Hypothetical Health Research Articles

Dynamic consent, communication and return of results in large-scale health data reuse: Survey of public preferences.

Dynamic consent forms a comprehensive, tailored approach for interacting with research participants. We conducted a survey study to inquire how research participants evaluate the elements of consent, information provision, communication and return of results within dynamic consent in a hypothetical health data reuse scenario. We distributed a digital questionnaire among a purposive sample of patient panel members. Data were analysed using descriptive and nonparametric inferential statistics. Respondents favoured the potential to manage changing consent preferences over time. There was much agreement between people favouring closer and more specific control over data reuse approval and those in favour of broader approval, facilitated by an opt-out system or an independent data reuse committee. People want to receive more information about reuse, outcomes and return of results. Respondents supported an interactive model of research participation, welcoming regular, diverse and interactive forms of communication, like a digital communication platform. Approval for reuse and providing meaningful information, including meaningful return of results, are intricately related to facilitating better communication. Respondents favoured return of actionable research results. These findings emphasize the potential of dynamic consent for enabling participants to maintain control over how their data are being used for which purposes by whom. Allowing different options to shape a dynamic consent interface in health data reuse in a personalized manner is pivotal to accommodate plurality in a flexible though robust manner. Interaction via dynamic consent enables participants to tailor the elements of participation they deem relevant to their own preferences, engaging diverse perspectives, interests and preferences.

Awakening Undergraduate Nursing Students' Critical Awareness About Men's Health, Health Literacy and Nursing Practice.

This article reports an evaluative replication study, including a workshop inspired by Paulo Freire's critical pedagogy. Purpose: Assess how the nursing students' participation in critiquing Canadian empirical evidence on men's health literacy provokes new perceptions; explore students' intentions of incorporating the aforementioned contents into their professional practice; and test students' skills to formulate a hypothetical short action plan about men's health literacy. A qualitative evaluation study inspired by the qualitative program evaluation approach. The setting was a university-based Canadian undergraduate nursing program located in a major metropolitan city. Seventeen undergraduate students (representing 3.65% of year 4 student population) composed the sample. The educational intervention was two workshops (6 h duration; February 2017) including a lecture about men's health literacy with video presentations, class discussions and group work using Freire's method of reflection and discussion for awareness awakening. Hypothetical health literacy promotion was the key outcome. All interactions were digitally audiorecorded, verbatim transcribed and submitted to thematic analysis having as themes: Perspectives of awareness and knowledge expansion, and New personal-professional assets. Students were able to relate new knowledge with their own experiences in the classroom or in the practicum. Application of new knowledge was related to students' social circles and reported familiar health matters. Cultural and community life shaped knowledge expansion and references to men's behaviors. Mobilization of personal knowledge awoke students' awareness about gaps in the nursing curriculum and the paucity of experiences in clinical placements relating to men's health literacy.

An experience- and preference-based EQ-5D-3L value set derived using 18 months of longitudinal data in patients who sustained a fracture: results from the ICUROS

IntroductionEQ-5D-3L preference-based value sets are predominately based on hypothetical health states and derived in cross-sectional settings. Therefore, we derived an experience-based value set from a prospective observational study.MethodsThe International Costs and Utilities Related to Osteoporotic fractures Study (ICUROS) was a multinational study on fragility fractures, prospectively collecting EQ-5D-3L and Time trade-off (TTO) within two weeks after fracture (including pre-fracture recall), and at 4, 12, and 18 months thereafter. We derived an EQ-5D-3L value set by regressing the TTO values on the ten impairment levels in the EQ-5D-3L. We explored the potential for response shift and whether preferences for domains vary systematically with prior impairment in that domain. Finally, we compared the value set to 25 other EQ-5D-3L preference-based value sets.ResultsTTO data were available for 12,954 EQ-5D-3L health states in 4683 patients. All coefficients in the value set had the expected sign, were statistically significant, and increased monotonically with severity of impairment. We found evidence for response shift in mobility, self-care, and usual activities. The value set had good agreement with the only other experience- and preference-based value set, but poor agreement with all hypothetical value sets.ConclusionsWe present an experience- and preference-based value set with high face validity. The study indicates that response shift may be important to account for when deriving value sets. Furthermore, the study suggests that perspective (experienced versus hypothetical) is more important than country setting or demographics for valuation of EQ-5D-3L health states.

Using Social Media to Engage Justice-Involved Young Adults in Digital Health Interventions for Substance Use: Pilot Feasibility Survey Study.

