Previous fracture and subsequent fracture risk: a meta-analysis to update FRAX.

A large international meta-analysis using primary data from 64 cohorts has quantified the increased risk of fracture associated with a previous history of fracture for future use in FRAX. INTRODUCTION: The aim of this study was to quantify the fracture risk associated with a prior fracture on an international basis and to explore the relationship of this risk with age, sex, time since baseline and bone mineral density (BMD). METHODS: We studied 665,971 men and 1,438,535 women from 64 cohorts in 32 countries followed for a total of 19.5 million person-years. The effect of a prior history of fracture on the risk of any clinical fracture, any osteoporotic fracture, major osteoporotic fracture, and hip fracture alone was examined using an extended Poisson model in each cohort. Covariates examined were age, sex, BMD, and duration of follow-up. The results of the different studies were merged by using the weighted ß-coefficients. RESULTS: A previous fracture history, compared with individuals without a prior fracture, was associated with a significantly increased risk of any clinical fracture (hazard ratio, HR = 1.88; 95% CI = 1.72-2.07). The risk ratio was similar for the outcome of osteoporotic fracture (HR = 1.87; 95% CI = 1.69-2.07), major osteoporotic fracture (HR = 1.83; 95% CI = 1.63-2.06), or for hip fracture (HR = 1.82; 95% CI = 1.62-2.06). There was no significant difference in risk ratio between men and women. Subsequent fracture risk was marginally downward adjusted when account was taken of BMD. Low BMD explained a minority of the risk for any clinical fracture (14%), osteoporotic fracture (17%), and for hip fracture (33%). The risk ratio for all fracture outcomes related to prior fracture decreased significantly with adjustment for age and time since baseline examination. CONCLUSION: A previous history of fracture confers an increased risk of fracture of substantial importance beyond that explained by BMD. The effect is similar in men and women. Its quantitation on an international basis permits the more accurate use of this risk factor in case finding strategies.

Update of the fracture risk prediction tool FRAX: a systematic review of potential cohorts and analysis plan.

We describe the collection of cohorts together with the analysis plan for an update of the fracture risk prediction tool FRAX with respect to current and novel risk factors. The resource comprises 2,138,428 participants with a follow-up of approximately 20 million person-years and 116,117 documented incident major osteoporotic fractures. INTRODUCTION: The availability of the fracture risk assessment tool FRAX® has substantially enhanced the targeting of treatment to those at high risk of fracture with FRAX now incorporated into more than 100 clinical osteoporosis guidelines worldwide. The aim of this study is to determine whether the current algorithms can be further optimised with respect to current and novel risk factors. METHODS: A computerised literature search was performed in PubMed from inception until May 17, 2019, to identify eligible cohorts for updating the FRAX coefficients. Additionally, we searched the abstracts of conference proceedings of the American Society for Bone and Mineral Research, European Calcified Tissue Society and World Congress of Osteoporosis. Prospective cohort studies with data on baseline clinical risk factors and incident fractures were eligible. RESULTS: Of the 836 records retrieved, 53 were selected for full-text assessment after screening on title and abstract. Twelve cohorts were deemed eligible and of these, 4 novel cohorts were identified. These cohorts, together with 60 previously identified cohorts, will provide the resource for constructing an updated version of FRAX comprising 2,138,428 participants with a follow-up of approximately 20 million person-years and 116,117 documented incident major osteoporotic fractures. For each known and candidate risk factor, multivariate hazard functions for hip fracture, major osteoporotic fracture and death will be tested using extended Poisson regression. Sex- and/or ethnicity-specific differences in the weights of the risk factors will be investigated. After meta-analyses of the cohort-specific beta coefficients for each risk factor, models comprising 10-year probability of hip and major osteoporotic fracture, with or without femoral neck bone mineral density, will be computed. CONCLUSIONS: These assembled cohorts and described models will provide the framework for an updated FRAX tool enabling enhanced assessment of fracture risk (PROSPERO (CRD42021227266)).

Use of pharmacologic agents for the primary prevention of osteoporosis among older women with low bone mass.

