Fibromyalgia syndrome module at OMERACT 9: domain construct.

The objective of the module was to (1) establish a core domain set for fibromyalgia (FM) assessment in clinical trials and practice, (2) review outcome measure performance characteristics, (3) discuss development of a responder index for assessment of FM in clinical trials, (4) review objective markers, (5) review the domain of cognitive dysfunction, and (6) establish a research agenda for outcomes research. Presentations at the module included: (1) Results of univariate and multivariate analysis of 10 FM clinical trials of 4 drugs, mapping key domains identified in previous patient focus group: Delphi exercises and a clinician/researcher Delphi exercise, and breakout discussions to vote on possible essential domains and reliable measures; (2) Updates regarding outcome measure status; (3) Update on objective markers to measure FM disease state; and (4) Review of the issue of cognitive dysfunction (dyscognition) in FM. Consensus was reached as follows: (1) Greater than 70% of OMERACT participants agreed that pain, tenderness, fatigue, patient global, multidimensional function and sleep disturbance domains should be measured in all FM clinical trials; dyscognition and depression should be measured in some trials; and stiffness, anxiety, functional imaging, and cerebrospinal fluid biomarkers were identified as domains of research interest. (2) FM domain outcome measures have generally proven to be reliable, discriminative, and feasible. More sophisticated and comprehensive measures are in development, as is a responder index for FM. (3) Increasing numbers of objective markers are being developed for FM assessment. (4) Cognitive dysfunction assessment by self-assessed and applied outcome measures is being developed. In conclusion, a multidimensional symptom core set is proposed for evaluation of FM in clinical trials. Research on improved measures of single domains and composite measures is ongoing.

Involvement in decision-making and breast cancer survivor quality of life.

OBJECTIVE: This study examined the long-term effects on women's health related quality of life (HRQOL) of involvement in decision-making about their treatment for breast cancer and about follow-up care after treatment. METHODS: Using a cross-sectional survey design, a sample of breast cancer survivors from Western Washington who were 2, 5, and 10 years postdiagnosis were recruited via a cancer registry and interviewed about their HRQOL and their involvement in decision-making about their cancer treatment and follow-up care. MAIN OUTCOME MEASURES: HRQOL was assessed using the SF-36. RESULTS: Multiple regression analyses examining demographic and disease characteristics revealed age, and education, but not stage of cancer at diagnosis, to be significant predictors of perceived involvement in decision-making about cancer treatment and follow-up. Controlling for demographic and disease characteristics, perceived involvement in decision-making about treatment overall, surgery, chemotherapeutic treatment, and follow-up care were each associated with improved HRQOL, including the general health and vitality subscales of the SF-36 (p < .05). Involvement in decision-making about surgery was also associated with better mental health among survivors of breast cancer. Congruence of involvement in decision-making with a patient's preferred level of involvement was also associated with improved survivor HRQOL on several subscales. CONCLUSIONS: Perceived involvement in decision-making about breast cancer treatment, and about follow-up care is associated with better HRQOL for survivors 2, 5, and 10 years postdiagnosis. Prospective studies may be warranted to determine the possible mechanisms by which perceived involvement in decision-making about aspects of treatment other than surgery type might influence survivor HRQOL.

Frequent search for sense by long-term breast cancer survivors associated with reduced HRQOL.

This study examined breast cancer survivors' reports of continuing efforts to make sense of their breast cancer experience and associations of such efforts with post-traumatic stress symptomology (PTSS) and long-term health related quality of life (HRQOL). A cross-sectional survey was conducted with 636 women in 2002-2003 two, five and ten years after their diagnosis of breast cancer. Only a minority of women with breast cancer reported frequently searching for sense in their cancer experience, or wondering "why did this happen to me?" two or more years after diagnosis. Controlling for key demographic and disease variables, greater involvement in search two, five and ten years post-diagnosis was associated with higher levels of PTSS (R2 = 0.26; p < 0.001) and with reduced HRQOL as measured using the SF-36 scale (p < 0.01 for all scales). It appears that continued efforts to search for sense in the cancer experience two or more years after cancer diagnosis are associated with PTSS and lower levels of HRQOL in long-term survivors of breast cancer.

Conceptualizing and measuring illness self-concept: a comparison with self-esteem and optimism in predicting fibromyalgia adjustment.

Illness self-concept (ISC), or the extent to which individuals are consumed by their illness, was theoretically described and evaluated with the Illness Self-Concept Scale (ISCS), a new 23-item scale, to predict adjustment in fibromyalgia. To establish convergent and discriminant validity, illness self-concept was compared to self-esteem and optimism in predicting health status, illness intrusiveness, depression, and life satisfaction. The ISCS demonstrated good reliability (alpha = .94; test-retest r = .80) and was a strong predictor of outcomes, even after controlling for optimism or self-esteem. The ISCS predicted unique variance in health-related outcomes; optimism and self-esteem did not, providing construct validation. Illness self-concept may play a significant role in coping with fibromyalgia and may prove useful in the evaluation of other chronic illnesses.