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INTRODUCTION: Geriatric assessment and management (GAM) is recommended by professional organizations and recently several randomized controlled trials (RCTs) demonstrated benefits in multiple health outcomes. GAM typically leads to one or more recommendations for the older adult on how to optimize their health. However, little is known about how well recommendations are adhered to. Understanding these issues is vital to designing GAM trials and clinical programs. Therefore, the aim of this study was to examine the number of GAM recommendations made and adherence to and satisfaction with the intervention in a multicentre RCT of GAM for older adults with cancer. MATERIALS AND METHODS: The 5C study was a two-group parallel RCT conducted in eight hospitals across Canada. Each centre kept a detailed recruitment and retention log. The intervention teams documented adherence to their recommendations. Medical records were also reviewed to assess which recommendations were adhered to. Twenty-three semi-structured interviews were conducted with 12 members of the intervention teams and 11 oncology team members to assess implementation of the study and the intervention. RESULTS: Of the 350 participants who were enrolled, 173 were randomized to the intervention arm. Median number of recommendations was seven. Mean adherence to recommendations based on the GAM was 69%, but it varied by type of recommendation, ranging from 98% for laboratory tests to 28% for psychosocial/psychiatry oncology referrals. There was no difference in the number of recommendations or non-adherence to recommendations by sex, level of frailty, or functional status. Oncologists and intervention team members were satisfied with the study implementation and intervention delivery. DISCUSSION: Adherence to recommendations was variable. Adherence to laboratory investigations and further imaging were generally high but much lower for recommendations regarding psychosocial support. Further collaborative work with older adults with cancer is needed to understand how to optimize the intervention to be consistent with patient goals, priorities, and values to ensure maximal impact on health outcomes.
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Fragilidade , Neoplasias , Humanos , Idoso , Avaliação Geriátrica , Canadá , Neoplasias/terapia , Satisfação Pessoal , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
PURPOSE: American Society of Clinical Oncology recommends that older adults with cancer being considered for chemotherapy receive geriatric assessment (GA) and management (GAM), but few randomized controlled trials have examined its impact on quality of life (QOL). PATIENTS AND METHODS: The 5C study was a two-group parallel 1:1 single-blind multicenter randomized controlled trial of GAM for 6 months versus usual oncologic care. Eligible patients were age 70+ years, diagnosed with a solid tumor, lymphoma, or myeloma, referred for first-/second-line chemotherapy or immunotherapy or targeted therapy, and had an Eastern Cooperative Oncology Group performance status of 0-2. The primary outcome QOL was measured with the global health scale of the European Organisation for the Research and Treatment of Cancer QOL questionnaire and analyzed with a pattern mixture model using an intent-to-treat approach (at 6 and 12 months). Secondary outcomes included functional status, grade 3-5 treatment toxicity; health care use; satisfaction; cancer treatment plan modification; and overall survival. RESULTS: From March 2018 to March 2020, 350 participants were enrolled. Mean age was 76 years and 40.3% were female. Fifty-four percent started treatment with palliative intent. Eighty-one (23.1%) patients died. GAM did not improve QOL (global QOL of 4.4 points [95% CI, 0.9 to 8.0] favoring the control arm). There was also no difference in survival, change in treatment plan, unplanned hospitalization/emergency department visits, and treatment toxicity between groups. CONCLUSION: GAM did not improve QOL. Most intervention group participants received GA on or after treatment initiation per patient request. Considering recent completed trials, GA may have benefit if completed before treatment selection. The COVID-19 pandemic may have affected our QOL outcome and intervention delivery for some participants.
