Effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program for hip osteoarthritis - protocol for the Better Hip randomised controlled trial.

BACKGROUND: Hip osteoarthritis (OA) is a leading cause of chronic pain and disability worldwide. Self-management is vital with education, exercise and weight loss core recommended treatments. However, evidence-practice gaps exist, and service models that increase patient accessibility to clinicians who can support lifestyle management are needed. The primary aim of this study is to determine the effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program (Better Hip) on the primary outcomes of hip pain on walking and physical function at 6 months, compared with an information-only control for people with hip OA. METHODS: A two-arm, parallel-design, superiority pragmatic randomised controlled trial. 212 members from a health insurance fund aged 45 years and over, with painful hip OA will be recruited. Participants will be randomly allocated to receive: i) Better Hip; or ii) web-based information only (control). Participants randomised to the Better Hip program will have six videoconferencing physiotherapist consultations for education about OA, prescription of individualised home-based strengthening and physical activity programs, behaviour change support, and facilitation of other self-management strategies. Those with a body mass index > 27 kg/m2, aged < 80 years and no specific health conditions, will also be offered six videoconferencing dietitian consultations to undertake a weight loss program. Participants in the control group will be provided with similar educational information about managing hip OA via a custom website. All participants will be reassessed at 6 and 12 months. Primary outcomes are hip pain on walking and physical function. Secondary outcomes include measures of pain; hip function; weight; health-related quality of life; physical activity levels; global change in hip problem; willingness to undergo hip replacement surgery; rates of hip replacement; and use of oral pain medications. A health economic evaluation at 12 months will be conducted and reported separately. DISCUSSION: Findings will determine whether a telehealth-delivered clinician-supported lifestyle management program including education, exercise/physical activity and, for those with overweight or obesity, weight loss, is more effective than information only in people with hip OA. Results will inform the implementation of such programs to increase access to core recommended treatments. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ACTRN12622000461796).

FEEDBACK trial - A randomised control trial to investigate the effect of personalised feedback and financial incentives on reducing the incidence of road crashes.

BACKGROUND: Road crashes continue to pose a significant threat to global health. Young drivers aged between 18 and 25 are over-represented in road injury and fatality statistics, especially the first six months after obtaining their license. This study is the first multi-centre two-arm parallel-group individually randomised controlled trial (the FEEDBACK Trial) that will examine whether the delivery of personalised driver feedback plus financial incentives is superior to no feedback and no financial incentives in reducing motor vehicle crashes among young drivers (18 to 20 years) during the first year of provisional licensing. METHODS: A total of 3,610 young drivers on their provisional licence (P1, the first-year provisional licensing) will participate in the trial over 28 weeks, including a 4-week baseline, 20-week intervention and 4-week post-intervention period. The primary outcome of the study will be police-reported crashes over the 20-week intervention period and the 4-week post-intervention period. Secondary outcomes include driving behaviours such as speeding and harsh braking that contribute to road crashes, which will be attained weekly from mobile telematics delivered to a smartphone app. DISCUSSION: Assuming a positive finding associated with personalised driver feedback and financial incentives in reducing road crashes among young drivers, the study will provide important evidence to support policymakers in introducing the intervention(s) as a key strategy to mitigate the risks associated with the burden of road injury among this vulnerable population. TRIAL REGISTRATION: Registered under the Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12623000387628p on April 17, 2023.

A structured, telephone-delivered intervention to reduce methamphetamine use: study protocol for a parallel-group randomised controlled trial.

