Development, feasibility testing, and preliminary evaluation of the Communication with an Artificial airway Tool (CAT): Results of the Crit-CAT pilot study.

BACKGROUND: A purpose-built outcome measure for assessing communication effectiveness in patients with an artificial airway is needed. OBJECTIVES: The objective of this study was to develop the Communication with an Artificial airway Tool (CAT) and to test the feasibility and to preliminary evaluate the clinical metrics of the tool. METHODS: Eligible patients with an artificial airway in the Intensive Care Unit were enrolled in the pilot study (Crit-CAT). The CAT was administered at least twice before and after the communication intervention. Item correlation analysis was performed. Participant and family member acceptability ratings and feedback were solicited. A qualitative thematic analysis was undertaken. RESULTS: Fifteen patients with a mean age of 53 years (standard deviation [SD]: 19.26) were included. The clinician-reported scale was administered on 50 attempts (100%) with a mean completion time of 4.5 (SD: 0.77) minutes. The patient-reported scale was administered on 46 out of 49 attempts (94%) and took a mean of 1.5 (SD: 0.39) minutes to complete. The CAT was feasible for use in the Intensive Care Unit, with patients with either an endotracheal or tracheostomy tube, whilst receiving invasive mechanical ventilation or not, and while using either verbal or nonverbal modes of communication. Preliminary establishment of responsiveness, validity, and reliability was made. The tool was acceptable to participants and their family members. CONCLUSION: The clinician-reported and patient-reported components of the study were feasible for use. The CAT has the potential to enable quantifiable comparison of communication interventions for patients with an artificial airway. Future research is required to determine external validity and reliability.

Critical Care Cycling to Improve Lower Extremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients.

INTRODUCTION: In-bed leg cycling with critically ill patients is a promising intervention aimed at minimising immobility, thus improving physical function following intensive care unit (ICU) discharge. We previously completed a pilot randomised controlled trial (RCT) which supported the feasibility of a large RCT. In this report, we describe the protocol for an international, multicentre RCT to determine the effectiveness of early in-bed cycling versus routine physiotherapy (PT) in critically ill, mechanically ventilated adults. METHODS AND ANALYSIS: We report a parallel group RCT of 360 patients in 17 medical-surgical ICUs and three countries. We include adults (≥18 years old), who could ambulate independently before their critical illness (with or without a gait aid), ≤4 days of invasive mechanical ventilation and ≤7 days ICU length of stay, and an expected additional 2-day ICU stay, and who do not fulfil any of the exclusion criteria. After obtaining informed consent, patients are randomised using a web-based, centralised system to either 30 min of in-bed cycling in addition to routine PT, 5 days per week, up to 28 days maximum, or routine PT alone. The primary outcome is the Physical Function ICU Test-scored (PFIT-s) at 3 days post-ICU discharge measured by assessors blinded to treatment allocation. Participants, ICU clinicians and research coordinators are not blinded to group assignment. Our sample size estimate was based on the identification of a 1-point mean difference in PFIT-s between groups. ETHICS AND DISSEMINATION: Critical Care Cycling to improve Lower Extremity (CYCLE) is approved by the Research Ethics Boards of all participating centres and Clinical Trials Ontario (Project 1345). We will disseminate trial results through publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT03471247 (Full RCT); NCT02377830 (CYCLE Vanguard 46 patient internal pilot).

Responsiveness of Critically Ill Adults With Multimorbidity to Rehabilitation Interventions: A Patient-Level Meta-Analysis Using Individual Pooled Data From Four Randomized Trials.

OBJECTIVE: To explore if patient characteristics (pre-existing comorbidity, age, sex, and illness severity) modify the effect of physical rehabilitation (intervention vs control) for the coprimary outcomes health-related quality of life (HRQoL) and objective physical performance using pooled individual patient data from randomized controlled trials (RCTs). DATA SOURCES: Data of individual patients from four critical care physical rehabilitation RCTs. STUDY SELECTION: Eligible trials were identified from a published systematic review. DATA EXTRACTION: Data sharing agreements were executed permitting transfer of anonymized data of individual patients from four trials to form one large, combined dataset. The pooled trial data were analyzed with linear mixed models fitted with fixed effects for treatment group, time, and trial. DATA SYNTHESIS: Four trials contributed data resulting in a combined total of 810 patients (intervention n = 403, control n = 407). After receiving trial rehabilitation interventions, patients with two or more comorbidities had HRQoL scores that were significantly higher and exceeded the minimal important difference at 3 and 6 months compared with the similarly comorbid control group (based on the Physical Component Summary score (Wald test p = 0.041). Patients with one or no comorbidities who received intervention had no HRQoL outcome differences at 3 and 6 months when compared with similarly comorbid control patients. No patient characteristic modified the physical performance outcome in patients who received physical rehabilitation. CONCLUSIONS: The identification of a target group with two or more comorbidities who derived benefits from the trial interventions is an important finding and provides direction for future investigations into the effect of rehabilitation. The multimorbid post-ICU population may be a select population for future prospective investigations into the effect of physical rehabilitation.

