A direct comparison of robotic and laparoscopic hernia repair: patient-reported outcomes and cost analysis.

PURPOSE: Hernia repair is one of the most commonly performed surgeries in the United States. Since the introduction of the Da Vinci robot, robot-assisted hernia repairs have become more common. In this study we aim to directly compare robotic and laparoscopic hernia repairs as well as explore potential cost differences. We hypothesize that robot-assisted hernia repairs are associated with better patient-reported outcomes. METHODS: We conducted retrospective review to create a cohort study of 53 robotic (37 inguinal and 16 ventral) and 101 laparoscopic (68 inguinal and 33 ventral) hernia repairs. Patient-reported outcomes were measured using the Carolinas Comfort Scale (CCS). Operative details were examined, and a cost analysis was performed. RESULTS: Combining both hernia types together as well as looking at inguinal and ventral repairs separately, we found that there was no difference in hernia recurrence or 1-year CCS between robotic and laparoscopic hernia repair. For ventral hernia repairs alone, robotic procedure was associated with a decreased length of stay. We found that our robotic cases did have longer operative times and higher costs. The operative times did decrease to a length comparable to that of the laparoscopic cases as experience operating with the robot increased. CONCLUSION: In comparison to laparoscopic hernia repair, robotic hernia repair does not improve long-term patient-reported surgical outcomes. However, it does increase the cost of the operation and, in general, result in longer operative times.

Bacterial immune evasion via an IL-10 mediated host response, a novel pathophysiologic mechanism for chronic rhinosinusitis.

BACKGROUND: Staphylococcus aureus is a frequently implicated pathogen in chronic rhinosinusitis (CRS). S. aureus may promote commensalism by downregulating pro-inflammatory T cell host responses via an IL-10 mediated pathway. This finding, coupled with the observation that S. aureus and CD8+ T cell numbers are inversely correlated in CRS mucosa, suggests that S. aureus may evade immune destruction via IL-10 induction. To support this hypothesis, we evaluated i) whether IL-10 levels differ in CRS compared to controls (CTL) using microarray and immunohistochemistry and ii) whether IL-10 levels correlate with S. aureus and CD8+ T cell levels. METHODOLOGY: Sinus epithelial brush samples from 12 patients undergoing ESS for CRS and 10 CTLs underwent microarray analysis of IL-10 gene expression. Microarray results were verified on simultaneously obtained surgical biopsy samples by immunohistochemistry staining for IL-10. Potential mechanisms were assessed by immunohistochemistry for CD8+ T cells and S. aureus. RESULTS: IL-10 gene expression was significantly higher in CRS vs CTL subjects at the time of surgery. Immunohistochemistry confirmed increased levels of intraepithelial IL-10. A strong inverse correlation was observed between intraepithelial IL-10 and CD8+ T cell levels as was intraepithelial IL-10 and S. aureus. CONCLUSION: Elevated IL-10 levels in sinus mucosa may be a potential pathophysiologic feature of CRS in association with a significant downregulation of host CD8+ T cell levels. While S. aureus is believed to play a role in IL-10 induction, a comparatively weaker relationship between S. aureus and IL-10 levels suggests other bacterial species may also induce IL-10 production as a common survival strategy in CRS.

Are women benefiting from the Affordable Care Act? A real-world evaluation of the impact of the Affordable Care Act on out-of-pocket costs for contraceptives.

