Bonnie Bruce

The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years.

Background:The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative (www.nihpromis.org) is a 5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes (PROs) relevant across common medical conditions. In this article, we will summarize the organization and scientific activity of the PROMIS network during its first 2 years. Design:The network consists of 6 primary research sites (PRSs), a statistical coordinating center (SCC), and NIH research scientists. Governed by a steering committee, the network is organized into functional subcommittees and working groups. In the first year, we created an item library and activated 3 interacting protocols: Domain Mapping, Archival Data Analysis, and Qualitative Item Review (QIR). In the second year, we developed and initiated testing of item banks covering 5 broad domains of self-reported health. Results:The domain mapping process is built on the World Health Organization (WHO) framework of physical, mental, and social health. From this framework, pain, fatigue, emotional distress, physical functioning, social role participation, and global health perceptions were selected for the first wave of testing. Item response theory (IRT)-based analysis of 11 large datasets supplemented and informed item-level qualitative review of nearly 7000 items from available PRO measures in the item library. Items were selected for rewriting or creation with further detailed review before the first round of testing in the general population and target patient populations. Conclusions:The NIH PROMIS network derived a consensus-based framework for self-reported health, systematically reviewed available instruments and datasets that address the initial PROMIS domains. Qualitative item research led to the first wave of network testing which began in the second year.

The Stanford Health Assessment Questionnaire: Dimensions and Practical Applications

The ability to effectively measure health-related quality-of-life longitudinally is central to describing the impacts of disease, treatment, or other insults, including normal aging, upon the patient. Over the last two decades, assessment of patient health status has undergone a dramatic paradigm shift, evolving from a predominant reliance on biochemical and physical measurements, such as erythrocyte sedimentation rate, lipid profiles, or radiographs, to an emphasis upon health outcomes based on the patients personal appreciation of their illness. The Health Assessment Questionnaire (HAQ), published in 1980, was among the first instruments based on generic, patient-centered dimensions. The HAQ was designed to represent a model of patient-oriented outcome assessment and has played a major role in many diverse areas such as prediction of successful aging, inversion of the therapeutic pyramid in rheumatoid arthritis (RA), quantification of NSAID gastropathy, development of risk factor models for osteoarthrosis, and examination of mortality risks in RA.Evidenced by its use over the past two decades in diverse settings, the HAQ has established itself as a valuable, effective, and sensitive tool for measurement of health status. It is available in more than 60 languages and is supported by a bibliography of more than 500 references. It has increased the credibility and use of validated self-report measurement techniques as a quantifiable set of hard data endpoints and has contributed to a new appreciation of outcome assessment. In this article, information regarding the HAQs development, content, dissemination and reference sources for its uses, translations, and validations are provided.

Binge eating in females: A population-based investigation†

Four hundred fifty-five females from a community-bgased, randomly sampled population were interviewed by telephone to estimate the prevalence of binge eating and to describe demographic and topographical characteristics of binge eating behaviour. Binge eaters were classified according to the DSM-111-R criteria for bulimia, excluding purging behavior. The estimate for subjects meeting criteria was 1.8%, while the percentage of females who met all but frequency criteria was estimated at 3.8%. The majority of binge eaters in this study was found to engage in behaviors typically associated with binge eating episodes. On average, this group of binge eaters was older and heavier than has been reported previously, which supported observed associations between binge eating and overweight in clinical populations [Telch, Agras, & Rossiter (1988). International Journal of Eating Disorders, 7, 115-119].

Nuts and plasma lipids : An almond-based diet lowers LDL-C while preserving HDL-C

OBJECTIVE To compare lipid-altering effects of an almond-based diet with an olive oil-based diet, against a cheese and butter-based control diet. METHODS Forty-five free-living hyperlipidemic men (n = 12) and women (n = 33) with a mean plasma total cholesterol (TC) of 251 +/- 30 mg/dL followed one of three diets; almond-based, olive oil-based, or dairy-based for 4 weeks. Total fat in each diet was matched, and the study-provided sources of fat comprised the major portion of fat intake. RESULTS Reductions in TC and low-density lipoprotein-cholesterol (LDL-C) between the three groups were significantly different from the almond group (both p < 0.001). Within group analysis revealed that the almond-based diet induced significant reductions in TC (p < 0.05), LDL-C (p < 0.001), and the TC:HDL ratio (p < 0.001), while HDL-C levels were preserved. TC and HDL-C in the control diet were significantly increased from baseline (both p < 0.05), while the olive oil-based diet resulted in no significant changes over the study period. Weight did not change significantly. CONCLUSION Results suggest that the more favorable lipid-altering effects induced by the almond group may be due to interactive or additive effects of the numerous bioactive constituents found in almonds.

