Balance measures for fall risk screening in community-dwelling older adults with COPD: A longitudinal analysis.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) increases fall risk, but consensus is lacking on suitable balance measures for fall risk screening in this group. We aimed to evaluate the reliability and validity of balance measures for fall risk screening in community-dwelling older adults with COPD. METHODS: In a secondary analysis of two studies, participants, aged ≥60 years with COPD and 12-month fall history or balance issues were tracked for 12-month prospective falls. Baseline balance measures - Brief Balance Evaluation Systems Test (Brief BESTest), single leg stance (SLS), Timed Up and Go (TUG), and TUG Dual-Task (TUG-DT) test - were assessed using intra-class correlation (ICC2,1) for reliability, Pearson/Spearman correlation with balance-related factors for convergent validity, t-tests/Wilcoxon rank-sum tests with fall-related and disease-related factors for known-groups validity, and area under the receiver operator characteristic curve (AUC) for predictive validity. RESULTS: Among 174 participants (73 ± 8 years; 86 females) with COPD, all balance measures showed excellent inter-rater and test-retest reliability (ICC2,1 = 0.88-0.97) and moderate convergent validity (r = 0.34-0.77) with related measures. Brief BESTest and SLS test had acceptable known-groups validity (p < 0.05) for 12-month fall history, self-reported balance problems, and gait aid use. TUG test and TUG-DT test discriminated between groups based on COPD severity, supplemental oxygen use, and gait aid use. All measures displayed insufficient predictive validity (AUC<0.70) for 12-month prospective falls. CONCLUSION: Though all four balance measures demonstrated excellent reliability, they lack accuracy in prospectively predicting falls in community-dwelling older adults with COPD. These measures are best utilized within multi-factorial fall risk assessments for this population.

In-person peer support for critical care survivors: The ICU REcovery Solutions cO-Led through surVivor Engagement (ICURESOLVE) pilot randomised controlled trial.

BACKGROUND: Peer support is a promising intervention to mitigate post-ICU disability, however there is a paucity of rigorously designed studies. OBJECTIVES: The objective of this study was to establish feasibility of an in-person, co-designed, peer-support model. METHODS: Prospective, randomised, adaptive, single-centre pilot trial with blinded outcome assessment, conducted at a university-affiliated hospital in Melbourne, Australia. Intensive care unit survivors (and their nominated caregiver, where survivor and caregiver are referred to as a dyad), >18 years of age, able to speak and understand English and participate in phone surveys, were eligible. Participants were randomised to the peer-support model (six sessions, fortnightly) or usual care (no follow-up or targeted information). Two sequential models were piloted: 1. Early (2-3 weeks post hospital discharge) 2. Later (4-6 weeks post hospital discharge). Primary outcome was feasibility of implementation measured by recruitment, intervention attendance, and outcome completion. Secondary outcomes included post-traumatic stress and social support. RESULTS: Of the 231 eligible patients, 80 participants were recruited. In the early model we recruited 38 participants (28 patients, 10 carers; 18 singles, 10 dyads), with an average (standard deviation) age of 60 (18) years; 55 % were female. Twenty-two participants (58 %) were randomised to intervention. Participants in the early intervention model attended a median (interquartile range) of 0 (0-1) sessions (total 24 sessions), with 53% (n = 20) completing the main secondary outcome of interest (Impact of Event Scale) at the baseline and 37 % (n = 14) at the follow-up. For the later model we recruited 42 participants (32 patients, 10 carers; 22 singles, 10 dyads), with an average (standard deviation) age of 60.4 (15.4) years; 50 % were female. Twenty-one participants (50 %) were randomised to intervention. The later intervention model attended a median (interquartile range) of 1 (0-5) sessions (total: 44 sessions), with the main secondary outcome impact of events scale (IES-R) completed by 41 (98 %) participants at baseline and 29 (69 %) at follow-up. CONCLUSIONS: In this pilot trial, a peer-support model that required in-person attendance delivered in a later posthospital phase of recovery appeared more feasible than an early model. Further research should investigate alternative modes of intervention delivery to improve feasibility (ACTRN12621000737831).

Exploring current physiotherapy practices in the care of people who are potential lung donors: A qualitative study.

