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Undertreatment of depression is common among children and adolescents, but evidence of the impact of undertreatment of depression on risk of suicide is limited due to the low base rate of suicide in the population and lack of sufficient data sources. We developed a microsimulation model that uses evidence from multiple sources to study the impact of different durations of antidepressant treatment on suicide risk in a synthesized sample that is nationally representative of children and adolescents with major depressive disorder. Compared with receiving no treatment, suicide rate and risk of suicide attempt both decreased with increasing duration of antidepressant treatment (for 12 weeks, suicide rate ratios = 0.78 (95% credible interval (CrI): 0.58, 1.15), 36 weeks, 0.65 (95% CrI: 0.44, 0.90), and 52 weeks, 0.63 (95% CrI: 0.45, 0.72); for suicide attempt: 12 weeks, suicide risk ratios = 0.68 (95% CrI: 0.62, 0.69), 36 weeks, 0.56 (95% CrI: 0.52, 0.57), and 52 weeks, 0.55 (95% CrI: 0.51, 0.56). The suicide rate and risk of suicide attempt were lower in children than in adolescents. Males had a lower risk of suicide attempt but higher suicide rate than females. The findings from the microsimulation model show that completion of 12–36 weeks of antidepressant treatment may reduce suicide attempt and suicide among children and adolescents with major depressive disorder.

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.

Introduction: While oncology clinical trials disproportionately recruit from academic medical centers, most patients receive care in the community setting. However, there is limited information regarding clinical trial participation rates, including inequities by race/ethnicity and the social determinants of health (SDoH), in community practices. Here we assessed factors associated with clinical study drug (CSD, proxy for trial participation) receipt among patients diagnosed with 21 common cancers in community practices. Methods: This retrospective study used the nationwide Flatiron Health electronic health record-derived de-identified database of patients with cancer. The cohort included patients (≥ 18 years) diagnosed with cancer (initial, advanced, or metastatic diagnosis; depending on the cancer type) between January 2011 and November 2021 (follow-up through March 2022). We examined inequities in receipt of CSD after diagnosis by race/ethnicity, insurance coverage, and area-level SDoH indicators (e.g., socioeconomic status [SES] and predominant race/ethnicity [proxy for residential segregation]). SDoH indicators contextualizing where patients live were defined using Census block group/tract data from the American Community Survey (2015-2019). To evaluate factors associated with CSD receipt, we used time-to-event analysis where patients were followed from index diagnosis to their first documented receipt of CSD, death, or last recorded activity. Separate Cox proportional hazards models adjusted for clinical characteristics (i.e., age, sex, performance status, and stage) were used to calculate hazard ratios (HR) and 95% confidence intervals (CI). Results: This study included 196,270 patients (median age: 69 years, 49.5% women; 75.2% non-Hispanic/Latinx [NH] White, 6.2% NH-Black, 3.3% Latinx), of whom 3.7% received CSDs. Black (2.6%, HR 0.56 [CI: 0.51- 0.62]) and Latinx patients (2.6% (HR 0.54 [CI: 0.48-0.62]) were less likely to receive CSDs than white patients (4.3%). Individual and area-level SDoH were associated with CSD receipt. For example, patients without documented insurance (2.7%, HR 0.61 [CI: 0.56-0.66]) or with Medicaid coverage (2.6%, HR 0.58 [CI: 0.52-0.65]) were less likely to receive CSDs than patients with commercial coverage (4.7%). Patients living in predominately non-white and lower SES neighborhoods were less likely to receive CSDs, as were those in neighborhoods whose residents disproportionately lacked U.S. citizenship, had limited English proficiency, and had low rates of vehicle ownership. Conclusion: There are substantial inequities in CSD receipt among patients who receive care in community cancer clinics. Black, Latinx, and uninsured patients, as well as those from historically marginalized neighborhoods were less likely to receive CSDs. Without focused policy and operational efforts to increase clinical trial enrollment of racially, ethnically, and socio-demographically diverse patient populations, clinical trials may proliferate inequities in investigational drug access and potentially cancer outcomes. Citation Format: Jenny Guadamuz, Ronac Mamtani, Xiaoliang Wang, Cleo A. Ryals, Ivy Altomare, Alemseged A. Asfaw, Wendy Camelo Castillo, Harlan Pittell, Gregory S. Calip, Somnath Sarkar. Racial/ethnic and socioeconomic inequities in clinical trial participation among US community oncology patients, 2011-2021 [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr A049.