OBJECTIVES: The Affordable Care Act (ACA) mandated that, starting between August 1, 2012 and July 31, 2013, health plans cover most Food and Drug Administration (FDA)-approved contraceptive methods for women without cost sharing. This study examined the impact of the ACA on out-of-pocket expenses for contraceptives. STUDY DESIGN: Women (ages 15-44years) with claims for any contraceptives in years 2011, 2012 and 2013 were identified from the MarketScan Commercial database. The proportions of women using contraceptives [including permanent contraceptives (PCs) and non-PCs: oral contraceptives (OCs), injectables, patches, rings, implants and intrauterine devices (IUDs)] in study years were determined, as well as changes in out-of-pocket expenses for contraceptives during 2011-2013. Demographics, including age, U.S. geographic region of residence and health plan type, were also evaluated. RESULTS: The number of women identified with any contraceptive usage in 2011 was 2,447,316 (mean age: 27.6years), in 2012 was 2,515,296 (mean age: 27.4years) and in 2013 was 2,243,253 (mean age: 27.4years). In 2011, 2012 and 2013, the proportions of women with any contraceptive usage were 26.3%, 26.2% and 26.9%, respectively. Over the three study years, mean total out-of-pocket expenses for PCs and non-PCs decreased from $298 to $82 and from $94 to $30, respectively. For non-PCs, mean total out-of-pocket expenses for OCs and IUDs decreased from $86 to $26 and from $83 to $20. CONCLUSIONS: Implementation of the ACA has saved women a substantial amount in out-of-pocket expenses for contraceptives. IMPLICATIONS: Mean total out-of-pocket expenses for FDA-approved contraceptives decreased approximately 70% from 2011 to 2013. Implementation of the ACA has saved women a substantial amount in out-of-pocket expenses for contraceptives. Longer-term studies, including clinical outcomes, are warranted.

The impact of risk information exposure on women's beliefs about direct-to-consumer genetic testing for BRCA mutations.

Despite an increase in direct-to-consumer (DTC) genetic testing, little is known about how variations in website content might alter consumer behavior. We evaluated the impact of risk information provision on women's attitudes about DTC BRCA testing. We conducted a randomized experiment; women viewed a 'mock' BRCA testing website without [control group (CG)] or with information on the potential risks of DTC testing [RG; framed two ways: unattributed risk (UR) information and risk information presented by experts (ER)]. Seven hundred and sixty-seven women participated; mean age was 37 years, mean education was 15 years, and 79% of subjects were white. Women in the RG had less positive beliefs about DTC testing (mean RG = 23.8, CG = 25.2; p = 0.001), lower intentions to get tested (RG = 2.8, CG = 3.1; p = 0.03), were more likely to prefer clinic-based testing (RG = 5.1, CG = 4.8; p = 0.03) and to report that they had seen enough risk information (RG = 5.3, CG = 4.7; p < 0.001). UR and ER exposure produced similar effects. Effects did not differ for women with or without a personal/family history of breast/ovarian cancer. Exposing women to the potential risks of DTC BRCA testing altered their beliefs, preferences, and intentions. Risk messages appear to be salient to women irrespective of their chance of having a BRCA mutation.

Prolactin and the expression of suppressor of cytokine signaling-3 in the sheep adrenal gland before birth.

The fetal pituitary-adrenal axis plays a key role in the fetal response to intrauterine stress and in the timing of parturition. The fetal sheep adrenal gland is relatively refractory to stimulation in midgestation (90-120 days) before the prepartum activation, which occurs around 135 days gestation (term=147+/-3 days). The mechanisms underlying the switch from adrenal quiescence to activation are unclear. Therefore, we have investigated the expression of suppressor of cytokine signaling-3 (SOCS-3), a putative inhibitor of tissue growth in the fetal sheep adrenal between 50 and 145 days gestation and in the adrenal of the growth-restricted fetal sheep in late gestation. SOCS-3 is activated by a range of cytokines, including prolactin (PRL), and we have, therefore, determined whether PRL administered in vivo or in vitro stimulates SOCS-3 mRNA expression in the fetal adrenal in late gestation. There was a decrease (P<0.005) in SOCS-3 expression in the fetal adrenal between 54 and 133 days and between 141 and 144 days gestation. Infusion of the dopaminergic agonist, bromocriptine, which suppressed fetal PRL concentrations but did not decrease adrenal SOCS-3 mRNA expression. PRL administration, however, significantly increased adrenal SOCS-3 mRNA expression (P<0.05). Similarly, there was an increase (P<0.05) in SOCS-3 mRNA expression in adrenocortical cells in vitro after exposure to PRL (50 ng/ml). Placental and fetal growth restriction had no effect on SOCS-3 expression in the adrenal during late gestation. In summary, the decrease in the expression of the inhibitor SOCS-3 after 133 days gestation may be permissive for a subsequent increase in fetal adrenal growth before birth. We conclude that factors other than PRL act to maintain adrenal SOCS-3 mRNA expression before 133 days gestation but that acute elevations of PRL can act to upregulate adrenal SOCS-3 expression in the sheep fetus during late gestation.