OBJECTIVE: The aim of this study was to determine physiotherapists' current practices and perspectives regarding their role in caring for people who are potential lung donors in the intensive care unit (ICU). METHODS: A qualitative descriptive design was used. Qualitative data were collected through audio-recorded, semistructured focus groups with a purposive sample of physiotherapists with experience working with people who are potential lung donors in ICUs. Two investigators completed independent thematic analysis to identify themes. RESULTS: Seven focus groups were completed with 27 physiotherapists at six metropolitan health services in Victoria, Australia. Six key themes were identified: (i) physiotherapists' involvement in care was highly variable; (ii) physiotherapists were not aware of existing evidence or guidelines for the care of people who are potential donors and followed usual practices; (iii) a consistent vision of the physiotherapy role was lacking; (iv) physiotherapists' engagement with the team routinely involved in care of people who are potential donors varied considerably; (v) physiotherapists faced practice challenges associated with delivering care to potential donors; and (vi) several enablers could support a role for physiotherapy in this patient population. CONCLUSIONS: Variability in physiotherapy practice is associated with local ICU culture, physiotherapy leadership capabilities, knowledge, and experience. The spectrum of practice ranged from physiotherapists being highly engaged to being completely uninvolved. Physiotherapists held mixed perspectives regarding whether physiotherapists should have a role in managing people who are potential lung donors. It would benefit the profession to develop consensus and standardisation of the role of physiotherapists in caring for these patients. TWEETABLE ABSTRACT: Variability in views and practices amongst physiotherapists who provide care to patients who are potential lung donors in the ICU.

Clinical Outcomes Following Exercise Rehabilitation in People with Multimorbidity: A Systematic Review.

OBJECTIVE: To determine the effectiveness of exercise rehabilitation in people with multimorbidity. Exercise capacity was the primary outcome. Secondary outcomes were: health-related quality of life, activities of daily living, cardiometabolic outcomes, mental health outcomes, symptom scores, resource utilization, health behaviours, economic outcomes, and adverse events. DATA SOURCES: A search was conducted in MEDLINE, CINHAL, EMBASE, and Cochrane Central Register of Controlled Trials databases. STUDY SELECTION AND EXTRACTION: Randomized and non-randomized controlled trials and cohort studies of exercise rehabilitation vs any comparison in people with multimorbidity. DATA SYNTHESIS: Forty-four reports (38 studies) were included. Rehabilitation ranged from 8 weeks to 4 years, with 1-7 sessions of rehabilitation weekly. Exercise included aerobic and resistance, limb training, aquatic exercises and tai chi. Compared with usual care, exercise rehabilitation improved 6-min walk distance (weighted mean difference (WMD) 64 m, 95% CI 45-82) and peak oxygen consumption (WMD 2.74 mL/kg/min, 95% CI -3.32 to 8.79). Effects on cardiometabolic outcomes and health-related quality of life also favoured rehabilitation; however; few data were available for other secondary outcomes. CONCLUSION: In people with multimorbidity, exercise rehabilitation improved exercise capacity, health-related quality of life, and cardiometabolic outcomes.

Activin A level is associated with physical function in critically ill patients.

BACKGROUND: Activin A is a potent negative regulator of muscle mass elevated in critical illness. It is unclear whether muscle strength and physical function in critically ill humans are associated with elevated activin A levels. OBJECTIVES: The objective of this study was to investigate the relationship between serum activin A levels, muscle strength, and physical function at discharge from the intensive care unit (ICU) and hospital. METHODS: Thirty-six participants were recruited from two tertiary ICUs in Melbourne, Australia. Participants were included if they were mechanically ventilated for >48 h and expected to have a total ICU stay of >5 days. The primary outcome measure was the Six-Minute Walk Test distance at hospital discharge. Secondary outcome measures included handgrip strength, Medical Research Council Sum Score, Physical Function ICU Test Scored, Six-Minute Walk Test, and Timed Up and Go Test assessed throughout the hospital admission. Total serum activin A levels were measured daily in the ICU. RESULTS: High peak activin A was associated with worse Six-Minute Walk Test distance at hospital discharge (linear regression coefficient, 95% confidence interval, p-value: -91.3, -154.2 to -28.4, p = 0.007, respectively). Peak activin A concentration was not associated with the secondary outcome measures. CONCLUSIONS: Higher peak activin A may be associated with the functional decline of critically ill patients. Further research is indicated to examine its potential as a therapeutic target and a prospective predictor for muscle wasting in critical illness. STUDY REGISTRATION: ACTRN12615000047594.

Validity of the Activities-specific Balance Confidence Scale in individuals with chronic obstructive pulmonary disease.

