title: What Outcomes are Important for Gout Patients? In-Depth Qualitative Research into the Gout Patient Experience to Determine Optimal Endpoints for Evaluating Therapeutic Interventions.
abstract: Characterized by sudden onset of severe joint pain, swelling, redness, and tenderness to touch, gout 'flare ups' have a substantial impact on quality of life (QoL). This research employed a patient-centered approach to explore the symptoms and impacts of gout, and assess the content validity of existing patient-reported outcomes (PROs).
  
  
  
  Qualitative interviews were conducted with 30 US gout patients (non-tophaceous: n = 20, tophaceous: n = 10) and five expert rheumatologists. Each interview included both concept elicitation (CE) questioning to learn about the patient experience and cognitive debriefing to assess the content validity of three PRO instruments (HAQ-DI, GAQ, and TIQ-20). Nine of the patients provided further real-time qualitative data through a smart phone application. All qualitative data were subject to thematic analysis using Atlas.ti. Two patient advisors and three expert clinicians were engaged as advisors at key stages throughout the research.
  
  
  
  Interview and real-time data identified the same core symptoms and proximal impact concepts. Severe pain (typically in joints of extremities) was described as the cardinal symptom, often accompanied by swelling, redness, heat, sensitivity to touch, and stiffness. Domains of QoL impacted included physical functioning, sleep, daily activities, and work. The PRO instruments were generally well-understood by patients, but each included items with questionable relevance to at least some of the sample, dependent on the specific joints affected.
  
  
  
  Gout patients experience severe pain in affected joints, resulting in substantial limitations in physical functioning. Both the HAQ-DI and the TIQ-20 are useful for specific research purposes in the gout population, although modifications are recommended.
authors.affiliation: Adelphi Values, Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK. sophi.tatlock@adelphivalues.com.
authors.forename: Sophi
authors.initials: S
authors.lastname: Tatlock
authors.affiliation: AstraZeneca, Da Vinci Building, Melbourn Science Park, Royston, Cambridgeshire, SG86EE, UK.
authors.forename: Katja
authors.initials: K
authors.lastname: Rüdell
authors.affiliation: Adelphi Values, Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Panter
authors.affiliation: Adelphi Values, Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK.
authors.forename: Rob
authors.initials: R
authors.lastname: Arbuckle
authors.affiliation: Department of Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA, 01655, USA.
authors.forename: Leslie R
authors.initials: LR
authors.lastname: Harrold
authors.affiliation: Rehabilitation Teaching and Research Unit, University of Otago Wellington, PO Box 7343, Wellington, New Zealand.
authors.forename: William J
authors.initials: WJ
authors.lastname: Taylor
authors.affiliation: Clinical Outcomes Solutions Ltd, Shearway Road, Folkestone, CT194RH, UK.
authors.forename: Tara
authors.initials: T
authors.lastname: Symonds
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006073:Gout / Q000175:diagnosis* / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D036301:Qualitative Research; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D063189:Symptom Assessment / Q000295:instrumentation* / Q000401:mortality*; D016896:Treatment Outcome; D014481:United States