Progress in Assessing Physical Function in Arthritis: PROMIS Short Forms and Computerized Adaptive Testing

Objective. Assessing self-reported physical function/disability with the Health Assessment Questionnaire Disability Index (HAQ) and other instruments has become central in arthritis research. Item response theory (IRT) and computerized adaptive testing (CAT) techniques can increase reliability and statistical power. IRT-based instruments can improve measurement precision substantially over a wider range of disease severity. These modern methods were applied and the magnitude of improvement was estimated. Methods. A 199-item physical function/disability item bank was developed by distilling 1865 items to 124, including Legacy Health Assessment Questionnaire (HAQ) and Physical Function-10 items, and improving precision through qualitative and quantitative evaluation in over 21,000 subjects, which included about 1500 patients with rheumatoid arthritis and osteoarthritis. Four new instruments, (A) Patient-Reported Outcomes Measurement Information (PROMIS) HAQ, which evolved from the original (Legacy) HAQ; (B) “best” PROMIS 10; (C) 20-item static (short) forms; and (D) simulated PROMIS CAT, which sequentially selected the most informative item, were compared with the HAQ. Results. Online and mailed administration modes yielded similar item and domain scores. The HAQ and PROMIS HAQ 20-item scales yielded greater information content versus other scales in patients with more severe disease. The “best” PROMIS 20-item scale outperformed the other 20-item static forms over a broad range of 4 standard deviations. The 10-item simulated PROMIS CAT outperformed all other forms. Conclusion. Improved items and instruments yielded better information. The PROMIS HAQ is currently available and considered validated. The new PROMIS short forms, after validation, are likely to represent further improvement. CAT-based physical function/disability assessment offers superior performance over static forms of equal length.

Compression of morbidity 1980-2011: a focused review of paradigms and progress.

The Compression of Morbidity hypothesis—positing that the age of onset of chronic illness may be postponed more than the age at death and squeezing most of the morbidity in life into a shorter period with less lifetime disability—was introduced by our group in 1980. This paper is focused upon the evolution of the concept, the controversies and responses, the supportive multidisciplinary science, and the evolving lines of evidence that establish proof of concept. We summarize data from 20-year prospective longitudinal studies of lifestyle progression of disability, national population studies of trends in disability, and randomized controlled trials of risk factor reduction with life-style-based “healthy aging” interventions. From the perspective of this influential and broadly cited paradigm, we review its current history, the development of a theoretical structure for healthy aging, and the challenges to develop coherent health policies directed at reduction in morbidity.

The Stanford Nutrition Action Program: a dietary fat intervention for low-literacy adults.

OBJECTIVES This study was undertaken to test the effectiveness of the Stanford Nutrition Action Program, an experimental trial to reduce dietary fat intake among low-literacy, low-income adults. METHODS Twenty-four paired adult education classes (351 participants, 85% women, mean age = 31 years) were randomly assigned to receive a newly developed dietary fat curriculum (the Stanford Nutrition Action Program) or an existing general nutrition curriculum. Food frequency and nutrition-related data, body mass index, and capillary blood cholesterol were collected at baseline and at two postintervention follow-ups. RESULTS The Stanford Nutrition Action Program classes showed significantly greater net improvements in nutrition knowledge (+7.7), attitudes (/0.2), and self-efficacy (-0.2) than the general nutrition classes; they also showed significantly greater reductions in the percentage of calories from total (-2.3%) and saturated (-0.9%) fat. There were no significant differences in body mass index or blood cholesterol. All positive intervention effects were maintained for 3 months postintervention. CONCLUSIONS The Stanford Nutrition Action Program curriculum, tailored to the cultural, economic, and learning needs of low-literacy, low-income adults, was significantly more effective in achieving fat-related nutritional changes than the general nutrition curriculum.

The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency.

