Mediators of racial and ethnic inequities in clinical trial participation among patients with cancer, 2011-2023.

BACKGROUND: Although racially and ethnically minoritized populations are less likely to participate in cancer trials, it is unknown whether social determinants of health (SDOH) explain these inequities. Here we identify SDOH factors that contribute to racial and ethnic inequities in clinical trial participation among patients with 22 common cancers. METHODS: This retrospective cohort study used electronic health record data (2011-2023) linked to neighborhood (US Census tract) data from multiple sources. Patients were followed from diagnosis to clinical study drug receipt (proxy for trial participation), death, or last recorded activity. Associations were assessed using Cox proportional hazards models adjusted for clinical factors (year of diagnosis, age, sex, performance status, disease stage, cancer type). To elucidate which area-level SDOH underlie racial and ethnic inequities, mediation analysis was performed using nonlinear multiple additive regression tree models. RESULTS: This study included 250 105 patients (64.7% non-Latinx White, 8.9% non-Latinx Black, 5.2% Latinx). Black and Latinx patients were more likely to live in economically or socially marginalized areas (eg, disproportionately minoritized [measure of segregation], limited English proficiency, low vehicle ownership) than White patients. Black (3.7%; hazard ratio = 0.55, 95% confidence interval [CI] = 0.52 to 0.60) and Latinx patients (4.4%; hazard ratio = 0.63, 95% CI = 0.58 to 0.69) were less likely to participate in trials than White patients (6.3%). Fewer patients in economically or socially marginalized neighborhoods participated in trials. Mediators explained 62.2% (95% CI = 49.5% to 74.8%) of participation inequities between Black and White patients; area-level SDOH-including segregation (29.9%, 95% CI = 21.2% to 38.6%) and vehicle ownership (11.6%, 95% CI = 7.0% to 16.1%)-were the most important mediators. Similarly, Latinx-White participation inequities were mediated (65.1%, 95% CI = 49.8% to 80.3%) by area-level SDOH, such as segregation (39.8%, 95% CI = 28.3% to 51.3%), limited English proficiency (11.6%, 95% CI = 2.8% to 20.4%), and vehicle ownership (9.6%, 95% CI = 5.8% to 13.5%). CONCLUSIONS: To improve racial and ethnic diversity in cancer trials, efforts to address barriers related to adverse neighborhood SDOH factors are necessary.

Impact of different interventions on preventing suicide and suicide attempt among children and adolescents in the United States: a microsimulation model study.

Introduction: Despite considerable investment in suicide prevention since 2001, there is limited evidence for the effect of suicide prevention interventions among children and adolescents. This study aimed to estimate the potential population impact of different interventions in preventing suicide-related behaviors in children and adolescents. Methods: A microsimulation model study used data from national surveys and clinical trials to emulate the dynamic processes of developing depression and care-seeking behaviors among a US sample of children and adolescents. The simulation model examined the effect of four hypothetical suicide prevention interventions on preventing suicide and suicide attempt in children and adolescents as follows: (1) reduce untreated depression by 20, 50, and 80% through depression screening; (2) increase the proportion of acute-phase treatment completion to 90% (i.e., reduce treatment attrition); (3) suicide screening and treatment among the depressed individuals; and (4) suicide screening and treatment to 20, 50, and 80% of individuals in medical care settings. The model without any intervention simulated was the baseline. We estimated the difference in the suicide rate and risk of suicide attempts in children and adolescents between baseline and different interventions. Results: No significant reduction in the suicide rate was observed for any of the interventions. A significant decrease in the risk of suicide attempt was observed for reducing untreated depression by 80%, and for suicide screening to individuals in medical settings as follows: 20% screened: -0.68% (95% credible interval (CI): -1.05%, -0.56%), 50% screened: -1.47% (95% CI: -2.00%, -1.34%), and 80% screened: -2.14% (95% CI: -2.48%, -2.08%). Combined with 90% completion of acute-phase treatment, the risk of suicide attempt changed by -0.33% (95% CI: -0.92%, 0.04%), -0.56% (95% CI: -1.06%, -0.17%), and -0.78% (95% CI: -1.29%, -0.40%) for reducing untreated depression by 20, 50, and 80%, respectively. Combined with suicide screening and treatment among the depressed, the risk of suicide attempt changed by -0.27% (95% CI: -0.dd%, -0.16%), -0.66% (95% CI: -0.90%, -0.46%), and -0.90% (95% CI: -1.10%, -0.69%) for reducing untreated depression by 20, 50, and 80%, respectively. Conclusion: Reducing undertreatment (the untreated and dropout) of depression and suicide screening and treatment in medical care settings may be effective in preventing suicide-related behaviors in children and adolescents.

