Optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS): statistical analysis plan for a randomised controlled trial

Authors: Norin Ahmed, Hakim-Moulay Dehbi, Nick Freemantle, Jonathan Best, Philip S. Nash, James K. Ruffle, David Doig, David J. Werring

Source: Trials, Vol 26, Iss 1, Pp 1-9 (2025)

Subject Terms: Statistical analysis plan, Atrial fibrillation, Acute ischaemic stroke, Anticoagulation, DOAC (direct oral anticoagulants), Timing, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/8e5c339a53574b1393d9f2468d4ee26e

Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial

Authors: Karen J. Bosma, Myriam Lafreniere-Roula, Arlene Jiang, Anna Heath, Yongdong Ouyang, Kaitlyn Wade, Pingzhao Hu, Karen E. A. Burns, Claudio M. Martin, Yoanna Skrobik, Sorcha Mulligan, Kevin E. Thorpe, Laurent Brochard, members of the Canadian Critical Care Trials Group and the REVA Network

Source: Trials, Vol 25, Iss 1, Pp 1-5 (2024)

Subject Terms: Proportional assist ventilation, Weaning from mechanical ventilation, Liberation, Statistical analysis plan, Ventilator-free days, Bayesian, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/fa61166b4df644e3979b33ad90d4e0f8

Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: update to the statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial

Authors: Sarah N. Dawson, Yi-Da Chiu, Andrew A. Klein, Melissa Earwaker, Sofia S. Villar, on behalf of the NOTACS study team

Source: Trials, Vol 25, Iss 1, Pp 1-9 (2024)

Subject Terms: Statistical analysis plan, Adaptive design, Sample size re-estimation, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/befe0c75d25c492eac8f966fbeab9caf

Proposal of an alternative way of reporting the results of comparative simulation studies

Authors: María Paula Fernández-García, Guillermo Vallejo-Seco, Pablo Livácic-Rojas, Francisco Javier Herrero-Díez

Source: Frontiers in Psychology, Vol 16 (2025)

Subject Terms: Monte Carlo simulation studies, Analysis Plan, results tables vs. Traceability Tables, Variability Set, demo example, repeated measures design results, Psychology, BF1-990

File Description: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fpsyg.2025.1549767/full; https://doaj.org/toc/1664-1078

Access URL: https://doaj.org/article/2c49f34fc2e5474f86e6d4f192678e1b

Decentralized Clinical Trials in the Era of Real‐World Evidence: A Statistical Perspective

Authors: Jie Chen, Junrui Di, Nadia Daizadeh, Ying Lu, Hongwei Wang, Yuan‐Li Shen, Jennifer Kirk, Frank W. Rockhold, Herbert Pang, Jing Zhao, Weili He, Andrew Potter, Hana Lee

Source: Clinical and Translational Science, Vol 18, Iss 2, Pp n/a-n/a (2025)

Subject Terms: digital healthcare technology, estimand, remote data acquisition, statistical analysis plan, Therapeutics. Pharmacology, RM1-950, Public aspects of medicine, RA1-1270

File Description: electronic resource

Relation: https://doaj.org/toc/1752-8054; https://doaj.org/toc/1752-8062

Access URL: https://doaj.org/article/df57a2e515894228a958eed5c9857175

Statistical analysis plan for the LAST ACT clinical trial; a Leukotriene A4 hydrolase Stratified non-inferiority Trial of Adjunctive Corticosteroids for HIV-negative adults with Tuberculous meningitis [version 2; peer review: 2 approved, 1 approved with reservations]

Authors: Joseph Donovan, Dong Huu Khanh Trinh, Ronald B. Geskus, Marcel Wolbers, Guy E. Thwaites, Nguyen Thuy Thuong Thuong, Le Thanh Hoang Nhat

Source: Wellcome Open Research, Vol 9 (2025)

