Controlled CMS Data Demonstrates a Cost and Clinical Advantage for Hyperbaric Oxygen for Radiation Cystitis.

Introduction: Increasing cancer survivorship, in part due to new radiation treatments, has created a larger population at risk for delayed complications of treatment. Radiation cystitis continues to occur despite targeted radiation techniques. Materials and Methods: To investigate value-based care applying hyperbaric oxygen (HBO2) to treat delayed radiation cystitis, we reviewed public-access Medicare data from 3,309 patients from Oct 1, 2014, through Dec 31, 2019. Using novel statistical modeling, we compared cost and clinical effectiveness in a hyperbaric oxygen group to a control group receiving conventional therapies. Results: Treatment in the hyperbaric group provided a 36% reduction in urinary bleeding, a 78% reduced frequency of blood transfusion for hematuria, a 31% reduction in endoscopic procedures, and fewer hospitalizations when study patients were compared to control. There was a 53% reduction in mortality and reduced unadjusted Medicare costs of $5,059 per patient within the first year after completion of HBO2 treatment per patient. When at least 40 treatments were provided, cost savings per patient increased to $11,548 for the HBO2 study group compared to the control group. This represents a 37% reduction in Medicare spending for the HBO2-treated group. We also validate a dose-response curve effect with a complete course of 40 or more HBO2 treatments having better clinical outcomes than those treated with fewer treatments. Conclusion: These data support previous studies that demonstrate clinical benefits now with cost- effectiveness when adjunctive HBO2 treatments are added to routine interventions. The methodology provides a comparative group selected without bias. It also provides validation of statistical modeling techniques that may be valuable in future analysis, complementary to more traditional methods.

National Trends of Inpatient Radiation Cystitis: 2016-2019.

INTRODUCTION: Radiation cystitis with hematuria (RCH) is a potentially devastating complication after pelvic radiation. The cumulative incidence of RCH is debated, and certain severe manifestations may require hospital admission. We aimed to evaluate demographics and outcomes of patients hospitalized for RCH. METHODS: We performed a retrospective review of hospitalized patients with a primary or secondary diagnosis of RCH from 2016 to 2019 using the National Inpatient Sample. Our unit of analysis was inpatient encounters. Our primary outcome was inpatient mortality. Secondary outcomes included need for inpatient procedures, transfusion, length of stay (LOS), and cost of admission. We then performed multivariate analysis using either a logistic or linear regression to identify predictors of mortality and LOS. Cost was analyzed using a generalized linear model controlling for LOS. RESULTS: We identified 21,320 weighted cases of hospitalized patients with RCH. The average patient age was 75.4 years, with 84.7% male and 69.3% White. The median LOS was 4 days, and the median cost was $8767. The inpatient mortality rate was 1.3%. The only significant predictor for mortality was older age. The only significant predictor of both higher cost and longer LOS was an Elixhauser Comorbidity Score ≥ 3. CONCLUSIONS: RCH represents a significant burden to patients and the health care system, and we observed an increasing number of hospitalized patients over time. Additional research is needed to identify underlying causes of RCH and effective treatments for this sometimes-severe complication of pelvic radiation.

High burden of BK virus-associated hemorrhagic cystitis in patients undergoing allogeneic hematopoietic stem cell transplantation.

BK virus (BKV) reactivation has been increasingly associated with the occurrence of late-onset hemorrhagic cystitis (HC) after allogeneic hematopoietic SCT (allo-HSCT) resulting in morbidity and sometimes mortality. We investigated the incidence, risk factors and outcome of BKV-HC in 323 consecutive adult patients undergoing allo-HSCT over a 5-year period. BK viremia values for HC staging were evaluated, as well as the medico-economic impact of the complication. Forty-three patients developed BKV-HC. In univariate analysis, young age (P=0.028), unrelated donor (P=0.0178), stem cell source (P=0.0001), HLA mismatching (P=0.0022) and BU in conditioning regimen (P=0.01) were associated with a higher risk of developing BKV-HC. In multivariate analysis, patients receiving cord blood units (CBUs) (P=0.0005) and peripheral blood stem cells (P=0.011) represented high-risk subgroups for developing BKV-HC. BK viremia was directly correlated to HC severity (P=0.011) with a 3 to 6-log peak being likely associated with grades 3 or 4 HC. No correlation was found between BKV-HC and acute graft versus host disease or mortality rate. Patients with BKV-HC required a significantly longer duration of hospitalization (P<0.0001), more RBC (P=0.0003) and platelet transfusions (P<0.0001). Over the 5-year study period, the financial cost of the complication was evaluated at \[euro]2 376 076 ($3 088 899). Strategies to prevent the occurrence of late-onset BKV-HC after allo-HSCT are urgently needed, especially in CBU and peripheral blood stem cell recipients. BK viremia correlates with the severity of the disease. Prospective studies are required to test prophylactic approaches.

