At the intersection of pharmacovigilance (PV), Participant Data Return (PDR), and health literacy lies a social contract in healthcare. This implicit agreement reflects the shared responsibilities of pharmaceutical companies, healthcare providers, and patients to protect individual rights while promoting collective well-being. PV, PDR, and health literacy form a triad that ensures patients are not only protected but actively informed and engaged in their healthcare journey, fostering transparency, trust, and empowerment. PV, as a cornerstone of drug safety, upholds this social contract by continuously monitoring, identifying, and mitigating adverse reactions through collaboration with patients and healthcare providers. By encouraging patient participation in adverse event reporting, PV systems strengthen safety surveillance and reinforce the reciprocal nature of trust and accountability in healthcare. PDR strengthens this relationship by promoting ethical transparency in clinical trials. It gives participants access to their own data, supporting informed decisions and increasing public confidence in research. Health literacy empowers individuals by helping them understand and act upon health information. By leveraging tools and strategies that simplify complex medical data, pharmaceutical companies fulfill their responsibility to equip patients with the knowledge to make informed healthcare decisions. In doing so, all three honor the social contract by fostering equitable access to information and promoting patient-centered care. This manuscript highlights how PV, PDR, and health literacy work together to uphold ethical healthcare practices. Each contributes to a system built on trust, transparency, and shared responsibility; core values that reinforce positive patient outcomes and the foundation of a fair, effective healthcare ecosystem.

The United States Centers for Disease Control and Prevention (CDC) advises testing individuals for COVID-19 after exposure or if they display symptoms. However, a deeper understanding of demographic factors associated with testing hesitancy is necessary. A US nationwide cross-sectional survey of adults with risk factors for developing severe COVID-19 (“high-risk” individuals) was conducted from August 18–September 5, 2023. Objectives included characterizing demographics and attitudes associated with COVID-19 testing. Inverse propensity weighting was used to weight the data to accurately reflect the high-risk adult US population as reflected in IQVIA medical claims data. We describe here the weighted results modeled to characterize demographic factors driving hesitancy. In the weighted sample of 5019 respondents at high risk for severe COVID-19, 58.2

Objective: Advancements in diagnostics and treatment options for cardiac amyloidosis have improved patient outcomes, yet few patient education materials exist to help patients understand the disease and diagnosis process. We sought to develop and evaluate a set of plain language, patient-centered infographics describing the condition and common diagnostic tests. Methods: Using health literacy best practices, we developed 7 infographics which were further revised based on multilevel stakeholder feedback. To evaluate the materials, we recruited 100 patients from healthcare settings in Chicago, IL; participants completed a web-assisted interview during which they were randomized 1:1 to first view either our infographics or a standard material. Participants completed a knowledge assessment on their assigned material and subsequently reported impressions of both materials. Results: No differences were found between study arms in knowledge. The infographics took significantly less time to read and were more highly rated by participants in terms of appearance and understandability. Over two-thirds of participants preferred the infographics to the standard. Conclusions: The infographics created may improve the learning process about a complex condition and diagnosis process unknown to most adults. Innovation: These infographics are the first of their kind for cardiac amyloidosis and were created using health literacy best practices.

Background: A 2019 public workshop convened by the National Academies of Sciences, Engineering and Medicine (NASEM) Roundtable on Health Literacy identified a need to develop evidence-based guidance for best practices for health literacy and patient activation in clinical trials. Purpose: To identify studies of health literacy interventions within medical care or clinical trial settings that were associated with improved measures of health literacy or patient activation, to help inform best practices in the clinical trial process. Data sources: Literature searches were conducted in PubMed, the Cumulative Index to Nursing and Allied Health Literature, SCOPUS, Cochrane, and Web of Science from January 2009 to June 2021. Study selection: Of 3592 records screened, 22 records investigating 27 unique health literacy interventions in randomized controlled studies were included for qualitative synthesis. Data extraction: Data screening and abstraction were performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Data synthesis: Types of health literacy interventions were multimedia or technology-based (11 studies), simplification of written material (six studies) and in-person sessions (five studies). These interventions were applied at various stages in the healthcare and clinical trial process. All studies used unique outcome measures, including patient comprehension, quality of informed consent, and patient activation and engagement. Conclusions: The findings of our study suggest that best practice guidelines recommend health literacy interventions during the clinical trial process, presentation of information in multiple forms, involvement of patients in information optimization, and improved standardization in health literacy outcome measures.

