An economic evaluation of chronic obstructive pulmonary disease clinical pathway in Saskatchewan, Canada: Data-driven techniques to identify cost-effectiveness among patient subgroups.

BACKGROUND: Saskatchewan has implemented care pathways for several common health conditions. To date, there has not been any cost-effectiveness evaluation of care pathways in the province. The objective of this study was to evaluate the real-world cost-effectiveness of a chronic obstructive pulmonary disease (COPD) care pathway program in Saskatchewan. METHODS: Using patient-level administrative health data, we identified adults (35+ years) with COPD diagnosis recruited into the care pathway program in Regina between April 1, 2018, and March 31, 2019 (N = 759). The control group comprised adults (35+ years) with COPD who lived in Saskatoon during the same period (N = 759). The control group was matched to the intervention group using propensity scores. Costs were calculated at the patient level. The outcome measure was the number of days patients remained without experiencing COPD exacerbation within 1-year follow-up. Both manual and data-driven policy learning approaches were used to assess heterogeneity in the cost-effectiveness by patient demographic and disease characteristics. Bootstrapping was used to quantify uncertainty in the results. RESULTS: In the overall sample, the estimates indicate that the COPD care pathway was not cost-effective using the willingness to pay (WTP) threshold values in the range of $1,000 and $5,000/exacerbation day averted. The manual subgroup analyses show the COPD care pathway was dominant among patients with comorbidities and among patients aged 65 years or younger at the WTP threshold of $2000/exacerbation day averted. Although similar profiles as those identified in the manual subgroup analyses were confirmed, the data-driven policy learning approach suggests more nuanced demographic and disease profiles that the care pathway would be most appropriate for. CONCLUSIONS: Both manual subgroup analysis and data-driven policy learning approach showed that the COPD care pathway consistently produced cost savings and better health outcomes among patients with comorbidities or among those relatively younger. The care pathway was not cost-effective in the entire sample.

Real-World Cost-Consequence Analysis of an Integrated Chronic Disease Management Program in Saskatchewan, Canada.

An integrated disease management program otherwise called a clinical pathway was recently implemented in Saskatchewan, Canada for patients living with chronic obstructive pulmonary disease (COPD). This study compared the real-world costs and consequences of the COPD clinical pathway program with 2 control treatment programs. The study comprised adult COPD patients in Regina (clinical pathway group, N = 759) matched on propensity scores to 2 independent control groups of similar adults in (1) Regina (historical controls, N = 759) and (2) Saskatoon (contemporaneous controls, N = 759). The study measures included patient-level healthcare costs and acute COPD exacerbation outcomes, both tracked in population-based administrative health data over a one-year follow-up period. Analyses included Cox proportional hazards models and differences in means between groups. The bias-corrected and accelerated bootstrap method was used to calculate 95% confidence intervals (CI). The COPD pathway patients had lower risks of moderate (hazard ratio [HR] =0.57, 95% CI [0.40-0.83]) and severe (HR = 0.43, 95% CI [0.28-0.66]) exacerbations compared to the historical control group, but similar risks compared with the contemporaneous control group. The COPD pathway patients experienced fewer episodes of exacerbations compared with the historical control group (mean difference = -0.30, 95% CI [-0.40, -0.20]) and the contemporaneous control group (mean difference = -0.12, 95% CI [-0.20, -0.03]). Average annual healthcare costs in Canadian dollars were marginally higher among patients in the COPD clinical pathway (mean = $10 549, standard deviation [SD] =$18 149) than those in the contemporaneous control group ($8841, SD = $17 120), but comparable to the historical control group ($10 677, SD = $21 201). The COPD pathway provides better outcomes at about the same costs when compared to the historical controls, but only slightly better outcomes and at a marginally higher cost when compared to the contemporaneous controls.

Health Care Utilization and Costs in Lung Cancer Screening Participants-A Propensity-Matched Economic Analysis.