Identifying newborns at risk of significant hyperbilirubinaemia: a comparison of two recommended approaches.

AIMS: To compare the predictive performance of clinical risk factor assessment and pre-discharge bilirubin measurement as screening tools for identifying infants at risk of developing significant neonatal hyperbilirubinaemia (post-discharge total serum bilirubin (TSB) >95th centile). METHODS: Retrospective cohort study of term and near term infants born in an urban community teaching hospital in Pennsylvania (1993-97). A clinical risk factor scoring system was developed and its predictive performance compared to a pre-discharge TSB expressed as a risk zone on a bilirubin nomogram. Main outcome measures were prediction model discrimination, range of predicted probabilities, and sensitivity, specificity, positive and negative predictive values, and likelihood ratios for various positivity criteria. RESULTS: The clinical risk factor scoring system developed included birth weight, gestational age <38 weeks, oxytocin use during delivery, vacuum extraction, breast feeding, and combination breast and bottle feeding. The pre-discharge bilirubin risk zone had better discrimination (c = 0.83; 95% CI 0.80 to 0.86) than the clinical risk factor score (c = 0.71; 95% CI 0.66 to 0.76) and predicted risk of significant hyperbilirubinaemia as high as 59% compared with a maximum of 44% for the clinical risk factor score. Neither the risk score nor the pre-discharge TSB risk zone predicted the outcome with > or =0.98 sensitivity without significantly compromising specificity (0.13 and 0.21, respectively). Multi-level clinical risk factor scores and TSB risk zones produced likelihood ratios of 0.15-3.25 and 0.05-9.43, respectively. CONCLUSIONS: The pre-discharge bilirubin expressed as a risk zone on an hour specific bilirubin nomogram is more accurate and generates wider risk stratification than a clinical risk factor score.

Channelling of patients taking NSAIDs or cyclooxygenase-2-specific inhibitors and its effect on interpretation of outcomes.

When new drugs with improved safety or efficacy are introduced, they may be preferentially prescribed to specific populations of patients. Safety and efficacy may be underestimated if such channelling effects are not recognized. Meloxicam and cyclooxygenase (COX)-2-specific inhibitors were developed as safer alternatives to non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of osteoarthritis and rheumatoid arthritis. Studies of the use of meloxicam and COX-2-specific inhibitors demonstrate that both of these drugs are being prescribed to patients at increased risk of gastrointestinal adverse drug events. In the case of COX-2-specific inhibitors, this channelling appears to represent a prescribing pattern consistent with current recommendations. Subsequent analysis of the data, after adjusting for channelling bias, showed that the risk of gastrointestinal toxicity for meloxicam was similar to that for other NSAIDs, while COX-2-specific inhibitors reduced the risk of developing gastrointestinal adverse drug events by approximately 60%. These studies serve as examples of observed channelling bias and highlight the need for adjusting for channelling in order to provide a valid assessment of relevant outcomes for drugs likely to be preferentially prescribed to specific populations.

Using survival curve comparisons to inform patient decision making can a practice exercise improve understanding?

BACKGROUND: Patients often face medical decisions that involve outcomes that occur and change over time. Survival curves are a promising communication tool for patient decision support because they present information about the probability of an outcome over time in a simple graphic format. However, previous studies of survival curves did not measure comprehension, used face-to-face explanations, and focused on a VA population. METHODS: In this study, 246 individuals awaiting jury duty at the Philadelphia County Courthouse were randomized to receive one of two questionnaires. The control group received a questionnaire describing two hypothetical treatments and a graph with two survival curves showing the outcomes of each treatment. The practice group received the same questionnaire preceded by a practice exercise asking questions about a graph containing a single curve. Subjects' ability to interpret survival from a curve and ability to calculate change in survival over time were measured. RESULTS: Understanding of survival at a single point in time from a graph containing two survival curves was high overall, and was improved by the use of a single curve practice exercise. With a practice exercise, subjects were over 80% accurate in interpreting survival at a single point in time. Understanding of changes in survival over time was lower overall, and was not improved by the use of a practice exercise. With or without a practice exercise, subjects were only 55% accurate in calculating changes in survival. CONCLUSION: The majority of the general public can interpret survival at a point in time from self-administered survival curves. This understanding is improved by a single curve practice exercise. However, a significant proportion of the general public cannot calculate change in survival over time. Further research is necessary to determine the effectiveness of survival curves in improving risk communication and patient decision making.

