Abstract Introduction: Pragmatic trials aim to speed translation to practice by integrating study procedures in routine care settings. This study evaluated implementation outcomes related to clinician and patient recruitment and participation in a trial of community paramedicine (CP) and presents successes and challenges of maintaining pragmatic study features. Methods: Adults in the pre-hospital setting, emergency department (ED), or hospital being considered for referral to the ED/hospital or continued hospitalization for intermediate-level care were randomized 1:1 to CP care or usual care. Referral and enrollment data were tracked administratively, and patient characteristics were abstracted from the electronic health record (EHR). Enrolled patients completed baseline surveys, and a subset of intervention patients were interviewed. All CPs and a sample of clinicians and administrators were invited to complete a survey and interview. Results: Between January 2022 and February 2023, 240 enrolled patients (42% rural) completed surveys, and 22 completed an interview; 63 staff completed surveys and 20 completed an interview. Ninety-three clinicians in 27 departments made at least one referral. Factors related to referrals included program awareness and understanding the CP practice scope. Most patients were enrolled in the hospital, but characteristics were similar to the primary care population and included older and medically complex patients. Challenges to achieving representativeness included limited EHR infrastructure, constraints related to patient consenting, and clinician concerns about patient randomization disrupting preferred care. Conclusion: Future pragmatic trials in busy clinical settings may benefit from regulatory policies and EHR capabilities that allow for real-world study conduct and representative participation. Trial registration: NCT05232799.
Postoperative Complications After Sling Operations for Incontinence: Is Race a Factor?
Importance Racial and ethnic disparities exist in urogynecologic surgery; however, literature identifying specific disparities after sling operations for stress incontinence are limited. Objective The objective of this study was to evaluate racial and ethnic disparities in surgical complications within 30 days of midurethral sling operations. Study Design This retrospective cohort study identified women who underwent an isolated midurethral sling operation between 2014 and 2021 using the American College of Surgeons National Surgical Quality Improvement Program database. Women were stratified by racial and ethnic category to assess the primary outcome, 30-day surgical complications, and the secondary outcome, comparison of urinary tract infections (UTIs). Results There were 20,066 patients included. Mean age and body mass index were 53.9 years and 30.8, respectively. More Black or African American women had diabetes and hypertension, and more American Indian or Alaska Native women used tobacco. The only difference in 30-day complications was stroke/cerebrovascular accident, which occurred in only 1 Asian, Native Hawaiian or other Pacific Islander patient (0.1%, P < 0.0001). The most frequent complication was UTI (3.3%). Black or African American women were significantly less likely to have a diagnosis of UTI than non-Hispanic White (P = 0.04), Hispanic White (P = 0.03), and American Indian or Alaska Native women (P = 0.04). Conclusions Surgical complications within 30 days of sling operations are rare. No clinically significant racial and ethnic differences in serious complications were observed. Urinary tract infection diagnoses were lower among Black or African American women than in non-Hispanic White, Hispanic White, and American Indian or Alaska Native women despite a greater comorbidity burden. No known biologic reason exists to explain lower UTI rates in this population; therefore, this finding may represent a disparity in diagnosis and treatment.
Distinct presentation of melanoma in Black patients may inform strategies to improve outcomes
AbstractIntroductionMelanoma guidelines stem largely from data on non‐Hispanic White (NHW) patients. We aimed to identify features of melanoma within non‐Hispanic Black (NHB) patients to inform strategies for earlier detection and treatment.MethodsFrom 2004 to 2019 Surveillance, Epidemiology, and End Results (SEER) data, we identified nonmetastatic melanoma patients with known TN category and race. Kaplan–Meier cancer‐specific survival (CSS) estimates and multivariable Cox proportional hazard modeling analyses were performed.ResultsOf 492 597 patients, 1499 (0.3%) were NHB, who were younger (21% vs. 17% age <50) and more commonly female (54% vs. 41%) than NHW, both p < 0.0005. For NHBs, lower extremity was the most common site (52% vs. 15% for NHWs, p < 0.0001), T category was higher (55% Tis–T1 vs. 82%; 27% T3–T4 vs. 8%, p < 0.0001) and stage at presentation was higher (19% Stage III, vs. 6%, p < 0.0001). Within the NHB cohort, males were older, and more often node‐positive than females. Five‐year Stage III CSS was 42% for NHB males versus 71% for females, adjusting for age and clinical nodal status (hazard ratio 2.48).ConclusionsNHB melanoma patients presented with distinct tumor characteristics. NHB males with Stage III disease had inferior CSS. Focus on this high‐risk patient cohort to promote earlier detection and treatment may improve outcomes.
