Peanut allergy burden survey: Factors associated with health-related quality of life in adolescents.

BACKGROUND: Patients with peanut allergy (PA) experience significant burden of illness, which impacts health-related quality of life (HRQoL), particularly in adolescence. There is a paucity of research evaluating drivers of HRQoL scores. METHODS: A prospective, online survey of adolescents with self-reported, provider-diagnosed PA completed from November 2018 to January 2019 was used to explore drivers of the real-world impact of PA on HRQoL using the Pediatric Quality of Life Inventory 4.0 (PedsQL) and other measures. Univariate and multivariate analyses were used to identify potential factors associated with PedsQL scores and to understand the level of association. RESULTS: A total of 102 adolescents were included. The final model included 10 variables: race, reported strict peanut avoidance, satisfaction with prophylaxis, moderate-to-severe reaction within the past 12 months, touching peanut as cause of most severe reaction, fear of reaction, age, gender, comorbidities, and daily life limitations. In total, three items were shown to be strong predictors of the PedsQL total score including cause of severe reaction was touching peanut (yes), level of agreement with avoiding peanut (completely agree), and satisfaction with prophylaxis (not very much/not at all). CONCLUSIONS: There is substantial heterogeneity in the impact of the burden of PA on PedsQL scores across patients. This indicates the importance of shared and individualized decision making for PA management to optimize outcomes and improve HRQoL.

The Peanut Allergy Burden Study: Real-world impact of peanut allergy on resource utilization and productivity.

BACKGROUND: There is limited research demonstrating the real-world economic burden of peanut allergy (PA) in the United States. The Peanut Allergy Burden Study (PABS) is a cross-sectional quantitative survey designed to determine the real-world experience of patients and caregivers with PA. The objective of the study was to understand the real-world utilization of PA-related healthcare resources and the impact of PA on productivity. METHODS: Participants completed an online survey to examine the real-world 12-month and lifetime healthcare utilization and past week productivity impact of PA in children (as reported by caregiver proxy), adolescents with PA, adults with PA, and caregivers of children with PA. RESULTS: Healthcare resource use over the past 12 months was frequent for adults (n = 153), adolescents (n = 102), and children (as reported by caregivers) (n = 382) with PA. Patients and caregivers reported the following rates of PA-related utilization in the past 12 months: at least 3 regular allergist appointments (28.8%-39.3%), unscheduled allergist appointments (15.6%-18.3%), general practitioner appointments (16.7%-24.2%), over-the-counter (OTC) medication usage (28.5%-35.7%), and epinephrine autoinjector usage (17.7%-26.2%). Additionally, over half of patients and caregivers reported ≥1 PA-related emergency department (ED)/urgent care visit (57.5%-59.9%), overnight hospital admission (36.3%-47.4%), IV epinephrine use (37.2%-52.3%), or intubation (26.2%-39.8%) over the past 12 months for PA. Healthcare resource use was high among all groups. Regarding productivity, PA significantly impacted household work, schoolwork, and employed work for patients and caregivers. PA-related reactions also impacted school attendance of children with PA. CONCLUSION: Many healthcare resources were utilized by patients with PA and there was a loss of productivity associated with PA for patients and caregivers. New treatments to prevent or lower the risk of PA reactions could potentially help reduce healthcare resource utilization and PA-related productivity loss among patients and their families, particularly for patients for whom avoidance as a treatment strategy has not been reliable.

The Peanut Allergy Burden Study: Impact on the quality of life of patients and caregivers.

BACKGROUND: Peanut allergy (PA) places significant burden on peanut-allergic individuals and their families, yet limited research in the United States has quantitatively examined the impact on peanut-allergic individuals and their families' health-related quality of life (HRQoL). The Peanut Allergy Burden Study (PABS) aimed to quantify the impact of PA on the general and disease-specific HRQoL of children, adolescents, and adults with PA, as well as caregivers of children with PA. METHODS: A cross-sectional survey design was employed to examine the real-world impact of PA in children, adolescents, and adults with PA, and caregivers of children with PA. RESULTS: Of 153 adult patients, 102 adolescents, and 382 caregivers of peanut-allergic children (n = 382), 6.8% and 24.8% of participants indicated being dissatisfied or somewhat dissatisfied, respectively, with current approaches to avoid or prevent PA reactions. Approximately two-thirds of patients and caregivers indicated that PA interferes at least somewhat with daily living. In terms of general HRQoL, adolescents, adult patients, and caregivers indicated that mental/psychosocial health was more problematic than physical health. PA patients and caregivers indicated worse HRQoL in all domains compared to healthy samples, and worse overall HRQoL, psychosocial, emotional, and social functioning than a sample of chronically ill patients. Results from the allergy-specific HRQoL measures showed that adolescents experienced greater impairment in overall HRQoL due to PA and in allergen avoidance and dietary restriction than adults. CONCLUSION: PA negatively affects the general and PA-specific HRQoL of both patients and caregivers. The high emotional and psychosocial burden, in particular, demonstrates significant unmet need for patients with PA and their caregivers. Future work on treatment and preventive options to improve HRQoL for PA patients, particularly adolescents and their families, is needed.

