Consent document translation expense hinders inclusive clinical trial enrolment.

Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA1-3. As these patients often have limited English proficiency4-7, we hypothesized that one barrier to their inclusion is the cost to investigators of translating consent documents. To test this hypothesis, we evaluated more than 12,000 consent events at a large cancer centre and assessed whether patients requiring translated consent documents would sign consent documents less frequently in studies lacking industry sponsorship (for which the principal investigator pays the translation costs) than for industry-sponsored studies (for which the translation costs are covered by the sponsor). Here we show that the proportion of consent events for patients with limited English proficiency in studies not sponsored by industry was approximately half of that seen in industry-sponsored studies. We also show that among those signing consent documents, the proportion of consent documents translated into the patient's primary language in studies without industry sponsorship was approximately half of that seen in industry-sponsored studies. The results suggest that the cost of consent document translation in trials not sponsored by industry could be a potentially modifiable barrier to the inclusion of patients with limited English proficiency.

FAPI PET uptake patterns after invasive medical interventions: a single center retrospective analysis.

PURPOSE: Fibroblast activation protein (FAP)-inhibitor (FAPI)-PET tracers allow imaging of the FAP-expressing cancer associated fibroblasts (CAF) and also the normal activated fibroblasts (NAF) involved in inflammation/fibrosis that may be present after invasive medical interventions. We evaluated [68Ga]Ga-FAPI-46 uptake patterns post-medical/invasive non-systemic interventions. METHODS: This single-center retrospective analysis was conducted in 79 consecutive patients who underwent [68Ga]Ga-FAPI-46 PET/CT. Investigators reviewed prior patient medical/invasive interventions (surgery, endoscopy, biopsy, radiotherapy, foreign body placement (FBP) defined as implanted medical/surgical material present at time of scan) and characterized the anatomically corresponding FAPI uptake intensity both visually (positive if above surrounding background) and quantitatively (SUVmax). Interventions with missing data/images or confounders of [68Ga]Ga-FAPI-46 uptake (partial volume effect, other cause of increased uptake) were excluded. Available correlative FDG, DOTATATE and PSMA PET/CTs were analyzed when available. RESULTS: 163 medical/invasive interventions (mostly surgeries (49%), endoscopies (18%) and non-surgical biopsies (10%)) in 60 subjects were included for analysis. 43/163 (26%) involved FBP. FAPI uptake occurred in 24/163 (15%) of interventions (average SUVmax 3.2 (mild), range 1.5-5.1). The median time-interval post-intervention to FAPI-PET was 47.5 months and was shorter when FAPI uptake was present (median 9.5 months) than when absent (median 60.1 months; p = 0.001). Cut-off time beyond which no FAPI uptake would be present post-intervention without FBP was 8.2 months, with a sensitivity, specificity, positive predictive value and negative predictive value of 82, 90, 99 and 31% respectively. No optimal cutoff point could be determined when considering interventions with FBP. No significant difference was detected between frequency of [68Ga]Ga-FAPI-46 and [18F]FDG uptake in intervention sites. Compared to [68Ga]Ga-PSMA-11, [68Ga]Ga-FAPI-46 revealed more frequent and intense post-interventional tracer uptake. CONCLUSION: [68Ga]Ga-FAPI-46 uptake from medical/invasive interventions without FBP appears to be time dependent, nearly always absent beyond 8 months post-intervention, but frequently present for years with FBP.

Utility of preoperative troponin I to predict mortality in adult liver transplant recipients: Revisiting pretransplant cardiac risk in the current MELD-allocation era.

BACKGROUND: Preoperative risk assessment in liver transplant (LT) candidates, particularly related to cardiac risk, is an area of intense interest for transplant clinicians. Various cardiac testing methods are employed by transplant centers to characterize cardiac risk. Serum troponin is an established method for the detection of myocardial injury in a wide variety of clinical settings. Preoperative troponin screening has been reported to predict postoperative cardiac events and mortality in various surgical patient populations, however, the utility of preoperative troponin to predict posttransplant outcomes in current LT candidate populations requires further investigation. METHODS: We performed a prospective blinded study in a cohort of 275 consecutive LT recipients at a single transplant center to determine if preoperative serum troponin I (TnI) was predictive for postoperative 1-year mortality. RESULTS: Abnormal preoperative TnI levels (>.1 ng/mL) were found in 38 patients (14%). One-year mortality occurred in 19 patients (7%). There was no significant difference in mortality between patients with normal and abnormal troponin levels. Additionally, we found that there was no significant difference in early postoperative major adverse cardiac events between patient groups. CONCLUSIONS: Contrary to previous reports, elevated preoperative TnI was not significantly predictive of posttransplant mortality in LT recipients at our institution.

