A meta-analysis of microbial thermal inactivation in low moisture foods.

Microbial thermal inactivation in low moisture foods is challenging due to enhanced thermal resistance of microbes and low thermal conductivity of food matrices. In this study, we leveraged the body of previous work on this topic to model key experimental features that determine microbial thermal inactivation in low moisture foods. We identified 27 studies which contained 782 mean D-values and developed linear mixed-effect models to assess the effect of microorganism type, matrix structure and composition, water activity, temperature, and inoculation and recovery methods on cell death kinetics. Intraclass correlation statistics (I2) and conditional R2 values of the linear mixed effects models were: E. coli (R2-0.91, I2-83%), fungi (R2-0.88, I2-85%), L. monocytogenes (R2-0.84, I2-75%), Salmonella (R2-0.69, I2-46%). Finally, global response surface models (RSM) were developed to further study the non-linear effect of aw and temperature on inactivation. The fit of these models varied by organisms from R2 0.88 (E. coli) to 0.35 (fungi). Further dividing the Salmonella data into individual RSM models based on matrix structure improved model fit to R2 0.90 (paste-like products) and 0.48 (powder-like products). This indicates a negative relationship between data diversity and model performance.

The efficacy of sleep lifestyle interventions for the management of overweight or obesity in children: a systematic review and meta-analysis.

BACKGROUND: Childhood obesity remains a significant public health concern. Sleep duration and quality among children and youth are suboptimal worldwide. Accumulating evidence suggests an association between inadequate sleep and obesity risk, yet it is unclear whether this relationship is causal. This systematic review examines the efficacy of sleep interventions alone or as a part of lifestyle interventions for the management of overweight or obesity among children and adolescents. METHODS: A keyword/reference search was performed twice, in January 2021 and May 2022 in MEDLINE/PubMed, EMBASE/Ovid, PsycINFO/EBSCO, The Cochrane Library, Web of Science Core Collection/Web of Science, SciELO/Web of Science, and CINAHL/EBSCO. Study eligibility criteria included youth with overweight or obesity between 5 and 17, were RCTs or quasi-randomized, and focused on the treatment of overweight and obesity with a sleep behavior intervention component. Risk of bias was assessed using the Cochrane Risk of Bias assessment tool (RoB2). A Meta-analysis was conducted to estimate the effect of interventions with a sleep component on BMI. The study protocol was registered in PROSPERO (CRD42021233329). RESULTS: A total of 8 studies (2 quasi-experiments, 6 RCTs) met inclusion criteria and accounted for 2,231 participants across 7 countries. Only one study design isolated the effect of sleep in the intervention and reported statistically significant decreases in weight and waist circumference compared to control, though we rated it at high risk of bias. Our meta-analysis showed no significant overall effect on children's BMI as a result of participation in an intervention with a sleep component (Cohen's d = 0.18, 95% CI= -0.04, 0.40, Z = 1.56, P = .11), though caution is warranted due to substantial heterogeneity observed across studies (Tau2 = 0.08; X2 = 23.05, df = 7; I2 = 83.73%). CONCLUSIONS: There were mixed results on the effect of sleep interventions across included studies on BMI, other weight-related outcomes, diet, physical activity, and sleep. Except for one study at low risk of bias, three were rated as 'some concerns' and four 'high risk of bias'. Findings from this study highlight the need for additional RCTs isolating sleep as a component, focusing on children and adolescents living with overweight and obesity.

Ultrasonographic criteria in the diagnosis of polycystic ovary syndrome: a systematic review and diagnostic meta-analysis.

