Decreased brain iron deposition based on quantitative susceptibility mapping correlates with reduced neurodevelopmental status in children with autism spectrum disorder.

To investigate potential correlations between the susceptibility values of certain brain regions and the severity of disease or neurodevelopmental status in children with autism spectrum disorder (ASD), 18 ASD children and 15 healthy controls (HCs) were recruited. The neurodevelopmental status was assessed by the Gesell Developmental Schedules (GDS) and the severity of the disease was evaluated by the Autism Behavior Checklist (ABC). Eleven brain regions were selected as regions of interest and the susceptibility values were measured by quantitative susceptibility mapping. To evaluate the diagnostic capacity of susceptibility values in distinguishing ASD and HC, the receiver operating characteristic (ROC) curve was computed. Pearson and Spearman partial correlation analysis were used to depict the correlations between the susceptibility values, the ABC scores, and the GDS scores in the ASD group. ROC curves showed that the susceptibility values of the left and right frontal white matter had a larger area under the curve in the ASD group. The susceptibility value of the right globus pallidus was positively correlated with the GDS-fine motor scale score. These findings indicated that the susceptibility value of the right globus pallidus might be a viable imaging biomarker for evaluating the neurodevelopmental status of ASD children.

The Lipidomics Reporting Checklist A framework for transparency of lipidomic experiments and repurposing resource data.

The rapid increase in lipidomic studies has led to a collaborative effort within the community to establish standards and criteria for producing, documenting, and disseminating data. Creating a dynamic easy-to-use checklist that condenses key information about lipidomic experiments into common terminology will enhance the field's consistency, comparability, and repeatability. Here, we describe the structure and rationale of the established Lipidomics Minimal Reporting Checklist to increase transparency in lipidomics research.

Moving Forward on Tumor Pathology Research Reporting: A Guide for Pathologists From the World Health Organization Classification of Tumors Living Evidence Gap Map by Tumour Type Group.

Evidence-based medicine (EBM) can be an unfamiliar territory for those working in tumor pathology research, and there is a great deal of uncertainty about how to undertake an EBM approach to planning and reporting histopathology-based studies. In this article, reviewed and endorsed by the Word Health Organization International Agency for Research on Cancer's International Collaboration for Cancer Classification and Research, we aim to help pathologists and researchers understand the basics of planning an evidence-based tumor pathology research study, as well as our recommendations on how to report the findings from these. We introduce some basic EBM concepts, a framework for research questions, and thoughts on study design and emphasize the concept of reporting standards. There are many study-specific reporting guidelines available, and we provide an overview of these. However, existing reporting guidelines perhaps do not always fit tumor pathology research papers, and hence, here, we collate the key reporting data set together into one generic checklist that we think will simplify the task for pathologists. The article aims to complement our recent hierarchy of evidence for tumor pathology and glossary of evidence (study) types in tumor pathology. Together, these articles should help any researcher get to grips with the basics of EBM for planning and publishing research in tumor pathology, as well as encourage an improved standard of the reports available to us all in the literature.

Reporting of Harms in Randomized Controlled Trials Published in Urology Journals: An Updated Analysis.

PURPOSE: Harms are often overlooked, but important, outcomes of randomized controlled trial reporting. Our goal was to determine if harms reporting has improved in high-impact urology journals. MATERIALS AND METHODS: Randomized controlled trials published in The Journal of Urology®, Urology, European Urology, and BJU International in 2012 and 2020 were analyzed. Each randomized controlled trial was evaluated by 2 authors in a masked-duplicate fashion to evaluate for adherence to harms reporting guidelines recommended by the Consolidated Standards of Reporting Trials (CONSORT) group. RESULTS: One hundred and thirty-two published studies met inclusion criteria. Between 2012 and 2020, there was a statistically significant increase in the median number of harms criteria reported between 2012 and 2020 (5.3 vs 7.2; P = .01). Methods criteria demonstrating the greatest improvements included item #3 "which harms were assessed," item #4a "when harm information was collected," and item #4b "methods to attribute harm to intervention." Results sections with the most improvement in reporting include item #6 "reasons for patient withdrawal," item #8a "effect size for harms," and item #8b "stratified serious + minor harms." CONCLUSIONS: Reporting of adverse events in randomized trials published in several top urology journals has demonstrated marked improvement. Studies published in 2020 reported approximately 70% of CONSORT-Harms criteria-an increase of nearly 40% since 2004. While these improvements mark significant change, deficits remain present and should be addressed to provide clinicians with the most complete perspective possible.