Subject Terms: tuberculous meningitis, corticosteroids, clinical trial, analysis plan, leukotriene A4 hydrolase (LTA4H), personalised medicine, eng, Medicine, Science

File Description: electronic resource

Relation: https://wellcomeopenresearch.org/articles/9-695/v2; https://doaj.org/toc/2398-502X

Access URL: https://doaj.org/article/99df0b0d17f54fa49384a7006f80d183

Statistical analysis plan for the SOLUTIONS randomised controlled trial with internal pilot: Solution Focused Brief Therapy (SFBT) in 10–17 year olds presenting at police custody

Authors: Paul A. Thompson, Gwenllian Moody, Elinor Coulman, Eleri Owen-Jones, Faizan Patel, Kylie M. Gray, Richard P. Hastings, Andrea Longman, Fiona Lugg-Widger, Jeremy Segrott, Julia Badger, Samantha Flynn, Peter E. Langdon, Rebecca Playle

Source: Trials, Vol 25, Iss 1, Pp 1-13 (2024)

Subject Terms: Statistical analysis plan, Therapy, Youth offending, RCT, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/d588bc92718f4aa5946c00745845ec75

The PRIME-NL study: evaluating a complex healthcare intervention for people with Parkinson’s disease in a dynamic environment

Authors: Bart R. Maas, Robin van den Bergh, Sanne W. van den Berg, Eveline Hulstein, Niek Stadhouders, Patrick P.T. Jeurissen, Nienke M. de Vries, Bastiaan R. Bloem, Marten Munneke, Yoav Ben-Shlomo, Sirwan K.L. Darweesh

Source: BMC Neurology, Vol 24, Iss 1, Pp 1-8 (2024)

Subject Terms: Complex intervention, Integrated Care Model, Parkinson’s disease, Parkinsonism, Design, Statistical analysis plan, Neurology. Diseases of the nervous system, RC346-429

File Description: electronic resource

Relation: https://doaj.org/toc/1471-2377

Access URL: https://doaj.org/article/26ae6b05f74e4fcba9d5f13d23d82a4a

Multicomponent family support intervention in intensive care units: statistical analysis plan for the cluster-randomized controlled FICUS trial

Authors: Stefanie von Felten, Miodrag Filipovic, Marie-Madlen Jeitziner, Lotte Verweij, Marco Riguzzi, Rahel Naef

Source: Trials, Vol 25, Iss 1, Pp 1-12 (2024)

Subject Terms: Statistical analysis plan, Cluster-randomized trial, Critical care, Complex intervention, Family care, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/11631b9808864a1183c9cb93ea8c7e55

Statistical analysis plan for cluster randomised trial to evaluate a community-level complementary food safety and hygiene and nutrition intervention in Mali: the MaaCiwara study

Authors: Laura Quinn, James Martin, Evans Asamane, Semira Manaseki-Holland, Richard J. Lilford, Lacina Traore, Jacqueline Thompson, Samuel I. Watson, Karla Hemming

Source: Trials, Vol 25, Iss 1, Pp 1-10 (2024)

Subject Terms: Statistical analysis plan, Cluster randomised controlled trial, Food safety and hygiene, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/08da3d4587a3476d9d2d104b950be152

Development of a prediction model of conversion to Alzheimer’s disease in people with mild cognitive impairment: the statistical analysis plan of the INTERCEPTOR project

Authors: Flavia L. Lombardo, Patrizia Lorenzini, Flavia Mayer, Marco Massari, Paola Piscopo, Ilaria Bacigalupo, Antonio Ancidoni, Francesco Sciancalepore, Nicoletta Locuratolo, Giulia Remoli, Simone Salemme, Stefano Cappa, Daniela Perani, Patrizia Spadin, Fabrizio Tagliavini, Alberto Redolfi, Maria Cotelli, Camillo Marra, Naike Caraglia, Fabrizio Vecchio, Francesca Miraglia, Paolo Maria Rossini, Nicola Vanacore, the INTERCEPTOR Network

