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Biomedical subjects

F Wolfe

Publications and source records attributed to F Wolfe.

At least 127 records · Page 7Linked to original sources

Radiological progression in rheumatoid arthritis: how many patients are required in a treatment trial to test disease modification?

OBJECTIVE: To determine whether the number of patients required in a therapeutic trial that uses progression of radiological abnormalities as the outcome measure would be similar for multiple centres. METHODS: The progression of radiological damage to the fingers and wrists of patients with rheumatoid arthritis in five centres, three in North America and two in Europe, was examined. The reproducibility of repeated readings by the same and multiple observers was examined. The number of patients required in a two group trial was calculated for several combinations of power and significance. RESULTS: Scoring progression of radiological abnormalities in sequential films taken between 0.5 and 2.1 years was found to be highly reproducible. When the scores of a single reader were used the rate of change of radiological scores was similar in all centres. Based on the mean progression rate for all centres it was estimated that 153 patients in each group would be required to assure 90% power for detecting a 50% slowing of radiological progression at a significance of 0.05. Review of the experience in three trials showed a large variability in the radiological progression rates. CONCLUSION: The progression of scores for radiological damage in rheumatoid arthritis is relatively uniform in North America and Europe and thus the number of patients required in a trial would be similar. Experience in three trials showed that patient selection is of paramount importance in setting up a successful study.

Adult↗

The prognosis of rheumatoid arthritis and undifferentiated polyarthritis syndrome in the clinic: a study of 1141 patients.

OBJECTIVE: To determine the prognosis of undifferentiated polyarthritis syndrome in the clinic compared with rheumatoid arthritis (RA). METHODS: We identified consecutive patients seen within the first 2 years of disease (and further subset into 6-month groups) diagnosed as having either RA or undifferentiated polyarthritis syndrome at the first clinic visit. Undifferentiated polyarthritis syndrome was characterized by clinical presentation, laboratory data, and American College of Rheumatology (ACR) 1958 and 1987 RA criteria. Followup evaluations were done to determine change in diagnosis, resolution of symptoms, and clinical remission of RA. RESULTS: Undifferentiated polyarthritis syndrome was more common in the clinic than RA (638 vs 503). Of patients with RA 7.6% were symptom free an average of 6.9 years after the first clinic visit. For those with disease onset between 0-6 months and 0-2 years, complete resolution of undifferentiated polyarthritis syndrome occurred in 57.9 and 53.9% of cases, including 46.1 and 35.6% meeting ACR 1987 criteria for RA. Latex positivity was the strongest predictor of failure to resolve subsequently (25.0 and 29.2% resolution) and the best predictor of development of RA (41.7 and 43.1%). CONCLUSIONS: Nonrheumatoid undifferentiated polyarthritis syndrome is more common in the clinic than RA. Undifferentiated polyarthritis syndrome resolves in more than half the cases, while RA remits in 7.6%. Finally, resolution of RA criteria positive undifferentiated polyarthritis syndrome occurs predominantly in those who are seronegative.

Adult↗

Depression is not more common in rheumatoid arthritis: a 10-year longitudinal study of 6,153 patients with rheumatic disease.

OBJECTIVE: To determine if depression scores and depressive symptoms are higher in patients with rheumatoid arthritis (RA) than among those with other rheumatic disorders; and to describe norms for the Arthritis Impact Measurement Scale (AIMS) depression scale. METHODS: A 100% sample of all clinic visits of 6,153 consecutive patients with rheumatic disease seen in an outpatient rheumatic disease clinic during a 10-year period. 19,122 AIMS depression scores were utilized. For each patient an average depression score was calculated. Covariates included age, sex, education level, ethnic origin, and number of clinic visits. RESULTS: RA depressive symptoms and depression scores did not differ from all other clinic patients (taken as a whole). Patients with fibromyalgia had significantly more abnormal scores. CONCLUSION: Depression scores are not higher or depressive symptoms more common in patients with RA compared with other clinic patients. By every measure depression is increased in fibromyalgia. The notion that patients with RA have increased depression or are somehow more susceptible to depression is not supported by the data and should be abandoned.

Adult↗

The relationship between clinical activity and depression in rheumatoid arthritis.

