Enhancing patient engagement: the influence of an in-consult patient decision aid on shared decision-making for lung tumour radiation – protocol for the randomised trial ‘SDM Lung... by Karina Dahl Steffensen, Signe Timm, Torben Frøstrup Hansen, Thomas Leth Fink, Charlotte Kristiansen, Torben Schjødt Hansen, Rune Slot Thing

“…Secondary outcomes are patient-reported outcomes, quality of life and side effects following treatment.Ethics and dissemination All patients give informed consent to participate. …”
Get full text

The effect of an additional pre-extubational loading dose of caffeine citrate on mechanically ventilated preterm infants (NEOKOFF trial): Study protocol for a multicenter randomize... by Kinga Kovács, Rita Nagy, Lilla Andréka, Brigitta Teutsch, Miklós Szabó, Péter Varga, Péter Hegyi, Péter Hársfalvi, Nándor Ács, Ágnes Harmath, Csaba Nádor, Ákos Gasparics

“…<h4>Trial registration number</h4>The study protocol was approved by the Hungarian Ethics Committee for Clinical Pharmacology of the Medical Research Council and National Institute of Pharmacy and Nutrition (OGYÉI/6838-11/2023). …”
Get full text

Protocol for a systematic review on routine use of antibiotics for infants less than 6 months of age with growth failure/faltering by Jai K Das, Zulfiqar Ahmed Bhutta, Abigail Smith, Aamer Imdad, Emily Tanner-Smith, Melissa François, Fanny F Chen, Olivia J Tsistinas

“…We will use the Grading of Recommendations Assessment, Development, and Evaluation approach to reporting the overall evidence quality for an outcome.Ethics and dissemination This is a systematic review and will not involve contact with a human subject. …”
Get full text

Characteristics of Slovenian Adults in Community-Based Whole-Food Plant-Based Lifestyle Program by Boštjan Jakše, Barbara Jakše, Stanislav Pinter, Jernej Pajek, Nataša Fidler Mis

“…The motives for WFPB lifestyle included health benefits (score: 7.9/8), body mass management (6.3), eating to satiety (4.9), convenience (4.3), environmental concerns (4.1), affordability (3.7), animal ethics (3.6), and religious reasons (1.1). Conclusion. …”
Get full text

Why do acute healthcare staff engage in unprofessional behaviours towards each other and how can these behaviours be reduced? A realist review protocol by Ruth Abrams, Aled Jones, Johanna Westbrook, Jill Maben, Russell Mannion, Judy M Wright, Mark Pearson, Justin Avery Aunger

“…We seek to go beyond these, to understand the range and causes of such behaviours, their negative effects and how mitigation strategies may work, in which contexts and for whom.Methods and analysis This study uses a realist review methodology with stakeholder input comprising a number of iterative steps: (1) formulating initial programme theories drawing on informal literature searches and literature already known to the study team, (2) performing systematic and purposive searches for grey and peer-reviewed literature on Embase, CINAHL and MEDLINE databases as well as Google and Google Scholar, (3) selecting appropriate documents while considering rigour and relevance, (4) extracting data, (5) and synthesising and (6) refining the programme theories by testing the theories against the newly identified literature.Ethics and dissemination Ethical review is not required as this study is a secondary research. …”
Get full text

Phase I trial on the safety of olprinone for low central venous pressure management aimed at haemorrhage control during open and laparoscopic hepatectomy: a study protocol by Katsuhiko Uesaka, Yuya Miura, Teiichi Sugiura, Ryo Ashida, Katsuhisa Ohgi, Mihoko Yamada, Shimpei Otsuka, Yoshiyasu Kato, Takuya Oyakawa, Eiji Ando, Sunao Tamai

“…This could lead to reduced blood loss, shorter operative time and fewer postoperative complications.Ethics and dissemination The study protocol was approved by the Certified Review Board of Shizuoka Cancer Center (approval number CRB4180010).Trial registration number jRCTs041230110 and jRCTs041230111.…”
Get full text

Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial by Kenny A Rodriguez-Wallberg, Christina Bergh, Ali Khatibi, Annika Strandell, Mats Brännström, Caroline Stadelmann, Kristbjörg Heiður Olsen, Margareta Kitlinski, Susanne Liffner, Eva Lundborg, Göran Westlander, Gabriella Widlund, Åsa Magnusson

“…The primary outcome is to investigate if luteal phase support (LPS) by vaginal progesterone increases the chance of a live birth per randomised patient in a natural FET cycle compared with no LPS.Ethics and dissemination The trial was approved by the Swedish Ethical Review Authority (ID 2020-06774, 2021-02822 and 2022-01502-02) and the Swedish Medical Products Agency (ID nr 5.1-2020-102613). …”
Get full text

Neonatal morbidity after fetal exposure to antipsychotics: a national register-based study by Karin Kallen, Lisa Forsberg, Essi Heinonen, Katarina Wide, Ulrika Nörby

Get full text

Remote symptom monitoring with patient-reported outcomes and nudges during lung cancer immunotherapy in China (PRO-NET): protocol for a randomised controlled trial by Ping He, Yanan Luo, Zhenyu Shi, Yiqi Xia, Xiaolong Guan

“…Differences in HRQoL between the groups will be compared using general linear mixed model, accounting for potential confounding.Ethics and dissemination The study was approved by the Institutional Review Board of the Peking University protocol on 21 July 2024 (No. …”
Get full text

Assessing routine childhood vaccination acceptance, hesitancy and refusal in Cape Town, Western Cape, South Africa: a mixed-method study protocol by Charles Shey Wiysonge, Lindi Mathebula, Moleen Zunza, Sara Cooper