Extinction risk predictions for the world's flowering plants to support their conservation.

More than 70% of all vascular plants lack conservation status assessments. We aimed to address this shortfall in knowledge of species extinction risk by using the World Checklist of Vascular Plants to generate the first comprehensive set of predictions for a large clade: angiosperms (flowering plants, c. 330 000 species). We used Bayesian Additive Regression Trees (BART) to predict the extinction risk of all angiosperms using predictors relating to range size, human footprint, climate, and evolutionary history and applied a novel approach to estimate uncertainty of individual species-level predictions. From our model predictions, we estimate 45.1% of angiosperm species are potentially threatened with a lower bound of 44.5% and upper bound of 45.7%. Our species-level predictions, with associated uncertainty estimates, do not replace full global, or regional Red List assessments, but can be used to prioritise predicted threatened species for full Red List assessment and fast-track predicted non-threatened species for Least Concern assessments. Our predictions and uncertainty estimates can also guide fieldwork, inform systematic conservation planning and support global plant conservation efforts and targets.

A dedicated structured data set for reporting of invasive carcinoma of the breast in the setting of neoadjuvant therapy: recommendations from the International Collaboration on Cancer Reporting (ICCR).

AIMS: The International Collaboration on Cancer Reporting (ICCR), a global alliance of major (inter-)national pathology and cancer organisations, is an initiative aimed at providing a unified international approach to reporting cancer. ICCR recently published new data sets for the reporting of invasive breast carcinoma, surgically removed lymph nodes for breast tumours and ductal carcinoma in situ, variants of lobular carcinoma in situ and low-grade lesions. The data set in this paper addresses the neoadjuvant setting. The aim is to promote high-quality, standardised reporting of tumour response and residual disease after neoadjuvant treatment that can be used for subsequent management decisions for each patient. METHODS: The ICCR convened expert panels of breast pathologists with a representative surgeon and oncologist to critically review and discuss current evidence. Feedback from the international public consultation was critical in the development of this data set. RESULTS: The expert panel concluded that a dedicated data set was required for reporting of breast specimens post-neoadjuvant therapy with inclusion of data elements specific to the neoadjuvant setting as core or non-core elements. This data set proposes a practical approach for handling and reporting breast resection specimens following neoadjuvant therapy. The comments for each data element clarify terminology, discuss available evidence and highlight areas with limited evidence that need further study. This data set overlaps with, and should be used in conjunction with, the data sets for the reporting of invasive breast carcinoma and surgically removed lymph nodes from patients with breast tumours, as appropriate. Key issues specific to the neoadjuvant setting are included in this paper. The entire data set is freely available on the ICCR website. CONCLUSIONS: High-quality, standardised reporting of tumour response and residual disease after neoadjuvant treatment are critical for subsequent management decisions for each patient.

Measurement properties of the Iranian version of the breast cancer perception scale (BCPS) according to the COSMIN checklist.

