ClinicoEconomics and Outcomes Research最新文献

Purpose: To model the potential clinical and economic impact of blister-packaging medications for chronic conditions on medication adherence and healthcare costs in a commercially insured population.

Methods: A health economic model was developed to evaluate the potential impact of blister-packaging chronic medications for a commercially insured population. The chronic medication classes assessed were renin-angiotensin-system (RAS) antagonists, statins, non-insulin oral antidiabetics, and direct oral anticoagulants (DOACs). The model was designed to reflect the perspective of a hypothetical commercially insured health plan with 100,000 members, over a one-year time horizon. Literature-based or best available epidemiologic references were used to inform the number of patients utilizing each medication class, the impact of blister-packaging on the number of patients who become adherent, as well as the impact of medication adherence in a commercially insured population on healthcare costs for each medication class assessed. Impact on costs was measured in total net healthcare costs, as well as being stratified by medical costs and medication costs.

Results: Following the blister-packaging intervention, there were an additional 591 patients adherent to RAS antagonists, 1196 patients adherent to statins, 169 patients adherent to oral antidiabetics, and 25 patients adherent to DOACs. While pharmacy costs increased, these costs were more than offset by the reduction in medical costs. Overall, the increase in patients adherent to therapy due to blister-packaging led to a reduction in total healthcare costs of $879,312 for RAS antagonists (-$0.73 per-member per-month (PMPM)), $343,322 for statins (-$0.29 PMPM), $78,917 for oral antidiabetics (-$0.07 PMPM), and $120,793 for DOACs (-$0.10 PMPM).

Conclusion: Blister-packaging chronic medications in a commercially insured population has the potential to reduce healthcare costs. Future research is needed to confirm these findings in real-world settings and to fully understand the clinical and economic implications of blister-packaging chronic medications.

Background: Cost-effectiveness analysis (CEA) compares interventions based on relative value and is an integral part of value assessment. Despite recommendations for economists to consider disparities in CEAs that impact health-care resource allocation decisions, the perception held by stakeholders is that value assessment frameworks are inconsistent in practice.

Methods: We reviewed value assessment reports produced by a United States (US)-based value assessment organization to identify how patients and caregiver input may contribute to how the organization considers health disparities. We purposefully extracted and categorized information relevant to health disparities from report sections on Patient and Caregiver Perspectives and Contextual Considerations and Other Potential Benefits to represent the data acknowledged by the organization's patient engagement efforts. We conducted a thematic analysis of the text in these sections and mapped to a health disparities framework endorsed by the National Institute on Minority Health and Health Disparities (NIMHD).

Results: Nineteen evidence reports were included in our analysis. We identified 30 equity-related themes from external stakeholder perspectives or acknowledged in the report and 17 equity-related themes that reflect the actions taken by the economic model developers to address health disparities as a formal part of the CEA. We found examples of the value assessment organization explicitly considering health disparities in cost-effectiveness estimates. However, explicit considerations were not consistent across reports and were not necessarily aligned with patient and caregiver input during model development or consistent with the organization's own contextual considerations.

Conclusion: Our findings highlight the need for a systematic approach for the consideration of health disparities within a value assessment framework and more transparency around how final cost-effectiveness approaches are determined.

Background: Multidrug-resistant tuberculosis presents a challenging obstacle in global TB control. It necessitates complex and long-term therapy, which can potentially lead to medication-related burdens that may ultimately reduce therapy adherence and quality of life.

Purpose: This study aimed to gain a deep understanding of the medication-related burdens experienced by multidrug-resistant tuberculosis patients.

Methods: The study was conducted using a convergent mixed-method approach involving MDR-TB patients and their caregivers. Qualitative data were collected through semi-structured in-depth interviews, while quantitative data were gathered using the validated Living with Medicine Questionnaire 3. In the quantitative part, associations between patients' characteristics and burden levels were analysed using bivariate and multivariate analyses.

Results: Seventy-four participants were involved in the study, with 71 of them completing the questionnaire and 36 participating in interviews. The qualitative results revealed the subjectivity of medication-related burden perception, which could not be fully captured by the quantitative method. Four themes of medication-related burdens emerged: personal beliefs, regimen burdens, socioeconomic burdens, and healthcare burdens. The quantitative results provided a generalized representation of the population. Age and side effects were found to be significantly associated with higher burden levels, with those aged 18-30 having an odds ratio (OR) of 7.303 (95% CI: 1.045-51.034), and those aged 31-40 having an OR of 6.53 (95% CI: 1.077-39.607). Additionally, experiencing side effects had a substantial impact, with an OR of 46.602 (95% CI: 2.825-768.894). Both sets of results are valuable for designing patient-centered care.

