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Minji K Lee,1 Jennifer L St Sauver,1,2 Roger T Anderson,3 Mark Linzer,4 David T Eton1,2 1Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA; 2Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 3Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA; 4Hennepin Healthcare, Minneapolis, Minnesota, USA, University of Minnesota Medical School, Minneapolis, MN, USACorrespondence: Minji K LeeRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Harwick Building, Second Floor, 200 First St SW, Rochester, MN 55905, USATel +1 507 284 1310Email Lee.Minji@mayo.eduDavid T Eton Email eton.david@mayo.eduPurpose: To examine the factor structure and differential item functioning (DIF) of the Patient Experience with Treatment and Self-management (PETS version 2.0), a measure of treatment burden.Patients and Methods: Version 2.0 of the PETS has 60 items, extending the previously-validated 48-item version 1.0 by three domains (nine items) and three additional items in an existing domain. We conducted confirmatory factor analyses (CFA) on survey responses of 439 community-dwelling adults living with multiple chronic conditions who completed PETS version 2.0, using R packages, “lavaan” and “semTools.” We tested fit of second-order factors to explore simplifying the reporting of PETS scores. We examined DIF for the two second-order factors with “lordif” R package, testing groups by gender, education, and health literacy, using the McFadden pseudo R2 change criterion of ≥ 0.02 to flag items with DIF. Cronbach’s alpha and the intraclass correlation coefficient (ICC) were used to determine the reliability of PETS domains.Results: The first-order CFA model featuring 12 multi-item domains had an excellent fit (Comparative Fit Index [CFI]=0.989), as did the second-order CFA model (CFI=0.987), specifying two superordinate factors of treatment burden (workload and impact). Items in the workload and impact second-order factors did not show any DIF across gender, education, and health literacy groups as shown by McFadden pseudo R2 changes < 0.02. Cronbach’s alphas for all multi-item domain scales were ≥ 0.80, and ICCs of ten scales were ≥ 0.70, meeting the threshold for adequate test–retest reliability.Conclusion: Findings support the construct validity and reliability of PETS version 2.0. The fit of a factor model featuring superordinate (ie, second-order) factors of workload and impact supports index scoring that will simplify reporting of PETS scores. DIF analyses indicate that items from these indices can be interpreted in the same way, regardless of gender, education, or health literacy.Keywords: factor structure, patient-reported outcomes, multi-morbidity, psychometric testing, questionnaire, validation

Guilherme S Lopes,1,2 Suzette J Bielinski,2 Ann M Moyer,3 John Logan Black III,3 Debra J Jacobson,1 Ruoxiang Jiang,1 Nicholas B Larson,1 Jennifer L St Sauver2 1Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 2Division of Epidemiology, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 3Division of Laboratory Genetics and Genomics, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USACorrespondence: Guilherme S LopesDivision of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USATel +1 507 422 6094Email lopes.guilherme@mayo.eduBackground: Several small studies have previously investigated associations between the cytochrome P450 2D6 (CYP2D6) metabolism and response to opioids. We used a large sample of patients to study associations between CYP2D6 phenotypes and estimated CYP2D6 enzymatic activity scores with pain control and adverse reactions related to codeine and tramadol use. We conducted additional analyses to determine whether our results were consistent among men and women.Methods: We used data from 2,877 participants in the RIGHT Protocol who were prescribed codeine and/or tramadol between 01/01/2005 and 12/31/2017 and who were not prescribed CYP2D6 inhibitors within 1 year prior to the opioid prescription. CYP2D6 phenotype categories were condensed into four groups: (1) Ultra-rapid and Rapid (n = 61), (2) Normal and Intermediate to Normal (n = 1,448), (3) Intermediate and Intermediate to Poor (n = 1,175), and (4) Poor metabolizer status (n = 193). Opioid-related outcomes included indications of poor pain control or adverse reactions related to medication use. We modeled the risk of each outcome using logistic regression, adjusting for age, sex, race, and ethnicity.Results: The results revealed a trend from poor to ultra-rapid and rapid CYP2D6 phenotypes in which the risk of adverse reactions incrementally increased and the risk of poor pain control incrementally decreased. This trend reached statistical significance among female (but not male) participants. Among normal and intermediate to normal metabolizers, a larger proportion of women experienced adverse reactions relative to men.Discussion: We replicated and extended the findings of previous research indicating associations between CYP2D6 phenotypes and response to opioids. In addition, the observed associations were stronger in women than in men. We recommend sex differences to be factored in future research investigating associations between pharmacogenomics and response to medications.Keywords: opioids, codeine, tramadol, pharmacogenomics, sex differences, CYP2D6