A Prospective Observational Cohort Study of Language Preference and Preoperative Cognitive Screening in Older Adults: Do Language Disparities Exist in Cognitive Screening and Does the Association Between Test Results and Postoperative Delirium Differ Based on Language Preference?

BACKGROUND: A greater percentage of surgical procedures are being performed each year on patients 65 years of age or older. Concurrently, a growing proportion of patients in English-speaking countries such as the United States, United Kingdom, Australia, and Canada have a language other than English (LOE) preference. We aimed to measure whether patients with LOE underwent cognitive screening at the same rates as their English-speaking counterparts when routine screening was instituted. We also aimed to measure the association between preoperative Mini-Cog and postoperative delirium (POD) in both English-speaking and LOE patients. METHODS: We conducted a single-center, observational cohort study in patients 65 years old or older, scheduled for surgery and evaluated in the preoperative clinic. Cognitive screening of older adults was recommended as an institutional program for all patients 65 and older presenting to the preoperative clinic. We measured program adherence for cognitive screening. We also assessed the association of preoperative impairment on Mini-Cog and POD in both English-speaking and LOE patients, and whether the association differed for the 2 groups. A Mini-Cog score ≤2 was considered impaired. Postoperatively, patients were assessed for POD using the Confusion Assessment Method (CAM) and by systematic chart review. RESULTS: Over a 3-year period (February 2019-January 2022), 2446 patients 65 years old or older were assessed in the preoperative clinic prior. Of those 1956 patients underwent cognitive screening. Eighty-nine percent of English-speaking patients underwent preoperative cognitive screening, compared to 58% of LOE patients. The odds of having a Mini-Cog assessment were 5.6 times higher (95% confidence interval [CI], 4.6-7.0) P < .001 for English-speaking patients compared to LOE patients. In English-speaking patients with a positive Mini-Cog screen, the odds of having postop delirium were 3.5 times higher (95% CI, 2.6-4.8) P < .001 when compared to negative Mini-Cog. In LOE patients, the odds of having postop delirium were 3.9 times higher (95% CI, 2.1-7.3) P < .001 for those with a positive Mini-Cog compared to a negative Mini-Cog. The difference between these 2 odds ratios was not significant (P = .753). CONCLUSIONS: We observed a disparity in the rates LOE patients were cognitively screened before surgery, despite the Mini-Cog being associated with POD in both English-speaking and LOE patients. Efforts should be made to identify barriers to cognitive screening in limited English-proficient older adults.

Laboratory Result Reference Ranges Stratified for Patient-Reported Sex and Ethnicity Are More Closely Associated With Postoperative Outcomes Than Currently Used Reference Ranges: A Retrospective Data Analysis.

BACKGROUND: A single laboratory range for all individuals may fail to take into account underlying physiologic differences based on sex and genetic factors. We hypothesized that laboratory distributions differ based on self-reported sex and ethnicity and that ranges stratified by these factors better correlate with postoperative mortality and acute kidney injury (AKI). METHODS: Results from metabolic panels, complete blood counts, and coagulation panels for patients in outpatient encounters were identified from our electronic health record. Patients were grouped based on self-reported sex (2 groups) and ethnicity (6 groups). Stratified ranges were set to be the 2.5th/97.5th percentile for each sex/ethnic group. For patients undergoing procedures, each patient/laboratory result was classified as normal/abnormal using the stratified and nonstratified (traditional) ranges; overlap in the definitions was assessed between the 2 classifications by looking for the percentage of agreement in result classifications of normal/abnormal using the 2 methods. To assess which definitions of normal are most associated with adverse postoperative outcomes, the odds ratio (OR) for each outcome/laboratory result pair was assessed, and the frequency that the confidence intervals of ORs for the stratified versus nonstratified range did not overlap was examined. RESULTS: Among the 300 unique combinations (race × sex × laboratory type), median proportion overlap (meaning patient was either "normal" or "abnormal" for both methodologies) was 0.86 [q1, 0.80; q3, 0.89]. All laboratory results except 6 overlapped at least 80% of the time. The frequency of overlap did not differ among the racial/ethnic groups. In cases where the ORs were different, the stratified range was better associated with both AKI and mortality (P < .001). There was no trend of bias toward any specific sex/ethnic group. CONCLUSIONS: Baseline "normal" laboratory values differ across sex and ethnic groups, and ranges stratified by these groups are better associated with postoperative AKI and mortality as compared to the standard reference ranges.

Incidence of Intraoperative Vasoplegic Syndrome in Lung Transplantation.