Young adults involved in the justice system have high rates of substance use disorders and low rates of treatment engagement. Most justice-involved young adults are supervised in the community-not incarcerated in jail or prison-where they have ongoing access to substances and experience significant barriers to care. When they do engage in treatment, they tend to have worse outcomes than justice-involved adolescents and older adults. Despite the need to develop targeted treatments, there are unique challenges in recruiting this population into clinical research. Digital health technology offers many novel avenues for recruiting justice-involved young adults into clinical research studies and disseminating substance use disorder treatments to justice-involved young adults. Because the vast majority of young adults regularly use one or more social media platforms, social media may offer a cost-effective and efficient way to achieve these goals. This study aimed to describe the process and feasibility of using social media platforms (Facebook and Reddit) to recruit justice-involved young adults into clinical research. Justice-involved young adults recruited from these platforms completed a survey assessing the acceptability of digital health interventions to address substance use in this population. Justice-involved young adults (aged 18-24 years) were recruited through paid advertisements placed on Facebook and Reddit. Participants responded to a web-based survey focused on their substance use, treatment use history, and acceptability of various digital health interventions focused on substance use. A national sample of justice-involved young adults were successfully enrolled and completed the survey (N=131). Participants were racially diverse (8/131, 6.1% American Indian individuals; 27/131, 20.6% Asian individuals; 23/131, 17.6% Black individuals; 26/131, 19.8% Latinx individuals; 8/131, 6.1% Pacific Islander individuals; 49/131, 37.4% White individuals; and 2/131, 1.5% individuals who identified as "other" race and ethnicity). Advertisements were cost-effective (US $0.66 per click on Facebook and US $0.47 per click on Reddit). More than half (72/131, 54.9%) of the participants were on probation or parole in the past year and reported hazardous alcohol (54/131, 51.9%) or drug (66/131, 57.4%) use. Most of the participants (103/131, 78.6%) were not currently participating in substance use treatment. Nearly two-third (82/131, 62.6%) of the participants were willing to participate in one or more hypothetical digital health interventions. Social media is a feasible and cost-effective method for reaching justice-involved young adults to participate in substance use research trials. With limited budgets, researchers can reach a broad audience, many of whom could benefit from treatment but are not currently engaged in care. Proposed digital health interventions focusing on reducing substance use, such as private Facebook groups, SMS text message-based appointment reminders, and coaching, had high acceptability. Future work will build on these findings to develop substance use treatment interventions for this population.

Cost impact of different treatment regimens of brolucizumab in neovascular age-related macular degeneration: A budget impact analysis.

BACKGROUND: Brolucizumab is a new anti-vascular endothelial growth factor (anti-VEGF) approved for treating neovascular age-related macular degeneration (nAMD). Multiple treatment regimens are available for treating nAMD. These regimens include manufacturer-recommended regimens, pro re nata (PRN) regimens, and treat-and-extend (T&E) regimens, which are based on clinical practice guidelines and data observed in the real-world clinical setting, classified as real-world evidence (RWE). Most budget impact models predict the financial consequences of adding a new drug to the formulary based on the manufacturer-recommended regimen. With different anti-VEGF treatment regimens being used in nAMD by ophthalmologists, it is OBJECTIVE: To estimate the budget impact of different treatment regimens of brolucizumab in nAMD from a US payer perspective. METHODS: A Microsoft Excel-based budget impact model was developed for different treatment regimens of brolucizumab over a 1-year time frame from a US payer perspective. A separate analysis was performed to estimate the budget impact from a US patient population perspective. Model inputs included drug costs, administration costs, physician visit costs, and disease monitoring costs. Outcomes in the budget impact model included the cost per member per month, annual health plan cost, and the US patient population-based annual cost. Based on the prevalence of nAMD in public and commercial health plans, a scenario analysis was conducted on the US population to account for the differences in the drug cost to the public and commercial payers. Further, 1-way sensitivity analyses were conducted to test model assumptions and uncertainty in model inputs. RESULTS: The addition of brolucizumab to the formulary increased the net budgetary impact under PRN and T&E regimens. The maximum increase in expenditure for a hypothetical health plan with 1 million enrollees was associated with the PRN regimen ($824,696), followed by the T&E regimen ($163,101). In contrast, using the manufacturer-recommended and RWE regimens led to an annual saving of $93,068 and $94,170 for the health plan, respectively. In the US patient population model, the introduction of brolucizumab resulted in savings in the manufacturer-recommended ($30.99 million) and RWE regimens ($31.35 million) but led to an increase in annual expenditures for the PRN ($274.58 million) and T&E ($54.30 million) regimens. CONCLUSIONS: Payers need to evaluate the cost impact of different treatment regimens of existing and new anti-VEGFs when making formulary decisions in nAMD management. DISCLOSURES: Mr Siddiqui, Ms Dhumal, Dr Patel, and Dr LeMasters have nothing to disclose. Dr Kamal has received research funding from Cerevel Therapeutics, served as a consultant to Pfizer/Cytel Inc, and received honoraria from Pharmacy Times Continuing Education. Dr Almony has served as a consultant to Cardinal Health and received honoraria from Pharmacy Times Continuing Education and Prime Education.

