Early In-Bed Cycle Ergometry in Mechanically Ventilated Patients.

BACKGROUND: Critical illness requiring invasive mechanical ventilation can precipitate important functional disability, contributing to multidimensional morbidity following admission to an intensive care unit (ICU). Early in-bed cycle ergometry added to usual physiotherapy may mitigate ICU-acquired physical function impairment. METHODS: We randomly assigned 360 adult ICU patients undergoing invasive mechanical ventilation to receive 30 minutes of early in-bed Cycling + Usual physiotherapy (n=178) or Usual physiotherapy alone (n=182). The primary outcome was the Physical Function ICU Test-scored (PFIT-s) at 3 days after discharge from the ICU (the score ranges from 0 to 10, with higher scores indicating better function). RESULTS: Cycling began within a median (interquartile range) of 2 (1 to 3) days of starting mechanical ventilation; patients received 3 (2 to 5) cycling sessions for a mean (±standard deviation) of 27.2 ± 6.6 minutes. In both groups, patients started Usual physiotherapy within 2 (2 to 4) days of mechanical ventilation and received 4 (2 to 7) Usual physiotherapy sessions. The duration of Usual physiotherapy was 23.7 ± 15.1 minutes in the Cycling + Usual physiotherapy group and 29.1 ± 13.2 minutes in the Usual physiotherapy group. No serious adverse events occurred in either group. Among survivors, the PFIT-s at 3 days after discharge from the ICU was 7.7 ± 1.7 in the Cycling + Usual physiotherapy group and 7.5 ± 1.7 in the Usual physiotherapy group (absolute difference, 0.23 points; 95% confidence interval, -0.19 to 0.65; P=0.29). CONCLUSIONS: Among adults receiving mechanical ventilation in the ICU, adding early in-bed Cycling to usual physiotherapy did not improve physical function at 3 days after discharge from the ICU compared with Usual physiotherapy alone. Cycling did not cause any serious adverse events. (Funded by the Canadian Institutes of Health Research and others; ClinicalTrials.gov numbers, NCT03471247 [full randomized clinical trial] and NCT02377830 [CYCLE Vanguard 46-patient internal pilot].).

"My Biggest Fear Is She'll Die Alone": Care Partner Perspectives of Institutional COVID-19 Visitor Restrictions in Ontario, Canada.

In March 2020, the Government of Ontario, Canada implemented public health measures, including visitor restrictions in institutional care settings, to protect vulnerable populations, including older adults (> 65 years), against COVID-19 infection. Prior research has shown that visitor restrictions can negatively influence older adults' physical and mental health and can cause increased stress and anxiety for care partners. This study explores the experiences of care partners separated from the person they care for because of institutional visitor restrictions during the COVID-19 pandemic. We interviewed 14 care partners between the ages of 50 and 89; 11 were female. The main themes that emerged were changing public health and infection prevention and control policies, shifting care partner roles as a result of visitor restrictions, resident isolation and deterioration from the care partner perspective, communication challenges, and reflections on the impacts of visitor restrictions. Findings may be used to inform future health policy and system reforms.

Comparator Groups in ICU-Based Studies of Physical Rehabilitation: A Scoping Review of 125 Studies.

