Showing papers by "James F. Fries published in 2015"

Validation of the PROMIS physical function measures in a diverse US population-based cohort of cancer patients

Abstract: To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function measures in a diverse, population-based cancer sample. Cancer patients 6–13 months post-diagnosis (n = 4840) were recruited for the Measuring Your Health study. Participants were diagnosed between 2010 and 2013 with non-Hodgkin lymphoma or cancers of the colorectum, lung, breast, uterus, cervix, or prostate. Four PROMIS physical function short forms (4a, 6b, 10a, and 16) were evaluated for validity and reliability across age and race–ethnicity groups. Covariates included gender, marital status, education level, cancer site and stage, comorbidities, and functional status. PROMIS physical function short forms showed high internal consistency (Cronbach’s α = 0.92–0.96), convergent validity (fatigue, pain interference, FACT physical well-being all r ≥ 0.68), and discriminant validity (unrelated domains all r ≤ 0.3) across survey short forms, age, and race–ethnicity. Known-group differences by demographic, clinical, and functional characteristics performed as hypothesized. Ceiling effects for higher-functioning individuals were identified on most forms. This study provides strong evidence that PROMIS physical function measures are valid and reliable in multiple race–ethnicity and age groups. Researchers selecting specific PROMIS short forms should consider the degree of functional disability in their patient population to ensure that length and content are tailored to limit response burden.

Responsiveness and minimally important difference for the patient-reported outcomes measurement information system (PROMIS) 20-item physical functioning short form in a prospective observational study of rheumatoid arthritis.

Abstract: Objective To estimate responsiveness (sensitivity to change) and minimally important difference (MID) for the Patient-Reported Outcomes Measurement Information System (PROMIS) 20-item physical functioning scale (PROMIS PF-20). Methods The PROMIS PF-20, short form 36 (SF-36) physical functioning scale, and Health Assessment Questionnaire (HAQ) were administered at baseline, and 6 and 12 months later to a sample of 451 persons with rheumatoid arthritis. A retrospective change (anchor) item was administered at the 12-month follow-up. We estimated responsiveness between 12 months and baseline, and between 12 months and 6 months using one-way analysis of variance F-statistics. We estimated the MID for the PROMIS PF-20 using prospective change for people reporting getting ‘a little better’ or ‘a little worse’ on the anchor item. Results F-statistics for prospective change on the PROMIS PF-20, SF-36 and HAQ by the anchor item over 12 and 6 months (in parentheses) were 16.64 (14.98), 12.20 (7.92) and 10.36 (12.90), respectively. The MID for the PROMIS PF-20 was 2 points (about 0.20 of an SD). Conclusions The PROMIS PF-20 is more responsive than two widely used (‘legacy’) measures. The MID is a small effect size. The measure can be useful for assessing physical functioning in clinical trials and observational studies.

Establishing a Common Metric for Physical Function: Linking the HAQ-DI and SF-36 PF Subscale to PROMIS ® Physical Function

Abstract: BACKGROUND Physical function (PF) is a common health concept measured in clinical trials and clinical care. It is measured with different instruments that are not directly comparable, making comparative effectiveness research (CER) challenging when PF is the outcome of interest.

Perspectives From Masters in Rheumatology and Autoimmunity: Perspectives on the Conventional Wisdom

Abstract: The term “perspectives” suggests thoughtful opinions accumulated over some period of time and from a great height. “Perspectives” are linked opinions. There will always be omissions by accident and embellishments from distant memories. The perspective is always better from 35,000 feet and is best painted with a broad brush. The “conventional wisdom” is another useful term, one which reminds us that today’s wisdom will be tomorrow’s ignorance and that “truth” in science and medicine often has an expiration date. “Thinking outside the box” means thinking beyond the conventional wisdom. Challenging the conventional wisdom can be quite challenging. When I entered rheumatology, the conventional wisdom held that rheumatoid arthritis (RA) was best treated according to a pyramid strategy designed to “first, do no harm,” with rest and aspirin at the pyramid base. Unfortunately, the pyramid mandated that the most effective treatments would reach few patients and that research into more effective treatments reserved for the top was discouraged. This period ended with “inversion of the pyramid,” and thus began the flowering of rheumatology. Another conventional wisdom of the time held that activity aggravated inflammation and that complete bed rest should be the basic treatment for RA. Of the available treatments, nonsteroidal antiinflammatory drugs (NSAIDs) were preferred because they were safer, until it became known that they often caused gastrointestinal (GI) problems, heart attacks, strokes, and deaths in large numbers— many more than were caused by disease-modifying antirheumatic drugs (DMARDs). Exercise, as conventionally viewed, was bad for arthritis because it put stress on the joints. Now, it is good for the joints and essential for health. Where did all this mistaken conventional “wisdom” come from? What were people thinking? How were these opinions identified as false and diverting? Are replacements for the mistaken conventional wisdom still around? How can we recognize them? Such heretical musings have occupied much of my professional life and have shaped my perspectives. The perspectives elaborated below involve drawing valid conclusions from soft data, and our group was involved in the study of each of these issues (Table 1). In one, a patient with a uniformly and rapidly fatal syndrome was treated based on pathophysiologic reasoning (1,2). The patient recovered and lived normally for the next 2 decades, as do most with this syndrome who came after him. No animal models and only an “n of 1” trial. Just connecting the dots. A second perspective argues for patient-reported outcomes to standardize outcome metrics and to set more relevant outcome targets, measuring morbidity outcomes to emphasize the longitudinal assessment of chronic illness (3). A third perspective emphasizes surveillance of the harms that drugs sometimes do and is presented against the perspective that the Food and Drug Administration (FDA) and industry have long since ensured the public safety (4). The fourth perspective focuses on the need for longitudinal data on human morbidity as well as mortality (5). The final perspective argues that the way to postpone human aging is to reduce behavioral health risks and that this postponement is best begun decades before the observable clinical events (6,7). Overall, these perspectives challenge the conventional wisdom.

Abstract 18634: Favorable Cardiovascular Health and the Compression of Morbidity: Findings From the Chicago Heart Detection Project in Industry Study

Abstract: Introduction: We sought to determine the association of CV health at younger ages with the proportion of life lived free of morbidity, the cumulative burden of morbidity, and average healthcare cos...