Operative Time and Accrual of Postoperative Complications in Minimally Invasive Versus Open Myomectomy.

STUDY OBJECTIVE: To compare the prevalence and accrual of 30-day postoperative complications by operative time for open myomectomy (OM) and minimally invasive myomectomy (MIM). DESIGN: Retrospective cohort study SETTING: Hospitals participating in the National Surgical Quality Improvement Program database from January 2015 to December 2021. PATIENTS: Female patients aged ≥18 years undergoing OM or MIM. INTERVENTIONS: Patients were categorized into OM and MIM cohorts. Covariates associated with operative time and composite complications were identified using general linear model and chi-square or Fisher's exact test as appropriate. Adjusted spline regression was performed as a test of linearity between operative time and composite complications. Adjusted risk ratios of 30-day postoperative individual, minor, major, and composite complications by 60-minute operative time increments were estimated using Poisson regression with robust error variance. MEASUREMENTS AND MAIN RESULTS: Of 27 728 patients, 11 071 underwent MIM and 16 657 underwent OM. Mean operative times (SD) were 164.6 (82.0) for MIM and 129.2 (67.0) for OM. Raw composite complication rates were 5.5% for MIM and 15.8% for OM. Adjusted spline regression demonstrated linearity between operative time and relative risk of composite postoperative complications for both MIM and OM. MIM had higher adjusted relative risk (aRR, 95% CI) compared to OM of blood transfusion (1.55, 1.45-1.64 versus 1.29, 1.25-1.34), overall minor complications (1.13, 1.03-1.23 versus 1.01, 0.92-1.10), and overall major complications (1.43, 1.35-1.51 versus 1.27, 1.12-1.32). Operative time had greater impact on risk of composite complications for MIM than OM, reaching aRR 2.0 at 296 minutes versus 461 minutes for OM. CONCLUSION: OM has a higher overall rate of composite, minor, and major complications compared to MIM. While operative time is independently and linearly associated with postoperative complications with myomectomy regardless of approach, optimizing surgical efficiency for MIM may be more critical than for OM.

Variation in diagnosis of urinary incontinence in women by provider and patient demographic factors.

INTRODUCTION: Urinary incontinence (UI) among women is under-recognized in primary care setting. We hypothesized that UI is, therefore, more commonly diagnosed by specialists. Our aim was to determine the rate of UI diagnosis by provider and patient demographics, and whether these factors affect the likelihood of UI diagnosis. METHODS: Retrospective study using electronic medical records from 2010 to 2019. Ambulatory patient encounters by adult females were identified. Encounters with new diagnosis of UI (stress, urgency, mixed, or unspecified) were identified using ICD 9 and 10 codes. The following data were extracted: diagnosing provider specialty and sex, patient age, BMI, race, estimated household income, insurance coverage and type, and primary care provider (PCP). Rate of UI diagnosis was calculated using proportions. Univariable comparison and multivariable logistic regression were performed. RESULTS: 576,110 patient encounters were captured. 14,378 patient encounters had UI diagnosis (2.5%). UI population had the following characteristics: Mean age of 60.1 ± 15.5 years, 65.6% identified as white, 75.7% had a PCP, and 87.9% had insurance. UI diagnosis rate was < 1% for PCPs. Multivariable logistic regression showed that urogynecologists and female providers were more likely to diagnose UI; patient demographics associated with UI diagnosis included older age, elevated BMI, white race, commercial insurance, and having a PCP. Estimated household income did not have a significant effect. CONCLUSION: Diagnosis of UI is seldom made by PCPs. Race, insurance, and having a PCP may affect the likelihood of receiving UI diagnosis. Continued efforts to promote equity in recognizing UI may be warranted.

Development of a patient-centered text message-based platform for the self-management of interstitial cystitis/bladder pain syndrome symptoms.

