Reflections on FDA Draft Guidance on Bayesian Methods in Trials-Protecting Scientific Integrity and Evidentiary Standards

# Reflections on FDA Draft Guidance on Bayesian Methods in Trials-Protecting Scientific Integrity and Evidentiary Standards *Published: 2026 May 19* print. Remote Multicomponent Rehabilitation in Intensive Care Unit Survivors: A Randomized Clinical Trial. O'Neill B(1), Bradley JM(2), Connolly B(2)(3), Bruce J(4)(5), Ratna M(4), Lall R(4), Underwood M(4)(5), Ji C(4), Costley J(1), Clarke R(6), Dark P(7), Duffy O(1), Firshman P(8), Hart ND(2), Henderson A(1), Jones K(4), Kenyon R(9), Madan J(4), Murphy D(1), Perkins GD(4), Raynes K(4), Terblanche E(10), Zanganeh M(4), McAuley DF(2); iRehab Trial Investigators. Collaborators: Snell J, O'Kane S, Weblin J, McFarland D, Hedley J, Tantam K, Varga S, Donnison C, Davies J, Coetzee S, Champman K, Arnold A, Hayter H, Gonzales I, North J, Phull M, Morino E, Paripoorani D, Doble P, Martin-Lazaro J, Tai C, Wood R, Hodgkiss T, Birchall K, Hirst E, Skinner D, Adeniji K, Trues E, Graham C, Compton F, Truman N, McDonnell L, Jeyakumar K, Gibson B, Law D, Waite A, Chadwick R, Hansen D, Howard E, Howe S, Van Willigen Z, Duggleby P, Rostron A, Hagan S, McWilliams D, Thomas J, Abdelaty A, Page V, Geer K, Wilson S, Udberg M, Pratley A, Charnock A, Ward L, Knights E. Author information: (1)Institute of Nursing and Health Research, School of Health Sciences, Ulster University, Belfast, Northern Ireland. (2)Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry, and Biomedical Sciences, Queen's University Belfast, Belfast, Northern Ireland. (3)Department of Physiotherapy, University of Melbourne, Melbourne, Victoria, Australia. (4)Warwick Clinical Trials Unit, University of Warwick, Coventry, England. (5)University Hospitals of Coventry and Warwickshire, Coventry, England. (6)University Hospitals Plymouth NHS Trust, Derriford Hospital, Plymouth, England. (7)Division of Immunology, Immunity to Infection and Respiratory Medicine, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, England. (8)Surrey and Sussex Healthcare NHS Trust, Redhill, England. (9)Patient Advisory Group, iRehab Trial Management Group, Preston, England. (10)School of Health Rehabilitation Sciences, Health Sciences University, Bournemouth, England. Comment in doi: 10.1001/jama.2026.5761. Comment in doi: 10.1001/jama.2025.23666. doi: 10.1001/jama.2025.23871. doi: 10.1001/jama.2026.8431. ## IMPORTANCE Evidence for remote multicomponent rehabilitation among critical care survivors is sparse. ## OBJECTIVE To investigate the effects of a 6-week, remote, multicomponent rehabilitation intervention in survivors of critical illness following discharge from the hospital after an intensive care unit (ICU) admission compared with standard care on health-related quality of life at 8 weeks. DESIGN, SETTING, AND PARTICIPANTS Pragmatic, multicenter, assessor-blinded, randomized clinical trial conducted from December 2022 to November 2025 at 52 National Health Service hospitals in the UK. Participants were adults who had been discharged from the hospital within the last 12 weeks with an ICU admission (required mechanical ventilation for ≥48 hours during ICU stay). ## INTERVENTIONS Individuals were randomized to a 6-week, remote, multicomponent, individualized, rehabilitation intervention incorporating weekly symptom management; targeted exercise; psychological support; and peer support and information commenced within 12 weeks of hospital discharge (n = 231) or standard care (n = 198). MAIN OUTCOMES AND MEASURES The primary outcome was health-related quality of life at 8 weeks measured by the EuroQoL 5-dimension 5-level questionnaire (EQ-5D-5L) utility score (from -0.285 [worst/worse than dead] to 1 [best health]; minimum clinically important difference: 0.08) and analyzed using linear regression (adjusted for baseline covariates). The secondary outcomes included leg strength and exercise capacity; self-reported perception of fatigue, anxiety, or depression; illness perception; and acceptability of the intervention and any adverse events. ## RESULTS Of the 3705 screened patients, 429 (12%) were randomized (mean age, 55.4 [SD, 13.9] years; 184 female [42.9%]; 245 male [57.1%]; and had median Acute Physiology and Chronic Health Evaluation II score of 18 [IQR, 14 to 22]). The mean EQ-5D-5L utility score at 8 weeks was 0.69 (SD, 0.26) in the intervention group compared with 0.67 (SD, 0.27) in the standard care group (adjusted mean difference, 0.04 [95% CI, -0.001 to 0.09]; P = .05). The intervention improved 4 of the 6 secondary outcomes, including leg strength and exercise capacity, fatigue, anxiety, and acceptability of the intervention and any adverse events; there was no change in perception of depression or illness. CONCLUSIONS AND RELEVANCE A 6-week, multicomponent, rehabilitation program did not improve health-related quality of life at 8 weeks after discharge in ICU survivors who required mechanical ventilation. ## TRIAL REGISTRATION isrctn.org Identifier: ISRCTN11266403. DOI: 10.1001/jama.2026.7401 PMCID: PMC13184783 DOI: 10.1001/jama.2026.4175