BACKGROUND: Australia has one of the highest rates of methamphetamine (MA) use in the world; however, uptake of in-person psychological treatment remains extremely low due to numerous individual (e.g. stigma, shame) and structural (e.g. service accessibility, geographical location) barriers to accessing care. Telephone-delivered interventions are ideally placed to overcome many of the known barriers to treatment access and delivery. This randomised controlled trial (RCT) will examine the efficacy of a standalone, structured telephone-delivered intervention to reduce MA problem severity and related harms. METHODS: This study is a double-blind, parallel-group RCT. We will recruit 196 ± 8 individuals with mild to moderate MA use disorder from across Australia. After eligibility and baseline assessments, participants will be randomly allocated to receive either the Ready2Change-Methamphetamine (R2C-M) intervention (n = 98 ± 4; four to six telephone-delivered intervention sessions, R2C-M workbooks and MA information booklet) or control (n = 98 ± 4; four to six ≤5-min telephone check-ins and MA information booklet including information on accessing further support). Telephone follow-up assessments will occur at 6 weeks and 3, 6 and 12 months post-randomisation. The primary outcome is change in MA problem severity (Drug Use Disorders Identification Test, DUDIT) at 3 months post-randomisation. Secondary outcomes are as follows: MA problem severity (DUDIT) at 6 and 12 months post-randomisation, amount of methamphetamine used, methamphetamine use days, methamphetamine use disorder criteria met, cravings, psychological functioning, psychotic-like experiences, quality of life and other drug use days (at some or all timepoints of 6 weeks and 3, 6 and 12 months post-randomisation). Mixed-methods program evaluation will be performed and cost-effectiveness will be examined. DISCUSSION: This study will be the first RCT internationally to assess the efficacy of a telephone-delivered intervention for MA use disorder and related harms. The proposed intervention is expected to provide an effective, low-cost, scalable treatment for individuals otherwise unlikely to seek care, preventing future harms and reducing health service and community costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04713124 . Pre-registered on 19 January 2021.

Neurophysiological evidence against attentional suppression as the source of the same-location cost in spatial cueing.

Spatial cues that mismatch the colour of a subsequent target have been shown to slow responses to targets that share their location. The source of this 'same location cost' (SLC) is currently unknown. Two potential sources are attentional signal suppression and object-file updating. Here, we tested a direct prediction of the suppression account using data from a spatial-cueing study in which we recorded brain activity using electroencephalography (EEG), and focusing on the event-related PD component, which is thought to index attentional signal suppression. Correlating PD amplitude with SLC magnitude, we tested the prediction that if attentional signal suppression is the source of the SLC, then the SLC should be positively correlated with PD amplitude. Across 48 participants, SLC and PD magnitudes were negatively correlated, in direct contradiction to a suppression account of the SLC. These results are compatible with an object-file updating account of the SLC in which updating is facilitated by reactive suppression of the to-be-updated stimulus information.

Cost-Effectiveness of Telehealth-Delivered Exercise and Dietary Weight Loss Programs for Knee Osteoarthritis Within a Twelve-Month Randomized Trial.

OBJECTIVE: To evaluate the cost-effectiveness of telehealth-delivered exercise and diet-plus-exercise programs within 12 months. METHODS: An economic evaluation within a 12-month, 3-arm, parallel randomized trial of two 6-month telehealth-delivered exercise programs, with and without a dietary component. A total of 415 people with knee osteoarthritis ages 45-80 years and body mass index of 28-40 kg/m2 were assigned to 1 of 2 telehealth-delivered exercise programs, 1 without (n = 172) and 1 with (n = 175) a dietary component (ketogenic very low calorie diet), or to an education control (n = 67), for 6 months, with 6 months follow-up. The primary economic outcomes were quality-adjusted life years (QALYs) and health system costs. Measured costs were the direct intervention (consultations, equipment/resources, and meal replacements) and health care use in 2020 Australian dollars ($AU1.5 = $US1). Secondary analysis included weight loss and work productivity gains. RESULTS: The clinical trial demonstrated greater improvements in pain and function compared to information only for individuals with knee osteoarthritis and overweight/obesity. We can be 88% confident that diet plus exercise is cost effective ($45,500 per QALY), 53% confident that exercise is cost-effective ($67,600 per QALY) compared to the control, and 86% confident that augmenting exercise with the diet program is cost effective ($21,100 per QALY). CONCLUSION: Telehealth-delivered programs targeting exercise with dietary intervention for people with knee osteoarthritis who have overweight/obesity are likely to be cost-effective, particularly if potential long-term gains from weight loss and work productivity are realized.

Economic Evaluation of National Patient Blood Management Clinical Guidelines in Cardiac Surgery.

OBJECTIVES: To the best of our knowledge, no published clinical guidelines have ever undergone an economic evaluation to determine whether their implementation represented an efficient allocation of resources. Here, we perform an economic evaluation of national clinical guidelines designed to reduce unnecessary blood transfusions before, during, and after surgery published in 2012 by Australia's sole public blood provider, the National Blood Authority (NBA). METHODS: We performed a cost analysis from the government perspective, comparing the NBA's cost of implementing their perioperative patient blood management guidelines with the estimated resource savings in the years after publication. The impact on blood products, patient outcomes, and medication use were estimated for cardiac surgeries only using a large national registry. We adopted conservative counterfactual positions over a base-case 3-year time horizon with outcomes predicted from an interrupted time-series model controlling for differences in patient characteristics and hospitals. RESULTS: The estimated indexed cost of implementing the guidelines of A$1.5 million (2018-2019 financial year prices) was outweighed by the predicted blood products resource saving alone of A$5.1 million (95% confidence interval A$1.4 million-A$8.8 million) including savings of A$2.4 million, A$1.6 million, and A$1.2 million from reduced red blood cell, platelet, and fresh frozen plasma use, respectively. Estimated differences in patient outcomes were highly uncertain and estimated differences in medication were financially insignificant. CONCLUSIONS: Insofar as they led to a reduction in red blood cell, platelet, and fresh frozen plasma use during cardiac surgery, implementing the perioperative patient blood management guidelines represented an efficient use of the NBA's resources.

