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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

Elizabeth A Rogers,1,2 Kathleen J Yost,3 Jordan K Rosedahl,3 Mark Linzer,4 Deborah H Boehm,5 Azra Thakur,5 Sara Poplau,5 Roger T Anderson,6 David T Eton3 1Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; 2Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA; 3Department of Health Services Research, Mayo Clinic, Rochester, MN, USA; 4Department of Medicine, Hennepin County Medical Center, Minneapolis, MN, USA; 5Minneapolis Medical Research Foundation, Minneapolis, MN, USA; 6University of Virginia School of Medicine, Charlottesville, VA, USA Aims: To validate a comprehensive general measure of treatment burden, the Patient Experience with Treatment and Self-Management (PETS), in people with diabetes. Methods: We conducted a secondary analysis of a cross-sectional survey study with 120 people diagnosed with type 1 or type 2 diabetes and at least one additional chronic illness. Surveys included established patient-reported outcome measures and a 48-item version of the PETS, a new measure comprised of multi-item scales assessing the burden of chronic illness treatment and self-care as it relates to nine domains: medical information, medications, medical appointments, monitoring health, interpersonal challenges, health care expenses, difficulty with health care services, role activity limitations, and physical/mental exhaustion from self-management. Internal reliability of PETS scales was determined using Cronbach’s alpha. Construct validity was determined through correlation of PETS scores with established measures (measures of chronic condition distress, medication satisfaction, self-efficacy, and global well-being), and known-groups validity through comparisons of PETS scores across clinically distinct groups. In an exploratory test of predictive validity, step-wise regressions were used to determine which PETS scales were most associated with outcomes of chronic condition distress, overall physical and mental health, and medication adherence. Results: Respondents were 37–88 years old, 59% female, 29% non-white, and 67% college-educated. PETS scales showed good reliability (Cronbach’s alphas ≥0.74). Higher PETS scale scores (greater treatment burden) were correlated with more chronic condition distress, less medication convenience, lower self-efficacy, and worse general physical and mental health. Participants less (versus more) adherent to medications and those with more (versus fewer) health care financial difficulties had higher mean PETS scores. Medication burden was the scale that was most consistently associated with well-being and patient-reported adherence. Conclusion: The PETS is a reliable and valid measure for assessing perceived treatment burden in people coping with diabetes. Keywords: treatment burden, patient-reported measure, measurement, patient perspective, disease management

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

Background: PCEs are hypothesized to increase affinity for primary care careers. Subjects: Four focus groups (FGs) of randomly chosen medical students stratified by gender and year of medical school ( 40 students invited, 30 attended). Approximately 150 year I medical students surveyed by questionnaire. Design: Students were surveyed before and after year I (average response rate, 92%). FGs assessed year I students after the PCE and year 2 students without a PCE (controls). This pilot PCE included 14 half-days of "shadowing'' an office-based generalist during first semester. Analysis: FG transcripts were coded using a published model of career choice in Internal Medicine. Results: Among many positive comments (e.g., "wonderful role models", "'got me fired up about med school"), some unexpected themes emerged, including discomfort with patient relationships("direct patient contact was intimidating and a “tum off"), boredom ("Internal Medicine ... gotrepetitious", "peds was boring ... so many well-child exams") and primary care backlash ("too much push to primary care'). Learning climate comments were often negative in controls but less so in PCE students. When compared with men, women cared more about role conflict (work/home) issues, and made more positive comments about intellectual stimulation of the PCE. Survey results showed no change in interest in a primary care career after the PCE (44% interested before vs 46% after, P = 0.09). Conclusions: A PCE can have positive and negative influences on career choice. These influences may differ by gender. Students could gain a greater affinity for generalism by better preparation for interacting with patients, careful selection of preceptors, and less pressure to enter primary care.

