams, Haleema Shakur-Still, Nuha Bazeer

“…Objective To perform an economic evaluation of tranexamic acid (TXA) versus no-TXA, in addition to current clinical practice, for acute gastrointestinal bleeding, using the results of the HALT-IT trial (NCT01658124), a large randomised controlled trial which included 11 937 patients.Design A cost-effectiveness modelling analysis, performed over a lifetime time horizon.Setting The analysis was performed from a UK health service perspective.Participants The model includes adults with acute gastrointestinal bleeding.Outcomes measures The model reports costs in Great British pounds in 2021 and outcomes as life years (LYs) and quality-adjusted life years (QALYs). …”
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Effectiveness of a personalised self-management intervention for people living with long covid (Listen trial): pragmatic, multicentre, parallel group, randomised controlled trial by Fiona Jones, Nick Sevdalis, Adrian Edwards, Bernadette Sewell, Monica Busse, Philip Pallmann, Rachel Lowe, Shaun Harris, Aloysius Niroshan Siriwardena, Jessica Fish, Claire Potter, Muhammad Riaz, Fiona J Leggat, Andrea Jane Longman, Jackie McRae

“…Objective To evaluate the effectiveness of Listen, a self-management support intervention, for people living with long covid who were not in hospital.Design Pragmatic, multicentre, parallel group, randomised controlled trial.Setting Twenty four sites in England and Wales.Participants Identified from long covid clinic waiting lists, word of mouth, and adverts/social media self-referred to the trial, 554 adults with long covid were randomised to receive either the Listen trial intervention or NHS usual care.Interventions The Listen intervention involved up to six one-to-one personalised sessions with trained healthcare practitioners and an accompanying handbook co-designed by people with lived experience and health professionals. …”
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Impact of early versus late artificial rupture of membranes during oxytocin induction of labour on the incidence of chorioamnionitis: a randomised controlled trial (ARM trial) by Meghan G. Hill, Michelle R. Wise, Emmanuelle Pauleau, Beatrice Treadwell, Lynn Sadler

“…Methods This is a randomised controlled trial at a single centre in New Zealand. …”
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Effects of inulin-type fructans supplementation on cardiovascular disease risk factors: a protocol for a systematic review and meta-analysis of randomised controlled trials by Russell J de Souza, Lawrence Mbuagbaw, John L Sievenpiper, Dena Zeraatkar, Laura Banfield, Vanessa Ha, David J A Jenkins, Jhalok Ronjan Talukdar, Matthew Adam Cooper, Lyuba Lyutvyn, Rahim Ali, Rachel Bierbrier, Sabrina Janes, Pauline B Darling

“…Introduction This review aims to assess the effects of dietary supplementation with inulin-type fructans (ITF) compared with no supplementation on cardiovascular disease risk factors in adults and assess the quality of trial reporting using the Consolidated Standards of Reporting Trials (CONSORT) and CONSORT for abstract (CONSORT-A) checklists.Methods and analysis We will search randomised controlled trials (RCTs) in MEDLINE, EMBASE, CINAHL, Emcare, AMED and the Cochrane Database of Systematic Reviews from inception to 31 March 2022, without any language restrictions. …”
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Duration of External Neck Stabilisation (DENS) following odontoid fracture in older or frail adults: protocol for a randomised controlled trial of collar versus no collar by John Norrie, Julie Woodfield, David J Lowe, Paul M Brennan, Catriona Keerie, Julia Lawton, Matthew J Reed, Andrew Stoddart, Julia Boyd, Helen Eborall, Gina Cranswick, James Tomlinson, Polly L Black, Sadaquate Khan, Patrick Statham, Ellie Edlmann, Phillip Correia Copley, Angela Niven, Susan Deborah Shenkin