Geographic Trends in Pediatric Psychotropic Medication Dispensing Before and After the Start of the COVID-19 Pandemic.

OBJECTIVE: This study examined trends and geographic variability in dispensing of prescription psychotropic medications to U.S. youths before and after the start of the COVID-19 pandemic. METHODS: Using national data on prescription medication dispensing, the authors performed a cross-sectional study examining the monthly percent change in psychotropic medications dispensed (total N=95,639,975) to youths (ages 5-18 years) in 2020 versus 2019, across medication classes and geographic regions. RESULTS: For many medications, more were dispensed in March 2020 than in March 2019 and fewer in April-May 2020 versus April-May 2019. Stimulants had the largest decline: -26.4% in May 2020 versus May 2019. The magnitude of the monthly percent change varied by region. CONCLUSIONS: Fewer psychotropic medications were dispensed to U.S. youths after the start of the COVID-19 pandemic compared with 2019. Although some medication classes rebounded to prepandemic dispensing levels by September 2020, dispensing varied by class and region.

Caregiver Burden in Caregivers of Children With Special Health Care Needs and Association With Chronic Pain.

BACKGROUND/OBJECTIVES: Chronic noncancer pain (CNCP) affects millions of individuals in the United States but evidence of its prevalence among caregivers of children with special health care needs is sparse. We sought to estimate the prevalence of CNCP and its association with caregiver burden, in a nationally representative sample. METHODS: Retrospective cross-sectional study using pooled Medical Expenditure Panel Survey data for 2010-2015. Within interviewed households, family groups consisting of at least 1 parent and 1 child (0-17 y) were identified. CNCP was identified by one or more International Classification of Diseases, Ninth Revision (ICD-9)-CM codes utilizing previously published approaches. Level of caregiver burden was defined using a validated screener questionnaire identifying children with high burden of care (ie, special health care needs), for example, high or low burden. We estimated prevalence of CNCP as a function of caregiver burden, as well as the association of risk factors with CNCP, including parent sociodemographic features, clinical diagnoses, and family level characteristics. RESULTS: We identified 46,525 caregivers of whom 3.6% reported experiencing high caregiving burden. The prevalence of CNCP was 25.5% and 14.0% among parents with high compared with low caregiving burden, respectively. Odds of CNCP were higher among parents with high compared to those with lower caregiver burden (odds ratio=1.29, 95% confidence interval=1.06-1.55). Being obese, experiencing disability, and having a mental health diagnosis were associated with higher odds of CNCP. CONCLUSIONS: Chronic pain is more common among caregivers with high caregiver burden. Our findings highlight the need to further explore the nature and impact of risk factors on caregiver health and disability.

Patterns of opioid and benzodiazepine use with gabapentin among disabled Medicare beneficiaries - A retrospective cohort study.

BACKGROUND: Our goal was to describe specific patterns associated with co-prescriptions of gabapentin, opioids, and benzodiazepines among disabled Medicare beneficiaries. METHODS: Using 2013-2015 Medicare data, we conducted a retrospective cohort study among fee-for-service disabled beneficiaries continuously enrolled in Medicare Parts A, B, and D. The index date was defined as the earliest fill date for a gabapentin, opioid, or benzodiazepine prescription. Monotherapy, dual therapy, and tri-therapy were defined as utilization of one, two, and three medication classes, respectively. Augmentation was defined as a prescription for a different medication class in addition to prescription for initial medication; switching referred to a change in prescription for a different medication class with no subsequent fills of initial medication. We used descriptive statistics, Kaplan Meier analyses and Cox proportional hazards to examine the association between initial therapy and monotherapy, dual therapy, tri-therapy, switching and augmentation. RESULTS: Among 151,552 disabled beneficiaries, gabapentin initiators were more likely to augment therapy (50.1%) when compared to opioid (28.7%) and benzodiazepine (38.7%) users. When compared to opioid initiators, the risk of augmentation (HR[95%CI]: 1.85[1.82-1.89]) and switching (1.62 [1.51-1.73]) was significantly higher among gabapentin initiators. Risk of augmentation was also significantly higher among beneficiaries with co-morbid pain and mental health conditions (p < 0.01). Overall, the majority of beneficiaries augmented and switched within 2-months and 4-months after initiating therapy, respectively. CONCLUSIONS: Given safety concerns associated with gabapentin, opioids, and benzodiazepines, it is imperative that the benefits and risks of co-prescribing these medications be examined comprehensively, especially for those in vulnerable sub-groups.

