Do Quality-Adjusted Life Years Discriminate Against the Elderly? An Empirical Analysis of Published Cost-Effectiveness Analyses.

OBJECTIVES: Critics of quality-adjusted life-years argue that it discriminates against older individuals. However, little empirical evidence has been produced to inform this debate. This study aimed to compare published cost-effectiveness analyses (CEAs) on patients aged ≥65 years and those aged <65 years. METHODS: We used the Tufts Cost-Effectiveness Analysis Registry to identify CEAs published in MEDLINE between 1976 and 2021. Eligible CEAs were categorized according to age (≥65 years vs <65 years). The distributions of incremental cost-effectiveness ratios (ICERs) were compared between the age groups. We used logistic regression to assess the association between age groups and the cost-effectiveness conclusion adjusted for confounding factors. We conducted sensitivity analyses to explore the impact of mixed age and age-unknown groups and all ICERs from the same CEAs. Subgroup analyses were also conducted. RESULTS: A total of 4445 CEAs categorized according to age <65 years (n = 3784) and age ≥65 years (n = 661) were included in the primary analysis. The distributions of ICERs and the likelihood of concluding that the intervention was cost-effective were similar between the 2 age groups. Adjusted odds ratios ranged from 1.132 (95% CI 0.930-1.377) to 1.248 (95% CI 0.970-1.606) (odds ratio >1 indicating that CEAs for age ≥65 years were more likely to conclude the intervention was cost-effective than those for age <65 years). Sensitivity and subgroup analyses found similar results. CONCLUSION: Our analysis found no systematic differences in published ICERs using quality-adjusted life-years between CEAs for individuals aged ≥65 years and those for individuals aged <65 years.

Assessment of a venous thromboembolism prophylaxis shared decision-making intervention (DASH-TOP) using the decisional conflict scale: a mixed-method study.

BACKGROUND: Venous thromboembolism (VTE) in pregnancy is a major cause of maternal morbidity and death. The use of low-molecular-weight heparin (LMWH), despite being the standard of care to prevent VTE, comes with some challenges. Shared decision-making (SDM) interventions are recommended to support patients and clinicians in making preference-sensitive decisions. The quality of the SDM process has been widely assessed with the decisional conflict scale (DCS). Our aim is to report participants' perspectives of each of the components of an SDM intervention (DASH-TOP) in relation to the different subscales of the DCS. METHODS: Design: A convergent, parallel, mixed-methods design. PARTICIPANTS: The sample consisted of 22 health care professionals, students of an Applied Clinical Research in Health Sciences (ICACS) master program. INTERVENTION: We randomly divided the participants in three groups: Group 1 received one component (evidence -based information), Group 2 received two components (first component and value elicitation exercises), and Group 3 received all three components (the first two and a decision analysis recommendation) of the SDM intervention. ANALYSIS: For the quantitative strand, we used a non-parametric test to analyze the differences in the DCS subscales between the three groups. For the qualitative strand, we conducted a content analysis using the decisional conflict domains to deductively categorize the responses. RESULTS: Groups that received more intervention components experienced less conflict and better decision-making quality, although the differences between groups were not statistically significant. The decision analysis recommendation improved the efficacy with the decision-making process, however there are some challenges when implementing it in clinical practice. The uncertainty subscale showed a high decisional conflict for all three groups; contributing factors included low certainty of the evidence-based information provided and a perceived small effect of the drug to reduce the risk of a VTE event. CONCLUSIONS: The DASH-TOP intervention reduced decisional conflict in the decision -making process, with decision analysis being the most effective component to improve the quality of the decision. There is a need for more implementation research to improve the delivery of SDM interventions in the clinical encounter.

Resource use and cost associated with computerized decision support system and usual care in managing patients with atrial fibrillation: analysis of IMPACT-AF randomized trial data.

BACKGROUND: IMPACT-AF is a prospective, randomized, cluster design trial comparing atrial fibrillation (AF) management with a computerized decision support system (CDS) to usual care (control) in the primary care setting of Nova Scotia, Canada. The objective of this analysis was to compare the resource use and costs between CDS and usual care groups. METHODS: Case costing data, 12-month self-administered questionnaires, and monthly diaries from IMPACT-AF were used in this analysis. Descriptive statistics were used to compare costs and resource use between groups. All costs are presented in 2021 Canadian dollars and cover the 12-month period of participation in the study. RESULTS: A total of 1,145 patients enrolled in the trial. Case costing data were available for 466 participants (41.1%), 12-month self-administered questionnaire data for 635 participants (56.0%) and monthly diary data for 223 participants (19.7%). Emergency department visits and hospitalizations comprised the most expensive component of AF care. Across all three datasets, there were no statistically significant differences in costs or resource use between CDS and usual care groups. CONCLUSIONS: Although there were no significant differences in resource use or costs among CDS and usual care groups in the IMPACT-AF trial, this study provides insight into the methodology and practical challenges of collecting economic data alongside a trial. REGISTRATION: Clinicaltrials.gov (registration number: NCT01927367, date of registration: 2013-08-20).

