Patient-Informed Value Elements in Cost-Effectiveness Analyses of Major Depressive Disorder Treatment: A Literature Review and Synthesis.

OBJECTIVES: Prior work identified 6 key value elements (attributes of treatment and desired outcomes) for individuals living with major depressive disorder (MDD) in managing their condition: mode of treatment, time to treatment helpfulness, MDD relief, quality of work, interaction with others, and affordability. The objective of our study was to identify whether previous cost-effectiveness analyses (CEAs) for MDD treatment addressed any of these value elements. A secondary objective was to identify whether any study engaged patients, family members, and caregivers in the model development process. METHODS: We conducted a systematic literature review to identify published model-based CEAs. We compared the elements of the published studies with the MDD patient value elements elicited in prior work to identify gaps and areas for future research. RESULTS: Of 86 published CEAs, we found that 7 included patient out-of-pocket costs, and 32 included measures of productivity, which were both priorities for individuals with MDD. We found that only 2 studies elicited measures from patients for their model, and 2 studies engaged patients in the modeling process. CONCLUSIONS: Published CEA models for MDD treatment do not regularly include value elements that are a priority for this patient population nor do they include patients in their modeling process. Flexible models that can accommodate elements consistent with patient experience are needed, and a multistakeholder engagement approach would help accomplish this.

The Financial Impact of COVID on Radiology Health Systems.

The coronavirus pandemic of 2019 (COVID-19) was arguably the most pivotal global event that current generations have witnessed, with unprecedented global challenges, and colossal effects on health systems. The financial consequences, in particular, were profound and far-reaching. Staggering estimates of up to $50.7 billion dollars per month in lost revenue for the US health system were reported by the American Hospital Association (Kaye et al., 2021). The pandemic caused significant increases in cost of drugs, disruptions to medical supply chains, day-to-day workflow, and operations in all areas of medicine and various healthcare systems. Radiology experienced a significant burden of the damage, finding itself at the forefront of the pandemic's economic fallout (American Hospital Association).

Understanding the training, mentorship, and professional development priorities of early career embedded researchers.

INTRODUCTION: Health systems are constantly evolving in response to existing and emerging health challenges and are increasingly adopting the Quintuple Aim to guide transformation and improvement efforts. Addressing health challenges and achieving the Quintuple Aim (enhancing patient experience, improving healthcare provider experience, promoting population health, optimising the value of healthcare services, and advancing health equity) may be enhanced with the use of a Learning Health Systems approach that fosters the real-time use of data and evidence to inform improvement efforts and harnesses embedded researchers to co-produce timely, relevant evidence to address priorities. Training programs have emerged to build embedded research capacity within health system organisations and have focused predominantly on the postdoctoral career stage, with little attention paid to the early career researcher (ECR) stage. The objective of this study was to understand ECR training and mentorship needs in the embedded research context to inform the creation new or adaptation of existing programs to build embedded ECR capacity. METHODS: This study used a qualitative approach to garner insight from embedded and applied scholars and health systems leaders in Canada from various professional backgrounds and at various career stages using a combination of focus group discussions, key informant interviews, and an online survey. Thematic content analysis was used to examine the responses of study participants within the interview themes. RESULTS: Twenty-six (26) participants were included in the study. Results were organised according to four key themes: (1) key competencies and skills needed by embedded ECRs; (2) additional training and capacity development needs; (3) training delivery approaches; and (4) enablers and challenges faced by embedded ECRs. Results highlight the importance of supporting ECRs to develop their leadership and organisational management capabilities; their knowledge of and ability to use research approaches that are well-suited to real-world, complex, evolving environments; and their opportunities to learn with and from each other and mentors. Results underscore the perceived importance of context, including being embedded in a supportive environment that values research and evidence and of academic incentives that recognise and value real-world research impact. The challenges of responding to shifting organisational and system priorities were identified. Additional insights from health systems leaders were also highlighted. CONCLUSION: This study identified the multifaceted needs of embedded ECRs and the challenges they face within healthcare systems. Designing new programs or tailoring existing ones to address these needs would build their capacity, foster career progression, and ensure their impact as leaders of evidence-informed health system improvement which is crucial for achieving the Quintuple Aim.

Impacts of a health literacy-informed intervention in people with chronic obstructive pulmonary disease (COPD) on hospitalization, health literacy, self-management, quality of life, and health costs - A randomized controlled trial.