Hypothetical versus experienced health state valuation: a qualitative study of adult general public views and preferences

ObjectivesResponses from hypothetical and experienced valuation tasks of health-related quality of life differ, yet there is limited understanding of why these differences exist, what members of the public think about them, and acceptable resolutions. This study explores public understanding of, opinions on, and potential solutions to differences between hypothetical versus experienced responses, in the context of allocating health resources.MethodsSix focus groups with 30 members of the UK adult public were conducted, transcribed verbatim, and analysed using framework analysis. Participants self-completed the EQ-5D-5L, before reporting the expected consequences of being in two hypothetical EQ-5D-5L health states for ten years. Second, participants were presented with prior results on the same task from a public (hypothetical) and patient (experienced) sample. Third, a semi-structured discussion explored participants’: (1) understanding, (2) opinions, and (3) potential resolutions.ResultsTwenty themes emerged, clustered by the three discussion points. Most participants found imagining the health states difficult without experience, with those aligned to mental health harder to understand. Participants were surprised that health resource allocation was based on hypothetical responses. They viewed experienced responses as more accurate, but noted potential biases. Participants were in favour of better informing, but not influencing the public. Other solutions included incorporating other perspectives (e.g., carers) or combining/weighting responses.ConclusionMembers of the UK public appear intuitively not to support using potentially uninformed public values to hypothetical health states in the context of health resource allocation. Acceptable solutions involve recruiting people with greater experience, including other/combinations of views, or better informing respondents.

Projecting the economic outcomes of switching patients with schizophrenia from oral atypical antipsychotics to once-monthly, once-every-3-months, and once-every-6-months paliperidone palmitate.

BACKGROUND: Among patients with schizophrenia, nonadherence to oral atypical antipsychotics (OAAs) leads to increased risk of relapses, which entails substantial economic burden. OBJECTIVE: To evaluate the impact on health care costs and relapse rates of switching patients with schizophrenia from OAAs to once-monthly paliperidone palmitate (PP1M), with subsequent transitions to once-every-3-months (PP3M) and once-every-6-months paliperidone palmitate (PP6M). METHODS: A 36-month Markov model was developed from a Medicaid payer's perspective. Two non-mutually exclusive subpopulations of adults with schizophrenia who were nonadherent to OAAs were considered: (1) recently relapsed and (2) young adults (aged 18-35). Patients were assumed nonadherent to OAAs until switching treatments, which was permissible multiple times during the 36-month period. Patients switching to PP1M could subsequently transition to PP3M and PP6M. Relapse rates were assumed consistent across treatments based on patients' adherence. Model inputs were literature based. PP6M transition rates were assumed similar to PP3M. Cost savings were reported at the plan level and per patient switched. RESULTS: In a hypothetical health plan of 1 million Medicaid beneficiaries, an estimated 10,053 adults with schizophrenia were nonadherent to OAAs, among whom 7,454 were recently relapsed and 4,002 were young adults. Switching 5% of recently relapsed adults (N = 373) from OAAs to PP1M prior to subsequent relapse resulted in 541 relapses avoided and plan-level savings of $8.2M after 3 years. Incorporating transitions to PP3M/PP6M increased net savings to $9.1M and 631 relapses were avoided. Among young adults, switching 5% (N = 200) from OAAs to PP1M saved $1.8M at the plan level with 178 relapses avoided after 3 years. Including transitions to PP3M/PP6M, 3-year plan-level savings were $2.0M with 223 relapses avoided. Per recently relapsed patient switched to PP1M, and subsequently to PP3M/PP6M, cumulative 3-year cost savings were $22,100 and $24,300, respectively. Among young adults, corresponding 3-year cost savings per patient were $8,900 and $9,800. CONCLUSIONS: Switching nonadherent patients from OAAs to PP1M results in substantial cost savings and reduces relapse rates. Incorporating transitions to PP3M/PP6M leads to incremental cost savings and additional relapses avoided. DISCLOSURES: Financial support for this research was provided by Janssen Scientific Affairs, LLC. Ms Morrison, Ms Ghelerter, Ms Vermette-Laforme, Mr Lefebvre, and Mr Pilon are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC., which funded the development and conduct of this study and manuscript. Dr Lin and Ms Benson are employees of Janssen Scientific Affairs, LLC., and stockholders of Johnson & Johnson.

