Incorporating Molecular Data Into Treatment Decision Making in Gastroesophageal and Pancreaticobiliary Cancers: Timing and Strategies.

Gastroesophageal (GE) and pancreatobiliary (PB) cancers represent a significant clinical challenge. In this context, it is critical to understand the key molecular targets within these malignancies including how they are assayed for as well as the clinical actionability of these targets. Integrating biomarkers into the standard of care presents a critical avenue for refining treatment paradigms. This review aims to explore these complexities, offering insights into the optimal sequencing of chemotherapy and targeted therapies and their utility in the management of GE and PB cancers. The timely integration of promising investigational therapies into clinical practice has broader implications around strategies for future clinical trial designs, which would pave the way for advancements in the management of GE and PB cancers. This review provides guidance in navigating the evolving landscape of GE and PB cancer care, which ultimately will drive forward progress in the field and lead to improved patient outcomes.

Computational approaches identify a transcriptomic fingerprint of drug-induced structural cardiotoxicity.

Structural cardiotoxicity (SCT) presents a high-impact risk that is poorly tolerated in drug discovery unless significant benefit is anticipated. Therefore, we aimed to improve the mechanistic understanding of SCT. First, we combined machine learning methods with a modified calcium transient assay in human-induced pluripotent stem cell-derived cardiomyocytes to identify nine parameters that could predict SCT. Next, we applied transcriptomic profiling to human cardiac microtissues exposed to structural and non-structural cardiotoxins. Fifty-two genes expressed across the three main cell types in the heart (cardiomyocytes, endothelial cells, and fibroblasts) were prioritised in differential expression and network clustering analyses and could be linked to known mechanisms of SCT. This transcriptomic fingerprint may prove useful for generating strategies to mitigate SCT risk in early drug discovery.

3D printed temporal bones for preoperative simulation and planning.

OBJECTIVE: Demonstrate the utility of 3D printed temporal bone models in individual patient preoperative planning and simulation. METHODS: 3D models of the temporal bone were made from 5 pediatric and adult patients at a tertiary academic hospital with challenging surgical anatomy planned for cochlear implantation or exteriorization of cholesteatoma with complex labyrinthine fistula. The 3D models were created from CT scan used for preoperative planning, simulation and intraoperative reference. The utility of models was assessed for ease of segmentation and production and impact on surgery in regard to reducing intraoperative time and costs, improving safety and efficacy. RESULTS: Three patients received cochlear implants, two exteriorization of advanced cholesteatoma with fistulas (1 internal auditory canal/cochlea, 1 all three semicircular canals). Surgical planning and intraoperative referencing to the simulations by the attending surgeon and trainees significantly altered original surgical plans. In a case of X-linked hereditary deafness, optimal angles and rotation maneuvers for cochlear implant insertion reduced operating time by 93 min compared to the previous contralateral side surgery. Two cochlear implant cases planned for subtotal petrosectomy approach due to aberrant anatomy were successfully approached through routine mastoidectomy. The cholesteatoma cases were successfully exteriorized without necessitating partial labyrinthectomy or labyrinthine injury. There were no complications. CONCLUSION: 3D printed models for simulation training, surgical planning and use intraoperatively in temporal bone surgery demonstrated significant benefits in designing approaches, development of patient-specific techniques, avoidance of potential or actual complications encountered in previous or current surgery, and reduced surgical time and costs.

Sarcopenia prevalence using handgrip strength or chair stand performance in adults living with type 2 diabetes mellitus.

