Developing a core outcome set for assessing interventions and care for parents after neonatal death in high-income countries (iCHOOSE Neonatal study): protocol for a mixed-methods... by James Webbe, Mehali Patel, Danya Bakhbakhi, Christy Burden, Mary Lynch, Laura Timlin, Lisa Hinton, Abigail Fraser, Anna Davies, Maggie Redshaw, David Odd, Charlotte Williams, Dimitris Siasakos, Abi Merriel, Sadie Mullin, Lucy Moy, Leanne Watts

“…A parent involvement group and stakeholder steering committee have been established and have informed each planned phase: (1) systematic review of quantitative studies evaluating care and interventions provided after neonatal death, to describe interventions, outcomes and outcome measurement tools used to assess intervention effectiveness; (2) qualitative interviews with parents who have experienced neonatal death to identify outcomes important and relevant to them; (3) think-aloud interviews with stakeholders (bereaved parents, healthcare professionals and other stakeholders) to develop and refine an online survey; (4) real-time online international Delphi survey with bereaved parents, healthcare professionals and other stakeholders to shortlist outcomes for consideration in the COS; (5) adapted nominal group online consensus meetings with parents, healthcare professionals and other stakeholders to agree final COS and (6) identification of a preliminary set of measurement tools.Ethics and dissemination Ethical approval has been granted for all activities to be undertaken by the University of Bristol Health Sciences Faculty Research Ethics Committee (reference: 15121). …”
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RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B study by Andrea Miranda-Mendizabal, Diana Vetter, Juan Zambrano, Jeff Zarp, Victor Chavarría, Anna Giménez-Palomo, Meritxell Gonzalez-Campos, Marc Valenti, Lara Walczer Baldinazzo, Sara Siddi, Maurizio Ferrari, Dinah Weissmann, Chantal Henry, Josep Maria Haro, Lars Vedel Kessing, Eduard Vieta

“…The Research Ethics Committees of the participating centres approved the study. …”
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Air pollution exposures in early life and brain development in children (ABC): protocol for a pregnancy cohort study by John Kinuthia, R Scott McClelland, Barbra A Richardson, Elizabeth Maleche-Obimbo, Brent R Collett, Sarah Benki-Nugent, Faridah H Were, Anne M Riederer, Michael Gatari, CJ Karr, Edmund YW Seto, Beatrice C Mutai, Susan Wamithi, Priscilla Wanini Edemba, Timothy V Larson, Julian D Marshall

“…Additional exposure assessment in a subset of the cohort includes residential indoor and outdoor air monitoring for fine particulate matter (PM2.5), carbon monoxide (CO), ultrafine particles (UFP) and black carbon (BC).Ethics and dissemination This study was approved by the Kenyatta National Hospital - University of Nairobi Ethics and Research Committee, and the University of Washington Human Subjects Division. …”
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Protocol for the implementation evaluation of an integrated paediatric and primary care model: Strengthening Care for Children (SC4C) by Yvonne Zurynski, Susan Woolfenden, Peter D Hibbert, Harriet Hiscock, Raghu Lingam, Karen Wheeler, Michael Hodgins, Jade Burley, Rachel Pelly, Jane Le, Sonia Khano, Tammy Meyers Morris, Stephanie Germano

“…An inductive approach to the analysis of qualitative data will identify additional emerging themes that may not be covered by the formal frameworks underpinning our analysis.Ethics and dissemination Ethical approval was granted by the Royal Children’s Hospital Ethics Committee in August 2020 (HREC: 65955). …”
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Effect of propofol and ciprofol in patients undergoing bronchoscopy: protocol for a double-blind, randomised controlled trial by Fang Chen, Cheng Li, Dongliang Li, Jinxuan Tang, Jiayu Huang

“…The secondary outcomes are the incidence of choking and injection pain, the type and dose of vasoactive drugs used during the operation, and the level of postoperative satisfaction among surgeons, anaesthesiologists and patients.Ethics and dissemination This trial was approved by the Medical Ethics Committee of Shanghai Fourth People’s Hospital, School of Medicine, Tongji University and registered with the Chinese Clinical Trials Registry (Identifier: ChiCTR2200063048) on 29 August 2022. …”
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Establishing primary care physician commitment in Canadian long-term care homes: a protocol for a modified e-Delphi study by Andrew P Costa, Aaron Jones, Darly Dash, Paula Rochon, Patrick Quail, Rachel D Savage, Henry Yu-Hin Siu, Lisa M McCarthy, Nathan Stall, Dee Tripp, Maya Potter, Paul Katz, Samantha Peck

