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PARTNER is a prospective, phase II-III, randomized controlled clinical trial that recruited patients with triple-negative breast cancer1,2, who were germline BRCA1 and BRCA2 wild type3. Here we report the results of the trial. Patients (n = 559) were randomized on a 1:1 basis to receive neoadjuvant carboplatin-paclitaxel with or without 150 mg olaparib twice daily, on days 3 to 14, of each of four cycles (gap schedule olaparib, research arm) followed by three cycles of anthracycline-based chemotherapy before surgery. The primary end point was pathologic complete response (pCR)4, and secondary end points included event-free survival (EFS) and overall survival (OS)5. pCR was achieved in 51% of patients in the research arm and 52% in the control arm (P = 0.753). Estimated EFS at 36 months in the research and control arms was 80% and 79% (log-rank P > 0.9), respectively; OS was 90% and 87.2% (log-rank P = 0.8), respectively. In patients with pCR, estimated EFS at 36 months was 90%, and in those with non-pCR it was 70% (log-rank P < 0.001), and OS was 96% and 83% (log-rank P < 0.001), respectively. Neoadjuvant olaparib did not improve pCR rates, EFS or OS when added to carboplatin-paclitaxel and anthracycline-based chemotherapy in patients with triple-negative breast cancer who were germline BRCA1 and BRCA2 wild type. ClinicalTrials.gov ID: NCT03150576 .
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Protocolos de Quimioterapia Combinada Antineoplásica , Terapia Neoadjuvante , Ftalazinas , Piperazinas , Neoplasias de Mama Triplo Negativas , Adulto , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Antraciclinas/uso terapêutico , Antraciclinas/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carboplatina/administração & dosagem , Carboplatina/uso terapêutico , Genes BRCA1 , Genes BRCA2 , Paclitaxel/administração & dosagem , Paclitaxel/uso terapêutico , Resposta Patológica Completa , Ftalazinas/administração & dosagem , Ftalazinas/uso terapêutico , Piperazinas/administração & dosagem , Piperazinas/uso terapêutico , Intervalo Livre de Progressão , Estudos Prospectivos , Análise de Sobrevida , Fatores de Tempo , Neoplasias de Mama Triplo Negativas/tratamento farmacológico , Neoplasias de Mama Triplo Negativas/metabolismo , Neoplasias de Mama Triplo Negativas/cirurgia , Adolescente , Adulto JovemRESUMO
Objectives: The aim was to comprehensively identify published research evaluating continuing medical education conferences, to search for validated tools and perform a content analysis to identify the relevant domains for conference evaluation. Methods: We used scoping review methodology and searched MEDLINE® for relevant English or French literature published between 2008 and 2022 (last search June 3, 2022). Original research (including randomized controlled trials, non-randomized studies, cohort, mixed-methods, qualitative studies, and editorial pieces) where investigators described impact, experience, or motivations related to conference attendance were eligible. Citations were assessed in triplicate, and data extracted in duplicate. Results: Eighty-three studies were included, 69 (83%) of which were surveys or interview based, with the majority conducted at the end of or following conference conclusion. Of the 74 tools identified, only one was validated and was narrowly focused on a specific conference component. A total of 620 items were extracted and categorized into 4 a priori suggested domains (engagement-networking, education-learning, impact, scholarship), and an additional 4 identified through content analysis (value-satisfaction, logistics, equity-diversity-inclusivity, career influences). Time trends were evident, including the absence of items related to equity-diversity-inclusivity prior to 2019, and a focus on logistics, particularly technology and virtual conferences, since 2020. Conclusions: This study identified 8 major domains relevant for continuing medical education conference evaluation. This work is of immediate value to individuals and organizations seeking to either design or evaluate a conference and represents a critical step in the development of a standardized tool for conference evaluation.
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Educação Médica Continuada , Aprendizagem , Humanos , Escolaridade , Motivação , Pesquisa QualitativaRESUMO
BACKGROUND: The use of virtual care has increased dramatically in response to the COVID-19 pandemic, yet evidence is lacking regarding the impact of virtual care on patient outcomes, particularly in pediatrics. A standardized evaluation approach is required to support the integration of virtual care into pediatric health care delivery programs. The objective of this work was to develop a comprehensive and structured framework for pediatric virtual care evaluation. This framework is intended to engage and guide care providers, health centres, and stakeholders towards the development of a standardized approach to the evaluation of pediatric virtual care. METHODS: We brought together a diverse multidisciplinary team, including pediatric clinicians, researchers, digital health leads and analysts, program leaders, a human factors engineer, a family advisor and our manager of health equity and diversity. The team reviewed the literature, including published evaluation frameworks, and used a consensus-based method to develop a virtual care evaluation framework applicable to a broad spectrum of pediatric virtual care programs. We used an iterative process to develop framework components, including domains and sub-domains, examples of evaluation questions, measures, and data sources. Team members met repeatedly over seven months to generate and provide feedback on all components of the framework, making revision as needed until consensus was reached. The framework was then applied to an existing virtual care program. RESULTS: The resulting framework includes four domains (health outcomes, health delivery, individual experience, and program implementation) and 19 sub-domains designed to support the development and evaluation of pediatric virtual care programs. We also developed guidance on how to use the framework and illustrate its utility by applying it to an existing pediatric virtual care program. CONCLUSIONS: This virtual care evaluation framework expands on previously developed frameworks by providing additional detail and a structure that supports practical application. It can be used to evaluate a wide range of pediatric virtual care programs in a standardized manner. Use of this comprehensive yet easy to use evaluation framework will inform appropriate implementation and integration of virtual care into routine practice and support its sustainability and continuous improvement.
