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Several tests have recently been developed to measure changes in patient strength and functional outcomes in the intensive care unit (ICU). The original Physical Function ICU Test (PFIT) demonstrates reliability and sensitivity. The aims of this study were to further develop the original PFIT, to derive an interval score (the PFIT-s), and to test the clinimetric properties of the PFIT-s. A nested cohort study was conducted. One hundred forty-four and 116 participants performed the PFIT at ICU admission and discharge, respectively. Original test components were modified using principal component analysis. Rasch analysis examined the unidimensionality of the PFIT, and an interval score was derived. Correlations tested validity, and multiple regression analyses investigated predictive ability. Responsiveness was assessed using the effect size index (ESI), and the minimal clinically important difference (MCID) was calculated. The shoulder lift component was removed. Unidimensionality of combined admission and discharge PFIT-s scores was confirmed. The PFIT-s displayed moderate convergent validity with the Timed \"Up & Go\" Test (r=-.60), the Six-Minute Walk Test (r=.41), and the Medical Research Council (MRC) sum score (rho=.49). The ESI of the PFIT-s was 0.82, and the MCID was 1.5 points (interval scale range=0-10). A higher admission PFIT-s score was predictive of: an MRC score of ≥48, increased likelihood of discharge home, reduced likelihood of discharge to inpatient rehabilitation, and reduced acute care hospital length of stay. Scoring of sit-to-stand assistance required is subjective, and cadence cutpoints used may not be generalizable. The PFIT-s is a safe and inexpensive test of physical function with high clinical utility. It is valid, responsive to change, and predictive of key outcomes. It is recommended that the PFIT-s be adopted to test physical function in the ICU.

Background It is widely acknowledged that health policy and management decisions rarely reflect research evidence. Therefore, it is important to determine how to improve evidence-informed decision-making. The primary aim of this systematic review was to evaluate the effectiveness of research implementation strategies for promoting evidence-informed policy and management decisions in healthcare. The secondary aim of the review was to describe factors perceived to be associated with effective strategies and the inter-relationship between these factors. Methods An electronic search was developed to identify studies published between January 01, 2000, and February 02, 2016. This was supplemented by checking the reference list of included articles, systematic reviews, and hand-searching publication lists from prominent authors. Two reviewers independently screened studies for inclusion, assessed methodological quality, and extracted data. Results After duplicate removal, the search strategy identified 3830 titles. Following title and abstract screening, 96 full-text articles were reviewed, of which 19 studies (21 articles) met all inclusion criteria. Three studies were included in the narrative synthesis, finding policy briefs including expert opinion might affect intended actions, and intentions persisting to actions for public health policy in developing nations. Workshops, ongoing technical assistance, and distribution of instructional digital materials may improve knowledge and skills around evidence-informed decision-making in US public health departments. Tailored, targeted messages were more effective in increasing public health policies and programs in Canadian public health departments compared to messages and a knowledge broker. Sixteen studies (18 articles) were included in the thematic synthesis, leading to a conceptualisation of inter-relating factors perceived to be associated with effective research implementation strategies. A unidirectional, hierarchal flow was described from (1) establishing an imperative for practice change, (2) building trust between implementation stakeholders and (3) developing a shared vision , to (4) actioning change mechanisms . This was underpinned by the (5) employment of effective communication strategies and (6) provision of resources to support change. Conclusions Evidence is developing to support the use of research implementation strategies for promoting evidence-informed policy and management decisions in healthcare. The design of future implementation strategies should be based on the inter-relating factors perceived to be associated with effective strategies. Trial registration This systematic review was registered with Prospero (record number: 42016032947).

