Headache infusion centers: A survey on treatments provided, infusion center operations, and barriers to developing new infusion centers.

BACKGROUND: Infusion therapy refers to the intravenous administration of medicines and fluids for the treatment of status migrainosus, severe persistent headaches, or chronic headache. Headache practices and centers offer this treatment for patients as an alternative to the emergency department (ED) setting. However, little information is available in the literature on understanding the operations of an infusion center. OBJECTIVE: We sought to survey the Inpatient Headache & Emergency Medicine specialty section and the Academic Program Directors listserv of the American Headache Society (AHS) to better understand current practices. METHODS: A survey was advertised and distributed to the listservs of both the Inpatient Headache & Emergency Medicine specialty section and the Academic Program Directors, which combined included both academic and private practices. In addition, the survey was available on laptops at related events at an annual AHS meeting in Scottsdale. RESULTS: Of the 127 members of the combined group of both listservs, 50 responded with an overall survey response rate of 39%. Ten out of fifty were from programs with more than one responder completing the survey, leaving 40 unique headache programs. Academic programs made up the majority of programs (85%, 34/40). The total of 40 participating programs is comparable with the 47 academic headache programs listed on the American Migraine Foundation website at the time of the survey. Of the academic programs surveyed, most were hospital based (n = 23) compared with a satellite location (n = 11). Of all programs surveyed, 68% (27/40) offered infusion therapy. Of those that did not have an infusion practice (n = 13), the most common reason cited was insufficient staffing (n = 8). Key highlights of the survey included the following: The majority of programs offering infusions obtain prior authorization before scheduling (70%, 19/27) and offer patient availability 5 days/week (78%, 21/27) typically only during business hours (81%, 22/27). Programs reported that they typically give three to four medications during each infusion session (72%, 18/25). Treatment paradigms varied between programs. Programs surveyed were concentrated in the Northeast and Midwest regions of the United States. CONCLUSION: The limited number of headache infusion centers overall may contribute to the limited ability of headache infusion centers to prevent ED migraine visits. Headache patients can have unpredictable headache onset, and most of the infusion practices surveyed appeared to adapt to this by offering infusions most days during a work week. However, this need for multiple days per week may also explain the most common reason for not having an infusion practice, which is insufficient staffing. Various treatment paradigms are implemented by different practitioners, and future studies will have to focus on investigation of best practice.

Fabry disease during the COVID-19 pandemic. Why and how treatment should be continued.

Fabry disease is an X-linked disease due to a deficiency of the lysosomal enzyme alpha-galactosidase A. Clinical symptoms in classically affected males include acroparesthesia, anhydrosis and angiokeratoma, which may present during childhood followed by cardiac, cerebral and renal complications. Even though pulmonary involvement is not widely appreciated by clinicians, an obstructive lung disease is another recognized component of Fabry disease. Coronavirus Disease-19 (COVID-19), caused by the SARS-CoV-2 virus was labeled as a global pandemic and patients with Fabry disease can be considered at high risk of developing severe complications. The impact of COVID-19 on patients with Fabry disease receiving enzyme replacement therapy is still unknown. Many patients who receive treatment in the hospital experienced infusion disruptions due to fear of infection. Effects of temporary treatment interruption was described in more detail in other lysosomal storage diseases, but the recommencement of therapy does not fully reverse clinical decline due to the temporary discontinuation. When possible, home-therapy seems to be the most efficient way to maintain enzyme replacement therapy access during pandemic. Sentence take-home message: Home-therapy, when possible, seems to be the most efficient way to maintain enzyme replacement therapy access during pandemic in patients with Fabry disease.

Risk factors of 30-days re-hospitalization after Hospital at Home in a cohort of patients treated with parenteral therapy.

BACKGROUND: Hospital at Home provides acute medical treatment in the patient's home. To prevent re-hospitalization in these outpatients, it is decisive to identify high-risk groups. This study aimed to identify patient characteristics for increased risk of 30 days re-hospitalization, after referral to Hospital at Home. METHODS: A registry-based study was conducted using information from a hospital and a team providing Hospital at Home treatment. A total of 379 patients above the age of 18, who had received parenteral therapy by the team, in the period 01.03.2011 to 31.12.2012, were identified. Comorbid conditions were defined using Charlson's Comorbidity Index and divided into groups of score (0, 1 and ≥ 2). Cox regression analysis was used to estimate a risk of 30 days re-hospitalization by computing the hazard ratios (HR) with 95% confidence interval (95% CI). RESULTS: Within 30 days after referral to Hospital at Home 32.5% of the population was re-hospitalized. An increased risk of readmission was found in patients with a comorbidity score ≥ 2 (HR 2.06, 95% CI 1.33-3.18) and in patients referred to Hospital at Home from a hospital department (HR 1.56, 95% CI 1.02-2.38). Primary care tended to reduce the risk of readmission although not significant (HR 0.65, 95% CI 0.41-1.04). CONCLUSIONS: This study suggests that, patients with comorbidities and/or patients referred by the hospital are in a greater risk of readmission. Further readmission may be prevented in patients receiving primary care.