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COVID-19 , Equidade em Saúde , Humanos , Criança , Consenso , Pandemias , Instalações de SaúdeRESUMO
PURPOSE: We aimed to describe the Canadian public's understanding and perception of how death is determined in Canada, their level of interest in learning about death and death determination, and their preferred strategies for informing the public. METHODS: We conducted a nationwide cross-sectional survey of a representative sample of the Canadian public. The survey presented two scenarios of a man who met current criteria for neurologic death determination (scenario 1) and a man who met current criteria for circulatory death determination (scenario 2). Survey questions evaluated understanding of how death is determined, acceptance of death determination by neurologic and circulatory criteria, and interest and preferred strategies in learning more about the topic. RESULTS: Among 2,000 respondents (50.8% women; n = 1,015), nearly 67.2% believed that the man in scenario 1 was dead (n = 1,344) and 81.2% (n = 1,623) believed that the man in scenario 2 was dead. Respondents who believed that the man was not dead or were unsure endorsed several factors that may increase their agreement with the determination of death, including requiring more information about how death was determined, seeing the results of brain imaging/tests, and a third doctor's opinion. Predictors of disbelief that the man in scenario 1 is dead were younger age, being uncomfortable with the topic of death, and subscribing to a religion. Predictors of disbelief that the man in scenario 2 is dead were younger age, residing in Quebec (compared with Ontario), having a high school education, and subscribing to a religion. Most respondents (63.3%) indicated interest in learning more about death and death determination. Most respondents preferred to receive information about death and death determination from their health care professional (50.9%) and written information provided by their health care professional (42.7%). CONCLUSION: Among the Canadian public, the understanding of neurologic and circulatory death determination is variable. More uncertainty exists with death determination by neurologic criteria than with circulatory criteria. Nevertheless, there is a high level of general interest in learning more about how death is determined in Canada. These findings provide important opportunities for further public engagement.
RéSUME: OBJECTIF: Notre objectif était de décrire la compréhension et la perception du public canadien quant à la façon dont le décès est déterminé au Canada, son niveau d'intérêt à en apprendre davantage sur le décès et la détermination du décès, et ses stratégies préférées pour informer le public. MéTHODE: Nous avons réalisé un sondage transversal national auprès d'un échantillon représentatif de la population canadienne. L'enquête a présenté deux scénarios : un homme qui répondait aux critères actuels de détermination d'un décès neurologique (scénario 1) et un homme qui répondait aux critères actuels de détermination d'un décès cardiocirculatoire (scénario 2). Les questions de l'enquête évaluaient la compréhension de la façon dont le décès est déterminé, l'acceptation de la détermination du décès selon des critères neurologiques et circulatoires, et l'intérêt et les stratégies préférées pour en apprendre davantage sur le sujet. RéSULTATS: Parmi les 2000 répondants (50,8 % de femmes; n = 1015), près de 67,2 % ont estimé que l'homme du scénario 1 était décédé (n = 1344) et 81,2 % (n = 1623) ont estimé que l'homme du scénario 2 était décédé. Les répondants qui croyaient que l'homme n'était pas décédé ou qui n'étaient pas sûrs ont acquiescé à plusieurs facteurs qui pourraient accroître leur accord avec la détermination du décès, y compris le besoin de plus de renseignements sur la façon dont le décès a été déterminé, la consultation des résultats d'imagerie et des tests cérébraux et l'opinion d'un troisième médecin. Les prédicteurs de non-conviction que l'homme dans le scénario 1 était décédé étaient le fait d'être plus jeune, le fait d'être mal à l'aise avec le sujet de la mort et la croyance en une religion. Les prédicteurs de non-conviction à l'égard du décès de l'homme dans le scénario 2 étaient le fait d'être plus jeune, d'être résident du Québec (comparativement à l'Ontario), d'avoir complété des études secondaires et la croyance en une religion. La plupart des répondants (63,3 %) ont indiqué qu'ils souhaiteraient en apprendre davantage sur le décès et la détermination du décès. La plupart des répondants préféraient recevoir de l'information sur le décès et la détermination du décès de leur professionnel de la santé (50,9 %) et de l'information écrite fournie par leur professionnel de la santé (42,7 %). CONCLUSION: Parmi le public canadien, la compréhension de la détermination du décès neurologique et cardiocirculatoire est variable. Il existe plus d'incertitude en matière de détermination du décès selon des critères neurologiques que selon des critères cardiocirculatoires. Néanmoins, il existe un grand intérêt général à en apprendre davantage sur la façon dont le décès est déterminé au Canada. Ces résultats offrent d'importantes possibilités de participation accrue du public à l'avenir.