Accuracy of MR imaging for staging prostate cancer: a meta-analysis to examine the effect of technologic change.

RATIONALE AND OBJECTIVES: The purpose of this study was to summarize the accuracy of magnetic resonance (MR) imaging for staging prostate cancer and to determine the effect of high magnetic field strength, use of the endorectal coil, use of fast spin-echo (SE) imaging, and study size on staging accuracy. MATERIALS AND METHODS: A literature search and review yielded 27 studies comparing MR imaging to a pathologic standard in patients with clinically limited prostate cancer. Subgroup analyses examined magnetic field strength, use of an endorectal coil, use of fast SE imaging, publication date, and study size. RESULTS: A summary receiver operating characteristic curve for all studies had a maximum joint sensitivity and specificity of 74%. At a specificity of 80% on this curve, sensitivity was 69%. Subgroup analyses showed that fast SE imaging was statistically significantly more accurate than conventional SE techniques (P < .001). Unexpectedly, studies employing higher magnetic field strength and those employing an endorectal coil were less accurate. CONCLUSION: Seemingly small technologic advances may influence test accuracy. Early and small studies, however, may overstate accuracy because of publication bias, bias in small samples, or earlier studies being performed by the experts who developed the technology itself.

Barriers to influenza immunization in a low-income urban population.

BACKGROUND: Although influenza immunization significantly reduces mortality from influenza, over one third of elderly Americans are not immunized each year. Low rates of immunization are particularly concerning among African-American low-income populations. Preliminary interviews suggested that fear of undisclosed ingredients in the influenza vaccine may impede vaccine acceptance in this vulnerable population. OBJECTIVES: To assess the role of concern about vaccine contents and other factors in the use of influenza immunization among a predominantly African-American low-income urban population. METHODS: Cross-sectional, health-system-population-based, telephone survey of a random sample of West Philadelphia residents aged > or =65 years. RESULTS: Of 659 eligible individuals, 486 (73.8%) were successfully interviewed. Concern about undisclosed shot contents was reported by 132 (20%) respondents and was inversely associated with vaccine receipt (OR 0. 49, 95% CI 0.26-0.91). This association was similar among African Americans and Caucasians. In addition, receipt of influenza vaccine was inversely associated with belief that immunization is inconvenient (OR 0.14, 95% CI 0.05-0.36), belief that immunization is painful (OR 0.21, 95% CI 0.08-0.54), and history of previous side effects (OR 0.33, 95% CI 0.18-0.60), and positively associated with physician recommendation (OR 3.22, 95% CI 1.76-5.93). CONCLUSIONS: In a low-income urban population, concern about undisclosed vaccine contents appears to impede acceptance of influenza immunization among both African Americans and Caucasians. Directly addressing this concern offers a new approach to increasing immunization in this vulnerable population.

Cost-effectiveness of raloxifene and hormone replacement therapy in postmenopausal women: impact of breast cancer risk.

OBJECTIVE: To examine the life expectancy and cost-effectiveness of hormone replacement therapy (HRT) and raloxifene therapy in healthy 50-year-old postmenopausal women. METHODS: We performed a cost-effectiveness analysis using a Markov model, discounting the value of future costs and benefits to account for their time of occurrence. RESULTS: Both HRT and raloxifene therapy increase life expectancy and are cost-effective relative to no therapy for 50-year-old postmenopausal women. For women at average breast cancer and coronary heart disease risk, lifetime HRT increases quality-adjusted life expectancy more (1.75 versus 1.32 quality-adjusted life years) and costs less ($3802 versus $12,968) than lifetime raloxifene therapy. However, raloxifene is more cost-effective than HRT for women at average coronary risk who have a lifetime breast cancer risk of 15% or higher or who receive 10 years or less of postmenopausal therapy. Raloxifene is also the more cost-effective alternative if HRT reduces coronary heart disease risk by less than 20%. CONCLUSIONS: Assuming the benefit of HRT in coronary heart disease prevention from observational studies, long-term HRT is the most cost-effective alternative for women at average breast cancer and coronary heart disease risk seeking to extend their quality-adjusted life expectancy after menopause. However, raloxifene is the more cost-effective alternative for women at average coronary risk with one or more major breast cancer risk factors (first-degree relative, prior breast biopsy, atypical hyperplasia or BRCA1/2 mutation). These results can help inform decisions about postmenopausal therapy until the results of large scale randomized trials of these therapies become available.