BACKGROUND: The updated European Working Group on Sarcopenia in Older People (EWGSOP2) recommends handgrip strength (HGS) and the chair stand test (CST) to assess muscle strength, with the CST being a convenient proxy for lower limb strength. However, adiposity may differentially influence these strength criteria and produce discrepant sarcopenia prevalence. OBJECTIVE: To determine the prevalence of sarcopenia using HGS or the CST, and to investigate the associations between these strength criteria and adiposity in adults with type 2 diabetes mellitus. METHODS: The EWGSOP2 definition was used to assess the prevalence of probable (low muscle strength), confirmed (plus low muscle mass) and severe (plus poor physical performance) sarcopenia. Linear regression models were used to study the association between different measures of muscle strength and adiposity. RESULTS: We used data from 732 adults with type 2 diabetes mellitus (35.7% female, aged 64 ± 8 years, body mass index 30.7 ± 5.0 kg/m2). Using the CST compared with HGS produced a higher prevalence of probable (31.7% vs. 7.1%), confirmed (5.6% vs. 1.6%) and severe (1.0% vs. 0.3%) sarcopenia, with poor agreement between strength criteria to identify probable sarcopenia. CST performance, but not HGS, was significantly associated with all measures of adiposity in unadjusted and adjusted models. CONCLUSIONS: Higher levels of adiposity may impact CST performance, but not HGS, resulting in a higher prevalence of sarcopenia in adults with type 2 diabetes mellitus. Consideration should be paid to the most appropriate measure of muscle function in this population.

NGAL in the Development of Acute Kidney Injury in a Murine Model of Remote Ischaemic Preconditioning and Liver Ischaemia Reperfusion.

Acute kidney injury (AKI) is common following liver transplantation and is associated with liver ischeamia reperfusion (IR) injury. The purpose of this study was to use a mouse model of liver IR injury and AKI to study the role of Neutrophil Gelatinase Associated Lipocalin (NGAL), a biomarker of AKI, in liver IR injury and AKI. We demonstrate an adapted, reproducible model of liver IR injury and AKI in which remote ischemic preconditioning (RIPC) by repeated episodes of hindleg ischemia prior to liver IR reduced the severity of the IR injury. In this model, serum NGAL at 2 h post reperfusion correlated with AKI development early following IR injury. This early rise in serum NGAL was associated with hepatic but not renal upregulation of NGAL mRNA, suggesting NGAL production in the liver but not the kidney in the early phase post liver IR injury.

Morphological and molecular preservation through universal preparation of fresh-frozen tissue samples for multimodal imaging workflows.

The landscape of tissue-based imaging modalities is constantly and rapidly evolving. While formalin-fixed, paraffin-embedded material is still useful for histological imaging, the fixation process irreversibly changes the molecular composition of the sample. Therefore, many imaging approaches require fresh-frozen material to get meaningful results. This is particularly true for molecular imaging techniques such as mass spectrometry imaging, which are widely used to probe the spatial arrangement of the tissue metabolome. As high-quality fresh-frozen tissues are limited in their availability, any sample preparation workflow they are subjected to needs to ensure morphological and molecular preservation of the tissues and be compatible with as many of the established and emerging imaging techniques as possible to obtain the maximum possible insights from the tissues. Here we describe a universal sample preparation workflow, from the initial step of freezing the tissues to the cold embedding in a new hydroxypropyl methylcellulose/polyvinylpyrrolidone-enriched hydrogel and the generation of thin tissue sections for analysis. Moreover, we highlight the optimized storage conditions that limit molecular and morphological degradation of the sections. The protocol is compatible with human and plant tissues and can be easily adapted for the preparation of alternative sample formats (e.g., three-dimensional cell cultures). The integrated workflow is universally compatible with histological tissue analysis, mass spectrometry imaging and imaging mass cytometry, as well as spatial proteomic, genomic and transcriptomic tissue analysis. The protocol can be completed within 4 h and requires minimal prior experience in the preparation of tissue samples for multimodal imaging experiments.

Effectiveness of In-Theater Mental Health Assessments.

