The CHOICES Study: Facility Level Comparative Cost, Resource Utilization, and Outcomes Analysis of Myomectomy Compared to Transcervical Fibroid Ablation.

PURPOSE: The CHOICES study compared short-term resource utilization, facility costs, and perioperative patient outcomes between transcervical fibroid ablation (TFA) with the Sonata® system and myomectomy through a case-matched comparative trial design. This is the first facility-level comparative study conducted for TFA. PATIENTS AND METHODS: The study enrolled 88 patients from 4 centers equally divided among the two cohorts. The TFA arm consisted of 44 women who had enrolled in the SONATA Pivotal IDE trial, whereas the myomectomy arm included 44 patients who were identified through retrospective case-matching to the enrolled SONATA patients at the same 4 centers. RESULTS: TFA had a significantly lower mean operating room duration (90 minutes) and length of stay (5.2 hours) than myomectomy (143 minutes and 45.8 hours, respectively). The average total mean facility costs for TFA procedure ($7,563) were significantly lower than those associated with myomectomy ($11,425; p=0.002). TFA mean facility costs were also compared with other stratifications of myomectomy (inpatient or outpatient and surgical route). TFA facility costs were significantly lower than that associated with inpatient, abdominal, or laparoscopic myomectomy (all p<0.001). CONCLUSION: TFA using the Sonata system has a significantly shorter operating room time and length of stay than myomectomy for the treatment of symptomatic uterine fibroids. All procedure, anesthesia, laboratory, pathology, and pharmacy costs were significantly higher for myomectomy as compared to TFA. TFA was also associated with significantly lower facility procedure-related costs compared to myomectomy, including inpatient, abdominal, or laparoscopic myomectomy.

The INSPIRE Comparative Cost Study: 12-Month Health Economic and Clinical Outcomes Associated with Hysterectomy, Myomectomy, and Treatment with the Sonata System.

PURPOSE: The INSPIRE study compared perioperative and 12-month health economic and clinical outcomes associated with hysterectomy, myomectomy, and sonography-guided transcervical fibroid ablation (TFA) using the Sonata® system. PATIENTS AND METHODS: Cost and health care resource utilization (HCRU) data for TFA were obtained from a prospective, multicenter, single-arm clinical trial. Data for hysterectomy and myomectomy arms were derived from the Truven Health MarketScan commercial payer claims database. The Truven data was used to determine health economic outcomes and costs for the hysterectomy and myomectomy arms. For each arm, payer perspective costs were estimated from the available charge and HCRU data. RESULTS: TFA with Sonata had significantly lower mean length of stay (LOS) of 5 hrs versus hysterectomy (73 hrs) or myomectomy (79 hrs; all p< 0.001). The average payer cost for TFA treatment, including the associated postoperative HCRU was $8,941. This was significantly lower compared to hysterectomy ($24,156) and myomectomy ($22,784; all p< 0.001). In the TFA arm, there were no device- or procedure-related costs associated with complications during the peri- or postoperative time frame. TFA subjects had significantly lower costs associated with complications, prescription medications, and radiology. CONCLUSION: Compared to hysterectomy and myomectomy, TFA treatment with the Sonata system was associated with significantly lower index procedure cost, complication cost, and LOS, contributing to a lower total payer cost through 12 months.

The association between hydroxyurea treatment and pain intensity, analgesic use, and utilization in ambulatory sickle cell anemia patients.

BACKGROUND: We compared daily pain, home analgesic use, and utilization among ambulatory adults in the randomized multicenter study of hydroxyurea in sickle cell anemia (MSH). We related the fetal hemoglobin (HbF) hydroxyurea response to these response variables. METHODS: Patients rated their sickle cell pain intensity (0-9), use of analgesics, and visits for pain daily. Diaries were collected biweekly, and intensity was collapsed into single interval ratings. The interval proportions of days of analgesic use and medical visits for pain were also calculated. Group comparisons were made by intention to treat as well as by HbF change levels from baseline to 2 years of treatment (placebo and low, medium, high, or very high response). RESULTS: A total of 134 (44.8%) enrollees completed 2 years of follow-up. Pain intensity correlated with analgesic use (r = 0.83, P > 0.0001) and utilization (r = 0.50, P < 0.0001). Pain intensity was lower for patients on hydroxyurea (2.51 ± 0.062 vs 2.82 ± 0.063 placebo, F(1270) = 11.65, P = 0.0007). The difference, though small, appeared early and was sustained. Analgesic use and utilization were also slightly lower (analgesic use: F (1270) = 11.97, P = 0.0006; utilization: F(1270) = 32.0, P < 0.0001). Each was statistically significantly lower among hydroxyurea patients with higher HbF treatment responses to hydroxyurea. CONCLUSIONS: Hydroxyurea usage led to a small, statistically significant reduction in daily pain, analgesic use, and utilization in adults in MSH, corroborating previously shown larger reductions in crises and mortality. The degree of daily symptomatic reduction was related to the size of the HbF treatment response, further confirming HbF response as a useful laboratory correlate.

The impact of hydroxyurea on career and employment of patients with sickle cell anemia.

The purpose of this study was to determine the association between hydroxyurea treatment and changes in employment status, if any, among patients with sickle cell anemia enrolled in the Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH). To that end, we compared the employment status among treatment responders, treatment nonresponders, and placebo groups of patients enrolled in MSH during the clinical trial and follow-up periods. Treatment with hydroxyurea did not significantly (p > .05) affect employment status, but there was a trend for more consistent employment in the hydroxyurea group. Given the fact that patients enrolled in MSH had moderate to severe disease with irreversible complications such as avascular necrosis, if would be attractive to hypothesize that future treatment of young patients with hydroxyurea could prevent or mitigate the incidence of complications of sickle cell anemia and, hence, improve the employment status of treated patients.

