Marc L. Berger

Patients with prior fractures have an increased risk of future fractures : A summary of the literature and statistical synthesis

Numerous studies have reported increased risks of hip, spine, and other fractures among people who had previous clinically diagnosed fractures, or who have radiographic evidence of vertebral fractures. However, there is some variability in the magnitudes of associations among studies. We summarized the literature and performed a statistical synthesis of the risk of future fracture, given a history of prior fracture. The strongest associations were observed between prior and subsequent vertebral fractures; women with preexisting vertebral fractures (identified at baseline by vertebral morphometry) had approximately 4 times greater risk of subsequent vertebral fractures than those without prior fractures. This risk increases with the number of prior vertebral fractures. Most studies reported relative risks of approximately 2 for other combinations of prior and future fracture sites (hip, spine, wrist, or any site). The confidence profile method was used to derive a single pooled estimate from the studies that provided sufficient data for other combinations of prior and subsequent fracture sites. Studies of peri‐ and postmenopausal women with prior fractures had 2.0 (95% CI = 1.8, 2.1) times the risk of subsequent fracture compared with women without prior fractures. For other studies (including men and women of all ages), the risk was increased by 2.2 (1.9, 2.6) times. We conclude that history of prior fracture at any site is an important risk factor for future fractures. Patients with a history of prior fracture, therefore, should receive further evaluation for osteoporosis and fracture risk

Osteoporosis and fracture risk in women of different ethnic groups.

Osteoporosis and 1‐year fracture risk were studied in 197,848 postmenopausal American women from five ethnic groups. Weight explained differences in BMD, except among blacks, who had the highest BMD. One SD decrease in BMD predicted a 50% increased fracture risk in each group. Despite similar relative risks, absolute fracture rates differed.

The assessment of chronic health conditions on work performance, absence, and total economic impact for employers.

Objective: The objective of this study was to determine the prevalence and estimate total costs for chronic health conditions in the U.S. workforce for the Dow Chemical Company (Dow). Methods: Using the Stanford Presenteeism Scale, information was collected from workers at five locations on work impairment and absenteeism based on self-reported “primary” chronic health conditions. Survey data were merged with employee demographics, medical and pharmaceutical claims, smoking status, biometric health risk factors, payroll records, and job type. Results: Almost 65% of respondents reported having one or more of the surveyed chronic conditions. The most common were allergies, arthritis/joint pain or stiffness, and back or neck disorders. The associated absenteeism by chronic condition ranged from 0.9 to 5.9 hours in a 4-week period, and on-the-job work impairment ranged from a 17.8% to 36.4% decrement in ability to function at work. The presence of a chronic condition was the most important determinant of the reported levels of work impairment and absence after adjusting for other factors (P < 0.000). The total cost of chronic conditions was estimated to be 10.7% of the total labor costs for Dow in the United States; 6.8% was attributable to work impairment alone. Conclusion: For all chronic conditions studied, the cost associated with performance based work loss or “presenteeism” greatly exceeded the combined costs of absenteeism and medical treatment combined.

Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: the ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report--Part I.

OBJECTIVES Health insurers, physicians, and patients worldwide need information on the comparative effectiveness and safety of prescription drugs in routine care. Nonrandomized studies of treatment effects using secondary databases may supplement the evidence based from randomized clinical trials and prospective observational studies. Recognizing the challenges to conducting valid retrospective epidemiologic and health services research studies, a Task Force was formed to develop a guidance document on state of the art approaches to frame research questions and report findings for these studies. METHODS The Task Force was commissioned and a Chair was selected by the International Society for Pharmacoeconomics and Outcomes Research Board of Directors in October 2007. This Report, the first of three reported in this issue of the journal, addressed issues of framing the research question and reporting and interpreting findings. RESULTS The Task Force Report proposes four primary characteristics-relevance, specificity, novelty, and feasibility while defining the research question. Recommendations included: the practice of a priori specification of the research question; transparency of prespecified analytical plans, provision of justifications for any subsequent changes in analytical plan, and reporting the results of prespecified plans as well as results from significant modifications, structured abstracts to report findings with scientific neutrality; and reasoned interpretations of findings to help inform policy decisions. CONCLUSIONS Comparative effectiveness research in the form of nonrandomized studies using secondary databases can be designed with rigorous elements and conducted with sophisticated statistical methods to improve causal inference of treatment effects. Standardized reporting and careful interpretation of results can aid policy and decision-making.

The effect of age and bone mineral density on the absolute, excess, and relative risk of fracture in postmenopausal women aged 50–99: results from the National Osteoporosis Risk Assessment (NORA)