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Estudos Transversais , Humanos , Feminino , Masculino , Inquéritos e Questionários , OntárioRESUMO
PURPOSE: Currently, there is little empirical data on family understanding about brain death and death determination. The purpose of this study was to describe family members' (FMs') understanding of brain death and the process of determining death in the context of organ donation in Canadian intensive care units (ICUs). METHODS: We conducted a qualitative study using semistructured, in-depth interviews with FMs who were asked to make an organ donation decision on behalf of adult or pediatric patients with death determination by neurologic criteria (DNC) in Canadian ICUs. RESULTS: From interviews with 179 FMs, six main themes emerged: 1) state of mind, 2) communication, 3) DNC may be counterintuitive, 4) preparation for the DNC clinical assessment, 5) DNC clinical assessment, and 6) time of death. Recommendations on how clinicians can help FMs to understand and accept DNC through communication at key moments were described including preparing FMs for death determination, allowing FMs to be present, and explaining the legal time of death, combined with multimodal strategies. For many FMs, understanding of DNC unfolded over time, facilitated with repeated encounters and explanation, rather than during a single meeting. CONCLUSION: Family members' understanding of brain death and death determination represented a journey that they reported in sequential meeting with health care providers, most notably physicians. Modifiable factors to improve communication and bereavement outcomes during DNC include attention to the state of mind of the family, pacing and repeating discussions according to families' expressed understanding, and preparing and inviting families to be present for the clinical determination including apnea testing. We have provided family-generated recommendations that are pragmatic and can be easily implemented.
RéSUMé: OBJECTIF: À l'heure actuelle, il y a peu de données empiriques sur la compréhension des familles de la mort cérébrale et de la détermination du décès. Le but de cette étude était de décrire la compréhension des membres de la famille de la mort cérébrale et du processus de détermination du décès dans le contexte du don d'organes dans les unités de soins intensifs (USI) canadiennes. MéTHODE: Nous avons mené une étude qualitative à l'aide d'entrevues semi-structurées et approfondies avec des membres de la famille à qui on a demandé de prendre une décision de don d'organes au nom de patients adultes ou pédiatriques dont le décès avait été déterminé selon des critères neurologiques (DCN) dans les unités de soins intensifs canadiennes. RéSULTATS: Sur la base d'entrevues avec 179 membres de la famille, six thèmes principaux ont émergé : 1) l'état d'esprit, 2) la communication, 3) le DCN peut être contre-intuitif, 4) la préparation à l'évaluation clinique pour un DCN, 5) l'évaluation clinique pour un DCN et 6) le moment du décès. Des recommandations sur la façon dont les cliniciens peuvent aider les membres de la famille à comprendre et à accepter un DCN par la communication à des moments clés ont été décrites, y compris la préparation des membres de la famille à la détermination du décès, l'autorisation de la présence des membres de la famille et l'explication de l'heure légale du décès, combinées à des stratégies multimodales. Pour de nombreux membres de la famille, la compréhension du DCN s'est développée au fil du temps et a été facilitée par des rencontres et des explications répétées plutôt qu'au cours d'une seule rencontre. CONCLUSION: La compréhension qu'ont les membres de la famille de la mort cérébrale et de la détermination du décès représente un parcours qu'ils ont décrit lors de rencontres successives avec des acteurs de soins de santé, et particulièrement avec des médecins. Les facteurs modifiables pour améliorer la communication et les issues du deuil pendant un DCN comprennent l'attention portée à l'état d'esprit de la famille, le rythme et la répétition des discussions en fonction de la compréhension exprimée par les familles, ainsi que la préparation et l'invitation des familles à être présentes pour la détermination clinique, y compris pendant le test d'apnée. Nous avons fourni des recommandations familiales qui sont pragmatiques et peuvent être facilement mises en Åuvre.