OBJECTIVES: Severe hypotension and low systemic vascular resistance in the setting of adequate cardiac output, known as "vasoplegic syndrome" (VS), is a physiologic disturbance reported in 9% to 44% of cardiac surgery patients. Although this phenomenon is well-documented in cardiac surgery, there are few studies on its occurrence in lung transplantation. The goal of this study was to characterize the incidence of VS in lung transplantation, as well as identify associated risk factors and outcomes. DESIGN: Retrospective study of single and bilateral lung transplants from April 2013 to September 2021. SETTING: The study was conducted at an academic hospital. PARTICIPANTS: Patients ≥18 years of age who underwent lung transplantation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The authors defined VS as mean arterial pressure <65 mmHg, cardiac index ≥2.2 L/min/m2, and ≥30 minutes of vasopressor administration after organ reperfusion. The association between VS and risk factors or outcomes was assessed using t tests, Mann-Whitney U, and chi-square tests. The authors ran multivariate logistic regression models to determine factors independently associated with VS. The incidence of VS was 13.9% (CI 10.4%-18.4%). In the multivariate model, male sex (odds ratio 2.85, CI 1.07-7.58, p = 0.04) and cystic fibrosis (odds ratio 5.76, CI 1.43-23.09, p = 0.01) were associated with VS. CONCLUSIONS: The incidence of VS in lung transplantation is comparable to that of cardiac surgery. Interestingly, male sex and cystic fibrosis are strong risk factors. Identifying lung transplant recipients at increased risk of VS may be crucial to anticipating intraoperative complications.

A Pilot Single-Site Randomized Control Trial: Investigating the Use of Donor Milk in Late Preterm and Term Infants in the Neonatal Intensive Care Unit.

OBJECTIVE: We aimed to study donor milk (DM) supplementation when mother's own milk (MOM) was unavailable in term and late preterm infants (LPIs) admitted to the neonatal intensive care unit (NICU). We hypothesized that this study would be feasible, defined by the rate of consent, diet adherence, and study completion. We further hypothesized that compared with formula supplementation, DM supplementation, for no longer than 7 days from birth, would be associated with an increase in breastfeeding attempts and the percentage of MOM (MOM%) without adversely affecting growth. Breastfeeding attempts and MOM% were assessed over 48 hours at the end of the intervention, which was defined as NICU discharge or at the end of supplementation, whichever came sooner. STUDY DESIGN: This was a pilot study (n = 32). Infants with a gestational age > 34 weeks admitted to the NICU were included. Infants were randomized to one of two groups: human milk (MOM + DM) or formula (MOM + F). RESULTS: The consent rate was 52%. Adherence to the study diet was 97%, and completion was 100%. When the MOM + DM group was compared with the MOM + F group, there was no difference in breastfeeding attempts (median [interquartile range]: 3.5 [1.5-6] vs. 1.5 [0.5-4] times, p = 0.1) or MOM% (60 vs. 59%, p = 0.9). Weight and length at multiple time points were similar when the groups were compared. CONCLUSION: A study randomizing term and LPIs in the NICU to DM or formula when MOM was unavailable is feasible. It remains unclear if DM improves breastfeeding success in this population. KEY POINTS: · A study that randomizes term and late preterm infants in the NICU to DM or formula supplementation when mother's own milk is not available is feasible.. · It remains unclear if DM compared to formula supplementation improves direct breastfeeding.. · In general, growth was similar in infants who received DM or formula as a supplement..

Preoperative Point-of-Care Ultrasound to Identify Frailty and Predict Postoperative Outcomes: A Diagnostic Accuracy Study.

