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Theodore Pincus

Publications and source records attributed to Theodore Pincus.

At least 37 records · Page 2Linked to original sources
PubMed2005

Further development of a physical function scale on a MDHAQ [corrected] for standard care of patients with rheumatic diseases.

OBJECTIVE: To analyze a further version of the Multidimensional Health Assessment Questionnaire (MDHAQ) with 10 activities of daily living (ADL), which is more easily completed by patients and scored by health professionals than a 14-ADL MDHAQ; and to determine if the 10-ADL MDHAQ would be as informative as the 14-ADL MDHAQ, the 20-ADL HAQ, and the 8-ADL modified HAQ (MHAQ), which is more easily reviewed and scored than the HAQ, but scores are routinely 0.3-0.5 units lower than HAQ scores. METHODS: In standard care, 144 consecutive patients completed a HAQ, which includes a MHAQ, and 14-ADL MDHAQ, which includes a 10-ADL MDHAQ subscale, all scored 0-3. These scales were analyzed for mean and median scores, Cronbach's alpha to estimate internal consistency, factor analysis to estimate construct validity, and cumulative percentile scores. RESULTS: Mean (median) scores for the HAQ, MHAQ, 14-ADL MDHAQ, and 10-ADL MDHAQ physical function scales were 0.80 (0.75), 0.48 (0.38), 0.83 (0.79), and 0.73 (0.70), respectively. Internal consistency of each scale was very good. The lowest 25 percentile score was 0.16 on the HAQ, 0.0 on the MHAQ, 0.36 on the 14-ADL MDHAQ, and 0.20 on the 10-ADL MDHAQ. CONCLUSION: The MDHAQ physical function scale of 10 ADL is more easily completed and scored than the 14-ADL MDHAQ or 20-ADL HAQ, while providing similar information.

Activities of Daily Living↗
PubMed2005

A composite disease activity scale for clinical practice, observational studies, and clinical trials: the patient activity scale (PAS/PAS-II).

OBJECTIVE: To develop and validate a composite patient self-report disease activity scale for use in clinical practice and in observational studies and clinical trials. METHODS: A total of 9078 patients with rheumatoid arthritis completed detailed questionnaires that included measure of quality of life in the form of utilities. We evaluated several disease activity scales by measuring their agreement with the utility scales, and also their assessed ability to predict mortality and prescription for anti-tumor necrosis factor therapy. RESULTS: A composite index composed of a visual analog scale (VAS) for pain, a patient global VAS, and the Health Assessment Questionnaire (HAQ) or the HAQ II formed the Patient Activity Scale (PAS) and PAS-II. These scales performed as well as or better than longer, more complex scales. CONCLUSION: A simple, useful clinical scale, the PAS or PAS-II, can be formed by the use of common clinical variables. It is well correlated with and relevant to a wide range of clinical variables. This scale should be useful for comparative studies, clinical care, and regulatory documentation.

Aged↗
PubMed2004

Development and validation of the health assessment questionnaire II: a revised version of the health assessment questionnaire.

OBJECTIVE: The Health Assessment Questionnaire (HAQ) has become the most common tool for measuring functional status in rheumatology. However, the HAQ is long (34 questions, including 20 concerning activities of daily living and 14 relating to the use of aids and devices) and somewhat burdensome to score, has some floor effects, and has psychometric problems relating to linearity and confusing items. We undertook this study to develop and validate a revised version of the HAQ (the HAQ-II). METHODS: Using Rasch analysis and a 31-question item bank, including 20 HAQ items, the 10-item HAQ-II was developed. Five original items from the HAQ were retained. We studied the HAQ-II in 14,038 patients with rheumatic disease over a 2-year period to determine its validity and reliability. RESULTS: The HAQ-II was reliable (reliability of 0.88, compared with 0.83 for the HAQ), measured disability over a longer scale than the HAQ, and had no nonfitting items and no gaps. Compared with the HAQ, modified HAQ, and Medical Outcomes Study Short Form 36 physical function scale, the HAQ-II was as well correlated or better correlated with clinical and outcome variables. The HAQ-II performed as well as the HAQ in a clinical trial and in prediction of mortality and work disability. The mean difference between the HAQ and HAQ-II scores was 0.02 units. CONCLUSION: The HAQ-II is a reliable and valid 10-item questionnaire that performs at least as well as the HAQ and is simpler to administer and score. Conversion from HAQ to HAQ-II and from HAQ-II to HAQ for research purposes is simple and reliable. The HAQ-II can be used in all places where the HAQ is now used, and it may prove to be easier to use in the clinic.

Activities of Daily Living↗
PubMed2004

Quantitative measures and indices to assess rheumatoid arthritis in clinical trials and clinical care.

