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2.
JAMA Netw Open ; 7(3): e242684, 2024 Mar 04.
Article in English | MEDLINE | ID: mdl-38517441

ABSTRACT

Importance: Surgery with complete tumor resection remains the main treatment option for patients with breast cancer. Yet, current technologies are limited in providing accurate assessment of breast tissue in vivo, warranting development of new technologies for surgical guidance. Objective: To evaluate the performance of the MasSpec Pen for accurate intraoperative assessment of breast tissues and surgical margins based on metabolic and lipid information. Design, Setting, and Participants: In this diagnostic study conducted between February 23, 2017, and August 19, 2021, the mass spectrometry-based device was used to analyze healthy breast and invasive ductal carcinoma (IDC) banked tissue samples from adult patients undergoing breast surgery for ductal carcinomas or nonmalignant conditions. Fresh-frozen tissue samples and touch imprints were analyzed in a laboratory. Intraoperative in vivo and ex vivo breast tissue analyses were performed by surgical staff in operating rooms (ORs) within 2 different hospitals at the Texas Medical Center. Molecular data were used to build statistical classifiers. Main Outcomes and Measures: Prediction results of tissue analyses from classification models were compared with gross assessment, frozen section analysis, and/or final postoperative pathology to assess accuracy. Results: All data acquired from the 143 banked tissue samples, including 79 healthy breast and 64 IDC tissues, were included in the statistical analysis. Data presented rich molecular profiles of healthy and IDC banked tissue samples, with significant changes in relative abundances observed for several metabolic species. Statistical classifiers yielded accuracies of 95.6%, 95.5%, and 90.6% for training, validation, and independent test sets, respectively. A total of 25 participants enrolled in the clinical, intraoperative study; all were female, and the median age was 58 years (IQR, 44-66 years). Intraoperative testing of the technology was successfully performed by surgical staff during 25 breast operations. Of 273 intraoperative analyses performed during 25 surgical cases, 147 analyses from 22 cases were subjected to statistical classification. Testing of the classifiers on 147 intraoperative mass spectra yielded 95.9% agreement with postoperative pathology results. Conclusions and Relevance: The findings of this diagnostic study suggest that the mass spectrometry-based system could be clinically valuable to surgeons and patients by enabling fast molecular-based intraoperative assessment of in vivo and ex vivo breast tissue samples and surgical margins.


Subject(s)
Breast Neoplasms , Adult , Female , Humans , Middle Aged , Breast Neoplasms/diagnosis , Breast Neoplasms/surgery , Breast Neoplasms/pathology , Margins of Excision , Breast/surgery , Breast/pathology , Mastectomy , Mass Spectrometry
3.
CHEST Crit Care ; 1(3)2023 Dec.
Article in English | MEDLINE | ID: mdl-38188262

ABSTRACT

BACKGROUND: The introduction of COVID-19 vaccines exposed volatility and hesitancy around vaccines. Some health care models, including ICU recovery clinics (ICU-RCs), are structured to provide vaccine counseling. However, information regarding provider and patient vaccine conversations is limited in this postacute setting. RESEARCH QUESTION: What factors influence the decision-making process of patients who have survived an ICU stay surrounding influenza and COVID-19 vaccination? STUDY DESIGN AND METHODS: To understand further vaccine perceptions after critical illness, a secondary qualitative thematic analysis was performed using transcripts from a randomized controlled trial designed to develop and refine a telemedicine approach to ICU recovery. Thirty-three ICU-RC visits with 19 adult patients and 13 caregivers were conducted within 12 weeks of hospital discharge. The analysis was guided by the theory of planned behavior (TPB). RESULTS: Five themes were elicited from the data. The first four themes arose from the TPB: (1) behavioral and attitudinal beliefs (not being susceptible to the flu, concerns about the COVID-19 vaccine causing fertility issues, and not being tested enough), (2) normative beliefs (everyone they know is getting the influenza vaccine so they are, too), (3) control vaccine beliefs (patients are more likely to get the COVID-19 vaccine if it is easy to obtain), and (4) intention to vaccinate. Another theme not related to the TPB arose and could contribute to vaccine intent and behavior: (5) health team engagement with patients and caregivers (allowing for ICU clinicians to correct vaccine misinformation in real time). INTERPRETATION: Using the information learned in our study, the period after critical illness or other acute illness events may be an especially fruitful target for designing an action plan for improving public trust in vaccines and improving overall completion rates; however, further research is needed. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03926533; URL: www.clinicaltrials.gov.