The ICU Mobility Scale (IMS) is a measure of mobility milestones in critically ill patients. This study aimed to determine the validity and responsiveness of the IMS from a prospective cohort study of adults admitted to the intensive care unit (ICU). Construct and predictive validity were assessed by comparing IMS values at ICU discharge in 192 patients to other variables using Spearman rank correlation coefficient, Mann-Whitney U tests, and logistic regression. Responsiveness was assessed using change over time, effect size, floor and ceiling effects, and percentage of patients showing change. The IMS at ICU discharge demonstrated a moderate correlation with muscle strength (r = 0.64, P < 0.001). There was a significant difference between the IMS at ICU discharge in patients with ICU-acquired weakness (median, 4.0; interquartile range, 3.0-5.0) compared with patients without (median, 8.0; interquartile range, 5.0-8.0; P < 0.001). Increasing IMS values at ICU discharge were associated with survival to 90 days (odds ratio [OR], 1.38; 95% confidence interval [CI], 1.14-1.66) and discharge home (OR, 1.16; 95% CI, 1.02-1.32) but not with return to work at 6 months (OR, 1.09; 95% CI, 0.92-1.28). The IMS was responsive with a significant change from study enrollment to ICU discharge (d = 0.8, P < 0.001), with IMS values increasing in 86% of survivors during ICU admission. No substantial floor (14% scored 0) or ceiling (4% scored 10) effects were present at ICU discharge. Our findings support the validity and responsiveness of the IMS as a measure of mobility in the ICU.

Survivors of critical illness can experience long-standing functional limitations that negatively affect their health-related quality of life. To date, no model of rehabilitation has demonstrated sustained improvements in physical function for survivors of critical illness beyond hospital discharge. The aims of this study were: (1) to describe a model of rehabilitation for survivors of critical illness, (2) to compare the model to local standard care, and (3) to report the safety and feasibility of the program. This was a cohort study. As part of a larger randomized controlled trial, 74 participants were randomly assigned, 5 days following admission to the intensive care unit (ICU), to a protocolized rehabilitation program that commenced in the ICU and continued on the acute care ward and for a further 8 weeks following hospital discharge as an outpatient program. Exercise training was prescribed based on quantitative outcome measures to achieve a physiological training response. During acute hospitalization, 60% of exercise sessions were able to be delivered. The most frequently occurring barriers to exercise were patient safety and patient refusal due to fatigue. Point prevalence data showed patients were mobilized more often and for longer periods compared with standard care. Outpatient classes were poorly attended, with only 41% of the patients completing more than 70% of outpatient classes. No adverse events occurred. Limitations included patient heterogeneity and delayed commencement of exercise in the ICU due to issues of consent and recruitment. Exercise training that commences in the ICU and continues through to an outpatient program is safe and feasible for survivors of critical illness. Models of care that maximize patient participation across the continuum of care warrant further investigation.

