Practical notes on popular statistical tests in renal physiology.

Competent statistical analysis is essential to maintain rigor and reproducibility in physiological research. Unfortunately, the benefits offered by statistics are often negated by misuse or inadequate reporting of statistical methods. To address the need for improved quality of statistical analysis in papers, the American Physiological Society released guidelines for reporting statistics in journals published by the society. The guidelines reinforce high standards for the presentation of statistical data in physiology but focus on the conceptual challenges and, thus, may be of limited use to an unprepared reader. Experimental scientists working in the renal field may benefit from putting the existing guidelines in a practical context. This paper discusses the application of widespread hypothesis tests in a confirmatory study. We simulated pharmacological experiments assessing intracellular calcium in cultured renal cells and kidney function at the systemic level to review best practices for data analysis, graphical presentation, and reporting. Such experiments are ubiquitously used in renal physiology and could be easily translated to other practical applications to fit the reader's specific needs. We provide step-by-step guidelines for using the most common types of t tests and ANOVA and discuss typical mistakes associated with them. We also briefly consider normality tests, exclusion criteria, and identification of technical and experimental replicates. This review is supposed to help the reader analyze, illustrate, and report the findings correctly and will hopefully serve as a gauge for a level of design complexity when it might be time to consult a biostatistician.

A Pilot Study Examining the Effects of Ischemic Conditioning on Walking Capacity and Lower Extremity Muscle Performance in Patients with Claudication.

INTRODUCTION: This study investigated whether a novel therapy called ischemic conditioning (IC) improves walking capacity and lower extremity muscle performance in patients with peripheral vascular disease who experience intermittent claudication. METHODS: Forty-three patients with claudication were enrolled and received either IC or IC Sham for 2 weeks in this randomized, controlled, double-blinded, prospective study. IC sessions involved five cycles of alternating 5-min inflations of a blood pressure cuff to 225 mm Hg (25 mm Hg for IC Sham) and 5-min deflations, around the thigh of the affected lower extremity. RESULTS: There was no difference in the change in claudication onset time (Δ = 114 ± 212 s IC vs. 104 ± 173 s IC Sham; p = 0.67) or peak walking time (Δ = 42 ± 139 s IC vs. 12 ± 148 s IC Sham; p = 0.35) between the IC and IC Sham groups. At the level of the knee, participants in the IC group performed more work (Δ = 3,029 ± 4,999 J IC vs. 345 ± 2,863 J IC Sham; p = 0.03) and displayed a greater time to muscle fatigue (Δ = 147 ± 221 s IC vs. -27 ± 236 s IC Sham; p = 0.01). DISCUSSION/CONCLUSION: In patients with claudication, IC improved total work performed and time to fatigue at the knee but did not change walking parameters.

Association Between Nonsurgical Weight Loss From Body Mass Index >40 to Body Mass Index <40 and Complications and Readmissions Following Total Hip Arthroplasty.

BACKGROUND: Elevated body mass index (BMI) is a risk factor for adverse outcomes following total hip arthroplasty (THA). It is unknown if preoperative weight loss to a BMI <40 kg/m2 is associated with reduced risk of adverse outcomes. METHODS: We retrospectively reviewed elective, primary THA performed at an academic center from 2015 to 2019. Patients were split into groups based on their BMI trajectory prior to THA: BMI consistently <40 ("BMI <40"); BMI >40 at the time of surgery ("BMI >40"); and BMI >40 within 2 years preoperatively, but <40 at the time of surgery ("Weight Loss"). Length of stay (LOS), 30-day readmissions, and complications as defined by Centers for Medicare and Medicaid Services were compared between groups using parsimonious regression models and Fisher's exact testing. Adjusted analyses controlled for sex, age, and American Society of Anesthesiologists class. RESULTS: In total, 1589 patients were included (BMI <40: 1387, BMI >40: 96, Weight Loss: 106). The rate of complications in each group was 3.5%, 6.3%, and 8.5% and the rate of 30-day readmissions was 3.0%, 4.2%, and 7.5%, respectively. Compared to the BMI <40 group, the weight loss group had a significantly higher risk of 30-day readmission (odds ratio [OR] 2.70, 95% confidence interval [CI] 1.19-6.17, P = .02), higher risk of any complication (OR 2.47, 95% CI 1.09-5.59, P = .03), higher risk of mechanical complications (OR 3.07, 95% CI 1.14-8.25, P = .03), and longer median LOS (16% increase, P = .002). The BMI >40 group had increased median LOS (10% increase, P = .03), but no difference in readmission or complications (P > .05) compared to BMI <40. CONCLUSION: Weight loss from BMI >40 to BMI <40 prior to THA was associated with increased risk of readmission and complications compared to BMI <40, whereas BMI >40 was not. LEVEL OF EVIDENCE: Level III - Retrospective Cohort Study.

