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Background: The value of the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program has been questioned as a marker of physician quality., Objective: To assess whether physician MOC status is associated with performance on selected Healthcare Effectiveness Data and Information Set (HEDIS) process measures., Design: Annual comparisons of HEDIS process measures among physicians who did or did not maintain certification 20 years after initial certification., Setting: Fee-for-service Medicare., Participants: 1260 general internists who were initially certified in 1991 and provided care for 85 931 Medicare patients between 2009 and 2012., Measurements: Annual percentage of a physician's Medicare patients meeting each of 5 HEDIS annual or biennial standards and a composite indicating meeting all 3 HEDIS diabetes standards., Results: Among the 1260 physicians, 786 maintained their certification from 1991 to 2012 and 474 did not. The mean annual percentage of HEDIS-eligible diabetic patients who completed semiannual hemoglobin A1c testing was 58.4% among physicians who maintained certification and 54.4% among those who did not (regression-adjusted difference, 4.2 percentage points [95% CI, 2.0 to 6.5 percentage points]; P < 0.001). Diabetic patients of physicians who maintained certification more frequently met the annual standard for low-density lipoprotein (LDL) cholesterol measurement (83.1% vs. 80.5%; regression-adjusted difference, 2.3 percentage points [CI, 0.6 to 4.1 percentage points]; P = 0.008) and all 3 diabetic standards (46.0% vs. 41.6%; regression-adjusted difference, 3.1 percentage points [CI, 0.5 to 5.7 percentage points]; P = 0.019). The regression-adjusted difference in biennial eye examinations was statistically insignificant (P = 0.112). Measures for LDL cholesterol testing in patients with coronary heart disease and biennial mammography were also met more frequently among physicians who maintained certification (79.4% vs. 77.4% and 72.0% vs. 67.8%, respectively), with regression-adjusted differences of 1.7 percentage points (CI, 0.2 to 3.3 percentage points; P = 0.032) and 4.6 percentage points (CI, 2.9 to 6.3 percentage points; P < 0.001), respectively., Limitation: Potential confounding by unobserved patient, physician, and practice characteristics; inability to determine clinical significance of observed differences., Conclusion: Maintaining certification was positively associated with physician performance scores on a set of HEDIS process measures., Primary Funding Source: American Board of Internal Medicine.

Background: Limited data suggest high rates of unplanned rehospitalization after endovascular and surgical revascularization for peripheral arterial disease. However, the overall burden of readmissions has not been comprehensively explored., Objective: To evaluate nationwide readmissions after peripheral arterial revascularization for peripheral arterial disease and to assess whether readmission risk varies among hospitals., Design: Retrospective cohort study., Setting: 1085 U.S. acute care hospitals participating in the Nationwide Readmissions Database., Patients: 61 969 unweighted hospitalizations of patients with peripheral arterial disease who had peripheral arterial revascularization and were discharged alive between 1 January and 30 November 2014., Measurements: 30-day readmission rates, causes, and costs of unplanned rehospitalizations after peripheral arterial revascularization; 30-day risk-standardized readmission rates (RSRRs), calculated using hierarchical logistic regression, to assess for heterogeneity of readmission risk between hospitals., Results: Among 61 969 hospitalizations of patients with peripheral arterial disease who were discharged alive after peripheral arterial revascularization, the 30-day nonelective readmission rate was 17.6%. The most common cause of readmission was procedural complications (28.0%), followed by sepsis (8.3%) and complications due to diabetes mellitus (7.5%). Among rehospitalized patients, 21.0% underwent a subsequent peripheral arterial revascularization or lower extremity amputation, 4.6% died, and the median cost of a readmission was $11 013. Thirty-day RSRRs varied from 10.0% to 27.3% (interquartile range, 16.6% to 18.8%)., Limitation: Inability to distinguish out-of-hospital deaths after discharge and potential misclassification bias due to use of billing codes to ascertain diagnoses and interventions., Conclusion: More than 1 in 6 patients with peripheral arterial disease who undergo peripheral arterial revascularization have unplanned readmission within 30 days, with high associated mortality risks and costs. Procedure- and patient-related factors were the primary reasons for readmission. Readmission rates varied moderately between institutions after hospital case mix was accounted for, suggesting that differences in hospital quality may only partially account for readmission., Primary Funding Source: Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center.