OBJECTIVE: To develop a patient-centered text message-based platform that promotes self-management of symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: Adult women with IC/BPS interested in initiating a first- or second-line treatments per American Urological Association guidelines (recategorized as "behavioral/non-pharmacologic treatments" and "oral medicines" in the 2022 version) participated in rapid cycle innovation consisting of iterative cycles of contextual inquiry, prototype design and development. We delivered treatment modules and supportive messages using an algorithm-driven interactive messaging prototype through a HIPAA-compliant texting platform. Patients provided feedback through narrative text messages and an exit interview. Feedback was analyzed qualitatively and used to iteratively revise the platform until engagement ≥ 85% and accuracy ≥ 80% were achieved. The final version consisted of four treatment module categories (patient education and behavioral modification, cognitive behavioral therapy, pelvic floor physical therapy, and guided mindfulness practices) and supportive messages delivered through an automated algorithm over 6 weeks. RESULTS: Thirty IC/BPS patients with moderate symptom bother (median IC Problem Index score 9, range 6-12) participated in five cycles of contextual inquiry. Qualitative analysis identified three overarching concepts that informed the development of the platform: preference for patient centered terms, desire to gain self-efficacy in managing symptoms, and need for provider support. Patients preferred the term "interstitial cystitis" to "bladder pain syndrome" which carried the stigma of chronic pain. Patients reported greater self-efficacy in managing symptoms through improved access to mind-body and behavioral treatment modules that helped them to gain insight into their motivations and behaviors. The concept of provider support was informed by shared decision making (patients could choose preferred treatment modules) and reduced sense of isolation (weekly check in messages to check on symptom bother). CONCLUSION: A patient centered text message-based platform may be clinically useful in the self-management of IC/BPS symptoms.

Is the volume of Burch urethropexy sufficient for urogynecology fellows to meet the ACGME requirement?

INTRODUCTION AND HYPOTHESIS: Urogynecology fellows report low exposure to nonsling retropubic anti-incontinence procedures such as Burch urethropexy and thus may have difficulty meeting the required minimum case numbers, but there has been an even more objective exploration of this observation. Thus, our objective was to assess the feasibility of meeting the Accreditation Council for Graduate Medical Education (ACGME) requirement for each urogynecology fellow to perform five nonsling retropubic anti-incontinence procedures during fellowship. METHODS: Cross-sectional study using the National Surgical Quality Improvement Program (NSQIP) and National Resident Matching Program (NRMP) databases from 2009 to 2019. From NSQIP, the number of nonsling retropubic anti-incontinence procedures (open and laparoscopic Burch urethropexy and bladder neck needle suspension) and midurethral sling procedures was extracted using CPT codes. The number of fellows was extracted from the NRMP database. Trends in the number of anti-incontinence procedures were compared with the trend in the number of fellows using linear regression. RESULTS: From 2009 to 2019 the number of fellows doubled from 81 to 176. An average of 97 nonsling retropubic anti-incontinence and 6,372 sling procedures were performed annually. Linear regression showed an increase of 10.7 fellows per year (95% CI 9.3-12.1) versus an increase of 5.8 nonsling retropubic anti-incontinence procedures per year (95% CI -0.4 to 12.1). This contrasts with an increase of 690.9 slings per year (95% CI 509.9-872.0). CONCLUSIONS: The increase in the number of nonsling retropubic anti-incontinence procedures does not appear to match the increase in the number of urogynecology fellows. Supplementary educational approaches such as simulation may be prudent.

"Every minute counts": association between operative time and post-operative complications for patients undergoing minimally invasive sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: Our aim was to assess whether operative time is independently associated with post-operative complications for minimally invasive sacrocolpopexy (MISCP). METHODS: Using the National Surgical Quality Improvement Program (NSQIP) database, patients undergoing MISCP from 2015 to 2020 were identified by CPT code. The following data were extracted: demographics, concomitant procedures (hysterectomies, midurethral sling, and anterior or posterior repair), and post-operative complications. Complications were categorized into minor, major, and composite, modeled after the Clavien-Dindo classification. For analysis, covariates associated with operative time and composite complications were identified using a general linear model and Chi-squared or Fisher's exact test as appropriate. Then, adjusted spline regression was performed as a test of nonlinearity between operative time and composite complications. Adjusted relative risks of complications by 60-min increments were estimated using Poisson regression with robust error variance. RESULTS: A total of 13,239 patients who underwent MISCP were analyzed. Overall, mean operative time (SD) was 189.5 (78.3) min. Post-operative complication rates were 2.6% for minor, 4.7% for major, and 7.3% for composite complications. Age, smoking, and sling were the only covariates associated with both operative time and post-operative complications. Adjusted spline regression demonstrated linearity (p<0.0001). With each 60-min increase in operative time, adjusted relative risks (95% CI) were 1.14 for composite (1.09, 1.19), 1.16 for minor (1.10, 1.21), and 1.11 (1.03, 1.20) for major complications. CONCLUSIONS: Operative time is independently and linearly associated with post-operative complications for patients undergoing MISCP, even when adjusted for demographic variables and concomitant procedures.