Non-parametric recurrent events analysis with BART and an application to the hospital admissions of patients with diabetes.

Much of survival analysis is concerned with absorbing events, i.e., subjects can only experience a single event such as mortality. This article is focused on non-absorbing or recurrent events, i.e., subjects are capable of experiencing multiple events. Recurrent events have been studied by many; however, most rely on the restrictive assumptions of linearity and proportionality. We propose a new method for analyzing recurrent events with Bayesian Additive Regression Trees (BART) avoiding such restrictive assumptions. We explore this new method via a motivating example of hospital admissions for diabetes patients and simulated data sets.

Abnormal hearing patterns are not associated with endothelium-dependent vasodilation and carotid intima-media thickness: The Framingham Heart Study.

INTRODUCTION: Prior data suggest associations between hearing loss, cardiovascular (CV) risk factors, and CV disease. Whether specific hearing loss patterns, including a strial pattern associated with inner ear vascular disease, are associated with systemic endothelial dysfunction and carotid intima-media thickness (IMT) remains unclear. METHODS: We evaluated participants without prevalent CVD in the Framingham Offspring Study who underwent formal audiogram testing and brachial and carotid artery ultrasounds. Audiograms were categorized as normal or as belonging to one of four abnormal patterns: cochlear-conductive, low-sloping, sensorineural, or strial. Endothelial function as measured by brachial artery flow-mediated dilation (FMDmm and FMD%). Internal and common intima-media thicknesses (icIMT and ccIMT, respectively) were compared between audiogram patterns. RESULTS: We studied 1672 participants (mean age 59 years, 57.6% women). The prevalence of each hearing pattern was as follows: 43.7% normal; 20.3% cochlear-conductive; 20.3% sensorineural; 7.7% low-sloping; and 8.0% strial. Strial pattern hearing loss was nearly twice as prevalent (p = 0.001) in those in the highest quartile of ccIMT and nearly 50% higher in those in the highest icIMT quartile (p = 0.04). There were no statistically significant differences between the prevalence of the strial pattern comparing the lowest quartiles of FMDmm and FMD% with the upper three quartiles. Age- and sex-adjusted linear regression models did not show significant associations between the vascular measures and hearing patterns. CONCLUSION: Abnormal hearing patterns were not significantly associated with impaired brachial FMD and increased carotid IMT after adjusting for age and sex effects, which may reflect age and sex-related distributional differences based on hearing loss pattern.

Mobilizing individual social capital resources for HIV care support: results of a pilot intervention in St. Petersburg, Russia.

Half of HIV-positive persons in Russia are on antiretroviral therapy (ART), and only 27% are virally suppressed. A feasibility pilot intervention to mobilize social capital resources for HIV care support was conducted in St. Petersburg. Out-of-care or ART-nonadherent HIV-positive persons (n = 24) attended a five-session intervention to increase access social capital resources (i.e., family, friends, or providers) to mobilize supports for entering care, initiating care, and adhering to ART. HIV care indicators were assessed at baseline, an immediate followup (FU-1), and 6-month followup (FU-2) points. At FU-1, participants more frequently discussed their care experiences with others, verifying the intervention's mechanism of action. Participants increased in scales of medication taking adherence (p = 0.002, FU-1; p = 0.011, FU-2), self-efficacy (p = 0.042; FU-1), and outcome expectancies (p = 0.016, FU-2). Among persons not on ART, HIV Medication Readiness scale scores increased at FU-1 (p = 0.032) but became attenuated at FU-2. Participants tended to more frequently keep care appointments (79%, baseline to 90%, FU-1, p = 0.077); to have undetectable viral load (54%, baseline to 74%, FU-2; p = 0.063); and to have fewer past-month days with delayed or incomplete medication doses (7.8, baseline to 4.2, FU-1; p = 0.084). This novel social capital intervention is promising for improving HIV care-related outcomes and warrants a full-scale evaluation.