David T Eton,1,2 Roger T Anderson,3 Wendy F Cohn,3 Erin M Kennedy,3 Jennifer L St. Sauver,1,2 Bayly J Bucknell,1 Kathryn J Ruddy4 1Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 2Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA; 3Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA; 4Department of Oncology, Mayo Clinic, Rochester, MN, USA Purpose: The purpose of this study was to identify risk factors for poor health-related quality of life (HRQL) in multi-morbid adult cancer survivors and explore whether perceived treatment and self-management burden mediate any of these relationships.Methods: Ninety-one multi-morbid cancer survivors (median age: 65 years) completed surveys at baseline and 6 months. Demographic, psychosocial, and health care-related factors were assessed as were perceived treatment burden and general HRQL (physical and mental health). Data on medical diagnoses and cancer treatment were extracted from the medical record. Bivariate correlations screened for associations between predictors and outcomes, with significant predictors entered into multivariable linear regressions to identify unique risk factors for greater treatment burden and poorer HRQL. Follow-up regressions examined whether treatment burden mediated any of the risk factor–outcome relationships.Results: Factors that correlated with higher baseline treatment burden included: having more diagnoses, less formal education, having seen more physicians in the past 6 months, having a mental health diagnosis, not having a set routine for one’s self-management, low health literacy, low self-efficacy for self-management, and low social support (Ps

David T Eton,1,2 Roger T Anderson,3 Wendy F Cohn,3 Erin M Kennedy,3 Jennifer L St. Sauver,1,2 Bayly J Bucknell,1 Kathryn J Ruddy4 1Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 2Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA; 3Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA; 4Department of Oncology, Mayo Clinic, Rochester, MN, USA Purpose: The purpose of this study was to identify risk factors for poor health-related quality of life (HRQL) in multi-morbid adult cancer survivors and explore whether perceived treatment and self-management burden mediate any of these relationships.Methods: Ninety-one multi-morbid cancer survivors (median age: 65 years) completed surveys at baseline and 6 months. Demographic, psychosocial, and health care-related factors were assessed as were perceived treatment burden and general HRQL (physical and mental health). Data on medical diagnoses and cancer treatment were extracted from the medical record. Bivariate correlations screened for associations between predictors and outcomes, with significant predictors entered into multivariable linear regressions to identify unique risk factors for greater treatment burden and poorer HRQL. Follow-up regressions examined whether treatment burden mediated any of the risk factor–outcome relationships.Results: Factors that correlated with higher baseline treatment burden included: having more diagnoses, less formal education, having seen more physicians in the past 6 months, having a mental health diagnosis, not having a set routine for one’s self-management, low health literacy, low self-efficacy for self-management, and low social support (Ps