Safety of Same-Day Discharge Versus Hospital Admission in Minimally Invasive Myomectomy.

STUDY OBJECTIVE: To compare postoperative complication rates between same-day discharge patients and patients admitted to hospital after minimally invasive myomectomy, stratified by patient demographics and perioperative variables including myoma burden. DESIGN: Retrospective cohort study. Setting Hospitals participating in the National Surgical Quality Improvement Program database from January 2015 to December 2019. PATIENTS: Female patients aged ≥18 years undergoing minimally invasive myomectomy. INTERVENTIONS: Patients were categorized into either the same-day discharge or admitted patient cohort. Univariate comparisons of demographics, perioperative variables, and 30-day postoperative complications were performed. Multivariate logistic regression was used to 1) identify demographic and perioperative factors associated with admission, and 2) compare postoperative complication rates of same-day discharge patients with those of admitted patients while adjusting for demographic and perioperative factors. MEASUREMENTS AND MAIN RESULTS: Eight thousand one hundred patients were recruited during the study period. The overall rate of same-day discharge was 57.2% in 2015 and 65.0% in 2019. The same-day discharge rate was 64.6% for patients with a smaller myoma burden (1-4 fibroids and ≤250 grams, Current Procedural Terminology 58545) and 56.8% for larger myoma burden (≥5 fibroids or >250 grams, Current Procedural Terminology 58546). Age, race, American Society of Anesthesiologists classification III or IV, preoperative hematocrit <36%, hypertension, diabetes, bleeding disorder, and increasing operative time were associated with admission to hospital. After adjusting for these variables, composite postoperative complication rates were similar between admitted patients and patients who were discharged the same day regardless of myoma burden (adjusted OR [aOR], 0.66; 95% confidence interval [CI] 0.18-2.47 for low myoma burden and aOR, 0.91; 95% CI 0.18-4.63 for high myoma burden). Admitted patients with both low (aOR, 9.1; 95% CI 2.27-37.04) and high (aOR, 8.24; 95% CI 1.59-42.49) myoma burdens were significantly more likely to receive a blood transfusion compared to same-day discharge patients. CONCLUSION: Same-day discharge after minimally invasive myomectomy, regardless of myoma burden, is associated with low complication rates. Our findings may aid in shared decision making on discharge planning.

A statewide colectomy experience: the role of full bowel preparation in preventing surgical site infection.

OBJECTIVE: To assess the utility of full bowel preparation with oral nonabsorbable antibiotics in preventing infectious complications after elective colectomy. BACKGROUND: Bowel preparation before elective colectomy remains controversial. We hypothesize that mechanical bowel preparation with nonabsorbable oral antibiotics is associated with a decreased rate of postoperative infectious complications when compared with no bowel preparation. METHODS: Patient and clinical data were obtained from the Michigan Surgical Quality Collaborative-Colectomy Best Practices Project. Propensity score analysis was used to match elective colectomy cases based on primary exposure variable-full bowel preparation (mechanical bowel preparation with nonabsorbable oral antibiotics) or no bowel preparation (neither mechanical bowel preparation given nor nonabsorbable oral antibiotic given). The primary outcomes for this study were occurrence of surgical site infection and Clostridium difficile colitis. RESULTS: In total, 2475 cases met the study criteria. Propensity analysis created 957 paired cases (n = 1914) differing only by the type of bowel preparation. Patients receiving full preparation were less likely to have any surgical site infection (5.0% vs 9.7%; P = 0.0001), organ space infection (1.6% vs 3.1%; P = 0.024), and superficial surgical site infection (3.0% vs 6.0%; P = 0.001). Patients receiving full preparation were also less likely to develop postoperative C difficile colitis (0.5% vs 1.8%, P = 0.01). CONCLUSIONS: In the state of Michigan, full bowel preparation is associated with decreased infectious complications after elective colectomy. Within this context, the Michigan Surgical Quality Collaborative recommends full bowel preparation before elective colectomy.