Willingness to pay for a National Health Insurance Scheme in The Gambia: a contingent valuation study.

In pursuit of universal health coverage, many low- and middle-income countries are reforming their health financing systems and introducing health insurance schemes. As part of these reforms, lawmakers in The Gambia enacted 'The National Health Insurance Bill, 2021'. The Act will establish a National Health Insurance Scheme (NHIS) that pays for the cost of healthcare services for its members. This study assessed Gambians' willingness to pay (WTP) for a NHIS. Using multistage sampling design with no replacement, head/co-head of households were presented with a hypothetical health insurance scheme from July to August 2020. Their WTP and factors influencing WTP were elicited using a contingent valuation method. Descriptive statistics were used to describe sample characteristics. Lopez-Feldman's modified ordered probit model and linear regression were applied to estimate respondents' WTP as well as identify factors that influence their WTP. More than 90% of the respondents-677 (94.4%) were willing to join and pay for the scheme. Half of these respondents-398 (58.8%) agreed to pay the first bid of US dollars (US$) 20.78 or Gambian dalasi (GMD) 1000. The average WTP was estimated at US$23.27 (GMD1119.82), whereas average maximum amount to pay was US$26.01 (GMD1251.16). Results of the two models together showed that gender, level of education and household income were statistically significant, with the latter showing negative influence on WTP. The study found that Gambians were largely receptive to the scheme and have stated their willingness to contribute. Our findings can inform policymakers in The Gambia and other sub-Saharan countries when establishing contribution rates and exemption criteria during social health insurance scheme implementation.

Resilience analysis of a PV/battery system of health care centres in Rohingya refugee camp

Due to frequent natural disasters, it is required for the energy systems to be more resilient and affordable. Numerous investigations can be found in the publications that proposed renewable energy systems to deliver power to localities. Nevertheless, researchers have yet to explore the resiliency benefits of renewable energy systems in refugee camps. Therefore, in this study, we modelled the performance of a PV/battery system for hypothetical health care centres located in the Rohingya refugee camp, Bangladesh. A 24-h grid outage was assigned to the REopt software to observe the survival possibility of the system. An optimized mixed-integer linear programming model is used as it considers several practical parameters such as reducing total cost sufficiently robust to handle the simulated outages perfectly. The optimum system consists of a 643 kW PV and a 102 kW battery. The potential life cycle savings of the system are $27,212, and the system can successfully handle a 24-h duration outage. The system also reduces CO2 emissions by 69% in resilient mode compared to 44% in financial mode. Therefore, it can contribute to climate change mitigation.

Budget impact analysis of belumosudil for chronic graft-versus-host disease treatment in the United States

Aims To assess the impact of belumosudil on the cost of care in chronic graft-versus-host disease (cGVHD) patients who have failed at least two prior lines of systemic therapy using a budget impact model. Methods A budget impact model with a 5-year time horizon was constructed in Microsoft Excel. The base case model uses the US prevalence rate of 3 L/4L + cGVHD patients from literature and secondary sources, with the potential for user-defined inputs, including model perspectives. The model includes data for two perspectives: the national US population and a hypothetical US private payer health insurance plan with 10 million (Mil) members. Additional model inputs include market share of cGVHD treatments, their associated adverse event rates, and healthcare resource utilization. Results The potential annual budget impact for the US national and payer plans was evaluated for cGVHD patients. Based on belumosudil utilization increasing to 55% in 3 L and 4 L + by 2026, cost savings of ∼5.5% and 6.7% ($128.8 and $4.9 Mil USD) were observed from national and payer perspectives, respectively. Cost savings in 2026 were derived from fewer AEs ($108.4 and $3.9 Mil USD, for national and payer perspectives; e.g. neutropenia, and thrombocytopenia) and reduced HCRU ($65.1 and $2.3 Mil USD, for national and payer perspectives; e.g. emergency room visits, ICU stays, etc.). Limitations Results from the model were dependent on the available data inputs and assumptions. Real-world values may differ from the assumed performance of treatments, market growth, and treatment dosing and duration. Conclusion The model results suggest that the introduction of belumosudil to treat cGVHD would be associated with substantial cost savings when evaluating a scenario with versus without belumosudil from a US payer perspective.

