Viral Conjunctivitis Rates Unchanged Before and During the COVID-19 Pandemic in an Ophthalmology Clinic.

Background: Millions of acute conjunctivitis cases occur in the United States annually. The impact of COVID-19 mitigation practices on viral conjunctivitis incidence within ophthalmology clinics has not been reported. We hypothesized that viral conjunctivitis rates would decrease with implementation of such practices. Methods: A retrospective chart review was conducted at a single academic center's ophthalmology clinics. Electronic health record data was queried using ICD-10 diagnostic codes to include 649 patients aged 2-97 with viral, bacterial, or allergic conjunctivitis diagnosed either before (6/1/2018-5/1/2019) or during (6/1/2020-5/1/2021) COVID-19 precautions. Conjunctivitis rates per ophthalmology clinic visit were compared using rate-ratio analysis. Logistic regression evaluated the effects of age, sex, and race among those with conjunctivitis. Results: A total of 66,027 ophthalmology clinic visits occurred during the study period. Viral conjunctivitis rates per visit did not significantly change after enacting COVID-19 mitigation strategies, but allergic conjunctivitis rates significantly increased (viral: RR 0.82, 95% CI 0.51 to 1.31, p=0.408; allergic: RR 1.70, 95% CI 1.43 to 2.03, p<0.001). When controlling for time, younger age (≤ median age 55) (p=0.005) and Caucasian race (p=0.009) were associated with higher viral conjunctivitis frequency. Conclusion: Contrary to trends reported in emergency departments, viral conjunctivitis rates within an ophthalmology clinic did not significantly change after COVID-19 mitigation strategies, though allergic conjunctivitis rates increased. Patients' avoidance of emergency departments during the pandemic may have contributed. Further investigation is required to explore variation in ophthalmology patient populations and needs based on care setting.

A retrospective review included 649 patients with viral, bacterial, or allergic conjunctivitis diagnosed at a single center's ophthalmology clinics before (6/1/2018­5/1/2019) or during (6/1/2020­5/1/2021) COVID-19 precautions. Contrary to emergency department experiences, viral conjunctivitis rates did not significantly change after COVID-19 precautions. However, allergic conjunctivitis rates significantly increased. Conjunctivitis presentation in ophthalmology clinics differed from that reported in emergency departments, warranting further evaluation of variation in patient needs by setting.

Optimizing Longitudinal Tobacco Cessation Treatment in Lung Cancer Screening: A Sequential, Multiple Assignment, Randomized Trial.

Importance: Nearly half of the 14.8 million US adults eligible for lung cancer screening (LCS) smoke cigarettes. The optimal smoking cessation program components for the LCS setting are unclear. Objective: To assess the effect of adding a referral to prescription medication therapy management (MTM) to the tobacco longitudinal care (TLC) program among patients eligible for LCS who smoke and do not respond to early tobacco treatment and to assess the effect of decreasing the intensity of TLC among participants who do respond to early treatment. Design, Setting, and Participants: This randomized clinical trial included patients who currently smoked cigarettes daily and were eligible for LCS. Recruitment took place at primary care centers and LCS programs at 3 large health systems in the US and began in October 2016, and 18-month follow-up was completed April 2021. Interventions: (1) TLC comprising intensive telephone coaching and combination nicotine replacement therapy for 1 year with at least monthly contact; (2) TLC with MTM, MTM offered pharmacist-referral for prescription medications; and (3) Quarterly TLC, intensity of TLC was decreased to quarterly contact. Intervention assignments were based on early response to tobacco treatment (abstinence) that was assessed either 4 weeks or 8 weeks after treatment initiation. Main outcomes and Measures: Self-reported, 6-month prolonged abstinence at 18-month. Results: Of 636 participants, 228 (35.9%) were female, 564 (89.4%) were White individuals, and the median (IQR) age was 64.3 (59.6-68.8) years. Four weeks or 8 weeks after treatment initiation, 510 participants (80.2%) continued to smoke (ie, early treatment nonresponders) and 126 participants (19.8%) had quit (ie, early treatment responders). The 18 month follow-up survey response rate was 83.2% (529 of 636). Across TLC groups at 18 months follow-up, the overall 6-month prolonged abstinence rate was 24.4% (129 of 529). Among the 416 early treatment nonresponders, 6-month prolonged abstinence for TLC with MTM vs TLC was 17.8% vs 16.4% (adjusted odds ratio [aOR] 1.13; 95% CI, 0.67-1.89). In TLC with MTM, 98 of 254 participants (39%) completed at least 1 MTM visit. Among 113 early treatment responders, 6-month prolonged abstinence for Quarterly TLC vs TLC was 24 of 55 (43.6%) vs 34 of 58 (58.6%) (aOR, 0.54; 95% CI, 0.25-1.17). Conclusions and Relevance: In this randomized clinical trial, adding referral to MTM with TLC for participants who did not respond to early treatment did not improve smoking abstinence. Stepping down to Quarterly TLC among early treatment responders is not recommended. Integrating longitudinal tobacco cessation care with LCS is feasible and associated with clinically meaningful quit rates. Trial Registration: ClinicalTrials.gov Identifier: NCT02597491.