The PhLIP team: Feasibility of a physiotherapy-led intensive prone positioning team initiative during the COVID-19 pandemic.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic resulted in a surge of patients with refractory hypoxaemic respiratory failure being admitted to the intensive care unit (ICU). Prone positioning can improve oxygenation but requires a team of skilled personnel to complete safely. Critical care physiotherapists (PTs) are ideally suited to lead proning teams, due to their expertise in moving critically unwell, invasively ventilated patients. OBJECTIVES: The aim of this study was to describe the feasibility of implementing a physiotherapy-led intensive proning (PhLIP) team to support the critical care team during surges. METHODS: This study involves descriptive evaluation of feasibility and implementation of the PhLIP team, a novel model of care, during the Delta wave of the COVID-19 pandemic, through a retrospective, observational audit of PhLIP team activity, ICU clinical activity, and a description of clinical outcomes. RESULTS: Between 17 September and 19 November 2021, 93 patients with COVID-19 were admitted to the ICU. Fifty-one patients (55%) were positioned prone, a median [interquartile range] 2 [2, 5] times, for a mean (±standard deviation) duration of 16 (±2) h, across 161 episodes. Twenty-three PTs were upskilled and deployed to the PhLIP team, adding 2.0 equivalent full time to the daily service. Ninety-four percent of prone episodes (154) were led by the PhLIP PTs with a median 4 [interquartile range: 2, 8] turns per day. Potential airway adverse events occurred on three occasions (1.8%) and included an endotracheal tube leak, displacement, and obstruction. Each incident was promptly managed without prolonged impact on the patient. No manual handling injuries were reported. CONCLUSION: The implementation of a physiotherapy-led proning team was safe and feasible and can release critical care-trained medical and nursing staff to other duties in the ICU.

Physical therapy and nutrition therapy: synergistic, antagonistic, or independent interventions?

PURPOSE OF REVIEW: Physical therapy and nutrition therapy have predominantly been studied separately in the critically ill, however in clinical practice are often delivered in combination. It is important to understand how these interventions interact. This review will summarize the current science - where they are potentially synergistic, antagonistic, or independent interventions. RECENT FINDINGS: Only six studies were identified within the ICU setting that combined physical therapy and nutrition therapy. The majority of these were randomized controlled trials with modest sample sizes. There was an indication of benefit in the preservation of femoral muscle mass and short-term physical quality of life - particularly with high-protein delivery and resistance exercise, in patients who were predominantly mechanically ventilated patients, with an ICU length of stay of approximately 4-7 days (varied across studies). Although these benefits did not extend to other outcomes such as reduced length of ventilation, ICU or hospital admission. No recent trials were identified that combined physical therapy and nutrition therapy in post-ICU settings and is an area that warrants investigation. SUMMARY: The combination of physical therapy and nutrition therapy might be synergistic when evaluated within the ICU setting. However, more careful work is required to understand the physiological challenges in the delivery of these interventions. Combining these interventions in post-ICU settings is currently under-investigated, but may be important to understand any potential benefits to patient longitudinal recovery.

Defining effective communication for critically ill patients with an artificial airway: An international multi-professional consensus.

