Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 2 approved, 2 approved with reservations] by Pauline Frizelle, Darren Dahly, Aoife O'Shea, Aileen Murphy, Cristina McKean

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Effects of nurse-home visiting on intimate partner violence and maternal income, mental health and self-efficacy by 24 months postpartum: a randomised controlled trial (British Columbia Healthy Connections Project) by Susan Jack, Charlotte Waddell, Michael Boyle, Harriet MacMillan, Yufei Zheng, Hui Xie, Colleen Varcoe, Amiram Gafni, Andrea Gonzalez, Debbie Sheehan, Lil Tonmyr, Ronald Barr, Lenora Marcellus, Nicole L A Catherine

“…Objective To evaluate the impact of Nurse-Family Partnership (NFP), a home-visiting programme, on exploratory maternal outcomes in British Columbia (BC), Canada.Design Pragmatic, parallel arm, randomised controlled trial conducted October 2013–November 2019. …”
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Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 2; peer review: 2 approved, 1 approved with reservations] by Pauline Frizelle, Darren Dahly, Aoife O'Shea, Aileen Murphy, Cristina McKean

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Development and internal validation of prognostic models for event-free survival in newly diagnosed Ewing sarcoma patients based on routinely collected clinical characteristics from the European randomised controlled trial, EE2012 by Richard Riley, BERNADETTE BRENNAN, Kym Snell, Piers Gaunt, Laura Kirton

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Feasibility and therapeutic efficacy of a two-week low-level laser acupuncture therapy for shoulder and neck pain in office workers: Protocol for a pilot, single-blind, double-armed, randomised controlled trial. by Carol Chunfeng Wang, Lisa Whitehead, Travis Cruickshank, Johnny Lo, Jianhong Cecilia Xia, Jun Wen

“…<h4>Methods</h4>This is a pilot, single-blind, double-armed, randomised controlled trial on the feasibility and therapeutic efficacy of a two-week LLLA therapy for office workers with SNP, aged 18 to 65 years. …”
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Economic evaluation of encorafenib with cetuximab in patients with BRAF V600E-mutant metastatic colorectal cancer in France: a cost-effectiveness analysis using data from the BEACON CRC randomised controlled trial by David Malka, Philippe Laramée, Mondher Toumi, Jean-Baptiste Trouiller, Bérengère Macabeo, Andrew Poll, Dan Howard, Andy Buckland, Marine Sivignon, Emilie Clay, Emmanuelle Samalin

“…Objective The BEACON CRC randomised controlled trial (NCT02928224) in BRAF-mutant metastatic colorectal cancer (mCRC) patients showed improved overall survival for the combination treatment of encorafenib (BRAF inhibitor) with cetuximab (EGFR inhibitor) compared with cetuximab with chemotherapy (FOLFIRI (folinic acid, fluorouracil and irinotecan) or irinotecan). …”
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Efficacy of solution-focused brief therapy versus case management for psychological distress in adolescents and young adults in a community-based youth mental health service in Singapore: protocol for a randomised controlled trial by Janhavi Ajit Vaingankar, Edimansyah Abdin, Charmaine Tang, Cheryl Yunn Shee Foo, Tianyi Hui, Nur Khairunisa Binte Ngaiman, Darshan s/o Dahjalarrajah, Yi Chian Chua, Yi Ping Lee

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Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trialResearch in context by Gabriela Tapia-Calle, Gloria Aguilar, Nathalie Vaissiere, Carla Truyers, Pedro Ylisastigui, Erik Buntinx, Mathieu Le Gars, Frank Struyf, Gert Scheper, Macaya Douoguih, Javier Ruiz-Guiñazú, Robert Patrizi, Wai Ling, Sanne de Ridder, Marit de Groot, Maria Grazia Pau, Gerald Weidinger, Srividya Pradeep, Nadine Salisch, Sophie Cambre

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Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain–related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial by Claudia Buntrock, Harald Baumeister, Yannik Terhorst, Lina Braun, Ingrid Titzler, Johanna Freund, Janika Thielecke, David Ebert