Introduction: Lung cancer screening (LCS) for high-risk populations has been firmly established to reduce lung cancer mortality, but concerns exist regarding unintended downstream costs. Methods: Mean health care utilization and costs were compared in the Alberta Lung Cancer Screening Study in a cohort undergoing LCS versus a propensity-matched control group who did not. Results: A cohort of 651 LCS participants was matched to 336 unscreened controls. Over the study period (mean 3.6 y), a modest increase in the number of claims (22.4 versus 21.9 per person-year [PY]; Δ 0.50 [95% confidence interval: 0.15-0.86], p = 0.006) and outpatient visits (4.01 versus 3.50 per PY; Δ 0.51 [0.37-0.65], p <0.0001), but not in inpatient admissions, was noted in the screened cohort. Claims payments, inpatient costs, and cancer care costs were similar in the screening arm versus the unscreened. Outpatient encounter costs per participant were higher in the screened group ($2662.18 versus $2040.67 per PY; Δ -$621.51 [-1118.05 to -124.97], p = 0.014). Removing the additional computed tomography screening examinations rendered differences not significant. Mean total costs were not significantly different at $6461.10 per PY in the screening group and $6125.31 in the unscreened group (Δ -$335.79 [-2009.65 to 1338.07], p = 0.69). Conclusions: Modest increases in outpatient costs are noted in individuals undergoing LCS, in part attributable to the screening examinations, without differences in overall health care costs. Health care costs and utilization seem otherwise similar in individuals participating in LCS and those who do not.

Impacts of Chronic Obstructive Pulmonary Disease Care Pathway on Healthcare Utilization and Costs: A Matched Multiple Control Cohort Study in Saskatchewan, Canada.

OBJECTIVES: This study aimed to evaluate the real-world impacts of a chronic obstructive pulmonary disease (COPD) care pathway program on healthcare utilization and costs in Saskatchewan, Canada. METHODS: A difference-in-differences evaluation of a real-life deployment of a COPD care pathway, using patient-level administrative health data in Saskatchewan, was conducted. The intervention group (n = 759) included adults (35+ years) with spirometry-confirmed COPD diagnosis recruited into the care pathway program in Regina between April 1, 2018 and March 31, 2019. The 2 control groups comprised adults (35+ years) with COPD who lived in Saskatoon during the same period (n = 759) or Regina between April 1, 2015 and March 31, 2016 (n = 759) who did not participate in the care pathway. RESULTS: Compared with the individuals in the Saskatoon control groups, individuals in the COPD care pathway group had shorter inpatient hospital length of stay (average treatment effect on the treated [ATT] -0.46, 95% CI -0.88 to -0.04) but a higher number of general practitioner visits (ATT 1.46, 95% CI 1.14 to 1.79) and specialist physician visits (ATT 0.84, 95% CI 0.61 to 1.07). Regarding healthcare costs, individuals in the care pathway group had higher COPD-related specialist visit costs (ATT $81.70, 95% CI $59.45 to $103.96) but lower COPD-related outpatient drug dispensation costs (ATT -$4.81, 95% CI -$9.34 to -$0.27). CONCLUSIONS: The care pathway reduced inpatient hospital length of stay, but increased general practitioner and specialist physician visits for COPD-related services within the first year of implementation.

Economic Evaluation of Telerobotic Ultrasound Technology to Remotely Provide Ultrasound Services in Rural and Remote Communities.

