Audrey D. Zhang

Background and Objectives: Caregiver burden has many definitions in aging research. To better understand how caregivers conceptualize and describe challenges in their own words, we analyzed Reddit posts about the difficulties of caring for an older adult. Research Design and Methods: Inductive content analysis of a stratified random sample of posts from 5 subreddit communities from December 2022 to December 2023 (r/dementia, r/AgingParents, r/CaregiverSupport, r/caregivers, and r/caregiving); included posts described any negative experience about caregiving. We excluded posts written by paid caregivers and those caring for persons identified as younger than 65. We coded themes and narratively synthesized findings with a focus on how findings could inform the theory and measurement of caregiver burden. Results: We identified 387 posts from 315 unique caregivers caring for 352 care recipients. Where reported, mean caregiver age was 40 (SD 13.7) and 60% were female, and mean care recipient age was 79 (10.4 SD) and 61% were female. 69% of caregivers were children. Users provided intense descriptions of the challenges of caregiving. Analysis yielded 5 themes, illustrating how caregiving is difficult when it: (a) disrupts the caregiver’s sense of self, (b) leads to resentment, (c) leads to burnout, (d) strains family relationships, and (e) encounters challenges navigating the long-term care system. Discussion and Implications: In unstructured qualitative data, caregivers describe their challenges in terms other than burden and include frustrations with family members and the long-term care system. Results could inform dimensions of caregiver strain to include in caregiver burden measures and targeted intervention.

Background: Treatment burden refers to the patient‐perceived effort of managing health and health care, which impacts quality of life and engagement in care. International studies of treatment burden have found high rates of treatment burden among adults with chronic conditions. However, the scope of treatment burden among US older adults is unknown. We described the prevalence of and characteristics associated with treatment burden among US adults age ≥ 50 years.Methods: We performed a cross‐sectional study of 1795 adult respondents to the 2022 Health and Retirement Study (HRS) Treatment Burden Questionnaire (TBQ), a random sub‐sample from a nationally‐representative panel study of community‐dwelling US adults age ≥ 50 years. The primary outcome was total treatment burden score (15 items each scored 0–10, total 0–150; threshold ≥ 59 for high burden). We used multivariable linear regression to examine the association between log‐transformed total treatment burden score and sociodemographic, health, and functional status characteristics.Results: The mean age of 1795 respondents was 68.5 (SD 8.5) years, 56% were female, and the median TBQ score was 12 (IQR 5–25). Overall, 87% (n = 1550) reported treatment burden (TBQ score ≥ 1); 5% reported high burden. The most common sources of treatment burden were reminders of health problems (61%) and administrative (53%) and financial burdens (46%). Adults age ≥ 65 years were both less likely to report treatment burden and reported lower burden than adults age 50–64 years. Factors associated with greater burden included a higher number of chronic conditions, vision or hearing impairment, ADL/IADL difficulty, and mobility difficulty.Conclusions: Most US adults age ≥ 50 years report treatment burden, though there is wide variation in the degree of burden reported. Reducing treatment burden within the US may require reducing administrative and financial burdens of care and addressing factors that impair patient capacity to manage health and health care.

This study characterizes 2008-2022 FDA advisory committee discussions of new supplemental indication applications that were not approved by FDA. Discussion themes included contextual concerns unique to already-approved drugs, including insights from prior experience and concerns about off-label use, and efficacy and safety concerns also observed for new drugs. These findings highlight advisory committees’ role in transparency of regulatory decision-making, specifically for drugs already authorized for use.