Retrograde incision from orifice (RIO) technique for endoscopic incision of ureterocele: 15 years of outcomes.

INTRODUCTION: Management of obstructing ureterocele often includes endoscopic transurethral incision (TUI) that can be challenging secondary to uncertainty in anatomic landmarks with risk of serious complications. To this end, we innovated a technique using predictable landmarks that begins endoscopic incision at the ureterocele orifice and extends retrograde proximal to the bladder neck (Figure). OBJECTIVE: With over 15 years of experience in performing this retrograde incision from orifice (RIO) technique, we aimed to examine post-operative outcomes and risk of surgical failure after RIO compared to traditional TUI techniques for ureteroceles. We hypothesized that clinical outcomes after RIO would be superior to traditional endoscopic approaches to decompression of obstructing ureterocele in infants. STUDY DESIGN: A retrospective study of patients ≤12 months old who underwent TUI ureterocele at our institution between 2007 and -2021 was conducted. Pre-, intra- and post-operative characteristics were compared between patients who underwent RIO vs non-RIO TUI. Primary outcome was post-incision febrile urinary tract infection (fUTI). Secondary outcome was a composite failure measure of fUTI, secondary surgery, de novo bladder outlet obstruction, or vesicoureteral reflux. Multivariable Cox proportional hazard models were fitted to compare the time-to-event risk of primary and secondary outcomes between groups. RESULTS: Ninety patients with 92 ureteroceles were included (49 RIO, 43 non-RIO). Median follow-up from TUI was 33 months. RIO had a shorter median operative duration (27 vs 35 min, p = 0.021). Primary and secondary outcomes were similar between groups (fUTI: 29% RIO vs 19% non-RIO, p = 0.27; composite failure 54% RIO vs 69% non-RIO, p = 0.15). In multivariable Cox proportional hazard models, there was no significant difference in risk of fUTI (RIO aHR 0.98, 95% CI 0.38-2.54, p = 0.97) or composite failure (RIO aHR 0.80, 95% CI 0.45-1.44, p = 0.46) between TUI techniques. DISCUSSION: RIO technique for TUI ureterocele is attractive in that it uses predictable anatomic landmarks making it simple to perform. In analyzing this 15-year institutional experience of TUI ureterocele, RIO showed similar success to non-RIO endoscopic incisions. This study is a retrospective, non-randomized, single-institutional study over 15 years and is therefore subject to change in surgeon practice over time and variable practices between providers. CONCLUSIONS: Given comparable success and durability over time to other TUI ureterocele techniques, and with the advantage of operator ease using consistent anatomic landmarks, RIO is a worthy option for endoscopic ureterocele decompression.

Robot-assisted Laparoscopic Pyeloplasty: Experience of a Single Pediatric Institution, Including Long-term and Safety Outcomes.