Modern medical care has been advanced, in large part, by quantitative measures that provide single, easily-assessed end points for clinical trials, clinical research, or clinical care (eg, blood pressure, serum cholesterol). In rheumatoid arthritis, several types of quantitative measures are used to assess patient status, including formal joint counts; radiographic scores; laboratory tests; patient self-report questionnaire measures of physical function, pain, global status, morning stiffness, and fatigue; as well as physical measures of functional status. Each of these measures is effective to document changes of status with treatment in groups of patients; however, no single measure can serve as a "gold standard" to document changes in each individual patient. Therefore, the measures have been combined into pooled indices that can be applied to individual patients in clinical research and clinical care.

Arthritis, Rheumatoid↗
PubMed2004

Clinical trials in rheumatic diseases: designs and limitations.

Randomized controlled clinical trials provide the best method to distinguish a drug from placebo without the inevitable selection biases that are seen in standard clinical care. This article reviews designs and limitations of clinical trials that are used in rheumatic diseases. The primary design in clinical trials is a parallel, in which patients are randomized in parallel to different therapies at different dosages or placebo. In recent years, other designs have been used increasingly, including "step-up," "step-down," and "cross-over" designs. Limitations of clinical trials in chronic diseases include a short time frame versus the long duration of disease, inclusion and exclusion criteria, use of surrogate markers that may not represent clinically relevant markers, statistical significance does not necessarily indicate clinical significance necessarily, and the fact that a control group does not assure the absence of bias. Therefore, long-term databases are needed to supplement clinical trials in analyzing results of therapy for rheumatoid arthritis.

Clinical Trials as Topic↗
PubMed2004

Patient questionnaires and formal education level as prospective predictors of mortality over 10 years in 97% of 1416 patients with rheumatoid arthritis from 15 United States private practices.

OBJECTIVE: To prospectively analyze patient questionnaire scores concerning functional disability as well as formal education level as potential predictors of premature mortality over 10 years in 1416 patients with rheumatoid arthritis (RA) from 15 private practice rheumatology settings in 11 diverse cities in the United States. METHODS: At baseline in 1985 and periodically over 10 years, patients completed mailed self-report multidimensional health assessment questionnaires (MDHAQ) that included functional disability scores, formal education level, and other demographic and clinical data. Vital status was determined 10 years after baseline. Potential predictors of 10 year mortality were analyzed using descriptive statistics and Cox proportional hazards models. RESULTS: Vital status was accounted for in 1378 patients, 97.3% of the cohort. The standard mortality ratio was 1.6, similar to most reported series of patients with RA, as 401 patients died versus 251 expected over 10 years. Evidence of "dose-response" relations was seen for age, formal education level, functional disability scores, and helplessness scores as predictors of mortality. In Cox proportional hazards models, age, sex, formal education level, functional disability, and helplessness scores remained significant independent predictors of 10 year mortality. CONCLUSION: Functional disability and low formal education level are significant predictors of premature mortality in people with RA under care in US private practice settings, as in most reported cohorts of patients with RA. This study shows that it is possible to account for more than 95% of patients over 10 years using mailed questionnaires to monitor patient status.

Adult↗
PubMed2004

Morning stiffness in patients with early rheumatoid arthritis is associated more strongly with functional disability than with joint swelling and erythrocyte sedimentation rate.

OBJECTIVE: To compare the level of morning stiffness in a cohort of patients with early rheumatoid arthritis (RA), assessed on a self-report questionnaire, to levels of patient self-report scores and clinical and laboratory variables. METHODS: A total of 337 patients with recent onset RA since 1998 were assessed for tender and swollen joint counts, erythrocyte sedimentation rate (ESR), physician global assessment, and radiographs of the hands and feet, as well as Multidimensional Health Assessment Questionnaire (MDHAQ) scores for functional disability, pain, fatigue, global status, morning stiffness, and number of symptoms. Regression models were used to estimate possible associations between these variables and morning stiffness. RESULTS: At study entry, 70 patients (21%) reported no morning stiffness, 52 (15%) reported morning stiffness < 15 minutes, 52 (15%) for 16-59 minutes, and 163 (49%) for >/= 1 one hour. At baseline and in longitudinal analyses, morning stiffness was significantly associated with functional disability scores on the MDHAQ and with other patient self-report data, and was associated at lower levels with swollen and tender joint counts and erythrocyte sedimentation rate (ESR). CONCLUSION: The degree of morning stiffness appears to reflect functional disability and pain more than traditional markers of inflammation such as joint counts and ESR in patients with early RA. Inclusion of morning stiffness as a marker of inflammatory activity in classification criteria for RA, inclusion criteria for most clinical trials in RA, and RA remission criteria, may be open to reassessment.

Activities of Daily Living↗
PubMed2003

The assessment of rheumatoid arthritis and the acceptability of self-report questionnaires in clinical practice.