David T Eton,1,2 Jennifer L Ridgeway,1,2 Mark Linzer,3 Deborah H Boehm,4 Elizabeth A Rogers,5 Kathleen J Yost,1,2 Lila J Finney Rutten,1,2 Jennifer L St Sauver,1,2 Sara Poplau,4 Roger T Anderson6 1Department of Health Sciences Research, 2Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, 3Division of General Internal Medicine, Hennepin County Medical Center, 4Minneapolis Medical Research Foundation, 5Division of General Internal Medicine, University of Minnesota Medical School, Minneapolis, MN, 6Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA Purpose: Having multiple chronic conditions (MCCs) can lead to appreciable treatment and self-management burden. Healthcare provider relational quality (HPRQ) – the communicative and interpersonal skill of the provider – may mitigate treatment burden and promote self-management. The objectives of this study were to 1) identify the associations between HPRQ, treatment burden, and psychosocial outcomes in adults with MCCs, and 2) determine if certain indicators of HPRQ are more strongly associated than others with these outcomes.Patients and methods: This is a cross-sectional survey study of 332 people with MCCs. Patients completed a 7-item measure of HPRQ and measures of treatment and self-management burden, chronic condition distress, self-efficacy, provider satisfaction, medication adherence, and physical and mental health. Associations between HPRQ, treatment burden, and psychosocial outcomes were determined using correlational analyses and independent samples t-tests, which were repeated in item-level analyses to explore which indicators of HPRQ were most strongly associated with the outcomes.Results: Most respondents (69%) were diagnosed with ≥3 chronic conditions. Better HPRQ was found to be associated with less treatment and self-management burden and better psychosocial outcomes (P

Jennifer L St Sauver,1,2 Janet E Olson,1,3 Veronique L Roger,1,2,4 Wayne T Nicholson,5 John L Black III,3,6 Paul Y Takahashi,7 Pedro J Caraballo,7 Elizabeth J Bell,2 Debra J Jacobson,1,2 Nicholas B Larson,1 Suzette J Bielinski,1,3 1Department of Health Sciences Research, 2Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, 3Center for Individualized Medicine, 4Department of Cardiovascular Diseases, 5Department of Anesthesiology and Perioperative Medicine, 6Department of Laboratory Medicine and Pathology, 7Department of Primary Care Internal Medicine, Mayo Clinic, Rochester, MN,USA Background: Variation in the CYP2D6 gene may affect response to opioids in both poor and ultrarapid metabolizers, but data demonstrating such associations have been mixed, and the impact of variants on toxicity-related symptoms (e.g., nausea) is unclear. Therefore, we examined the association between CYP2D6 phenotype and poor pain control or other adverse symptoms related to the use of opioids in a sample of primary care patients.Materials and methods: We identified all patients in the Mayo Clinic RIGHT Protocol who were prescribed an opioid medication between July 01, 2013 and June 30, 2015, and categorized patients into three phenotypes: poor, intermediate to extensive, or ultrarapid CYP2D6 metabolizers. We reviewed the electronic health record of these patients for indications of poor pain control or adverse symptoms related to medication use. Associations between phenotype and outcomes were assessed using Chi-square tests and logistic regression.Results: Overall, 257 (25% of RIGHT Protocol participants) patients received at least one opioid prescription; of these, 40 (15%) were poor metabolizers, 146 (57%) were intermediate to extensive metabolizers, and 71 (28%) were ultrarapid metabolizers. We removed patients that were prescribed a CYP2D6 inhibitor medication (n=38). After adjusting for age and sex, patients with a poor or ultrarapid phenotype were 2.7 times more likely to experience either poor pain control or an adverse symptom related to the prescription compared to patients with an intermediate to extensive phenotype (odds ratio: 2.68; 95% CI: 1.39, 5.17; p=0.003).Conclusion: Our results suggest that >30% of patients with a poor or ultrarapid CYP2D6 phenotype may experience an adverse outcome after being prescribed codeine, tramadol, oxycodone, or hydrocodone. These medications are frequently prescribed for pain relief, and ~39% of the US population is expected to carry one of these phenotypes, suggesting that the population-level impact of these gene–drug interactions could be substantial. Keywords: CYP2D6, opioid, phenotype, adverse effects