BACKGROUND: Frailty is increasingly being recognized as a public health issue, straining healthcare resources and increasing costs to care for these patients. Frailty is the decline in physical and cognitive reserves leading to increased vulnerability to stressors such as surgery or disease states. The goal of this pilot diagnostic accuracy study was to identify whether point-of-care ultrasound measurements of the quadriceps and rectus femoris muscles can be used to discriminate between frail and not-frail patients and predict postoperative outcomes. This study hypothesized that ultrasound could discriminate between frail and not-frail patients before surgery. METHODS: Preoperative ultrasound measurements of the quadriceps and rectus femoris were obtained in patients with previous computed tomography scans. Using the computed tomography scans, psoas muscle area was measured in all patients for comparative purposes. Frailty was identified using the Fried phenotype assessment. Postoperative outcomes included unplanned intensive care unit admission, delirium, intensive care unit length of stay, hospital length of stay, unplanned skilled nursing facility admission, rehospitalization, falls within 30 days, and all-cause 30-day and 1-yr mortality. RESULTS: A total of 32 patients and 20 healthy volunteers were included. Frailty was identified in 18 of the 32 patients. Receiver operating characteristic curve analysis showed that quadriceps depth and psoas muscle area are able to identify frailty (area under the curve-receiver operating characteristic, 0.80 [95% CI, 0.64 to 0.97] and 0.88 [95% CI, 0.76 to 1.00], respectively), whereas the cross-sectional area of the rectus femoris is less promising (area under the curve-receiver operating characteristic, 0.70 [95% CI, 0.49 to 0.91]). Quadriceps depth was also associated with unplanned postoperative skilled nursing facility discharge disposition (area under the curve 0.81 [95% CI, 0.61 to 1.00]) and delirium (area under the curve 0.89 [95% CI, 0.77 to 1.00]). CONCLUSIONS: Similar to computed tomography measurements of psoas muscle area, preoperative ultrasound measurements of quadriceps depth shows promise in discriminating between frail and not-frail patients before surgery. It was also associated with skilled nursing facility admission and postoperative delirium.

Impact of solid organ transplant status on outcomes of hospitalized patients with COVID-19 infection.

BACKGROUND: The COVID-19 pandemic has caused significant morbidity and mortality in solid organ transplant (SOT) recipients. However, it remains unclear whether the risk factor for SOT patients is the immunosuppression inherent to transplantation versus patient comorbidities. METHODS: We reviewed outcomes in a cohort of SOT (n = 129) and non-SOT (NSOT) patients (n = 708) admitted to the University of California, Los Angeles for COVID-19 infection. Data analyses utilized multivariate logistic regression to evaluate the impact of patient demographics, comorbidities, and transplant status on outcomes. SOT patients were analyzed by kidney SOT (KSOT) versus nonkidney SOT (NKSOT) groups. RESULTS: SOT and NSOT patients with COVID-19 infection differed in terms of patient age, ethnicity, and comorbidities. NKSOT patients were the most likely to experience death, with a mortality rate of 16.2% compared with 1.8% for KSOT and 8.3% for NSOT patients (p = .013). Multivariable analysis of hospitalized patients revealed that patient age (odds ratio [OR] 2.79, p = .001) and neurologic condition (OR 2.66, p < .001) were significantly associated with mortality. Analysis of ICU patients revealed a 2.98-fold increased odds of death in NKSOT compared with NSOT patients (p = .013). CONCLUSIONS: This study demonstrates the importance of transplant status in predicting adverse clinical outcomes in patients hospitalized or admitted to the ICU with COVID-19, especially for NKSOT patients. Transplant status and comorbidities, including age, could be used to risk stratify patients with COVID-19. This data suggests that immunosuppression contributes to COVID-19 disease severity and mortality and may have implications for managing immunosuppression, especially for critically ill patients admitted to the ICU.

Relationship Between the Anion Gap and Serum Lactate in Hypovolemic Shock.

Background and objectives: Previous studies evaluating patients in the Intensive Care Unit with established lactic acidosis determined that the anion gap is an insensitive screening tool for elevated blood lactate. No prior study has examined the relationship between anion gap and serum lactate within the first hours of the development of lactic acidosis. Design, setting, participants, & measurements: Data were obtained prospectively from a convenience sample of adult trauma patients at a single level 1 trauma center. Venous samples were drawn prior to initiation of intravenous fluid resuscitation. A linear regression model was constructed to assess the relationship between serum lactate and anion gap, and 95% prediction intervals were computed. Logistic regression models were constructed to determine the sensitivity and specificity for several different anion gap and lactate cutpoints. Results: 128 patients with elevated serum lactate levels (>2.1 mmol/L) and 63 patients with normal serum lactate levels (< 2.1 mmol/L) were included. The sensitivity of an elevated anion gap (> 10) to reveal hyperlactatemia was only 43% whereas specificity was 84%. Sensitivity improved if the upper limit of normal anion gap was lowered and with increasing levels of serum lactate. The coefficient of determination between serum lactate level and AG yielded an R2 of 0.30 (p < 0.001) and the slope of this relationship was 2.185 with a 95% confidence interval of 2.011-2.359. The mean 95% prediction interval was + 8.9. Conclusions: Within the first hour of the development of lactic acidosis due to hypovolemic shock, the anion gap was not a sensitive indicator of an elevated serum lactate level, but it was fairly specific. The anion gap increased to a greater extent than the serum lactate, the 95% mean prediction interval was wide and approximately 70% of the change in anion gap could not be explained by increases in serum lactate, suggesting that other anions contribute to the anion gap in lactic acidosis.

