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

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...

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Main Authors: M. Di Franco, C. Iannuccelli, F. Atzeni, P. Sarzi Puttini, A. Ciapetti, F. Salaffi, M. Cazzola, L. Bazzichi
Format: Article
Language:English
Published: PAGEPress Publications 2012-03-01
Series:Reumatismo
Subjects:
Online Access:http://www.reumatismo.org/index.php/reuma/article/view/520
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author M. Di Franco
C. Iannuccelli
F. Atzeni
P. Sarzi Puttini
A. Ciapetti
F. Salaffi
M. Cazzola
L. Bazzichi
author_facet M. Di Franco
C. Iannuccelli
F. Atzeni
P. Sarzi Puttini
A. Ciapetti
F. Salaffi
M. Cazzola
L. Bazzichi
author_sort M. Di Franco
collection DOAJ
description 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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spelling doaj.art-9bf36bd37eb2404dac0904473e4aad812022-12-22T02:30:43ZengPAGEPress PublicationsReumatismo0048-74492240-26832012-03-01641273410.4081/reumatismo.2012.27Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method: the Italian experienceM. Di FrancoC. IannuccelliF. AtzeniP. Sarzi PuttiniA. CiapettiF. SalaffiM. CazzolaL. BazzichiFibromyalgia (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.http://www.reumatismo.org/index.php/reuma/article/view/520fibromyalgia, Delphi method, pain scales, health-related quality of life, patient-reported outcomes
spellingShingle M. Di Franco
C. Iannuccelli
F. Atzeni
P. Sarzi Puttini
A. Ciapetti
F. Salaffi
M. Cazzola
L. Bazzichi
Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method: the Italian experience
Reumatismo
fibromyalgia, Delphi method, pain scales, health-related quality of life, patient-reported outcomes
title Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method: the Italian experience
title_full Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method: the Italian experience
title_fullStr Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method: the Italian experience
title_full_unstemmed Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method: the Italian experience
title_short Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method: the Italian experience
title_sort preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the delphi method the italian experience
topic fibromyalgia, Delphi method, pain scales, health-related quality of life, patient-reported outcomes
url http://www.reumatismo.org/index.php/reuma/article/view/520
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