INTRODUCTION: Telerobotic ultrasound technology allows radiologists and sonographers to remotely provide ultrasound services in underserved areas. This study aimed to compare costs associated with using telerobotic ultrasound to provide ultrasound services in rural and remote communities to costs associated with alternate models. METHODS: A cost-minimization approach was used to compare four ultrasound service delivery models: telerobotic ultrasound (Model 1), telerobotic ultrasound and an itinerant sonographer (Model 2), itinerant sonographer without telerobotic ultrasound (Model 3), and travel to another community for all exams (Model 4). In Models 1-3, travel was assumed when exams could not be successfully performed telerobotically or by an itinerant sonographer. A publicly funded healthcare payer perspective was used for the reference case and a societal perspective was used for a secondary non-reference case. Costs were based on the literature and experience using telerobotic ultrasound in Saskatchewan, Canada. Costs were expressed in 2020 Canadian dollars. RESULTS: Average cost per ultrasound exam was $342, $323, $368, and $478 for Models 1, 2, 3, and 4, respectively, from a publicly funded healthcare payer perspective, and $461, $355, $447, and $849, respectively, from a societal perspective. In one-way sensitivity analyses, Model 2 was the lowest cost from a payer perspective for communities with population >2075 people, distance >350 km from the nearest ultrasound facility, or >47% of the population eligible for publicly funded medical transportation. CONCLUSION: Health systems may wish to consider solutions such as telerobotic ultrasound and itinerant sonographers to reduce healthcare costs and improve access to ultrasound in rural and remote communities.

Disease burden in individuals with symptomatic undiagnosed asthma or COPD.

BACKGROUND: The actual burden of COPD and asthma may be much higher than appreciated, since a large proportion of individuals are not diagnosed. Our study objective was to compare health care utilization, burden of symptoms and quality of life in subjects with self-reported respiratory symptoms who were subsequently found to have undiagnosed airflow obstruction compared to those having no airflow obstruction. METHODS: This cross-sectional case-finding study used data from the Undiagnosed COPD and Asthma Population (UCAP) study. Adult subjects with respiratory symptoms who had no history of diagnosed lung disease were recruited in a two-step case-finding process using random digit-dialling of land lines and cell phones located within a 90-min radius of 16 Canadian study sites. Participants were assessed for COPD, asthma or no airflow obstruction using pre- and post-bronchodilator spirometry based on American Thoracic Society diagnostic criteria. RESULTS: 1660 participants were recruited, of these 1615 had adequate spirometry and 331 (20.5%) subjects met spirometry criteria for undiagnosed asthma or COPD. Subjects with undiagnosed asthma or COPD had increased respiratory symptoms as assessed by the COPD Assessment Test (CAT), and higher St. George's Respiratory Questionnaire (SGRQ) scores indicating worse health-related quality of life, compared to subjects with no airflow obstruction. No between-group differences were found in health care utilization or work or school absenteeism. CONCLUSION: Undiagnosed asthma and COPD are common in Canadian adults experiencing breathing problems and are associated with a greater burden of symptoms and poorer health-related quality of life. These results suggest that patients may benefit from early identification and treatment of undiagnosed asthma and COPD.

Economic Burden of Chronic Obstructive Pulmonary Disease and Lung Cancer Between 2000 and 2015 in Saskatchewan: Study Protocol.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) and lung cancer are both detrimental diseases that present great burdens on society. Years of life lost (YLL), premature years of life lost (PYLL), working years lost (WYL), and productivity loss are all effective measures in identifying economic burden of disease. OBJECTIVE: We propose a population-based study to analyze comprehensive provincial cohorts of Saskatchewan residents with COPD, lung cancer, and combined COPD and lung cancer in order to identify the burden these diseases present. METHODS: Saskatchewan residents over the age of 35 years who had COPD, lung cancer, or both, between January 1, 2000, and December 31, 2015, will be identified and used in this study. Data for analysis including age, gender, and date of death, alongside Statistics Canada income estimates, will be used to estimate productivity loss and WYL. Statistics Canada life tables will be used to calculate YLL and PYLL by subtracting the patients' ages at death by their life expectancies, adjusted using sex and age at death. We will link the Saskatchewan cancer registry with Saskatchewan health administrative databases to create three cohorts: (1) COPD; (2) lung cancer; and (3) COPD and lung cancer. Individuals with lung cancer will be identified using ICDO-T (International Classification of Diseases for Oncology-Topography) codes, and those with COPD will be defined and identified as individuals who had at least 1 visit to a physician with a diagnosis of COPD or 1 hospital separation with a diagnosis of COPD. Those without a valid health care coverage for a consecutive 12 months prior to the first diagnostic code will be excluded from the study. Those with a combined diagnosis of COPD and lung cancer will be identified as individuals who were diagnosed with COPD in the 12 months following their lung cancer diagnosis or anytime preceding their lung cancer diagnosis. RESULTS: As of April 2021, we have had access to all relevant data for this study, have received funding (January 2020), and have begun the preliminary analysis of our data set. CONCLUSIONS: It is well documented that COPD and lung cancer are both destructive diseases in terms of YLL, PYLL, WYL, and productivity loss; however, no studies have been conducted to analyze a cohort with combined COPD and lung cancer. Understanding the economic burden associated with each of our 3 cohorts is necessary in understanding and thus reducing the societal impact of COPD and lung cancer. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/31350.