BACKGROUND: Limited research assessed the validity of the Activities-specific Balance Confidence, ABC) Scale in individuals with chronic obstructive pulmonary disease, COPD) at risk of falls. We report on the scale's construct and criterion validity. METHODS: Construct validity was established by assessing known groups, convergent, and divergent validity. A receiver operating characteristic, (ROC) curve and logistic regression examined the criterion validity of the scale. RESULTS: In 223 individuals with COPD, the ABC Scale significantly, (p < 0.001) discriminated between groups, with lower scores for females [Mean difference (MD) = 10%], rollator use [MD = 13%], and fallers [MD = 12%], and had a strong association [r = 0.58, p < 0.001] with Berg Balance Scale. The scale distinguished fallers from non-fallers with a cutoff value of 58% [Area Under the Curve = 0.64, 95% CI = 0.57-0.72, p < 0.001] and significantly identified fall status [B, SE = -0.03, 0.01, p < 0.001] with an odds ratio of 0.97 [95%CI = 0.96-0.99]. The sensitivity, specificity, and test accuracy were: 61, 58, and 60%, respectively. CONCLUSION: The ABC Scale showed evidence for known groups, convergent, and divergent validity and can assist in identifying fall status in individuals with COPD.

Age and Sex Differences in Balance Outcomes among Individuals with Chronic Obstructive Pulmonary Disease (COPD) at Risk of Falls.

No previous research has examined age and sex differences in balance outcomes in individuals with chronic obstructive pulmonary disease (COPD) at risk of falls. A secondary analysis of baseline data from an ongoing trial of fall prevention in COPD was conducted. Age and sex differences were analyzed for the Berg Balance scale (BBS), Balance Evaluation System Test (BEST test) and Activities-specific Balance Confidence Scale (ABC). Overall, 223 individuals with COPD were included. Females had higher balance impairments than males [BBS: mean (SD) = 47 (8) vs. 49 (6) points; BEST test: 73 (16) vs. 80 (16) points], and a lower confidence to perform functional activities [ABC = 66 (21) vs. 77 (19)]. Compared to a younger age (50-65 years) group, age >65 years was moderately associated with poor balance control [BBS (r = - 0.37), BEST test (r = - 0.33)] and weakly with the ABC scale (r = - 0.13). After controlling for the effect of balance risk factors, age, baseline dyspnea index (BDI), and the 6-min walk test (6-MWT) explained 38% of the variability in the BBS; age, sex, BDI, and 6-MWT explained 40% of the variability in the BEST test; And BDI and the 6-MWT explained 44% of the variability in the ABC scale. This study highlights age and sex differences in balance outcomes among individuals with COPD at risk of falls. Recognition of these differences has implications for pulmonary rehabilitation and fall prevention in COPD, particularly among females and older adults.

Physical Rehabilitation in the ICU: A Systematic Review and Meta-Analysis.

OBJECTIVES: Significant variability exists in physical rehabilitation modalities and dosage used in the ICU. Our objective was to investigate the effect of physical rehabilitation in ICU on patient outcomes, the impact of task-specific training, and the dose-response profile. DATA SOURCES: A systematic search of Ovid MEDLINE, Cochrane Library, EMBASE, and CINAHL plus databases was undertaken on the May 28, 2020. STUDY SELECTION: Randomized controlled trials and controlled clinical trials investigating physical rehabilitation commencing in the ICU in adults were included. Outcomes included muscle strength, physical function, duration of mechanical ventilation, ICU and hospital length of stay, mortality, and health-related quality of life. Two independent reviewers assessed titles, abstracts, and full texts against eligibility criteria. DATA EXTRACTION: Details on intervention for all groups were extracted using the template for intervention description and replication checklist. DATA SYNTHESIS: Sixty trials were included, with a total of 5,352 participants. Random-effects pooled analysis showed that physical rehabilitation improved physical function at hospital discharge (standardized mean difference, 0.22; 95% CI, 0.00-0.44), reduced ICU length of stay by 0.8 days (mean difference, -0.80 d; 95% CI, -1.37 to -0.23 d), and hospital length of stay by 1.75 days (mean difference, -1.75 d; 95% CI, -3.03 to -0.48 d). Physical rehabilitation had no impact on the other outcomes. The intervention was more effective in trials where the control group received low-dose physical rehabilitation and in trials that investigated functional exercises. CONCLUSIONS: Physical rehabilitation in the ICU improves physical function and reduces ICU and hospital length of stay. However, it does not appear to impact other outcomes.

Feasibility and adherence to moderate intensity cardiovascular fitness training following stroke: a pilot randomized controlled trial.