OBJECTIVE: To evaluate the efficacy and safety of robot-assisted laparoscopic pyeloplasty (RALP) and describe the short and long-term outcomes of pediatric RALP. METHODS: We retrospectively reviewed all patients ..±21 years old who underwent primary RALP from 7/2007 through 12/2019. Patients were excluded from postoperative analysis if follow-up data after stent removal was not available. The primary outcome was surgical success, defined as radiographic improvement of hydronephrosis without need for reoperation. Secondary outcomes were time to reoperation and 90-day complication rate. RESULTS: A total of 356 patients underwent primary repair of ureteropelvic junction obstruction during the study period; 29.ßpatients were limited to intraoperative data due to lack of follow-up imaging. Radiographic improvement at latest follow-up was seen in 308/327 (94.2%). Ten of 327 patients (3.1%) underwent reoperation: 7 were identified within 1 year of RALP and 3 were identified over 1 year after RALP. The median time to reoperation was 13.0 months (IQR 9.3-21.7). We defined long-term as>3 years after pyeloplasty. Over one-third (122/327, 37.3%) of the cohort had>3 years of follow-up, none of whom developed evidence of recurrent obstruction requiring reoperation beyond 3 years. Complications occurred within 90 days of surgery in 20/327 (6.1%). CONCLUSION: This largest single-institution series confirms short- and long-term surgical effectiveness and safety of RALP. Our data also indicate that most patients who needed reoperation were identified within 1 year, and reoperation more than 3 years after RALP is rare.

MRI Signal Intensity Varies Along the Course of the Normal Optic Nerve.

BACKGROUND: MRI can help distinguish various causes of optic neuropathy including optic neuritis. Importantly, neuromyelitis optica spectrum disorder (NMOSD) has a propensity to cause enhancement of the prechiasmatic optic nerves. To determine whether the prechiasmatic optic nerve (PC-ON) demonstrates a different intensity from the midorbital optic nerve (MO-ON) on MRI among patients without optic neuropathy. METHODS: Data were retrospectively obtained from 75 patients who underwent brain MRI for an ocular motor nerve palsy between January 2005 and April 2021. Inclusion criteria were patients aged 18 years or older with visual acuities of at least 20/25 and no evidence of optic neuropathy on neuro-ophthalmic examination. A total of 67 right eyes and 68 left eyes were assessed. A neuroradiologist performed quantitative intensity measurements of the MO-ON and PC-ON on precontrast and postcontrast T1 axial images. Normal-appearing temporalis muscle intensity was also measured and used as a reference to calculate an intensity ratio to calibrate across images. RESULTS: The mean PC-ON intensity ratio was significantly higher than the MO-ON intensity ratio on both precontrast (19.6%, P < 0.01) and postcontrast images (14.2%, P < 0.01). Age, gender, and laterality did not independently affect measurements. CONCLUSIONS: The prechiasmatic optic nerve shows brighter intensity ratios on both precontrast and postcontrast T1 images than the midorbital optic nerve among normal optic nerves. Clinicians should recognize this subtle signal discrepancy when assessing patients with presumed optic neuropathy.

Knowledge, Attitudes and Perceptions of Dental Hygiene and Dental Therapy Students towards End-stage Renal Disease: A pilot study.

Purpose Chronic kidney disease is highly prevalent in the general population and can progress to end-stage renal disease (ESRD). The purpose of this pilot study was to assess dental hygiene and dental therapy students' knowledge, attitudes, and perceptions towards ESRD and evaluate the feasibility of a larger scale study.Methods A convenience sample (n=59) of dental hygiene (DH) and dual degree DH/dental therapy students were invited to participate in an electronic survey for the pilot study. The investigator designed survey consisted of a total of 37 items: demographics (4), perceived knowledge, confidence, importance and attitudes (14), knowledge of chronic kidney disease (18). The knowledge questions were adapted from the Chronic Kidney Disease Self-Management Knowledge Tool (CKD-SMKT) with permission. Descriptive statistics and the non-parametric two-sample Wilcoxon rank sum test were used to analyze the data.Results Twenty-five participants completed the survey for a 42% response rate. Fewer than half (36%) perceived having some knowledge regarding ESRD, its oral manifestations (28%) and mental health implications (12%). The importance of managing oral health for ESRD was rated by most respondents as "very important" or "extremely important" (76%). Respondent attitudes indicated high interest (68%) regarding employment in hospital settings to care for individuals with ESRD.Knowledge scores from the CKD-SMKT were low in the categories of general knowledge of ESRD and dental hygiene care modifications for individuals with ESRD.Conclusion Results of this pilot study indicate that using a validated instrument on a national sample is feasible to determine the knowledge, attitudes and perceptions of dental hygiene students regarding ESRD. Future research should include knowledge and awareness of hypertension, diabetes, and the role that management of chronic kidney disease plays in the prevention of ESRD.