BACKGROUND: Polycystic ovary morphology (PCOM) on ultrasonography is considered as a cardinal feature of polycystic ovarian syndrome (PCOS). Its relevance as a diagnostic criterion for PCOS was reaffirmed in the most recent International Evidence-Based Guideline for the Assessment and Management of PCOS. However, there remains a lack of clarity regarding the best practices and specific ultrasonographic markers to define PCOM. OBJECTIVE AND RATIONALE: The aim of this systematic review and diagnostic meta-analysis was to assess the diagnostic accuracy of various ultrasonographic features of ovarian morphology in the diagnosis of PCOS. SEARCH METHODS: Relevant studies published from 1 January 1990 to 12 June 2023 were identified by a systematic search in PubMed, Web of Science, Scopus, CINAHL, and CENTRAL. Studies that generated diagnostic accuracy measures (e.g. proposed thresholds, sensitivity, specificity) for PCOS using the following ultrasonographic markers met criteria for inclusion: follicle number per ovary (FNPO) or per single cross-section (FNPS), ovarian volume (OV), and stromal features. Studies on pregnant or post-menopausal women were excluded. Risk of bias and applicability assessment for diagnostic test accuracy studies were determined using the QUADAS-2 and QUADAS-C tool for a single index test or between multiple index tests, respectively. Diagnostic meta-analysis was conducted using a bivariate model of pooled sensitivity and specificity, and visualized using forest plots and summary receiver-operating characteristic (SROC) curves. OUTCOMES: From a total of 2197 records initially identified, 31 studies were included. Data from five and two studies were excluded from the meta-analysis due to duplicate study populations or limited data for the index test, leaving 24 studies. Pooled results of 20 adult studies consisted of 3883 control participants and 3859 individuals with PCOS. FNPO was the most accurate diagnostic marker (sensitivity: 84%, CI: 81-87%; specificity: 91%, CI: 86-94%; AUC: 0.905) in adult women. OV and FNPS had similar pooled sensitivities (OV: 81%, CI: 76-86%; FNPS: 81%, CI: 70-89%) but inferior pooled specificities (OV: 81%, CI: 75-86%; FNPS: 83%, CI: 75-88%) and AUCs (OV: 0.856; FNPS: 0.870) compared to FNPO. Pooled results from four adolescent studies consisting of 210 control participants and 268 girls with PCOS suggested that OV may be a robust ultrasonographic marker for PCOS diagnosis albeit the current evidence remains limited. The majority of the studies had high risk of bias for the patient selection (e.g. lack of randomized/consecutive patient selection) and index test (e.g. lack of pre-proposed thresholds for comparison) domains across all ultrasonographic markers. As such, diagnostic meta-analysis was unable to determine the most accurate cutoff for ultrasonographic markers to diagnose PCOS. Subgroup analysis suggested that stratification based on previously proposed diagnostic thresholds, age, BMI, or technology did not account for the heterogeneity in diagnostic accuracy observed across the studies. Studies that diagnosed PCOS using the Rotterdam criteria had improved sensitivity for FNPO. Studies from North America had lower diagnostic accuracy when compared to Asian studies (FNPO: sensitivity) and European studies (OV: specificity, diagnostic odds ratio and positive likelihood ratio). Geographic differences in diagnostic accuracy may potentially be due to differences in age, BMI, and diagnostic criteria of the PCOS group across regions. WIDER IMPLICATIONS: This diagnostic meta-analysis supports the use of FNPO as the gold standard in the ultrasonographic diagnosis of PCOS in adult women. OV and FNPS provide alternatives if total antral follicle counts cannot be accurately obtained. Our findings support the potential for ultrasonographic evidence of PCOM in adolescents as more data becomes available. Subgroup analysis suggests the need to investigate any relative contributions of geographical differences on PCOS phenotypes. These findings may provide the basis for the development of strategies and best practices toward a standardized definition of PCOM and a more accurate ultrasonographic evaluation of PCOS.

Effect of Hand and Ultrasonic Scaling-Root Planing Methods on Tooth Surface Topography: An In-Vitro Atomic Force Microscopy Study.