BACKGROUND: Breast cancer is a prevalent cancer characterized by its aggressive nature and potential to cause mortality among women. The rising mortality rates and women's inadequate perception of the disease's severity in developing countries highlight the importance of screening using conventional methods and reliable scales. Since the validity and reliability of the breast cancer perception scale (BCPS) have not been established in the Iranian context. Therefore, this study aimed to determine the measurement properties of the BCPS in women residing in Tabriz, Iran. METHODS: The present study comprised a cross-sectional design, encompassing a sample of 372 Iranian women. The participants were selected through a multi-stage cluster random sampling technique conducted over a period spanning from November 2022 to February 2023. The measurement properties of the Iranian version of BCPS were assessed following the guidelines outlined in the COSMIN checklist. This involved conducting various steps, including the translation process, reliability testing (internal consistency, test-retest reliability, and measurement error), and methodological tests for validity (content validity, face validity, construct validity, and hypothesis testing). The study also investigated the factors of responsiveness and interpretability. The presence of floor and ceiling effects was assessed. RESULTS: The internal consistency of the scale was assessed using Cronbach's alpha, yielding a satisfactory value of 0.68. Additionally, McDonald's omega (95% CI) was computed, resulting in a value of 0.70 (0.66 to 0.74). Furthermore, the test-retest reliability was evaluated, revealing a high intraclass correlation coefficient (ICC) of 0.97 (95% CI: 0.94 to 0.99). The CVI, CVR, and impact scores of the BCPS were determined to be 0.98, 0.95, and 3.70, respectively, indicating favorable levels of content and face validity. To assess construct validity, an examination of the Exploratory Factor Analysis (EFA) was conducted on a set of 24 items. This analysis revealed the presence of six distinct factors, which collectively accounted for 52% of the cumulative variance. The fit indices of the validity model (CFI = 0.91, NFI = 0.96, RFI = 0.94, TLI = 0.90, χ2/df = 2.03, RMSEA = 0.055 and SRMR = 0.055) were confirmed during the confirmatory factor analysis (CFA). The overall score of BCPS exhibited a ceiling effect of 0.3%. The floor effect observed in the overall score (BCPS) was found to be 0.5%. Concerning the validation of the hypothesis, Spearman's correlation coefficient of 0.55 was obtained between the BCPS and the QLICP-BR V2.0. This correlation value signifies a statistically significant association. Furthermore, it is worth noting that the minimum important change (MIC) of 3.92 exhibited a higher value compared to the smallest detectable change (SDC) of 3.70, thus suggesting a satisfactory level of response. CONCLUSIONS: The obtained findings suggest that the Iranian version of the BCPS demonstrates satisfactory psychometric properties for assessing the perception of breast cancer among Iranian women. Furthermore, it exhibits favorable responsiveness to clinical variations. Consequently, it can serve as a screening instrument for healthcare professionals to comprehend breast cancer and as a reliable tool in research endeavors.

Aberrant behavior checklist in youth with Prader-Willi syndrome: Preliminary study of cross-sectional and longitudinal behavior characterization.

Prader-Willi syndrome (PWS) is a rare genetic disorder caused by the loss of paternal genes on chromosome 15. The Aberrant Behavior Checklist (ABC) is a standardized rating scale for assessing problematic behaviors in persons with developmental disabilities. Our study aims to describe ABC scores in youth with PWS and track their change over time. The analysis included 69 patients. Mean ABC scores were compared in four age groups (5-8, 9-12, 13-16, and 17-22 years). A statistically significant difference was found only in the Irritability subscale, with lower scores in the 5-8 age group compared to the 9-12 age group. For change over time, scores for Irritability, Lethargy, Stereotypic Behavior, Hyperactivity subscales, and Total score were likely to decrease after age 12. Irritability subscale scores of males were predicted to increase more than those of females between ages of 5 and 12 . The Lethargy score in the nondeletion group had a greater reduction than the deletion group in the 12-20 year range. This study highlights the need for systematic collection and characterization of behavioral data given the burden of maladaptive behaviors that often persist for a lifetime.

Oncology clinicians' feelings towards patients presented in supervision: A pre-post assessment using the feeling word checklist.

OBJECTIVE: Clinical supervision of oncology clinicians by psycho-oncologists is an important means of psychosocial competence transfer and support. Research on this essential liaison activity remains scarce. The aim of this study was to assess the impact of supervision on oncology clinicians' feelings towards patients presented in supervision. METHODS: Oncology clinicians' (n = 23) feelings towards patients presented in supervision were assessed with the Feeling Word Checklist (FWC). The FWC was filled in by supervisees prior and after their supervision sessions (n = 91), which were conducted by experienced supervisors (n = 6). Pre- post-modification of feelings was evaluated based on a selection of FWC items, which were beforehand considered as likely to change in a beneficial supervision. Items were evaluated on session level using t-tests for dependent groups. Composite scores were calculated for feelings expected to raise and feelings expected to decrease and analysed on the level of supervisees. RESULTS: Feelings related to threats, loss of orientation or hostility such as "anxious", "overwhelmed", "impotent", "confused", "angry", "depreciated" and "guilty" decreased significantly after supervision, while feelings related to the resume of the relationship ("attentive", "happy"), a better understanding of the patient ("empathic"), a regain of control ("confident") and being "useful" significantly increased. Feeling "interested" and "calm" remained unchanged. Significant increase or decrease in the composite scores for supervisees confirmed these results. CONCLUSIONS: This study demonstrates modification of feelings towards patients presented in supervision. This modification corresponds to the normative, formative, and especially restorative function (support of the clinician) of supervision.