BACKGROUND: Stroke is a leading cause of disability worldwide and the cardiovascular fitness levels of stroke survivors are diminished to an extent that impairs functioning and activities of daily living performance. While cardiovascular training seems an empirically appropriate intervention, the optimal dosage and intensity of cardiovascular training in stroke survivors remains unclear. The aim was to determine the safety and feasibility of moderate-intensity cardiovascular training following stroke, including measurement of adherence to training. METHODS: A pilot, prospective, patient- and assessor-blinded randomised controlled trial conducted in a tertiary, metropolitan hospital-based community rehabilitation centre. Eligibility criteria included ambulant (> 100 m), 6 weeks-12 months post stroke. Moderate-intensity fitness training or control (low-intensity) exercise was offered biweekly for 12 weeks. Outcome measures included adverse events, peak oxygen uptake (VO2), functional exercise capacity (6-Minute Walk Test, 10-m Walk Test) and health-related quality of life (Short Form-36) and mood (Patient Health Questionnaire, PHQ9). RESULTS: Feasibility: Seventy-one (50%) of 141 screened participants were eligible (29% did not agree to participate). Twenty participants (10 intervention, 10 control) were recruited. The median (%; IQR) supervised sessions was 19.5 (81%; 12, 20); and 20 (83%; 19, 22) in the intervention and control groups, respectively. Progression of duration and intensity was limited; mean of 10 sessions to achieve target duration (30 min). There were no adverse events. Baseline peak oxygen uptake (VO2) levels were low (15.94 ml/kg/min). Significant improvements in VO2 peak in both groups were observed (p < 0.05). Although there were no significant between-group differences, this feasibility trial was not powered to detect change. CONCLUSIONS: Moderate-intensity fitness training was safe but achievement of target duration and intensity was challenging for stroke survivors. A definitive adequately-powered randomised trial is required. Alternative fitness training protocols may need to be explored. TRIAL REGISTRATION: The trial protocol was prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN 12613000822785 ) on 25/07/2013.

Preoperative physiotherapy is cost-effective for preventing pulmonary complications after major abdominal surgery: a health economic analysis of a multicentre randomised trial.

QUESTION: Is preoperative physiotherapy cost-effective in reducing postoperative pulmonary complications (PPC) and improving quality-adjusted life years (QALYs) after major abdominal surgery? DESIGN: Cost-effectiveness analysis from the hospitals' perspective within a multicentre randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: Four hundred and forty-one adults awaiting elective upper abdominal surgery attending pre-anaesthetic clinics at three public hospitals in Australia and New Zealand. INTERVENTIONS: The experimental group received an information booklet and a 30-minute face-to-face session, involving respiratory education and breathing exercise training, with a physiotherapist. The control group received the information booklet only. OUTCOME MEASURES: The probability of cost-effectiveness and incremental net benefits was estimated using bootstrapped incremental PPC and QALY cost-effectiveness ratios plotted on cost-effectiveness planes and associated probability curves through a range of willingness-to-pay amounts. Cost-effectiveness modelling utilised 21-day postoperative hospital cost audit data and QALYs estimated from Short Form-Six Domain health utilities and mortality to 12 months. RESULTS: Preoperative physiotherapy had 95% probability of being cost-effective with an incremental net benefit to participating hospitals of A$4,958 (95% CI 10 to 9,197) for each PPC prevented, given that the hospitals were willing to pay $45,000 to provide the service. Cost-utility for QALY gains was less certain. Sensitivity analyses strengthened cost-effectiveness findings. Improved cost-effectiveness and QALY gains were detected when experienced physiotherapists delivered the intervention. CONCLUSIONS: Preoperative physiotherapy aimed at preventing PPCs was highly likely to be cost-effective from the hospitals' perspective. For each PPC prevented, preoperative physiotherapy is likely to cost the hospitals less than the costs estimated to treat a PPC after surgery. Potential QALY gains require confirmation. TRIAL REGISTRATION: ACTRN12613000664741.

Postgraduate clinical physiotherapy education in acute hospitals: a cohort study.

