Multidimensional daily diary of fatigue–fibromyalgia–17 items (MDF-fibro-17). part 1: development and content validity

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Abstract

Background

Fibromyalgia (FM), a disorder characterized by chronic widespread pain and tenderness, affects greater than five million individuals in the United States alone. Patients experience multiple symptoms in addition to pain, and among them, fatigue is one of the most bothersome and disabling. There is a growing body of literature suggesting that fatigue is a multidimensional concept. Currently, to our knowledge, no multidimensional Patient Reported Outcome (PRO) measure of FM-related fatigue meets Food and Drug Administration (FDA) requirements to support a product label claim. Therefore, the objective of this research was to evaluate qualitative and quantitative data previously gathered to inform the development of a comprehensive, multidimensional, PRO measure to assess FM-related fatigue in FM clinical trials.

Methods

Existing qualitative and quantitative data from three previously conducted studies in patients with FM were reviewed to inform the initial development of a multidimensional PRO measure of FM-related fatigue: 1) a concept elicitation study involving in-depth, open-ended interviews with patients with FM in the United States (US) ( N = 20), Germany ( N = 10), and France ( N = 10); 2) a cognitive debriefing and pilot study of a preliminary pool of 23 items ( N = 20 US patients with FM); and 3) a methodology study that explored initial psychometrics of the item pool ( N = 145 US patients with FM).

Results

Five domains were identified that intend to capture the broad experience of FM-related fatigue reported in the qualitative research: the Global Fatigue Experience, Cognitive Fatigue, Physical Fatigue, Motivation, and Impact on Function. Seventeen of the original pool of 23 items were selected to best capture these five dimensions. These 17 items formed the basis of a newly developed multidimensional PRO measure to assess FM-related fatigue in clinical trials: the Multidimensional Daily Diary of Fatigue-Fibromyalgia-17 (MDF-Fibro-17).

Conclusion

Qualitative analysis, and preliminary quantitative item level data, confirmed that FM-related fatigue is multidimensional and provided strong support for the content validity of the MDF-Fibro-17. The next stage was to quantitatively evaluate the measure to confirm the factor structure, psychometric properties, sensitivity to change, and meaningful change. This has been conducted and is being reported separately.

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Most cited references 21

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The prevalence and characteristics of fibromyalgia in the general population.

Margaret Ross, Roger Shere-Wolfe, Harry L. Hebert … (1994)

To determine the prevalence and characteristics of fibromyalgia in the general population. A random sample of 3,006 persons in Wichita, KS, were characterized according to the presence of no pain, non-widespread pain, and widespread pain. A subsample of 391 persons, including 193 with widespread pain, were examined and interviewed in detail. The prevalence of fibromyalgia was 2.0% (95% confidence interval [95% CI] 1.4, 2.7) for both sexes, 3.4% (95% CI 2.3, 4.6) for women, and 0.5% (95% CI 0.0, 1.0) for men. The prevalence of the syndrome increased with age, with highest values attained between 60 and 79 years (> 7.0% in women). Demographic, psychological, dolorimetry, and symptom factors were associated with fibromyalgia. Fibromyalgia is common in the population, and occurs often in older persons. Characteristic features of fibromyalgia--pain threshold and symptoms--are similar in community and clinic populations, but overall severity, pain, and functional disability are more severe in the clinic population.

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Efficacy of multicomponent treatment in fibromyalgia syndrome: a meta-analysis of randomized controlled clinical trials.

Martin Offenbächer, Kathrin Bernardy, Winfried Häuser … (2009)

To systematically review the efficacy of multicomponent treatment of fibromyalgia syndrome (FMS). We screened Medline, PsychINFO, Scopus, and the Cochrane Library (through December 2007), as well as reference sections of original studies, reviews, and evidence-based guidelines. Randomized controlled trials (RCTs) on the multicomponent treatment (at least 1 educational or other psychological therapy with at least 1 exercise therapy) of FMS were analyzed. We included 9 (of 14) RCTs with 1,119 subjects (median treatment time 24 hours) in the meta-analysis. Effects were summarized using standardized mean differences (SMDs) or weighted mean differences (WMDs). There was strong evidence that multicomponent treatment reduces pain (SMD -0.37; 95% confidence interval [95% CI] -0.62, -0.13), fatigue (WMD -0.85; 95% CI -1.50, -0.20), depressive symptoms (SMD -0.67; 95% CI -1.08, -0.26), and limitations to health-related quality of life (HRQOL) (SMD -0.59; 95% CI -0.90, -0.27) and improves self-efficacy pain (SMD 0.54; 95% CI 0.26, 0.82) and physical fitness (SMD 0.30; 95% CI 0.02, 0.57) at posttreatment. There was no evidence of its efficacy on pain, fatigue, sleep disturbances, depressive symptoms, HRQOL, or self-efficacy pain in the long term. There was strong evidence that positive effects on physical fitness (SMD 0.30; 95% CI 0.09, 0.51) can be maintained in the long term (median followup 7 months). There is strong evidence that multicomponent treatment has beneficial short-term effects on the key symptoms of FMS. Strategies to maintain the benefits of multicomponent treatment in the long term need to be developed.