Racial and socioeconomic disparities in fertility treatment provision for patients with polycystic ovary syndrome.

OBJECTIVE: To assess whether provision of fertility treatment for patients with polycystic ovary syndrome (PCOS) varies by patient and physician level demographics. DESIGN: Retrospective cohort study SUBJECTS: Patients at a university health system seeking care for PCOS and infertility from 2007-2021. EXPOSURE: Patient age, BMI, race, ethnicity, estimated household income, primary insurance payor, provider sex, and provider medical specialty. MAIN OUTCOME MEASURES: Prescriptions for fertility treatment, including clomiphene citrate, letrozole, and injectable gonadotropins. Differences in patient and physician demographics between patients who did and did not receive a prescription were identified with univariable analysis. Multilevel mixed-effects logistic regression was performed to determine associations between patient and physician demographics and prescription receipt. RESULTS: 3,435 patients with PCOS and infertility were identified with a mean age of 31.1 +/- 5.7 years. Of the 68.8% of patients who received a prescription, 47.8% of prescriptions were clomiphene citrate, 38.6% letrozole, and 13.7% injectable gonadotropins. There were lower odds of prescription receipt for Black patients compared to White patients (aOR 0.75, 95% CI 0.61-0.93), those with estimated household income below the federal poverty level (FPL) compared to above the national median (aOR 0.71, 95% CI 0.46-0.97), and those with public compared to commercial insurance (aOR 0.53, 95% CI 0.40-0.71). These disparities persisted in a subanalysis of patients prescribed oral medications only with lower odds of prescription receipt for Black compared to White patients (aOR 0.74, 95% CI 0.57-0.95), those with estimated household income below the FPL compared to above the national median (aOR 0.93, 95% CI 0.87-0.98), and those with public compared to commercial insurance (aOR 0.57, 95% CI 0.42-0.76). Black patients waited on average 153.3 days longer than White patients from initial visit to prescription receipt. Patients had lower odds of receiving any prescription from family medicine physicians (aOR 0.36, 95% CI 0.24-0.52) and general internal medicine physicians (aOR 0.55, 95% CI 0.42-0.73) compared to reproductive endocrinologists. CONCLUSION: Racial and socioeconomic disparities exist in the provision of infertility treatments for patients with PCOS. Fewer primary care physicians engaged in first-line fertility treatment, indicating an opportunity for physician education to improve access to fertility care.

Dual Incontinence and Risk of Fall: A Retrospective Cohort Study.

IMPORTANCE: Although there is a known association between urinary incontinence (UI) and fall risk, it is unclear if having both UI and fecal incontinence, or dual incontinence (DI), increases this risk. OBJECTIVE: The objective of our study was to elucidate a relationship between DI and falls. STUDY DESIGN: This was a retrospective cohort study at a tertiary academic health system of female patients 65 years and older presenting for a new patient visit to a urogynecology health care professional for UI from 2019 to 2021. Demographic data and responses to intake questionnaires on fall and markers of frailty were extracted. Multivariable logistic regression was performed to identify factors associated with fall adjusting for covariates identified upon univariate comparison. RESULTS: A total of 2,814 women were included in the analysis; 2,661 patients reported UI alone, and 153 reported DI. A greater proportion of women with DI reported a fall in the past year compared with those with UI alone (22.9% vs 12.2%, P < 0.001). Univariable comparison showed that these 2 groups differed regarding age, body mass index, and estimated median household income. On multivariable logistic regression, DI was significantly associated with falls (adjusted odds ratio 2.56; 95% confidence interval, 1.02-5.46). Other factors independently associated with falls in older women with UI include (adjusted odds ratio, 95% confidence interval): lower income groups (2.35, 1.50-3.67 for $20,000-$40,000, compared with $100,000 and higher-income group), difficulty with activities of daily living (1.60, 1.25-2.13), and unintentional weight loss (1.68, 1.05-2.68). CONCLUSION: Patients with DI have a 2-fold higher risk of fall compared with patients with UI alone.