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COVID-19 , Neoplasias , Humanos , Feminino , Idoso , Masculino , Qualidade de Vida , Avaliação Geriátrica , Método Simples-Cego , Pandemias , Neoplasias/tratamento farmacológico , Hospitalização , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
INTRODUCTION: Geriatric assessment and management is recommended for older adults with cancer referred for chemotherapy but no randomised controlled trial has been completed of this intervention in the oncology setting. TRIAL DESIGN: A two-group parallel single blind multi-centre randomised trial with a companion trial-based economic evaluation from both payer and societal perspectives with process evaluation. PARTICIPANTS: A total of 350 participants aged 70+, diagnosed with a solid tumour, lymphoma or myeloma, referred for first/second line chemotherapy, who speak English/French, have an Eastern Collaborative Oncology Group Performance Status 0-2 will be recruited. All participants will be followed for 12 months. INTERVENTION: Geriatric assessment and management for 6 months. The control group will receive usual oncologic care. All participants will receive a monthly healthy ageing booklet for 6 months. OBJECTIVE: To study the clinical and cost-effectiveness of geriatric assessment and management in optimising outcomes compared with usual oncology care. RANDOMISATION: Participants will be allocated to one of the two arms in a 1:1 ratio. The randomisation will be stratified by centre and treatment intent (palliative vs other). OUTCOME: Quality of life. SECONDARY OUTCOMES: (1) Cost-effectiveness, (2) functional status, (3) number of geriatric issues successfully addressed, (4) grades3-5 treatment toxicity, (5) healthcare use, (6) satisfaction, (7) cancer treatment plan modification and (8) overall survival. PLANNED ANALYSIS: For the primary outcome we will use a pattern mixture model using an intent-to-treat approach (at 3, 6 and12 months). We will conduct a cost-utility analysis alongside this clinical trial. For secondary outcomes 2-4, we will use a variety of methods. ETHICS AND DISSEMINATION: Our study has been approved by all required REBs. We will disseminate our findings to stakeholders locally, nationally and internationally and by publishing the findings. TRIAL REGISTRATION NUMBER: NCT03154671.
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Avaliação Geriátrica , Neoplasias/terapia , Idoso , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Canadá , Análise Custo-Benefício , Avaliação Geriátrica/métodos , Humanos , Neoplasias/tratamento farmacológico , Neoplasias/economia , Método Simples-Cego , Resultado do TratamentoRESUMO
OBJECTIVE: This study used a virtual patient simulation (VPS) to quantifiably and objectively assess undergraduate (UG) to postgraduate (PG) medical learners' acquisition of the entrustable professional activity (EPA) "handover," focusing particularly on the transition to residency. This EPA is critical because it is part of a core competency for UG and PG training in both the United States and Canada, and is essential for patient safety and comprehensive professional communication. DESIGN: Data were collected from 3 separate groups of participants: 2 UG cohorts from an earlier study, as well as a PG cohort at the beginning of residency. All participants completed the same trauma VPS, which required a free text summary statement that was used as a surrogate for an oral handover. These were collected and scored independently, using previously developed validated rubrics, one procedural and the second semantic. SETTING: All study participants were from one site. The VPS case was completed online. PARTICIPANTS: Two different UG groups, one designated junior (Nâ¯=â¯52), was studied at the beginning of their clerkship year, a second group, designated senior (Nâ¯=â¯30), was studied at the end of their clerkship year. These groups were compared to a third group of PG learners (Nâ¯=â¯31) during the initial 2 weeks of their residency. Informed consent was obtained from all participants. RESULTS: A procedural rubric assessed learners' cognitive knowledge of trauma care-management. A semantic rubric assessed their use of the professional language necessary for a safe and succinct clinical handover communication. An Analysis of Variance comparing scores on the procedural rubric was highly significant with Tukey LSD tests indicating that all 3 groups were significantly different. Students increased their scores on the procedural rubric at each stage of their training. A parallel Analysis of Variance comparing students' scores on the semantic rubric revealed no significant increase in scores, indicating that students did not improve in their capacity to communicate professionally as they progressed through their training. CONCLUSIONS: Taken together, these results demonstrate that training was successful in teaching cognitive-based procedures, but not effective in teaching professional communication, which is critical to the EPA handover. Greater emphasis needs to be placed on ensuring the acquisition of professional communication skills throughout the continuum of UG and PG clinical activities. Faculty development should serve as a support to assist medical educators to address this requirement. These results also demonstrate that VPS with associated objective and validated rubrics can be used as an assessment methodology to quantifiably measure learner performance with respect to the EPA handover. A similar strategy should be considered across the UG and PG continuum for other EPAs and could form the nexus for further research.
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Educação de Graduação em Medicina , Cirurgia Geral/educação , Internato e Residência , Educação de Pós-Graduação em Medicina , Humanos , Simulação de PacienteRESUMO
BACKGROUND: The purpose of this study was to determine the impact of a formal surgical research program (leading to a postgraduate degree) during residency, on future research productivity. METHODS: We surveyed all North American graduates of the McGill University general surgery residency program between 1987 and 2005. The survey included questions on research involvement before, during, and after general surgery residency. This was combined with a literature search revealing all research publications of the participants. Outcomes were the yearly average of publications and awarded funding as faculty members. RESULTS: Seventy-five of 119 graduates (63%) responded. Staff physicians who had participated in formal research programs during residency (n = 35), compared with those who had not (n = 40), produced more publications per year (2.8 ± 2.3 vs 1.1 ± 1.2, P < .01) and had greater funding success (81% vs 55%, P = .03). CONCLUSIONS: Residents who had participated in formal research programs during residency were more likely to have greater academic success.