[The first trial of OPAT (outpatient parenteral antimicrobial therapy) with continuous infusions in Japan].

OPAT (Outpatient Parenteral Antimicrobial Therapy) is widely utilized in various countries. Although once-daily parenteral antimicrobials are often prescribed in outpatient clinics, the term "OPAT" is not commonly used, and no well-organized OPAT practice has been reported in Japan. We implemented OPAT with continuous infusion using elastomeric infusion devices, which are commonly used in Australia and Singapore. We collected data about diseases, organisms, antimicrobials, treatment duration, bed days saved, outcome, readmission rate and cost reductions of all patients who were treated with OPAT with continuous infusions from July 2012 till June 2013. Ten patients (5 osteomyelitis, 4 abscess and 1 endocarditis) were treated and only one patient discontinued therapy due to the side effects of the antimicrobial. The most commonly targeted organism was Staphylococcus aureus. Cefazolin was the most frequently prescribed antimicrobial. The median OPAT days were 15 (range 4-29 days). Total bed days saved were 159. A peripherally inserted central catheter (PICC) was inserted for all patients and only one had to change the PICC during the treatment. Eight patients were cured and 2 were improved. No patient needed readmission. The estimated medical cost reduction was 1,655,930 yen, that is approximately 16,000 US dollars. Administration with continuous infusion makes it possible to continue the optimal parenteral antimicrobials for outpatients, which avoids prescribing unnecessary once-daily antimicrobials with a broader spectrum. Our experience shows OPAT with continuous infusion is safe and feasible practice not only for improving the QOL of patients but also for efficient bed utilization and medical cost savings.

Village-randomized clinical trial of home distribution of zinc for treatment of childhood diarrhea in rural Western kenya.

BACKGROUND: Zinc treatment shortens diarrhea episodes and can prevent future episodes. In rural Africa, most children with diarrhea are not brought to health facilities. In a village-randomized trial in rural Kenya, we assessed if zinc treatment might have a community-level preventive effect on diarrhea incidence if available at home versus only at health facilities. METHODS: We randomized 16 Kenyan villages (1,903 eligible children) to receive a 10-day course of zinc and two oral rehydration solution (ORS) sachets every two months at home and 17 villages (2,241 eligible children) to receive ORS at home, but zinc at the health-facility only. Children's caretakers were educated in zinc/ORS use by village workers, both unblinded to intervention arm. We evaluated whether incidence of diarrhea and acute lower respiratory illness (ALRI) reported at biweekly home visits and presenting to clinic were lower in zinc villages, using poisson regression adjusting for baseline disease rates, distance to clinic, and children's age. RESULTS: There were no differences between village groups in diarrhea incidence either reported at the home or presenting to clinic. In zinc villages (1,440 children analyzed), 61.2% of diarrheal episodes were treated with zinc, compared to 5.4% in comparison villages (1,584 children analyzed, p<0.0001). There were no differences in ORS use between zinc (59.6%) and comparison villages (58.8%). Among children with fever or cough without diarrhea, zinc use was low (<0.5%). There was a lower incidence of reported ALRI in zinc villages (adjusted RR 0.68, 95% CI 0.46-0.99), but not presenting at clinic. CONCLUSIONS: In this study, home zinc use to treat diarrhea did not decrease disease rates in the community. However, with proper training, availability of zinc at home could lead to more episodes of pediatric diarrhea being treated with zinc in parts of rural Africa where healthcare utilization is low. TRIAL REGISTRATION: ClinicalTrials.gov NCT00530829.

Association of overweight and obesity with the use of self and home-based infusion therapy among haemophilic men.