Decision Analysis in SHared decision making for Thromboprophylaxis during Pregnancy (DASH-TOP): a sequential explanatory mixed-methods pilot study.

OBJECTIVES: To gain insight into formal methods of integrating patient preferences and clinical evidence to inform treatment decisions, we explored patients' experience with a personalised decision analysis intervention, for prophylactic low-molecular-weight heparin (LMWH) in the antenatal period. DESIGN: Mixed-methods explanatory sequential pilot study. SETTING: Hospitals in Canada (n=1) and Spain (n=4 sites). Due to the COVID-19 pandemic, we conducted part of the study virtually. PARTICIPANTS: 15 individuals with a prior venous thromboembolism who were pregnant or planning pregnancy and had been referred for counselling regarding LMWH. INTERVENTION: A shared decision-making intervention that included three components: (1) direct choice exercise; (2) preference elicitation exercises and (3) personalised decision analysis. MAIN OUTCOME MEASURES: Participants completed a self-administered questionnaire to evaluate decision quality (decisional conflict, self-efficacy and satisfaction). Semistructured interviews were then conducted to explore their experience and perceptions of the decision-making process. RESULTS: Participants in the study appreciated the opportunity to use an evidence-based decision support tool that considered their personal values and preferences and reported feeling more prepared for their consultation. However, there were mixed reactions to the standard gamble and personalised treatment recommendation. Some participants could not understand how to complete the standard gamble exercises, and others highlighted the need for more informative ways of presenting results of the decision analysis. CONCLUSION: Our results highlight the challenges and opportunities for those who wish to incorporate decision analysis to support shared decision-making for clinical decisions.

Reverse Total Shoulder Arthroplasty Is the Most Cost-effective Treatment Strategy for Proximal Humerus Fractures in Older Adults: A Cost-utility Analysis.

BACKGROUND: Proximal humerus fractures are the second-most common fragility fracture in older adults. Although reverse total shoulder arthroplasty (RTSA) is a promising treatment strategy for proximal humerus fractures with favorable clinical and quality of life outcomes, it is associated with much higher, and possibly prohibitive, upfront costs relative to nonoperative treatment and other surgical alternatives. QUESTIONS/PURPOSES: (1) What is the cost-effectiveness of open reduction internal fixation (ORIF), hemiarthroplasty, and RTSA compared with the nonoperative treatment of complex proximal humerus fractures in adults older than 65 years from the perspective of a single-payer Canadian healthcare system? (2) Which factors, if any, affect the cost-effectiveness of ORIF, hemiarthroplasty, and RTSA compared with nonoperative treatment of proximal humerus fractures including quality of life outcomes, cost, and complication rates after each treatment? METHODS: This cost-utility analysis compared RTSA, hemiarthroplasty, and ORIF with the nonoperative management of complex proximal humerus fractures in adults older than 65 years over a lifetime time horizon from the perspective of a single-payer healthcare system. Short-term and intermediate-term complications in the 2-year postoperative period were modeled using a decision tree, with long-term outcomes estimated through a Markov model. The model was initiated with a cohort of 75-year-old patients who had a diagnosis of a comminuted (three- or four-part) proximal humerus fractures; 90% of the patients were women. The mean age and gender composition of the model's cohort was based on a systematic review conducted as part of this analysis. Patients were managed nonoperatively or surgically with either ORIF, hemiarthroplasty, or RTSA. The three initial surgical treatment options of ORIF, hemiarthroplasty, and RTSA resulted in uncomplicated healing or the development of a complication that would result in a subsequent surgical intervention. The model reflects the complications that result in repeat surgery and that are assumed to have the greatest impact on clinical outcomes and costs. Transition probabilities and health utilities were derived from published sources, with costs (2020 CAD) sourced from regional costing databases. The primary outcome was the incremental cost-utility ratio, which was calculated using expected quality-adjusted life years (QALYs) gained and costs. Sensitivity analyses were conducted to explore the impact of changing key model parameters. RESULTS: Based on both pairwise and sequential analysis, RTSA was found to be the most cost-effective strategy for managing complex proximal humerus fractures in adults older than 65 years. Compared with nonoperative management, the pairwise incremental cost-utility ratios of hemiarthroplasty and RTSA were CAD 25,759/QALY and CAD 7476/QALY, respectively. ORIF was dominated by nonoperative management, meaning that it was both more costly and less effective. Sequential analysis, wherein interventions are compared from least to most expensive in a pairwise manner, demonstrated ORIF to be dominated by hemiarthroplasty, and hemiarthroplasty to be extendedly dominated by RTSA. Further, at a willingness-to-pay threshold of CAD 50,000/QALY, RTSA had 66% probability of being the most cost-effective treatment option. The results were sensitive to changes in the parameters for the probability of revision RTSA after RTSA, the treatment cost of RTSA, and the health utilities associated with the well state for all treatment options except ORIF, although none of these changes were found to be clinically realistic based on the existing evidence. CONCLUSION: Based on this economic analysis, RTSA is the preferred treatment strategy for complex proximal humerus fractures in adults older than 65 years, despite high upfront costs. Based on the evidence to date, it is unlikely that the parameters this model was sensitive to would change to the degree necessary to alter the model's outcome. A major strength of this model is that it reflects the most recent randomized controlled trials evaluating the management of this condition. Therefore, clinicians should feel confident recommending RTSA for the management of proximal humerus fractures in adults older than 65 years, and they are encouraged to advocate for this intervention as being a cost-effective practice, especially in publicly funded healthcare systems wherein resource stewardship is a core principle. Future high-quality trials should continue to collect both clinical and quality of life outcomes using validated tools such as the EuroQOL-5D to reduce parameter uncertainty and support decision makers in understanding relevant interventions' value for money. LEVEL OF EVIDENCE: Level III, economic and decision analysis.