A cost-analysis case study of radiation cystitis treatment including hyperbaric oxygen therapy.

AIM: To undertake an economic analysis of the direct costs of treating radiation cystitis from a purchaser perspective, comparing conservative, non-operative and surgical interventions with hyperbaric oxygen treatment (HBOT). METHODS: A male in his 60s with prostatic carcinoma consented to this study. Full details of treatment costs in AUD were obtained (AUD 1.0, approx. EUR 0.6). A detailed patient diary accurately cross-referenced the consultations, investigations, admissions and treatment. Costs were recorded on a spreadsheet, dated and grouped under eight major headings related to treatment. Costs were compared for radiation cystitis treatment pre- and post-HBOT, to calculate savings or losses. RESULTS: The study covered three years (including 2.5 years post successful HBOT). Costs prior to HBOT (139 days) were AUD32,571.42 at an average of AUD231.09 per day, 70% from inpatient fees. Direct HBOT costs were AUD12,014.95 for 38 treatments, AUD316.18 per treatment. Post-HBOT (897 days), healthcare costs were AUD17,113.42 (AUD19.08 per day), with no emergency admissions. HBOT reduced costs of inpatient admissions, consultations, investigations and procedures and provided a projected healthcare saving of AUD187,483.96 over a 2.5 year follow up. CONCLUSIONS: The cost of HBOT compared favourably against other costs, and HBOT may provide major health cost savings in this condition. There are significant hidden costs associated with radiation cystitis, not apparent to health funders, because the reasons for admissions and procedures are not easily captured with current information systems.

Nitrofurantoin compares favorably to recommended agents as empirical treatment of uncomplicated urinary tract infections in a decision and cost analysis.

OBJECTIVE: To analyze the costs of nitrofurantoin use compared to those of other antibiotics recommended for treatment of uncomplicated urinary tract infection (UTI). PATIENTS AND METHODS: We used a decision analysis model to perform cost-minimization and sensitivity analyses to determine the level of trimethoprim-sulfamethoxazole (TMP-SMX) and fluoroquinolone resistance that would favor the use of nitrofurantoin as a first-line empirical treatment of uncomplicated UTIs. The model used a program perspective to evaluate costs. RESULTS: Nitrofurantoin was cost-minimizing when the prevalence of fluoroquinolone resistance exceeded 12% among uropathogens or the prevalence of TMP-SMX resistance exceeded 17%. On 2-way sensitivity analysis, variables that had a significant impact on our cost-minimization threshold included cost of antibiotics and probability of clinical cure with antibiotics. CONCLUSION: From a payer perspective, nitrofurantoin appears to be a reasonable alternative to TMP-SMX and fluoroquinolones for empirical treatment of uncomplicated UTIs, especially given the current prevalence of antibiotic resistance among community uropathogens. On the basis of efficacy, cost, and low impact on promoting antimicrobial resistance, clinicians should consider nitrofurantoin as a reasonable alternative to TMP-SMX and fluoroquinolones for first-line therapy for uncomplicated UTIs.

Overestimation error and unnecessary antibiotic prescriptions for acute cystitis in adult women.

BACKGROUND: Empiric antibiotic prescribing for suspected acute cystitis may lead to unnecessary prescriptions when urine cultures are negative. This study assessed whether physician overestimation of the likelihood of bacterial infection contributed to unnecessary antibiotic prescriptions. METHODS: This was a cross-sectional study in Toronto, Canada, from 1998 to 2000 of 231 women 16 years and older who underwent standardized clinical assessments and urine culture testing. The main outcome was an unnecessary antibiotic prescription, defined as a prescription where the urine culture was negative. The difference between physician estimates of the likelihood of a positive urine culture and the measured culture rate for women with similar symptoms was used to measure overestimation error. Logistic regression was used to assess associations between unnecessary prescriptions and clinical factors or overestimation error. Multiple logistic regression was used to adjust for the effect of clinical factors. RESULTS: Of 230 women assessed, 186 (80.9%) were prescribed antibiotics and 74 (32.2%) were prescribed an unnecessary antibiotic where the urine culture was negative. When an overestimation error above the median value (14.75%) was present, the odds of an unnecessary antibiotic prescription were increased (adjusted odds ratio = 3.72; 95% confidence interval = 1.75-7.89). A high overestimation error was associated with the symptoms of urinary frequency or suprapubic tenderness and costovertebral angle tenderness on examination. CONCLUSIONS: Physician overestimation of the likelihood of a positive urine culture in women with symptoms of acute cystitis was associated with unnecessary antibiotic prescribing. Antibiotic overuse may be reduced by developing treatment strategies that deemphasize nonspecific clinical findings that contribute to physician overestimation error.

