Measurement and reporting of physical rehabilitation interventions in pediatric critical care: a scoping review.

PURPOSE: To describe and evaluate physical rehabilitation research in critically ill children, including physical rehabilitation intervention reporting. METHODS: We searched five electronic databases to 31 December 2018 for prospective physical rehabilitation studies conducted in pediatric intensive care units (PICU). Screening was conducted independently in duplicate. Study characteristics, outcomes, and interventions were extracted from included studies. Quality of study reporting was assessed using standardized tools. Completeness of physical rehabilitation intervention reporting was assessed using the Consensus on Exercise Reporting Template (CERT). RESULTS: We included 20 studies enrolling a total of 2644 patients. Median (Q1,Q3) sample size was 57 (44,104). Seven studies (35%) were randomized controlled trials. Eleven studies (55%) evaluated respiratory interventions, most commonly multicomponent chest physiotherapy (73%). Nine studies (45%) evaluated physical activity interventions, most commonly progressive mobility (56%). The majority of stated outcomes (92.5%) were limited to the PICU setting. Median [Q1,Q3] quality of study reporting was good (77.2% [66.7%,87.4%]), and completeness of physical rehabilitation intervention reporting was moderate (61.9% [45.9%,71.5%]). CONCLUSION: Physical rehabilitation studies in critically ill children were small, and focused on evaluating respiratory-based interventions and short-term PICU-based outcomes. Reporting of physical rehabilitation interventions was suboptimal. Use of CERT may improve design and reporting in future studies.Implications for rehabilitationWhile physical rehabilitation research in critically ill children is a growing field, there are currently few studies evaluating physical rehabilitation interventions in this population.Physical rehabilitation studies to date have been small, focused on evaluating respiratory-based interventions and short-term outcomes limited to the PICU setting.The reporting of physical rehabilitation interventions in this population is suboptimal, making it challenging for clinicians to reproduce interventions and appraise their efficacy or safety.

Therapist perceptions of a rehabilitation research study in the intensive care unit: a trinational survey assessing barriers and facilitators to implementing the CYCLE pilot randomized clinical trial.

BACKGROUND: Rehabilitation interventions, including novel technologies such as in-bed cycling, could reduce critical illness-associated morbidity. Frontline intensive care unit (ICU) therapists often implement these interventions; however, little is known about their perceptions of engaging in clinical research evaluating these technologies. OBJECTIVE: To understand frontline therapist perceptions of barriers and facilitators to implementing a pilot randomized controlled trial (RCT) of early in-bed cycling with mechanically ventilated patients in the ICU and outcome measures (CYCLE Pilot RCT; NCT02377830). METHODS: We developed a 115-item, self-administered, electronic survey informed by 2 complementary knowledge translation (KT) models: the Capability-Opportunity-Motivation-Behaviour (COM-B) system and the Theoretical Domains Framework (TDF). We included demographics and 3 sections: Rehabilitation Practice and Research, Cycling, and Physical Outcome Measures. Each section contained items related to the COM-B system and TDF domains. Item formats included 7-point Likert-type scale questions (1 = strongly disagree, 7 = strongly agree) and free-text responses. We invited therapists (physiotherapists, occupational therapists, and therapy assistants) who participated in the international, multi-center, CYCLE Pilot RCT to complete this cross-sectional survey. We descriptively analyzed results by survey section, COM-B attribute, TDF domain, and individual question within and across sections. We identified barriers based on items with median scores < 4/7. RESULTS: Our response rate was 85% (45/53). Respondents were from Canada (67%), the USA (21%), and Australia (11%). The majority had a physiotherapy background (87%) and previous research experience (87%). By section, Rehabilitation Practice and Research (85%; 95% confidence interval (CI) [82%, 87%]) was higher than Cycling (77%; 95% CI [73%, 80%]) and Outcome Measures (78%; 95% CI [75%, 82%]). Across the 3 sections, Motivation was lower than Capability and Opportunity. The most common Motivation barrier was the emotion TDF domain, related to the time required to conduct cycling and outcome measures (median [1st, 3rd quartiles] 3/7 [2, 6]). CONCLUSIONS: Frontline ICU therapists had positive perceptions of research engagement. However, we identified barriers related to Motivation, and concerns regarding time to implement the research protocol. Our results can inform specific KT strategies to engage frontline ICU therapists and optimize protocol implementation in critical care rehabilitation research.

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.