4.
Am J Crit Care ; 31(4): 275-282, 2022 07 01.
Article in English | MEDLINE | ID: mdl-35425952

ABSTRACT

BACKGROUND: The COVID-19 pandemic has challenged health care professionals, especially those working in intensive care units (ICUs). OBJECTIVES: To explore critical care nurses' experiences with and perceptions of the COVID-19 pandemic during the early phases of the pandemic. METHODS: Data were from national surveys conducted during March and April 2020 to assess ICU providers' perceptions of the initial phases of the pandemic. A total of 831 responses from nurses to open-ended questions were examined by using thematic analysis. The questions assessed potentially limited resources in the ICU, adequacy of staffing, and measures used to reduce the possibility of spreading COVID-19 to family members. RESULTS: Overarching themes concerned access to equipment and preventive measures taken to reduce exposure to the virus. These themes included "sheltering the patient when I don't have enough" and "protecting those I love when I am a vector of transmission." Subthemes for the first overarching theme included not having enough personal protective equipment, not enough staff and not enough properly trained staff, and not enough institutional support. Subthemes for the second overarching theme included "isolating myself from everyone I care about" and "isolating everything I touch from everyone I care about." CONCLUSIONS: This thematic analysis identified several concerns of ICU nurses related to caring for patients in the initial phases of the COVID-19 pandemic. Ensuring adequate supplies, staffing, and administrative and emotional support are provided to frontline health care providers during the ongoing pandemic remains essential.


Subject(s)
COVID-19 , Nurses , Critical Care , Humans , Intensive Care Units , Pandemics/prevention & control
5.
Clin Chem ; 67(9): 1271-1280, 2021 09 01.
Article in English | MEDLINE | ID: mdl-34263289

ABSTRACT

BACKGROUND: Intraoperative tissue analysis and identification are critical to guide surgical procedures and improve patient outcomes. Here, we describe the clinical translation and evaluation of the MasSpec Pen technology for molecular analysis of in vivo and freshly excised tissues in the operating room (OR). METHODS: An Orbitrap mass spectrometer equipped with a MasSpec Pen interface was installed in an OR. A "dual-path" MasSpec Pen interface was designed and programmed for the clinical studies with 2 parallel systems that facilitated the operation of the MasSpec Pen. The MasSpec Pen devices were autoclaved before each surgical procedure and were used by surgeons and surgical staff during 100 surgeries over a 12-month period. RESULTS: Detection of mass spectral profiles from 715 in vivo and ex vivo analyses performed on thyroid, parathyroid, lymph node, breast, pancreatic, and bile duct tissues during parathyroidectomies, thyroidectomies, breast, and pancreatic neoplasia surgeries was achieved. The MasSpec Pen enabled gentle extraction and sensitive detection of various molecular species including small metabolites and lipids using a droplet of sterile water without causing apparent tissue damage. Notably, effective molecular analysis was achieved while no limitations to sequential histologic tissue analysis were identified and no device-related complications were reported for any of the patients. CONCLUSIONS: This study shows that the MasSpec Pen system can be successfully incorporated into the OR, allowing direct detection of rich molecular profiles from tissues with a seconds-long turnaround time that could be used to inform surgical and clinical decisions without disrupting tissue analysis workflows.


Subject(s)
Pancreatic Neoplasms , Humans , Mass Spectrometry , Parathyroidectomy , Thyroid Gland
6.
BMJ Health Care Inform ; 28(1)2021 Feb.
Article in English | MEDLINE | ID: mdl-33547086

ABSTRACT

Machine learning algorithms are being used to screen and diagnose disease, prognosticate and predict therapeutic responses. Hundreds of new algorithms are being developed, but whether they improve clinical decision making and patient outcomes remains uncertain. If clinicians are to use algorithms, they need to be reassured that key issues relating to their validity, utility, feasibility, safety and ethical use have been addressed. We propose a checklist of 10 questions that clinicians can ask of those advocating for the use of a particular algorithm, but which do not expect clinicians, as non-experts, to demonstrate mastery over what can be highly complex statistical and computational concepts. The questions are: (1) What is the purpose and context of the algorithm? (2) How good were the data used to train the algorithm? (3) Were there sufficient data to train the algorithm? (4) How well does the algorithm perform? (5) Is the algorithm transferable to new clinical settings? (6) Are the outputs of the algorithm clinically intelligible? (7) How will this algorithm fit into and complement current workflows? (8) Has use of the algorithm been shown to improve patient care and outcomes? (9) Could the algorithm cause patient harm? and (10) Does use of the algorithm raise ethical, legal or social concerns? We provide examples where an algorithm may raise concerns and apply the checklist to a recent review of diagnostic imaging applications. This checklist aims to assist clinicians in assessing algorithm readiness for routine care and identify situations where further refinement and evaluation is required prior to large-scale use.


