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.
| Original language | English |
|---|---|
| Pages (from-to) | 27-34 |
| Number of pages | 8 |
| Journal | Reumatismo |
| Volume | 64 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2012 |
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Keywords
- Delphi method
- Fibromyalgia
- Health-related quality of life
- Pain scales
- Patient-reported outcomes
ASJC Scopus subject areas
- Rheumatology
- Medicine(all)
Cite this
Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method : The Italian experience. / Salaffi, Fausto; Ciapetti, A.; Sarzi Puttini, P.; Atzeni, F.; Iannuccelli, C.; Di Franco, M.; Cazzola, M.; Bazzichi, L.
In: Reumatismo, Vol. 64, No. 1, 2012, p. 27-34.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method
T2 - The Italian experience
AU - Salaffi, Fausto
AU - Ciapetti, A.
AU - Sarzi Puttini, P.
AU - Atzeni, F.
AU - Iannuccelli, C.
AU - Di Franco, M.
AU - Cazzola, M.
AU - Bazzichi, L.
PY - 2012
Y1 - 2012
N2 - 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.
AB - 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.
KW - Delphi method
KW - Fibromyalgia
KW - Health-related quality of life
KW - Pain scales
KW - Patient-reported outcomes
UR - http://www.scopus.com/inward/record.url?scp=84875881156&partnerID=8YFLogxK
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U2 - 10.4081/reumatismo.2012.27
DO - 10.4081/reumatismo.2012.27
M3 - Article
VL - 64
SP - 27
EP - 34
JO - Reumatismo
JF - Reumatismo
SN - 0048-7449
IS - 1
ER -