Efficacy and cost-effectiveness of Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis: protocol for a randomised placebo-controlled trial (the SCUlpTOR trial).

INTRODUCTION: Knee osteoarthritis (KOA) is a highly prevalent disabling joint disease. Intra-articular stem cell therapy is increasingly being used for treating KOA with little high-quality evidence to support its use. The aim of this study is to investigate the efficacy, safety and cost-effectiveness of allogeneic mesenchymal stem cells (Cymerus MSCs) for treating symptomatic tibiofemoral KOA and improving knee structure over 24 months. METHODS AND ANALYSIS: The Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis study is a phase III, multi-centre, parallel, superiority, randomised, double-blind, placebo-controlled trial, which will be conducted in Sydney and Hobart, Australia. 440 participants (220 per arm) aged over 40 years with painful KOA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) with medial minimum joint space width between 1 and 4 mm in the study knee will be recruited from the community and randomly allocated to receive either intra-articular MSCs or saline at baseline, week 3 and week 52. The coprimary outcomes will be the proportion of participants achieving patient-acceptable symptom state for knee pain at 24 months and quantitative central medial femorotibial compartment cartilage thickness change from baseline to 24 months. Main secondary outcomes include change in knee pain, Patient Global Assessment, physical function, quality of life and other structural changes. Additional data for cost-effectiveness analysis will also be recorded. Adverse events will be monitored throughout the study. The primary analysis will be conducted using modified intention-to-treat. ETHICS AND DISSEMINATION: This protocol has been approved by The University of Sydney (USYD) Human Research Ethics Committee (HREC) #: 2020/119 and The University of Tasmania (UTAS) HREC #: H0021868. All participants will be required to provide informed consent. Dissemination will occur through conferences, social media, and scientific publications. TRIAL REGISTRATION NUMBERS: Australian New Zealand Clinical Trials Registry (ACTRN12620000870954); U1111-1234-4897.

The effect of telematic based feedback and financial incentives on driving behaviour: A randomised trial.

AIM: In-vehicle telematics monitoring systems that provide driver feedback have been identified as a promising intervention to influence driver behaviours and reduce the growing burden of road injury. The current study was undertaken to assess the effect of driver feedback alone and feedback plus financial incentives on driving behaviours (speeding, hard acceleration and hard braking). METHOD: A pragmatic randomised trial was undertaken over a 28-week observational period. Drivers were recruited and randomly allocated to one of three groups namely, driver feedback, driver feedback plus incentives and a control group. The feedback group received a weekly summary of their driving performance via SMS text message and access to more detailed feedback via an online dashboard or smartphone application. The feedback plus financial incentive group received the feedback but lost financial incentives for risky driving behaviour above a threshold. RESULTS: A total of 174 drivers completed at least one driving trip during the study period; 18,082 trip days completed by these 174 drivers during the study period provided the sample for analysis. For the primary outcomes of probability of speeding, hard acceleration and hard braking on any given trip, neither feedback alone nor feedback plus incentives delivered statistically significant improvements in driving behaviour relative to the controls. Treatment effects for feedback plus incentives were, however, consistently in the expected direction and large enough to warrant further investigation. For the secondary composite measure of risky driving, namely the DriveScore™, a statistically significant improvement was observed for the feedback and incentive group compared to the control group (TE = 2.6 points on a 0-100 scale, p < 0.05). DISCUSSION: This study adds to our understanding of the potential effects of feedback and financial incentives. Findings suggest that, while feedback alone may be insufficient to motivate behaviour change, combining feedback with financial incentives can deliver potentially important and statistically significant reductions in risky driving behaviours.

Association of Postoperative Infections After Fractures With Long-term Income Among Adults.