Risk Factors for Prolonged Symptoms of Mild Traumatic Brain Injury: A Pediatric Sports Concussion Clinic Cohort.

OBJECTIVE: To examine predictors of prolonged symptom duration from mild traumatic brain injury (mTBI) in a pediatric sports medicine specialty clinic cohort as these predictors may be distinct in this population. DESIGN: Retrospective chart review. SETTING: Outpatient specialty clinic. PATIENTS: Charts of 549 patients (age range: 10-18 years) with concussions were reviewed in an outpatient clinic that predominantly managed sports-related injuries (77.3%). Patients (n = 431) included in the final analysis met the criteria for mTBI and were symptomatic at their first visit. ASSESSMENT OF RISK FACTORS: Patient history, injury, and recovery variables were evaluated. MAIN OUTCOME MEASURES: Predictors of prolonged time to reach self-reported symptom recovery were evaluated using Cox proportional hazards. RESULTS: Median time to symptom recovery of the 431 patients who presented to clinic with symptoms was 40 days (full clinic sample median = 34 days). Analyses identified 3 unique predictors of symptom recovery: loss of consciousness (LOC) [hazard ratio (HR) = 0.56, P < 0.0001], female sex (HR = 0.57, P < 0.0001), and concussion symptom score at first clinic visit (HR = 0.76, P < 0.0001). CONCLUSIONS: Prolonged duration of mTBI symptoms in patients who present to a pediatric sports-based concussion clinic is related to initial symptom severity, female sex, and LOC.

The Health and Sociocultural Correlates of AIDS Genocidal Beliefs and Medical Mistrust Among African American MSM.

This study examined social and health-related correlates of AIDS conspiracy theories among 464 African American men who have sex with men (MSM). Exploratory factor analysis revealed two subscales within the AIDS conspiracy beliefs scale: medical mistrust and AIDS genocidal beliefs. Multiple regression analyses revealed medical mistrust and AIDS genocidal beliefs were both associated negative condom use attitudes and higher levels of internalized homonegativity. Medical mistrust was also associated with lower knowledge of HIV risk reduction strategies. Finally, we conducted bivariate regressions to examine the subsample of participants who reported being HIV-positive and currently taking HIV antiretroviral therapy (ART) to test associations between sexual behavior and HIV treatment and AIDS conspiracy theories. Among this subsample, medical mistrust was associated with having a detectable viral load and not disclosing HIV-status to all partners in the previous 3 months. Collectively, these findings have implications for HIV prevention and treatment for African American MSM.

Predictors of HIV Care Engagement, Antiretroviral Medication Adherence, and Viral Suppression Among People Living with HIV Infection in St. Petersburg, Russia.

Over 1 million HIV infections have been diagnosed in Russia, and HIV care uptake and viral suppression are very low. 241 HIV-positive individuals in St. Petersburg were enrolled through social networks, provided blood for viral load testing, and completed measures of medication-taking adherence, readiness, and self-efficacy; psychosocial well-being; and substance use. Outcomes included attending an HIV care appointment in the past 6 months, >90% ART adherence, and undetectable viral load. 26% of participants had no recent care appointment, 18% had suboptimal adherence, and 56% had detectable viral load. Alcohol use consistently predicted all adverse health outcomes. Having no recent care visit was additionally associated with being single and greater past-month drug injection frequency. Poor adherence was additionally predicted by lower medication-taking self-efficacy and lower anxiety. Detectable viral load was additionally related to younger age. Comprehensive interventions to improve HIV care in Russia must address substance abuse, anxiety, and medication-taking self-efficacy.

Correlates of Sexual HIV Risk Among African American Men Who Have Sex With Men.