Cost-effectiveness of prophylaxis against Pneumocystis carinii pneumonia in patients with Wegner's granulomatosis undergoing immunosuppressive therapy.

OBJECTIVE: To assess the incremental cost-effectiveness of 3 Pneumocystis carinii pneumonia (PCP) prophylaxis strategies in patients with Wegener's granulomatosis (WG) receiving immunosuppressive therapies: 1) no prophylaxis; 2) trimethoprim/sulfamethoxazole (TMP/SMX) 160 mg/800 mg 3 times a week, which is discontinued if patients experience an adverse drug reaction (ADR); and 3) TMP/SMX 160 mg/800 mg 3 times a week, which is replaced by monthly aerosolized pentamidine (300 mg) if patients experience an ADR. METHODS: A Markov state-transition model was developed to follow a hypothetical cohort of WG patients over their lifetimes starting from the time of initial exposure to the immunosuppressive therapy. The effect of PCP prophylaxis on life expectancy, quality-adjusted life expectancy, average discounted lifetime cost (ADLC), and incremental cost-effectiveness was estimated based on data obtained from a literature review. Direct medical costs were examined from a societal perspective, and costs and benefits were discounted at 3% annually. RESULTS: No prophylaxis resulted in a life expectancy of 13.36 quality-adjusted life years (QALY) at an ADLC of $4,538. In comparison, prophylaxis with TMP/ SMX alone increased the QALY to 13.54 and was cost saving, with an ADLC of $3,304. The addition of pentamidine in patients who had an ADR to TMP/SMX resulted in 13.61 QALY, with an ADLC of $7,428. Compared with TMP/SMX alone, TMP/SMX followed by pentamidine increased the QALY by 0.07 at an incremental cost of $58,037 per QALY. Both TMP/SMX alone and TMP/SMX followed by pentamidine prophylaxis strategies dominated the no prophylaxis strategy until the incidence of PCP fell below 0.2% and 2.25%, respectively. Institution of pentamidine therapy for patients with a TMP/SMX ADR increased quality-adjusted life expectancy compared with that with TMP/ SMX alone until the incidence of PCP rose above 7.5%. CONCLUSION: Prophylaxis using TMP/SMX alone increased life expectancy and reduced cost for patients with WG receiving immunosuppressive therapy. Replacing TMP/SMX with monthly aerosolized pentamidine in cases of ADR further increased life expectancy, although at an increased cost.

Azathioprine for maintenance of remission in Crohn's disease: benefits outweigh the risk of lymphoma.

BACKGROUND & AIMS: Azathioprine is a commonly used and effective treatment for maintenance of remission for patients with steroid-dependent Crohn's disease (CD). However, azathioprine therapy is associated with an increased risk of non-Hodgkin's lymphoma. The objective of this analysis was to determine the impact of azathioprine therapy on survival and quality-adjusted life expectancy after accounting for both the benefits of therapy and potential increased risk of lymphoma. METHODS: A decision analysis using a Markov model depicting the natural history of alternative management strategies for maintenance of remission in patients with CD was performed. RESULTS: In the base-case analysis, treatment of CD patients with a steroid-induced remission with azathioprine resulted in an average increase in life expectancy of 0.04 years and 0.05 quality-adjusted years. The incremental gain in life expectancy decreased with increasing patient age and increasing risk of lymphoma. CONCLUSIONS: Therapy with azathioprine to preserve remission in patients with CD results in increased quality-adjusted life expectancy. This increase was greatest in young patients who have the lowest baseline risk of non-Hodgkin's lymphoma and who have the greatest life expectancy in the absence of a CD-related death.

Overview of the arthritis Cost Consequence Evaluation System (ACCES): a pharmacoeconomic model for celecoxib.