Disinvestment (removal, reduction, or reallocation) of routinely provided health services can be difficult when there is little published evidence examining whether the services are effective or not. Evidence is required to understand if removing these services produces outcomes that are inferior to keeping such services in place. However, organisational imperatives, such as budget cuts, may force healthcare providers to disinvest from these services before the required evidence becomes available. There are presently no experimental studies examining the effectiveness of allied health services (e.g., physical therapy, occupational therapy, and social work) provided on weekends across acute medical and surgical hospital wards, despite these services being routinely provided internationally. The aim of this study was to understand the impact of removing weekend allied health services from acute medical and surgical wards using a disinvestment-specific non-inferiority research design. We conducted 2 stepped-wedge cluster randomised controlled trials between 1 February 2014 and 30 April 2015 among patients on 12 acute medical or surgical hospital wards spread across 2 hospitals. The hospitals involved were 2 metropolitan teaching hospitals in Melbourne, Australia. Data from n = 14,834 patients were collected for inclusion in Trial 1, and n = 12,674 in Trial 2. Trial 1 was a disinvestment-specific non-inferiority stepped-wedge trial where the 'current' weekend allied health service was incrementally removed from participating wards each calendar month, in a random order, while Trial 2 used a conventional non-inferiority stepped-wedge design, where a 'newly developed' service was incrementally reinstated on the same wards as in Trial 1. Primary outcome measures were patient length of stay (proportion staying longer than expected and mean length of stay), the proportion of patients experiencing any adverse event, and the proportion with an unplanned readmission within 28 days of discharge. The 'no weekend allied health service' condition was considered to be not inferior if the 95% CIs of the differences between this condition and the condition with weekend allied health service delivery were below a 2% increase in the proportion of patients who stayed in hospital longer than expected, a 2% increase in the proportion who had an unplanned readmission within 28 days, a 2% increase in the proportion who had any adverse event, and a 1-day increase in the mean length of stay. The current weekend allied health service included physical therapy, occupational therapy, speech therapy, dietetics, social work, and allied health assistant services in line with usual care at the participating sites. The newly developed weekend allied health service allowed managers at each site to reprioritise tasks being performed and the balance of hours provided by each professional group and on which days they were provided. Analyses conducted on an intention-to-treat basis demonstrated that there was no estimated effect size difference between groups in the proportion of patients staying longer than expected (weekend versus no weekend; estimated effect size difference [95% CI], p-value) in Trial 1 (0.40 versus 0.38; estimated effect size difference 0.01 [-0.01 to 0.04], p = 0.31, CI was both above and below non-inferiority margin), but the proportion staying longer than expected was greater with the newly developed service compared to its no weekend service control condition (0.39 versus 0.40; estimated effect size difference 0.02 [0.01 to 0.04], p = 0.04, CI was completely below non-inferiority margin) in Trial 2. Trial 1 and 2 findings were discordant for the mean length of stay outcome (Trial 1: 5.5 versus 6.3 days; estimated effect size difference 1.3 days [0.9 to 1.8], p < 0.001, CI was both above and below non-inferiority margin; Trial 2: 5.9 versus 5.0 days; estimated effect size difference -1.6 days [-2.0 to -1.1], p < 0.001, CI was completely below non-inferiority margin). There was no difference between conditions for the proportion who had an unplanned readmission within 28 days in either trial (Trial 1: 0.01 [-0.01 to 0.03], p = 0.18, CI was both above and below non-inferiority margin; Trial 2: -0.01 [-0.02 to 0.01], p = 0.62, CI completely below non-inferiority margin). There was no difference between conditions in the proportion of patients who experienced any adverse event in Trial 1 (0.01 [-0.01 to 0.03], p = 0.33, CI was both above and below non-inferiority margin), but a lower proportion of patients had an adverse event in Trial 2 when exposed to the no weekend allied health condition (-0.03 [-0.05 to -0.004], p = 0.02, CI completely below non-inferiority margin). Limitations of this research were that 1 of the trial wards was closed by the healthcare provider after Trial 1 and could not be included in Trial 2, and that both withdrawing the current weekend allied health service model and installing a new one may have led to an accommodation period for staff to adapt to the new service settings. Stepped-wedge trials are potentially susceptible to bias from naturally occurring change over time at the service level; however, this was adjusted for in our analyses. In Trial 1, criteria to say that the no weekend allied health condition was non-inferior to current weekend allied health condition were not met, while neither the no weekend nor current weekend allied health condition demonstrated superiority. In Trial 2, the no weekend allied health condition was non-inferior to the newly developed weekend allied health condition across all primary outcomes, and superior for the outcomes proportion of patients staying longer than expected, proportion experiencing any adverse event, and mean length of stay. Australian New Zealand Clinical Trials Registry ACTRN12613001231730 and ACTRN12613001361796.

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 (VO 2 ), 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 (VO 2 ) levels were low (15.94 ml/kg/min). Significant improvements in VO 2 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.

Background and objectives Available evidence suggests that adults with chronic obstructive pulmonary disease (COPD) performed substantially worse than healthy controls on many balance measures and balance training can improve the balance measures in this population. We conducted this study to determine the effects of incorporating balance training into pulmonary rehabilitation (PR) on the incidence of falls at 12 months follow-up in high fall risk adults with COPD. Methods We conducted a prospective international multi-center randomized controlled trial. Eligible participants were adults with COPD at a high risk of future falls and were randomly assigned (1:1) to the intervention or control group. The intervention included personalized balance training for a targeted total of 90 min per week. Both the intervention and control groups received usual PR (2–3 times per week for 8–12 weeks). The primary outcome was the incidence of falls at 12-month follow-up using monthly fall diary calendars. Negative binomial regression or recurrent events models were used to examine the effects of the intervention on fall events. Multiple imputations were performed to deal with missing values. Results Of 258 participants who were enrolled in the trial, 178 provided falls information (intervention group = 91, control group = 87) and were included in the main analysis. Forty-one participants (45%) experienced at least one fall event in the intervention group and 33 (38%) in the control group ( p  = 0.34). The mean incidence of falls at 12 months was similar between the two groups (128 versus 128 per 100 person-years; mean difference: 0.30, 95% CI: -0.76 to 1.36 per 100 person-years). The results are robust after multiple imputations for missing data ( n  = 67). Conclusions PR incorporating balance training compared to PR alone did not reduce the incidence of falls over the 12-month period in high fall risk adults with COPD. Trial registration The study was registered with ClinicalTrials.gov (NCT02995681) on 14/12/2016.