Background: Junior physiotherapists require satisfactory clinical skills to work effectively within the acute hospital setting for service quality and consistency. Objective: To investigate the effects of stream-specific clinical training on junior physiotherapist self-efficacy, self-rated confidence, and self-rated ability to work independently during weekend shifts. Design: Prospective cohort study. Participants: Eighteen junior physiotherapists. Methods: Physiotherapists undertook 8 h of stream-specific education in: pediatrics, women's health, neuro-medical, musculoskeletal, cardiorespiratory, and critical care over 8 weeks. Learning objectives were evaluated using a self-efficacy (0-100) scale and self-rated confidence was measured with a 4-point Likert scale (not confident to independent). Self-rated ability to independently work weekend shifts was measured dichotomously (yes/no). Results: Participants completed an average of three stream-specific programs in the study period. Post-training, mean improvement in self-efficacy across objectives ranged from 2.9 (95% CI -8.7 to 14.5) to 43.3 (95% CI 4.8-81.8) points, p < 0.05 for 80% of objectives. Self-rated confidence scores improved for 45.6% of stream-specific learning objectives; 52.8% were unchanged and 1.7% reported a decrease in confidence. Self-rated ability to work stream-specific weekend shifts increased from 56-70%, but no stream achieved a significant increase in staff able to independently work weekend shifts (p range 0.10 to 1.0). Conclusions: A stream-specific education program increased junior physiotherapists' self-efficacy and self-rated confidence but not perceived ability to work independently on weekends. Results were non-randomized and actual practice change was not assessed. Future studies could investigate different educational structures in a blinded, randomized manner on clinical practice change.

Lung management protocols increase the incidence of lung procurement and organ transplantation: A meta-analysis.

Background: Improved donor management, including respiratory physiotherapy, may optimize donor suitability and increase successful lung procurement. This review aimed to determine the efficacy of lung management protocols on the incidence of successful lung procurement and transplantation. Methods: Searches were completed in MEDLINE, CINAHL, EMBASE, PubMed, PEDRO, and Cochrane Registry of Controlled Clinical Trials, from database inception to March 2018. Randomized controlled trials and observational studies, with a control or comparison group, of humans, published in English, in peer-reviewed journals were included. Any respiratory management was eligible. Two investigators assessed eligibility and study quality. Meta-analysis and narrative analysis were completed. Results: Ten of 430 articles identified were eligible for inclusion. Implementation of protocols in potential donors increased the incidence of lung procurement, odds ratio (OR), 95% CI: 3.42 (2.48, 4.71) and transplantation procedures OR 2.56 (1.41, 4.62) compared to control groups. Recipient survival was significantly higher, in favor of lung management protocols compared to control groups at 30 days (OR 2.37 (1.14, 4.95)) and 1 year (OR 1.82 (1.02, 3.27)). Pooling of randomized controlled trials was not possible due to heterogeneity between interventions. No studies reported adverse events associated with lung management protocols or the incidence of ventilator-associated pneumonia. Despite differences in intervention design and study quality, observational studies reported consistent direction and magnitude of effects in favor of protocolized interventions. Conclusions: Lung management protocols appear to increase transplantation success. High-quality randomized trials are warranted to test observed effects and ascertain the effects of specific protocol components on transplantation outcomes.

Patient-reported outcome measurement in community-acquired pneumonia: feasibility of routine application in an elderly hospitalized population.

BACKGROUND: Community-acquired pneumonia (CAP) is a leading cause of morbidity and mortality worldwide, but few studies have evaluated the feasibility of routine patient-reported outcome measures (PROMs) in this illness. This study investigates the feasibility and limitations of three credible PROM instruments in a representative hospitalized cohort to identify potential barriers to routine application. METHODS: A sample of multimorbid hospitalized subjects meeting a standardized CAP definition was recruited. Demographic and clinical data of those able and unable to participate in PROM assessment were compared. The EQ-5D-5L, CAP-Sym 18 Questionnaire, and Late-Life Function and Disability Instrument (LLFDI) were administered (via face-to-face interview) at admission and discharge and (via phone interview or mail) at 30 and 90 days post-discharge. Feasibility measures included the proportion of individuals able to participate in assessment, attrition rates, data completeness, and instrument completion times. Scores at admission and 30 days post-discharge were examined for association with age. RESULTS: Of 82 subjects screened, 44 (54%) participated. Cognitive impairment (n = 12, 15%) commonly precluded participation. Seventeen (39%) participants were lost to follow-up by 90 days. Missing data at item level was negligible for all instruments, regardless of the mode of completion. Completion of the three instruments collectively in a face-to-face interview took a median of 17 min (IQ range 13-21) per participant. The burden of reported symptoms at admission was higher for younger participants aged 18-74 years (mean (standard deviation)) CAP-Sym 18 score at admission 34.2 (18.6) vs. 19.0 (11.3) for those aged ≥ 75 years. CONCLUSIONS: Routine application of PROMs can provide valuable information relating to multiple aspects of clinical recovery for individuals hospitalized with CAP. However, heterogeneous demographic characteristics and complex underlying health status introduce challenges to feasibility and interpretability of these instruments in this population. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02835040.

