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Hospital-acquired infections pose significant costly global challenges to patient care. Rapid and sensitive methods to identify potential outbreaks are integral to infection control measures. Whole-genome sequencing (WGS)-based bacterial strain typing provides higher discriminatory power over standard nucleotide banding pattern-based methods such as repetitive sequence-based PCR (rep-PCR). However, integration of WGS into clinical epidemiology is limited by the lack of consensus in methodology and data analysis/interpretation. In this study, WGS was performed on genomic DNA extracted from 22 multidrug-resistant Pseudomonas aeruginosa (MDR-PA) isolates using next-generation sequencing. Resulting high-quality reads were analyzed for phylogenetic relatedness using a whole-genome multilocus sequence typing (wgMLST)-based software program and single-nucleotide variant phylogenomics (SNVPhyl). WGS-based results were compared with conventional MLST and archived rep-PCR results. Rep-PCR identified three independent clonal clusters of MDR-PA. Only one clonal cluster identified by rep-PCR, an endemic strain within the pediatric cystic fibrosis population at Texas Children's Hospital, was concordantly identified using wgMLST and SNVPhyl. Results were highly consistent between the three sequence-based analyses (conventional MLST, wgMLST, and SNVPhyl), and these results remained consistent with the addition of 74 MDR-PA genomes. These WGS-based methods provided greater resolution for strain discrimination than rep-PCR or standard MLST classification, and the ease of use of wgMLST software renders it clinically viable for analysis, interpretation, and reporting of WGS-based strain typing.

SARS-CoV-2 has profoundly affected the way healthcare is delivered and has created significant strain on medical facilities globally. As a result, hospitals have had to continuously adapt in order to provide optimal patient care while minimizing the risk of SARS-CoV-2 transmission, particularly in the surgical setting. Texas Children's Hospital developed a set of protocols for surgical screening and clearance of patients in the context of the COVID-19 pandemic. These screening protocols were designed to mitigate the risk of exposing patients and healthcare providers to SARS-CoV-2 and have evolved significantly as a result of the emerging changes in medicine, technology, and governmental regulations. In this article, we share the reasoning behind the development, implementation, and successive modification of our institutional screening protocols.

Purpose To determine classification criteria for Vogt-Koyanagi-Harada (VKH) disease Design Machine learning of cases with VKH disease and 5 other panuveitides. Methods Cases of panuveitides were collected in an informatics-designed preliminary database, and a final database was constructed of cases achieving supermajority agreement on the diagnosis, using formal consensus techniques. Cases were split into a training set and a validation set. Machine learning using multinomial logistic regression was used on the training set to determine a parsimonious set of criteria that minimized the misclassification rate among the panuveitides. The resulting criteria were evaluated on the validation set. Results One thousand twelve cases of panuveitides, including 156 cases of early-stage VKH and 103 cases of late-stage VKH, were evaluated. Overall accuracy for panuveitides was 96.3% in the training set and 94.0% in the validation set (95% confidence interval 89.0, 96.8). Key criteria for early-stage VKH included: 1) exudative retinal detachment with characteristic appearance on fluorescein angiogram or optical coherence tomography or 2) panuveitis with ≥2 of 5 neurologic symptoms/signs. Key criteria for late-stage VKH included history of early-stage VKH and either: 1) sunset glow fundus or 2) uveitis and ≥1 of 3 cutaneous signs. The misclassification rates in the learning and validation sets for early-stage VKH were 8.0% and 7.7%, respectively, and for late-stage VKH 1.0% and 12%, respectively. Conclusions The criteria for VKH had a reasonably low misclassification rate and appeared to perform sufficiently well for use in clinical and translational research.

Purpose To determine classification criteria for Behcet disease uveitis. Design Machine learning of cases with Behcet disease and 5 other panuveitides. Methods Cases of panuveitides were collected in an informatics-designed preliminary database, and a final database was constructed of cases achieving supermajority agreement on the diagnosis, using formal consensus techniques. Cases were split into a training set and a validation set. Machine learning using multinomial logistic regression was used on the training set to determine a parsimonious set of criteria that minimized the misclassification rate among the intermediate uveitides. The resulting criteria were evaluated on the validation set. Results One thousand twelve of cases panuveitides, including 194 cases of Behcet disease with uveitis, were evaluated by machine learning. The overall accuracy for panuveitides was 96.3% in the training set and 94.0% in the validation set (95% confidence interval 89.0, 96.8). Key criteria for Behcet disease uveitis were a diagnosis of Behcet disease using the International Study Group for Behcet Disease criteria and a compatible uveitis, including: 1) anterior uveitis; 2) anterior chamber and vitreous inflammation; 3) posterior uveitis with retinal vasculitis and/or focal infiltrates; or 4) panuveitis with retinal vasculitis and/or focal infiltrates. The misclassification rates for Behcet disease uveitis were 0.6 % in the training set and 0% in the validation set, respectively. Conclusions The criteria for Behcet disease uveitis had a low misclassification rate and appeared to perform sufficiently well for use in clinical and translational research.

The low prevalence effect is a phenomenon whereby target prevalence affects performance in visual search (e.g., baggage screening) and comparison (e.g., fingerprint examination) tasks, such that people more often fail to detect infrequent target stimuli. For example, when exposed to higher base-rates of ‘matching’ (i.e., from the same person) than ‘non-matching’ (i.e., from different people) fingerprint pairs, people more often misjudge ‘non-matching’ pairs as ‘matches’–an error that can falsely implicate an innocent person for a crime they did not commit. In this paper, we investigated whether forensic science training may mitigate the low prevalence effect in fingerprint comparison. Forensic science trainees (n = 111) and untrained novices (n = 114) judged 100 fingerprint pairs as ‘matches’ or ‘non-matches’ where the matching pair occurrence was either high (90%) or equal (50%). Some participants were also asked to use a novel feature-comparison strategy as a potential attenuation technique for the low prevalence effect. Regardless of strategy, both trainees and novices were susceptible to the effect, such that they more often misjudged non-matching pairs as matches when non-matches were rare. These results support the robust nature of the low prevalence effect in visual comparison and have important applied implications for forensic decision-making in the criminal justice system.