OBJECTIVE: To determine the extent to which clinical variables and changes in clinical variables explain depression and depression changes in patients with rheumatoid arthritis (RA). METHODS: 713 patients with RA attending an outpatient rheumatology clinic were studied at their 2 most recent clinic visits as part of their ordinary rheumatic disease care. Six demographic variables and 7 clinical variables were assessed including the Arthritis Impact Measurement Scale depression score, Stanford Health Assessment Questionnaire Functional Disability Index (HAQ-DI), visual analog scale (VAS) pain scales, joint count, grip strength, am stiffness, and erythrocyte sedimentation rate. Change scores representing the difference between the scores at the last and the next to last visit were calculated for all clinical variables. RESULTS: About 20% of the variance in depression change scores was explained by changes in clinical variables. The amount of variance explained appeared to be inversely related to the time between visits. Thirty-four percent of the variance in current levels of depression scores was explained by current clinical and demographic variables. The most important predictors of depression score and depression change were VAS Pain and HAQ-DI. At the last clinic visit between 11 and 16% of the depression score was explained by changes in depression scores since the previous clinic visit. CONCLUSION: Clinical changes explain 20% of depressive changes between visits, while 34% of current depression scores are explained by current clinical status. Changes in pain and HAQ-DI predict changes in depression.

Adult↗

Fractures in rheumatoid arthritis: an evaluation of associated risk factors.

OBJECTIVE: Our purpose was to identify factors indicative of a high fracture risk during the disease course of rheumatoid arthritis (RA). METHODS: In 1110 patients (879 women and 231 men) with RA from five Arthritis, Rheumatism and Aging Medical Information System centers, information from history, clinical and laboratory examination, outcome assessment, and therapy was evaluated for association with the 226 first fractures having occurred during the years from 1975 to 1988. RESULTS: The mean age of the patients was 54 years, the mean time of observation was 8 years. Multivariate analyses identified the following factors to be associated with fracturing: years taking prednisone, previous diagnosis of osteoporosis, disability, age, lack of physical activity, female sex, disease duration, impaired grip strength, and low body mass. CONCLUSION: We conclude that patients with RA at greatest risk for fracturing are easily identified by using a few clinical variables. These findings support encouragement of active lifestyle habits and avoidance of longterm administration of corticosteroids in patients with RA.

Aging↗

Prospective 5-year followup of recombinant interferon-gamma in rheumatoid arthritis.

OBJECTIVE: To define clinical and laboratory outcomes of longterm recombinant interferon-gamma (rIFN-gamma) treatment of patients with rheumatoid arthritis (RA). METHODS: Patients with RA (70) completing a 12-week multicenter double blind trial comparing rIFN-gamma with placebo were enrolled in a longterm prospective protocol evaluating rIFN-gamma in RA. RESULTS: The majority of patients sustained clinical improvement for one year. Eight (11%) patients with RA continued to receive rIFN-gamma after 5 years. One patient fulfilled remission criteria. rIFN-gamma was well tolerated with remarkably few suspected adverse drug reactions. Forty-seven (67%) patients discontinued rIFN-gamma because of lack of efficacy, 7 (10%) because of concurrent illnesses, 5 (7%) were not compliant to study protocol, 3 (4%) developed suspected adverse drug reactions for a total of 62 (89%) withdrawals over the 5 years of followup. Patients continuing rIFN-gamma treatment for 5 years had lower initial total leukocyte and neutrophil counts and higher hemoglobin and hematocrit levels than patients who discontinued rIFN-gamma during the 5-year followup. CONCLUSIONS: Longterm treatment of RA with rIFN-gamma was generally well tolerated. Although many patients maintained sustained clinical improvement for at least one year, the main reason for discontinuing the drug over 5 years was the lack of continued benefit.

Arthritis, Rheumatoid↗

Measurement of gold treatment effect in clinical practice: evidence for effectiveness of intramuscular gold therapy.

OBJECTIVE: To determine the extent of efficacy of intramuscular (im) gold in clinical practice. METHODS: Ninety-eight patients who received im gold treatment for at least 1 year were assessed during ordinary clinic visits over the 12 month period following gold initiation. Assessments included joint counts, erythrocyte sedimentation rate (ESR), morning stiffness, visual analog scale (VAS) patient pain, VAS patient global, grip strength, prednisone dose, hemoglobin, and Stanford Health Assessment Questionnaire (HAQ) disability index. RESULTS: All outcome measures showed significant improvements at one year by standardized pretest posttest differences (effect size) and by measurement of the area under the curve (AUC). Important improvement (at least 50% improvement) was common: joint count (63.3%), global severity (41.1%), ESR (48.2%), grip strength (42.7%) HAQ disability (45.3%), and morning stiffness (72.2%). Effect sizes were substantial, even after correcting for placebo effect and withdrawals. Overall improvement was clinically significant, amounting to the equivalent of 2 months without pain or disability. CONCLUSION: Patients receiving gold for 12 months improved significantly and importantly in all measures studied. Improvement was clinically significant, amounting to the equivalent of 2 months without pain or disability. The degree of improvement was similar to, but somewhat greater, than that seen in controlled clinical trials, and could not be explained by regression to the mean.