To characterize comparator groups (CGs) in ICU-based studies of physical rehabilitation (PR), including the type, content, and reporting. DATA SOURCES: We followed a five-stage scoping review methodology, searching five databases from inception to June 30, 2022. Study selection and data extraction were completed independently, in duplicate. STUDY SELECTION: We screened studies by title and abstract, then full-text. We included prospective studies with greater than or equal to two arms enrolling mechanically ventilated adults (≥ 18 yr), with any planned PR intervention initiated in the ICU. DATA EXTRACTION: We conducted a quantitative content analysis of authors' description of CG type and content. We categorized similar CG types (e.g., usual care), classified content into unique activities (e.g., positioning), and summarized these data using counts (proportions). We assessed reporting using Consensus on Exercise Reporting Template (CERT; proportion of reported items/total applicable). DATA SYNTHESIS: One hundred twenty-five studies were included, representing 127 CGs. PR was planned in 112 CGs (88.2%; 110 studies), representing four types: usual care (n = 81, 63.8%), alternative treatment than usual care (e.g., different from intervention; n = 18, 14.2%), alternative treatment plus usual care (n = 7, 5.5%), and sham (n = 6, 4.7%). Of 112 CGs with planned PR, 90 CGs (88 studies) reported 60 unique activities, most commonly passive range of motion (n = 47, 52.2%). The remaining 22 CGs (19.6%; 22 studies) reported vague descriptions. PR was not planned in 12 CGs (9.5%; 12 studies), and three CGs (2.4%; three studies) reported no details. Studies reported a median (Q1-Q3) of 46.6% (25.0-73.3%) CERT items. Overall, 20.0% of studies reported no detail to understand planned CG activities. CONCLUSIONS: The most common type of CG was usual care. We identified heterogeneity in planned activities and CERT reporting deficiencies. Our results could help guide the selection, design, and reporting of CGs in future ICU-based PR studies.

Learning needs and perceived barriers and facilitators to end-of-life care: a survey of front-line nurses on acute medical wards.

OBJECTIVES: Caring for dying hospitalised patients is a healthcare priority. Our objective was to understand the learning needs of front-line nurses on the general internal medicine (GIM) hospital wards, and perceived barriers to, and facilitators of, optimal end-of-life care. METHODS: We developed an 85-item survey informed by the Theoretical Domains Framework and Capability-Opportunity-Motivation-Behaviour system. We included demographics and two main domains (knowledge and practice; delivering end-of-life care) with seven subsections. Nurses from four GIM wards and the nursing resource team completed this survey. We analysed and compared results overall, by Capability, Opportunity, and Motivation, and by survey domain. We considered items with median scores <4/7 barriers. We conducted an a priori subgroup analysis based on duration of practice (≤5 and >5 years). RESULTS: Our response rate was 60.5% (144/238). 51% had been practising for >5 years; most respondents were female (93.1%). Nurses had similar scores on the knowledge (mean 76.0%; SD 11.6%) and delivering care (mean 74.5% (8.6%)) domains. Scores for items associated with Capability were higher than those associated with Opportunity (median (first, third quartiles) 78.6% (67.9%, 87.5%) vs 73.9% (66.0%, 81.8%); p=0.04). Nurses practising >5 years had significantly higher scores on all analyses. Barriers included engaging with families having strong emotional reactions, managing goals of care conflicts between patients and families, and staffing challenges on the ward. Additional requested resources included formal training, information binders and more staff. Opportunities for consideration include formalised on-the-job training, access to comprehensive information, including symptom management at the end of life, and debriefing sessions. CONCLUSIONS: Front-line nurses reported an interest in learning more about end-of-life care and identified important barriers that are feasible to address. These results will inform specific knowledge translation strategies to build capacity among bedside nurses to enhance end-of-life care practices for dying patients on GIM wards.

Enhancing end of life care on general internal medical wards: the 3 Wishes Project.

BACKGROUND: Initially developed in the intensive care unit (ICU) at St. Joseph's Healthcare Hamilton (SJHH) the 3 Wishes Project (3WP) provides personalized, compassionate care to dying patients and their families. The objective of this study was to develop and evaluate 3WP expansion strategies for patients cared for on General Internal Medicine (GIM) wards in our hospital. METHODS: From January 2020-November 2021, we developed a phased, multicomponent approach for program expansion. We enrolled patients on the GIM wards who had a high probability of dying in hospital, then elicited, implemented, and documented wishes for them or their families. Data were analyzed descriptively. RESULTS: From March 2020 to November 2020, we implemented staff education and engagement activities, created an Expansion Coordinator position, held strategic consultations, and offered enabling resources. From March 2020 to November 2021, we enrolled 62 patients and elicited 281 wishes (median [1st, 3rd quartiles] 4 [4, 5] wishes/patient). The most common wish categories were personalizing the environment (67 wishes, 24%), rituals and spiritual support (42 wishes, 15%), and facilitating connections (39 wishes, 14%). The median [1st, 3rd] cost/patient was $0 [0, $10.00] (range $0 to $86); 91% of wishes incurred no cost to the program. CONCLUSIONS: The formal expansion of the 3WP on GIM wards has been successful despite COVID-19 pandemic disruptions. While there is still work ahead, these data suggest that implementing the 3WP on the GIM wards is feasible and affordable. Increased engagement of the clinical team during the pandemic suggests that it is positively received.

