Improving health system responses when patients are harmed: a protocol for a multistage mixed-methods study.

INTRODUCTION: At least 10% of hospital admissions in high-income countries, including Australia, are associated with patient safety incidents, which contribute to patient harm ('adverse events'). When a patient is seriously harmed, an investigation or review is undertaken to reduce the risk of further incidents occurring. Despite 20 years of investigations into adverse events in healthcare, few evaluations provide evidence of their quality and effectiveness in reducing preventable harm.This study aims to develop consistent, informed and robust best practice guidance, at state and national levels, that will improve the response, learning and health system improvements arising from adverse events. METHODS AND ANALYSIS: The setting will be healthcare organisations in Australian public health systems in the states of New South Wales, Queensland, Victoria and the Australian Capital Territory. We will apply a multistage mixed-methods research design with evaluation and in-situ feasibility testing. This will include literature reviews (stage 1), an assessment of the quality of 300 adverse event investigation reports from participating hospitals (stage 2), and a policy/procedure document review from participating hospitals (stage 3) as well as focus groups and interviews on perspectives and experiences of investigations with healthcare staff and consumers (stage 4). After triangulating results from stages 1-4, we will then codesign tools and guidance for the conduct of investigations with staff and consumers (stage 5) and conduct feasibility testing on the guidance (stage 6). Participants will include healthcare safety systems policymakers and staff (n=120-255) who commission, undertake or review investigations and consumers (n=20-32) who have been impacted by adverse events. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Northern Sydney Local Health District Human Research Ethics Committee (2023/ETH02007 and 2023/ETH02341).The research findings will be incorporated into best practice guidance, published in international and national journals and disseminated through conferences.

Detecting Algorithmic Errors and Patient Harms for AI-Enabled Medical Devices in Randomized Controlled Trials: Protocol for a Systematic Review.

BACKGROUND: Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report. OBJECTIVE: This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes. METHODS: This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate. RESULTS: The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024. CONCLUSIONS: Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance. TRIAL REGISTRATION: PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51614.

Lessons learnt on patient safety in dentistry through a 5-year nationwide database study on iatrogenic harm.

Safe delivery of care is a priority in dentistry, while basic epidemiological knowledge of patient safety incidents is still lacking. The objectives of this study were to (1) classify patient safety incidents related to primary dental care in Denmark in the period 2016-2020 and study the distribution of different types of dental treatment categories where harm occurred, (2) clarify treatment categories leading to "nerve injury" and "tooth loss" and (3) assess the financial cost of patient-harm claims. Data from the Danish Dental Compensation Act (DDCA) database was retrieved from all filed cases from 1st January 2016 until 31st December 2020 pertaining to: (1) The reason why the patient applied for treatment-related harm compensation, (2) the event that led to the alleged harm (treatment category), (3) the type of patient-harm, and (4) the financial cost of all harm compensations. A total of 9069 claims were retrieved, of which 5079 (56%) were found eligible for compensation. The three most frequent categories leading to compensation were "Root canal treatment and post preparation"(n = 2461, 48% of all approved claims), "lack of timely diagnosis and initiation of treatment" (n = 905, 18%) and "surgery" (n = 878, 17%). Damage to the root of the tooth accounted for more than half of all approved claims (54.36%), which was most frequently a result of either parietal perforation during endodontic treatment (18.54%) or instrument fracture (18.89%). Nerve injury accounted for 16.81% of the approved claims. Total cost of all compensation payments was €16,309,310, 41.1% of which was related to surgery (€6,707,430) and 20.4% (€3,322,927) to endodontic treatment. This comprehensive analysis documents that harm permeates all aspects of dentistry, especially in endodontics and surgery. Neglect or diagnostic delays contribute to 18% of claims, indicating that harm does not solely result from direct treatment. Treatment harm inflicts considerable societal costs.

Drug-Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation.

