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Summary In this real-world retrospective cohort, subsequent hip fracture occurred in one in four patients with any initial fracture, most often after hip fracture, on average within 1.5 years. These data support the need for early post-fracture interventions to help reduce imminent hip fracture risk and high societal and humanistic costs. Purpose This large retrospective cohort study aimed to provide hip fracture data, in the context of other fractures, to help inform efforts related to hip fracture prevention focusing on post-fracture patients. Methods A cohort of 115,776 patients (72.3% female) aged > 65 (median age 81) with an index fracture occurring at skeletal sites related to age-related bone loss between January 1, 2011, and March 31, 2015, was identified using health services data from Ontario, Canada, and followed until March 31, 2017. Results Hip fracture was the most common second fracture (27.8%), occurring in ≥ 19% of cases after each index fracture site and most frequently (33.0%) after hip index fracture. Median time to a second fracture of the hip was ~ 1.5 years post-index event. Patients with index hip fracture contributed the most to fracture-related initial surgeries (64.1%) and post-surgery complications (71.9%) and had the second-highest total mean healthcare cost per patient in the first year after index fracture ($62,793 ± 44,438). One-year mortality (any cause) after index hip fracture was 26.2% vs. 15.9% in the entire cohort, and 25.9% after second hip fracture. Conclusion A second fracture at the hip was observed in one in four patients after any index fracture and in one in three patients with an index hip fracture, on average within 1.5 years. Index hip fracture was associated with high mortality and post-surgery complication rates and healthcare costs relative to other fractures. These data support focusing on early hip fracture prevention efforts in post-fracture patients. Supplementary Information The online version contains supplementary material available at 10.1007/s00198-021-06080-5.

Summary This study evaluated the cost-effectiveness of 1 year of romosozumab followed by alendronate versus oral bisphosphonates alone in women with postmenopausal osteoporosis at very high risk for fracture in Canada. Results showed that romosozumab sequenced to alendronate is a cost-effective treatment option, dominating both alendronate and risedronate alone. Purpose To demonstrate the value of romosozumab sequenced to alendronate compared to alendronate or risedronate alone, for the treatment of osteoporosis in postmenopausal women with a history of osteoporotic fracture and who are at very high risk for future fracture in Canada. Methods A Markov model followed a hypothetical cohort of postmenopausal osteoporotic women at very high risk for future fractures, to estimate the cost-effectiveness of romosozumab and alendronate compared to oral bisphosphonates alone. A total treatment period of 5 years was assumed. Quality-adjusted life years and costs were estimated for each comparator across health states defined by different types of fragility fractures. Results Romosozumab/alendronate was associated with a lifetime gain of 0.103 and 0.127 QALYs and a cost reduction of $343 and $3805, relative to alendronate and risedronate, respectively. These results were driven by a reduction of the number of fractures (2561 per 1000 patients, versus 2700 for alendronate and 2724 for risedronate over lifetime). Romosozumab/alendronate had the highest probability of being cost-effective, relative to alendronate and risedronate, at any willingness to pay threshold value. Conclusion Romosozumab/alendronate was associated with reduced costs and greater benefit relative to other comparators. Probabilistic, deterministic, and scenario analyses indicate that romosozumab/alendronate represents the best value for money; the uncertainty analyses are robust, and therefore romosozumab should be considered for reimbursement by public drug plans in Canada .

Summary The scorecard evaluates the burden and management of osteoporosis in Canada and how care pathways differ across Canadian provinces. The results showed there are inequities in patients’ access to diagnosis, treatment, and post-fracture care programs in Canada. Interventions are needed to close the osteoporosis treatment gap and minimize these inequities. Introduction The purpose of this study was to develop a visual scorecard that assesses the burden of osteoporosis and its management within Canada and seven Canadian provinces. Methods We adapted the Scorecard for Osteoporosis in Europe (SCOPE) to score osteoporosis indicators for Canada and seven provinces (British Columbia, Alberta, Saskatchewan, Ontario, Quebec, New Brunswick, and Newfoundland). We obtained data from a comprehensive literature review and interviews with osteoporosis experts. We scored 20 elements across four domains: burden of disease, policy framework, service provision, and service uptake. Each element was scored as red, yellow, or green, indicating high, intermediate, or low risk, respectively. Elements with insufficient data were scored black. Results Canada performed well on several elements of osteoporosis care, including high uptake of risk assessment algorithms and minimal wait times for hip fracture surgery. However, there were no established fracture registries, and reporting on individuals with high fracture risk who remain untreated was limited. Furthermore, osteoporosis was not an official health priority in most provinces. Government-backed action plans and other osteoporosis initiatives were primarily confined to Ontario and Alberta. Several provinces (Saskatchewan, New Brunswick, Newfoundland) did not have any registered fracture liaison service (FLS) programs. Access to diagnosis and treatment was also inconsistent and reimbursement policies did not align with clinical guidelines. Conclusion Government-backed action plans are needed to address provincial inequities in patients’ access to diagnosis, treatment, and FLS programs in Canada. Further characterization of the treatment gap and the establishment of fracture registries are critical next steps in providing high-quality osteoporosis care. Electronic supplementary material The online version of this article (10.1007/s00198-020-05554-2) contains supplementary material, which is available to authorized users.