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Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises.

Roderick Williams, P J Mease, Leslie Crofford … (2008)

In evaluating the effectiveness of fibromyalgia (FM) therapies, it is important to assess the impact of those therapies on the full array of domains considered important by both clinicians and patients. The objective of this research was to identify and prioritize the key clinically relevant and important domains impacted by FM that should be evaluated by outcome assessment instruments used in FM clinical trials, and to approach consensus among clinicians and patients on the priority of those domains to be assessed in clinical care and research. Group consensus was achieved using the Delphi method, a structured process of consensus building via questionnaires together with systematic and controlled opinion feedback. The Delphi exercises involved 23 clinicians with expertise in FM and 100 patients with FM as defined by American College of Rheumatology criteria. The Delphi exercise revealed that the domains ranked most highly by patients were similar to the domain rankings by clinicians. Pain was consistently ranked highest by both panels. Fatigue, impact on sleep, health-related quality of life, comorbid depression, and cognitive difficulty were also ranked highly. Stiffness was ranked highly by patients but not clinicians. In contrast, side effects was important to clinicians but was not identified as important in the patient Delphi exercise. The clinician and patient Delphi exercises identified and ranked key domains that need to be assessed in FM research. Based on these results, a conceptual framework for measuring patient-reported outcomes is proposed.

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Author and article information

Contributors

S. Morris: SMorris@theravance.com

Y. Li: YLi@theravance.com

J.A.M. Smith: jamsmith64@gmail.com

S. Dube’: sdube2@stanford.edu

C. Burbridge:

ORCID: http://orcid.org/0000-0003-0117-7169

claire.burbridge@clinoutsolutions.com

T. Symonds: tara.symonds@clinoutsolutions.com

Journal

Journal ID (nlm-ta): BMC Musculoskelet Disord

Journal ID (iso-abbrev): BMC Musculoskelet Disord

Title: BMC Musculoskeletal Disorders

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2474

Publication date (Electronic): 16 May 2017

Publication date PMC-release: 16 May 2017

Publication date Collection: 2017

Volume: 18

Electronic Location Identifier: 195

Affiliations

[1 ]Former employees, current consultants of Theravance Biopharma US, Inc, 901 Gateway Boulevard, South San Francisco, CA 94080 USA

[2 ]Former employees of Theravance Biopharma US, Inc, 901 Gateway Boulevard, South San Francisco, CA 94080 USA

[3 ]ISNI 0000000419368956, GRID grid.168010.e, Consulting Associate Professor Department of Psychiatry, , Behavioral Medicine Stanford University School of Medicine, ; Stanford, CA 94305 USA

[4 ]ISNI 0000 0004 1936 9000, GRID grid.21925.3d, , Adjunct Professor of Psychiatry University of Pittsburgh School of Medicine, ; Pittsburgh, PA 15260 USA

[5 ]Clinical Outcomes Solutions, Unit 68 Basepoint, Shearway Business Park, Shearway Road, Folkestone, Kent, UK

Author information

C. Burbridge http://orcid.org/0000-0003-0117-7169

Article

Publisher ID: 1544

DOI: 10.1186/s12891-017-1544-y

PMC ID: 5434627

PubMed ID: 28511678

SO-VID: 0cbc7528-d436-4396-92fd-6f3b5d4a8a7d

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 10 October 2016

Date accepted : 30 April 2017

Funding

Funded by: Theravance Theravance Biopharma US, Inc

Custom metadata

ScienceOpen disciplines: Orthopedics

Keywords: fibromyalgia,fatigue,diary,patient reported outcome (pro),qualitative,conceptual model,mdf-fibro-17

Data availability:

ScienceOpen disciplines: Orthopedics

Keywords: fibromyalgia, fatigue, diary, patient reported outcome (pro), qualitative, conceptual model, mdf-fibro-17

Multidimensional daily diary of fatigue–fibromyalgia–17 items (MDF-fibro-17). part 1: development and content validity

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Abstract

Background

Methods

Results

Conclusion

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Orthopedics

Most cited references 21

The prevalence and characteristics of fibromyalgia in the general population.

Efficacy of multicomponent treatment in fibromyalgia syndrome: a meta-analysis of randomized controlled clinical trials.

Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises.

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