David T Eton,1,2 Jennifer L Ridgeway,1,2 Jason S Egginton,1,2 Kristina Tiedje,3 Mark Linzer,4,5 Deborah H Boehm,4 Sara Poplau,6 Djenane Ramalho de Oliveira,7 Laura Odell,8 Victor M Montori,1,9 Carl R May,10 Roger T Anderson11 1Division of Health Care Policy and Research, Department 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 Sociology and Anthropology, Université Lumière Lyon 2, Lyon, France; 4Division of General Internal Medicine, Hennepin County Medical Center, Minneapolis, MN, USA; 5University of Minnesota Medical School, University of Minnesota, Minneapolis, MN, USA; 6Minneapolis Medical Research Foundation, Minneapolis, MN, USA; 7Department of Social Pharmacy, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil; 8Pharmacy Services, Mayo Clinic, Rochester, MN, USA; 9Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA; 10Faculty of Health Sciences and NIHR CLAHRC Wessex, University of Southampton, Southampton, UK; 11School of Medicine, University of Virginia, Charlottesville, VA, USA Purpose: The workload of health care and its impact on patient functioning and well-being is known as treatment burden. The purpose of this study was to finalize a conceptual framework of treatment burden that will be used to inform a new patient-reported measure of this construct. Patients and methods: Semi-structured interviews were conducted with 50 chronically ill patients from a large academic medical center (n=32) and an urban safety-net hospital (n=18). We coded themes identifying treatment burden, with the themes harmonized through discussion between multiple coders. Four focus groups, each with five to eight participants with chronic illness, were subsequently held to confirm the thematic structure that emerged from the interviews. Results: Most interviewed patients (98%) were coping with multiple chronic conditions. A preliminary conceptual framework using data from the first 32 interviews was evaluated and was modified using narrative data from 18 additional interviews with a racially and socioeconomically diverse sample of patients. The final framework features three overarching themes with associated subthemes. These themes included: 1) work patients must do to care for their health (eg, taking medications, keeping medical appointments, monitoring health); 2) challenges/stressors that exacerbate perceived burden (eg, financial, interpersonal, provider obstacles); and 3) impacts of burden (eg, role limitations, mental exhaustion). All themes and subthemes were subsequently confirmed in focus groups. Conclusion: The final conceptual framework can be used as a foundation for building a patient self-report measure to systematically study treatment burden for research and analytical purposes, as well as to promote meaningful clinic-based dialogue between patients and providers about the challenges inherent in maintaining complex self-management of health. Keywords: treatment burden, conceptual framework, adherence, questionnaire, self-management, multi-morbidity

Jennifer L Ridgeway,1,2 Jason S Egginton,1,2 Kristina Tiedje,3 Mark Linzer,4,5 Deborah Boehm,4 Sara Poplau,6 Djenane Ramalho de Oliveira,7 Laura Odell,8 Victor M Montori,2,9 David T Eton1,2 1The Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, 2Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 3Department of Anthropology, Université Lumière Lyon 2, Lyon, France; 4Division of General Internal Medicine, Hennepin County Medical Center, 5University of Minnesota Medical School, 6Minneapolis Medical Research Foundation, Minneapolis, MN, USA; 7Department of Social Pharmacy, Universidade Federal de Minas Gerais, Brazil; 8Pharmacy Services, 9Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA Purpose: Patients with multiple chronic conditions (multimorbidity) often require ongoing treatment and complex self-care. This workload and its impact on patient functioning and well-being are, together, known as treatment burden. This study reports on factors that patients with multimorbidity draw on to lessen perceptions of treatment burden. Patients and methods: Interviews (n=50) and focus groups (n=4 groups, five to eight participants per group) were conducted with patients receiving care in a large academic medical center or an urban safety-net hospital. Interview data were analyzed using qualitative framework analysis methods, and themes and subthemes were used to identify factors that mitigate burden. Focus groups were held to confirm these findings and clarify any new issues. This study was part of a larger program to develop a patient-reported measure of treatment burden. Results: Five major themes emerged from the interview data. These included: 1) problem-focused strategies, like routinizing self-care, enlisting support of others, planning for the future, and using technology; 2) emotion-focused coping strategies, like maintaining a positive attitude, focusing on other life priorities, and spirituality/faith; 3) questioning the notion of treatment burden as a function of adapting to self-care and comparing oneself to others; 4) social support (informational, tangible, and emotional assistance); and 5) positive aspects of health care, like coordination of care and beneficial relationships with providers. Additional subthemes arising from focus groups included preserving autonomy/independence and being proactive with providers. Conclusion: Patients attempt to lessen the experience of treatment burden using a variety of personal, social, and health care resources. Assessing these factors in tandem with patient perceptions of treatment burden can provide a more complete picture of how patients fit complex self-care into their daily lives. Keywords: adherence, patient-centered, minimally disruptive medicine, patient preferences