“…The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+).Methods and analysis A two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. …”
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To remove or to replace traditional electronic games? A crossover randomised controlled trial on the impact of removing or replacing home access to electronic games on physical activity and sedentary behaviour in children aged 10–12 years by Anne J Smith, Leon M Straker, Rebecca A Abbott

“…Objective To evaluate the impact of (1) the removal of home access to traditional electronic games or (2) their replacement with active input electronic games, on daily physical activity and sedentary behaviour in children aged 10–12 years.Design Crossover randomised controlled trial, over 6 months.Setting Family homes in metropolitan Perth, Australia from 2007 to 2010.Participants 10-year-old to 12-year-old children were recruited through school and community media. …”
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The MyLungHealth study protocol: a pragmatic patient-randomised controlled trial to evaluate a patient-centred, electronic health record-integrated intervention to enhance lung cancer screening in primary care by Rachel Hess, Angela Fagerlin, Devin Mann, Tanner Caverly, Yue Zhang, Guilherme Del Fiol, Jorie Butler, Michael Flynn, Kensaku Kawamoto, Douglas Martin, Chelsey R Schlechter, Haojia Li, Polina Kukhareva, Christian Balbin, Elizabeth Stevens, Victoria Tiase, Kim Kaphingst, Chakravarthy Reddy, Phillip Warner, Joshua Choi, Claude Nanjo, Quyen Metzger

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Azithromycin to prevent acute lower respiratory infections among Australian and New Zealand First Nations and Timorese children (PETAL trial): study protocol for a multicentre, international, double-blind, randomised controlled trial by Anne B Chang, Keith Grimwood, Yuejen Zhao, Gabrielle B McCallum, Catherine A Byrnes, Heidi Smith-Vaughan, Peter S Morris, Christine Connors, Adrian Trenholme, Shirley Lawrence, Joshua Francis, Kobi L Schutz, Mark D Chatfield, Nevio Sarmento, Robyn L. Marsh, Emily R Bowden, Nicholas Fancourt, Adriano Vieira, Kim M Hare, Dennis Bonney, Felicity Marwick, Bronwyn Karvonen, Carolyn Maclennan, Milena Santos Lay, Endang Soares da Silva

“…Despite the high burden and long-term consequences of severe ALRIs, clinical, evidence-based and feasible interventions (other than vaccine programmes) that reduce ALRI hospitalisations in children are limited. This randomised controlled trial (RCT) will address this unmet need by trialling a commonly prescribed macrolide antibiotic (azithromycin) for 6–12 months. …”
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Exploring how PRIME-Parkinson care is implemented and whether, how and why it produces change, for who and under what conditions: a protocol for an embedded process evaluation within the PRIME-UK randomised controlled trial by Yoav Ben-Shlomo, Sabi Redwood, Judi Kidger, Emma Tenison, Heather Brant, Emily J Henderson, Fiona Lithander, Katherine Lloyd, Safi Smith

“…Introduction The PRIME-UK randomised controlled trial (RCT) aims to establish whether a model of care that seeks to be proactive, integrated and empower participants, caregivers and healthcare professionals can improve outcomes in people with parkinsonism. …”
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How pragmatic are randomised controlled trials evaluating minimally invasive surgery for oesophageal cancer?... by Natalie S Blencowe, Jane Blazeby, Sian Cousins, Katy Chalmers

“…Background Surgical interventions are inherently complex and designing and conducting surgical randomised controlled trials (RCTs) can be challenging. Trial design impacts the applicability of trial results to clinical practice. …”
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Effects of a multicomponent resistance-based exercise program with protein, vitamin D and calcium supplementation on cognition in men with prostate cancer treated with ADT: secondary analysis of a 12-month randomised controlled trial by Helen Macpherson, Robin M Daly, Patricia M Livingston, Declan G Murphy, Patrick J Owen, Timo Rantalainen, Niamh L Mundell, Jeremy L Millar, Steve F Fraser, Jack Dalla Via, Stephen J Foulkes