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Luto , Obtenção de Tecidos e Órgãos , Adulto , Humanos , Criança , Morte Encefálica/diagnóstico , Canadá , Pesar , FamíliaRESUMO
Patient-reported outcome measures (PROMs) are self-reported questionnaires that allow patients and families to evaluate health-related experiences without influence or oversight from health care professionals. This study aimed to rate the relevance of existing PROMs for pediatric hematology patients, as identified by a recent systematic review, as well as to evaluate the receptivity of electronic PROM integration into clinical practice. Focus groups and interviews were conducted with children (10) and parents (19) impacted by nonmalignant hematological disorders, as well as with health care professionals (6). We observed strong support for the TranQol in thalassemia (100% for both parents [P] and children [C]); the Canadian Haemophilia Outcomes-Kids' Life Assessment Tool (CHO-KLAT) (100% P, 75% C) and Haemophilia Quality of Life questionnaire (Haemo-QoL) (100% P and C) in hemophilia; the Pediatric Quality of Life Inventory (PedsQL) Sickle Cell Module (75% P, 100% C); and the Kids ITP Tool in immune thrombocytopenia (100% P, 66.7% C). Generic tools such as the PedsQL Generic were met with mixed support. Electronic PROM integration received universal support. We obtained strong support for the integration of a web-based platform into clinical practice and a preference for disease-specific PROMs over generic PROMs. Future projects may explore the development of a child-friendly Canadian web-based platform to standardize quality-of-life evaluation within the clinical encounter.
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Hematologia , Hemofilia A , Humanos , Qualidade de Vida , Canadá , Inquéritos e Questionários , Medidas de Resultados Relatados pelo PacienteRESUMO
Although evidence supports diverse assessment strategies, including patient/caregiver involvement in Competency-Based Medical Education (CBME), few residency programs formally include patients/caregivers in assessment. We aimed to determine the milestones for which patient/caregiver inclusion would be valuable in the Canadian Pediatric Competence By Design (CBD) curriculum.Program directors from 17 Canadian pediatric residency programs were invited to participate in a Delphi study. This Delphi included 209 milestones selected by the study team from the 320 milestones of the draft pediatric CBD curriculum available at the time of the study. In round 1, 16 participants representing 13 institutions rated the value of including patients/caregivers in the assessment of each milestone using a 4-point scale. We obtained consensus for 150 milestones, leaving 59 for re-exposure. In round 2, 14/16 participants rated remaining items without consensus. Overall, 67 milestones met consensus for 'valuable,' of which 11 met consensus for 'extremely valuable.' The majority of these milestones related to communication skills.Patient/caregiver assessment is valuable for 21% of milestones in the draft pediatric CBD curriculum, predominantly those relating to communication skills. This confirms the perceived importance of patient/caregiver assessment of trainees in CBME curricula; formal inclusion may be considered. Future directions could include exploring patients/caregivers' perspectives of their roles in assessment in CBD.
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Cuidadores , Internato e Residência , Humanos , Criança , Competência Clínica , Canadá , Currículo , Técnica DelphiRESUMO
BACKGROUND: Decisions about organ donation are stressful for family members of potential organ donors. We sought to comprehensively explore the donation process from interviews conducted with family members of patients admitted to pediatric and adult intensive care units in Canada. METHODS: We conducted a qualitative study using semistructured, in-depth interviews with 271 family members asked to make an organ donation decision. We recruited participants from all provinces with an organ donation organization (n = 10), and analyzed themes using a modified grounded theory approach. On the basis of these interviews, suggestions were made by researchers and family members on how to improve the process of organ donation. RESULTS: We identified 3 main themes and 9 subthemes. Families need more comprehensive support around the time of donation, including having access to someone with shared experiences, support during specific moments as needed and better support during critical transitions (e.g., when the donor body goes to the operating room). The theme of better connection to recipient(s) included receiving information about the donation surgery (e.g., which organs were recovered), establishing connection with recipients (e.g., via social networks or letters) and planned encounters. Support after donation, such as updates on organ transplantation, early mental health checks and continued connection to donor organizations, could be improved. We derived 20 suggestions for improving the organ donation process, derived from interviews with family members of pediatric and adult organ donors. INTERPRETATION: We found gaps in family support during end-of-life and donation care. Feelings of abandonment, lack of support and poor-to-little follow-up provide the empirical findings needed for hospitals and organ donor organizations to provide better support to donor families.