UNLABELLED: We examined the use of pharmacologic agents for the primary prevention of osteoporosis among older women with osteopenia. We found that these individuals were not managed in concordance with the National Osteoporosis Foundation (NOF) guidelines and that self-perceived osteoporosis risk and lower bone density were strongly associated with receipt of treatment. INTRODUCTION: Although osteoporosis medications are used for the primary prevention of osteoporosis among persons with low bone mass (osteopenia), their use may be discordant with clinical practice guidelines. METHODS: We studied women 55 years and older participating in the Global Longitudinal Study of Osteoporosis in Women (GLOW). Eligible participants had a dual energy x-ray absorptiometry (DXA) test performed at the University of Alabama at Birmingham hospital and had an osteopenia diagnosis based on their DXA test results. Participants' demographics, fracture risk factors, and exposure to osteoporosis medications were determined from the GLOW survey. We examined the proportions of women managed in concordance with the National Osteoporosis Foundation 2008 guidelines, and we assessed factors independently associated with osteoporosis treatment decisions. Women with a prior spine or hip fracture were excluded. RESULTS: Among 597 eligible women from GLOW, the mean age ± standard deviation (SD) was 70 ± 7 years. Among all subjects, 309 (52%) were treated in concordance with the NOF 2008 guidelines. Greater self-perceived osteoporosis risk and lower bone mineral density were significantly and consistently associated with receipt of osteoporosis treatment, both for those considered appropriate and for those considered inappropriate for treatment based on the NOF guidelines. CONCLUSIONS: We found significant discordance between NOF 2008 guidelines and pharmacologic management of women with osteopenia. A person's self-perceived osteoporosis risk and bone mineral density were most strongly associated with receipt of osteoporosis medication use among women with low bone mass.

Disease-specific perception of fracture risk and incident fracture rates: GLOW cohort study.

UNLABELLED: Accurate patient risk perception of adverse health events promotes greater autonomy over, and motivation towards, health-related lifestyles. INTRODUCTION: We compared self-perceived fracture risk and 3-year incident fracture rates in postmenopausal women with a range of morbidities in the Global Longitudinal study of Osteoporosis in Women (GLOW). METHODS: GLOW is an international cohort study involving 723 physician practices across ten countries (Europe, North America, Australasia); 60,393 women aged ≥55 years completed baseline questionnaires detailing medical history and self-perceived fracture risk. Annual follow-up determined self-reported incident fractures. RESULTS: In total 2,945/43,832 (6.8%) sustained an incident fracture over 3 years. All morbidities were associated with increased fracture rates, particularly Parkinson's disease (hazard ratio [HR]; 95% confidence interval [CI], 3.89; 2.78-5.44), multiple sclerosis (2.70; 1.90-3.83), cerebrovascular events (2.02; 1.67-2.46), and rheumatoid arthritis (2.15; 1.53-3.04) (all p < 0.001). Most individuals perceived their fracture risk as similar to (46%) or lower than (36%) women of the same age. While increased self-perceived fracture risk was strongly associated with incident fracture rates, only 29% experiencing a fracture perceived their risk as increased. Under-appreciation of fracture risk occurred for all morbidities, including neurological disease, where women with low self-perceived fracture risk had a fracture HR 2.39 (CI 1.74-3.29) compared with women without morbidities. CONCLUSIONS: Postmenopausal women with morbidities tend to under-appreciate their risk, including in the context of neurological diseases, where fracture rates were highest in this cohort. This has important implications for health education, particularly among women with Parkinson's disease, multiple sclerosis, or cerebrovascular disease.

Non-hip, non-spine fractures drive healthcare utilization following a fracture: the Global Longitudinal Study of Osteoporosis in Women (GLOW).