“…A second questionnaire will be distributed to evaluate the remaining statements that have not reached consensus, and any new statements added based on the same criteria.Ethics and dissemination The Hamilton Integrated Research Ethics Board (Project ID #17321) approved our study. …”
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Patient-centered outcomes for gastrointestinal cancer care: a scoping review protocol by Natalie G Coburn, Frances C Wright, Alyson L Mahar, Lesley Gotlib Conn, Julie Hallet, Amy T Hsu, Paul D James, Joanna Yang, Tori Barabash, Luckshi Rajendran, Claire Ludwig, Ekaterina Kosyachkova, Julie Deleemans

“…The data from full texts will be extracted, charted and summarised both quantitatively and qualitatively.Ethics and dissemination No ethics approval is required for this scoping review. …”
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Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, contro... by Stephanie Book, Elmar Graessel, Julia Schneider, Michael Jeitler, Petra Scheerbaum, Michael Jank, Etienne Hanslian, Melanie DellO’ro, Julia-Sophia Scheuermann, Sophia Bösl, Christian Kessler

“…The treatment phase is 6 months with follow-ups after six and 12 months after baseline.Ethics and dissemination All procedures were approved by the Friedrich-Alexander-Universität Erlangen-Nürnberg Ethics Committee (Ref. 21-318-1-B). …”
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Effectiveness of educational interventions to promote safe handling of pesticides: protocol for a systematic review and meta-analysis by Anne Cockcroft, Neil Andersson, Sergio Paredes-Solís, José Legorreta-Soberanis, Belén Madeline Sánchez-Gervacio, Víctor Manuel Alvarado-Castro, Miguel Flores-Moreno, Claudia Erika Rios-Rivera, Janet Saldaña-Almazán

“…Subgroup analyses will examine the impact of different kinds of educational interventions.Ethics and dissemination Ethics approval is not required as no information from individuals are collected. …”
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The Application of Machine Learning Algorithms to Predict HIV Testing in Repeated Adult Population–Based Surveys in South Africa: Protocol for a Multiwave Cross-Sectional Analysis... by Musa Jaiteh, Edith Phalane, Yegnanew A Shiferaw, Refilwe Nancy Phaswana-Mafuya

“…ResultsThe SABSSM datasets are open access datasets available on the HSRC database. Ethics approval for this study was obtained from the University of Johannesburg Research and Ethics Committee on April 23, 2024 (REC-2725-2024). …”
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Standardised protocol for a prospective cross-sectional multicentre clinical utility evaluation of two dual point-of-care tests in non-clinical settings for the screening of HIV an... by James Kiarie, Karel Blondeel, Igor Toskin, Jordi Casabona, Soe Soe Thwin, Massimo Mirandola, Rosanna Peeling, Ronald Ballard, Laura Fernàndez-López, Inga Upmace, Juliana Reyes-Urueña, Mara Vaselova, Mitja Ćosić, Simon Maljevac, William Mejías, Ander Pazos, Andrii Chernyshev

“…An analysis of the feasibility of introducing the dual POCT for the screening of HIV and syphilis in MSM at CBVCT services will be performed, by assessing its acceptability and usability at CBVCT service among MSM users and providers.Ethics and dissemination This core protocol was independently peer reviewed and approved by the Research Project Review Panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). …”
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Preoxygenation in difficult airway management: high-flow oxygenation by nasal cannula versus face mask (the PREOPTIDAM study). Protocol for a single-centre randomised study by Samir Jaber, Karim Asehnoune, Fanny Feuillet, Mickael Vourc’h, Donatien Huard, Gabrielle Baud, Arthur Guichoux, Marielle Surbled, Melanie Tissot, Anne Chiffoleau, Christophe Guitton

“…Intent-to-treat and per-protocol analysis are planned for the primary outcome.Ethics and dissemination The study project has been approved by an independent ethics committee. …”
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Prevalence and risk factors of postpartum depression, general depressive symptoms, anxiety and stress (PODSAS) among mothers during their 4-week postnatal follow-up in five public... by Boon How Chew, Subashini Ambigapathy, Saidatul Akmar Mohammad Redzuan, Priyasini Suntharalingam, Thenmoli Palaniyappan, Venotha Ganasan, Puteri Normalina Megat Abu Bakar, Paream Kaur, Lili Zuryani Marmuji, V Paranthaman

“…Besides descriptive statistics, multivariable regression analyses will be done to identify possible risk factors and their independent associations with depression (PPD and general depressive symptoms, combined and separately), anxiety and stress.Ethics and dissemination The study protocol was reviewed and approved by the Medical Research Ethics Committee, Ministry of Health Malaysia on 7 August 2019. …”
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Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled t... by Jie Qiao, Yan Wang, Rong Li, Ping Liu, Liang Hu, Lin Zeng, Guimin Hao, Jin Huang, Bing Yao, Junzhao Zhao, Juanzi Shi, Liyi Cai, Xiu-Xia Wang, Yanwen Xu, Yuanqing Yao, Yichun Guan, Weiping Qian, Sijia Lu

