A psychometric evaluation of the Diabetes Symptom Checklist-Revised (DSC-R) cognitive distress, fatigue, hyperglycemia, and hypoglycemia subscales in patients with type 1 and type 2 diabetes

April N Naegeli1, Timothy E Stump2, Risa P Hayes11Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; 2Consultant, Indianapolis, IN, USAObjective: To explore the use of Diabetes Symptom Checklist-Revised (DSC-R) Cognitive Distress, Fatigue, Hyperglycemia, and Hypoglycemia subscales as measures of acute diabetesassociated symptoms in patients with both type 1 and 2 diabetes.Research design and methods: Our study was conducted in context of two international, multicenter, randomized clinical trials for inhaled insulin. Confirmatory factor analyses and assessments of reliability and construct validity were performed.Results: Study participants were 371 patients with type 2 (56% male; mean age, 57 years) and 481 with type 1 diabetes (57% male, mean age, 40 years). In both populations a four-factor model was the best fit. Cronbach’s α ≥ 0.79 and intraclass correlation coefficient ≥0.63; subscales correlated (P ≤ 0.05) with measures of well-being and satisfaction (0.12 ≤ r ≤ 0.71). In patients with type 1 diabetes, three subscales correlated (P < 0.05) with A1C.Conclusions: The psychometric properties of the DSC-R Cognitive Distress, Fatigue, Hyperglycemia, and Hypoglycemia suggest they may be utilized in clinical trials as reliable and valid measures of acute symptoms of diabetes.Keywords: Diabetes Symptom Checklist-Revised, DSC-R, type 1 diabetes, type 2 diabetes, psychometric validatio

The Development of a Patient-Reported Outcome Measure for Assessment of Genital Psoriasis Symptoms: The Genital Psoriasis Symptoms Scale (GPSS)

INTRODUCTION: Patient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described. METHODS: In this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs. RESULTS: Relevant psoriasis or GenPs symptoms from the literature review included itch, pain, scaling, redness/erythema, and stinging/burning. The validity of these symptoms for GenPs and potentially relevant PROs was corroborated by clinical experts. After gap analysis, a draft symptom scale consisting of Numeric Rating Scale (NRS) items was constructed. We then conducted interviews with GenPs patients (n = 20) to support content validity and use of the draft symptom NRS items in routine practice and in clinical trials. Participants identified and confirmed relevant symptoms and evaluated the utility of the draft PRO. A new PRO was developed: the Genital Psoriasis Symptoms Scale (GPSS). Cognitive debriefing and cultural adaptation/translation interviews with a second group of patients confirmed cultural appropriateness of the GPSS. CONCLUSION: The GPSS may be useful for assessing symptoms before, during, and after treatment in routine clinical practice and in clinical trials involving patients with GenPs. FUNDING: Eli Lilly & Company. Plain language summary available for this article

The Development of the Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) to Assess the Impact of Genital Psoriasis on Sexual Health

INTRODUCTION: Patient-reported outcome measures (PROs) exist for psoriasis but not genital psoriasis (GenPs). METHODS: This cross-sectional, qualitative study in patients with moderate-to-severe GenPs was conducted to support development of a PRO for measuring the impact of GenPs on sexual activity and to establish content validity. The impacts of GenPs were identified in a literature review. Findings from the literature review were discussed with clinicians, and then patients with GenPs were interviewed. RESULTS: From the literature review, 52 articles, 44 abstracts, and 41 clinical trials met predefined search criteria. Of these, 11 concepts emerged as having theoretical support for use as measurable impacts of psoriasis symptoms on patients; these concepts included sexual functioning and general health-related quality of life (HRQoL). These concepts were confirmed and expanded upon by two clinicians who routinely care for patients with GenPs. Interviews were then conducted with GenPs patients (n = 20) to discuss the impact of GenPs on their HRQoL. Eighty percent of patients reported that GenPs impacted sexual frequency. The two-item GenPs Sexual Frequency Questionnaire (GenPs-SFQ) was developed to assess limitations on sexual activity frequency because of GenPs. Cognitive debriefing with an additional 50 patients with GenPs confirmed the utility and understandability of the GenPs-SFQ. CONCLUSION: The GenPs-SFQ may have utility in clinical trials involving GenPs patients and in routine clinical practice. FUNDING: Eli Lilly and Company. Plain language summary available for this article

Identifying Measures of Suboptimal Healthcare Interaction (SOHI) to Develop a Claims-Based Model for Predicting Patients with Inflammatory Bowel Disease at Risk for SOHI

Abstract Background Understanding the demographic and clinical characteristics of patients with Inflammatory Bowel Disease (IBD) who are likely to experience poor disease outcomes may allow early interventions that can improve health outcomes. Objectives To describe demographic and clinical characteristics of patients with ulcerative colitis (UC) and Crohn’s disease (CD) with the presence of at least one Suboptimal Healthcare Interaction (SOHI) event, which can inform the development of a model to predict SOHI in members with IBD based on insurance claims, with the goal of offering these patients some additional intervention. Methods We identified commercially insured individuals with IBD between 01 January 2019 and 31 December 2019 using Optum Labs’ administrative claims database. The primary cohort was stratified on the presence or absence of ≥ 1 SOHI event (a SOHI-defining data point or characteristic at a specific time point) during the baseline observation period. SOHI was deployed as the basis for the development of a model to predict which individuals with IBD were most likely to continue to have SOHI within a 1-year timeframe (follow-up SOHI) using insurance claims data. All baseline characteristics were analyzed descriptively. Multivariable logistic regression was used to examine the association of follow-up SOHI with baseline characteristics. Results Of 19,824 individuals, 6872 (34.7%) were found to have follow-up SOHI. Individuals with follow-up SOHI were more likely to have had similar SOHI events in the baseline period than those with non-SOHI. A significantly greater proportion of individuals with SOHI had ≥ 1 claims-based C-reactive protein (CRP) test order and ≥ 1 CRP lab results compared with non-SOHI. Individuals with follow-up SOHI were more likely to incur higher healthcare expenditures and resource utilization as compared with non-SOHI individuals. A few of the most important variables used to predict follow-up SOHI included baseline mesalamine use, count of baseline opioid fills, count of baseline oral corticosteroid fills, baseline extraintestinal manifestations of disease, proxy for baseline SOHI, and index IBD provider specialty. Conclusion Individuals with SOHI are likely to have higher expenditures, higher healthcare resource utilization, uncontrolled disease, and higher CRP lab results as compared with non-SOHI members. Distinguishing SOHI and non-SOHI patients in a dataset could efficiently identify potential cases of poor future IBD outcomes