Readability of Participant Informed Consent Forms and Informational Documents: From Phase 3 COVID-19 Vaccine Clinical Trials in the United States

ObjectiveTo assess the readability of the informed consent forms from the phase 3 COVID-19 vaccine trials conducted in the United States.Patients and MethodsEnglish consent forms were used for patients in phase 3 COVID-19 vaccine clinical trials. Consent forms were obtained in October 2020. Using Microsoft Word tools, we analyzed the readability (ie, the ease of reading) of written consent forms and informational documents from phase 3 COVID-19 vaccine clinical trials in the United States from the following manufacturers: AstraZeneca, Moderna, Pfizer, Johnson & Johnson, and Novavax.ResultsOwing to low readability and several format factors, this study determined that none of the consent forms or informational documents from the recent phase 3 COVID-19 vaccine clinical trials conducted in the United States met readability standards at the recommended 7th grade readability level for the average vaccine research volunteer in any readability category. The average English-speaking vaccine trial volunteer would have great difficulty comprehending the information provided in the consent forms and informational documents. To ensure that study subjects receive and fully comprehend information regarding a clinical study and can provide reliable consent, greater attention should be given to the development and use of simplified consent forms, multimedia formatting, personal discussion, and comprehension assessments.     

Artificial Intelligence Application in Graves Disease: Atrial Fibrillation,Heart Failure and Menstrual Changes

ObjectiveTo study the utility of artificial intelligence (AI)–enabled electrocardiograms (ECGs) in patients with Graves disease (GD) in identifying patients at high risk of atrial fibrillation (AF) and heart failure with reduced ejection fraction (HFrEF), and to study whether AI-ECG can reflect hormonal changes and the resulting menstrual changes in GD.Patients and MethodsPatients diagnosed with GD between January 1, 2009, and December 31, 2019, were included. We considered AF diagnosed at 30 days or fewer before or any time after GD and de novo HFrEF not explained by ischemia, valve disorder, or other cardiomyopathy at/after GD diagnosis. Electrocardiograms at/after index condition were excluded. A subset analysis included females younger than 45 years of age to study the association between ECG-derived female probability and menstrual changes (shorter, lighter, or newly irregular cycles).ResultsAmong 430 patients (mean age, 50±17 years; 337 (78.4%) female), independent risk factors for AF included ECG probability of AF (hazard ratio [HR], 1.5; 95% CI, 1.2 to 1.6 per 10%; P<.001), older age (HR, 1.05; 95% CI, 1.03 to 1.07 per year; P<.001), and overt hyperthyroidism (HR, 3.9; 95% CI, 1.2 to 12.7; P=.03). The C-statistic was 0.85 for the combined model. Among 495 patients (mean age, 52±17 years; 374 (75.6%) female), independent risk factors for HFrEF were ECG probability of low ejection fraction (HR, 1.4; 95% CI, 1.1 to 1.6 per 10%; P=.001) and presence of AF (HR, 8.3; 95% CI, 2.2 to 30.9; P=.002), and a C-statistic of 0.89 for the combined model. Lastly, of 72 females younger than 45 years, 30 had menstrual changes at time of GD and had a significantly lower AI ECG–derived female probability [median 77.3; (IQR 57.9 to 94.4)% vs. median 97.7 (IQR 92.4 to 99.5)%, P<.001].ConclusionAI-enabled ECG identifies patients at risk for GD-related AF and HFrEF and was associated with menstrual changes in women with GD.     