PURPOSE: Any instrumentation on the tooth surface for plaque or calculus removal will cause some amount of roughness on the tooth surface. Hence, this study was proposed to investigate the effects of hand and ultrasonic scaling and root planing on enamel and cementum, respectively. MATERIALS AND METHODS: Forty tooth samples were prepared from extracted maxillary and mandibular first pre-molars and were divided randomly into four groups of 10 samples each. Group l: received ultrasonic scaling on enamel; Group II: received hand scaling on enamel surface; Group III: root planing with an ultrasonic unit on the cementum samples; and Group IV: root planing using hand curettes on cementum surface. The amount of roughness produced on the surface of each sample of all four groups was evaluated using atomic force microscopy (AFM) and statistically analyzed using Chi-square, ANOVA, and Wilcoxon tests. RESULTS: The results suggested that the surface roughness produced on both crown and root after scaling and root planing (SRP) using a hand instrument is lower than that of an ultrasonic unit. The roughness of the crown was found to be lower than that of the root after SRP using both a hand instrument and an ultrasonic unit and was also statistically significant (P = 0.034). In contrast, there is not enough evidence to conclude a significant difference (P=0.13) between root planing using hand instruments and ultrasonic scaler groups. The combined p-value using the Chi-square test (P=0.026) suggests a statistically significant overall difference between crown and root groups. CONCLUSION: From the present study, the authors concluded that scaling as well as root planing using an ultrasonic unit cause more tooth (enamel and cementum) surface roughness as compared to hand scaling and root planing. While there is no significant difference in the surface roughness of root-cementum produced due to the root planing in both groups, crown-enamel exhibits a significant difference after scaling in both groups. Clinical significance of the study: Rough, uneven tooth surfaces negatively influence the anticipated healing of the periodontium by providing retention areas for microbial dental plaque.

Impact of periodontitis on oral health-related quality of life of patients with psoriatic arthritis.

BACKGROUND: Since oral health issues can have a negative influence on a person's physical functioning, social status, and wellbeing, oral health-related quality of life (OHRQoL) becomes an indispensable part of overall health. Previous published studies report that periodontitis (PD) and psoriatic arthritis (PsA) have a significant negative impact on OHRQoL. Based on these findings, it would be reasonable to assume that patients with coexisting PsA and PD would see a comparable or maybe synergistic effect on their OHRQoL. Hence, the aim of the present study is to evaluate the OHRQoL and its impact among subjects with concurrent PsA and PD. MATERIAL AND METHODS: The present study was a comparative, cross-sectional investigation. A total of 200 participants were categorized into four groups- PD-PsA (n = 50), PsA (n = 50), PD (n = 50), and healthy controls (n = 50). Demographic data and periodontal parameters-plaque index, sites with gingival bleeding, probing pocket depth, gingival recession, and clinical attachment level were recorded for all the four groups. Number of mobile teeth due to periodontitis was recorded for the PSA-PD and PD groups. OHIP-14 questionnaire was administered to all the four groups. Collected data was then subjected to statistical analysis. RESULTS: The severity of OHIP-14 summary scores was highest in the PsA-PD group (18.06 ± 11.22) followed by the PD group (17.02 ± 9.99) and lowest in the healthy group (6.32 ± 5.59) (p < .0001). The scores of all the domains- oral pain, oral function, orofacial appearance and psychological impact were highest among the PsA-PD group followed by the PD group (p < .0001). The combined interaction of PsA and PD on the OHRQoL was statistically significant (F = 6.33, p = .012). Results of the multiple linear regression analysis indicated that there was a moderate collective significant effect between age, past dental visit, frequency of daily tooth brushing, use of other oral hygiene aids, and OHIP-14 (F(3,196) = 13.08, p < .001, R2  = 0.17, adjusted R2  = 0.15). CONCLUSION: The negative impact on OHRQoL was highest in the patients with concurrent presence of PD with PsA followed by those with PD alone. While the summary scores and dimensional scores of OHIP-14 were insignificant when patients with PsA-PD and PD alone were compared, these scores were significantly higher in patients with PsA-PD than patients with PsA alone.

Effect of Commercially Available Nano-Hydroxyapatite Containing Desensitizing Toothpaste and Mouthwash on Dentinal Tubular Occlusion: A SEM Analysis.

The aim of this in vitro study was to evaluate and compare the dentinal tubule occlusion using nano-hydroxyapatite (n-HAP) containing toothpaste and mouthwash under a scanning electron microscope. The specimens were randomly divided into two groups with five specimens each: group 1-toothpaste group and group 2-mouthwash group. The percentage of the occluded dentinal tubules was assessed at the baseline, 7th, 14th, 21st, and 28th days under a scanning electron microscope. The toothpaste group showed a higher percentage of occluded dentinal tubules as compared to the mouthwash group at the 7th, 14th, 21st, and 28th days, respectively. It can be concluded that brushing twice daily with n-HAP containing toothpaste for duration of 28 days produced good dentinal tubule occlusion.