OBJECTIVES: To define effective communication and identify its key elements specific to critically ill patients with an artificial airway. DESIGN: A modified Consensus Development Panel methodology. SETTING: International video-conferences. MAIN OUTCOME MEASURES: Definition of effective communication and it's key elements. RESULTS: Eight experts across four international regions and three professions agreed to form the Consensus Development Panel together with a Chair and one person with lived experience who reviewed the outputs prior to finalisation. "Communication for critically ill adult patients with an artificial airway (endotracheal or tracheostomy tube) is defined as the degree in which a patient can initiate, impart, receive, and understand information, and can range from an ineffective to effective exchange of basic to complex information between the patient and the communication partner(s). Effective communication encompasses seven key elements including: comprehension, quantity, rate, effort, duration, independence, and satisfaction. In critically ill adults, communication is impacted by factors including medical, physical and cognitive status, delirium, fatigue, emotional status, the communication partner and the nature of the ICU environment (e.g., staff wearing personal protective equipment, noisy equipment, bright lights)." The panel agreed that communication occurs on a continuum from ineffective to effective for basic and complex communication. CONCLUSION: We developed a definition and list of key elements which constitute effective communication for critically ill patients with an artificial airway. These can be used as the basis of standard terminology to support future research on the development of communication-related outcome measurement tools in this population. IMPLICATIONS FOR CLINICAL PRACTICE: This study provides international multi-professional consensus terminology and a definition of effective communication which can be used in clinical practice. This standard definition and key elements of effective communication can be included in our clinical impressions of patient communication, and be used in discussion with the patient themselves, their families and the multi-professional team, to guide care, goal development and intervention.

Barriers and enablers to telehealth use by physiotherapists during the COVID-19 pandemic.

OBJECTIVES: To investigate the perceived barriers and enablers experienced by physiotherapists whilst delivering community and outpatient services during the COVID-19 pandemic. METHODS: Qualitative study undertaken at a University-affiliated hospital in Melbourne, Australia. Physiotherapists working in the outpatient setting participated in a semi-structured interview. Interviews were analysed using Framework Analysis, with themes mapped to the Theoretical Domains Framework (TDF). RESULTS: From 19 interviews, we identified major themes and mapped these to the TDF domains: 1. The pandemic rapidly closed the knowledge-practice gap; 2. Adaptation of existing skills and integration of new skills were required; 3. Supportive senior leadership helped the transition; 4. Capabilities and confidence improved with time; 5. Environmental factors were crucial to success or failure of telehealth; 6. Access to and delivery of care improved for some; 7. Identification of appropriate patients and future hybrid models of care; 8. Changes in work practices, role certainty and identity; 9. Development of educational resources consolidated knowledge; 10. Socialisation of telehealth and optimism for the future. Within each domain, key barriers and enablers were also identified. CONCLUSIONS: The findings of this study suggest that the delivery of community and outpatient physiotherapy via telehealth during the COVID-19 pandemic was an initial challenge. Growing knowledge, confidence and ability to problem solve barriers enabled physiotherapists to move along the continuum of 'fear' to 'triumph' as the pandemic progressed. These results can be used by clinicians, managers, and academics to guide future workforce planning, hospital environmental design, and service delivery. CLINICAL MESSAGE.

Tracheostomy clinical practices and patient outcomes in three tertiary metropolitan hospitals in Australia.

BACKGROUND: There is a paucity of literature in Australia on patient-focused tracheostomy outcomes and process outcomes. Exploration of processes of care enables teams to identify and address existing barriers that may prevent earlier therapeutic interventions that could improve patient outcomes following critical care survival. OBJECTIVES: The objectives of this study were to examine and provide baseline data and associations between tracheostomy clinical practices and patient outcomes across three large metropolitan hospitals. METHODS: We performed a retrospective multisite observational study in three tertiary metropolitan Australian health services who are members of the Global Tracheostomy Collaborative. Deidentified data were entered into the Global Tracheostomy Collaborative database from Jan 2016 to Dec 2019. Descriptive statistics were used for the reported outcomes of length of stay, mortality, tracheostomy-related adverse events and complications, tracheostomy insertion, airway, mechanical ventilation, communication, swallowing, nutrition, length of cannulation, and decannulation. Pearson's correlation coefficient and one-way analyses of variance were performed to examine associations between variables. RESULTS: The total cohort was 380 patients. The in-hospital mortality of the study cohort was 13%. Overall median hospital length of stay was 46 days (interquartile range: 31-74). Length of cannulation was shorter in patients who did not experience any tracheostomy-related adverse events (p= 0.036) and who utilised nonverbal communication methods (p = 0.041). Few patients (8%) utilised verbal communication methods while mechanically ventilated, compared with 80% who utilised a one-way speaking valve while off the ventilator. Oral intake was commenced in 20% of patients prior to decannulation. Patient nutritional intake varied prior to and at the time of decannulation. Decannulation occurred in 83% of patients. CONCLUSIONS: This study provides baseline data for tracheostomy outcomes across three large metropolitan Australian hospitals. Most outcomes were comparable with previous international and local studies. Future research is warranted to explore the impact of earlier nonverbal communication and interventions targeting the reduction in tracheostomy-related adverse events.

