Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method: the Italian experience

  • F. Salaffi | fsalaff@tin.it Università Politecnica delle Marche, Italy.
  • A. Ciapetti Università Politecnica delle Marche, Italy.
  • P. Sarzi Puttini Azienda Ospedaliera Polo Universitario “L. Sacco” Milano, Italy.
  • F. Atzeni Azienda Ospedaliera Polo Universitario “L. Sacco” Milano, Italy.
  • C. Iannuccelli Università “La Sapienza”, Roma, Italy.
  • M. Di Franco Università “La Sapienza”, Roma, Italy.
  • M. Cazzola Ospedale di Circolo, Busto Arsizio, Italy.
  • L. Bazzichi Università di Pisa, Italy.

Abstract

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. 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. 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. 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.

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Author Biographies

F. Salaffi, Università Politecnica delle Marche
Clinica Reumatologica
A. Ciapetti, Università Politecnica delle Marche
Clinica Reumatologica
P. Sarzi Puttini, Azienda Ospedaliera Polo Universitario “L. Sacco” Milano
Unità di Reumatologia
F. Atzeni, Azienda Ospedaliera Polo Universitario “L. Sacco” Milano
Unità di Reumatologia
C. Iannuccelli, Università “La Sapienza”, Roma
Dipartimento di Medicina Interna – Reumatologia
M. Di Franco, Università “La Sapienza”, Roma
Dipartimento di Medicina Interna – Reumatologia
M. Cazzola, Ospedale di Circolo, Busto Arsizio
Unità Operativa Medicina Riabilitativa
L. Bazzichi, Università di Pisa
Dipartimento di Medicina Interna Divisione di Reumatologia, Ospedale S. Chiara
Published
2012-03-19
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Articles
Keywords:
fibromyalgia, Delphi method, pain scales, health-related quality of life, patient-reported outcomes
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How to Cite
Salaffi, F., Ciapetti, A., Sarzi Puttini, P., Atzeni, F., Iannuccelli, C., Di Franco, M., Cazzola, M., & Bazzichi, L. (2012). Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method: the Italian experience. Reumatismo, 64(1), 27-34. https://doi.org/10.4081/reumatismo.2012.27