INTRODUCTION: The leading cause for medical evacuation from the U.S. Central Command area of responsibility is because of mental health conditions. The In-Theater Mental Health Assessment (ITMHA) is a DoD-required screening of deployed personnel. It is vital to examine the efficacy of ITMHA's potential to significantly impact the mental health outcomes of service members. MATERIALS AND METHODS: All ITMHA results of individuals in 2 deployed Army battalions along with a brigade headquarters deployed to U.S. Central Command between October 2022 and October 2023 were collected and analyzed. Descriptive statistics were used to characterize the results of the ITMHA. RESULTS: Of 670 deployed service members, 157 (23%) scored positive on ITMHA. Ten service members were referred for additional mental health evaluation. The remaining 147 (22%) service members who scored positive were not referred because of a lack of significant impairment or were already engaged in mental health services. One service member in the study was evacuated because of a mental health condition. The most common major life stressors identified were family/relationship issues, sleep problems, and mental health concerns. CONCLUSIONS: The number of deployed personnel identified through the ITMHA as requiring mental health care was modest. The ITMHA has multiple limitations that, if addressed, will improve its utility to mitigate mental health decline in the expeditionary environment.

The USCENTCOM Walking Blood Bank Performance Benchmark and Anticipated Benefit of Universal Low Titer Type O Screening.

The walking blood bank (WBB) is a system for emergency blood acquisition from nearby donors if a patient's blood needs exceed the immediate supply. USCENTCOM medical units will perform a walking blood bank if immediate blood requirements exceed the local supply. A benchmark WBB performance time was needed to provide a training goal for military WBB exercises. An expeditionary WBB performance time benchmark was created from prospective measurements of USCENTCOM medical unit performance times over 9 months. The mean total time, and new performance benchmark, for a WBB in USCENTCOM was 41.4 min +/- 13.2 min. USCENTCOM time from donor arrival to a transfusable unit mean time was 34.4 +/- 12.1 min. Expeditionary medical units conducting a WBB should expect to meet or exceed the provided benchmark.

Military Blood Supply and Distribution in USCENTCOM.

In expeditionary environments, the consistent availability of blood for casualty care is imperative yet challenging. Responding to evidence and the specific needs of its expeditionary context, the US Central Command (USCENTCOM) prioritized supplying stored low titer O whole blood (LTOWB) to its units from March, 2023 onward. A strategy was devised to set minimal LTOWB on-hand supply benchmarks, determined by the number of operating beds and point of injury teams. This transition led to a 54% reduction in orders for packed red blood cells. As a countermove, the Armed Services Blood Program (ASBP) enhanced LTOWB production at a conversion rate 2:1 from packed red blood cell to LTOWB. Consequently, there was a decline in expired blood products, and fulfillment rates for blood requests are projected to reach 100% consistently. This paper delves into the intricacies of the expeditionary blood supply, the rationale behind the LTOWB transition, the devised allocation strategy, and the subsequent impacts of this change.

The incidence of subsequent contralateral hip fracture and factors associated with increased risk: the IMPACT Contralateral Fracture Study.

Patients who sustain a contralateral hip fracture experience significantly inferior outcomes; however, the incidence and predictors of contralateral hip fracture remain poorly understood. In the present study, 2.5% of patients sustained a contralateral hip fracture within 12 months, and socioeconomic deprivation was associated with reduced risk of contralateral hip fracture. INTRODUCTION: Hip fractures are associated with high morbidity and mortality, and patients that sustain a subsequent contralateral fracture experience inferior outcomes. The risk of contralateral fracture is highest within the first year; however, the incidence and associated factors remain poorly understood. The aims were to investigate (i) the incidence of a subsequent contralateral hip fracture within the first year, (ii) identify factors associated with an increased risk of contralateral fracture and (iii) compare early mortality risk after index versus contralateral hip fracture. METHODS: This study included all patients aged over 50 years admitted to NHS hospitals in Scotland between 1st March 2020 and 31st December 2020 (n = 5566) as routine activity of the Scottish Hip Fracture Audit (SHFA). Multivariate logistic regression was used to examine factors associated with 30-day mortality, and cox regression was used to identify factors associated with a contralateral fracture. RESULTS: During the study period 2.5% (138/5566) of patients sustained a contralateral hip fracture within 12 months of the index hip fracture. Socioeconomic deprivation was inversely associated with increased risk of contralateral fracture (odds ratio 2.64, p < 0.001), whilst advancing age (p = 0.427) and sex (p = 0.265) were not. After adjusting for significant cofounders, there was no significant difference in 30-day mortality following contralateral fracture compared to index fracture (OR 1.22, p = 0.433). CONCLUSION: One in 40 (2.5%) hip fracture patients sustained a contralateral fracture within 12 months of their index fracture, and deprivation was associated with a reduced risk of contralateral fracture. No difference in 30-day mortality was found.