Effects of Virtual Reality and Task-Oriented Training on Hand Function and Activity Performance in Pediatric Hand Burns: A Randomized Controlled Trial

ObjectiveTo assess the efficacy of a motion-sensing, hands-free gaming device and task-oriented training (TOT) programs on improving hand function, activity performance, and satisfaction in pediatric hand burns.DesignA randomized controlled trial.SettingOutpatient rehabilitation center.ParticipantsFifty children with deep partial-thickness or full-thickness hand burns. (N=50; mean age, 10.70±1.64y; range, 7-14y)InterventionsChildren were randomized into 1 of the following 3 groups: the motion-sensing, hands-free gaming device group that used interactive video games plus traditional rehabilitation (TR); the TOT group that used real materials plus TR; and the control group that only received TR, all groups received the interventions 3 days per week for 8 weeks.Main Outcome MeasuresWe assessed the children at the baseline and after 8 weeks of intervention. The primary outcome measures were the Jebsen-Taylor Hand Function Test, Duruoz Hand Index (DHI), and Canadian Occupational Performance Measure (COPM). The secondary outcome measures were range of motion (ROM) of the digits, grip strength, and pinch strengths (tip, palmer, and lateral pinch).ResultsThere was a significant increase in all measurements of the motion-sensing, hands-free gaming device and TOT groups compared with that of the control group postintervention (P<.05). There was no significant change in Jebsen-Taylor Hand Function Test, COPM performance, ROM, grip strength, and tip and lateral pinch strengths between the motion-sensing, hands-free gaming device group and TOT group (P>.05), whereas there was a significant increase in DHI, COPM satisfaction, and palmer pinch strength (P<.05) in the motion-sensing, hands-free gaming device group compared with the TOT group postintervention.ConclusionsThe motion-sensing, hands-free gaming device and TOT programs resulted in significant improvement in hand function, activity performance and satisfaction, ROM of the digits, grip strength, and pinch strengths in pediatric hand burns compared with the traditional hand rehabilitation.     

Investigating Characteristics of Quality Peer Mentors With Spinal Cord Injury

ObjectiveTo identify characteristics (1) of high- and low-quality spinal cord injury (SCI) peer mentors; (2) that should be used to match SCI peer mentors and mentees.DesignThe study was conducted in partnership with three Canadian provincial SCI organizations using an integrated knowledge translation approach. The Delphi exercise was completed in three rounds. In Round 1, people with SCI completed a thought-listing exercise to identify characteristics of high- and low-quality peer mentors and for matching. In Rounds 2 and 3, people with SCI and community organization staff rated characteristics from the previous round on an 11-point scale. After the final round, the remaining characteristics were thematically analyzed.SettingCommunity-based peer mentorship programs in three Canadian provinces.ParticipantsPeople with SCI and SCI community organization staff (Round 1, n=45; Round 2, n=27; Round 3, n=25).InterventionsNot applicable.Main Outcome MeasuresConsensus-based list of characteristics.ResultsParticipants reached consensus on 215 characteristics of quality peer mentors and 11 characteristics for peer mentor-mentee matching (ICC=0.96). A consensus-based characterization of high- and low-quality peer mentorship was created and included six overarching themes: competencies, personality characteristics, emotional state, mentor outlook, reason for mentoring, and role model.ConclusionA consensus-based characterization of quality peer mentorship was co-developed with input from over 50 members of the SCI community. Findings highlight that peers have both interpersonal and intrapersonal characteristics that contribute to quality mentorship. The findings highlighted the importance of matching mentors on lived experience and shared interests. Findings will inform future research and SCI peer mentorship programs.     

Machine Learning Techniques Differentiate Alcohol-Associated Hepatitis From Acute Cholangitis in Patients With Systemic Inflammation and Elevated Liver Enzymes

