Developing a preference-based utility scoring algorithm for the Psoriasis Area Severity Index (PASI)

Introduction It is challenging to identify health state utilities associated with psoriasis because generic preference-based measures may not capture the impact of dermatological symptoms. The Psoriasis Area Severity Index (PASI) is one of the most commonly used psoriasis rating scales in clinical trials. The purpose of this study was to develop a utility scoring algorithm for the PASI. Methods Forty health states were developed based on PASI scores of 40 clinical trial patients. Health states were valued in time trade-off interviews with UK general population participants. Regression models were conducted to crosswalk from PASI scores to utilities (e.g., OLS linear, random effects, mean, robust, spline, quadratic). Results A total of 245 participants completed utility interviews (51.4% female; mean age =45.3y). Models predicting utility based on the four PASI location scores (head, upper limbs, trunk, lower limbs) had better fit/accuracy (e.g., R2, mean absolute error [MAE]) than models using the PASI total score. Head/upper limb scores were more strongly associated with utility than trunk/lower limb. The recommended model is the OLS linear model based on the four PASI location scores (R2 = 0.13; MAE =0.03). An alternative is recommended for situations when it is necessary to estimate utility based on the PASI total score. Conclusions The recommended scoring algorithm may be used to estimate utilities based on PASI scores of any treatment group with psoriasis. Because the PASI is commonly used in psoriasis clinical trials, this scoring algorithm greatly expands options for quantifying treatment outcomes in cost-effectiveness analyses of psoriasis therapies. Results indicate that psoriasis of the head/upper limbs could be more important than trunk/lower limbs, suggesting reconsideration of the standard PASI scoring approach

Development and validation of the Crohn’s disease patient-reported outcomes signs and symptoms (CD-PRO/SS) diary

Abstract Background The clinical course of Crohn’s disease (CD) and the effect of its treatment are monitored through patient-reported signs and symptoms (S&S), and endoscopic evidence of inflammation. The Crohn’s Disease Patient-reported Outcomes Signs and Symptoms (CD-PRO/SS) measure was developed to standardize the quantification of gastrointestinal S&S of CD through direct report from patient ratings. Methods The CD-PRO/SS was developed based on data from concept elicitation (focus groups, interviews; n = 29), then refined through cognitive interviews of CD patients (n = 20). Measurement properties, including item-level statistics, scaling structure, reliability, and validity, were examined using secondary analyses of baseline and two-week clinical trial data of adults with moderate-to-severe CD (n = 238). Results Findings from qualitative interviews identified nine S&S items covering bowel and abdominal symptoms. The final CD-PRO/SS daily diary includes two scales: Bowel S&S (three items) and Abdominal Symptoms (three items), each scored separately. Each scale showed evidence of adequate reliability (α = 0.74 and 0.67, respectively); reproducibility (intraclass correlation coefficient > 0.80), and validity, with the last including moderate correlations with the Inflammatory Bowel Disease Questionnaire bowel symptom score and select items (ranging from r = 0.43–0.54). Scores distinguished patients categorized by patient global ratings of disease severity (p < 0.0001). Conclusions Results suggest the CD-PRO/SS is a reliable and valid measure of gastrointestinal symptom severity in CD patients. Additional longitudinal data are needed to evaluate the ability of the CD-PRO/SS scores to detect responsiveness and inform the selection of responder definitions.https://deepblue.lib.umich.edu/bitstream/2027.42/143542/1/41687_2018_Article_44.pd

Development and validation of a patient-based measure of pharmaceutical care

The objectives of this study were to develop and validate a patient-based measure of pharmaceutical care and to examine associations between patient and pharmacy site characteristics and pharmaceutical care. The domains of pharmaceutical care identified from the literature were (1) establishing and maintaining the therapeutic relationship, (2) assessment, (3) establishing therapeutic goals, (4) implementing the therapy plan, (5) monitoring, and (6) documentation. Items were written for all domains except documentation because it cannot be directly assessed by patients. Content validity was assessed based on expert panel ratings. Respondent debriefing was conducted in six consecutive sessions to better understand respondents\u27 interpretations of key terms. Items were pretested using 60 surveys collected at an outpatient pharmacy in a primary care center. Large scale validation was conducted using 352 surveys collected in three pharmacy sites. Inclusion criteria were being 18 years or older and visiting the pharmacy for one\u27s own health-related needs. Reliability and validity were examined using Rasch analysis and confirmatory factor analysis. Two dimensions of pharmaceutical care were identified, one related to technical aspects of pharmaceutical care and another related to interpersonal aspects of pharmaceutical care. Item reduction resulted in a 21-item measure of technical aspects of pharmaceutical care with a person reliability of 0.93 and an 8-item measure of interpersonal aspects of pharmaceutical care with a person reliability of 0.82. Convergent validity was evident in a positive correlation between technical aspects of pharmaceutical care and interpersonal aspects of pharmaceutical care with patient satisfaction. Confirmatory factor analysis showed acceptable fit for the two factor solution. Respondents receiving new medications had significantly higher scores for technical aspects of pharmaceutical care, after controlling for pharmacy site, age, and gender. Respondents at a Veteran\u27s Administration Clinic had higher mean scores for interpersonal aspects of pharmaceutical care than those at a primary care center. Person separation indices were 3.68 for the technical aspects scale and 7.98 for the interpersonal aspects scale, suggesting that the measures had good responsiveness. The measures for technical aspects of pharmaceutical care and interpersonal aspects of pharmaceutical care also detected significant differences across sites indicating sensitivity of the scales

Patterns of Care in Community-Based Oncology Practices for Anemia Associated With Myelosuppressive Chemotherapy

Use of erythropoiesis-stimulating agents in the treatment of myelosuppresive chemotherapy–induced anemia has been shown to increase hemoglobin levels and reduce the need for transfusions in patients with cancer