An elevated body mass index (BMI) may make venipuncture more difficult, potentially impacting the use of home infusion (HI) and self-infusion (SI). We sought to determine whether above-normal BMI is associated with decreased use of HI treatment and SI of clotting factor concentrate among haemophilic persons. We analysed data from 10,814 male patients with haemophilia A and B (45% with severe disease) aged 6-79 years enrolled in the Centers for Disease Control and Prevention Universal Data Collection surveillance project between 1998 and 2008. Associations between the use of HI and SI and BMI were evaluated using logistic regression. Fifty per cent of haemophilic men were overweight or obese, similar to rates reported among the general US population by the 2007-2008 National Health and Nutrition Examination Survey [Flegal, KM et al., JAMA 2010;303:235-241;]. Twenty per cent of children and 22% of teens were obese, as were 28% of adults [Ogden, CL et al., JAMA 2010;303:235, 242]. Overall, 70% of the study sample used HI; 44% of those who used HI also used SI. Overweight and obese men were each less likely to use HI than those of normal weight [odds ratio (OR) 0.8; 95% confidence interval (CI) 0.7-1.0 and OR 0.7; 95% CI 0.6-0.8 respectively]. Obese teens and adult men were also less likely to practice SI than teens and adults of normal weight (OR 0.8; 95% CI 0.7-0.9 for each). We conclude that overweight and obese haemophilic men are less likely to use HI and obese men are less likely to use SI than their normal-weight counterparts.

[Home-based infusion therapy--a feasible approach for chronically ill patients? A new path to provide superior patient care exemplified for Fabry's disease]. / Infusionsbehandlung in häuslicher Umgebung--ein praktikabler Ansatz für chronisch Kranke? Neue Wege der Versorgung am Beispiel des Morbus Fabry.

BACKGROUND: As there are scarce data from Germany addressing home-based infusion therapy in chronically ill patients, a study on transferring infusion therapy from in-patient-treatment to home care, exemplified for Fabry's disease, was conducted. METHODS: A total of 69 patients on enzyme replacement infusion therapy (ERT with agalsidase alfa every two weeks) were enrolled in the open, non-controlled, multicentre, non-interventional observational study. After uneventful ERT in a hospital setting, intravenous treatment was administered at home by a specially-trained nurse. Primary outcome measure was change in patient satisfaction measured by an eleven-item Likert scale. RESULTS: The in-home observation period lasted between 96 und 401 days (median 180; IQR 166-184). Patient satisfaction increased significantly with home-based therapy (p = 0.001). A quality of life analysis (SF-36) demonstrated significant improvements in role-physical (p = 0.003), bodily pain (p = 0.032), vitality (p < 0.001), social functioning (p = 0.020), role-emotional (p = 0.007), mental well-being (p = 0.007) and mental sum score (p = 0.002). Home infusions turned out to be safe and were well tolerated. CONCLUSION: Chronically ill patients with need for regular infusion therapy may benefit from a home care setting. Home-based infusion therapy as exemplified by agalsidase alfa ERT in Fabry's disease is a viable option for patients who received uneventful infusions within the hospital.

Place of death among patients with terminal heart failure in a continuous inotropic infusion program.

Although most patients with terminal heart failure (HF) prefer to die at home, the majority die in hospitals. To determine the impact of home inotropic support in the place of death among patients with terminal HF, this retrospective study compared the place of death in patients with terminal HF enrolled in an inotropic infusion program to place of death in a national sample of patients with HF. The rate of home death among program participants (64.5%; n = 217) was significantly higher (P < .001) than an age- and sex-adjusted rate of home death in a national sample (35.9%; n = 56 596). Patients with HF participating in home inotropic support can remain at home during the final stage of life and are less likely to die in hospitals.

Intravenous enzyme replacement therapy: hospital vs home.

Two surveys were carried out to establish the status of enzyme replacement therapy (ERT) for lysosomal storage diseases in Italy. The first was a national survey covering the regional reference centres (RRCs) for these diseases; replies disclosed that 57.7% of patients are on ERT, administered almost exclusively in hospital settings (local hospital 60.7%, RRC 34.8%, home 2.6%); Italian health service procedures do not support ERT at home. The second survey was a regional survey in Lombardy, involving 48 patients (six of whom were on ERT at home). According to 40% of the patients, hospital-based ERT is disruptive, causing loss of days at school/work, stress and family issues. The patients on home therapy did not have these problems. However, 93% of patients receiving ERT in hospital perceived the advantages of greater safety, closer monitoring and more support from health professionals and experts. A total of 55% were willing to receive ERT at home, but 33% were against it. This may be the result of a lack of experience with ERT at home in Italy, or because of different opinions between family members and physicians. As international experience shows that ERT at home saves healthcare resources and improves quality of life, the issue should be raised with Italian healthcare policy makers, who should ensure nursing support for home-based ERT.