To compare 2 mg intravitreal triamcinolone (IVT) versus 40 mg posterior sub-Tenon triamcinolone acetonide (STT) for the treatment of eyes with pseudophakic cystoid macular edema.A retrospective, single-center review of eyes receiving 2 mg IVT between 3/1/2012-3/1/2017 and 40 mg STT between 1/1/2015-3/1/2017. Visual acuity (VA) and central macular thickness (CMT) were recorded at baseline, 1-, 3-, and 6-month follow-up visits.Forty-five eyes were included in the IVT group and 50 eyes in the STT group. Change in VA from baseline to 1, 3, and 6 months was not significantly different between IVT and STT (6 months: 2.3 lines vs. 2.4 lines,2 mg IVT and 40 mg STT both achieved significant improvement in vision and CMT with no significant difference between interventions at 3- and 6-month follow-up.

Infants and young children are uniquely susceptible to primary viral and bacterial infections, predisposing them to responses of greater frequency and severity than in adults. Etiologies and manifestations of infections in pediatric patients are often different than those in adults. It can be challenging for clinical laboratories to implement appropriate microbiologic methods for rapid and accurate diagnoses in this population. Laboratorians should be cognizant of the distinctive features of children to provide comprehensive pediatric clinical microbiology services. This article discusses laboratory aspects of several clinically significant pediatric pathogens that cause severe harm to patients and impact public health responses.

Purpose One in 5000 newborns is diagnosed with Hirschsprung disease each year in the United States. The potential of employing neural crest stem cells to restore the enteric nervous system has been investigated. Skin-derived precursor cells (SKPs) are multipotent progenitor cells that can differentiate into neurons and gliocytes in vitro and generate enteric ganglion-like structures in rodents. Here we examined the behavior of human SKPs (hSKPs) after their transplantation into a large animal model of colonic aganglionosis. Methods Juvenile minipigs underwent a chemical denervation of the colon to establish an aganglionosis model. The hSKPs were generated from human foreskin and were cultured in neuroglial-selective medium. Cells were labeled with a fluorescent dye and were injected into the porcine aganglionic colon. After one week, transplanted hSKPs were assessed by immunofluorescence for markers of multipotency and neuroglial differentiation. Results In culture, hSKPs expressed nestin and S100b indicative of neuroglial precursors. After xenografting in pigs, hSKPs were identified in the myenteric and submucosal plexuses of the colons. The hSKPs expressed nestin and early neuroglial differentiation markers. Conclusions Human SKPs transplanted into aganglionic colon demonstrated immunophenotypes of neuroglial progenitors, suggesting their potential use for Hirschsprung disease. Level of evidence

PURPOSE: To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, “implant”) therapy. DESIGN: Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort METHODS: Patients with intermediate, posterior or panuveitis randomized to implant or systemic therapy (corticosteroid plus immunosuppression in >90%) were followed prospectively for glaucoma incidence and outcome. RESULTS: Among 405 uveitic at-risk eyes of 232 patients (median follow-up=6.9 years), 40% (79/196) of eyes assigned and treated with implant and 8% (17/209) of eyes assigned and treated with systemic therapy (censoring eyes receiving an implant upon implantation) developed glaucoma (Hazard Ratio (HR)=5.9 (95% CI: 3.2, 10.8); p

Background Hyperalgesia is a heightened pain response to a noxious stimulus and is a hallmark of many common neuropathic and chronic pain conditions. In a double-blind placebo-controlled drug-crossover trial, the effects of concomitant and delayed minocycline treatment on the initiation and resolution of muscle hyperalgesia were tested. Methods An initial cohort (n = 10) received repeated injections (5 mu g: days 0, 2 and 4) of nerve growth factor (NGF) in the flexor carpi ulnaris muscle of the forearm and pressure pain thresholds were collected at day 0 (control), day 7 (peak) and day 14 (recovery). A second cohort (n = 18) underwent an identical procedure, however, half received a placebo between days 0 and 7 before switching to minocycline from days 7 to 14 (P1/M2), while the remaining subjects received minocycline (day 0: 200mg then 100mg b.i.d. for 7 days) before switching to placebo (M1/P2). Results The initial cohort exhibited a diffuse muscular pain hypersensitivity with a decrease in pressure pain thresholds at day 7 before a partial return to normalcy at day 14. The P1/M2 treatment group exhibited an identical peak in hypersensitivity at day 7, however, after switching to minocycline in week 2 showed a significant reduction in muscle hyperalgesia compared with the initial cohort at day 14. The M1/P2 treatment group had significantly less (similar to 43%) hyperalgesia at day 7 compared with the other groups. Conclusions The study indicates that the administration of minocycline can reduce experimentally induced muscle pain regardless of the time of administration. Significance In a double-blind placebo-controlled drug-crossover study, the common antibiotic minocycline was found to reduce the muscle hyperalgesia induced by intramuscular injection of nerve growth factor. The results of the study showed that both concomitant (pre-emptive) and delayed administration of minocycline can ameliorate the onset and facilitate the resolution of experimentally induced muscle hyperalgesia. Funding Agencies|Western Sydney University School of Medicine under the Research Training Program (RTP)

Background The Streptococcus anginosus group (SAG, S. anginosus, S. intermedius and S. constellatus) are often associated with severe disease and abscess formation. In our institution, we observed an apparent increase in frequency of intraorbital and intracranial infections resulting from SAG at Texas Children's Hospital. We undertook a retrospective review to describe the frequency and clinical features of these infections. Methods We reviewed the database of the microbiology laboratory at Texas Children's Hospital from 2011 to 2018 for SAG-positive cultures. Cases included were those associated with (1) either otitis media or sinusitis and (2) Pott's puffy tumor, orbital abscesses, mastoiditis, epidural abscesses, subdural empyema, brain parenchymal abscesses or dural enhancement by imaging. The number of overall diagnoses were determined using diagnostic codes and used to estimate the proportion of disease caused by SAG. Results Ninety-five cases were identified meeting inclusion criteria. The median age of patients was 11.4 years, and 75.8% were previously healthy. S. intermedius was most commonly isolated (80%) followed by S. constellatus (12.6%) and S. anginosus (7.4%); 50.5% of cases were polymicrobial. Among polymicrobial cases, Staphylococcus aureus was most frequently isolated. All patients underwent surgical intervention. 8.4% of patients experienced persistent neurologic deficits. We observed a significant increase in disease incidence during the study period; in addition, the overall proportion of all intracranial infections caused by SAG increased. Conclusions Complications of otitis media and sinusitis caused by SAG are associated with substantial morbidity. These infections are becoming increasingly common at our center although the precise reason for this temporal trend is unclear.