Infliximab in hidradenitis suppurativa: A systematic review and meta-analysis.

Hidradenitis suppurativa (HS) is a chronic inflammatory often recalcitrant to treatment. There is a lack of an updated systematic data review for infliximab use in HS. We conducted a systematic review and meta-analysis of literature on infliximab in HS. This study was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and was pre-registered on PROSPERO (CRD42021283596). In 9/2021, MEDLINE and EMBASE were systematically searched for articles on infliximab in HS. Non-English, duplicate, and studies with <5 HS patients were excluded. Study quality was assessed utilizing Cochrane Risk of Bias for prospective trials and Newcastle-Ottawa Scale for cohort studies. Random effects meta-analytical model, Cochran's Q statistic, and I squared index were performed. Nineteen articles (314 patients) met inclusion criteria (six prospective, 13 retrospective studies). All patients with HS severity data available (n = 299) had moderate-to-severe disease. Outcome measures used for meta-analysis of the pooled response rate were largely based on clinician reported outcomes (16 studies). One utilized both clinician and patient assessment. Two utilized patient-reported response alone. The pooled response rate of HS patients to infliximab was 83% (95% CI, 0.71-0.91). The most common adverse events (AEs) included non-serious infections (13.2%) and infusion reaction (2.9%). The rate of serious AEs was 2.9%. Study limitations include the small number of prospective studies and heterogeneity between studies. Overall, infliximab is an effective treatment for moderate-to-severe HS. Efficacy of infliximab in HS should be compared to other biologics in larger, randomized controlled trials.

Impact of Pregnancy on Hidradenitis Suppurativa Disease Course: A Systematic Review and Meta-Analysis.

BACKGROUND: Hormones are thought to play a role in hidradenitis suppurativa (HS). However, data on the HS disease course during pregnancy and the postpartum period has not been well established. The objective of this study is to analyze the available literature to determine HS disease activity during pregnancy and the postpartum period. METHODS: The PubMed and Embase databases were systematically searched for relevant articles from database inception until November 22, 2020. The inclusion criteria were a study population with the diagnosis of HS and discussion of pregnancy impact on the HS disease course or postpartum flare. Study characteristics, patient demographics, HS severity, and HS disease course during pregnancy and the postpartum period were extracted by 2 independent reviewers. The quality of included studies was assessed using the Newcastle-Ottawa Scale for observational studies. Heterogeneity was assessed using Cochran's Q statistic and I2 index. The random-effects meta-analytical model was used. The primary study outcome was the pooled odds ratio of improvement or of worsening of HS disease activity during pregnancy. RESULTS: The systematic search identified 8 studies for analysis. There was a total of 672 cases for which data on the patient-reported HS disease course during pregnancy were available, and 164 cases for which data on patient-reported postpartum flare were available. In the meta-analyses, the rate of HS disease improvement was 24% (95% CI 0.13-0.40) and the rate of HS disease worsening was 20% (95% CI 0.11-0.34). Sixty percent (99/164) of patients experienced a postpartum flare. CONCLUSION: While about a quarter of women will experience an improvement in HS during pregnancy, the majority will have a stable or worsened disease course, and over half of patients will experience a postpartum flare. Close monitoring of HS patients is needed during pregnancy and postpartum periods, as patients may need continued, or even escalated, disease management.

Association Between Preoperative Hemodialysis Timing and Postoperative Mortality in Patients With End-stage Kidney Disease.