Adverse outcomes associated with concurrent gabapentin, opioid, and benzodiazepine utilization: A nested case-control study.

Background: Gabapentin, opioids, and/or benzodiazepines are commonly prescribed for a variety of pain and psychiatric conditions. Despite the high likelihood of co-prescription of these medications, little is known about co-utilization of gabapentin (GABA), opioids (OP), and benzodiazepines (BZD) and associated public health outcomes. Methods: Using Medicare CCW Data, 2013-2016, we conducted a nested case-control study to examine the association between concurrent utilization of GABA, OP, and BZD and respiratory depression, opioid, and substance-related overdose among Medicare disabled beneficiaries. Cases and controls were Fee-for-service disabled beneficiaries who had a diagnosis of acute pain (AP), chronic pain (CP) or mental health conditions (MH) and received GABA, OP or BZD. Cases with respiratory depression, opioid or substance-related overdose were matched with up to 4 controls on socio-demographics, year of cohort entry and disease risk score. Primary exposure was concurrent medication utilization defined as an overlap of at least one day in prescriptions for GABA, OP and BZD. Findings: Across all cohorts, the majority of cases and controls were under 65, female, dually eligible and had prior histories of pain and mental health conditions. GABA+OP+BZD use was associated with increased odds of respiratory depression [AOR(95%CI)-AP: 1.35 (1.19-1.52), CP:1.24 (1.11-1.38) and MH: 1.16 (1.02-1.32) vs. OP only], opioid-related overdose [AP: 1.43 (1.04-1.98), CP: 1.47 (1.07-2.00) and MH: 1.44 (1.04-2.00) vs. OP only], and substance-related overdose [AP: 1.77 (1.26-2.50), CP: 1.70 (1.24-2.34) and MH: 1.92 (1.31-2.82) vs. GABA only]. While there were cohort differences in the association between GABA+OP and both respiratory depression and opioid-related overdose, GABA+OP and GABA+BZD use were associated with significantly higher odds of substance-related overdose across all clinical cohorts. Interpretation: Among Medicare disabled beneficiaries, concurrent utilization of gabapentin, opioids, and benzodiazepines is associated with multiple adverse outcomes. Given this, it is imperative that the benefits and risks of co-prescribing these medications be comprehensively examined. Funding: None.

Cost-Related Non-Utilization of Health Services and Self-Perceived Reactions to Race.

Purpose: There is limited information regarding the prevalence and predictors of cost-related non-utilization (CRNU), while there is increasing attention to the rising out-of-pocket cost of health services including prescription medications. Prior studies have not quantified the role of perceived racism despite its documented relationship with health services utilization. We examine perceptions of reactions to race and quantify their relationship with CRNU. Methods: This retrospective cross-sectional study utilized data from the 2014 Behavioral Risk Factor Surveillance System (BRFSS) public use file, an annual, state-based telephone survey of US adults aged 18 and older. We utilized data for four states that provided responses to five Reactions to Race items, including information about the self-perceived quality of the respondent's health care experience compared with people of other races (worse vs same or better) and whether the respondent experienced physical symptoms because of treatment due to their race. The three binary outcomes were: 1) did not visit a physician; 2) did not visit a physician due to cost; 3) did not fill a prescription due to cost. We estimated covariate-adjusted odds ratios associated with each outcome using logistic regression models. Results: The BRFSS sample consisted of 20,366 respondents of whom 8% were African American non-Hispanic, 12% were Hispanic and 73% were White. Three percent of respondents considered their experience to be worse than people of other races. Three percent of individuals reported physical symptoms because of treatment due to their race while 5% of respondents reported becoming emotionally upset because of treatment due to their race. The proportions for the three study outcomes were 11%, 13% and 7%, respectively. In covariate-adjusted models, a worse experience with the health care system was statistically significantly associated with CRNU (physician visit: 2.6 [95% CI: 1.6 - 4.3]). The experience of physical symptoms because of treatment due to race was statistically significantly associated with CRNU (physician visit: 2.6 [95% CI: 1.7 - 4]; prescription fills: 2.1 [1.2 - 3.6]). No Reactions to Race items were associated with general non-utilization. Conclusions: Negative perceptions of reactions to race during the time of health services utilization is positively associated with CRNU, ie, foregoing physician visits and prescription fills due to cost.