Background: Higher hospital and surgeon volumes are independently associated with improved mortality after open repair of abdominal aortic aneurysms (AAAs) in the era before endovascular AAA repair (EVAR). The effects of both surgeon and hospital volume on mortality after EVAR and open repair in the current era are less well defined., Methods: We studied Medicare beneficiaries who underwent elective AAA repair from 2001 to 2008. Volume was measured by procedure type during the 1-year period preceding each procedure and was further categorized into quintiles of volume for surgeon and hospital. Multilevel logistic regression models were used to evaluate the effect of surgeon volume, accounting for hospital volume, on mortality after adjusting for patient demographic and comorbid conditions as well as the analogous effect of hospital volume adjusting for surgeon volume. The multilevel models included random effects for surgeon and hospital to account for the clustering of multiple patients within the same surgeon and within the same hospital., Results: We studied 122,495 patients who underwent AAA repair (open: 45,451; EVAR: 77,044). After EVAR, perioperative mortality did not differ by surgeon volume (quintile 1 [0-6 EVARs]: 1.8%; quintile 5 [28-151 EVARs]: 1.6%; P = .29), but decreased with greater hospital volume (quintile 1 [0-9 EVARs]: 1.9%; quintile 5 [49-198 EVARs]: 1.4%; P < .01). After open repair, perioperative mortality decreased with both higher surgeon volume (quintile 1 [0-3 open repairs]: 6.4%; quintile 5 [14-62 open repairs]: 3.8%; P < .01) and hospital volume (quintile 1 [0-5 open repairs]: 6.3%; quintile 5 [14-62 open repairs]: 3.8%; P < .01). After adjustment for other predictors, surgeon volume was not associated with perioperative mortality after EVAR (odds ratio [OR], 0.9; 95% confidence interval [CI], 0.7-1.1); however, hospital volume was associated with higher perioperative mortality (quintile 1: OR, 1.5; 95% CI, 1.2-1.9; quintile 2: OR, 1.3; 95% CI, 1.02-1.6; and quintile 3: OR, 1.2; 95% CI, 1.01-1.5, compared with 5). After open repair, higher surgeon volume was also associated with lower mortality (quintile 1: OR, 1.5; 95% CI, 1.3-1.8; quintile 2: OR, 1.3; 95% CI, 1.1-1.6; and quintile 3: OR, 1.2; 95% CI, 1.1-1.4, compared with 5). Risk of mortality also was higher for patients treated at lower-volume hospitals (quintile 1: OR, 1.3; 95% CI, 1.1-1.5; quintile 2: OR, 1.3; 95% CI, 1.1-1.5; and quintile 3: OR, 1.2; 95% CI, 1.1-1.4, compared with 5)., Conclusions: After EVAR, hospital volume is minimally associated with perioperative mortality, with no such association for surgeon volume. After open AAA repair, surgeon and hospital volume are both strongly associated with mortality. These findings suggest that open surgery should be concentrated in hospitals and surgeons with high volume., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Excitement around the adoption of electronic communication between physicians and patients is tempered by the possibility of increased clinical and legal risk. If patients do not read messages in a timely fashion, duplicative communication efforts may be required and patient safety may be jeopardized., Objective: We sought to assess the prevalence and risk profile of unread messages in a mature patient portal., Methods: We analyzed six years of messages (2005-2010) from physicians to patients to determine the prevalence and associated characteristics of unread messages in a patient portal. We focused on clinical messages, and excluded announcements. Because some physicians sent clinical messages to groups of patients, we labeled messages sent to more than 5 patients as "outreach" messages and excluded them from general analyses. We performed a chart review of 75 clinical messages to assess for harm., Results: We found that 3% of clinical messages were unread after 21 days. Messages arriving outside of business hours were slightly more likely to go unread (RR 1.15 95% CI 1.11-1.19). Patients who were male (OR 1.14 CI 1.04-1.26) African American (OR 1.69 CI 1.29-2.22) or Hispanic (OR 1.74 CI 1.17-2.59), or in the lowest income group (OR 1.72 CI 1.19-2.49) were more likely to have unread messages. Chart review showed no evidence of harm, but 13% of sampled unread messages were associated with potential delays in care. Incidentally, we found 50% of the physician-initiated outreach messages were unread., Conclusions: Overall, secure messaging appears a safe form of communication, but systems to notify senders when messages are unread may have value. While most clinical messages were read, many outreach messages were not, providing caution for relying on such systems for information dissemination. Similar to other studies, differences by race and income were observed and require further study.