OBJECTIVES: We examined correlates of condomless anal intercourse with nonmain sexual partners among African American men who have sex with men (MSM). METHODS: We recruited social networks composed of 445 Black MSM from 2012 to 2014 in Milwaukee, Wisconsin; Cleveland, Ohio; and Miami Beach, Florida. Participants reported past-3-month sexual behavior, substance use, and background, psychosocial, and HIV-related characteristics. RESULTS: Condomless anal intercourse outside main concordant partnerships, reported by 34.4% of MSM, was less likely in the case of no alcohol and marijuana use in the past 30 days, and higher risk-reduction behavioral intentions. High frequency of condomless anal intercourse acts with nonmain partners was associated with high gay community participation, weak risk-reduction intentions, safer sex not being perceived as a peer norm, low condom-use self-efficacy, and longer time since most recent HIV testing. CONCLUSIONS: Condomless anal intercourse with nonmain partners among Black MSM was primarily associated with gay community participation, alcohol and marijuana use, and risk-reduction behavioral intentions.

Prevalence of lateral epicondylosis in veteran manual wheelchair users participating in adaptive sports.

Objective: Determine the prevalence of lateral epicondylosis (LE) of the dominant elbow in manual wheelchair users based on ultrasound assessment and physical exam.Design: Prospective, cross-sectional.Setting: National Veteran Wheelchair Games 2018 and 2019 (event medical services).Participants: Manual wheelchair users who attended the National Veteran Wheelchair Games (n = 87).Interventions: Participants completed a questionnaire then underwent an ultrasound assessment and a physical exam of their dominant arm evaluating for common extensor tendinopathy (CET) or clinically LE.Main Outcome Measure: Prevalence of CET diagnosed by ultrasound criteria was compared with other diagnostic criteria with MaNemar test for paired binary data.Results: Forty-six percent (N = 40) of participants met diagnostic criteria for CET by ultrasound assessment and 17% (N = 15) of participants met criteria for LE based on physical exam. These values are dramatically higher than what has been reported in the able-bodied population where the prevalence is estimated to be <2%. Age and number of years of wheelchair use were significant predictors of ultrasound diagnosis of LE (P = 0.02, 95% confidence interval [CI] 1.01-1.11) and (P = 0.05, 95% CI 1.00-1.09), respectively. Association analysis based on odds ratio and CI found no association between ultrasound findings suggestive of LE with regular adaptive sport participation greater than 1.5 h per week.Conclusion: Compared to able-bodied population, there is an increased prevalence of both CET and LE in manual wheelchair users based on either ultrasound assessment or physical exam. CET is associated with increased age and increased years using a manual wheelchair. There is no association between the diagnosis of LE and participation in adaptive sport.

People Living With HIV in St. Petersburg, Russia: Gender and Exposure Group Differences in HIV Care Engagement, Psychosocial Health, Substance Use, and Transmission Risk Behavior.

This study examined psychosocial and health needs of persons living with HIV (PLWH) in Russia. The study combined baseline datasets from two social network samples of PLWH in St. Petersburg (N = 872). Samples were recruited between 2014 and 2018 by enrolling a PLWH seed who was either out-of-care or treatment nonadherent as well as network members surrounding each seed, assessing each participant's HIV care, transmission risk, substance use, and mental health characteristics. Almost one-quarter of participants said they were never offered antiretroviral therapy (ART), and-among those offered ART-one-quarter refused or discontinued therapy and 45% were <95% ART-adherent. Almost half of participants had detectable viral load, and many reported continued condomless intercourse with potentially nonconcordant serostatus partners or needle sharing. Over 46% of participants had elevated scores on measures of depression, hopelessness, state anxiety, or poor social support. Study findings illustrate unmet needs of PLWH in Russia.

Pain relief following genicular nerve radiofrequency ablation: does knee compartment matter?

Aim: To investigate the effect of knee osteoarthritis (OA) compartment location on pain relief following genicular radiofrequency ablation. Materials & methods: A retrospective chart review was performed on 62 patients. Visual analog scale scores at 3 and 6 months post procedure were compared with baseline and between compartment groups. Results: Pain significantly improved for all patients at 3 and 6 months (p < 0.001 and p = 0.005, respectively). Medial compartment OA was a significant predictor of improvement at 3 months (p = 0.042). Patellofemoral compartment OA was a significant predictor for a higher visual analog scale at 3 months (p = 0.018). Conclusion: Compartmental location of knee OA impacts pain relief following genicular radiofrequency ablation. Future protocols could target nerves based on which compartments are more affected on imaging.