Effectiveness of a Bundled Intervention Including Adjunctive Corticosteroids on Outcomes of Hospitalized Patients With Community-Acquired Pneumonia: A Stepped-Wedge Randomized Clinical Trial.

IMPORTANCE: Community-acquired pneumonia remains a leading cause of hospitalization, mortality, and health care costs worldwide. Randomized clinical trials support the use of adjunctive corticosteroids, early progressive mobilization, antibiotic switching rules, and dietary interventions in improving outcomes. However, it is uncertain whether implementing these interventions will translate into effectiveness under routine health care conditions. OBJECTIVE: To evaluate the effectiveness of a bundle of evidence-supported treatments under conditions of routine care in a representative population hospitalized for community-acquired pneumonia. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, stepped-wedge, cluster-randomized clinical trial with 90-day follow-up was conducted between August 1, 2016, and October 29, 2017, in the general internal medicine service at 2 tertiary hospitals in Melbourne, Australia, among a consecutive sample of patients with community-acquired pneumonia. The primary analysis and preparation of results took place between May 14 and November 25, 2018. INTERVENTIONS: Treating clinical teams were advised to prescribe prednisolone acetate, 50 mg/d, for 7 days (in the absence of any contraindication) and de-escalate from parenteral to oral antibiotics according to standardized criteria. Algorithm-guided early mobilization and malnutrition screening and treatment were also implemented. MAIN OUTCOMES AND MEASURES: Hospital length of stay, mortality, readmission, and intervention-associated adverse events (eg, gastrointestinal bleeding and hyperglycemia). RESULTS: A total of 917 patients were screened, and 816 (351 women and 465 men; mean [SD] age, 76 [13] years) were included in the intention-to-treat analysis, with 401 patients receiving the intervention and 415 patients in the control group. An unadjusted geometric mean ratio of 0.95 (95% CI, 0.78-1.16) was observed for the difference in length of stay (days) between the intervention and control groups. Similarly, no significant differences were observed for the secondary outcomes of mortality and readmission, and the results remained unchanged after further adjustment for sex and age. The study reported higher proportions of gastrointestinal bleeding in the intervention group (9 [2.2%]) compared with the controls (3 [0.7%]), with an unadjusted estimated difference in mean proportions of 0.008 (95% CI, 0.005-0.010). CONCLUSIONS AND RELEVANCE: This bundled intervention including adjunctive corticosteroids demonstrated no evidence of effectiveness and resulted in a higher incidence of gastrointestinal bleeding. Efficacy of individual interventions demonstrated in clinical trials may not necessarily translate into effectiveness when implemented in combination and may even result in net harm. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02835040.

A novel counterbalanced implementation study design: methodological description and application to implementation research.

BACKGROUND: Implementation research is increasingly being recognised for optimising the outcomes of clinical practice. Frequently, the benefits of new evidence are not implemented due to the difficulties applying traditional research methodologies to implementation settings. Randomised controlled trials are not always practical for the implementation phase of knowledge transfer, as differences between individual and organisational readiness for change combined with small sample sizes can lead to imbalances in factors that impede or facilitate change between intervention and control groups. Within-cluster repeated measure designs could control for variance between intervention and control groups by allowing the same clusters to receive a sequence of conditions. Although in implementation settings, they can contaminate the intervention and control groups after the initial exposure to interventions. We propose the novel application of counterbalanced design to implementation research where repeated measures are employed through crossover, but contamination is averted by counterbalancing different health contexts in which to test the implementation strategy. METHODS: In a counterbalanced implementation study, the implementation strategy (independent variable) has two or more levels evaluated across an equivalent number of health contexts (e.g. community-acquired pneumonia and nutrition for critically ill patients) using the same outcome (dependent variable). This design limits each cluster to one distinct strategy related to one specific context, and therefore does not overburden any cluster to more than one focussed implementation strategy for a particular outcome, and provides a ready-made control comparison, holding fixed. The different levels of the independent variable can be delivered concurrently because each level uses a different health context within each cluster to avoid the effect of treatment contamination from exposure to the intervention or control condition. RESULTS: An example application of the counterbalanced implementation design is presented in a hypothetical study to demonstrate the comparison of 'video-based' and 'written-based' evidence summary research implementation strategies for changing clinical practice in community-acquired pneumonia and nutrition in critically ill patient health contexts. CONCLUSION: A counterbalanced implementation study design provides a promising model for concurrently investigating the success of research implementation strategies across multiple health context areas such as community-acquired pneumonia and nutrition for critically ill patients.