Smoking and Tuberculosis Risk: High Attributable Risk in a Low- Incidence Environment

Objectives: To evaluate the potential impact of smoking cessation strategies on TB incidence in Victoria, Australia.
 Methods: A previously validated model of TB in migrants was adapted to concentrate on the attributable TB risk arising from smoking. This model included realistic estimates of population smoking rates, and incorporation of risk factors for TB disease such as smoking, HIV and diabetes. A baseline scenario was compared with an alternative scenario in which a hypothetical public health strategy eliminating smoking was introduced.
 Outcome measures: The primary outcome was the number of TB cases in the Australian state of Victoria in the year 2050. Secondary outcomes considered were total case burden during the period considered and the population attributable fraction of TB cases related to smoking.
 Results: Under the baseline scenario, a median of 318 cases of TB occurred in the target year of 2050, corresponding to an estimated incidence of 3.5 cases/100,000 population. The alternative scenario, where no smoking occurred, found 272 cases (2.95 cases/100,000 population) occurring in 2050; a 14.5% reduction in TB cases. Over the entire period considered, 1650 fewer cases of TB occurred in the alternative scenario, suggesting a population attributable fraction of 11.2% of TB cases from smoking in the Australian context.
 Conclusions: Smoking cessation strategies may have disproportionate benefits in TB incidence reduction. Such benefits should be considered in additional to other well-recognised population health effects from smoking reduction.

What public health interventions do people in Canada prefer to fund? A discrete choice experiment

ObjectiveTo assess public support of tailored and targeted public health interventions for marginalized communities.MethodsWe conducted a discrete choice experiment using a web-based survey advertised to Facebook and Instagram users living in Canada, aged > 16. Participants were asked to choose between funding two hypothetical public health programs. Each program was described by its purpose; expected increase in life expectancy; and target audience. Demographically weighted generalized linear mixed-effects models were constructed to identify program factors associated with program selection.ResultsParticipants completed up to 8 discrete choice comparison exercises each resulting in 23,889 exercises were completed by 3054 participants. Selected programs were less likely to focus on prevention (vs. treatment). For each 1-year increase in the marginal years of life gained, there was a 15% increase in the odds of a program being selected. Interventions tailored to marginalized communities or targeting stigmatized health conditions were less likely to be selected compared to interventions targeted to the general population or targeting chronic health conditions. Noteworthy exceptions included an increased preference for interventions aligning with the perceived needs or cultural expectations for marginalized communities.ConclusionsStigmatizing perceptions of health conditions and key populations likely influence public health programming preferences of Canadians.Public health implicationsInformational campaigns highlighting disparities experienced by marginalized populations may improve support for targeted and tailored interventions.

Intergenerational contract in Ageing Democracies: sustainable Welfare Systems and the interests of future generations.

As the assumptions of perpetual economic and population growth no longer stand, the welfare systems built on such promises are in peril. Policymakers must reallocate the responsibility for providing care between generations. Democratic theories can help establish procedures for finding solutions, particularly in ageing democratic countries. By analysing existing representative and deliberative democratic theories, this paper explores how the interests of future generations could be included in such procedures. A hypothetical social health insurance scheme with the pay-as-you-go financial arrangement is selected as an illustrative case. This paper argues that due to the intrinsic bias towards the current generation, both representative and deliberative democratic health policymaking are limited in making decisions that account for future generations. Instead, their interests could be at best represented by benevolent representatives.

Assessment of health state utilities in dermatology: an experimental time trade-off value set for the dermatology life quality index

