Faculty Entrustment of Students in the Core Clerkships: A Comparison between the Longitudinal Integrated Clerkship and the Block Clerkship

INTRODUCTION: Entrustable Professional Activities (EPAs) have been proposed for use in undergraduate medical education. The ability of faculty to entrust students with EPAs may differ between Longitudinal Integrated Clerkships (LICs) and traditional block clerkships. METHODS: Participants were core clerkship faculty, 64 in a LIC and 31 in a sequential block clerkship. We administered a web-based survey at the end of the core clerkship year to measure preceptors’ typical entrustment (on a scale of 0–10) in students for the 13 American Association of Medical Colleges Core EPAs. We compared entrustment between LIC and block faculty using a Mann-Whitney test. RESULTS:LIC faculty were more entrusting of students than block faculty in 12 out of 13 Core EPAs (p DISCUSSION: LIC faculty were more likely than block clerkship faculty to entrust core clerkship students with performance of most EPAs. This finding is likely the result of LIC faculty having increased familiarity with student abilities because of the continuity of supervision and education inherent to LIC. More research is needed to ascertain the specific features of longitudinal clerkships that increase faculty entrustment of students. CONCLUSIONS: Longitudinal educational experiences may facilitate the assessment of medical students with EPAs

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial

Background Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. Methods RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov , NCT00541047 . Findings Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Interpretation Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Funding Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society

Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial

Background Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear. Methods RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Findings Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1–10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4–82·5) in the no ADT group and 80·4% (76·6–83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths. Interpretation Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population

A Four-Year Longitudinal Curriculum to Improve Feedback-Seeking Behaviors for Medical Students

Introduction: Feedback is essential for performance improvement and plays a pivotal role in competency-based medical education. Medical learners need training to acquire skills to effectively seek feedback for their unique situations. Methods: We developed a 4-year longitudinal curriculum designed to encourage feedback-seeking by medical students. The 4.5-hour curriculum consisted of interactive lectures, feedback-seeking surveys, trigger videotapes, and peer-group discussions in small- and large-group formats.  A volunteer study cohort (n = 14/37, 38%) was interviewed in 4 separate waves in individual and focus-group formats to explore perceptions about feedback-seeking and effectiveness of the curriculum. Results: Themes and student quotes related to the learning objectives were summarized. The students expressed appreciation for the value of seeking feedback. They appreciated the techniques they learned and the frequent reminders. They particularly appreciated the opportunities to share successes and failures related to feedback-seeking with their peers. Discussion: Our novel feedback-seeking curriculum supported students’ understanding of the importance of feedback and their effective use of multiple feedback-seeking techniques. The longitudinal component supports greater opportunity for building space in the curriculum, incorporating reflection and reinforcement, and creating capacity for student application and technique refinement. Conclusions: Teaching students feedback-seeking through various techniques tailored for their unique situations, rather than waiting to potentially receive feedback, is important for their professional development and overall medical education

Faculty Entrustment of Students in the Core Clerkships: A Comparison between the Longitudinal Integrated Clerkship and the Block Clerkship

INTRODUCTION: Entrustable Professional Activities (EPAs) have been proposed for use in undergraduate medical education. The ability of faculty to entrust students with EPAs may differ between Longitudinal Integrated Clerkships (LICs) and traditional block clerkships. METHODS: Participants were core clerkship faculty, 64 in a LIC and 31 in a sequential block clerkship. We administered a web-based survey at the end of the core clerkship year to measure preceptors’ typical entrustment (on a scale of 0–10) in students for the 13 American Association of Medical Colleges Core EPAs. We compared entrustment between LIC and block faculty using a Mann-Whitney test. RESULTS:LIC faculty were more entrusting of students than block faculty in 12 out of 13 Core EPAs (p DISCUSSION: LIC faculty were more likely than block clerkship faculty to entrust core clerkship students with performance of most EPAs. This finding is likely the result of LIC faculty having increased familiarity with student abilities because of the continuity of supervision and education inherent to LIC. More research is needed to ascertain the specific features of longitudinal clerkships that increase faculty entrustment of students. CONCLUSIONS: Longitudinal educational experiences may facilitate the assessment of medical students with EPAs

A population pharmacokinetic model based on HPTN 077 of long‐acting injectable cabotegravir for HIV PrEP

AimsCabotegravir delivered as a long-acting intramuscular injection has shown superior efficacy to oral tenofovir-emtricitabine as pre-exposure prophylaxis (PrEP) for HIV. Cabotegravir pharmacokinetics (PK), like those of other long-acting depot preparations, exhibit variability between individuals and between injection occasions. The aim of this study is to describe the population pharmacokinetics of long-acting cabotegravir (CAB-LA).MethodsUsing available PK measurements from 133 participants in the HIV Prevention Trials Network (HPTN) 077 trial, we analysed CAB-LA PK data using nonlinear mixed-effects modelling to develop a population PK model.ResultsA two-compartment model with first order absorption best described the CAB-LA PK. The analysis identified between-occasion variability (BOV, i.e., differences in PK within one individual from one injection to the next) as a significant covariate affecting the absorption rate, with an estimated contribution of BOV to PK variability on the absorption rate (ka ) of 38.5%. Sex and body weight were identified as significant covariates influencing the absorption rate and apparent clearance of CAB-LA after intramuscular injection at various doses and frequencies. Male participants had 67% higher ka than female participants. Serially adding to the model body weight on clearance, sex on ka , and BOV on ka led to a decrease in the objective function value (OFV) of 24.4, 36 and 321.4, respectively.ConclusionThe public availability of this model will facilitate and enable a wide variety of future clinically relevant simulations to inform the optimal use of CAB-LA