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Pesquisa Biomédica/educação , Cirurgia Geral/educação , Internato e Residência , Editoração/estatística & dados numéricos , Apoio à Pesquisa como Assunto , Pesquisa Biomédica/economia , Canadá , Escolha da Profissão , Docentes de Medicina , Humanos , Motivação , Estados UnidosRESUMO
BACKGROUND: What is the source of inadequate performance in the operating room? Is it a lack of technical skills, poor judgment or a lack of procedural knowledge? We created a surgical procedural knowledge (SPK) assessment tool and evaluated its use. METHODS: We interviewed medical students, residents and training program staff on SPK assessment tools developed for 3 different common general surgery procedures: inguinal hernia repair with mesh in men, laparoscopic cholecystectomy and right hemicolectomy. The tools were developed as a step-wise assessment of specific surgical procedures based on techniques described in a current surgical text. We compared novice (medical student to postgraduate year [PGY]-2) and expert group (PGY-3 to program staff) scores using the Mann-Whitney U test. We calculated the total SPK score and defined a cut-off score using receiver operating characteristic analysis. RESULTS: In all, 5 participants in 7 different training groups (n = 35) underwent an interview. Median scores for each procedure and overall SPK scores increased with experience. The median SPK for novices was 54.9 (95% confidence interval [CI] 21.6-58.8) compared with 98.05 (95% CP 94.1-100.0) for experts (p = 0.012). The SPK cut-off score of 93.1 discriminates between novice and expert surgeons. CONCLUSION: Surgical procedural knowledge can reliably be assessed using our SPK assessment tool. It can discriminate between novice and expert surgeons for common general surgical procedures. Future studies are planned to evaluate its use for more complex procedures.
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Competência Clínica , Educação de Pós-Graduação em Medicina/organização & administração , Educação de Graduação em Medicina/organização & administração , Cirurgia Geral/educação , Salas Cirúrgicas/organização & administração , Adulto , Canadá , Intervalos de Confiança , Currículo , Avaliação Educacional , Feminino , Cirurgia Geral/organização & administração , Humanos , Internato e Residência , Entrevistas como Assunto , Masculino , Corpo Clínico Hospitalar , Pessoa de Meia-Idade , Desenvolvimento de Programas , Avaliação de Programas e Projetos de Saúde , Curva ROC , Estatísticas não Paramétricas , Estudantes de Medicina , Adulto JovemRESUMO
BACKGROUND: There is a pressing need for an intraoperative assessment tool that meets high standards of reliability and validity to use as an outcome measure for different training strategies. The aim of this study was to develop a tool specific for laparoscopic skills and to evaluate its reliability and validity. METHODS: The Global Operative Assessment of Laparoscopic Skills (GOALS) consists of a 5-item global rating scale. A 10-item checklist and 2 visual analogue scales (VAS) for competence and case difficulty were also used. During laparoscopic cholecystectomy, 21 participants were evaluated by the attending surgeon, by 2 trained observers and by self-assessment while dissecting the gallbladder from the liver bed. RESULTS: The intraclass correlation coefficient (ICC) for the total GOALS score was .89 (95% confidence interval [CI] .74 to .95) between observers, .82 (95% CI .67 to .92) between observers and attending surgeons, and .70 (95% CI .37 to .87) between participants and attending surgeons. The ICCs (observers) for the VAS (competence) and the checklist were .69 and .70, respectively. The mean total GOALS score (observers) for novices (postgraduate years [PGYs] 1 through 3) was 13 (95% CI 10.3 to 15.7) compared with 19.4 (95% CI 17.2 to 21.5) for experienced (PGY 4 through attending surgeons, P = .0006). The VAS demonstrated a difference in scores between novice and experienced participants (P = .001); however, the task checklist did not (P = .09). CONCLUSIONS: These data indicate that GOALS is feasible, reliable, and valid. They also suggest that it is superior to the task checklist and VAS for evaluation of technical skill by experienced raters. The findings support the use of GOALS in the training and evaluation of laparoscopic skills.