Undertaking Rehabilitation Research During the COVID-19 Pandemic: Emergent Strategies From a Trainee-Faculty Workshop.

Background: The COVID-19 pandemic has disrupted everyday rehabilitation research. Many academic institutions have halted in-person human research including rehabilitation sciences. Researchers are faced with several barriers to continuing their research programs. The purpose of this perspective article is to report the results of an interdisciplinary workshop aimed at understanding the challenges and corresponding strategies for conducting rehabilitation research during the COVID-19 pandemic. Methods: Twenty-five rehabilitation researchers (17 trainees and eight faculty) attended a 2-h facilitated online workshop in to discuss challenges and strategies they had experienced and employed to conduct rehabilitation research during the COVID-19 pandemic. Results: Rehabilitation researchers reported challenges with (1) pandemic protocol adjustments, (2) participant accessibility, and (3) knowledge dissemination, along with corresponding strategies to these challenges. Researchers experienced disruptions in study outcomes and intervention protocols to adhere to public health guidelines and have suggested implementing novel virtual approaches and study toolkits to facilitate offsite assessment. Participant accessibility could be improved by engaging community stakeholders in protocol revisions to ensure equity, safety, and feasibility. Researchers also experienced barriers to virtual conferences and publication, suggested opportunities for smaller networking events, and revisiting timeframes for knowledge dissemination. Conclusion: This perspective article served as a catalyst for discussion among rehabilitation researchers to identify novel and creative approaches that address the complexities of conducting rehabilitation research during the COVID-19 pandemic and beyond.

Interventions Including Smart Technology Compared With Face-to-face Physical Activity Interventions in Older Adults: Systematic Review and Meta-analysis.

BACKGROUND: This is a systematic review of randomized controlled trials and a meta-analysis comparing smart technology with face-to-face physical activity (PA) interventions in community-dwelling older adults (mean age 60 years). OBJECTIVE: This study aims to determine the effect of interventions including smart technology components compared with face-to-face PA interventions on PA and physical function in older adults. The secondary outcomes are depression, anxiety, and health-related quality of life. METHODS: We searched MEDLINE, Embase, CINAHL, and AMED electronic databases from inception to February 2021. Two independent reviewers screened titles, abstracts, and full texts and performed data extraction and risk of bias assessments using the Cochrane risk of bias tool. The Grading of Recommendations Assessment, Development and Evaluation was used to evaluate the quality of the evidence. We provided a narrative synthesis on all included studies and, where possible, performed meta-analyses for similar outcomes. RESULTS: This review included 19 studies with a total of 3455 participants. Random effects meta-analyses showed that interventions with smart technology components resulted in improved step count (mean difference 1440 steps, 95% CI 500-2390) and total PA (standardized mean difference 0.17, 95% CI 0.02-0.32) compared with face-to-face alone. There was no difference between groups in terms of the measures of physical function. Smart technology alone did not show significant differences between groups in any outcome. The quality of the evidence was very low based on the Grading of Recommendations Assessment, Development and Evaluation criteria. CONCLUSIONS: Interventions that include smart technology may improve daily step counts by an average of 1440 steps in community-dwelling older adults; however, the quality of the evidence was very low. Future studies are needed to improve the certainty of these results. TRIAL REGISTRATION: PROSPERO CRD42020135232; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=135232.

Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic.

