A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer.

Background: The traditional management of papillary thyroid cancer (PTC) is thyroidectomy (total or partial removal of the thyroid). Active surveillance (AS) may be considered as an alternative option for small, low risk PTC. AS involves close follow-up (including regularly scheduled clinical and radiological assessments), with the intention of intervening with surgery for disease progression or patient preference. Methods: This is a protocol for a prospective, observational, long-term follow-up multi-centre Canadian cohort study. Consenting eligible adults with small, low risk PTC (< 2cm in maximal diameter, confined to the thyroid, and not immediately adjacent to critical structures in the neck) are offered the choice of AS or surgery for management of PTC. Patient participants are free to choose either option (AS or surgery) and the disease management course is thus not assigned by the investigators. Surgery is provided as usual care by a surgeon in an institution of the patient's choice. Our primary objective is to determine the rate of 'failure' of disease management in respective AS and surgical arms as defined by: i) AS arm - surgery for progression of PTC, and ii) surgical arm - surgery or other treatment for disease persistence or progression after completing initial treatment. Secondary outcomes include long-term thyroid oncologic and treatment outcomes, as well as patient-reported outcomes. Discussion: The results from this study will provide long-term clinical and patient reported outcome evidence regarding active surveillance or immediate surgery for management of small, low risk PTC. This will inform future clinical trials in disease management of small, low risk papillary thyroid cancer. Registration details: This prospective observational cohort study is registered on clinicaltrials.gov (NCT04624477), but it should not be considered a clinical trial as there is no assigned intervention and patients are free to choose either AS or surgery.

Proceedings of the Canadian Thyroid Cancer Active Surveillance Study Group 2019 national investigator meeting.

Active surveillance (AS) in the management of small, low risk papillary thyroid cancer (PTC) as an alternative option to thyroidectomy, is an area of active research. A national Canadian study is proposed to evaluate the long-term outcomes of patients with small, low risk PTC who choose AS or surgery. This letter describes the proceedings of a national investigator meeting to plan the study.

Closing the Gap: Results of the Multicenter Canadian Randomized Controlled Trial of Structured Transition in Young Adults With Type 1 Diabetes.

OBJECTIVE: To determine if a structured transition program for young adults with type 1 diabetes improves clinic attendance, glycemic control, diabetes-related distress, quality of life, and satisfaction with care. RESEARCH DESIGN AND METHODS: In this multicenter randomized controlled trial, young adults (17-20 years) with type 1 diabetes were randomly assigned to a transition program with a transition coordinator or to standard care. The intervention lasted 18 months (6 in pediatric and 12 in adult care). The primary outcome was the proportion of participants who failed to attend at least one adult diabetes clinic visit during the 12-month follow-up after completion of the intervention. RESULTS: We randomized 205 participants, 104 to the transition program and 101 to standard care. Clinic attendance was improved in the transition program (mean [SD] number of visits 4.1 [1.1] vs. 3.6 [1.2], P = 0.002), and there was greater satisfaction with care (mean [SD] score 29.0 [2.7] vs. 27.9 [3.4], P = 0.032) and less diabetes-related distress (mean [SD] score 1.9 [0.8] vs. 2.1 [0.8], P = 0.049) reported than in standard care. There was a trend toward improvement in mean HbA1c (8.33% [68 mmol/mol] vs. 8.80% [73 mmol/mol], P = 0.057). During the 12-month follow-up, there was no difference in those failing to attend at least one clinic visit (P = 0.846), and the mean change in HbA1c did not differ between the groups (P = 0.073). At completion of follow-up, the groups did not differ with respect to satisfaction with care or diabetes-related distress and quality of life. CONCLUSIONS: Transition support during this 18-month intervention was associated with increased clinic attendance, improved satisfaction with care, and decreased diabetes-related distress, but these benefits were not sustained 12 months after completion of the intervention.

Preparing the Next Generation of Code Blue Leaders Through Simulation: What's Missing?

INTRODUCTION: Despite the increasing reliance on simulation to train residents as code blue leaders, the perceived role and effectiveness of code blue simulations from the learners' perspective have not been explored. A code blue Simulation Program (CBSP), developed based on evidence-based simulation principles, was implemented at our institution. We explored the role of simulation in code blue training and the differences between real and simulated code blues from the learner perspective. METHODS: Using a thematic analysis approach and a purposeful sampling strategy, residents who participated in the CBSP were invited to participate in one of the three focus groups. Data were collected through small group discussions guided by semistructured interviews. The interviews were audio-recorded and transcribed. Interview transcripts were coded to assess underlying themes. RESULTS: Thematic analysis revealed that participants believed that the CBSP enhanced preparedness by capturing aspects of real codes (eg, inclusion of precode scenarios with awake patients, lack of readily available information) and facilitating automatization of code blue processes. Despite efforts to develop a high-fidelity simulation, participants noted that they experienced more anxiety, observed more chaos in the environment, and encountered different communication challenges in real codes. CONCLUSIONS: The CBSP enhanced resident preparedness to serve as code blue leaders. Learners highlighted that they valued the CBSP; however, differences remain between simulated and real codes that could be addressed to enhance the fidelity of future simulations.