Purpose: To review the literature on diagnostic testing in syncope that remains unexplained after initial clinical assessment.Data Sources: MEDLINE search.Study Selection: Published papers were selected if they addressed diagnostic testing in syncope, near syncope, or dizziness.Data Extraction: Studies were identified as population studies, referral studies, or case series.Data Synthesis: After a thorough history, physical examination, and electrocardiography, the cause of syncope remains undiagnosed in 50% of patients. In such patients, information may be derived from the results of carefully selected diagnostic tests, especially 1) electrophysiologic studies in patients with organic heart disease, 2) Holter monitoring or telemetry in patients known to have or suspected of having heart disease, 3) loop monitoring in patients with frequent events and normal hearts, 4) psychiatric evaluation in patients with frequent events and no injury, and 5) tilt-table testing in patients who have infrequent events or in whom vasovagal syncope is suspected. Hospitalization is indicated for high-risk patients, especially those with known heart disease and elderly patients.Conclusions: A flexible, focused approach is required to diagnose syncope. Features of the initial history and physical examination help guide diagnostic testing. [ABSTRACT FROM AUTHOR]

Purpose: To review the literature on diagnostic testing in syncope and provide recommendations for a comprehensive, cost-effective approach to establishing its cause.Data Sources: Studies were identified through a MEDLINE search (1980 to present) and a manual review of bibliographies of identified articles.Study Selection: Papers were eligible if they addressed diagnostic testing in syncope or near syncope and reported results for at least 10 patients.Data Extraction: The usefulness of tests was assessed by calculating diagnostic yield: the number of patients with diagnostically positive test results divided by the number of patients tested or, in the case of monitoring studies, the sum of true-positive and true-negative test results divided by the number of patients tested.Data Synthesis: Despite the absence of a diagnostic gold standard and the paucity of data from randomized trials, several points emerge. First, history, physical examination, and electrocardiography are the core of the syncope workup (combined diagnostic yield, 50%). Second, neurologic testing is rarely helpful unless additional neurologic signs or symptoms are present (diagnostic yield of electroencephalography, computed tomography, and Doppler ultrasonography, 2% to 6%). Third, patients in whom heart disease is known or suspected or those with exertional syncope are at higher risk for adverse outcomes and should have cardiac testing, including echocardiography, stress testing. Holter monitoring, or intracardiac electrophysiologic studies, alone or in combination (diagnostic yields, 5% to 35%). Fourth, syncope in the elderly often results from polypharmacy and abnormal physiologic responses to daily events. Fifth, long-term loop electrocardiography (diagnostic yield, 25% to 35%) and tilt testing (diagnostic yield < or = 60%) are most useful in patients with recurrent syncope in whom heart disease is not suspected. Sixth, psychiatric evaluation can detect mental disorders associated with syncope in up to 25% of cases. Seventh, hospitalization may be indicated for patients at high risk for cardiac syncope (those with an abnormal electrocardiogram, organic heart disease, chest pain, history of arrhythmia, age > 70 years) or with acute neurologic signs.Conclusions: Many tests for syncope have a low diagnostic yield. A careful history, physical examination, and electrocardiography will provide a diagnosis or determine whether diagnostic testing is necessary in most patients. [ABSTRACT FROM AUTHOR]