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 sit-to-stand test as a patient-centered functional outcome for critical care research: a pooled analysis of five international rehabilitation studies.

BACKGROUND: With ICU mortality rates decreasing, it is increasingly important to identify interventions to minimize functional impairments and improve outcomes for survivors. Simultaneously, we must identify robust patient-centered functional outcomes for our trials. Our objective was to investigate the clinimetric properties of a progression of three outcome measures, from strength to function. METHODS: Adults (≥ 18 years) enrolled in five international ICU rehabilitation studies. Participants required ICU admission were mechanically ventilated and previously independent. Outcomes included two components of the Physical Function in ICU Test-scored (PFIT-s): knee extensor strength and assistance required to move from sit to stand (STS); the 30-s STS (30 s STS) test was the third outcome. We analyzed survivors at ICU and hospital discharge. We report participant demographics, baseline characteristics, and outcome data using descriptive statistics. Floor effects represented ≥ 15% of participants with minimum score and ceiling effects ≥ 15% with maximum score. We calculated the overall group difference score (hospital discharge score minus ICU discharge) for participants with paired assessments. RESULTS: Of 451 participants, most were male (n = 278, 61.6%) with a median age between 60 and 66 years, a mean APACHE II score between 19 and 24, a median duration of mechanical ventilation between 4 and 8 days, ICU length of stay (LOS) between 7 and 11 days, and hospital LOS between 22 and 31 days. For knee extension, we observed a ceiling effect in 48.5% (160/330) of participants at ICU discharge and in 74.7% (115/154) at hospital discharge; the median [1st, 3rd quartile] PFIT-s difference score (n = 139) was 0 [0,1] (p < 0.05). For STS assistance, we observed a ceiling effect in 45.9% (150/327) at ICU discharge and in 77.5% (79/102) at hospital discharge; the median PFIT-s difference score (n = 87) was 1 [0, 2] (p < 0.05). For 30 s STS, we observed a floor effect in 15.0% (12/80) at ICU discharge but did not observe a floor or ceiling effect at hospital discharge. The median 30 s STS difference score (n = 54) was 3 [1, 6] (p < 0.05). CONCLUSION: Among three progressive outcome measures evaluated in this study, the 30 s STS test appears to have the most favorable clinimetric properties to assess function at ICU and hospital discharge in moderate to severely ill participants.

Physical activity of patients with critical illness undergoing rehabilitation in intensive care and on the acute ward: An observational cohort study.

BACKGROUND: There are limited published data on physical activity of survivors of critical illness engaged in rehabilitation in hospital, despite it plausibly influencing outcome. OBJECTIVE: The aims of this study were to measure physical activity of patients with critical illness engaged in rehabilitation in the intensive care unit (ICU) and on the acute ward and report discharge destination, muscle strength, and functional outcomes. METHODS: This was a single-centre, prospective observational study. Adults with critical illness, who received ≥48 h of invasive mechanical ventilation, and who were awake and able to participate in rehabilitation were eligible. To record physical activity, participants wore BodyMedia SenseWear Armbands (BodyMedia Incorporated, USA), during daylight hours, from enrolment until hospital discharge or day 14 of ward stay (whichever occurred first). The primary outcome was time (minutes) spent performing physical activity at an intensity of greater than 1.5 Metabolic Equivalent Tasks. Secondary outcomes included discharge destination, muscle strength, and physical function. RESULTS: We collected 807 days of physical activity data (363 days ICU, 424 days ward) from 59 participants. Mean (standard deviation) duration of daily physical activity increased from the ICU, 17.8 (22.8) minutes, to the ward, 52.8 (51.2) minutes (mean difference [95% confidence interval] = 35 [23.8-46.1] minutes, P < .001). High levels of activity in the ICU were associated with higher levels of activity on the ward (r = .728), n = 48, P < .001. CONCLUSIONS: Patients recovering from critical illness spend less than 5% of the day being physically active throughout hospital admission, even when receiving rehabilitation. Physical activity increased after discharge from intensive care, but had no relationship with discharge destination. Only the absence of ICU-acquired weakness on awakening was associated with discharge directly home from the acute hospital. Future studies could target early identification of ICU-acquired weakness and the preservation of muscle strength to improve discharge outcomes.