Subject(s)
Checklist , Delivery of Health Care , Machine Learning , Algorithms , Delivery of Health Care/methods , Humans
7.
Am Soc Clin Oncol Educ Book ; 39: 42-48, 2019 Jan.
Article in English | MEDLINE | ID: mdl-31099648

ABSTRACT

Greater use of neoadjuvant chemotherapy in patients with breast cancer has led surgeons and radiation oncologists to have frequent encounters with women with upfront node-positive disease and a clinical complete response. These cases raise many important questions about what the optimal locoregional management should be to minimize recurrence risk while minimizing treatment-related toxicities. A particular point of debate is whether all patients who are known to have had node-positive disease before neoadjuvant chemotherapy should receive complete axillary lymph node dissection (ALND) if they have had a complete clinical and radiologic response. In this article, we present arguments and evidence in favor of and against axillary dissection after a complete response to neoadjuvant chemotherapy, followed by a brief data-driven review of implications for adjuvant radiotherapy in this context. We conclude that as trials continue to gather more evidence to guide decisions in the future, we must encourage patients to enroll in clinical trials when eligible, and otherwise support them to make decisions that are informed and congruent with their personal values in areas where there is clinical equipoise.


Subject(s)
Breast Neoplasms/pathology , Breast Neoplasms/therapy , Adult , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Axilla , Chemotherapy, Adjuvant , Clinical Decision-Making , Combined Modality Therapy , Disease Management , Female , Humans , Lymph Node Excision , Lymph Nodes/pathology , Lymphatic Metastasis , Neoadjuvant Therapy , Neoplasm Staging , Radiotherapy, Adjuvant , Sentinel Lymph Node Biopsy , Treatment Outcome
8.
Anal Chem ; 90(19): 11324-11332, 2018 10 02.
Article in English | MEDLINE | ID: mdl-30170496

ABSTRACT

The histological and molecular subtypes of breast cancer demand distinct therapeutic approaches. Invasive ductal carcinoma (IDC) is subtyped according to estrogen-receptor (ER), progesterone-receptor (PR), and HER2 status, among other markers. Desorption-electrospray-ionization-mass-spectrometry imaging (DESI-MSI) is an ambient-ionization MS technique that has been previously used to diagnose IDC. Aiming to investigate the robustness of ambient-ionization MS for IDC diagnosis and subtyping over diverse patient populations and interlaboratory use, we report a multicenter study using DESI-MSI to analyze samples from 103 patients independently analyzed in the United States and Brazil. The lipid profiles of IDC and normal breast tissues were consistent across different patient races and were unrelated to country of sample collection. Similar experimental parameters used in both laboratories yielded consistent mass-spectral data in mass-to-charge ratios ( m/ z) above 700, where complex lipids are observed. Statistical classifiers built using data acquired in the United States yielded 97.6% sensitivity, 96.7% specificity, and 97.6% accuracy for cancer diagnosis. Equivalent performance was observed for the intralaboratory validation set (99.2% accuracy) and, most remarkably, for the interlaboratory validation set independently acquired in Brazil (95.3% accuracy). Separate classification models built for ER and PR statuses as well as the status of their combined hormone receptor (HR) provided predictive accuracies (>89.0%), although low classification accuracies were achieved for HER2 status. Altogether, our multicenter study demonstrates that DESI-MSI is a robust and reproducible technology for rapid breast-cancer-tissue diagnosis and therefore is of value for clinical use.


Subject(s)
Breast Neoplasms/diagnostic imaging , Molecular Imaging , Spectrometry, Mass, Electrospray Ionization , Breast Neoplasms/metabolism , Female , Humans , Racial Groups , Receptor, ErbB-2/metabolism , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism
9.
J Am Soc Mass Spectrom ; 28(6): 1166-1174, 2017 06.
Article in English | MEDLINE | ID: mdl-28247296

ABSTRACT

Ambient ionization mass spectrometry has been widely applied to image lipids and metabolites in primary cancer tissues with the purpose of detecting and understanding metabolic changes associated with cancer development and progression. Here, we report the use of desorption electrospray ionization mass spectrometry (DESI-MS) to image metastatic breast and thyroid cancer in human lymph node tissues. Our results show clear alterations in lipid and metabolite distributions detected in the mass spectra profiles from 42 samples of metastatic thyroid tumors, metastatic breast tumors, and normal lymph node tissues. 2D DESI-MS ion images of selected molecular species allowed discrimination and visualization of specific histologic features within tissue sections, including regions of metastatic cancer, adjacent normal lymph node, and fibrosis or adipose tissues, which strongly correlated with pathologic findings. In thyroid cancer metastasis, increased relative abundances of ceramides and glycerophosphoinisitols were observed. In breast cancer metastasis, increased relative abundances of various fatty acids and specific glycerophospholipids were seen. Trends in the alterations in fatty acyl chain composition of lipid species were also observed through detailed mass spectra evaluation and chemical identification of molecular species. The results obtained demonstrate DESI-MSI as a potential clinical tool for the detection of breast and thyroid cancer metastasis in lymph nodes, although further validation is needed. Graphical Abstract Desorption electrospray ionization mass spectrometry imaging is used to differentiate metastatic cancer from adjacent lymph node tissue.