Source: Diagnostic and Prognostic Research, Vol 8, Iss 1, Pp 1-11 (2024)

Subject Terms: Statistical analysis plan, Longitudinal study, Mild cognitive impairment, Dementia, Alzheimer’s disease, Biomarker, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/2397-7523

Access URL: https://doaj.org/article/179f70c48a084692b2d8c1eb22dc4865

Coping or hoping? Livelihood diversification and food insecurity in the COVID-19 pandemic

Authors: Furbush, Ann M. ^a, Josephson, Anna ^b, Kilic, Talip ^c, Michler, Jeffrey D. ^{b, ⁎}

Source: In Food Policy February 2025 131

Efficacy and safety analysis of Kaiyu Jiangzhuo Tongzhi prescription for the treatment of pre-diabetic overweight/obese patients: A multicentre randomised controlled clinical study protocol and statistical analysis plan

Authors: XU, Xiaoxuan ^{a, 1}, ZHANG, Boxun ^{b, 1}, QU, Xue ^a, QU, Dongqi ^a, LIU, Hang ^a, ZHANG, Wenlin ^a, SUN, Rui ^a, ZHAO, Linhua ^{c, ⁎}, REN, Jixiang ^{d, ⁎}, ZHANG, Ying ^{e, ⁎}, LIU, Yangyang ^{d, f, ⁎}

Source: In Chinese Journal of Analytical Chemistry February 2025 53(2)

Statistical analysis plan for the LAST ACT clinical trial; a Leukotriene A4 hydrolase Stratified non-inferiority Trial of Adjunctive Corticosteroids for HIV-negative adults with Tuberculous meningitis [version 1; peer review: 2 approved, 1 approved with reservations]

Authors: Joseph Donovan, Dong Huu Khanh Trinh, Ronald B. Geskus, Marcel Wolbers, Guy E. Thwaites, Nguyen Thuy Thuong Thuong, Le Thanh Hoang Nhat

Source: Wellcome Open Research, Vol 9 (2024)

Subject Terms: tuberculous meningitis, corticosteroids, clinical trial, analysis plan, leukotriene A4 hydrolase (LTA4H), personalised medicine, eng, Medicine, Science

File Description: electronic resource

Relation: https://wellcomeopenresearch.org/articles/9-695/v1; https://doaj.org/toc/2398-502X

Access URL: https://doaj.org/article/595ea5cdd06e40d0b2ae4b3dc6095491

Statistical analysis plan for the TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation of potentially clinically significant prostate cancer) multicentre randomised controlled trial

Authors: Ioana R. Marian, Alexander Ooms, Jane Holmes, Matthew J. Parkes, Alastair D. Lamb, Richard J. Bryant

Source: Trials, Vol 25, Iss 1, Pp 1-9 (2024)

Subject Terms: Statistical analysis plan, Randomised controlled trial, Prostate cancer, Cancer biopsy, Cancer diagnosis, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/06521101632f458bae35061011c1d43c

Statistical analysis plan for the replacing protein via enteral nutrition in a stepwise approach in critically ill patients (REPLENISH) randomized clinical trial

