Medication Cost Concerns and Disparities in Patient-Reported Outcomes Among a Multiethnic Cohort of Patients With Systemic Lupus Erythematosus.

OBJECTIVE: Concerns about the affordability of medications are common in systemic lupus erythematosus (SLE), but the relationship between medication cost concerns and health outcomes is poorly understood. We assessed the association of self-reported medication cost concerns and patient-reported outcomes (PROs) in a multiethnic SLE cohort. METHODS: The California Lupus Epidemiology Study is a cohort of individuals with physician-confirmed SLE. Medication cost concerns were defined as having difficulties affording SLE medications, skipping doses, delaying refills, requesting lower-cost alternatives, purchasing medications outside the United States, or applying for patient assistance programs. Linear regression and mixed effects models assessed the cross-sectional and longitudinal association of medication cost concerns and PROs, respectively, adjusting for age, sex, race and ethnicity, income, principal insurance, immunomodulatory medications, and organ damage. RESULTS: Of 334 participants, medication cost concerns were reported by 91 (27%). Medication cost concerns were associated with worse Systemic Lupus Activity Questionnaire (SLAQ; beta coefficient [ß] 5.9, 95% CI 4.3-7.6; P < 0.001), 8-item Patient Health Questionnaire depression scale (PHQ-8; ß 2.7, 95% CI 1.4-4.0; P < 0.001), and Patient-Reported Outcomes Measurement Information System (PROMIS; ß for physical function -4.6, 95% CI -6.7 to -2.4; P < 0.001) scores after adjusting for covariates. Medication cost concerns were not associated with significant changes in PROs over 2-year follow-up. CONCLUSION: More than a quarter of participants reported at least 1 medication cost concern, which was associated with worse PROs. Our results reveal a potentially modifiable risk factor for poor outcomes rooted in the unaffordability of SLE care.

Examining socioeconomic status disparities in facility-based childbirth in Kenya: role of perceived need, accessibility, and quality of care.

BACKGROUND: Giving birth in health facilities with skilled birth attendants (SBAs) is one of the key efforts promoted to reduce preventable maternal deaths in sub-Saharan Africa. However, research has revealed large socioeconomic status (SES) disparities in facility-based childbirth. We seek to extend the literature on the factors underlying these SES disparities. Drawing on the Disparities in Skilled Birth Attendance (DiSBA) framework, we examined the contribution of three proximal factors-perceived need, accessibility, and quality of care-that influence the use of SBAs. METHODS: We used data from a survey conducted in Migori County, Kenya in 2016, among women aged 15-49 years who gave birth nine weeks before the survey (N = 1020). The primary outcome is facility-based childbirth. The primary predictors are wealth, measured in quintiles calculated from a wealth index based on principal component analysis of household assets, and highest education level attained. Proposed mediating variables include maternal perceptions of need, accessibility (physical and financial), and quality of care (antenatal services received and experience of care). Logistic regression with mediation analysis was used to investigate the mediating effects. RESULTS: Overall, 85% of women in the sample gave birth in a health facility. Women in the highest wealth quintile were more likely to give birth in a facility than women in the lowest quintile, controlling for demographic factors (adjusted odds ratio [aOR]: 2.97, 95% CI: 1.69-5.22). College-educated women were five times more likely than women with no formal education or primary education to give birth in a health facility (aOR: 4.96; 95% CI: 1.43-17.3). Women who gave birth in health facilities had higher perceived accessibility and quality of care than those who gave birth at home. The five mediators were estimated to account for between 15% and 48% of the differences in facility births between women in the lowest and higher wealth quintiles. CONCLUSION: Our results confirm SES disparities in facility-based childbirth, with the proximal factors accounting for some of these differences. These proximal factors - particularly perceived accessibility and quality of care - warrant attention due to their relationship with facility-birth overall, and their impact on inequities in this care.

Insurance impacts survival for children, adolescents, and young adults with bone and soft tissue sarcomas.