Healthcare-related correlates of recent HIV testing in New York City.

OBJECTIVE: To examine healthcare-related correlates of recent HIV testing among New York City (NYC) residents, controlling for socio-demographic and HIV-related risk factors. METHODS: Using the NYC 2007 Community Health Survey (population-based telephone survey, n=8911), recent HIV testing was examined for its association with healthcare-related variables, including medical screening for other conditions, controlling for other HIV testing correlates using multiple logistic regression. RESULTS: Factors associated with a recent HIV test included: provider recommendation for an HIV test (adjusted odds ratio [AOR]: 10.1, 95% confidence interval [CI]:7.6-13.5), Medicaid versus private insurance (AOR: 1.6, 95% CI: 1.2-2.1), and having a personal doctor (AOR: 1.6, 95% CI: 1.3-2.1). The proportion of HIV tests attributed to each factor (attributable-fraction [AF]) was 49% for provider recommendation, 33% for having a personal doctor, and 8.3% for Medicaid insurance. Among subgroups eligible for other medical screening, factors associated with recent HIV testing included recent receipt of blood lipid testing (AOR: 2.2, 95% CI: 1.6-3.0; AF: 45%), and Pap smear (AOR: 2.7, 95% CI: 2.1-3.5; AF: 52%). Recent receipt of mammography and colonoscopy was not associated with recent HIV testing. CONCLUSIONS: A substantial proportion of recent HIV testing coverage among New Yorkers may be attributable to healthcare-related factors. Joint medical screening may provide opportunities to increase population HIV testing coverage.

Trends in Same-Day Discharge Rate After Minimally Invasive Sacrocolpopexy and Propensity Score-Matched Analysis of Postoperative Complication Rates Using the National Surgical Quality Improvement Program Database.

OBJECTIVE: The primary aim of this study was to review trends in the same-day discharge (SDD) rate after minimally invasive sacrocolpopexy (MISCP). The secondary aim was to compare the composite 30-day postoperative complication rates between propensity score-matched SDD and admitted cohorts. METHODS: This was a retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program database from 2015 to 2019. Patients who underwent MISCP were identified by Current Procedural Terminology codes. Concurrent hysterectomy, anterior or posterior repairs, rectopexy, and midurethral sling were also identified. Multivariable logistic regression and propensity score matching were performed. RESULTS: A total of 12,762 MISCP patients were captured: 3,968 underwent MISCP only, 4,065 underwent MISCP with total laparoscopic hysterectomy, 734 underwent MISCP with laparoscopically assisted vaginal hysterectomy, and 3,995 underwent MISCP with laparoscopic supracervical hysterectomy. Overall, the SDD rate was 16.3%, with an increase from 12.3% in 2015 to 23.1% in 2019. Multivariable logistic regression showed that admitted patients were more likely to be older, to be of Black race, have an American Society of Anesthesiologists classification of 3 or 4, have hypertension requiring medication, have longer operative time, and have undergone concurrent anterior or posterior repair, rectopexy, or sling. After propensity score matching, the composite postoperative complication rates were similar between the 2 cohorts (5.7% vs 6.4%, P = 0.818). However, superficial surgical site infection was more likely in the SDD cohort (adjusted odds ratio, 2.3; P < 0.001) and blood transfusion in the admitted cohort (adjusted odds ratio, 11.9; P = 0.0.34). CONCLUSIONS: The rate of SDD after MISCP seems to be increasing. Composite postoperative complication rates are similar between SDD and admitted cohorts.