Development of a Peer Support Model Using Experience-Based Co-Design to Improve Critical Care Recovery.

To use experience-based co-design to identify the key design requirements of a peer support model for critical care survivors; understand the use of the experience-based co-design method from clinician, patients, and family perspectives. DESIGN: Using experience-based co-design, qualitative data about participants' preferences for a peer support model were generated via workshops. Participants' perspectives of experience-based co-design were evaluated with focus groups. SETTING: University-affiliated hospital in Melbourne, Australia. SUBJECTS: Snowball sampling was used to recruit clinicians from across the care spectrum (ICU-community); critical care survivors and nominated family members were recruited using convenience sampling. MEASUREMENTS AND MAIN RESULTS: Consensus on a peer support model was reached through the experience-based co-design process, with the following key themes: 1) socialization and group cohesion; 2) management of potential risks; and 3) individualized needs of patients and families. Evaluation of participants' perspectives of the experience-based co-design method identified five key themes: 1) participation as a positive experience; 2) emotional engagement in the process; 3) learning from patients and family members; 4) feeling heard; and 5) practical challenges of experience-based co-design and readiness to participate. CONCLUSIONS: Experience-based co-design was a feasible approach to developing a peer support model for use with critical care survivors and was well received by participants. Future testing of the co-designed peer support model in a pilot randomized controlled trial will enhance understanding of peer support in critical care and the use of experience-based co-design as a design methodology.

Commencing Out-of-Bed Rehabilitation in Critical Care-What Influences Clinical Decision-Making?

OBJECTIVES: To develop a decision tree that objectively identifies the most discriminative variables in the decision to provide out-of-bed rehabilitation, measure the effect of this decision and to identify the factors that intensive care unit (ICU) practitioners think most influential in that clinical decision. DESIGN: A prospective 3-part study: (1) consensus identification of influential factors in mobilization via survey; (2) development of an early rehabilitation decision tree; (3) measurement of practitioner mobilization decision-making. Treating practitioners of patients expected to stay >96 hours were asked if they would provide out-of-bed rehabilitation and rank factors that influenced this decision from an a priori defined list developed from a literature review and expert consultation. SETTING: Four tertiary metropolitan ICUs. PARTICIPANTS: Practitioners (ICU medical, nursing, and physiotherapy staff) (N=507). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A decision tree was constructed using binary recursive partitioning to determine the factor that best classified patients suitable for out-of-bed rehabilitation. Descriptive statistics were used to describe practitioner and patient samples as well as patient adverse events associated with out-of-bed rehabilitation and the factors prioritized by ICU practitioners. RESULTS: There were 1520 practitioner decisions representing 472 individual patient decisions. Practitioners classified patients suitable for out-of-bed rehabilitation on 149 occasions and not suitable on 323 occasions. Decision tree analysis showed the presence of an endotracheal tube (ETT) and sedation state were the only discriminative variables that predicted patient suitability for rehabilitation. In contrast, medical staff and nurses reported that ventilator status was the most influential factor in their decision not to provide rehabilitation while physiotherapists ranked sedation most highly. The presence of muscle weakness did not inform the decision to provide rehabilitation. CONCLUSION: These results confirm previous observational reports that the presence of an ETT remains a major obstacle to the provision of rehabilitation for critically ill patients. Despite rehabilitation being effective for improving muscle strength, the presence of muscle weakness did not influence the decision to provide rehabilitation.

Multimorbidity rehabilitation versus disease-specific rehabilitation in people with chronic diseases: a pilot randomized controlled trial.