Should learners reason one step at a time? A randomised trial of two diagnostic scheme designs.

CONTEXT: Making a diagnosis can be difficult for learners as they must integrate multiple clinical variables. Diagnostic schemes can help learners with this complex task. A diagnostic scheme is an algorithm that organises possible diagnoses by assigning signs or symptoms (e.g. systolic murmur) to groups of similar diagnoses (e.g. aortic stenosis and aortic sclerosis) and provides distinguishing features to help discriminate between similar diagnoses (e.g. carotid pulse). The current literature does not identify whether scheme layouts should guide learners to reason one step at a time in a terminally branching scheme or weigh multiple variables simultaneously in a hybrid scheme. We compared diagnostic accuracy, perceptual errors and cognitive load using two scheme layouts for cardiac auscultation. METHODS: Focused on the task of identifying murmurs on Harvey, a cardiopulmonary simulator, 86 internal medicine residents used two scheme layouts. The terminally branching scheme organised the information into single variable decisions. The hybrid scheme combined single variable decisions with a chart integrating multiple distinguishing features. Using a crossover design, participants completed one set of murmurs (diastolic or systolic) with either the terminally branching or the hybrid scheme. The second set of murmurs was completed with the other scheme. A repeated measures manova was performed to compare diagnostic accuracy, perceptual errors and cognitive load between the scheme layouts. RESULTS: There was a main effect of the scheme layout (Wilks' λ = 0.841, F3,80 = 5.1, p = 0.003). Use of a terminally branching scheme was associated with increased diagnostic accuracy (65 versus 53%, p = 0.02), fewer perceptual errors (0.61 versus 0.98 errors, p = 0.001) and lower cognitive load (3.1 versus 3.5/7, p = 0.023). CONCLUSIONS: The terminally branching scheme was associated with improved diagnostic accuracy, fewer perceptual errors and lower cognitive load, suggesting that terminally branching schemes are effective for improving diagnostic accuracy. These findings can inform the design of schemes and other clinical decision aids.

Recombinant Human Thyroid Stimulating Hormone versus Thyroid Hormone Withdrawal for Radioactive Iodine Treatment of Differentiated Thyroid Cancer with Nodal Metastatic Disease.

Introduction. Recombinant human thyroid stimulating hormone (rhTSH) is approved for preparation of thyroid remnant ablation with radioactive iodine (RAI) in low risk patients with well differentiated thyroid cancer (DTC). We studied the safety and efficacy of rhTSH preparation for RAI treatment of thyroid cancer patients with nodal metastatic disease. Methods. A retrospective analysis was performed on 108 patients with histopathologically confirmed nodal metastatic DTC, treated with initial RAI between January 1, 2000, and December 31, 2007. Within this selected group, 31 and 42 patients were prepared for initial and all subsequent RAI treatments by either thyroid hormone withdrawal (THW) or rhTSH protocols and were followed up for at least 3 years. Results. The response to initial treatment, classified as excellent, acceptable, or incomplete, was not different between the rhTSH group (57%, 21%, and 21%, resp.) and the THW group (39%, 13%, and 48%, resp.; P = 0.052). There was no significant difference in the final clinical outcome between the groups. The rhTSH group received significantly fewer additional doses of RAI than the THW group (P = 0.03). Conclusion. In patients with nodal-positive DTC, preparation for RAI with rhTSH is a safe and efficacious alternative to THW protocol.

Is lower socioeconomic status associated with more advanced thyroid cancer stage at presentation? A study in two Canadian centers.

BACKGROUND: Some studies have shown a higher incidence of thyroid cancer in patients with insurance coverage and higher socioeconomic status (SES), and a higher thyroid cancer stage in patients with lower SES, suggesting SES-related health disparity in thyroid cancer. However, it is not known if the same is evident under a universal healthcare system such as that in Canada. METHODS: We used data from the Canadian Thyroid Cancer Consortium, a large thyroid cancer registry that collects data from two major thyroid cancer referral centers (London, Ontario, and Halifax, Nova Scotia). We included patients who presented with thyroid cancer between 1998 and 2011. We determined age at presentation, sex, and thyroid cancer status using the American Joint Committee on Cancer (AJCC) staging criteria. Individuals' postal codes were used to retrieve data from the Canadian census for the years 1996, 2001, and 2006 to approximate household income. Ordered logistic regression was used to determine odds ratios of presenting with more advanced stage thyroid cancer as they relate to income, age, and sex. RESULTS: We included 1701 patients: 1334 cases from London and 367 from Halifax. Thyroid cancer was diagnosed more frequently in the higher SES groups (p<0.001). Compared to patients in the top income quintile, patients in the lowest and second-lowest income quintiles had significantly higher odds of having more advanced stage thyroid cancer at presentation (OR 1.58, p=0.002; 1.37, p=0.024 respectively). CONCLUSIONS: Our study suggests that, similar to countries that lack a universal healthcare system, health disparity in thyroid cancer also exists in Canada. It appears that while thyroid cancers were diagnosed more frequently in Canadian patients of higher SES, Canadian patients in the lower SES groups had more advanced stage thyroid cancer at presentation.