Background There is strong public support for acute hospital services to move to genuine 7-day models, including access to multidisciplinary team assessment. This study aimed to identify factors that might enable an effective and cost-effective weekend allied health services on acute hospital wards. Methods This qualitative study included 22 focus groups within acute wards with a weekend allied health service and 11 telephone interviews with weekend service providers. Data were collected from 210 hospital team members, including 17 medical, 97 nursing, and 96 allied health professionals from two Australian tertiary public hospitals. All were recorded and imported into nVivo 10 for analysis. Thematic analysis methods were used to develop a coding framework from the data and to identify emerging themes. Results Key themes identified were separated into issues perceived as being enablers or barriers to the effective or cost-effective delivery of weekend allied health services. Perceived enablers of effectiveness and cost-effectiveness included prioritizing interventions that prevent decline, the right person delivering the right service, improved access to the patient’s family, and ability to impact patient flow. Perceived barriers were employment of inexperienced weekend staff, insufficient investment to see tangible benefit, inefficiencies related to double-handling, unnecessary interventions and/or inappropriate referrals, and difficulty recruiting and retaining skilled staff. Conclusions Suggestions for ensuring effective and cost effective weekend allied health care models include minimization of task duplication and targeting interventions so that the right patients receive the right interventions at the right time. Further research into the effectiveness and cost effectiveness of these services should factor in hidden costs, including those associated with managing the service.

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.

Background Pulmonary rehabilitation (PR) is accepted as standard care for individuals with COPD. We conducted an international, multi-centred randomized controlled trial (RCT) to determine if adding balance training to PR would reduce the incidence of falls in people with COPD. While there have been many trials investigating the effectiveness of PR, few have involved international collaboration. Successful execution of rehabilitation trials requires a significant investment of time, staffing, and resources. With the recent completion of the Balance Training for Fall Reduction in COPD RCT, we report on the design, implementation, and execution of our trial using project management phases. We also highlight our lessons learned for consideration in future multi-centre rehabilitation trials. Methods This was a retrospective review of the planning, preparation, timelines, and personnel training involved in the execution of this study using four of the five project management phases described by Farrell et al. in 2010: (1) initiation, (2) planning, (3) execution, and (4) monitoring and controlling. We report descriptive statistics as percentages and counts and summarize our lessons learned. Results Ten outpatient PR programs in three continents participated. Thirty-one personnel worked on the trial across all sites. Enrolment began in January 2017 and was suspended in March 2020 due to the COVID-19 pandemic. Approximately 1275 patients were screened, 455 (36%) were eligible, 258 (57%) consented, 243 (53%) participated, and 130 (61%) completed the 12-month follow-up assessment. Lessons learned through our experience included (1) ensuring awareness of funder policies and considering the impact on collaborating sites; (2) preparing for the possibility of human resource and program disruptions; (3) anticipating site dropout and having a contingency plan in place; (4) planning and monitoring process measure data before, during, and after trial initiation; (5) ensuring frequent and consistent communication with and between collaborating sites; (6) maximizing features of database platform to ensure data set completeness and controlled data access; and (7) identifying strategies for increasing patient engagement in a high-demand study. Conclusions We identify seven lessons learned through our experience conducting an international, multicentre rehabilitation-based RCT. These lessons can provide guidance to other trialists conducting studies with similar logistics and may assist with future trial planning and implementation.