Effectiveness of a specialist palliative home care nurse–patient consultation followed by an interprofessional telephone case conference compared with usual care among patients wit... by Judith Dams, Hans-Helmut König, Tim Friede, Nils Schneider, Stephanie Stiel, Martin Scherer, Silke Böttcher, Gabriella Marx, Ingmar Schäfer, Nadine Janis Pohontsch, Hendrik van den Bussche, Friedemann Nauck, Michael Freitag, Eva Hummers, Tina Mallon, Franziska Schade, Manuel Zimansky, Thomas Asendorf, Christiane A Mueller

“…Intervention will be evaluated after the observation period using qualitative methods.Ethics and dissemination The responsible ethics committees of the cooperating centres approved the study. …”
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Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial — the PRE-STORK trial by Tina Vilsbøll, Signe S Torekov, Julie Lyng Forman, Romain Barrès, Andreas Andersen, Filip K Knop, Signe Foghsgaard, Klaus Bønnelykke, Thomas Bergholt, Karoline Kragelund Nielsen, Christina Anne Vinter, Majken Lillholm Pico, Louise Groth Grunnet, Nina Kornerup, Julie Hagstrøm Danielsen, Ronni Eg Sahl, Mette Yun Johansen, Louise Kelstrup, Nida Ghauri, Emilie Grønlund, Lærke Lund

“…Children conceived during the trial will constitute a birth cohort, monitoring the effects on their health until the age of 18 years.Ethics and dissemination The trial has been approved by the Regional Committee on Health Research Ethics in the Capital Region of Denmark (identification number H-22011403) and will be conducted in agreement with the Declaration of Helsinki. …”
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Interventions for the management of post-COVID-19 condition (long COVID): protocol for a living systematic review and network meta-analysis by Paul Garner, Lawrence Mbuagbaw, Jason W Busse, Dena Zeraatkar, Thomas Agoritsas, Ariel Izcovich, Tari Turner, Lyn Turkstra, Roger S McIntyre, Rachel J Couban, Tyler Pitre, Sarah Kirsh, Tanvir Jassal, Michael Ling, Samantha Chakraborty, Signe A Flottorp

“…Therefore, the study is exempt from ethics review. We intend to deposit all data in a public repository and publish each iteration of the living review online.…”
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Protocol for the enhanced management of multimorbid patients with COPD and severe asthma: role of indoor air quality by Emili Vela, Isaac Cano, Josep Roca, Antoni Sisó-Almirall, Carme Hernandez, Ebymar Arismendi, Ramon Farré, Alba Gómez-López, María Figols, Antonio Montilla-Ibarra, Núria Sánchez-Ruano, Benigno Sánchez, Marta Sorribes, Jordi Piera-Jiménez, Jaume Benavent, Jose Fermoso, Rubèn González-Colom

“…Each cycle involves a targeted cocreation process following a mixed-methods approach with the active participation of patients, health professionals, managers and digital experts.Ethics and dissemination The Ethics Committee for Human Research at Hospital Clinic de Barcelona approved the protocol on 29 June 2023 (HCB/2023/0126). …”
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plaTform fOr Urinary tract infection diagnostiC evAluatioN (TOUCAN): a protocol for a prospective diagnostic accuracy study of point-of-care testing in patients suspected of acute... by Thomas R Fanshawe, Philip J Turner, Gail N Hayward, Margaret Glogowska, Alastair D Hay, Michael Moore, Mark Lown, Christopher C Butler, Mandy Wootton, Mark H Wilcox, Jane Freeman, Nicola Kenealy, Valerie Tate, Owain Llion, Rebecca Lowe

“…Secondary outcomes will include the symptom profile of patients presenting with uncomplicated UTI, a theoretical determination of how use of POCT results might change prescribing, an understanding of POCT failure rate and qualitative capture of the experiences of those using the POCT to deliver the study in primary care clinics.Ethics and dissemination Ethical approval was received from the London Central Research Ethics Committee (23/LO/0371) and the UK Health Research Authority. …”
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A consensus statement on child and family health during the COVID-19 pandemic and recommendations for post-pandemic recovery and re-build by Caroline A. B. Redhead, Sergio A. Silverio, Sergio A. Silverio, Elana Payne, Elana Payne, Mari Greenfield, Mari Greenfield, Sara M. Barnett, Anna Chiumento, Beth Holder, Helen Skirrow, Ofelia Torres, Carmen Power, Staci M. Weiss, Laura A. Magee, Soo Downe, Lucy Frith, Claire Cameron