Vaginal Hysterectomy Performed Under General Versus Neuraxial Regional Anesthesia: Comparison of Patient Characteristics and 30-Day Outcomes Using Propensity Score-Matched Cohorts.

OBJECTIVES: Compared with surgery under general anesthesia (GA), surgery under neuraxial regional anesthesia (RA) has been associated with economic and clinical benefits in certain populations. Our aim was to compare preoperative and postoperative characteristics and 30-day outcomes, including intraoperative complications, for patients undergoing benign vaginal hysterectomy under GA versus RA. METHODS: This is a retrospective cohort study of patients who underwent vaginal hysterectomy for benign indications between 2015 and 2019 using the American College of Surgeons National Surgical Quality Improvement Program database. Patients were identified using Current Procedural Terminology codes and stratified into GA and RA groups. Propensity score matching was performed to account for selection bias between anesthesia groups. RESULTS: Of 18,030 vaginal hysterectomies performed during this study period, 17,472 (96.9%) were performed under GA and 558 (3.1%) under RA. The RA group was older, more likely to be White, and more likely to have a history of chronic obstructive pulmonary disease and chronic steroid use (P < 0.01 for all); they were less likely to be discharged the same day (8.6% vs 12.2%, P = 0.01). In the matched cohort, there were similar proportions of major, minor, and composite complications between RA and GA groups (major: odds ratio [OR], 0.95; 95% confidence interval [CI], 0.51-1.78; minor: OR, 1.18; 95% CI, 0.74-1.88; composite: OR, 1.10; 95% CI, 0.75-1.64). Similar proportions of same-day discharge were observed (OR, 0.72; 95% CI, 0.47-1.10). CONCLUSIONS: Although RA comprises only 3% of the anesthetic modalities used for benign vaginal hysterectomies, it is associated with a similar incidence of postoperative complications compared with general anesthesia.

Relationship Between Opioid Prescriptions and Number of Chronic Pain Conditions in Women With Interstitial Cystitis.

OBJECTIVES: The aim of this study was to determine the relationship between opioid prescriptions and number of chronic pain conditions in women with interstitial cystitis (IC). METHODS: This was a cross-sectional study. Women diagnosed with IC based on International Classification of Diseases, Ninth Revision/Tenth Revision codes over an 11-year period (2010-2020) were identified from electronic medical records. Data on comorbidities and ambulatory opioid prescriptions were also extracted. Univariable and multivariable logistic regressions were used to assess the relationship between opioid prescriptions and the number and type of coexisting chronic pain conditions. RESULTS: Of the 1,219 women with IC, 207 (17%) had received at least 1 opioid prescription. The proportions of women with opioid prescriptions for no, 1, 2, and 3 or more coexisting chronic pain conditions were 13%, 20%, 28%, and 32%, respectively. On univariable analysis, factors significantly associated with opioid use were higher body mass index ( P < 0.001), depression ( P < 0.001), sleep disorder ( P < 0.001), endometriosis ( P < 0.05), chronic pelvic pain ( P < 0.001), fibromyalgia ( P < 0.05), joint pain ( P < 0.001), and number of coexisting chronic pain diagnoses ( P < 0.001). On multivariable analysis, opioid prescriptions remained significantly associated with the number of coexisting chronic pain diagnoses: 1 diagnosis (adjusted odds ratio [aOR], 1.8; 95% confidence interval [CI], 1.3-2.7), 2 diagnoses (aOR, 2.6; 95% CI, 1.6-4.3), 3 or more diagnoses (aOR, 2.5; 95% CI, 1.1-5.5), diagnosis of chronic pelvic pain (aOR, 2.1; 95% CI, 1.3-3.5), endometriosis (aOR, 2.4; 95% CI, 1.4-4.3), chronic joint pain (aOR, 1.8; 95% CI, 1.1-2.9), and sleep disorders (aOR, 2.4; 95% CI, 1.6-3.6). CONCLUSION: The likelihood of opioid prescriptions in women with IC increases with the number and type of coexisting chronic pain conditions and sleep disorders.

Review of Malpractice Litigations Involving Vesicovaginal and Rectovaginal Fistulas Following Elective Hysterectomy for Benign Indications in the United States From 1970 to 2020.