Family Adverse Experiences and Psychotropic Polypharmacy Among US Youth: 2009-2015.

OBJECTIVE: To determine if adverse family factors are associated with a higher likelihood of psychotropic polypharmacy among US youth with a mental health condition. METHODS: The 2009-2015 Medical Expenditure Panel Survey data were used to identify family characteristics of 5136 youth aged ≤18 years with an emotional or behavioral health condition. Family adversity was based on family size, number of parents in the household, parental education and income, and parent-reported physical and/or cognitive or mental health disability. Cluster analysis identified family adversity subgroups. Polypharmacy was defined as 3 or more psychotropic classes (eg, stimulants, antipsychotics, antidepressants, mood stabilizers, and sedatives) in at least 1 interview round in a calendar year. Weighted logistic regression evaluated associations between family adversity and psychotropic polypharmacy among youth. RESULTS: Nearly half (47.8%) of youth lived with parents who had a disability. Parents in the least socioeconomically disadvantaged cluster mainly had a mental illness, and 94% of parents in the most socioeconomically disadvantaged cluster had a parent-reported physical and/or cognitive disability and mental illness. Among youth, mood disorder (24.2%; 95% confidence interval [CI]: 12.6%-16.0%), antidepressant use (16.0%; 95% CI: 10.6%-21.5%), and antipsychotic use (7.5%; 95% CI: 5.4%-9.6%) were higher in the most socioeconomically disadvantaged cluster relative to the other clusters. Approximately 3% of youth received psychotropic polypharmacy. The odds of psychotropic polypharmacy were 2.7 (95% CI: 1.1-6.4) times greater among youth in the most relative to the least socioeconomically disadvantaged cluster. CONCLUSIONS: Higher use of psychotropic polypharmacy among youth with parents who have multiple disabilities raises concerns about oversight and monitoring of complex psychotropic treatment.

Patterns of prescription opioid utilization among adolescents and adults with comorbid chronic pain and mental health diagnosis.

Our goal was to examine the association between mental health disorders (MHD) and subsequent risk of opioid use among commercially insured youth and adults (aged 14-64 years) with comorbid chronic noncancer pain (CNCP) conditions. We conducted a retrospective cohort study using IQVIA Health Plan Claims database from January 1, 2006, to December 31, 2015. Chronic noncancer pain was defined as any diagnosis of back, head, neck, arthritis, or chronic pain (index date). Mental health disorders were assessed in the 12 months before the index pain diagnosis. Based on days supply (none, acute, and chronic) and average daily dose (none, low, medium, and high), we constructed a 7-level categorical dependent measure of opioid use. We estimated the overall prevalence of MHD and opioid receipt. Among those with CNCP, multinomial logistic regression (AOR; 95 confidence interval) was used to estimate the association of MHD with opioid receipt. Among 879,815 individuals diagnosed with CNCP, 143,923 (16.4%) had comorbid MHD. Chronic/high-dose use of opioids was more common among those with CNCP and MHD compared to those with only CNCP. After adjusting for demographic and clinical factors, individuals with comorbid CNCP and MHD were significantly more likely to be prescribed opioids compared to those with only CNCP conditions. This effect varied by average daily dose and days supply: acute/low dose (1.08; 1.07-1.08); chronic/low dose (1.49; 1.49-1.50); acute/medium dose (1.07; 1.07-1.08); chronic/medium dose (1.61; 1.61-1.62); acute/high dose (1.03; 1.02-1.03); and chronic/high dose (1.53; 1.53-1.54). In individuals with CNCP, having a MHD was a strong predictor of prescription opioid use, particularly chronic use.

