Barriers, Solutions, and Opportunities for Adapting Critical Care Clinical Trials in the COVID-19 Pandemic.

Importance: The COVID-19 pandemic created unprecedented challenges for clinical trials worldwide, threatening premature closure and trial integrity. Every phase of research operations was affected, often requiring modifications to protocol design and implementation. Objectives: To identify the barriers, solutions, and opportunities associated with continuing critical care trials that were interrupted during the pandemic, and to generate suggestions for future trials. Design, Setting, and Participants: This mixed-methods study performed an explanatory sequential analysis involving a self-administered electronic survey and focus groups of principal investigators (PIs) and project coordinators (PCs) conducting adult and pediatric individual-patient randomized trials of the Canadian Critical Care Trials Group during the COVID-19 pandemic. Eligible trials were actively enrolling patients on March 11, 2020. Data were analyzed between September 2023 and January 2024. Main Outcomes and Measures: Importance ratings of barriers to trial conduct and completion, solutions employed, opportunities arising, and suggested strategies for future trials. Quantitative data examining barriers were analyzed using descriptive statistics. Data addressing solutions, opportunities, and suggestions were analyzed by qualitative content analysis. Integration involved triangulation of data sources and perspectives about 13 trials, synthesized by an interprofessional team incorporating reflexivity and member-checking. Results: A total of 13 trials run by 29 PIs and PCs (100% participation rate) were included. The highest-rated barriers (on a 5-point scale) to ongoing conduct during the pandemic were decisions to pause all clinical research (mean [SD] score, 4.7 [0.8]), focus on COVID-19 studies (mean [SD] score, 4.6 [0.8]), and restricted family presence in hospitals (mean [SD] score, 4.1 [0.8]). Suggestions to enable trial progress and completion included providing scientific leadership, implementing technology for communication and data management, facilitating the informed consent process, adapting the protocol as necessary, fostering site engagement, initiating new sites, streamlining ethics and contract review, and designing nested studies. The pandemic necessitated new funding opportunities to sustain trial enrollment. It increased public awareness of critical illness and the importance of randomized trial evidence. Conclusions and Relevance: While underscoring the vital role of research in society and drawing the scientific community together with a common purpose, the pandemic signaled the need for innovation to ensure the rigor and completion of ongoing trials. Lessons learned to optimize research procedures will help to ensure a vibrant clinical trials enterprise in the future.

The response of Canada's clinical health research ecosystem to the COVID-19 pandemic.

BACKGROUND: The response of Canada's research community to the COVID-19 pandemic provides a unique opportunity to examine the country's clinical health research ecosystem. We sought to describe patterns of enrolment across Canadian Institutes of Health Research (CIHR)-funded studies on COVID-19. METHODS: We identified COVID-19 studies funded by the CIHR and that enrolled participants from Canadian acute care hospitals between January 2020 and April 2023. We collected information on study-and site-level variables from study leads, site investigators, and public domain sources. We described and evaluated factors associated with cumulative enrolment. RESULTS: We obtained information for 23 out of 26 (88%) eligible CIHR-funded studies (16 randomized controlled trials [RCTs] and 7 cohort studies). The 23 studies were managed by 12 Canadian and 3 international coordinating centres. Of 419 Canadian hospitals, 97 (23%) enrolled a total of 28 973 participants - 3876 in RCTs across 78 hospitals (median cumulative enrolment per hospital 30, interquartile range [IQR] 10-61), and 25 097 in cohort studies across 62 hospitals (median cumulative enrolment per hospital 158, IQR 6-348). Of 78 hospitals recruiting participants in RCTs, 13 (17%) enrolled 50% of all RCT participants, whereas 6 of 62 hospitals (9.7%) recruited 54% of participants in cohort studies. INTERPRETATION: A minority of Canadian hospitals enrolled the majority of participants in CIHR-funded studies on COVID-19. This analysis sheds light on the Canadian health research ecosystem and provides information for multiple key partners to consider ways to realize the full research potential of Canada's health systems.

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].).

Sex and gender-based analysis and diversity metric reporting in acute care trials published in high-impact journals: a systematic review.

OBJECTIVE: To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline. DESIGN: Systematic review. DATA SOURCES: We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020. STUDY SELECTION: Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome. DATA ABSTRACTION AND SYNTHESIS: 4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials. RESULTS: We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005). CONCLUSIONS: Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials. PROSPERO REGISTRATION NUMBER: CRD42022282565.

Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients (FORECAST): a prospective, multi-centre, cohort study.

PURPOSE: Frailty is common in critically ill patients but the timing and optimal method of frailty ascertainment, trajectory and relationship with care processes remain uncertain. We sought to elucidate the trajectory and care processes of frailty in critically ill patients as measured by the Clinical Frailty Scale (CFS) and Frailty Index (FI). METHODS: This is a multi-centre prospective cohort study enrolling patients ≥ 50 years old receiving life support > 24 h. Frailty severity was assessed with a CFS, and a FI based on the elements of a comprehensive geriatric assessment (CGA) at intensive care unit (ICU) admission, hospital discharge and 6 months. For the primary outcome of frailty prevalence, it was a priori dichotomously defined as a CFS ≥ 5 or FI ≥ 0.2. Processes of care, adverse events were collected during ICU and ward stays while outcomes were determined for ICU, hospital, and 6 months. RESULTS: In 687 patients, whose age (mean ± standard deviation) was 68.8 ± 9.2 years, frailty prevalence was higher when measured with the FI (CFS, FI %): ICU admission (29.8, 44.8), hospital discharge (54.6, 67.9), 6 months (34.1, 42.6). Compared to ICU admission, aggregate frailty severity increased to hospital discharge but improved by 6 months; individually, CFS and FI were higher in 45.3% and 50.6% patients, respectively at 6 months. Compared to hospital discharge, 18.7% (CFS) and 20% (FI) were higher at 6 months. Mortality was higher in frail patients. Processes of care and adverse events were similar except for worse ICU/ward mobility and more frequent delirium in frail patients. CONCLUSIONS: Frailty severity was dynamic, can be measured during recovery from critical illness using the CFS and FI which were both associated with worse outcomes. Although the CFS is a global measure, a CGA FI based may have advantages of being able to measure frailty levels, identify deficits, and potential targets for intervention.

Arm cycle ergometry in critically ill patients: A systematic review.

BACKGROUND: Intensive care unit (ICU) survivors face functional limitations due to ICU-acquired weakness. Arm cycle ergometry (ACE) introduced in the ICU may improve physical function. To our knowledge, there is limited evidence on the effectiveness of ACE and physical function outcomes in critically ill patients. OBJECTIVE: The objective of this systematic review was to examine the impact of ICU-based ACE on physical function, safety, and other clinical outcomes. REVIEW METHOD USED: Systematic Review. DATA SOURCES: A search of seven databases was conducted from the inception to January 1, 2023: Medline Ahead of Print, Ovid MEDLINE(R), Allied and Complementary Medicine Database (AMED), Embase, Cochrane Central, Physiotherapy Evidence Database, and Cumulative Index to Nursing and Allied Health Literature (CINAHL). REVIEW METHODS: We included two arm studies of critically ill adults admitted to the ICU who received ACE and any comparator for our primary outcome, physical function. Our secondary outcomes included severe events. We included safety studies with or without a comparator group. Screening, data abstraction, and risk-of-bias assessments were completed independently, in duplicate. We used the Grading of Recommendations, Assessment, Development, and Evaluation approach to assess the overall certainty of evidence. RESULTS: We screened 651 citations and included eight studies that enrolled 183 patients. Due to heterogeneity, meta-analysis was not performed. For our primary outcome, one randomised controlled trial found significant improvements in physical function, measured by the Barthel Index with ACE, whereas a nonrandomised study showed no difference. Out of the six studies reporting safety, none reported any severe safety events. The overall certainty of evidence was very low. CONCLUSION: ACE initiated in the ICU is a likely safe intervention. Based on the limited ACE studies and heterogeneity between studies, further research with more rigorous studies evaluating important outcomes for patients is needed.

Exploring the use of rehabilitation in individuals with head and neck cancer undergoing treatment: a scoping review.

