Vaginal hysterectomy versus vaginal assisted NOTES hysterectomy (VANH): a protocol for a randomised controlled trial by Merel Kimman, Ilse Bekkers, Lynn Hoen, Huib A A M van Vliet, Nicol A C Smeets, Anne Damoiseaux, Martine M L H Wassen

“…Secondary outcomes are; surgery-related complications, surgical outcomes, postoperative recovery, quality of life, costs and cost-effectiveness.Ethics and dissemination The study was approved on 27 May 2021 by the Ethics Committee of the Zuyderland Medical Centre Heerlen. …”
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Patient and family engagement in infection prevention in the context of the COVID-19 pandemic: defining a consensus framework using the Q methodology – NOSO-COVID study protocol by Laurence Bernard, Nathalie Camille Clavel, Mélanie Lavoie-Tremblay, Alain Biron, Anaick Briand, Jesseca Paquette, Carol Fancott, Marie-Pascale Pomey, Vincent Dumez

“…This exploratory Q research approach will provide a structured way to elicit the stakeholders’ perspectives on patient and family engagement in infection prevention.Ethics and dissemination The research ethics board approved this study. …”
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Observational study protocol: the faecal microbiome in the acute stage of new-onset paediatric type 1 diabetes in an Irish cohort by Eugene Dempsey, Catherine Stanton, Paul Ross, Colin Patrick Hawkes, Aonghus Lavelle, Carol-Anne O’Shea, Elaine Catherine Kennedy, Fiona Catherine Ross

“…Through this initial exploratory study, we aim to identify specific microbial biomarkers which may be used as future interventional targets throughout the various stages of T1D progression.Ethics and dissemination This study has been approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals. …”
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Improving patient safety through better teamwork: how effective are different methods of simulation debriefing? Protocol for a pragmatic, prospective and randomised study by Wolf E Hautz, Juliane E Kämmer, Julia Freytag, Fabian Stroben, Dorothea Eisenmann

“…Analyses will include descriptive, inferential and explorative statistics.Ethics and dissemination The study protocol was approved by the institutional office for data protection and the ethics committee of Charité Medical School Berlin and registered under EA2/172/16. …”
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Mapping existing research on flushing peripheral vascular catheters: a scoping review protocol by Liping Liu, Peter J Carr, Orlaith Hernon, Jiaxin Deng, Catriona Duggan, Leo R Quinlan, Zina Alfahl

“…The reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews, with the results and discussion structured according to the Patterns, Advances, Gaps, Evidence for practice and Research recommendations framework.Ethics and dissemination Ethics approval is not required for this study. …”
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Promoting physical activity in vulnerable adults ‘at risk’ of homelessness: a randomised controlled trial protocol by Sarah E Jackson, Lee Smith, Charlotte Stringer, Mike Loosemore, Eloise Moller, Guillermo Felipe López-Sánchez, Joseph Firth, James Johnstone, Brendon Stubbs, Davy Vancampfort

“…Changes in drug use and alcohol dependency will also be explored.Ethics and dissemination Ethical approval to process and analyse data and disseminate findings was obtained through the Anglia Ruskin University Department of Sport and Exercise Sciences Research Ethics Committee. …”
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Assessing research methodologies used to evaluate inequalities in end-of-life cancer care research: a scoping review protocol by Sam Harper, Natalie G Coburn, Alyson L Mahar, Laura E Davis, Julie Hallet, Peter Tanuseputro, Geetanjali D Datta, Colleen Webber, Allison Wiens, Lauren Konikoff

“…Extracted information will be summarised quantitatively and qualitatively.Ethics and dissemination No ethics approval is required for this scoping review. …”
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DEPEND study protocol: early detection of patients with pancreatic cancer – a pilot study to evaluate the utility of faecal elastase-1 and 13C-mixed triglyceride breath test as scr... by Christopher D Byrne, Sam Wilding, Paul Remi Afolabi, Declan McDonnell, Victoria Goss, Jocelyn Walters, Zaed Z Hamady

“…Potential biomarkers of PC showing abilities to discriminate between patients with PC from healthy subjects or patients with chronic pancreatitis will be selected by metabolomic analysis.Ethics and dissemination The study was approved by the North of Scotland Research and Ethics Committee on 1 October 2020 (reference: 20/NS/0105, favourable opinion granted). …”
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Comparative efficacy and safety of neoadjuvant radiotherapy for patients with borderline resectable, and locally advanced pancreatic ductal adenocarcinoma: a systematic review and... by Xin Wang, Dan Cao, Qingfeng Wang, Qiancheng Hu, Wanrui Lv

“…As no primary data collection will be undertaken, no ethics approval is required. The results will be disseminated through peer-reviewed journal.PROSPERO registration number CRD42020222408.…”
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Total glucosides of paeony for rheumatoid arthritis: a protocol for a systematic review by Jing Luo, Guo-Yan Yang, Di-Er Jin, Ying-Ze Zhang, Jian-Ming Wang, Wei-Ping Kong, Qing-Wen Tao

