Correction to: Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial.

Following publication of the original article [1], we have been notified that one of the authors' names is spelled incorrectly. In this Correction the incorrect and correct author name are shown.

Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial.

BACKGROUND: Clinical trials management can be studied using project management theory. The CYCLE pilot randomized controlled trial (RCT) was conducted to determine the feasibility of a future rehabilitation trial of early in-bed cycling in the intensive care unit (ICU). In-bed cycling is a novel intervention, not typically available in ICUs. Implementation of this intervention requires personnel with specialized clinical expertise caring for critically ill patients and use of the in-bed cycle. Our objective was to describe the implementation and conduct of our pilot RCT using a project management approach. METHODS: We retrospectively reviewed activities, timelines, and personnel involved in the trial. We organized activities into four project management phases: initiation, planning, execution, and monitoring and controlling. Data sources included Methods Centre documents used for trial coordination and conduct, and the trial data set. We report descriptive statistics as counts and proportions and also medians and quartiles, and we summarize the lessons learned. RESULTS: Seven ICUs in Canada participated in the trial. Time from research ethics board and contracts submission to first enrolment was a median (first quartile, third quartile) of 185 (146, 209) and 162 (114, 181) days, respectively. We trained 128 personnel on the CYCLE pilot RCT protocol, and 80 (63%) completed trial-related activities. Four sites required additional training after start-up due to staff turnover and leaves of absence. Over 15 months, we screened 864 patients: 256 were eligible and 66 were enrolled. Despite an 85% consent rate, 74% (190/256) of eligible patients were not randomized, largely (80% [152/190]) due to physiotherapist availability. Thirteen percent of recruitment weeks were lost due to physiotherapist staffing shortages. We highlight five key lessons learned: (1) prepare and anticipate site needs; (2) communicate regularly; (3) proactively analyse and act on process measure data; (4) develop contingency plans; (5) express appreciation to participating sites. CONCLUSIONS: Our analysis highlights the scope of relevant activities, rigorous training and monitoring, number and types of required personnel, and time required to conduct a multicentre ICU rehabilitation intervention trial. Our lessons learned can help others interested in implementing complex intervention trials, such as rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02377830 . Registered prospectively on 4 March 2015.

Physical rehabilitation interventions in the intensive care unit: a scoping review of 117 studies.

BACKGROUND: Physical rehabilitation (PR) interventions in the intensive care unit (ICU) can improve patients' functional outcomes, yet systematic reviews identified discordant effects and poor reporting. We conducted a scoping review to determine the extent of ICU PR interventions and how they were reported and measured. METHODS: We searched five databases from inception to December 2016 for prospective studies evaluating adult ICU PR interventions. Two independent reviewers screened titles, abstracts, and full texts for inclusion. We assessed completeness of reporting using the Consolidated Standards of Reporting Trials, Strengthening the Reporting of Observational Studies in Epidemiology, or Standards for Quality Improvement Reporting Excellence guidelines, as appropriate. For planned PR interventions, we evaluated reporting with the Consensus on Exercise Reporting Template (CERT) and assessed intervention and control groups separately. We calculated completeness of reporting scores for each study; scores represented the proportion of reported items. We compared reporting between groups using Kruskal-Wallis with Bonferroni corrections and t tests, α = 0.05. RESULTS: We screened 61,774 unique citations, reviewed 1429 full-text publications, and included 117: 39 randomized trials, 30 case series, 9 two-group comparison, 14 before-after, and 25 cohort. Interventions included neuromuscular electrical stimulation (NMES) (14.5%), passive/active exercises (15.4%), cycling (6.8%), progressive mobility (32.5%), and multicomponent (29.9%). The median (first,third quartiles) study reporting score was 75.9% (62.5, 86.7) with no significant differences between reporting guidelines. Of 87 planned intervention studies, the median CERT score was 55.6%(44.7,75.0); cycling had the highest (85.0%(62.2,93.8)), and NMES and multicomponent the lowest (50.0% (39.5, 70.3) and 50.0% (41.5, 58.8), respectively) scores. Authors reported intervention groups better than controls (p < 0.001). CONCLUSIONS: We identified important reporting deficiencies in ICU PR interventions, limiting clinical implementation and future trial development.