RATIONALE: The COVID-19 pandemic disrupted non-COVID critical care trials globally as intensive care units (ICUs) prioritized patient care and COVID-specific research. The international randomized controlled trial CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) was forced to halt recruitment at all sites in March 2020, creating immediate challenges. We applied the CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstance) statement as a framework to report the impact of the pandemic on CYCLE and describe our mitigation approaches. METHODS: On March 23, 2020, the CYCLE Methods Centre distributed a standardized email to determine the number of patients still in-hospital and those requiring imminent 90-day endpoint assessments. We assessed protocol fidelity by documenting attempts to provide the in-hospital randomized intervention (cycling or routine physiotherapy) and collect the primary outcome (physical function 3-days post-ICU discharge) and 90-day outcomes. We advised sites to prioritize data for the study's primary outcome. We sought feedback on pandemic barriers related to trial procedures. RESULTS: Our main Methods Centre mitigation strategies included identifying patients at risk for protocol deviations, communicating early and frequently with sites, developing standardized internal tools focused on high-risk points in the protocol for monitoring patient progress, data entry, and validation, and providing guidance to conduct some research activities remotely. For study sites, our strategies included determining how institutional pandemic research policies applied to CYCLE, communicating with the Methods Centre about capacity to continue any part of the research, and developing contingency plans to ensure the protocol was delivered as intended. From 15 active sites (12 Canada, 2 US, 1 Australia), 5 patients were still receiving the study intervention in ICUs, 6 required primary outcomes, and 17 required 90-day assessments. With these mitigation strategies, we attempted 100% of ICU interventions, 83% of primary outcomes, and 100% of 90-day assessments per our protocol. CONCLUSIONS: We retained all enrolled patients with minimal missing data using several time-sensitive strategies. Although CONSERVE recommends reporting only major modifications incurred by extenuating circumstances, we suggest that it also provides a helpful framework for reporting mitigation strategies with the goal of improving research transparency and trial management. TRIAL REGISTRATION: NCT03471247. Registered on March 20, 2018.

The use of co-design in developing physical activity interventions for older adults: a scoping review.

BACKGROUND: Promoting physical activity (PA) participation in older adults is important for preserving quality of life and functional independence. Co-design has been shown to increase engagement of end-users in health-related policies and interventions. This scoping review aimed to examine how co-design has been used to develop PA interventions for older adults. METHODS: We searched MEDLINE, EMBASE, AMED, and CINAHL. Peer-reviewed primary research studies that met the following criteria were included: had at least one participant aged ≥60 years involved in the co-design process and the intervention was delivered to individuals whose mean age was ≥60, used co-design methodologies, and any form of PA. After duplicate removal, two or more independent reviewers completed title and abstract and full text screening. Data were extracted from the included studies according to study aims. RESULTS: Of the 29 included studies, 12 different terms were used to describe co-design with variable operational definitions that we consolidated into five proposed components. Fifteen studies engaged users in a consultative way, 13 studies using collaboration, and one study engaged end-users in consumer-control. No studies involved end-users in the dissemination phase. Further, no studies directly measured the effectiveness of the co-design process. Five categories of barriers and facilitators to co-design were identified including frameworks and methodologies, logistics, relationships, participation, and generalizability. CONCLUSIONS: There is a large degree of variability in how co-design is used to develop PA interventions for older adults. Our findings can be used by researchers to improve rigor and standardization in this emerging field. TRIAL REGISTRATION: osf.io/vsw2m.

The use of co-design in developing physical activity interventions for older adults: a scoping review protocol.

