Assessment of functional ability in patients with fibromyalgia.
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Biomedical subjects
Publications and source records attributed to F Wolfe.
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One hundred five patients were enrolled in a 12-week, randomized, prospective, double-blind, placebo-controlled trial of recombinant human gamma-interferon (rHu gamma-IFN) for the treatment of rheumatoid arthritis. Fifty-four patients received rHu gamma-IFN and 51 received placebo. Forty-two patients in each group completed the 12-week trial. Some clinical improvement occurred in both groups of patients. Although the improvement with rHu gamma-IFN was greater than that with placebo, the differences were generally not statistically significant.
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Increasing recognition of the fibromyalgia syndrome together with concerns about limitations of currently available criteria led most centers engaged in fibromyalgia research in Canada and the United States to undertake a multicenter effort to define epidemiologically correct criteria for the diagnosis of fibromyalgia. Five hundred fifty-eight consecutive patients (293 with fibromyalgia and 265 controls) were recruited from 16 private practice and university centers. The study used training sessions to increase interrater reliability, and included methods to determine reliability of examination and historical data. Standardized definition and methods of data acquisition by independent, blinded assessors were employed.
To test the observation that was made in a largely nonwhite, lower socioeconomic class clinic sample that parents of patients with rheumatoid arthritis (RA) had an earlier age of death than control parents, we determined parental age of death in 499 patients with RA and 491 controls (381 with osteoarthritis and 110 with fibromyalgia). Patients and controls were largely white (greater than 94%) and had a mean education level greater than 12 years. Parents did not differ in survival time or age of death at the 0.05 level, but parents in our series lived 6 years longer than those studied in the lower socioeconomic community.
Fibromylagia is a painful musculoskeletal disorder composed of core features that are always present (wide-spread pain and tenderness), characteristic features that are present more than 75 per cent of the time (fatigue, nonrefreshed sleep, and morning stiffness), and common features that are present more than 25 per cent of the time (for example, paresthesia, irritable bowel syndrome, functional disability). The syndrome is common, occurring in 2.1 per cent of family practice clinic patients, 5 per cent of general medical patients, and 10 to 20 per cent of rheumatic disease clinic patients. Evolving diagnostic criteria permit identification of patients for clinical and research purposes.
Human leukocyte antigen (HLA) typing was performed in 174 patients with rheumatoid arthritis and 222 white control subjects. Increases in HLA-DR4 and HLA-DR1 were observed as in previous studies. Each of these appeared to be inherited as dominant risk factors. Southern blotting with a DR-beta probe after digestion of genomic DNA with the restriction enzyme Bam HI showed seven bands. Three of them correlated with DR4 and were increased in rheumatoid arthritis patients. Subsets of DR4 were determined by polymerase chain reaction amplification followed by hybridization with oligonucleotide probes. Dw4 was increased in rheumatoid arthritis patients, and the frequency of the other subsets appeared to be similar in rheumatoid arthritis patients and control subjects. A polymorphism associated with the T cell receptor V-beta-8 gene family was significantly increased in rheumatoid arthritis patients.
We studied 985 consecutive patients with definite or classical rheumatoid arthritis (RA) at an arthritis clinic, between April 1976 and August 1986, to investigate the prevalence of familial disease. We have demonstrated that at least 10.9% of unrelated patients with definite or classical RA have one or more first-degree relative(s) affected with definite or classical RA. Moreover, familial RA is not more severe than the more prevalent non-familial, i.e. sporadic, form of the disease.
We have studied HLA-A, B, C, and DR antigens in 75 unrelated white families, each with multiple cases of adult-onset definite or classical rheumatoid arthritis (RA) (by ARA criteria). There was no difference in age of onset or serological features of RA between males and females. HLA-DR4 phenotype frequency among female (68%) and male (71%) patients also did not differ significantly. The observed frequencies of HLA-DR4 genotypes (homozygous, heterozygous, and those lacking it) differed significantly (p less than 0.005) between affected and unaffected individuals. However, the observed genotype distribution did not differ from what is expected given the Hardy-Weinburg equilibrium. There is a direct correlation between the number of DR4 allele(s) carried (two, one, or zero) and the percent affected (p less than 0.026 for females and p less than 0.052 for males). These findings highlight the importance of discerning the additional genetic determinants, including those that are gender-associated, which influence susceptibility to RA.
Fibromyalgia in the elderly often occurs in the presence of other musculoskeletal disorders where it is often unsuspected. The clue to the diagnosis of concomitant fibromyalgia lies in the widespread distribution of the pain and in its severity. All patients with this disorder have multiple, symmetrically distributed "tender points," a physical sign which is specific for fibromyalgia. Treatment includes, first, explanation. Aerobic exercise may be helpful in many patients, and administration of tricyclic compounds in very low doses is often effective in treating the associated sleep disorder and in reducing overall disease severity.