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Iterative delivery of an implementation support package to increase and sustain the routine provision of antenatal care addressing alcohol consumption during pregnancy: study proto... by John Attia, Luke Wolfenden, Nicole Nathan, Melanie Kingsland, Olivia Wynne, Penny Reeves, Alix Hall, John Wiggers, Elizabeth J Elliott, Tameka McFadyen, Tracey W Tsang, Emma Doherty, Belinda Tully, Adrian John Dunlop, Ian Symonds

“…Economic and process evaluation measures will also be reported.Ethics and dissemination Ethical approval was obtained through the Hunter New England (16/11/16/4.07, 16/10/19/5.15) and University of Newcastle Human Research Ethics Committees (H-2017-0032, H-2016-0422) and the Aboriginal Health and Medical Research Council (1236/16). …”
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Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial by Ben J Marais, Joel Negin, James Johnston, Virginia Wiseman, Greg J Fox, Thu Anh Nguyen, Binh Hoa Nguyen, Viet Nhung Nguyen, Justin Beardsley, Guy Barrington Marks, Kavindhran Velen, Tho Dang, Hoang Anh Nguyen, Dinh Hoa Vu, Thu Thuong Do, Cuong Pham Duc, Huu Lan Nguyen, Huu Thuong Pham, Warwick Britton

“…Cost-effectiveness will be presented as an incremental cost per patient successfully treated and an incremental cost per quality-adjusted life-year gained.Ethics Ethical approval for the study was granted by The University of Sydney Human Research Ethics Committee (2019/676).Dissemination Study findings will be disseminated to participants and published in peer-reviewed journals and conference proceedings.Trial registration number ACTRN12620000681954.…”
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Motor Neuron Disease Systematic Multi-Arm Adaptive Randomised Trial (MND-SMART): a multi-arm, multi-stage, adaptive, platform, phase III randomised, double-blind, placebo-controlle... by Jeremy Chataway, Suvankar Pal, Charis Wong, Elizabeth Elliott, Jenna M Gregory, Siddharthan Chandran, Judith Newton, Shuna Colville, Maria Stavrou, Christopher J Weir, Nigel Stallard, Malcolm R Macleod, Michelle Steven, Richard Anthony Parker, Arpan R Mehta, Robert J Swingler, Mahesh K B Parmar, Rachel S Dakin, Jill Williamson

“…Using this novel trial design reduces time, cost and number of participants required to definitively (phase III) evaluate drugs and reduces exposure of participants to potentially ineffective treatments.Ethics and dissemination MND-SMART was approved by the West of Scotland Research Ethics Committee on 2 October 2019. …”
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Microbiota, parasitic infections and their relationship with nutritional status and neurocognitive functioning in children from Ecuador—Proyecto Guagua: research protocol for a cro... by Sandra Victoria Abril-Ulloa, Tannia Valeria Carpio-Arias, Renata Alejandra Alvarado-Barba, Cristina Gabriela Ríos-Romero, Pamela Vinueza-Veloz, Sueny Paloma Lima-dos-Santos, Sueny Paloma Lima-dos-Santos, Igor Eduardo Astudillo-Skliarova, Igor Eduardo Astudillo-Skliarova, Ruth Irene Arias-Gutiérrez, Manuel Pérez-Quintana, Henk-Jan Boele, Henk-Jan Boele, Henk-Jan Boele, María Fernanda Vinueza-Veloz

“…We also plan to test the hypothesis that an altered microbiota mediates the influence of malnutrition on neurocognitive functioning and parasitosis.Ethics and disseminationProyecto Guagua received ethical approval from the Ethics Committee of Universidad de Cuenca in July 2022. …”
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Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial by Li Wang, Li Jin, Yao Lu, Chen Zhang, He-Feng Huang, Yun Sun, Xian-hua Lin, Meng-xi Guo, Dan-dan Wu, Jian-lin Zhang, Cheng-liang Zhou, Chen-ming Xu, Song-chang Chen, Song-ying Zhang, Xiao-xi Sun, Yan-ting Wu

