Rhythm and Movement for Self-Regulation (RAMSR) intervention for preschool self-regulation development in disadvantaged communities: a clustered randomised controlled trial study protocol by Kate E Williams, Sally Savage, Rebecca Eager

Get full text

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

Get full text

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. …”
Get full text

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. …”
Get full text

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). …”
Get full text

Effectiveness of Fewer Falls, an online group-based self-management fall prevention programme for people with multiple sclerosis: protocol of a randomised controlled trial by Maria Flink, Charlotte Ytterberg, Kristina Gottberg, Marie Kierkegaard, Susanna Tuvemo Johnson, Elizabeth Walker Peterson, Ulrika Meijer, Johanna Bylinder

“…Findings from a feasibility study indicate the necessity of a full-scale randomised controlled trial (RCT).Methods and analysis A parallel-group RCT with a mixed methods process evaluation as well as a cost-effectiveness evaluation will be conducted. …”
Get full text

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. …”
Get full text

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. …”
Get full text

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. …”
Get full text

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). …”
Get full text

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. …”
Get full text

Influence of intravenous lidocaine infusion on haemodynamic response to tracheal intubation and metabolic-hormonal responses during laparoscopic procedures in children: a randomised controlled trial by Maciej Kaszyński, Alicja Kuczerowska, Justyna Pietrzyk, Piotr Sawicki, Paweł Witt, Barbara Stankiewicz, Marek Darowski, Izabela Pągowska-Klimek

Get full text

Oxygenation targets for endovascular therapy in acute ischemic stroke patients (Oxy-TARGET): protocol for a single-centre, open-label randomised controlled trial by Anxin Wang, Zhengfang Hu, Ruquan Han, Fa Liang, Youxuan Wu, Minyu Jian, Xinyan Wang, Yunzhen Wang, Haiyang Liu, Xuan Hou, Kangda Zhang, Zihui Zhang

“…Therefore, we are conducting a randomised controlled trial (RCT) to evaluate the impact of high-concentration oxygen vs low-concentration normobaric oxygen on early neurological function after EVT.Methods and analysis The Oxy-TARGET trial is an ongoing prospective, open-label, parallel-design RCT being conducted at Beijing Tiantan Hospital, Capital Medical University. …”
Get full text

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. …”
Get full text

Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trial by Christina Psaros, Ingrid Bassett, Sabina Medal Govere, Jana Jarolimova, Joyce Yan, Sthabile Shezi, Lungile M Ngcobo, Shruti Sagar, Dani Zionts, Nduduzo Dube, RA Parker

“…We are evaluating the feasibility, acceptability and preliminary effectiveness of a novel intervention offering PrEP, contraception and STI screening in hair salons.Methods and analysis We will conduct a pilot cluster randomised controlled trial in hair salons in urban KwaZulu-Natal, South Africa. …”
Get full text

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. …”
Get full text

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

Get full text

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. …”
Get full text

Randomised, multicentre, placebo-controlled trial of fenofibrate for treatment of diabetic macular oedema with economic evaluation (FORTE study): study protocol for a randomised control trial by Gerald Liew, Paul Mitchell, Bamini Gopinath, Helen Nguyen, Richard Kha

Get full text

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

Get full text