Outcomes of a pharmacoepidemiological survey on the antibiotic treatment of uncomplicated acute cystitis in community.

We carried out a community-based survey in order to emphasize the importance of therapeutic appropriateness of antibiotic prescription by local physicians and the close connection between pharmacotherapy and pharmacoeconomics. Twenty general practitioners belonging to the local sanitary firm of Paola (CS, Italy) provided information, including their prescription, regarding 64 patients, both male and female, presenting clinical symptoms of uncomplicated acute cystitis. The data collected were compared with those of a previous trial performed in the same setting and documenting the effectiveness and advantages associated with the use of amoxicillin against community-acquired uncomplicated urinary tract infections (UTI). By comparing the prescriptive behaviour of physicians between the first and the present survey, we detected a significant increase in the use of amoxicillin (from 0 to 26.56%), paralleled by a decrease in prescribing aminoglycosides (from 18.18 to 1.56%). In addition, this resulted in a significant reduction in the costs of treatment (from 23.06 to 12.75 euros). Therefore, given the vast consensus concerning the adoption of empirical treatment for the eradication of UTI, the present survey underlines the crucial role of local antibiotic resistance monitoring in order to optimize the use of these drugs. Moreover, we have also observed a significant reduction in treatment costs associated with an appropriate and effective treatment of UTI.

Economic evaluation of an updated guideline for the empiric treatment of uncomplicated urinary tract infection in women.

BACKGROUND: Until recently trimethoprim-sulfamethoxazole was the drug recommended in the Leumit Health Fund for the empiric treatment of uncomplicated urinary tract infection in women. However, due to increased uropathogen resistance to this drug, the fund has designated nitrofurantoin as its new drug of choice. OBJECTIVES: To evaluate the potential economic impact of implementing this new pharmaco-policy. METHODS: Using data derived from the electronic patient records of the Leumit Health Fund, we identified all non-recurrent cases of women aged 18-49 with a diagnosis of acute cystitis or UTI without risk factors for complicated UTI and empirically treated with antibiotics throughout 2003. The final sample comprised 5,489 physician-patient encounters. The proportion of cases treated with each individual drug was calculated, and the excess expenditure due to non-adherence to the new guideline from the perspective of the health fund was evaluated using 5 days of therapy with nitrofurantoin as the reference treatment. RESULTS: Ofloxacin was the most frequently prescribed drug (30.24%), followed by TMP-SMX (22.43%), cephalexin (15.08%), and nitrofurantoin (12.59%). The observed net aggregate drug expenditure was 2.3 times greater than expected had all cases been treated with nitrofurantoin according to the guideline duration of 5 days. The cost of treatment in 53% of the cases exceeded the expected cost of the guideline therapy. CONCLUSIONS: Successful implementation of the new drug will likely improve quality of care and reduce costs to the health fund.

Outcomes from use of an evidence-based practice guideline.

The aim of evidence-based guidelines is primarily to improve patient outcomes without adding to the existing cost of care because both payers and policymakers want to identify health care costs that do not result in benefit to the patient. The purpose of the reported project was to generate a practice guideline for the treatment of uncomplicated acute cystitis in a female population, to determine the extent to which the guideline would be used by providers and to measure the cost and quality of outcomes from its use. A retrospective chart review was used to gather pre-guideline practice and cost data. Measurements included the type, frequency, and duration of antibiotic therapy and the use of urine cultures and both complications and routine followup visits. The implementation of an outpatient practice guideline resulted in a significant change in antibiotic prescribing and a trend toward a change in ordering cultures and clinic followup. There was also a significant decrease in treatment costs.

'Telephone treatment' of uncomplicated acute cystitis.