BACKGROUND: While racial/ethnic survival disparities have been described in pediatric oncology, the impact of income has not been extensively explored. We analyzed how public insurance influences 5-year overall survival (OS) in young patients with sarcomas. METHODS: The University of California San Francisco Cancer Registry was used to identify patients aged 0-39 diagnosed with bone or soft tissue sarcomas between 2000 and 2015. Low-income patients were defined as those with no insurance or Medicaid, a means-tested form of public insurance. Survival curves were computed using the Kaplan-Meier method and compared using log-rank tests and Cox models. Causal mediation was used to assess whether the association between public insurance and mortality is mediated by metastatic disease. RESULTS: Of 1106 patients, 39% patients were classified as low-income. Low-income patients were more likely to be racial/ethnic minorities and to present with metastatic disease (OR 1.96, 95% CI 1.35-2.86). Low-income patients had significantly worse OS (61% vs 71%). Age at diagnosis and extent of disease at diagnosis were also independent predictors of OS. When stratified by extent of disease, low-income patients consistently had significantly worse OS (localized: 78% vs 84%, regional: 64% vs 73%, metastatic: 23% vs 30%, respectively). Mediation analysis indicated that metastatic disease at diagnosis mediated 15% of the effect of public insurance on OS. CONCLUSIONS: Low-income patients with bone and soft tissue sarcomas had decreased OS regardless of disease stage at presentation. The mechanism by which insurance status impacts survival requires additional investigation, but may be through reduced access to care.

Shamba Maisha: randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes.

OBJECTIVES: Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. DESIGN: This is a pilot cluster randomized controlled trial. METHODS: The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years' old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for 1 year. Data were collected on nutritional parameters, CD4 T-lymphocyte counts, and HIV RNA. Differences in fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. RESULTS: We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/µl, P < 0.001) and proportion virologically suppressed in the intervention arm compared with the control arm (comparative improvement in proportion of 0.33 suppressed, odds ratio 7.6, 95% confidence interval: 2.2-26.8). Intervention participants experienced significant improvements in food security (3.6 scale points higher, P < 0.001) and frequency of food consumption (9.4 times per week greater frequency, P = 0.013) compared to controls. CONCLUSION: Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity.

Projected future increase in aging hepatitis C virus-infected liver transplant candidates: a potential effect of hepatocellular carcinoma.

In the United States, the peak hepatitis C virus (HCV) antibody prevalence of 4% occurred in persons born in the calendar years 1940-1965. The goal of this study was to examine observed and projected age-specific trends in the demand for liver transplantation (LT) among patients with HCV-associated liver disease stratified by concurrent hepatocellular carcinoma (HCC). All new adult LT candidates registered with the Organ Procurement and Transplantation Network for LT between 1995 and 2010 were identified. Patients who had primary, secondary, or text field diagnoses of HCV with or without HCC were identified. There were 126,862 new primary registrants for LT, and 52,540 (41%) had HCV. The number of new registrants with HCV dramatically differed by the age at calendar year, and this suggested a birth cohort effect. When the candidates were stratified by birth year in 5-year intervals, the birth cohorts with the highest frequency of HCV were as follows (in decreasing order): 1951-1955, 1956-1960, 1946-1950, and 1941-1945. These 4 birth cohorts, spanning from 1941 to 1960, accounted for 81% of all new registrants with HCV. A 4-fold increase in new registrants with HCV and HCC occurred between the calendar years 2000 and 2010 in the 1941-1960 birth cohorts. By 2015, we anticipate that an increasing proportion of new registrants with HCV will have HCC and be ≥60 years old (born in or before 1955). In conclusion, the greatest demand for LT due to HCV-associated liver disease is occurring among individuals born between 1941 and 1960. This demand appears to be driven by the development of HCC in patients with HCV. During the coming decade, the projected increase in the demand for LT from an aging HCV-infected population will challenge the transplant community to reconsider current treatment paradigms.

Gene expression profile testing for breast cancer and the use of chemotherapy, serious adverse effects, and costs of care.