Background Recent studies are lacking reports on mortality after non-hip fractures in adults aged > 65. Methods This retrospective, matched-cohort study used de-identified health services data from the publicly funded healthcare system in Ontario, Canada, contained in the ICES Data Repository. Patients aged 66 years and older with an index fragility fracture occurring at any osteoporotic site between 2011 and 2015 were identified from acute hospital admissions, emergency and ambulatory care using International Classification of Diseases (ICD)-10 codes and data were analyzed until 2017. Thus, follow-up ranged from 2 years to 6 years. Patients were excluded if they presented with an index fracture occurring at a non-osteoporotic fracture site, their index fracture was associated with a trauma code, or they experienced a previous fracture within 5 years prior to their index fracture. This fracture cohort was matched 1:1 to controls within a non-fracture cohort by date, sex, age, geography and comorbidities. All-cause mortality risk was assessed. Results The survival probability for up to 6 years post-fracture was significantly reduced for the fracture cohort vs matched non-fracture controls (p n = 101,773 per cohort), with the sharpest decline occurring within the first-year post-fracture. Crude relative risk of mortality (95% confidence interval) within 1-year post-fracture was 2.47 (2.38–2.56) in women and 3.22 (3.06–3.40) in men. In the fracture vs non-fracture cohort, the absolute mortality risk within one year after a fragility fracture occurring at any site was 12.5% vs 5.1% in women and 19.5% vs 6.0% in men. The absolute mortality risk within one year after a fragility fracture occurring at a non-hip vs hip site was 9.4% vs 21.5% in women and 14.4% vs 32.3% in men. Conclusions In this real-world cohort aged > 65 years, a fragility fracture occurring at any site was associated with reduced survival for up to 6 years post-fracture. The greatest reduction in survival occurred within the first-year post-fracture, where mortality risk more than doubled and deaths were observed in 1 in 11 women and 1 in 7 men following a non-hip fracture and in 1 in 5 women and 1 in 3 men following a hip fracture.

Idiopathic pulmonary fibrosis (IPF) is a rare disease, with estimates of prevalence varying considerably across countries due to paucity in data collection. The aim of this study was to investigate the prevalence and incidence of IPF in Canada using administrative data requiring minimal extrapolation.We used mandatory national administrative data from 2007–2011 to identify IPF cases of all ages with an International Classification of Diseases (Version 10, Canadian) diagnosis code of J84.1. We used a broad definition that excluded cases with subsequent diagnosis of other interstitial lung diseases, and a narrow definition that required further diagnostic testing prior to IPF diagnosis. We explored survival and quality of life.For all ages, the broad prevalence of IPF was 41.8 per 100 000 (14 259 cases) and was higher for men. The incidence rate was 18.7 per 100 000 (6390 cases) and was higher for men. The narrow prevalence was 20.0 per 100 000 (6822 cases) and incidence was 9.0 per 100 000 (3057 cases). The 4-year risk of death was 41.0% and the quality of life with IPF after 2 years was lower than for Global Initiative for Chronic Obstructive Lung Disease stage IV chronic obstructive pulmonary disease.Using comprehensive national data, the prevalence of IPF in Canada was higher than other national estimates, suggesting that either IPF may be more common in Canada or that data capture may have been previously limited.

