Favorable Cardiovascular Health at Young and Middle Ages and Dementia in Older Age-The CHA Study.

Background Data are sparse on the association of cardiovascular health ( CVH ) in younger/middle age with the incidence of dementia later in life. Methods and Results We linked the CHA (Chicago Heart Association Detection Project in Industry) study data, assessed in 1967 to 1973, with 1991 to 2010 Medicare and National Death Index data. Favorable CVH was defined as untreated systolic blood pressure/diastolic blood pressure ≤120/≤80 mm Hg, untreated serum total cholesterol <5.

Varying the item format improved the range of measurement in patient-reported outcome measures assessing physical function.

Background: Physical function (PF) is a core patient-reported outcome domain in clinical trials in rheumatic diseases. Frequently used PF measures have ceiling effects, leading to large sample size requirements and low sensitivity to change. In most of these instruments, the response category that indicates the highest PF level is the statement that one is able to perform a given physical activity without any limitations or difficulty.

Validity of PROMIS physical function measured in diverse clinical samples.

Objectives: To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function measures using longitudinal data collected in six chronic health conditions.

Study Design And Setting: Individuals with rheumatoid arthritis (RA), major depressive disorder (MDD), back pain, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), and cancer completed the PROMIS Physical Function computerized adaptive test or fixed-length short form at baseline and at the end of clinically relevant follow-up intervals. Anchor items were also administered to assess change in physical function and general health.

PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions.

Objective: To present an overview of a series of studies in which the clinical validity of the National Institutes of Health's Patient Reported Outcome Measurement Information System (NIH; PROMIS) measures was evaluated, by domain, across six clinical populations.

Study Design And Setting: Approximately 1,500 individuals at baseline and 1,300 at follow-up completed PROMIS measures. The analyses reported in this issue were conducted post hoc, pooling data across six previous studies, and accommodating the different designs of the six, within-condition, parent studies.

Prednisone Use and Risk of Mortality in Patients With Rheumatoid Arthritis: Moderation by Use of Disease-Modifying Antirheumatic Drugs.

Objective: Medications for rheumatoid arthritis (RA) may affect survival. However, studies often include limited followup and do not account for selection bias in treatment allocation. Using a large longitudinal database, we examined the association between prednisone use and mortality in RA, and whether this risk was modified with concomitant disease-modifying antirheumatic drug (DMARD) use, after controlling for propensity for treatment with prednisone and individual DMARDs.

Do workplace health promotion (wellness) programs work?

Objective: To respond to the question, "Do workplace health promotion programs work?"

Methods: A compilation of the evidence on workplace programs' effectiveness coupled with recommendations for critical review of outcome studies. Also, reviewed are recent studies questioning the value of workplace programs.

Results: Evidence accumulated over the past three decades shows that well-designed and well-executed programs that are founded on evidence-based principles can achieve positive health and financial outcomes.

Extending the floor and the ceiling for assessment of physical function.

Objective: To improve the assessment of physical function by enhancing precision of physical function assessment as it pertains to subjects at extreme ends of the health continuum (i.e., subjects with extremely poor function ["floor"] or extremely good health ["ceiling"]).

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.

Item response theory, computerized adaptive testing, and PROMIS: assessment of physical function.

Objective: Patient-reported outcome (PRO) questionnaires record health information directly from research participants because observers may not accurately represent the patient perspective. Patient-reported Outcomes Measurement Information System (PROMIS) is a US National Institutes of Health cooperative group charged with bringing PRO to a new level of precision and standardization across diseases by item development and use of item response theory (IRT).

Methods: With IRT methods, improved items are calibrated on an underlying concept to form an item bank for a "domain" such as physical function (PF).

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.

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.

Upper-extremity and mobility subdomains from the Patient-Reported Outcomes Measurement Information System (PROMIS) adult physical functioning item bank.

Objective: To create upper-extremity and mobility subdomain scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning adult item bank.

Design: Expert reviews were used to identify upper-extremity and mobility items from the PROMIS item bank. Psychometric analyses were conducted to assess empirical support for scoring upper-extremity and mobility subdomains.

The theory and practice of active aging.

"Active aging" connotes a radically nontraditional paradigm of aging which posits possible improvement in health despite increasing longevity. The new paradigm is based upon postponing functional declines more than mortality declines and compressing morbidity into a shorter period later in life. This paradigm (Compression of Morbidity) contrasts with the old, where increasing longevity inevitably leads to increasing morbidity.