Matching the identity of unfamiliar faces is important in applied identity verification tasks, for example when verifying photo ID at border crossings, in secure access areas, or when issuing identity credentials. In these settings, other biographical details—such as name or date of birth on an identity document—are also often compared to existing records, but the impact of these concurrent checks on decisions has not been examined. Here, we asked participants to sequentially compare name, then face information between an ID card and digital records to detect errors. Across four experiments (combined n = 274), despite being told that mismatches between written name pairs and face image pairs were independent, participants were more likely to say that face images matched when names also matched. Across all experiments, we found that this bias was unaffected by the image quality, suggesting that the source of the bias is somewhat independent of perceptual processes. In a final experiment, we show that this decisional bias was found only for name checks, but not when participants were asked to check ID card expiration dates or unrelated object names. We conclude that the bias arises from processing identity information and propose that it operates at the level of unfamiliar person identity representations. Results are interpreted in the context of theoretical models of face processing, and we discuss applied implications.

Preservation of native esophagus is a tenet of esophageal atresia (EA) repair. However, techniques for delayed primary anastomosis are severely limited for surgically and medically complex patients at high-risk for operative repair. We report our initial experience with the novel application of the Connect-EA, an esophageal magnetic compression anastomosis device, for salvage of primary repair in 2 high-risk complex EA patients. Compassionate use was approved by the FDA and treating institutions.Two approaches using the Connect-EA are described - a totally endoscopic approach and a novel hybrid operative approach. To our knowledge, this is the first successful use of a hybrid operative approach with an esophageal magnetic compression device.Salvage of delayed primary anastomosis was successful in both patients. The totally endoscopic approach significantly reduced operative time and avoided repeat high-risk operation. The hybrid operative approach salvaged delayed primary anastomosis and avoided cervical esophagostomy.The Connect-EA is a novel intervention to achieve delayed primary esophageal repair in complex EA patients with high-risk tissue characteristics and multi-system comorbidities that limit operative repair. We propose a clinical algorithm for use of the totally endoscopic approach and hybrid operative approach for use of the Connect-EA in high-risk complex EA patients.

Contains fulltext : 243880.pdf (Publisher’s version ) (Open Access) Visual comparison - comparing visual stimuli (e.g., fingerprints) side by side and determining whether they originate from the same or different source (i.e., "match") - is a complex discrimination task involving many cognitive and perceptual processes. Despite the real-world consequences of this task, which is often conducted by forensic scientists, little is understood about the psychological processes underpinning this ability. There are substantial individual differences in visual comparison accuracy amongst both professionals and novices. The source of this variation is unknown, but may reflect a domain-general and naturally varying perceptual ability. Here, we investigate this by comparing individual differences (N = 248 across two studies) in four visual comparison domains: faces, fingerprints, firearms, and artificial prints. Accuracy on all comparison tasks was significantly correlated and accounted for a substantial portion of variance (e.g., 42% in Exp. 1) in performance across all tasks. Importantly, this relationship cannot be attributed to participants’ intrinsic motivation or skill in other visual-perceptual tasks (visual search and visual statistical learning). This paper provides novel evidence of a reliable, domain-general visual comparison ability. 16 p.

Forensic science practitioners compare visual evidence samples (e.g. fingerprints) and decide if they originate from the same person or different people (i.e. fingerprint ‘matching’). These tasks are perceptually and cognitively complex—even practising professionals can make errors—and what limited research exists suggests that existing professional training is ineffective. This paper presents three experiments that demonstrate the benefit of perceptual training derived from mathematical theories that suggest statistically rare features have diagnostic utility in visual comparison tasks. Across three studies (N = 551), we demonstrate that a brief module training participants to focus on statistically rare fingerprint features improves fingerprint-matching performance in both novices and experienced fingerprint examiners. These results have applied importance for improving the professional performance of practising fingerprint examiners, and even other domains where this technique may also be helpful (e.g. radiology or banknote security).

A growing body of research has documented a well-established link between socioeconomic conditions and mortality among older adults. This study aims to understand (a) whether housing assets and income are associated with mortality and (b) if the value of housing assets affects the relationship between income and mortality; both questions are studied among older adults aged 65 or over in Canada.Using the population-based linked dataset (2011 Canadian Census Health and Environment Cohorts) of 881,220 older adults over six years of follow-up (2011-2017), this study uses survival analysis to estimate the link between housing assets, income level and mortality. We also assess the potential moderating effect of housing asset levels on the association between income and mortality by categorizing individuals along two dimensions: whether they are income-poor and whether they are housing assets-poor.The mortality rate was higher among both the lowest asset (HR = 1.346) and the lowest income group (HR = 1.203). The association is pronounced for older adults aged 65 to 74. Assets did not significantly moderate the link between income and mortality. Income-related inequalities in mortality are observed among each group of housing asset level. Compared to those who are neither income-poor nor housing assets-poor, individuals who were income poor but not housing assets-poor were more likely to die (HR = 1.067) over seven years of follow-up, and people who were housing assets-poor only were more likely to die (HR = 1.210). Being housing-assets poor and income-poor yielded a higher hazard ratio (HR = 1.291).Housing assets and income are associated with mortality of older adults. It is important to identify people who are assets poor and/or income poor who are at higher risks of mortality. Social policies aimed at reducing income insecurity and housing insecurity can reduce mortality inequalities.

Purpose To assess whether vitreous culture results affect the clinical management of patients with acute endophthalmitis after intravitreal anti–vascular endothelial growth factor (VEGF) injection. Design Retrospective case series. Methods Setting : Single-center. Study Population : Patients who developed endophthalmitis after intravitreal injection of aflibercept, bevacizumab, or ranibizumab between January 1, 2016, and May 31, 2018. Observation : A change in clinical management was defined as additional intravitreal antibiotic injections or pars plana vitrectomy. Main Outcome Measures : A change in clinical management within 2 weeks of initial endophthalmitis culture and treatment; visual acuity. Results Of 204,986 intravitreal anti-VEGF injections performed, 60 cases (0.0293%) of endophthalmitis were identified, 18 of which were culture-positive. Six of 60 eyes (10%) had a change in clinical management. A change in clinical management was initiated in 3 of 18 (17%) culture-positive cases compared to 3 of 42 (7%) culture-negative cases (P = .357). Changes in management for culture-positive cases were performed based on declining vision (2 cases) and worsening clinical examination (1 case). Changes in management for culture-negative endophthalmitis cases were performed based on declining vision (1 case) and worsening clinical examination (2 cases). No additional interventions were initiated based on positive-culture results. Comparing vision loss from baseline by culture result, at final follow-up, oral flora-associated culture-positive cases lost 17.5 lines, non–oral flora-associated culture-positive cases lost 9.1 lines, and culture-negative cases lost 2.5 lines of vision (P Conclusion Following endophthalmitis from intravitreal injection of anti-VEGF agents, vitreous culture data may help prognosticate visual outcomes but appear to have a limited effect on clinical management.