Subject(s)
Breast Neoplasms/pathology , Lymph Nodes/chemistry , Lymph Nodes/diagnostic imaging , Spectrometry, Mass, Electrospray Ionization/methods , Thyroid Neoplasms/pathology , Fatty Acids/analysis , Female , Glycerophospholipids/analysis , Glycolipids/analysis , Humans , Image Processing, Computer-Assisted , Lymph Nodes/pathology , Sphingolipids/analysis
10.
Ann Surg Oncol ; 23(10): 3190-8, 2016 10.
Article in English | MEDLINE | ID: mdl-27406093

ABSTRACT

BACKGROUND: Oncoplastic reconstruction is an approach that enables patients with locally advanced or adversely located tumors to undergo breast conserving surgery (BCS). The objectives were to identify the use of BCS with oncoplastic reconstruction (BCS + R) and determine the operative and oncologic outcomes compared with other breast surgical procedures for breast cancer. METHODS: This retrospective cohort study interrogated a single institution's prospectively maintained databases to identify patients who underwent surgery for breast cancer between 2007 and 2014. Surgeries were categorized as BCS, BCS + R, total mastectomy (TM), or TM with immediate reconstruction (TM + R). Demographic and clinicopathologic characteristics and postoperative complications were analyzed. RESULTS: There were 10,607 operations performed for 9861 patients. Median follow-up was 3.4 years (range, 0-9.1 years). The use of BCS + R had a nearly fourfold increase in the percentage of all breast cancer surgeries during the study period; 75 % of patients who underwent BCS + R had a T1 or T2 tumor. There was no difference in the use of BCS + R compared with BCS for any quadrant of the breast except the lower outer quadrant (11.1 vs. 6.8 %; p < .0001). BCS + R had a lower rate of seroma formation (13.4 vs. 18 %; p = .002) and positive or close margins compared with BCS (5.8 vs. 8.3 %; p = .04). There was no difference in overall survival or recurrence-free survival when comparing BCS and BCS + R. CONCLUSIONS: Patients undergoing BCS + R are not disadvantaged in terms of complications and short-term (3-year) outcomes compared with BCS patients or patients who underwent TM.


Subject(s)
Breast Neoplasms/pathology , Breast Neoplasms/surgery , Mammaplasty , Mastectomy, Segmental , Mastectomy, Simple , Adult , Aged , Aged, 80 and over , Disease-Free Survival , Female , Follow-Up Studies , Humans , Mammaplasty/adverse effects , Mammaplasty/trends , Margins of Excision , Mastectomy, Segmental/adverse effects , Mastectomy, Segmental/trends , Mastectomy, Simple/adverse effects , Middle Aged , Neoplasm Staging , Neoplasm, Residual , Retrospective Studies , Seroma/etiology , Survival Rate , Treatment Outcome , Young Adult
11.
Urology ; 86(5): 914-21, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26335495

ABSTRACT

OBJECTIVE: To describe guideline adherence for patients with suspected upper tract stones. PATIENTS AND METHODS: We performed a cross-sectional analysis of visits recorded by the National Hospital Ambulatory Medical Care Survey (emergency department [ED] component) in 2007-2010 (most recent data). We assessed adherence to clinical guidelines for diagnostic laboratory testing, imaging, and pharmacologic therapy. Multivariable regression models controlled for important covariates. RESULTS: An estimated 4,956,444 ED visits for patients with suspected kidney stones occurred during the study period. Guideline adherence was highest for diagnostic imaging, with 3,122,229 (63%) visits providing optimal imaging. Complete guideline-based laboratory testing occurred in only 2 of every 5 visits. Pharmacologic therapy to facilitate stone passage was prescribed during only 17% of eligible visits. In multivariable analysis of guideline adherence, we found little variation by patient, provider, or facility characteristics. CONCLUSION: Guideline-recommended care was absent from a substantial proportion of acute care visits for patients with suspected kidney stones. These failures of care delivery likely increase costs and temporary disability. Targeted interventions to improve guideline adherence should be designed and evaluated to improve care for patients with symptomatic kidney stones.


