Trial protocol of an open-label pilot study of oral naltrexone–bupropion combination pharmacotherapy for the treatment of methamphetamine use disorder (the NABU trial) by Jonathan Brett, Paul S Haber, Nicholas Lintzeris, Didier Jutras-Aswad, Nadine Ezard, Brendan Clifford, Krista J Siefried, Adrian John Dunlop, Liam Acheson, Carl Moller, Michael Christmass, Kirsten Morley, Steven Shoptaw, Madhukar H Trivedi

“…One recent randomised controlled trial conducted in the USA examined a combination of bupropion and naltrexone not readily available globally. …”
Get full text

Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults by Florence Ader, Jean-François Timsit, Yazdan Yazdanpanah, François-Xavier Lescure, Laetitia Moinot, Christelle Delmas, Hélène Espérou, Laurent Abel, Benjamin Leveau, Vinca Icard, Toni Alfaiate, Linda Wittkop, Charles Burdet, France Mentré, Marion Schneider, Nathan Peiffer-Smadja, Julien Poissy, Lila Bouadma, Bruno Lina, Florence Morfin-Sherpa, Maude Bouscambert, Alexandre Gaymard, Gilles Peytavin, Jeremie Guedj, Claire Andrejak, Cedric Laouenan, Drifa Belhadi, Axelle Dupont, Basma Basli, Anissa Chair, Samira Laribi, Julie Level, Marie-Capucine Tellier, Aline Dechanet, Dominique Costagliola, Sandrine Couffin-Cadiergues, Juliette Saillard, Claire Fougerou, Carole Cagnot, Soizic Le Mestre, Delphine Lebrasseur-Longuet, Ventzislava Petrov-Sanchez, Alpha Diallo, NoéMie Mercier, Sarah Tubiana, Benjamin Hamze, Ambre Gelley, Marion Noret, Eric D’Ortenzio, Oriane Puechal, Caroline Semaille

“…As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19.Methods and analysis DisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms: (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-β−1a + SoC and (5) hydroxychloroquine + SoC. …”
Get full text

Effects of mosquito-proofing storm drains on adult and larvae mosquito abundance: Protocol of the IDAlErt storm drAin randomiSed controlled trial (IDEAS) by Marina Treskova, Tomás Montalvo, Joacim Rocklöv, Charles Hatfield, Frederic Bartumeus, Shouro Dasgupta, João Encarnação, Rachel Lowe, Jan C. Semenza, Pascale Stiles, Jordi Noya, Andrea Valsecchi, Till Bärnighausen, John R.B. Palmer, Aditi Bunker

“…Together with the Agency, we designed a randomised controlled trial (RCT) to experimentally assess the effectiveness of these modifications on adult Aedes albopictus and Culex pipiens populations. …”
Get full text

FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder by Li Ling, Wei Wei, Li Lin, Li Ke, Ye Chen, Li Ning, Wang Yu, Zhang Xin, Yang Rong, Zhang Xueying, Cui Jiaqu, Chen Qiyi, Qin Huanlong, Du Yasong, Zhao Xiaoxin, Lu Jubao, Lv Xiaoqiong, Ma Chunlian, Chen Shidong, Kuang Guifang, Zhao Dongmei, Fang Shuanfeng, Zhang Xujing, Yang Binrang, Wang Yanxia, Yuan Song, Zhou Xiang, Zhang Beihua, Jiang Lin, Ji Hong, Yan Yinmei, Yan Peihua, Huang Linsheng, Zhang Shaoyi, Ma Chenhuan, Miao Yun, Ling Wenqi, Geng Bojing, Feng Xueying, Li Huilin, Liu Liyan, Wu Weijia, Li Dexin, Jiang Qianru

“…We are undertaking the first-ever multicentre, double-blind, randomised controlled trial of FMT for the treatment of children with both ASD and gastrointestinal symptoms and will assess the feasibility and efficacy outcomes of this strategy.Methods In total, 318 children with both ASD and gastrointestinal symptoms will be enrolled (from 15 hospitals in China) to receive either FMT intervention (n=212) or a placebo (control, n=106). …”
Get full text

Impact of a phone call with a medical student/general practitioner team on morbidity of chronic patients during the first French COVID-19 lockdown (COVIQuest): a cluster randomised... by Bruno Giraudeau, Estelle Boivin, Vincent Camus, Agnes Caille, Olivier Saint-Lary, Jean-Pierre Lebeau, Stéphanie Sidorkiewicz, Denis Pouchain, Maeva Jego, Sophie Sun, Denis Angoulvant, Wissam El-Hage, Sébastien Bruel, Clarisse Dibao-Dina, Julie Léger, Isabelle Ettori-Ajasse, Juliette Chambe, Karim Abou-Mrad-Fricquegnon, Baptiste Motte, Benoit Chiron, Cam-Anh Khau, Tiphanie Bouchez, Maria Ghali, Leslie Guillon-Grammatico, Emeline Laurent, Rémy Boussageon