Rural vs urban inequalities in stage at diagnosis for lung cancer.

OBJECTIVES: Early diagnosis of lung cancer increases the chance of survival. The aim of this study was to measure the relationship between geographic residence in Saskatchewan and stage of lung cancer at the time of diagnosis. MATERIALS AND METHODS: Retrospective cohort analysis of 2,972 patients with a primary diagnosis of either non-small cell cancer (NSCLC) or small cell lung cancer (SCLC) between 2007 and 2012 was performed. Incidence proportion of early and advanced stage cancer, and relative risk of being diagnosed with advanced-stage lung cancer relative to early-stage was calculated. RESULTS: Compared to urban Saskatchewan, rural Saskatchewan lung cancer patients had a higher relative risk of advanced stage NSCLC (relative risk [RR] = 1.11, 95% confidence interval [CI]: 1.01-1.22). Rural Saskatchewan was further subdivided into north and south. The relative risk of advanced stage NSCLC in rural north Saskatchewan compared to urban Saskatchewan was even greater (RR = 1.17, 95% CI: 1.03-1.31). Although not statistically significant, there was a trend for a higher incidence of advanced stage SCLC in rural and rural north vs urban Saskatchewan (RR = 1.16, 95% CI: 0.95-1.43 and RR = 1.22; 95% CI: 0.94-1.58, respectively). There was a higher incidence proportion of advanced stage NSCLC in rural areas relative to urban (31.6-34.4 vs 29.5 per 10,000 people). CONCLUSION: Patients living in rural Saskatchewan have higher incidence proportion of and were more likely to present with advanced stage NSCLC in comparison to urban Saskatchewan patients at time of diagnosis. This inequality was even greater in rural north Saskatchewan.

Development and Cost Analysis of a Lung Nodule Management Strategy Combining Artificial Intelligence and Lung-RADS for Baseline Lung Cancer Screening.

OBJECTIVES: To develop a lung nodule management strategy combining the Lung CT Screening Reporting and Data System (Lung-RADS) with an artificial intelligence (AI) malignancy risk score and determine its impact on follow-up investigations and associated costs in a baseline lung cancer screening population. MATERIALS AND METHODS: Secondary analysis was undertaken of a data set consisting of AI malignancy risk scores and Lung-RADS classifications from six radiologists for 192 baseline low-dose CT studies. Low-dose CT studies were weighted to model a representative cohort of 3,197 baseline screening patients. An AI risk score threshold was defined to match average sensitivity of six radiologists applying Lung-RADS. Cases initially Lung-RADS category 1 or 2 with a high AI risk score were upgraded to category 3, and cases initially category 3 or higher with a low AI risk score were downgraded to category 2. Follow-up investigations resulting from Lung-RADS and the AI-informed management strategy were determined. Investigation costs were based on the 2019 US Medicare Physician Fee Schedule. RESULTS: The AI-informed management strategy achieved sensitivity and specificity of 91% and 96%, respectively. Average sensitivity and specificity of six radiologists using Lung-RADS only was 91% and 66%, respectively. Using the AI-informed management strategy, 41 (0.2%) category 1 or 2 classifications were upgraded to category 3, and 5,750 (30%) category 3 or higher classifications were downgraded to category 2. Minimum net cost savings using the AI-informed management strategy was estimated to be $72 per patient screened. CONCLUSION: Using an AI risk score combined with Lung-RADS at baseline lung cancer screening may result in fewer follow-up investigations and substantial cost savings.