INTRODUCTION: Drug-drug interactions (DDIs) have potential to cause patient harm, including lowering therapeutic efficacy. This study aimed to (i) determine the prevalence of potential DDIs (pDDIs); clinically relevant DDIs (cDDIs), that is, DDIs that could lead to patient harm, taking into account a patient's individual clinical profile, drug effects and severity of potential harmful outcome; and subsequent actual harm among hospitalized patients and (ii) examine the impact of transitioning from paper-based medication charts to electronic medication management (eMM) on DDIs and patient harms. METHODS: This was a secondary analysis of the control arm of a controlled pre-post study. Patients were randomly selected from three Australian hospitals. Retrospective chart review was conducted before and after the implementation of an eMM system, without accompanying clinical decision support alerts for DDIs. Harm was assessed by an expert panel. RESULTS: Of 1186 patient admissions, 70.1% (n = 831) experienced a pDDI, 42.6% (n = 505) a cDDI and 0.9% (n = 11) an actual harm in hospital. Of 15,860 pDDIs identified, 27.0% (n = 4285) were classified as cDDIs. The median number of pDDIs and cDDIs per 10 drugs were 6 [interquartile range (IQR) 2-13] and 0 (IQR 0-2), respectively. In cases where a cDDI was identified, both drugs were 44% less likely to be co-administered following eMM (adjusted odds ratio 0.56, 95% confidence interval 0.46-0.73). CONCLUSION: Although most patients experienced a pDDI during their hospital stay, less than one-third of pDDIs were clinically relevant. The low prevalence of harm identified raises questions about the value of incorporating DDI decision support into systems given the potential negative impacts of DDI alerts.

How current law and policy supports providers of NHS healthcare in England to respond to patient harm: A scoping review protocol.

INTRODUCTION: Harm arising from National Health Service (NHS) healthcare results in significant human cost for the patient, those who care for them, and the medical staff involved. Furthermore, patient harm results in substantial financial costs to the public purse. Improving how NHS providers in England respond to patient harm could reduce the number of claims for clinical negligence brought against NHS. Doing so will ensure those affected receive the justice they deserve and protect the public purse. Law and policy are key to supporting providers of NHS healthcare to respond to patient harm but are not necessarily understood and therefore can be challenging to apply to practice. Research exploring how law and policy supports this understanding is limited. The purpose of this scoping review is to address this knowledge gap and improve understanding by critically evaluating how law and policy supports providers of NHS healthcare in England to respond to patient harm. METHODS AND ANALYSIS: The review will use the methodological framework proposed by Arskey and O'Malley, Levac et al and the Joanna Briggs Institute. Search strategies will be developed using selected key words and index terms. MEDLINE, CINAHL, and Westlaw and reference lists of relevant publications will be searched to identify relevant grey literature. Two reviewers will independently assess the extracted data against the eligibility criteria. All studies identified will be charted and the results presented as a narrative synthesis.

Prevalence of Triggers and Patient Harm Identified by Global Trigger Tool in Specialized Palliative Care.

Background: Global trigger tool (GTT) was developed for identification of patient harm. In palliative patients deterioration can be expected, and there are no data on whether cases classified as "patient harm" actually represents a potential for improved patient safety. Objectives: The primary aim was to test the performance and suitability of GTT in palliative care patients. The secondary aim was to pilot triggers for substandard palliative care. Design and Measurements: GTT was applied in 113 consecutive patients at a palliative ward at a Norwegian university hospital. Cases of patient harm were further evaluated to decide if the case was (a) a natural part of the disease trajectory or (b) a foreseeable consequence of treatment decisions. Potential triggers for substandard palliative care were tested. Results: Two hundred twelve triggers (1.9 per hospitalization) and 26 cases of patient harm were identified. The positive predictive value (PPV) for identifying patient harm was 0.12. The most prevalent harm was pressure ulcers (8.8%). Of the 26 cases of patient harm, 6 cases were a natural part of the disease trajectory and 10 consequences of treatment decisions. In 21 (18%) patients triggers being piloted for substandard palliative care were present, identifying 9 cases of substandard palliative care. The highest PPV (0.67) was observed for "Cessation of antibiotics less than 5 days before death." Conclusions: With the exception of pressure ulcers, GTT triggers were infrequent or had a very poor PPV for patient harm. Triggers related to overtreatment might be suitable for identifying substandard palliative care.