Nursing Home Use Across The Spectrum of Cognitive Decline: Merging Mayo Clinic Study of Aging With CMS MDS Assessments.

BACKGROUND/OBJECTIVES: Objective, complete estimates of nursing home (NH) use across the spectrum of cognitive decline are needed to help predict future care needs and inform economic models constructed to assess interventions to reduce care needs. DESIGN: Retrospective longitudinal study. SETTING: Olmsted County, MN. PARTICIPANTS: Mayo Clinic Study of Aging participants assessed as cognitively normal (CN), mild cognitive impairment (MCI), previously unrecognized dementia, or prevalent dementia (age = 70-89 years; N = 3,545). MEASUREMENTS: Participants were followed in Centers for Medicare and Medicaid Services (CMS) Minimum Data Set (MDS) NH records and in Rochester Epidemiology Project provider-linked medical records for 1-year after assessment of cognition for days of observation, NH use (yes/no), NH days, NH days/days of observation, and mortality. RESULTS: In the year after cognition was assessed, for persons categorized as CN, MCI, previously unrecognized dementia, and prevalent dementia respectively, the percentages who died were 1.0%, 2.6%, 4.2%, 21%; the percentages with any NH use were 3.8%, 8.7%, 19%, 40%; for persons with any NH use, median NH days were 27, 38, 120, 305, and median percentages of NH days/days of observation were 7.8%, 12%, 33%, 100%. The year after assessment, among persons with prevalent dementia and any NH use, >50% were a NH resident all days of observation. Pairwise comparisons revealed that each increase in cognitive impairment category exhibited significantly higher proportions with any NH use. One-year mortality was especially high for persons with prevalent dementia and any NH use (30% vs 13% for those with no NH use); 58% of all deaths among persons with prevalent dementia occurred while a NH resident. CONCLUSIONS: Findings suggest reductions in NH use could result from quality alternatives to NH admission, both among persons with MCI and persons with dementia, together with suitable options for end-of-life care among persons with prevalent dementia.

Direct medical costs and source of cost differences across the spectrum of cognitive decline: a population-based study.

BACKGROUND: Objective cost estimates and source of cost differences are needed across the spectrum of cognition, including cognitively normal (CN), mild cognitive impairment (MCI), newly discovered dementia, and prevalent dementia. METHODS: Subjects were a subset of the Mayo Clinic Study of Aging stratified-random sampling of Olmsted County, MN, residents aged 70 to 89 years. A neurologist reviewed provider-linked medical records to identify prevalent dementia (review date = index). Remaining subjects were invited to participate in prospective clinical/neuropsychological assessments; participants were categorized as CN, MCI, or newly discovered dementia (assessment date = index). Costs for medical services/procedures 1-year pre-index (excluding indirect and long-term care costs) were estimated using line-item provider-linked administrative data. We estimated contributions of care-delivery site and comorbid conditions (including and excluding neuropsychiatric diagnoses) to between-category cost differences. RESULTS: Annual mean medical costs for CN, MCI, newly discovered dementia, and prevalent dementia were $6042, $6784, $9431, $11,678, respectively. Hospital inpatient costs contributed 70% of total costs for prevalent dementia and accounted for differences between CN and both prevalent and newly discovered dementia. Ambulatory costs accounted for differences between CN and MCI. Age-, sex-, education-adjusted differences reached significance for CN versus newly discovered and prevalent dementia and for MCI versus prevalent dementia. After considering all comorbid diagnoses, between-category differences were reduced (e.g., prevalent dementia minus MCI (from $4842 to $3575); newly discovered dementia minus CN (from $3578 to $711)). Following the exclusion of neuropsychiatric diagnoses from comorbidity adjustment, between-category differences tended to revert to greater differences. CONCLUSIONS: Cost estimates did not differ significantly between CN and MCI. Substantial differences between MCI and prevalent dementia reflected high inpatient costs for dementia and appear partly related to co-occurring mental disorders. Such comparisons can help inform models aimed at identifying where, when, and for which individuals proposed interventions might be cost-effective.