Economic analysis of new workplace technology including productivity and injury: The case of needle-less injection in swine.

Increasing intensification in swine production has led to new and specialized technologies, but the occupational health and safety impacts are rarely quantified in the business plans for adoption. Needle-less injection has potential to increase productivity and eliminate needle stick injury in workers, but it is not clear whether these benefits offset high capital investment and potential increases in musculoskeletal loads. This economic evaluation employed probabilistic scenario analysis using injury, cost, and production data gathered from interviews with swine producers in Manitoba and Saskatchewan. After adoption of needle-less injection, rates of needle-stick injury went down with no measureable effect on upper limb musculoskeletal disorders, resulting in lower health and safety costs for needle-less injectors. Needle-less injection duration was 40% faster once workers acclimatized, but large start-up costs mean economic benefits are realized only after the first year. The incremental benefit cost ratio promoted adoption of needle-less injectors over conventional needles for the base case of a 1200 sow barn; the conventional method is beneficial for barns with 600 sows or less. Findings indicate that well-designed technologies have the potential to achieve the dual ergonomics goals of enhancing human wellbeing and system performance. We anticipate that the economic and decision models developed in this study can be applied to other new technologies in agriculture and animal production.

A Randomized Controlled Trial of an Alternative Care Provider Clinic for Severe Sleep-disordered Breathing.

Rationale: Lack of timely access to diagnosis and treatment of sleep-disordered breathing (SDB) has sparked interest in using nonphysician providers. Previous studies of these alternative care providers (ACPs) excluded patients with more complicated forms of SDB and did not directly explore the impacts of a model incorporating ACPs on healthcare system performance, such as wait times.Objectives: To evaluate the use of ACPs in the management of patients with severe SDB from a clinical and system perspective.Methods: In this noninferiority study, patients with severe SDB (N = 156) were enrolled from October 2014 to July 2016 and randomized to either sleep physician management or management by ACP with same-day sleep physician review. Severe SDB was defined as one of 1) respiratory event index greater than 30/h, 2) mean nocturnal oxygen saturation less than 85%, and 3) arterial carbon dioxide greater than 45 mm Hg with respiratory event index greater than 15/h. The primary outcome was nightly positive airway pressure adherence at 3 months, using a noninferiority margin of 1 hour. Secondary outcomes included sleepiness, quality of life, patient satisfaction, wait times for diagnosis and treatment initiation, and demand for further testing and clinical assessment. Outcomes were evaluated using modified intention-to-treat and per-protocol analyses.Results: Care delivery using ACPs was indeterminate compared with sleep physician care with respect to treatment adherence, because the 95% confidence interval included the noninferiority margin of 1 hour (mean difference, -0.5 [-1.49 to 0.49] h). Patients in the ACP arm reported greater improvements in sleepiness and quality of life; wait times were shorter for initial assessment (28%) and treatment initiation (18%). There was no difference in demand for sleep testing or clinical follow-up. Per-protocol analysis revealed similar results.Conclusions: Management of severe SDB using ACPs was indeterminate compared with sleep physician care. The small decrease in adherence in the ACP arm was balanced by benefits in patient-reported outcomes and reduction in wait times. In systems with unacceptably long wait times for SDB diagnosis and treatment, a small decrease in treatment adherence, as was observed in this study, may be an acceptable trade-off to improve access to care for patients with severe SDB.Clinical trial registered with www.clinicaltrials.gov (NCT02191085).

Cost-effectiveness of intrapleural use of tissue plasminogen activator and DNase in pleural infection: evidence from the MIST2 randomised controlled trial.