Purpose: In November 2009, the US Preventive Services Task Force (USPSTF) changed its mammography recommendations from every 1 to 2 years among women age ≥ 40 years to personalized screening decisions for women age 40 to 49 years and screening every 2 years for women age 50 to 74 years., Methods: We studied mammography trends among 5.5 million women age 40 to 64 years enrolled in a large national health insurer. We used 2005 to 2009 mammography trends to predict 2012 rates. Our primary measure was the estimated difference between observed and predicted 2012 annual and biennial mammography rates. We stratified results by age group and race/ethnicity., Results: Among women age 40 to 49 years, 2012 mammography rates declined by 9.9% (95% CI, -10.4% to -9.3%) relative to the predicted 2012 rate. Decreases were lowest among black women (-2.3%; 95% CI, -6.3% to 1.8%) and highest among Asian women (-17.4; 95% CI, -20.0 to -14.8). Annual mammography rates among women age 50 to 64 years declined by 6.1% (95% CI, -6.5% to -5.7%) by 2012. Regarding biennial mammography rates, women age 40 to 49 years experienced a 9.0% relative reduction (95% CI, -9.6% to -8.4%). White, Hispanic, and Asian women age 40 to 49 years demonstrated similar relative reductions of approximately 9% to 11%, whereas black women had no detectable changes (0.1%; 95% CI, -4.0% to 4.3%). Women age 50 to 64 years had a 6.2% relative reduction (95% CI, -6.6% to -5.7%) in biennial mammography that was similar among white, Hispanic, and Asian women. Black women age 50 to 64 years did not have changes in biennial mammography (0.4%; 95% CI, -2.6% to 3.5%)., Conclusion: Three years after publication of the 2009 USPSTF guidelines, mammography rates declined by 6% to 17% among white, Hispanic, and Asian women but not among black women. Small reductions in biennial mammography might be an unintended consequence of the updated guidelines., (© 2015 by American Society of Clinical Oncology.)

Background: In 2009-2010, Blue Cross Blue Shield of Massachusetts entered into global payment contracts (the Alternative Quality contract, AQC) with 11 provider organizations. We evaluated the impact of the AQC on spending and utilization of several categories of medical technologies, including one considered high value (colonoscopies) and three that include services that may be overused in some situations (cardiovascular, imaging, and orthopedic services)., Methods: Approximately 420,000 unique enrollees in 2009 and 180,000 in 2010 were linked to primary care physicians whose organizations joined the AQC. Using three years of pre-intervention data and a large control group, we analyzed changes in utilization and spending associated with the AQC with a propensity-weighted difference-in-differences approach adjusting for enrollee demographics, health status, secular trends, and cost-sharing., Results: In the 2009 AQC cohort, total volume of colonoscopies increased 5.2 percent (p=0.04) in the first two years of the contract relative to control. The contract was associated with varied changes in volume for cardiovascular and imaging services, but total spending on cardiovascular services in the first two years decreased by 7.4% (p=0.02) while total spending on imaging services decreased by 6.1% (p<0.001) relative to control. In addition to lower utilization of higher-priced services, these decreases were also attributable to shifting care to lower-priced providers. No effect was found in orthopedics., Conclusions: As one example of a large-scale global payment initiative, the AQC was associated with higher use of colonoscopies. Among several categories of services whose value may be controversial, the contract generally shifted volume to lower-priced facilities or services.

Background: Posttraumatic stress disorder (PTSD) is a commonly occurring and often debilitating psychiatric condition. There currently is not definitive information regarding the efficacy of repetitive transcranial magnetic stimulation (rTMS) for PTSD., Objective: This study seeks to examine the efficacy of rTMS for PTSD., Methods: Twenty subjects with PTSD were randomly assigned to receive either 10 rTMS sessions delivered at 1 Hz to the right dorsolateral prefrontal cortex (DLPRC) or 10 sham rTMS sessions to the same area. A blinded rater assessed PTSD, depressive, anxiety, and neurocognitive symptoms before treatment, after the treatment series, and during a 2-month follow-up period., Results: Trancranial magnetic stimulation delivered at 1 Hz to the right DLPRC resulted in statistically and clinically significant improvements in core PTSD symptoms and depressive symptoms compared with sham treatments. The effectiveness showed some degradation during the 2 months after treatments were stopped., Conclusions: This blinded sham controlled trial supports the efficacy of 10 sessions of right DLPRC rTMS delivered at 1 Hz for the treatment of PTSD symptoms., (Published by Elsevier Inc.)