OBJECTIVE: To compare the effect of motivational interviewing (MI) and tailored health literacy (HL) follow-up with usual care on hospitalization, costs, HL, self-management, Quality of life (QOL), and psychological stress in people with chronic obstructive pulmonary disease (COPD). METHODS: A RCT was undertaken in Norway between March 2018-December 2020 (n = 127). The control group (CG, n = 63) received usual care. The intervention group (IG, n = 64) received tailored HL follow-up from MI-trained COPD nurses with home visits for eight weeks and phone calls for four months after hospitalization. Primary outcomes were hospitalization at eight weeks, six months, and one year from baseline. The trial was registered with ClinicalTrials.gov (NCT03216603) and analysed per protocol. RESULTS: Compared with the IG, the CG had 2.8 higher odds (95% CI [1.3 to 5.8]) of hospitalization and higher hospital health costs (MD=€ -6230, 95% CI [-6510 to -5951]) and lower QALYs (MD=0.1, 95% CI [0.10 to 0.11]) that gives an ICER = - 62,300. The IG reported higher QOL, self-management, and HL (p = 0.02- to <0.01). CONCLUSION: MI-trained COPD nurses using tailored HL follow-up is cost-effective, reduces hospitalization, and increases QOL, HL, and self-care in COPD. PRACTICE IMPLICATION: Tailored HL follow-up is beneficial for individuals with COPD and the healthcare system.

Hereditary factor X deficiency in America survey: impact on quality of life and burden of disease in patients and caregivers.

Hereditary factor X deficiency (HFXD) is a rare bleeding disorder causing delayed haemostasis and potentially life-threatening bleeds. Patient/caregiver burden and diagnosis path have not been well characterized. THE AIM OF THIS STUDY WAS TO: describe the diagnosis path, disease burden, and HFXD impact on quality of life (QoL) in patients and caregivers.This was a prospective, cross-sectional, web-based survey of patients with HFXD and caregivers addressing the patient/caregiver experience, QoL, humanistic and unmet needs.Thirty patients and 38 caregivers completed the survey with mean ages 24.7 and 44.6 years, respectively. Mean age at diagnosis was 4.1 years. The diagnostic process was somewhat/very difficult for 23% of patients and 26% of caregivers. Approximately half (53%) received single factor replacement (SFR) as prophylaxis or on-demand. Most patients (71%) reported regular prophylaxis treatment. Over one-fourth (27%) reported treatment with fresh frozen plasma. Bleeding episodes were less common in patients using SFR versus non-SFR: three bleeds or fewer were reported by 92% SFR and 75% non-SFR patients. HFXD patients reported low well being in work/school/social activities with mean HFXD-adapted Hemophilia Well being Index. Patient symptoms negatively impacted caregiver burden with a mean HFXD-adapted Hemophilia Caregiver Index (±SD) of 15.9 (4.6), but also unexpectedly had a positive impact on self-worth and inner strength.To our knowledge, this is the first study to assess patient and caregiver burden of HFXD and impact on QoL. Improvements in symptom recognition, prompt diagnosis, and adherence to expert recommendations for treatment could improve QoL and decrease burden on HFXD patients and caregivers.

Reverse Iontophoresis: Noninvasive Assessment of Topical Drug Bioavailability.

Assessing drug disposition in the skin after the application of a topical formulation is difficult. It is hypothesized that reverse iontophoresis (RI), which can extract charged/polar molecules for monitoring purposes, may provide a noninvasive approach for the assessment of local drug bioavailability. The passive and RI extraction of salicylic acid (SA) and nicotine (NIC) from porcine skin in vitro was assessed after a simple solution of the former and a transdermal patch of the latter had been applied for 24 and 8 h, respectively. Immediately after this "passive skin loading", the amount of drug in the stratum corneum (SC) and "viable" tissue (VT) was measured either (a) after tape-stripping and subsequent solvent extraction of both skin layers or (b) following RI extraction over 4 h. Parallel experiments were then performed in vivo in healthy volunteers; in this case, the VT was not sampled and the skin loading period for NIC was only 4 h. RI extraction of both drugs was significantly higher (in vitro and in vivo) than that achieved passively, and the cumulative RI extraction profiles as a function of time were mathematically analyzed using a straightforward compartmental model. Best-fit estimates of drug amounts in the SC and VT (ASC,0 and AVT,0, respectively) at the end of "loading" and two first-order rate constants describing transfer between the model compartments were then determined. The in vitro predictions of ASC,0 and AVT,0 were in excellent agreement with the experimental results, as was the value of the former in vivo. The rate constants derived from the in vitro and in vivo results were also similar. In summary, the results provide proof-of-concept that the RI method has the potential to noninvasively assess relevant metrics of drug bioavailability in the skin.

