Research Protocol for an Observational Health Data Analysis on the Adverse Events of Systemic Treatment in Patients with Metastatic Hormone-sensitive Prostate Cancer: Big Data Analytics Using the PIONEER Platform.

Combination therapies in metastatic hormone-sensitive prostate cancer (mHSPC), which include the addition of an androgen receptor signaling inhibitor and/or docetaxel to androgen deprivation therapy, have been a game changer in the management of this disease stage. However, these therapies come with their fair share of toxicities and side effects. The goal of this observational study is to report drug-related adverse events (AEs), which are correlated with systemic combination therapies for mHSPC. Determining the optimal treatment option requires large cohorts to estimate the tolerability and AEs of these combination therapies in "real-life" patients with mHSPC, as provided in this study. We use a network of databases that includes population-based registries, electronic health records, and insurance claims, containing the overall target population and subgroups of patients defined by unique certain characteristics, demographics, and comorbidities, to compute the incidence of common AEs associated with systemic therapies in the setting of mHSPC. These data sources are standardised using the Observational Medical Outcomes Partnership Common Data Model. We perform the descriptive statistics as well as calculate the AE incidence rate separately for each treatment group, stratified by age groups and index year. The time until the first event is estimated using the Kaplan-Meier method within each age group. In the case of episodic events, the anticipated mean cumulative counts of events are calculated. Our study will allow clinicians to tailor optimal therapies for mHSPC patients, and they will serve as a basis for comparative method studies.

The impact of comprehensive air purification on patient duration of stay, discharge outcomes, and health care economics: A retrospective cohort study.

BACKGROUND: Infectious airborne and surface pathogens constitute a substantial and poorly explored source of patient subclinical illness and infections. With that in mind, a system of advanced air purification technology was designed to destroy the DNA and RNA of all bacteria, fungi, and viruses. This study compares the effects of advanced air purification technology versus high efficiency particulate air filtration with respect to certain metrics of health care economics and resource utilization at a large, community-based, urban hospital. Our hypothesis was that the use of the advanced air purification technology would decrease health care durations of stay, lead to fewer nonhome discharges, and decrease hospital charges. METHODS: After the installation of advanced air purification technology, 3 resultant air purification "zones" were established: zone C, a control floor with high efficiency particulate air filtration; zone B, a mixed high efficiency particulate air and advanced air purification technology floor; and zone A, a comprehensive advanced air purification technology remediation. This study included nonbariatric surgical patients admitted to any zone between December 2017 and December 2018, with reported case mix index on discharge. We analyzed hospital duration of stays, discharge destination, and hospital charges with adjustment for severity of illness using the case mix index. The likelihood of mortality, health care-associated infection, and readmission for each study zone was examined using logistic regression adjusting for case mix index, age, sex, and source of admission. RESULTS: The study included 1,002 patients across the 3 zones, with mean age of 55.8 years (53.7% female), average case mix index of 1.98, and mortality of 1.7%. Compared with zone C, patients in zones A and B demonstrated decreased hospital stays, a greater percentage of home discharges (86.5-87.8% vs 64.7%), and less hospital charges. In addition, logistic regression modeling performed on 999 study patients showed that the likelihood of mortality, hospital-acquired infections, and readmissions did not differ among the 3 zones. A trend toward a lesser incidence of hospital-acquired infections was noted in zones A and B (0.40% and 0.48%, respectively) when compared with zone C (0.63%). CONCLUSION: Patients in the advanced air purification technology zones demonstrated statistically significant improvements in durations of stay, discharge to home, and costs after adjusting for case mix index. In addition, a trend toward fewer hospital-acquired infections in advanced air purification technology zones was noted. These findings suggest that environmental factors may affect key clinical and economic outcomes, supporting further research in this important and largely unexplored area.

Impact of Injury Mechanisms on Patterns and Management of Facial Fractures.

