Search

Abstract Background The objective of this qualitative study was to better understand the impact of psoriasis symptoms using a 3-part process: 1) develop a disease model for psoriasis to identify the most important concepts relevant to psoriasis patients; 2) conduct interviews with dermatologists to identify key areas of clinical concern; and 3) explore psoriasis patients' perceptions of the impact of psoriasis. Methods A disease model was developed from a review of the published literature and later revised based on the findings of clinician interviews and patient focus groups. To confirm the clinical relevance of the concepts identified in the disease model, 5 dermatologists were selected and interviewed one-on-one. They were asked to rate major psoriasis symptoms according to importance and bothersomeness level to patients on separate scales of 1 to 10. Results of clinician interviews were used to develop interview guides for patient focus groups. To identify important domains of psoriasis, 39 patients participated in 5 separate concept elicitation focus groups. Four focus groups included patients with severe psoriasis (n = 31) and one included patients with mild psoriasis (n = 8). Patients were asked to describe their current psoriasis symptoms and to rate them on a scale of 1 to 10, according to importance, severity, and troublesomeness. An average mean rating was calculated for each symptom throughout all focus groups. Results Clinicians most frequently mentioned itch (n = 5), psoriatic arthritis or "joint pains" (n = 4), flaking (n = 4), and pain (n = 3) as primary physical symptoms of psoriasis. Three clinicians gave a rating of 10 for the importance of itch; two clinicians gave ratings of 8 and 7 for importance. The majority of patients rated itch as the most important (31/39), most severe (31/39), and most troublesome (24/39) symptom and noted that itch negatively impacted daily activities (eg, concentration, sleep, ability to attend work or school), as well as emotions (eg, anxiety and embarrassment). Conclusion These analyses suggest that itch is one of the most important symptoms of psoriasis, contributing to diminished health-related quality of life (HRQoL) in patients with both mild and severe disease.

Abstract Background Primary care physicians are caring for increasing numbers of persons with comorbid chronic illness. Longitudinal information on health outcomes associated with specific chronic conditions may be particularly relevant in caring for these populations. Our objective was to assess the effect of certain comorbid conditions on physical well being over time in a population of persons with chronic medical conditions; and to compare these effects to that of hypertension alone. Methods We conducted a secondary analysis of 4-year longitudinal data from the Medical Outcomes Study. A heterogeneous population of 1574 patients with either hypertension alone (referent) or one or more of the following conditions: diabetes, coronary artery disease, congestive heart failure, respiratory illness, musculoskeletal conditions and/or depression were recruited from primary and specialty (endocrinology, cardiology or mental health) practices within HMO and fee-for-service settings in three U.S. cities. We measured categorical change (worse vs. same/better) in the SF-36® Health Survey physical component summary score (PCS) over 4 years. We used logistic regression analysis to determine significant differences in longitudinal change in PCS between patients with hypertension alone and those with other comorbid conditions and linear regression analysis to assess the contribution of the explanatory variables. Results Specific diagnoses of CHF, diabetes and/or chronic respiratory disease; or 4 or more chronic conditions, were predictive of a clinically significant decline in PCS. Conclusions Clinical recognition of these specific chronic conditions or 4 or more of a list of chronic conditions may provide an opportunity for proactive clinical decision making to maximize physical functioning in these populations.

Background: Primary care physicians are caring for increasing numbers of persons with comorbid chronic illness. Longitudinal information on health outcomes associated with specific chronic conditions may be particularly relevant in caring for these populations. Our objective was to assess the effect of certain comorbid conditions on physical well being over time in a population of persons with chronic medical conditions; and to compare these effects to that of hypertension alone. Methods: We conducted a secondary analysis of 4-year longitudinal data from the Medical Outcomes Study. A heterogeneous population of 1574 patients with either hypertension alone (referent) or one or more of the following conditions: diabetes, coronary artery disease, congestive heart failure, respiratory illness, musculoskeletal conditions and/or depression were recruited from primary and specialty (endocrinology, cardiology or mental health) practices within HMO and fee-for-service settings in three U.S. cities. We measured categorical change (worse vs. same/better) in the SF-36® Health Survey physical component summary score (PCS) over 4 years. We used logistic regression analysis to determine significant differences in longitudinal change in PCS between patients with hypertension alone and those with other comorbid conditions and linear regression analysis to assess the contribution of the explanatory variables. Results: Specific diagnoses of CHF, diabetes and/or chronic respiratory disease; or 4 or more chronic conditions, were predictive of a clinically significant decline in PCS. Conclusions: Clinical recognition of these specific chronic conditions or 4 or more of a list of chronic conditions may provide an opportunity for proactive clinical decision making to maximize physical functioning in these populations. [ABSTRACT FROM AUTHOR]