“…Finally, for phase III of the study, we will explore the behavioural and social drivers of childhood vaccination from the perspective of 20–25 healthcare workers providing vaccinations to children aged 0–2 years purposively sampled from primary healthcare facilities.Ethics and dissemination Ethical approval was obtained from Stellenbosch University (S23/10/232). …”
Get full text

Protocol for the development of a reporting guideline for causal and counterfactual prediction models in biomedicine by Yi Guo, Hua Xu, Fei Wang, Jie Xu, Jiang Bian, Robert Lucero, Mattia Prosperi

“…Stage 5 will seek the peer-reviewed publication of the guideline, the scoping/systematic review and dissemination.Ethics and dissemination The study will follow the principles of the Declaration of Helsinki. …”
Get full text

Tough choices: the experience of family members of critically ill patients participating in ECMO treatment decision-making: a descriptive qualitative study by Xiangying Yang, Yao Lin, Amao Tang, Xiaokang Zeng, Weiying Dai, Qian Zhang, Li Ning

“…Results Eleven family members consented to ECMO treatment, and 8 refused. 4 themes and 10 subthemes emerged: (1) tough choices: the dilemma in the emergency situation, the guilt and remorse after giving up; (2) rationalisation of decision-making: ethics and morality guide decision-making, expected efficacy influences decision making, and past experience promotes decision making; (3) decision-making methods: independent decision-making, group decision-making, decision making based on patient preferences; (4) influencing factors of decision making: information and communication, social support. …”
Get full text

The Risk Assessment of Pesticide Ingestion with Fruit and Vegetables for Consumer’s Health by Gordana Jurak, Jasna Bošnir, Domagoj Đikić, Ana Mojsović Ćuić, Iva Pavlinić Prokurica, Aleksandar Racz, Tomislav Jukić, David Stubljar, Andrej Starc

Get full text

Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic (TRACE II): study protocol for a multicentre prospective observational study by Markus W Hollmann, Gert Jan Scheffer, Wolfgang Buhre, Sander van Kuijk, Seppe Koopman, Dianne de Korte-de Boer, Peter G Noordzij, Alice C Werger, Jennifer Breel, Carolien S E Bulte, Bas A in ‘t Veld, Carin G C L Wensing

“…Multivariable logistic mixed-effects regression analysis with a random intercept for hospital will be used to test group differences on the primary outcome.Ethics and dissemination Ethical approval was obtained from the Institutional Review Board of Maastricht University Medical Centre+ and Amsterdam UMC. …”
Get full text

Nurturing care during COVID-19: a rapid review of early evidence by Bernadette Daelmans, Tarun Dua, Vanessa Cavallera, Kristy Hackett, Kerrie Proulx, Rachel Lenzi-Weisbecker, Rachel Hatch, Carina Omoeva

Get full text

Protocols for the application of human embryonic stem cell-derived neurons for aging modeling and gene manipulation by Hui Zhang, Shuhui Sun, Juan Carlos Izpisua Belmonte, Guang-Hui Liu, Si Wang, Weiqi Zhang, Jing Qu

“…Our protocol enables investigations of the molecular mechanism underlying neuronal aging and facilitates drug evaluation.For complete details on the use and execution of this protocol, please refer to Zhang et al.1 : Publisher’s note: Undertaking any experimental protocol requires adherence to local institutional guidelines for laboratory safety and ethics.…”
Get full text

Experience of Kenyan researchers and policy-makers with knowledge translation during COVID-19: a qualitative interview study by Edwine Barasa, Benjamin Tsofa, Mike English, Sassy Molyneux, Dorcas Mwikali Kamuya, Fatuma Hassan Guleid, Alex Njeru, Joy Kiptim, Emelda Okiro, David Kariuki

Get full text

Willingness to donate eyes and associated factors among adults in Addis Ababa City, Ethiopia: a mixed-methods approach by Ejigu Gebeye Zeleke, Merkineh Markos Lorato, Wubalem Addis Tefera, Hirut Gebremeskel Mengistu

“…Data collection involved a pretested, semistructured questionnaire for quantitative data and an open-ended guiding questionnaire for qualitative insights. Ethical approval was granted by the University of Gondar, School of Medicine ethics review committee. …”
Get full text

Bilateral prophylactic mastectomy: should we preserve the pectoral fascia? Protocol of a Dutch double blinded, prospective, randomised controlled pilot study with a within-subject... by Cornelis Verhoef, Linetta B Koppert, Marloes E Clarijs, Laurentine S E van Egdom, Dalibor Vasilic, T. van Dalen, C. de Betue, J. Rothbarth, E.V.E. Madsen, L.M. Beelen, M.A.M. Mureau, E.M.L. Corten, A.J.M. Luijsterburg, M.J. Hop, H.M. Zuijdendorp, N.A.S. Posch, C.M.C.A. van Laarhoven, M. de Kraker

“…Secondary study outcomes include time to drain removal, number of needle aspirations, postoperative complications and length of hospital stay.Ethics and dissemination The study is approved by the Erasmus Medical Center Review Board (REC 2020–0431). …”
Get full text

Acupuncture as prophylaxis for chronic migraine: a protocol for a single-blinded, double-dummy randomised controlled trial by Claire Shuiqing Zhang, Bin Li, Lin Zeng, Lu Liu, Luo-peng Zhao, Kelun Wang, Jingxia Zhao, Linpeng Wang, Xianghong Jing

“…The primary outcome is the reduction of monthly headache days, and the secondary outcomes include the reduction of the number of days with acute headache medications, and changes of Migraine Disability Assessment, Migraine-Specific Quality of Life Questionnaire, Headache Impact Test, State-Trait Anxiety Inventory-trait, and Beck Depression Inventory-II scores from baseline to endpoints.Ethics and dissemination Ethical approval of this study was granted by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (2017BL-045-01). …”
Get full text