Factors that influence the use of community assets by people with physical disabilities: results of participatory mapping in Envigado, Colombia.

BACKGROUND: Disability is an evolving concept that results from the complex interaction between a person with an impairment and the context in which he/she lives. There is limited understanding on the types, access and use of community assets valuable for people with disabilities, and the role of contextual factors in Colombia. Our goal with this work was to identify the factors at the levels of the socio-ecological framework, and their interaction, that influence the use of community assets among people with physical disabilities and community stakeholders in Envigado, Colombia. METHODS: Using participatory mapping, a community based participatory approach, we carried out an assessment of community assets identified by people with disabilities and rehabilitation professionals. In-depth interviews (n = 32) informed the design of two participatory mapping activities, one among people with disabilities (n = 5) and a second with rehabilitation professionals (n = 4). Results were presented in a community forum to receive feedback on the findings. RESULTS: Main findings indicate a chain of contextual factors that limit access and use of assets stemming from the personal (e.g. financial resources, inaccessible housing), interpersonal level (e.g. lack of a personal assistance or aid), and community levels (e.g. lack of accessible public transportation and inaccessible buildings). In most cases these barriers are heightened by system level barriers (e.g. lack of effective enforcement of the legal framework). CONCLUSIONS: Identifying these contextual factors, and their interactions, calls for stronger enforcement of the existing legal framework through articulated work between different stakeholders, so that people with disabilities can enjoy community assets.

Care Management for Youth With Comorbid Developmental and Mental Health Conditions: A Discrete Choice Experiment Pilot Study.

OBJECTIVE: Caregivers of a child with a coexisting cognitive/intellectual and an emotional/behavior/developmental disability have difficult decisions regarding care management options for their child. This study aimed to pilot and refine an instrument to elicit caregivers' preferences in managing their child's care needs. METHODS: Subjects were 38 caregivers of a child aged 21 and younger with a coexisting cognitive/intellectual and an emotional/behavior/developmental disability. A mixed-methods design was used to develop and pilot a discrete choice experiment (DCE) to elicit care management preferences for their child. Six attributes of care management decisions were tested in the DCE: medication use, parental custody, time cost, social interactions, medication effects, and school placement. Subjects completed a paper-and-pencil survey after which a debriefing discussion was held to obtain feedback that would aid in refining the attribute descriptions. Conditional logistic regression generated mean scores for each attribute. Comments from the debriefing sessions were audio-recorded and used to modify the attribute descriptions. RESULTS: The majority (84%) of subjects were aged 40 years or older and a female caregiver. Common diagnoses of the children were autism spectrum disorder (55%) and attention-deficit/hyperactivity disorder (76%). Subjects preferred using fewer medications and maintaining decision-making authority as opposed to delegating authority to a third party. Medication effects on the child's mood were more important than effects on personality or body weight. CONCLUSIONS: The DCE was sensitive to caregivers' preferences for managing their child's coexisting cognitive/intellectual and emotional/behavior/developmental disability. Findings may help providers gauge treatment in a broader context of health outcomes.

Experiences with rehabilitation and impact on community participation among adults with physical disability in Colombia: perspectives from stakeholders using a community based research approach.

BACKGROUND: Despite representing 70 million people in Latin America, access to comprehensive rehabilitation and participation in the community remains a challenge for persons with disability (PWDs) in the region. Through enactment of the Disability Law, Colombia has made improvements to recognize and address some of the barriers for PWDs, including access to comprehensive rehabilitation. However access remains limited with significant disconnect between perspectives of various stakeholders and the needs of the population. We examined the unique perceptions on access to comprehensive rehabilitation services and participation of PWDs. We also explored the perspective of caregivers of PWDs, rehabilitation professionals, and other stakeholders on the experiences of PWDs. Our goal was to identify gaps in the implementation of comprehensive rehabilitation programs, and barriers to access resources for comprehensive rehabilitation or services that would impact participation of PWDs. METHODS: Qualitative study conducted in 2017. Data was collected from a purposive sample of adults with physical disability, aged 18-44 years, who had received rehabilitation services at a local partner organization and with different backgrounds and experiences with disability. Purposive sampling was also conducted with caregivers, rehabilitation professionals, and other stakeholders. Socio-demographic information was collected and semi-structured interviews were conducted by a research team member, recorded, transcribed and analyzed using a thematic analysis method to identify main themes related to our aim. CES University ethical review board approved this study. RESULTS: Thirty-two participants were interviewed: eight were male, 42.1 ± 11.1 years old, and 44% (n = 14) were PWDs. Three main themes were identified among all the participants: the meaning of rehabilitation, challenges to access services, and participation. Challenges to access services had three sub-themes: barriers to personal mobility, perceptions and knowledge on disability, and navigating the system. CONCLUSION: The main focus of rehabilitation as perceived by stakeholders is still on functional rehabilitation. If healthcare personnel is better trained on disability and if those with disabilities are actively involved in the developing these programs, the focus may evolve to a comprehensive and equitable rehabilitation process that fosters full participation.