More work needed on decision analysis for shared decision-making: A scoping review.

OBJECTIVE: To explore and characterize published evidence on the ways decision analysis has been used to inform shared decision-making. STUDY DESIGN AND SETTING: For this scoping review, we searched five bibliographic databases (from inception until February 2021), reference lists of included studies, trial registries, a thesis database and websites of relevant interest groups. Studies were eligible if they evaluated the application of decision analysis in a shared decision-making encounter. Pairs of reviewers independently screened and selected studies for inclusion, extracted study information using a data extraction form developed by the research team and assessed risk of bias for all studies with an experimental or quasi-experimental design. Data were narratively synthesized. RESULTS: We identified 27 studies that varied greatly with regard to their patient population, design, content and delivery. A range of outcomes were evaluated to explore the effectiveness and acceptability of decision analytic interventions, with little information about the implementation process. Most studies found that decision analysis was broadly beneficial. CONCLUSION: Despite the compelling rationale on the potential for decision analysis to support shared decision-making, rigorous randomized controlled trials are needed to confirm these interventions' effectiveness, while qualitative studies should seek to understand their potential implementation.

Decision Analysis in SHared decision making for Thromboprophylaxis during Pregnancy (DASH-TOP): a sequential explanatory mixed methods pilot study protocol.

INTRODUCTION: Decision analysis is a quantitative approach to decision making that could bridge the gap between decisions based solely on evidence and the unique values and preferences of individual patients, a feature especially important when existing evidence cannot support clear recommendations and there is a close balance between harms and benefits for the treatments options under consideration. Low molecular weight heparin (LMWH) for the prevention of venous thromboembolism (VTE) during pregnancy represents one such situation. The objective of this paper is to describe the rationale and methodology of a pilot study that will explore the application of decision analysis to a shared decision-making process involving prophylactic LMWH for pregnant women or those considering pregnancy who have experienced a VTE. METHODS AND ANALYSIS: We will conduct an international, mixed methods, explanatory, sequential study, including quantitative data collection and analysis followed by qualitative data collection and analysis. In step I, we will ask women who are pregnant or considering pregnancy and have experienced VTE to participate in a shared decision-making intervention for prophylactic LMWH. The intervention consists of three components: a direct choice exercise, a values elicitation exercise and a personalised decision analysis. After administration of the intervention, we will ask women to make a treatment decision and measure decisional conflict, self-efficacy and satisfaction. In step II, which follows the analysis of quantitative data, we will use the results to inform the qualitative interview. Step III will be a qualitative descriptive study that explores participants' experiences and perceptions of the intervention. In step IV, we will integrate findings from the qualitative and quantitative analyses to obtain meta-inferences. ETHICS AND DISSEMINATION: Site-specific ethics boards have approved the study. All participants will provide informed consent. The research team will take an integrated approach to knowledge translation.