Objectives: This study assessed trends in open and endovascular repair (EVAR) of intact and ruptured abdominal aortic aneurysm (AAA) in the Medicare population and evaluated recent trends in AAA repair at vascular fellowship training programs., Methods: We identified all Medicare beneficiaries with a diagnosis of AAA who underwent repair or had a primary diagnosis of rupture (1995-2008). Cohorts were compared by type of repair (open vs EVAR) and presentation (intact vs ruptured AAA). Demographics of age, sex, and race were evaluated. We used unique hospital identifier codes to compare trends and 30-day mortality between hospitals that participate in vascular surgery fellowship training and those that do not. American Council on Graduate Medical Education data, only available for the years 1999 to 2008, were further used to better understand the changes in number of EVAR and open repairs of AAA performed each year for vascular fellows and general surgery residents, over time., Results: We identified 449,122 patients (76% men), with 376,355 intact AAAs (84%) and 72,767 ruptured AAAs (16%). Mean age was 75.1 years. Use of EVAR for intact AAA rose to from 35% in 2001 to 63% in 2005 and comprised 78% of repairs by 2008. During the same period, the number of ruptured AAAs decreased by 40% overall, with nonoperative ruptured AAAs decreasing by 29% and EVAR increasing to 31% of rupture repairs. Hospitals training vascular fellows were quicker to adopt EVAR (2-year lag time) for intact AAA and had higher rates of EVAR for ruptured AAA (41.1% vs 29.2%; P = .001) than did hospitals without fellows. Mortality rates for open repairs of intact (4.0% vs 5.0%; P = .01) and ruptured AAA (34.1% vs 41.0%; P = .031) were lower at fellowship hospitals. The average number of open AAA repairs performed by vascular fellows dropped 50% (44.1 to 21.6/year) from 1999 to 2008., Conclusions: Contrary to the expectation of a plateau, use of EVAR for intact AAA continues to rise at fellowship and nonfellowship hospitals. Use of EVAR for rupture is being used more often at fellowship programs. The decline in open repairs performed by vascular fellows, and at fellowship and non-fellowship hospitals, may have important implications for future attending experience., (Copyright © 2011. Published by Mosby, Inc.)

Background: Data on complications of gastrointestinal endoscopic procedures are limited. We evaluated prospectively the incidence and cost of hospital visits resulting from outpatient endoscopy., Methods: We developed an electronic medical record-based system to record automatically admissions to the emergency department (ED) within 14 days after endoscopy. Physicians evaluated all reported cases for relatedness of the ED visit to the prior endoscopy based on predetermined criteria., Results: We evaluated 6383 esophagogastroduodenoscopies (EGDs) and 11 632 colonoscopies (7392 for screening and surveillance). Among these, 419 ED visits and 266 hospitalizations occurred within 14 days after the procedure. One hundred thirty-four (32%) of the ED visits and 76 (29%) of the hospitalizations were procedure related, whereas 31 complications were recorded by standard physician reporting (P < .001). Procedure-related hospital visits occurred in 1.07%, 0.84%, and 0.95% of all EGDs, all colonoscopies, and screening colonoscopies, respectively. The mean costs were $1403 per ED visit and $10 123 per hospitalization based on Medicare standardized rates. Across the overall screening/surveillance colonoscopy program, these episodes added $48 per examination., Conclusions: Using a novel automated system, we observed a 1% incidence of related hospital visits within 14 days of outpatient endoscopy, 2- to 3-fold higher than recent estimates. Most events were not captured by standard reporting, and strategies for automating adverse event reporting should be developed. The cost of unexpected hospital visits postendoscopy may be significant and should be taken into account in screening or surveillance programs.