Subject(s)
Diagnostic Imaging/statistics & numerical data , Emergency Service, Hospital/statistics & numerical data , Guideline Adherence/statistics & numerical data , Quality of Health Care , Urinary Calculi/epidemiology , Urinary Calculi/therapy , Adult , Age Factors , Aged , Cross-Sectional Studies , Diagnostic Imaging/methods , Emergency Medical Services/methods , Emergency Medical Services/statistics & numerical data , Female , Health Care Surveys , Humans , Incidence , Logistic Models , Male , Middle Aged , Multivariate Analysis , Risk Assessment , Sex Factors , United States , Urinary Calculi/diagnosis
12.
Urol Oncol ; 33(2): 69.e29-34, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25017694

ABSTRACT

OBJECTIVES: To perform a population-based analysis to characterize the effect of prostate-specific antigen (PSA) testing on oncologic outcomes in men diagnosed with prostate cancer. MATERIALS AND METHODS: We used the Surveillance, Epidemiology, and End Results-Medicare-linked data to identify 98,883 men diagnosed with prostate cancer from 1996 to 2007. We stratified frequency of PSA testing as none, 1 to 2, 3 to 5, and≥6 tests in the 5 years before prostate cancer diagnosis. We used propensity scoring methods to assess the effect of frequency of PSA testing on likelihood of (1) metastases at diagnosis and (2) overall mortality and prostate cancer-specific mortality. RESULTS: In adjusted analyses, the likelihood of being diagnosed with metastatic prostate cancer decreased with greater frequency of PSA testing (none, 10.6; 1-2, 8.3; 3-5, 3.7; and≥6, 2.5 events per 100 person years, P<0.001). Additionally, greater frequency of PSA testing was associated with improved overall survival and prostate cancer-specific survival (P<0.001 for both). CONCLUSIONS: Greater frequency of PSA testing in men 70 years of age or older in the 5 years before prostate cancer diagnosis is associated with lower likelihood of being diagnosed with metastatic prostate cancer and improved overall and prostate cancer-specific survival.


Subject(s)
Kallikreins/analysis , Prostate-Specific Antigen/analysis , Prostatic Neoplasms/diagnosis , Age Factors , Aged , Aged, 80 and over , Cohort Studies , Humans , Male , Prostatic Neoplasms/epidemiology , Prostatic Neoplasms/pathology , SEER Program , Treatment Outcome , United States/epidemiology
13.
Ann Surg ; 261(5): 870-5, 2015 May.
Article in English | MEDLINE | ID: mdl-24887970

ABSTRACT

OBJECTIVE: To examine the feasibility and outcomes of video-based peer feedback through social networking to facilitate robotic surgical skill acquisition. BACKGROUND: The acquisition of surgical skills may be challenging for novel techniques and/or those with prolonged learning curves. METHODS: Randomized controlled trial involving 41 resident physicians performing the Tubes (Da Vinci Intuitive Surgical, Sunnyvale, CA) simulator exercise with versus without peer feedback of video-recorded performance through a social networking Web page. Data collected included simulator exercise score, time to completion, and comfort and satisfaction with robotic surgery simulation. RESULTS: There were no baseline differences between the intervention group (n = 20) and controls (n = 21). The intervention group showed improvement in mean scores from session 1 to sessions 2 and 3 (60.7 vs 75.5, P < 0.001, and 60.7 vs 80.1, P < 0.001, respectively). The intervention group scored significantly higher than controls at sessions 2 and 3 (75.5 vs 59.6, P = 0.009, and 80.1 vs 65.9, P = 0.019, respectively). The mean time (seconds) to complete the task was shorter for the intervention group than for controls during sessions 2 and 3 (217.4 vs 279.0, P = 0.004, and 201.4 vs 261.9, P = 0.006, respectively). At the study conclusion, feedback subjects were more comfortable with robotic surgery than controls (90% vs 62%, P = 0.021) and expressed greater satisfaction with the learning experience (100% vs 67%, P = 0.014). Of the intervention subjects, 85% found that peer feedback was useful and 100% found it effective. CONCLUSIONS: Video-based peer feedback through social networking appears to be an effective paradigm for surgical education and accelerates the robotic surgery learning curve during simulation.