Systematic Review Assessing Quality of the Survey Literature in Surgery.

INTRODUCTION: The use of survey methodology in surgical research has proliferated in recent years, but the quality of these surveys and of their reporting is understudied. METHODS: We conducted a comprehensive review of surgical survey literature (January 2022-July 2023) via PubMed in July 2023. Articles which (1) reported data gleaned from a survey, (2) were published in an English language journal, (3) targeted survey respondents in the United States or Canada, and (4) pertained to general surgery specialties were included. We assessed quality of survey reports using the Checklist for Reporting Of Survey Studies (CROSS) guidelines. Articles were evaluated for concordance with CROSS using a dichotomous (yes or no) scale. RESULTS: Initial literature search yielded 481 articles; 57 articles were included in analysis based on the inclusion criteria. The mean response rate was 37% (range 0.62%-98%). The majority of surveys were administered electronically (n = 50, 87.8%). No publications adhered to all 40 CROSS items; on average, publications met 61.2% of items applicable to that study. Articles were most likely to adhere to reporting criteria for title and abstract (mean adherence 99.1%), introduction (99.1%), and discussion (92.4%). Articles were least adherent to items related to methodology (42.6%) and moderately adherent to items related to results (76.6%). Only five articles cited CROSS guidelines or another standardized survey reporting tool (10.5%). CONCLUSIONS: Our analysis demonstrates that CROSS reporting guidelines for survey research have not been adopted widely. Surveys reported in surgical literature may be of variable quality. Increased adherence to guidelines could improve development and dissemination of surveys done by surgeons.

Consolidated Health Economic Evaluation Reporting Standards for Interventions That Use Artificial Intelligence (CHEERS-AI).

OBJECTIVES: Economic evaluations (EEs) are commonly used by decision makers to understand the value of health interventions. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022) provide reporting guidelines for EEs. Healthcare systems will increasingly see new interventions that use artificial intelligence (AI) to perform their function. We developed Consolidated Health Economic Evaluation Reporting Standards for Interventions that use AI (CHEERS-AI) to ensure EEs of AI-based health interventions are reported in a transparent and reproducible manner. METHODS: Potential CHEERS-AI reporting items were informed by 2 published systematic literature reviews of EEs and a contemporary update. A Delphi study was conducted using 3 survey rounds to elicit multidisciplinary expert views on 26 potential items, through a 9-point Likert rating scale and qualitative comments. An online consensus meeting was held to finalize outstanding reporting items. A digital health patient group reviewed the final checklist from a patient perspective. RESULTS: A total of 58 participants responded to survey round 1, 42, and 31 of whom responded to rounds 2 and 3, respectively. Nine participants joined the consensus meeting. Ultimately, 38 reporting items were included in CHEERS-AI. They comprised the 28 original CHEERS 2022 items, plus 10 new AI-specific reporting items. Additionally, 8 of the original CHEERS 2022 items were elaborated on to ensure AI-specific nuance is reported. CONCLUSIONS: CHEERS-AI should be used when reporting an EE of an intervention that uses AI to perform its function. CHEERS-AI will help decision makers and reviewers to understand important AI-specific details of an intervention, and any implications for the EE methods used and cost-effectiveness conclusions.

A deeper consideration of sex/gender in quantitative health research: a checklist for incorporating multidimensionality, variety, embodiment, and intersectionality throughout the whole research process.