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Transplante de Órgãos , Obtenção de Tecidos e Órgãos , Adulto , Criança , Família/psicologia , Humanos , Pesquisa Qualitativa , Doadores de TecidosRESUMO
Background: During the 1950s, advances in critical care, and organ transplantation altered the relationship between organ failure and death. There has since been a shift away from traditional cardiocirculatory based to brain-based criteria of death, with resulting academic controversy, despite the practice being largely accepted worldwide. Our objective is to develop a comprehensive description of the current understandings of healthcare professionals regarding the meaning, definition, and determination of death. Methods: Online databases were used to identify papers published from 2003 to 2020. Additional sources were searched for conference proceedings and theses. Two reviewers screened papers using predefined inclusion and exclusion criteria. Complementary searches and review of reference lists complemented the final study selection. A data extraction instrument was developed to iteratively chart the results of the review. A qualitative approach was conducted to thematically analyze the data. Results: Seven thousand four hundred twenty-eight references were identified. In total, 75 papers met the inclusion criteria. Fourteen additional papers were added from complementary searches. Most were narratives (35%), quantitative investigations (21%), and reviews (18%). Identified themes included: (1) the historical evolution of brain death (BD), (2) persistent controversies about BD and death determination, (3) wide variability in healthcare professionals' knowledge and attitudes, (4) critical need for BD determination revision. Conclusions: We concluded that although BD is widely accepted, there exists variation in healthcare providers' understanding of its conceptual basis. Death determination remains a divisive issue among scholars. This review identified a need for increased opportunities for formal training on BD among healthcare providers.
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Background: Advances in medicine and technology that have made it possible to support, repair, or replace failing organs challenge commonly held notions of life and death. The objective of this review is to develop a comprehensive description of the current understandings of the public regarding the meaning/definition and determination of death. Methods: This scoping review was conducted in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. Online databases were used to identify articles published from 2003 to 2021. Two reviewers (S.S. and K.Z.) screened the articles using predefined inclusion and exclusion criteria, extracted data for specific content variables, and performed descriptive examination. Complementary searches of reference lists complemented the final study selection. A search strategy using vocabulary of the respective databases was created, and criteria for the inclusion and exclusion of the articles were established. Results: Seven thousand four hundred twenty-eight references were identified. Sixty were retained for analysis, with 4 additional references added from complementary searches. A data extraction instrument was developed to iteratively chart the results. A qualitative approach was conducted to thematically analyze the data. Themes included public understanding/attitudes toward death and determination of death (neurological determination and cardiocirculatory determination of death), death and organ donation, public trust and legal variability, and media impacts. Conclusions: This review provides a current and comprehensive overview of the literature related to the general public's understanding and attitudes toward death and death determination and serves to highlight the gaps in this topic.
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BACKGROUND: There is an unmet need for mental health care in Canada. Primary care providers such as general practitioners and family physicians are the essential part of mental health care services; however, mental health is often underestimated and underprioritized by family physicians. It is currently not known what is required to increase care providers' willingness, comfort, and skills to adequately provide care to patients who present with mental health issues. OBJECTIVE: The aim of this study was to understand the need of caregivers (family members overseeing care of an individual with a mental health diagnosis) and family physicians regarding the care and medical management of individuals with mental health conditions. METHODS: A needs assessment was designed to understand the educational needs of caregivers and family physicians regarding the provision of mental health care, specifically to seek advice on the format and delivery mode for an educational curriculum to be accessed by both stakeholder groups. Exploratory qualitative interviews were conducted, and data were collected and analyzed iteratively until thematic saturation was achieved. RESULTS: Caregivers of individuals with mental health conditions (n=24) and family physicians (n=10) were interviewed. Both the caregivers and the family physicians expressed dissatisfaction with the status quo regarding the provision of mental health care at the family physician's office. They stated that there was a need for more educational materials as well as additional support. The caregivers expressed a general lack of confidence in family physicians to manage their son's or daughter's mental health condition, while family physicians sought more networking opportunities to improve and facilitate the provision of mental health care. CONCLUSIONS: Robust qualitative studies are necessary to identify the educational and medical management needs of caregivers and family physicians. Understanding each other's perspectives is an essential first step to collaboratively designing, implementing, and subsequently evaluating community-based mental health care. Fortunately, there are initiatives underway to address these need areas (eg, websites such as the eMentalHealth, as well as the mentorship and collaborative care network), and information from this study can help inform the gaps in those existing initiatives.
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OBJECTIVES: Although spontaneous breathing trials (SBTs) are standard of care to extubation readiness, no tool exists that optimises prediction and standardises assessment. In this study, we evaluated the feasibility and clinical impressions of Extubation Advisor (EA), a comprehensive clinical extubation decision support (CDS) tool. DESIGN: Phase I mixed-methods observational study. SETTING: Two Canadian intensive care units (ICUs). PARTICIPANTS: We included patients on mechanical ventilation for ≥24 hours and clinicians (respiratory therapists and intensivists) responsible for extubation decisions. INTERVENTIONS: Components included a predictive model assessment, feasibility evaluation, questionnaires and interviews with clinicians. RESULTS: We enrolled 117 patients, totalling 151 SBTs and 80 extubations. The incidence of extubation failure was 11% in low-risk patients and 21% in high-risk patients stratified by the predictive model; 38% failed extubation when both the model and clinical impression were at high risk. The tool was well rated: 94% and 75% rated the data entry and EA report as average or better, respectively. Interviews (n=15) revealed favourable impressions regarding its user interface and functionality, but unexpectedly, also concerns regarding EA's potential impact on respiratory therapists' job security. CONCLUSIONS: EA implementation was feasible, and users perceived it to have potential to support extubation decision-making. This study helps to understand bedside implementation of CDS tools in a multidisciplinary ICU. TRIAL REGISTRATION NUMBER: NCT02988167.