[Daptomycin in home hospitalization]. / Daptomicina en el paciente con hospitalización a domicilio.

Outpatient Parenteral Antimicrobial Therapy (OPAT) is widely used in the United States and has advantages for both patients and hospitals. In the last few years, several European countries such as the United Kingdom and Italy have begun to show interest in OPAT, developing this therapeutic modality through distinct healthcare structures. In Spain, the most widely used resources are hospital at home units. Daptomycin is an antibiotic that is administered in a single daily dose, which allows its rapid infusion, and does not require monitoring of plasma levels. These two factors greatly facilitate the ambulatory treatment of severe infections due to Gram-positive microorganisms. The results of clinical trials, case series and post-commercialization registries support the safety and efficacy of the use of daptomycin in OPAT.

Outpatient parenteral antibiotic therapy with daptomycin: insights from a patient registry.

AIM: To compare and contrast the characteristics and clinical outcomes of patients who have received daptomycin as outpatients and inpatients. METHODS: The Cubicin Outcomes Registry and Experience (CORE) is a retrospective chart review of patients who have received daptomycin in participating institutions. Patients treated in 2005 were included in this analysis. Demographic characteristics and clinical outcomes (success = cured + improved) were compared among patients who received outpatient parenteral antibiotic therapy (OPAT) and patients who had received inpatient parenteral antibiotic therapy (IPAT). RESULTS: Of 1172 patients reported by 52 CORE 2005 participating institutions/investigators, 949 (81.0%) patients were evaluable: 539 (56.8%) received OPAT (OPAT patients), and 410 (43.2%) received only IPAT (IPAT patients). Of the 539 OPAT patients, 273 (50.6%) also received some IPAT, usually preceding OPAT therapy. Successful outcomes [no. of successes/(no. of successes + no. of failures)] for OPAT patients vs. IPAT patients were 94.6% and 86.3% respectively (chi-square test, p < 0.001). OPAT patients were younger, had fewer underlying diseases, were clinically stable, and had fewer adverse events than IPAT patients. CONCLUSIONS: Outpatient parenteral antibiotic therapy use was common (539/949 or 56.8%) among patients in CORE 2005. Clinical outcomes among OPAT patients appeared at least as good as or better than IPAT patients. Better outcomes among OPAT patients were most likely because of patient selection for OPAT. Additional studies should focus on clinical characteristics of patients who would be ideal candidates for daptomycin OPAT.

Catheter outcomes in home infusion.

Intravenous catheter outcomes are a prominent topic for healthcare providers whose patients receive intravenous medications. There are thousands of products being marketed today claiming to improve catheter outcomes, thus improving overall patient outcomes and reducing provider costs associated with catheter infections and replacement. Catheter-related bloodstream infections (CR-BSIs) cost hospitals between $5000 and $34,000 per infection, and 12% to 25% of bloodstream infections are attributable to patient mortality. Products that claim to prevent CR-BSIs and subsequently reduce the number of bloodstream infections are a multimillion-dollar industry.

[Specialized home care for infectious disease. Experience from 1995 to 2002]. / Hospitalización a domicilio especializada en enfermedades infecciosas. Experiencia de 1995 a 2002.

OBJECTIVE: In 1995 a specialized home care service for infectious diseases was created in our institution. The aim was to improve the quality of life of patients with prolonged parenteral antimicrobial therapy requirements, reduce the length of hospital stay, and improve the care received after discharge by clinical and analytical surveillance. This study reviews the experience of this service from 1995 to 2002 using prospectively recorded data. METHODS: An analysis was performed of the number of patients included in the home care program per year, number of patients with HIV infection, infectious disease diagnosed, department referring the patient, antimicrobial treatment administered, destination at discharge, and reason for hospital re-admission. RESULTS: The number of patients included each year from 1995 to 2002 was 52, 55, 77, 232, 213, 321, 280 and 219, respectively. The percentage of HIV-infected patients decreased from 90% in 1995 to 23% in 2002. The main reason for referral to the program changed from substitution of day-care hospital treatment to early discharge from hospitalization. Whereas CMV infection was the most frequent infection treated during the 1995-1998 period, bacterial infections predominated in the following years. In 148 episodes, self-administration or a portable infusion pump was used for drug administration. Self-administration was associated with a greater risk of complications (24% vs. 12%, OR 2.3, 95% CI 1.5-3.6, P < 0.001) and catheter-related sepsis (4% vs. 0%, OR 12.9, 95% CI 10.9-15.3, P < 0.001). HIV-infected patients were re-hospitalized due to complications unrelated to the home care service more frequently than HIV-uninfected patients. CONCLUSIONS: The percentage of HIV-infected patients included in the infectious disease home care service has progressively decreased since 1996, a fact likely to be related to the introduction of highly active antiretroviral therapy and better control of opportunistic infections. Currently, bacterial infections are the most frequent infections treated in the service. Early hospital discharge is now the main reason for referral to the home program.