Pharmacoeconomic analyses have become useful and essential tools for health care decision makers who increasingly require such analyses prior to placing a drug on a national, regional or hospital formulary. Previous health economic models of non-steroidal anti-inflammatory drugs (NSAIDs) have been restricted to evaluating a narrow range of agents within specific health care delivery systems using medical information derived from homogeneous clinical trial data. This paper summarizes the Arthritis Cost Consequence Evaluation System (ACCES)--a pharmacoeconomic model that has been developed to predict and evaluate the costs and consequences associated with the use of celecoxib in patients with arthritis, compared with other NSAIDs and NSAIDs plus gastroprotective agents. The advantage of this model is that it can be customized to reflect local practice patterns, resource utilization and costs, as well as provide context-specific health economic information to a variety of providers and/or decision makers.

Chronic/subacute total occlusion of the left main coronary artery--a case report and review of literature.

Total occlusion of the left main coronary artery is rare. Acute occlusion is invariably fatal; however, survival is possible if the patient reaches the hospital in time. Patients usually present with acute myocardial infarction, cardiogenic shock, and sudden cardiac death. Chronic total occlusion presents with angina, myocardial infarction, or congestive heart failure. The authors describe complete occlusion of the left main coronary artery in a patient who presented with recent-onset angina. They review the clinical and angiographic features of 60 cases described in the literature.

Cost-effectiveness of MR imaging and core-needle biopsy in the preoperative work-up of suspicious breast lesions.

PURPOSE: To assess the clinical and economic consequences of the use of preoperative breast magnetic resonance (MR) imaging and core-needle biopsy (CNB) to avert excisional biopsy (EXB). MATERIALS AND METHODS: A decision-analytic Markov model was constructed to compare MR imaging, CNB, and EXB without preoperative testing in a woman with a suspicious breast lesion. Stage-specific cancer prevalence, tumor recurrence, progression rates, and MR imaging and CNB sensitivity and specificity were obtained from the literature. Cost estimates were obtained from the literature and from the Medicare fee schedule. RESULTS: EXB without preoperative testing was associated with the greatest quality-adjusted life expectancy, followed by MR imaging and CNB; life expectancies were 17.409, 17.405, and 17.398 years, respectively. EXB resulted in the greatest lifetime treatment cost ($31,438), followed by MR imaging ($29,072) and CNB ($28,573). Results were robust over a wide range of cancer prevalence, stage distribution, tumor progression rates, and procedure and treatment costs. Incremental cost-effectiveness ratios showed that preoperative testing was cost-effective, but the choice between MR imaging and CNB was highly dependent on the accuracy of each test and to patient preferences. CONCLUSION: Preoperative testing of most suspicious breast lesions was cost-effective. More precise estimates of MR imaging and CNB test performance characteristics are needed. Until those are available, patient preferences should inform individual decisions regarding preoperative testing.

Educational content and the effectiveness of influenza vaccination reminders.

OBJECTIVE: To determine if a mailed patient education brochure (addressing demonstrated reasons for vaccination refusal) would result in a higher rate of influenza vaccination than a mailed postcard reminder without educational content. DESIGN: Randomized, controlled trial. SETTING: Urban, predominantly African-American, low-income community. PARTICIPANTS: There were 740 community-dwelling individuals aged 65 years and older in the study. MEASUREMENTS: Receipt of influenza vaccination and beliefs about influenza and influenza vaccination were measured by telephone survey self-report. MAIN RESULTS: We successfully contacted 202 individuals (69.9%) who received the postcard reminder and 229 individuals (71.1%) who received the educational brochure. People receiving the educational brochure were more likely to report influenza vaccination during the previous vaccination season than those who received the postcard reminder (66.4% vs 56.9%, p =.04). They also reported more interest in influenza vaccination in the coming year. (66.5% vs 57.1%, p =.05). CONCLUSIONS: A mailed educational brochure is more effective than a simple reminder in increasing influenza vaccination rates among inner-city, elderly patients.

Infection and antimicrobial use in laparoscopic cholecystectomy.

Retrospective chart review of 1,702 patients undergoing laparoscopic cholecystectomy (LC) revealed an overall infection rate of 2.3% and a surgical-site infection rate of 0.4%. Preoperative antimicrobial prophylaxis was received by 79% of patients, but only 33% of these received the agent within 1 hour or less prior to surgery. These facts suggest that antimicrobial prophylaxis may not be necessary for low-risk LC patients.