Sound transmission loss of periodic Mindlin plates with non-uniformly spaced mass attachmentsa).

The sound transmission loss (STL) of wall partitions, especially in the coincidence region, is investigated. A Mindlin plate with periodically attached masses in a periodic "supercell" pattern is analyzed theoretically and experimentally for sound attenuation. Modeling the masses as points, analytical expressions for predicting the dispersion relation and frequency bandgaps of the plate are developed. The results show that varying the distances between the masses or the masses themselves can lead to the emergence of additional lower-frequency bandgaps and slightly decrease the bandwidth of the primary complete bandgap. Additionally, a triangular periodic pattern of point masses can provide a larger complete bandgap than the conventional rectangular pattern. The results are validated by numerical analyses using the wave and finite element method. Experimental testing is conducted on large-scale plates (2.4 m × 1 m) with periodically attached masses under diffuse field conditions, demonstrating the benefits of utilizing multiple scattering to increase the STL in the coincidence region of the bare plate. The proposed approach is seen to significantly increase the STL of wall partitions in the coincidence region and provides insights into the fundamental principles of sound and vibration attenuation in complex structures based on multiple scattering.

Competence By Design: a transformational national model of time-variable competency-based postgraduate medical education.

Postgraduate medical education is an essential societal enterprise that prepares highly skilled physicians for the health workforce. In recent years, PGME systems have been criticized worldwide for problems with variable graduate abilities, concerns about patient safety, and issues with teaching and assessment methods. In response, competency based medical education approaches, with an emphasis on graduate outcomes, have been proposed as the direction for 21st century health profession education. However, there are few published models of large-scale implementation of these approaches. We describe the rationale and design for a national, time-variable competency-based multi-specialty system for postgraduate medical education called Competence by Design. Fourteen innovations were bundled to create this new system, using the Van Melle Core Components of competency based medical education as the basis for the transformation. The successful execution of this transformational training system shows competency based medical education can be implemented at scale. The lessons learned in the early implementation of Competence by Design can inform competency based medical education innovation efforts across professions worldwide.

Waking Up to the Importance of Sleep in Type 2 Diabetes Management: A Narrative Review.

For the first time, the latest American Diabetes Association/European Association for the Study of Diabetes (ADA/EASD) consensus guidelines have incorporated a growing body of evidence linking health outcomes associated with type 2 diabetes to the movement behavior composition over the whole 24-h day. Of particular note, the importance of sleep as a key lifestyle component in the management of type 2 diabetes is promulgated and presented using three key constructs: quantity, quality, and timing (i.e., chronotype). In this narrative review we highlight some of the key evidence justifying the inclusion of sleep in the latest consensus guidelines by examining the associations of quantity, quality, and timing of sleep with measures of glycemia, cardiovascular disease risk, and mortality. We also consider potential mechanisms implicated in the association between sleep and type 2 diabetes and provide practical advice for health care professionals about initiating conversations pertaining to sleep in clinical care. In particular, we emphasize the importance of measuring sleep in a free-living environment and provide a summary of the different methodologies and targets. In summary, although the latest ADA/EASD consensus report highlights sleep as a central component in the management of type 2 diabetes, placing it, for the first time, on a level playing field with other lifestyle behaviors (e.g., physical activity and diet), the evidence base for improving sleep (beyond sleep disorders) in those living with type 2 diabetes is limited. This review should act as a timely reminder to incorporate sleep into clinical consultations, ongoing diabetes education, and future interventions.