BACKGROUND The direct costs associated with menopausal and postmenopausal symptoms (hereafter "menopausal symptoms") may include the costs of physician and emergency department visits, medications, laboratory testing, and the management of side effects. However, much remains unknown about the costs related to menopausal symptoms, including how they compare with the costs of other diseases that are common among menopausal women. OBJECTIVE To compare the economic burden of menopausal symptoms with other select prevalent chronic conditions among a nationally representative sample of US menopausal women aged 45 to 65 years. METHODS Women aged 45 to 65 years who have not had a hysterectomy and who participated in the 2010-2012 Medical Expenditure Panel Survey Household Component were included in the analysis. We estimated the direct costs of care associated with the management of menopausal symptoms and compared them with the direct costs of care for other indications, including osteoporosis, influenza, disorders of lipid metabolism, essential hypertension, mood disorders, esophageal disorders, headache, osteoarthritis, urinary tract infections, asthma, glaucoma, anxiety disorder, diabetes, chronic obstructive pulmonary disease/bronchiectasis, and cataract. Regression analyses were used to estimate the differences in direct costs, which included total expenditures and charges for inpatient, outpatient, and emergency department visits. RESULTS The annual per-patient direct cost of menopausal symptoms was $248 in 2010-2012 dollars. Based on the modeled costs, menopausal symptoms were associated with significantly higher annual costs than osteoporosis, disorders of lipid metabolism, and esophageal disorders; and these annual costs were comparable to those of influenza, asthma, anxiety disorder, essential hypertension, and headache. The direct costs associated with the management of menopausal symptoms were significantly lower than the direct costs associated with osteoarthritis, mood disorders, chronic obstructive pulmonary disease/bronchiectasis, urinary tract infections, diabetes, glaucoma, and cataract. CONCLUSION The direct costs of care for menopausal symptoms are substantial and are similar to or greater than the direct healthcare costs associated with a number of medical conditions often requiring medical attention in menopausal women.

Objective:This post hoc analysis compared body weight, body mass index (BMI), and BMI category changes in postmenopausal women treated with conjugated estrogens/bazedoxifene (CE/BZA) versus placebo in the Selective Estrogens, Menopause, and Response to Therapy (SMART) trials.Methods:Data were pooled from five randomized, double-blind, placebo- and active-controlled studies in postmenopausal women aged 40 to 75 years with a uterus given CE 0.45mg/BZA 20mg (n=1,607), CE 0.625mg/BZA 20mg (n=1,598), or placebo (n=1,256) for at least 12 weeks and up to 2 years. Changes from baseline in body weight, BMI (kg/m(2)), and World Health Organization BMI category (underweight <18.5; normal 18.5 to <25; overweight 25 to <30; obese 30) during treatment were evaluated.Results:Mean body weight increased less than 0.9kg and mean BMI increased less than 0.4kg/m(2) in all treatment groups at all time points. There were no statistically significant between-group differences, except for significantly greater increases in weight (P=0.015) and BMI (P=0.014) with placebo versus CE 0.625mg/BZA 20mg at month 12. Approximately, 10% of women in the CE/BZA groups and 11% in the placebo group had increases in body weight greater than 7% of baseline. The majority of BMI changes were within 7%, and there were no statistically significant between-group differences in BMI category distributions during treatment.Conclusions:Significant increases in body weight or BMI were not observed in postmenopausal women receiving CE 0.45mg/BZA 20mg or CE 0.625mg/BZA 20mg for up to 2 years in the Selective Estrogens, Menopause, and Response to Therapy trials.