OBJECTIVE: To determine which initial surgical treatment results in the lowest rate of death or neurodevelopmental impairment (NDI) in premature infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP). SUMMARY BACKGROUND DATA: The impact of initial laparotomy versus peritoneal drainage for NEC or IP on the rate of death or NDI in extremely low birth weight infants is unknown. METHODS: We conducted the largest feasible randomized trial in 20 US centers, comparing initial laparotomy versus peritoneal drainage. The primary outcome was a composite of death or NDI at 18–22 months corrected age, analyzed using prespecified frequentist and Bayesian approaches. RESULTS: Of 992 eligible infants, 310 were randomized and 96% had primary outcome assessed. Death or NDI occurred in 69% of infants in the laparotomy group versus 70% with drainage (adjusted relative risk [aRR] = 1.0; 95% confidence interval [CI]: 0.87–1.14). A preplanned analysis identified an interaction between preoperative diagnosis and treatment group (p = 0.03). With a preoperative diagnosis of NEC, death or NDI occurred in 69% after laparotomy versus 85% with drainage (aRR=0.81; 95% CI: 0.64 to 1.04). The Bayesian posterior probability that laparotomy was beneficial (risk difference

Although vaccination has reduced the incidence of Haemophilus influenzae type b, nontypeable H. influenzae and other encapsulated types remain a health threat. Little is known regarding the contemporary molecular epidemiology of these organisms. We conducted multilocus sequence typing on invasive H. influenzae during a period of increasing incidence.

Background Fever is a common symptom in children presenting to the Emergency Department (ED). We aimed to describe the epidemiology of systemic viral infections and their predictive values for excluding serious bacterial infections (SBIs), including bacteremia, meningitis and urinary tract infections (UTIs) in children presenting to the ED with suspected systemic infections. Methods We enrolled children who presented to the ED with suspected systemic infections who had blood cultures obtained at seven healthcare facilities. Whole blood specimens were analyzed by an experimental multiplexed PCR test for 7 viruses. Demographic and laboratory results were abstracted. Results Of the 1114 subjects enrolled, 245 viruses were detected in 224 (20.1%) subjects. Bacteremia, meningitis and UTI frequency in viral bloodstream-positive patients was 1.3, 0 and 10.1% compared to 2.9, 1.3 and 9.7% in viral bloodstream-negative patients respectively. Although viral bloodstream detections had a high negative predictive value for bacteremia or meningitis (NPV = 98.7%), the frequency of UTIs among these subjects remained appreciable (9/89, 10.1%) (NPV = 89.9%). Screening urinalyses were positive for leukocyte esterase in 8/9 (88.9%) of these subjects, improving the ability to distinguish UTI. Conclusions Viral bloodstream detections were common in children presenting to the ED with suspected systemic infections. Although overall frequencies of SBIs among subjects with and without viral bloodstream detections did not differ significantly, combining whole blood viral testing with urinalysis provided high NPV for excluding SBI.

Purpose Explore the spectrum of clinical manifestations of pentosan polysulfate sodium (PPS) maculopathy observed across a range of practice settings. Design Multi-institutional retrospective study. Participants Patients exhibiting findings suggestive of PPS maculopathy identified from April 30, 2019, to December 4, 2020. Methods Members of the Macula Society submitted cases of presumed PPS maculopathy for consideration in this series. Diagnosis was confirmed by masked review of fundus imaging. Clinical characteristics of confirmed cases were summarized with descriptive statistics. Main Outcome Measures Pentosan polysulfate exposure characteristics and fundus imaging features. Results There were 74 patients with PPS maculopathy included in the current study. Median (interquartile range) age at diagnosis was 62.0 years (56.0–65.8). The median duration of exposure to PPS was 14.0 years (10.2–18.9), with a median cumulative exposure of 1.5 kg (0.9–2.4). The most common presenting symptom was decreased or blurry vision (66.2%), followed by prolonged dark adaption or nyctalopia (32.4%). The most common referral diagnosis was age-related macular degeneration (54.1%); 16.2% of patients were referred for suspected PPS maculopathy. Novel imaging findings emerged, including highly asymmetric disease in 2 patients and a prominent vitelliform maculopathy in 2 patients. Conclusions Most patients with PPS maculopathy exhibit characteristic findings on multimodal fundus imaging in the setting of high cumulative exposure to the oral drug. Some patients in the current study manifested novel imaging findings, expanding our understanding of the phenotypic spectrum of this condition. We recommend considering standardized ophthalmic screening of patients treated with PPS.

Variability in appearance across different images of the same unfamiliar face often causes participants to perceive different faces. Because perceptual information is not sufficient to link these encounters, top-down guidance may be critical in the initial stages of face learning. Here, we examine the interaction between top-down guidance and perceptual information when forming memory representations of unfamiliar faces. In two experiments, we manipulated the names associated with images of a target face that participants had to find in a search array. In Experiment 1, wrongly labelling two images of the same face with different names resulted in more errors relative to when the faces were labelled correctly. In Experiment 2, we compared this cost of mislabelling with the established “dual-target search cost,” where searching for two targets produces more search errors relative to one target. We found search costs when searching for two different faces, but not when searching for mislabelled images of the same face. Together, these results suggest that perceptual and semantic information interact when we form face memory representations. Mislabelling the identity of perceptually similar faces does not cause dual representations to be created, but rather it impedes the process of forming a single robust representation.

Background/Purpose Distraction enterogenesis with intraluminal spring technology has been successfully used to lengthen segments of murine small intestine. We hypothesized that biocompatible springs could also be used to lengthen murine large intestine. Methods Age and weight matched C57BL/6 mice underwent surgical insertion of nitinol spring-loaded capsules into the cecum. Segment lengths were measured at initial spring placement and at euthanasia after 7 and 14 days. Histologic adaptations were evaluated at scarification. Results Cecal segments loaded with compressed springs lengthened an average of 150%, which was significantly longer than control segments loaded with either empty capsules or uncompressed springs. Muscularis layers tended to be thicker in the compressed spring groups compared to control groups. Conclusions Insertion of a compressed nitinol spring into the cecum results in significant colonic lengthening in a mouse model. The ability to increase cecum length serves as proof of concept that distraction enterogenesis technology may be feasibly applied to large intestinal models. The use of distraction enterogenesis technology shows promise for application to clinical models in the treatment of pediatric intestinal disease.