BackgroundDermatology Life Quality Index (DLQI) scores are used in many countries as access and reimbursement criteria for costly dermatological treatments. In this study we examined how time trade-off (TTO) utility valuations made by individuals from the general population are related to combinations of DLQI severity levels characterizing dermatologically relevant health states, with the ultimate purpose of developing a value set for the DLQI.MethodsWe used data from an online cross-sectional survey conducted in Hungary in 2020 (n = 842 after sample exclusions). Respondents were assigned to one of 18 random blocks and were asked to provide 10-year TTO valuations for the corresponding five hypothetical health states. To analyze the relationship between DLQI severity levels and utility valuations, we estimated linear, censored, ordinal, and beta regression models, complemented by two-part scalable models accommodating heterogeneity effects in respondents’ valuation scale usage. Successive severity levels (0–3) of each DLQI item were represented by dummy variables. We used cross-validation methods to reduce the initial set of 30 dummy variables and improve model robustness.ResultsOur final, censored linear regression model with 13 dummy variables had R2 = 0.136, thus accounting for 36.9% of the incremental explanatory power of a maximal (full-information) benchmark model (R2 = 0.148) over the uni-dimensional model (R2 = 0.129). Each DLQI item was found to have a negative effect on the valuation of health states, yet this effect was largely heterogeneous across DLQI items, and the relative contribution of distinctive severity levels also varied substantially. Overall, we found that the social/interpersonal consequences of skin conditions (in the areas of social and leisure activities, work and school, close personal relationships, and sexuality) had roughly twice as large disutility impact as the physical/practical aspects.ConclusionsWe have developed an experimental value set for the DLQI, which could prospectively be used for quantifying the quality-adjusted life years impact of dermatological treatments and serve as a basis for cost-effectiveness analyses. We suggest that, after validation of our main results through confirmatory studies, population-specific DLQI value sets could be developed and used for conducting cost-effectiveness analyses and developing financing guidelines in dermatological care.

Development the societal preference-based utility value set for the Patient Health Questionnaire depression scale in Hungary

IntroductionDepression is associated with high impact on health-related quality of life (HRQoL). Health state valuations are used for cost-effectiveness analysis to provide results for health-policy interventions.ObjectivesThe study aims to estimate a population-based value set of depression described by Patient Health Questionnaire (PHQ-9). We intend to assess vignettes describing PHQ-9 health states to estimate utility valuesMethodsCurrent research elicited direct utility scores using time trade-off (TTO) method obtained from the Hungarian general population (N=2,000). TTO vignettes were created to describe hypothetical health states of depression based on the nine items of PHQ-9. The hypothetical health states were sorted orthogonally in 11 blocks, each containing 4 vignettes (combinations of no; mild; moderate; severe depression). All respondents valued the four health states of one randomly given block. Conventional TTO method was applied, using a 10-year timeframe, while the first iteration step was randomized to 1,3 and 5 year. Preference weights were estimated using regression model fitted to TTO utility results.ResultsAltogether 1,999 respondents valued overall 34 different health states. The mean age was 47.3 (16.9) years, the majority was female (57.2%). Nearly half of the respondents were secondary educated 45.4%, 27.3% higher educated and 27.2% completed primary school. The mean TTO utility of selected mild, moderate and severe depression was: 0.83; 0.82 and 0.77 respectively.ConclusionsOur results constitute the first population-based value set for PHQ-9. Utility scores give useful information for cost-effectiveness assessments. Estimates provide preference-based quality of life weights for the Hungarian population.DisclosureNo significant relationships.

891-P: Health Care Economic Burden and Resource Utilization in Adults with Type 2 Diabetes and Myocardial Infarction

Objectives: To evaluate health care resource utilization and cost in adults with type 2 diabetes mellitus (T2DM) and myocardial infarction (MI) . Methods: We conducted a retrospective cohort study using the Optum® Clinformatics® Data Mart claims database. Patients ≥ 18 years of age with T2DM, with or without incident MI, were identified between January 1, 2012 and December 31, 2020. Healthcare resource utilization and cost were measured in the 12 months following index. MI was defined as a hospitalization with a qualifying primary discharge diagnosis code. Patient cohorts were compared using an inverse probability of treatment weighting approach. Results: Incidence of MI was 0.7% (n = 13,681) in the one year following T2DM diagnosis. For the weighted analysis, 9,474 patients with T2DM and incident MI (mean age, 73.6; mean Charlson comorbidity index [CCI], 4.6) were compared to 9,536 patients with T2DM alone (mean age, 73.7; mean CCI, 4.7) . Compared to patients with T2DM alone, patients with T2DM and MI were more likely to have an inpatient (IP) visit (adjusted rate ratio [ARR], 5.4; 95% CI, 5.2-5.6; p < 0.01) , outpatient (OP) visit (ARR, 1.6; 95% CI, 1.6-1.6; p < 0.01) , or emergency room (ER) visit (ARR, 1.8; 95% CI, 1.7-1.8; p < 0.01) , and had longer IP length of stay (ARR, 5.4; 95% CI, 5.4-5.5; p < 0.01) . Healthcare costs from IP visits, OP visits, ER visits, and pharmacy costs were all higher in patients with T2DM and MI compared to patients with T2DM alone (Total costs, $10,929 per patient per month [PPPM] vs. $2,997 PPPM; p < 0.01) . In a hypothetical health plan population of one million adults with T2DM, we project patients with T2DM and MI would have +$676 million higher annual costs than patients with T2DM alone. Conclusions: Having MI in addition to T2DM increased healthcare resource utilization and costs. Proactively managing patients’ T2DM to reduce risk of MI and the increased healthcare utilization and costs associated with MI may improve clinical outcomes and reduce overall costs. Disclosure A.A.King: Advisory Panel; Novo Nordisk, Board Member; JDRF, Speaker's Bureau; Abbott, Dexcom, Inc., Lilly Diabetes, MannKind Corporation, Medtronic, Novo Nordisk. J.J.Rajpura: Employee; Novo Nordisk. Y.Liang: Employee; Novo Nordisk. Y.M.Paprocki: Employee; Novo Nordisk, Stock/Shareholder; Novo Nordisk. C.Uzoigwe: Employee; Novo Nordisk, Stock/Shareholder; Novo Nordisk.