ObjectiveTo develop machine learning algorithms (MLAs) that can differentiate patients with acute cholangitis (AC) and alcohol-associated hepatitis (AH) using simple laboratory variables.MethodsA study was conducted of 459 adult patients admitted to Mayo Clinic, Rochester, with AH (n=265) or AC (n=194) from January 1, 2010, to December 31, 2019. Ten laboratory variables (white blood cell count, hemoglobin, mean corpuscular volume, platelet count, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, direct bilirubin, albumin) were collected as input variables. Eight supervised MLAs (decision tree, naive Bayes, logistic regression, k-nearest neighbor, support vector machine, artificial neural networks, random forest, gradient boosting) were trained and tested for classification of AC vs AH. External validation was performed with patients with AC (n=213) and AH (n=92) from the MIMIC-III database. A feature selection strategy was used to choose the best 5-variable combination. There were 143 physicians who took an online quiz to distinguish AC from AH using the same 10 laboratory variables alone.ResultsThe MLAs demonstrated excellent performances with accuracies up to 0.932 and area under the curve (AUC) up to 0.986. In external validation, the MLAs showed comparable accuracy up to 0.909 and AUC up to 0.970. Feature selection in terms of information-theoretic measures was effective, and the choice of the best 5-variable subset produced high performance with an AUC up to 0.994. Physicians did worse, with mean accuracy of 0.790.ConclusionUsing a few routine laboratory variables, MLAs can differentiate patients with AC and AH and may serve valuable adjunctive roles in cases of diagnostic uncertainty.     

Redevelopment after spontaneous sputum conversion in noncavitary nodular bronchiectatic Mycobacterium avium complex lung disease

BackgroundAlthough spontaneous sputum conversion can occur in noncavitary nodular bronchiectatic (NC-NB) Mycobacterium avium complex lung disease (MAC-LD), little is known about redevelopment after spontaneous conversion. We investigated the redevelopment phenomenon after spontaneous sputum conversion in patients with NC-NB MAC-LD.Material and methodsAmong patients diagnosed with NC-NB MAC-LD between 2000 and 2013, 140 patients who experienced spontaneous sputum conversion, and whose follow-up duration after conversion was ≥6 months, were enrolled at a tertiary referral center in South Korea. Their medical records were retrospectively reviewed.ResultsOf the 140 patients, 34 (24.3%) underwent redevelopment during the median follow-up period of 71.0 months (interquartile range [IQR], 58.8–87.5). Redevelopment occurred at a median interval of 25.0 months (IQR, 11.5–41.8) after spontaneous sputum conversion. The mean age of the 34 patients with redevelopment was 63.6 years, and 73.5% were women. No statistically significant differences in clinical characteristics were noted between the 34 patients with redevelopment and those with persistent conversion. Among the 34 patients with redevelopment, 6 received treatment at a median interval of 8 months (IQR, 1.5–16.8) after redevelopment. No significant differences in clinical characteristics were noted between the six treated and 28 untreated patients.ConclusionAt least approximately 24% of patients with spontaneous sputum conversion in NC-NB MAC-LD had redevelopment, and a portion of them required treatment. These findings suggest that long-term follow-up is necessary for patients with NC-NB MAC-LD, even those who experience spontaneous sputum conversion.     

Factors associated with acid-fast bacillus isolation in patients with noncystic fibrosis bronchiectasis: A cross-sectional study

IntroductionAcid-fast bacillus (AFB) is a major pathogen that causes noncystic fibrosis bronchiectasis requiring multidrug chemotherapy. Bronchoscopic bronchial wash is performed to determine the causative pathogens of bronchiectasis; but, predictive factors for AFB isolation have not been fully elucidated. This study aimed to determine the factors associated with AFB isolation from bronchial wash samples.MethodsThis was a single-center, cross-sectional study. Patients undergoing bronchoscopic bronchial wash for bronchiectasis were included, whereas those who did not undergo high-resolution computed tomography (HRCT); had acute pneumonia, interstitial lung disease, and a positive polymerase chain reaction result but a negative culture result for AFB; or in whom a guide sheath was used for suspected lung cancer were excluded. Binomial logistic regression was used to analyze the factors associated with a positive culture for AFB.ResultsOf the 96 included cases, AFB isolation was observed in the bronchial wash fluid of 26 patients (27%). No smoking history, a positive result for antiglycopeptidolipid (GPL)-core IgA antibody, and the presence of tree-in-bud appearance, multiple granular and nodular images on HRCT were more commonly observed in patients with AFB isolation than in those without. In the multivariate analysis, the tree-in-bud appearance (odds ratio, 4.223; 95% CI, 1.046–17.052) and anti-GPL core IgA antibody (odds ratio, 9.443; 95% CI, 2.206–40.421) were significantly associated with AFB isolation.ConclusionsThe tree-in-bud appearance on HRCT is likely to predict AFB isolation independent of anti-GPL core IgA antibody results. Bronchoscopic bronchial wash should be recommended for bronchiectasis with multiple granulomas on HRCT.     