UNLABELLED: We evaluated healthcare utilization associated with treating fracture types in >51,000 women aged ≥55 years. Over the course of 1 year, there were five times more non-hip, non-spine fractures than hip or spine fractures, resulting in twice as many days of hospitalization and rehabilitation/nursing home care for non-hip, non-spine fractures. INTRODUCTION: The purpose of this study is to evaluate medical healthcare utilization associated with treating several types of fractures in women ≥55 years from various geographic regions. METHODS: Information from the Global Longitudinal Study of Osteoporosis in Women (GLOW) was collected via self-administered patient questionnaires at baseline and year 1 (n = 51,491). Self-reported clinically recognized low-trauma fractures at year 1 were classified as incident spine, hip, wrist/hand, arm/shoulder, pelvis, rib, leg, and other fractures. Healthcare utilization data were self-reported and included whether the fracture was treated at a doctor's office/clinic or at a hospital. Patients were asked if they had undergone surgery or been treated at a rehabilitation center or nursing home. RESULTS: During 1-year follow-up, there were 195 spine, 134 hip, and 1,654 non-hip, non-spine fractures. Clinical vertebral fractures resulted in 617 days of hospitalization and 512 days of rehabilitation/nursing home care; hip fractures accounted for 1,306 days of hospitalization and 1,650 days of rehabilitation/nursing home care. Non-hip, non-spine fractures resulted in 3,805 days in hospital and 5,186 days of rehabilitation/nursing home care. CONCLUSIONS: While hip and vertebral fractures are well recognized for their associated increase in health resource utilization, non-hip, non-spine fractures, by virtue of their 5-fold greater number, require significantly more healthcare resources.

The Global Longitudinal Study of Osteoporosis in Women (GLOW): rationale and study design.

SUMMARY: The Global Longitudinal study of Osteoporosis in Women (GLOW) is a prospective cohort study involving 723 physicians and 60,393 women subjects >or=55 years. The data will provide insights into the management of fracture risk in older women over 5 years, patient experience with prevention and treatment, and distribution of risk among older women on an international basis. INTRODUCTION: Data from cohort studies describing the distribution of osteoporosis-related fractures and risk factors are not directly comparable and do not compare regional differences in patterns of patient management and fracture outcomes. METHODS: The GLOW is a prospective, multinational, observational cohort study. Practices typical of each region were identified through primary care networks organized for administrative, research, or educational purposes. Noninstitutionalized patients visiting each practice within the previous 2 years were eligible. Self-administered questionnaires were mailed, with 2:1 oversampling of women >or=65 years. Follow-up questionnaires will be sent at 12-month intervals for 5 years. RESULTS: A total of 723 physicians at 17 sites in ten countries agreed to participate. Baseline surveys were mailed (October 2006 to February 2008) to 140,416 subjects. After the exclusion of 3,265 women who were ineligible or had died, 60,393 agreed to participate. CONCLUSIONS: GLOW will provide contemporary information on patterns of management of fracture risk in older women over a 5-year period. The collection of data in a similar manner in ten countries will permit comparisons of patient experience with prevention and treatment and provide insights into the distribution of risk among older women on an international basis.

Effects of Redox Disturbances on Intestinal Contractile Reactivity in Rats Fed with a Hypercaloric Diet.

Few studies have associated the effects of changes in caloric intake and redox disturbances in the gastrointestinal tract. Therefore, the present study aimed at evaluating the hypercaloric diet consumption influence on the contractile reactivity of intestinal smooth muscle, morphology, and oxidative stress of rat ileum. Wistar rats were randomly divided into groups that received a standard diet and fed with a hypercaloric diet for 8 weeks. Animals were euthanized, and the ileum was isolated to isotonic contraction monitoring. Morphology was evaluated by histological staining and oxidative stress by quantification of malondialdehyde levels and total antioxidant activity. Cumulative concentration-response curves to KCl and carbachol were attenuated in rats fed with a hypercaloric diet compared to those that received a standard diet. In addition, an increase in caloric intake promotes a rise in the thickness of the longitudinal smooth muscle layer of rat ileum and tissue malondialdehyde levels, characterizing lipid peroxidation, as well as a decrease in the antioxidant activity. Thus, it was concluded that the consumption of a hypercaloric diet impairs rat intestinal contractility due to mechanisms involving modifications in the intestinal smooth muscle architecture triggered by redox disturbances.

Diagnostic tests for deep vein thrombosis. Clinical usefulness depends on probability of disease.