OBJECTIVE: The objective of this scoping review is to map the available evidence on the use of co-design in developing physical activity interventions for older adults. INTRODUCTION: Remaining physically active throughout life is important for maintaining independence and quality of life. Co-design is an effective way to engage end users in health-related policy development and health care interventions; however, the definition and operational use of co-design varies widely. This scoping review will summarize the available evidence on how co-design is used to engage older adults in physical activity interventions and identify areas for future research. INCLUSION CRITERIA: Studies must have at least one participant aged 60 years or older and include concepts related to co-design and physical activity to be eligible for inclusion. Eligible studies must be original, peer-reviewed research. METHODS: MEDLINE, Embase, CINAHL, and AMED databases will be searched from inception to February 18, 2021. Following duplicate removal, titles and abstracts will be screened and selected according to predefined inclusion criteria by two or more independent reviewers. Kappa level of agreement will be calculated between reviewers for selection of titles and abstracts. The remaining full texts will be screened against inclusion criteria, and reasons for exclusion will be reported. Data will be extracted from included studies by two or more independent reviewers according to the Participant, Concept, Context framework. Information pertaining to the aims of this scoping review and the study methodology will be extracted and presented in tabular format, accompanied by a narrative summary. SCOPING REVIEW REGISTRATION NUMBER: Open Science Framework Registration (osf.io/vsw2m).

Functional recovery following hospitalisation of patients diagnosed with COVID-19: a protocol for a longitudinal cohort study.

INTRODUCTION: COVID-19 is an international public health crisis with more than 132 million infections worldwide. Beyond acute infection, emerging data indicate patients diagnosed with COVID-19 may experience persistent sequelae similar to survivors of sepsis or acute respiratory syndromes, including mobility limitations and fatigue. However, there is limited evidence on the trajectory of functional recovery in those hospitalised with COVID-19. The primary aim of the Coronavirus Registry Functional Recovery (COREG-FR) study is to understand the trajectory of functional recovery among individuals hospitalised for COVID-19 over the medium (up to 6 months) and longer term (6-12 months) that will guide clinical care and optimal management of serious COVID-19 illness and recovery. METHODS AND ANALYSIS: COREG-FR is a multicentre longitudinal cohort study. We will enrol a minimum of 211 adults age 18 years and older with COVID-19 from five hospitals. Participants will be followed from admission to hospital as an inpatient, to hospital discharge, and at 3-month, 6-month, 9-month and up to 12-month post-hospital discharge. We will conduct telephone interviews at ward admission and discharge, and telephone interviews plus in-person assessments of physical function and lung function at all remaining follow-ups. Our primary outcome is the Activity Measure for Post-Acute Care mobility scale measured at all time points. We will conduct linear mixed effects regression analyses to explore determinants of functional outcomes after COVID-19 illness. Subgroup analyses based on age (≤65 vs >65 years), frailty status (Clinical Frailty Scale score ≤4 vs >5) and variants of concern will be conducted. ETHICS AND DISSEMINATION: COREG-FR has been approved by Research Ethics Boards at participating sites. We will disseminate this work through peer-reviewed manuscripts, presentations at national and international meetings and through the established COREG website (www.coregontario.ca). COREG-FR is designed as a data platform for future studies evaluating COVID-19 recovery. TRIAL REGISTRATION NUMBER: NCT04602260; Pre-results.

Smart technology vs. face-to-face physical activity interventions in older adults: a systematic review protocol.

OBJECTIVE: The objective of this review is to determine the effect of physical activity interventions delivered via smart technology compared with face-to-face interventions for improving physical activity and physical function in older adults. INTRODUCTION: Physical activity is a modifiable risk factor for multiple noncommunicable diseases and reduces the risk of premature mortality. Despite this, one in four adults does not meet recommended levels of physical activity. This pattern of inactivity increases with age. Smart technology, such as wearables, tablets, or laptops, is one solution for improving physical activity. Research has shown that different smart technology solutions can increase physical activity in older adults. While individual studies support smart technology to increase physical activity, there are no systematic reviews comparing the effects of smart technology with traditional face-to-face physical activity interventions. INCLUSION CRITERIA: We will include randomized controlled trials of physical activity interventions delivered via smart technology (eg, wearables, tablets, computers) compared with face-to-face (ie, in person) interventions for community-dwelling older adults aged 60 years or older. METHODS: We will search four databases (AMED, CINAHL, Embase, MEDLINE) from inception for relevant studies. All abstracts and full texts will be screened independently and in duplicate. Risk of bias, data extraction, and quality assessment will be completed in the same manner. If possible, a meta-analysis will be performed of the primary outcomes of physical activity, physical function, and adherence rate. Subgroup analyses will be conducted by type of physical activity, and type of smart technology, where possible. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42020135232.