A Comparative Analysis of the Occluding Effects on Dentinal Tubules With the Use of Er:YAG Laser and a Commercially Available Desensitizing Agent: An In Vitro Scanning Electron Microscopic Study.

Objective This in vitro scanning electron microscopic (SEM) study aimed to compare the effect of Er:YAG laser and a commercially launched dental product namely 8% arginine-calcium carbonate on exposed dentinal tubules. Materials and methods A total of 120 tooth samples prepared from healthy maxillary first premolars extracted due to orthodontic reasons were grouped randomly into four groups of 30 samples each - Group I: control group (C); Group II: laser group (LG); Group III: toothpaste group (TP) and Group IV: laser + toothpaste group (LT). The samples in Group II-IV were treated with the respective test agents and were placed under SEM to study the changes in the dentinal tubule number and diameter. The data obtained from SEM were then subjected to statistical analysis using an unpaired t-test. Results The unpaired t-test revealed extreme statistical differences in means between the test and the control groups and among the test groups (p<0.0001). The results we obtained within the scope of this study showed that both the Er:YAG laser (1.3 W, 100 mJ, 3 Hz, 60 s twice) and dentifrice containing 8% arginine-calcium carbonate as the main ingredient can significantly reduce the number and diameter of the open dentinal tubules. Conclusion Our findings have demonstrated that both the 8% arginine-calcium carbonate technology and Er:YAG laser successfully reduced the number and diameter of the open dentinal tubules and hence can be promising agents to deal with dentinal hypersensitivity in future clinical studies.

A Comparative Evaluation of Efficacy of BioMin F and Propolis Containing Toothpastes on Dentinal Tubule Occlusion with and Without Use of an Adjunct 810 nm Diode Laser: An In vitro Scanning Electron Microscope Study.

Introduction: Dentinal hypersensitivity (DH) is a common chronic condition that affects a high proportion of the adult population and is one of the main reasons why patients seek dental opinion and treatment. Despite considerable success in reducing DH, unfortunately, most of the present methods can provide only temporary and unpredictable desensitization. Therefore, new treatment methods that are effective for long periods and at the same time do not have the complications are needed. Recently, two new desensitizing agents BioMin F and Propolis have been introduced for the treatment of DH. Aim: The aim of the study was to compare and evaluate the efficacy of BioMin F and Propolis containing toothpastes on dentinal tubule occlusion with and without the use of an adjunct 810 nm Diode Laser. Materials and Methods: Forty-five freshly extracted teeth were taken out of which thirty were sectioned into halves and divided into four test groups BioMin F, Propolis, BioMin F + Laser, and Propolis + Laser and control group. All the specimens were treated twice a day for 7 days and then evaluated under scanning electron microscope for partial and complete dentinal tubule occlusion. Results: A significantly higher number of completely occluded tubules were seen in BioMin F + laser group followed by Propolis + laser, Biomin F, and Propolis. Conclusion: Combination approach of desensitizing agent and laser provided a better result than the desensitizing agent alone and when compared individually Biomin F was more effective desensitizer as compared to Propolis.

Gut microbial features and dietary fiber intake predict gut microbiota response to resistant starch supplementation.

Resistant starch (RS) consumption can have beneficial effects on human health, but the response, in terms of effects on the gut microbiota and host physiology, varies between individuals. Factors predicting the response to RS are not yet established and would be useful for developing precision nutrition approaches that maximize the benefits of dietary fiber intake. We sought to identify predictors of gut microbiota response to RS supplementation. We enrolled 76 healthy adults into a seven-week crossover study. Participants consumed RS type 2 (RS2), RS type 4 (RS4), and a digestible starch, for ten days each with five-day washout periods in between. We collected fecal and saliva samples and food records before and during each treatment period. We performed 16S rRNA gene sequencing and measured fecal short-chain fatty acids (SCFAs), salivary amylase gene copy number, and salivary amylase activity (SAA). Dietary fiber intake was predictive of relative abundance of several amplicon sequence variants (ASVs) at the end of both RS treatments. Treatment order (the order of consumption of RS2 and RS4), alpha diversity, and a subset of ASVs were predictive of SCFA changes after RS supplementation. SAA was only predictive of the relative abundance of ASVs after digestible starch supplementation. Based on our findings, dietary fiber intake and gut microbiome composition would be informative if assessed prior to recommending RS supplementation. Using a precision nutrition approach to optimize the benefits of dietary fibers such as RS could be an effective strategy to compensate for the low consumption of dietary fiber nationwide.