Outcome measurement tools for communication, voice and speech intelligibility in the ICU and their clinimetric properties: A systematic review.

Purpose: To identify outcome measurement tools used to evaluate communication, voice and speech intelligibility in the mechanically ventilated ICU population. Secondly, to evaluate, synthesise and compare the clinimetric properties of the tools identified. Materials and methods: A systematic review of articles was undertaken via electronic databases in two parts. Eligibility criteria for selection: part one - quantitative or mixed methods studies which assessed communication, voice or speech intelligibility; part two - studies which evaluated a clinimetric property for one of the tools identified in part one. Two independent reviewers assessed articles for inclusion and used the consensus-based standards for health status measurement instruments (COSMIN) risk of bias checklist. Results: The part one search yielded five included studies comprised of eight outcome measurement tools. The part two search yielded 22 included studies comprised of nine tools. Few studies had adequate reliability and measurement error properties. No studies established responsiveness. A notable proportion of studies utilised tools that have no clinimetric properties. Conclusions: There is a relatively small number of studies which have established clinimetric properties for outcome measurement tools that evaluate communication, voice and/or speech intelligibility, and a fewer number which have done so in the mechanically ventilated ICU population.

Recumbent cycling to improve outcomes in people with hip fracture: a feasibility randomized trial.

BACKGROUND: Early mobilization after surgery is a key recommendation for people with hip fracture, however this is achieved by only 50% of people. Recumbent bike riding has been used in other populations with limited mobility and has potential to allow early exercise in people post hip fracture. The primary aim of this pilot trial was to demonstrate the feasibility of a trial protocol designed to determine the effect of early post-operative cycling in bed on outcomes in people with hip fracture. METHODS: Single-blinded, multi-site randomized controlled pilot trial. Fifty-one people with hip fracture were recruited within 4 days of surgery from two sites in Victoria. Participants were randomly allocated to receive either usual care (n = 25) or usual care plus active cycling in bed (n = 26). The cycling intervention was delivered on weekdays until the participant could walk 15 m with assistance of one person. The primary outcomes were trial feasibility and safety. Clinical outcomes, including mobility (Modified Iowa Level of Assistance Scale) and delirium were measured at day seven post-operatively and at hospital discharge by an assessor blinded to group. Additional outcomes at discharge included gait speed, cognition and quality of life. RESULTS: The intervention was safe, feasible and acceptable to patients and staff. Delivery of the intervention was ceased on (median) day 9.5 (IQR 7, 12); 73% of scheduled sessions were delivered; (median) 4 sessions (IQR 2.0, 5.5) were delivered per participant with (median) 9 min 34 s (IQR 04:39, 17:34) of active cycling per session. The trial protocol was feasible, however at day seven 75% of participants had not met the criterion (able to walk 15 m with assistance of one person) to cease the cycling intervention.. CONCLUSION: In bed cycling is feasible post-operatively following hip fracture, however seven days post-operatively is too early to evaluate the impact of the cycling intervention as many participants were still receiving the intervention. A fully powered RCT to explore the effectiveness and cost efficiency of this novel intervention is warranted. TRIAL REGISTRATION: The trial was prospectively registered (25/09/2017) with the Australian New Zealand Clinical Trials Registry ACTR N12617001345370 .

Factors Impacting Early Mobilization Following Hip Fracture: An Observational Study.