Explore the use, characteristics, feasibility, and functional outcomes of rehabilitation interventions used for individuals with head and neck cancer (HNC) during treatment.Searches were conducted in four databases from Jan 2011 to Dec 31, 2022. Included studies had to include adults with HNC undergoing treatment, a rehabilitation intervention, an assessment of functional outcome(s) addressed by the International Classification of Functioning Framework (ICF) and be published in English language. Title and abstract screening, full-text review, and data extraction were completed independently, in duplicate. Descriptive statistics and a qualitative synthesis summarized findings.Twenty-seven studies were included in this review. The majority of studies were randomized controlled trials (70%). Most individuals represented in the included studies were males (92% of all participants) between 50 and 60 years of age. Interventions led by a speech language pathologist (33%) were most commonly described. Sixteen studies (59%) described primary outcomes that fit the ICF "impairment" domain.We identified few studies that explored the use, feasibility, and effectiveness of rehabilitation interventions for individuals with HNC during treatment. Future research should assess the effectiveness of rehabilitation interventions on functional outcomes beyond the ICF body function and structure domain.

Rehabilitation for individuals with Head and Neck Cancer (HNC) undergoing treatment should not only focus on impairment outcomes but also evaluate activity and participation outcomes as these directly impact overall function.Rehabilitation for individuals with HNC undergoing treatment should include a coordinated team of multidisciplinary rehabilitation professionals to optimize whole-body functioning.Studies on rehabilitation during HNC treatment should report more specifically on intervention adherence, safety, cohort retention, and fidelity.

Post-Intensive Care Sequelae in Pediatrics-Results of an Early Rehabilitation Implementation Study.

OBJECTIVES: To compare post-PICU discharge functioning, health-related quality of life (HRQL), and parental stress before and after the implementation of an early rehabilitation bundle. DESIGN AND SETTING: Prospective cohort substudy within an early rehabilitation implementation program, conducted at the PICUs at McMaster Children's Hospital and London Health Sciences, London, Ontario, Canada. INTERVENTIONS: A bundle consisting of: 1) analgesia-first sedation; 2) delirium monitoring and prevention; and 3) early mobilization. Patients with an anticipated 48-hour PICU length of stay were approached for consent to participate. PATIENTS: Critically ill children with an anticipated 48-hour PICU length of stay were approached for consent to participate. MEASUREMENTS AND MAIN RESULTS: Patient-/proxy-reported outcome measures were assessed at baseline, PICU discharge, and 1 and 3 months post-PICU discharge using: 1) Pediatric Evaluation of Disability Inventory Computer Adaptive Test to assess physical, social, cognitive, and responsibility/caregiver domains of functioning; 2) KIDSCREEN to assess HRQL; and 3) the Pediatric Inventory for Parents to assess caregiver stress. A total of 117 participants were enrolled. Patient demographic characteristics were similar in the pre- and post-intervention groups. Following bundle implementation, 30 of 47 respondents (63.8%) experienced functional decline and 18 of 45 (40%) experienced low HRQL at PICU discharge. Eighteen of 36 (50%) at 1 month and 14 of 38 (36.8%) at 3 months experienced either persistent functional decline and/or low HRQL; 2.8% and 2.6% at 1- and 3-month follow-up, respectively, experienced both persistent functional decline and low HRQL. There were no significant differences in the rates of persistent functional decline, low HRQL, or caregiver stress scores post-bundle compared with pre-rehabilitation bundle implementation. CONCLUSIONS: We were unable to adequately determine the efficacy of a rehabilitation bundle on patient-centered outcomes as this substudy was not powered for these outcomes. Our results did reveal that persistent low functioning is common in PICU survivors, more common than low HRQL, while experiencing both functional decline and low HRQL was uncommon.

Treatment Fidelity in 94 Randomized Controlled Trials of Physical Rehabilitation in the ICU: A Scoping Review.

