A systematic review of the accessibility, acceptability, safety, efficiency, clinical effectiveness, and cost-effectiveness of private cataract and orthopedic surgery clinics.

OBJECTIVES: Many publicly funded health systems use a mix of privately and publicly operated providers of care to deliver elective surgical services. The aim of this systematic review was to assess the role of privately operated but publicly funded provision of surgical services for adult patients who had cataract or orthopedic surgery within publicly funded health systems in high-income countries. METHODS: Electronic databases (Ovid MEDLINE, OVID Embase, and EBSCO EconLit) were searched on 26 March 2021, and gray literature sources were searched on 6 April 2021. Two reviewers independently applied inclusion and exclusion criteria to identify studies, and extracted data. The outcomes evaluated include accessibility, acceptability, safety, clinical effectiveness, efficiency, and cost/cost-effectiveness. RESULTS: Twenty-nine primary studies met the inclusion criteria and were synthesized narratively. We found mixed results across each of our reported outcomes. Wait times were shorter for patients treated in private facilities. There was evidence that some private facilities cherry-pick or cream-skim by selecting less complex patients, which increases the postoperative length of stay and costs for public facilities, restricts access to private facilities for certain groups of patients, and increases inequality within the health system. Seven studies found improved safety outcomes in private facilities, noting that private patients had a lower preoperative risk of complications. Only two studies reported cost and cost-effectiveness outcomes. One costing study concluded that private facilities' costs were lower than those of public facilities, and a cost-utility study showed that private contracting to reduce public waiting times for joint replacement was cost-effective. CONCLUSIONS: Limited evidence exists that private-sector contracts address existing healthcare delivery problems. Value for money also remains to be evaluated properly.

Cost Analysis of a Transition Care Bundle Compared with Usual Care for COPD Patients Being Discharged from Hospital: Evaluation of a Randomized Controlled Trial.

BACKGROUND: Appropriate management of chronic obstructive pulmonary disease (COPD) patients following acute exacerbations can reduce the risk of future exacerbations, improve health status, and lower care costs. While a transition care bundle (TCB) was associated with lower readmissions to hospitals than usual care (UC), it remains unclear whether the TCB was associated with cost savings. OBJECTIVE: The aim of this study was to evaluate how this TCB was associated with future Emergency Department (ED)/outpatient visits, hospital readmissions, and costs in Alberta, Canada. METHODS: Patients who were aged 35 years or older, who were admitted to hospital for a COPD exacerbation, and had not been treated with a care bundle received either TCB or UC. Those who received the TCB were then randomized to either TCB alone or TCB enhanced with a care coordinator. Data collected were ED/outpatient visits, hospital admissions and associated resources used for index admissions, and 7-, 30- and 90-day post-index discharge. A decision model with a 90-day time horizon was developed to estimate the cost. A generalized linear regression was conducted to adjust for imbalance in patient characteristics and comorbidities, and a sensitivity analysis was conducted on the proportion of patients' combined ED/outpatient visits and inpatient admissions as well as the use of a care coordinator. RESULTS: Differences in length of stay (LOS) and costs between groups were statistically significant, although with some exceptions. Inpatient LOS and costs were 7.1 days (95% confidence interval [CI] 6.9-7.3) and Canadian dollars (CAN$) 13,131 (95% CI CAN$12,969-CAN$13,294) in UC, 6.1 days (95% CI 5.8-6.5) and CAN$7634 (95% CI CAN$7546-CAN$7722) in TCB with a coordinator, and 5.9 days (95% CI 5.6-6.2) and CAN$8080 (95% CI CAN$7975-CAN$8184) in TCB without a coordinator. Decision modelling indicated TCB was less costly than UC, with a mean (standard deviation [SD]) of CAN$10,172 (40) versus CAN$15,588 (85), and TCB with a coordinator was slightly less costly than without a coordinator (CAN$10,109 [49] versus CAN$10,244 [57]). CONCLUSION: This study suggests that the use of the TCB, with or without a care coordinator, appears to be an economically attractive intervention compared with UC.

The Costs of Industry-Sponsored Drug Trials in Canada.

OBJECTIVE: The objective of this study was to estimate the provincial and nationwide costs of industry-sponsored drug clinical trials (CTs) in Canada. METHODS: We used the Aggregate Analysis of ClinicalTrials.gov (AACT) database, and included all industry-sponsored drug CTs that were conducted in Canada and completed in 2016. We estimated the costs of the study drugs using the market price. Estimates of the costs of management and patient services were based on industry contracts. RESULTS: The sample included 394 CTs that were conducted in 2039 facilities in Canada and provided services for 20,126 Canadian enrollees. Two-thirds of the CTs (277 of 394) were in the non-cancer category. On average, the drug costs per patient were 89,680 Canadian dollars ($Can) during the lifespan of the CTs, and were higher in cancer CTs than in non-cancer CTs ($Can216,876 vs. $Can65,274). The total costs of industry-sponsored drug CTs completed in 2016 was $Can2093.7 million. Drug costs accounted for the majority of this total ($Can1804.9 million). Ontario ($Can781.2 million) and Quebec ($Can757.5 million) had the highest costs. CONCLUSION: The costs of industry-sponsored drug CTs completed in 2016 when measured in terms of market prices in Canada were valued at $Can2.1 billion.