Importance: Postoperative infections after a fracture exert tremendous costs on the health care system. However, the patient economic burden associated with a postoperative infection is unclear. Objective: To evaluate the association between a postoperative infection and long-term income among patients with surgically treated fractures. Design, Setting, and Participants: A retrospective cohort study linked academic trauma center data with Maryland tax records using inverse probability of treatment weighting to estimate between-group differences among 11 673 adults who underwent surgery to treat fractures of the extremities or pelvis between January 1, 2003, and December 31, 2016. Statistical analysis was performed from November 5, 2019, to August 30, 2020. Exposure: A postoperative infection within 1 year of injury. Main Outcomes and Measures: The primary outcome was the annual household income up to 6 years after injury. Household income incorporates multiple types of income, including wage earnings, taxable Social Security benefits, workers' compensation, and disability benefits. Secondary outcomes included individual earnings, Social Security benefits, unemployment benefits, and catastrophic income loss. Results: The study included 11 673 patients (7756 male patients [66.4%]; mean [SD] age, 45.2 [19.2] years) with a mean (SD) preinjury household income of $30 505 ($89 030). A total of 403 patients (3.5%) had a postoperative infection. Postoperative infections were associated with a $6080 annual decrease (95% CI, -$12 114 to -$47; P = .048) in household income in the 6 years after injury. Postoperative infections were associated with a 6.6% increase (95% CI, 4.9%-8.3%; P < .001) in the risk of catastrophic wage loss within 2 years of the fracture and were associated with a 45% increase in the odds of receiving Social Security benefits (odds ratio, 1.45; 95% CI, 1.25-1.68; P < .001). However, incurring a postoperative infection was not associated with an increase in the value of the Social Security benefits received. Conclusions and Relevance: This study suggests that postoperative infections have significant and sustained income-associated implications for patients who experience a fracture. Current Social Security mechanisms may not offset the decreased income.

Participatory health through behavioural engagement and disruptive digital technology for postoperative rehabilitation: protocol of the PATHway trial.

INTRODUCTION: Postsurgical rehabilitation is critical for optimal recovery in people undergoing orthopaedic surgery. Currently, knee and lumbar spine postsurgical care is not standardised, economically sustainable, nor based on quality evidence, contributing to substantial clinical variation, poor outcomes and increasing healthcare costs. This protocol describes the design of a randomised controlled trial aiming to evaluate the effectiveness and cost-effectiveness of a postsurgical clinical pathway augmented by disruptive technology and compared with standardised rehabilitation alone, in decreasing pain and improving function after total knee replacement (TKR) or lumbar laminectomy (with or without fusion). METHODS: An assessor-blinded, parallel group, randomised controlled trial will be conducted to recruit 204 consenting participants (102 per arm) of whom 50% are undergoing TKR and 50% lumbar surgery. The intervention group will receive a 6-month technology-enabled rehabilitation package in addition to usual postsurgical care. The package includes (1) an exercise program delivered via the Physitrack app on the iPad, (2) a health-coaching program delivered via video calls and motivational messages, (3) use of physical activity tracker with goal setting and motivational reminders (Fitbit). For those undergoing TKR, the intervention will also include knee joint range of motion self-monitoring via the Goniometer app. The control group will receive usual postsurgical care. Participants will be followed up at 3, 6 and 12 months from the enrolment date. The primary outcome is pain measured with the Numerical Rating Scale at 3 months. Secondary outcomes include pain-related disability, quality of life, computer self-efficacy, physical activity participation and sedentary behaviour. Data analysis will be blinded and by intention-to-treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life-year gained. ETHICS AND DISSEMINATION: This protocol is approved by the human research ethics committee of the University of Sydney. Dissemination will occur through lay summary, infographics, conferences and journal publications. TRIAL REGISTRATION NUMBER: ACTRN12618001448235.

The Limited Utility of Ranking Hospitals Based on Their Colon Surgery Infection Rates.

BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) use colon surgical site infection (SSI) rates to rank hospitals and apply financial penalties. The CMS' risk-adjustment model omits potentially impactful variables that might disadvantage hospitals with complex surgical populations. METHODS: We analyzed adult patients who underwent colon surgery within facilities associated with HCA Healthcare from 2014 to 2016. SSIs were identified from National Health Safety Network (NHSN) reporting. We trained and validated 3 SSI prediction models, using (1) current CMS model variables, including hospital-specific random effects (HCA-adapted CMS model); (2) demographics and claims-based comorbidities (expanded-claims model); and (3) demographics, claims-based comorbidities, and NHSN variables (claims-plus-electronic health record [EHR] model). Discrimination, calibration, and resulting rankings were compared among all models and the current CMS model with published coefficient values. RESULTS: We identified 39 468 colon surgeries in 149 hospitals, resulting in 1216 (3.1%) SSIs. Compared to the HCA-adapted CMS model, the expanded-claims model had similar performance (c-statistic, 0.65 vs 0.67, respectively), while the claims-plus-EHR model was more accurate (c-statistic, 0.70; 95% confidence interval, .67-.73; P = .004). The sampling variation, due to the low surgical volume and small number of infections, contributed 74% of the total variation in observed SSI rates between hospitals. When CMS model rankings were compared to those from the expanded-claims and claims-plus-EHR models, 18 (15%) and 26 (22%) hospitals changed quartiles, respectively, and 10 (8.3%) and 12 (10%) hospitals changed into or out of the lowest-performing quartile, respectively. CONCLUSIONS: An expanded set of variables improved colon SSI risk predictions and quartile assignments, but low procedure volumes and SSI events remain a barrier to effectively comparing hospitals.

The cost-effectiveness of early goal-directed therapy: an economic evaluation alongside the ARISE trial.

Objective: To determine the cost-effectiveness of early goal-directed therapy (EGDT) for patients with early septic shock. Design: Within-trial cost-effectiveness evaluation. Setting: Nineteen hospitals in Australia and New Zealand. Participants and interventions: Patients with early septic shock enrolled in the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial were randomly assigned to EGDT versus usual care. A subgroup of patients participated in a nested economic evaluation study in which detailed resource use data were collected until 12 months after randomisation. Outcome measures: Clinical outcomes included lives saved, life-years gained and quality-adjusted life-years (QALYs), with mortality collected until 12 months and health-related quality of life assessed at baseline, 6 and 12 months using the 3-level EuroQol five dimensions questionnaire (EQ-5D-3L). Economic outcomes included health care resource use, costs and cost-effectiveness from the Australian health care payer perspective. Results: A total of 205 patients (100 EGDT, 105 usual care) participated in the nested economic evaluation study, of which 203 had complete resource use data. Unadjusted mean health care costs to 12 months were $67 223 (standard deviation [SD], $72 397) in the EGDT group and $54 179 (SD, $61 980) in the usual care group, with a mean difference of $13 044 (95% CI, -$5791 to $31 878). There was no difference between groups with regards to lives saved (EGDT, 69.4% v usual care, 68.6%; P = 1.0), life-years gained (mean EGDT, 0.746 [SD, 0.406] v usual care, 0.725 [SD, 0.417]; P = 0.72) or QALYs (mean EGDT, 0.318 [SD, 0.291] v usual care, 0.367 [SD, 0.295]; P = 0.24). EGDT was dominated (higher costs, lower effectiveness) by usual care in 80.4% of bootstrap replications. For a willingness-to-pay threshold of $50 000 per QALY, the probability of EGDT being cost-effective was only 6.4%. Conclusions: In patients presenting to the emergency department with early septic shock, EGDT compared with usual care was not cost-effective. Clinical trial registration:ClinicalTrials.gov number NCT00975793.

The Impact of Financial Incentives on Physical Activity: A Systematic Review and Meta-Analysis.

OBJECTIVE: To evaluate the effects of financial incentives on physical activity (PA). DATA SOURCES: MEDLINE, Embase, 7 other databases, and 2 trial registries until July 17, 2019. STUDY INCLUSION AND EXCLUSION CRITERIA: Randomized controlled trials with adults aged ≥18 years assessing the effect of financial incentives on PA. Any comparator was eligible provided the only difference between groups was the incentive strategy. DATA EXTRACTION: Two independent reviewers extracted data and assessed study quality. Of 5765 records identified, 57 records (51 unique trials; n = 17 773 participants) were included. DATA SYNTHESIS: Random-effects models pooling data for each of the 5 PA domains. RESULTS: Financial incentives increase leisure time PA (gym or class attendance; standardized mean difference [95% CI], 0.46 [0.28-0.63], n = 5057) and walking behavior (steps walked; 0.25 [0.13-0.36], n = 3254). No change in total minutes of PA (0.52 [-0.09 to 1.12], n = 968), kilocalories expended (0.19 [-0.06 to 0.44], n = 247), or the proportion of participants meeting PA guidelines (risk ratio [95% CI] 1.53 [0.53-4.44], n = 650) postintervention was observed. After intervention has ceased, incentives sustain a slight increase in leisure time PA (0.10 [0.02-0.18], n = 2678) and walking behavior (0.11 [0.00-0.22], n = 2425). CONCLUSIONS: Incentives probably improve leisure time PA and walking at intervention end, and small improvements may be sustained over time once incentives have ceased. They lead to little or no difference in kilocalories expended or minutes of PA. It is uncertain whether incentives change the likelihood of meeting PA guidelines because the certainty of the evidence is low.