Evaluation of Smart Pump Interoperability with an Electronic Medical Record System to Improve Infusion Safety.

Medications administered via intravenous (IV) infusions have high potential for patient harm. Evaluation of the rate of variances between the medication order on the Electronic Medical Record (EMR) and IV infusion details in the smart pump was performed pre and post- implementation of smart pump and EMR interoperability. Introduction of smart pumps with EMR interoperability resulted in a statistically significant reduction in frequency of variances.

Citing Harms, Momentum Grows to Remove Race From Clinical Algorithms.

This Medical News article discusses efforts to evaluate the inclusion of race as a factor in widely used clinical decision-making algorithms.

Impactos de incidentes de segurança do paciente na enfermagem: um olhar para a segunda vítima / Impacts of patient safety incidentes on nursing: a look at the second victim Impactos de incidentes de seguridad del paciente en enfermería: una mirada hacia la segunda víctima / Impacts of patient safety incidentes on nursing: a look at the second victim Impactos de incidentes de seguridad del paciente en enfermería: una mirada hacia la segunda víctima

Objetivo: compreender os impactos para os profissionais de enfermagem como segunda vítima de incidentes de segurança do paciente. Método: estudo qualitativo aprovado pelo comitê de ética em pesquisa, do tipo exploratório-descritivo, realizado com 20 profissionais de enfermagem em hospital universitário do Sul do Brasil, entre novembro de 2021 e janeiro de 2022, por meio de entrevistas semiestruturadas analisadas a partir da análise textual discursiva. Resultados: as categorias sentimentos das segundas vítimas, demonstrando a presença de sentimentos negativos, sendo o medo o mais recorrente; e, impacto na trajetória profissional e no ambiente de trabalho, questionando sua habilidade como um bom profissional e a escolha da profissão como sendo adequada permitiram compreender o impacto no profissional de enfermagem. Considerações finais: os impactos relacionaram-se ao sentimento de culpa pelo fato ocorrido, autojulgamento, julgamento pelos pares e pelo paciente, medo do desfecho ao paciente e das consequências para si e dúvidas quanto à sua habilidade e desempenho no trabalho(AU)

Objective: to understand the impacts on nursing professionals as the second victim of patient safety incidents. Method: qualitative exploratory-descriptive study approved by the research ethics committee, carried out with 20 nursing professionals at a university hospital in southern Brazil, between November 2021 and January 2022, through semi-structured interviews analyzed from the discursive textual analysis. Results: the second victims' feelings categories, demonstrating the presence of negative feelings, with fear being the most recurrent; and impact on the professional path and on the work environment, questioning their ability as a good professional and the choice of profession as being adequate, allowed understanding the impact on the nursing professional. Final considerations: the impacts were related to the feeling of guilt for the fact that occurred, self-judgment, judgment by peers and by the patient, fear of the outcome for the patient and the consequences for himself, and doubts about his ability and performance at work(AU)