OBJECTIVE: The aims of this study were to review malpractice litigations involving vesicovaginal and rectovaginal fistulas after elective hysterectomy for benign indications in the United States and identify the most common themes in allegations by the plaintiffs and defenses by the defendants. METHODS: Using the Lexis Nexis legal database, we searched for and reviewed all U.S. malpractice litigations pertinent to this question between 1970 and 2020. RESULTS: Out of 82 cases that were identified and reviewed, 17 cases met our inclusion and exclusion criteria. These cases were decided between 1973 and 2019. Nine cases involved total abdominal hysterectomies, 1 involved total laparoscopic hysterectomy (TLH), 1 involved total vaginal hysterectomy (TVH), and the rest were not specified. Fifteen cases involved vesicovaginal fistulas and 2 involved rectovaginal fistulas. Three cases were ruled in favor of the plaintiffs, with monetary compensation ranging from $250,000 to $753,722 (approximately $364,120 to $1.8 million when adjusted for inflation), whereas 14 cases were ruled in favor of the defending surgeons. Common allegations were negligence in 15 cases and lack of informed consent in 2 cases. Factors that strengthened the defendants' arguments were thorough documentation, informed consent, and prompt referral to specialists. Intraoperative cystoscopy may have benefited in some cases. CONCLUSIONS: Thorough documentation, informed consent, and prompt referral to specialists strengthened the defendants' legal arguments. Intraoperative cystoscopy may also be beneficial.

Addressing obesity and diabetes among African American men: examination of a community-based model of prevention.

The Save Our Sons study is a community-based, culturally responsive, and gender-specific intervention aimed at reducing obesity and diabetes among a small sample (n = 42) of African American men. The goals of the study were to: (1) test the feasibility of implementing a group health education and intervention model to reduce the incidence of diabetes and obesity among African American men; (2) improve regular access to and utilization of health care services and community supportive resources to promote healthy lifestyles among African American men; and (3) build community networks and capacity for advocacy and addressing some of the health needs of African American men residing in Lorain County, Ohio. Trained community health workers facilitated activities to achieve program aims. Following the 6-week intervention, results indicated that participant's had greater knowledge about strategies for prevention and management of obesity and diabetes; increased engagement in exercise and fitness activities; decreased blood pressure, weight, and body mass index levels; and visited a primary care doctor more frequently. Also, local residents elevated African American men's health and identified it as a priority in their community. This model of prevention appears to be a substantial, robust, and replicable approach for improving the health and wellbeing of African American men.

Lessons Learned From a Review of Malpractice Litigations Involving Obstetric Anal Sphincter Injury in the United States.

OBJECTIVE: The aim of this article is to review all litigations involving obstetric anal sphincter injury (OASIS) in the United States to highlight the most common allegations and factors that aided the involved obstetricians and gynecologists (ob/gyns). METHODS: We used Lexis Nexis, a comprehensive legal database, to search all publicly available high-profile federal and state level litigations related to OASIS. RESULTS: Of 68 cases that resulted and reviewed, 19 were deemed to be pertinent to the question being addressed. These 19 cases occurred between 1964 and 2011 and all alleged medical negligence. Among these 19 cases, 6 were ruled in favor of the plaintiffs, with most of them being awarded an amount ranging from US $110,000 to US $841,810.80. All 6 cases involved episiotomy. Thorough medical recordkeeping, comprehensive discharge instructions and counseling, and timely evaluation and referral to a female pelvic medicine and reconstructive surgery specialist were the key factors that aided the ob/gyns facing these litigations. CONCLUSIONS: Avoidance of episiotomy, thorough medical recordkeeping, comprehensive discharge instruction and counseling, and timely evaluation and referral to a female pelvic medicine and reconstructive surgery specialist may help an ob/gyn prevail in OASIS-related litigations.

Calcium Dynamics in Astrocytes During Cell Injury.