“…The objective of COVIQuest was to evaluate whether a general practitioner (GP)-initiated phone call to patients with CVD and MHD during the COVID-19 lockdown could reduce the number of hospitalisation(s) over a 1-month period.Design This is a cluster randomised controlled trial. Clusters were GPs from eight French regions.Participants Patients ≥70 years old with chronic CVD (COVIQuest_CV subtrial) or ≥18 years old with MHD (COVIQuest_MH subtrial).Interventions A standardised GP-initiated phone call aiming to evaluate patients’ need for urgent healthcare, with a control group benefiting from usual care (ie, the contact with the GP was by the patient’s initiative).Main outcome measures Hospital admission within 1 month after the phone call.Results In the COVIQuest_CV subtrial, 131 GPs and 1834 patients were included in the intervention group and 136 GPs and 1510 patients were allocated to the control group. …”
Get full text

Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma (FiTNEss (UK-MRA Myeloma XIV Trial)): a study protocol for a randomised phase III... by Roger Owen, John Jones, David Meads, David A Cairns, Christopher Parrish, Gordon Cook, Neil Rabin, Matthew Jenner, Martin Kaiser, Kevin Boyd, Graham Jackson, Catherine Olivier, Amy Beth Coulson, Kara-Louise Royle, Charlotte Pawlyn, Anna Hockaday, Jennifer Bird, Stella Bowcock, Ruth de Tute, Hayley Gardner, Bryony Dawkins, Rowena Henderson, Phillip Best, Bhuvan Kishore, Mark Drayson

“…Research is required in this patient group, taking into account frailty and aiming to improve: treatment tolerability, clinical outcomes and quality of life.Methods and analysis Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma is a national, phase III, multicentre, randomised controlled trial comparing standard (reactive) and frailty-adjusted (adaptive) induction therapy delivery with ixazomib, lenalidomide and dexamethasone (IRD), and to compare maintenance lenalidomide to lenalidomide+ixazomib, in patients with newly diagnosed multiple myeloma not suitable for stem cell transplant. …”
Get full text

Protocol for a process evaluation: face-to-face physiotherapy compared with a supported home exercise programme for the management of musculoskeletal conditions: the REFORM trial by David Wong, Catherine Sherrington, Manuela L Ferreira, Christopher G Maher, Hueiming Liu, Joshua R Zadro, Lisa A Harvey, Hannah G Withers, Joanne V Glinsky, Jackie Chu, Matthew D Jennings, Alison J Hayes, Ian J Starkey, Blake A Palmer, Lukas Szymanek, Jackson J Cruwys, Kitty Duong, Anne Barnett, Matthew J Tindall, Barbara R Lucas, Tara E Lambert, Deborah A Taylor

“…Introduction The REFORM (REhabilitation FOR Musculoskeletal conditions) trial is a non-inferiority randomised controlled trial (n=210) designed to determine whether a supported home exercise programme is as good or better than a course of face-to-face physiotherapy for the management of some musculoskeletal conditions. …”
Get full text

Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes m... by Umberto Simeoni, Antje Horsch, Arnaud Chiolero, Yvan Vial, Nicole Sekarski, Jardena J Puder, Pascal Bovet, Yvan Mivelaz, Adina Mihaela Epure, Bobby Stuijfzand, Leah Gilbert, Stefano Lanzi, Justine Gross, Didier Hans, Stefano Di Bernardo, Elena Gonzalez-rodriguez, Alain Lacroix, Jean-Benoît Rossel, Dan Yedu Quansah, Amar Arhab, Sandrine Estoppey Younes, Seyda Mayerat

“…Objective To test the effect of a complex, interdisciplinary, lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus during pregnancy and in the post partum.Design Single centred, single blinded, randomised, controlled trial (the MySweetheart trial).Setting Lausanne University Hospital, Switzerland, from 2 September 2016 to 25 October 2021.Participants 211 women aged at least 18 years with a diagnosis of gestational diabetes mellitus at 24-32 gestational weeks were randomly assigned (1:1) to the intervention (n=105) or to usual care (n=106).Interventions In addition to a comparator based on active guidelines for prepartum and postpartum usual care, the intervention consisted of four individual lifestyle visits during pregnancy and four interdisciplinary visits in the postpartum group, a peer support group workshop in pregnancy and post partum, and a bimonthly lifestyle coach support through telemedicine. …”
Get full text