Mechanisms causing facial fractures have evolved over time and may be predictive of the types of injuries sustained. The objective of this study is to examine the impact of mechanisms of injury on the type and management of facial fractures at our Level 1 Trauma Center. The authors performed an Institutional Review Board-approved review of our network's trauma registry from 2006 to 2010, documenting age, sex, mechanism, Injury Severity Score, Glasgow Coma Scale, facial fracture patterns (nasal, maxillary/malar, orbital, mandible), and reconstructions. Mechanism rates were compared using a Pearson χ2 test. The database identified 23,318 patients, including 1686 patients with facial fractures and a subset of 1505 patients sustaining 2094 fractures by motor vehicle collision (MVC), fall, or assault. Nasal fractures were the most common injuries sustained by all mechanisms. MVCs were most likely to cause nasal and malar/maxillary fractures (P < 0.01). Falls were the least likely and assaults the most likely to cause mandible fractures (P < 0.001), the most common injury leading to surgical intervention (P < 0.001). Although not statistically significant, fractures sustained in MVCs were the most likely overall to undergo surgical intervention. Age, number of fractures, and alcohol level were statistically significant variables associated with operative management. Age and number of fractures sustained were associated with operative intervention. Although there is a statistically significant correlation between mechanism of injury and type of facial fracture sustained, none of the mechanisms evaluated herein are statistically associated with surgical intervention. Clinical Question/Level of Evidence: Therapeutic, III.

Tissue Expander Complications Predict Permanent Implant Complications and Failure of Breast Reconstruction.

BACKGROUND: Two-stage tissue expander-based breast reconstruction is the most commonly used reconstructive modality following mastectomy. We sought to determine if patients who experienced complications during the expansion phase were at increased risk for complications or reconstructive failure after the exchange procedure. METHODS: A retrospective review of tissue expander-based breast reconstructions was performed from January 2007 through December 2011. Variables evaluated included age, presence of cancer, tobacco use, body mass index, comorbidities, use of acellular dermal matrix, chemotherapy, radiation, timing of reconstruction (delayed/immediate), intraoperative tissue expander fill, complications, and explantation or salvage of the reconstruction by means of debridement and closure or myocutaneous flap. RESULTS: A total of 196 patients underwent mastectomy with 304 tissue expander reconstructions. Tobacco use (active and remote), hypertension, and radiation were associated with complications. Patients with a salvaged tissue expander complication were 3 times more likely to have a complication after placement of a permanent implant and 9 times more likely to fail permanent implant reconstruction (ie, require explantation). CONCLUSIONS: Women with complications after placement of a tissue expander are at significantly increased risk for both complications and reconstructive failure after placement of a permanent implant. Consideration for earlier autologous reconstruction as a salvage should be strongly considered in patients with a tissue expander complication, particularly in smokers and those undergoing radiation therapy.

Determinants of distal radius fracture management in polytrauma patients.

BACKGROUND: Over 640,000 distal radius fractures occur annually in the United States. No studies have been performed looking specifically at polytrauma patients who sustain distal radius fractures. We sought to determine variables affecting management of distal radius fractures in polytrauma patients. METHODS: An IRB-approved review of trauma patients from 2008-2011 was performed. Records for patients with distal radius fractures were examined, assessing age, gender, Glascow Coma Score, Injury Severity Score, mechanism, type, and characteristics of injury, as well as operative repair. A logistic regression was performed using SPSS 15.0. RESULTS: The database identified 12,054 patients, 434 sustaining a distal radius fracture. No statistically significant difference in operative repair based on mechanism of injury (p = 0.465) was identified. A total of 285 patients (65.7 %) underwent surgery for distal radius fractures. In univariate analysis, younger age was the only statistically significant demographic predictor of surgical intervention (p = 0.003). In both univariate analysis and logistic regression, open, intra-articular, displaced, and comminuted fractures, as well as those with concomitant ulna fractures were statistically significantly associated with operative repair. Fracture displacement was the most likely variable to be associated with surgical intervention (OR = 12.761, 95 % CI[7.219, 22.556]) (p < 0.001). CONCLUSIONS: In polytrauma patients, surgery for distal radius fractures is associated with younger age, open, intra-articular, displaced, and comminuted fractures, as well as concomitant ulna fractures. Displaced fractures were almost 13 times more likely to undergo surgical intervention than non-displaced fractures. Gender and mechanism of injury are not predictive of surgical intervention.

Effect of subcutaneous epinephrine/saline/local anesthetic versus saline-only injection on split-thickness skin graft donor site perfusion, healing, and pain.