Validation of Upper Extremity Motor Function as a Key Predictor of Bladder Management After Spinal Cord Injury

ObjectiveTo validate if better upper extremity (UE) motor function predicts clean intermittent catheterization (CIC) adoption and adherence after spinal cord injury (SCI) using a validated instrument (as opposed to prior research using scales based on expert opinion).DesignWe examined data from the Neurogenic Bladder Research Group SCI registry, a multicenter, prospective, observational study assessing persons with neurogenic bladder following SCI. All participants who were unable to volitionally void and were >1 year post injury were included. Participants were dichotomized into those performing CIC vs those using other bladder management methods. In addition to demographic and clinical characteristics, UE motor function was examined using the SCI-Fine Motor Function Index using validated categorization levels: (1) no activities requiring hand function, (2) some activities involving gross hand movement, (3) some activities requiring dexterity or coordinated UE movement, or (4) most activities requiring dexterity and coordinated UE movement. Associations were examined using logistic regression.SettingMulticenter study.ParticipantsRegistry participants unable to volitionally void after SCI (N=1236).InterventionNot applicable.Main Outcome MeasureUpper extremity motor function association with CIC.ResultsA total of 1326 individuals met inclusion criteria (66% performing CIC, 60% male, and 82% white). On multivariate analysis, better UE motor function was associated with a statistically increased odds of performing CIC (odds ratio, 3.10 [Level 3] and odds ratio, 8.12 [Level 4] vs Levels 1 and 2 [P<.001]).ConclusionIn persons with SCI who are unable to volitionally void, UE motor function is highly associated with CIC. These results validate prior findings and continue to suggest that following SCI, the degree of preserved UE motor function is associated with CIC more than any other factor.     

Cardiometabolic Health Outcomes Associated With Discordant Visceral and Liver Fat Phenotypes: Insights From the Dallas Heart Study and UK Biobank

ObjectiveTo evaluate the cardiometabolic outcomes associated with discordant visceral adipose tissue (VAT) and liver fat (LF) phenotypes in 2 cohorts.Patients and MethodsParticipants in the Dallas Heart Study underwent baseline imaging from January 1, 2000, through December 31, 2002, and were followed for incident cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM) through 2013. Associations between VAT-LF groups (low-low, high-low, low-high, and high-high) and outcomes were assessed using multivariable-adjusted regression and were replicated in the independent UK Biobank.ResultsThe Dallas Heart Study included 2064 participants (mean ± SD age, 44±9 years; 54% female; 47% black). High VAT–high LF and high VAT–low LF were associated with prevalent atherosclerosis, whereas low VAT–high LF was not. Of 1731 participants without CVD/T2DM, 128 (7.4%) developed CVD and 95 (5.5%) T2DM over a median of 12 years. High VAT–high LF and high VAT–low LF were associated with increased risk of CVD (hazard ratios [HRs], 2.0 [95% CI, 1.3 to 3.2] and 2.4 [95% CI, 1.4 to 4.1], respectively) and T2DM (odds ratios [ORs], 7.8 [95% CI, 3.8 to 15.8] and 3.3 [95% CI, 1.4 to 7.8], respectively), whereas low VAT–high LF was associated with T2DM (OR, 2.7 [95% CI, 1.1 to 6.7]). In the UK Biobank (N=22,354; April 2014-May 2020), only high VAT–low LF remained associated with CVD after multivariable adjustment for age and body mass index (HR, 1.5 [95% CI, 1.2 to 1.9]).ConclusionAlthough VAT and LF are each associated with cardiometabolic risk, these observations demonstrate the importance of separating their cardiometabolic implications when there is presence or absence of either or both in an individual.     