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We administered the Stanford Health Assessment Questionnaire functional disability questionnaire to a cohort of 400 patients with rheumatoid arthritis (RA) every 6 months during a mean followup of 3.1 years. Simple classification into 3 groups based on Functional Disability Index (FDI) scores (0-1, 1.1-2, 2.1-3) identified patients with increasingly more severe scores for clinical, psychological, and demographic variables; and FDI scores at entry predicted increased inpatient and outpatient utilization of services, and mortality. The FDI provided important and clinically useful current and predictive information regarding RA status, utilization of services, and mortality that was not available through conventional testing. Our data suggest that such information can be easily and inexpensively obtained.
We mailed monthly questionnaires regarding fibromyalgia symptoms to 75 patients during a one-year period. Fibromyalgia symptoms in individual patients were generally stable over time as assessed by repeated measures and slope analyses, but patients clearly differed from one another in symptom severity. Pain, psychological status, and functional disability, but not sleep disturbance or morning stiffness, were the independent explanatory factors for disease severity in regression models. Functional disability has not been recognized previously as an important factor in fibromyalgia severity, but our data suggest that it should be assessed as a process and outcome measure in future fibromyalgia studies.
Fibrositis (fibromyalgia) is a common disorder, but is often not considered or diagnosed by clinicians. It is characterized by widespread musculoskeletal pain and aching, disturbed sleep, fatigue, morning stiffness, and local tenderness. The presence of multiple (seven or more) tender points and widespread pain or aching are necessary and sufficient conditions for diagnosis. Fibrositis occurs in a "primary" form, but most commonly in association with other rheumatic diseases where it is a concomitant condition. The designation "myofascial pain syndrome" has replaced older concepts of localized fibrositis, and is considered a separate entity.
We studied the demographic, clinical, and disease severity characteristics of 96 patients with rheumatoid arthritis (RA) from multicase families (familial RA+) and 860 nonfamilial RA cases (familial RA-) seen consecutively in an outpatient rheumatic disease clinic between April, 1976 and August, 1986. Familial RA (+) and (-) cases were similar in essentially all demographic, clinical, and disease severity characteristics. Subgroups of 2nd generation patients with familial RA and sib-sib patients were similar, and neither group differed from the set of familial RA (-) individuals. The failure to find differential severity in these groups indicates that inferences from studies of families with RA may be extrapolated safely to patients with RA at large, but differences between rheumatoid factor positive (RF+) and RF (-) patients suggest that RA (+) and RF (-) patients should be analyzed separately.
We investigated psychological and clinical factors in patients with rheumatoid arthritis (RA) by studying 400 patients at 6 month intervals over a mean 3.1 (1.2 SD) years utilizing the Arthritis Impact Measurement Scales psychological scales. Entry clinical and demographic variables explained 25% of the variance in psychological scores. Patients with RA had scores similar to those with other rheumatic disorders (n = 441), and scores remained stable over the study period. Development of depression was associated with socioeconomic not clinical factors, and disease activity appeared to have a limited effect on psychological status. Initial psychological scores were associated with subsequent pain levels and number of physician visits.
The American Rheumatism Association Medical Information System (ARAMIS) is a consortium of North American rheumatic disease data banks. Founded in 1974, it has grown to include more than 16 centers, 22,000 patients, 140,000 patient encounters, and 80,000,000 observations. Traditionally, data storage and computer programs have resided on the IBM "2"-370 system at Stanford University. Distant peripheral centers have entered and retrieved data and performed analyses using proprietary long distance telephone networks. With growth, ARAMIS has placed strong emphasis on data quality and epidemiological soundness. "Core" groups at Stanford specifically address issues of quality control, biostatistics, health care economics, outcome assessment, study design, and administration. Advances in microcomputers and software has led ARAMIS to begin a migration from mainframe computing to distributed systems using IBM PC/XT/AT type computers and the Medlog software system. Substantial cost savings have been noted with distributed processing. The ability to easily transfer data and software forms a groundwork for international data banks and data exchange, but common vocabulary and common quality control procedures are essential for effective international cooperation and exchange.
We studied HLA antigens in 105 unrelated American Caucasian patients with rheumatoid arthritis (RA), 70 of them with familial disease. HLA-DR4 was observed in 71% of familial RA, 63% of non-familial RA, and 27% of normal controls, confirming the already well-established association between HLA-DR4 and both familial and non-familial RA. HLA-B27 was present in 14.3% of patients, versus 8% of normal controls (p = 0.04), and was not more common in familial (10 of 70, or 14.3%) versus non-familial (5 of 35, or 14.3%) disease. These results are compared with those observed in Scandinavian patients.