BACKGROUND: There is a growing awareness of the need to adequately integrate sex and gender into health-related research. Although it is widely known that the entangled dimensions sex/gender are not comprehensively considered in most studies to date, current publications of conceptual considerations and guidelines often only give recommendations for certain stages of the research process and - to the best of our knowledge - there is a lack of a detailed guidance that accompanies each step of the entire research process. The interdisciplinary project "Integrating gender into environmental health research" (INGER) aimed to fill this gap by developing a comprehensive checklist that encourages sex/gender transformative research at all stages of the research process of quantitative health research. In the long term this contributes to a more sex/gender-equitable research. METHODS: The checklist builds on current guidelines on sex/gender in health-related research. Starting from important key documents, publications from disciplines involved in INGER were collected. Furthermore, we used a snowball method to include further relevant titles. The identification of relevant publications was continued until saturation was reached. 55 relevant publications published between 2000 and 2021 were identified, assessed, summarised and included in the developed checklist. After noticing that most publications did not cover every step of the research process and often considered sex/gender in a binary way, the recommendations were modified and enriched based on the authors' expertise to cover every research step and to add further categories to the binary sex/gender categories. RESULTS: The checklist comprises 67 items in 15 sections for integrating sex/gender in quantitative health-related research and addresses aspects of the whole research process of planning, implementing and analysing quantitative health studies as well as aspects of appropriate language, communication of results to the scientific community and the public, and research team composition. CONCLUSION: The developed comprehensive checklist goes beyond a binary consideration of sex/gender and thus enables sex/gender-transformative research. Although the project INGER focused on environmental health research, no aspects that were specific to this research area were identified in the checklist. The resulting comprehensive checklist can therefore be used in different quantitative health-related research fields.

Feature group partitioning: an approach for depression severity prediction with class balancing using machine learning algorithms.

In contemporary society, depression has emerged as a prominent mental disorder that exhibits exponential growth and exerts a substantial influence on premature mortality. Although numerous research applied machine learning methods to forecast signs of depression. Nevertheless, only a limited number of research have taken into account the severity level as a multiclass variable. Besides, maintaining the equality of data distribution among all the classes rarely happens in practical communities. So, the inevitable class imbalance for multiple variables is considered a substantial challenge in this domain. Furthermore, this research emphasizes the significance of addressing class imbalance issues in the context of multiple classes. We introduced a new approach Feature group partitioning (FGP) in the data preprocessing phase which effectively reduces the dimensionality of features to a minimum. This study utilized synthetic oversampling techniques, specifically Synthetic Minority Over-sampling Technique (SMOTE) and Adaptive Synthetic (ADASYN), for class balancing. The dataset used in this research was collected from university students by administering the Burn Depression Checklist (BDC). For methodological modifications, we implemented heterogeneous ensemble learning stacking, homogeneous ensemble bagging, and five distinct supervised machine learning algorithms. The issue of overfitting was mitigated by evaluating the accuracy of the training, validation, and testing datasets. To justify the effectiveness of the prediction models, balanced accuracy, sensitivity, specificity, precision, and f1-score indices are used. Overall, comprehensive analysis demonstrates the discrimination between the Conventional Depression Screening (CDS) and FGP approach. In summary, the results show that the stacking classifier for FGP with SMOTE approach yields the highest balanced accuracy, with a rate of 92.81%. The empirical evidence has demonstrated that the FGP approach, when combined with the SMOTE, able to produce better performance in predicting the severity of depression. Most importantly the optimization of the training time of the FGP approach for all of the classifiers is a significant achievement of this research.

The factor structure of the Hopkins Symptom Checklist 25 among persons seeking HIV testing.

Rates of anxiety and depression are high among individuals living with HIV. The Hopkins Symptom Checklist (HSCL) is a screening tool to identify symptoms of depression and anxiety. The objective of this study was to determine the factor structure of the 25-item HSCL in a population-based sample of individuals seeking HIV testing in the Western Cape in South Africa. Participants volunteered for HIV testing at two non-medical HIV testing sites in the Western Cape. We used convenience sampling to administer the scale prior to their undergoing HIV testing. Data were analysed using exploratory factor analysis, using an extraction method of principal components with Promax (oblique) rotation. The Cronbach's alpha reliability indices were calculated for each of the independent factors to determine internal consistency. Factor analysis revealed a three-factor structure that explained 56.86% of the total variance. These factors included depression (14 items), anxiety (7 items) and somatic symptoms (4 items). Alpha levels ranged from 0.67 to 0.94. We found that the HSCL is a reliable measure for depression and anxiety, and consists of 3 distinguishable factors depression, anxiety, and somatic symptoms.