The technique for split-thickness skin graft harvest varies among surgeons. Even though there is scientific evidence that the subcutaneous injection of modified tumescent solution reduces blood loss during burn surgery, the technique has not been unanimously adapted because of, in part, fear of healing retardation. This study prospectively examines the effect of tumescent injection on donor site perfusion, healing, and pain. Ten burn patients in need of grafting with a need for two distinctly different donor sites were included. During the grafting procedure, the two donor areas were randomly assigned to receive either modified tumescent solution or warm sterile saline solution subcutaneously before skin graft harvest with a dermatome. Perfusion, pain, pruritus, and donor site healing were measured, and a follow-up evaluation on scar quality was performed. Baseline perfusion on day 1 was significantly less in the donor site injected with modified tumescent solution (62.26 vs 95.71 perfusion units; P = .031), whereas the response to heat was similar in both sites. The physiologic response to injury (hyperemia) on days 2 and 3 was not suppressed in the modified tumescent group. Pain reported on day 1 was 2.38/10 in the tumescent site and 3.38/10 in the saline site (P = .21). On all other days, measurements showed no difference between the two sites. Donor sites healed in an average of 16.1 days with modified tumescent solution and in 16.4 days with saline. Late follow-up showed no difference in scar quality. The subcutaneous injection of modified tumescent solution before split-thickness donor site harvest has no adverse effect on donor site perfusion past day 1 or donor site healing. The addition of a local anesthetic may decrease pain for 24 hours postoperatively, but the difference in this study group was not significant. This technique should be universally recommended.

Delayed diagnosis of hand injuries in polytrauma patients.

Trauma patients are at high risk for delayed diagnosis of injuries, including those to the hand, with reports in the literature as high as 50%. As a result, patients may have prolonged disability and longer hospital stays with associated increased costs. Our objective was to elucidate risk factors for the delayed diagnosis of hand injuries. A review was performed from 2000 through 2009, assessing for age, sex, blood alcohol level, Glasgow Coma Score (GCS), Injury Severity Score (ISS), mechanism, injury type, length of stay, and timing of hand injury diagnosis. In this study, 36,568 patients were identified; 738 meeting criteria; 21.7% of patients had delayed diagnoses with 91.3% of patients diagnosed by the day after admission. Delayed diagnoses were more than 2 times higher for severely injured patients. Patients with delayed diagnoses had a lower GCS and a higher ISS and length of hospitalization. With a decreased GCS and elevated ISS, patients are at risk for delayed diagnoses of hand injuries. A focused tertiary survey is mandatory, particularly in patients with an altered mental status or with multiple injuries.

Reduction mammaplasty trends: a quality and fiscal analysis update.

BACKGROUND: Reduction mammaplasty remains one of the most common procedures performed by plastic surgeons today. The national health care quality and fiscal environments continue to evolve, with increasing emphasis on outpatient procedures and reduced lengths of stay (LOS). This study was designed to analyze the trends in reduction mammaplasty at our institution during the last 10 years with particular attention to LOS, complication rate, and readmission. We also evaluated the institutional fiscal implications with regard to reimbursement in the changing health care environment. MATERIALS AND METHODS: Institutional review board approval was obtained for this retrospective chart review. An analysis of all reduction mammaplasties during the last 10 years was undertaken. Admission status [same day surgery (SDS), outpatient ambulatory, observation, and inpatient], LOS, mortality, morbidity, and readmissions were documented. A financial analysis was also performed comparing trends in hospital revenue and operating income. Revenue was defined as the amount that the hospital received from all sources, whereas operating income was the revenue reduced by all costs incurred to provide services. RESULTS: In this population, 1779 patients were identified (SDS, 499; outpatient ambulatory or observational, 694; and inpatient, 586). Twenty patients were readmitted within 30 days. The all-cause 30-day readmission rate was 11.24 per 1000 patients. The disease-specific readmission rate was 5.06 per 1000 patients (n=9). Only 1 patient with disease-specific complication requiring readmission had been classified as SDS. No cases of nipple compromise were identified in our study. Revenue per case was highly variable throughout the study period. In general, operating income has decreased during the last decade, despite a small increase for those patients who were truly inpatient. CONCLUSIONS: Reduction mammaplasty is a common procedure that is safe when performed on an outpatient basis. Institutional operating income, except in the case of inpatients, continues to decrease and could pose a challenge in the future should present trends continue.