Health literacy and older adults: Findings from a national population-based survey.

ISSUE ADDRESSED: With an ageing population and growing complexity and fragmentation of health care systems, health literacy is increasingly important in managing health. This study investigated health literacy strengths and challenges reported by older Australians (people aged 65 or over) and identified how socio-demographic and health factors related to their health literacy profiles. METHODS: The sample comprised 1578 individuals responding to the Australian Government's 2018 Health Literacy Survey, conducted between January and August. Regression modelling was used to estimate the association between each of nine domains of the Health Literacy Questionnaire (HLQ) and individual socio-demographic and health characteristics. The model allowed for correlation between HLQ scores that was linked to unobserved characteristics of individuals. RESULTS: Across the health literacy domains, few individuals received mean scores in the lowest score range. Key individual characteristics associated with higher health literacy were increasing age, English proficiency, higher education levels, better self-assessed health and having certain chronic conditions (cancer, hypertension and arthritis). CONCLUSIONS: Our findings suggest that, among those aged 65 or over, being older or living with chronic illnesses were associated with greater confidence in engaging with providers, accessing information and navigating health services compared to individuals aged 65-69 and those older individuals without chronic illness. Lower health literacy was associated with psychological distress and low English proficiency. SO WHAT?: Interventions to improve individual health literacy and organisation health literacy responsiveness to minimise complexity of the Australian health system are required. This may enhance uptake and use of health information and services for the underserviced members of the community.

The Effect of Remote Digital Services on Health Care Inequalities Among People Under Long-Term Dermatology Follow-Up: Cross-Sectional Questionnaire Study.

BACKGROUND: Given the expansion of remote digital dermatology services from the National Health Service, particularly during the COVID-19 pandemic, there is a need for methods that identify patients at risk of digital exclusion to guide equitable representation in service co-design processes and tailor remote services to the needs of their patient population. OBJECTIVE: This quality improvement project aims to inform the redesign of remote services to optimally support the ongoing needs of patients with chronic skin diseases, ensuring that the services are tailored to patients' digital health literacy requirements. METHODS: We profiled the digital health literacy of 123 people with chronic skin conditions who require long-term surveillance in 2 specialist clinics (London, United Kingdom) using the Multidimensional Readiness and Enablement Index for Health Technology (READHY) questionnaire alongside the Optimizing Health Literacy and Access (Ophelia) process for hierarchical cluster analysis. RESULTS: The cluster analysis of READHY dimensions in responding participants (n=116) revealed 7 groups with distinct digital and health literacy characteristics. High READHY scores in groups 1 (n=22, 19%) and 2 (n=20, 17.2%) represent those who are confident with managing their health and using technology, whereas the lower-scoring groups, 6 (n=4, 3.4%) and 7 (n=12, 10.3%), depended on traditional services. Groups 3 (n=27, 23.3%), 4 (n=23, 19.8%), and 5 (n=8, 6.9%) had varying digital skills, access, and engagement, highlighting a population that may benefit from a co-designed dermatology service. CONCLUSIONS: By identifying patient groups with distinguishable patterns of digital access and health literacy, our method demonstrates that 63.8% (n=74) of people attending specialist clinics in our center require support in order to optimize remote follow-up or need an alternative approach. Future efforts should streamline the READHY question profile to improve its practicality and use focus groups to elicit strategies for engaging patients with digital services.

The Case for Conducting Pragmatic Dementia Care Trials in Medicaid Home and Community-Based Service Settings.

Medicaid-funded home and community-based services (HCBSs) reach large numbers of individuals living with dementia who would otherwise reside in nursing homes with Medicaid funding. Medicaid HCBSs also often augment care provided by family and other informal caregivers to individuals living with dementia. Although Medicaid-funded HCBSs are offered in most states in lieu of nursing home care, they have been largely overlooked as health care system partners for implementation and testing of evidence-based dementia care interventions using embedded pragmatic clinical trial (ePCT) designs. In this article, we make the case for the importance of Medicaid-funded HCBSs as dementia care ePCT partners because of the volume of vulnerable clients with dementia served and the potential positive impacts that evidence-based dementia care programs can have on clients and their informal caregivers. This article first characterizes the Medicaid HCBS setting in terms of populations served and organizational arrangements across states. We then characterize strengths and potential limitations presented by Medicaid HCBSs as settings within which to implement dementia care ePCTs, using as a conceptual framework the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS-2) tool and its domains. We draw on our experiences implementing the Care of Persons with Dementia in their Environments (COPE) program in a statewide Medicaid HCBS setting to highlight how these potential ePCT partners can help optimize pragmatic approaches to several PRECIS-2 domains. We found that partners are especially effective in implementing pragmatic ways to determine eligibility for evidence-based dementia care programs; assist with recruitment of eligible individuals; incorporate dementia care interventions into the range of existing HCBSs; and track outcomes relevant to persons living with dementia, caregivers, HCBS providers, and Medicaid insurance stakeholders. We conclude with recommendations for researchers, potential ePCT partners, and policymakers to help facilitate the growth of dementia care ePCTs in Medicaid HCBS settings across the United States.