A Target Antigen–Based Approach to the Classification of Membranous Nephropathy

ObjectiveTo describe the clinical and pathological phenotype of membranous nephropathy (MN) associated with M-type-phospholipase–A₂-receptor (PLA₂R), thrombospondin-type-1-domain-containing-7A (THSD7A), semaphorin 3B (SEMA3B), neural-epidermal-growth-factor-like-1-protein (NELL-1), protocadherin 7 (PCDH7), exostosin 1/exostosin 2 (EXT1/EXT2) and neural cell adhesion molecule 1 (NCAM-1) as target antigens.MethodsA retrospective cohort of 270 adult patients with biopsy-proven MN diagnosed between January 2015 and April 2020 was classified as PLA₂R-, THSD7A-, SEMA3B-, NELL-1–, PCDH7-, EXT1/EXT2-, NCAM-1–associated or septuple-negative MN using serologic tests, immunostaining, and/or mass spectrometry. Clinical, biochemical, pathologic, and follow-up data were systematically abstracted from the medical records, including disease activity of conditions traditionally associated with MN and occurring within 5 years of MN diagnosis.ResultsPatients with PLA₂R-associated MN were predominantly middle-aged white men without associated disease. The presence of associated disease did not affect the clinical and pathologic characteristics of PLA₂R-associated MN, suggesting that they were coincidental rather than causally linked. THSD7A-, NELL-1–, PCDH7-, and NCAM-1–associated MN were rare and SEMA3B-associated MN was not discovered in our cohort. EXT1/EXT2-associated MN was primarily diagnosed in younger women with active systemic autoimmunity. A significant proportion of septuple-negative patients had associated malignancy or systemic autoimmunity.ConclusionThe widely used distinction between primary and secondary MN has limitations. We propose a refined terminology that combines the target antigen and associated disease to better classify MN and guide clinical decision making.     

Health Care Provider Characteristics Associated With Colorectal Cancer Screening Preferences and Use

ObjectiveTo assess health care provider (HCP) preferences related to colorectal cancer (CRC) screening overall, and by HCP and patient characteristics.Participants and MethodsWe developed a survey based on the Theoretical Domains Framework to assess factors associated with CRC screening preferences in clinical practice. The survey was administered online November 6 through December 6, 2019, to a validated panel of HCPs drawn from US national databases and professional organizations. The final analysis sample included 779 primary care clinicians (PCCs) and 159 gastroenterologists (GIs).ResultsHCPs chose colonoscopy as their preferred screening method for average-risk patients (96.9% (154/159) for GIs, 75.7% (590/779) for PCCs). Among PCCs, 12.2% (95/779) preferred multi-target stool DNA (mt-sDNA), followed by fecal immunochemical test (FIT), (7.3%; 57/779) and guaiac-based fecal occult blood test (gFOBT) (4.8%; 37/779). Preference among PCCs and GIs generally shifted toward noninvasive screening options for patients who were unable to undergo invasive procedures; concerned about taking time from work; unconvinced about need for screening; and refusing other screening recommendations. Among PCCs, preference for mt-sDNA over FIT and gFOBT was less frequent in larger compared with smaller clinical practices. Additionally, preference for mt-sDNA over FIT was more likely among PCCs with more years of clinical experience, higher patient volumes (> 25/day), and practice locations in suburban and rural settings (compared to urban).ConclusionBoth PCCs and GIs preferred colonoscopy for CRC screening of average-risk patients, although PCCs did so less frequently and with approximately a quarter preferring stool-based tests (particularly mt-sDNA). PCCs’ preference varied by provider and patient characteristics. Our findings underscore the importance of informed choice and shared decision-making about CRC screening options.     