Surgical and financial implications of genetic counseling and requests for concurrent prophylactic mastectomy.

Risk assessment evaluation and breast cancer (BRCA) testing can occur in situations where a woman considers herself to be at increased risk for developing breast cancer or her physicians, either during routine evaluation or after diagnosis of unilateral breast cancer, consider her to be at risk for harboring a genetic predisposition to breast malignancy. This study examined the impact of risk assessment counseling on trends in breast surgery and cost of care. A retrospective chart review was performed from January 1, 1999 to December 31, 2008 for women older than 18 years who underwent breast surgery for malignancy or prophylaxis, had at least 1-year follow-up, and underwent genetic counseling. From the total number of women treated at our institution who underwent unilateral or bilateral mastectomy, we identified 102 women who underwent genetic counseling and selected 199 patients who did not undergo counseling to create a 4:1 retrospective case-control study. Patients who underwent BRCA gene testing and/or counseling were compared with patients who did not (controls). The study was powered at 70%, and alpha was set at 0.05. Counseled patients were >9 times more likely to undergo bilateral mastectomies (odds ratio = 9.18). They were younger (46.4 vs. 61.8) and incurred higher total costs ($10,810 vs. $7,266) (P < 0.002). The same trend was observed in each group. In counseled and control groups, younger women chose bilateral mastectomies (mean 44.4; 55.5), whereas older women chose unilateral procedures (mean 49.8; 63.02) (P < 0.014). Total cost for bilateral mastectomies was greater than unilateral mastectomies for both groups. Of 55 counseled patients undergoing mastectomies (85 breasts), 78 (92%) breasts were reconstructed, whereas 113 (49%) of 230 breasts were reconstructed in the control group. There was a statistically significant association between counseling with BRCA testing and decision to undergo bilateral as opposed to unilateral mastectomies. Younger women were also more likely to choose bilateral mastectomies whether or not they underwent counseling. Furthermore, a greater proportion of counseled women who underwent reconstruction opted to have bilateral implants. At our institution, younger women tend to choose costlier options.

Demographic determinants and effect of pre-operative angiotensin converting enzyme inhibitors and angiotensin receptor blockers on the occurrence of atrial fibrillation after CABG surgery.

BACKGROUND: Atrial fibrillation (AF) occurs in about 27% to 40% of post cardiac surgery patients. AF following coronary artery bypass graft surgery (CABG) is associated with a two-fold increase in morbidity and mortality. Various demographic risk factors and medications have been studied to predict the occurrence of this arrhythmia. The role of angiotensin related medications on the occurrence of AF in CABG patients is not determined. METHODS: Retrospective clinical and statistical analysis was made of all the patients who had undergone CABG surgery at Lehigh Valley Hospital during the years 2005 and 2006. Patients with chronic AF and those undergoing valvular surgery with CABG were excluded. Statistic analysis included chi-square test for categorical and student t-test for continuous variables. RESULTS: 757 patients (560 males and 197 females) were studied. AF occurred in 19% of the patients. Age (70.5 vs. 65.1, p < 0.005. OR per year of age: 1.02, 95%CI: 1.018-1.023) and presence of hypertension (OR: 1.92, 95%CI: 1.086-3.140, p = 0.025) were significantly associated with occurrence of AF. Neither ARBs (OR: 0.78, 95%CI: 0.431-1.410, p = 0.41) nor ACE inhibitors (OR: 1.01, 95%CI: 0.753-1.608, p = 0.63) reduced the occurrence of post operative AF. Patients with post operative AF had a significantly longer hospital stay (9.5 +/- 5.4 days vs. 6.9 +/- 4.3 days, p = 0.001). CONCLUSIONS: Advanced age and presence of hypertension were independent predictors of post-CABG AF. Patients with post operative AF had significantly longer hospital stay. Neither ARBs nor ACE inhibitors were associated with reduction of post-surgical AF. Further studies are needed to better delineate the role of angiotensin related medications on reduction of post-surgical AF.