Engaging stakeholders in pharmacoepidemiology research: Current state and recommendations.

PURPOSE: Given current efforts to enhance patient-centered care and shared decision-making, the International Society of Pharmacoepidemiology Workgroup on Patient Engagement assessed patient and other stakeholder engagement in pharmacoepidemiology research and provides recommendations for the field. METHODS: A systematic review used MEDLINE and EMBASE to identify published literature from 2005 to 2016 addressing how stakeholders-patients, caregivers, and others-assisted researchers conducting pharmacoepidemiologic research. Three pairs of Workgroup members screened titles and abstracts to select articles for full-text review and analysis. Two Workgroup members abstracted the following data: research focus, characterization and role of stakeholders, and type(s) of engagement strategy employed. Data were summarized descriptively. RESULTS: We identified 5717 references for abstract screening. Of these, 69 met the criteria for full-text screening, and 11 were selected for data abstraction. Of these 11 studies, seven focused on the development of a research agenda and eight had stakeholders react or advise on an aspect of the study. Although patients were the most commonly identified stakeholders, advocacy groups and health care professionals were also frequently identified. Some studies reported the engagement of other stakeholders, including local government or policy experts. Engagement strategies varied, with five studies using more than one strategy. Studies often did not indicate the involvement of stakeholders in developing the study design or with implementation. CONCLUSIONS: Currently, few pharmacoepidemiology publications mention patient or other stakeholder engagement in the design, analysis, or reporting of research. This suggests that there are opportunities to expand stakeholder engagement and/or increase the transparency of reporting stakeholder engagement.

Psychiatric Services Preceding Initiation of Antipsychotic Medication Among Youth in Foster Care.

Objectives: To characterize psychotropic use preceding antipsychotic initiation in a population of youth in foster care and to determine whether the use of intensive psychiatric services before initiating an antipsychotic differs across subgroup of youth defined by past psychotropic use. Methods: We identified youth in foster care in one U.S. State who initiated an antipsychotic from 2010 to 2015 and were aged ≤21 years at initiation. No antipsychotic use 1-year before the index prescription defined new use. Psychotropic class use in the year preceding the index antipsychotic prescription distinguished three subgroups: no psychotropic use, single-class use, and concomitant (>1 class) use. The temporal association of antipsychotic initiation with intensive services (psychiatric hospitalizations or emergency department visits) was estimated through regression models adjusted for psychiatric diagnoses and demographic characteristics. Logistic regression models assessed the interaction between psychotropic class subgroup and psychiatric diagnosis with the odds of hospitalization. Results: Of the 753 youth initiating an antipsychotic, 279 (37%) had no psychotropic use, 304 (40%) had single-class use, and 170 (23%) had concomitant use in the year before. In the year preceding antipsychotic initiation, 183 (24%) were hospitalized and 118 (16%) were hospitalized 1 month before antipsychotic initiation. The number of days between hospital discharge and antipsychotic initiation was 47 (SE = 19) days longer in concomitant users relative to youth with no psychotropic use (p = 0.01). In the year preceding antipsychotic initiation, concomitant users with severe mental illness were less likely to have a hospitalization (OR = 0.24; 95% CI = 0.06-0.93) than youth with no psychotropic use diagnosed with severe mental illness. Conclusions: Variation in psychotropic medication treatment, hospitalizations, and psychiatric diagnosis before antipsychotic initiation distinguished subgroups of youth initiating an antipsychotic. Single-class and concomitant users may have initiated an antipsychotic to augment existing regimen, whereas youth with no psychotropic use may have initiated an antipsychotic following a first episode crisis.