Polyhexamethylene biguanide discs versus unmedicated dressings for prevention of central venous catheter–associated infection in the intensive care unit: A pilot randomised controlled trial to assess protocol safety and feasibility

BackgroundCentral venous catheters are prone to infectious complications, affecting morbidity, mortality and healthcare costs. Polyhexamethylene biguanide-impregnated discs at the catheter insertion site may prevent local and bloodstream infection; however, efficacy has not been established in a critical care setting.ObjectiveThe objective of this study was to pilot test polyhexamethylene biguanide–impregnated discs compared to standard unmedicated dressings for central venous catheter infection prevention in critically ill patients.MethodsThis was a single-centre pilot randomised controlled trial. Adults admitted to intensive care requiring a central venous catheter for >72 h were eligible. Patients with a current bloodstream infection, concurrent central venous catheter, chlorhexidine or polyhexamethylene biguanide allergy, or sensitive skin were excluded. Patients were randomised to receive standard central venous catheter dressings with/without polyhexamethylene biguanide discs.Outcome measuresThe primary outcome was feasibility, defined by patient eligibility, recruitment, retention, protocol adherence, missing data, and staff satisfaction. Secondary outcomes included: central line–associated infection; primary bloodstream infection; local infection; skin complications; device/dressing dwell time; serious adverse events, and cost-effectiveness.ResultsOf 309 patients screened, 80 participants were recruited with 98% (n = 78) receiving an internal jugular catheter which dwelled for a median of 5 days (interquartile range = 4.0, 6.0). Feasibility criteria were predominantly met (recruitment 88%; retention 100%; protocol fidelity 91%); however, eligibility criteria were not met (32%; most commonly owing to short predicted catheter dwell). Staff acceptability criteria were met, with 83% of staff scoring dressing application and removal ≥7 on a numerical rating scale. There were no central line–associated bloodstream infections and no local infections. Insertion site itch occurred in 4% (control [n = 0], intervention [n = 3]) of participants, while 32% (24/76) reported pain, and 46% (35/76) tenderness.ConclusionsPolyhexamethylene biguanide discs appear safe for central venous catheter infection prevention. Feasibility of a large efficacy trial was established with some modifications to screening processes. Large, adequately powered randomised controlled trials are needed to test the infection prevention hypotheses.     

Fecal Microbiota Transplantation for Recurrent C difficile Infection During the COVID-19 Pandemic: Experience and Recommendations

ObjectiveTo report experience with fecal microbiota transplantation (FMT) for recurrent Clostridioides difficile infection (rCDI) and provide recommendations for management of rCDI and donor testing during the COVID-19 pandemic.MethodsA retrospective study of patients with rCDI who underwent FMT from May 26, 2020, to September 30, 2020, with stool from well-screened donors with health and infectious screening and a newly implemented strategy for COVID-19 screening with every 2-week bookend testing with stool quarantine. Patients were followed up for development of rCDI and COVID-19.ResultsOf the 57 patients who underwent FMT for rCDI, 29 were tested for COVID-19 via nasopharyngeal polymerase chain reaction (PCR) and 22 via serology. All results were negative, except for 1 positive serology. Donor testing every 2 weeks for COVID-19 via serology and nasopharyngeal swab PCR was negative, except for 2 donors at 1 center who were excluded. Three patients had rCDI after FMT, and 1 underwent repeat FMT. One patient developed respiratory symptoms suggestive of COVID-19 and tested negative via nasopharyngeal PCR. Eleven patients who underwent COVID-19 testing for elective procedures or hospitalizations tested negative. No SARS-CoV-2 transmission was noted.ConclusionsWith appropriate donor screening, FMT can be performed safely for rCDI during the COVID-19 pandemic. Development of a validated stool assay for SARS-CoV-2 will simplify this process further.     

