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

Get full text

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. …”
Get full text

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. …”
Get full text

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. …”
Get full text

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. …”
Get full text

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. …”
Get full text

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

Get full text

Evaluation of efficacy of two bag-mask ventilation techniques by novice airway providers: Two-handed CE versus dominant-hand CE–non-dominant-hand thenar eminence techniques – A randomised controlled trial by Neetu Saroye, Gurpreeti Kaur, Udeyana Singh, Anju Grewal, Akshita Khanna, Rushal Nayyar

Get full text

Adherence and efficacy outcomes in young Australians with suicidal ideation using a self-management app and digital engagement strategy compared with a sham app: a three-arm randomised controlled trialResearch in context by Michelle Torok, Lauren McGillivray, Daniel Z.Q. Gan, Jin Han, Sarah Hetrick, Quincy J.J. Wong

“…Methods: This was an online double-blind, three-arm parallel randomised controlled trial in Australia. Recruitment occurred between May 30 and August 8, 2023 and eligible participants were aged 17–24 years and had suicidal ideation in the prior 30 days. …”
Get full text

Efficacy and safety of NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr (NAIVE study) in China: study protocol of an open-label, phase II, randomised controlled trial by Ying Zhu, Jianwei Zhou, Zhigang Zhang, Jiaojiao Zhang, Jing Fei, Xiaoqing Zhu

“…The NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr(NAIVE) study aims to assess the clinical efficacy and safety of NACT in combination with tislelizumab (a monoclonal antibody for programmed cell death protein 1) for advanced EOC.Methods and analysis The NAIVE study is an investigator-initiated, prospective, single-centre, open-label, randomised controlled trial for advanced EOC with the International Federation of Gynaecology and Obstetrics (FIGO) stage IIIc with a Suidan CT score of 3 or greater or a Fagotti laparoscopic score of 8 or greater; or FIGO stage IV. …”
Get full text

Solving unknown primary cancer with earlier diagnosis - the SUPER-ED trial: study protocol for a stepped-wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary origin by Anna Ugalde, Richard W. Tothill, Stephen Quinn, Hui-Li Wong, Owen Prall, Catherine Mitchell, Nilmini Wickramasinghe, Clare Fedele, Natalie Richards, Elizabeth Todio, Cindy Bryant, Louisa G. Collins, Sarah McLean, Hyun Soo Ko, Tim Akhurst, Christopher Steer, Bo Gao, Mark Wong, Chloe Georgiou, Narayan Karanth, Anna Kuchel, Louise Nott, Shamsudheen Padinharakam, Mark Shackleton, Ian M. Collins, Madhu Singh, Rachel Wong, Zee Wan Wong, Alexis Butler, Tharani Sivakumaran, Penelope Schofield, Linda Mileshkin

Get full text

Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness by Jeanne Cho, Michael Hill, Corita R Grudzen, Deborah J Shim, Abigail M Schmucker, Keith S Goldfeld, Lauren Southerland, Jeffrey M Caterino, Marie-Carmelle Elie, Robert Swor, Susan E Cohen, Arum Kim, Joseph Lowy, Jennifer S Scherer, Nancy E Bael, Ellin Gafford, Joshua Lakin, Paige Barker, Angela Chmielewski, Jennifer Kapo, Audrey Tan, Rebecca Yamarik, Susan Salz, Stephen Ryan, Anne Kim, Isabel Castro, Amelia Hargrove, Laura Stuecher, Nora Daut, Juanita Booker-Vaughns, Garrett K Chan, J Nicholas Dionne-odom, Patrick Dunn, Robert Galvin, Ernest A Hopkins III, Margaret M Maguire, Neha Reddy Pidatala, Dawn Rosini, Sally Welsh, Karen Jubanyik, Ada L Rubin, Kei Ouchi, Rebecca Murray, Nicole Tang, Marie Bakitas, Abraham Brody, Caroline Blaum, Mara Flannery, Richard Tamirian, Pamela Marsack, Jennifer Bonito, Romilla Batra, Donna C Sadasivan, Eric David Isaacs, Constance L Kizzie-Gillett, William K Vaughan, Pluscedia G Williams, Angela Young-Brinn

