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.

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.

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.

Impact of disinvestment from weekend allied health services across acute medical and surgical wards: 2 stepped-wedge cluster randomised controlled trials.

BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613001231730 and ACTRN12613001361796.

What makes weekend allied health services effective and cost-effective (or not) in acute medical and surgical wards? Perceptions of medical, nursing, and allied health workers.

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.

Comparative effectiveness research for the clinician researcher: a framework for making a methodological design choice.

Comparative effectiveness research compares two active forms of treatment or usual care in comparison with usual care with an additional intervention element. These types of study are commonly conducted following a placebo or no active treatment trial. Research designs with a placebo or non-active treatment arm can be challenging for the clinician researcher when conducted within the healthcare environment with patients attending for treatment.A framework for conducting comparative effectiveness research is needed, particularly for interventions for which there are no strong regulatory requirements that must be met prior to their introduction into usual care. We argue for a broader use of comparative effectiveness research to achieve translatable real-world clinical research. These types of research design also affect the rapid uptake of evidence-based clinical practice within the healthcare setting.This framework includes questions to guide the clinician researcher into the most appropriate trial design to measure treatment effect. These questions include consideration given to current treatment provision during usual care, known treatment effectiveness, side effects of treatments, economic impact, and the setting in which the research is being undertaken.

The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial.

BACKGROUND: Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. METHODS/DESIGN: The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. DISCUSSION: The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and physiotherapy, measures many known confounders, and includes a post-discharge follow-up of complication rates, functional capacity, and health-related quality of life. This trial is currently recruiting. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry number: ACTRN12613000664741 , 19 June 2013.

Study protocol for two randomized controlled trials examining the effectiveness and safety of current weekend allied health services and a new stakeholder-driven model for acute medical/surgical patients versus no weekend allied health services.

BACKGROUND: Disinvestment from inefficient or ineffective health services is a growing priority for health care systems. Provision of allied health services over the weekend is now commonplace despite a relative paucity of evidence supporting their provision. The relatively high cost of providing this service combined with the paucity of evidence supporting its provision makes this a potential candidate for disinvestment so that resources consumed can be used in other areas. This study aims to determine the effectiveness, cost-effectiveness and safety of the current model of weekend allied health service and a new stakeholder-driven model of weekend allied health service delivery on acute medical and surgical wards compared to having no weekend allied health service. METHODS/DESIGN: Two stepped wedge, cluster randomised trials of weekend allied health services will be conducted in six acute medical/surgical wards across two public metropolitan hospitals in Melbourne (Australia). Wards have been chosen to participate by management teams at each hospital. The allied health services to be investigated will include physiotherapy, occupational therapy, speech therapy, dietetics, social work and allied health assistants. At baseline, all wards will be receiving weekend allied health services. Study 1 intervention will be the sequential disinvestment (roll-in) of the current weekend allied health service model from each participating ward in monthly intervals and study 2 will be the roll-out of a new stakeholder-driven model of weekend allied health service delivery. The order in which weekend allied health services will be rolled in and out amongst participating wards will be determined randomly. This trial will be conducted in each of the two participating hospitals at a different time interval. Primary outcomes will be length of stay, rate of unplanned hospital readmission within 28 days and rate of adverse events. Secondary outcomes will be number of complaints and compliments, staff absenteeism, and patient discharge destination, satisfaction, and functional independence at discharge. DISCUSSION: This is the world's first application of the recently described non-inferiority (roll-in) stepped wedge trial design, and the largest investigation of the effectiveness of weekend allied health services on acute medical surgical wards to date. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry. REGISTRATION NUMBER: ACTRN12613001231730 (first study) and ACTRN12613001361796 (second study). Was this trial prospectively registered?: Yes. Date registered: 8 November 2013 (first study), 12 December 2013 (second study). Anticipated completion: June 2015. Protocol version: 1. Role of trial sponsor: KP and DL are directly employed by one of the trial sponsors, their roles were: KP assisted with overall development of research design and assisted with overall project management; DL contributed to project management, administration and communications strategy.

Physiotherapy departments in Australian tertiary hospitals regularly participate in and disseminate research results despite a lack of allocated staff: a prospective cross-sectional survey.

OBJECTIVES: To establish the level of research activity in physiotherapy departments of Australian tertiary hospitals. DESIGN: Prospective cross-sectional survey. PARTICIPANTS: Physiotherapy managers from 37 principal referral hospitals and specialist women's and children's hospitals as identified from the Australian Institute of Health and Welfare (2011). MAIN OUTCOME MEASURES: A purpose-designed predominantly open-response questionnaire investigating site demographics, research activity and research support was developed, piloted and administered. RESULTS: Thirty-seven surveys were completed (54% response rate). Median [IQR] respondent equivalent full-time staffing was 23.8 (19-39). Respondents represented a median [IQR] 6.5 (3-20) publication output in the past 2 years. Twelve respondents (32%) reported that staff had completed a doctorate in the past 5 years and 49% of respondents reported no staff had completed higher degrees. A total of 71 grants had been received and 73% of respondents indicated they had no allocated staffing for research activity. The most common indicators of research culture were organization-led research dissemination events and research training (i.e. manager attending research events and celebrating research achievements). CONCLUSIONS: This is the first study to report on research activity in hospital-based Australian physiotherapy departments. Few sites allocate staff to conduct or support research. Despite this, physiotherapy departments regularly publish and present research results. Future studies could investigate how hospital-based physiotherapy departments can optimize research culture and output.

Effect of health insurance on the utilisation of allied health services by people with chronic disease: a systematic review and meta-analysis.

Allied health services benefit the management of many chronic diseases. The effects of health insurance on the utilisation of allied health services has not yet been established despite health insurance frequently being identified as a factor promoting utilisation of medical and hospital services among people with chronic disease. The objective of this systematic review and meta-analysis was to establish the effects of health insurance on the utilisation of allied health services by people with chronic disease. Medline (Ovid Medline 1948 to Present with Daily Update), EMBASE (1980 to 1 April 2011), CINAHL, PsychINFO and the Cochrane Central Register of Controlled Trials were searched to 12 April 2011 inclusive. Studies were eligible for inclusion if they were published in English, randomised controlled trials, quasi-experimental trials, quantitative observational studies and included people with one or more chronic diseases using allied health services and health insurance. A full-text review was performed independently by two reviewers. Meta-analyses were conducted. One hundred and fifty-eight citations were retrieved and seven articles were included in the meta-analyses. The pooled odds ratio (95% CI) of having insurance (versus no insurance) on the utilisation of allied health services among people with chronic disease was 1.33 (1.16-1.52; P<0.001). There was a significant effect of insurance on the utilisation of non-physiotherapy services, pooled odds ratio (95% CI) 4.80 (1.46-15.79; P=0.01) but having insurance compared with insurance of a lesser coverage was not significantly associated with an increase in physiotherapy utilisation, pooled odds ratio (95% CI) 1.53 (0.81-2.91; P=0.19). The presence of co-morbidity or functional limitation and higher levels of education increased utilisation whereas gender, race, marital status and income had a limited and variable effect, according to the study population. The review was limited by the considerable heterogeneity in the research questions being asked, sample sizes, study methodology (including allied health service), insurance type and dependent variables analysed. The presence of health insurance was generally associated with increased utilisation of allied health services; however, this varied depending on the population, provider type and insurance product.