Biomineralogical signatures of breast microcalcifications.

Microcalcifications, primarily biogenic apatite, occur in cancerous and benign breast pathologies and are key mammographic indicators. Outside the clinic, numerous microcalcification compositional metrics (e.g., carbonate and metal content) are linked to malignancy, yet microcalcification formation is dependent on microenvironmental conditions, which are notoriously heterogeneous in breast cancer. We interrogate multiscale heterogeneity in 93 calcifications from 21 breast cancer patients using an omics-inspired approach: For each microcalcification, we define a "biomineralogical signature" combining metrics derived from Raman microscopy and energy-dispersive spectroscopy. We observe that (i) calcifications cluster into physiologically relevant groups reflecting tissue type and local malignancy; (ii) carbonate content exhibits substantial intratumor heterogeneity; (iii) trace metals including zinc, iron, and aluminum are enhanced in malignant-localized calcifications; and (iv) the lipid-to-protein ratio within calcifications is lower in patients with poor composite outcome, suggesting that there is potential clinical value in expanding research on calcification diagnostic metrics to include "mineral-entrapped" organic matrix.

Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation.

The current compendial sterility test has a 14-day incubation time and is often the time-limiting step in the Assess and Release Process of pharmaceutical products. There is an ever-increasing number of technologies available on the market that have benefits in addition to faster Time to Result, such as standardization and automation of readout (eliminating analyst subjectivity) and improved data integrity (including eliminating the need for contemporaneous verification of the result by another analyst). Regulators have been encouraging the pharmaceutical industry to adopt these innovative systems; however, it has taken a considerable time before receiving the first approvals from various health authorities (including both the European Medicines Agency and Food and Drug Administration) for the use of an alternative and rapid sterility test for the release of sterile drug product lots. This article describes a systematic 9-step approach to the evaluation, equipment qualification, validation, and deployment of alternative sterility tests that can be applied by pharmaceutical companies wanting to take advantage of the numerous benefits of alternative sterility tests. Two case studies are presented to illustrate the validation and implementation approach, including statistical methods. Although most of the steps toward implementation are aligned, the validation and transfer have been approached differently for each of the case studies because of differences in the chosen technology as well as independent company internal decisions to comply with validation guidelines. However, both case studies show successful implementation of an alternative sterility test for sterile drug products with an ∼50% reduced incubation time.

Systemic immune-inflammation index in patients with generalized stage III grade C periodontitis.

OBJECTIVES: Systemic immune-inflammation index (SII) is a novel, inflammatory biomarker whose role in predicting several chronic systemic diseases has been recently identified. However, its association with generalized stage III grade C periodontitis in young adults remains unknown. MATERIAL AND METHODS: The study is a multicentered, double-blind, hospital-based case-control clinical study. Periodontal examination comprised of recording plaque index, sites with bleeding on probing, pocket depth and clinical attachment loss for patients with generalized stage III grade C periodontitis and periodontally healthy group. Complete blood counts were obtained and used for calculating SII, neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio. Collected data were then subjected to statistical analyses. RESULTS: SII was significantly higher in patients with generalized stage III grade C periodontitis compared to periodontally healthy individuals (723.87 vs. 537.74 × 109 /L, p < 0.0001). SII is associated with severe periodontitis in young adults (odds ratio [OR]:11.86, 95% CI 9.61-20.76, p < 0.0001) after adjusting for factors found significant in univariate analysis. Receiver operative curve analysis demonstrated a fair predictive validity of SII in detecting generalized stage III grade C periodontitis in young adults (AUC: 0.766, 95%CI 0.731-0.799, p < 0.0001, sensitivity 81.27%, specificity 76.50% and diagnostic accuracy 78.89%). SII did not exhibit superior predictive validity when compared with NLR in the context of generalized stage III grade C periodontitis (AUC for SII: 0.766, 95%CI 0.731-0.799, AUC for NLR: 0.788, 95% CI 0.754-0.819; p = 0.28). CONCLUSION: SII is associated with generalized stage III grade C periodontitis in young adults.