We review the general principles that govern the clinical utility of diagnostic tests, particularly with respect to the diagnosis of deep vein thrombosis (DVT). We stress the importance of clinical probability of disease, which strongly influences the positive predictive value (true-positive rate) and negative predictive value (true-negative rate) of all diagnostic tests. In selecting a diagnostic procedure for DVT, the physician must first consider the clinical probability of disease and then the local accuracy of the test employed and its cost-effectiveness. In 75% to 80% of patients suspected to have DVT, clinical management can be based on the results of noninvasive tests, such as ultrasonography or impedance plethysmography (IPG), rather than venography. Ultrasonography has clear advantages over venography with respect to cost and patient comfort, and it defines the anatomic extent of the thrombus. It should be considered the new diagnostic standard for symptomatic DVT. Despite recent reports of lower sensitivity than previously reported, IPG remains an acceptable alternative to ultrasonography for symptomatic DVT in selected patients. Even if the recently reported lower sensitivity proves to be accurate, the probability of adverse clinical outcomes as a result of overlooked disease is still extremely low in patients with a low probability of DVT. The negative predictive value of IPG under these circumstances approaches 99%. Impedance plethysmography is also useful in patients with a high probability of DVT, in whom the positive predictive value may be as high as 97%. When the findings of IPG (or ultrasonography) are at variance with a strong clinical impression, venography should be considered, especially when there is a high clinical probability of disease and a negative noninvasive test result.

The prevalence of risk factors for venous thromboembolism among hospital patients.

BACKGROUND: This study provides an estimate of the prevalence of risk factors for venous thromboembolism among hospital patients. METHODS: The presence of risk factors for venous thromboembolism was determined from a retrospective review of the medical records of 1,000 randomly selected patients in 16 acute care hospitals in central Massachusetts. RESULTS: The most common risk factors for venous thromboembolism were age 40 years (59%) or more, obesity (28%), and major surgery (23%). The average number of risk factors increased with increasing age. One or more risk factors for venous thromboembolism were present in 78% of hospital patients, two or more in 48%, three or more in 19%, four or more in 6%, and five or more in 1%. CONCLUSION: Risk factors for venous thromboembolism are common among hospital patients, suggesting that prophylaxis should be widely employed. The cost-effectiveness and risk benefit of prophylaxis is well established in patients undergoing major surgery. Further studies are needed to confirm the benefit of prophylaxis in patients with nonsurgical risk factors for venous thromboembolism.

The epidemiology of diagnosed pulmonary embolism and deep venous thrombosis in the elderly.

BACKGROUND: There are no studies that define the basic epidemiology of pulmonary embolism (PE) and deep venous thrombosis (DVT) in the elderly. This project was undertaken to provide that information. METHODS: We obtained all Medicare claims during the period 1986 through 1989 from a random 5% sample of US Medicare enrollees. By selecting codes used for diagnoses and treatment, we identified 7174 cases of PE and 8923 cases of DVT. These cohorts were analyzed to provide incidence by age, race, sex, and geographic location; frequency of invasive treatment; frequency of PE after treatment for DVT; frequency of recurrence of PE; and survival after diagnosis. RESULTS: Annual incidence rates per 1000 at age 65 to 69 years for PE and DVT were 1.3 and 1.8, respectively. Both rates increased steadily with age to 2.8 and 3.1 by age 85 to 89 years. For PE, women had lower rates than men (adjusted relative risk, 0.86; 95% confidence interval, 0.82 to 0.90), and blacks had higher rates than whites (adjusted relative risk, 1.25; 95% confidence interval, 1.15 to 1.36). For DVT, the associations with gender and race were weaker and in the opposite direction. Pulmonary embolectomy was done in 0.2% of cases of PE; interruption of the vena cava was done in 4.4% of cases of PE and in 2% of cases of DVT. Thrombectomy was done in 0.3% of all cases. Pulmonary embolism occurred in 1.7% of patients with DVT within 1 year of hospital discharge for initial treatment. The 1-year recurrence rate for PE was 8.0%. In-hospital mortality associated with PE and DVT was 21% and 3%, respectively. One-year mortality was 39% and 21%, respectively. CONCLUSIONS: Pulmonary embolism and DVT are common problems in the elderly. Both increase with age, but the effects of race and sex are small. Current treatment patterns appear to be effective in preventing both PE after DVT and recurrence of PE. Both are associated with substantial 1-year mortality, suggesting the need to understand the role of associated conditions as well as the indications for prophylaxis and the methods of treatment.

