Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial): A clinical and economic analysis.

BACKGROUND: Radiofrequency endometrial ablation (REA) is currently a second line treatment in women with heavy menstrual bleeding (MHB) if medical therapy (MTP) is contraindicated or unsatisfactory. Our objective is to compare the effectiveness and cost burden of MTP and REA in the initial treatment of HMB. METHODS: We performed a randomized trial at Mayo Clinic Rochester, Minnesota. The planned sample size was 60 patients per arm. A total of 67 women with HMB were randomly allocated to receive oral contraceptive pills (Nordette ®) or Naproxen (Naprosyn®) (n = 33) or REA (n = 34). Primary 12-month outcome measures included menstrual blood loss using pictorial blood loss assessment chart (PBLAC), patients' satisfaction, and Menorrhagia Multi-Attribute Scale (MMAS). Secondary outcomes were total costs including direct medical and indirect costs associated with healthcare use, patient out-of-pocket costs, and lost work days and activity limitations over 12 months. RESULTS: Compared to MTP arm, women who received REA had a significantly lower PBLAC score (median [Interquartile range, IQR]: 0 [0-4] vs. 15 [0-131], p = 0.003), higher satisfaction rates (96.8%vs.63.2%, p = 0.003) and higher MMAS (median [IQR]: 100 [100-100] vs. 100 [87-100], p = 0.12) at 12 months. Direct medical costs were higher for REA ($5,331vs.$2,901, 95% confidence interval (CI) of mean difference:$727,$4,852), however, when indirect costs are included, the difference did not reach statistical significance ($5,469 vs. $3,869, 95% CI of mean difference:-$339, $4,089). CONCLUSION: For women with heavy menstrual bleeding, initial radiofrequency endometrial ablation compared to medical therapy offered superior reduction in menstrual blood loss and improvement in quality of life without significant differences in total costs of care. CLINICAL TRIAL REGISTRATION: NCT01165307.

Medical care costs associated with traumatic brain injury over the full spectrum of disease: a controlled population-based study.

Data on traumatic brain injury (TBI) economic outcomes are limited. We used Rochester Epidemiology Project (REP) resources to estimate long-term medical costs for clinically-confirmed incident TBI across the full range of severity after controlling for pre-existing conditions and co-occurring injuries. All Olmsted County, Minnesota, residents with diagnoses indicative of potential TBI from 1985-2000 (n=46,114) were identified, and a random sample (n=7175) was selected for medical record review to confirm case status, and to characterize as definite (moderate/severe), probable (mild), or possible (symptomatic) TBI. For each case, we identified one age- and sex-matched non-TBI control registered in REP in the same year (±1 year) as case's TBI. Cases with co-occurring non-head injuries were assessed for non-head-injury severity and assigned similar non-head-injury-severity controls. The 1145 case/control pairs for 1988-2000 were followed until earliest death/emigration of either member for medical costs 12 months before and up to 6 years after baseline (i.e., injury date for cases and comparable dates for controls). Differences between case and control costs were stratified by TBI severity, as defined by evidence of brain injury; comparisons used Wilcoxon signed-rank plus multivariate modeling (adjusted for pre-baseline characteristics). From baseline until 6 years, each TBI category exhibited significant incremental costs. For definite and probable TBI, most incremental costs occurred within the first 6 months; significant long-term incremental medical costs were not apparent among 1-year survivors. By contrast, cost differences between possible TBI cases and controls were not as great within the first 6 months, but were substantial among 1-year survivors. Although mean incremental costs were highest for definite cases, probable and possible cases accounted for>90% of all TBI events and 66% of total incremental costs. Preventing probable and possible events might facilitate substantial reductions in TBI-associated medical care costs.

A prospective, randomized, double-blind trial of 3 regimens for sedation and analgesia after cardiac surgery.

OBJECTIVE: The aim of this study was to evaluate cardiac risk as a consideration for selecting postoperative sedation and analgesia regimens used for cardiac surgical patients requiring cardiopulmonary bypass and early extubation. DESIGN: An observer-blind, randomized, controlled trial. SETTING: A tertiary referral medical center involving an intensive care unit. PARTICIPANTS: One hundred forty-five adults requiring elective cardiac surgery. INTERVENTIONS: Patients were stratified preoperatively as low, moderate, or high cardiac risk based on established criteria and then assigned to 1 of 3 postoperative regimens: propofol infusion beginning at 25 µg/kg/min and morphine boluses (P), fentanyl infusion beginning at 2 µg/kg/h and midazolam boluses (F), or propofol and fentanyl infusions beginning at 25 µg/kg/min and 0.5 µg/kg/h (PF), respectively. MEASUREMENTS AND MAIN RESULTS: Postoperative regimen P was associated with a significantly reduced time to extubation (median value, 264 minutes; p = 0.05) compared with F (295 minutes) but not PF (278 minutes) in patients characterized as low cardiac risk. The time to extubation did not differ among regimens in patients of moderate/high cardiac risk. CONCLUSION: Patients with low cardiac risk undergoing cardiac surgery had statistically significantly shorter times to extubation with propofol infusion and intermittent morphine than a fentanyl infusion and intermittent midazolam. These differences were not sustained in patients considered at higher cardiac risk. The time to extubation after cardiac surgery may further improve if postoperative sedation and analgesia are not administered uniformly to all patients but selected based on individual characteristics.

Hospitalizations after heart failure diagnosis a community perspective.