Making certain that noninvasive therapy for vasovagal syncope has failed before proceeding to invasive interventions.

There is a perceived need to express concisely the advice of guidelines in the context of consideration of invasive management of highly symptomatic vasovagal syncope. In response to this need the table is presented as a checklist and the text adds explanation and details. It is anticipated that this will prove to be of value for clinicians.

Validity and Reliability of the Turkish Version of Mild Behavioral Impairment Checklist in Patients With Cognitive Impairment.

BACKGROUND AND OBJECTIVE: The Mild Behavioral Impairment-Checklist (MBI-C) was developed to detect and standardize neuropsychiatric symptoms. The objective of this study was to evaluate the Turkish adaptation, validity, and reliability of the MBI-C. METHODS: The sample of our study consisted of 80 patients with cognitive impairment and a control group with 113 participants whose cognitive impairment was not detected in standard tests. Participants were evaluated with the Standardized Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Geriatric Depression Scale-15 (GDS-15), MBI-C and Neuropsychiatric Inventory (NPI). RESULTS AND CONCLUSION: In the reliability analysis, the Cronbach-alpha value for MBI-C was found to be .810. In the ROC analysis performed with the total MBI-C score, the area under the curve (AUC) was calculated as .821 and the cut-off score was determined as 8.5; sensitivity was calculated as .77 and specificity as .83. A strong positive correlation was found between test-retest MBI-C scores (r = .886, P < .0019). A strong positive correlation was found between MBI-C and NPI scores (r = .964, P < .001). MBI-C scores were significantly negatively correlated with MMSE and MoCA scores and positively correlated with GDS-15 scores. The results of our study showed that the Turkish version of the MBI-C is a valid and reliable measurement.

Providing a framework for evaluation disease registry and health outcomes Software: Updating the CIPROS checklist.

BACKGROUND AND AIMS: Properly designed and implemented registry systems play an important role in improving health outcomes and reducing care costs, and can provide a true representation of clinical practice, disease outcomes, safety, and efficacy. Therefore, the aim of this study was to redesign and develop a checklist with items for a patient registry software system (CIPROS) Checklist. METHOD: The study is descriptive-cross-sectional. The extraction of the data elements of the checklist was first done through a comprehensive review of the texts in PubMed, Science Direct and Scopus databases and receiving articles related to the evaluation of registry systems. Based on the extracted data, a five-point Likert scale questionnaire was created and 30 experts in this field were asked for their opinions using the two-step Delphi method. RESULTS: A total of 100 information items were determined as a registry software evaluation checklist. This checklist included 12 groups of software architecture factors, development, interfaces and interactivity, semantics and standardization, internationality, data management, data quality and usability, data analysis, security, privacy, organizational, education and public factors. CONCLUSION: By using the results of this research, it is possible to identify the defects and possible strengths of the registry software and put it at the disposal of the relevant officials to make a decision in this field. In this way, among the designers and developers of these softwares, the best and most appropriate ones are selected with the needs of the registry programs.

Implementation of the TALK© clinical self-debriefing tool in operating theatres: a single-centre interventional study.