Shortening duration of untreated illness in young people with first episode eating disorders: protocol of a randomised controlled feasibility trial of a smartphone friendly multi-m... by Luiza Grycuk, Dina Monssen, Molly R. Davies, Helen Sharpe, Karina L. Allen, Vibhore Prasad, Rachel Potterton, Priya Popat, Victoria A. Mountford, Sheryllin McNeil, Vanessa Lawrence, Nina Grant, Kimberley A. Goldsmith, Danielle Glennon, Sarah Byford, Amy Brown, Ulrike Schmidt

“…The objectives of the proposed trial are to establish/estimate: (a) attrition rates at follow-up (primary feasibility outcome); (b) participant recruitment; (c) intervention uptake, completion rates and acceptability; (d) intervention effect sizes and standard deviations for outcomes to inform the sample size calculation for a large-scale randomised controlled trial (RCT); (e) stakeholder views on the intervention. …”
Get full text

School-based mindfulness training in early adolescence: what works, for whom and how in the MYRIAD trial? by Susan Ball, Obioha C Ukoumunne, Tamsin Ford, Sarah Byford, Tim Dalgleish, Willem Kuyken, Jesus Montero-Marin, Kate Tudor, Alice Tickell, Catherine Crane, Ariane Petit, Elise Sellars, Laura Taylor, Maris Vainre, Benjamin Jones, Kirsty Griffiths, Elizabeth Nuthall, J Mark G Williams, Sarah-Jayne Blakemore, Katie Fletcher, Emma Medlicott, Anam Raja, Matthew Allwood, Louise Aukland, Tríona Casey, Nicola Dalrymple, Katherine De Wilde, Eleanor-Rose Farley, Jennifer Harper, Nils Kappelmann, Maria Kempnich, Liz Lord, Lucy Palmer, Alice Philips, Isobel Pryor-Nitsch, Lucy Radley, Anna Sonley, Jem Shackleford, Mark T Greenberg, Verena Hinze, Saz Ahmed, Marc Bennett, Lucy Foulkes, Cait Griffin, Konstantina Komninidou, Rachel Knight, Suzannah Laws, Jovita Leung, Jenna Parker, Blanca Piera Pi-Sunyer, Ashok Sakhardande, Lucy Warriner, Brian Wainman

“…School-based mindfulness training (SBMT) is an approach with mixed evidence.Objectives To explore for whom SBMT does/does not work and what influences outcomes.Methods The My Resilience in Adolescence was a parallel-group, cluster randomised controlled trial (K=84 secondary schools; n=8376 students, age: 11–13) recruiting schools that provided standard social–emotional learning. …”
Get full text

Study protocol for Video Images about Decisions to Improve Ethical Outcomes with Palliative Care Educators (VIDEO-PCE): a pragmatic stepped wedge cluster randomised trial of older... by Joshua R Lakin, Na Wang, Howard J Cabral, Michael K Paasche-Orlow, Charlotta Lindvall, Angelo Volandes, Aretha Delight Davis, Michael R Winter, Edward T Moseley, Lori Henault, Sophia N Zupanc, Sophiya Das, Kate Sciacca, Edith A Burns, Maria T Carney, Jennifer Itty, Santiago Lopez, Kaitlin Emmert, Narda J Martin, Sherene Lambert, Jennifer Polo, Shreya Sanghani, Julianne N Dugas, Michele Gomez, Shira Gabry-Kalikow, Alexandra Dobie, Meredith Amshoff, Traci Cucinotta, Milton Joel, Lisa B Caruso, Ana Maria Ramirez, Kathleen Salerno, Qausarat Ogunneye

“…This paper presents the rationale, design and methods for a trial aimed at addressing barriers to goals-of-care conversations for hospitalised adults aged 65 and older and those with Alzheimer’s disease and related Dementias, regardless of age.Methods and analysis The Video Image about Decisions to Improve Ethical Outcomes with Palliative Care Educators is a pragmatic stepped wedge, cluster randomised controlled trial, which aims to improve and extend goals-of-care conversations in the hospital setting with palliative care educators trained in serious illness communication and video decision aids. …”
Get full text

Photoaging smartphone app promoting poster campaign to reduce smoking prevalence in secondary schools: the Smokerface Randomized Trial: design and baseline characteristics by Michael Kreuter, Fabian N Fries, Titus J Brinker, Ute Mons, David A Groneberg, Anil Batra, Werner Seeger, Felix Herth, Julia Holzapfel, Tanja G Baudson, Katharina Sies, Lena Jakob, Hannah Maria Baumert, Marlene Heckl, Ana Cirac, Janina L Suhre, Verena Mathes, Hannah Spielmann, Nancy Rigotti, Tobias Raupach, Henning Gall, Claudia Bauer, Pat Marek, Chase H Harrison, Lava Taha, Andreas Owczarek, Felix J Hofmann, Roger Thomas