Opportunities for digital health technology: identifying unmet needs for bipolar misdiagnosis and depression care management.

Introduction: Digital health technologies (DHTs) driven by artificial intelligence applications, particularly those including predictive models derived with machine learning methods, have garnered substantial attention and financial investment in recent years. Yet, there is little evidence of widespread adoption and scant proof of gains in patient health outcomes. One factor of this paradox is the disconnect between DHT developers and digital health ecosystem stakeholders, which can result in developing technologies that are highly sophisticated but clinically irrelevant. Here, we aimed to uncover challenges faced by psychiatrists treating patients with major depressive disorder (MDD). Specifically, we focused on challenges psychiatrists raised about bipolar disorder (BD) misdiagnosis. Methods: We conducted semi-structured interviews with 10 United States-based psychiatrists. We applied text and thematic analysis to the resulting interview transcripts. Results: Three main themes emerged: (1) BD is often misdiagnosed, (2) information crucial to evaluating BD is often occluded from clinical observation, and (3) BD misdiagnosis has important treatment implications. Discussion: Using upstream stakeholder engagement methods, we were able to identify a narrow, unforeseen, and clinically relevant problem. We propose an organizing framework for development of digital tools based upon clinician-identified unmet need.

Early Career Outcomes of Embedded Research Fellows: An Analysis of the Health System Impact Fellowship Program.

BACKGROUND: This descriptive study reports the early career outcomes of postdoctoral fellows who completed a novel embedded fellowship training program, the Canadian Institutes of Health Research (CIHR) Health System Impact (HSI) Fellowship. The program was designed to support impact-oriented career paths of doctoral graduates, build research capacity within health system organizations, and help to advance learning health systems in Canada. METHODS: Employment of fellowship alumni upon completion of the program were tracked using internet searches of publicly accessible online sources and complemented with program survey data. RESULTS: Descriptive analyses show that all 87 eligible alumni included in the study are currently employed (100% of 87), with 92% employed in Canada. Their employment spans several sectors, including in academic (37%), public (29%), healthcare delivery (17%), and private (14%) sectors. Altogether, 32% of alumni held hybrid roles with an affiliation in academia and another sector. The most common position types were senior scientist (42%), professorships (18%), and director, manager or administrator roles (12%). Program reporting data indicate that these employment outcomes are generally consistent with the group's career aspirations reported at the start of the fellowship program, and that the program receives high ratings from fellows in the extent it is believed to support their career preparedness and readiness (4.49 out of 5). CONCLUSION: We find that HSI Fellow alumni are employed mostly in research-related roles in a range of sectors including, but not limited to academia, that they positively perceive the program's success in elevating their career readiness and potential to make an impact - suggesting that the program may help equip fellows with the skills, readiness and networks for a broad array of employment sectors and roles. The findings are a promising signal of the demand for research talent and the growing capacity for learning health systems in Canada.

Real-world treatment modalities, health care resource utilization, and costs among commercially insured patients with newly diagnosed major depressive disorder in the United States.