Background Executive functions can be adversely affected by contextual risks in the home environment including chaos and parenting challenges. Furthermore, household chaos negatively influences parenting practices. Few studies, however, have examined the role of parenting in the association between household chaos and child executive functions. Methods Using a sample of 128 school-aged children (mean = 61.9 months, SD = 2.0, range 58–68 months) and their mothers, the present study examined direct and indirect effects (via parental responsiveness) of household chaos on child executive functioning. Multi-measures were used including performance-based assessments, behavioural observations, questionnaires, and video-home tours. Results Household chaos had both a direct effect on child executive functions (β = − .31, 95% CI [− .58, − .04]) and an indirect effect (β = − .05, 95% [− .13, − .01]) via parental responsiveness. Further, the indirect effect was only significant for household instability. Conclusion These findings indicate that parental responsiveness may be compromised by household chaos, with implications for the executive functions of school-aged children. Preventative strategies are needed to improve the stability in the home and strengthen parenting practices.

Background Nasopharyngeal (NP) specimen testing by reverse transcriptase polymerase chain reaction (RT-PCR) is the standard of care for detecting SARS-CoV-2. Data comparing the sensitivity and specificity of the NP specimen to the less invasive, mid-turbinate (MT) nasal specimen in children are limited. Methods Paired clinical NP and research MT specimens were collected from children Results Out of 907 children, 569 (62.7%) had parental consent and child assent when appropriate to participate and provided paired MT and NP specimens a median of 4 days after symptom onset (range 1-14 days). 16.5% (n = 94) of MT specimens were positive for SARS-CoV-2 compared with 20.0% (n = 114) of NP specimens. The sensitivity of research MT compared to clinical NP specimens was 82.5% (95% CI: 74.2%, 88.9%), specificity was 100.0% (95% CI: 99.2%, 100.0%), and overall agreement was 96.1% (κ = 0.87). The sensitivity of MT specimens decreased with time from 100% (95% CI: 59.0%, 100.0%) on day 1 of illness to 82.1% (95% CI: 73.8%, 88.7%) within 14 days of illness onset; sensitivity was generally >90% when specimens were collected within the first week of illness. Conclusion MT specimens, particularly those collected within the first week of illness, have moderately reduced sensitivity and equivalent specificity to less-tolerated NP specimens in pediatric outpatients. MT specimen use in children may represent a viable alternative to NP specimen collection.

Detection of Bordetella pertussis and Bordetella parapertussis using molecular methods is sensitive and specific with a short turnaround time compared to other diagnostic methods. In this multicenter study, we compared the performance of the Simplexa Bordetella Direct kit to those of other molecular assays in detecting and differentiating B. pertussis and B. parapertussis in nasopharyngeal swab specimens. The limits of detection (LODs) were 150 CFU/ml or 3 fg/μl of DNA for B. pertussis and 1,500 CFU/ml or 10 fg/μl of DNA for B. parapertussis. A total of 1,103 fresh and residual frozen specimens from eight clinical sites were tested. Combining the data from individual clinical sites using different comparative assays, the overall positive percent agreement (PPA) and negative percent agreement (NPA) for B. pertussis were 98.7% and 97.3%, respectively. The overall PPA and NPA for B. parapertussis were 96.7% and 100%, respectively. For prospective fresh specimens, the overall PPA and NPA for both targets were 97.7% and 99.3%, respectively. For retrospective frozen specimens, the overall PPA and NPA for both targets were 92.6% and 93.2%, respectively. The percentage of invalid results was 1.0%. A cross-reactivity study using 74 non-Bordetella bacterial species and five yeast species revealed that the Simplexa Bordetella Direct kit was 100% specific. The hands-on time and assay run time of the Simplexa Bordetella Direct kit are favorable compared to those of other commercial and laboratory-developed tests. In summary, the Simplexa Bordetella Direct kit has a performance comparable to those of other molecular assays for the detection of B. pertussis and B. parapertussis.

Pertussis is a highly contagious disease for which prompt, point-of-care diagnosis remains an unmet clinical need. Results from conventional test modalities (nucleic acid detection, serology, and culture) take hours to days. To overcome this challenge, we identified a new biomarker (tracheal colonization factor A, TcfA) for detection of Bordetella pertussis infection by lateral flow immunoassay (LFIA). We developed a library of 28 epitope-mapped monoclonal antibodies against TcfA and incorporated three antibodies into a LFIA. The LFIA did not cross-react with common bacterial or fungal organisms, but did react with nine distinct B. pertussis strains. The minimal linear epitope sequences targeted by the LFIA were conserved in 98% of 954 B. pertussis isolates collected across 12 countries from 1949–2017. The LFIA’s limit of detection was 3.0 × 105 CFU/mL with B. pertussis cells in buffer, 6.2 × 105 CFU/mL with nasopharyngeal washes from a non-human primate model, and 2.3 ng/mL with recombinant TcfA. The LFIA reacted with patient nasopharyngeal swab specimens containing as few as 1.8 × 106B. pertussis genomes/mL and showed no false-positives. Rapid (B. pertussis infection is feasible and may facilitate early detection of pertussis.

Background An understanding of the clinical characteristics of children with coronavirus disease 2019 in diverse communities is needed to optimize the response of healthcare providers during this pandemic. Methods We performed a retrospective review of all children presenting to the Texas Children’s Hospital system with testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from March 10, 2020, through June 28, 2020. Demographics were recorded for all patients undergoing testing and clinical characteristics and outcomes were recorded for children with positive tests. Results Of 16 554 unique patients ≤ 21 years of age who were tested for SARS-CoV-2, 1215 (7.3%) patients tested positive. Infants under 1 year of age and patients aged 18–21 years had the highest percent of positive tests at 9.9% (230/2329) and 10.7% (79/739), respectively. Hispanic children accounted for 66% (802/1215) of positive tests, though they only represented 42.1% (6972/16 554) of all children tested for SARS-CoV-2. Of the 1215 children with a positive test, 55.7% had fever, 40.9% had cough, 39.8% had congestion or rhinorrhea, 21.9% had gastrointestinal complaints, and 15.9% were asymptomatic. Only 97 (8%) patients were hospitalized (of which 68% were Hispanic). Most of the hospitalized patients had underlying medical conditions (62/97, 63.9%), including obesity. Thirty-one hospitalized patients (31/97, 32%) required respiratory support and 9 patients (9/97, 9.3%) received SARS-CoV-2 antiviral therapy. Two patients died. Conclusions A relatively high percentage of Hispanic children tested positive for SARS-CoV-2 and were hospitalized. Most of the children with detection of SARS-CoV-2 had uncomplicated illness courses; some children were critically ill; and 2 patients died.

