Developmental validation of the ANDE™ rapid DNA system with FlexPlex™ assay for arrestee and reference buccal swab processing and database searching

A developmental validation was performed to demonstrate reliability, reproducibility and robustness of the ANDE System with the FlexPlex assay, including an integrated Expert System, across a number of laboratories and buccal sample variations. Previously, the related DNAscan™/ANDE 4C Rapid DNA System using the PowerPlex^®16 assay and integrated Expert System Software received NDIS approval in March 2016. The enhanced ANDE instrument, referred to as ANDE 6C, and the accompanying 6-dye, 27-locus STR assay, referred to as FlexPlex, have been developed to be compatible with all widely used global loci, including the expanded set of the CODIS core 20 loci.Six forensic and research laboratories participated in the FlexPlex Rapid DNA developmental validation experiments, testing a total of 2045 swabs, including those obtained from 1387 unique individuals. The goal of this extensive and comprehensive validation was to thoroughly evaluate and document the ANDE System and its internal Expert System to reliably genotype reference buccal swab samples in a manner compliant with the FBI’s Quality Assurance Standards and the NDIS Operational Procedures.The ANDE System, including automated Expert System analysis, generated reproducible and concordant results for buccal swabs when testing various instruments at different laboratories by a number of different operators. When testing a number of non-human DNAs, including oral bacteria, the ANDE System and FlexPlex assay demonstrated limited cross-reactivity. Potential PCR inhibitors were evaluated as part of the validation and no inhibition was detected. Reproducible and concordant profiles were generated from buccal swab samples collected with a limit of detection appropriate for buccal swab collections from arrestees. The precision and resolution of the System met industry standards for detection of microvariants and single base resolution.The integrated Expert System appropriately demonstrated the ability to correctly pass or fail profiles for CODIS upload without human review. During this comprehensive developmental validation, the ANDE System successfully interpreted over 2000 samples tested with over 99.99% concordant alleles. The data package described herein led to the ANDE System with the FlexPlex assay receiving NDIS approval in June 2018.     

The 2018 International Consensus Meeting Minor Criteria for Chronic Hip and Knee Periprosthetic Joint Infection: Validation From a Single Center

BackgroundRecently, a revised definition of the minor criteria scoring system for diagnosing periprosthetic joint infection (PJI) was developed by the second International Consensus Meeting on musculoskeletal infection. The new system combines preoperative and intraoperative findings, reportedly achieving high sensitivity and specificity. We aimed to validate the modified scoring system at a high-volume center.MethodsWe retrospectively reviewed patients who underwent a revision total hip or knee arthroplasty at our institution from May 2015 to August 2018. Serum C-reactive protein, synovial white blood cell count and polymorphonuclear percentage, leukocyte esterase test, alpha-defensin, microbiological and histologic results, and documented existence of sinus tract and intraoperative purulence were available for all patients. Cases with at least 1 major criterion were considered as infected. Using the new minor criteria, a score of ≥6 reflects PJI, while a score <3 can be considered as noninfected. Sensitivity, specificity, mean accuracy (ACC), positive predictive value (PPV), and negative predictive value (NPV) were analyzed.ResultsA total of 345 cases were included. A cutoff score of ≥6 points had the following diagnostic performance: area under the curve (AUC) = 0.90; ACC = 0.88; sensitivity = 0.96; specificity = 0.84; PPV = 0.70; NPV = 0.98. Diagnostic performance was better for the hip (AUC = 0.92; ACC = 0.90; sensitivity = 0.96; specificity = 0.86; PPV = 0.81; NPV = 0.98) than the knee (AUC = 0.89; ACC = 0.85; sensitivity = 0.95; specificity = 0.83; PPV = 0.59; NPV = 0.98).ConclusionThe modified scoring system proposed by the 2018 International Consensus Meeting in diagnosing PJI showed high sensitivity and a good performance, especially as rule-out diagnostic criteria. The cutoff level seems to be different between the hip and knee. Further validation studies considering the acknowledged limitations are recommended.     

Acute total hip arthroplasty for older patients with acetabular fractures: A meta-analysis

ObjectiveMultiple treatment options for acetabular fractures in geriatric patients exist. However, no large-scale studies have reported the outcomes of acute total hip arthroplasty (THA) in this patient population. We systematically evaluated all available evidence to characterize clinical outcomes, complications, and revisions of acute THA for acetabular fractures in geriatric patients.MethodsMeta-analysis of 21 studies of 430 acetabular fractures with mean follow-up of 44 months (range, 17−97 months). Two independent researchers searched and evaluated the databases of Ovid, Embase, and United States National Library of Medicine using a Boolean search string up to December 2019. Population demographics and complications, including presence of heterotopic ossification (HO), dislocation, infection, revision rate, neurological deficits, and venous thromboembolic event (VTE), were recorded and analyzed.ResultsWeighted mean Harris Hip Score was 83.3 points, and 20% of the patients had reported complications. The most common complication was HO, with a rate of 19.5%. Brooker grade III and IV HO rates were lower at 6.8%. Hip dislocation occurred at a rate of 6.1%, 4.1% of patients developed VTE, deep infection occurred in 3.8%, and neurological complications occurred in 1.9%. Although the revision rate was described in most studies, we were unable to perform a survival analysis because the time to each revision was described in only a few studies. The revision rate was 4.3%.ConclusionsAcute THA is a viable option for treatment of acetabular fracture and can result in acceptable clinical outcomes and survivorship rates in older patients but with an associated complication rate of approximately 20%. Considering the limited treatment options, THA might be a viable alternative for appropriately selected patients.     