Importance: For patients with end-stage kidney disease treated with hemodialysis, the optimal timing of hemodialysis prior to elective surgical procedures is unknown. Objective: To assess whether a longer interval between hemodialysis and subsequent surgery is associated with higher postoperative mortality in patients with end-stage kidney disease treated with hemodialysis. Design, Setting, and Participants: Retrospective cohort study of 1 147 846 procedures among 346 828 Medicare beneficiaries with end-stage kidney disease treated with hemodialysis who underwent surgical procedures between January 1, 2011, and September 30, 2018. Follow-up ended on December 31, 2018. Exposures: One-, two-, or three-day intervals between the most recent hemodialysis treatment and the surgical procedure. Hemodialysis on the day of the surgical procedure vs no hemodialysis on the day of the surgical procedure. Main Outcomes and Measures: The primary outcome was 90-day postoperative mortality. The relationship between the dialysis-to-procedure interval and the primary outcome was modeled using a Cox proportional hazards model. Results: Of the 1 147 846 surgical procedures among 346 828 patients (median age, 65 years [IQR, 56-73 years]; 495 126 procedures [43.1%] in female patients), 750 163 (65.4%) were performed when the last hemodialysis session occurred 1 day prior to surgery, 285 939 (24.9%) when the last hemodialysis session occurred 2 days prior to surgery, and 111 744 (9.7%) when the last hemodialysis session occurred 3 days prior to surgery. Hemodialysis was also performed on the day of surgery for 193 277 procedures (16.8%). Ninety-day postoperative mortality occurred after 34 944 procedures (3.0%). Longer intervals between the last hemodialysis session and surgery were significantly associated with higher risk of 90-day mortality in a dose-dependent manner (2 days vs 1 day: absolute risk, 4.7% vs 4.2%, absolute risk difference, 0.6% [95% CI, 0.4% to 0.8%], adjusted hazard ratio [HR], 1.14 [95% CI, 1.10 to 1.18]; 3 days vs 1 day: absolute risk, 5.2% vs 4.2%, absolute risk difference, 1.0% [95% CI, 0.8% to 1.2%], adjusted HR, 1.25 [95% CI, 1.19 to 1.31]; and 3 days vs 2 days: absolute risk, 5.2% vs 4.7%, absolute risk difference, 0.4% [95% CI, 0.2% to 0.6%], adjusted HR, 1.09 [95% CI, 1.04 to 1.13]). Undergoing hemodialysis on the same day as surgery was associated with a significantly lower hazard of mortality vs no same-day hemodialysis (absolute risk, 4.0% for same-day hemodialysis vs 4.5% for no same-day hemodialysis; absolute risk difference, -0.5% [95% CI, -0.7% to -0.3%]; adjusted HR, 0.88 [95% CI, 0.84-0.91]). In the analyses that evaluated the interaction between the hemodialysis-to-procedure interval and same-day hemodialysis, undergoing hemodialysis on the day of the procedure significantly attenuated the risk associated with a longer hemodialysis-to-procedure interval (P<.001 for interaction). Conclusions and Relevance: Among Medicare beneficiaries with end-stage kidney disease, longer intervals between hemodialysis and surgery were significantly associated with higher risk of postoperative mortality, mainly among those who did not receive hemodialysis on the day of surgery. However, the magnitude of the absolute risk differences was small, and the findings are susceptible to residual confounding.

Implementation and Evaluation of a Neurology Telemedicine Initiative at a Major Academic Medical Center.

Introduction: The COVID-19 pandemic forced rapid adoption of telemedicine for care of neurology patients. This study contributes to this literature by describing the structure and implementation of telemedicine-based outpatient neurology clinics at the UCLA Medical Center and estimates patient cost savings, before and after the California COVID-19 "Safer at Home" directive, and patient satisfaction. Methods: This was a retrospective, nonrandomized, case series study of telemedicine-based neurological management in an urban academic medical center from October 2018 to June 2020. We estimated roundtrip travel time, roundtrip travel distance, total savings, and surveyed patient and provider satisfaction with telemedicine care. We supported these findings through evaluation of 7,194 patients by telemedicine and conducted 9,189 video visits for neurological care. Results: The median telemedicine patient avoided a roundtrip driving distance of 33 miles and roundtrip travel time of 75 min. Within sample, median hourly earnings were $27/h. The median patient saved $18 on fuel and parking and $36 of time-based opportunity savings, for total savings of $54 per video visit. Eighty-six percent of patients surveyed were satisfied with their video visit experience. Conclusions: Telemedicine reduced travel time and also reduced costs for neurology patients. Patients and providers both reported high levels of satisfaction with telemedicine.

Effect of Throat Pack Placement on the Incidence of Sore Throat and Postoperative Nausea and Vomiting in Septorhinoplasty Patients: A Randomized Controlled Trial.

BACKGROUND: Advances in surgical and anesthetic techniques have led to a growing interest in performing procedures at ambulatory surgery centers. However, procedures involving the oropharyngeal or nasopharyngeal region may lead to the ingestion of blood, which can lead to postoperative nausea and vomiting (PONV). To date, limited studies have largely failed to demonstrate the benefits of oropharyngeal throat packing. OBJECTIVES: The authors aimed to investigate whether throat packing during elective septorhinoplasty increases the incidence of postoperative throat pain and assess its effects on PONV. METHODS: A randomized, prospective, single-blinded study was performed on 101 patients undergoing elective septorhinoplasty who received oropharyngeal throat packing vs no packing to compare the incidence of PONV and throat pain in the immediate postoperative period in addition to postoperative day (POD) 1 and 2. RESULTS: The incidence and severity of postoperative throat pain were significantly greater in patients receiving throat packs in the immediate postoperative period and on POD 1. Significant differences in throat pain and incidence between the 2 groups diminished by POD 2. Patients having received throat packs also demonstrated a higher utilization of opioids in postanesthesia care unit. The incidence of PONV did not significantly differ between the 2 cohorts at any point of observations. CONCLUSIONS: The results of this study largely agree with previous data that throat packs may contribute to postoperative throat pain while not significantly altering the incidence of PONV. Considering these data, we do not recommend routine utilization of throat packing during elective septorhinoplasty.