Background/PurposeLittle information exists on the comparative patient and economic burden of chronic widespread pain (CWP) and fibromyalgia (FM) in the United States.MethodsThis multistage, observational study included an online screening survey of a large geographically diverse US sample to assess CWP status, a physician/site visit to determine FM diagnosis, and an online subject questionnaire to capture clinical characteristics, pain, health status, functioning, sleep, healthcare resource use (HRU), productivity, and costs. Based on the screener and physician evaluation, mutually exclusive groups of subjects without CWP (CWP-), with CWP but without FM (CWP+), and with confirmed FM were identified.ResultsDisease burden was examined in 472 subjects (125 CWP-, 176 CWP+, 171 FM). Age, race, and ethnicity were similar across groups. Mean body mass index and number of comorbidities increased from CWP- to CWP+ to FM (P=0.0044, P<0.0001, respectively). From CWP- to CWP+ to FM, there were reductions in health status (EQ-5D, SF-12) and sleep outcomes (MOS-SS, SSQ) (all P<0.05). Pain severity, interference with function (BPI-SF), and overall work impairment (WPAI:SHP) increased from CWP- to CWP+ to FM (all P<0.0001). Higher proportions of CWP+ (52.8%) and FM subjects (62.6%) were taking pain-related prescription medications relative to CWP- subjects (32.8%; P<0.0001). Significant differences in total direct and indirect costs across the three groups (both P<0.0001) were observed, with highest costs among FM subjects.ConclusionFibromyalgia subjects were characterized by the greatest disease burden with more comorbidities and pain-related medications, poorer health status, function, sleep, lower productivity, and higher costs.

Background Intensive dietary intervention programs may lead to benefits in vitality and other components of health quality. The Women's Health Initiative Dietary Modification (DM) intervention includes a large randomized controlled trial of an intensive intervention.Objective To evaluate whether the intervention is associated with improved health-related quality of life (HRQoL) subscales, overall self-reported health, depression symptoms, cognitive functioning, and sleep quality.Design This randomized controlled trial was analyzed as intent to treat.Participants Between 1993 and 1998, 48,835 women aged 50 to 79 years were recruited by 40 clinical centers across the United States. Eligibility included having fat intake at baseline >= 32% of total calories, and excluded women with any prior colorectal or breast cancer, recent other cancers, type 1 diabetes, or medical conditions with predicted survival <3 years.Intervention Goals were to reduce calories from fat to 20%, increase vegetables and fruit to 5+ servings, and increase grain servings to 6+ servings a day. During the first year, 18 group sessions were held, with quarterly sessions thereafter.Main outcome measures The RAND 36-Item Health Survey was used to assess HRQoL at baseline, Year 1, and close-out (about 8 years postrandomization), and estimate differential HRQoL subscale change scores.Statistical analyses performed Mean change in HRQoL scores (Year 1 minus baseline) were compared by randomization group using linear models.Results At 1 year, there was a differential change between intervention and comparison group of 1.7 units (95% CI 1.5, 2.0) in general health associated with the intervention. DM intervention improved physical functioning by 2.0 units (95% CI 1.7, 2.3), vitality by 1.9 units (95% CI 1.6, 2.2), and global quality of life by 0.09 units (95% CI 0.07, 0.12). With the exception of global quality of life, these effects were significantly modified by body mass index at baseline.Conclusions DM intervention was associated with small, but significant improvements in three HRQoL subscales: general health, physical functioning, and vitality at 1 year follow-up, with the largest improvements seen in the women with the greatest baseline body mass index.