Background: Central nervous system (CNS) medications are linked to higher morbidity and mortality in older adults. Hospitalization allows for deprescribing opportunities. This qualitative study investigates clinician and patient perspectives on CNS medication deprescribing during hospitalization using a behavioral change framework, aiming to inform interventions and identify recommendations to enhance hospital deprescribing processes. Methods: This qualitative study focused on hospitalists, primary care providers, pharmacists, and patients aged ≥60 years hospitalized on a general medicine service and prescribed ≥1 CNS medications. Using semi‐structured interviews and focus groups, we aimed to evaluate patient medication knowledge, prior deprescribing experiences, and decision‐making preferences, as well as provider processes and tools for medication evaluation and deprescribing. Rapid qualitative analysis applying the Capability, Opportunity, Motivation, and Behavior (COM‐B) framework revealed themes influencing deprescribing behavior in patients and providers. Results: A total of 52 participants (20 patients and 32 providers) identified facilitators and barriers across deprescribing steps and generated recommended strategies to address them. Clinicians and patients highlighted the opportunity for CNS medication deprescribing during hospitalizations, facilitated by multidisciplinary teams enhancing clinicians' capability to make medication changes. Both groups also stressed the importance of intensive patient engagement, education, and monitoring during hospitalizations, acknowledging challenges in timing and extent of deprescribing, with some patients preferring decisions deferred to outpatient clinicians. Hospitalist and pharmacist recommendations centered on early pharmacist involvement for medication reconciliation, expanding pharmacy consultation and clinician education on deprescribing, whereas patients recommended enhancing shared decision‐making through patient education on medication adverse effects, tapering plans, and alternatives. Hospitalists and PCPs also emphasized standardized discharge instructions and transitional care calls to improve medication review and feedback during care transitions. Conclusions: Clinicians and patients highlighted the potential advantages of hospital interventions for CNS medication deprescribing, emphasizing the necessity of addressing communication, education, and coordination challenges between inpatient and outpatient settings.

The impact and effectiveness of clinical trial data sharing initiatives may differ depending on the data sharing model used. We characterized outcomes associated with models previously used by the U.S. National Institutes of Health (NIH): National Heart, Lung, and Blood Institute’s (NHLBI) centralized model and National Cancer Institute’s (NCI) decentralized model. We identified trials completed in 2010–2013 that met NIH data sharing criteria and matched studies based on cost and/or size, determining whether trial data were shared, and for those that were, the frequency of secondary internal publications (authored by at least one author from the original research team) and shared data publications (authored by a team external to the original research team). We matched 77 NHLBI-funded trials to 77 NCI-funded trials; among these, 20 NHLBI-sponsored trials (26%) and 4 NCI-sponsored trials (5%) shared data (OR 6.4, 95% CI: 2.1, 19.8). From the 4 NCI-sponsored trials sharing data, we identified 65 secondary internal and 2 shared data publications. From the 20 NHLBI-sponsored trials sharing data, we identified 188 secondary internal and 53 shared data publications. The NHLBI’s centralized data sharing model was associated with more trials sharing data and more shared data publications when compared with the NCI’s decentralized model.

Background The impact and value of clinical trial data sharing, including the number and quality of publications that result from shared data – “shared data publications” – may differ depending on the data sharing model used. Methods We characterized the outcomes associated with two data sharing models previously used by Institutes of the U.S. National Institutes of Health (NIH): NHLBI’s centralized model, which uses a repository to manage data sharing requests, and NCI’s decentralized model, which entrusted research groups to independently manage data sharing requests. We identified trials completed in 2010 that met NIH data sharing criteria and matched studies sponsored by each Institute based on cost or size, determining whether trial data were shared and the frequency of shared data publications. Results We identified 14 NHLBI-funded trials and 48 NCI-funded trials that met NIH data sharing criteria. We matched 14 NCI-funded trials to the 14 NHLBI-funded trials; among these, 4 NHLBI-sponsored trials (29%) and 2 NCI-sponsored trials (14%) shared data. From the 2 NCI-sponsored trials sharing data, we identified 2 shared data publications, one per trial, both of which were meta-analyses. From the 4 NHLBI-sponsored trials sharing data, we identified 7 shared data publications, all using data from 1 trial, 5 of which were pooled analyses and 2 reported secondary outcomes. Conclusion When characterizing the outcomes associated with two NIH data sharing models, both the NHLBI and the NCI models resulted in only 21% of trials sharing data and few shared data publications. There are opportunities to optimize clinical trial data sharing efforts both to enhance clinical trial data sharing and increase the number of shared data publications.

