Clinical Impact and Cost-effectiveness of Genotype Testing at Human Immunodeficiency Virus Diagnosis in the United States.

BACKGROUND: US guidelines recommend genotype testing at human immunodeficiency virus (HIV) diagnosis ("baseline genotype") to detect transmitted drug resistance (TDR) to nonnucleoside reverse transcriptase inhibitors (NNRTIs), nucleoside reverse transcriptase inhibitors (NRTIs), and protease inhibitors. With integrase strand inhibitor (INSTI)-based regimens now recommended as first-line antiretroviral therapy (ART), the of baseline genotypes is uncertain. METHODS: We used the Cost-effectiveness of Preventing AIDS Complications model to examine the clinical impact and cost-effectiveness of baseline genotype compared to no baseline genotype for people starting ART with dolutegravir (DTG) and an NRTI pair. For people with no TDR (83.8%), baseline genotype does not alter regimen selection. Among people with transmitted NRTI resistance (5.8%), baseline genotype guides NRTI selection and informs subsequent ART after adverse events (DTG AEs, 14%). Among people with transmitted NNRTI resistance (7.2%), baseline genotype influences care only for people with DTG AEs switching to NNRTI-based regimens. The 48-week virologic suppression varied (40%-92%) depending on TDR. Costs included $320/genotype and $2500-$3000/month for ART. RESULTS: Compared to no baseline genotype, baseline genotype resulted in <1 additional undiscounted quality-adjusted life-day (QALD), cost an additional $500/person, and was not cost-effective (incremental cost-effectiveness ratio: $420 000/quality-adjusted life-year). In univariate sensitivity analysis, clinical benefits of baseline genotype never exceeded 5 QALDs for all newly diagnosed people with HIV. Baseline genotype was cost-effective at current TDR prevalence only under unlikely conditions, eg, DTG-based regimens achieving ≤50% suppression of transmitted NRTI resistance. CONCLUSIONS: With INSTI-based first-line regimens in the United States, baseline genotype offers minimal clinical benefit and is not cost-effective.

Incorporation of Trauma-Informed Care Into Entrustable Professional Activities for Medical Student Assessment.

PROBLEM: Trauma-informed care (TIC) provides a medical framework for addressing and mitigating the negative consequences of trauma. In response to student and faculty advocacy, medical schools are developing trauma-informed curricular content. However, medical education literature does not present a comprehensive assessment rubric to evaluate medical students' acquisition of trauma-informed clinical skills. APPROACH: A committee of medical students, trainees, and faculty developed a longitudinal TIC curricular theme at Harvard Medical School (HMS). Guided by the National Collaborative on Trauma-Informed Health Care Education and Research competencies, the committee created a set of medical student TIC competencies from July to December 2019. From November 2021 to November 2022, 3 committee subgroups generated new TIC descriptors for each HMS entrustable professional activity (EPA), then circulated these to other subgroups, external experts, and stakeholders for review and feedback. From April to June 2023, the committee iteratively reviewed the materials until reaching consensus for content and pedagogy. The committee integrated TIC content into HMS's existing EPAs expected of students, provided anchoring descriptions of each level, and achieved consensus using a process of iterative review with TIC content experts. OUTCOMES: The committee identified 10 TIC competencies and revised all 13 general HMS EPAs to include specific items based on these competencies. The committee incorporated at least 1 trauma-informed competency into each HMS EPA. NEXT STEPS: This novel set of HMS EPAs provides a framework for assessment of TIC clinical skills. Faculty will be trained to correctly and reliably incorporate TIC competencies into patient care and to use the TIC-inclusive EPAs for student assessment, ensuring that TIC is standard medical practice at HMS. This work may facilitate the adoption of trauma-inclusive EPAs by other institutions to educate the next generation of physicians to practice TIC and thus promote a more accessible, safe, and equitable health care system.

Assessing the Impact of a Hospice and Palliative Medicine Mentored Clinical Shadowing Experience for First-Year Medical and Dental Students: A Pilot Study.

Background: All physicians encounter patients with serious illness. Medical students recognize the value of hospice and palliative medicine (HPM) and desire more knowledge and skills in this area. However, both pre-clinical and clinical HPM content are underrepresented within medical school curricula. Objectives: To conduct a pilot study examining the impact of a novel required HPM clinical experience on pre-clinical medical and dental students' learning through mixed methods evaluation of student responses. Design: Students completed a two-part electronic survey following a half-day HPM mentored clinical shadowing experience (HPM-MCSE) which included an introductory session, a faculty-mentored shadowing experience and a debriefing session. Setting/subjects: 163 first-year students at Harvard Medical School in Boston, Massachusetts, USA in 2022. Measurements: The survey collected demographic information and student responses to both closed-ended (Likert-scale) and open-ended prompts. Data were analyzed quantitatively using descriptive statistics and qualitatively using constant comparative methodology. Results: 127 medical and dental students responded (78% response rate). Qualitative analysis yielded three overarching themes: acquisition of knowledge about operational dimensions of HPM, acquisition of knowledge about psychosocial dimensions of HPM, and personal impact including an awareness of discordance between expectations and lived experience of HPM practice. Of the 109 students who completed the entire survey, 67% indicated that this experience increased their interest in palliative care and 98% reported an increase in their understanding of how palliative care enhances patient care. Conclusions: Early clinical exposure to HPM for first year students stimulates multi-dimensional learning about HPM and evokes personal reflection about serious illness care.

Clinical and Economic Impact of Ibalizumab for People With Multidrug-Resistant HIV in the United States.

BACKGROUND: We projected the clinical outcomes, cost-effectiveness, and budget impact of ibalizumab plus an optimized background regimen (OBR) for people with multidrug-resistant (MDR) HIV in the United States. METHODS: Using the Cost-Effectiveness of Preventing AIDS Complications microsimulation model and a health care sector perspective, we compared 2 treatment strategies for MDR HIV: (1) IBA + OBR-ibalizumab plus OBR and (2) OBR-OBR alone. Ibalizumab efficacy and cohort characteristics were from trial data: mean age 49 years, 85% male, and mean CD4 150/µL. Six-month viral suppression was 50% with IBA + OBR and 0% with OBR. The ibalizumab loading dose cost $10,500, and subsequent ibalizumab injections cost $8400/month; OBR cost $4500/month. Incremental cost-effectiveness ratios (ICERs) were calculated using discounted (3%/year) quality-adjusted life years (QALYs) and costs. ICERs ≤$100,000/QALY were considered cost-effective. We performed sensitivity analysis on key parameters and examined budget impact. RESULTS: In the base case, 5-year survival increased from 38% with OBR to 47% with IBA + OBR. Lifetime costs were $301,700/person with OBR and $661,800/person with IBA + OBR; the ICER for IBA + OBR compared with OBR was $260,900/QALY. IBA + OBR was not cost-effective even with 100% efficacy. IBA + OBR became cost-effective at base case efficacy if ibalizumab cost was reduced by ≥88%. For an estimated 12,000 people with MDR HIV in the United States, IBA + OBR increased care costs by $1.8 billion (1.5% of total treatment budget) over 5 years. CONCLUSIONS: For people with MDR HIV lacking other treatment options, ibalizumab will substantially increase survival when effective. Although adding ibalizumab to OBR is not cost-effective, the low number of eligible patients in the United States makes the budget impact relatively small.