A Systematic Review of Methods Used for Confounding Adjustment in Observational Economic Evaluations in Cardiology Conducted between 2013 and 2017.

Background. Observational economic evaluations (i.e., economic evaluations in which treatment allocation is not randomized) are prone to confounding bias. Prior reviews published in 2013 have shown that adjusting for confounding is poorly done, if done at all. Although these reviews raised awareness on the issues, it is unclear if their results improved the methodological quality of future work. We therefore aimed to investigate whether and how confounding was accounted for in recently published observational economic evaluations in the field of cardiology. Methods. We performed a systematic review of PubMed, Embase, Cochrane Library, Web of Science, and PsycInfo databases using a set of Medical Subject Headings and keywords covering topics in "observational economic evaluations in health within humans" and "cardiovascular diseases." Any study published in either English or French between January 1, 2013, and December 31, 2017, addressing our search criteria was eligible for inclusion in our review. Our protocol was registered with PROSPERO (CRD42018112391). Results. Forty-two (0.6%) out of 7523 unique citations met our inclusion criteria. Fewer than half of the selected studies adjusted for confounding (n = 19 [45.2%]). Of those that adjusted for confounding, propensity score matching (n = 8 [42.1%]) and other matching-based approaches were favored (n = 8 [42.1%]). Our results also highlighted that most authors who adjusted for confounding rarely justified their methodological choices. Conclusion. Our results indicate that adjustment for confounding is often ignored when conducting an observational economic evaluation. Continued knowledge translation efforts aimed at improving researchers' knowledge regarding confounding bias and methods aimed at addressing this issue are required and should be supported by journal editors.

Wage losses among spouses of women with nonmetastatic breast cancer.

BACKGROUND: The aim of this study was to evaluate the wage losses incurred by spouses of women with nonmetastatic breast cancer in the 6 months after the diagnosis. METHODS: A prospective cohort study of spouses of women diagnosed with nonmetastatic breast cancer who were recruited in 8 hospitals in the province of Quebec (Canada) was performed. Information for estimating wage losses was collected by telephone interviews conducted 1 and 6 months after the diagnosis. Log-binomial regressions were used to identify personal, medical, and employment characteristics associated with experiencing wage losses, and generalized linear models were used to identify characteristics associated with the proportion of usual wages lost. RESULTS: Overall, 829 women (86% participation) and 406 spouses (75% participation) consented to participate. Among the 279 employed spouses, 78.5% experienced work absences because of breast cancer. Spouses were compensated for 66.3% of their salary on average during their absence. The median wage loss was $0 (mean, $1820) (2003 Canadian dollars). Spouses were more likely to experience losses if they were self-employed or lived 50 km or farther from the hospital. Among spouses who experienced wage losses, those who were self-employed or whose partners had invasive breast cancer lost a higher proportion of wages. CONCLUSIONS: Although spouses took some time off work, for many, the resulting wage losses were modest because of compensation received. Still, the types of compensation used may hide other forms of burden for families facing breast cancer.

How do financial (dis)incentives influence health behaviour and costs? Protocol for a systematic literature review of randomised controlled trials.

INTRODUCTION: In this era of rising healthcare costs, there is a growing interest in understanding how funding policies can be used to improve health and healthcare efficiency. Financial incentives (eg, vouchers or access to health insurance) or disincentives (eg, fines or out-of-pocket costs) affect behaviours. To date, reviews have explored the effects of financial (dis)incentives on patient health and behaviour by focusing on specific behaviours or geographical areas. The objective of this systematic review is to provide a comprehensive overview on the use of financial (dis)incentives as a means of influencing health-related behaviour and costs in randomised trials. METHODS AND ANALYSIS: We will search electronic databases, clinical trial registries and websites of health economic organisations for randomised controlled trials. The initial searches, which were conducted on 13 January 2018, will be updated every 12 months until the completion of data analysis. The reference lists of included studies will be manually screened to identify additional eligible studies. Two researchers will independently review titles, abstracts and full texts to determine eligibility according to a set of predetermined inclusion criteria. Data will be extracted from included studies using a form developed and piloted by the research team. Discrepancies will be resolved through discussion with a third reviewer. Risk of bias will be assessed using the Cochrane Collaboration tool. ETHICS AND DISSEMINATION: Ethics approval is not required since this is a review of published data. Results will be disseminated through publication in peer-reviewed journals and presentations at relevant conferences. PROSPERO REGISTRATION NUMBER: CRD42018097140.