Objective

To determine the effect of an ambulatory surgery center (ASC) opening in a healthcare market on utilization and quality of outpatient urologic surgery.

Methods

This is a retrospective cohort study of Medicare beneficiaries undergoing outpatient urologic surgery from 2001 to 2010. Markets were classified into 3 groups based on ASC status (ie, those with ASCs, those without ASCs, and those where ASCs were introduced). Multiple propensity score methods adjusted for differences between markets and general linear mixed models determined the effect of ASC opening on utilization and quality, defined by mortality and hospital admission within 30 days of the index procedure.

Results

During the study period, 195 ASCs opened in markets previously without one. Rates of hospital-based urologic surgery in markets where ASCs were introduced declined from 221 to 214 procedures per 10,000 beneficiaries in the 4 years after baseline. In contrast, rates in the other 2 market types increased over the same period (P<.001). Rates of outpatient urologic surgery overall (ie, in the hospital and ASC) demonstrated similar growth across market types during same period (P=.56). The introduction of an ASC into a market was not associated with increases in hospital admission or mortality (P>.5).

Conclusion

The introduction of an ASC into a healthcare market lowered rates of outpatient urologic surgery performed in the more expensive hospital setting. This redistribution was not associated with declines in quality or with greater growth in overall outpatient surgery use.

Objectives

To assess the impact of ambulatory surgery centers (ASCs) on rates of hospital-based outpatient procedures and adverse events.

Data sources

Twenty percent national sample of Medicare beneficiaries.

Study design

A retrospective study of beneficiaries undergoing outpatient surgery between 2001 and 2010. Health care markets were sorted into three groups-those with ASCs, those without ASCs, and those where one opened for the first time. Generalized linear mixed models were used to assess the impact of ASC opening on rates of hospital-based outpatient surgery, perioperative mortality, and hospital admission.

Principal findings

Adjusted hospital-based outpatient surgery rates declined by 7 percent, or from 2,333 to 2,163 procedures per 10,000 beneficiaries, in markets where an ASC opened for the first time (p < .001 for test between slopes). Within these markets, procedure use at ASCs outpaced the decline observed in the hospital setting. Perioperative mortality and admission rates remained flat after ASC opening (both p > .4 for test between slopes).

Conclusions

The opening of an ASC in a Hospital Service Area resulted in a decline in hospital-based outpatient surgery without increasing mortality or admission. In markets where facilities opened, procedure growth at ASCs was greater than the decline in outpatient surgery use at their respective hospitals.

Background

Outpatient surgery is increasingly delivered at freestanding ambulatory surgery centers (ASCs), which are thought to deliver quality care at lower costs per episode. The objective of this study was to understand potential facilitators and/or barriers to the introduction of freestanding ASCs in the United States.

Methods

This is an observational study conducted from 2008 to 2010 using a 20% sample of Medicare claims. Potential determinants of ASC dissemination, including population, system, and legal factors, were compared between markets that always had ASCs, never had ASCs, and those that had new ASCs open during the study. Multivariable logistic regression was used to determine characteristics of markets associated with the opening of a new facility in a previously naïve market.

Results

New ASCs opened in 67 previously naïve markets between 2008 and 2010. ASCs were more likely to open in hospital service areas that were urban (adjusted odds ratio [OR], 4.10; 95% confidence interval [CI], 1.51-10.96), had higher per capita income (adjusted OR, 3.83; 95% CI, 1.43-10.45), and had less competition for outpatient surgery (adjusted OR, 2.13; 95% CI, 1.02-4.45). Legal considerations and latent need, as measured by case volumes of hospital-based outpatient surgery in 2007, were not associated with the opening of a new ASC.

Conclusions

Freestanding ASCs opened in advantageous socioeconomic environments with the least amount of competition. Because of their associated efficiency advantages, policy makers might consider strategies to promote ASC diffusion in disadvantaged markets to potentially improve access and reduce costs.

Aims

The Michigan Incontinence Symptom Index (M-ISI) is a validated measure for urinary incontinence. This study evaluates the M-ISI as a screening tool for clinically relevant urinary incontinence in a population-based sample of women.

Methods

The Establishing the Prevalence of Incontinence (EPI) Study is a case-control, population-based study that enrolled women ages 35-64, with and without urinary incontinence. The M-ISI is a validated questionnaire with subdomains for stress and urgency urinary incontinence. Two hundred fourteen EPI subjects underwent a clinical evaluation and urodynamic testing to establish the presence and type of urinary incontinence, and also completed the M-ISI. The M-ISI scores were evaluated using receiver operating characteristic (ROC) curves to determine the optimal diagnostic threshold scores above which women were likely to have clinically relevant urinary incontinence.