Willingness to pay to assess patient preferences for therapy in a Canadian setting.

BACKGROUND: Adult outpatient parenteral antibiotic therapy (OPAT) programs have been reported in the literature for over 20 years, however there are no published reports quantifying preference for treatment location of patients referred to an OPAT program. The purpose of this study was to elicit treatment location preferences and willingness to pay (WTP) from patients referred to an OPAT program. METHODS: A multidisciplinary, single centre, prospective study at a 1000-bed Canadian adult tertiary care teaching hospital. This study involved a WTP questionnaire that was administered over a 9-month study period. Eligible and consenting patients referred to the OPAT program were asked to state their preference for treatment location and WTP for a hypothetical treatment scenario involving intravenous antibiotic therapy. Multiple linear regression analysis was performed to determine predictors of WTP. RESULTS: Of 131 eligible patients, 91 completed the WTP questionnaire. The majority of participants were males, married, in their sixth decade of life and had a secondary school education or greater. The majority of participants were retired or they were employed with annual household incomes less than 60,000 dollars. Osteomyelitis was the most common type of infection for which parenteral therapy was required. Of those 87 patients who indicated a preference, 77 (89%) patients preferred treatment at home, 10 (11%) patients preferred treatment in hospital. Seventy-one (82%) of these patients provided interpretable WTP responses. Of these 71 patients, 64 preferred treatment at home with a median WTP of 490 dollars CDN (mean 949 dollars, range 20 to 6250 dollars) and 7 preferred treatment in the hospital with a median WTP of 500 dollars CDN (mean 1123 dollars, range 10 to 3000 dollars). Tests for differences in means and medians revealed no differences between WTP values between the treatment locations. The total WTP for the seven patients who preferred hospital treatment was 7,859 dollars versus 60,712 dollars for the 64 patients who preferred home treatment. Income and treatment location preference were independent predictors of WTP. CONCLUSION: This study reveals that treatment at home is preferred by adult inpatients receiving intravenous antibiotic therapy that are referred to our OPAT program. Income and treatment location appear to be independently associated with their willingness to pay.

Ambulatory perineural infusion: the patients' perspective.

BACKGROUND AND OBJECTIVES: Ambulatory perineural local anesthetic infusion is a relatively new method for providing postoperative analgesia, and many aspects of this technique remain in the domain of conjecture and speculation. This retrospective chart review and survey was undertaken to investigate patients' opinions on various aspects of their ambulatory perineural infusion experience. METHODS: Patients who had received an ambulatory perineural infusion from the University of Florida were identified via pharmacy records. Patients were contacted by phone and were asked various questions regarding their experiences and preferences during and after their perineural infusion. RESULTS: Of 217 patients identified, 215 charts were located and retrieved. Of these, 137 (64%) were successfully contacted and 131 (61%) consented to take part in the survey. More than 97% of patients reported that they felt "safe" during home infusion, that one physician telephone call each night was optimal contact, and that they were comfortable removing the catheter with instructions given over the phone. Only 4% would have preferred to return for catheter removal, and 43% felt that they would have been comfortable with only written instructions for catheter removal. CONCLUSION: This investigation suggests that perineural local anesthetic infusion is generally well tolerated by ambulatory patients.

Why is high-tech healthcare at home purchasing underdeveloped and what could be done to improve it?