Lay abstract Aim: To investigate the effect of knee arthritis location on pain relief following planned nerve disruption using radiofrequency ablation (RFA). Materials & methods: This study analyzed existing records of 62 cases of patients who underwent an ablation procedure to the sensory nerves of the knee. On a scale from one to ten, pain after RFA at 3 and 6 months was compared with baseline and compared between arthritis location groups. Results: Pain decreased for all patients at 3 and 6 months. Inner knee arthritis was a predictor of pain improvement at 3 months. Arthritis of the kneecap was a predictor for worse pain at 3 months. Conclusion: Location of knee arthritis impacts pain relief following nerve disruption using RFA. Future protocols could target nerves based on arthritis location.

Validation of an Objective Assessment Tool for Tonsillectomy in Otolaryngology Resident Training.

OBJECTIVE: Create and validate an objective structured assessment of technical skills (OSATS) for otolaryngology residents learning how to perform a tonsillectomy. STUDY DESIGN: Multicenter prospective longitudinal validation study. METHODS: A multi-institutional study at six tertiary academic otolaryngology residency programs from July 2009 to May 2012. Using the modified Delphi technique, a panel of pediatric otolaryngologists created a tonsillectomy task-based checklist (TBC) for a tonsil OSATS using a 5-point Likert-type scale. Residents were assessed by pediatric otolaryngology staff at the time of surgery with the TBC and a global rating scale. Procedure time, patient age, number of previously performed tonsillectomies, and surgical technique were also collected. RESULTS: One hundred sixty-seven tonsil OSATS were completed for 38 residents, and competency was recorded for 99 (59.2%). Residents scored as competent had performed significantly more previous tonsillectomies than those deemed noncompetent, 44.4 ± 35.6 and 13.5 ± 11.6, respectively (P < .001). The mean overall score on the tonsil TBC was 4.0 ± 0.8 and 2.6 ± 1.0 for competent and noncompetent, respectively (P < .001). Higher number of tonsillectomies performed and mean tonsil TBC score significantly increased the likelihood of competency (P < .001). Each additional tonsillectomy performed increased the likelihood of achieving competency by 6.3% (P = .006, 95% confidence interval (CI): 1.330-1.110), and each 1.0 point increase in mean tonsil TBC score increased the likelihood of competency by a factor of 2.71 (P = .006, 95% CI:1.330-5.513). There is a 95% likelihood of competency at 48 tonsillectomies or a tonsil TBC score of 4.91. CONCLUSION: The tonsil OSATS is a valid and feasible instrument to assess resident competency with tonsillectomy and provides timely objective feedback. LEVEL OF EVIDENCE: 4. Laryngoscope, 131:E359-E366, 2021.

Comparing pain relief and functional improvement between methylprednisolone and dexamethasone lumbosacral transforaminal epidural steroid injections: a self-controlled study.

BACKGROUND: Previous studies have shown varying results between lumbosacral transforaminal epidural steroid injections (TFESIs) performed with particulate versus non-particulate corticosteroids. The purpose of this study was to investigate the difference in pain relief and functional improvement between particulate and non-particulate lumbosacral TFESIs in patients who had undergone both injections, sequentially. METHODS: This was a self-controlled, retrospective study of 20 patients who underwent both a methylprednisolone and a dexamethasone TFESI to the same vertebral level and side. Primary outcomes included pain relief according to the visual analogue scale (VAS) and functional improvement determined by a yes/no answer to questions regarding mobility and the activities of daily living. Post-injection data was recorded at 2, 3, and 6 months. RESULTS: A decrease in VAS scores of -3.4 ± 3.0 (mean ± standard deviation), -3.1 ± 3.1, and -2.8 ± 3.4 was seen for the methylprednisolone group at 2, 3, and 6 months, respectively. Similar decreases of -3.9 ± 3.5, -3.4 ± 2.8, and -2.3 ± 3.4 were seen in the dexamethasone group. There was no significant difference in pain relief at any point between the two medications. The percentage of subjects who reported improved function at 2, 3, and 6 months was 65%, 51%, and 41%, respectively, for the methylprednisolone group and 75%, 53%, and 42% for the dexamethasone group. CONCLUSIONS: These findings support the use of non-particulate corticosteroids for lumbosacral TFESIs in the context of documented safety concerns with particulate corticosteroids.