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.

Feasibility, Reliability, Responsiveness, and Validity of the Patient-Reported Functional Scale for the Intensive Care Unit: A Pilot Study.

BACKGROUND: Although many performance-based measures assess patients' physical function in intensive care unit (ICU) survivors, to our knowledge, there are no patient-reported ICU rehabilitation-specific measures assessing function. We developed the Patient-Reported Functional Scale-ICU (PRFS-ICU), which measures patients' perceptions of their ability to perform 6 activities (rolling, sitting edge of bed, sit-to-stand and bed-to-chair transfers, ambulation, and stair climbing). Each item is scored from 0 (unable) to 10 (able to perform at pre-ICU level) to a maximum of 60. OBJECTIVES: Estimate the feasibility, reliability, responsiveness, and validity of the PRFS-ICU. METHODS: This was a substudy of TryCYCLE, a single-center, prospective cohort examining the safety and feasibility of early in-bed cycling with mechanically ventilated patients (NCT01885442). To determine feasibility, we calculated the number of patients with at least 1 PRFS-ICU assessment during their hospital stay. To assess reliability, 2 raters blinded to each other's assessments administered the PRFS-ICU within 24-hours of each other. We calculated the intraclass correlation coefficient (ICC; 95% confidence interval [CI]), standard error of measurement (SEM, 95% CI), and minimal detectable change (MDC90). To assess validity, we estimated convergent validity of the PRFS-ICU with the Functional Status Score for ICU (FSS-ICU), Medical Research Council Sum Score (MRC-SS), Physical Function Test for ICU (PFIT-s), Katz Index of Independence in Activities of Daily Living (Katz ADLs), and a pooled index using Pearson's correlation coefficient (r, 95% CI). RESULTS: Feasibility: 20 patients completed a PRFS-ICU assessment. Reliability and responsiveness: 16 patients contributed data. The ICC, SEM, and MDC90 were 0.91 (0.76, 0.97), 4.75 (3.51, 7.35), and 11.04 points, respectively. Validity: 19 patients contributed data and correlations were (r [95% CI]): FSS-ICU (0.40 [-0.14, 0.76]), MRC-SS (0.51 [0.02, 0.80]), PFIT-s (0.43 [-0.13, 0.78]), Katz ADLs (0.53 [0.10, 0.79]), and pooled index (0.48 [-0.14, 0.82]). CONCLUSIONS: Our pilot work suggests the PRFS-ICU may be a useful tool to assess and monitor patients' perceptions of function over time.

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.

I SURVIVE: inter-rater reliability of three physical functional outcome measures in intensive care unit survivors.

PURPOSE: We prospectively assessed inter-rater reliability of three physical function measures in Canadian intensive care unit (ICU) survivors in the inpatient setting. METHODS: We enrolled patients who had an ICU length of stay of ≥ three days, were mechanically ventilated for ≥ 24 hr, and were ambulating independently before hospital admission. Weekly from ICU discharge to hospital discharge, two trained frontline clinicians, blinded to each other's findings, independently performed the Physical Function ICU Test-scored (PFIT-s; score out of 10), 30-sec sit-to-stand (30STS; # of stands), and two-minute walk test (2MWT; distance in m), all within 24 hr. We calculated the intraclass correlation coefficient (ICC), standard error of measurement (SEM), and minimal detectable change (MDC90). RESULTS: We enrolled 42 patients. PFIT-s: in 36 patients with 66 paired scores, the ICC was 0.78 (95% confidence interval [CI], 0.66 to 0.86), the SEM was 1.04, and the MDC90 was 2.42. 30STS: in 35 patients with 67 paired scores, the ICC was 0.85 (95% CI, 0.76 to 0.90), the SEM was 1.91, and the MDC90 was 4.45. 2MWT: in 35 patients with 58 paired scores, the ICC was 0.78 (95% CI, 0.66 to 0.87), the SEM was 20.87, and the MDC90 was 48.69. CONCLUSION: These three measures show good inter-rater reliability when used by trained frontline clinicians to assess physical function in ICU survivors in the inpatient setting.