This study compared direct and indirect costs associated with chronic widespread pain (CWP) and fibromyalgia (FM) in the US. Participants ≥18 years old from the general population (N=8,382; females were oversampled), completed an online screener including the London Fibromyalgia Epidemiology Study Screening Questionnaire. Subjects who screened positive (bilateral pain, above/below waist over ≥3 months, lasting ≥1 week; CWP+), and a control group (CWP-) were invited for physician evaluation of FM including a tender point exam. Of 1,331 CWP+ and 502 CWP- subjects who consented to schedule a visit, mutually exclusive groups of CWP- (n=125), CWP+ (n=176) and confirmed FM subjects (n=171) completed a visit and questionnaire including the Work Productivity and Impairment Index (WPAI) and questions on healthcare resource utilization and costs. Statistical significance was tested (0.05 significance level) across the 3 groups using ANOVA (continuous variables) and chi-square or Fisher's exact test (categorical variables). Age and race were similar across groups (46.1-47.2 years, 76.7%-86.4% white), but proportion of females was higher with FM (90.6%) and CWP+ (80.7%) relative to CWP- (64.8%) (P<0.0001). Fewer FM subjects were employed (38.0%) relative to CWP+ (53.4%) and CWP- (51.2%) (P=0.0092). Among those employed, the WPAI showed increases from CWP- to CWP+ to FM in absenteeism (P=0.0076), presenteeism (P<0.0001), and overall work impairment (P<0.0001). In the past 3 months relative to the other two groups, more FM subjects consulted primary care physicians (PCP) for pain (P<0.0001), had more pain-related PCP visits (P<0.05), and had highest prescription pain medication use (P<0.0001). Total direct costs/subject in prior 3 months were $1,394 for FM, $831 for CWP+, and $556 for CWP- (P<0.0001); indirect costs were $6,354, $2,951, and $1,185, respectively (P<0.0001). Subjects with CWP+ and FM were characterized by greater economic burden relative to CWP-, which was highest with FM. This research was supported by Pfizer Inc.

OBJECTIVES:The purpose of our study was to use health-related quality of life data from the Women's Health Initiative to calculate health-related utility weights and examine differences in these health utility weights across different hemoglobin (Hgb) levels. These utility weights could then be used in future cost-effectiveness studies.METHODS:Health utility weights were measured by the Short Form-6D (SF-6D), a health utility index derived from the Short Form Medical Outcomes questionnaire. Adjusted least square means were calculated for each level of Hgb at baseline and in longitudinal regression analysis the relationship between change in Hgb and change in the SF-6D was examined. Both baseline and longitudinal analyses were performed for all postmenopausal women and separately for those with self-reported heart failure, cancer, and osteoarthritis.RESULTS:Women with Hgb in the anemic range had lower health utility weights than those with higher Hgb levels. Longitudinally, a loss of of 2 g/dl Hgb or more was associated with a statistically significant and clinically meaningfully decline in SF-6D in all participants and also in the group of participants with cancer and osteoarthritis, but not in those with heart failure.CONCLUSIONS:Lower levels of Hgb and a loss of Hgb are associated with a statistically significant and clinically meaningful decrement in health utility in all postmenopausal women we studied and also in those with chronic conditions.

Objectives: Gastrointestinal blood loss is a recognized complication of the use of nonsteroidal anti-inflammatory drugs (NSAIDS) in patients with arthritis. We examined the cross-sectional relationship of patient-reported outcomes of overall health, physical function, vitality, and quality of life to hemoglobin (hgb) levels in postmenopausal women with self-reported osteoarthritis to determine whether hgb levels as potential markers of chronic blood loss were associated with these functional outcomes.Methods: Postmenopausal women (N = 64,850) with self-reported osteoarthritis (srOA) at baseline in the Women's Health Initiative study, excluding participants with chronic or hemolytic diseases associated with anemia, had hgb levels measured and completed Short-Form Health Surveys. General linear models analysis adjusting for potential confounders was performed.Results: A nonlinear plateauing relationship between hgb levels and functional outcomes was found. Participants with srOA had statistically significantly worse overall health, physical function, and vitality, but not quality of life, for each gram of hgb below 14 g/dL, compared with those with hgb 14 g/dL (P < 0.001). Participants with srOA taking NSAIDS had worse functional outcomes for each level of hgb compared with those not reporting NSAIDS use.Conclusions: In cross-sectional analyses of postmenopausal women with srOA, differences in hgb levels are related to differences in functional outcomes of overall health, physical function, and vitality at clinically important levels. Prospective studies evaluating whether changes in hgb levels result in changes in functional outcomes in participants with osteoarthritis are needed to confirm of our findings and before any changes in therapeutics based on hemoglogin levels are considered in the care of patients with osteoarthritis. (C) 2011 Elsevier Inc. All rights reserved. Semin Arthritis Rheum 41:406-414