Best-Worst Scaling to Prioritize Outcomes Meaningful to Caregivers of Youth with Mental Health Multimorbidities: A Pilot Study.

OBJECTIVE: Health care decision-making for youth with mental health multimorbidity is guided by outcomes that are considered most meaningful and important. The study objective was to pilot test a best-worst scaling (BWS) instrument designed to assess trade-offs among caregiver-defined, meaningful health care outcomes. METHODS: A BWS was designed with continuous stakeholder involvement to elicit caregiver-defined outcomes in 4 domains: school, behavioral, social, and independence. Four attributes were identified for each outcome domain, for a total of 16 attributes. Using a balanced incomplete block design, a BWS instrument was developed with 16 choice task questions displaying 6 attributes at a time. A convenience sample was selected from Maryland caregivers of children who were 21 years old or younger and had a developmental delay and a comorbid mental health condition. Participants completed a survey that included demographics and the BWS instrument. Conditional logit was used to estimate utility scores and 95% confidence intervals (CI) for each attribute, which were ranked in order of importance. Attribute statements were refined after a respondent debriefing session. RESULTS: A total of 38 caregivers participated in the pilot study. Child safety to self was the most important outcome (1.01, CI, 0.78-1.24). This was followed by securing support for an Individualized educational plan in school (0.77, CI, 0.54-1.01) and the child being able to stay in school all day (0.53, CI, 0.29-0.77). CONCLUSION: BWS scenarios that resemble real-life decision-making can be a useful tool to identify preferences for health care outcomes.

Association of Adverse Pregnancy Outcomes With Glyburide vs Insulin in Women With Gestational Diabetes.

IMPORTANCE: Glyburide is thought to be safe for use during pregnancy for treatment of gestational diabetes mellitus (GDM). However, there are limited data on the effectiveness of glyburide when compared with insulin as used in a real-world setting. OBJECTIVE: To estimate the risk of adverse maternal and neonatal outcomes in women with GDM treated with glyburide compared with insulin. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of a population-based cohort from a nationwide US employer-based insurance claims database from January 1, 2000, to December 31, 2011. We identified women with GDM and their newborns. We excluded those with type 1 or 2 diabetes and those younger than 15 years or older than 45 years. EXPOSURES: Treatment with glyburide or insulin during pregnancy within 150 days before delivery. MAIN OUTCOMES AND MEASURES: We used binomial regression to estimate risk ratios (RRs) and risk differences with 95% confidence intervals for the association of glyburide with diagnosis codes for obstetric trauma, cesarean delivery, birth injury, preterm birth, hypoglycemia, respiratory distress, jaundice, large for gestational age, and hospitalization in the neonatal intensive care unit. Inverse probability of treatment weights were used to adjust for maternal characteristics that differed between the treatment groups. RESULTS: Among 110,879 women with GDM, 9173 women (8.3%) were treated with glyburide (n = 4982) or insulin (n = 4191). After adjusting for differences at baseline, newborns of women treated with glyburide were at increased risk for neonatal intensive care unit admission (RR = 1.41; 95% CI, 1.23-1.62), respiratory distress (RR = 1.63; 95% CI, 1.23-2.15), hypoglycemia (RR = 1.40; 95% CI, 1.00-1.95), birth injury (RR = 1.35; 95% CI, 1.00-1.82), and large for gestational age (RR = 1.43; 95% CI, 1.16-1.76) compared with those treated with insulin; they were not at increased risk for obstetric trauma (RR = 0.92; 95% CI, 0.71-1.20), preterm birth (RR = 1.06; 95% CI, 0.93-1.21), or jaundice (RR = 0.96; 95% CI, 0.48-1.91). The risk of cesarean delivery was 3% lower in the glyburide group (adjusted RR = 0.97; 95% CI, 0.93-1.00). The risk difference associated with glyburide was 2.97% (95% CI, 1.82-4.12) for neonatal intensive care unit admission, 1.41% (95% CI, 0.61-2.20) for large for gestational age, and 1.11% (95% CI, 0.50-1.72) for respiratory distress. CONCLUSIONS AND RELEVANCE: Newborns from privately insured mothers treated with glyburide were more likely to experience adverse outcomes than those from mothers treated with insulin. Given the widespread use of glyburide, further investigation of these differences in pregnancy outcomes is a public health priority.