A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study.

A community-wide study was conducted in 16 short-stay hospitals in metropolitan Worcester, Mass, to examine the incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism in patients hospitalized between July 1, 1985, and December 31, 1986. The average annual incidence of deep vein thrombosis alone was 48 per 100,000, while the incidence of pulmonary embolism with or without deep vein thrombosis was 23 per 100,000. The incidence rates of deep vein thrombosis and pulmonary embolism increased exponentially with age. The in-hospital case-fatality rate of venous thromboembolism was 12%. Among patients discharged from the hospital, the long-term case-fatality rates were 19%, 25%, and 30% at 1, 2, and 3 years after hospital discharge. Extrapolation of the data from this population-based study suggests that there are approximately 170,000 new cases of clinically recognized venous thromboembolism in patients treated in short-stay hospitals in the United States each year, and 99,000 hospitalizations for recurrent disease. Because of the silent nature of this disease and the low rate of autopsy in the United States, the total incidence, prevalence, and mortality rates of venous thromboembolism remain elusive.

The clinical implications of bilaterally abnormal impedance plethysmography.

Although impedance plethysmography (IPG) is a test of recognized value in the diagnosis of acute proximal deep venous thrombosis (DVT), its meaning in patients with bilaterally abnormal IPGs is unclear. Consequently, we sought to determine the clinical significance of the bilaterally abnormal IPG in hospitalized patients. In a five-month prospective study, 19% (81/425) of all IPGs done at our institution were bilaterally abnormal (55% of all abnormal IPGs). Acute proximal DVT was found in 26% (14/53) of patients with bilaterally abnormal IPGs who underwent further diagnostic testing. Thirty-five percent of the patients with DVT were found to have either bilateral lower extremity DVT or clots in the inferior vena cava. A numerical score, the venous function index (VFI), was computed for the 101 legs for which further definitive diagnostic evaluations for DVT had been completed. The mean VFI of seven for legs with acute proximal DVT was significantly less than the mean VFI of 13 for legs with no DVT. Fifty percent of legs with a VFI less than or equal to five had DVT, whereas only 7% of legs with a VFI greater than 15 had DVT. The bilaterally abnormal IPG is a common clinical occurrence, is frequently associated with acute DVT, and the VFI is helpful in discriminating legs with acute proximal DVT from normal legs in patients with a bilaterally abnormal IPG.

Occult malignant neoplasm in patients with deep venous thrombosis.

An association between venous thrombosis and cancer was first suggested by Armand Trousseau and subsequently confirmed by multiple postmortem studies. In a previous study, patients with pulmonary embolism, as assessed by pulmonary angiography, were at significantly increased risk of occult cancer with a comparison group of patients without pulmonary embolism. This nonconcurrent prospective epidemiologic study extends these findings by demonstrating a significantly increased risk of occult cancer in patients with deep venous thrombosis (DVT) confirmed by impedance plethysmography as compared with those with suspected DVT in whom the diagnosis was ruled out. Differences in the incidence of malignant neoplasms were greatest within the first two years after the diagnosis of DVT, and patients younger than 50 years with venous thrombosis were at particularly increased risk of occult cancer (relative risk, 19.0). These findings indicate that all patients with DVT or pulmonary embolism should have an appropriate diagnostic workup and careful follow-up, particularly with regard to the risk of occult cancer.

Changing clinical practice. Prospective study of the impact of continuing medical education and quality assurance programs on use of prophylaxis for venous thromboembolism.