Arthritis, Rheumatoid↗

The curious case of intramuscular gold.

Controlled clinical trials, meta-analysis, and observational studies provide strong evidence of short-term gold efficacy. There is also substantial evidence for the retardation of radiographic abnormality. Although gold therapy is discontinued by most patients within 2 years of onset, a minority of patients sustain important long-term benefit.

Evaluation Studies as Topic↗

The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis.

OBJECTIVE: To develop and validate revised criteria for global functional status in rheumatoid arthritis (RA). METHODS: Revised criteria were formulated and tested for criterion and discriminant validity in 325 patients with RA. RESULTS: The revised criteria developed are as follows: class I = able to perform usual activities of daily living (self-care, vocational, and avocational); class II = able to perform usual self-care and vocational activities, but limited in avocational activities; class III = able to perform usual self-care activities but limited in vocational and avocational activities; class IV = limited in ability to perform usual self-care, vocational, and avocational activities. Usual self-care activities include dressing, feeding, bathing, grooming, and toileting; vocational and avocational activities are both patient-desired and age-, and sex-specific. The distribution properties of this classification schema were superior to those of the original Steinbrocker criteria. Mean Health Assessment Questionnaire scores were significantly (P less than 0.0001) different between, and increased across, the 4 classes. CONCLUSION: Although there are limitations inherent in the use of global ordinal scales, the American College of Rheumatology revised criteria will be useful in describing the functional consequences of RA. A more detailed quantitative measure of physical disability should be used, however, for optimal monitoring of patients' clinical status in office practice and clinical research.

Activities of Daily Living↗

Sensitivity to change of the health assessment questionnaire (HAQ) and other clinical and health status measures in rheumatoid arthritis: results of short-term clinical trials and observational studies versus long-term observational studies.

To obtain evidence concerning short-term and long-term efficacy of clinical and health status measures in rheumatoid arthritis (RA), we conducted two observational studies--a 6-month study of 233 patients receiving methotrexate and a 10-year study of 157 patients receiving multiple treatments in a rheumatic disease clinic. Results of the 6-month study yielded effect sizes for treatment similar to the meta-analyses reported by Felson [corrected] et al. (Arthritis Rheum 33:1449-1461, 1990) and the controlled trials of methotrexate reported by Weinblatt et al. (Arthritis Rheum 33:330-338, 1990), suggesting that observational studies provide valid measurements of treatment effect. The effect size for the Health Assessment Questionnaire (HAQ) was 0.5. By contrast, the 10-year study suggested that standard clinical variables changed little and were not useful in assessing RA outcome, while the effect size of the HAQ was -2.39. These data continue to underscore the differences between short-term trials and the long-term outcome of RA, and suggest an important place for the HAQ or similar instruments in all phases of RA evaluation and assessment.

Arthritis, Rheumatoid↗

The sense of coherence questionnaire in patients with rheumatic disorders.

Aaron Antonovsky's Sense of Coherence (SOC) questionnaire with its 3 subscales is designed to measure strengths within individuals that allow them to survive in the face of extreme stresses, including chronic illness. We administered the SOC to 1333 patients with rheumatic disorders. Although the instrument had high alpha reliability, factor analysis did not support the concept of distinct subscales. The SOC was strongly related to the Arthritis Impact Measurement Scales anxiety and depression scores (r = -0.63 to -0.69), less strongly related to clinical variables (r = -0.20 to -0.33), and was minimally related to demographic variables. When psychological variables were controlled for, almost no association between the SOC and clinical variables remained (r = 0.06). Whether the SOC will be more useful than standard psychological instruments awaits the result of ongoing studies.

Adaptation, Psychological↗

The fibromyalgia and myofascial pain syndromes: a preliminary study of tender points and trigger points in persons with fibromyalgia, myofascial pain syndrome and no disease.