Nomograms to predict outcomes after 177Lu-PSMA therapy in men with metastatic castration-resistant prostate cancer: an international, multicentre, retrospective study.

BACKGROUND: Lutetium-177 (177Lu) prostate-specific membrane antigen (177Lu-PSMA) is a novel targeted treatment for patients with metastatic castration-resistant prostate cancer (mCRPC). Predictors of outcomes after 177Lu-PSMA to enhance its clinical implementation are yet to be identified. We aimed to develop nomograms to predict outcomes after 177Lu-PSMA in patients with mCRPC. METHODS: In this multicentre, retrospective study, we screened patients with mCRPC who had received 177Lu-PSMA between Dec 10, 2014, and July 19, 2019, as part of the previous phase 2 trials (NCT03042312, ACTRN12615000912583) or compassionate access programmes at six hospitals and academic centres in Germany, the USA, and Australia. Eligible patients had received intravenous 6·0-8·5 GBq 177Lu-PSMA once every 6-8 weeks, for a maximum of four to six cycles, and had available baseline [68Ga]Ga-PSMA-11 PET/CT scan, clinical data, and survival outcomes. Putative predictors included 18 pretherapeutic clinicopathological and [68Ga]Ga-PSMA-11 PET/CT variables. Data were collected locally and centralised. Primary outcomes for the nomograms were overall survival and prostate-specific antigen (PSA)-progression-free survival. Nomograms for each outcome were computed from Cox regression models with LASSO penalty for variable selection. Model performance was measured by examining discrimination (Harrell's C-index), calibration (calibration plots), and utility (patient stratification into low-risk vs high-risk groups). Models were validated internally using bootstrapping and externally by calculating their performance on a validation cohort. FINDINGS: Between April 23, 2019, and Jan 13, 2020, 414 patients were screened; 270 (65%) of whom were eligible and were divided into development (n=196) and validation (n=74) cohorts. The median duration of follow-up was 21·5 months (IQR 13·3-30·7). Predictors included in the nomograms were time since initial diagnosis of prostate cancer, chemotherapy status, baseline haemoglobin concentration, and [68Ga]Ga-PSMA-11 PET/CT parameters (molecular imaging TNM classification and tumour burden). The C-index of the overall survival model was 0·71 (95% CI 0·69-0·73). Similar C-indices were achieved at internal validation (0·71 [0·69-0·73]) and external validation (0·72 [0·68-0·76]). The C-index of the PSA-progression-free survival model was 0·70 (95% CI 0·68-0·72). Similar C-indices were achieved at internal validation (0·70 [0·68-0·72]) and external validation (0·71 [0·68-0·74]). Both models were adequately calibrated and their predictions correlated with the observed outcome. Compared with high-risk patients, low-risk patients had significantly longer overall survival in the validation cohort (24·9 months [95% CI 16·8-27·3] vs 7·4 months [4·0-10·8]; p<0·0001) and PSA-progression-free survival (6·6 months [6·0-7·1] vs 2·5 months [1·2-3·8]; p=0·022). INTERPRETATION: These externally validated nomograms that are predictive of outcomes after 177Lu-PSMA in patients with mCRPC might help in clinical trial design and individual clinical decision making, particularly at institutions where 177Lu-PSMA is introduced as a novel therapeutic option. FUNDING: Prostate Cancer Foundation.

Accuracy of administrative database estimates of national surgical volume: Solid organ transplantation in the National Inpatient Sample.

BACKGROUND: Little is known about the accuracy of procedural coding in the National Inpatient Sample, in part because it is challenging to validate population-level estimates. METHODS: We evaluated the accuracy of the National Inpatient Sample by comparing estimates of solid organ transplantation to known national transplant volumes from the Organ Procurement and Transplant Network. RESULTS: The mean deviation of National Inpatient Sample point estimates from true transplant volume for the study period was 17.5 ± 20.8%. The mean deviation of point estimates from 2005 to 2011 was 26.4 ± 22.8% compared to 4.9 ± 6.3% from 2012 to 2016 (P < .001). CONCLUSIONS: Although future National Inpatient Sample transplantation research may be limited by the inability to subgroup procedures by donor type, surgical procedure coding of solid organ transplantation within the National Inpatient Sample appears to be accurate and reliable for generating national estimates, particularly after the National Inpatient Sample redesign in 2012.

