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.

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.

Assessment of Periodontal status in Patients with Psoriatic Arthritis: A retrospective, case-control study.

BACKGROUND: Psoriatic arthritis (PsA) and periodontitis both represent chronic inflammatory disorders that share similar pathophysiological processes. However, very few studies have been done to address the link between the two diseases which remains poorly understood. The present study aimed to assess and compare the periodontal status in patients suffering from PsA and systemically healthy subjects to identify whether a possible association exists between PsA and periodontitis. MATERIAL AND METHODS: Periodontal parameters - PI, BOP, mGI, PPD and CAL were recorded in 110 patients with PsA and 110 age- and gender-matched systemically healthy patients. Mean values of the periodontal parameters were calculated for both groups and subjected to statistical analysis. Logistic regression analysis was performed to correlate the demographic data with periodontitis. RESULTS: The frequency of periodontitis and mean values of BOP, mGI, PPD and CAL were found to be significantly higher in patients with PsA than in systemically healthy controls. The number of patients with stage III periodontitis was found to be significantly higher in the PsA group. CONCLUSIONS: A possible link exists between periodontitis and psoriatic arthritis, as exhibited by the results of the present study. Dental and medical health professionals should be aware of this relationship depending on which, they should carry out adequate treatment strategies involving periodic periodontal evaluation and care. Key words:Periodontitis, psoriatic arthritis, chronic inflammation, probing pocket depth, clinical attachment loss.

A sorghum practical haplotype graph facilitates genome-wide imputation and cost-effective genomic prediction.

Successful management and utilization of increasingly large genomic datasets is essential for breeding programs to accelerate cultivar development. To help with this, we developed a Sorghum bicolor Practical Haplotype Graph (PHG) pangenome database that stores haplotypes and variant information. We developed two PHGs in sorghum that were used to identify genome-wide variants for 24 founders of the Chibas sorghum breeding program from 0.01x sequence coverage. The PHG called single nucleotide polymorphisms (SNPs) with 5.9% error at 0.01x coverage-only 3% higher than PHG error when calling SNPs from 8x coverage sequence. Additionally, 207 progenies from the Chibas genomic selection (GS) training population were sequenced and processed through the PHG. Missing genotypes were imputed from PHG parental haplotypes and used for genomic prediction. Mean prediction accuracies with PHG SNP calls range from .57-.73 and are similar to prediction accuracies obtained with genotyping-by-sequencing or targeted amplicon sequencing (rhAmpSeq) markers. This study demonstrates the use of a sorghum PHG to impute SNPs from low-coverage sequence data and shows that the PHG can unify genotype calls across multiple sequencing platforms. By reducing input sequence requirements, the PHG can decrease the cost of genotyping, make GS more feasible, and facilitate larger breeding populations. Our results demonstrate that the PHG is a useful research and breeding tool that maintains variant information from a diverse group of taxa, stores sequence data in a condensed but readily accessible format, unifies genotypes across genotyping platforms, and provides a cost-effective option for genomic selection.

ADEA-ADEE Shaping the Future of Dental Education III: The impact of scientific technologies and discoveries on oral health globally.

The central purpose of scientific research and emerging dental health technologies is to improve care for patients and achieve health equity. The Impact of Scientific Technologies and Discoveries on Oral Health Globally workshop conducted joint American Dental Education Association (ADEA) and the Association for Dental Education in Europe (ADEE) 2019 conference, Shaping the Future of Dental Education III, highlighted innovative technologies and scientific discoveries to support personalized dental care in an academic and clinical setting. The 2019 workshop built upon the new ideas and way forward identified in the 2017 ADEE-ADEA joint American Dental Education Association (ADEA) and the Association for Dental Education in Europe (ADEE) 2019 conference, Shaping the Future of Dental Education II held in London. During the most recent workshop the approach was to explore the "Teaching Clinic of the Future". Participants applied ideas proposed by keynote speakers, Dr. Walji and Dr. Vervoorn to educational models (Logic Model) in an ideal dental education setting. It is only through this continuous improvement of our use of scientific and technological advances that dental education will be able to convey to students the cognitive skills required to continually adapt to the changes that will affect them and consequently their patients throughout their career. This workshop was a valuable experience for highlighting opportunities and challenges for all stakeholders when aiming to incorporate new technologies to facilitate patient care and students' education.