OBJECTIVES: Recent reviews demonstrated discordant effects of ICU-based physical rehabilitation on physical function. These inconsistencies may be related to differences in treatment fidelity-the extent to which a protocol is delivered as planned. Before evaluating the association of fidelity with outcomes, we must first understand the extent of treatment fidelity reporting in ICU-based physical rehabilitation randomized controlled trials (RCTs). DATA SOURCES: Six electronic databases from inception to December 2022. STUDY SELECTION: We included RCTs enrolling adults or children admitted to the ICU, if greater than or equal to 50% were invasively mechanically ventilated greater than 24 hours, and underwent an ICU-based physical rehabilitation intervention, with no limitation to comparators or outcomes. DATA EXTRACTION: We screened and extracted data independently and in duplicate, with a third reviewer as needed. Extracted data included study characteristics, treatment descriptions, and the presence of National Institutes of Health Behaviour Change Consortium (NIH-BCC) treatment fidelity tool components. Treatment fidelity scores were calculated as the proportion of reported (numerator) out of total NIH-BCC components (denominator). We calculated scores across studies and by treatment group (intervention vs. comparator). We used linear regression to assess for a time trend in study treatment fidelity scores. DATA SYNTHESIS: Of 20,433 citations, 94 studies met inclusion criteria. Authors reported a median (first-third quartiles) of 19% (14-26%) of treatment fidelity components across studies. Intervention group scores were higher than comparator groups (24% [19-33%] vs. 14% [5-24%], p < 0.01). We found a mean increase in study treatment fidelity scores by 0.7% (0.3 points) per year. CONCLUSIONS: Only 19% of treatment fidelity components were reported across studies, with comparator groups more poorly reported. Future research could investigate ways to optimize treatment fidelity reporting and determine characteristics associated with treatment fidelity conduct in ICU-based physical rehabilitation RCTs.

Early Rehabilitation in Critically ill Children: A Two Center Implementation Study.

OBJECTIVES: To implement an early rehabilitation bundle in two Canadian PICUs. DESIGN AND SETTING: Implementation study in the PICUs at McMaster Children's Hospital (site 1) and London Health Sciences (site 2). PATIENTS: All children under 18 years old admitted to the PICU were eligible for the intervention. INTERVENTIONS: A bundle consisting of: 1) analgesia-first sedation; 2) delirium monitoring and prevention; and 3) early mobilization. MEASUREMENTS AND MAIN RESULTS: Primary outcomes were the duration of implementation, bundle compliance, process of care, safety, and the factors influencing implementation. Secondary endpoints were the impact of the bundle on clinical outcomes such as pain, delirium, iatrogenic withdrawal, ventilator-free days, length of stay, and mortality. Implementation occurred over 26 months (August 2018 to October 2020). Data were collected on 1,036 patients representing 4,065 patient days. Bundle compliance was optimized within 6 months of roll-out. Goal setting for mobilization and level of arousal improved significantly (p < 0.01). Benzodiazepine, opioid, and dexmedetomidine use decreased in site 1 by 23.2% (95% CI, 30.8-15.5%), 26.1% (95% CI, 34.8-17.4%), and 9.2% (95% CI, 18.2-0.2%) patient exposure days, respectively, while at site 2, only dexmedetomidine exposure decreased significantly by 10.5% patient days (95% CI, 19.8-1.1%). Patient comfort, safety, and nursing workload were not adversely affected. There was no significant impact of the bundle on the rate of delirium, ventilator-free days, length of PICU stay, or mortality. Key facilitators to implementation included institutional support, unit-wide practice guidelines, dedicated PICU educators, easily accessible resources, and family engagement. CONCLUSIONS: A rehabilitation bundle can improve processes of care and reduce patient sedative exposure without increasing patient discomfort, nursing workload, or harm. We did not observe an impact on short-term clinical outcomes. The efficacy of a PICU-rehabilitation bundle requires ongoing study. Lessons learned in this study provide evidence to inform rehabilitation implementation in the PICU setting.

Development, Implementation and Evaluation of an Acute Care Physical Therapy 'Float' Placement during the COVID-19 Pandemic: A Case Report.

Clinical education is a mandatory component of physical therapy curricula globally. COVID-19 disrupted clinical education, jeopardizing students' abilities to meet graduation requirements. The objective of this case report is to outline the development, implementation and evaluation of a multiple clinical instructor (CI), multiple unit, acute care float clinical placement for a final year, entry-level physical therapy student and offer implementation recommendations. This placement included an eight-week, multiple CI (one primary, four supporting), multiple (five) unit clinical placement which was developed between St. Joseph's Healthcare and the McMaster University Masters of Science (Physiotherapy) Program between 10 August and 2 October 2020. Student evaluations and reflections by the student and CIs were collected and analyzed using interpretive description. Analysis from the reflections revealed six themes: (1) CI and student attributes; (2) increased feasibility; (3) varied exposure; (4) central communication and resources; (5) organization; and (6) managing expectations. An acute care clinical experience is required for students in Canadian entry-to-practice physical therapy programs. Due to COVID-19, placement opportunities were limited. The float placement allowed clinicians to offer supervision despite staff re-deployment and increased organizational and work-life pressures during the pandemic. This model provides an approach to extenuating circumstances and may also increase acute care placements during non-pandemic times for physical therapy and other similarly structured healthcare professions.