Results

The optimal M-ISI diagnostic threshold scores were determined to be ≥ 3 for the stress urinary incontinence subdomain (area under the curve of 0.79), ≥ 5 for the urgency urinary incontinence subdomain (area under the curve of 0.88), and ≥ 7 for the Total M-ISI score (area under the curve of 0.89). The sensitivity and specificity of the M-ISI questionnaire for stress, urgency, and total urinary incontinence were 77% and 73%, 86% and 76%, and 84% and 75%, respectively.

Conclusions

The M-ISI may be used to screen for clinically relevant urinary incontinence with high sensitivity and specificity among women ages 35-64. A brief, self-administered tool such as the M-ISI can help health care providers identify and manage women with urinary incontinence.

Background

There has been a strong push to move outpatient surgery from hospital settings to ambulatory surgery centers (ASCs). Despite the efficiency advantages of ASCs, many are concerned that these facilities could increase overall utilization.

Objective

To assess the impact of ASC opening on rates of outpatient surgery.

Design

This was a retrospective cohort study of Medicare beneficiaries undergoing outpatient surgery between 2001 and 2010. We compared population-based rates of outpatient surgery in Hospital Service Areas (HSAs) with freestanding ASCs to those without. After adjusting for differences using multiple propensity score methods, we assessed the impact of ASC opening in an HSA previously without one on rates of outpatient surgery.

Subjects

Patients included were Medicare beneficiaries with Part B eligibility.

Main outcome measure

Adjusted HSA-level rates of outpatient surgery.

Results

Adjusted outpatient surgery rates increased from 2806 to 3940 per 10,000 and the number of ASC operating rooms grew from 7036 to 11,223 (both P<0.001 for trend). By the fourth year after opening, rates of outpatient surgery increased by 10.9% (from 3338 to 3701 per 10,000) in HSAs adding an ASC for the first time. In contrast, outpatient surgery rates grew by only 2.4% and 0.6% in HSAs where an ASC was always or never present, respectively (P<0.001 for test between 3 slopes).

Conclusions

Rather than redistributing patients from one setting to another, the opening of ASCs increases outpatient surgery use. However, the 10.9% increase is more modest than previously suggested by state-level data.

Objective

To assess the effectiveness of mesh compared with nonmesh slings placed in different surgical settings as measured by the frequency of complications within 1 year.

Methods

We performed a retrospective cohort study of Medicare beneficiaries undergoing sling surgery from 2006 to 2008 in hospital outpatient departments and hospital-based ambulatory surgery centers. Slings were identified and categorized according to the use of mesh by Healthcare Common Procedure Coding System codes and temporary "C" Healthcare Common Procedure Coding System codes. Patients were followed for 1 year after each procedure to identify complications. Logistic models were fit to assess relationships among sling type, surgical setting, and various complications.

Results

We identified 6,698 Medicare beneficiaries who underwent mesh sling procedures and 445 Medicare beneficiaries who underwent nonmesh sling procedures. The overall frequency of complications was similar between the two groups at 69.8% and 72.6% in the mesh and nonmesh groups, respectively (P=.22). Infectious complications were the most common complication at 45.4% and 50.1% of the mesh and nonmesh groups, respectively (P=.06). Patients undergoing mesh procedures were less likely than patients undergoing nonmesh procedures to require management for bladder outlet obstruction (13.9% compared with 19.3%, adjusted odds ratio [OR] 0.66, 95% confidence interval [CI] 0.52-0.85) and were less likely to have a subsequent sling removal and revision or urethrolysis (2.7% compared with 4.7%, adjusted OR 0.56, 95% CI 0.35-0.89).

Conclusion

Frequencies of most complications were similar regardless of the use of mesh except for the management of bladder outlet obstruction. These results did not differ based on the surgical setting where the sling procedure was performed.

Level of evidence

II.

Aims

To develop a clinically relevant, easy to use, and validated instrument for assessing severity and bother related to urinary incontinence.

Methods

Survey items were piloted and refined following psychometric principles in five separate patient cohorts. Patient and expert endorsement of items, factor analyses, Spearman rank correlations and response distributions were employed for item selection. Formal reliability and validity evaluation were conducted for the final questionnaire items.

Results

Expert physicians and patient focus groups confirmed face and content validity for the measure. A 10-item measure called the Michigan Incontinence Symptom Index (M-ISI) was developed with two domains: a Total M-ISI Domain consisting of subdomains for stress urinary incontinence, urgency urinary incontinence, and pad use, and a Bother Domain. High construct validity was demonstrated with a Cronbach's alpha for the Total M-ISI Domain (items 1-8) of 0.90 and for the Bother Domain (items 9-10) of 0.82. Cronbach's alpha for the subdomains were all > 0.85. Construct validity, convergent and divergent validity, internal discriminant validity, and predictive validity were all robust. The minimally important difference for the measure was determined to be 4 points (out of 32) for the Total M-ISI Severity Domain, and 1-2 points (out of 8-12) for the individual subdomains.