Cost Comparison of an On-Premise IT Solution with a Cloud-Based Solution for Electronic Health Records in a Dental School Clinic.

Electronic health records (EHRs) are increasingly moving towards cloud-based web environments. While cloud-based EHRs claim substantial benefits at reduced cost, little cost-benefit research exists for dental schools. The aim of this study was to examine the cost-benefits of a cloud-based EHR compared to an on-premise client-server EHR in the University of Michigan School of Dentistry (U-M Dent). Data were collected in 2016 from the U-M Dent cost-benefit comparison of tangible and intangible factors associated with implementing a new EHR, using the Total Cost of Ownership (TCO) framework from EDUCAUSE. The TCO framework assessed three factors: foundational (overarching aspects: three items), qualitative (intangibles: 56 items), and quantitative (actual costs). Stakeholders performed factor grading, and relative assessment scores were derived for each item as well as the overall factor. The cloud-based EHR solution received higher foundational and qualitative factor summary scores. The overall cost of an on-premise solution over a two-year period was approximately $2,000,000 higher than a cloud-based solution. Cloud solutions did not carry any hidden costs, while such costs accounted for 8% (~$540,000) of the overall costs of the on-premise solution. Across the two-year period, both one-time and ongoing costs were higher for the on-premise solution than the cloud-based solution (by 40.5% and 20.5%, respectively). This study found that a cloud-based EHR system in the U-M Dent offered significant cost savings and unique benefits that were not available with the on-premise EHR solution. Based on cost, the U-M Dent has made a case for cloud-based EHR systems.

Effectiveness of a Trauma-Informed Care Initiative in a State Child Welfare System: A Randomized Study.

Trauma-informed care (TIC) initiatives in state child welfare agencies are receiving more attention, but little empirical evidence exists as to their efficacy. The purpose of this study was to assess changes in self-reported practices and perceptions of child welfare staff involved in a multifaceted, statewide TIC intervention. Ten child welfare offices were matched and randomized to an early or delayed cohort. Staff were surveyed at Time 1 prior to any intervention, Time 2 postintervention for Cohort 1, and Time 3 postintervention for Cohort 2. The survey covered six domains: trauma screening, case planning, mental health and family involvement, progress monitoring, collaboration, and perceptions of the state's overall system performance. Linear mixed modeling assessed the effect of the intervention. Cohort by time interaction was significant for three intervention targets. We demonstrate, using a rigorous study design, the mixed results of a multimodal intervention to improve trauma-informed attitudes, practices, and system performance. TIC initiatives must account for complex, dynamic contextual factors.

Performance-Based Financing Empowers Health Workers Delivering Prevention of Vertical Transmission of HIV Services and Decreases Desire to Leave in Mozambique.

BACKGROUND: Despite increased access to treatment and reduced incidence, vertical transmission of HIV continues to pose a risk to maternal and child health in sub-Saharan Africa. Performance-based financing (PBF) directed at healthcare providers has shown potential to improve quantity and quality of maternal and child health services. However, the ways in which these PBF initiatives lead to improved service delivery are still under investigation. METHODS: Therefore, we implemented a longitudinal-controlled proof-of-concept PBF intervention at health facilities and with community-based associations focused on preventing vertical transmission of HIV (PVT) in rural Mozambique. We hypothesized that PBF would increase worker motivation and other aspects of the workplace environment in order to achieve service delivery goals. In this paper, we present two objectives from the PBF intervention with public health facilities (n=6): first, we describe the implementation of the PBF intervention and second, we assess the impact of the PBF on health worker motivation, key factors in the workplace environment, health worker satisfaction, and thoughts of leaving. Implementation (objective 1) was evaluated through quantitative service delivery data and multiple forms of qualitative data (eg, quarterly meetings, participant observation (n=120), exit interviews (n=11)). The impact of PBF on intermediary constructs (objective 2) was evaluated using these qualitative data and quantitative surveys of health workers (n=83) at intervention baseline, midline, and endline. RESULTS: We found that implementation was challenged by administrative barriers, delayed disbursement of incentives, and poor timing of evaluation relative to incentive disbursement (objective 1). Although we did not find an impact on the motivation constructs measured, PBF increased collegial support and worker empowerment, and, in a time of transitioning implementing partners, decreased against desire to leave (objective 2). CONCLUSION: Areas for future research include incentivizing meaningful quality- and process-based performance indicators and evaluating how PBF affects the pathway to service delivery, including interactions between motivation and workplace environment factors.