Randomized controlled trial of a quadratus lumborum block with liposomal bupivacaine for postoperative analgesia in laparoscopic donor nephrectomy.

Perioperative pain management is an important consideration in early recovery and patient satisfaction following laparoscopic donor nephrectomy. Transmuscular quadratus lumborum block has been described to reduce pain and opioid usage following several abdominal surgeries. In this prospective single-blind randomized controlled trial, we compared 52 patients who adhered to our institutional donor nephrectomy Early Recovery After Surgery pathway, which includes a laparoscopic-guided transversus abdominus plane block, to 40 patients who additionally received a transmuscular quadratus lumborum block with liposomal bupivacaine. Compared to control patients, those who received the block spent longer in the operating room prior to the surgical start (65.4 vs. 51.6 min, P < .001). Both groups had similar total hospital length of stay (33.3 h vs. 34.4 h, P = .61). Pain scores from postoperative days 0-30, number of patients requiring opioids, postoperative nausea, and pain management satisfaction were similar between both groups. Patients who received the block consumed less opioid on postoperative day 1 compared to controls (P = .006). No complications were attributable to the block. The quadratus lumborum block provides a safe pain management adjunct for some patients, and may reduce opioid use in the early postoperative period when combined with our standard institutional protocol for kidney donors.

Combined Percutaneous Tracheostomy and Endoscopic Gastrostomy Tubes in COVID-19: A Prospective Series of Patient Outcomes.

Background: A significant number of patients with severe respiratory failure related to COVID-19 require prolonged mechanical ventilation. Minimal data exists regarding the timing, safety, and efficacy of combined bedside percutaneous tracheostomy and endoscopy gastrostomy tube placement in these patients. The safety for healthcare providers is also in question. This study's objective was to evaluate the effectiveness and safety of combined bedside tracheostomy and gastrostomy tube placement in COVID-19 patients. Design and Methods: This is a single arm, prospective cohort study in patients with COVID-19 and acute respiratory failure requiring prolonged mechanical ventilation who underwent bedside tracheostomy and percutaneous endoscopic gastrostomy placement. Detailed clinical and procedural data were collected. Descriptive statistics were employed and time to event curves were estimated and plotted using the Kaplan Meier method for clinically relevant prespecified endpoints. Results: Among 58 patients, the median total intensive care unit (ICU) length of stay was 29 days (24.7-33.3) with a median of 10 days (6.3-13.7) postprocedure. Nearly 88% of patients were weaned from mechanical ventilation postprocedure at a median of 9 days (6-12); 94% of these were decannulated. Sixty-day mortality was 10.3%. Almost 90% of patients were discharged alive from the hospital. All procedures were done at bedside with no patient transfer required out of the ICU. A median of 3.0 healthcare personnel total were present in the room per procedure. Conclusion: This study shows that survival of critically ill COVID-19 patients after tracheostomy and gastrostomy was nearly 90%. The time-to-event curves are encouraging regarding time to weaning, downsizing, decannulation, and discharge. A combined procedure minimizes the risk of virus transmission to healthcare providers in addition to decreasing the number of anesthetic episodes, transfusions, and transfers patients must undergo. This approach should be considered in critically ill COVID-19 patients requiring prolonged mechanical ventilation.

Physician perspectives on complementary and alternative medicine in hidradenitis suppurativa.

Hidradenitis suppurativa (HS) is a chronic and often debilitating inflammatory condition characterized by frequent nodules, abscesses, sinus tracts, and scars impacting the intertriginous areas. Many patients with HS often report limited treatment success and symptom coverage with conventional therapies. Recent studies have reported the widespread use of complementary and alternative medicine (CAM) among patients with HS. In this study, our aim was to examine current physician practice patterns, opinions, and comfort with recommending CAM. Our results indicate that provider comfort and opinions on CAM varied based on the provider's experiences, demographics, and the CAM modality itself. Overall, nearly two-thirds (n = 30, 61.2%) of respondents agreed that CAM and conventional medicine were more effective together than either alone. Meanwhile, 44.9% (n = 22) of respondents routinely recommend CAM while 64.6% (n = 31) of respondents reported that they are routinely asked about CAM. The majority (n = 41, 83.7%) of respondents indicated a lack of scientific evidence in the medical literature as a barrier to recommending CAM along with efficacy concerns (n = 34, 69.4%) and ability to recommend reputable CAM products (n = 32, 65.3%) and practitioners (n = 32, 65.3%). Future investigations are warranted to establish a better understanding of the efficacy and benefit of CAM methods in conjunction with conventional methods.