Different Responses to Social Capital Among Black People and White People: What Racial Differential Item Functioning Reveals for Racial Health Equity.

Social capital has been conceptualized as features of social organization, such as networks, and norms that facilitate coordination and cooperation for mutual benefit. Because of long-standing anti-Black structural oppression in the United States, social capital may be associated with health differently for Black people than for other racial/ethnic groups. Our aim was to examine the psychometric properties of social capital indicators, comparing responses from Black and White people to identify whether there is differential item functioning (DIF) in social capital according to race. DIF examines how items are related to a latent construct and whether this relationship differs across groups such as different racial groups. We used data from respondents to the Southeastern Pennsylvania Household Health Survey in 2004, who lived in Philadelphia (n = 2,048), a city with a large Black population. We used item response theory analysis to test for racial DIF. We found DIF across the items, indicating measurement error, which could be related to the way these items were developed (i.e., based on cultural assumptions tested in mainstream White America). Hence, our findings underscore the need to interrogate the assumptions that underly existing social capital items through an equity-based lens, and to take corrective action when developing new items to ensure that they are racially and culturally congruent.

Advancing pharmacist prescribing privileges: Is it time?

OBJECTIVES: The rising cost of health care, impact of the aging population, physician shortages, and access to care issues have stressed the U.S. health care system. There is no single solution to combat the complexity of issues concerning the health care system; however, there are potential solutions, such as expanding the role of pharmacists, in efforts to alleviate some stress. Advancing the scope of pharmacy practice with the inclusion of autonomous prescribing authority may enhance access to health care if barriers to pharmacist-provided patient care are removed. Understanding the perceptions of pharmacists, providers, and patients regarding the expansion of prescribing privileges may assist in this effort. SUMMARY: Collaborative practice agreements between physicians and pharmacists have fostered the expansion of the role of pharmacists; however, autonomous prescriptive authority for pharmacists would promote access to vaccines, naloxone for opioids, hormonal contraceptives, travel medications, tobacco cessation medications, and more. Before experiencing the integration of a pharmacist into their practice, an initial concern of physicians consisted of not fully understanding the role of pharmacists. Additional concerns in advancing the pharmacy profession include liability, provider-provider communication, payment for services, as well as training and inadequate infrastructure. CONCLUSION: Among the states that have expanded prescriptive authority for pharmacists, experiences among stakeholders have been positive. As with any major change, it will take time to implement proper structures and processes, with continuous revisions to address barriers and challenges that may arise. There will be a need for training as well as educating various stakeholders about the changes in the scope of pharmacy practice. Leveraging the experience of states that already have prescriptive authority protocols in place can aid in this endeavor. Limiting pharmacists by not providing prescriptive authority would not be a good alternative-tapping into an underused resource is better than reinventing the wheel.

Longitudinal impact of volunteering on the cognitive functioning of older adults: A secondary analysis from the US Health and Retirement Study.

Objectives: To examine the relationship of volunteering with cognitive activity, social activity, and physical activity among older adults and, ultimately, with later cognitive functioning across different time periods. Methods: We used individual responding to three waves of the US Health and Retirement Study panel data from 2008, 2012, and 2016 (n = 2,862). Self-reported questionnaires were used to assess annual volunteering frequency (non volunteering, volunteering <100 h and ≥100 h), and an adapted version of the Telephone Interview for Cognitive Status (TICS) was used to assess memory, mental processing, knowledge, language, and orientation. A structural equation model was estimated to assess effects on cognitive functioning throughout waves. Results: Those participants that were part of volunteering activities in 2012 showed an increase between 2008 and 2012 in moderate physical activity (ß = 0.19, P < 0.001 for those volunteering less than 100 h and ß = 0.21, P < 0.001 for those volunteering at least 100 h), increase in social activity (ß = 0.10, P = 0.052 for those volunteering less than 100 h and ß = 0.12, P = 0.018 for those volunteering at least 100 h) and increase in higher cognitive activity (ß = 0.13, P < 0.001 for those volunteering at least 100 h), compared to participants who did not volunteer. Higher levels of cognitive activity in 2008 and 2012 were associated with higher cognitive functioning on the following waves (ß = 0.66 and ß = 0.60, P < 0.001, respectively). Discussion: Volunteering is a modifiable activity that can be increased to bolster cognitive functioning in older adulthood, primarily mediated by increased cognitive activity.

Capturing the patient experience in systemic lupus erythematosus: Are widely used measures fit-for-purpose and adherent to FDA PRO guidance recommendations?