Objetivo: comprender los impactos sobre los profesionales de enfermería como segunda víctima de los incidentes de seguridad del paciente. Método: estudio cualitativo, de tipo exploratorio-descriptivo, aprobado por el comité de ética en investigación, y realizado junto a 20 profesionales de enfermería de un hospital universitario del sur de Brasil, entre noviembre de 2021 y enero de 2022, a través de entrevistas semiestructuradas analizadas a partir del análisis textual discursivo. Resultados: las categorías de sentimientos de las segundas víctimas han permitido comprender el impacto sobre el profesional de enfermería: indican la presencia de sentimientos negativos, el miedo siendo el más recurrente; el impacto en la trayectoria profesional y en el ambiente de trabajo, ya que los enfermeros cuestionan su habilidad de buen profesional y si ha sido adecuada la elección de la profesión. Consideraciones finales: los impactos se relacionaron con el sentimiento de culpa por el hecho ocurrido, el juicio propio, el juicio de los pares y del paciente, el miedo al desenlace para el paciente y las consecuencias para él mismo, y las dudas sobre su capacidad y desempeño en el trabajo(AU)

Gaming Disorder em Minorias Sexuais e de Gênero / Gaming Disorder in sexual and gender minorities / Trastorno de juego en minorías sexuales y de género

ntrodução: Os jogos eletrônicos são agora reconhecidos como um problema de saúde mental, especialmente entre a comunidade LGBTQIA+. Objetivo: explorar os efeitos do transtorno de jogo (gaming disorder) na população LGBTQIA+. Método: A revisão narrativa abordou hábitos de jogo e gaming disorder em minorias sexuais e de gênero, usando PubMed, Google Scholar, Embase e Web of Science. Das 1640 pesquisas, apenas 3 abordaram gaming disorder nessa população. Resultado: consumidores LGBTQ+ gastam mais em jogos digitais. Jogadores LGBTQIA+ consomem mais jogos de exploração de identidade, possivelmente relacionados ao estresse de minoria. Discussão: minorias sexuais têm maior risco de gaming disorder. Para indivíduos LGBTQIA+, os jogos podem servir como escape e plataforma de apoio, mas o uso problemático pode estar associado a desfechos psiquiátricos negativos. Conclusão: Os jogos online têm o potencial de serem ferramentas de apoio para minorias, no entanto, as evidências são limitadas. É necessária mais pesquisa para compreender melhor a relação entre o uso de jogos e a saúde mental da população LGBTQIA+.

ntroduction: Electronic games are now recognized as a mental health issue, especially within the LGBTQIA+ community. Objective: To explore the effects of gaming disorder in the LGBTQIA+ population. Method: The narrative review addressed gaming habits and gaming disorder in sexual and gender minorities, utilizing PubMed, Google Scholar, Embase, and Web of Science. Out of 1640 studies, only 3 focused on gaming disorder in this population. Result: LGBTQ+ consumers spend more on digital games. LGBTQIA+ players engage more in identity exploration games, possibly linked to minority stress. Discussion: Sexual minorities face a higher risk of gaming disorder. For LGBTQIA+ individuals, games can serve as an escape and support platform, but problematic use may be associated with negative psychiatric outcomes. Conclusion: Online games have the potential as support tools for minorities, but evidence is limited. Further research is needed to better understand the relationship between game use and mental health in the LGBTQIA+ population.

Introducción: Los videojuegos electrónicos son reconocidos actualmente como un problema de salud mental, especialmente dentro de la comunidad LGBTQIA+. Objetivo: Explorar los efectos del trastorno de juego (gaming disorder) en la población LGBTQIA+. Método: La revisión narrativa abordó los hábitos de juego y el gaming disorder en minorías sexuales y de género, utilizando PubMed, Google Scholar, Embase y Web of Science. De las 1640 investigaciones, solo 3 se centraron en el gaming disorder en esta población. Resultado: Los consumidores LGBTQ+ gastan más en juegos digitales. Los jugadores LGBTQIA+ consumen más juegos de exploración de identidad, posiblemente relacionados con el estrés de minoría. Discusión: Las minorías sexuales enfrentan un mayor riesgo de gaming disorder. Para los individuos LGBTQIA+, los juegos pueden servir como un escape y plataforma de apoyo, pero el uso problemático puede estar asociado con resultados psiquiátricos negativos. Conclusión: Los juegos en línea tienen el potencial como herramientas de apoyo para las minorías, pero la evidencia es limitada. Se requiere más investigación para comprender mejor la relación entre el uso de juegos y la salud mental en la población LGBTQIA+.