Conclusion: MDR-TB therapy imposes a significant burden, particularly regarding the characteristics of regimen. By understanding this burden, healthcare professionals can help improve the quality of life for these patients.

Background: The adoption of remote monitoring (RM) is especially relevant for patients with implantable cardiac devices due to their high risk of hospitalization and the need for frequent outpatient visits. Though RM can help with early detection of cardiac episodes, it may also increase the number of tasks healthcare providers engage in to monitor patients' health. The adoption of RM may increase healthcare providers' workloads, potentially impacting the quality of care and increasing the risk of clinician-provider burnout. Little is known about the link between RM adoption and changes in healthcare providers' workloads.

Methods: Using data from a non-randomized clinical trial conducted in 2021-2022 at a University Hospital in Korea, we examined the relationship between RM adoption and changes in patient time savings and healthcare providers' workloads. The clinical trial included patients with a cardiac implantable electronic device compatible with the Biotronik Home Monitoring System.

Results: For patients, RM was associated with a 41-minute decrease in total visit duration, attributed to reductions in both wait time (37 minutes; P<0.001) and total examination time (3.7 minutes; P=0.137). For healthcare providers, RM was linked to an increase in overall workload by 107.9 minutes per patient. The increase was primarily due to managing RM alerts (91.8 minutes) and preparing monthly patient reports (19.9 minutes). Our findings suggest that RM was associated with a decrease of 1540 KRW (44%) in average cost of care per minute.

Conclusion: RM is associated with time-saving patient benefits and increased healthcare providers' workloads. Even though this was a single-center study with a small number of patients, our research highlights the importance of carefully examining changes in healthcare staff workloads linked to the adoption of RM within the national health insurance system.

Background: Automated Drug Dispensing (ADD) systems are considered to be strategic hospital assets used to reduce errors and enhance economic and organizational sustainability. With regards to efficacy and safety, the literature evidence demonstrates the incremental benefits of centralised or decentralised systems compared to manual dispensing. Analyses about organisational and economic sustainability are still lacking and the present study aims to perform a Health Technology Assessment (HTA), producing multidimensional evidence on the use of ADD systems within hospitals.

Methods: In 2023, a comprehensive HTA draws insights from healthcare professionals across six European nations: Italy, France, Germany, the Netherlands, the United Kingdom, and Belgium. This appraisal juxtaposed four drug dispensing scenarios: manual methods, centralized ADD systems, decentralized ADD systems, and integrated solutions employing cutting-edge technologies in both central pharmacies and wards. The study deployed an Activity-Based Costing approach that was combined with a cost-effectiveness and Budget Impact Analysis to evaluate economic impacts. Qualitative questionnaires were implemented to assess ethical, legal, organizational, safety, and efficacy aspects.

Results: From a multidimensional perspective, healthcare professionals acknowledged ADD manifold advantages of ADD systems. From an organizational perspective and within a 12-month timeframe, transitioning to automation may face initial challenges that are attributed to potential resistance from professionals and significant investments. However, 36 months past its adoption, automation's superiority over manual methods was recognized. Economically, savings burgeoned from +17.9% in UK to +26.6% in Belgian hospitals that adopted integrated systems in comparison to traditional manual approaches.

Conclusion: Compared to traditional methods, implementing ADD systems could improve the logistic management of drug in the hospital setting, thereby enhancing safety and efficacy, streamlining the healthcare professionals' workflow, and bolstering financial stability.

Background: Schizophrenia is a complex, chronic mental health disorder that confers a substantial disease burden globally. Oral antipsychotic treatments (OATs) are the mainstay for treating early and advanced stages of schizophrenia. Our systematic review aimed to synthesize literature describing real-world effectiveness, economic, and humanistic outcomes of OATs (asenapine, brexpiprazole, cariprazine, iloperidone, lumateperone, lurasidone, olanzapine/samidorphan, paliperidone, and quetiapine) for successful management of the disease.

Methods: PubMed, American Psychological Association PsycINFO (EBSCOhost), and Cumulative Index of Nursing and Allied Health Literature were searched according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies reporting real-world effectiveness, costs, humanistic, behavioral (eg, interpersonal relations, suicide ideation), medication adherence, and product-switching outcomes for selected OATs published in English from January 2010 to March 2022 were identified and evaluated qualitatively.