“…This study aims to evaluate its effectiveness regarding smoking prevalence and students’ attitudes towards smoking.Methods and analysis A randomised controlled trial is conducted with 9851 students of both genders with an average age of 12 years in grades 6 and 7 of 126 secondary schools in Germany. …”
Get full text

Effectiveness of a physiotherapist-led triage and treatment service on WAITing time for adults with musculoskeletal pain referred to Australian public hospital physiotherapy clinic... by Ian A Harris, Andrew Lawson, Bethan Richards, Chris G Maher, Laurent Billot, David Roberts, Chris Needs, David Anderson, Nadine E Foster, Danielle Coombs, Marnee McKay, Joshua R Zadro, Tarcisio F de Campos, Michael Swain, Daniel Treacy, Lisa A Harvey, Gustavo Machado, Jackie Chu, Christopher S Han, Andrew R Gamble, Timothy Shaw, Mark Halliday, Joshua M Hutton, Tom Lung, Lisa Gridley, Joshua Wakefield

“…This paper describes the protocol for a randomised controlled trial investigating whether a physiotherapist-led triage and treatment service is non-inferior for improving function at 6 months and superior for reducing treatment waiting times, compared with usual care for patients with musculoskeletal pain referred to public hospital outpatient physiotherapy clinics.Methods and analysis A total of 368 participants (184 per arm) will be recruited from six public hospitals located in metropolitan Sydney, Australia. …”
Get full text

Olanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility study by Olena Said, Dominic Stringer, Ece Sengun Filiz, Hiba Mutwalli, Sevgi Bektas, Melahat Nur Akkese, Vanessa Kellermann, Katie Ireland, Elizabeth Tyrrell-Bunge, Demelza Beishon-Murley, Joel W. T. Khor, Lee Allman, Joanna Barker, Nicus Kotze, Ben Carter, Mima Simic, Dilveer Singh Sually, Jessica Bentley, Allan H. Young, Sloane Madden, Sarah Byford, Sabine Landau, Vanessa Lawrence, Janet Treasure, Ulrike Schmidt, Dasha Nicholls, Hubertus Himmerich

“…Trial registration International standard randomised controlled trial register number: ISRCTN80075010. …”
Get full text

The Protocol for the Multi-Ethnic, multi-centre raNdomised controlled trial of a low-energy Diet for improving functional status in heart failure with Preserved ejection fraction (... by Noelle Robertson, Melanie J Davies, Thomas Yates, Gerry P McCann, Gaurav Singh Gulsin, Emer M Brady, Joanne V Wormleighton, Eylem Levelt, Oliver Rider, Jiliu Pan, Christopher Miller, Iain Squire, Mehak Asad, Fardad Soltani, Michelle Hadjiconstantinou, Rachel L Brown, Joanna M Bilak

“…This pragmatic randomised trial aims to evaluate the efficacy of MRP-directed weight loss on exercise intolerance, symptoms, quality of life and cardiovascular remodelling in a multiethnic cohort with obesity and HFpEF.Methods and analysis Prospective multicentre, open-label, blinded endpoint randomised controlled trial comparing low-energy MRP with guideline-driven care plus health coaching. …”
Get full text

Pathway Of Low Anterior Resection syndrome (LARS) relief after Surgery (POLARiS): protocol for an international, open-label, multi-arm, phase 3 randomised superiority trial within... by Deborah D Stocken, Charles H Knowles, Jared Torkington, David Jayne, Julie Hepburn, Laura Knight, Neil Corrigan, Julie Cornish, Katie Gordon, Ashley Douglas, Kate Wilson, Megan Dale, Julie Croft, Christina Lloydwin, Alexandra Harriet Coxon-Meggy, Judith White, Alun Meggy, Aaron Quyn, Emily Farrow, Kheng-Seong Ng, Hannah Mather, Huey Yi Chong, Betty Tan, Ralph Powell, Andrea Warwick

“…Six-hundred participants from the UK and 200 participants from Australia, with major LARS symptoms, defined as a LARS score of ≥30, will be recruited to the randomised controlled trial (RCT) element. Participants entering the RCT will be randomised between OCM, TAI or SNM, all with equal allocation ratios.Cohort and RCT participants will be followed up for a 24-month period, completing a series of questionnaires measuring LARS symptoms and QoL, as well as clinical review for those in the RCT. …”
Get full text