“…We hypothesise that management with no immobilisation may be superior to management in a hard collar for older or frail adults with odontoid fractures.Methods and analyses This is the protocol for the Duration of External Neck Stabilisation (DENS) trial—a non-blinded randomised controlled trial comparing management in a hard collar with management without a collar for older (≥65 years) or frail (Rockwood Clinical Frailty Scale ≥5) adults with a new odontoid fracture. 887 neurologically intact participants with any odontoid process fracture type will be randomised to continuing with a hard collar (standard care) or removal of the collar (intervention). …”
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Cluster randomised controlled trial of screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the pilot study for the SAFER trial by Martin R Cowie, Stephen Morris, Gregory Lip, Richard J McManus, Stephen Sutton, Jonathan Mant, Simon J Griffin, Sarah Hoare, Jenni Burt, Rachel Johnson, Mark Lown, Alison Powell, Natalie Armstrong, FD Richard Hobbs, Trudie Lobban, Rakesh Narendra Modi, Ben Freedman, David A Fitzmaurice, Stephen Kaptoge, Jenny Lund, Duncan Edwards, Kate Williams, H Thom, Francesco Fusco, Michael J Sweeting, Andrew Dymond, The SAFER Authorship Group

“…The aim of the pilot study is to assess feasibility of the main trial and inform implementation of screening and trial procedures.Methods and analysis SAFER is planned to be a pragmatic randomised controlled trial (RCT) of over 100 000 participants aged 70 years and over, not on long-term anticoagulation therapy at baseline, with an average follow-up of 5 years. …”
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Effectiveness of physical activity interventions on reducing perceived fatigue among adults with chronic conditions: a systematic review and meta-analysis of randomised controlled trials by Ioulia Barakou, Kandianos Emmanouil Sakalidis, Ulric Sena Abonie, Tracy Finch, Katie L. Hackett, Florentina Johanna Hettinga

“…This systematic review and meta-analysis aimed to (1) synthesise evidence from randomised controlled trials (RCTs) exploring the effects of physical activity interventions on fatigue reduction and (2) evaluate their effectiveness. …”
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A randomised controlled trial to compare the occurrence of postoperative nausea and vomiting in early versus conventional feeding in children undergoing daycare surgery under general anaesthesia by Ranju Singh, H Santoshkumar Huligeri, Pooja Singh

“…Methods: A randomised controlled trial was conducted in 300 children undergoing daycare surgery under general anaesthesia. …”
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How does a social norms-based intervention affect behaviour change? Interim findings from a cluster randomised controlled trial in Odisha, India by Hagere Yilma, Erica Sedlander, Satyanarayan Mohanty, Ichhya Pant, Jeffrey Bingenheimer, Lipika Patro, Rohini Ganjoo, Rajiv Rimal

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Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial protocol by Danielle Mazza, Angela Taft, Kevin McGeechan, Kirsten Black, Heather McKay, Marion Haas, Jayne Lucke, Jeffery F Peipert

“…This protocol paper describes the Australian Contraceptive ChOice pRojet (ACCORd), a cluster randomised control trial that aims to test whether an educational intervention targeting general practitioners (GPs) and establishing a rapid referral service are a cost-effective means of increasing LARC uptake.Methods and analysis The ACCORd intervention is adapted from the successful US Contraceptive CHOICE study and involves training GPs to provide ‘LARC First’ structured contraceptive counselling to women seeking contraception, and implementing rapid referral pathways for LARC insertion. …”
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Vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment: study protocol for a prospective randomised controlled trial by Xun Xu, Tianwei Qian, Hao Zhou, Weijun Wang, Ying Fan, Lin Xue, Xia Wu, Qiaoyun Gong, Luyao Ye

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Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial by Harald Baumeister, Michael Witthöft, Eileen Bendig, Severin Hennemann, Katja Böhme, Maria Kleinstäuber, David Daniel Ebert

“…The planned study aims to investigate the feasibility and efficacy of an internet-based intervention in reducing somatic and psychological symptoms in an international population of university students with somatic symptom burden.Methods and analysis This parallel two-armed randomised controlled trial evaluates an 8-week guided intervention, including web-based consecutive modules based on cognitive behavioural therapy (CBT) principles against a waitlist control group. …”
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Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England? by Jeremy Horwood, Alastair D Hay, Patricia Jane Lucas, Clare Clement, Peter S Blair, Jodi Taylor, Christie Cabral, Martin C Gulliford, Jenny Ingram, Padraig Dixon, Nick Francis, Athene Lane, Grace Young, Elizabeth Beech, Penny Seume, Scott Bevan, Sam T Creavin

“…Objectives Conducting randomised controlled trials (RCTs) in primary care is challenging; recruiting patients during time-limited or remote consultations can increase selection bias and physical access to patients’ notes is costly and time-consuming. …”
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