Objectives There is a paucity of information concerning the cost of hypoglycemia events in Canadians with type 1 or type 2 diabetes. The objective of this study was to estimate the direct health-care costs and indirect costs associated with hypoglycemia based on a Canadian cohort of 498 patients from the global Hypoglycemia Assessment Tool (HAT) study. Methods A costing model was developed to estimate the direct costs related to experiencing hypoglycemia by using health-care resources associated with hospital admissions and additional clinical appointments that were prospectively reported 1 month after baseline in the HAT study. Data collected retrospectively on work absenteeism in the year prior to baseline were used to estimate the indirect costs of hypoglycemia events. All costs were annualized and reported in 2016 Canadian dollars. Results Of the 403 patients with diabetes who experienced hypoglycemia events in the first month after baseline (81%), 10 (2.5%) patients required hospitalization or clinical appointments. Over 1 year, the mean direct health-care costs were estimated to be C$90,300 (C$1,777 per patient) for hospitalizations and C$14,695 (C$204 per person) for additional clinical appointments. Work absenteeism resulted in a total annual indirect cost of C$20,937 for time off due to sick leave (C$500 per patient), arriving late (C$187 per patient) or leaving work early (C$128 per patient). The annual direct and indirect costs of hypoglycemia events total C$125,932. Conclusions The impact of hypoglycemia events on health-care resource utilization and work productivity leads to substantial direct and indirect costs in Canadian patients with diabetes.

To identify patient management patterns in patients with solid tumors and metastatic bone disease who are receiving intravenous (IV) bisphosphonates (zoledronic acid and pamidronate), and to estimate the time and health care resources used for preparation and administration of zoledronic acid and pamidronate in patients with metastatic bone disease in Canada.A modified 2-round Delphi technique was used, which was composed of 7 clinical experts. The first round was performed through telephone interviews with individual clinical experts to assess the management of patients with bone metastases receiving IV zoledronic acid and pamidronate. The interviews focused on qualitative issues, such as drugs administered, cancers identified, and the method of drug administration. The information obtained from the first round was used to describe typical patient management patterns. The information obtained from the second round was done by a face-to-face meeting involving all expert members, with the aim of confirming the management patterns, and identifying commonality and uniqueness across institutions. The time and health care resources needed for preparation and administration of the IV bisphosphonates were estimated.The expert panel comprised 4 pharmacists and 3 nurses from 2 centers in Ontario and 3 centers in Quebec. The main stages identified, which were associated with the preparation and administration of pamidronate and zoledronic acid, included preinfusion activities, IV access set-up, IV bisphosphonate preparation, chemotherapy infusion (if applicable), IV bisphosphonate infusion, and postinfusion activities. Five patient management patterns were identified and varied with respect to inclusion of chemotherapy and the use of ambulatory infusion devices. Without chemotherapy, the mean time for preparation and administration of zoledronic acid ranged from 38 minutes in a community service center to 85 minutes in a hospital-based cancer center. With chemotherapy, the total mean time increased to 119 minutes for patients with prostate cancer and 173 minutes for patients with breast cancer. The mean time for preparation and administration of pamidronate was 159 minutes with the use of a regular infusion device, and the time in the clinic was only 14 minutes with the use of an ambulatory infusion device. If chemotherapy was scheduled on the same visits, the mean time increased substantially, and varied depending on the type of cancer being treated.Preparation and administration of IV bisphosphonates are associated with notable burden to health care providers and patients, even if the waiting time, including preinfusion (eg, IV access set-up, serum creatinine level monitoring) and postinfusion activities, were excluded. Variations in the time and health care resources utilized for preparing and administering IV bisphosphonates were observed across the centers in Canada. The variation could be primarily due to the difference in patient management patterns.

We estimate the current burden of illness of osteoporosis in Canada is double ($4.6 billion) our previous estimates ($2.3 billion) due to improved data capture of the multiple encounters and services that accompany a fracture: emergency room, admissions to acute and step-down non-acute institutions, rehabilitation, home-assisted or long-term residency support. We previously estimated the economic burden of illness of osteoporosis-attributable fractures in Canada for the year 2008 to be $2.3 billion in the base case and as much as $3.9 billion. The aim of this study is to update the estimate of the economic burden of illness for osteoporosis-attributable fractures for Canada based on newly available home care and long-term care (LTC) data. Multiple national databases were used for the fiscal-year ending March 31, 2011 (FY 2010/2011) for acute institutional care, emergency visits, day surgery, secondary admissions for rehabilitation, and complex continuing care, as well as national dispensing data for osteoporosis medications. Gaps in national data were supplemented by provincial and community survey data. Osteoporosis-attributable fractures for Canadians age 50+ were identified by ICD-10-CA codes. Costs were expressed in 2014 dollars. In FY 2010/2011, the number of osteoporosis-attributable fractures was 131,443 resulting in 64,884 acute care admissions and 983,074 acute hospital days. Acute care costs were $1.5 billion, an 18 % increase since 2008. The cost of LTC was 33.4 times the previous estimate ($31 million versus $1.03 billion) because of improved data capture. The cost for rehabilitation and secondary admissions increased 3.4 fold, while drug costs decreased 19 %. The overall cost of osteoporosis was over $4.6 billion, an increase of 83 % from the 2008 estimate. Since the 2008 estimate, new Canadian data on home care and LTC are available which provided a better estimate of the burden of osteoporosis in Canada. This suggests that our previous estimates were seriously underestimated.

