| Authors | Peter E. Morris, Michael J. Berry, D. Clark Files, Joanne Thompson, Jordan I. Hauser, Lori Flores, Sandipan Dhar, Elizabeth A. Chmelo, James Lovato, L. Douglas Case, Rita N. Bakhru, Aarti Sarwal, Selina M. Parry, Pamela Campbell, Arthur Mote, Chris Winkelman, R. Duncan Hite, Barbara J. Nicklas, Arjun Chatterjee, Michael Young |
| Journal | JAMA |
| Year | 2016 |
| DOI | 10.1001/jama.2016.7201 |
| Citations | 406 |
TL;DR
A structured daily rehabilitation program (passive range of motion, physical therapy, and progressive resistance exercise) for patients on mechanical ventilation did not shorten hospital stays or reduce time on the ventilator compared to usual care, but it did improve physical function and self-reported physical health at six months after discharge.
The researchers compared two approaches to rehabilitation for patients who were in the intensive care unit (ICU) because their lungs had failed and they needed a breathing machine (mechanical ventilation).
Intervention (Standardized Rehabilitation Therapy, SRT): A daily, protocol-driven program delivered seven days per week until hospital discharge. It included three components:
Comparator (Usual Care): Patients received physical therapy only if the clinical team (doctors or nurses) ordered it, and only on weekdays (Monday through Friday). There was no standard protocol — the type, frequency, and intensity of therapy varied based on individual clinician judgment.
Primary Outcome: Hospital length of stay (LOS) — the number of days from admission to discharge from the hospital.
Secondary Outcomes: Days on the ventilator, days in the ICU, physical function (measured by the Short Physical Performance Battery, or SPPB), self-reported physical and mental health (SF-36 questionnaire), ability to perform daily activities (Functional Performance Inventory, or FPI), cognitive function (Mini-Mental State Examination, or MMSE), and muscle strength (handgrip dynamometer and handheld dynamometer).
Study design: Single-center, parallel-group, randomized clinical trial (RCT).
Randomisation: Patients were randomly assigned (1:1 ratio) to SRT or usual care using a computer-generated randomisation sequence. The allocation was concealed — meaning the researchers enrolling patients did not know which group the next patient would be assigned to. This prevents selection bias (e.g., unconsciously enrolling sicker patients into one group).
Blinding: This was an assessor-blinded trial. The patients and the therapists delivering the intervention obviously knew which group they were in (you cannot blind a patient to whether they are receiving daily therapy or not). However, the researchers who performed the outcome assessments (e.g., the SPPB test, handgrip strength, questionnaires) were blinded to group assignment. This is critical because it prevents the assessor's expectations from influencing the results (e.g., unconsciously encouraging a patient in the SRT group to try harder). The statisticians were also blinded to group assignment until after the primary analysis was complete.
Duration:
Statistical approach: The primary analysis was intention-to-treat — meaning all patients were analysed in the group they were randomised to, regardless of whether they actually received the therapy. This preserves the benefits of randomisation and gives a real-world estimate of the intervention's effect (since some patients will inevitably not complete the full protocol). The primary outcome (hospital LOS) was compared using the Wilcoxon rank-sum test (a non-parametric test appropriate for skewed data like length of stay). Results are reported as medians with interquartile ranges (IQR) and median differences with 95% confidence intervals.
What this design can and cannot prove:
Major methodological weaknesses:
Primary outcome — Hospital length of stay:
Secondary outcomes — Ventilator and ICU days:
Secondary outcomes — Physical function at 6 months:
Secondary outcomes — No significant difference at 6 months:
For someone running their own n=1 experiment (e.g., recovering from a serious illness or surgery that required bed rest):
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