Pregnancy-associated melanoma: characteristics and outcomes from 2002 to 2020
Melanoma diagnosed within 1 year of pregnancy is defined as pregnancy-associated melanoma (PAM). No robust data on how pregnancy influences melanoma nor guidelines for PAM management exist. With IRB approval, female patients with a pathology-confirmed melanoma diagnosis within 1 year of pregnancy treated at our institution from 2000 to 2020 were identified. Controls from the cancer registry were matched 1 : 4 when available on decade of age, year of surgery (±5), and stage. We identified 83 PAM patients with median follow-up of 86 months. Mean age at diagnosis was 31 years. 80% AJCC V8 stage I, 2.4% stage II, 13% stage III, 4.8% stage IV. Mean Breslow thickness was 0.79 mm and 3.6% exhibited ulceration. The mean mitotic rate was 0.76/mm 2 . In terms of PAM management, 98.6% of ESD patients and 86.7% of LSD patients received standard-of-care therapy per NCCN guidelines for their disease stage. No clinically significant delays in treatment were noted. Time to treatment from diagnosis to systemic therapy for LSD patients was an average of 46 days (95% CI: 34–59 days). Comparing the 83 PAM patients to 309 controls matched on age, stage, and year of diagnosis, similar 5-year overall survival (97% vs. 97%, P = 0.95) or recurrence-free survival (96% vs. 96%, P = 0.86) was observed. The outcomes of PAM following SOC treatment at a highly specialized center for melanoma care were comparable to non-PAM when matched by clinical-pathologic features. Specialty center care is encouraged for women with PAM.
Accuracy of DOTATATE PET imaging in the preoperative planning of small bowel neuroendocrine tumor resection
AbstractBackground and ObjectivesWe assessed the accuracy of preoperative gallium‐68 DOTA‐Tyr3‐octreotate (DOTATATE) positron emission tomography (PET) imaging in estimating multifocality and nodal metastases of small bowel neuroendocrine tumors (sbNETs).MethodsA multicenter analysis was performed on patients with sbNETs who underwent preoperative DOTATATE PET imaging and surgical resection, with manual palpation of the entire length of the small bowel, between January 2016 and August 2022. Preoperative imaging reports and blinded secondary imaging reviews were compared to the final postoperative pathology reports. Descriptive statistics were applied.ResultsOne‐hundred and four patients met inclusion criteria. Pathology showed 53 (51%) patients had multifocal sbNETs and 96 (92%) had nodal metastases. The original preoperative DOTATATE PET imaging identified multifocal sbNET in 28 (27%) patients and lymph node (LN) metastases in 80 (77%) patients. Based on original radiology reports, sensitivity for multifocal sbNET identification was 45%, specificity was 92%, positive predictive value (PPV) was 86%, and negative predictive value (NPV) was 62%. For the identification of LN metastases, sensitivity was 82%, specificity was 88%, PPV was 99%, and NPV was 29%.ConclusionsAlthough DOTATATE PET imaging is specific and relatively accurate, sensitivity and NPV are insufficient to guide surgical planning. Preoperative use should not replace open palpation to identify additional synchronous lesions or to omit regional lymphadenectomy.