InCISE: Instrument for Comprehensive Incisional and Surgical Evaluation.

OBJECTIVE: The evaluation of healing after head and neck surgery is currently qualitative and non-standardized, limiting the quality of surgical healing assessments in clinical and research settings. We sought to develop an objective, standardized wound assessment score, and hypothesize that a reliable instrument can be developed to evaluate head and neck surgical wounds. METHODS: A prospective cohort study was conducted in a tertiary-care, academic head and neck surgery practice. Patients undergoing head and neck surgery were enrolled. A digital photograph protocol was developed for evaluating healing surgical wounds. A panel of experts developed and refined a wound healing score and established reliability, reproducibility, internal consistency, and validity of the score. RESULTS: InCISE: Instrument for comprehensive incisional and surgical evaluation was created. The utility of our wound healing score was assessed using classical test theory. We performed the major steps of establishing reliability in head and neck surgeons: (1) internal consistency (Cronbach's α = 0.81), (2) inter-observer reliability (intra-class correlation = 0.76), and (3) intra-rater reliability (intra-class correlation = 0.87), and content validity (through focus groups). Our composite measure was found to have strong internal consistency, inter-rater reliability, and intra-rater reliability. Preliminary work suggests criterion validity via associations with physical health related quality of life (SF-12). CONCLUSION: A wound healing score for head and neck surgery, InCISE, has been developed and is reliable, reproducible, and consistent. Although content validity is present and criterion validity is suggested, work continues to establish validity in this instrument to allow for expanded clinical and research use. LEVEL OF EVIDENCE: NA Laryngoscope, 133:2166-2173, 2023.

Increased Levels of the Acrolein Metabolite 3-Hydroxypropyl Mercapturic Acid in the Urine of e-Cigarette Users.

Carcinogen and toxicant uptake by e-cigarette users have not been fully evaluated. In the study reported here, we recruited 30 e-cigarette users, 63 nonsmokers, and 33 cigarette smokers who gave monthly urine samples over a period of 4-6 months. Their product use status was confirmed by measurements of exhaled CO, urinary total nicotine equivalents, cyanoethyl mercapturic acid (CEMA), and total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol. Urinary biomarkers of exposure to the carcinogens acrolein (3-hydroxypropyl mercapturic acid, 3-HPMA), benzene (S-phenyl mercapturic acid, SPMA), acrylonitrile (CEMA), and a combination of crotonaldehyde, methyl vinyl ketone, and methacrolein (3-hydroxy-1-methylpropyl mercapturic acid, HMPMA) were quantified at each visit. Data from subject visits with CEMA > 27 pmol/mL were excluded from the statistical analysis of the results because of possible unreported exposures to volatile combustion products such as secondhand cigarette smoke or marijuana smoke exposure; this left 22 e-cigarette users with 4 or more monthly visits and all 63 nonsmokers. Geometric mean levels of 3-HPMA (1249 versus 679.3 pmol/mL urine) were significantly higher (P = 0.003) in e-cigarette users than in nonsmokers, whereas levels of SPMA, CEMA, and HMPMA did not differ between these two groups. All analytes were significantly higher in cigarette smokers than in either e-cigarette users or nonsmokers. The results of this unique multimonth longitudinal study demonstrate consistent significantly higher uptake of the carcinogen acrolein in e-cigarette users versus nonsmokers, presenting a warning signal regarding e-cigarette use.

Adult Hematology/Oncology Patient Perspectives on Telemedicine Highlight Areas of Focus for Future Hybrid Care Models.

Introduction: Telemedicine use expanded rapidly during the COVID-19 pandemic, but publications analyzing patient perspectives on telemedicine are few. We aimed to study whether patient perspectives offer insights into how best to utilize telemedicine in the future for hematology and cancer care. Methods: A modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) was sent to adult hematology/oncology outpatients at the University of Minnesota Masonic Cancer Clinic who had ≥1 prior phone and/or video visit between March 15, 2020, and March 31, 2021. Two focus groups were subsequently conducted with volunteers who completed the survey. We evaluated dichotomized TSUQ items using logistic regression, and focus group data were analyzed qualitatively using constant comparison analysis. Results: Of 7,848 invitations, 588 surveys were completed. Focus groups included 16 survey respondents. Most respondents found telemedicine satisfactory, easy to use, and convenient, with the majority preferring a hybrid approach going forward. Oncology patients, females, and higher income earners endorsed decreased telemedicine satisfaction. Concerns were voiced about fewer in-person interactions, communication gaps, and provider style variability. Discussion: Adult hematology/oncology patients had varied perspectives on telemedicine utilization success based on gender, income, and disease burden, suggesting that a one-size-fits-all approach, as was implemented nearly universally during the COVID-19 pandemic, is not an ideal approach for the long term. Given that telemedicine use is likely to remain in some form in most centers, our findings suggest that a nuanced and tailored approach for some patient subgroups and using feedback from patients will make implementation more effective.