Development of a clinical decision support tool for Primary care Management of lower Urinary tract Symptoms in men: the PriMUS study by Adrian Edwards, Ridhi Agarwal, Janine Bates, Alison Bray, Sarah Milosevic, Emma Thomas-Jones, Michael Drinnan, Marcus Drake, Peter Michell, Bethan Pell, Haroon Ahmed, Natalie Joseph-Williams, Kerenza Hood, Yemisi Takwoingi, Chris Harding

“…Future work Economic modelling, a feasibility trial and powered randomised controlled trial are needed to evaluate the Primary care Management of lower Urinary tract Symptoms tool in practice. …”
Get full text

Mesothelioma and Radical Surgery 2 (MARS 2): protocol for a multicentre randomised trial comparing (extended) pleurectomy decortication versus no (extended) pleurectomy decorticati... by Liz Darlison, John Edwards, Apostolos Nakas, Nick A Maskell, Wendy Underwood, Chris Rogers, Matthew Callister, David Waller, Richard Milton, Victoria Ashford-Turner, Paul Taylor, Claire Matthews, Victoria Hughes, Kelvin Lau, Alan Kirk, Robert C Rintoul, Elizabeth A Stokes, Kate Ashton, Daisy Elliott, Rosie Harris, Marie Kirwan, Juliette Novasio, Sara Waplington, Eric Lim, Holly Mckeon, Charlotte Jacobs, Laura White, Mary O’Brien, Judith Moore, Louise Li, Nicola Mills, Sanjay Popat, Suzanne Miller, Nadia Yousaf, D A Fennell, Clinton Ali, Andrea Bille, Liz Fuller, Andreea Ionescu, Manjusha Keni, Pek Koh, Talal Mansy, Dakshinamoorthy Muthukumar, Tony Pope, Amy Roy, Riyaz Shah, Jonathan Shamash, Zacharias Tasigiannopoulos, Sarah Treece, Katherine Joyce, Barbara Warnes, Athanasia Gravani, Rachel Brophy, Nicola Farrar, Jane Elliott, Philip Noyes, Louise Nelson, Sara Tenconi, Laura Socci, Hilary Wood, Helena Hanratty, Helena Stanley, Robert Rintoul, Amy Gladwell, Jenny Castedo, Amanda Stone, Charlotte Ingle, Hayley Hewer, Eleanor Aynsley, Andrea Watson, Alison Hassall, Masuma Begum, Christopher Worth, Ellie Piggott, Elizabeth Nadin, Yvonne Summers, Raffaele Califano, Laura Cove-Smith, Matt Evison, Maria Blinston, Amal Ismail, Rachel Chant, Asmita Desai, Ian Morgan, Victoria Lake, Nichola Harris, Simon Hodge, Nadza Tokaca, Adam Januszewski, Avani Athauda, Anisha Ramessur, Emily Grist, Niamh Colman, Michael Flynn, Joan Joyce, Sarah Vaughan, Maria Piga, Derya Sahin, Agnieszka Yongue, Emma Turay, Jaishree Bhosle, Rajiv Kumar, Charlotte Milner-Watts, Jessica Brown, David Walder, Alexandros Georgiou, Xiaorong Wu, Naila Kaudeer, Kroopa Joshi, Michael Davidson, Shelize Khakoo, Bee Ayite, Kathryn Priest, James Dobbyn, Vasanthi Prathapan, Deborah McCrimmon, Natalie Ash, Alison Norton, Bianca Peet, Libby Hennessy, Rosemary Johnson

“…Therefore, clinicians are now looking to evaluate pleurectomy decortication, the only radical treatment option left.Methods and analysis The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery—(extended) pleurectomy decortication—versus no surgery for the treatment of pleural mesothelioma. …”
Get full text

Multi-cancer early detection tests for general population screening: a systematic literature review by Ros Wade, Sarah Nevitt, Yiwen Liu, Melissa Harden, Claire Khouja, Gary Raine, Rachel Churchill, Sofia Dias

“…Thirty-six studies met the inclusion criteria: 1 ongoing randomised controlled trial, 13 completed cohort studies, 17 completed case-control studies and 5 ongoing cohort or case-control studies. …”
Get full text

Effectiveness of case management interventions for frequent users of healthcare services: a scoping review by Catherine Hudon, Maud-Christine Chouinard, Isabelle Dufour, Mireille Lambert, Cynthia Krieg

“…Eligible designs included randomised and non-randomised controlled trials and controlled and non-controlled before–after studies. …”
Get full text