title: Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method: the Italian experience.
abstract: OBJECTIVE
  Fibromyalgia (FM) is a complex syndrome that, in Italy, affects at least 2% of the adult population. It is characterized by chronic widespread musculoskeletal pain often accompanied by multiple other symptoms. The aim of this study was to identify a set of clinical domains for FM considered relevant by both clinicians and patients using a consensus process.
  
  
  METHODS
  Consensus was achieved using the Delphi method based on questionnaires and systematic, controlled opinion feedback. The Delphi exercise involved a panel of 252 rheumatologists and 86 patients with FM as defined by the American College of Rheumatology criteria. All of the patients and clinicians were asked to rank the relative different domains of FM in order of priority. The content validity index (CVI) was used to establish the percentage agreement. The importance of each item was ranked on a 0-3 Likert scale. The frequency, mean relevance scores, and frequency importance product were also calculated.
  
  
  RESULTS
  The Delphi exercise showed that the domains ranked highest by patients were similar to those of the clinicians, with the exception of tender point intensity (considered relevant by the clinicians but not by the patients) and environmental sensitivity (considered important by the patients but not by the clinicians). A final 8-item model was developed which was considered to demonstrate adequate validity.
  
  
  CONCLUSIONS
  The Delphi exercises identified and ranked relevant key clinical domains that need to be assessed in FM research. On the basis of these results, a new patient-reported composite outcome index can be developed and used in clinical trials.
authors.affiliation: Università Politecnica delle Marche. fsalaff@tin.it.
authors.forename: F
authors.initials: F
authors.lastname: Salaffi
authors.forename: A
authors.initials: A
authors.lastname: Ciapetti
authors.forename: P
authors.initials: P
authors.lastname: Sarzi Puttini
authors.forename: F
authors.initials: F
authors.lastname: Atzeni
authors.forename: C
authors.initials: C
authors.lastname: Iannuccelli
authors.forename: M
authors.initials: M
authors.lastname: Di Franco
authors.forename: M
authors.initials: M
authors.lastname: Cazzola
authors.forename: L
authors.initials: L
authors.lastname: Bazzichi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D032921:Consensus; D003697:Delphi Technique; D003863:Depression / Q000209:etiology / Q000523:psychology; D005221:Fatigue / Q000209:etiology / Q000523:psychology; D005260:Female; D005356:Fibromyalgia / Q000453:epidemiology / Q000523:psychology / Q000628:therapy*; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008569:Memory Disorders / Q000209:etiology / Q000523:psychology; D008875:Middle Aged; D010146:Pain / Q000209:etiology / Q000523:psychology; D010147:Pain Measurement; D010361:Patients / Q000523:psychology; D010820:Physicians / Q000523:psychology; D011788:Quality of Life; D015203:Reproducibility of Results; D012219:Rheumatology; D012720:Severity of Illness Index; D020919:Sleep Disorders, Intrinsic / Q000209:etiology / Q000523:psychology; D012959:Socioeconomic Factors; D016896:Treatment Outcome; D055815:Young Adult