Functional Oral Health Literacy and Periodontal Health.

Purpose: Growing evidence associates low oral health literacy (OHL) with poor oral health outcomes. While nearly half of United States adults have periodontal disease (PD), there are conflicting results on association between OHL and PD. The purpose of this pilot study was to explore the association between functional OHL and periodontal health as defined by the American Academy of Periodontology (AAP) classification system.Methods: A cross-sectional study was conducted with a convenience sample of dental patients presenting for care at a Midwestern Federally Qualified Health Center. Functional OHL was measured using the Oral Health Literacy Adults Questionnaire (OHL-AQ), and periodontal health was measured clinically and categorized by stage and grade using the recently revised AAP classification system. Additional demographic factors and health history information related to periodontal health were collected. Descriptive analysis reported the median and range for ordered variables, and frequency and percentages for categorical variables. Wilcoxon rank sum test, Kruskal-Wallis test, and Spearman correlation coefficients were used to find association between functional OHL and periodontal health.Results: Among fifty-four participants, statistically significant associations were found between OHL-AQ scores and AAP staging and grading categories. Periodontal disease stage increased with age, and periodontal disease grades progressed among participants with diabetes. No associations were found between periodontal health and sex, race, ethnicity, education, insurance, or country of origin.Conclusion: Functional oral health literacy had a significant inverse relationship with both AAP periodontal disease staging and grading. A larger study is needed to confirm the findings of this pilot study.

Latent constructs identified in older individuals who smoke cigarettes and are eligible for lung cancer screening: Factor analysis of baseline data from the PLUTO smoking cessation trial.

Introduction: Lung cancer screening (LCS) combined with smoking cessation intervention is currently recommended for older individuals with a history of heavy smoking. Tailoring tobacco treatment for this patient population of older, people who smoke (PWS) may improve cessation rates while efficiently using limited smoking cessation resources. Although some older people who smoke will need more intensive treatment to achieve sustained abstinence, others may be successful with less intensive treatment. A framework to identify them a priori would be helpful to distribute smoking cessation resources accordingly. Methods: Baseline demographic, smoking, and health data are reported from a randomized clinical trial of longitudinal smoking cessation interventions delivered in the setting of LCS. Candidate variables were factor analyzed to identify latent factors, or constructs, to identify subgroups of older participants among the heterogenous population of older people who smoke. Results: We identified three factor-derived constructs: self-reported health status, heaviness of smoking, and nicotine dependence. Nicotine dependence was moderately correlated with both of the other two factors. Conclusions: This factor analysis of baseline participant characteristics identified a set of latent constructs - based on a few practical clinical variables -- that can be used to classify the heterogenous population of older people who smoke to identify. We propose this framework to identify subgroups of people who smoke who might successfully quit with less intense treatment at the time of lung cancer screening.

Prospective Trial of Neutrophil/Lymphocyte Ratio and Other Blood Counts as Biomarkers of Survival among Patients with High-Grade Soft Tissue Sarcomas Treated with Pegylated Liposomal Doxorubicin and Ifosfamide.

Several studies have reported an association between levels of circulating blood cells, in particular the neutrophil to lymphocyte ratio (absolute neutrophil count (ANC)/absolute lymphocyte count (ALC)) and outcomes in patients with cancer. In the current study, the association between lymphocyte, neutrophil, monocyte, and platelet counts and survival was examined in a prospective trial of preoperative pegylated-liposomal doxorubicin and ifosfamide for high-grade soft-tissue sarcomas. A statistically significant association between overall survival, but not progression free-survival, was observed with the ANC/ALC ratio at a cutoff value of ≥2 and a statistically significant trend using a cutoff of ≥5. Our results suggest that a balance between the lymphocyte count and the number of circulating myeloid cells that can suppress lymphocyte function may be predictive of survival in patients with soft-tissue sarcomas. Future research should therefore examine the role of lymphocyte-myeloid cell balance in sarcoma biology.