Early detection of response to hydroxyurea therapy in patients with sickle cell anemia.

Red blood cells (RBC) and reticulocyte parameters were determined on peripheral blood from a subset of patients enrolled in the multicenter study of hydroxyuea (HU) in sickle cell anemia. Multiple blood samples were obtained every 2 weeks. Cellular indices were measured by flow cytometry. Generalized linear models were used to determine the relationship between the longitudinal trajectories of RBC and reticulocyte indices and HU usage. There was a significant relationship between HU usage and most of the RBC and reticulocyte indices. Hydroxyurea produced higher value trajectories than those generated by placebo usage for the hemoglobin (Hb) content of both the RBCs and reticulocytes and for the mean corpuscular volume (MCV) of reticulocytes. These changes were first detected 10 weeks after starting HU and before the increase in Hb F levels. The data suggest that subtle and early markers of response to HU reside in the hemogram.

Hydroxyurea and acute painful crises in sickle cell anemia: effects on hospital length of stay and opioid utilization during hospitalization, outpatient acute care contacts, and at home.

CONTEXT: Exploratory findings from the randomized, double-blind, placebo-controlled, multicenter study of hydroxyurea (MSH) in sickle cell anemia (SS). Recurrent acute painful crises may be mild, moderate, or severe in nature and often require treatment at home, in acute care facilities as outpatients, and in the hospital with oral and/or parenteral opioids. OBJECTIVES: The objectives of this study were to determine the effects of hydroxyurea (HU) on length of stay (LOS) in hospital and opioid utilization during hospitalization, outpatient acute care contacts, and at home. METHODS: Data from patient diaries, follow-up visit forms, and medical contact forms for the 299 patients enrolled in the MSH were analyzed. Types and dosages of at home, acute care, and in-hospital analgesic usage were explored descriptively. RESULTS: At-home analgesics were used on 40% of diary days and 80% of two-week follow-up periods, with oxycodone and codeine the most frequently used. Responders to HU used analgesics on fewer days. During hospitalization, 96% were treated with parenteral opioids, with meperidine the most frequently used; oxycodone was the most commonly used oral medication. The average LOS for responders to HU was about two days less than for other groups, and their cumulative time hospitalized during the trial was significantly less than for nonresponders or placebo groups (P<0.022). They also had the lowest doses of parenteral opioids during acute care crises (P=0.015). CONCLUSION: Beneficial effects of HU include shortening the duration of hospitalization because of acute painful episodes and reducing the net amount of opioid utilization.

Climatic and geographic temporal patterns of pain in the Multicenter Study of Hydroxyurea.

No multi-site comparisons have tested whether seasonally cold temperature or climate exacerbate pain intensity in sickle cell disease (SCD). We examined seasonal SCD pain intensity and frequency patterns and compared them with concurrent climate conditions (temperature and barometric pressure) and geography of patient residence in the Multicenter Study of Hydroxyurea (MSH). We conducted a time series analysis of the monthly average daily pain intensity (0-9 scale) and pain frequency of the 299 MSH patients from December 1991 to December 1994. We used both an unobserved component model (UCM) and a nonparametric local regression (LOESS) to probe for a cycle and/or trend associated with the time series. We also examined base mixed regression models of season, monthly average temperature and barometric pressure, and geographic region as stand-alone predictors of pain intensity and frequency. Expanded models included additional predictor variables. UCM and LOESS analyses showed a cyclic pattern of pain intensity and frequency with peaks in late Fall/early Winter and troughs in Spring. Base regression models showed colder seasons were significantly associated with greater pain intensity (p = .0035) but not frequency (p = .07); higher monthly temperatures were significantly associated with both lower pain intensity and pain frequency, but higher monthly barometric pressures were significantly associated with greater pain intensity and frequency (all p's < .0001); and northern sites had nonsignificantly higher pain intensity (p = .40) and frequency (p = .07) than southern sites. This pattern of results did not change in expanded models including other predictors. Our results suggest that seasonably colder temperatures exacerbate sickle cell-related pain, but low barometric pressure does not, and geographic region of residence is not significantly related to pain in this sample.

HIV prevention with jail and prison inmates: Maryland's Prevention Case Management program.

Prevalence of HIV infection and AIDS cases is higher among inmates of correctional facilities than among the general population, especially for female inmates. This creates a strong need for effective HIV prevention with this population. Maryland's Prevention Case Management (PCM) program provides individual or group counseling to inmates nearing release to promote changes in risk behavior. Pretest and posttest surveys assess changes in perceived risk, condom attitudes, condom use self-efficacy, self-efficacy to reduce injection drug risk and other substance use risk, and behavioral intentions during participation in the program. Client contact logs, kept by counselors, document the number and duration of sessions, and the specific modules, completed by participants. Over a 4-year period, PCM records identified 2,610 participants in the program. Pre-intervention and postintervention data were available for 745 participants, with client contact log records available for 529 (71%) of these individuals. Significant, positive changes were found in self-reported condom attitudes, self-efficacy for condom use, self-efficacy for injection drug use risk, self-efficacy for other substance use risk, and intentions to practice safer sex post-release. Inmate populations are a crucial audience for HIV/AIDS testing, treatment, and prevention efforts. The Maryland PCM program has documented positive changes in participants' attitudes, self-efficacy, and intentions related to HIV risk, over a 4-year period.