Mechanism of action of yoga on prevention and management of type 2 diabetes mellitus: Narrative review

BackgroundResearch in India has recognized Type 2 Diabetes Mellitus (t2dm) and prediabetes (pdm) as psychosomatic metabolic endocrine disorders characterized by glycemic disharmony. This review aimed at collating information from published e-papers on mechanism of action (MOA) of yoga therapy(YT) and integrated approach of yoga therapy (IAYT) on pdm and t2dm.MethodContent on YT and the MOA on prevention and management of t2dm were extracted from online sources such as PubMed, Google Scholar, Cochrane library and Library genesis. This review included 58 articles related to prediabetes, t2dm, pre-diabetes to t2dm conversion, mechanism of action of Yoga, Yoga and t2dm, prediabetes and yoga. Articles related to type 1 diabetes, diabetes insipidus and gestational diabetes were excluded.ResultCurrent scientific review resulted in understanding the different mechanisms involved in rejuvenating effect of Yoga as YT and IAYT in prediabetes and t2dm. However, the various mechanisms by which the interventions work are understood either through a single or combined impact on regaining autonomic balance, vagal modulation, regulation of hormones and thereby attaining glycemic control. Moreover, these mechanisms are the forthcomings of the cross talk between brain, mind and body systems under branches of neurophysiology, neuroendocrinology, psychophysiology, psycho neuroendocrinology and/or neuropsychology.ConclusionEvidence sought from published research works proclaim YT based life style modification for prevention and management of t2dm. Summing up, the effect is stipulated based on the approach, method of practice, time of the day, belief and dedication of the practitioners.     

Retrospective evaluation of appropriate dosing of cefmetazole for invasive urinary tract infection due to extended-spectrum β-lactamase-producing Escherichia coli

IntroductionThe frequency of urinary tract infections (UTIs) caused by extended-spectrum β-lactamase (ESBL)-producing Enterobacterales is steadily increasing worldwide. Therefore, we aimed to evaluate the efficacy and appropriate dosing of cefmetazole (CMZ) in invasive urinary tract infection (iUTI) caused by ESBL-producing Escherichia coli (ESBLEC).MethodsPatients who developed ESBLEC iUTI and received CMZ between January 2007 and December 2018 were identified, and their medical records were reviewed. The time above minimum inhibitory concentration (MIC) (TAM) was calculated using the MIC value obtained from each patient and its simulated CMZ concentration.ResultsThirty-nine patients were included in the study. The median TAM was 92.6% (interquartile range [IQR], 67.6–100). CMZ was clinically efficacious in 38 (97.4%) patients overall and in 11 out of 12 (91.7%) patients with normal renal function who received CMZ at 1 g every 8 h.ConclusionsIn normal renal function, 1 g CMZ infused for over 1 h every 8 h is an efficacious treatment for iUTI caused by ESBLEC with MIC =< 4 mg/L.     

Noninvasive Voice Biomarker Is Associated With Incident Coronary Artery Disease Events at Follow-up

ObjectiveTo evaluate the association between a preidentified voice biomarker and incident coronary artery disease (CAD) events.MethodsPatients referred for clinically indicated coronary angiography underwent a total of three 30-second voice recordings using the Vocalis Health smartphone application between January 1, 2015, and February 28, 2017. A pre-established voice biomarker was derived from each individual recording, and the mean biomarker value was calculated for each patient. Individuals were clinically observed through December 31, 2019. The prespecified primary outcome was a composite of presenting to the emergency department with chest pain, being admitted to the hospital with chest pain, or having an acute coronary syndrome; the prespecified secondary outcome was a composite of a positive stress test result at follow-up or the presence of CAD at follow-up coronary angiography.ResultsIn the final analysis, 108 patients were included (mean age, 59.47±11.44 years; male, 59 [54.6%]). The median follow-up time was 24 months (range, 1 to 60 months). In multivariable Cox proportional hazards models adjusting for CAD grade on baseline angiography, a high baseline mean voice biomarker was significantly associated with both the primary (hazard ratio, 2.61; 95% CI, 1.42 to 4.80; P=.002) and secondary (hazard ratio, 3.13; 95% CI, 1.13 to 8.68; P=.03) composite outcomes.ConclusionThis study found a significant association between a noninvasive voice biomarker and incident CAD events at follow-up. These results may have important clinical implications for the remote and noninvasive screening of patients to identify those at risk of coronary disease and its complications.