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T Pincus

Publications and source records attributed to T Pincus.

242 records · Page 14Linked to original sources
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The American College of Rheumatology (ACR) Core Data Set and derivative "patient only" indices to assess rheumatoid arthritis.

Pooled indices of several measures have been developed to assess and monitor patients with rheumatoid arthritis in clinical trials and clinical care, as no single measure can serve as a "gold standard" in all individual patients. Early indices of disease activity include the Steinbrocker "therapeutic scorecard in rheumatoid arthritis," the Lansbury Index, and Paulus criteria. The most widely used indices at this time are the American College of Rheumatology (ACR) Core Data Set and disease activity score (DAS). A simplified disease activity index (SDAI) and clinical disease activity index (CDAI) are derived from the DAS. The ACR Core Data Set includes 7 measures--swollen joint count, tender joint count, patient assessment of global status, an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)], health professional assessment of global status, physical function, and pain; the first four of these measures are included on the DAS. Improvement criteria for the ACR Core Data Set are based on improvement of at least 20% in both tender and swollen joint counts, and three of the five additional measures (ACR 20), and corresponding "ACR 50," and "ACR 70." A pooled index which includes only the three patient self-report questionnaire measures from the Core Data Set, physical function, pain, and patient assessment of global status performs as well as ACR 20 or DAS to discriminate between efficacy of active versus placebo treatment in a clinical trial.

Arthritis, Rheumatoid↗
PubMedDate not supplied

A 3-page standard protocol to evaluate rheumatoid arthritis (SPERA): efficient capture of essential data for clinical trials and observational studies.

An efficient 3-page format known as the "standard protocol to evaluate rheumatoid arthritis" (SPERA) has been developed to collect essential baseline clinical data in clinical trials and clinical research studies. The three pages address: 1) clinical features of rheumatoid arthritis (RA), 2) medications taken, and 3) a 42-joint count. Two additional documents, a patient questionnaire and a radiographic scoring sheet, are included for a comprehensive database. The 15-20 minutes needed to complete the SPERA generally adds efficiency over time in standard clinical care, and does not preclude the collection of additional information for clinical care and/or clinical research. The SPERA is presented not as the most desirable format, but rather as an example of a possible approach to the development of a consensus in the rheumatology community regarding a common format for the collection of core clinical data in RA.

Arthritis, Rheumatoid↗
PubMedDate not supplied

An Early Rheumatoid Arthritis Treatment Evaluation Registry (ERATER) in the United States.

An Early Rheumatoid Arthritis Treatment Evaluation Registry (ERATER) was established in 2001 to enroll patients with a disease duration of 3 years or less, in order to analyze treatment patterns in an era of biological therapies and to study the long-term outcomes of rheumatoid arthritis (RA). Patients were assessed at baseline according to a standard protocol to evaluate their rheumatoid arthritis (SPERA). Similar data from earlier cohorts with RA in the same community will allow for comparisons with treatments and outcomes from previous decades. This essay describes the background regarding the identification of the cohort, methods for data collection, and observations to date.

Antirheumatic Agents↗
PubMedDate not supplied

Complexities in defining remission in rheumatic diseases.

The rheumatology community has devoted increasing attention to the subject of remission over the past 2 decades, on the basis of greater appreciation of the long-term severity of inflammatory rheumatic diseases and availability of new therapies and approaches to improve outcomes. Nonetheless, description of remission in rheumatic diseases is complex, compared to many nonrheumatic diseases. Recognition of remission requires a set of measures or an index rather than a single "gold standard." Spontaneous remission is not infrequent in people with early inflammatory arthritis, including some who may meet criteria for rheumatoid arthritis (RA) over less than a few months, and may be confused with a drug-induced remission. Remission may be transient in many patients over short periods, and the length of time required to maintain remission status varies in different reports. Maintenance of a state of remission in autoimmune diseases that result from dysregulatory processes, rather than invasion of foreign cells or toxins, generally requires ongoing therapy indefinitely. Patients who have organ damage or functional disability may be described as "in remission," although they are free of disease activity only, but not necessarily free of disease consequences. A status of "low disease activity" or "near remission" with 70% to 90% of the features of an ideal remission may be adequate for many people with rheumatic diseases to avoid risks that may be required to reach 100% remission status. Thus, the subject of remission remains under active discussion in the rheumatology community.

Antirheumatic Agents↗
PubMedDate not supplied

A proposed approach to recognise "near-remission" quantitatively without formal joint counts or laboratory tests: a patient self-report questionnaire routine assessment of patient index data (RAPID) score as a guide to a "continuous quality improvement" s.

A proposed approach is presented to recognise a status of "near-remission" in a patient with rheumatoid arthritis (RA) on the basis of patient self-report questionnaire data without formal joint counts or laboratory tests. Indices of patient-reported outcome (PRO) measures distinguish active from control treatments in RA clinical trials at levels similar to American College of Rheumatology (ACR) or disease activity score (DAS) 28 improvement levels. PRO measures on a multidimensional health assessment questionnaire (MDHAQ) can be compiled into a routine assessment of patient index data (RAPID) score. RAPID 3 includes the three PRO measures from the ACR Core Data Set - physical function, pain, and global estimate. RAPID 4 adds a self-report joint count from a rheumatoid arthritis disease activity index (RADAI). RAPID 5 adds a physician estimate of global status. RAPID cores may be classified into four preliminary proposed categories, as "near-remission" (0-1), "low severity" (1.01-2), "moderate severity" (2.01-4), and "high severity" (> 4), analogous to the four categories of the DAS28 of "remission" (< 2.6), as well as "low" (2.6-3.19), "moderate" (3.2-5.1), and "high" (> 5.1) disease activity. RAPID scores are correlated significantly with DAS28 (rho = 0.64-0.67, p < 0.001), and about 75% of patients with DAS < 2.6 have RAPID scores < 2, while about 75% of patients with DAS > 5.1 have RAPID scores > 4. RAPID data are available on one side of one page, and are feasible to collect in standard clinical care. RAPID 3 scores may be calculated in about 10 seconds, and RAPID 4 and RAPID 5 scores in 20 to 30 seconds. RAPID scores every 3 months or more on simple flowsheets can be a basis for a "continuous quality improvement" strategy in standard clinical care to recognise a need for aggressive therapy, an inadequate response to a therapy, and "near- remission" status.

Activities of Daily Living↗
PubMedDate not supplied

Why randomized controlled clinical trials do not depict accurately long-term outcomes in rheumatoid arthritis: some explanations and suggestions for future studies.

The randomized controlled clinical trial is the "gold standard" to evaluate therapeutic interventions, but is more effectively applied to studies of the short-term treatment of acute diseases than to the long-term treatment of chronic diseases. Clinical observations often provide more accurate outcome data in rheumatoid arthritis (RA) than clinical trials. Limitations of clinical trials to depict long-term outcomes in RA include a relatively short observation period, patient selection resulting from exclusion criteria, inflexible dosage schedules and concomitant drug therapies, evidence that some markers of inflammatory activity are suboptimal surrogate indicators of long-term articular damage, the fact that statistically significant results are not necessarily clinically important, the influence of the design on the results-despite a control group, ignoring of individual variation in reporting results, the non-standardized interpretation of side effects which introduces bias, distortion of the "placebo effect", and lack of capacity to detect rare side effects. The clinical trial represents only an initial step in the evaluation of a therapy for a chronic disease. Awareness of these limitations should lead to the improved design of clinical trials and clinical studies to improve the long-term outcome for people with RA.

Antirheumatic Agents↗