To estimate the financial burden of schizophrenia in Canada in 2004.A prevalence-based cost-of-illness (COI) approach was used. The primary sources of information for the study included a review of the published literature, a review of published reports and documents, secondary analysis of administrative datasets, and information collected directly from various federal and provincial government programs and services. The literature review included publications up to April 2005 reported in MedLine, EMBASE and PsychINFO. Where specific information from a province was not available, the method of mean substitution from other provinces was used. Costs incurred by various levels/departments of government were separated into healthcare and non-healthcare costs. Also included in the analysis was the value of lost productivity for premature mortality and morbidity associated with schizophrenia. Sensitivity analysis was used to test major cost assumptions used in the analysis. Where possible, all resource utilization estimates for the financial burden of schizophrenia were obtained for 2004 and are expressed in 2004 Canadian dollars (CAN dollars).The estimated number of persons with schizophrenia in Canada in 2004 was 234 305 (95% CI, 136 201-333 402). The direct healthcare and non-healthcare costs were estimated to be 2.02 billion CAN dollars in 2004. There were 374 deaths attributed to schizophrenia. This combined with the high unemployment rate due to schizophrenia resulted in an additional productivity morbidity and mortality loss estimate of 4.83 billion CAN dollars, for a total cost estimate in 2004 of 6.85 billion CAN dollars. By far the largest component of the total cost estimate was for productivity losses associated with morbidity in schizophrenia (70% of total costs) and the results showed that total cost estimates were most sensitive to alternative assumptions regarding the additional unemployment due to schizophrenia in Canada.Despite significant improvements in the past decade in pharmacotherapy, programs and services available for patients with schizophrenia, the economic burden of schizophrenia in Canada remains high. The most significant factor affecting the cost of schizophrenia in Canada is lost productivity due to morbidity. Programs targeted at improving patient symptoms and functioning to increase workforce participation has the potential to make a significant contribution in reducing the cost of this severe mental illness in Canada.

Our objectives were to determine the reporting of symptoms, the medical outcome and the work status of meat plant workers diagnosed with clinical carpal tunnel syndrome (CTS). Forty-seven cases of CTS were identified from a previously reported study, and were matched by age, gender and hand use. Cases and controls were followed up for 24 months. The Provincial Workers' Compensation Board and company health records were used to determine the reporting of symptoms, interventions and work status. Thirty-one study cases and all control cases were followed for the full 24 months (16 study cases were lost to follow-up). In total, 12 cases reported symptoms of CTS during the 24 months (eight study cases and four controls). Of the eight study cases, one required surgical release of the carpal tunnel. After a period of work modification, five of the eight study cases returned to regular duty and the remainder were placed on permanent job restrictions. Of the four controls, one subject had a surgical release and returned to regular work, two subjects' jobs were permanently modified, and the fourth returned to regular duty. Occupation-related CTS in meat packers appears to be transient and responsive to conservative measures, with a surgical rate comparable to other occupations.

To estimate, using a time and motion method, the time and labor costs associated with the administration of zoledronic acid and pamidronate in cancer patients with metastatic bone diseases.During clinic visits for participating patients receiving intravenous zoledronic acid or pamidronate, all times and activities associated with the administration of bisphosphonates were recorded by a trained observer using a stopwatch and data recording forms. The total time associated with the administration of bisphosphonates was estimated and converted to labor costs by applying corresponding health care professional hourly wage rates plus the fringe-benefit rate. The costs were presented in 2011 Canadian dollars.A convenience sample of 37 patients from 2 hospital outpatient oncology clinics in Ontario and Quebec participated in the study. Nineteen patients were diagnosed with breast cancer and 18 with prostate cancer. The average patient age was 66 years, and patients had been diagnosed with cancer and metastatic bone disease for 8 years and 3 years, respectively. The times and costs associated with the administration of bisphosphonates for the 28 patients who did not receive concurrent chemotherapy during the scheduled clinic visits are also reported. The mean infusion time for patients receiving zoledronic acid was 20.6 minutes. With the use of ambulatory infusion devices, the mean infusion time of pamidronate was 23 minutes (limited to observations of patients who were seated during administration). In contrast, the mean infusion time using regular infusion devices was 162 minutes. The mean labor cost for administering zoledronic acid was $20. The mean labor cost for administering pamidronate was $10 using ambulatory infusion devices and $68 using regular infusion devices.The time burden to cancer patients with metastatic bone disease who receive intravenous bisphosphonates and the costs to the health care system are substantial, especially when regular infusion devices are used.