Background: Health-Related Social Needs (HRSN) are unmet person-level social and economic challenges, such as food and housing insecurity, that potentially impact health outcomes. Evidence of HRSN burden in cancer survivors is limited and differences across age groups largely unexplored. Our goal is to estimate the prevalence of HRSN among cancer survivors across age groups and explore associated factors in a nationally representative sample. Methods: A cross-sectional cohort of cancer survivors, 18 years and older, was identified from the National Health Interview Survey (NHIS), 2016-2018. Survivorship (i.e., time since cancer diagnosis) was assessed at the time of the survey. Key needs for cancer survivors (food insecurity, transportation needs, inability to pay for utilities, inability to pay for housing, and inability to pay for healthcare needs) were used in this analysis. Individuals report their current experience with needs at the time of the survey. Prevalence rates were estimated as the proportion of cancer survivors with a given need within each of the five key needs. A measure of HRSN was developed to indicate whether an individual experienced at least one or more HRSN (any HRSN). Multivariable logistic regression was used to explore the association between having any HRSN and current age (young [YA], 18-39y; middle age [MA], 40-64y; older adult [OA], >=65 y), key sociodemographic characteristics, age at cancer diagnosis, and survivorship. All estimates, including Odds Ratios (OR) and 95% confidence intervals (CI), were weighted to represent the US census-based population. Results: We identified 7,179 cancer survivors, 44.9% under 65 years old, 59.1% female, 85.9% White. Overall, 44.8% reported experiencing any HRSN at any time during survivorship, with 21.4% experiencing any HRSN in their first two years after cancer diagnosis. Inability to pay for utilities was the most prevalent need, with differences across age groups (40.7% YA, 33.4% MA, 17.2% OA). Higher inability to pay for housing was reported among YA (28.64%) than MA (25.9%) or OA (11.9%). There were no differences in reported food insecurity across age groups (YA 16.2%, MA 16.5%, OA 16.5%). When compared to OA, YA (OR 1.77, CI 1.24-2.60) and MA (OR 1.74, CI 1.49-2.01) had higher odds of having any HRSN. Key factors associated with higher odds of any HRSN include being non-White (OR 1.42, CI 1.16-1.74), Hispanic (OR 1.46, CI 1.08-1.98), female (OR 1.31, CI 1.14-1.51), or being diagnosed with cancer during childhood (OR 1.62, CI 1.04-2.52) or young adulthood (OR 1.65, CI 1.29-2.23). Conclusion: HRSN are prevalent throughout cancer survivorship. Our findings show that young and middle age are more likely than older adults to experience HRSN at any point during survivorship. Further exploration of pathways leading to unmet needs is needed to address inequalities and improve survivorship care across age groups. Citation Format: Wendy Camelo Castillo, Udim Damachi, Phuong Tran, Christabel K. Cheung, Ester Villalonga-Olives, Eberechukwu Onukwugha. Differences in health-related social needs between younger and older cancer survivors in a United States representative sample, 2016-2018 [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B097.

OBJECTIVE To define patterns of prescription and factors associated with choice of pharmacotherapy for gestational diabetes mellitus (GDM), namely metformin, glyburide and insulin, during a period of evolving professional guidelines. DESING Cross-sectional study. SETTING US commercial insurance beneficiaries from Market-Scan (late 2015 to 2018). STUDY DESIGN We included women with GDM, singleton gestations, 15-51 years of age on pharmacotherapy. The exposure was pharmacy claims for metformin, glyburide and insulin. MAIN OUTCOMES Pharmacotherapy for GDM with either oral agent, metformin or glyburide, compared with insulin as the reference, and secondarily, consequent treatment modification (addition and/or change) to metformin, glyburide or insulin. RESULTS Among 37 762 women with GDM, we analysed data from 10 407 (28%) with pharmacotherapy, 21% with metformin (n = 2147), 48% with glyburide (n = 4984) and 31% with insulin (n = 3276). From late 2015 to 2018, metformin use increased from 17 to 29%, as did insulin use from 26 to 44%, whereas glyburide use decreased from 58 to 27%. By 2018, insulin was the most common pharmacotherapy for GDM; metformin was more likely to be prescribed by 9% compared with late 2015/16, but glyburide was less likely by 45%. Treatment modification occurred in 20% of women prescribed metformin compared with 2% with insulin and 8% with glyburide. CONCLUSIONS Insulin followed by metformin has replaced glyburide as the most common pharmacotherapy for GDM among a privately insured US population during a time of evolving professional guidelines. Further evaluation of the relative effectiveness and safety of metformin compared with insulin is needed. TWEETABLE ABSTRACT Insulin followed by metformin has replaced glyburide as the most common pharmacotherapy for gestational diabetes mellitus in the USA.

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. Electronic supplementary material The online version of this article (10.1186/s12939-019-0923-4) contains supplementary material, which is available to authorized users.

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.

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 b...