We determined if specific tumor types of non-small cell lung cancer can be identified by variance in FDG-PET standard uptake value (SUV) in combination with characteristics on CT. Staging FDG-PET and CT scans of 81 patients (34 men and 47 women, average age 67+/-11 years) with 82 lung cancers were analyzed. Mean tumor SUV was calculated at the location of maximum FDG uptake. Tumor size, margins, and location were analyzed on CT. Statistical analysis compared SUV between tumor subtypes, assessed relationship between tumor subtype and features on CT and determined if combination of CT and SUV patterns predicted tumor type. In total 35 adenocarcinomas (AC); 15 bronchioloalveolar cell carcinomas (BAC), 23 squamous cell carcinomas and 9 large cell carcinomas were evaluated. Significant differences were found between SUV of all AC and squamous cell (p<0.0001); between all AC and large cell (p=0.03); between non-BAC AC and squamous cell types (p=0.0005); BAC and non-BAC AC (p=0.04), BAC and squamous cell (p<0.0001); BAC and large cell (p=0.004). Ground glass was the most significant CT feature in distinguishing tumor types, which was seen in BAC (p<0.0003). In conclusion, SUVs for non-small cell lung cancer were most significantly different between BAC and all other NCLC cell subtypes. The presence of ground glass in a nodule on CT is a significant feature for BAC and should raise the suspicion for this tumor type despite low FDG uptake.

Introduction: A flywheel ergometer has been devised which employs gravity-independent inertial resistance. Concentric and eccentric actions, which are integral to weight-bearing and ambulation activities, may be done on this ergometer. However, blood lactate responses to exercise on the ergometer by contractile mode and training volume are unknown., Methods: Workout order was balanced so that subjects performed each type of ergometer leg press workout twice in a nonsequential manner. Per workout, 10 repetitions were performed per set. Workouts were as follows: three sets with concentric and eccentric (CE3) actions, three sets with concentric-only (CO3) actions, and six sets with concentric-only (CO6) actions. Pre- and 5-min post-exercise lactate was measured from a fingertip blood drop. Lactate means were compared with a 2 x 3 (time X workout) ANOVA with repeated measures applied to both independent variables and Scheffe's post hoc test. With body mass and performance measures as predictor variables, multivariate regression attempted to explain post-exercise and delta (post-pre) lactate variance., Results: Post-exercise blood lactate values (mmol x L(-1), mean +/- SEM) were as follows: CE3, 8.08 +/- 0.44; CO3, 7.57 +/- 0.49; and CO6, 6.96 +/- 0.43. CE3 and CO6 workouts produced comparable volumes of work. Though several CE3 performance measures were significantly correlated to post-exercise and delta lactate values, power indices had the strongest relationship., Discussion: Factors related to lactate production and clearance caused CE3 values to be highest. Power indices were most correlated to lactate as they denote a higher work rate and reliance on glycolysis.

Context: The Community Health Aide Program (CHAP) is a unique program employing local, indigenous peoples as primary care nonphysician providers in extremely remote frontier, tribal Alaskan communities. With attrition rates up to 20%, recommendations for improving retention are necessary to maintain access to health services for Alaska Natives in these communities., Purpose: The purpose of this study was to identify factors contributing to retention in Alaska's CHAP program., Methods: Key informant interviews were conducted with 41 community health aides/practitioners (CHA/Ps) in 15 villages statewide. Efforts were made to ensure the sample included a mix of villages with high retention of health aides and villages with lower retention. Geographic and ethnic diversity were also considered. Transcripts were coded using NUD*IST software, and data were analyzed for differences between high retention and low retention villages and between more experienced and less experienced CHA/Ps., Findings: Five fundamental needs of health aides were identified as crucial for retention of personnel. These needs include strong co-worker support, access to basic training, a fully staffed clinic, good community support, and supportive families., Conclusions: For 35 years, the CHAP program has worked to diminish health disparities for Alaska Natives. Though unique challenges associated with the job have factored into low retention of CHA/Ps, improved retention is possible with easier access to basic training, increased support from colleagues and community, enhanced team-building skills, and better on-call schedules.

Paying health care providers to meet quality goals is an idea with widespread appeal, given the common perception that quality of care in the United States remains unacceptably low despite a decade of benchmarking and public reporting. There has been little critical analysis of the design of the current generation of quality incentive programs. In this paper we examine public reports of paying for quality over the past five years and assess each of the identified programs in terms of key design features, including the market share of payers, the structure of the reward system, the amount of revenue at stake, and the targeted domains of health care quality.

Physicians' acceptance of care management tools--practice guidelines, patient satisfaction surveys and practice profiling--is an important indication of whether these efforts to improve quality and control health costs will succeed. According to a new study by the Center for Studying Health System Change (HSC), a majority of physicians affected by these tools believe the overall effect of each on the quality and efficiency of care they provide has been positive. Physicians affected by related financial incentives are more likely to view care management techniques positively if they are risk adjusted to reflect the greater need for services by people with health problems.