Streamlining surgical trays for common pediatric urology Procedures: A quality improvement initiative.

INTRODUCTION: Procedures involving the external genitalia are the most common pediatric urologic operations. Our group identified excess instrumentation for these cases to be a potential cause of operating room (OR) inefficiency at our large, freestanding pediatric hospital. This quality improvement (QI) initiative aimed to streamline surgical instrumentation for the most-performed pediatric urologic procedures at our hospital. MATERIAL AND METHODS: Six Sigma DMAIC methodology (Define, Measure, Analyze, Improve, Control) guided this multidisciplinary, iterative QI effort. A stakeholder team utilized data review, direct observations, and multiple in-person discussions to create a new "Groin-Penis Tray" (GPT) to replace a larger tray for the 90 most common pediatric urologic procedures. Suture preference cards and expectations about which sutures would be opened for each case were updated. The primary outcome was estimated yearly cost-avoidance due to reduced sterile processing. Additional outcomes included: instruments opened/case, % cases with complete trays, Mayo stand set-up time, and % cases with unused sutures. Balancing measures included: total median OR time and tray weights. Baseline and post-implementation measures were characterized and compared. RESULTS: A QI professional, 10 pediatric urologists, 2 pediatric urology fellows, and multiple OR and sterile processing staff members participated. The Summary Figure compares baseline and post-implementation measurements. The number of instruments opened/case decreased from 146 to 65. Annual sterile reprocessing costs decreased by >$51,000. Median Mayo stand set-up time decreased from 7.3 to 3.5 min (p < 0.001). The number of cases with complete trays increased from 7/20 (35%) to 11/20 (55%, p = 0.34). The new GPT is 2.7 kg lighter than the prior tray. Median OR time remained stable (baseline: 91 min; post-implementation: 102 min, p = 0.44). The number of cases with suture waste decreased from 78% to 0% immediately post-implementation but increased to 40% one year later. DISCUSSION: This systematic, iterative QI process spanned the course of ∼2 years, including planning, building, and updating new trays, then assessing longer-term success via the control phase. The new GPT is used for most pediatric urologic procedures at our hospital, and benefits include sterile reprocessing cost savings and ergonomics. Our team gained valuable experience related to assessing QI project scope, determining key stakeholders and roles, and strategies for sustainability that we will apply to future initiatives. CONCLUSIONS: Streamlining surgical trays for common pediatric urologic procedures at a large freestanding children's hospital using established QI methodology reduced OR cost by >$51,000/year and Mayo stand set-up times without compromising balancing measures.

Prospective Trial of Monocyte Count as a Biomarker of Hand-Foot Syndrome Among Patients With Soft Tissue Sarcomas Treated With Pegylated Liposomal Doxorubicin and Ifosfamide.

Pegylated liposomal doxorubicin (PLD) is widely used and can be used for prolonged periods, with the limiting toxicity usually being hand-foot syndrome (HFS). The pharmacokinetics of PLD is variable between patients, leading to variability in the risk of developing HFS. Dosing based on body surface area does not decrease variability in PLD clearance; thus, other predictive markers could be useful. The peripheral blood absolute monocyte count (AMC) has been suggested as a possible marker of both reticuloendothelial system function and PLD pharmacokinetics. The present study examined the AMC as a potential predictive biomarker in a prospective trial of pre-operative PLD combined with ifosfamide in soft tissue sarcomas (STSs). While our results suggest a relationship between pre-treatment AMC and PLD-induced HFS, the association did not reach statistical significance. The clinical utility of the AMC as a predictor of PLD-induced HFS appears limited, at least when given with ifosfamide.

Peer Group Support Intervention to Reduce Cardiovascular Disease Risk for African American Men According to Life's Simple 7 in Faith-Based Communities.