Two weeks of remote ischemic conditioning improves brachial artery flow mediated dilation in chronic stroke survivors.

Many stroke survivors have reduced cardiorespiratory fitness as a result of their stroke. Ischemic conditioning (IC) is a noninvasive, cost-effective, easy-to-administer intervention that can be performed at home and has been shown to improve both motor function in stroke survivors and vascular endothelial function in healthy individuals. In this study, we examined the effects of 2 wk of remote IC (RIC) on brachial artery flow mediated dilation (FMD) in chronic stroke survivors. We hypothesized that FMD would be improved following RIC compared with a sham RIC control group. This was a prospective, randomized, double-blinded, controlled study. Twenty-four chronic stroke survivors (>6 mo after stroke) were enrolled and randomized to receive either RIC or sham RIC on their affected thigh every other day for 2 wk. For the RIC group, a blood pressure cuff was inflated to 225 mmHg for 5 min, followed by 5 min of recovery, and repeated a total of five times per session. For the sham RIC group, the inflation pressure was 10 mmHg. Brachial artery FMD was assessed on the nonaffected arm at study enrollment and following the 2-wk intervention period. Nine men and fourteen women completed all study procedures. Brachial artery FMD increased from 5.4 ± 4.8 to 7.8 ± 4.4% (P = 0.030; n = 12) in the RIC group, while no significant change was observed in the sham RIC group (3.5 ± 3.9% pretreatment versus 2.4 ± 3.1% posttreatment; P = 0.281, n = 11). Two weeks of RIC increases brachial artery FMD in chronic stroke survivors.NEW & NOTEWORTHY In this study, we report that 2 wk of remote ischemic conditioning (RIC) improves brachial artery flow-mediated dilation in chronic stroke survivors. Because poor cardiovascular health puts stroke survivors at a heightened risk for recurrent stroke and other cardiovascular events, an intervention that is simple, cost-effective, and easy to perform like RIC holds promise as a means to improve cardiovascular health in this at-risk population.

Prevalence of Alcohol Use and Factors Associated With Problem Drinking in Social Networks of People Living With HIV Infection in St. Petersburg, Russia.

Russia has over 1.2 million HIV infections and Europe's highest HIV incidence. Although its HIV epidemic is intertwined with high alcohol consumption rates, the interaction between alcohol use and HIV care in Russia is understudied. Five hundred eighty-six HIV-positive persons were recruited using social network methods in St. Petersburg. Fifty-nine percent of males, and 45% of females, drank regularly. Thirty percent of alcohol users reported binge drinking (males: ≥ 5 drinks; females ≥ 4 drinks) in the past week. Alcohol use was associated with lower HIV care engagement and having a detectable viral load. Multivariate analyses showed that any alcohol consumption, number of alcohol drinks consumed, and having a binge drinking day in the past week were associated with male gender, use of illicit drugs, drug injection, smaller social network size, lower social supports, being unmarried, and reporting condomless intercourse with non-main partners. Interventions to improve HIV care in Russia must comprehensively address the use of alcohol and substances that interfere with care engagement.

Delayed lymphocyte re-population following discontinuation of dimethyl fumarate and after switching to other disease modifying drug therapies.

BACKGROUND: Dimethyl fumarate (DMF) reduces absolute lymphocyte counts, CD4, and CD8 counts, without significantly affecting total white blood cell counts. However, the recovery rate of these cells after discontinuation of DMF is unknown. The effect of subsequent disease modifying therapies (DMTs) on re-population rate is also unknown. OBJECTIVES: 1. To study the re-population rate of absolute lymphocytes, CD4, and CD8 counts back to baseline after discontinuation of DMF. 2. To measure the effect of subsequent DMTs on the re-population rate of these cells after DMF therapy. 3. To study the effect of the duration of exposure to DMF on repopulation of these cells. METHODS: A retrospective chart review of subjects who had discontinued DMF and in whom, CBC with differential, CD4 and CD8 counts were available at baseline, discontinuation and at follow-up (n = 113). Linear mixed models were used to analyze and assess linear trends in lymphocyte counts after DMF had been discontinued. RESULTS: DMF causes a significant drop in absolute lymphocyte, CD4, and CD8 counts. Re-population of these cells after discontinuation of DMF is significantly delayed, irrespective of whether or not a subsequent DMT is used, although there is a difference in re-population rate among DMTs. The re-population rate is also dependent on the duration of time patients have been exposed to DMF; longer exposure was associated with more delayed recovery. CONCLUSION: During this 30 month study period, re-population rates were significantly delayed post-DMF, irrespective of what subsequent DMT the patients received. Furthermore, no recovery of lymphocyte counts occurred in patients who were started on fingolimod or alemtuzumab after DMF was discontinued; in fact there was a continued decline in all of the cell populations studied.