Subject(s)
Computer Simulation , Feedback , General Surgery/education , Peer Group , Robotics , Social Networking , Video Recording , Clinical Competence , Humans , Internship and Residency , Learning Curve
14.
Surg Infect (Larchmt) ; 15(3): 187-93, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24773169

ABSTRACT

BACKGROUND: In 2010, the Ventral Hernia Working Group (VHWG) published a grading system to assess the risk of surgical site complications in patients undergoing ventral hernia repair. This study evaluated the predictive value of the VHWG classification for the surgical outcomes of laparoscopic ventral hernia repair (LVHR) and identified independent factors associated with surgical site infection (SSI) and surgical site occurrence (SSO). METHODS: A retrospective review was performed of all patients who underwent LVHR over a 10-year period at two institutions. The U.S. Centers for Disease Control and Prevention definition of SSI and the VHWG definition of SSO were used. Univariable analysis was performed using the Student t-test, analysis of variance, chi-square test, or Fisher exact test, as appropriate. Multivariable analysis was used to identify independent factors associated with SSI and SSO. RESULTS: Differences in American Society of Anesthesiologists class, body mass index, diabetes mellitus, chronic obstructive pulmonary disease, tobacco use, hernia type, prior abdominal surgery, prior ventral hernia repair, hernia size, and total infections were identified by grade. There was no difference in SSI or SSO by grade. Multivariable analysis revealed institution and number of prior abdominal operations to be associated with SSI. Institution, prostate disease, and prior ventral hernia repair were associated with SSO. CONCLUSIONS: The VHWG classification was unable to predict SSI and SSO and may not be applicable in LVHR. This study identified independent factors associated with SSI and SSO in LVHR. Although further study is warranted to validate these results, the factors presented may be a useful tool to stratify patient risk of SSI and SSO with LVHR.


Subject(s)
Epidemiologic Methods , Hernia, Ventral/surgery , Laparoscopy/adverse effects , Surgical Wound Infection/epidemiology , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Retrospective Studies , Risk Factors
15.
Urology ; 83(6): 1265-71, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24768014

ABSTRACT

OBJECTIVE: To examine the impact of radical prostatectomy (RP) operative time on outcomes and cost, we performed a population-based assessment of operative time as a predictor of outcomes. Although operative time has been used as a metric to evaluate RP surgeon learning curves, the effect of RP operative times on outcomes remains understudied. MATERIALS AND METHODS: We used US Surveillance, Epidemiology, and End Results-Medicare linked data to identify 7534 men aged≥66 years diagnosed with prostate cancer during 2003-2007 who underwent RP for localized prostate cancer through 2009. We categorized RP operative time into quartiles (short, intermediate, long, and very long) and used propensity score analyses to assess its impact on perioperative complications, mortality, length of hospitalization, readmissions, emergency room visits, and costs. RESULTS: Quartiles ranged from 0 to 172 minutes for short, 173 to 214 minutes for intermediate, 215 to 268 minutes for long, and ≥269 minutes for very long RP operative times. After propensity score adjustment, longer operative time was associated with more surgery-related complications (short, 12.0%; intermediate, 12.3%; long, 14.4%; and very long, 22.8%; P<.001), longer median (interquartile range) length of stay in days (short, 2 [2-3]; intermediate, 2 [2-3]; long, 2 [1-3]; and very long, 2 [1-3]; P<.001), and higher median costs (short, $10,647; intermediate, $10,957; long, $11,405; and very long, $11,966; P<.001). CONCLUSION: Longer RP operative time is associated with more complications, longer lengths of hospital stay, and higher costs. Increasing operative efficiency may reduce complications, length of stay, and health-care costs.


Subject(s)
Health Care Costs , Operative Time , Prostatectomy/economics , Prostatectomy/methods , Prostatic Neoplasms/surgery , Aged , Aged, 80 and over , Benchmarking , Cohort Studies , Humans , Length of Stay/economics , Male , Patient Readmission/economics , Patient Readmission/statistics & numerical data , Postoperative Complications/economics , Postoperative Complications/physiopathology , Prognosis , Prostatectomy/mortality , Prostatic Neoplasms/mortality , Prostatic Neoplasms/pathology , Registries , Retrospective Studies , Risk Assessment , Statistics, Nonparametric , Survival Rate , Treatment Outcome
16.
Am Surg ; 80(2): 138-48, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24480213

ABSTRACT

Laparoscopic ventral hernia repair (LVHR) is gaining popularity as an option to repair abdominal wall hernias. Bulging after repair remains common after this technique. This study evaluates the incidence and factors associated with bulging after LVHR. Between 2000 and 2010, 201 patients underwent LVHR at two affiliated institutions. Patients who developed recurrence or pseudorecurrence (seroma or eventration) were analyzed with univariate and multivariate analyses to identify predictors of these complications. Of the 201 patients who underwent LVHR, 40 (19.9%) patients developed a seroma, 63 (31.3%) patients had radiographically proven eventration, and 25 (12.4%) patients had a hernia recurrence. On multivariate analysis, seromas were associated with number of prior ventral hernia repairs, surgical site infections, and prostate disease. Mesh eventration was associated with hernia size and surgical technique. Tissue eventration was associated with primary hernias and surgical technique. Hernia recurrence was associated with incisional hernias and mesh type used. Recurrence and pseudorecurrence are important complications after LVHR. Large hernia size, infections, and surgical technique are important clinical factors that affect outcomes after LVHR.