Purpose : To determine classification criteria for intermediate uveitis, non-pars planitis type (IU- NPP, also known as undifferentiated intermediate uveitis) Design : Machine learning of cases with IU-NPP and 4 other intermediate uveitides. Methods : Cases of intermediate uveitides were collected in an informatics-designed preliminary database, and a final database was constructed of cases achieving supermajority agreement on the diagnosis, using formal consensus techniques. Cases were split into a training set and a validation set. Machine learning using multinomial logistic regression was used on the training set to determine a parsimonious set of criteria that minimized the misclassification rate among the intermediate uveitides. The resulting criteria were evaluated on the validation set. Results : Five hundred eighty-nine of cases of intermediate uveitides, including 114 cases of IU-NPP, were evaluated by machine learning. The overall accuracy for intermediate uveitides was 99.8% in the training set and 99.3% in the validation set (95% confidence interval 96.1, 99.9). Key criteria for IU-NPP included unilateral or bilateral intermediate uveitis with neither 1) snowballs in the vitreous nor 2) snowbanks on the pars plana. Other key exclusions included: 1) multiple sclerosis, 2) sarcoidosis, and 3) syphilis. The misclassification rates for pars planitis were 0 % in the training set and 0% in the validation set, respectively. Conclusions : The criteria for IU-NPP had a low misclassification rate and appeared to perform well enough for use in clinical and translational research.

We describe the clinical course of 57 children with coronavirus disease 2019 (COVID-19) cared for through a single hospital system. Most children were mildly symptomatic, and only a few patients with underlying medical conditions required hospitalization. Systemwide patient evaluation processes allowed for prompt identification and management of patients with COVID-19.

We present a new test–the UNSW Face Test (www.unswfacetest.com)–that has been specifically designed to screen for super-recognizers in large online cohorts and is available free for scientific use. Super-recognizers are people that demonstrate sustained performance in the very top percentiles in tests of face identification ability. Because they represent a small proportion of the population, screening large online cohorts is an important step in their initial recruitment, before confirmatory testing via standardized measures and more detailed cognitive testing. We provide normative data on the UNSW Face Test from 3 cohorts tested via the internet (combined n = 23,902) and 2 cohorts tested in our lab (combined n = 182). The UNSW Face Test: (i) captures both identification memory and perceptual matching, as confirmed by correlations with existing tests of these abilities; (ii) captures face-specific perceptual and memorial abilities, as confirmed by non-significant correlations with non-face object processing tasks; (iii) enables researchers to apply stricter selection criteria than other available tests, which boosts the average accuracy of the individuals selected in subsequent testing. Together, these properties make the test uniquely suited to screening for super-recognizers in large online cohorts.

Purpose To assess the utility of microbiologic culture data for the management of endophthalmitis after cataract surgery. Design Retrospective, single-center, cohort study. Participants All patients treated for endophthalmitis after cataract surgery between January 1, 2014, and December 31, 2017, at a single institution. Methods Endophthalmitis cases were determined from billing records and confirmed with chart review. A change in clinical management was defined as additional intravitreal antibiotic injections or pars plana vitrectomy. Main Outcome Measures A change in clinical management within 2 weeks of initial endophthalmitis culture and treatment; visual acuity (VA). Results A total of 111 eyes of 111 patients were treated for endophthalmitis after cataract surgery, of which 57 (51%) were culture-positive. After initial treatment of endophthalmitis, a change in clinical management after vitreous culture occurred in 9 of 111 eyes (8%), including 6 of 57 (11%) culture-positive eyes compared with 3 of 54 (6%) culture-negative eyes (P = 0.49). Change in clinical management for culture-positive eyes was based on declining vision (3 eyes), worsening clinical examination results (2 eyes), and retinal detachment (1 case). Change in clinical management for culture-negative endophthalmitis eyes was based on worsening clinical examination results (2 eyes) and declining vision (1 eye). No additional interventions were initiated on the basis of positive culture results. At final follow-up, mean logarithm of the minimum angle of resolution (logMAR) VA was 1.09 (∼20/250) for the culture-positive eyes compared with 0.59 (∼20/80) for culture-negative eyes (adjusted difference, 0.394; 95% confidence interval, 0.02–0.77, P = 0.03). Rhegmatogenous retinal detachments (RRDs) or retinal tears occurred in 19 of 111 eyes (17%) after developing endophthalmitis, and culture-positive eyes developed a secondary RRD in 11 of 57 eyes (19%) compared with 3 of 54 (6%) culture-negative eyes (P = 0.03). Conclusions After endophthalmitis related to cataract surgery, vitreous cultures may have prognostic value for final visual outcomes but have a limited effect on clinical management.

The proposed benefits of laparoscopic inguinal hernia repair in the pediatric population include easier access to the contralateral groin and avoidance of manipulation of the spermatic cord; however, some studies also report higher recurrence rates. Due to these differences, the traditional open technique is still used by many pediatric surgeons. The objective of this study is to compare the outcomes of two institutions that employed different techniques.We retrospectively reviewed pediatric patients who had open repair of inguinal hernias at hospital A or laparoscopic repair at hospital B. Data collection included age of patients, laterality, operative time, and complications.From 2010 to 2015, 154 patients underwent open repair at hospital A and 220 patients underwent laparoscopic repair at hospital B. The mean operative time was 52 min for the open technique and 23 min for the laparoscopic technique (p 0.01). There were 2.6% complications and 0.65% recurrences with the open technique, compared to 4.6% complications and 2.7% recurrences with the laparoscopic technique (p 0.2).Laparoscopic hernia repairs at hospital B are associated with shorter operative times and have similar outcomes as open repairs at hospital A. A prospective study with both techniques done at the same institution is warranted.

Oriented smooth muscle layers in the intestine contract rhythmically due to the action of interstitial cells of Cajal (ICC) that serve as pacemakers of the intestine. Disruption of ICC networks has been reported in various intestinal motility disorders, which limit the quality and expectancy of life. A significant challenge in intestinal smooth muscle engineering is the rapid loss of function in cultured ICC and smooth muscle cells (SMC). Here we demonstrate a novel approach to maintain the function of both ICC and SMC in vitro. Primary intestinal SMC mixtures cultured on feeder cells seeded electrospun poly(3-caprolactone) scaffolds exhibited rhythmic contractions with directionality for over 10 weeks in vitro. The simplicity of this system should allow for wide usage in research on intestinal motility disorders and tissue engineering, and may prove to be a versatile platform for generating other types of functional SMC in vitro.