BACKGROUND: The 2009 Food and Drug Administration (FDA) patient-reported outcome (PRO) guidance outlines characteristics of rigorous PRO-measure development. There are a number of widely used PRO measures for Systemic Lupus Erythematosus (SLE), but it is unknown how well the development processes of SLE PRO measures align with FDA guidance; including updated versions. The objective of this study was to assess how well the LupusQoL and LupusPRO, and corresponding updated versions, LupusQoL-US and LupusPROv1.8, align with Food and Drug Administration (FDA) 2009 patient-reported outcome (PRO) guidance. METHODS: LupusQoL and LupusPRO were selected as the most widely studied and used Lupus PROs in the UK and US. Original (LupusQoL (2007) and LupusQoL-US (2010)) and revised (LupusPROVv1.7 (2012) and LupusPROv1.8 (2018)) versions were reviewed. We used FDA PRO guidance to create evaluation criteria for key components: target population, concepts measured, measurement properties, documentation across the phases of content validity (item-generation and cognitive interviewing, separately) and other psychometric-property testing. Two reviewers abstracted data independently, compared results, and resolved discrepancies. RESULTS: For all measures, the target population was unclear as population characteristics (e.g., ethnicity, education, disease severity) varied, and/or were not consistently reported or not considered across the three phases (e.g., LupusQoL item-generation lacked male involvement, LupusPRO cognitive-interviewing population characteristics were not reported). The item-generation phase for both original measures was conducted with concepts elicited via patient-engagement interviews and item derivation from experts. Cognitive interviewing was conducted via patient feedback with limited item-tracking for original measures. In contrast, the revised measures assumed content validity. Other psychometric testing recommendations (reliability, construct validity, ability to detect change) were reported for both original and revised measures, except for ability to detect change for revised measures. CONCLUSIONS: The SLE PRO measures adhere to some but not all FDA PRO guidance recommendations. Limitations in processes and documentation of the study population, make it unclear for which target population(s) the current Lupus measures are fit-for-purpose.

Patient-reported outcomes in breast cancer FDA drug labels and review documents.

BACKGROUND: Patient-reported outcomes (PROs) can provide valuable information about drug benefit-risk tradeoffs from the patient perspective and are particularly important to patients with breast cancer due to its symptoms and adverse events from breast cancer treatments. The United States Food and Drug Administration (U.S. FDA) has acknowledged PROs as important approval endpoints used in clinical trials of cancer drugs. However, previous studies found that PROs are rarely mentioned in cancer drug labels, a widely used and trusted source of information about drugs. Our objectives were to compare PRO data reported in FDA labeling versus FDA medical review documents for breast cancer drugs approved in the U.S. between 2000 and 2019 to identify possible causes for PRO-data labeling exclusions. METHODS: We included new molecular entities (NMEs) and biologic license applications (BLAs) initially approved for breast cancer treatment by the FDA between 1/1/2000 and 12/31/2019. Product labeling and FDA medical review documents were collected from the FDA-Approved Drugs database (Drugs@FDA). From these resources, details on PRO measures used in trials, design of trials using PRO measures, PRO-endpoint status, analytical methods, and FDA reviewer comments regarding PRO measurement were extracted. RESULTS: Of 633 FDA-approved drugs, 13 were indicated for breast cancer treatment; none of their prescribing information contained information about PROs. However, 11 of 13 (85%) included PRO measures and endpoint information in FDA medical review documents. PRO measures were used in 14 different clinical trials, and FDA reviewers' comments regarding PRO measurement were related to lack of meaningfulness and clinical significance, lack of content validity, and inadequate analytical methods. CONCLUSIONS: Despite the importance of PROs to patients with breast cancer, PRO measures were only described in FDA medical review documents of breast cancer drugs, but not in drug product labeling. Therefore, it appears that PRO data are often collected in breast cancer trials, but have not been methodologically acceptable to FDA reviewers. Collaborative efforts between the FDA and industry are warranted to increase the number of breast cancer drug applications with appropriate use of PRO measures and endpoints.

Social capital and cost-related medication nonadherence (CRN): A retrospective longitudinal cohort study using the Health and Retirement Study data, 2006-2016.

Prescription drug spending and other financial factors (e.g., out-of-pocket costs) partially explain variation in cost-related medication nonadherence (CRN). Indicators of social capital such as neighborhood factors and social support may influence the health and well-being of older adults as they may rely on community resources and support from family and peers to manage conditions. Previous research on the relationship of social capital and CRN has limited evidence and contradictory findings. Hence, our objective is to assess the relationship of social capital indicators (neighborhood social cohesion, neighborhood physical disorder, positive social support, and negative social support) and CRN using a longitudinal design, 2006 to 2016, in a nationally representative sample of older adults in the United States (US). The Health and Retirement Study is a prospective panel study of US adults aged ≥ 50 years evaluated every two years. Data was pooled to create three waves and fitted using Generalized Estimating Equation modelling adjusting for both baseline and timevarying covariates (age, sex, education, race, total household income, and perceived health status). The three waves consisted of 11,791, 12,336, and 9,491 participants. Higher levels of neighborhood social cohesion and positive social support were related with lower CRN (OR 0.92, 95% CI 0.88-0.95 and OR 0.77, 95% CI 0.70-0.84, p<0.01). In contrast, higher levels of neighborhood physical disorder and negative social support were related to higher CRN (OR 1.07, 95% CI 1.03-1.11 and OR 1.46, 95% CI 1.32-1.62, p<0.01). Interventions targeting social capital are needed, reinforcing positive social support and neighborhood social cohesion and diminishing neighborhood physical disorder and negative social support for older adults.