Health economic evaluations of sepsis interventions in critically ill adult patients: a systematic review.

BACKGROUND: Sepsis is a global health priority. Interventions to reduce the burden of sepsis need to be both effective and cost-effective. We performed a systematic review of the literature on health economic evaluations of sepsis treatments in critically ill adult patients and summarised the evidence for cost-effectiveness. METHODS: We systematically searched MEDLINE, Embase, and the Cochrane Library using thesaurus (e.g. MeSH) and free-text terms related to sepsis and economic evaluations. We included all articles that reported, in any language, an economic evaluation of an intervention for the management of sepsis in critically ill adult patients. Data extracted included study details, intervention details, economic evaluation methodology, and outcomes. Included studies were appraised for reporting quality using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. RESULTS: We identified 50 records representing 46 economic evaluations for a variety of interventions including antibiotics (n = 5), fluid therapy (n = 2), early goal-directed therapy and other resuscitation protocols (n = 8), immunoglobulins (n = 2), and interventions no longer in clinical use such as monoclonal antibodies (n = 7) and drotrecogin alfa (n = 13). Twelve (26%) evaluations were of excellent reporting quality. Incremental cost-effectiveness ratios (ICERs) ranged from dominant (lower costs and higher effectiveness) for early goal-directed therapy, albumin, and a multifaceted sepsis education program to dominated (higher costs and lower effectiveness) for polymerase chain reaction assays (LightCycler SeptiFast testing MGRADE®, SepsiTest™, and IRIDICA BAC BSI assay). ICERs varied widely across evaluations, particularly in subgroup analyses. CONCLUSIONS: There is wide variation in the cost-effectiveness of sepsis interventions. There remain important gaps in the literature, with no economic evaluations identified for several interventions routinely used in sepsis. Given the high economic and social burden of sepsis, high-quality economic evaluations are needed to increase our understanding of the cost-effectiveness of these interventions in routine clinical practice and to inform decision makers. TRIAL REGISTRATION: PROSPERO CRD42018095980.

Recovery Assessment Scale-Domains and Stages: Measurement capacity, relevance, acceptability and feasibility of use with young people.

AIM: The Recovery Assessment Scale-Domains and Stages (RAS-DS) is a self-rated measure of mental health recovery. While this instrument has demonstrated good measurement properties and acceptability to clinicians and consumers in adult mental health services, it has not been evaluated in the context of youth-focused mental health services. This study was established to evaluate the measurement properties, feasibility and acceptability of the RAS-DS in a youth mental health service context. METHODS: Young people accessing a youth mental health service were invited to complete the RAS-DS and both young people and clinicians provided feedback about its usefulness. Analyses of the measurement properties of the RAS-DS were completed using Rasch analysis. Usability feedback was analysed using descriptive statistics and constant comparative analysis. RESULTS: Fifty-eight consumer-clinician dyads participated. Analyses revealed that items on the RAS-DS generally demonstrated good fit with the expectations of the Rasch model and clinician and consumer feedback was generally positive. Ninety-one percent of young people completed the RAS-DS in less than 15 minutes. Thirty-four percent of young people had measure scores above the level of the "hardest" item on the RAS-DS, suggesting that measurement precision is lower for individuals at more advanced stages of recovery. CONCLUSIONS: This study demonstrates that the RAS-DS has acceptable measurement properties and was acceptable to young people and clinicians. Future research should explore the use of the RAS-DS by young people in other contexts as well as explore whether additional items could be added to capture the later stages of recovery for young people.

Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial.