Previous studies that have explored the association between childhood trauma and homelessness indicate that traumatic events can lead to survivor distrust of interpersonal relationships and institutions, prolonged homelessness and poor health and social outcomes. The majority of this literature relies on quantitative data and fails to investigate the personal experiences of childhood trauma that are found to impact housing status later in life. Semi-structured, qualitative interviews were conducted with 25 men living in an urban area in Ontario who had spent more than 30 consecutive nights in an emergency shelter over the course of their housing histories. During data analysis, it was observed that all of the men had experienced some form of trauma or neglect in childhood which contributed to their entries into homelessness. Using a case study approach, three entry pathways into long term homelessness are described: 1) youth; 2) emerging or early adulthood; and 3) middle adulthood. Participants are classified into the pathways by the developmental period at which they first entered homelessness. These findings have implications for policy makers and service providers, as key intervention points are identified. Establishing effective interventions that address crises experienced at these points could assist with homelessness prevention across the life course.

PURPOSE OF REVIEW: The purpose of this review is to briefly summarize the notable structures and pathways in intestinal epithelial growth before presenting the current main areas of active research in intestinal regeneration. As a rapidly advancing field, a number of breakthroughs have recently been made related to the culture of intestinal stem cells and to the engineering of intestinal tissue. RECENT FINDINGS: Intestinal stem cells can be derived from fibroblasts and can be cultured in hydrogels under xenogeneic-free conditions. Intestinal organoids can be cultured with neural crest cells to form small intestinal tissues with neuromuscular networks. Endoluminal devices can be placed inside the native intestine to exert mechanical force to induce novel tissue growth. SUMMARY: A number of recent advances in the field of intestinal regeneration are encouraging and suggest that novel therapies for a wide range of intestinal disorders may be developed in the near future. There are still a number of obstacles before such stem cell therapies can be safely used in humans.

Purpose To identify determinants of adverse outcomes in acute retinal necrosis (ARN), presenting characteristics and incidence rates of vision loss and ocular complications in a cohort of polymerase chain reaction (PCR)-positive eyes were analyzed. Design Retrospective observational cohort study. Methods Forty-one eyes of 36 patients with clinically diagnosed ARN, PCR-positive for herpes simplex virus or varicella zoster virus and evaluated between January 2002 and June 2013, were included. Main outcome measures included incidence rates of vision loss and retinal detachment (RD). Results Presenting visual acuity was generally poor (20/50 to >20/200 in 27%; 20/200 or worse in 56%). The incidence rate of ≤20/200 was 0.66/eye-year (EY), (95% confidence interval [CI], 0.32/EY to 1.22/EY); the rate of light perception or no light perception vision was 0.07/EY (95% CI, 0.02/EY to 0.16/EY). During follow-up, 59% of eyes developed at least 1 RD (rate = 0.40/EY, 95% CI, 0.19/EY to 0.58/EY). Eyes with retinitis involving ≥25% of the retina at presentation detached at nearly 12 times the rate, as compared to those with P = .001). Development of an RD was the greatest determinant of adverse visual outcomes, with 4% of eyes, that had experienced at least 1 RD, achieving a best-corrected visual acuity of ≥20/40 compared to 53% of eyes that never detached ( P = .0003). Conclusions Poor outcomes in ARN were common in this cohort. RD confers the greatest risk of incident vision loss, and once 25% or more of the retina is involved the risk of RD and visual loss increases significantly.

Zika virus is an emerging mosquito-borne ( Aedes genus) arbovirus of the Flaviviridae family. Following epidemics in Micronesia and French Polynesia during the past decade, more recent Zika virus infection outbreaks were first reported in South America as early as May 2013 and spread to now 50 countries throughout the Americas. Although no other flavivirus has previously been known to cause major fetal malformations following perinatal infection, reports of a causal link between Zika virus and microcephaly, brain and ocular malformations, and fetal loss emerged from hard-hit regions of Brazil by October 2015. Among the minority of infected women with symptoms, clinical manifestations of Zika virus infection may include fever, headache, arthralgia, myalgia, and maculopapular rash; however, only 1 of every 4–5 people who are infected have any symptoms. Thus, clinical symptom reporting is an ineffective screening tool for the relative risk assessment of Zika virus infection in the majority of patients. As previously occurred with other largely asymptomatic viral infections posing perinatal transmission risk (such as HIV or cytomegalovirus), we must develop and implement rapid, sensitive, and specific screening and diagnostic testing for both viral detection and estimation of timing of exposure. Unfortunately, despite an unprecedented surge in attempts to rapidly advance perinatal clinical testing for a previously obscure arbovirus, there are several ongoing hindrances to molecular- and sonographic-based screening and diagnosis of congenital Zika virus infection. These include the following: (1) difficulty in estimating the timing of exposure for women living in endemic areas and thus limited interpretability of immunoglobulin M serologies; (2) cross-reaction of immunoglobulin serologies with other endemic flaviruses, such as dengue; (3) persistent viremia and viruria in pregnancy weeks to months after primary exposure; and (4) fetal brain malformations and anomalies preceding the sonographic detection of microcephaly. In this commentary, we discuss screening and diagnostic considerations that are grounded not only in the realities of current obstetrical practice in a largely global population but also in basic immunology and virology. We review recent epidemiological data pertaining to the risk of congenital Zika virus malformations based on trimester of exposure and consider side by side with emerging data demonstrating replication of Zika virus in placental and fetal tissue throughout gestation. We discuss limitations to ultrasound based strategies that rely largely or solely on the detection of microcephaly and provide alternative neurosonographic approaches for the detection of malformations that may precede or occur independent of a small head circumference. This expert review provides information that is of value for the following: (1) obstetrician, maternal-fetal medicine specialist, midwife, patient, and family in cases of suspected Zika virus infection; (2) review of the methodology for laboratory testing to explore the presence of the virus and the immune response; (3) ultrasound-based assessment of the fetus suspected to be exposed to Zika virus with particular emphasis on the central nervous system; and (4) identification of areas ready for development.