IntroductionThis study evaluates the effect of age and bone mineral density (BMD) on the absolute, excess, and relative risk for osteoporotic fractures at the hip, wrist, forearm, spine, and rib within 3 years of peripheral BMD testing in postmenopausal women over a wide range of postmenopausal ages.MethodsData were obtained from 170,083 women, aged 50–99 years, enrolled in the National Osteoporosis Risk Assessment (NORA) following recruitment from their primary care physicians’ offices across the United States. Risk factors for fracture and peripheral BMD T-scores at the heel, forearm, or finger were obtained at baseline. Self-reported new fractures at the hip, spine, rib, wrist, and forearm were obtained from questionnaires at 1- and 3-year follow-ups. Absolute, excess (attributable to low BMD), and unadjusted and adjusted relative risks of fracture were calculated.ResultsAt follow-up, 5312 women reported 5676 fractures (868 hip, 2420 wrist/forearm, 1531 rib, and 857 spine). Absolute risk of fracture increased with age for all fracture sites. This age-effect was most evident for hip fracture – both the incidence and the excess risk of hip fracture for women with low BMD increased at least twofold for each decade increase in age. The relative risk for any fracture per 1 SD decrease in BMD was similar across age groups (p>0.07). Women with low BMD (T-score <−1.0) had a similar relative risk for fracture regardless of age.ConclusionsAt any given BMD, not only the absolute fracture risk but also the excess fracture risk increased with advancing age. Relative risk of fracture for low bone mass was consistent across all age groups from 50 to 99 years.

Why Observational Studies Should Be Among The Tools Used In Comparative Effectiveness Research

Doctors, patients, and other decision makers need access to the best available clinical evidence, which can come from systematic reviews, experimental trials, and observational research. Despite methodological challenges, high-quality observational studies have an important role in comparative effectiveness research because they can address issues that are otherwise difficult or impossible to study. In addition, many clinical and policy decisions do not require the very high levels of certainty provided by large, rigorous randomized trials. This paper provides insights and a framework to guide good decision making that involves the full range of high-quality comparative effectiveness research techniques, including observational research.

Alternative valuations of work loss and productivity.

In this article, we examine the indirect costs (ie, work loss and productivity costs) of employee illness from the employer’s perspective. We provide a conceptual framework to help employers consider alternative views with regard to assessing indirect costs and valuing the health care they purchase. First, we discuss the matter of perspective and how an employer should view and assess indirect costs. We briefly review current models of measuring indirect costs, and we critique these models. Then we introduce a simple, conceptual framework based on the ideas of health capital and labor productivity, and we lay out the effects of health investment on indirect costs while considering what employees desire and employers can provide. Finally, we offer an agenda for further research.

Reliability and validity of the Stanford Presenteeism Scale.

Objective: This study reports the reliability and validity of the 13-item Stanford Presenteeism Scale (SPS). The SPS differs from similar scales by focusing on knowledge-based and production-based workers. Methods: Data were obtained from administrative and medical claims databases and from a survey that incorporated the SPS, SF-36, and the Work Limitations Questionnaire. Results: Sixty-three percent (7797) of employees responded. Cronbachs alpha (0.83) indicates adequate reliability. Factor analysis identified two underlying factors, “completing work” and “avoiding distraction.” Knowledge-based workers load on “completing work” (&agr; = 0.97), whereas production-based workers load on “avoiding distraction” (&agr; = 0.98). There were significant and positive relationships between the SPS, SF-36, and Work Limitations Questionnaire. Conclusions: The SPS demonstrates a high degree of reliability and validity and may be ideal for employers who seek a single scale to measure health-related productivity in a diverse employee population.

Investing in healthy human capital

Although the value of human capital is not captured on company balance sheets, it may account for about half of the gap between a company’s market value and book value. Yet, many companies do not focus comparable scrutiny on human capital management as compared with other large assets, nor do they systematically measure its output (ie, productivity). Methods are emerging to enable employers to assess productivity losses, including absenteeism and presenteeism, and to understand the associated costs (ie, direct medical costs, total productivity loss). This will permit employers to assess the value of programs to enhance health and productivity. We contend that the effective workforce is probably decreased by 5% to 10% because of health problems. We believe that employers who increase their investments in healthy human capital now will emerge tomorrow as the companies leading the gains in US productivity.

Recency and duration of postmenopausal hormone therapy : effects on bone mineral density and fracture risk in the National Osteoporosis Risk Assessment (NORA) study

ObjectivesResults from the Womens Health Initiative showed that postmenopausal hormone replacement therapy (HRT) prevents fractures but has an overall unfavorable risk:benefit ratio, leading to the recommendation that HRT be used only for women with troublesome menopause symptoms, and for as short a time as possible. This recommendation has important implications for the timing and duration of HRT and the prevention of osteoporosis. The large number of women participating in the National Osteoporosis Risk Assessment (NORA) program provided the opportunity to evaluate bone mineral density (BMD) and 1-year fracture risk in analyses stratified by duration and recency of HRT. DesignParticipants were 170,852 postmenopausal women aged 50 to 104, without known osteoporosis, who were recruited from primary physicians offices across the US. BMD was measured at one of four peripheral sites, and the 1-year risk of osteoporotic fracture was assessed by questionnaire. ResultsAt baseline, current HRT users had the highest T-scores at every age. Among current hormone users, women who had used HRT longest had the highest BMD levels. Women who had stopped HRT more than 5 years previously, regardless of duration of use, had T-scores similar to never-users. Current but not past hormone use at baseline was associated with a 25% to 29% lower risk of osteoporotic fracture (P < 0.0001) in 1 year, compared with nonusers. These findings were independent of age, ethnicity, body mass index, lifestyle, years postmenopausal, and site of BMD measurement. ConclusionsWe conclude that postmenopausal BMD and fracture are closely associated with current, but not prior, HRT use. Use of HRT for 5 years or less, as proposed for treatment of symptomatic women during menopause transition, is unlikely to preserve bone or significantly reduce fracture risk in later years.