Temporal Trends Of Pharmacologic Therapies For Patients With Chronic Obstructive Pulmonary Disease In Alberta, Canada.

Objectives: To describe the trends in pharmacologic treatment for patients newly diagnosed with chronic obstructive pulmonary disease (COPD) in Alberta, Canada. Methods: We linked Alberta health databases to identify patients aged ≥35 years with incident COPD between April 2010 and March 2017. Incident cases were defined as those who did not have a hospitalization or outpatient visit with COPD in the previous 2 years. Patients were categorized into two groups: 1) incident cases at a hospital and 2) incident cases at an outpatient clinic, and both were followed until death or being censored by 31 March 2018. Utilization of COPD medication for 30 days following incident event and adherence in maintenance therapy over time were reported. Results: The study included 33,169 patients with incident COPD (hospital: 9,089; outpatient: 24,080). In 18,666 (56.3%) patients starting medication within 30 days of the incident event (2010: 52.7%; 2016: 56.6%; p=0.002), SABA (60.5%) and LABA/ICS (41.6%) were most commonly used. ICS (without LABA) was used in 14.2% and was used as monotherapy in 4.5% of patients. The proportion of patients who initiated any ICS was similar (hospital: 56.7%; outpatient: 55.7%; p=0.194) and decreased in both settings over time (p<0.001). Drug adherence during the first year after the incident event was 54.3%, higher among hospital patients (66.5% vs 48.9%; p<0.001), and improved over time (2010: 53.4%; 2016: 57.4%; p<0.001). Conclusion: The initiation of and adherence to pharmacologic therapy for patients with COPD is low but improves over time. While SABA and LABA/ICS are most commonly used, ICS utilization decreases over time.

Publicly funded clinical research in Canada.

Clinical research is funded by industry, governments, charities, and hospitals. It is important to know the economic commitment of the various funding bodies, but until now there has been no national source available which provides these data. We surveyed the major funders to provide such a measure. There is evidence that government and charity funding of medical research is a trigger for private sector research investment; therefore, tracking all sources of funding for clinical research will provide policy-makers with an overall picture of health research funding. These data support policy decision-making related to clinical research in Canada.

The Costs of Industry-Sponsored Medical Device Clinical Trials in Alberta.

OBJECTIVE: Our objective was to describe the costs of industry-sponsored clinical trials for medical devices in Northern Alberta, Canada. METHODS: We used centralized data to identify all industry-sponsored medical device clinical trials initiated in Northern Alberta from 2012 to 2016. For each arm of each trial, we calculated the price of devices provided by the sponsor and the cost of clinical and administrative services that were incurred to clinically operationalize the treatment. RESULTS: Our sample consisted of 18 device trials initiated between January 2012 and January 2016. The overall cost (Canadian dollars [$Can], year 2018 values) per enrolee was $Can18,243 for the experimental arm and $Can13,827 for the control arm. Devices were the highest cost component, at $Can13,446 per enrollee in the experimental arm. Clinical costs in the control arms were higher on average ($Can7202 vs. 2504) than those in the experimental arms. CONCLUSION: Data from industry-sponsored clinical trials can provide important information on the full costs of device-related interventions. As device costs rise, and as policy makers require more evidence on device-related treatments, the cost of medical device-driven interventions should be documented along with their effectiveness.

The Economic Contribution of Industry-Sponsored Pharmaceutical Clinical Trials.

PURPOSE: In pharmaceutical clinical trials, industrial sponsors pay for study drugs and related healthcare services. We conducted a study to determine industry's economic contribution of these trials to the Alberta healthcare system.  Methods: We used data from two trial centers for cancer and non-cancer trials at the University of Alberta. For each trial (cancer, non-cancer), we calculated the cost of drugs provided by the sponsors using the market price, the cost of clinical services, and the cost of administrative services that they paid. We extrapolated these results to all trials in Alberta based on information obtained from the registration website ClinicalTrials.gov.  Results: Our sample consisted of 40 non-cancer and 39 cancer drug trials which were initiated in 2012. The monetary value of the industry sponsors' contribution was $799,055 per non-cancer and $630,243 per cancer drug trial. Drugs (in-trial and post-trial) accounted for 84% of the total contribution of the non-cancer drug trials whereas it represented 93% of all trial-related contributions in the cancer category. The total province-wide contribution of industry-sponsored drug trials which were initiated in 2012 was estimated to be $101 million, including open-label drugs in the non-cancer category.  Conclusions: Industry-sponsored pharmaceutical trials represent a major economic contributor to clinical research within the province.

Benefit of adjunct universal rectal screening for Chlamydia genital infections in women attending Canadian sexually transmitted infection clinics.