Levodopa-carbidopa intestinal gel in advanced Parkinson's disease open-label study: interim results.

Levodopa-carbidopa intestinal gel (LCIG) delivered continuously via percutaneous endoscopic gastrojejunostomy (PEG-J) tube has been reported, mainly in small open-label studies, to significantly alleviate motor complications in Parkinson's disease (PD). A prospective open-label, 54-week, international study of LCIG is ongoing in advanced PD patients experiencing motor fluctuations despite optimized pharmacologic therapy. Pre-planned interim analyses were conducted on all enrolled patients (n = 192) who had their PEG-J tube inserted at least 12 weeks before data cutoff (July 30, 2010). Outcomes include the 24-h patient diary of motor fluctuations, Unified Parkinson's Disease Rating Scale (UPDRS), Clinical Global Impression-Improvement (CGI-I), Parkinson's Disease Questionnaire (PDQ-39), and safety evaluations. Patients (average PD duration 12.4 yrs) were taking at least one PD medication at baseline. The mean (±SD) exposure to LCIG was 256.7 (±126.0) days. Baseline mean "Off" time was 6.7 h/day. "Off" time was reduced by a mean of 3.9 (±3.2) h/day and "On" time without troublesome dyskinesia was increased by 4.6 (±3.5) h/day at Week 12 compared to baseline. For the 168 patients (87.5%) reporting any adverse event (AE), the most common were abdominal pain (30.7%), complication of device insertion (21.4%), and procedural pain (17.7%). Serious AEs occurred in 60 (31.3%) patients. Twenty-four (12.5%) patients discontinued, including 14 (7.3%) due to AEs. Four (2.1%) patients died (none deemed related to LCIG). Interim results from this advanced PD cohort demonstrate that LCIG produced meaningful clinical improvements. LCIG was generally well-tolerated; however, device and procedural complications, while generally of mild severity, were common.

The association of consumer expectations, experiences and satisfaction with newly prescribed medications.

OBJECTIVE: To examine the association between medication expectations and subsequent experience on treatment satisfaction and intention to continue using the medication. METHODS: A longitudinal study with two surveys administered to each patient. Patients prescribed a new medication were recruited in pharmacies within Michigan. Medication-related expectations were evaluated at baseline. Experiences, satisfaction and intent to continue were evaluated a month later. Analyses used included factorial ANOVA models, multiple linear regressions and structural equation modeling (SEM). Impact of satisfaction on intention to continue was evaluated using correlation analysis and SEM. RESULTS: A total of 344 usable responses were obtained. SEM showed that expectation scores were not associated with both experience (path coefficient = 0.10) and satisfaction (path coefficient = 0.02, NS). On the other hand, experience was strongly associated with satisfaction (path coefficient = 0.89) and satisfaction was strongly associated with intent to continue using the new medication (path coefficient = 0.81). CONCLUSIONS: This study empirically supports the value of the patient's experience and its contribution to satisfaction, which in turn is associated with intended continued use mainly due to greater effectiveness of the newly prescribed medication. Satisfied consumers should be more adherent, thus enhancing the probability of positive therapeutic outcomes.

Hierarchical construct validity of the treatment satisfaction questionnaire for medication (TSQM version II) among outpatient pharmacy consumers.