We evaluated the outcomes for nonoperative management (NOM) of all children with suspected nonperforated appendicitis, including those patients with an appendicolith. Parents of all children with suspected nonperforated appendicitis were offered NOM versus laparoscopic appendectomy. NOM included administration of intravenous antibiotics and hospital admission. If no improvement within 24 hours, laparoscopic appendectomy was performed. Primary outcomes were initial success rate and recurrence rate. Fifty patients selected NOM. The initial failure rate for NOM was 20%. Of the 10 who failed, 7 had complicated appendicitis. The recurrence rate was 13%. Overall, 34 (68%) patients avoided appendectomy. Patients with an appendicolith had a higher initial failure rate (37%) compared to patients without an appendicolith (10%; P < .05). NOM is feasible and effective in pediatric nonperforated appendicitis. The presence of an appendicolith was associated with a higher failure rate but is not an absolute contraindication for NOM.

OBJECTIVETo investigate an outbreak ofBurkholderia cepaciacomplex and describe the measures that revealed the source.SETTINGA 629-bed, tertiary-care, pediatric hospital in Houston, Texas.PATIENTSPediatric patients without cystic fibrosis (CF) hospitalized in the pediatric and cardiovascular intensive care units.METHODSWe investigated an outbreak ofB. cepaciacomplex from February through July 2016. Isolates were evaluated for molecular relatedness with repetitive extragenic palindromic polymerase chain reaction (rep-PCR); specific species identification and genotyping were performed at an independent laboratory. The investigation included a detailed review of all cases, direct observation of clinical practices, and respiratory surveillance cultures. Environmental and product cultures were performed at an accredited reference environmental microbiology laboratory.RESULTSOverall, 18 respiratory tract cultures, 5 blood cultures, 4 urine cultures, and 3 stool cultures were positive in 24 patients. Among the 24 patients, 17 had symptomatic infections and 7 were colonized. The median age of the patients was 22.5 months (range, 2–148 months). Rep-PCR typing showed that 21 of 24 cases represented the same strain, which was identified as a novel species within theB. cepaciacomplex. Product cultures of liquid docusate were positive with an identical strain ofB. cepaciacomplex. Local and state health departments, as well as the CDC and FDA, were notified, prompting a multistate investigation.CONCLUSIONSOur investigation revealed an outbreak of a unique strain ofB. cepaciacomplex isolated in clinical specimens from non-CF pediatric patients and from liquid docusate. This resulted in a national alert and voluntary recall by the manufacturer.Infect Control Hosp Epidemiol2017;38:567–573

Human small intestinal crypts are the source of intestinal stem cells (ISCs) that are capable of undergoing self-renewal and differentiation to an epithelial layer. The development of methods to expand the ISCs has provided opportunities to model human intestinal epithelial disorders. Human crypt samples are usually obtained from either endoscopic or discarded surgical samples, and are thereby exposed to warm ischemia, which may impair their in vitro growth as three-dimensional culture as spheroids or enteroids. In this study we compared duodenal samples obtained from discarded surgical samples to those isolated from whole-body preserved cadaveric donors to generate in vitro cultures. We also examined the effect of storage solution (phosphate-buffered saline or University of Wisconsin [UW] solution) as well as multiple storage times on crypt isolation and growth in culture. We found that intestinal crypts were successfully isolated from cadaveric tissue stored for up to 144 h post-procurement and also were able to generate enteroids and spheroids in certain media conditions. Surgical samples stored in UW after procurement were sufficiently viable up to 24 h and also allowed the generation of enteroids and spheroids. We conclude that surgical samples stored for up to 24 h post-procurement in UW solution allowed for delayed crypt isolation and viable in vitro cultures. Furthermore, in situ, hypothermic preservation in cadaveric duodenal samples permitted crypt/ISC isolation, and successful culture of spheroids and enteroids from tissues held for up to 6 days post-procurement.

Housing is often described as an important determinant of health, but less commonly of child health. Despite acknowledgment of the importance of housing to health, however, there are relatively few studies of the effects of housing interventions on health, and again even fewer on child health. This article argues that a broad focus on healthy child development—as opposed to just physical health—coupled with a conceptual framework outlining specific attributes of housing with the potential to influence child health, should be adopted to guide a comprehensive approach to public health policy for healthy child development. Most housing interventions address direct pathways linking in-home hazard exposures to child health outcomes, with promising but mixed results. But few housing interventions address the broader aspects of healthy child development. This review addresses potential housing interventions that could impact the broader determinants of healthy child development and accompanying methodological challenges.

When matching and recognizing familiar faces, performance is unaffected by changes to image-specific details such as lighting, head angle, and expression. In contrast, these changes have a substantial impact on performance when faces are unfamiliar. What process can account for this difference? Recent evidence shows a memory disadvantage for remembering specific images of familiar people compared to unfamiliar people, suggesting that image invariance in familiar face processing may be supported by loss of image-specific details in memory. Here, we examine whether this cost results from loss of image specific details during encoding of familiar faces. Participants completed four tasks that required participants to retain image-specific information in working memory: duplicate detection (Experiment 1), change detection (Experiment 2), short-term recognition memory (Experiment 3 and 5), and visual search (Experiment 4). Across all experiments (combined n = 270), our results consistently show equivalent memory performance for specific images of familiar and unfamiliar faces. We conclude that familiarity does not influence encoding of pictorial details, suggesting that loss of image-specificity reported in previous work is a result of longer-term storage mechanisms. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Advanced microbiology technologies are rapidly changing our ability to diagnose infections, improve patient care, and enhance clinical workflow. These tools are increasing the breadth, depth, and speed of diagnostic data generated per patient, and testing is being moved closer to the patient through rapid diagnostic technologies, including point-of-care (POC) technologies., Advanced microbiology technologies are rapidly changing our ability to diagnose infections, improve patient care, and enhance clinical workflow. These tools are increasing the breadth, depth, and speed of diagnostic data generated per patient, and testing is being moved closer to the patient through rapid diagnostic technologies, including point-of-care (POC) technologies. While select stakeholders have an appreciation of the value/importance of improvements in the microbial diagnostic field, there remains a disconnect between clinicians and some payers and hospital administrators in terms of understanding the potential clinical utility of these novel technologies. Therefore, a key challenge for the clinical microbiology community is to clearly articulate the value proposition of these technologies to encourage payers to cover and hospitals to adopt advanced microbiology tests. Specific guidance on how to define and demonstrate clinical utility would be valuable. Addressing this challenge will require alignment on this topic, not just by microbiologists but also by primary care and emergency room (ER) physicians, infectious disease specialists, pharmacists, hospital administrators, and government entities with an interest in public health. In this article, we discuss how to best conduct clinical studies to demonstrate and communicate clinical utility to payers and to set reasonable expectations for what diagnostic manufacturers should be required to demonstrate to support reimbursement from commercial payers and utilization by hospital systems.