“…Objectives The aim of this preplanned secondary analysis of a 12-month randomised controlled trial was to investigate the effects of a multicomponent exercise programme combined with daily whey protein, calcium and vitamin D supplementation on cognition in men with prostate cancer treated with androgen deprivation therapy (ADT).Design 12-month, two-arm, randomised controlled trial.Setting University clinical exercise centre.Participants 70 ADT-treated men were randomised to exercise-training plus supplementation (Ex+ Suppl, n=34) or usual care (control, n=36).Intervention Men allocated to Ex + Suppl undertook thrice weekly resistance training with weight-bearing exercise training plus daily whey protein (25 g), calcium (1200 mg) and vitamin D (2000 IU) supplementation.Primary and secondary outcome measures Cognition was assessed at baseline, 6 and 12 months via a computerised battery (CogState), Trail-making test, Rey auditory-verbal learning test and Digit span. …”
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Yorkshire Lung Screening Trial (YLST): protocol for a randomised controlled trial to evaluate invitation to community-based low-dose CT screening for lung cancer versus usual care in a targeted population at risk by Richard D Neal, Kevin Franks, David Torgerson, Rachael L Murray, David R Baldwin, Michael Darby, Henrik Moller, Richard Booton, Una MacLeod, Sam M Janes, Samantha L Quaife, Sebastian Hinde, Matthew EJ Callister, Suzanne Rogerson, Rhian Gabe, Mark Sculpher, Philip AJ Crosbie, Irene Simmonds, Martyn Kennedy, Nazia Ahmed, Ann Cochrane, Mike Messenger, Puvanendran Tharmanathan

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A single-centre randomised controlled trial comparing the standard method and target-controlled infusion as a method of administering cefoxitin, which is used to prevent surgical site infections in colorectal surgical patients: study protocol by Ha-Jung Kim, Kyung Mi Kim, Jong Lyul Lee, In Ja Park, Byung-Moon Choi

“…Methods This prospective, single-centre, parallel-arm, single-blinded, randomised controlled trial with a 1:1 allocation was designed to compare the effectiveness of the TCI method with that of the standard cefoxitin administration method. …”
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Effectiveness and cost-effectiveness of a web-based routine assessment with integrated recommendations for action for depression and anxiety (RehaCAT+): protocol for a cluster randomised controlled trial for patients with elevated depressive symptoms in rehabilitation facilities by Reinhold Kilian, Harald Baumeister, Yannik Terhorst, Johannes Knauer, Paula Philippi, Selina Kallinger, Sandro Eiler, Tamara Waldmann, Morten Moshagen, Martina Bader

“…This study aims to evaluate the effectiveness and cost-effectiveness of such a platform for depression and anxiety (RehaCAT+) compared with the standard diagnostic system (RehaCAT) in cardiological and orthopaedic health clinics in routine care.Methods and analysis A two-arm, pragmatic, cluster-randomised controlled trial will be conducted. Twelve participating rehabilitation clinics in Germany will be randomly assigned to a control (RehaCAT) or experimental group (RehaCAT+) in a 1:1 design. …”
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Does awake prone positioning prevent the use of mechanical respiratory support or death in COVID-19 patients on standard oxygen therapy hospitalised in general wards? A multicentre randomised controlled trial: the PROVID-19 protocol by Benjamin Planquette, Christophe Perrin, Thierry Boulain, Mai-Anh Nay, Louis Bernard, Laurent Plantier, Léa Colombain, Jérémy Clément, Aymeric Sève, Sylvie Druelle, Marine Morrier, Jean-Baptiste Lainé, Grégory Corvaisier, Nicolas Bizien, Xavier Pouget-Abadie, Adrien Bigot, Elsa Nyamankolly, Guillaume Fossat

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Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes by Ulrich Mansmann, Claudia Spies, Ursula Marschall, Reinhard Busse, Christine Adrion, Bjoern Weiss, Nicolas Paul, Elke Berger, Jörg Caumanns, Simone Rosseau

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