OBJECTIVE: To determine the effect of continuing medical education (CME) with and without a quality assurance component (CME+QA) on physician practices in the prevention of venous thromboembolism. METHODS: A communitywide study was performed in 15 short-stay hospitals in central Massachusetts. The study population included 3158 patients in acute-care hospitals with multiple risk factors for venous thromboembolism. Study hospitals were randomly assigned to one of two educational strategies or to a control group that received no intervention. RESULTS: The proportion of patients at high risk for venous thromboembolism who received effective methods of prophylaxis increased significantly from 29% in 1986 to 52% in 1989 (P < .001). This increase was seen in all study groups: control hospitals, 40% to 51% (P < .001); CME hospitals, 21% to 49% (P < .0001); and CME+QA hospitals, 27% to 55% (P < .0001). The increase in prophylaxis use from 1986 to 1989 was significantly greater among patients cared for in hospitals whose physicians participated in a formal CME program (an increase of 28%) than in control hospitals (an increase of 11%) (P < .001). There was no significant difference in the use of prophylaxis in hospitals whose physicians received CME+QA interventions compared with hospitals whose physicians received CME interventions alone (identical increases of 28%). CONCLUSION: A formal CME program significantly increased the frequency with which physicians prescribed prophylaxis for venous thromboembolism. We believe the key factor in our CME interventions that motivated clinicians to change their practices was the provision of hospital-specific data demonstrating a compelling need for improvement. Despite the substantial investment by hospitals in QA, traditional QA intervention appeared to provide no additional benefit. Even after extensive CME/QA interventions, prophylaxis for venous thromboembolism remained underutilized, suggesting the need to develop new approaches to changing clinical practice.

Prevention of venous thromboembolism: adherence to the 1995 American College of Chest Physicians consensus guidelines for surgical patients.

BACKGROUND: The American College of Chest Physicians addressed the dilemma of identifying optimal therapy for venous thromboembolism (VTE) prophylaxis and published their Fourth Consensus Conference on Antithrombotic Therapy in 1995, with recommendations for prophylactic therapy. Despite these recommendations, appropriate VTE prophylactic therapy is underused. OBJECTIVES: To examine routine practices in the prevention of VTE in high-risk surgical patients and to determine the extent of adoption of grade A prophylactic therapies as recommended by the American College of Chest Physicians. METHODS: Retrospective medical record review in 10 teaching or community-based hospitals located in the United States. Medical charts of 1907 patients were randomly selected for review from the population of patients who underwent high-risk major abdominal surgery, total hip replacement, hip fracture repair, or total knee replacement between January 1, 1996, and February 28, 1997. RESULTS: Of 1907 patients, VTE prophylaxis was used in 89.3%; use was 93.7% in each of the 3 orthopedic surgery groups and 75.2% in the high-risk major abdominal surgery group. The percentage of patients receiving grade A therapy was highest in the hip replacement group (84.3%) vs. the other groups (knee replacement, 75.9%; hip fracture repair, 45.2%; abdominal surgery, 50.3%). CONCLUSIONS: The use of grade A prophylaxis was related to the type of surgery, with the highest use seen in total hip replacement and the lowest in hip fracture repair. One in 4 patients who underwent high-risk major abdominal surgeries failed to receive any form of VTE prophylaxis. Publication of consensus statements alone may be insufficient to ensure the incorporation of important new clinical information into routine practice.

Declining Long-term Risk of Adverse Events after First-time Community-presenting Venous Thromboembolism: The Population-based Worcester VTE Study (1999 to 2009).

INTRODUCTION: Contemporary trends in health-care delivery are shifting the management of venous thromboembolism (VTE) events (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) from the hospital to the community, which may have implications for its prevention, treatment, and outcomes. MATERIALS AND METHODS: Population-based surveillance study monitoring trends in clinical epidemiology among residents of the Worcester, Massachusetts, metropolitan statistical area (WMSA) diagnosed with an acute VTE in all 12 WMSA hospitals. Patients were followed for up to 3 years after their index event. Total of 2334 WMSA residents diagnosed with first-time community-presenting VTE (occurring in an ambulatory setting or diagnosed within 24 hours of hospitalization) from 1999 through 2009. RESULTS: While PE patients were consistently admitted to the hospital for treatment over time, the proportion diagnosed with DVT-alone admitted to the hospital decreased from 67% in 1999 to 37% in 2009 (p value for trend <0.001). Among hospitalized patients, the mean length of stay decreased from 5.6 to 4.8 days (p value for trend <0.001). Between 1999 and 2009, treatment of VTE shifted from warfarin and unfractionated heparin towards use of low-molecular-weight heparins and newer anticoagulants; also, 3-year cumulative event rates decreased for all-cause mortality (41-26%), major bleeding (12-6%), and recurrent VTE (17-9%). CONCLUSIONS: A decade of change in VTE management was accompanied by improved long-term outcomes. However, rates of adverse events remained fairly high in our population-based surveillance study, implying that new risk-assessment tools to identify individuals at increased risk for developing major adverse outcomes over the long term are needed.