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Extubação , Sistemas de Apoio a Decisões Clínicas , Canadá , Estudos de Viabilidade , Humanos , Unidades de Terapia Intensiva , Respiração Artificial , Desmame do RespiradorRESUMO
INTRODUCTION: Conventional adenomas (tubular adenoma [TA] or tubulovillous adenoma) and sessile serrated lesions (SSLs) are neoplastic precancerous lesions frequently detected in patients undergoing average risk screening colonoscopy and polyp surveillance. Metachronous risk stratification of adenomas is currently limited to histologic features and size of polyps. We report long interspersed nucleotide element-1 (LINE-1) methylation levels in SSL in comparison to TA and the impact of TA size and presence of high-grade dysplasia (HGD) on LINE-1 methylation. METHODS: LINE-1 methylation was assessed by pyrosequencing of bisulfite-converted DNA. We compared LINE-1 methylation between TA and SSL, among varying sizes of TA, and between TA with HGD and low-grade dysplasia (LGD). RESULTS: LINE-1 methylation declined with increasing polyp size in TA when comparing those <5 mm (72.31 ± 6.11), 5 to <10 mm (67.50 ± 7.00), and ≥10 mm (66.75 ± 11.89). There were lower LINE-1 methylation levels in TA with LGD (n = 119) compared with SSLs (n = 29) (69.11 ± 8.62 vs 81.41 ± 2.43, P < 0.001). TA containing HGD (n = 26) had lower LINE-1 methylation levels than those with LGD (n = 119) (59.86 ± 7.93 vs 69.11 ± 8.62, P < 0.001). DISCUSSION: HGD and increasing size of TA/tubulovillous adenoma were associated with lower LINE-1 methylation. This supports a hypothesis that LINE-1 hypomethylation in TAs indicates advancement along the CRC tumorigenesis pathway. Lower LINE-1 methylation and greater variance of global DNA methylation was seen in TA compared with SSL. LINE-1 methylation in adenomas correlates with polyp size and degree of dysplasia and deserves further study as a predictor of metachronous colorectal cancer risk.
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Adenoma/genética , Neoplasias Colorretais/genética , Metilação de DNA , Elementos Nucleotídeos Longos e Dispersos , Adenoma/patologia , Idoso , Colonoscopia , Neoplasias Colorretais/patologia , Bases de Dados Factuais , Feminino , Humanos , Hiperplasia/patologia , Masculino , Pessoa de Meia-IdadeRESUMO
Background CT and bone scintigraphy have limitations in evaluating systemic anticancer therapy (SACT) response in bone metastases from metastatic breast cancer (MBC). Purpose To evaluate whether whole-body MRI enables identification of progressive disease (PD) earlier than CT and bone scintigraphy in bone-only MBC. Materials and Methods This prospective study evaluated participants with bone-only MBC between May 2016 and January 2019 (ClinicalTrials.gov identifier: NCT03266744). Participants were enrolled at initiation of first or subsequent SACT based on standard CT and bone scintigraphy imaging. Baseline whole-body MRI was performed within 2 weeks of entry; those with extraosseous disease were excluded. CT and whole-body MRI were performed every 12 weeks until definitive PD was evident with one or both modalities. In case of PD, bone scintigraphy was used to assess for bone disease progression. Radiologists independently interpreted images from CT, whole-body MRI, or bone scintigraphy and were blinded to results with the other modalities. Systematic differences in performance between modalities were analyzed by using the McNemar test. Results Forty-five participants (mean age, 60 years ± 13 [standard deviation]; all women) were evaluated. Median time on study was 36 weeks (range, 1-120 weeks). Two participants were excluded because of unequivocal evidence of liver metastases at baseline whole-body MRI, two participants were excluded because they had clinical progression before imaging showed PD, and one participant was lost to follow-up. Of the 33 participants with PD at imaging, 67% (22 participants) had PD evident at whole-body MRI only and 33% (11 participants) had PD at CT and whole-body MRI concurrently; none had PD at CT only (P < .001, McNemar test). There was only slight agreement between whole-body MRI and CT (Cohen κ, 0.15). PD at bone scintigraphy was reported in 50% of participants (13 of 26) with bone progression at CT and/or whole-body MRI (P < .001, McNemar test). Conclusion Whole-body MRI enabled identification of progressive disease before CT in most participants with bone-only metastatic breast cancer. Progressive disease at bone scintigraphy was evident in only half of participants with bone progression at whole-body MRI. © RSNA, 2020 Online supplemental material is available for this article.
