Patient-Centered Core Impacts Sets (PC-CIS): What They Are and What They Are Not

Letter to the Editor We are writing regarding the Innovations in Pharmacy commentary entitled, “Evidentiary Standards for Patient-Centered Core Impact Value Claims.”(1) We thank Dr. Langley for commenting on the National Health Council’s work on patient-centered core impact sets (PC-CIS), an initiative spearheaded by the nonprofit organization and its membership with multi-stakeholder representation and input.(2-4) While we have tried to be clear and transparent about the intent of PC-CIS, the commentary made it apparent to us we need to (and will) do more to be explicit about what a PC-CIS is and is not, and its possible downstream uses.  We believe the PC-CIS concept was misrepresented in the commentary and want to provide clarification for readers so they can consider the merits of the initiative for themselves

Health-related quality of life in early rheumatoid arthritis: impact of disease and treatment response

OBJECTIVE: To document the burden of early rheumatoid arthritis (RA) on health-related quality of life (HQL) and compare changes in HQL across 2 treatments. STUDY DESIGN: Analysis of HQL scores among patients enrolled in a multicenter, double-blind, randomized control trial of early RA treatment. PATIENTS AND METHODS: A total of 424 patients with early RA were randomized to 1 of 2 treatment groups: etanercept or methotrexate. Patients were treated and followed for 52 weeks. Health-related quality of life was assessed before and throughout treatment using the Medical Outcomes Study Short Form 36 Health Survey (SF-36) and the Health Assessment Questionnaire (HAQ). The HQL burden of RA was established by comparing SF-36 scale scores to general US population norms. The impact of treatment on HQL was determined by comparing scores on both SF-36 and HAQ scales. RESULTS: Before treatment, RA patients showed significant decrements in scores on all SF-36 scales and summary measures in comparison with age- and sex-matched general US population norms, multivariate analysis of variance (MANOVA) F(8,2815) = 204.6, P \u3c .0001. After 52 weeks of treatment, 7 of 8 SF-36 scales and the physical summary measure remained significantly below the general US population norm, MANOVA F(8,2815) = 41.9, P \u3c .0001. Patients randomized to etanercept showed significantly better HQL improvement earlier in treatment than patients randomized to methotrexate on the SF-36 physical summary, MANOVA F(10,4230) = 6.1, P\u3c .0001, the SF-36 arthritis-specific health index, MANOVA F(10,4230) = 8.5, P \u3c .0001, and the HAQ, MANOVA F(10,4230) = 14.7, P \u3c .0001. At 52 weeks, there were no significant differences between treatment groups. CONCLUSIONS: Rheumatoid arthritis places tremendous disease burden on patients\u27 HQL. Successful treatment of early RA improved HQL. Etanercept showed a rapid HQL response