The MIST2 (Second Multicentre Intrapleural Sepsis Trial) trial showed that combined intrapleural use of tissue plasminogen activator (t-PA) and recombinant human DNase was effective when compared with single agents or placebo. However, the treatment costs are significant and overall cost-effectiveness of combined therapy remains unclear.An economic evaluation of the MIST2 trial was performed to assess the cost-effectiveness of combined therapy. Costs included were those related to study medications, initial hospital stay and subsequent hospitalisations. Outcomes were measured in terms of life-years gained. All costs were reported in euro and in 2016 prices.Mean annual costs were lowest in the t-PA-DNase group (EUR 10 605 for t-PA, EUR 17 856 for DNase, EUR 13 483 for placebo and EUR 7248 for t-PA-DNase; p=0.209). Mean 1-year life expectancy was 0.988 for t-PA, 0.923 for DNase, and 0.969 for both placebo and t-PA-DNase (p=0.296). Both DNase and placebo were less effective, in terms of life-years gained, and more costly than t-PA. When placebo was compared with t-PA-DNase, the incremental cost per life-year gained of placebo was EUR 1.6 billion, with a probability of 0.85 of t-PA-DNase being cost-effective.This study demonstrates that combined t-PA-DNase is likely to be highly cost-effective. In light of this evidence, a definitive trial designed to facilitate a thorough economic evaluation is warranted to provide further evidence on the cost-effectiveness of this promising combined intervention.

Evaluating quality of life and cost implications of prophylactic radiotherapy in mesothelioma: Health economic analysis of the SMART trial.

BACKGROUND: The SMART trial is a UK-based, multicentre RCT comparing prophylactic radiotherapy and symptom-based (deferred) radiotherapy in 203 patients with Malignant Pleural Mesothelioma who had undergone large bore pleural interventions. Using costs and quality of life data collected alongside the clinical trial, we will estimate the cost-effectiveness of prophylactic radiotherapy compared to deferred radiotherapy over a 1-year period. METHODS: Healthcare utilization and costs were captured during the trial. Utility weights produced by the EQ-5D questionnaire were used to determine quality-adjusted life-years (QALY) gained. The incremental cost-effectiveness ratio was calculated over the one-year trial period. RESULTS: Costs were similar in the immediate and deferred radiotherapy groups: £5480.40 (SD = £7040; n = 102) and £5461.40 (SD = £7770; n = 101) respectively. There was also no difference in QALY: 0.498 (95% CI: [0.45, 0.547]) in the prophylactic radiotherapy group versus 0.525 (95% CI: [0.471, 0.580]) in the deferred group. At a willingness to pay threshold of £30,000/QALY there was only a 24% chance that prophylactic radiotherapy was cost-effective compared to deferred radiotherapy. CONCLUSIONS: There was no significant effect of prophylactic radiotherapy on quality of life in the intervention group, nor was there any discernable decrease in healthcare costs. There is little evidence to suggest that prophylactic radiotherapy is a cost-effective intervention in this population. TRIAL REGISTRATION: ISRCTN72767336 with ISRCTN.

Evaluating Swine Injection Technologies as a Workplace Musculoskeletal Injury Intervention: A Study Protocol.

Intensification of modern swine production has led to many new technologies, including needleless injectors. Although needleless injectors may increase productivity (by reducing injection time) and reduce needlestick injuries, the effect on risk for musculoskeletal disorders is not clear. This project will compare conventional needles with needleless injectors in terms of cost, productivity, injury rates, biomechanical exposures, and worker preference. Muscle activity (EMG) and hand/wrist posture will be measured on swine workers performing injection tasks with both injection methods. Video recordings during the exposure assessments will compare the duration and productivity for each injection method using time-and-motion methods. Injury claim data from up to 60 pig barns will be analyzed for needlestick and musculoskeletal injuries before/after needleless injector adoption. Workers and managers will be asked about what they like and dislike about each method and what helps and hinders successful implementation. The information above will be input into a cost-benefit model to determine the incremental effects of needleless injectors in terms of occupational health, worker preference, and the financial "bottom line" of the farm. Findings will be relevant to the swine industry and are intended to be transferable to other new technologies in animal production.