Adding universal rectal screening to urogenital screening should positively impact rectal Chlamydia trachomatis (CT) incidence in affected populations. A dynamic Markov model was used to evaluate costs and outcomes of three rectal CT screening strategies among women attending sexually transmitted infection clinics in Alberta, Canada: universal urogenital-only screening (UG-only), additional selected (exposure-based) rectal screening (UG+SR), and additional universal rectal screening (UG+UR). The model included two mutually exclusive health states: infected and susceptible. Additionally, the model included two rounds of transmission: male sex partners of women infected with rectal-only CT and female sex partners of those men. CT complications impacting patients' quality of life (QALY) were considered. Alberta and Canadian data were used to estimate model inputs. We used a health care perspective, a time period of 10 years, and a discount rate of 3% for analyses. Compared to UG-only screening, the incremental cost effectiveness ratios (ICERs) were CA$34,000 and CA$49,000 per QALY gained for UG+SR and UG+UR screening strategies, respectively. Compared to UG+SR, the ICER was CA$62,000 per QALY gained for the UG+UR strategy. Both adjunct selected and universal rectal screening strategies are cost effective compared to UG-only screening, and UG+UR screening is cost effective when compared to UG+SR screening.

Forecasting Pharmaceutical Prices for Economic Evaluations When There Is No Market: A Review.

BACKGROUND: Economic evaluation helps policy makers and healthcare payers make decisions on drug listing, coverage, and reimbursement. When economic evaluations are conducted before a product launch, the prices of the pharmaceuticals have to be forecast. OBJECTIVE: The aim of this study was to examine the methods of establishing proxy prices and their accuracies compared with actual market prices after the product launch. METHODS: We searched the literature for evaluations for drugs that were licensed in the US between 2010 and 2015. We reviewed the studies for the forecasting strategies used, and then estimated the difference between actual 2016 post-launch prices and what the proxy prices would be if the forecast was carried out in the US in 2016. RESULTS: We identified six such studies, with seven drugs. Four studies used substitute drugs as proxies for the study drug, and three used other methods. The range of the values of actual minus proxy price varied considerably, and no trend was observed. CONCLUSION: Forecasting drug prices is as precarious as forecasting in other areas of the economy. We urge caution in reviewing and accepting a cost-effectiveness ratio that is based on forecast prices.

MEDICAL DEVICE PRICES IN ECONOMIC EVALUATIONS.

OBJECTIVES: Economic evaluations, although not formally used in purchasing decisions for medical devices in Canada, are still being conducted and published. The aim of this study was to examine the way that prices have been included in Canadian economic evaluations of medical devices. METHODS: We conducted a review of the economic concepts and implications of methods used for economic evaluations of the eleven most implanted medical devices from the Canadian perspective. RESULTS: We found Canadian economic studies for five of the eleven medical devices and identified nineteen Canadian studies. Overall, the device costs were important components of total procedure cost, with an average ratio of 44.1 %. Observational estimates of the device costs were obtained from buyers or sellers in 13 of the 19 studies. Although most of the devices last more than 1 year, standard costing methods for capital equipment was never used. In addition, only eight studies included a sensitivity analysis for the device cost. None of the sensitivity analyses were based on actual price distributions. CONCLUSIONS: Economic evaluations are potentially important for policy making, but although they are being conducted, there is no standardized approach for incorporating medical device prices in economic analyses. Our review provides suggestions for improvements in how the prices are incorporated for economic evaluations of medical devices.

Epimorphin expression in a rat model of pulmonary hypoplasia associated with congenital diaphragmatic hernia.

PURPOSE: The pathogenesis of pulmonary hypoplasia associated with congenital diaphragmatic hernia (CDH) remains unclear. Interactions between the epithelium and surrounding mesenchyme play an important role in normal lung morphogenesis. Epimorphin, a stromal protein, plays a role in epithelial morphogenesis and lung branching, both of which are involved in pulmonary hypoplasia. In this study, we aimed to examine the relationship between epimorphin and pulmonary hypoplasia associated with CDH in an animal model. METHODS: Time-pregnant rats were exposed to nitrofen or vehicle on gestational day 9 (D9). Fetuses were harvested on D16 and D20, and were divided into control, hypoplastic lungs with CDH (CDH+), and hypoplastic lungs without CDH (CDH-). Both lungs of each fetus were removed and subjected to morphometric and molecular biologic analyses. Lung-to-body weight ratios were calculated. Pulmonary RNA was extracted, and relative mRNA level of epimorphin was determined by quantitative real-time PCR (qRT-PCR). Protein expression of epimorphin was investigated by Western blotting. RESULTS: In groups D16 and D20, lung-to-body weight ratios in subgroups CDH+ were significantly lower than those of controls and CDH-. The relative mRNA expression levels of epimorphin were significantly increased in both lungs in subgroup CDH+ compared with controls and CDH- on D16. Pulmonary epimorphin gene expression levels were significantly decreased in CDH+ group on D20 compared to controls. Western blotting confirmed the qRT-PCR results showing decreased pulmonary epimorphin protein expression in CDH+ hypoplastic lungs compared to controls on D20. CONCLUSION: Our study shows that there is an association between the epimorphin expression and pulmonary hypoplasia associated with CDH. Although the cause-effect relationship is far from being established, epimorphin-related mechanisms have a more critical role in early (D16) developmental stage.