title: Evaluating the utility of existing patient-reported outcome scales in novel patient populations with pancreatic cancer, lung cancer, and myeloproliferative neoplasms using medicare current beneficiary survey data.
abstract: BACKGROUND
  While there are validated patient-reported outcomes (PRO) instruments for use in specific cancer populations, no validated general instruments exist for use in conditions common to multiple cancers, such as muscle wasting and consequent physical disability. The Medicare Current Beneficiary Survey (MCBS), a survey in a nationally representative sample of Medicare beneficiaries, includes items from three well known scales with general applicability to cancer patients: Katz activities of daily living (ADL), Rosow-Breslau instrumental ADL (IADL), and a subset of physical performance items from the Nagi scale.
  
  
  OBJECTIVE
  This study evaluated properties of the Katz ADL, Rosow-Breslau IADL, and a subset of the Nagi scale in patients with pancreatic cancer, lung cancer, and myeloproliferative neoplasms (MPN) using data from MCBS linked with Medicare claims in order to understand the potential utility of the three scales in these populations; understanding patient-perceived significance was not in scope.
  
  
  METHODS
  The study cohorts included Medicare beneficiaries aged ≥65 years as of 1 January of the year of their first cancer diagnosis with one or more health assessments in a community setting in the MCBS Access to Care data from 1991 to 2009. Beneficiaries had at least two diagnoses in de-identified Medicare claims data linked to the MCBS for one of the following cancers: pancreatic, lung, or MPN. The Katz ADL, Rosow-Breslau IADL, and Nagi scales were calculated to assess physical functioning over time from cancer diagnosis. Psychometric properties for each scale in each cohort were evaluated by testing for internal consistency, test-retest reliability, and responsiveness by comparing differences in mean scale scores over time as cancer progresses, and differences in mean scale scores before and after hospitalization (for lung cancer cohort).
  
  
  RESULTS
  The study cohorts included 90 patients with pancreatic cancer, 863 with lung cancer, and 135 with MPN. Among each cancer cohort, the Katz ADL, Rosow-Breslau IADL, and Nagi scales had acceptable internal consistency (Cronbach's alpha generally between 0.70 and 0.90) and test-retest reliability for consecutive surveys before diagnosis and consecutive surveys after diagnosis (when patients' functioning was more stable). Compared with mean scale scores at the survey 1-2 years before cancer diagnosis (baseline), mean scale scores at the first survey after cancer diagnosis were significantly higher (P < 0.05), indicating worsening, for Katz ADL, Rosow-Breslau IADL, and Nagi scales (items scored 0-1) (0.54 vs. 1.45, 1.15 vs. 2.20, and 2.29 vs. 3.08, respectively, for pancreatic cancer; 0.73 vs. 1.24, 1.29 vs. 2.01, and 2.41 vs. 2.85 for lung cancer; and 0.44 vs. 0.86, 0.87 vs. 1.36, and 1.87 vs. 2.32 for MPN). Among lung cancer patients, scale scores increased significantly following a hospitalization, suggesting a worsening of functional status.
  
  
  CONCLUSIONS
  The Katz ADL, Rosow-Breslau IADL, and Nagi scales collected in the MCBS demonstrate acceptable internal consistency and test-retest reliability among patients with pancreatic cancer, lung cancer, and MPN, and are consistent with clinical worsening following diagnosis or hospitalization. These results suggest that using retrospective data may allow researchers to conduct preliminary assessments of existing PRO instruments in new populations of interest and generate useful exploratory disease information before embarking on de novo PRO development.
authors.affiliation: Analysis Group, Inc., New York, NY, USA.
authors.forename: Jasmina I
authors.initials: JI
authors.lastname: Ivanova
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Mytelka
authors.forename: Mei Sheng
authors.initials: MS
authors.lastname: Duh
authors.forename: Howard G
authors.initials: HG
authors.lastname: Birnbaum
authors.forename: Alice Kate
authors.initials: AK
authors.lastname: Cummings
authors.forename: Alexandra M
authors.initials: AM
authors.lastname: San Roman
authors.forename: Gregory L
authors.initials: GL
authors.lastname: Price
authors.forename: Ralph W
authors.initials: RW
authors.lastname: Swindle
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D015897:Comorbidity; D005260:Female; D019538:Health Care Surveys; D006297:Health Services Accessibility; D006801:Humans; D008175:Lung Neoplasms / Q000523:psychology / Q000628:therapy; D008297:Male; D006278:Medicare / Q000706:statistics & numerical data*; D009196:Myeloproliferative Disorders / Q000523:psychology / Q000628:therapy; D009369:Neoplasms / Q000523:psychology / Q000628:therapy*; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010190:Pancreatic Neoplasms / Q000523:psychology / Q000628:therapy; D010358:Patient Participation; D014481:United States