RéSUMé: OBJECTIF: Nous avons évalué de manière prospective la fidélité interobservateurs de trois mesures de la capacité physique fonctionnelle auprès de survivants des unités de soins intensifs (USI) canadiennes dans un cadre hospitalier. MéTHODE: Nous avons recruté des patients qui avaient séjourné à l'USI ≥ trois jours, avaient été sous ventilation mécanique ≥ 24 h et se déplaçaient de façon autonome avant leur admission à l'hôpital. Entre le congé de l'USI et le congé de l'hôpital, deux cliniciens de première ligne formés ont réalisé chaque semaine et de manière indépendante trois tests : le PFIT (Test de la capacité physique fonctionnelle à l'USI - Physical Function ICU Test-scored; score sur 10), le test de 30 sec pour se lever d'une position assise (30STS; # de fois debout), et le test de marche pendant deux minutes (2MWT; distance en m). Les cliniciens n'avaient pas accès aux résultats de leur collègue. Nous avons calculé le coefficient de corrélation intraclasse (CCI), l'erreur type sur la mesure (ETM), et le changement minimal détectable (CMD90). RéSULTATS: Nous avons recruté 42 patients, et observé les résultats suivants : pour le PFIT : chez 36 patients avec 66 scores appariés, le CCI était de 0,78 (intervalle de confiance [IC] 95 %, 0,66 à 0,86), l'ETM de 1,04, et le CMD90 de 2,42; pour le test 30STS : chez 35 patients avec 67 scores appariés, le CCI était de 0,85 (IC 95 %, 0,76 à 0,90), l'ETM de 1,91, et le CMD90 de 4,45; pour le 2MWT : chez 35 patients avec 58 scores appariés, le CCI était de 0,78 (IC 95 %, 0,66 à 0,87, l'ETM de 20,87, et le CMD90 de 48,69. CONCLUSION: Ces trois mesures affichent une bonne fidélité interobservateurs lorsqu'elles sont utilisées par des cliniciens de première ligne formés afin d'évaluer la capacité physique fonctionnelle des survivants de l'USI dans un cadre hospitalier.

Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients.

Introduction: Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. In-bed cycling early in a patient's ICU stay is a promising intervention. The objective of this study was to determine the feasibility of recruitment, intervention delivery and retention in a multi centre randomised clinical trial (RCT) of early in-bed cycling with mechanically ventilated (MV) patients. Methods: We conducted a pilot RCT conducted in seven Canadian medical-surgical ICUs. We enrolled adults who could ambulate independently before ICU admission, within the first 4 days of invasive MV and first 7 days of ICU admission. Following informed consent, patients underwent concealed randomisation to either 30 min/day of in-bed cycling and routine physiotherapy (Cycling) or routine physiotherapy alone (Routine) for 5 days/week, until ICU discharge. Our feasibility outcome targets included: accrual of 1-2 patients/month/site; >80% cycling protocol delivery; >80% outcomes measured and >80% blinded outcome measures at hospital discharge. We report ascertainment rates for our primary outcome for the main trial (Physical Function ICU Test-scored (PFIT-s) at hospital discharge). Results: Between 3/2015 and 6/2016, we randomised 66 patients (36 Cycling, 30 Routine). Our consent rate was 84.6 % (66/78). Patient accrual was (mean (SD)) 1.1 (0.3) patients/month/site. Cycling occurred in 79.3% (146/184) of eligible sessions, with a median (IQR) session duration of 30.5 (30.0, 30.7) min. We recorded 43 (97.7%) PFIT-s scores at hospital discharge and 37 (86.0%) of these assessments were blinded. Discussion: Our pilot RCT suggests that a future multicentre RCT of early in-bed cycling for MV patients in the ICU is feasible. Trial registration number: NCT02377830.