Use of combination antihypertensive therapy initiation in older Americans without prevalent cardiovascular disease.

OBJECTIVES: To describe new users of antihypertensive medications and identify predictors of combination therapy initiation in older Americans. DESIGN: Retrospective observational cohort study. SETTING: Population-based study using U.S. Medicare fee-for-service healthcare claims (2007-2010). PARTICIPANTS: Medicare beneficiaries aged 65 and older with no recent diagnoses, procedures, or medications for cardiovascular disease who newly initiated an antihypertensive therapy (n = 275,493; 210,605 initiated monotherapy, 64,888 initiated combination therapy). MEASUREMENTS: Multivariable Poisson regression was used to assess factors associated with initiation of combination therapy versus monotherapy, including participant characteristics, prescriber characteristics, and participant encounters with the healthcare system. RESULTS: Initiation of combination therapy increased from 21.9% in 2007 to 24.7% in 2010. The most frequently initiated combinations were angiotensin-converting enzyme inhibitors with thiazide (29.7%) and angiotensin II receptor antagonists with thiazide (18.7%). Blacks (prevalence ratio (PR) = 1.48, 95% confidence interval (CI) = 1.45-1.51 vs. whites), individuals seeing a generalist (PR = 1.10, 95% CI = 1.07-1.14), individuals seeing more than one doctor (PR = 3.38, 95% CI = 3.33-3.44), and participants with no pharmacy claims in the previous 6 months (PR = 1.34, 95% CI = 1.30-1.37 vs. ≥3 unique drug classes) were more likely to initiate combination therapy, whereas those who had more outpatient visits in the previous 12 months were less likely to initiate combination therapy (per five visits, PR = 0.82, 95% CI = 0.80-0.83). CONCLUSION: Nearly one in four new users of antihypertensive medications aged 65 and older started treatment with combination therapy. Blacks, individuals living in the south, and those with fewer outpatient physician office visits were more likely to initiate combination therapy. Further research is needed to determine whether this approach to managing hypertension is being well targeted to individuals who will require combination treatment.

Trends in glyburide compared with insulin use for gestational diabetes treatment in the United States, 2000-2011.

OBJECTIVE: To describe trends and identify factors associated with choice of pharmacotherapy for gestational diabetes (GDM) from 2000-2011 using a healthcare claims database. METHODS: This was a retrospective cohort study of a large nationwide population of commercially insured women with GDM and pharmacy claims for glyburide or insulin before delivery, 2000-2011. We excluded women younger than 15 years or older than 50 years, those with prior noninsulin-dependent diabetes mellitus, or those who had multiple gestations. We estimated trends over time in the use of glyburide compared with insulin and prevalence ratios and 95% confidence intervals (CIs) for the association between covariates of interest and treatment with glyburide compared with insulin. RESULTS: We identified 10,778 women with GDM treated with glyburide (n=5,873) or insulin (n=4,905). From 2000 to 2011, glyburide use increased from 7.4% to 64.5%, becoming the more common treatment in 2007. Women less likely to be treated with glyburide were those with metabolic syndrome (prevalence ratio 0.71, 95% CI 0.50-0.99), hyperandrogenism (prevalence ratio 0.77, 95% CI 0.62-0.97), polycystic ovarian syndrome (prevalence ratio 0.88, 95% CI 0.78-0.99), hypothyroidism (prevalence ratio 0.89, 95% CI 0.83-0.96), or undergoing infertility treatment (prevalence ratio 0.93, 95% CI 0.86-1.02). The probability of receiving glyburide decreased by 5% for every 10-year increase in maternal age (prevalence ratio 0.95, 95% CI 0.91-0.99). Among women prescribed with glyburide, 7.8% switched or augmented to a different drug class compared with 1.1% of insulin initiators. CONCLUSION: Glyburide has replaced insulin as the more common pharmacotherapy for GDM over the past decade among those privately insured. Given its rapid uptake and the potential implications of suboptimal glucose control on maternal and neonatal health, robust evaluation of glyburide's relative effectiveness is warranted to inform treatment decisions for women with gestational diabetes. LEVEL OF EVIDENCE: II.