Propensity-adjusted association of methotrexate with overall survival in rheumatoid arthritis.

Objective: While medications used to treat rheumatoid arthritis (RA) may affect survival in RA, few studies take into account the propensity for medication use, which may reflect selection bias in treatment allocation in survival models. We undertook this study to examine the relationship between methotrexate (MTX) use and mortality in RA, after controlling for individual propensity scores for MTX use.

Methods: We studied 5,626 RA patients prospectively for 25 years to determine the risk of death associated with MTX use, modeled in time-varying Cox regression models.

Lifestyle risk factors predict disability and death in healthy aging adults.

Background: Associations between modifiable health risk factors during middle age with disability and mortality in later life are critical to maximizing longevity while preserving function. Positive health effects of maintenance of normal weight, routine exercise, and nonsmoking are known for the short and intermediate term. We studied the effects of these risk factors into advanced age.

Comparative risks of non-prescription analgesics: a structured topic review and research priorities.

Objective: The aims of this report are to quantify and compare competing risks associated with the use of non-prescription analgesics (daily doses of acetaminophen ≤ 4000 mg, aspirin ≤ 4000 mg, ibuprofen ≤ 1200 mg, naproxen ≤ 660 mg and ketoprofen ≤ 75 mg) and identify research needs.

Methods: Literature was searched and organized by medication, adverse effect and direction of effect. Causality was determined using structured consensus, using IOM and GRADE nomenclature.

Disability in rheumatoid arthritis in the era of biological treatments.

Objective: Rheumatoid arthritis (RA) is a disabling disease. The authors studied the impact of new, expensive and occasionally toxic biological treatments on disability outcomes in real-world populations of patients with RA.

Methods: The authors analysed Health Assessment Questionnaire Disability Index data on 4651 adult patients with RA collected prospectively from 1983 to 2006.

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

Introduction: The 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.

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.

Patient perspective: choosing or developing instruments.

Previous Outcome Measures in Rheumatology (OMERACT) meetings recognized that patients view outcomes of intervention from a different perspective. This preconference position paper briefly sets out 2 patient-reported outcome (PRO) instrument approaches, the PROMISE computer adaptive testing (CAT) system and development of a rheumatoid arthritis-specific questionnaire to measure fatigue; a tentative proposal for a PRO instrument development pathway is also made.

Patient perspective workshop: moving towards OMERACT guidelines for choosing or developing instruments to measure patient-reported outcomes.

The workshop Choosing or Developing Instruments held at the Outcome Measures in Rheumatology (OMERACT) 10 meeting was designed to help participants think about the underlying methods of instrument development. Conference pre-reading material and 3 brief introductory presentations elaborated the issues, and participants broke into discussion groups before reconvening to share insights, engage in a more general discussion of the issues, and vote on recommendations. Tradeoffs between using current imperfect measures and the long and complex process of developing new instruments were considered, together with the need for rigor in patient-reported outcome (PRO) instrument development.

The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008.

Objectives: Patient-reported outcomes (PROs) are essential when evaluating many new treatments in health care; yet, current measures have been limited by a lack of precision, standardization, and comparability of scores across studies and diseases. The Patient-Reported Outcomes Measurement Information System (PROMIS) provides item banks that offer the potential for efficient (minimizes item number without compromising reliability), flexible (enables optional use of interchangeable items), and precise (has minimal error in estimate) measurement of commonly studied PROs. We report results from the first large-scale testing of PROMIS items.

Better assessment of physical function: item improvement is neglected but essential.

Introduction: Physical function is a key component of patient-reported outcome (PRO) assessment in rheumatology. Modern psychometric methods, such as Item Response Theory (IRT) and Computerized Adaptive Testing, can materially improve measurement precision at the item level. We present the qualitative and quantitative item-evaluation process for developing the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function item bank.

A first step to assess harm and benefit in clinical trials in one scale.

Objective: To develop a simple system to assess benefit and harm of treatment on a single scale. Harm and benefit signals from trials need to be placed in the proper perspective to decide on the value of a treatment. Several systems have been developed for assessment, but few attempt to incorporate both benefit and risk in the same metric while retaining enough simplicity to aid patients and clinicians in their decision making.