title: Psychometric properties of Patient Reported Outcome Measures (PROMs) in patients diagnosed with Acute Respiratory Distress Syndrome (ARDS).
abstract: BACKGROUND
  The aim of this study was to assess the psychometric properties of the EQ-5D-3 L, the SF-12 v2 and its preference based derivative the SF-6D, and the St Georges Respiratory Questionnaire (SGRQ), in patients diagnosed with Acute Respiratory Distress Syndrome (ARDS).
  
  
  METHODS
  Data from the Oscillation in ARDS (OSCAR) randomised unblinded clinical trial of 795 patients diagnosed with ARDS provided the foundation of this secondary psychometric analysis. The three source patient reported outcome measures (PROMs) (EQ-5D-3 L, SF-12 and SGRQ) were collected at both 6 and 12 months post randomisation. All measures were tested for acceptability, reliability, internal consistency, validity and responsiveness. Data from responders at 6 months was used to test for acceptability, reliability, known groups validity and internal responsiveness. Data from patients who responded at both 6 and 12 months was used to test for convergent validity and external responsiveness.
  
  
  RESULTS
  Rates of response at both 6 and 12 months post randomisation were 89.88 % for the EQ-5D-3 L, 77.38 % for the SF-6D, 71.43 % for both the physical and mental components of the SF-12 and 38.10 % for the SGRQ. All measures had a Cronbach's Alpha statistic higher than 0.7. For known group's validity, there was no difference in mean summary or utility scores between known groups for all PROMs with minimal effect sizes. All three source measures showed strong convergent and discriminant validity. There was consistent evidence that the SF-6D is an empirically valid and efficient alternative to the EQ-5D-3 L. The EQ-5D-3 L and SGRQ were more responsive compared to the SF-12 and SF-6D with the EQ-5D-3 L generating greater effect sizes than the SGRQ.
  
  
  CONCLUSIONS
  The PROMs explored in this study displayed varying psychometric properties in the context of ARDS. Further research should focus on shortening the SGRQ whilst still maintaining its psychometric properties and mapping between the SGRQ and preference-based measures for future application within economic evaluations of respiratory focused interventions. The selection ofa preferred PROM for evaluative studies within the ARDS context should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purposes.
authors.affiliation: Public Health Foundation of India, Delhi NCR, India. hiral_shah1989@hotmail.com.
authors.forename: Hiral Anil
authors.initials: HA
authors.lastname: Shah
authors.affiliation: Oxford Clinical Trials Research Unit, Nuffield Department of Orthopeadics, Rheumatology and Musculosceletal Sciences, University of Oxford, Oxford, OX3 7HE, UK. M.S.Dritsaki@warwick.ac.uk.
authors.forename: Melina
authors.initials: M
authors.lastname: Dritsaki
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
authors.forename: Joshua
authors.initials: J
authors.lastname: Pink
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
authors.forename: Stavros
authors.initials: S
authors.lastname: Petrou
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D010808:Physical Examination; D011594:Psychometrics / Q000295:instrumentation*; D011788:Quality of Life / Q000523:psychology*; D015203:Reproducibility of Results; D012128:Respiratory Distress Syndrome / Q000523:psychology*; D011795:Surveys and Questionnaires; D013997:Time Factors
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