Background The primary objective was to estimate the national burden of illness in Canada for diabetic foot ulcer (DFU) for 2011. Secondary objectives included estimating the national incidence and prevalence of DFU, and the 3-year average cost for DFU incident cases. Methods Analyses were conducted using four national databases for the period April 1, 2006 to March 31, 2011, with cases being identified by ICD-10 CA codes. Resource utilization and costs, expressed in 2011 Canadian dollars, were estimated for DFU-related hospitalizations, emergency care (ER), same day surgeries, home care, long term care, physician visits and caregiver time losses. Results In Canada in the year 2011, DFU was associated with 16,883 hospital admissions (327,140 days), 31,095 ER or clinic visits, 41,367 rehabilitation clinic visits, and 26,493 interventions, including 6,036 amputations and 5,796 surgical debridements. This acute institution care represented $320.5 M, and with an additional $125.4 M for home care and $63.1 M for long term care, the annual cost associated with DFU-related care was $547.0 M, or $21,371 annual cost per prevalent case. In 2011, the national prevalence of DFU was 25,597 cases (75.1 per 100,000 population), consisting of 16,161 men (63.1%) and 9,436 women (36.9%), and an estimated 14,449 incident cases. For an incident case of DFU, the average 3-year cumulative cost was $52,360. Conclusion The annual burden for DFU cases that have at least one admission or ER/clinic visit over a 5 year period is higher than previously reported. Electronic supplementary material The online version of this article (doi:10.1186/s12913-015-0687-5) contains supplementary material, which is available to authorized users.

Background Atrial fibrillation (AF) is a common disease that frequently requires acute hospital care; however, the cost of hospital care in Canada has not been reported. The purpose of this study was to estimate the cost of AF related to hospital-based care in Canada. Methods Analyses were conducted with 2 national administrative databases for the fiscal year 2007-2008. Databases included information for hospital admissions, day operations, and ambulatory care. Records with a most responsible diagnosis of AF, atrial flutter, or a diagnosis related to AF with a concomitant comorbidity of AF were included. Hospital costs were estimated, in 2010 Canadian dollars, by applying an average cost per weighted case to the resource intensity weight for each admission or visit and then adding the separate billable fee for admissions, surgical procedures, and interventions. Results In 2007-2008, the number of acute care admissions with AF as the most responsible diagnosis was 22,823, same-day surgical procedures was 5707, and emergency department visits was 58,066. The hospital costs attributable to AF were $815 million in 2010 Canadian dollars: $710 million for hospitalizations; $32 million for same-day surgical procedures; and $73 million for emergency department visits. Most of the acute care costs were for hospitalizations when AF was listed as a comorbidity ($558 million, or 69%). Conclusion AF results in a substantial cost burden to the acute care hospital sector. Current hospital costs in AF patients are driven by the consequences of AF, while the costs for specific treatments for AF are relatively low.