Evaluation of Preference and Utility Measures for Transoral Thyroidectomy.

Traditional, trans-cervical thyroidectomy results in the presence of a neck scar, which has been shown to correlate with lower quality of life and lower patient satisfaction. Transoral thyroid surgery (TOTS) has been utilized as an alternative approach to avoid a cutaneous incision and scar by accessing the neck and thyroid through the oral cavity. This study was designed to evaluate patient preference through health-state utility scores for TOTS as compared to conventional trans-cervical thyroidectomy. In this cross-sectional study, patient preferences were elicited for TOTS and trans-cervical thyroidectomy with the use of an online survey. Respondents were asked to consider 4 hypothetical health scenarios involving thyroid surgery with varying approaches. Health-state utility scores were elicited using visual analog scale and standard gamble exercises. Overall, 516 respondents completed the survey, of whom 261 (50.6%) were included for analysis, with a mean age of 41.5 years (SD 14.9 years), including 171 (65.5%) females. Health utility scores were similar for TOTS and conventional transcervical techniques. Statistically significant differences in the standard gamble utility score were noted for gender and ethnicity across all scenarios. Comparisons of visual analog score utilities were not statistically significant based on respondent demographics. Preferences for TOTS and trans-cervical thyroidectomy did not significantly differ in the current study. Females and white ethnicity indicated stronger preference for a TOTs approach compared to males and other ethnicities, respectively. Some literature suggests certain types of patients who might prefer minimally invasive thyroidectomy more so than other patients-in keeping with the current findings of this study.

Dasiglucagon demonstrates reduced costs in the treatment of severe hypoglycemia in a budget impact model.

BACKGROUND: Approximately 7.3 million people with type 1 or type 2 diabetes (T1D/T2D) are treated with insulin, placing them at higher risk of severe hypoglycemia (SH). SH requires assistance of another individual and often necessitates the prompt administration of intravenous glucose, injectable glucagon, or both. Untreated, SH can progress to unconsciousness, seizures, coma, or death. Before 2018, all glucagon rescue treatments required reconstitution. The complexity of reconstitution is often a barrier to successful administration during a severe hypoglycemic event. Studies suggest successful administration of glucagon emergency kits range from 6%-56% of the time. Second-generation glucagon treatments and glucagon analogs do not require reconstitution and have caregiver administration success rates ranging from 94%-100%. Dasiglucagon is a glucagon analog administered via autoinjector or prefilled syringe and has been shown to result in rapid hypoglycemia recovery. Moreover, the autoinjector can be administered successfully 94% of the time by trained caregivers. Previous evaluation of costs in budget impact models (BIMs) demonstrated the potential for second-generation glucagon treatments to reduce the cost of SH events (SHEs). The current model expands on those findings with a treatment pathway and accompanying assumptions reflecting important aspects of real-world SHE treatment. OBJECTIVE: To evaluate the economic impact of dasiglucagon compared with available glucagon treatments for SHE management, considering direct cost of treatment and health care resource utilization. METHODS: A 1-year BIM with a hypothetical US commercial health plan of 1 million lives was developed with a target population of individuals with diabetes at risk of SHE. The treatment pathway model included initial and secondary treatment attempts, treatment administration success and failure, plasma glucose (PG) recovery within 15 minutes, emergency medical services, emergency department (ED) visits, and hospitalizations. A 1-way sensitivity analysis was conducted to assess the sensitivity of the model to changes in parameter values. RESULTS: In a 1 million-covered lives population, it was estimated that 12,006 SHEs would occur annually. The higher rate of initial treatment success and PG recovery within 15 minutes associated with dasiglucagon treatment resulted in lower total health care costs. Total SHE treatment costs with dasiglucagon were estimated at $13.4 million, compared with $16.7 million for injectable native glucagon, $20.7 million for nasal glucagon, $35.3 million for reconstituted glucagon, and $43.8 million for untreated individuals. Compared with untreated people, the number needed to treat (NNT) with dasiglucagon was 6 individuals to avoid 1 hospitalization. NNT for this same comparison was 59 for injectable native glucagon and 27 for nasal glucagon. CONCLUSIONS: Treatment of SH with dasiglucagon decreased total direct medical costs by reducing health care resource utilization (emergency calls, emergency transports, ED visits, and hospitalizations) and accompanying costs associated with the treatment of SH. DISCLOSURES: This research was funded by Zealand Pharma. Bromley, Hinahara, and Goss are employed by Boston Healthcare Associates, Inc., which received funding from Zealand Pharma for development of the health economic model and the manuscript. Kendall and Hammer are employed by Zealand Pharma. Weinzimer has received consulting fees from Zealand Pharma.