Subject(s)
Hernia, Ventral/surgery , Herniorrhaphy/adverse effects , Laparoscopy/adverse effects , Patient Satisfaction , Surgical Mesh/adverse effects , Aged , Analysis of Variance , Cohort Studies , Female , Follow-Up Studies , Hernia, Ventral/diagnostic imaging , Hernia, Ventral/physiopathology , Herniorrhaphy/methods , Humans , Laparoscopy/methods , Logistic Models , Male , Middle Aged , Multivariate Analysis , Predictive Value of Tests , Recurrence , Retrospective Studies , Risk Assessment , Seroma/etiology , Seroma/physiopathology , Seroma/surgery , Severity of Illness Index , Statistics, Nonparametric , Surgical Wound Infection/physiopathology , Surgical Wound Infection/surgery , Time Factors , Tomography, X-Ray Computed/methods , Treatment Outcome
17.
J Sex Med ; 11(4): 1063-1070, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24443943

ABSTRACT

INTRODUCTION: Late-onset hypogonadism may impair quality of life and contribute to metabolic and cardiovascular comorbidity in aging men. Testosterone replacement therapy is effective in treating hypogonadism. However, for the millions of men with a history of prostate cancer, exogenous testosterone has long been considered contraindicated, even though little data in such men are available. Clarification of this safety issue could allow treatment to be considered for a sizeable segment of the aging male population. AIM: The aim of this study is to examine population-based utilization and impact of testosterone replacement therapy in men with prostate cancer. METHODS: Using linked Surveillance, Epidemiology, and End Results-Medicare data, we identified 149,354 men diagnosed with prostate cancer from 1992 to 2007. Of those, 1181 (0.79%) men received exogenous testosterone following their cancer diagnosis. We used propensity scoring analysis to examine the effect of testosterone replacement on the use of salvage hormone therapy and overall and prostate cancer-specific mortality. MAIN OUTCOME MEASURES: We assessed overall mortality, cancer-specific mortality, and the use of salvage hormone therapy. RESULTS: Following prostate cancer diagnosis, testosterone replacement was directly related to income and educational status and inversely related to age (all P < 0.001). Men undergoing radical prostatectomy and men with well-differentiated tumors were more likely to receive testosterone (all P < 0.001). On adjusted analysis, testosterone replacement therapy was not associated with overall or cancer-specific mortality or with the use of salvage hormone therapy. CONCLUSIONS: In this population-based observational study of testosterone replacement therapy in men with a history of prostate cancer, treatment was not associated with increased overall or cancer-specific mortality. These findings suggest testosterone replacement therapy may be considered in men with a history of prostate cancer, but confirmatory prospective studies are needed.


Subject(s)
Androgens/therapeutic use , Hormone Replacement Therapy , Hypogonadism/drug therapy , Prostatic Neoplasms/mortality , Testosterone/therapeutic use , Aged , Hormone Replacement Therapy/mortality , Humans , Hypogonadism/mortality , Male , Prostate-Specific Antigen , Prostatectomy/mortality , Prostatic Neoplasms/surgery , Risk Factors , Salvage Therapy/mortality
18.
BJU Int ; 113(5b): E112-8, 2014 May.
Article in English | MEDLINE | ID: mdl-24053198

ABSTRACT

OBJECTIVES: To determine factors that influence radical prostatectomy (RP) operative times. Operative time assessment is inherent to defining surgeon learning curves and evaluating quality of care. SUBJECTS/PATIENTS AND METHODS: Population-based observational cohort study using USA Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data of men diagnosed with prostate cancer during 2003-2007 who underwent robot-assisted radical prostatectomy (RARP, 3458 men) and retropubic RP (RRP, 6993) through to 2009. We obtained median operative time using anaesthesia administrative data for RP and used median regression to assess the contribution of patient, surgeon, and hospital factors to operative times. RESULTS: The median RARP operative time decreased from 315 to 247 min from 2003 to 2008-2009 (P < 0.001), while the median RRP operative time remained similar (195 vs 197 min, P = 0.90). In adjusted analysis, RARP vs RRP (parameter estimate [PE] 70.9; 95% confidence interval [CI] 58, 84; P < 0.001) and obesity (PE 15; 95% CI 7, 23; P < 0.001) were associated with longer operative times while higher surgeon volumes were associated with shorter operative times (P < 0.001). RPs performed by surgeons employed by group (parameter estimate [PE] -22.76; 95% CI -38, -7.49; P = 0.004) and non-government (PE -35.59; 95% CI -68.15, -3.03; P = 0.032) vs government facilities and non-profit vs government hospital ownership (PE -21.85; 95% CI -32.28, -11.42; P < 0.001) were associated with shorter operative times. CONCLUSIONS: During our study period, RARP operative times decreased by 68 min while RRP operative times remained stagnant. Higher surgeon volume was associated with shorter operative times, and selective referral or improved efficiency to the level of high-volume surgeons would net almost $15 million (USA dollars) in annual savings.


