title: Item Development and Face Validity of the Rheumatoid Arthritis Patient Priorities in Pharmacological Interventions Outcome Measures.
abstract: BACKGROUND
  The assessment of rheumatoid arthritis (RA) is dominated by core sets and indices that have been developed by RA professionals. Previous research developed a set of eight priority treatment outcomes generated by patients to complement the professionally developed core sets for RA.
  
  
  OBJECTIVE
  This study aimed to facilitate quantitative measurement of these outcomes.
  
  
  METHODS
  Two consultation meetings with patient research partners diagnosed with RA (n = 18) were held to identify face validity in existing instruments (Phase 1) at the Bristol Royal Infirmary. Where validated measures did not exist, new numerical rating scales (NRS) were constructed and discussed at two focus groups with patients diagnosed with RA (n = 8) at the Bristol Royal Infirmary and the Royal National Hospital for Rheumatic Diseases (Phase 2). Feedback on the stem question, time frame, anchors and layout was recorded and transcribed verbatim.
  
  
  RESULTS
  Of the eight priorities, existing NRS for pain, activities of daily living and fatigue were voted as acceptable (Phase 1), but new NRS were required for five priorities. The partners strongly recommended that the three separate domains of severity, effect and ability to cope in each measurement area be assessed, as in the existing validated fatigue NRS. Focus group participants (Phase 2) made significant contributions to the phrasing of questions, for example how to ensure 'mobility' could be uniformly understood and how changes in valued activities be judged appropriately.
  
  
  CONCLUSIONS
  Through extensive patient feedback, 24 NRS were constructed based on priorities identified by patients and encompassing domains where existing questionnaires contain many more items and do not address three important concepts endorsed by patients: severity, effect and coping. The Rheumatoid Arthritis Patient Priorities in Pharmacological Interventions patient-reported outcome measures are now ready for the evaluation of comprehension, construct validity and sensitivity through an observational study.
authors.affiliation: Department of Anthropology, Durham University, Durham, DH1 3LE, UK. sandersontessa@hotmail.com.
authors.forename: Tessa
authors.initials: T
authors.lastname: Sanderson
authors.affiliation: Academic Rheumatology Unit, Bristol Royal Infirmary, University of Bristol, Bristol, BS2 8HW, UK.
authors.forename: John
authors.initials: J
authors.lastname: Kirwan
authors.affiliation: University of the West of England, Glenside Campus, Blackberry Hill, Bristol, BS16 1DD, UK.
authors.forename: Celia
authors.initials: C
authors.lastname: Almeida
authors.affiliation: University of the West of England, Glenside Campus, Blackberry Hill, Bristol, BS16 1DD, UK.
authors.forename: Marianne
authors.initials: M
authors.lastname: Morris
authors.affiliation: Academic Rheumatology Unit, Bristol Royal Infirmary, University of Bristol, Bristol, BS2 8HW, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Noddings
authors.affiliation: University of the West of England, Glenside Campus, Blackberry Hill, Bristol, BS16 1DD, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Hewlett
mesh_terms: D000203:Activities of Daily Living / Q000523:psychology*; D000223:Adaptation, Psychological; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000523:psychology* / Q000628:therapy; D004739:England; D005221:Fatigue / Q000209:etiology / Q000523:psychology* / Q000628:therapy; D005260:Female; D017144:Focus Groups; D006801:Humans; D016916:Joint Deformities, Acquired / Q000209:etiology / Q000517:prevention & control / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D051346:Mobility Limitation; D059408:Pain Management / Q000379:methods / Q000592:standards*; D057240:Patient Preference / Q000523:psychology / Q000706:statistics & numerical data*; D011788:Quality of Life / Q000523:psychology*; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D016896:Treatment Outcome