Background/Aims: The US Food and Drug Administration outlines clinical studies as postmarketing requirements and commitments to be fulfilled following approval of new drugs and biologics (“therapeutics”). Regulators have increasingly emphasized lifecycle evaluation of approved therapeutics, and postmarketing studies are intended to advance our understanding of therapeutic safety and efficacy. However, little is known about the indications that clinical studies outlined in postmarketing requirements and commitments investigate, including whether they are intended to generate evidence for approved or other clinical indications. Therefore, we characterized US Food and Drug Administration postmarketing requirements and commitments for new therapeutics approved from 2009 to 2018. Methods: We conducted a cross-sectional study of all novel therapeutics, including small-molecule drugs and biologics, receiving original US Food and Drug Administration approval from 2009 to 2018, using approval letters accessed through the Drug@FDA database. Outcomes included the number and characteristics of US Food and Drug Administration postmarketing requirements and commitments for new therapeutics at original approval, including the types of studies outlined, the indications to be investigated, and the clinical evidence to be generated. Results: From 2009 to 2018, the US Food and Drug Administration approved 343 new therapeutics with 1978 postmarketing requirements and commitments. Overall, 750 (37.9%) postmarketing requirements and commitments outlined clinical studies. For 71 of 343 (20.7%) therapeutics, no postmarketing requirements or commitments for clinical studies were outlined, while at least 1 was outlined for 272 (79.3%; median 2 (interquartile range: 1–4)). Among these 272 therapeutics, the number of postmarketing requirements and commitments for clinical studies per therapeutic did not change from 2009 (median: 2 (interquartile range: 1–4)) to 2018 (median: 2 (interquartile range: 1–3)). Among the 750 postmarketing requirements and commitments for clinical studies, 448 (59.7%) outlined new prospective cohort studies, registries, or clinical trials, while the remainder outlined retrospective studies, secondary analyses, or completion of ongoing studies. Although 455 (60.7%) clinical studies investigated only original approved therapeutic indications, 123 (16.4%) enrolled from an expansion of the approved disease population and 61 (8.1%) investigated diseases unrelated to approved indications. Conclusions: The US Food and Drug Administration approves most new therapeutics with at least 1 postmarketing requirement or commitment for a clinical study, and outlines investigations of safety or efficacy for both approved and unapproved indications. The median number of 2 clinical studies outlined has remained relatively constant over the last decade. Given increasing emphasis by the US Food and Drug Administration on faster approval and lifecycle evaluation of therapeutics, these findings suggest that more postmarketing requirements and commitments may be necessary to address gaps in the clinical evidence available for therapeutics at approval.

Background/Aims: The U.S. Food and Drug Administration (FDA) outlines clinical studies as postmarketing requirements and commitments to be fulfilled following FDA approval of new drugs and biologics (“therapeutics”). As regulators have increasingly emphasized lifecycle evaluation of approved therapeutics, postmarketing studies are intended to advance our understanding of therapeutic safety and efficacy, yet little is known about how often clinical studies are outlined or the indications they investigate. Therefore, we characterized FDA postmarketing requirements and commitments for new therapeutics approved from 2009-2018. Methods: We conducted a cross-sectional study of all novel therapeutics, including small molecule drugs and biologics, receiving original FDA approval from 2009-2018, using approval letters accessed through the Drug@FDA database. Outcomes included the number and characteristics of FDA postmarketing requirements and commitments for new therapeutics at original approval, including types of studies outlined, indications to be investigated, and clinical evidence to be generated. Results: From 2009-2018, FDA approved 343 new therapeutics with 1978 postmarketing requirements and commitments. Overall, 750 (37.9%) postmarketing requirements and commitments outlined clinical studies. For 71 of 343 (20.7%) therapeutics, no postmarketing requirements nor commitments for clinical studies were outlined, while at least 1 was outlined for 272 (79.3%; median = 2 (IQR, 1-4)). Among these 272 therapeutics, the number of postmarketing requirements and commitments for clinical studies per therapeutic did not significantly change from 2009 (median 2 (IQR, 1-4)) to 2018 (median 2 (IQR, 1-3); P = .54). Among the 750 postmarketing requirements and commitments for clinical studies, 448 (59.7%) outlined new prospective cohort studies, registries, or clinical trials, while the remainder outlined retrospective studies, secondary analyses, or completion of ongoing studies. Although 455 (60.7%) clinical studies investigated only original approved therapeutic indications, 123 (16.4%) enrolled from an expansion of the approved disease population and 61 (8.1%) investigated diseases unrelated to approved indications. Conclusions: Most therapeutics are approved by FDA with at least 1 postmarketing requirement or commitment for a clinical study, which outline investigations of safety or efficacy for both approved and unapproved indications. However, the median number of 2 clinical studies outlined has remained relatively constant over the last decade, despite increasing emphasis on lifecycle evaluation of approved therapeutics.