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The article discusses the challenges and lessons learned since the establishment of the Patient-Reported Outcome (PRO) Consortium. It states that the creation of the PRO Consortium has made significant progress in the development of PRO instruments for various diseases including mild cognitive impairment, asthma, and functional dyspepsia. However, the progress has been associated with considerable challenges in gaining consensus on important issues and in navigating new regulatory initiatives.

Purpose: To evaluate the reliability and validity of the Perceptions About Medications for Diabetes (PAM-D) instrument.Methods: The item pool was generated from a literature review and 18 focus groups of Type 2 diabetes patients. Surveys were mailed to 1,000 low-income diabetes patients; 362 were returned; 65 of 100 re-test surveys were returned.Results: This paper uses data from 343 Type 2 respondents. Mean age and age diagnosed were 59 and 48, respectively; 72% female; 52% African American; 51% were taking oral antihyperglycemic agents [OHA] monotherapy, 18% insulin monotherapy, and 28% insulin plus OHA. The initial 66 items were reduced to 37 across nine scales: scheduling flexibility, portability convenience, regimen inconvenience, medication effectiveness, difficulty remembering medications, gastrointestinal, hypoglycemia-related, and weight/edema physical side effects, and emotional side effects. Scale reliabilities ranged from 0.71 to 0.92 (coefficient alpha) and from 0.54 to 0.83 (test-retest coefficient, 37-81-day interval); factor loadings ranged from 0.35 to 0.86 (median, 0.67); significant scale differences across medication groups (insulin, OHA, insulin plus OHA) were consistent with a priori hypotheses.Conclusions: The PAM-D has substantial reliability and validity in a low-income, inner-city population of Type 2 diabetes patients and may be valuable for understanding multidimensional perceptions driving patients' treatment preferences. [ABSTRACT FROM AUTHOR]