“…To demonstrate or refute a difference between the two groups, we plan to include 188 participants in each group; taking consideration of 20% of dropout, the total target sample size is 450.Ethics and dissemination Ethical approval was obtained from International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University Medical Science Research Ethics Committee (GKLW2016-16). …”
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Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial by Michael Walsh, Salim Yusuf, Chirag Parikh, Jessica Vincent, P J Devereaux, Francois Lamontagne, Matthew T V Chan, Richard Whitlock, Meaghan Cuerden, Amit X Garg, Andre Lamy, Daniel I Sessler, Kevin Teoh, Ainslie Hildebrand, Yunxia Zuo, Pallav Shah, Seyed Hesameddin Abbasi, Mackenzie Quantz, Jean-Pierre Yared, Nicolas Noiseux, Georgios Tagarakis, Antoine Rochon, Janice Pogue, Abbas Salehiomran

“…Ethics approval was obtained for additional serum creatinine recordings in consecutive patients enrolled at participating centres. …”
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Role of cardiac CT in the diagnostic evaluation and risk stratification of patients with myocardial infarction and non-obstructive coronary arteries (MINOCA): rationale and design... by Konstantinos Tsioufis, Haralambos Karvounis, George Giannakoulas, Theodoros Karamitsos, Ronny R Buechel, Konstantinos Kouskouras, Ioannis Vogiatzis, Konstantinos Toutouzas, Nathaniel R Smilowitz, Georgios P Rampidis, Polydoros Ν Kampaktsis, Athanasios Samaras, Georgios Benetos, Andreas Α Giannopoulos, Alexandros Kallifatidis, Antonios Samaras, Stavros Hadjimiltiades, Antonios Ziakas, Catherine Gebhard, Panagiotis Prassopoulos, Harmony Reynolds

“…MINOCA-GR aims to be the first study to explore the role of CCTA in combination with CMR and ICA in the underlying pathophysiological mechanisms and assisting in diagnostic evaluation and prognosis of patients with MINOCA.Ethics and dissemination The study protocol has been approved by the institutional review board/independent ethics committee at each site prior to study commencement. …”
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Evaluation of parent and youth experiences in advisory groups as part of a mental healthcare clinical trial: protocol for a mixed-method study by Maria-Jose Santana, Gina Dimitropoulos, Suneeta Monga, Isabelle J Gagnon, Bruce Wright, Jananee Rasiah, Katrina Hurley, Antonia Stang, Amanda Newton, Stephen Freedman, Jennifer Thull-Freedman, Kassi Prisnie, Yazid N Al Hamarneh, Ellen Louise Lipman, Yaron Finkelstein, Robert Porter, Mohamed Eltorki, Lee Macdonald, Gareth Hopkin, Matthew Prebeg, Margaret Steele, Ahmed Mater, Laurence Katz, Brian Greenfield, Laurie Plotnick

“…Data from open-ended questions from the PPEET questionnaires and semi-structured interviews will be analysed using thematic analysis.Ethics and dissemination Approval from Athabasca University Research Ethics Board will be obtained for this project. …”
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Signature for Pain Recovery IN Teens (SPRINT): protocol for a multisite prospective signature study in chronic musculoskeletal pain by Fiona Campbell, Jennifer Stinson, Sara E Williams, Christopher D King, Laura Simons, Massieh Moayedi, Robert C Coghill, Martin S Angst, Nima Aghaeepour, Brice Gaudilliere, Marina López-Solà, Marie-Eve Hoeppli, Emma Biggs, Ed Ganio, Kenneth R Goldschneider, Danielle Ruskin, Elliot J Krane, Suellen Walker, Gillian Rush, Marissa Heirich

“…As foreign institutions, the University of Toronto and The Hospital for Sick Children (SickKids) are overseen by their respective ethics boards. All participants provide signed informed consent. …”
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Rationale and design of a multicentre randomised controlled trial on circulating tumour DNA-guided neoadjuvant treatment strategy for locally advanced rectal cancer (CINTS-R) by Bin Wu, Yi Xiao, Xiao Zhang, Tao Xu, Qian Liu, Wei Fu, Yang An, Yongheng Li, Guole Lin, Huadan Xue, Guoju Wu, Jiaolin Zhou, Hongwei Yao, Zhenjun Wang, Weijie Chen, Junyang Lu, Guannan Zhang, Xiaoyuan Qiu