Costs of health IT: beginning to understand the financial impact of a dental school EHR.

Health Information Technology (Health IT) constitutes an integral component of the operations of most academic dental institutions nowadays. However, the expenses associated with the acquisition and the ongoing maintenance of these complex systems have often been buried among costs for other electronic infrastructure systems, distributed across various cost centers including unmeasured central campus support, covered centrally and therefore difficult to quantify, and spread over years, denying school administrators a clear understanding of the resources that have been dedicated to Health IT. The aim of this study was to understand the financial impact of Health IT at four similar U.S. dental schools: two schools using a purchased Electronic Health Record (EHR), and two schools that developed their own EHR. For these schools, the costs of creating ($2.5 million) and sustaining ($174,000) custom EHR software were significantly higher than acquiring ($500,000) and sustaining ($121,000) purchased software. These results are based on historical data and should not be regarded as a gold standard for what a complete Health IT suite should cost. The presented data are intended to inform school administrators about the myriad of costs associated with Health IT and give them a point of reference when comparing costs or making estimates for implementation projects.

Use of lecture recordings in dental education: assessment of status quo and recommendations.

This research project was part of a planned initiative at the University of Pittsburgh School of Dental Medicine to incorporate lecture recordings as standard educational support technologies. The goal of an institutional survey was 1) to gather current data about how dental educators across the United States and Canada use lecture recordings; 2) determine dental educators' perceived value and outcomes of using lecture recordings; and 3) develop recommendations based on #1 and #2 for the dental education community. Of the sixty-six North American dental schools at the time of the study, forty-five schools responded to the survey, for a 68 percent response rate. Of the respondents, twenty-eight schools were found to currently conduct lecture recording; these comprised the study sample. This study focused on the dental schools' past experiences with lecture recording; thus, those not currently engaged in lecture recording were excluded from further analysis. The survey questions covered a wide range of topics, such as the scope of the lecture recording, logistics, instructional design considerations, outcomes related to student learning, evaluation and reception, barriers to lecture recording, and issues related to copyright and intellectual property. The literature review and results from the survey showed that no common guidelines for best practice were available regarding lecture recordings in dental education. The article concludes with some preliminary recommendations based on this study.

Framework for e-learning assessment in dental education: a global model for the future.

The framework presented in this article demonstrates strategies for a global approach to e-curricula in dental education by considering a collection of outcome assessment tools. By combining the outcomes for overall assessment, a global model for a pilot project that applies e-assessment tools to virtual learning environments (VLE), including haptics, is presented. Assessment strategies from two projects, HapTEL (Haptics in Technology Enhanced Learning) and UDENTE (Universal Dental E-learning), act as case-user studies that have helped develop the proposed global framework. They incorporate additional assessment tools and include evaluations from questionnaires and stakeholders' focus groups. These measure each of the factors affecting the classical teaching/learning theory framework as defined by Entwistle in a standardized manner. A mathematical combinatorial approach is proposed to join these results together as a global assessment. With the use of haptic-based simulation learning, exercises for tooth preparation assessing enamel and dentine were compared to plastic teeth in manikins. Equivalence for student performance for haptic versus traditional preparation methods was established, thus establishing the validity of the haptic solution for performing these exercises. Further data collected from HapTEL are still being analyzed, and pilots are being conducted to validate the proposed test measures. Initial results have been encouraging, but clearly the need persists to develop additional e-assessment methods for new learning domains.