Uncovering the Risks of Anticancer Therapy Through Incident Report Analysis Using a Newly Developed Medical Oncology Incident Taxonomy.

BACKGROUND: Incident reporting systems were developed to identify possible and actual harm in healthcare facilities. They have the potential to capture important safety trends and to enable improvements that can mitigate the risk of future patient harm and suffering. We recently developed and validated a taxonomy specific for medical oncology designed to enhance the identification, tracking, and trending of incidents that may lead to patient harm. The current project was designed to test the ability of such a taxonomy to be applied across different organizations delivering medical oncology care and to identify specific risks that could result in future harm. METHODS: We analyzed 309 randomly selected medical oncology-related incident reports from 3 different cancer centers that had been posted between January 2019 and December 2020. Each report was assigned up to 2 incident categories. We used a 2-step process to reconcile reviewer discrepancies. In a secondary analysis, each of the incidents was reviewed and recoded to identify events which may result in major or catastrophic harm. RESULTS: Three hundred four incidents met criteria for inclusion. Three hundred incidents (98.7%) were successfully coded. Sixty-seven percent of incidents were encompassed by the following 4 of 21 categories: prescriber ordering (22%), nursing care (15%), pharmacy (14%), and relational/communication issues (15%). Of 297 evaluable incidents, 47% did not reach the patient, 44.7% reached the patient without harm, 7.7% caused minor injury, and 0.7% caused severe injury or death. Submission rates by physicians varied between the 3 sites accounting for 1.7%, 10.7%, and 16.1% of reports. Secondary analysis identified 9 distinct scenarios that may result in major or catastrophic patient harm. CONCLUSIONS: A medical oncology-specific incident reporting taxonomy has the potential to increase our understanding of inherent risks and may lead to process improvements that improve patient safety.

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model.

BACKGROUND: In the United States, osteopathic manipulative treatment (OMT), is a popular complementary physical health approach for the treatment of neuromusculoskeletal disorders. However, post-OMT adverse events (AEs) are poorly defined in terms of frequency, severity, and temporal evolution. To date, no benchmark for patient safety exists. To improve understanding in this field, we set out to model the landscape of patient harm after OMT. METHODS: We conducted a comprehensive search of all available primary clinical research studies reporting on the occurrence of post-OMT AEs in nonpregnant, adult outpatients treated by an osteopathic physician in the United States. The methodology of eligible studies was then reviewed to select those containing the minimum required dataset to model the post-OMT AEs. The minimum required dataset consisted of four model parameters: 'post-OMT interval', 'OMT encounters with post-OMT interval assessment', 'AEs preceded by an OMT encounter', and 'AE severity.' We used the dataset extracted from selected studies to calculate a patient safety benchmark defined as the incidence rate of AEs per 100 post-OMT interval-days. RESULTS: From 212 manuscripts that we identified, 118 primary clinical research studies were assessed for eligibility. A total of 23 studies met inclusion criteria for methodological review, of which 13 studies passed and were selected for modeling. Mild AEs were the most frequent, accounting for n = 161/165 (98%) of total AEs observed in the literature. The cumulative incidence of mild AEs was also significantly greater (P = 0.01) than both moderate and severe grades. The benchmark incidence rate was 1.0 AEs per 100 post-OMT interval-days. CONCLUSIONS: The majority of post-OMT AEs observed in the primary clinical literature were of mild severity. Modeling of the combined dataset on post-OMT AEs allowed for the derivation of a patient safety benchmark that, to date, has not been established in the field of osteopathic manipulative medicine. Additional research is needed to improve model resolution during the post-OMT period. This work conceptualized a model for identifying and grading post-OMT AEs, which should facilitate future comparisons between institutions in order to continually improve patient safety standards in the field of osteopathic manipulative medicine.