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

Dissemination of information and results to patients and community stakeholders is critical for the advancement of research and clinical practice and is becoming a priority for funding agencies. This chapter focuses on dissemination of information before, during and after a pragmatic randomized clinical trial (pRCT), to patients and community stakeholders. We describe an applied approach for dissemination across categories of stakeholders to answer three main questions: To whom should one disseminate? What should be disseminated? How should dissemination happen? We conclude with a discussion on challenges for dissemination and strategies to overcome them.

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. Ethn Dis. 2020;30(3):399-410; doi:10.18865/ed.30.3.399

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.

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.

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.

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. Our goal with this work was to identify access and use of community assets, and the role of contextual factors among people with disabilities, and the perspectives of rehabilitation professionals, residents of a suburban area in 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 informed the design of two asset mapping activities, one among people with disabilities (n=5) and a second with rehabilitation professionals (n=4). 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, call for stronger enforcement of the existing legal framework through articulated work between different stakeholders so persons with disabilities can enjoy community assets.

Objectives To develop a methodological approach for selecting, validating, and prioritizing attributes for health care decision making. Methods Participants (n = 48) were recruited from community support groups if they had a child aged 26 years or younger diagnosed with a coexisting mental health condition and cognitive impairment. Six in-depth interviews eliciting care management experiences were transcribed and coded into themes following the principles of grounded theory and the constant comparative method. Six focus groups involving 42 participants assessed the relevance, priority, and meaning and inter-relationship among the themes. The positive predictive value and sensitivity assessed agreement on thematic meaning. A final list was selected from the top priorities with good agreement as candidate attributes. Attribute levels reflecting the range of experiences in care management decisions emerged from the verbatim passages within each coded theme. Results Participants were the child's mother (73%), white (77%), married (69%), and on average 48 years old. The children were on average 14 years old; 44% had an intellectual disability, 25% had autism, and more than half had anxiety or attention-deficit/hyperactivity disorder. All 14 attributes identified from the in-depth interviews were deemed relevant. The positive predictive value exceeded 90%, and the sensitivity ranged from 64% to 89%. The final set of attributes formed the framework for care management decisions consisting of six attributes (medication, behavior, services, social, treatment effects, and school) each with three levels. Conclusions A systematic approach grounded in qualitative methods produced a framework of relevant, important, and actionable attributes representing competing alternatives in clinical decisions.

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.

Candida duobushaemulonii , a yeast closely related to Candida auris , is thought to cause infections in rare cases and is often misidentified. In October 2016, the Panamanian Ministry of Health implemented laboratory surveillance for C. auris . Suspected C. auris isolates were forwarded to the national reference laboratory for identification by matrix-assisted laser desorption ionization–time of flight mass spectrometry and antifungal susceptibility testing. Between November 2016 and May 2017, 17 of 36 (47%) isolates suspected to be C. auris were identified as C. duobushaemulonii. These 17 isolates were obtained from 14 patients at six hospitals. Ten patients, including three children, had bloodstream infections, and MICs for fluconazole, voriconazole, and amphotericin B were elevated. No resistance to echinocandins was observed. C. duobushaemulonii causes more invasive infections than previously appreciated and poses a substantial problem, given its resistance to multiple antifungals. Expanded laboratory surveillance is an important step in the detection and control of such emerging pathogens.

Objective While some observational studies have suggested a protective effect of metformin on incident cancer, concerns about potential bias remain. We compared the incidence of endometrial cancer in metformin versus sulfonylurea initiators. Research design and methods We conducted a retrospective cohort analysis using US healthcare claims (MarketScan®), 2000–2011. We identified new users of metformin versus sulfonylureas with no prior cancer diagnoses and followed them until a diagnosis of endometrial cancer, hysterectomy, treatment change, or disenrollment. We estimated hazard ratios (HR) and 95% confidence intervals (CI) using Cox proportional hazards, using an as-treated analytic approach. Stabilized inverse probability of treatment weights were used to adjust for potential confounding at baseline. Results Of 541,128 eligible women, 456,838 (84%) initiated metformin and 84,290 (16%) initiated sulfonylurea. The treatment groups differed at baseline in terms of age and recent diagnosis codes for diabetes, polycystic ovarian syndrome, and endometrial hyperplasia. Over a median follow-up of 1.2 (IQR 0.4–2.3) years and a total of 2,030,914 person-years, 729 women developed endometrial cancer. Metformin initiation was associated with a lower risk of endometrial cancer in the unadjusted analysis (HR 0.81, 95% CI 0.67–0.97). However, after balancing baseline covariates across groups, metformin was not associated with a reduced risk of endometrial cancer (HR 1.09, 95% CI 0.88–1.35). This finding was consistent across multiple sensitivity analyses and subgroup analyses in diabetic patients and relevant age groups. Conclusions In this population-based cohort of >500,000 women, initiating metformin compared with sulfonylureas was not associated with a reduced risk of developing endometrial cancer.