Physicians and other providers have responded to the spread of managed care by adapting structures and strategies to accommodate or resist the pressures exerted on them to reduce costs. In this paper we examine how physician organizations have evolved in four markets and whether their features represent attempts to improve efficiency or resist change. The strategies adopted by physicians in terms of alignment with other providers and development of independent medical management capabilities appear to be sensitive to opportunities to reap cost savings and the competitiveness of physician, hospital, and health plan markets.

The proliferation of for-profit health plans has heightened concerns about quality of care, particularly with respect to Medicaid. We undertook this study to compare for-profit and not-for-profit health plans that participate in Medicaid, examining processes of care and the organizational characteristics related to utilization management, financial incentives, and quality of care. Our findings demonstrate that for-profit and not-for-profit plans appear to be more similar than dissimilar in many areas of management, although for-profit plans are more likely to use aggressive utilization review and have slightly less developed quality management systems. On balance, these findings should reassure critics of for-profit health care.

Many purchasers and consumers of health care have become concerned about the quality of care being delivered in managed care plans. Little is known, however, about the health plan characteristics that are associated with better performance. We used survey responses from 82,583 Medicare beneficiaries from 182 health plans to study the association of consumers' assessments of care with health plan characteristics. For-profit and nationally affiliated health plans received much worse scores on the outcomes of interest, particularly for overall ratings of the health plan and composite measures of customer service and access to care. Health plans accredited by the National Committee for Quality Assurance did not receive higher scores.

This study investigated the extent to which the Consumer Assessments of Health Plans Survey (CAHPS) distinguishes performance of Medicare managed care (MMC) health plans. Results indicate that CAHPS ratings and report composites distinguish among plans both nationally and within markets. Global ratings of a health plan and reports on customer services varied strongly at the individual plan level, with smaller effects seen at regional and Metropolitan Statistical Area (MSA) levels. Ratings of doctors and health care, and reports on experiences in the doctor's office varied more among regions and among MSAs than among plans within the same MSA. These patterns are consonant with our hypotheses about the determinants of these ratings: customer service is a distinct plan function, but medical services are provided by networks that often overlap for plans in the same area. We conclude that the CAHPS-MMC survey can inform consumers choosing among plans as well as policymakers and researchers.

There has been a great deal of interest in recent years in developing measures of health care quality that can be used to characterize and study the effects of health plans. However, because of the recent emergence of diverse types of health care organizations, it is often difficult to know which parts of a plan should be combined for analysis purposes. Also, simple taxonomies of health maintenance organizations (eg, staff, independent practice associations, group, and network) no longer adequately describe the diverse types of organizations that have become common. In this article we describe these trends, explain why older taxonomies of health care plans are not adequate, and present a new framework for characterizing and studying the effects of diverse types of plans.

In many health care marketplaces, outcomes assessment is central to monitoring quality while controlling costs. Comparing outcomes across providers generally requires adjustment for patient severity. For mortality rates and other adverse outcomes comparisons, severity adjustment ideally aims to control for patient characteristics prior to the health care intervention. A variety of severity methodologies, specifically for hospitalized patients, are commercially available. Some have been adopted by state or regional initiatives for publicly comparing hospital outcomes. We applied 14 common severity measures to the same data set to determine whether judgments about risk-adjusted hospital death rates are sensitive to the specific severity method. We examined 7,765 patients undergoing coronary artery bypass graft (CABG) surgery at 38 hospitals. Unadjusted death rates ranged from 0% to 11.2% across hospitals. Comparisons of relative hospital performance were relatively insensitive to the severity adjustment method.