BACKGROUND: Transient loss of consciousness (TLOC) is a common clinical problem. OBJECTIVE: The aim of this study was to assess the yield and accuracy of the initial evaluation, consisting of standardized history, physical examination, and ECG performed by attending physicians in patients with TLOC. METHODS AND RESULTS: Five hundred and three adult patients (mean age 53 +/- 19; 56% male) presenting with TLOC to the Academic Medical Center Amsterdam between February 2000 and May 2002 were included in this study. After initial evaluation, the physician made a certain, a highly likely (>80% certain), or no initial diagnosis. Initially undiagnosed patients received additional cardiological testing, additional history taking, and autonomic function tests. After 2 years of follow-up, an expert committee determined the final diagnoses. Two-year follow-up was obtained in 99% of the patients. The yield of certain diagnoses after the initial evaluation was 24%, increasing to 63% after including the highly likely diagnoses. The diagnostic accuracy of the initial certain diagnoses was 93% (95% CI 87-97%), decreasing to 88% (95% CI 84-91%) after inclusion of the initial highly likely diagnoses. CONCLUSION: Attending physicians can make a diagnosis based on initial evaluation in 63% of patients with TLOC, with an overall diagnostic accuracy of 88%. The use of additional testing, beyond history, physical examination, and ECG can be avoided in many patients with TLOC. [ABSTRACT FROM AUTHOR]

BACKGROUND: A report by the Institute of Medicine suggests that changing the culture of health care organizations may improve patient safety. Research in this area, however, is modest and inconclusive. Because culture powerfully affects providers, and providers are a key determinant of care quality, the MEMO study (Minimizing Error, Maximizing Outcome) introduces a new model explaining how physician work attitudes may mediate the relationship between culture and patient safety. RESEARCH QUESTIONS: (1) Which cultural conditions affect physician stress, dissatisfaction, and burnout? and (2) Do stressed, dissatisfied, and burned out physicians deliver poorer quality care? METHODS: A conceptual model incorporating the research questions was analyzed via structural equation modeling using a sample of 426 primary care physicians participating in MEMO. FINDINGS: Culture, overall, played a lesser role than hypothesized. However, a cultural emphasis on quality played a key role in both quality outcomes. Further, we found that stressed, burned out, and dissatisfied physicians do report a greater likelihood of making errors and more frequent instance of suboptimal patient care. PRACTICE IMPLICATIONS: Creating and sustaining a cultural emphasis on quality is not an easy task, but is worthwhile for patients, physicians, and health care organizations. Further, having clinicians who are satisfied and not burned out or stressed contributes substantially to the delivery of quality care. [ABSTRACT FROM AUTHOR]

INTRODUCTION: There are limited and conflicting data on the lifetime cumulative incidence of syncope in the general population. The aim of our study was to determine the lifetime cumulative incidence and triggers of syncope in the general population. METHODS: Questions about syncope were added to a cross-sectional survey on cardiovascular risk factors carried out between 2001 and 2003 in 549 native Dutch respondents, aged 35-60 years. RESULTS: The lifetime cumulative incidence of syncope in our study population was 35% (95% confidence interval 31-39%). Syncope occurred more often in women than in men (41% vs 28%; P = 0.003). A peak in the incidence of syncope occurred around the age of 15 years in both men and women. The median number of episodes in persons with syncope was 2 (Inter Quartile Range 1-5). The top five most frequently mentioned triggers of syncope included warm environment, pain, insufficient food intake, seeing blood/venipuncture, and emotion. CONCLUSION: In conclusion, our study shows that the lifetime cumulative incidence of syncope in the general population is high. Females experience syncope more often than males. The majority of the syncope triggers were related to conditions that affect orthostatic blood pressure regulation and vasomotor responses. [ABSTRACT FROM AUTHOR]