Enhancing Examination Success: the Cumulative Benefits of Self-Assessment Questions and Virtual Patient Cases.

Purpose: Research on the learning benefits of the feedback-rich formative assessment environment of virtual patient cases (VPCs) has largely been limited to single institutions and focused on discrete clinical skills or topical knowledge. To augment current understanding, we designed a multi-institutional study to explore the distinct and cumulative effects of VPC formative assessments and optional self-assessment questions (SAQs) on exam performance. Method: In this correlational study, we examined the records of 1,692 students on their family medicine (FM) clerkship at 20 medical schools during the 2014-2015 academic year. Schools utilized an established online curriculum, which included family medicine VPCs, embedded formative assessments, context-rich SAQs corresponding with each VPC, and an associated comprehensive family medicine exam. We used mixed-effects modeling to relate the student VPC composite formative assessment score, SAQ completion, and SAQ performance to students' scores on the FM final examination. Results: Students scored higher on the final exam when they performed better on the VPC formative assessments, completed associated SAQs, and scored higher on those SAQs. Students' SAQ completion enhanced examination performance above that explained by engagement with the VPC formative assessments alone. Conclusions: This large-scale, multi-institutional study furthers the body of research on the effect of formative assessments associated with VPCs on exam performance and demonstrates the added benefit of optional associated SAQs. Findings highlight opportunities for future work on the broader impact of formative assessments for learning, exploring the benefits of integrating VPCs and SAQs, and documenting effects on clinical performance and summative exam scores.

Low-Cost, Low-Resource Training Model to Enhance and Sustain Serious Illness Conversation Skills for Internal Medicine Residents.

Background: Funding and limited resources are barriers to required training of residents in serious illness conversation (SIC) skills. Objectives: To examine the effectiveness of a low-cost, low-resource (LCLR) SIC training embedded within a required palliative care rotation. Design: Pre-post prospective cohort study design. Setting/Subjects: Second year internal medicine (IM) residents received an LCLR three-hour training in the SIC Guide (SICG) with a single-faculty member and paired-participant practice replacing actors during a required two-week palliative medicine rotation. Measures: SIC competence checklist measured within simulated patient encounters longitudinally. Results: Twenty resident average SIC checklist scores improved from 11 (95% confidence interval [CI] 9-13) at the beginning of rotation to 19 (95% CI 17-20) at the end of rotation and 18 (95% CI 16-20) at six months after the rotation. Conclusions: LCLR SIC training for IM residents significantly increased the sustained use of basic SIC skills, but was less effective for more complex skills.

A multiple alignment workflow shows the effect of repeat masking and parameter tuning on alignment in plants.

Alignments of multiple genomes are a cornerstone of comparative genomics, but generating these alignments remains technically challenging and often impractical. We developed the msa_pipeline workflow (https://bitbucket.org/bucklerlab/msa_pipeline) to allow practical and sensitive multiple alignment of diverged plant genomes and calculation of conservation scores with minimal user inputs. As high repeat content and genomic divergence are substantial challenges in plant genome alignment, we also explored the effect of different masking approaches and parameters of the LAST aligner using genome assemblies of 33 grass species. Compared with conventional masking with RepeatMasker, a masking approach based on k-mers (nucleotide sequences of k length) increased the alignment rate of coding sequence and noncoding functional regions by 25 and 14%, respectively. We further found that default alignment parameters generally perform well, but parameter tuning can increase the alignment rate for noncoding functional regions by over 52% compared with default LAST settings. Finally, by increasing alignment sensitivity from the default baseline, parameter tuning can increase the number of noncoding sites that can be scored for conservation by over 76%. Overall, tuning of masking and alignment parameters can generate optimized multiple alignments to drive biological discovery in plants.

A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12 to 18 months living in urban slums.