“…Possible publication bias will also be checked using funnel plots once the number of included studies is sufficient.Ethics and dissemination Ethics approval is not required, as this study will not involve patients. …”
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Detection of exhaled methane levels for monitoring trauma-related haemorrhage following blunt trauma: study protocol for a prospective observational study by Péter Jávor, Ferenc Rárosi, Tamara Horváth, László Török, Endre Varga, Petra Hartmann

“…The relation of exhaled CH4 to study outcomes and its performance in predicting blood loss in comparison with conventional shock markers and microcirculatory indices will be tested.Ethics and dissemination Our protocol (ID: 5400/2021-SZTE) has been registered on ClinicalTrials.gov (NCT04987411) and complies with the Declaration of Helsinki and has been approved by the medical ethics committee at the University of Szeged (Ref.nr.:121/2021-SZTE RKEB). …”
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The efficacy of mindfulness-based interventions for patients with COPD: a systematic review and meta-analysis protocol by Li Li, Ying Wu, Ying Zhang, Lingyun Tian, Yinglan Li

“…All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0.Ethics and dissemination Since this study is a systematic review, the findings are based on the published evidence. …”
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Physical functioning outcome measures in the lumbar spinal surgery population and measurement properties of the physical outcome measures: protocol for a systematic review by Alison B Rushton, Jai Mistry, Michael J Lukacs, Katie L Kowalski, Maren Goodman

“…Results for each measurement property per physical outcome measure will be quantitatively pooled if there is adequate clinical and methodological homogeneity or qualitatively synthesised if there is high heterogeneity in studies.Ethics and dissemination Ethics approval is not required. …”
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Study protocol for virtual leisure investigating the effect of virtual reality-delivered stress reduction, entertainment and distraction on the use of coercion and need-based medic... by Julie Midtgaard, Lars Clemmensen, Louise Birkedal Glenthøj, Gry Jørgensen, Kristina Ballestad Gundersen, Lisa Charlotte Smith, Stephane Bouchard, Christina Plambøck Thomsen, Louise Turgut

“…The study began on 1 January 2023, and we expect to complete data collection by 31 December 2024.Ethics and dissemination The study is registered at Danish Data Protection Agency (j.no P-2022-466) and is approved by the Committee on Health Research Ethics of the capital region of Denmark (j.no 22013313). …”
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Accepting your Body after Cancer (ABC), a group-based online intervention for women treated for breast cancer: study protocol for a feasibility randomised controlled trial by Sarah Byford, Abigail Jones, Shelley Potter, Paul White, Diana Harcourt, Helena Lewis-Smith, Patricia Fairbrother

“…Qualitative data will also be collected to better understand the feasibility and acceptability of the research process and intervention, with data analysed using ‘codebook’ thematic analysis.Ethics and dissemination The study has received ethical approval from the Newcastle North Tyneside Research Ethics Committee (ref: 24/NE/0092). …”
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The Impact of DNA Methylation on IL6 mRNA Levels in Hematinic Deficiency and Atopy-Associated Recurrent Aphthous Stomatitis Patients by Nanan Nur’aeny, Dida Akhmad Gurnida, Oki Suwarsa, Irna Sufiawati

“…Hasan Sadikin Hospital, Bandung, from January–March 2019 and was approved by the Health Research Ethics Committee of Universitas Padjadjaran (Ethics No. 990/UN6.KEP/EC/2018). …”
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Role of the regulator in enabling a just culture: a qualitative study in mental health and hospital care by Roland Bal, Ian Leistikow, Jan-Willem Weenink, Iris Wallenburg, Guy Widdershoven, Laura Hartman, Eva van Baarle

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Understanding recruitment to a perioperative randomised controlled trial: protocol for a mixed-methods substudy nested within a feasibility trial of octreotide infusion during live... by Duncan Wagstaff, S Ramani Moonesinghe, Jez Fabes, Michael Spiro, Edgar Brodkin, Ee-Neng Loh, Vivienne Hannon

“…Findings from both workstreams will be formatively fed back to the trials team to enable iterative improvement to recruitment processes.Ethics and dissemination Approval has been granted by Greater Manchester West Research Ethics Committee (ref 20/NW/0071), the Health Research Authority and the local Research and Development offices. …”
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Exploring social capital for family caregivers of patients with chronic organ failure: study protocol for a concept mapping study by Kai Chow Choi, Carmen Wing Han Chan, Marques Shek Nam Ng, Winnie Kwok Wei So, Wallace Chi Ho Chan, Helen Yue Lai Chan

“…The findings will be presented to the public to produce recommendations for social policy.Ethics and dissemination This study was approved by The Chinese University of Hong Kong Survey and Behavioural Research Ethics Committee (Reference No.: SBRE-20-714). …”
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Cluster randomised controlled trial on the effects of long-term home-based exercise for patients with chronic obstructive pulmonary disease with recent exacerbation: research proto... by Ulla Møller Weinreich, Lars Pilegaard Thomsen, Jane Andreasen, Anna Lei Stoustrup, Thorvaldur S Palsson

“…A cost-effectiveness analysis will assess the impact on disease prevention and hospitalisation.Ethics and dissemination This study, approved by The North Denmark Region Committee on Health Research Ethics (N-20230008) and compliant with the Helsinki Declaration, includes annual safety and progress reporting of potential adverse events. …”
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