“…The primary outcome will be the ongoing pregnancy rate related to the first transfer cycle within 6 months after oocyte retrieval.Ethics and dissemination The study protocol is approved by the Ethics Committee of Peking University Third Hospital and the participating hospitals. …”
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Nissen-Sleeve procedure versus laparoscopic Roux-en-Y gastric bypass in patients with morbid obesity and gastro-oesophageal reflux disease: protocol for a non-inferiority randomise... by Jan A Apers, Martin Dunkelgrun, Ivonne Leeuwenburgh, Judith W H 't Hart, Bo J Noordman, Laser U Biter

“…Secondary outcome measures are long-term GORD improvement; failure rate of procedure; health-related quality of live; weight loss; proton pump inhibitor use; postoperative complications <30 days and >30 days; length of hospital stay; duration of primary surgery; effect on comorbidities; presence and grade of oesophagitis (grade A–D) and/or presence of Barrett’s oesophagus and cost-effectiveness.Ethics and dissemination The protocol was approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 15 September 2021. …”
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Intervening to eliminate the centre-effect variation in home dialysis use: protocol for Inter-CEPt—a sequential mixed-methods study designing an intervention bundle by Sarah Damery, Kerry Allen, Lisa Dikomitis, Harry Hill, David Coyle, Maatla Tshimologo, Mark Lambie, Simon J Davies, Iestyn Williams, James Fotheringham, Louise Phillips-Darby, Ivonne Solis-Trapala

“…Patient and public engagement and involvement is embedded throughout the project.Ethics and dissemination Ethics approval has been granted by the Health Research Authority reference 20-WA-0249. …”
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Effectiveness of progesterone supplementation in women presenting low progesterone levels on the day of frozen embryo transfer: a randomised controlled trial by Quang Thanh Le, Thi Minh Chau Le, Khue Tu Duong, Quoc Anh Nguyen, Phuc Thinh Ong, Thi Hong Nhung Nguyen, Thi Cam Thu Thai, Matheus Roque, Carlo Alviggi

“…Assuming a dropout rate of 10%, a total of 824 patients (412 per group) will be invited.Ethics and dissemination This study was approved by the Ethics Committee of Tu Du Hospital on 17 May 2021 (reference number: 1251/QĐ-BVTD). …”
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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-labe... by Ying Zhu, Jianwei Zhou, Zhigang Zhang, Jiaojiao Zhang, Jing Fei, Xiaoqing Zhu

“…The findings will contribute to the growing body of evidence in support of the incorporation of immunotherapy into the treatment paradigm for ovarian cancer, thus facilitating the development of more personalised and efficacious therapeutic modalities.Ethics and dissemination This trial has received ethical approval from the Institutional Ethics Committee of the Second Affiliated Hospital of the Medical College of Zhejiang University. …”
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Korean patients with hereditary cancer: a prospective multicentre cohort study protocol exploring psychosocial and health outcomes by Boyoung Park, Sun-young Kong, Dongju Won, Jong Eun Park, Jun-Kyu Kim, Mi-Ae Jang, Jung-Sook Ha, Kyoung-Bo Kim

“…The collected data will be linked to secondary sources such as cancer registries and National Health Insurance Service data to provide a comprehensive analysis of the impact of hereditary cancer on health and survival.Ethics and dissemination The study protocol was approved by all the Ethics Committees: the National Cancer Center IRB (NCC2023-0179), the Samsung Medical Center IRB (SMC2023-09-057), the Yonsei University Health System, Severance Hospital IRB (4-2023-0627), the Hanyang University Guri Hospital IRB (GURI2023-08-021) and the Keimyung University IRB (DSMC IRB 2024-05-048). …”
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The Australian and New Zealand Fontan Registry Quality of Life Study: Protocol for a population-based assessment of quality of life among people with a Fontan circulation, their pa... by Daniel S J Costa, Kim Dalziel, Yves d’Udekem, David S Winlaw, David S Celermajer, Nadine A Kasparian, Diana Zannino, Rachel Bishop, Kate H Marshall, Susan R Woolfenden, Gary F Sholler

“…Descriptive analyses and multilevel models will be used to examine QOL across groups and to investigate potential explanatory variables.Ethics and Dissemination Approval has been obtained from all relevant Human Research Ethics Committees (HRECs), including the Sydney Children’s Hospitals Network and the Royal Children’s Hospital Melbourne HRECs. …”
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