Dancers Show More Accurate Trunk-Pelvic Joint Angle Reproduction While Wearing a Jacket Augmented With Elastic Bands.

Purpose: The Backalast® compression jacket is intended to improve posture and proprioception of the trunk and shoulder girdle for dancers and dance students during dance training by way of elastic bands in the rear of the garment (which include bands enclosing the inferior thorax). This study was intended to investigate whether there is evidence to support those objectives. Materials and Methods: Fifteen dance students participated (4 male, mean age 19.9 ± 1.4 years old). The dependent variables of trunk-pelvis angle and proximity of trunk axis to global vertical for each participant were measured using optical motion capture before and after the completion of a series of trunk movements. The Helen Hayes model, which we used to represent the trunk, includes the shoulder girdles as part of the trunk. We compared the effect of the type of garment (Backalast® or control compression shirt) worn upon the 2 dependent variables, within-subject with paired t-tests. The order of whether Backalast® or control compression shirt was worn first was alternated between participants. Results: The pre/posttest difference in trunk proprioception as represented by the construct of ability to reproduce trunk-pelvis angle wearing the Backalast® was 0.8° ± 0.8°, but for the control shirt, the difference was 1.8° ± 1.4°, P = .03. The difference between garments in vertical trunk alignment, measured after the series of trunk movements, was not significant. Conclusion: Our findings suggest that the Backalast® can help enhance trunk proprioception when compared to the control compression shirt, although it did not change the angle at which the participants' held their trunks while standing erect (proximity to global vertical).

Current use of simulation for EPA assessment in emergency medicine.

OBJECTIVE: Approximately five years ago, the Royal College emergency medicine programs in Canada implemented a competency-based paradigm and introduced the use of Entrustable Professional Activities (EPAs) for assessment of units of professional activity to assess trainees. Many competency-based medical education (CBME) based curricula, involve assessing for entrustment through observations of EPAs. While EPAs are frequently assessed in clinical settings, simulation is also used. This study aimed to characterize the use of simulation for EPA assessment. METHODS: A study interview guide was jointly developed by all study authors and followed best practices for survey development. A national interview was conducted with program directors or assistant program directors across all the Royal College emergency medicine programs across Canada. Interviews were conducted over Microsoft Teams, interviews were recorded and transcribed, using Microsoft Teams transcribing service. Sample transcripts were analyzed for theme development. Themes were then reviewed by co-authors to ensure they were representative of the participants' views. RESULTS: A 64.7% response rate was achieved. Simulation has been widely adopted by EM training programs. All interviewees demonstrated support for the use of simulation for EPA assessment for many reasons, however, PDs acknowledged limitations and thematic analysis revealed certain themes and tensions for using simulation for EPA assessment. Thematic analysis revealed six major themes: widespread support for the use of simulation for EPA assessment, concerns regarding the potential for EPA assessment to become a "tick- box" exercise, logistical barriers limiting the use of simulation for EPA assessment, varied perceptions about the authenticity of using simulation for EPA assessment, the potential for simulation for EPA assessment to compromise learner psychological safety, and suggestions for the optimization of use of simulation for EPA assessment. CONCLUSIONS: Our findings offer insight for other programs and specialties on how simulation for EPA assessment can best be utilized. Programs should use these findings when considering using simulation for EPA assessment.