BACKGROUND AND PURPOSE: Hip fracture guidelines emphasize mobilization within 48 hours of surgery. The aims of this audit were to determine the proportion of patients with hip fracture who mobilize within 48 hours, identify factors associated with delayed mobilization, and identify barriers to mobilization. METHODS: Single-site prospective audit of 100 consecutive patients (age 82 ± 9 years) admitted for surgical management of hip fracture. Data collected included time to mobilization, factors that may impact mobilization (age, weight-bearing status, additional injuries, premorbid mobility status, time to surgery, dementia, delirium, and postoperative complications), and barriers to mobilization as identified by the physical therapist. RESULTS AND DISCUSSION: Mobilization within 48 hours of surgery was achieved by 43% of patients. Multivariate logistic regression demonstrated odds of mobilizing early increased with higher New Mobility Scores, representing better premorbid mobility (odds ratio [OR] = 1.30; 95% confidence interval [CI], 1.06-1.60); odds reduced if delirium was present on day 1 or 2 (OR = 0.25; 95% CI, 0.08-0.79). New Mobility Scores 5 or more, which indicate independent premorbid mobility inside and outside the house, best predicted early mobilization in patients who did not develop delirium. No cutoff score was identified for those with delirium. Identified barriers to mobilization included patient confusion, manual handling risk, patient declined, and hypotension. CONCLUSIONS: Less than half of this cohort achieved the guideline of mobilization within 48 hours of surgery. Patients who develop delirium within the first 2 days of surgery or who had premorbid mobility limitation were less likely to mobilize. Identification of patients likely to have delayed mobilization will assist physical therapists with delivering appropriate management to patients with hip fracture during their acute hospital stay.

Functional electrical stimulation in-bed cycle ergometry in mechanically ventilated patients: a multicentre randomised controlled trial.

PURPOSE: To investigate the effect of functional electrical stimulation-assisted cycle ergometry (FES-cycling) on muscle strength, cognitive impairment and related outcomes. METHODS: Mechanically ventilated patients aged ≥18 years with sepsis or systemic inflammatory response syndrome were randomised to either 60 min of FES-cycling >5 days/week while in the intensive care unit (ICU) plus usual care rehabilitation versus usual care rehabilitation alone, with evaluation of two primary outcomes: (1) muscle strength at hospital discharge and (2) cognitive impairment at 6-month follow-up. RESULTS: We enrolled 162 participants, across four study sites experienced in ICU rehabilitation in Australia and the USA, to FES-cycling (n=80; mean age±SD 59±15) versus control (n=82; 56±14). Intervention participants received a median (IQR) of 5 (3-9) FES-cycling sessions with duration of 56 (34-63) min/day plus 15 (10-23) min/day of usual care rehabilitation. The control group received 15 (8-15) min/day of usual care rehabilitation. In the intervention versus control group, there was no significant differences for muscle strength at hospital discharge (mean difference (95% CI) 3.3 (-5.0 to 12.1) Nm), prevalence of cognitive impairment at 6 months (OR 1.1 (95% CI 0.30 to 3.8)) or secondary outcomes measured in-hospital and at 6 and 12 months follow-up. CONCLUSION: In this randomised controlled trial, undertaken at four centres with established rehabilitation programmes, the addition of FES-cycling to usual care rehabilitation did not substantially increase muscle strength at hospital discharge. At 6 months, the incidence of cognitive impairment was almost identical between groups, but potential benefit or harm of the intervention on cognition cannot be excluded due to imprecision of the estimated effect. TRIAL REGISTRATION NUMBER: ACTRN 12612000528853, NCT02214823.

Searching for the Responder, Unpacking the Physical Rehabilitation Needs of Critically Ill Adults: A REVIEW.

Survivors of critical illness can experience persistent deficits in physical function and poor health-related quality of life and utilize significant health care resources. Short-term improvements in these outcomes have been reported following physical rehabilitation. Safety and feasibility of delivering physical rehabilitation are established; however, low physical activity levels are observed throughout the recovery of patients. We provide examples on how physical activity may be increased through interdisciplinary models of service delivery. Recently, however, there has been an emergence of large randomized controlled trials reporting no effect on long-term patient outcomes. In this review, we use a proposed theoretical construct to unpack the findings of 12 randomized controlled trials that delivered physical rehabilitation during the acute hospital stay. We describe the search for the responder according to modifiers of treatment effect for physical function, health-related quality of life, and health care utilization outcomes. In addition, we propose tailoring and timing physical rehabilitation interventions to patient subgroups that may respond differently based on their impairments and perpetuating factors that hinder recovery. We examine in detail the timing, components, and dosage of the trial intervention arms. We also describe facilitators and barriers to physical rehabilitation implementation and factors that are influential in recovery from critical illness. Through this theoretical construct, we anticipate that physical rehabilitation programs can be better tailored to the needs of survivors to deliver appropriate interventions to patients who derive greatest benefit optimally timed in their recovery trajectory.