BACKGROUND: In the United States, major depressive disorder (MDD) is one of the most prevalent mental health disorders. Treatment guidelines for MDD recommend pharmacologic and nonpharmacologic therapies tailored to the patient's disease severity, level of function, and comorbid health conditions. While previous studies examined real-world pharmacologic treatment patterns and costs among patients with MDD, few have examined the use of nonpharmacologic treatments and their association with health care resource utilization (HCRU) and cost. OBJECTIVE: To describe prevalence and associations between patient/provider characteristics and treatment modality and characterize HCRU and cost by treatment modality for patients with newly diagnosed MDD. METHODS: Commercially insured US patients, aged 18-62 years with newly diagnosed MDD between January 1, 2017, and September 30, 2019, were retrospectively identified from the Healthcare Integrated Research Database. Eligible patients were continuously enrolled in the health plan for 1 year before and 2 years after the first MDD diagnosis (index date). Those with co-occurring schizophrenia, bipolar disorder, postpartum depression, substance use disorder, and any prior MDD treatments were excluded. Treatment modalities assessed in the 2-year post-index period included antidepressant only (Rx-only), nonpharmacologic only (non-Rx-only), both antidepressant and nonpharmacologic (combination), and no treatment. HCRU and costs were assessed in the 2-year post-index period by treatment modality. Regression models identified associations between patient/provider characteristics and treatment modality, and the relationship between treatment modality and MDD severity changes. RESULTS: In total, 12,657 patients were included (mean age: 36 years; 60% female). During follow-up, 34% of patients received Rx-only, 25% received non-Rx-only, 28% received combination, and 13% received no treatment. MDD severity at diagnosis (26% mild, 54% moderate, 20% severe) was available for 51% of patients. Post-index inpatient hospitalizations were 11% for those with Rx-only, 10% for non-Rx-only, 16% for combination, and 29% for no treatment, whereas all-cause mean monthly total costs were $792, $633, $786, and $1,292, respectively. In multinomial logistic regression, age, sex, geographic region and urbanicity of patient residence, socioeconomic status, diagnosing provider specialty, and initial diagnosis location were significantly associated (P < 0.05) with treatment modality. In multivariable logistic regression, recipients of Rx-only (odds ratio = 2.03, P < 0.01) or combination (odds ratio = 3.26, P < 0.01) had higher odds of improving MDD severity than patients who received no treatment. CONCLUSIONS: In this real-world sample of commercially insured patients, we observed variations in outcomes by treatment modality and an association between treatment modality and disease severity. Further research is needed to explore the underlying causal relationships between treatment modality and patient outcomes. Study Registration: https://doi.org/10.17605/OSF.IO/YQ6B3 DISCLOSURES: Dr Grabner is an employee of Carelon Research, which received funding from the Innovation and Value Initiative for the conduct of the study on which this manuscript is based. Ms Pizzicato and Mr Yang were employees of Carelon Research at the time the study was conducted. Dr Grabner is a shareholder of Elevance Health. Drs Xie and Chapman are employees of the Innovation and Value Initiative.

Demographic and Socioeconomic Factors in Prospective Retina-Focused Clinical Trial Screening and Enrollment.

Historically marginalized populations are disproportionately affected by many diseases that commonly affect the retina, yet they have been traditionally underrepresented in prospective clinical trials. This study explores whether this disparity affects the clinical trial enrollment process in the retina field and aims to inform future trial recruitment and enrollment. Age, gender, race, ethnicity, preferred language, insurance status, social security number (SSN) status, and median household income (estimated using street address and zip code) for patients referred to at least one prospective, retina-focused clinical trial at a large, urban, retina-based practice were retrospectively extracted using electronic medical records. Data were collected for the 12-month period from 1 January 2022, through 31 December 2022. Recruitment status was categorized as Enrolled, Declined, Communication (defined as patients who were not contacted, were contacted with no response, were waiting for a follow-up, or were scheduled for screening following a clinical trial referral.), and Did Not Qualify (DNQ). Univariable and multivariable analyses were used to determine significant relationships between the Enrolled and Declined groups. Among the 1477 patients, the mean age was 68.5 years old, 647 (43.9%) were male, 900 (61.7%) were White, 139 (9.5%) were Black, and 275 (18.7%) were Hispanic. The distribution of recruitment status was: 635 (43.0%) Enrolled, 232 (15.7%) Declined, 290 (19.6%) Communication, and 320 (21.7%) DNQ. In comparing socioeconomic factors between the Enrolled and Declined groups, significant odds ratios were observed for age (p < 0.02, odds ratio (OR) = 0.98, 95% confidence interval (CI) [0.97, 1.00]), and between patients who preferred English versus Spanish (p = 0.004, OR = 0.35, 95% CI [0.17, 0.72]. Significant differences between the Enrolled and Declined groups were also observed for age (p < 0.05), ethnicity (p = 0.01), preferred language (p < 0.05), insurance status (p = 0.001), and SSN status (p < 0.001). These factors may contribute to patient participation in retina-focused clinical trials. An awareness of these demographic and socioeconomic disparities may be valuable to consider when attempting to make clinical trial enrollment an equitable process for all patients, and strategies may be useful to help address these challenges.