OBJECTIVE: To assess the acceptability of self-report questionnaires (SRQ) in clinical practice and to understand the value that rheumatologists give to various assessment methods in rheumatoid arthritis. METHODS: Rheumatologists who completed a training course in the use of SRQ in clinical trials and clinical practice used the SRQ in their practices. Six months later 221 rheumatologists completed a survey regarding their experiences in assessing rheumatoid arthritis and in the use of SRQ. RESULTS: Prior to the start of the program, 18% of rheumatologists used self-report questionnaires, 6 months later, 48% were using SRQ in their practices. Rheumatologists who did not use questionnaires placed less value on all assessment methods, and particularly on questionnaire assessments of function and pain. They also were more likely to report that questionnaires were difficult to use, not accepted by staff, were too long, and that they had limited staff. Rheumatologists who used the questionnaires reported none of these difficulties and were satisfied with the benefits provide by SRQ. When assessment measures were ranked, rheumatologist ranked ACR 20, radiography, and erythrocyte sedimentation rate/c-reactive protein as the least important in both clinical trials and in clinical practice, and they rated swollen and tender joint counts followed by SRQ as the most useful assessment tools. CONCLUSION: SRQ are well received by rheumatologists, and following a training program almost 50% continued to use SRQ in their practices. Those who used questionnaires were generally more positive about assessments and had little difficulty in the technical aspects of administration, scoring, and interpretation.

Aged↗
PubMed2003

Eligibility of patients in routine care for major clinical trials of anti-tumor necrosis factor alpha agents in rheumatoid arthritis.

OBJECTIVE: To identify the proportion of patients with rheumatoid arthritis (RA) in 2 cohorts from Nashville, Tennessee, who met basic criteria for inclusion in 2 important recent clinical trials of anti-tumor necrosis factor alpha (anti-TNFalpha) agents, the early RA (ERA) trial of etanercept versus methotrexate, and the anti-TNFalpha trial in RA with concomitant therapy (ATTRACT) study of infliximab plus methotrexate versus methotrexate. METHODS: Two cohorts of patients, all of whom had met the American College of Rheumatology criteria for RA at some time, were studied. Cohort E (early) comprised 232 patients who were under the care of 5 private practice rheumatologists, whose duration of RA was fewer than 3 years, and who were reviewed for basic inclusion criteria for the ERA clinical trial. Cohort L (long-term) comprised 152 consecutive patients who had been under care at a weekly academic rheumatology clinic for a mean of 4.5 years, and were reviewed for basic inclusion criteria for the ATTRACT study. RESULTS: In cohort E, basic inclusion criteria for the ERA trial were met by 11 of 36 patients (31%) who had not taken methotrexate, 8 of 19 patients (42%) who were at their first visit and had not taken methotrexate, and 37 of all 232 patients (16%). In cohort L, 5% of patients met the basic inclusion criteria for the ATTRACT study. CONCLUSION: Most patients who were seen in routine care in these 2 cohorts did not meet the criteria for inclusion in these 2 important recent clinical trials. The conclusion that anti-TNFalpha therapy has greater efficacy than methotrexate may be valid only in a limited number of patients with the most severe RA. Anti-TNFalpha therapy may be desirable in most patients with RA, but this possibility has not been studied formally. Criteria for inclusion in RA clinical trials might be modified for greater generalizability of results.

Adolescent↗
PubMed2003

Screening the genome for rheumatoid arthritis susceptibility genes: a replication study and combined analysis of 512 multicase families.

OBJECTIVE: A number of non-HLA loci that have shown evidence (P < 0.05) for linkage with rheumatoid arthritis (RA) have been previously identified. The present study attempts to confirm these findings. METHODS: We performed a second genome-wide screen of 256 new multicase RA families recruited from across the United States by the North American Rheumatoid Arthritis Consortium. Affected sibling pair analysis on the new data set was performed using SIBPAL. We subsequently combined our first and second data sets in an attempt to enhance the evidence for linkages in a larger sample size. We also evaluated the impact of covariates on the support for linkage, using LODPAL. RESULTS: Evidence of linkage at 1p13 (D1S1631), 6p21.3 (the HLA complex), and 18q21 (D18S858) (P < 0.05) was replicated in this independent data set. In addition, there was new evidence for linkage at 9p22 (D9S1121 [P = 0.001]) and 10q21 (D10S1221 [P = 0.0002] and D10S1225 [P = 0.0038]) in the current data set. The combined analysis of both data sets (512 families) showed evidence for linkage at the level of P < 0.005 at 1p13 (D1S1631), 1q43 (D1S235), 6q21 (D6S2410), 10q21 (D10S1221), 12q12 (D12S398), 17p13 (D17S1298), and 18q21 (D18S858). Linkage at HLA was also confirmed (P < 5 x 10(-12)). Inclusion of DRB1*04 as a covariate significantly increased the probability of linkage on chromosome 6. In addition, some linkages on chromosome 1 showed improved significance when modeling DRB1*04 or rheumatoid factor positivity as covariates. CONCLUSION: These results provide a rational basis for pursuing high-density linkage and association studies of RA in several regions outside of the HLA region, particularly on chromosomes 1p, 1q, and 18q.