Four experts on myofascial pain syndrome (MFP) performed trigger point examinations and 4 experts on fibromyalgia performed tender point examinations on 3 groups of subjects (7 patients with fibromyalgia, 8 with MFP, and 8 healthy persons) while blinded as to diagnosis. Local tenderness was common in both disease groups (65-82%), but was elicited in a greater proportion of MFP experts' examinations (82%). Active trigger points were found in about 18% of examinations of patients with fibromyalgia and MFP, but latent trigger points were rare in all groups. A more liberal definition of trigger point, however, resulted in a 38 and 23% positive rate among patients with fibromyalgia and MFP, respectively. Taut muscle bands and muscle twitches were common (50 and 30%, respectively) and noted equally in all 3 diagnostic groups. Problems with reliability were identified for taut bands, muscle twitch, and active trigger points. Our data are exploratory and tentative, but suggest that attention to definition and reliability are required to advance our knowledge of these common syndromes.

Fibromyalgia↗

The progression of erosion and joint space narrowing scores in rheumatoid arthritis during the first twenty-five years of disease.

Erosions and cartilage destruction are nearly universal features in peripheral joints that have been chronically affected by rheumatoid arthritis. Scoring methods to measure the extent of these abnormalities in hands and wrists have been developed and have been thoroughly tested in several studies to establish their reproducibility. In this study, we utilized one of these scoring methods to examine the progression of radiologic damage as related to duration of disease. Two hundred ninety-two patients from 3 different participating centers in the Arthritis, Rheumatism, and Aging Medical Information System were included. Six hundred fifty films of the hands and wrists, obtained from 210 patients, were scored for erosions and joint space narrowing. The average annual rate of progression of the total radiologic score, which sums erosion and joint space abnormalities and has a maximum possible score of 314, was approximately 4 units per year over the first 25 years after onset; this progression was more rapid in the earlier years of disease and slightly slower in the later years. Data were insufficient to accurately determine the progression rate in disease of more than 25 years duration.

Arthritis, Rheumatoid↗

The latex test revisited. Rheumatoid factor testing in 8,287 rheumatic disease patients.

Rheumatoid factor (RF) testing by latex fixation in 8,287 outpatients yielded a sensitivity of 81.6% and 78.0% at titers of 1:20 and 1:80, respectively, and a specificity against noninflammatory rheumatic disorders (NIRD) of 96.6% and 97.9% and against NIRD plus inflammatory disorders of 95.2% and 96.8%, respectively. The predictive value of a positive test result at the clinic prevalence rate for rheumatoid arthritis (RA) (16.4%) was approximately 80%, and was 70% at 10% prevalence and 10% at 1% prevalence. No associations of RF with age or sex were found in non-RA patients. RF titers increased minimally with age in RA patients and were higher in men than in women. This study suggests that latex testing is far more specific than has been believed and that the titer is not spuriously increased with age.

Adult↗

The epidemiology of NSAID associated gastrointestinal disease.

Many problems make it difficult to estimate the exact risk of peptic ulceration and its complications, perforation and bleeding, in patients receiving NSAIDs. Nevertheless the association of these events and treatment is now beyond dispute. Deaths are a particular problem in the elderly since mortality from peptic ulcer disease rises steeply after age 60. Risk factors identified with hospitalisation for gastrointestinal problems in patients receiving NSAIDs include age, previous gastrointestinal symptoms, corticosteroid use and disability. The risk of death is highest in elderly females and is substantial.

Adolescent↗

Clinical and health status measures over time: prognosis and outcome assessment in rheumatoid arthritis.

We studied clinical and health status measures in 561 patients with rheumatoid arthritis (RA). Two hundred sixty-four patients were seen within 2 years of disease onset and followed for an additional 2 years. Four other groups were each followed for 5 years, and had disease durations of 2-7, 7-12, 12-17, and 17-22 years, respectively, at the first clinic visit. Functional disability developed very early in the course of RA and continued to worsen at about an equal rate over 22 years. Anxiety, pain scores, and self-assessed severity also increased with time, but erythrocyte sedimentation rate (ESR), morning stiffness, and joint counts were unchanged. Treatment resulted in reduction in joint counts and in nonsignificant improvements in ESR, stiffness, and psychological scores. But functional loss increased in each time period in spite of treatment. Variables most effective in controlled clinical trials are not effective as longterm measures of RA outcome.

Adult↗