The changes in intracellular calcium concentration ([Ca2+]) following laser-induced cell injury in nearby cells were studied in primary mouse astrocytes selectively expressing the Ca2+ sensitive GFAP-Cre Salsa6f fluorescent tandem protein, in an Ast1 astrocyte cell line, and in primary mouse astrocytes loaded with Fluo4. Astrocytes in these three systems exhibit distinct changes in [Ca2+] following induced death of nearby cells. Changes in [Ca2+] appear to result from release of Ca2+ from intracellular organelles, as opposed to influx from the external medium. Salsa6f expressing astrocytes displayed dynamic Ca2+ changes throughout the phagocytic response, including lamellae protrusion, cytosolic signaling during vesicle formation, vesicle maturation, and vesicle tract formation. Our results demonstrate local changes in [Ca2+] are involved in the process of phagocytosis in astrocytes responding to cell corpses and/or debris.

Drug Information Association Pharmacovigilance and Risk Management Strategies 2017: Overview of the Generic Drug Program and Surveillance.

The US Food and Drug Administration's (FDA's) generic drug program has dramatically increased the availability of affordable, high quality generic drugs. The foundation of generic drug approvals is a two-tiered regulatory framework of pharmaceutical equivalence and bioequivalence. Intrinsic to both of these is consideration of the clinical relevance of formulation and bioequivalence data to support an inference of therapeutic equivalence, based on clear evidence that there are no significant differences between the generic drug and the brand name drug. These analyses allow FDA to determine that the generic drug will perform in the patient in the same way, with the same safety and efficacy profiles, as the brand name drug. Allowable differences and the precise definition of what is meant by equivalence are critical to maintaining the quality, efficacy, and safety of generic drugs. The FDA Office of Generic Drugs' (OGD's) Clinical Safety Surveillance Staff (CSSS) has developed investigative processes that complement the broader FDA safety efforts that focus on the potential impact of allowable differences and equivalence determinations for generic drugs. Two recent examples of the CSSS's processes include a clonidine transdermal system and lansoprazole oral disintegrating tablet. Ongoing efforts of the CSSS result in improvements to the FDA's review processes and the quality of generic drugs in the US market.

Morphometric age and mortality after liver transplant.

IMPORTANCE: Morphometric assessment has emerged as a strong predictor of postoperative morbidity and mortality. However, a gap exists in translating this knowledge to bedside decision making. We introduced a novel measure of patient-centered surgical risk assessment: morphometric age. OBJECTIVE: To investigate the relationship between morphometric age and posttransplant survival. DATA SOURCES: Medical records of recipients of deceased-donor liver transplants (study population) and kidney donors/trauma patients (morphometric age control population). STUDY SELECTION: A retrospective cohort study of 348 liver transplant patients and 3313 control patients. We assessed medical records for validated morphometric characteristics of aging (psoas area, psoas density, and abdominal aortic calcification). We created a model (stratified by sex) for a morphometric age equation, which we then calculated for the control population using multivariate linear regression modeling (covariates). These models were then applied to the study population to determine each patient's morphometric age. DATA EXTRACTION AND SYNTHESIS: All analytic steps related to measuring morphometric characteristics were obtained via custom algorithms programmed into commercially available software. An independent observer confirmed all algorithm outputs. Trained assistants performed medical record review to obtain patient characteristics. RESULTS: Cox proportional hazards regression model showed that morphometric age was a significant independent predictor of overall mortality (hazard ratio, 1.03 per morphometric year [95% CI, 1.02-1.04; P < .001]) after liver transplant. Chronologic age was not a significant covariate for survival (hazard ratio, 1.02 per year [95% CI, 0.99-1.04; P = .21]). Morphometric age stratified patients at high and low risk for mortality. For example, patients in the middle chronologic age tertile who jumped to the oldest morphometric tertile have worse outcomes than those who jumped to the youngest morphometric tertile (74.4% vs 93.2% survival at 1 year [P = .03]; 45.2% vs 75.0% at 5 years [P = .03]). CONCLUSIONS AND RELEVANCE: Morphometric age correlated with mortality after liver transplant with better discrimination than chronologic age. Assigning a morphometric age to potential liver transplant recipients could improve prediction of postoperative mortality risk.