Purpose A substantial clinical need exists for an alternative to vitamin K antagonists for treating deep-vein thrombosis in cancer patients who are at high risk of both recurrent venous thromboembolism and bleeding. Low-molecular-weight heparin, body-weight adjusted, avoids anticoagulant monitoring and has been shown to be more effective than vitamin-K-antagonist therapy. Subjects and Methods Subjects were patients with cancer and acute symptomatic proximal-vein thrombosis. We performed a multi-centre randomized, open-label clinical trial using objective outcome measures comparing long-term therapeutic tinzaparin subcutaneously once daily with usual-care long-term vitamin-K-antagonist therapy for 3 months. Outcomes were assessed at 3 and 12 months. Results Of 200 patients, 100 received tinzaparin and 100 received usual care. At 12 months, the usual-care group had an excess of recurrent venous thromboembolism; 16 of 100 (16%) versus 7 of 100 (7%) receiving low-molecular-weight heparin (P=.044; risk ratio=.44; absolute difference −9.0; 95% confidence interval [CI], −21.7 to −0.7). Bleeding, largely minor, occurred in 27 patients (27%) receiving tinzaparin and 24 patients (24%) receiving usual care (absolute difference −3.0; 95% CI, −9.1 to 15.1). In patients without additional risk factors for bleeding at the time of randomization, major bleeding occurred in 0 of 51 patients (0%) receiving tinzaparin and 1 of 48 patients (2.1%) receiving usual care. Mortality at 1 year was high, reflecting the severity of the cancers; 47% in each group died. Conclusion Our findings confirm the limited but benchmark data in the literature that long-term low-molecular-weight heparin is more effective than vitamin-K-antagonist therapy for preventing recurrent venous thromboembolism in patients with cancer and proximal venous thrombosis.

Background Cost-utility analyses are commonly used in economic evaluations of interventions or conditions that have an impact on health-related quality of life. However, evaluating utilities in children presents several challenges since young children may not have the cognitive ability to complete measurement tasks and thus utility values must be estimated by proxy assessors. Another solution is to use utilities derived from an adult population. To better inform the future conduct of cost-utility analyses in paediatric populations, we reviewed the published literature reporting utilities among children and adults across selected conditions common to paediatric and adult populations. Methods An electronic search of Ovid MEDLINE, EMBASE, and the Cochrane Library up to November 2008 was conducted to identify studies presenting utility values derived from the Health Utilities Index (HUI) or EuroQoL-5Dimensions (EQ-5D) questionnaires or using time trade off (TTO) or standard gamble (SG) techniques in children and/or adult populations from randomized controlled trials, comparative or non-comparative observational studies, or cross-sectional studies. The search was targeted to four chronic diseases/conditions common to both children and adults and known to have a negative impact on health-related quality of life (HRQoL). Results After screening 951 citations identified from the literature search, 77 unique studies included in our review evaluated utilities in patients with asthma (n = 25), cancer (n = 23), diabetes mellitus (n = 11), skin diseases (n = 19) or chronic diseases (n = 2), with some studies evaluating multiple conditions. Utility values were estimated using HUI (n = 33), EQ-5D (n = 26), TTO (n = 12), and SG (n = 14), with some studies applying more than one technique to estimate utility values. 21% of studies evaluated utilities in children, of those the majority being in the area of oncology. No utility values for children were reported in skin diseases. Although few studies provided comparative information on utility values between children and adults, results seem to indicate that utilities may be similar in adolescents and young adults with asthma and acne. Differences in results were observed depending on methods and proxies. Conclusions This review highlights the need to conduct future research regarding measurement of utilities in children.

Purpose A substantial clinical need exists for an alternate to vitamin K antagonists for treating deep vein thrombosis in many patients. Long-term low-molecular-weight heparin (LMWH), body-weight adjusted, avoids anticoagulant monitoring and may be associated with less bleeding. We evaluated the effectiveness and safety of long-term LMWH compared with vitamin K antagonist therapy in a broad spectrum of patients with proximal vein thrombosis. Methods We performed a multicenter, randomized, open-label clinical trial using objective outcome measures comparing therapy for 3 months. Outcomes were assessed at 3 and 12 months. Results Of 737 patients, 18 of 369 receiving tinzaparin (4.9%) had recurrent venous thromboembolism at 3 months compared with 21 of 368 (5.7%) receiving usual care (absolute difference, −0.8%, 95% confidence interval −4.1-2.4). Hemorrhagic complications occurred less frequently in the LMWH group largely because of less minor bleeding: 48 of 369 patients (13.0%) versus 73 of 368 patients (19.8%) receiving usual-care anticoagulation (absolute difference −6.8%; P = .011; risk ratio=0.66). New major bleeding events ceased early (by day 23, P = .034) for patients receiving LMWH but persisted throughout the study treatment interval for patients receiving vitamin K antagonist therapy. No mortality advantage was shown for LMWH. Conclusion Our study shows that LMWH is similar in effectiveness to the usual-care vitamin K antagonist treatment for preventing recurrent venous thromboembolism in a broad spectrum of patients. It causes less harm and enhances the clinicians' therapeutic options for patients with proximal deep vein thrombosis. Our findings reported here suggest the possibility of a broader role for long-term LMWH in selected patients.