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Neoplasias Ósseas/diagnóstico por imagem , Neoplasias Ósseas/secundário , Neoplasias Ósseas/terapia , Neoplasias da Mama/patologia , Neoplasias da Mama/terapia , Imagem Corporal Total/métodos , Meios de Contraste , Feminino , Humanos , Interpretação de Imagem Assistida por Computador , Imageamento por Ressonância Magnética , Pessoa de Meia-Idade , Estudos Prospectivos , Cintilografia , Compostos Radiofarmacêuticos , Tomografia Computadorizada por Raios XRESUMO
PURPOSE: This article shares our experience developing an integrated curriculum for the ACES (Acute Critical Event Simulation) program. The purpose of the ACES program is to ensure that health care providers develop proficiency in the early management of critically ill patients. The program includes multiple different types of educational interventions (mostly simulation-based) and targets both specialty and family physicians practicing in tertiary and community hospitals. METHODS: To facilitate integration between different educational interventions, we developed a knowledge repository consisting of cognitive sequence maps that make explicit the flow of cognitive activities carried out by experts facing different situations - the sequence maps then serving as the foundation upon which multimodal simulation scenarios would be built. To encourage participation of experts, we produced this repository as a peer-reviewed ebook. Five national organizations collaborated with the Royal College of Physicians and Surgeons of Canada to identify and recruit expert authors and reviewers. Foundational chapters, centered on goals/interventions, were first developed to comprehensively address most tasks conducted in the early management of a critically ill patient. Tasks from the foundational chapters were then used to complete the curriculum with situations. The curriculum development consisted of two-phases each followed by a peer-review process. In the first phase, focus groups using web-conferencing were conducted to map clinical practice approaches and in the second, authors completed the body of the chapter (e.g., introduction, definition, concepts, etc.) then provided a more detailed description of each task linked to supporting evidence. RESULTS: Sixty-seven authors and thirty-five peer reviewers from various backgrounds (physicians, pharmacists, nurses, respiratory therapists) were recruited. On average, there were 32 tasks and 15 situations per chapter. The average number of focus group meetings needed to develop a map (one map per chapter) was 6.7 (SD ± 3.6). We found that the method greatly facilitated integration between different chapters especially for situations which are not limited to a single goal or intervention. For example, almost half of the tasks of the Hypercapnic Ventilatory Failure chapter map were borrowed from other maps with some modifications, which significantly reduced the authors' workload and enhanced content integration. This chapter was also linked to 6 other chapters. CONCLUSIONS: To facilitate curriculum integration, we have developed a knowledge repository consisting of cognitive maps which organize time-sensitive tasks in the proper sequence; the repository serving as the foundation upon which other educational interventions are then built. While this methodology is demanding, authors welcomed the challenge given the scholarly value of their work, thus creating an interprofessional network of educators across Canada.
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INTRODUCTION: In a patient-centred and family-centred approach to organ donation, compassion is paramount. Recent guidelines have called for more research, interventions and approaches aimed at improving and supporting the families of critically ill patients. The objective of this study is to help translate patient-centred and family-centred care into practice in deceased organ donation. METHODS AND ANALYSIS: This will be a national, qualitative study of family members of deceased organ donors in Canada. We will include family members who had been approached regarding an organ donation decision, including those who agreed and declined, at least 2 months and no later than 3 years after the patients' death. Data collection and analysis is ongoing and will continue until September 2020 to include approximately 250 participants. Family members will be identified and recruited from provincial organ donation organisation databases. Four experienced qualitative researchers will conduct telephone interviews in English or French with audio-recording for subsequent transcription. The research team will develop a codebook iteratively through this process using inductive methods, thus generating themes directly from the dataset. ETHICS AND DISSEMINATION: Local research ethics boards (REB) at all participating sites across Canada have approved this protocol. The main REB involved is the Ottawa Health Science Network REB. Data collection began in August 2018. Publication of results is anticipated in 2021. Study findings will help improve healthcare provider competency in caring for potential organ donors and their families and improve organ donation consent rates. Findings will also help with the development of educational materials for a competency-based curriculum for critical care residents.