Results: We included 48 studies with different designs providing extensive evidence on schizophrenia. All studies were conducted in countries outside of the United States. In most studies, antipsychotic medications were more effective than placebo, suggesting their value in the management of schizophrenia. Sixteen studies measured the economic outcomes of OATs. Eight studies assessed humanistic outcomes, while one reported behavioral outcomes in three second-generation antipsychotics. Medication adherence was described in two studies, while five studies evaluated product switching. Non-adherence was commonly reported for OATs. Medication non-adherence and treatment discontinuation were predominant factors contributing to the economic burden of schizophrenia.

Conclusion: Our research showcased a significant knowledge gap across OATs spanning the humanistic and behavioral outcomes and medication adherence and switching, suggesting a need for robust evidence generation to help clinicians and payers make informed decisions regarding treatment opportunities and cost-effective strategies for patients with schizophrenia.

Purpose: To investigate the effect of StrataGraft (bioengineered allogeneic cellularized construct [BACC]) treatment on inpatient length of stay (LOS) as an indicator of hospital resource utilization.

Patients and methods: Data from the single-arm StrataCAT trial for adult patients with deep partial-thickness (DPT) burns who received BACC were compared with data from a matched external control arm comprising patients who received autografting for burn treatment from the National Burn Repository (NBR) during the same time period as StrataCAT. A matching, quasi-experimental approach was used to investigate the cause-and-effect relationship between BACC treatment and LOS (days). Matching factors included sex, age, ethnicity, race, burn causes, %TBSA burned (third-degree), %TBSA burned (second- and third-degrees), inhalation injury, diabetes mellitus, and hypertension. Balance was assessed between the cohorts for each confounder by standardized mean differences (SMD). Outcome was reported as average treatment effect on the treated.

Results: The BACC and NBR Autograft cohorts included 47 and 2641 patients, respectively. Following matching, the Autograft cohort had 137 patients and was weighted to 47 patients. Patients in the BACC and final (matched) Autograft cohorts were similar in all demographic and clinical covariate categories after matching (ie, the absolute SMD were < 0.1). Treatment with BACC reduced the inpatient LOS by an average of 4.84 days (P = 0.0127) relative to the comparable (matched) Autograft cohort. An ad hoc analysis revealed that mean [SD] LOS for BACC and the weighted Autograft cohorts were 17.68 [12.75] and 22.51 [19.75] days, respectively, and were 1.39 [0.94] and 1.88 [1.31] days per %TBSA burned, respectively.

Conclusion: The significantly reduced inpatient LOS observed with BACC compared to Autograft in adults with DPT burns may translate into reduced burden on the healthcare system, reduced costs for inpatient burn treatment, and clinical benefits for patients.

Background: Alterations in DNA damage repair genes in advanced prostate cancer (PC) may impact responses to therapy and clinical outcomes. This study described homologous recombination repair (HRR) testing patterns and clinical outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) by HRR alteration status and race in the United States (US).

Methods: Clinical data in the nationwide (US-based) Flatiron Health-Foundation Medicine, Inc. (FMI) Metastatic PC Clinico-Genomic Database were evaluated (01/01/2011-12/31/2022). Patients initiating first-line (1L) mCRPC therapy on or after mCRPC diagnosis were included. Testing patterns, time-to-next treatment, overall survival (OS), and time-to-prostate specific antigen response were described.

Results: Of the 1367 patients with mCRPC and at least one HRR panel test prior to or on the date of 1L mCRPC therapy initiation, 332 (24.3%) were HRR positive (White patients: n = 219 [66.0%]; Black patients: n = 37 [11.1%]) and 1035 (75.7%) were HRR negative (White patients: n = 702 [67.8%]; Black patients: n = 84 [8.1%]). The mean time between first positive test and 1L mCRPC therapy initiation date was 588 days (White patients: 589 days; Black patients: 639 days). Among HRR positive relative to negative patients, trends for faster progression (respective 12-month rate overall: 71.1% and 63.7%; White patients: 72.5% and 64.0%; Black patients: 65.4% and 56.4%), shorter OS (respective 24-month rate overall: 46.8% and 51.9%; White patients: 48.6% and 46.2%; Black patients: 52.8% and 54.1%), and decreased treatment response (respective 12-month rate overall: 24.3% and 37.9%; White patients: 24.5% and 35.2%; Black patients: 17.0% and 43.9%) were observed.

Conclusion: Patients with mCRPC positive for HRR alterations tended to exhibit poorer treatment responses and clinical outcomes than those with a negative status. These findings highlight the importance of timely genetic testing in mCRPC, particularly among Black patients, and the need for improved 1L targeted therapies to address the unmet need in HRR positive mCRPC.