BACKGROUND: Multimorbidity (the co-existence of two or more chronic conditions in an individual) is a growing healthcare burden internationally; however, healthcare and disease management, including rehabilitation, is often delivered in single-disease siloes. The aims of this study were to (1) evaluate the safety and feasibility of multimorbidity rehabilitation compared to a disease-specific rehabilitation program in people with multimorbidity and (2) gather preliminary data regarding clinical outcomes and resource utilization to inform the design of future trials. METHODS: A pilot feasibility randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Seventeen individuals with a chronic disease eligible for disease-specific rehabilitation (pulmonary, cardiac, heart failure rehabilitation) and at least one other chronic condition were recruited. The intervention group attended multimorbidity exercise rehabilitation and the control group attended disease-specific exercise rehabilitation. Participants attended twice-weekly exercise training and weekly education for 8 weeks. Feasibility measures included numbers screened, recruited, and completed. Other outcome measures were change in functional exercise capacity (6-minute walk test (6MWT)), health-related quality of life (HRQoL), activities of daily living (ADL), and resource utilization. RESULTS: Sixty-one people were screened to recruit seventeen participants (nine intervention, eight control); one withdrew prior to rehabilitation. Participants were mostly male (63%) with a mean (SD) age of 69 (9) years and body mass index of 29 (6). The intervention group attended a mean (SD) of 12 (6) sessions, and the control group attended 11 (4) sessions. One participant (6%) withdrew after commencing; two (12%) were lost to follow-up. The intervention group 6MWT distance increased by mean (SD) of 22 (45) meters (95% confidence interval - 16 to 60) compared to 22 (57) meters (95% confidence interval - 69 to 114) (control). CONCLUSIONS: It was feasible to recruit people with multimorbidity to a randomized controlled trial of rehabilitation. A large RCT with the power to make significant conclusions about the impact on the primary and secondary outcomes is now required. TRIAL REGISTRATION: The trial was registered with the Australian and New Zealand Clinical Trials Registry available at http://www.anzctr.org.au ACTRN12614001186640. Registered 12/11/2014.

A rehabilitation programme for people with multimorbidity versus usual care: A pilot randomized controlled trial.

BACKGROUND: Multimorbidity, the coexistence of two or more chronic conditions, is common in clinical practice. Rehabilitation for people with multimorbidity may provide access to a rehabilitation programme that can address common symptoms and risk factors for multiple chronic diseases. OBJECTIVE: The aims of this study were to (1) evaluate the feasibility of a rehabilitation programme compared to usual medical care (UMC) in people with multimorbidity and (2) gather preliminary data regarding clinical effects and impact on functional exercise capacity, activities of daily living, health-related quality of life and resource utilization. DESIGN: A pilot feasibility parallel randomized controlled trial was undertaken. Adults with multimorbidity were randomized to the rehabilitation programme (intervention) or UMC (control). The duration of the rehabilitation programme was 8 weeks and comprised exercise (1 h, twice weekly) and education (1 h, once weekly). The UMC group did not participate in a structured exercise programme. RESULTS: One hundred people were screened to recruit 16 participants, with a 71% completion rate for the intervention group. The rehabilitation group achieved a mean (standard deviation) improvement in 6-minute walk distance of 44 (41) m and the UMC group of 23 (29) m. CONCLUSIONS: This study suggests that it would be feasible to conduct a larger randomized control trial investigating a rehabilitation programme for people with multimorbidity. Low uptake of the study suggests that refinement of the inclusion criteria, recruitment sources and programme model will be needed to achieve the number of participants required.

Implementation of evidence-based weekend service recommendations for allied health managers: a cluster randomised controlled trial protocol.

BACKGROUND: It is widely acknowledged that health policy and practice do not always reflect current research evidence. Whether knowledge transfer from research to practice is more successful when specific implementation approaches are used remains unclear. A model to assist engagement of allied health managers and clinicians with research implementation could involve disseminating evidence-based policy recommendations, along with the use of knowledge brokers. We developed such a model to aid decision-making for the provision of weekend allied health services. This protocol outlines the design and methods for a multi-centre cluster randomised controlled trial to evaluate the success of research implementation strategies to promote evidence-informed weekend allied health resource allocation decisions, especially in hospital managers. METHODS: This multi-centre study will be a three-group parallel cluster randomised controlled trial. Allied health managers from Australian and New Zealand hospitals will be randomised to receive either (1) an evidence-based policy recommendation document to guide weekend allied health resource allocation decisions, (2) the same policy recommendation document with support from a knowledge broker to help implement weekend allied health policy recommendations, or (3) a usual practice control group. The primary outcome will be alignment of weekend allied health service provision with policy recommendations. This will be measured by the number of allied health service events (occasions of service) occurring on weekends as a proportion of total allied health service events for the relevant hospital wards at baseline and 12-month follow-up. DISCUSSION: Evidence-based policy recommendation documents communicate key research findings in an accessible format. This comparatively low-cost research implementation strategy could be combined with using a knowledge broker to work collaboratively with decision-makers to promote knowledge transfer. The results will assist managers to make decisions on resource allocation, based on evidence. More generally, the findings will inform the development of an allied health model for translating research into practice. TRIAL REGISTRATION: This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) ( ACTRN12618000029291 ). Universal Trial Number (UTN): U1111-1205-2621.