Systematic Evidence Review

[Pages:98]This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

AHRQ is the lead Federal agency charged with supporting research designed to improve the quality of health care, reduce its cost, address patient safety and medical errors, and broaden access to essential services. AHRQ sponsors and conducts research that provides evidence-based information on health care outcomes; quality; and cost, use, and access. The information helps health care decisionmakers-- patients and clinicians, health system leaders, and policymakers--make more informed decisions and improve the quality of health care services.

Systematic Evidence Review

Number 17

Screening for Postmenopausal Osteoporosis

Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 2101 East Jefferson Street Rockville, MD 20852

Contract No. 290-97-0018 Task Order No. 2 Technical Support of the U.S. Preventive Services Task Force

Prepared by: Oregon Health Sciences University Evidence-based Practice Center, Portland, Oregon

Heidi D. Nelson, MD, MPH Mark Helfand, MD, MS

September 2002

Preface

The Agency for Healthcare Research and Quality (AHRQ) sponsors the development of Systematic Evidence Reviews (SERs) through its Evidence-based Practice Program. With guidance from the third U.S. Preventive Services Task Force (USPSTF) and input from Federal partners and primary care specialty societies, two Evidence-based Practice Centers--one at the Oregon Health Sciences University and the other at Research Triangle Institute-University of North Carolina--systematically review the evidence of the effectiveness of a wide range of clinical preventive services, including screening, counseling, immunizations, and chemoprevention, in the primary care setting. The SERs--comprehensive reviews of the scientific evidence on the effectiveness of particular clinical preventive services--serve as the foundation for the recommendations of the third USPSTF, which provide age- and risk-factorspecific recommendations for the delivery of these services in the primary care setting. Details of the process of identifying and evaluating relevant scientific evidence are described in the "Methods" section of each SER.

The SERs document the evidence regarding the benefits, limitations, and cost-effectiveness of a broad range of clinical preventive services and will help to further awareness, delivery, and coverage of preventive care as an integral part of quality primary health care.

AHRQ also disseminates the SERs on the AHRQ Web site () and disseminates summaries of the evidence (summaries of the SERs) and recommendations of the third USPSTF in print and on the Web. These are available through the AHRQ Web site (), through the National Guideline Clearinghouse (), and in print through the AHRQ Publications Clearinghouse (1-800-358-9295).

We welcome written comments on this SER. Comments may be sent to: Director, Center for Practice and Technology Assessment, Agency for Healthcare Research and Quality, 6010 Executive Blvd., Suite 300, Rockville, MD 20852.

Carolyn M. Clancy, M.D. Acting Director Agency for Healthcare Research and Quality

Robert Graham, M.D. Director, Center for Practice and

Technology Assessment Agency for Healthcare Research and Quality

The USPSTF is an independent panel of experts in primary care and prevention first convened by the U.S. Public Health Service in 1984. The USPSTF systematically reviews the evidence on the effectiveness of providing clinical preventive services--including screening, counseling, immunization, and chemoprevention--in the primary care setting. AHRQ convened the third USPSTF in November 1998 to update existing Task Force recommendations and to address new topics.

iii

The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service.

iv

Structured Abstract

Context: The incidence of osteoporotic fractures increases with age and is associated with a significant health burden. Objective: To examine evidence on the benefits and harms of screening asymptomatic postmenopausal women for osteoporosis. Data Sources: MEDLINE (1966 to May 2001), HealthSTAR (1975 to May 2001), and Cochrane databases, reference lists of systematic reviews, and experts. Study Selection: We included English-language abstracts with original data about postmenopausal women and osteoporosis that addressed the effectiveness of risk factor assessment, bone measurement tests, or treatment. Two reviewers read each abstract to determine its eligibility. Data Extraction: We extracted selected information about the patient population, interventions, clinical endpoints, and study design, and applied a set of criteria to evaluate study quality. Data Synthesis: Although many studies have been published about osteoporosis in postmenopausal women, there have been no trials of screening and, therefore, no direct evidence that screening improves outcomes. Instruments developed to assess clinical risk factors for low bone density or fractures generally have moderate-to-high sensitivity and low specificity, many have not been validated, and none have been widely tested in a practice setting. Among different bone density tests measured at various sites, bone density measured at the femoral neck by dual-energy x-ray absorptiometry is the best predictor of hip fracture and is comparable to forearm measurements for predicting fractures at other sites. Women with low bone density have a 40% to 50% reduction in fracture risk when treated with raloxifene (vertebral fractures) or bisphosphonates (both vertebral and nonvertebral fractures). Trials of estrogen are inconclusive because of methodologic limitations. Conclusions: Although there is no direct evidence that screening prevents fractures, there is evidence that the prevalences of osteoporosis and fractures increase with age, that the short-term risk of fracture can be estimated by bone measurement tests and risk factor