Authors: Yaseen M Arabi, Hasan M. Al-Dorzi, Omar Aldibaasi, Musharaf Sadat, Jesna Jose, Dina Muharib, Haifa Algethamy, Abdulrahman A. Al-Fares, Fahad Al-Hameed, Ahmed Mady, Ayman Kharaba, Ali Al Bshabshe, Khalid Maghrabi, Khalid AlGhamdi, Ghulam Rasool, Adnan AlGhamdi, Ghaleb. A Almekhlafi, Jamal Chalabi, Haifaa Ibrahim AlHumedi, Maram Hasan Sakkijha, Norah Khalid Alamrey, Amjad Sami Alaskar, Rabeah Hamad Alhutail, Kaouthar Sifaoui, Rakan Alqahtani, Ahmad S. Qureshi, Mohammed Moneer Hejazi, Hatim Arishi, Samah AlQahtani, Amro Mohamed Ghazi, Saleh T. Baaziz, Abeer Othman Azhar, Sara Fahad Alabbas, Mohammed AlAqeely, Ohoud AlOrabi, Aliaa Al-Mutawa, Maha AlOtaibi, Madiha Fawazy Elghannam, Mohammed Almaani, Sarah Fadel Buabbas, Wadiah Alawi M. Alfilfil, Mohammed S. Alshahrani, Joel Starkopf, Jean-Charles Preiser, Anders Perner, Jumana Hani AlMubarak, Wafa Mansoor Hazem, Talal Albrahim, Abdulaziz Al-Dawood, and the Saudi Critical Care Trials Group

Source: Trials, Vol 25, Iss 1, Pp 1-10 (2024)

Subject Terms: Critical illness, Protein, Statistical analysis plan, Randomized clinical trial, Nutrition, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/3fcfbdc04e4d4a87abd08e5f3ab344c0

Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—statistical analysis plan for a multicenter randomized controlled trial

Authors: Sten P. Willemsen, Ronny Knol, Emma Brouwer, Thomas van den Akker, Philip L. J. DeKoninck, Enrico Lopriore, Wes Onland, Willem P. de Boode, Anton H. van Kaam, Debbie H. Nuytemans, Irwin K. M. Reiss, G. Jeroen Hutten, Sandra A. Prins, Estelle E. M. Mulder, Christian V. Hulzebos, Sam J. van Sambeeck, Mayke E. van der Putten, Inge A. Zonnenberg, Arjan B. te Pas, Marijn J. Vermeulen

Source: Trials, Vol 25, Iss 1, Pp 1-9 (2024)

Subject Terms: Preterm infants, Physiological-based cord clamping, Randomized clinical trial, Statistical Analysis Plan, Cord clamping, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/8717f45925ef4abeba353f4147ec8526

Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial

Authors: Eva Visser, Lianne Heuthorst, Shri Pathmakanthan, Willem A. Bemelman, Geert R. D’Haens, Kelly Handley, Apostolos Fakis, Thomas D. Pinkney, Christianne J. Buskens, Marcel G. W. Dijkgraaf

Source: Trials, Vol 25, Iss 1, Pp 1-11 (2024)

Subject Terms: Statistical analysis plan, Inflammatory bowel disease, Ulcerative colitis, Appendectomy, Disease recurrence, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/2602170777af489dba211b9c9a08e844

Update of statistical analysis plan for: Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR)

Authors: Karl Trygve Druckrey-Fiskaaen, Tesfaye Madebo, Jan Tore Daltveit, Jørn Henrik Vold, Einar Furulund, Torgeir Gilje Lid, Lars Thore Fadnes

Source: Trials, Vol 25, Iss 1, Pp 1-6 (2024)

Subject Terms: Statistical analysis plan, Randomised controlled trial, Smoking cessation, Opioid agonist treatment, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/f534597e046f4fd1b31a776221d12240

Initial treatment with a single capsule containing half-dose quadruple therapy versus standard-dose dual therapy in hypertensive patients (QUADUAL): statistical analysis plan for a randomized, blinded, crossover trial

Authors: Xiexiong Zhao, Xingli Li, Tao Liu, Guoping Yang, Ye Chen, Miao Huang, Lin Zhao, Xiaogang Li, Weihong Jiang

Source: Trials, Vol 25, Iss 1, Pp 1-7 (2024)

Subject Terms: Hypertension, Statistical analysis plan, Antihypertensive, Low-dose combination, Randomized controlled trial, Medicine (General), R5-920

File Description: electronic resource

Relation: https://doaj.org/toc/1745-6215

Access URL: https://doaj.org/article/5b68fb26a563448fb151a41285f3c5a6