Acute cystitis in women is typically uncomplicated and amenable to empiric antimicrobial therapy. We advocate a simple approach, in which women with uncomplicated cases are treated over the telephone. Such a program has been in place at the Cleveland Clinic since 1992, and has yielded good results.

Mechanism of action and impact of a cystitis clinical practice guideline on outcomes and costs of care in an HMO.

BACKGROUND: A study was conducted in 1995 at five primary care clinics of a staff-model health maintenance organization in the Midwest to assess the impact of a cystitis clinical guideline and to help elucidate the guideline implementation process. METHODOLOGY: Two hundred one eligible women with uncomplicated cystitis were treated in a three-month period before the guideline, and 241 similar cases were treated in a three-month period after the guideline. Nursing supervisors and clinic managers at each clinic were interviewed about how the cystitis guideline was implemented at each clinic. RESULTS: Use of a recommended three-day antibiotic treatment increased from 28% to 52% of cases (chi-square = 25.01, p < 0.001). Use of urine cultures decreased from 70% to 37% of cases (chi-square = 48.19, p < 0.001). The proportion of eligible cystitis cases coordinated primarily by the nurse increased from 21% to 78% (chi-square = 142.93, p < 0.001). However, desired changes in use of antibiotics and urine cultures were limited to nurse-coordinated cases. There was no increase in hospital admissions, emergency room visits, repeat office visits (p > 0.05), or repeat antibiotic courses (p > 0.05) after cystitis guideline implementation. Cost of cystitis care delivered after guideline implementation was 35% lower than before guideline implementation. CONCLUSIONS: Use of the guideline was associated with desirable changes in antibiotic use, nurse coordination of care, costs of care, and comparable clinical outcomes. Clinics that used clinical systems and tools to support nurse-coordinated cystitis care had greater guideline adherence than clinics that did not support nurse-coordinated care.

Randomized comparative trial and cost analysis of 3-day antimicrobial regimens for treatment of acute cystitis in women.

OBJECTIVE: To determine the efficacy, safety, and costs associated with four different 3-day regimens for the treatment of acute uncomplicated cystitis in women. DESIGN: A prospective randomized trial with a cost analysis. STUDY POPULATION: Women with acute cystitis attending a student health center. INTERVENTIONS: Treatment with 3-day oral regimens of trimethoprim-sulfamethoxazole, 160 mg/800 mg twice daily, macrocrystalline nitrofurantoin, 100 mg four times daily, cefadroxil, 500 mg twice daily, or amoxicillin, 500 mg three times daily. RESULTS: Six weeks after treatment, 32 (82%) of 39 women treated with trimethoprim-sulfamethoxazole were cured compared with 22 (61%) of 36 treated with nitrofurantoin (P = .04 vs trimethoprim-sulfamethoxazole), 21 (66%) of 32 treated with cefadroxil (P = .11 vs trimethoprim-sulfamethoxazole), and 28 (67%) of 42 treated with amoxicillin (P = .11 vs trimethoprim-sulfamethoxazole). Persistence of significant bacteriuria was less common with trimethoprim-sulfamethoxazole (3%) and cefadroxil (0%) compared with nitrofurantoin (16%; P = .05 vs trimethoprim-sulfamethoxazole) and amoxicillin (14%; P = .11 vs trimethoprim-sulfamethoxazole). Persistence of bacteriuria was associated with amoxicillin-resistant strains in the amoxicillin group but nitrofurantoin-susceptible strains in the nitrofurantoin group. Trimethoprim-sulfamethoxazole was more successful in eradicating Escherichia coli from rectal cultures soon after therapy and from urethral and vaginal cultures at all follow-up visits compared with the other treatment regimens. Adverse effects were reported by 16 (35%) of 46 patients receiving trimethoprim-sulfamethoxazole, 18 (43%) of 42 receiving nitrofurantoin, 12 (30%) of 40 receiving cefadroxil, and 13 (25%) of 52 receiving amoxicillin. The mean costs per patient were less with trimethoprim-sulfamethoxazole ($114) and amoxicillin ($131) compared with nitrofurantoin ($155) and cefadroxil ($155). CONCLUSIONS: A 3-day regimen of trimethoprim-sulfamethoxazole is more effective and less expensive than 3-day regimens of nitrofurantoin, cefadroxil, or amoxicillin for treatment of uncomplicated cystitis in women. The increased efficacy of trimethoprim-sulfamethoxazole is likely related to its antimicrobial effects against E coli in the rectum, urethra, and vagina.