“…This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysis This is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. …”
Get full text

FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study by Kerry Woolfall, Jamie J Kirkham, Jane Sandall, Mariana Popa, Enrico Lopriore, Mark Turner, Shakila Thangaratinam, Aris T Papageorghiou, Andrew Sharp, Lawrence Impey, Andy Healey, Jessica Mendoza, Asma Khalil, Dharmintra Pasupathy, Brigitte Vollmer, Zarko Alfirevic, Rajeswari Parasuraman, Jan Deprest, Richard Edmund Ashcroft, Kurt Hecher, Smriti Prasad, Baskaran Thilaganathan, Richard J Jackson, Tracy Karen Mitchell, Natasha Fenwick, Monique C Haak, Liesbeth Lewi, Shauna Leven, Fabricio Da Silva Costa, Odai Yaghi, Tracey Ricketts, George Attilakos, Carolyn Bailie, Christine Cornforth, Mark Denbow, Louise Hardman, Jane Harrold, Joel Marsden, Tommy Mousa, Surabhi Nanda, Michelle Watson, Karen Wilding, Dilly Anumba, Edward D Johnstone, Yoav Yinon, Ahmet Baschat

“…These management options have never been investigated in a randomised controlled trial (RCT). The best management option is unknown, and there are many challenges for a potential RCT. …”
Get full text

Effect of intermittent urethral catheter clamping combined with active urination training (ICCAUT) strategy on postoperative urinary dysfunction after radical rectal cancer surgery: single-centre randomised controlled trial (ICCAUT -1) study protocol by Yuchen Guo, Quan Wang, Tingting He, Sen Liang, Yunan Guan, Jianan Sun, Haiyan Hu

Get full text

Hydroxychloroquine plus personal protective equipment versus personal protective equipment alone for the prevention of laboratory-confirmed COVID-19 infections among healthcare workers: a multicentre, parallel-group randomised controlled trial from India by Rohina Joshi, Sudha Vidyasagar, Niveditha Devasenapathy, Rinaldo Bellomo, Vivekanand Jha, Chirag Patel, Vijay Kumar, Lachlan Donaldson, Oommen John, Balasubramanian Venkatesh, Michael John, Naomi Hammond, Jeyaraj Pandian, Ashwani Kumar, Arpita Ghosh, S Radhakrishnan, Rajib Paul, Bharath Kumar Tirupakuzhi Vijayaraghavan, Dorrilyn Rajbhandari, Sheila Nainan Myatra, Amritendu Bhattacharya, Sumaiya Arfin, Abhinav Bassi, Lachlan Hugh Donaldson, Naomi E Hammond, Mallikarjuna Kunigari, Cynthia Amrutha, Syed Haider Mehdi Husaini, Subir Ghosh, Santosh Kumar Nag, Hari Krishnan Selvaraj, Viny Kantroo, Kamal D Shah, Sheila Myatra, Amritendu Battacharya, Pavan Kumar Vecham, Evangeline Elvira, Gomathi Parthasarathy, Archana Ragunathan, Gnanavel Rajendra Kunjurao, Pavithra Sampath Kumar, Hilda Nirmala Kumari, Jayanthi Swaminathan, Murshid Cheriyeri Peediyekkal, Arun Chander Yadav, Aarthi Venkatramanan, Cynthia Amrutha Sukumar, Dharini Prasad, Krishnanda Nayak, Ravindra Prabhu, Rohini Bilagi, Akash Bhange, Bhumika Patel, Ekta Ramchandani, Jinesh Patel, Krupa Gandhi, N Prathyusha, Rayshma Rao Bonshlay Lakshmanan, S Hari Krishnan, Abhishek George Mehta, Mousumi Pradhan, Syed Haider Mehdi Husaini, Shahid Ali Siddique, Naved-ur Rahman, Mohammad Jamalludeen, Mounika Amarneni, Suresh Sankar, Vidya Rajesh Joshi, Alka Yadav, Nikhil Modi, Rinku Dahiya, Serena Knowles, Nikita Bathla, Fatima Butt