Evaluating the Long-term Impact of Implementing Standardized Postoperative Opioid Prescribing Recommendations Following Pelvic Organ Prolapse Surgery
Importance Improving opioid stewardship is important, given the common use of opioids and resultant adverse events. Evidence-based prescribing recommendations for surgeons may help reduce opioid prescribing after specific procedures. Objective The aim of this study was to assess longitudinal prescribing patterns for patients undergoing pelvic organ prolapse surgery in the 2 years before and after implementing evidence-based opioid prescribing recommendations. Study Design In December 2017, a 3-tiered opioid prescribing recommendation was created based on prospective data on postoperative opioid use after pelvic organ prolapse surgery. For this follow-up study, prescribing patterns, including quantity of opioids prescribed (in oral morphine equivalents [OMEs]) and refill rates, were retrospectively compared for patients undergoing prolapse surgery before (November 2015–November 2017; n = 238) and after (December 2017–December 2019; n = 361) recommendation implementation. Univariate analysis was performed using the Wilcoxon rank sum and χ 2 tests. Cochran-Armitage trend tests and interrupted time-series analysis tested for significance in the change in OMEs prescribed before versus after recommendation implementation. Results After recommendation implementation, the quantity of postoperative opioids prescribed decreased from median 225 mg OME (interquartile range, 225, 300 mg OME) to 71.3 mg OME (interquartile range, 0, 112.5 mg OME; P < 0.0001). Decreases also occurred within each subgroup of prolapse surgery: native tissue vaginal repair (P < 0.0001), robotic sacrocolpopexy (P < 0.0001), open sacrocolpopexy (P < 0.0001), and colpocleisis (P < 0.003). The proportion of patients discharged following prolapse surgery without opioids increased (4.2% vs 36.6%; P < 0.0001), and the rate of opioid refills increased (2.1% vs 6.0%; P = 0.02). Conclusions With 2 years of postimplementation follow-up, the use of procedure-specific, tiered opioid prescribing recommendations at our institution was associated with a significant, sustained reduction in opioids prescribed. This study further supports using evidence-based recommendations for opioid prescribing.
Racial disparities in surgical treatment of oropharyngeal cancer: A Surveillance, Epidemiology, and End Results review
AbstractObjectivesOropharyngeal squamous cell carcinoma (OPSCC) has been rising. This manuscript looks to explore racial disparities in the surgical management of OPSCC.MethodsA cancer database was queried for patients with OPSCC diagnosed from 2004 to 2017. Univariate and multivariable logistic regressions were used to evaluate associations between patient race/ethnicity, surgical treatment, and reasons for lack of surgery.Results37 306 (74.3%) patients did not undergo surgery, while 12 901 (25.7%) patients did. Non‐Hispanic black (NHB) patients were less likely to undergo surgery than other races (17.9% vs. 26.5%; p < 0.0001). In clinical discussions, the Asian, Native American, Hawaiian, Pacific Islander (ANAHPI), and unknown race group was more likely to directly refuse surgery when recommended (2.5% vs. 1.5%; p = 0.015).ConclusionRacial differences exist in treatment for OPSCC. NHB patients are less likely to actually undergo surgical management for OPSCC, while other patients are more likely to directly “refuse” surgery outright when offered.
A Community Paramedic Clinic at a Day Center for Adults Experiencing Homelessness
Abstract Background In this longitudinal cohort study, we examined the socio-demographic and psychological predictors of alcohol use initiation during the COVID-19 pandemic in a sample of never alcohol users aged ≥21 prior to COVID-19. Methods Our study population consisted of 56 930 patients aged ≥21, as of 30 March 2019 were collected from a pre-COVID period of 1 year before 31 March 2020, and during-COVID, a period between 1 April 2020 and 30 March 2021. Univariable and multivariable logistic regression models were utilized to examine the roles of socio-demographic variables (gender, age, education, Area Deprivation Index and rural residence) changes in anxiety and depression severity as predictors of alcohol use initiation. Results Age, gender, race, ethnicity, education and rural status were significant predictors in multivariable analysis. A subgroup analysis showed neither anxiety nor depression had a significant association with alcohol use initiation. Conclusion Women, younger individuals, those living in a rural area and people who smoke cigarettes were more likely to initiate alcohol use during the pandemic. Our study has public health and clinical implications such as the need for targeted alcohol use screening and intervention for vulnerable individuals.