OBJECTIVES:Gastrointestinal (GI) blood loss is a common medical condition which can have serious morbidity and mortality consequences and may pose an enormous burden on healthcare utilization. The purpose of this study was to conduct a systematic review to evaluate the impact of upper and lower GI blood loss on healthcare utilization and costs. METHODS:We performed a systematic search of peer-reviewed English articles from MEDLINE published between 1990 and 2010. Articles were limited to studies with patients ≥18 years of age, non-pregnant women, and individuals without anemia of chronic disease, renal disease, cancer, congestive heart failure, HIV, iron-deficiency anemia or blood loss due to trauma or surgery. Two reviewers independently assessed abstract and article relevance. RESULTS:Eight retrospective articles were included which used medical records or claims data. Studies analyzed resource utilization related to medical care although none of the studies assessed indirect resource use or costs. All but one study limited assessment of healthcare utilization to hospital use. The mean cost/hospital admission for upper GI blood loss was reported to be in the range $3180-8990 in the US, $2500-3000 in Canada and, in the Netherlands, the mean hospital cost/per blood loss event was €11,900 for a bleeding ulcer and €26,000 for a bleeding and perforated ulcer. Mean cost/ hospital admission for lower GI blood loss was $4800 in Canada, and $40,456 for small bowel bleeding in the US. CONCLUSIONS:Our findings suggest that the impact of GI blood loss on healthcare costs is substantial but studies are limited. Additional investigations are needed which examine both direct and indirect costs as well as healthcare costs by source of GI blood loss focusing on specific populations in order to target treatment pathways for patients with GI blood loss.

Gastrointestinal (GI) symptoms are common in patients taking nonselective, nonsteroidal anti-inflammatory drugs (nsNSAIDs) and are often a reason for therapy discontinuation. In osteoarthritis (OA) and rheumatoid arthritis (RA) patients requiring pain control, selective COX-2 NSAID use is typically associated with less dyspepsia than is nsNSAID use. Little is known about NSAID tolerance in patients with gastroesophageal reflux disease (GERD). This study assessed nsNSAID and celecoxib prescription patterns, in particular persistence, in OA/RA patients with concomitant diagnosis of GERD.An observational study of GERD patients with a diagnosis of OA/RA using two separate databases, the IMS Lifelink Health Plan Claims Database (PharMetrics) and Market Scan Claims Database (Medstat) was conducted. In each database, parallel and separate analyses were performed in adult patients who had their first GERD diagnosis in 2006 and who were subsequently diagnosed with OA or RA in the same year. From this subset of patients, celecoxib-naive and nsNSAID-naive cohorts were identified and patients were selected. Patients with pre-existing GI conditions were excluded from the study. Persistence, measured as time to discontinuation, was evaluated by Kaplan-Meier survival curves and Cox proportional hazards models. Reasons for discontinuations were not available in these databases.Fewer patients discontinued celecoxib as compared to nsNSAIDs during the 60 days of the first prescription and throughout the entire follow-up period. After adjusting for baseline characteristics, celecoxib patients still had significantly decreased risk of discontinuation as compared to nsNSAID patients (p < 0.0001). Replication of these observations in two separate, large patient databases increases the confidence in this study's conclusion.Limitations include those inherent to claims data analyses and retrospective review, e.g. these data do not provide clinical information related to reasons for medication discontinuation.In patients with concomitant GERD and OA or RA who require anti-inflammatory treatment, significantly more patients treated with celecoxib were persistent with their treatment than were patients treated with nsNSAIDs.