BACKGROUND AND PURPOSE: Adverse cardiovascular health disparities persist for African American men. Although changing health behaviors is perhaps one of the most effective methods to prevent cardiovascular disease (CVD)-related deaths, previous behavior change programs targeting single or multiple CVD risk factors in target groups have had mixed success. The purpose of this pilot study was to determine whether a multi-faceted peer group intervention model based on American Heart Association's Life's Simple 7 was feasible, safe, acceptable, and efficacious in producing meaningful risk reduction for African American men. METHODS: A convenience sample of 24 African American men with at least one CVD risk factor participated quasi-experimental study having peer intervention vs. nonequivalent comparison groups, with pretest-posttests at two church sites in Minneapolis, MN (MPLS) and Washington, D.C. (DC). Feasibility, safety, acceptability, and potential efficacy were assessed by examining completion of peer group sessions, adverse events, attendance, attrition, within and between-group changes in measures using nonparametric statistics. RESULTS: All twenty-four men completed the study with no study-related adverse symptoms and medical events. The peer groups had moderate to high attendance, and the peer program evaluation was highly positive among participants. Between baseline and 6-months, there were significant differences between the intervention and the comparison group in cholesterol levels and weights (p = .041, p = .034, respectively) at one site (DC). There were no significant between-group changes at the other site (MPLS). IMPLICATION FOR PRACTICE: The multi-faceted peer support intervention was feasible, acceptable, and shown to have potential efficacy to reduce CVD risk for highly motivated African American men. Future studies with a larger sample size are needed to test the effectiveness of this intervention model to reduce CVD risk among African American men.

Ganglion Cell Layer Thickness Variance Using SPECTRALIS Optical Coherence Tomography.

BACKGROUND: To determine the normal variance of the mean macular ganglion cell layer (GCL) volume among subjects without significant ocular pathology using SPECTRALIS optical coherence tomography (OCT). METHODS: Fifty subjects underwent a baseline scan using SPECTRALIS OCT followed by 2 more studies with (reg-ON) and without (reg-OFF) eye registration all taken at the same session. The mean GCL volume was measured using built-in SPECTRALIS software. Eyes with macular pathology were excluded. The reproducibility of the measurements of the GCL volume was evaluated with Bland-Altman plots and limits of agreement, intraclass correlation coefficient (ICC), and the coefficient of repeatability (CR). RESULTS: A total of 98 eyes met criteria for the analysis. The mean GCL volume difference was 0.0002 ± 0.029 and -0.0005 ± 0.035 mm 3 for scans 1 versus 2 (baseline vs reg-ON) and 3 (baseline vs reg-OFF), respectively. The ICCs were 0.985 and 0.977 for the baseline vs reg-ON and reg-OFF groups. The CR for baseline vs reg-ON was 0.056 while CR for baseline vs reg-OFF was 0.069. Ninety percent of eyes fell within 0.04 mm 3 of test-retest reliability. CONCLUSIONS: Our model found a predictable threshold of 0.07 mm 3 or less for SPECTRALIS OCT mean GCL volume variance, which did not significantly change with eye registration in eyes without macular pathology. Clinicians may also consider a threshold of 0.04 mm 3 when determining stable vs progressive changes in mean GCL volume using this device.

Increased acrolein-DNA adducts in buccal brushings of e-cigarette users.

DNA adducts are central in the mechanism of carcinogenesis by genotoxic agents. We compared levels of a DNA adduct of acrolein, a genotoxic carcinogen found in e-cigarette vapor, in oral cell DNA of e-cigarette users and non-users of any tobacco or nicotine product. e-Cigarette users and non-users visited our clinic once monthly for 6 months, and oral brushings and urine samples were collected. For this study, we analyzed oral cell DNA adducts from three monthly visits in e-cigarette users and non-users as confirmed by urinary cyanoethyl mercapturic acid and total nicotine equivalents. DNA was isolated from the oral brushings and analyzed by a validated liquid chromatography-nanoelectrospray ionization-high resolution tandem mass spectrometry method for the acrolein DNA adduct 8R/S-3-(2'-deoxyribos-1'-yl)-5,6,7,8-tetrahydro-8-hydroxypyrimido[1,2-a]purine-10-(3H)-one (γ-OH-Acr-dGuo). The median value of this DNA adduct in the e-cigarette users was 179 fmol/µmol dGuo (range 5.0 - 793 fmol/µmol dGuo) while that for non-users was 21.0 fmol/µmol dGuo (range 5.0 - 539 fmol/µmol dGuo), P = 0.001. These results demonstrate for the first time that e-cigarette users have elevated levels of a carcinogen-DNA adduct in their oral cells.