Executive Letter (95)5 initiated a change of health policy preventing general practitioners (GPs) from prescribing packages of "high-tech healthcare at home" (HTHC). From 1 April 1995, district health authorities were required to establish contracts to purchase such care. Several reasons were behind this policy change including the belief that contracting would improve service quality by encouraging competition between potential suppliers, securing better value for money, and establishing service specifications and monitoring mechanisms. Our survey of 98 health authorities, however, highlighted that contracting for home total parenteral nutrition, intravenous antibiotics for patients with cystic fibrosis, intravenous chemotherapy and continuous ambulatory peritoneal dialysis is largely undeveloped. The majority of districts contracted with historic providers and authorities freely admitted that they did not know whether they were obtaining value for money or a service of adequate quality. Only three districts had developed a strategy for purchasing HTHC as required by the Executive Letter, and only 17 had plans to re-examine their approach. Contracting for HTHC presents practical problems, including the complexity of the process and the significant time demands for efficient and effective contracting. Phase two of this research sought to produce a "guide to good practice" for health authorities wishing to re-examine and improve their purchasing. We conducted case study analyses in districts that had made effective progress and those that had encountered difficulties, drawing upon lessons learned. We reported our findings to the NHS Executive and supplemented this with a "toolbox" that included sample documents covering areas such as tendering, monitoring mechanisms, service specifications and different purchasing approaches.

Economic evaluation of antineoplasic chemotherapy administered at home or in hospitals.

OBJECTIVES: Comparative economic evaluations of chemotherapy administered in hospital day-care units or in the home are relatively scarce. Furthermore, most existing evaluations do not include methodologic studies. This study seeks to compare the costs of anticancer chemotherapy with hospital at-home care versus a hospital day-care unit in the Rhône-Alpes region of France. METHODS: This study is based on a randomized controlled crossover trial that included 42 patients, to whom chemotherapy courses were alternatively given in both settings. All cost categories were taken into account according to microcosting methods. A detailed assessment was performed on coordination and health care in both structures (marginal costs and average costs), from the viewpoint of society. RESULTS: The marginal cost for one chemotherapy administration was significantly higher with hospital at-home care than in the hospital day-care unit ($232.5 vs. $157, p < .0001). Conversely, the average cost was significantly lower with home care than at the hospital ($252.6 vs. $277.3, p = .0002). CONCLUSIONS: The results show that the interest of developing home care in anticancer chemotherapy is questionable regarding costs. In the French healthcare system, where there is a surplus of hospital beds, marginal costs seem to be more relevant indicators in most cases than average costs.

Use of insurance claims data to assess outpatient antimicrobial therapy for gram-positive infections.

With the increasing frequency of antibiotic-resistant gram-positive infections in the United States, many patients are being treated outside the hospital setting. The majority of studies on the cost of outpatient antimicrobial therapy involve retrospective medical record review or prospective data collection. These methods tend to be expensive and time consuming, and often fail to produce a sufficiently large sample size. Analysis of insurance claims data offers a convenient approach for studying the costs associated with outpatient therapy for gram-positive infections. To demonstrate this approach, a study of the cost of intravenous vancomycin home care therapy was conducted using claims data from a large insurance company.

The efficacy of continuous infusion flucloxacillin in home therapy for serious staphylococcal infections and cellulitis.

The efficacy and safety of continuous infusion flucloxacillin as home-based treatment was assessed in 62 consecutive patients with proven serious methicillin-susceptible Staphylococcus aureus (MSSA) infections (n = 36) and cellulitis (n = 26). The treatment was well tolerated and resulted in cure or adequate suppression of infection in 27 of 28 (96%) patients in the serious MSSA infection group, and in 24 of 26 (92%) patients in the cellulitis group.

Home-based factor infusion therapy and hospitalization for bleeding complications among males with haemophilia.

Information from the medical records of 2650 US males with haemophilia living in six states was used to examine the influence of infusing factor concentrate at home (home therapy) and other variables on rates of hospitalization for a haemorrhagic bleeding complication (HBC) over a 4-year period. Bleeding complications included actual and suspected haemorrhagic events but excluded elective admissions for procedures necessitated by haemorrhage (e.g. joint synovectomy). Other risk determinants considered in the analyses included age, race, employment status, health insurance type, care received in federally funded haemophilia treatment centres (HTCs), factor deficiency type and severity, amount of factor prescribed, prophylactic treatment, and presence of inhibitors at baseline. Survival analysis methods were used to evaluate relationships between baseline risk factors and subsequent hospitalization rates. During 8708 person years (PYs) of follow-up, 808 subjects (30.5%) had a total of 1847 bleeding-related hospitalizations; an overall rate of 21.2 admissions per 100 PYs. Using proportional hazards regression to adjust for all of the studied factors, we found that home therapy use (among residents of four of the states) and care in HTCs were independently associated with a decreased risk for a first HBC. Patients who had government-sponsored health insurance or who had no insurance, those of minority race or ethnicity, those with higher levels of factor use, and those with inhibitors were at increased HBC risk. We conclude that the use of home therapy and receipt of care in HTCs are each associated with a substantially lower risk for HBC among males with haemophilia.