Investigating Cost Implications of Incorporating Level III At-Home Testing into a Polysomnography Based Sleep Medicine Program Using Administrative Data.

OBJECTIVE: Obstructive sleep apnea is a common problem, requiring expensive in-lab polysomnography for proper diagnosis. Home monitoring can provide an alternative to in-lab testing for a subset of OSA patients. The objective of this project was to investigate the effect of incorporating home testing into an OSA program at a large, tertiary sleep disorders centre. METHODS: The Sleep Disorders Centre in Saskatoon, Canada, has been incorporating at-home testing into their diagnostic pathways since 2006. Administrative data from 2007 to 2013 were extracted (10030 patients) and the flow of patients through the program was followed from diagnosis to treatment. Costs were estimated using 2014 pricing and were stratified by disease attributes and sensitivity analysis was applied. RESULTS: The overall costs per patient were $627.40, with $419.20 for at-home testing and $746.20 for in-lab testing. The cost of home management would rise to $515 if all negative tests were required to be confirmed by an in-lab PSG. DISCUSSION: Our review suggests that at-home testing can be cost-effective alternative to in-lab testing when applied to the correct population, specifically, those with a high pretest probability of obstructive sleep apnea and an absence of significant comorbidities.

Evaluation of an alternative care provider clinic for severe sleep-disordered breathing: a study protocol for a randomised controlled trial.

INTRODUCTION: Despite the high prevalence of sleep-disordered breathing (SDB) and the significant health consequences associated with untreated disease, access to diagnosis and treatment remains a challenge. Even patients with severe SDB (severe obstructive sleep apnoea or hypoventilation), who are at particularly high risk of adverse health effects, are subject to long delays. Previous research has demonstrated that, within a sleep clinic, management by alternative care providers (ACPs) is effective for patients with milder forms of SDB. The purpose of this study is to compare an ACP-led clinic (ACP Clinic) for patients with severe SDB to physician-led care, from the perspective of clinical outcomes, health system efficiency and cost. METHODS AND ANALYSIS: The study is a randomised, controlled, non-inferiority study in which patients who are referred with severe SDB are randomised to management by a sleep physician or by an ACP. ACPs will be supervised by sleep physicians for safety. The primary outcome is positive airway pressure (PAP) adherence after 3 months of therapy. Secondary outcomes include: long-term PAP adherence; clinical response to therapy; health-related quality of life; patient satisfaction; healthcare usage; wait times from referral to treatment initiation and cost-effectiveness. The economic analysis will be performed using the perspective of a publicly funded healthcare system. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Conjoint Health Research Ethics Board (ID: REB13-1280) at the University of Calgary. Results from this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02191085; Pre-results.

Cost-effectiveness of indwelling pleural catheter compared with talc in malignant pleural effusion.

BACKGROUND AND OBJECTIVE: Malignant pleural effusion is associated with morbidity and mortality. A randomized controlled trial previously compared clinical outcomes and resource use with indwelling pleural catheter (IPC) and talc pleurodesis in this population. Using unpublished quality of life data, we estimate the cost-effectiveness of IPC compared with talc pleurodesis. METHODS: Healthcare utilization and costs were captured during the trial. Utility weights produced by the EuroQol Group five-dimensional three-level questionnaire and survival were used to determine quality-adjusted life-years (QALYs) gained. The incremental cost-effectiveness ratio (ICER) was calculated over the 1-year trial period. Sensitivity analysis used patient survival data and modelled additional nursing time required per week for catheter drainage. RESULTS: Utility scores, cost and QALYs gained did not differ significantly between groups. The ICER for IPC compared with talc was favorable at $US10 870 per QALY gained. IPC was less costly with a probability exceeding 95% of being cost-effective when survival was <14 weeks, and was more costly when 2-h nursing time per week was assumed for catheter drainage. CONCLUSION: IPC is cost-effective when compared with talc, although substantial uncertainty exists around this estimate. IPC appears most cost-effective in patients with limited survival. If significant nursing time is required for catheter drainage, IPC becomes less likely to be cost-effective. Either therapy may be considered as a first-line option in treating malignant pleural effusion in patients without history of prior pleurodesis, with consideration for patient survival, support and preferences.