As gene expression profile (GEP) testing for breast cancer may provide additional prognostic information to guide the use of adjuvant chemotherapy, we examined the association between GEP testing and use of chemotherapy, serious chemotherapy-related adverse effects, and total charges during the 12 months following diagnosis. Medical record review was conducted for women age 30-64 years, with incident, non-metastatic, invasive breast cancer diagnosed 2006-2008 in a large, national health plan. Of 534 patients, 25.8% received GEP testing, 68.2% received chemotherapy, and 10.5% experienced a serious chemotherapy-related adverse effect. GEP testing was most commonly used in women at moderate clinical risk of recurrence (52.0 vs. 25.0% of low-risk women and 5.5% of high-risk). Controlling for the propensity to receive GEP testing, women who had GEP were less likely to receive chemotherapy (propensity adjusted odds ratio, 95% confidence interval 0.62, 0.39-0.99). Use of GEP was associated with more chemotherapy use among women at low risk based on clinical characteristics (OR = 42.19; CI 2.50-711.82), but less use among women with a high risk based on clinical characteristics (OR = 0.12; CI 0.03-0.47). Use of GEP was not associated with chemotherapy for the moderate risk group. There was no significant relationship between GEP use and either serious chemotherapy-associated adverse effects or total charges. While GEP testing was associated with an overall decrease in adjuvant chemotherapy, we did not find differences in serious chemotherapy-associated adverse events or charges during the 12 months following diagnosis.

Impact of the lung allocation score on lung transplantation for pulmonary arterial hypertension.

RATIONALE: In 2005, lung allocation for transplantation in the United States changed from a system based on waiting time to a system based on the Lung Allocation Score (LAS). OBJECTIVES: To study the effect of the LAS on lung transplantation for idiopathic pulmonary arterial hypertension (IPAH) compared with other major diagnoses. METHODS: We studied 7,952 adults listed for lung transplantation between 2002 and 2008. Analyses were restricted to patients with IPAH, idiopathic pulmonary fibrosis (IPF), chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF). Transplantation, waiting list mortality, and post-transplant mortality were compared between diagnoses for patients listed before and after implementation of the LAS. MEASUREMENTS AND MAIN RESULTS: The likelihood of transplantation from the waiting list increased for all diagnoses after implementation of the LAS. Waiting list mortality decreased for every diagnosis, except for IPAH, which remained unchanged. Implementation of the LAS was not associated with changes in post-transplant mortality for any diagnosis. Under the LAS system, patients with IPAH were less likely to be transplanted than patients with IPF (hazard ratio [HR], 0.53; P < 0.001) or CF (HR, 0.49; P < 0.001) and at greater risk of death on the waiting list than patients with COPD (HR, 3.09; P < 0.001) or CF (HR, 1.83; P = 0.025) after adjustment for demographics and transplant type. Post-transplant mortality for IPAH was not statistically different from that of other diagnoses. CONCLUSIONS: Implementation of the LAS has improved the likelihood of lung transplantation for listed patients with IPAH, but mortality on the waiting list remains high compared with other major diagnoses.

Audio computer-assisted self-interviewing in reproductive health research: reliability assessment among women in Harare, Zimbabwe.

PURPOSE: Research on the measurement of HIV risk demonstrates that interview mode can affect reporting; however, few studies have applied these findings to assessments of hormonal contraceptive use. This paper examines how audio computer-assisted self-interviewing (ACASI) influenced reports of hormonal contraceptive use and pregnancy among Zimbabwean women. METHODS: Using a prospective, randomized, cross-over design, we compared self-reports obtained with ACASI and face-to-face (FTF) interview among 655 women enrolled in a prospective study on hormonal contraceptive use and HIV acquisition. In addition, self-report data were compared to those collected during clinical exams. RESULTS: Compared to FTF interviews, reports of hormonal contraceptive use were lower in ACASI [odds ratio (OR)=0.6; 95% confidence interval (95% CI)=0.5-0.6], and reports of pregnancy were higher (OR=1.5; 95% CI=1.1-1.9). Both modes of self-report differed from records on contraceptive method disbursement. CONCLUSION: Although ACASI yielded higher reports of several reproductive health behaviors, discrepancies between self-reports and clinical data on method disbursement highlight persistent measurement challenges.

Evaluating change in health-related quality of life in adult rhinitis: responsiveness of the Rhinosinusitis Disability Index.