RéSUMé: OBJECTIF: Il y a environ cinq ans, les programmes de médecine d'urgence du Collège royal au Canada ont mis en place un paradigme basé sur les compétences et ont introduit l'utilisation d'activités professionnelles confiables (APC) pour l'évaluation des unités d'activité professionnelle afin d'évaluer les stagiaires. De nombreux programmes d'enseignement médical basés sur les compétences (CBME) prévoient l'évaluation des compétences par l'observation des APC. Bien que les APC soient fréquemment évaluées en milieu clinique, la simulation est également utilisée. Cette étude visait à caractériser l'utilisation de la simulation pour l'évaluation de l'APC. MéTHODES: Un guide d'entretien d'étude a été élaboré conjointement par tous les auteurs de l'étude et a suivi les meilleures pratiques en matière d'élaboration d'enquêtes. Un entretien national a été réalisé avec les directeurs de programmes ou les directeurs adjoints de tous les programmes de médecine d'urgence du Collège royal au Canada. Les entretiens ont été menés sur Microsoft Teams, enregistrés et transcrits à l'aide du service de transcription de Microsoft Teams. Les transcriptions des échantillons ont été analysées pour développer des thèmes. Les thèmes ont ensuite été revus par les co-auteurs pour s'assurer qu'ils étaient représentatifs des points de vue des participants. RéSULTATS: Un taux de réponse de 64,7 % a été obtenu. La simulation a été largement adoptée par les programmes de formation en médecine d'urgence. Toutes les personnes interrogées se sont montrées favorables à l'utilisation de la simulation pour l'évaluation de l'APE pour de nombreuses raisons. Cependant, les DP ont reconnu des limites et l'analyse thématique a révélé certains thèmes et tensions liés à l'utilisation de la simulation pour l'évaluation de l'APC. L'analyse thématique a révélé six thèmes majeurs : un appui généralisé à l'utilisation de la simulation pour l'évaluation de l'APC, inquiétudes concernant la possibilité que l'évaluation de l'APC devienne un exercice de type « case à cocher ¼, des obstacles logistiques limitant l'utilisation de la simulation pour l'évaluation de l'APC, les perceptions variées quant à l'authenticité de l'utilisation de la simulation pour l'évaluation de l'APC, le potentiel de la simulation pour l'évaluation de l'APC de compromettre la sécurité psychologique des apprenants, et des suggestions pour l'optimisation de l'utilisation de la simulation pour l'évaluation de l'APC. CONCLUSIONS: Nos résultats offrent un aperçu à d'autres programmes et spécialités sur la meilleure façon d'utiliser la simulation pour l'évaluation de l'APC. Les programmes devraient utiliser ces résultats lorsqu'ils envisagent d'utiliser la simulation pour l'évaluation de l'APC.

Exploring the impact of the PNPLA3 I148M variant on primary human hepatic stellate cells using 3D extracellular matrix models.