Evaluating healthcare education: Issues and methods

This paper analyses the methodological issues inherent in evaluating healthcare education and considers approaches for addressing these.Recent policies have exhorted practitioners to base their practice on evidence; however in healthcare education the evidence base is not extensive. Whilst educational evaluation has advanced in the last decades, standardised designs and toolkits are not available. Each evaluation has different aims and occurs in specific contexts, thus the design has to fit the circumstances, yet meet the challenge of scientific credibility. Indicators of educational processes and outcomes are not scientifically verified; no toolkit of standardised ‘off-the-shelf’ valid, reliable and sensitive measures exists. The evidence base of educational practice is largely derived from small-scale, single case studies; the majority of measures are self-devised, unvalidated tools of unproven reliability, thus meta-synthesis is not appropriate and results are not generalisable. Healthcare educational evaluators need valid and reliable assessments of both knowledge acquisition and its application to practice. The need to establish and explain attribution, i.e. the relationship between educational inputs and outcomes is complex and requires experimental/quasi-experimental design. In addition, educational evaluators face the pragmatic challenge of practice in healthcare contexts, where confounding variables are hard to control and resources are scarce.     

Validating the eating disorder inventory (EDI‐2) in two danish samples: A comparison between female eating disorder patients and females from the general population

The Eating Disorder Inventory, Version 2 (EDI‐2) is a questionnaire used clinically and in research all over the world. EDI‐2 is cross‐culturally valid, yet normative values may depend on culture. Norms and reliability of the Danish version have to date been lacking, and will be presented in this article, comparing patients (N = 575) and controls (N = 881). Also, internal reliability of scales is tested for both groups. Differences between norms of the Danish and the North American version of EDI were small but significant for all scales except asceticism (eating disorder patients) and ineffectiveness, interpersonal distrust and maturity fears (normal controls). For both groups the internal consistency was >0.70 for all subscales except asceticism. Although differences across the eating disorder diagnostic groups were dubious, the EDI‐2 is useful to screen for eating problems in the general population as well as to rate progress and outcome among eating disorder patients. Copyright © 2009 John Wiley & Sons, Ltd and Eating Disorders Association.     

Bayesian estimation of a random effects heteroscedastic probit model

Summary Bayesian analysis is given of a random effects binary probit model that allows for heteroscedasticity. Real and simulated examples illustrate the approach and show that ignoring heteroscedasticity when it exists may lead to biased estimates and poor prediction. The computation is carried out by an efficient Markov chain Monte Carlo sampling scheme that generates the parameters in blocks. We use the Bayes factor, cross‐validation of the predictive density, the deviance information criterion and Receiver Operating Characteristic (ROC) curves for model comparison.     

‘Translation is not enough’: using the Global Person Generated Index (GPGI) to assess individual quality of life in Bangladesh,Thailand, and Ethiopia

Currently few subjective measures of Quality of Life (QoL) are available for use in developing countries, which limits their theoretical, methodological, and practical contribution (for example, exploring the relationship between economic development and QoL, and ensuring effective and equitable service provision). One reason for this is the difficulty of ensuring that translated measures preserve conceptual, item, semantic, operational, measurement; and functional equivalence (Herdman, M., Fox-Rushby, J., & Badia, X. (1998). Quality of Life Research, 7, 331), which is illustrated by an account of the translation, pre-piloting, and administration of a new individualised QoL measure, the Global Person Generated Index or 'GPGI'. The GPGI is based on the widely used Patient Generated Index (Ruta, Camfield, & Martin, (2004) Quality of Life Research, 13, 1545.) and offers many of the advantages of the participatory approaches commonly used in developing countries, with added methodological rigour, and quantitative outcomes. It was successfully validated in Bangladesh, Thailand, and Ethiopia, using quantitative and qualitative methods--open-ended, semi-structured interviews (SSIs), conducted immediately post-administration. Both the measure and method of 'qualitative validation' described later in the paper offer an exciting alternative for future researchers and practitioners in this field. The quantitative results suggest the GPGI shows cultural sensitivity, and is able to capture both the areas that are important to respondents, and aspects of life one would expect to impact on QoL in developing countries. There were strong correlation between scores from the GPGI and SSIs for the area of health, and moderate correlations for 'material wellbeing' (MWB)('Material wellbeing' refers to respondents' perceptions of their achievement in the areas of farming, debt reduction, assets, crops, livestock, job, land, property, and agriculture) and children. Weak to moderate correlations were observed between the Satisfaction with Life Scale and the GPGI; however, the highest coefficient was between the GPGI and the most conceptually similar item. Statistically significant differences were seen in GPGI scores between rich and poor, urban and rural respondents, and different countries. Health and material wellbeing scores, derived from the SSIs, also showed a linear relationship with GPGI scores, with a suggestion of curvilinearity at the higher levels, as predicted by a general QoL causal model. In conclusion, the GPGI has great potential for use in this area, especially when supported by extensive interviewer training, and supplemented with a cognitive appraisal schedule.