OBJECTIVE: Evaluate a physiotherapist-led telephone-delivered exercise advice and support intervention for people with knee osteoarthritis. METHODS: Participant-blinded, assessor-blinded randomised controlled trial. 175 people were randomly allocated to (1) existing telephone service (≥1 nurse consultation for self-management advice) or (2) exercise advice and support (5-10 consultations with a physiotherapist trained in behaviour change for a personalised strengthening and physical activity programme) plus the existing service. Primary outcomes were overall knee pain (Numerical Rating Scale, range 0-10) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, range 0-68) at 6 months. Secondary outcomes, cost-effectiveness and 12-month follow-up were included. RESULTS: 165 (94%) and 158 (90%) participants were retained at 6 and 12 months, respectively. At 6 months, exercise advice and support resulted in greater improvement in function (mean difference 4.7 (95% CI 1.0 to 8.4)), but not overall pain (0.7, 0.0 to 1.4). Eight of 14 secondary outcomes favoured exercise advice and support at 6 months, including pain on daily activities, walking pain, pain self-efficacy, global improvements across multiple domains (overall improvement, improved pain, improved function and improved physical activity) and satisfaction. By 12 months, most outcomes were similar between groups. Exercise advice and support cost $A514/participant and did not save other health service resources. CONCLUSION: Telephone-delivered physiotherapist-led exercise advice and support modestly improved physical function but not the co-primary outcome of knee pain at 6 months. Functional benefits were not sustained at 12 months. The clinical significance of this effect is uncertain. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (#12616000054415).

Fresh Red Cells for Transfusion in Critically Ill Adults: An Economic Evaluation of the Standard Issue Transfusion Versus Fresher Red-Cell Use in Intensive Care (TRANSFUSE) Clinical Trial.

OBJECTIVES: Trials comparing the effects of transfusing RBC units of different storage durations have considered mortality or morbidity as outcomes. We perform the first economic evaluation alongside a full age of blood clinical trial with a large population assessing the impact of RBC storage duration on quality-of-life and costs in critically ill adults. DESIGN: Quality-of-life was measured at 6 months post randomization using the EuroQol 5-dimension 3-level instrument. The economic evaluation considers quality-adjusted life year and cost implications from randomization to 6 months. A generalized linear model was used to estimate incremental costs (2016 U.S. dollars) and quality-adjusted life years, respectively while adjusting for baseline characteristics. SETTING: Fifty-nine ICUs in five countries. PATIENTS: Adults with an anticipated ICU stay of at least 24 hours when the decision had been made to transfuse at least one RBC unit. INTERVENTIONS: Patients were randomized to receive either the freshest or oldest available compatible RBC units (standard practice) in the hospital transfusion service. MEASUREMENTS AND MAIN RESULTS: EuroQol 5-dimension 3-level utility scores were similar at 6 months-0.65 in the short-term and 0.63 in the long-term storage group (difference, 0.02; 95% CI, -0.00 to 0.04; p = 0.10). There were no significant differences in resource use between the two groups apart from 3.0 fewer hospital readmission days (95% CI, -5.3 to -0.8; p = 0.01) during follow-up in the short-term storage group. There were no significant differences in adjusted total costs or quality-adjusted life years between the short- and long-term storage groups (incremental costs, -$2,358; 95% CI, -$5,586 to $711) and incremental quality-adjusted life years: 0.003 quality-adjusted life years (95% CI, -0.003 to 0.008). CONCLUSIONS: Without considering the additional supply cost of implementing a freshest available RBC strategy for critical care patients, there is no evidence to suggest that the policy improves quality-of-life or reduces other costs compared with standard transfusion practice.

A methodological comparison of risk scores versus decision trees for predicting drug-resistant infections: A case study using extended-spectrum beta-lactamase (ESBL) bacteremia.

BACKGROUND: Timely identification of multidrug-resistant gram-negative infections remains an epidemiological challenge. Statistical models for predicting drug resistance can offer utility where rapid diagnostics are unavailable or resource-impractical. Logistic regression-derived risk scores are common in the healthcare epidemiology literature. Machine learning-derived decision trees are an alternative approach for developing decision support tools. Our group previously reported on a decision tree for predicting ESBL bloodstream infections. Our objective in the current study was to develop a risk score from the same ESBL dataset to compare these 2 methods and to offer general guiding principles for using each approach. METHODS: Using a dataset of 1,288 patients with Escherichia coli or Klebsiella spp bacteremia, we generated a risk score to predict the likelihood that a bacteremic patient was infected with an ESBL-producer. We evaluated discrimination (original and cross-validated models) using receiver operating characteristic curves and C statistics. We compared risk score and decision tree performance, and we reviewed their practical and methodological attributes. RESULTS: In total, 194 patients (15%) were infected with ESBL-producing bacteremia. The clinical risk score included 14 variables, compared to the 5 decision-tree variables. The positive and negative predictive values of the risk score and decision tree were similar (>90%), but the C statistic of the risk score (0.87) was 10% higher. CONCLUSIONS: A decision tree and risk score performed similarly for predicting ESBL infection. The decision tree was more user-friendly, with fewer variables for the end user, whereas the risk score offered higher discrimination and greater flexibility for adjusting sensitivity and specificity.