People living with moderate-to-severe COPD prefer improvement of daily symptoms over the improvement of exacerbations: a multicountry patient preference study.

IntroductionThis patient preference study sought to quantify the preferences of people living with COPD regarding symptom improvement in the UK, USA, France, Australia and Japan.MethodsThe inclusion criteria were people living with COPD aged 40 years or older who experienced ≥1 exacerbation in the previous year with daily symptoms of cough and excess mucus production. The study design included: 1) development of an attributes and levels grid through qualitative patient interviews; and 2) implementation of the main online quantitative survey, which included a discrete choice experiment (DCE) to allow assessment of attributes and levels using hypothetical health state profiles. Preference weights (utilities) were derived from the DCE using hierarchical Bayesian analysis. A preference simulator was developed that enabled different health state scenarios to be evaluated based on the predicted patient preferences.Results1050 people living with moderate-to-severe COPD completed the survey. All attributes were considered important when patients determined their preferences in the DCE. In a health state preference simulation, two hypothetical health states (comprising attribute levels) with qualitatively equivalent improvements in A) cough and mucus and B) shortness of breath (SOB) resulted in a clear preference for cough and mucus improved profile. When comparing two profiles with C) daily symptoms improved and D) exacerbations improved, there was a clear preference for the daily symptoms improved profile.ConclusionsPeople living with moderate-to-severe COPD prefer to reduce cough and mucus production together over improvement of SOB and would prefer to reduce combined daily symptoms over an improvement in exacerbations.

Self-esteem in patients with venous thromboembolism predicts time trade-off values for own health

BackgroundThe time trade-off (TTO) is a commonly used preference based method to assess health related values used in health economic analyses. Surprisingly little is known about the factors influencing the TTO. Since self-esteem is a predictor for health status measurements, and health status affects the TTO, we studied the relation between self-esteem and TTO values.MethodsData of 128 patients treated with vitamin K antagonists for venous thromboembolism on Short Form-36 (SF-36), Rosenberg self-esteem and patient characteristics were collected. TTO values were obtained for ‘current health’ and three chronic health states related to thrombosis, in face-to-face interviews with patients. Regression analyses were performed with the TTO as dependent variable. Analyses were performed in two groups; the complete sample, and traders only. Selected predictors were entered in four blocks: socio-demographic factors, medical-clinical factors, health status, and self-esteem.ResultsIn the complete sample (N = 128), bivariate regression analysis showed that self-esteem explained 14% of the variance in TTO values for current health (p < .000, N = 117). In traders, multivariate regression analysis showed a significant relationship between self-esteem and TTO values for current health. Self-esteem increased the variance explained (R2) by 8.8%, from 28.1 to 36.9%, (p = 0.01; N = 57). For hypothetical health states, the effect of self-esteem was weaker and mostly absent after controlling for selected variables.ConclusionsIn patients willing to trade-off time, higher self-esteem was associated with higher TTO values for own current health. Self-esteem explained an appreciable proportion of the variance in TTO values in traders. For hypothetical health states such associations were weak or absent.