Arthritis, Rheumatoid↗
PubMed2003

Quantitative measures for assessing rheumatoid arthritis in clinical trials and clinical care.

There is no single 'gold standard' quantitative measure to assess and monitor the clinical status in patients with rheumatoid arthritis (RA). Therefore, a variety of measures have been used in clinical research and clinical care, including laboratory tests, radiographic scores, formal joint counts, physical measures of functional status, global measures and patient self-report questionnaires. These measures may address disease activity, joint damage, both activity and damage, or long-term outcomes. Measures of disease activity, such as joint swelling, are reversible and are emphasized in clinical trials. However, activity measures may be improved over 5 years while measures of damage, such as radiographic score, indicate disease progression. Two quantitative indices which are widely used in clinical trials are the (1) American College of Rheumatology (ACR) Core Data Set, which includes swollen joint count, tender joint count, physician assessment of global status, acute-phase reactant-erythrocyte sedimentation rate or C-reactive protein, functional status, pain, patient estimate of global status, a radiograph in studies over 1 year or longer, and (2) the disease activity score(DAs), which includes a swollen joint count, tender joint count, acute-phase reactant, and patient assessment of global status. Randomized controlled clinical trials provide the optimal method to evaluate new therapies, by comparing a therapy with a placebo or another therapy without selecting patients for specific therapies. However, randomized trials in chronic diseases have important limitations, including a relatively short observation period, patient selection for inclusion and exclusion criteria, inflexible dosage schedules, influence of the design on results despite a control group, emphasis on group data while ignoring individual variation in treatment responses, non-standardized interpretation of adverse effects, and others. Therefore, clinical trials in RA must be supplemented by long-term observational studies to assess results of therapy in regard to long-term outcomes such as work disability, joint replacement surgery and premature mortality. The most simple and effective method of collecting important long-term data from patients in routine clinical care is through patient self-report questionnaires.

Arthritis, Rheumatoid↗
PubMed2003

Most patients receiving routine care for rheumatoid arthritis in 2001 did not meet inclusion criteria for most recent clinical trials or american college of rheumatology criteria for remission.

OBJECTIVE: To determine the proportion of 2 cohorts of patients with rheumatoid arthritis (RA) in Nashville, Tennessee, who met 4 common criteria for inclusion in clinical trials: > or = 6 swollen joints, > or = 6 tender joints, erythrocyte sedimentation rate > or = 28 mm/h, and/or morning stiffness > or = 45 min. METHODS: Two cohorts of patients with RA, all of whom had met American Rheumatism Association (ARA) [now American College of Rheumatology (ACR)] criteria for RA at some time, were studied. Cohort L (late) included 146 consecutive patients whose mean disease duration was 14.0 years and who had been under care at a weekly academic rheumatology clinic for a mean of 6.2 years when seen in 1998-2001. Cohort E (early) included 232 patients of 5 private practice rheumatologists whose symptoms began in 1998 or later and whose mean disease duration was 1.8 years when seen in 2001. Patients were reviewed for the 4 inclusion criteria as well as 6 ARA remission criteria. RESULTS: In Cohort L, on a 28 joint count, 42.5% of patients had > or = 6 swollen joints, 25.3% had > or = 6 tender joints, 19.9% had both > or = 6 swollen and > or = 6 tender joints, 25.0% had ESR > or = 28, and 45.9% had morning stiffness > or = 45 min. In Cohort E, on a 42 joint count, 63.4% of patients had > or = 6 swollen joints, 50.4% had > or = 6 tender joints, 38.8% had both > or = 6 swollen and > or = 6 tender joints, 49.3% had ESR > or = 28, and 50.9% had morning stiffness > or = 45 min. Overall, 15.3% of Cohort L and 34.1% of Cohort E patients had > or = 6 swollen and tender joints, as well as an ESR > or = 28 or morning stiffness > or = 45 min. Only 4.1% of Cohort L and no patient in Cohort E met ARA criteria for remission. CONCLUSION: The majority of patients seen in routine care in these 2 cohorts did not meet criteria for inclusion in most contemporary RA clinical trials, including clinical trials sponsored by pharmaceutical companies to introduce new drugs or biological agents. Few of these patients met ARA criteria for remission. Controlled trial data are not available concerning results of treatment with new biological agents or disease modifying antirheumatic drugs in a large proportion, if not a majority, of patients with RA at this time.

Adult↗