BACKGROUND & AIMS: The PNPLA3 rs738409 C>G (encoding for I148M) variant is a risk locus for the fibrogenic progression of chronic liver diseases, a process driven by hepatic stellate cells (HSCs). We investigated how the PNPLA3 I148M variant affects HSC biology using transcriptomic data and validated findings in 3D-culture models. METHODS: RNA sequencing was performed on 2D-cultured primary human HSCs and liver biopsies of individuals with obesity, genotyped for the PNPLA3 I148M variant. Data were validated in wild-type (WT) or PNPLA3 I148M variant-carrying HSCs cultured on 3D extracellular matrix (ECM) scaffolds from human healthy and cirrhotic livers, with/without TGFB1 or cytosporone B (Csn-B) treatment. RESULTS: Transcriptomic analyses of liver biopsies and HSCs highlighted shared PNPLA3 I148M-driven dysregulated pathways related to mitochondrial function, antioxidant response, ECM remodelling and TGFB1 signalling. Analogous pathways were dysregulated in WT/PNPLA3-I148M HSCs cultured in 3D liver scaffolds. Mitochondrial dysfunction in PNPLA3-I148M cells was linked to respiratory chain complex IV insufficiency. Antioxidant capacity was lower in PNPLA3-I148M HSCs, while reactive oxygen species secretion was increased in PNPLA3-I148M HSCs and higher in bioengineered cirrhotic vs. healthy scaffolds. TGFB1 signalling followed the same trend. In PNPLA3-I148M cells, expression and activation of the endogenous TGFB1 inhibitor NR4A1 were decreased: treatment with the Csn-B agonist increased total NR4A1 in HSCs cultured in healthy but not in cirrhotic 3D scaffolds. NR4A1 regulation by TGFB1/Csn-B was linked to Akt signalling in PNPLA3-WT HSCs and to Erk signalling in PNPLA3-I148M HSCs. CONCLUSION: HSCs carrying the PNPLA3 I148M variant have impaired mitochondrial function, antioxidant responses, and increased TGFB1 signalling, which dampens antifibrotic NR4A1 activity. These features are exacerbated by cirrhotic ECM, highlighting the dual impact of the PNPLA3 I148M variant and the fibrotic microenvironment in progressive chronic liver diseases. IMPACT AND IMPLICATIONS: Hepatic stellate cells (HSCs) play a key role in the fibrogenic process associated with chronic liver disease. The PNPLA3 genetic mutation has been linked with increased risk of fibrogenesis, but its role in HSCs requires further investigation. Here, by using comparative transcriptomics and a novel 3D in vitro model, we demonstrate the impact of the PNPLA3 genetic mutation on primary human HSCs' behaviour, and we show that it affects the cell's mitochondrial function and antioxidant response, as well as the antifibrotic gene NR4A1. Our publicly available transcriptomic data, 3D platform and our findings on NR4A1 could facilitate the discovery of targets to develop more effective treatments for chronic liver diseases.

Implementing Competence Committees on a National Scale: Design and Lessons Learned.

Competence committees (CCs) are a recent innovation to improve assessment decision-making in health professions education. CCs enable a group of trained, dedicated educators to review a portfolio of observations about a learner's progress toward competence and make systematic assessment decisions. CCs are aligned with competency based medical education (CBME) and programmatic assessment. While there is an emerging literature on CCs, little has been published on their system-wide implementation. National-scale implementation of CCs is complex, owing to the culture change that underlies this shift in assessment paradigm and the logistics and skills needed to enable it. We present the Royal College of Physicians and Surgeons of Canada's experience implementing a national CC model, the challenges the Royal College faced, and some strategies to address them. With large scale CC implementation, managing the tension between standardization and flexibility is a fundamental issue that needs to be anticipated and addressed, with careful consideration of individual program needs, resources, and engagement of invested groups. If implementation is to take place in a wide variety of contexts, an approach that uses multiple engagement and communication strategies to allow for local adaptations is needed. Large-scale implementation of CCs, like any transformative initiative, does not occur at a single point but is an evolutionary process requiring both upfront resources and ongoing support. As such, it is important to consider embedding a plan for program evaluation at the outset. We hope these shared lessons will be of value to other educators who are considering a large-scale CBME CC implementation.

Evaluating Competence by Design as a Large System Change Initiative: Readiness, Fidelity, and Outcomes.

Program evaluation is an essential, but often neglected, activity in any transformational educational change. Competence by Design was a large-scale change initiative to implement a competency-based time-variable educational system in Canadian postgraduate medical education. A program evaluation strategy was an integral part of the build and implementation plan for CBD from the beginning, providing insights into implementation progress, challenges, unexpected outcomes, and impact. The Competence by Design program evaluation strategy was built upon a logic model and three pillars of evaluation: readiness to implement, fidelity and integrity of implementation, and outcomes of implementation. The program evaluation strategy harvested from both internally driven studies and those performed by partners and invested others. A dashboard for the program evaluation strategy was created to transparently display a real-time view of Competence by Design implementation and facilitate continuous adaptation and improvement. The findings of the program evaluation for Competence by Design drove changes to all aspects of the Competence by Design implementation, aided engagement of partners, supported change management, and deepened our understanding of the journey required for transformational educational change in a complex national postgraduate medical education system. The program evaluation strategy for Competence by Design provides a framework for program evaluation for any large-scale change in health professions education.