BACKGROUND & AIMS: Biofortification of staple crops with higher levels of micronutrients via traditional breeding methods is a sustainable strategy and can possibly complement fortification and other interventions to target micronutrient deficiencies in low resource settings, particularly among vulnerable populations such as children. We aimed to determine if iron- and zinc-biofortified pearl millet (FeZnPM, Dhanashakti, ICTP-8203Fe)-based complementary feeding improves nutritional status, including iron biomarkers and growth, in children living in urban slums of Mumbai. METHODS: We conducted a randomized controlled trial of FeZnPM among 223 children aged 12-18 months who were not severely anemic at baseline (hemoglobin ≥9.0 g/dL). Children were randomized to receive either FeZnPM or conventional non-biofortified pearl millet (CPM) daily for 9 months. Iron status (hemoglobin, serum ferritin), plasma zinc, and anthropometric indicators (length, weight, mid-upper arm circumference, triceps and subscapular skinfolds) were evaluated at enrollment and throughout the trial. World Health Organization (WHO) anthropometric z-scores were calculated using WHO growth standards. Primary outcomes were hemoglobin and serum ferritin concentrations, and growth, defined as WHO z-scores. An intent to treat approach was used for analyses. We used the Hodges-Lehmann-Sen test to assess the change in primary outcomes between baseline and the last visit and report corresponding 95% confidence intervals. RESULTS: At baseline, 67.7% of children were anemic (hemoglobin <11.0 g/dL) and 59.6% were iron deficient (serum ferritin <12.0 µg/L). FeZnPM did not significantly increase iron biomarkers or improve growth, compared to CPM. In subgroup analyses, FeZnPM improved hemoglobin concentrations in male children, and in children with iron deficiency or iron depletion (serum ferritin <25.0 µg/L) at baseline, relative to CPM. CONCLUSIONS: Daily consumption of FeZnPM-based complementary foods did not significantly impact iron and zinc status or growth in children living in Mumbai's urban slums. However, the intervention significantly improved hemoglobin concentrations among male children and among individuals who were iron-deficient or iron-depleted at baseline. TRIAL REGISTRATION: This trial is registered with Clinicaltrials.gov (ID: NCT02233764), and Clinical Trials Registry of India (ID: REF/2014/10/007731).

A Systematic Approach for the Evaluation, Validation, and Implementation of Automated Colony Counting Systems.

For several years, automated colony counting systems have been available with varying degrees of automation. Ever more sophisticated instruments are now increasingly used in microbiological laboratories of pharmaceutical quality control. In addition to the colony counting device, the instruments are now also equipped with robotic systems performing the entire handling of the petri dishes, e.g., automated internal transportation of petri dishes from the incubator chamber to the instrument's enumeration device and back. Moreover, the subjective evaluation of microbial enumeration tests by analysts is replaced with a more accurate and precise process. This leads to significant improvements to data integrity compliance. Automated colony counting systems also often enable cost reduction in the microbiological laboratory, e.g., by not requiring a contemporaneous verification by a second analyst. They also enable direct integration of count data into an existing laboratory information management system, reducing the hands-on time, costs per test and also preventing human errors caused by manual transcription. Altogether, these instruments will lead to improved monitoring and assurance of control of biopharmaceutical processes and manufacturing environments, as well as shortened cycle times in the supply chain. Regulators are encouraging the biopharmaceutical industry to adopt these innovative systems. For example, this year a BioPhorum member company received the first health authority approvals from EU, US, CH, Canada, Australia, and China for the use of automated colony counting systems for in-process bioburden testing and the release of drug substance lots, with an incubation time reduced by about 50%. Although these approvals are for release testing of drug substance lots, the instruments can also be used for environmental monitoring, testing of water samples, etc. This article describes a systematic 9-step approach to the evaluation, equipment qualification, and deployment of automated colony counting systems, which can be applied by biopharmaceutical companies wanting to take advantage of their numerous benefits.

The Effect of Implicit Bias and Role Misidentification in the Learning Environment.

BACKGROUND: Little is known about the impact of implicit bias our trainees experience in the form of role misidentification in the clinical learning environment. ACTIVITY: We surveyed 540 residents and clinical medical students to determine the frequency and impact of role misidentification. RESULTS AND DISCUSSION: Most respondents (85%, n = 162) experienced role misidentification, directly resulting in heightened emotions that led to guarded behavior. An additional indirect impact for trainees is transmitted through frequent non-promotional role misidentification and personalizing the incidents. Women and trainees with marginalized identities had significant impacts. These findings present an opportunity to improve our understanding of the trainee experience. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40670-021-01475-9.