CHI study: protocol for an observational cohort study on ageing and mental health in community-dwelling older adults by Lei Feng, Lieng Hsi Ling, Qiushi Feng, Rachael Zhi Yi Lee, Junhong Yu, Iris Rawtaer, Patrick Finbarr Allen, Zhiming Bao, Jeong Kyu Lee, Chin Tat Lim, Leng Leng Thang, Thet Naing, D Y Wang, Kai Zhen Yap, EH Kua, Rathi Mahendran

“…The Community Health and Intergenerational study aims to holistically examine ageing in place by investigating the resilience and vulnerability factors of the ageing process in the biological, psychological and social domains within the environment.Methods and analysis Using a cohort multiple randomised controlled trial design, comprehensive health profiles of community-dwelling older adults will be collected. …”
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Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and i... by Sofia Ramiro, Désirée van der Heijde, Atul Deodhar, Xenofon Baraliakos, Denis Poddubnyy, Lianne S Gensler, Helena Marzo-Ortega, Natasha de Peyrecave, Victoria Navarro-Compán, Tetsuya Tomita, Carmen Fleurinck, Ute Massow, Thomas Vaux

“…Objective Assess long-term safety, tolerability and efficacy of bimekizumab in ankylosing spondylitis (radiographic axial spondyloarthritis (r-axSpA)).Methods Patients with active r-axSpA completing the dose-ranging 48-week randomised controlled trial could enrol in the open-label extension, where patients received bimekizumab 160 mg every 4 weeks. …”
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Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes: the Youth Empowerment Skill... by Nick Sevdalis, Khalida Ismail, Tayana Soukup, Trevor Murrells, Dulmini Kariyawasam, Stephen Thomas, Judith Parsons, Angus Forbes, Rita Forde, Maria Baldellou Lopez, Marie Jones, Martha Ford-Adams, Nardos Yemane, Siobhan Pender, Alex Silverstien

“…We will conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. …”
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Mamá Empoderada: study protocol for a pilot trial of a novel parenting and mental health prevention intervention for migrant mothers with young children at the Mexico-US border by Gudelia Rangel, Shira M Goldenberg, Eileen Pitpitan, Kaylee Ramage, Ietza Bojorquez-Chapela, Cecilia Martinez-Torteya, Katherine Rosenblum, Chelsie Hernandez, Monica Alvarez

“…We have recently adapted this intervention for MMC in Mexico and will conduct a pilot randomised controlled trial (RCT) of the intervention with MMC (n=100; Ntreatment=50; Ncontrol=50). …”
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Identifying barriers and potential solutions to improve equitable access to community eye services: an exploratory sequential mixed methods study protocol by Min Kim, David Macleod, Michael Gichangi, Andrew Bastawrous, Matthew J Burton, Jacqueline Ramke, Oathokwa Nkomazana, Sailesh Mishra, Shalinder Sabherwal, Luke Nelson Allen, Abhishek Roshan, Sarah Karanja, Ari Ho-Foster, Keneilwe Motlhatlhedi, Nigel Bolster, Mohd Javed, Malebogo Tlhajoane, Bakgaki Ratshaa, John Tlhakanelo

“…The most promising service modifications will be implemented and evaluated in a follow-on randomised controlled trial, the methods for which will be reported elsewhere.Ethics and dissemination This project has been approved by independent research ethics committees in Botswana, Kenya, India, Nepal and the UK. …”
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Patients’ acceptability and implementation outcomes of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia: a qualita... by Tempei Miyaji, Yosuke Uchitomi, Hiroyuki Okada, Masatoshi Inagaki, Maiko Fujimori, Taichi Shimazu, Masaki Fujiwara, Masafumi Kodama, Ryuhei So, Takanori Matsushita, Yusaku Yoshimura, Shigeo Horii, Hirokazu Takahashi, Naoki Nakaya, Shiro Hinotsu, Keita Harada, Norihito Yamada, Yuto Yamada, Tsuyoshi Etoh

“…Simultaneously, the study aimed to determine the acceptability, appropriateness and feasibility of the intervention from the perspective of psychiatric care providers.Study design and setting This study was a secondary qualitative analysis of a mixed-method randomised controlled trial that evaluated the efficacy of the CM approach to encourage participation in cancer screening for people with schizophrenia. …”
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Antenatal pelvic floor muscle exercise intervention led by midwives in England to reduce postnatal urinary incontinence: APPEAL feasibility and pilot randomised controlled cluster... by Karla Hemming, Jonathan Bishop, Sarah Dean, Jean Hay-Smith, Tim Coleman, Elizabeth Edwards, Christine MacArthur, Debra Bick, Mark Pearson, Rohini Terry, Eivor Oborn, Sara Webb, Eleni Gkini, Victoria Salmon, Ellie Jones, Helena Frawley

“…Objectives To assess the feasibility of an intervention of midwifery support for antenatal pelvic floor muscle exercises (PFME) to prevent postnatal urinary incontinence (UI).Design Feasibility and pilot cluster randomised controlled trial. Clusters were community midwifery teams.Setting Community maternity antenatal care.Participants One hundred seventy-five women; 186 midwives.Intervention Midwifery training and resources for midwives and women to support antenatal PFME. …”
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Can nebulised heparin reduce acute lung injury in patients with SARS‑CoV‑2 requiring advanced respiratory support in Ireland: the CHARTER‑Ireland phase Ib/IIa, randomised, parallel... by David Cosgrave, Bairbre McNicholas, Ciara Hanley, John Robert Sheehan, Padraig Calpin, Maeve Kernan, Darragh Murphy, Alberto Alvarez‑Iglesias, John Ferguson, Camilla Giacomini, Christine Greene, Catriona Cody, Shane McGeary, Marion Murphy, Marianne Fitzgerald, Gerard Curley, Barry Dixon, Roger J. Smith, Claire Masterson, Daniel O’Toole, Frank van Haren, John G. Laffey

“…Methods This was a phase Ib/IIa open-label multi-centre, randomised controlled trial. The study was designed to evaluate whether nebulised unfractionated heparin decreased d-dimer concentrations, with safety as a co-primary outcome. …”
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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. …”
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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). …”
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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. …”
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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. …”
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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. …”
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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. …”
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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. …”
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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. …”
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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. …”
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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. …”
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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. …”
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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. …”
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