A retrospective study to characterize determinants of subjective outcome following removal of silicone gel-filled mammary implants was undertaken. One hundred consecutive female patients (aged 24 to 69 years, mean 46 years) who underwent removal of implants were surveyed. Eighty-two patients had mammary implants for cosmetic indications, 17 for postmastectomy reconstruction, and 1 for correction of congenital breast absence. The survey was conducted 6 to 12 months after explantation. Sixty-three patients (63%) returned questionnaires. Fifty-one patients were satisfied with the overall outcome of explantation (81% of respondees). Quality of life, as measured by self-assessed physical and cognitive functions, and improvement of symptoms attributed by the patients to the presence of implants, improved in 49 patients (78%), worsened in 2 patients (3%), and has not changed in 12 patients (19%). Twenty-one patients (33%) judged postexplantation and/or breast recontouring surgery aesthetic outcome as expected, 26 (41%) as an improvement better than expected, 9 (14%) judged their appearance as worse than expected, and 7 have not responded. Twenty-three patients (37%) perceived their postoperative course as "complicated" (scarring, inflammation, infection, seroma, asymmetry, distortion of breast contour, among those items listed). Five patients (8%) complained of mastalgia (not present prior to explantation). However, only 1 patient stated that the "complications" changed her opinion about "benefits" of this procedure. Sixty respondents (95%) indicated that comprehensive informed consent prior to explantation was instrumental in their acceptance of the outcome. If convinced that implants are safe, fifteen patients (24%) would and 41 patients (65%) would not like implants "back," and 7 patients (11%) gave no answer. Analysis of the patients' perspective should help to care for patients who contemplate or have undergone surgery with mammary implants.

The purpose of this project was to examine the incidence of microbial presence on the surface of mammary implants and its correlation with clinical presentation. The significance of microbial presence without signs of overt infection is questioned. Several issues are raised, including whether the presence of micro-organisms may immunize the host, trigger autoimmune reactions, or locally change the course of healing (resulting in capsular contracture). A total of 150 explanted silicone mammary implants from 87 patients were cultured. Cultures of 81 devices were positive (54%); the predominant isolate was Staphylococcus epidermidis (found on 68 implants, or 84%). Bacteria were detected on 76% (62 of 82) of implants surrounded by contracted capsules and on 28% (19 of 68) of those without capsular contracture (p < 0.05). Among 40 patients (46%) who had no general health problems, 11 (28%) had positive cultures of explanted devices (15 of 62 explants, or 24%). In the remaining 47 patients (54%) who complained of myalgia (77%), arthralgia (68%), chronic fatigue (38%), skin rashes (21%), cognitive problems (19%), dry mucosal membranes (19%), episodes of low-grade fever (17%), and hair loss (13%), 38 (81%) had positive cultures (66 of 88 explants, or 75%) (p < 0.05). The hypothesis that capsular contracture or problems that might be related to chronic infection and immunization are associated with subclinical infection is supported by this study.

Our previous clinical study supported the concept that capsular contracture is associated with subclinical infection of silicone implants. If bacterial presence, indeed, contributes to capsular contracture, then fibroblast behavior might be expected to change in the presence of bacteria by-products. Therefore, study of possible alteration of fibroblast behavior by bacteria products was undertaken using an in vitro model with cultured dermal fibroblasts. Coagulase-negative staphylococci from silicone mammary and penile implants were isolated and their phenotypic features were characterized. All represented nonbiofilm-producing strains. Products of isolate cultures were noncytotoxic and did not alter matrix reorganization (collagen gel contraction model) or collagen production by fibroblasts. Isolates from either mammary or penile implants exerted similar effects.

Biologic consequences of silicone implantation may include changes in host connective tissue metabolism. Lysosomal beta-galactosidase (beta-GAL) activity, which is a sensitive marker of fibrotic diseases and may be a useful marker of collagen turnover, was examined in the serum of rats with implanted silicones. No significant difference in spectrofluorometrically determined enzyme activity was demonstrated in rats subjected to dorsal submuscular pocket dissection without implantation and corresponding nonoperative controls. Rats with implanted solid silicone elastomer or free polydimethylsiloxane gel (both components obtained from mammary implant) revealed enhanced activity of serum beta-GAL. Higher enzyme activity was observed in animals with implanted silicone gel with a peak level of 2.73 +/- 0.08 pmol/30 min/ml 16 weeks after implantation. Increased collagen deposition and capsular thickness was demonstrated around implanted gel material as compared with that around elastomer shell. Animals with implanted absorbable and nonabsorbable materials, polyglactin and Teflon (polytetrafluoroethylene), respectively, after initial increase of beta-GAL activity demonstrated enzyme activity within the normal range. Findings indicate that there is enhanced lysosomal beta-GAL activity after silicone implantation in rats. Clinical relevance and its possible significance as a predictor or indicator of local or systemic fibrosis after silicone implantation seems worthy of further investigation.