Walking away from back pain: one step at a time - a community-based randomised controlled trial.

BACKGROUND: Low back pain is highly prevalent and a significant public health burden in Western society. Feasibility studies suggest personalised pedometer-driven walking is an acceptable and effective motivating tool in the management of chronic low back pain (CLBP ≥ 12 weeks). The proposed study will investigate pedometer-driven walking as a low cost, easily accessible, and sustainable means of physical activity to improve disability and clinical outcomes for people with CLBP in Saskatchewan, Canada. METHODS/DESIGN: A fully-powered single-blinded randomised controlled trial will compare back care advice and education with back care advice and education followed by a 12-week pedometer-driven walking programme in adults with CLBP. Adults with self-reported CLBP will be recruited from the community and screened for elibility. Two-hundred participants will be randomly allocated to one of two intervention groups. All participants will receive a single back care advice and education session with a physiotherapist. Participants in the walking group will also receive a physiotherapist-facilitated pedometer based walking programme. The physiotherapist will facilitate the participant to monitor and progress the walking programme, by phone, on a weekly basis over 10 weeks following two face-to-face sessions. Outcome measures of self-reported disability, physical activity, participants' low back pain beliefs/perceptions, quality of life and direct/indirect cost estimates will be gathered at baseline, three months, six months, and 12 months by a different physiotherapist blinded to group allocation. Following intervention, focus groups will be used to explore participants' thoughts and experiences of pedometer-driven walking as a management tool for CLBP. DISCUSSION: This paper describes the design of a community-based RCT to determine the effectiveness of a pedometer-driven walking programme in the management of CLBP. TRIAL REGISTRATION: United States National Institutes of Health Clinical Trails registry (http://ClinicalTrials.gov/) No. NCT02284958 . Registered on 27(th) October 2014).

Comparing cost of indwelling pleural catheter vs talc pleurodesis for malignant pleural effusion.

BACKGROUND: Malignant pleural effusion is associated with short life expectancy and significant morbidity. A randomized controlled trial comparing indwelling pleural catheters (IPCs) with talc pleurodesis found that IPCs reduced in-hospital time and the need for additional procedures but were associated with excess adverse events. METHODS: Using data from the clinical trial, we compared costs associated with use of IPCs and with talc pleurodesis. Resource use and adverse events were captured through case report forms over the 1-year trial follow-up. Costs for outpatient and inpatient visits, diagnostic imaging, nursing, and doctor time were obtained from the UK National Health Service reference costs and University of Kent's Unit Costs of Health and Social Care 2011 and inflated to 2013 using the UK Consumer Price Index. Procedure supply costs were obtained from the manufacturer. Difference in mean costs was compared using nonparametric bootstrapping. All costs were converted to US dollars using the Organisation for Economic Co-operation and Development Purchasing Power Parity Index. RESULTS: Overall mean cost (SD) for managing patients with IPCs and talc pleurodesis was $4,993 ($5,529) and $4,581 ($4,359), respectively. The incremental mean cost difference was $401, with 95% CI of -$1,387 to $2,261. The mean cost related to ongoing drainage in the IPC group was $1,011 ($732) vs $57 ($213) in the talc pleurodesis group (P = .001). This included the cost of drainage bottles, dressing changes in the first month, and catheter removal. There was no significant difference in cost of the initial intervention or adverse events between the groups. For patients with survival < 14 weeks, IPC is significantly less costly than talc pleurodesis, with mean cost difference of -$1,719 (95% CI, -$3,376 to -$85). CONCLUSIONS: There is no significant difference in the mean cost of managing patients with IPCs compared with talc pleurodesis. For patients with limited survival, IPC appears less costly. TRIAL REGISTRY: isrctn.org; No.: ISRCTN87514420; URL: www.isrctn.org.