v

assessment, and that treatment may reduce fracture risk among women with low bone density.

vi

Contents

Systematic Evidence Review

Chapter 1. Introduction .......................................................................................................1 Burden of Suffering/Epidemiology............................................................................2 Health Care Interventions ..........................................................................................3 Prior Recommendations.............................................................................................5 Analytic Framework and Key Questions...................................................................5

Chapter 2. Methods.............................................................................................................7 Literature Search Strategy..........................................................................................7 Inclusion/Exclusion Criteria ......................................................................................7 Size of Literature Reviewed.......................................................................................8 Literature Synthesis ...................................................................................................8

Chapter 3. Results .............................................................................................................10 Arrow 1. Does screening using risk factor assessment and/or bone density testing reduce fractures? .........................................................................10 Arrow 2. Does risk factor assessment accurately identify women who may benefit from bone density testing? ...................................................10 Risk Assessment Based on the Likeliehood of Low Bone Density...............10 Risk Assessment Based on Risk of Fracture .................................................12 Arrow 3. Do bone density measurements accurately identify women who may benefit from treatment?....................................................................13 Accuracy and Reliability of Tests..................................................................14 Prediction of Short-term Risk of Fractures ....................................................15 Arrow 4. What are the harms of screening? ...........................................................17 Arrow 5. Does treatment reduce the risk of fractures in women identified by screening? ...........................................................................................19 Estrogen Replacement Therapy .....................................................................19 Selective Estrogen Receptor Modulators.......................................................21 Biophosphonates ............................................................................................22 Generalizability of Randomized Trials..........................................................24 Arrow 6. What are the harms of treatment?............................................................26

Chapter 4. Discussion .......................................................................................................27 Summary of Evidence Quality.................................................................................27 Outcomes Table .......................................................................................................27 Conclusions..............................................................................................................29 Limitations of the Literature ....................................................................................30 Future Research .......................................................................................................31

Acknowledgements............................................................................................................33

References ..........................................................................................................................34

v

Figures

Figure 1. Osteoporosis Screening Analytic Framework ...................................................55 Figure 2. Number Needed to Screen to Prevent 1 Hip Fracture in 5 Years......................56

Tables

Table 1. Recent Systematic Reviews of Osteoporosis......................................................57 Table 2. Prevalence of Low Femoral Neck Bone Density in U.S. Women

Over Age 50........................................................................................................60 Table 3. Osteoporosis Prevalence (%) in White Women in the U.S. Over

Age 50 by Decade...............................................................................................61 Table 4. 5-Year Hip Fracture Rates for Women Without Previous Hip

Fracture by Age....................................................................................................62 Table 5. Studies of Risk Factor Assessment.....................................................................63 Table 6. Characteristics of Bone Density and Quantitative Ultrasound Tests..................67 Table 7. Prospective Studies of DXA of the Hip Reporting Hip Fractures......................68 Table 8. Randomized Controlled Trials of Estrogen and SERMs with Fracture

Outcomes ............................................................................................................69 Table 9. Randomized Controlled Trials of Alendronate with Fracture Outcomes ...........72 Table 10. Summary of Evidence Quality..........................................................................74 Table 11. Screening for Osteoporosis in 10,000 Postmenopausal Women ......................75

Appendices

Appendix 1. Search Strategies for Individual Topics .......................................................76 Appendix 2. Criteria for Grading the Internal Validity of Individual Studies..................81

vi

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download