OBJECTIVES: The purpose of this study was to determine the lifetime burden and risk factors for hospitalization after heart failure (HF) diagnosis in the community. BACKGROUND: Hospitalizations in patients with HF represent a major public health problem; however, the cumulative burden of hospitalizations after HF diagnosis is unknown, and no consistent risk factors for hospitalization have been identified. METHODS: We validated a random sample of all incident HF cases in Olmsted County, Minnesota, from 1987 to 2006 and evaluated all hospitalizations after HF diagnosis through 2007. International Classification of Diseases-9th Revision codes were used to determine the primary reason for hospitalization. To account for repeated events, Andersen-Gill models were used to determine the predictors of hospitalization after HF diagnosis. Patients were censored at death or last follow-up. RESULTS: Among 1,077 HF patients (mean age 76.8 years, 582 [54.0%] female), 4,359 hospitalizations occurred over a mean follow-up of 4.7 years. Hospitalizations were common after HF diagnosis, with 895 (83.1%) patients hospitalized at least once, and 721 (66.9%), 577 (53.6%), and 459 (42.6%) hospitalized > or =2, > or =3, and > or =4 times, respectively. The reason for hospitalization was HF in 713 (16.5%) hospitalizations and other cardiovascular in 936 (21.6%), whereas over one-half (n = 2,679, 61.9%) were noncardiovascular. Male sex, diabetes mellitus, chronic obstructive pulmonary disease, anemia, and creatinine clearance <30 ml/min were independent predictors of hospitalization (p < 0.05 for each). CONCLUSIONS: Multiple hospitalizations are common after HF diagnosis, though less than one-half are due to cardiovascular causes. Comorbid conditions are strongly associated with hospitalizations, and this information could be used to define effective interventions to prevent hospitalizations in HF patients.

The economic implications of a multimodal analgesic regimen for patients undergoing major orthopedic surgery: a comparative study of direct costs.

BACKGROUND AND OBJECTIVES: Total knee and total hip arthoplasty (THA) are 2 of the most common surgical procedures performed in the United States and represent the greatest single Medicare procedural expenditure. This study was designed to evaluate the economic impact of implementing a multimodal analgesic regimen (Total Joint Regional Anesthesia [TJRA] Clinical Pathway) on the estimated direct medical costs of patients undergoing lower extremity joint replacement surgery. METHODS: An economic cost comparison was performed on Mayo Clinic patients (n = 100) undergoing traditional total knee or total hip arthroplasty using the TJRA Clinical Pathway. Study patients were matched 1:1 with historical controls undergoing similar procedures using traditional anesthetic (non-TJRA) techniques. Matching criteria included age, sex, surgeon, type of procedure, and American Society of Anesthesiologists (ASA) physical status (PS) classification. Hospital-based direct costs were collected for each patient and analyzed in standardized inflation-adjusted constant dollars using cost-to-charge ratios, wage indexes, and physician services valued using Medicare reimbursement rates. The estimated mean direct hospital costs were compared between groups, and a subgroup analysis was performed based on ASA PS classification. RESULTS: The estimated mean direct hospital costs were significantly reduced among TJRA patients when compared with controls (cost difference, 1999 dollars; 95% confidence interval, 584-3231 dollars; P = 0.0004). A significant reduction in hospital-based (Medicare Part A) costs accounted for the majority of the total cost savings. CONCLUSIONS: Use of a comprehensive, multimodal analgesic regimen (TJRA Clinical Pathway) in patients undergoing lower extremity joint replacement surgery provides a significant reduction in the estimated total direct medical costs. The reduction in mean cost is primarily associated with lower hospital-based (Medicare Part A) costs, with the greatest overall cost difference appearing among patients with significant comorbidities (ASA PS III-IV patients).

The economic burden of complications during percutaneous coronary intervention.

BACKGROUND: Technological advances have enabled percutaneous coronary intervention (PCI) to be applied with expanding indications. However, escalating costs are of concern. This study assessed the incremental medical costs of major in-hospital procedural complications incurred by patients undergoing PCI. METHODS: We considered all patients undergoing elective, urgent, or emergent PCI at Mayo Clinic Rochester between 3/1/1998-3/31/2003 in analyses. Clinical, angiographic, and outcome data were derived from the Mayo Clinic PCI Registry. In-hospital PCI complications included major adverse cardiac and cerebrovascular events (MACCE) and bleeding of clinical significance. Administrative data were used to estimate total costs in standardised, year 2004, constant-US dollars. We used generalised linear modeling to estimate costs associated with complications adjusting for baseline and procedural characteristics. RESULTS: 1071 (13.2%) of patients experienced complications during hospitalisation. Patients experiencing complications were older, more likely to present with emergent PCI, recent or prior myocardial infarction, multi-vessel disease, and comorbid conditions than patients who did not experience these events. Unadjusted total costs were, on average, $27,865+/-$39,424 for complicated patient episodes compared to $12,279+/-$6796 for episodes that were complication free (p<0.0001). Adjusted mean costs were $6984 higher for complicated PCIs compared with uncomplicated PCI episodes (95% CI of cost difference: $5801, $8168). Incremental costs associated with isolated bleeding events, MACCE, or for both bleeding and MACCE events were $5883, $5086, and $15,437, respectively (p<0.0001). CONCLUSIONS: This high-volume study highlights the significant economic burden associated with procedural complications. Resources and systems approaches to minimising clinical and economic complications in PCI are warranted.