Paul Y Takahashi,1 Jennifer L St Sauver,2 Lila J Finney Rutten,2 Robert M Jacobson,3 Debra J Jacobson,2 Michaela E McGree,2 Jon O Ebbert1 1Department of Internal Medicine, Division of Primary Care Internal Medicine, 2Department of Health Sciences Research, Mayo Clinic Robert D and Patricia E Kern Center for the Science of Health Care Delivery, 3Department of Pediatric and Adolescent Medicine, Division of Community Pediatrics, Mayo Clinic, Rochester, MN, USA Objective: Our objective was to understand the relationship between optimal diabetes control, as defined by Minnesota Community Measurement (MCM), and adverse health outcomes including emergency department (ED) visits, hospitalizations, 30-day rehospitalization, intensive care unit (ICU) stay, and mortality. Patients and methods: In 2009, we conducted a retrospective cohort study of empaneled Employee and Community Health patients with diabetes mellitus. We followed patients from 1 September 2009 until 30 June 2011 for hospitalization and until 5 January 2014 for mortality. Optimal control of diabetes mellitus was defined as achieving the following three measures: low-density lipoprotein (LDL) cholesterol

Lila J Finney Rutten,1 Sana N Vieux,2 Jennifer L St Sauver,1 Neeraj K Arora,2 Richard P Moser,2 Ellen Burke Beckjord,3 Bradford W Hesse2 1Robert D. and Patricia E. Kern Center for the Science of Healthcare Delivery, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 2Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, USA; 3Biobehavioral Medicine in Oncology Program, University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA Purpose: Despite considerable potential for improving health care quality, adoption of new technologies, such as electronic medical records (EMRs), requires prudence, to ensure that such tools are designed, implemented, and used meaningfully to facilitate patient-centered communication and care processes, and better health outcomes. The association between patients’ perceptions of health care provider use of EMRs and health care quality ratings was assessed. Method: Data from two iterations of the Health Information National Trends Survey, fielded in 2011 and 2012, were pooled for these analyses. The data were collected via mailed questionnaire, using a nationally representative listing of home addresses as the sampling frame (n=7,390). All data were weighted to provide representative estimates of quality of care ratings and physician use of EMR, in the adult US population. Descriptive statistics, t-tests, and multivariable linear regression analyses were conducted. Results: EMR use was reported significantly more frequently by females, younger age groups, non-Hispanic whites, and those with higher education, higher incomes, health insurance, and a usual source of health care. Respondents who reported physician use of EMRs had significantly higher ratings of care quality (Beta=4.83, standard error [SE]=1.7, P

Paul Y Takahashi.1 Jennifer L St Sauver,2 Timothy C Olson,1 Jill M Huber,1 Stephen S Cha,2 Jon O Ebbert11Division of Primary Care Internal Medicine, 2Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USABackground: In older adults, underweight (body mass index [BMI] < 18.5) has been associated with increased mortality. This increased mortality risk may be associated with increased health care utilization. We evaluated the relationship between underweight and hospitalization, emergency room visits, and mortality.Methods: An analysis of a retrospective cohort study was conducted at a multisite academic primary care medical practice in Minnesota. The patients were ≥60 years of age, impaneled within primary care on January 1, 2011, and had a BMI measurement recorded between January 1, 2011, and December 31, 2011. Individuals were excluded if they refused review of their medical record. The primary measurement was BMI, which was categorized as underweight (BMI < 18.5) or normal and obese (BMI ≥ 18.5). The outcomes were hospitalization, emergency room visits, and mortality in the 2011 calendar year. Associations between underweight and each outcome were calculated using logistic regression. Interactions between underweight and gender were assessed in the logistic regression models. The final results were adjusted for age, gender, comorbid health conditions, and single living status.Results: The final cohort included 21,019 patients, of whom 220 (1%) were underweight. Underweight patients had a higher likelihood of hospitalization compared with patients with higher BMI (adjusted odds ratio [OR] 1.64; 95% confidence interval [CI] 1.21–2.22). Underweight patients were also more likely to visit the emergency room (adjusted OR 1.70; 95% CI 1.28–2.25) or to die (adjusted OR 3.64; 95% CI 2.33–5.69). Men with a BMI < 18.5 compared with those having a BMI ≥ 18.5 had the highest odds of hospitalization (OR 3.45; 95% CI 1.59–7.48).Conclusion: Underweight older adults, especially men, have higher odds of hospitalization, emergency room visits, and mortality. Future work on underweight might involve improving weight status, which may reduce the risk of hospitalization, emergency room visits, and mortality.Keywords: aging, health care utilization, nutrition, population health