BACKGROUND: The Rhinosinusitis Disability Index (RSDI) is a validated measure of health-related quality of life (HRQL) in rhinitis. Responsiveness of the RSDI to changes in health status over time has not been described. METHODS: We studied adults with a self-reported physician diagnosis of rhinitis identified through a national telephone survey. HRQL was assessed at baseline and at 24 months using the RSDI. Symptom severity, physical health status (SF-12 PCS), psychological mood (CES-D), and perceived control of symptoms were also assessed at the time of each interview. In addition, we ascertained specific health outcomes attributed to rhinitis, including days of restricted activity, job effectiveness, number of physician visits, and medication costs. RESULTS: Of 109 subjects interviewed at baseline, 69 (63%) were re-interviewed 24 months later. RSDI scores improved by = 0.5 standardized response mean in 13 (19%) subjects and worsened in 17 (25%). Change in the RSDI over time correlated with changes in symptom severity (r = 0.38, p = 0.001), physical health (r = -0.39, p = 0.001), mood (r = 0.37, p = 0.002) and perceived control of symptoms (r = -0.37, p = 0.01). In multivariate analyses adjusted for baseline health status, improvement in RSDI was associated with less restricted activity (p = 0.01), increased job effectiveness (p = 0.03), and decreased medication costs (p = 0.05), but was not associated with change in the number of physician visits from baseline (p = 0.45). CONCLUSION: The RSDI is responsive to changes in health status and predicts rhinitis-specific health outcomes.

A comprehensive study of the direct and indirect costs of adult asthma.

BACKGROUND: Asthma is a common and costly health condition, but most estimates of its economic effect have relied on secondary sources with limited condition-specific detail. OBJECTIVE: We sought to estimate the magnitude of direct and indirect costs of adult asthma from the perspective of society. METHODS: We used cross-sectional survey data from an ongoing community-based panel study of 401 adults with asthma originally derived from random samples of northern California pulmonologists, allergist-immunologists, and family practitioners to assess health care use for asthma, to assess purchase of items to assist with asthma care, and to measure work and other productivity losses. Unit costs derived from public-use and proprietary data sources were then assigned to the survey items. RESULTS: Total per-person annual costs of asthma averaged $4912 US dollars, with direct and indirect costs accounting for $3180 US dollars (65%) and $1732 US dollars (35%), respectively. The largest components within direct costs were pharmaceuticals ($1605 US dollars [50%]), hospital admissions ($463 US dollars[15%]), and non-emergency department ambulatory visits ($342 US dollars [11%]). Within indirect costs, total cessation of work accounted for $1062 US dollars (61%), and the loss of entire work days among those remaining employed accounted for another $486 US dollars (28%). Total per-person costs were $2646, $4530, and $12,813 US dollars for persons self-reporting mild, moderate, and severe asthma, respectively (P <.0001, 1-way ANOVA). CONCLUSION: Asthma-related costs are substantial and are driven largely by pharmaceuticals and work loss.

Applications of continuous time hidden Markov models to the study of misclassified disease outcomes.

Disease progression in prospective clinical and epidemiological studies is often conceptualized in terms of transitions between disease states. Analysis of data from such studies can be complicated by a number of factors, including the presence of individuals in various prevalent disease states and with unknown prior disease history, interval censored observations of state transitions and misclassified measurements of disease states. We present an approach where the disease states are modelled as the hidden states of a continuous time hidden Markov model using the imperfect measurements of the disease state as observations. Covariate effects on transitions between disease states are incorporated using a generalized regression framework. Parameter estimation and inference are based on maximum likelihood methods and rely on an EM algorithm. In addition, techniques for model assessment are proposed. Applications to two binary disease outcomes are presented: the oral lesion hairy leukoplakia in a cohort of HIV infected men and cervical human papillomavirus (HPV) infection in a cohort of young women. Estimated transition rates and misclassification probabilities for the hairy leukoplakia data agree well with clinical observations on the persistence and diagnosis of this lesion, lending credibility to the interpretation of hidden states as representing the actual disease states. By contrast, interpretation of the results for the HPV data are more problematic, illustrating that successful application of the hidden Markov model may be highly dependent on the degree to which the assumptions of the model are satisfied.