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Estado Terminal , Tomada de Decisões , Família/psicologia , Doadores de Tecidos , Canadá , Humanos , Pesquisa Qualitativa , Projetos de PesquisaRESUMO
BACKGROUND: The demand for solid organ transplantation has spurred countries around the world to search for innovative policies and practices to increase the supply of organs. Spain has become a global reference point for organ donation with the highest transplantation rates. In Ontario, Canada the Ontario Trillium Gift of Life (TGLN) has sought to replicate some of the successes in Spain. In particular, TGLN's implementation of the Physician Leadership Model has been viewed as a promising strategy to improve donation conversion rates. OBJECTIVE: The objective of this study was to evaluate the implementation of TGLNs (TGLN) Physician Leadership Model by examining critical implementation process variables (education/training, communication, satisfaction, participation and reach). METHODS: This mixed-method implementation evaluation included data from all members of the Physician Leadership Model including the Chief Medical Officer, five Regional Medical Leads (RMLs), and the 52 Hospital Donation Physicians (HDPs). Social Network Analysis (SNA) surveys were sent to all 52 HDPs and yielded an 85% rate. Analysis included constructing sociograms and qualitatively analyzing interviews. RESULTS: TGLN's PLM was poised for success by utilizing the existing RMLs' network as a foundation. The social network analysis measures, particularly participation and reach, indicated the PLM was quite dense (ie, the degree to which members are connected) at baseline. HDPs reported communication to be facilitated by their connections to their RMLs. Early evaluative data indicated that lack of education and training was viewed by HDPs as a barrier, and thus more capacity would need to be directed to this issue. Overall, HDPs reported that various intended outcomes were being met. CONCLUSION: We have demonstrated that an implementation evaluation helps us to understand which elements of the PLM were successful and which elements required immediate attention. This evaluation helped to highlight the successes and challenges in implementing the TGLN Physician Leadership Model in Ontario. Social network analysis of publicly funded capacity building systems has been identified as a promising area for health program evaluation to answer questions at a system level, such as identifying service provisions among information exchange networks and ultimately better health care.
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BACKGROUND: The shift in the medical education system from a time-based to a competency-based model has encouraged its adoption and application in competency-based education in anatomy classrooms, such as team-based learning models and flipped classroom models. This pilot study aimed to build on previous work of the linkages between anatomy-based learning (a flipped classroom model inspired by a modified team-based learning) and student learning and engagement, and further to assess the linkage between anatomy-based learning and academic performance. METHODS: A sequential mixed-methods design was employed to first gather and analyse quantitative data, including confidential student first semester scores in anatomy: gender, stream, anatomy-based learning, and final anatomy overall mark. The quantitative phase was followed by a qualitative phase in which a series of 8 anatomy laboratories were observed (4 anatomy-based learning and 4 traditional). Thematic analysis was performed on the observation data. RESULTS: Aggregate anatomy-based learning and traditional stream tests, and final unit scores were compared. The anatomy-based learning and final unit scores showed little difference between students in the anatomy-based learning and students in the traditional stream. Students using anatomy-based learning had an aggregate score of 1.15 and final aggregate mark of 72, whereas students in the traditional section had an aggregate score of 1.19 and final mark of 79. Qualitative phase was undertaken to try to assess the linkages between anatomy-based learning and student learning. Observations showed that students in the anatomy-based learning section spent more time on task as compared with their peers in the traditional stream. The anatomy-based learning students also seemed to practice more self-directed learning and employed more multimodal learning strategies than the traditional section stream. DISCUSSION/CONCLUSIONS: Although the quantitative results of this study showed no significant difference in mean scores between anatomy-based learning and traditional designs, it was possible to observe the potential of flipped classroom model in engaging students in individual preparation, in team-based learning, and in consensus-based learning approaches.
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BACKGROUND: Genomic tests are increasingly being used by clinicians when considering adjuvant chemotherapy for patients with oestrogen receptor-positive (ER+), human epidermal growth factor 2-negative (HER2-) breast cancer. The Oncotype DX breast recurrence score assay was the first test available in the UK National Health Service. This study looked at how UK clinicians were interpreting Recurrence Scores (RS) in everyday practice. METHODS: RS, patient and tumour characteristics and adjuvant therapy details were retrospectively collected for 713 patients from 14 UK cancer centres. Risk by RS-pathology-clinical (RSPC) was calculated and compared to the low/intermediate/risk categories, both as originally defined (RS < 18, 18-30 and > 30) and also using redefined boundaries (RS < 11, 11-25 and > 25). RESULTS: 49.8%, 36.2% and 14% of patients were at low (RS < 18), intermediate (RS 18-30) and high (RS > 30) risk of recurrence, respectively. Overall 26.7% received adjuvant chemotherapy. 49.2% of those were RS > 30; 93.3% of patients were RS > 25. Concordance between RS and RSPC improved when intermediate risk was defined as RS 11-25. CONCLUSIONS: This real-world data demonstrate the value of genomic tests in reducing the use of adjuvant chemotherapy in breast cancer. Incorporating clinical characteristics or RSPC scores gives additional prognostic information which may also aid clinicians' decision making.