Get full text

A Study to Inform the Design of a National Multicentre Randomised Controlled Trial to Evaluate If Reducing Serum Phosphate to Normal Levels Improves Clinical Outcomes including Mortality, Cardiovascular Events, Bone Pain, or Fracture in Patients on Dialysis by Ramya Bhargava, Philip A. Kalra, Paul Brenchley, Helen Hurst, Alastair Hutchison

“…This generates research hypotheses but does not establish “cause-and-effect.” A large randomised controlled trial (RCT) of about 3000 patients randomised 50 : 50 to lower or higher phosphate ranges is required to answer the key question: does reducing phosphate levels improve clinical outcomes? …”
Get full text

Cost-utility of behavioural activation for mitigating psychological impacts of COVID-19 on socially isolated older adults with depression and multiple long-term conditions compared with usual care: results from a pragmatic randomised controlled trial by Simon Gilbody, Caroline Fairhurst, Catherine Hewitt, Dean McMillan, Carolyn Chew-Graham, Della Bailey, David Ekers, Steve Parrott, Elizabeth Littlewood, Peter Coventry, Han-I Wang, Kalpita Baird

“…Behavioural activation (BA) shows promise as a remote intervention for depression during isolation, but its cost-effectiveness for depressed, socially isolated older adults remains uncertain.Objective This study aimed to assess the cost-utility of BA versus usual care for older adults with depression and MLTCs during COVID-19 restrictions.Methods A randomised controlled trial recruited and randomised individuals aged 65 and over with depressive symptoms and MLTC (n=435) to either the BA intervention or usual care. …”
Get full text

Structured lactation support for mothers of very low birthweight preterm infants and establishment of human donor milk banks in German NICUs (Neo-MILK): protocol for a hybrid type 1 effectiveness-implementation cluster-randomised controlled trial by Angela Kribs, Nicole Ernstmann, Nadine Scholten, Martin Hellmich, Antje Hammer, Eva Mildenberger, Andreas Müller, Dirk Horenkamp-Sonntag, Juliane Köberlein-Neu, Tim Ohnhäuser, Katja Matthias, Jens Ulrich Rüffer, Nicola Gabriela Dymek, Julia Jaschke, Anna Katharina Stirner, Isabella Schwab, Daniel Wiesen, Till Dresbach, Friederike Eyssel, Katharina Lugani, Anne Sunder-Plaßmann, Melanie Klein, Christoph Rupprecht

“…This protocol describes the design of a study evaluating the effectiveness, implementation and economic aspects of an intervention, which aims to ensure access to MOM or HDM for VLBW infants from the first day of life in German neonatal intensive care units (NICUs).Methods and analysis The hybrid type 1 effectiveness-implementation cluster-randomised controlled trial, using a stepped-wedge design, will be conducted in 15 level I and level II NICUs across Germany over 26 months. …”
Get full text

Protocol for a multicentre randomised controlled trial examining the effects of temporarily pausing Bruton tyrosine kinase inhibitor therapy to coincide with SARS-CoV-2 vaccination and its impact on immune responses in patients with chronic lymphocytic leukaemia by Abhishek Abhishek, Jonathan A Cook, Helen M Parry, Anne Francis, Lelia Duley, Vicki S Barber, Paul Moss, Nicholas Peckham

Get full text

NIFTy: near-infrared fluorescence (NIRF) imaging to prevent postsurgical hypoparathyroidism (PoSH) after thyroid surgery—a phase II/III pragmatic, multicentre randomised controlled trial protocol in patients undergoing a total or completion thyroidectomy by Deborah D Stocken, Maureen Twiddy, Hisham Mehanna, Jonathan Wadsley, Neil Corrigan, Katie Gordon, Julie Croft, Neil Sharma, Anna Perry, Mark Strachan, Gemma Ainsworth, Elizabeth Glenister, Sabapathy Prakash P Balasubramanian

“…Some studies have shown promising results using near-infrared fluorescence (NIRF) imaging in reducing the risk of PoSH which has the potential to significantly reduce morbidity and costs associated with monitoring and treatment.Methods and analysis NIFTy is an unblinded, parallel group, multicentre, seamless phase II/III randomised controlled trial in patients undergoing total or completion thyroidectomy. …”
Get full text