Assessment of Machine Learning vs Standard Prediction Rules for Predicting Hospital Readmissions.

Importance: Hospital readmissions are associated with patient harm and expense. Ways to prevent hospital readmissions have focused on identifying patients at greatest risk using prediction scores. Objective: To identify the type of score that best predicts hospital readmissions. Design, Setting, and Participants: This prognostic study included 14 062 consecutive adult hospital patients with 16 649 discharges from a tertiary care center, suburban community hospital, and urban critical access hospital in Maryland from September 1, 2016, through December 31, 2016. Patients not included as eligible discharges by the Centers for Medicare & Medicaid Services or the Chesapeake Regional Information System for Our Patients were excluded. A machine learning rank score, the Baltimore score (B score) developed using a machine learning technique, for each individual hospital using data from the 2 years before September 1, 2016, was compared with standard readmission risk assessment scores to predict 30-day unplanned readmissions. Main Outcomes and Measures: The 30-day readmission rate evaluated using various readmission scores: B score, HOSPITAL score, modified LACE score, and Maxim/RightCare score. Results: Of the 10 732 patients (5605 [52.2%] male; mean [SD] age, 54.56 [22.42] years) deemed to be eligible for the study, 1422 were readmitted. The area under the receiver operating characteristic curve (AUROC) for individual rules was 0.63 (95% CI, 0.61-0.65) for the HOSPITAL score, which was significantly lower than the 0.66 for modified LACE score (95% CI, 0.64-0.68; P < .001). The B score machine learning score was significantly better than all other scores; 48 hours after admission, the AUROC of the B score was 0.72 (95% CI, 0.70-0.73), which increased to 0.78 (95% CI, 0.77-0.79) at discharge (all P < .001). At the hospital using Maxim/RightCare score, the AUROC was 0.63 (95% CI, 0.59-0.69) for HOSPITAL, 0.64 (95% CI, 0.61-0.68) for Maxim/RightCare, and 0.66 (95% CI, 0.62-0.69) for modified LACE score. The B score was 0.72 (95% CI, 0.69-0.75) 48 hours after admission and 0.81 (95% CI, 0.79-0.84) at discharge. In directly comparing the B score with the sensitivity at cutoff values for modified LACE, HOSPITAL, and Maxim/RightCare scores, the B score was able to identify the same number of readmitted patients while flagging 25.5% to 54.9% fewer patients. Conclusions and Relevance: Among 3 hospitals in different settings, an automated machine learning score better predicted readmissions than commonly used readmission scores. More efficiently targeting patients at higher risk of readmission may be the first step toward potentially preventing readmissions.

Cost-Effectiveness of Erythropoietin in Traumatic Brain Injury: A Multinational Trial-Based Economic Analysis.

The EPO-TBI multi-national randomized controlled trial found that erythropoietin (EPO), when compared to placebo, did not affect 6-month neurological outcome, but reduced illness severity-adjusted mortality in patients with traumatic brain injury (TBI), making the cost-effectiveness of EPO in TBI uncertain. The current study uses patient-level data from the EPO-TBI trial to evaluate the cost-effectiveness of EPO in patients with moderate or severe TBI from the healthcare payers' perspective. We addressed the issue of transferability in multi-national trials by estimating costs and effects for specific geographical regions of the study (Australia/New Zealand, Europe, and Saudi Arabia). Unadjusted mean quality-adjusted life-years (QALYs; 95% confidence interval [CI]) at 6 months were 0.027 (0.020-0.034; p < 0.001) higher in the EPO group, with an adjusted QALY increment of 0.014 (0.000-0.028; p = 0.04). Mean unadjusted costs (95% CI) were $US5668 (-9191 to -2144; p = 0.002) lower in the treatment group; controlling for baseline IMPACT-TBI score and regional heterogeneity reduced this difference to $2377 (-12,446 to 7693; p = 0.64). For a willingness-to-pay threshold of $US50,000 per QALY, 71.8% of replications were considered cost-effective. Therefore, we did not find evidence that EPO was significantly cost-effective in the treatment of moderate or severe TBI at 6-month follow-up.