Use of secondary clinical data for research related to diabetes self-management education.

BACKGROUND: Diabetes self-management education (DSME) is a key component of ensuring optimal diabetes outcomes. Electronic medical record (EMR) systems have transformed diabetes management by providing organized and useful data. However, important gaps remain in the process of how practice settings track referrals and attendance to DSME. PURPOSE: The purpose of this study was to use EMR data to examine patients' demographic, behavioral, and diabetes risk factors by referral pattern to a DSME program in a large midwestern Academic Medical Center. METHODS: A retrospective cross-sectional design using 2006-2013 EMR data from a Clinical Research Data Warehouse (CRDW). Data on 10,000 patients with type 2 diabetes mellitus (T2DM) were randomly extracted from the CRDW for analysis. Multiple logistic regression analysis was employed to explore adjusted associations with referral to DSME. RESULTS: Seven hundred forty patients with T2DM were referred to DSME. Results show that age at diagnosis, insurance status, race/ethnicity, language, alcohol use, use of insulin, HbA1c, LDL, systolic blood pressure, ophthalmology appointment, coronary artery disease, neuropathy, diabetic-retinopathy, and nephropathy were found to be factors significantly associated with a referral to DSME. Language emerged as a significant result; non-English speakers were more likely to receive a referral to DSME. CONCLUSIONS: Patients referred for DSME had appropriate medical complications or social needs that would benefit from intensive education; however, there remains a considerable opportunity for improving the DSME referral process. Aspects of the physician decision-making process to refer or not refer patients to DSME warrant further investigation.

Validation of a hand-held point of care device for lactate in adult and pediatric patients using traditional and locally-smoothed median and maximum absolute difference curves.

BACKGROUND: Lactate is commonly used in septic patients and is a viable biomarker for trauma patients. Its pre-hospital use could assist triaging and managing patients with these conditions. METHODS: We evaluated the analytical performance of the point-of-care (POC) StatStrip Xpress Lactate Meter (Nova Biomedical) and compared it to the ABL 800 (Radiometer). We measured lactate in 250 adult and 250 pediatric whole blood samples in 2 laboratories. The performance of the POC meter was assessed by traditional linear regression and Bland-Altman plots, and locally-smoothed (LS) median absolute difference and maximum absolute difference (MAD and MaxAD) curves. RESULTS: The StatStrip was linear with acceptable reproducibility at clinically relevant concentrations. Correlation with the ABL800 showed a negative bias for both populations with slope, bias ±SD (% bias) of 0.78, -0.4±0.7 (-14.5%) in children and 0.80-0.3±0.6 (-13.3%) in adults. The proportional bias appeared more significant at concentrations >4mmol/l (36.0mg/dl). The StatStrip misclassified 7.6 and 8.8% pediatric and adult samples, respectively, to lower risk categories defined using guidelines driven cut-offs. The LS MAD curves identified one breakout, concentration where the LS MAD exceeds the total allowable error limit of 0.3mmol/l (2.7mg/dl), at lactate concentrations of 3.8 and 3.2mmol/l (34.2 and 28.8mg/dl) in the pediatric and adult curves, respectively. Breakthroughs, points at which the LS MaxAD curve exceeds the 95th percentile of MaxADs, occur at concentrations above 7.5mmol/l (67.6mg/dl) for both populations where the performance of the POC meter became erratic. We concluded that if serial lactate measurements are performed, the same method should be used for baseline and follow up measurements. The LS MAD and LS MaxAD curves allowed visual and quantitative mapping of the performance of the lactate POC meter over the range of concentrations measured. CONCLUSIONS: This approach seems useful for the identification of points at which the performance of a POC meter differs significantly from a comparison method and thresholds of poor analytical performance.