Temporomandibular disorders cases with high-impact pain are more likely to experience short-term pain fluctuations.

Temporomandibular disorders (TMD) patients can present clinically significant jaw pain fluctuations which can be debilitating and lead to poor global health. The Graded Chronic Pain Scale evaluates pain-related disability and its dichotomous grading (high/low impact pain) can determine patient care pathways and in general high-impact pain patients have worse treatment outcomes. Individuals with low-impact TMD pain are thought to have better psychosocial functioning, more favorable disease course, and better ability to control pain, while individuals with high-impact pain can present with higher levels of physical and psychological symptoms. Thereby, there is reason to believe that individuals with low- and high-impact TMD pain could experience different pain trajectories over time. Our primary objective was to determine if short-term jaw pain fluctuations serve as a clinical marker for the impact status of TMD pain. To this end, we estimated the association between high/low impact pain status and jaw pain fluctuations over three visits (≤ 21-day-period) in 30 TMD cases. Secondarily, we measured the association between jaw pain intensity and pressure pain thresholds (PPT) over the face and hand, the latter measurements compared to matched pain-free controls (n = 17). Jaw pain fluctuations were more frequent among high-impact pain cases (n = 15) than low-impact pain cases (n = 15) (OR 5.5; 95% CI 1.2, 26.4; p value = 0.033). Jaw pain ratings were not associated with PPT ratings (p value > 0.220), suggesting different mechanisms for clinical versus experimental pain. Results from this proof-of-concept study suggest that targeted treatments to reduce short-term pain fluctuations in high-impact TMD pain is a potential strategy to achieve improved patient perception of clinical pain management outcomes.

Randomized trial of prophylactic antibiotics vs. placebo after midshaft-to-distal hypospadias repair: the PROPHY Study.

BACKGROUND: Use of prophylactic antibiotics after stented hypospadias repair is very common, but most research has not identified any clinical benefits of this practice. Only one study has found that postoperative prophylaxis reduces symptomatic urinary tract infections (UTIs). Data from the same trial suggested that prophylaxis may also reduce urethroplasty complications. No studies on this subject have been placebo-controlled. OBJECTIVE: We performed a randomized, double-blind, placebo-controlled study to evaluate the effect of postoperative prophylactic antibiotics on the incidence of infection or urethroplasty complications after stented repair of midshaft-to-distal hypospadias. STUDY DESIGN: Boys were eligible for this multicenter trial if they had a primary, single-stage repair of mid-to-distal hypospadias with placement of an open-drainage urethral stent for an intended duration of 5-10 days. Participants were randomized in a double-blind fashion to receive oral trimethoprim-sulfamethoxazole or placebo twice daily for 10 days postoperatively. The primary outcome was a composite of symptomatic UTI, surgical site infection (SSI), and urethroplasty complications, including urethrocutaneous fistula, meatal stenosis, and dehiscence. Secondary outcomes included each component of the primary outcome as well as acute adverse drug reactions (ADRs) and C. difficile colitis. RESULTS: Infection or urethroplasty complications occurred in 10 of 45 boys (22%) assigned to receive antibiotic prophylaxis as compared with 5 of 48 (10%) who received placebo (relative risk [RR], 2.1; 95% confidence interval [CI], 0.8 to 5.8; p = 0.16). There were no significant differences between groups in symptomatic UTIs, SSIs, or any urethroplasty complications. Mild ADRs occurred in 3 of 45 boys (7%) assigned to antibiotics as compared with 5 of 48 (10%) given placebo (RR, 0.6; 95% CI, 0.2 to 2.5; p = 0.72). There were no moderate-to-severe ADRs, and no patients developed C. difficile colitis. CONCLUSIONS: In this placebo-controlled trial of 93 patients, prophylactic antibiotics were not found to reduce infection or urethroplasty complications after stented mid-to-distal hypospadias repair. The study did not reach its desired sample size and was therefore underpowered to independently support a conclusion that prophylaxis is not beneficial. However, the result is consistent with most prior research on this subject. GOV IDENTIFIER: NCT02096159.