Background: Immunoglobulin light-chain amyloidosis (AL amyloidosis) is a rare and often fatal disease for which there is currently no treatment approved by the US Food and Drug Administration or the European Medicines Agency. Treatment options, which are typically based on therapies for multiple myeloma and are used off-label, are associated with substantial adverse events (AEs). Because the severity of AEs is often determined by clinicians, evaluations of treatment tolerability may not fully consider patients' own experience with treatment., Objectives: To explore the prevalence of AEs and treatment tolerability problems as reported by patients who received therapies for AL amyloidosis, and to examine the effects of AEs on treatment continuation and on health-related quality of life (HRQOL)., Methods: Patients with AL amyloidosis were recruited for this noninterventional, longitudinal, online survey. The patients responded to survey items regarding demographics, disease characteristics, most recent AL amyloidosis treatment, and HRQOL. The study analyses are based on data collected during the 6-month follow-up survey and are restricted to patients who completed the baseline and 6-month surveys and received treatment for AL amyloidosis within 6 months before the follow-up survey., Results: A total of 100 patients met the inclusion criteria and were included in the study. The patients self-reported having a variety of AEs, which ranged in severity. Overall, 69.4% of patients had problems tolerating their treatment in the past 6 months, of whom 22% discontinued at least 1 therapy. In addition, approximately 33% of patients reduced their AL amyloidosis treatment because of AEs. Most often reported AEs included fatigue (83%), shortness of breath (53%), nausea (52%), and diarrhea (51%). Overall, 50% of the patients reported that their treatment was moderately well-tolerated and 41% said it was very well-tolerated. Those whose treatment was not well-tolerated had significantly worse HRQOL than patients whose treatment was well-tolerated., Conclusions: Patient-reported experiences should be considered by clinicians when making treatment-related decisions. More research is needed to explore additional factors that may contribute to treatment discontinuation in patients with AL amyloidosis.

Background: Allergic rhinitis affects 10%-20% of the US population. Its chronic nature, combined with patients' perceptions of safety/efficacy, administration, and sensory attributes of nasal sprays (corticosteroids), impact patient adherence to therapy. The purpose of this study was to develop a measure of experience with and preference for corticosteroid therapy for treatment of allergic rhinitis., Methods: Questionnaire development was conducted through qualitative research including concept elicitation and content testing in 153 patients with allergic rhinitis. Patient focus groups (n = 66), in conjunction with content confirmation and saturation in additional groups (n = 87), provided research data. A literature-based conceptual framework was incorporated into the interview guide. An iterative process of data collection, analysis, and theory development yielded the conceptual framework., Results: Consistent comments from the focus groups combined with those from cognitive debriefing interviews led to the incorporation of 14 finalized attributes into the Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q) items. Between the first and second cognitive debriefing interviews, researchers revised the EARNS-Q for retesting. Face and content validity tests indicated that the items, responses, and instructions were understood by study participants. The EARNS-Q is comprised of two modules that measure patient experience with nasal sprays (experience module), and patient preference for a nasal spray relative to another (preference module)., Conclusion: The EARNS-Q accurately measured patient experience with and preference for nasal sprays used in treating allergic rhinitis. A potential application of this questionnaire may be as a patient-reported outcomes endpoint in clinical trials of intranasal corticosteroids in patients with allergic rhinitis.

Background: Patient experience and preference are critical factors influencing compliance in patients with allergic rhinitis (AR) receiving intranasal corticosteroids. The Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q) was developed to measure subject experiences with and preferences for nasal sprays., Objective: To describe the psychometric validation of the EARNS-Q modules., Methods: An observational study was conducted with subjects aged 18-65 years with physician-diagnosed vasomotor, seasonal, and/or perennial allergic rhinitis who were using a prescription nasal spray. Subjects completed the experience module of the EARNS-Q and the Treatment Satisfaction Questionnaire with Medication (TSQM) at baseline and after 2 weeks. Further validation analyses were conducted in a 3-week, randomized, single-blind, crossover, multicenter clinical study in which subjects ≥18 years of age with documented seasonal AR received flunisolide and beclomethasone and completed the EARNS-Q experience module on days 1 and 8, the EARNS-Q preference module on day 22, and the TSQM on days 8 and 22., Results: The observational and clinical studies were completed by 121 and 89 subjects, respectively. Both modules demonstrated acceptable reliability (α = 0.72 experience module; α = 0.93 preference module global scores) and validity (intraclass correlation coefficient or ICC 0.64 to 0.82 test-retest validity). Correlations among the experience and preference modules were moderate (r = 0.39 to 0.79) and within internal consistency reliability estimates, indicating measurement of distinct constructs., Conclusion: The EARNS-Q is a patient-reported outcomes measure that enables reliable and valid measurement of subject experience with, and preference for, prescription intranasal corticosteroid sprays for allergic rhinitis.