Purpose Estimating drug effectiveness and safety among older adults in population-based studies using administrative health care claims can be hampered by unmeasured confounding as a result of frailty. A claims-based algorithm that identifies patients likely to be dependent, a proxy for frailty, may improve confounding control. Our objective was to develop an algorithm to predict dependency in activities of daily living (ADL) in a sample of Medicare beneficiaries. Methods Community-dwelling respondents to the 2006 Medicare Current Beneficiary Survey, >65 years old, with Medicare Part A, B, home health, and hospice claims were included. ADL dependency was defined as needing help with bathing, eating, walking, dressing, toileting, or transferring. Potential predictors were demographics, International Classification of Diseases, Ninth Revision Clinical Modification diagnosis/procedure and durable medical equipment codes for frailty-associated conditions. Multivariable logistic regression was used to predict ADL dependency. Cox models estimated hazard ratios for death as a function of observed and predicted ADL dependency. Results Of 6391 respondents, 57% were female, 88% white, and 38% were ≥80. The prevalence of ADL dependency was 9.5%. Strong predictors of ADL dependency were charges for a home hospital bed (OR = 5.44, 95%CI = 3.28–9.03) and wheelchair (OR = 3.91, 95%CI = 2.78–5.51). The c-statistic of the final model was 0.845. Model-predicted ADL dependency of 20% or greater was associated with a hazard ratio for death of 3.19 (95%CI: 2.78, 3.68). Conclusions An algorithm for predicting ADL dependency using health care claims was developed to measure some aspects of frailty. Accounting for variation in frailty among older adults could lead to more valid conclusions about treatment use, safety, and effectiveness. Copyright © 2014 John Wiley & Sons, Ltd.

One of the challenges of pharmacoepidemiology that is both exciting and frustrating is the replication of findings. It is often easy to frame the question as “does drug X cause side effect Y”, but this ignores subtle differences in the actual contrasts that are being made. This issue is well highlighted by three recent studies of the cardiovascular safety of the medication Olmesartan published in this issue of the Journal 1–3. These non-experimental (observational) studies were motivated by safety signals from two randomized, placebo controlled trials that suggested that Olmesartan increased all-cause mortality in patients with diabetes4–5. Although the absolute number of deaths observed in the randomized trials was small, the possibility of such an effect is a legitimate cause for concern 1–3. The three non-experimental studies are all well designed and placed in independent populations in two different countries (the United States of America and the United Kingdom).

STUDY OBJECTIVE To determine whether distressing adverse events (DAEs) experienced during initial antidepressant treatment are associated with subsequent DAEs after switching to a second antidepressant. DESIGN Secondary analysis of data from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. SETTING Primary care and psychiatric care facilities. PATIENTS A total of 727 outpatients aged 18-75 years with nonpsychotic major depressive disorder who failed first-step therapy with citalopram and were switched to second-step monotherapy with an alternative antidepressant. MEASUREMENTS AND MAIN RESULTS In the STAR*D trial, patient-reported DAEs were entered into the Patient-Rated Inventory of Side Effects (PRISE). In this secondary analysis, data from PRISE were used to determine the incidence of DAEs during first-step treatment with citalopram and second-step treatment with sustained-release bupropion, sertraline, or extended-release venlafaxine. Regression models were used to compare the risk of adverse events during second-step treatment between those who reported similar adverse events during first-step treatment and those who did not, while controlling for potential confounders. Of the 727 patients analyzed, DAEs were reported by 514 patients (70.7%) during first-step treatment and 626 (86.1%) during second-step treatment; no significant differences were observed among the three second-step treatment groups. Overall, patients reporting DAEs during first-step treatment were more likely to report DAEs during second-step treatment (risk ratio [RR] 1.11, 95% confidence interval [CI] 1.03-1.20). After controlling for confounders, patients were significantly more likely to report DAEs specific to a body function or organ system, such as those involving the genitourinary system (RR 3.39, 95% CI 2.41-4.78) or sexual functioning (RR 2.75, 95% CI 2.29-3.29), if the patients had reported similar events during initial treatment. CONCLUSION Patients who experienced DAEs with initial antidepressant treatment were likely to report similar adverse events after switching to an alternative antidepressant, even when subsequent treatment is from a different class of antidepressants.

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.

To describe trends and identify factors associated with choice of pharmacotherapy for gestational diabetes (GDM) from 2000-2011 using a healthcare claims database.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.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.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.II.

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.