Conclusions

The M-ISI is a parsimonious measure that has established reliability and validity on several levels and complements current clinical evaluative methods for patients with urinary incontinence.

Purpose

We expanded the clinical usefulness of EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) by evaluating its responsiveness to health related quality of life changes, defining the minimally important differences for an individual patient change in each domain and applying it to a sexual outcome prediction model.

Materials and methods

In 1,201 subjects from a previously described multicenter longitudinal cohort we modeled the EPIC-CP domain scores of each treatment group before treatment, and at short-term and long-term followup. We considered a posttreatment domain score change from pretreatment of 0.5 SD or greater clinically significant and p ≤ 0.01 statistically significant. We determined the domain minimally important differences using the pooled 0.5 SD of the 2, 6, 12 and 24-month posttreatment changes from pretreatment values. We then recalibrated an EPIC-CP based nomogram model predicting 2-year post-prostatectomy functional erection from that developed using EPIC-26.

Results

For each health related quality of life domain EPIC-CP was sensitive to similar posttreatment health related quality of life changes with time, as was observed using EPIC-26. The EPIC-CP minimally important differences in changes in the urinary incontinence, urinary irritation/obstruction, bowel, sexual and vitality/hormonal domains were 1.0, 1.3, 1.2, 1.6 and 1.0, respectively. The EPIC-CP based sexual prediction model performed well (AUC 0.76). It showed robust agreement with its EPIC-26 based counterpart with 10% or less predicted probability differences between models in 95% of individuals and a mean ± SD difference of 0.0 ± 0.05 across all individuals.

Conclusions

EPIC-CP is responsive to health related quality of life changes during convalescence and it can be used to predict 2-year post-prostatectomy sexual outcomes. It can facilitate shared medical decision making and patient centered care.

Objectives

To assess trends in the use of sacral neuromodulation and to measure the magnitude of variation in its use across geographic regions.

Methods

We used the State Ambulatory Surgery Database (SASD) from 2002 to 2009 from Florida to identify patients implanted with a neuromodulator. Age- and gender-adjusted rates of implantation were calculated by year and by geographic region, defined by the Hospital Service Area. The coefficient of variation was estimated to quantify the magnitude of variation for different time periods.

Results

Adjusted rates of sacral neuromodulation increased significantly from 1.1 per 100,000 population in 2002 to 10.4 per 100,000 population in 2009. The majority of cases were performed for overactive bladder. There was a very large amount of geographic variation in rates of these procedures as evidenced by the high coefficients of variation: 1.67 (2002 and 2003), 1.70 (2004 and 2005), 1.49 (2006 and 2007), and 1.05 (2008 and 2009).

Conclusions

Rates of sacral neuromodulation have increased dramatically over the past decade. However, these rates of utilization are highly variable across regions, with some regions performing large numbers of these procedures and other regions performing few to no procedures. This range in practice patterns may reflect medical uncertainty surrounding the role of this procedure.

Objective

To establish a score threshold that constitutes a clinically relevant change for each domain of the Expanded Prostate Cancer Index Composite (EPIC) Short Form (EPIC-26). Although its use in clinical practice and clinical trials has increased worldwide, the clinical interpretation of this 26-item disease-specific patient-reported quality of life questionnaire for men with localized prostate cancer would be facilitated by characterization of score thresholds for clinically relevant change (the minimally important differences [MIDs]).

Methods

We used distribution- and anchor-based approaches to establish the MID range for each EPIC-26 domain (urinary, sexual, bowel, and vitality/hormonal) based on a prospective multi-institutional cohort of 1201 men treated for prostate cancer between 2003 and 2006 and followed up for 3 years after treatment. For the anchor-based approach, we compared within-subject and between-subject score changes for each domain to an external "anchor" measure of overall cancer treatment satisfaction.

Results

We found the bowel and vitality/hormonal domains to have the lowest MID range (a 4-6 point change should be considered clinically relevant), whereas the sexual domain had the greatest MID values (10-12). Urinary incontinence appeared to have a greater MID range (6-9) than the urinary irritation/obstruction domain (5-7).

Conclusion

Using 2 independent approaches, we established the MIDs for each EPIC-26 domain. A definition of these MID values is essential for the researcher or clinician to understand when changes in symptom burden among prostate cancer survivors are clinically relevant.