OBJECTIVES: The objectives of this study were twofold: 1) to evaluate the construct validity of the Treatment Satisfaction Questionnaire for Medication (TSQM v. II) using structural equation modeling (SEM); and 2) to assess its concurrent validity using medication adherence criteria. METHODS: Pharmacy patients filling a new medication prescription (n = 342) were recruited from 14 Michigan pharmacies to participate in a 4-week treatment satisfaction study. The TSQM v. II was tested for model fit against an established theoretical model (the Decisional Balance Model of Treatment Satisfaction) using hierarchical confirmatory factor analysis (HCFA). Regression and discriminant analytic models were used to examine the criterion-related validity of the measure. RESULTS: An exploratory factor analysis, used for TSQM v. II item reduction, revealed a strongly dimensional instrument (Effectiveness, Side Effects, and Convenience) and explained 88% of total pooled variance. Results of an HCFA using the final TSQM v. II items suggested a good model fit with the data (P > 0.54). In support of concurrent validity, the TSQM scales explained between 9% and 20% of the variance in dosing adherence and 60% of the variance in the likelihood of future use. Discriminant analysis demonstrated the superior classification power of the hierarchical model of treatment satisfaction over the discrete attribute model when predicting medication discontinuation. CONCLUSIONS: The TSQM v. II has equivalent measurement characteristics as the TSQM v. I, yet uses four fewer items and more consistent wording. The value of the Decisional Balance Model for estimation of dosing adherence and medication persistence over time is discussed.

The impact of depression on the academic productivity of university students.

BACKGROUND: Depression is a common disorder that impacts an individual's ability to perform life activities, including those required by the workplace. Academic performance can be viewed as a direct parallel to workforce performance, with students belonging to a unique set of individuals whose ability to perform can be measured on criteria applied by an observer and by self-report. While the prevalence of depression for this group is high and preparation for entry into the workplace is critical for these individuals, this relationship has not been adequately investigated. AIMS OF THE STUDY: This study investigates the relationship between depression and its treatments and the academic performance of undergraduate students. METHODS: Data regarding academics, health and productivity for students from Western Michigan University were obtained from the University's Registrar's Office, the campus Health Center and a survey delivered to the students. The primary outcomes of interest were the student's grade point average (GPA), an objective, observer generated measure of academic productivity, and the students' self-reported academic performance. RESULTS: Diagnosed depression was associated with a 0.49 point, or half a letter grade, decrease in student GPA, while treatment was associated with a protective effect of approximately 0.44 points. The self-reported data regarding the impact of depression on the performance of academic tasks was consistent with these findings. Depressed students reported a pattern of increasing interference of depression symptoms with academic performance peaking in the month of diagnosis and decreasing thereafter with the lowest levels reported in months 4 through 6 post-diagnosis, each of which is significantly less than the month of diagnosis. DISCUSSION: The finding of a significant relationship between depression and academic performance was robust to the variety of analyses employed within this study. However, interpretation of the findings must be tempered by a number of facts. The sample was drawn from a subset of students at a single university, those willing to complete a questionnaire regarding their health and productivity. Due to non-availability of the treatment data from other health care providers, the treatment variable used within the regression models represents an imprecise proxy for the totality of treatment methods received by depressed subjects from a variety of on-campus and off-campus health care providers. Another challenge to the interpretation of this data is the interrelatedness of depression and school performance. Because of this, it was not possible to evaluate the extent to which the association between depression and academic performance is driven by causality in either direction. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: While depression and its effects have been studied in many different population groups and subgroups, the effect of this disease on college students has not been well documented. This research demonstrates the impact of depression and the effectiveness of its treatment on a student sample. From a public health perspective, this analysis highlights the importance of access to mental health treatment facilities among the college aged and the potential value of efforts to educate this population segment on the availability of that resource.

Incidence and characterization of diagnosed endometriosis in a geographically defined population.

OBJECTIVE: We examined whether widespread use of laparoscopy was accompanied by increased diagnosis of asymptomatic endometriosis, inflated rates of diagnosis, or changes in the clinical spectrum of disease. DESIGN: Population-based cohort. SETTING: Olmsted County, Minnesota. PATIENT(S): All participants were women residents, aged > or =15 years. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): We estimated the likelihood that women with a surgical procedure during which endometriosis could be visualized would receive a surgical diagnosis, as well as the proportions of all diagnoses, regardless of setting, that were [1] assigned without surgery, [2] refuted by surgery, [3] surgically confirmed, and [4] asymptomatic. The incidence of diagnosed endometriosis for 1987 to 1999 was compared with published rates for 1970 to 1979. RESULT(S): Of 8,229 women aged > or =15 years with > or =1 surgery during which endometriosis could be visualized, 11.5% received a surgical diagnosis of endometriosis. The incidence of diagnosed endometriosis, regardless of setting, was 1.9 per 1,000 person-years (10% were without relevant surgery, 6% had surgery but no surgical evidence, 85% had surgical evidence); 85% of surgically confirmed diagnoses had presenting symptoms. Using definitions comparable with those in the 1970 to 1979 study, the 1987 to 1999 incidence was 2.46 per 1,000 versus 2.49 per 1,000 for 1970 to 1979; 88% of symptomatic incident diagnoses were surgically confirmed versus 65% for 1970 to 1979. CONCLUSION(S): Widespread use of laparoscopy does not appear to have contributed to dramatically increased rates of endometriosis diagnoses but rather to a smaller proportion of diagnoses being assigned without surgical confirmation.

Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease.

BACKGROUND: The objective of this study was to develop and psychometrically evaluate a general measure of patients' satisfaction with medication, the Treatment Satisfaction Questionnaire for Medication (TSQM). METHODS: The content and format of 55 initial questions were based on a formal conceptual framework, an extensive literature review, and the input from three patient focus groups. Patient interviews were used to select the most relevant questions for further evaluation (n = 31). The psychometric performance of items and resulting TSQM scales were examined using eight diverse patient groups (arthritis, asthma, major depression, type I diabetes, high cholesterol, hypertension, migraine, and psoriasis) recruited from a national longitudinal panel study of chronic illness (n = 567). Participants were then randomized to complete the test items using one of two alternate scaling methods (Visual Analogue vs. Likert-type). RESULTS: A factor analysis (principal component extraction with varimax rotation) of specific items revealed three factors (Eigenvalues > 1.7) explaining 75.6% of the total variance; namely Side effects (4 items, 28.4%, Cronbach's Alpha =.87), Effectiveness (3 items, 24.1%, Cronbach's Alpha =.85), and Convenience (3 items, 23.1%, Cronbach's Alpha =.87). A second factor analysis of more generally worded items yielded a Global Satisfaction scale (3 items, Eigenvalue = 2.3, 79.1%, Cronbach's Alpha =.85). The final four scales possessed good psychometric properties, with the Likert-type scaling method performing better than the VAS approach. Significant differences were found on the TSQM by the route of medication administration (oral, injectable, topical, inhalable), level of illness severity, and length of time on medication. Regression analyses using the TSQM scales accounted for 40-60% of variation in patients' ratings of their likelihood to persist with their current medication. CONCLUSION: The TSQM is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication. Preliminary evidence suggests that the TSQM may also be a good predictor of patients' medication adherence across different types of medication and patient populations.

Validation of the Health-Related Productivity Questionnaire Diary (HRPQ-D) on a sample of patients with infectious mononucleosis: results from a phase 1 multicenter clinical trial.

The objective of this work was to assess the performance of the newly developed Health-Related Productivity Questionniare-Diary (HRPQ-D). Patients completed the HRPQ-D daily for 1-week periods during weeks 1, 2, 4, and 8 of a clinical trial for infectious mononucleosis. Productivity data were collected on a daily basis in terms of absenteeism, presenteeism, and combined lost productivity for three work venues (work outside home, housework, and classes/homework). These were then correlated with patient symptom scores. Symptom scores were positively correlated with lost work hours because of absenteeism and combined lost productivity scores. However, negative correlations were observed between symptom scores and the lost work hours due to presenteeism. The HRPQ-D demonstrated good construct validity, making it a useful tool for determining productivity levels across different work venues within clinical trial or survey research applications.

Reliability and validity of the sexual life quality questionnaire (SLQQ).

The sexual life quality questionnaire (SLQQ) was developed to evaluate sexual quality of life (QOL) and satisfaction with treatments for erectile dysfunction among patients and their sexual partners. This paper describes the development of the instrument and reports its psychometric properties as observed in two studies involving patients under treatment for erectile dysfunction. The instrument consists of 16 items, 10 of which deal with dimensions of sexual QOL that can be summed to a sexual QOL scale measure. The remaining six items comprise a scale measuring satisfaction with treatment dimensions. The composite sexual QOL and treatment satisfaction scales met established psychometric goals overall and within select subgroups (length of time quartiles, patient/partner). A significant correlation between the treatment satisfaction scale score and the patients' responses to a question asking their likelihood of selecting the method for continued treatment (r: 0.89) showed the measure to be a good indicator of treatment preference. Finally, there were significant differences in sexual QOL scale scores between screening and first treatment, indicating the instrument was responsive and able to detect changes in sexual QOL.