RANDOMIZED CONTROLLED TRIAL

Participant recruitment and attrition in surgical randomised trials with placebo controls versus non-operative controls: a meta-epidemiological study and meta-analysis
Pragadesh Natarajan, Spiro Menounos, Laura Harris, Masiath Monuja, Alexandra Gorelik, Teemu Karjalainen, Rachelle Buchbinder, Ian A Harris, Justine M Naylor, Sam Adie

BMJ Open Apr 2024, 14 (4) e080258; DOI: 10.1136/bmjopen-2023-080258
Cavitron ultrasonic surgical aspirator (CUSA) compared with conventional pancreatic transection in distal pancreatectomy: study protocol for the randomised controlled CUSA-1 pilot trial
Magdalena Holze, Martin Loos, Felix Hüttner, Solveig Tenckhoff, Manuel Feisst, Phillip Knebel, Rosa Klotz, Arianeb Mehrabi, Christoph Michalski, Frank Pianka

BMJ Open Apr 2024, 14 (4) e082024; DOI: 10.1136/bmjopen-2023-082024
Functional therapy and adenotonsillectomy clinical trial for class II malocclusion (FACT-II): protocol for a randomised controlled trial
Feiyang Guo, Chenxing Lv, Bojun Tang, Lizhuo Lin, Chen Zhang, Jie Zheng, Tingting Zhao, Hong He

BMJ Open Apr 2024, 14 (4) e079571; DOI: 10.1136/bmjopen-2023-079571
Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions
Leher Gumber, Opeyemi Agbeleye, Alex Inskip, Ross Fairbairn, Madeleine Still, Luke Ouma, Jingky Lozano-Kuehne, Michelle Bardgett, John D Isaacs, James MS Wason, Dawn Craig, Arthur G Pratt

BMJ Open Apr 2024, 14 (4) e077132; DOI: 10.1136/bmjopen-2023-077132
Predictive performance of machine learning compared to statistical methods in time-to-event analysis of cardiovascular disease: a systematic review protocol
Abubaker Suliman, Mohammad Masud, Mohamed Adel Serhani, Aminu S. Abdullahi, Abderrahim Oulhaj

BMJ Open Apr 2024, 14 (4) e082654; DOI: 10.1136/bmjopen-2023-082654
Impact of health education on promoting influenza vaccination health literacy in primary school students: a cluster randomised controlled trial protocol
Weiguang Xie, Jingyi Xiao, Jingyi Chen, Hanzhong Huang, Xuehua Huang, Shaoyi He, Lin Xu

BMJ Open Apr 2024, 14 (4) e080115; DOI: 10.1136/bmjopen-2023-080115
Do patients with type 2 diabetes mellitus included in randomised clinical trials differ from general-practice patients? A cross-sectional comparative study
Amandine Dugard, Bruno Giraudeau, Clarisse Dibao-Dina

BMJ Open Apr 2024, 14 (4) e077582; DOI: 10.1136/bmjopen-2023-077582
Protocol for evaluating the effects of the Reducing Cardiometabolic Diseases Risk dietary pattern in the Chinese population with dyslipidaemia: a single-centre, open-label, dietary intervention study
Qi Wu, Liyang Zhang, Cheng Cheng, Xukun Chen, Shanshan Bian, Li Huang, Tongtong Li, Zhenshu Li, Huan Liu, Jing Yan, Yue Du, Yongjie Chen, Meilin Zhang, Lichun Cao, Wen Li, Fei Ma, Guowei Huang

BMJ Open Apr 2024, 14 (4) e082957; DOI: 10.1136/bmjopen-2023-082957
Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B trial): protocol for a mixed-methods process evaluation of a randomised controlled trial
Leanne M Aitken, Lydia M Emerson, Kalliopi Kydonaki, Bronagh Blackwood, Benedict Creagh-Brown, Nazir I Lone, Cathrine A McKenzie, Michael C Reade, Christopher J Weir, Matt P Wise, Timothy S Walsh

BMJ Open Apr 2024, 14 (4) e081637; DOI: 10.1136/bmjopen-2023-081637
Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multicentre, randomised controlled trial with integrated Quintet Recruitment Intervention (RaCeR 2)
Bruno Mazuquin, Maria Moffatt, Alba Realpe, Rachelle Sherman, Katie Ireland, Zak Connan, Jack Tildsley, Andrea Manca, Vijay Singh Gc, Nadine E Foster, Jonathan Rees, Steven Drew, Marcus Bateman, Apostolos Fakis, Malin Farnsworth, Chris Littlewood

BMJ Open Apr 2024, 14 (4) e081284; DOI: 10.1136/bmjopen-2023-081284

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