OBJECTIVE To document the development and psychometric evaluation of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) item bank and static instruments. STUDY DESIGN AND SETTING The items were evaluated using qualitative and quantitative methods. A total of 16,065 adults answered item subsets (n>2,200/item) on the Internet, with oversampling of the chronically ill. Classical test and item response theory methods were used to evaluate 149 PROMIS PF items plus 10 Short Form-36 and 20 Health Assessment Questionnaire-Disability Index items. A graded response model was used to estimate item parameters, which were normed to a mean of 50 (standard deviation [SD]=10) in a US general population sample. RESULTS The final bank consists of 124 PROMIS items covering upper, central, and lower extremity functions and instrumental activities of daily living. In simulations, a 10-item computerized adaptive test (CAT) eliminated floor and decreased ceiling effects, achieving higher measurement precision than any comparable length static tool across four SDs of the measurement range. Improved psychometric properties were transferred to the CATs superior ability to identify differences between age and disease groups. CONCLUSION The item bank provides a common metric and can improve the measurement of PF by facilitating the standardization of patient-reported outcome measures and implementation of CATs for more efficient PF assessments over a larger range.

A Diet High in Whole and Unrefined Foods Favorably Alters Lipids, Antioxidant Defenses, and Colon Function

Objective: Diets rich in whole and unrefined foods, like whole grains, dark green and yellow/orange-fleshed vegetables and fruits, legumes, nuts and seeds, contain high concentrations of antioxidant phenolics, fibers and numerous other phytochemicals that may be protective against chronic diseases. This study compared the effects of a phytochemical-rich diet versus a refined-food diet on lipoproteins, antioxidant defenses and colon function. Methods: Twelve hyperlipidemic women followed two diets for four weeks starting with a refined-food diet. Subjects then directly crossed over to the phytochemical-rich diet. Duplicate, fasting serum lipids and single, fasting antioxidant enzymes were measured at the end of the four-week refined-food diet period (baseline) and again at the end of the phytochemical-rich diet period. Results: Total energy and total fat intake were similar during both diet periods, but there was a decrease in saturated fat (SFA) of 61% in the phytochemical-rich diet group. Dietary fiber, vitamin E, vitamin C and carotene intakes were 160%, 145%, 160% and 500% more, respectively, than during the refined-food diet period. The phytochemical-rich diet induced a drop of 13% in total cholesterol (TC) (p < 0.05) and 16% (p < 0.001) in low density lipoprotein-cholesterol (LDL-C). Erythrocyte superoxide dismutase decreased 69% (p < 0.01) and glutathione peroxidase dropped 35% (p < 0.01). Colon function was improved on the phytochemical-rich diet Conclusions: A diet abundant in phytochemically-rich foods beneficially affected lipoproteins, decreased need for oxidative defense mechanisms and improved colon function

Improved responsiveness and reduced sample size requirements of PROMIS physical function scales with item response theory

IntroductionThe Health Assessment Questionnaire Disability Index (HAQ) and the SF-36 PF-10, among other instruments, yield sensitive and valid Disability (Physical Function) endpoints. Modern techniques, such as Item Response Theory (IRT), now enable development of more precise instruments using improved items. The NIH Patient Reported Outcomes Measurement Information System (PROMIS) is charged with developing improved IRT-based tools. We compared the ability to detect change in physical function using original (Legacy) instruments with Item-Improved and PROMIS IRT-based instruments.MethodsWe studied two Legacy (original) Physical Function/Disability instruments (HAQ, PF-10), their item-improved derivatives (Item-Improved HAQ and PF-10), and the IRT-based PROMIS Physical Function 10- (PROMIS PF 10) and 20-item (PROMIS PF 20) instruments. We compared sensitivity to detect 12-month changes in physical function in 451 rheumatoid arthritis (RA) patients and assessed relative responsiveness using P-values, effect sizes (ES), and sample size requirements.ResultsThe study sample was 81% female, 87% Caucasian, 65 years of age, had 14 years of education, and had moderate baseline disability. All instruments were sensitive to detecting change (< 0.05) in physical function over one year. The most responsive instruments in these patients were the Item-Improved HAQ and the PROMIS PF 20. IRT-improved instruments could detect a 1.2% difference with 80% power, while reference instruments could detect only a 2.3% difference (P < 0.01). The best IRT-based instruments required only one-quarter of the sample sizes of the Legacy (PF-10) comparator (95 versus 427). The HAQ outperformed the PF-10 in more impaired populations; the reverse was true in more normal populations. Considering especially the range of severity measured, the PROMIS PF 20 appears the most responsive instrument.ConclusionsPhysical Function scales using item improved or IRT-based items can result in greater responsiveness and precision across a broader range of physical function. This can reduce sample size requirements and thus study costs.