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).

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.

From Strict Bedrest to Early Mobilization: A History of Physiotherapy in the Intensive Care Unit.

Critically ill patients are at risk of post-intensive care syndrome, including physical, cognitive, and psychological sequelae. Physiotherapists are rehabilitation experts who focus on restoring strength, physical function, and exercise capacity. Critical care has evolved from a culture of deep sedation and bed rest to one of awakening and early mobility; physiotherapeutic interventions have developed to address patients' rehabilitation needs. Physiotherapists are assuming more prominent roles in clinical and research leadership, with opportunities for wider interdisciplinary collaboration. This paper reviews the evolution of critical care from a rehabilitation perspective, highlights relevant research milestones, and proposes future opportunities for improving survivorship outcomes.

Co-designing and pilot testing an infographic to support patients/families through the REMAP-CAP consent process: a mixed-methods study protocol.

BACKGROUND: Informed consent is critical to the ethical conduct of clinical research and requires understanding of a trial including its purpose, process, potential risks and benefits, and alternatives to participation. This can be challenging for complex trials, such as platform trials, and in high-stress environments, such as the intensive care unit (ICU). REMAP-CAP (randomized, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia) is a platform trial which studies treatments for ICU patients with community-acquired pneumonia, including COVID-19. Patient/family partners (PFP) identified challenges during the REMAP-CAP consent process. METHODS: This is a patient-centred co-design study to refine and test an infographic to supplement current REMAP-CAP consent documents. Infographic prototypes were developed by patients, substitute decision-makers (SDMs), and researchers with lived experience in the ICU or with ICU research. We will apply a two-phase exploratory sequential, mixed-methods research design. In phase 1, we will conduct focus groups with ICU patients, SDMs, and research coordinators (RCs). We will use inductive content analysis to inform infographic refinement, to be pilot tested in phase 2. Phase 2 is a prospective study within a trial (SWAT) at ≤ 5 REMAP-CAP sites. We will collect self-reported data from patients/SDMs and RCs. The primary outcome is feasibility (eligible consent encounters, receipt of infographic, consent to follow-up, completion of follow-up surveys). Data will be integrated to understand if/how quantitative results build upon the qualitatively informed infographic. DISCUSSION: Phase 1 results will be used to co-design an infographic, directly informed by the perspectives of patients, SDMs, and RCs involved in ICU research consent discussions. Results from phase 2 will determine the feasibility of infographic implementation in REMAP-CAP consent encounters. These feasibility data will inform a larger SWAT to evaluate our consent infographic. If successful, use of a co-designed infographic to support REMAP-CAP consent documents may improve the experience of consent for patients, SDMs, and RCs. TRIAL REGISTRATION: The Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT no. 176).

Cough Assessment and Management in Pulmonary Rehabilitation- A Canadian Survey.

Pulmonary rehabilitation is a cornerstone intervention for controlling respiratory symptoms in people with chronic respiratory diseases. Chronic cough affects up to 90% of people with chronic respiratory diseases, however, it is currently unknown whether chronic cough is assessed and/or managed in pulmonary rehabilitation. This study aimed to determine if and how chronic cough is assessed and managed in pulmonary rehabilitation. This was a cross-sectional study. Pulmonary rehabilitation programs in Canada were identified via online websites. A representative from each program was invited to complete an online survey including the following topics: program demographics, assessment and management practices, and barriers and facilitators. Of 133 programs contacted, 31 returned a completed survey (23% response rate). Approximately half (52%) of respondents reported enrolling patients with chronic cough. Of those, 45% reported assessing and 62% reported intervening in chronic cough. Inadequate knowledge of assessment and management techniques was commonly identified to be a barrier and increased education was suggested as a possible facilitator. Based on pulmonary rehabilitation programs that responded to our survey, chronic cough is a prevalent symptom; however, it is scarcely assessed and managed. A need for structured education and the use of standardised strategies were reported as facilitators to the assessment and management of chronic cough in pulmonary rehabilitation.