title: Validation of the Patient Care Monitor (Version 2.0): a review of system assessment instrument for cancer patients.
abstract: BACKGROUND
  The Patient Care Monitor (PCM) is a review of systems survey delivered by means of an electronic patient-reported outcomes (ePRO) data capture system that uses wireless tablet computers. Although the PCM 1.0 is validated, the updated PCM 2.0 has not been validated nor tested in the academic setting.
  
  
  OBJECTIVE
  To validate and test the PCM 2.0 in three cancer populations.
  
  
  METHODS
  Two hundred seventy-five individuals participated in three clinical trials enrolling breast (n=65), gastrointestinal (n=113), and lung (n=97) cancer patients. Internal consistency was evaluated using Cronbach's alpha coefficients calculated for six PCM subscales (general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation) and a Quality-of-Life Index. Construct validity was evaluated through Pearson's correlation between PCM subscales and subscales of the Functional Assessment of Cancer Therapy--General (FACT-G), the M.D. Anderson Symptom Inventory (MDASI), and the Functional Assessment of Chronic Illness Therapy--Fatigue (FACIT-F). The participants had the following characteristics: mean age was 58 years (standard deviation: 11), 52% were females, 79% were whites, 17% were blacks, 62% had no college degree, and 78% had metastatic or recurrent disease.
  
  
  RESULTS
  Raw and normalized scores for PCM 2.0 subscales were internally consistent across study cohorts. PCM 2.0 subscales correlated significantly (P<0.05) with the corresponding subscales on FACT-G, MDASI, and FACIT-F, with the exception of FACT-G social well-being, particularly for the lung cancer population. These correlations demonstrated construct validity. PCM 2.0 results followed expected patterns by cancer etiology. Prior reports demonstrate patient satisfaction with PCM 2.0.
  
  
  CONCLUSIONS
  Within three unique academic oncology populations, PCM 2.0 is a valid ePRO instrument for assessing symptoms with seven patient-centered subscale or index domains.
authors.affiliation: Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, North Carolina 27710, USA. amy.abernethy@duke.edu
authors.forename: Amy P
authors.initials: AP
authors.lastname: Abernethy
authors.forename: Syed Yousuf
authors.initials: SY
authors.lastname: Zafar
authors.forename: Hope
authors.initials: H
authors.lastname: Uronis
authors.forename: Jane L
authors.initials: JL
authors.lastname: Wheeler
authors.forename: April
authors.initials: A
authors.lastname: Coan
authors.forename: Krista
authors.initials: K
authors.lastname: Rowe
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Shelby
authors.forename: Robin
authors.initials: R
authors.lastname: Fowler
authors.forename: James E
authors.initials: JE
authors.lastname: Herndon
mesh_terms: D000368:Aged; D001943:Breast Neoplasms / Q000150:complications / Q000503:physiopathology* / Q000523:psychology; D003625:Data Collection / Q000295:instrumentation / Q000379:methods; D005221:Fatigue / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000150:complications / Q000503:physiopathology* / Q000523:psychology; D006304:Health Status; D006801:Humans; D008175:Lung Neoplasms / Q000150:complications / Q000503:physiopathology* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000150:complications / Q000175:diagnosis* / Q000503:physiopathology / Q000523:psychology; D010147:Pain Measurement / Q000295:instrumentation / Q000379:methods*; D017060:Patient Satisfaction; D011788:Quality of Life / Q000523:psychology; D012044:Regression Analysis