ALS care: a resource for measuring and improving ALS outcomes.

The Amyotrophic Lateral Sclerosis Clinical Assessment, Research, and Education Project (ALS CARE) will conduct outcomes research and develop educational programs that benefit ALS patients and neurologists. An advisory board of neurologists, who are experts in ALS, will establish the policies governing this project and control the dissemination of aggregate data on ALS practices and outcomes. As a first step toward improving the care of ALS patients, a data coordinating center has been established in the Center for Outcomes Research at the University of Massachusetts Medical Center, which will manage a North American Database of ALS Outcomes. This voluntary database is designed to (1) guide the development of educational programs to improve the care of ALS patients and (2) provide a mechanism for neurologists to evaluate the impact of their diagnostic and therapeutic decisions in a manner that is timely, confidential, and objective.

The ALS patient care database: goals, design, and early results. ALS C.A.R.E. Study Group.

OBJECTIVE: The ALS Patient Care Database was created to improve the quality of care for patients with ALS by 1) providing neurologists with data to evaluate and improve their practices, 2) publishing data on temporal trends in the care of patients with ALS, and 3) developing hypotheses to be tested during formal clinical trials. BACKGROUND: Substantial variations exist in managing ALS, but there has been no North American database to measure outcomes in ALS until now. METHODS: This observational database is open to all neurologists practicing in North America, who are encouraged to enroll both incident and prevalent ALS patients. Longitudinal data are collected at intervals of 3 to 6 months by using standard data collection instruments. Forms are submitted to a central data coordinating center, which mails quarterly reports to participating neurologists. RESULTS: Beginning in September 1996 through November 30, 1998, 1,857 patients were enrolled at 83 clinical sites. On enrollment, patients had a mean age of 58.6 years +/-12.9 (SD) years (range, 20.1 to 95.1 years), 92% were white, and 61% were men. The mean interval between onset of symptoms and diagnosis was 1.2+/-1.6 years (range, 0 to 31.9 years). Riluzole was the most frequently used disease-specific therapy (48%). Physical therapy was the most common nonpharmacologic intervention (45%). The primary caregiver was generally the spouse (77%). Advance directives were in place at the time of death for 70% of 213 enrolled patients who were reported to have died. CONCLUSIONS: The ALS Patient Care Database appears to provide valuable data on physician practices and patient-focused outcomes in ALS.

Diagnostic approaches for deep vein thrombosis.

This article briefly reviews the advantages and limitations of currently available methods for the diagnosis of deep vein thrombosis (DVT). Clinical evaluation alone is inadequate but still useful in assessing the need for further testing. The medical history, especially the detection of risk factors for DVT, is as important as the physical examination. Confirmation by objective diagnostic tests is essential. Venography has been the traditional standard for determining the optimal management of DVT, but has significant limitations which are not widely appreciated. Noninvasive diagnostic methods for DVT are essential for effective management, but the optimal method for a particular hospital depends on the personnel and resources available.

Do graduated compression stockings and pneumatic boots have an additive effect on the peak velocity of venous blood flow?

Graduated compression stockings and intermittent pneumatic compression boots reduce the incidence of deep vein thrombosis. Recent studies suggest that the simultaneous use of these devices may have a synergistic prophylactic effect; however, conflicting reports also exist. Using duplex imaging, we analyzed the effect on peak venous velocity in the superficial femoral vein produced by the individual and simultaneous use of graduated compression stockings and intermittent pneumatic compression boots. Normal volunteers and postoperative patients were examined. The use of intermittent pneumatic compression boots significantly increased the peak venous velocity relative to rest, whereas the use of graduated compression stockings did not alter the peak venous velocity. Also, the addition of graduated compression stockings to legs already being treated with intermittent pneumatic compression boots did not produce a further augmentation of peak venous velocity. This study demonstrates that the simultaneous use of graduated compression stockings and intermittent pneumatic compression boots does not produce a synergistic augmentation of peak venous velocity in the superficial femoral vein.