Subject(s)
Operative Time , Prostatectomy/standards , Aged , Cohort Studies , Humans , Male
19.
Eur Urol ; 65(3): 659-64, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24139942

ABSTRACT

BACKGROUND: Pure laparoscopic donor nephrectomy (LDN) is a unique intervention because it carries known risks and complications, yet carries no direct benefit to the donor. Therefore, it is critical to continually examine and improve quality of care. OBJECTIVE: To identify factors affecting LDN outcomes and complications. DESIGN, SETTING, AND PARTICIPANTS: A retrospective analysis of prospectively collected data for 1204 consecutive LDNs performed from March 2000 through August 2012. INTERVENTION: LDN performed at an academic training center. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Using multivariable regression, we assessed the effect of age, sex, body mass index (BMI), laterality, and vascular variation on operative time, estimated blood loss (EBL), complications, and length of stay. RESULTS AND LIMITATIONS: The following variables were associated with longer operative time (data given as parameter estimate plus or minus the standard error): female sex (9.09 ± 2.43; p<0.001), higher BMI (1.03 ± 0.32; p=0.001), two (7.87 ± 2.70; p=0.004) and three or more (22.45 ± 7.13; p=0.002) versus one renal artery, and early renal arterial branching (5.67 ± 2.82; p=0.045), while early renal arterial branching (7.81 ± 3.85; p=0.043) was associated with higher EBL. Overall, 8.2% of LDNs experienced complications, and by modified Clavien classification, 74 (5.9%) were grade 1, 13 (1.1%) were grade 2a, 10 (0.8%) were grade 2b, and 2 (0.2%) were grade 2c. There were no grade 3 or 4 complications. Three or more renal arteries (odds ratio [OR]: 2.74; 95% CI, 1.05-7.16; p=0.04) and late renal vein confluence (OR: 2.42; 95% CI, 1.50-3.91; p=0.0003) were associated with more complications. Finally, we did not find an association of the independent variables with length of stay. A limitation is that warm ischemia time was not assessed. CONCLUSIONS: In our series, renal vascular variation prolonged operative time and was associated with more complications. While complicated donor anatomy is not a contraindication of LDN, surgical decision-making should take into consideration these results.


Subject(s)
Laparoscopy , Living Donors , Nephrectomy/adverse effects , Nephrectomy/methods , Tissue and Organ Harvesting/adverse effects , Tissue and Organ Harvesting/methods , Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective Studies , Retrospective Studies , Treatment Outcome , Young Adult
20.
J Comp Eff Res ; 2(3): 293-9, 2013 May.
Article in English | MEDLINE | ID: mdl-24236628

ABSTRACT

Prostate cancer is the second leading cause of cancer death among men in the USA. Use of robot-assisted radical prostatectomy (RARP) for the management of localized prostate cancer has increased dramatically in recent years. This review focuses on comparing quality of life following RARP versus retropubic radical prostatectomy. RARP is associated with improved perioperative outcomes, such as reduced blood loss and fewer transfusions. In addition, cancer control after RARP versus retropubic radical prostatectomy is equivalent, with similar incidences of positive surgical margins and comparable early oncological outcomes. RARP appears to provide advantages in recovery of continence, potency and quality of life compared with retropubic radical prostatectomy; however, methodological limitations exist in current literature.


Subject(s)
Laparoscopy/methods , Prostatectomy/methods , Prostatic Neoplasms/surgery , Robotics , Comparative Effectiveness Research , Disease-Free Survival , Erectile Dysfunction/drug therapy , Erectile Dysfunction/surgery , Humans , Laparoscopy/instrumentation , Laparoscopy/mortality , Male , Neoplasm Recurrence, Local/mortality , Organ Sparing Treatments , Prostatectomy/instrumentation , Prostatectomy/mortality , Prostatic Neoplasms/mortality , Quality of Life , Treatment Outcome , Urinary Incontinence/mortality , Urinary Incontinence/surgery
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