Diagnostic Errors: A Stronger Role for Nursing Could Help Reduce Patient Harm.

Institutional support and better nurse training are key.

Development of the Harm Prevention Partners Clinical Model: An Academic-Practice Partnership for Prevention of Patient Harm Events.

This innovative academic-practice partnership applied user-centered design, resulting in a new clinical model, the "Harm Prevention Partners Program." The model engaged students working as teams with faculty to intervene on nurse-sensitive indicators by documenting care on a novel smartphone tool and generating an intervention dashboard to visualize impact. Faculty utilized the dashboard to guide postclinical debriefing and highlight students' impact on patient outcomes.

Preventing Potential Patient Harm Through Clinical Content Interventions During Oncology Clinical Trial Implementation.

OBJECTIVES: Clinical trial documents are complex and may have inconsistencies, leading to potential site implementation errors and may compromise participant safety. This study characterizes the frequency and type of administrative and potential patient safety interventions (PPSIs) made during the review of oncology trial documents for clinical trial implementation by centralized clinical content specialists. METHODS: A dedicated group of centralized clinical content specialists reviewed trial documents, including the protocol, laboratory manual, and pharmacy/cellular therapy manual, and collected intervention data over a 1-year period. Each trial was categorized by study phase and sponsor type, and multiple interventions could be identified per trial. Interventions were deemed administrative or PPSIs, with PPSIs further subcategorized as medication, laboratory, procedure related, or other. RESULTS: Of 585 clinical trials reviewed, 269 (46%) required intervention(s). Among 1001 interventions, 171 (17.1%) were PPSIs. Most PPSIs were medication related (45.6%), with drug dosing interventions most frequently identified (53.8%). Phase 1 trials had the highest proportion of PPSIs (0.35:1) and administrative interventions (2:1) per trial compared with all other phases. Investigator-initiated trials saw the highest proportion of PPSIs per trial (0.44:1) of all sponsor types. CONCLUSIONS: This study demonstrates a gap in patient safety when assessing trial documents for clinical trial implementation. One solution to address this gap is the utilization of a centralized team of clinical specialists to preemptively review trial documents, thereby enhancing patient safety during clinical trial conduct.

Identifying the patient harms to include in an in silico clinical trial.

BACKGROUND AND OBJECTIVE: Clinical trials represent a crucial step in the development and approval of medical devices. These trials involve evaluating the safety and efficacy of the device in a controlled setting with human subjects. However, traditional clinical trials can be expensive, time-consuming, and ethically challenging. Augmenting clinical trials with data from computer simulations, so called in silico clinical trials (ISCT), has the potential to address these challenges while satisfying regulatory requirements. However, determination of the patient harms in scope of an ISCT is necessary to ensure all harms are sufficiently addressed while maximizing the utility of the ISCT. This topic is currently lacking guidance. The objective of this work is to propose a general method to determine which patient harms should be included in an ISCT for a regulatory submission. METHODS: The proposed method considers the risk associated with the harm, the impact of the device on the likelihood of occurrence of the harm and the technical feasibility of evaluating the harm via ISCT. Consideration of the risk associated with the harm provides maximum clinical impact of the ISCT, in terms of focusing on those failure modes which are most relevant to the patient population. Consideration of the impact of the device on a particular harm, and the technical feasibility of modeling a particular harm supports that the technical effort is devoted to a problem that (1) is relevant to the device in question, and (2) can be solved with contemporary modeling techniques. RESULTS AND CONCLUSIONS: As a case study, the proposed method is applied to a total shoulder replacement humeral system. With this framework, it is hoped that a consistent approach to scoping an ISCT can be adopted, supporting investment in ISCT by the industry, enabling consistent review of the ISCT approach across device disciplines by regulators, and providing maximum impact of modeling technologies in support of devices to improve patient outcomes.