BACKGROUND: Debriefing in operating theatre environments leads to benefits in mortality, efficiency, productivity, and safety culture; however, it is still not regularly performed. TALK© is a simple and widely applicable team self-debriefing method to collaboratively learn and improve. METHODS: An interventional study introducing TALK© for voluntary clinical debriefing was carried out in operating theatre environments in a UK National Health Service hospital over 18 months. It explored compliance with the Five Steps to Safer Surgery and changes in behaviour in surgical teams regarding consideration and completion of debriefing. RESULTS: Team briefing and compliance with the WHO surgical safety checklist were performed consistently (>95% and >98%, respectively) throughout the study, which included 460 surgical lists. Consideration of debriefing increased at all data collection periods after intervention, from 35.6% to 60.3-97.4% (P≤0.003). Performance of debriefing, which was 23.3% at baseline, reached 39% at 6 months (P=0.039). Team planning of actions for improvement during debriefing also increased (P<0.001). A decline in performance of debriefing and subsequent improvement actions was observed after 6 months, albeit rates were above baseline at 18 months. The most reported reason not to carry out a debriefing was 'lack of issues'. After implementation, nurses and allied healthcare professionals increased their contribution to initiating and leading debriefing. Reported barriers were <18% at baseline, and decreased after intervention. CONCLUSIONS: A simple intervention introducing TALK© for voluntary debriefing in theatres prompted significant changes in team behaviour and sustained growth regarding consideration and performance of debriefing, especially in the first 6 months.

Assessment of pharmacovigilance guidelines in the Southern African Development Community: A document review.

BACKGROUND: Lack of harmonization in pharmacovigilance (PV) practice in resource-limited states in Africa has led to differentiation and marginalization, thus creating an environment where weak or absent PV systems may benefit from regional guidelines. PURPOSE: To compare the PV guidelines of Southern African Development Community (SADC) member states to international guidelines and identify areas for improvement for aligning PV practice within the SADC region. METHODS: We utilized a 73-item checklist to assess the PV guidelines of the SADC member states. Checklist parameters were rated using binary scoring. RESULTS: Only seven (Botswana, Mauritius, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe) of the 16 SADC member states had guidelines to assess. Of these, only four had supporting legislation. All seven national medicines regulatory authorities (NMRA)'s guidelines required reporting of local serious adverse drug reactions (ADRs). Four NMRAs implemented device vigilance; none specified submission timelines for ADRs associated with substandard or falsified medicines. Only three NMRAs required electronic transmission of individual case safety reports in the E2B format. Five NMRAs mandated safety monitoring during interventional clinical trials. Five NMRAs required aggregate reporting through periodic safety update reports. Only two NMRAs required submission of the development safety update report. Regarding risk management, four NMRAs required notification of actions taken by foreign NMRAs and four NMRAs expected to review Dear Healthcare Professional Letters before distribution by the marketing authorization holder. CONCLUSIONS: Areas for improvement of guidelines to establish common process standards and allow for synchronized submissions of comparable data to SADC NMRAs are provided.

Impact of team performance on the surgical safety checklist on patient outcomes: an operating room black box analysis.

BACKGROUND: Surgical safety checklists reduce adverse events, but monitoring adherence to checklists is confounded by observation bias. The ORBB platform can monitor checklist compliance and correlate compliance with outcomes. This study aims to evaluate the association between checklist compliance and patient outcomes using the ORBB platform. METHODS: This is a retrospective analysis of data from the electronic medical record of cases performed in ORBB-equipped operating rooms at a single quaternary referral center. All patients who did not opt out and underwent surgery at UT Southwestern Medical Center in ORBB-equipped rooms from August 2020 to September 2022 were included. The ORBB platform was set-up in five operating rooms and surgical safety checklist compliance was monitored by way of AI-based video review. RESULTS: Overall, 4581 patients were included in this analysis.. Performance on the checklist was associated with lower mortality (OR, 0.96; 95% CI, 0.94-0.98; P < 0.05), and decreased length of stay (estimate [E]: -0.02 days; 95% CI, -0.03 to -0.005; P < 0.05). Performance during "timeouts" was associated with mortality (OR, 0.97; 95% CI, 0.94-0.99; P < 0.05). "Debriefings" were independently associated with mortality (OR, 0.98; 95% CI, 0.96-0.99; P < 0.05), length of stay (Estimate, -0.0009 days; 95% CI, -0.02 to -0.001; P < 0.05), and ICU admission (OR, 0.99; 95% CI, 0.98-0.99; P < 0.05). CONCLUSION: Procedures performed by surgical teams who performed better on the surgical safety checklist tended to have better outcomes. This innovative technology could substantially enhance our ability to understand and mitigate threats to patients in real-time.