“…The secondary endpoints include time to recurrence, 2-year overall survival, 2-year disease-free survival, clinical complete response (cCR) rate, near cCR rate and pathologically complete response rate, pathological tumour regression grade and quality of life.Ethics and dissemination This protocol has been approved by the ethics committee of Peking Union Medical College Hospital, with approval number I-23PJ157, and by the institutional review boards of all the participating centres. …”
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Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial by Patrick WHE Vriens, Edith M Willigendael, Maarten A Lijkwan, Friedo W Dekker, Chava L Ramspek, Michiel W de Haan, Çaĝdaş Ünlü, Boudewijn DC Heggen, Koen E A van der Bogt, Marc H Hemmelder, Mickaël J C Hiligsmann, Magda M van Loon, Joris I Rotmans, Jan H M Tordoir, Geert Willem H Schurink, Maarten G J Snoeijs, Marijke J Molegraaf, Philippe WM Cuypers, Denise Nio, Cora H Arts, Jacobien C Verhave, Goos D Laverman, Aron S Bode, Marcel C Weijmer, Bas Govaert, Aaltje Y Adema, Gijs MJM Welten, Michel MPJ Reijnen, Marc JH Groeneveld, Hans S Brink, Jeroen B van der Net, Arno Kuijper, Hilde PE Peters, Roos C van Nieuwenhuizen, Rombout R Kruse, Yvonne C Schrama, Karina A de Groot, Karima Farhat

“…The study was approved by an accredited medical ethics review committee. The results will be disseminated through peer-reviewed publications and will be implemented in clinical practice guidelines.Trial registration number NL7933.Protocol version and date V.5, 25 February 2021.…”
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Study protocol of a pilot randomised controlled trial assessing the feasibility and acceptability of RecoverEsupport: a digital health intervention to enhance recovery in women und... by Christopher Oldmeadow, Mitch J Duncan, Penny Reeves, Priscilla Viana da Silva, Rebecca Wyse, Helen Moore, Alison Zucca, Sancha Robinson, Stephen Ridley Smith, Emma Sansalone, Owen Morris, Rebecca Chenery, Lara Riley, Anna Palazzi-Parsons

“…Data regarding patient behaviours related to patient-managed ERAS recommendations, Quality of Life, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Quality of Recovery (QOR-15), Anxiety (Hospital Anxiety and Depression Scale), hospital readmissions, emergency department presentations and health service utilisation postdischarge will also be collected.Ethics and dissemination This study has been approved by the Human Research Ethics Committees of the Hunter New England Local Health District (2022/ETH02010), the University of Newcastle (H-2023–0298) and the Calvary Mater Newcastle (2022/STE03757). …”
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Effectiveness–implementation hybrid-2 randomised trial of a collaborative Shared Care Model for Detecting Neurodevelopmental Impairments after Critical Illness in Young Children (D... by Paula Lister, Kristen Gibbons, Zephanie Tyack, Luregn J Schlapbach, Samudragupta Bora, Maria Isabel Castillo, James Best, Debbie Long, Helen G Liley, Belinda Dow, Kerri-Lyn Webb, Christian Stocker, Debra Thoms, Carolyn Wharton, Lori Matuschka

“…An implementation evaluation will analyse barriers to and facilitators of the intervention.Ethics and dissemination The study is expected to lead to a full trial, which will provide much-needed guidance about the clinical effectiveness and implementation of follow-up models of care for children after critical illness or injury. …”
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Impact of prior SARS-CoV-2 infection and COVID-19 vaccination on the subsequent incidence of COVID-19: a multicentre prospective cohort study among UK healthcare workers – the SIRE... by Nick Andrews, Mary Ramsay, Maria Zambon, Victoria Hall, Sarah Wallace, Susan Hopkins, Jean Timeyin, Tim J G Brooks, Amoolya Vusirikala, Meera Chand, Andre Charlett, Sakib Rokadiya, Colin S Brown, Madhumita Shrotri, Peter D Kirwan, Michele Cole, Natalie Gillson, Ana Atti, Sarah Foulkes, Andrew Taylor-Kerr, Blanche Oguti, Jasmin Islam

“…Secondary outcomes include incidence and prevalence (both RNA and antibody) of SARS-CoV-2, viral genomics, viral culture, symptom history and antibody/neutralising antibody titres.Ethics and dissemination The study was approved by the Berkshire Research Ethics Committee, Health Research Authority (IRAS ID 284460, REC reference 20/SC/0230) on 22 May 2020; the vaccine amendment was approved on 12 January 2021. …”
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