SOMC 220 Small Literature Groups Analyzing and Explaining Medical Research

Class Details Group Leader Mark Lawson, Ph.D. Professor, Reproductive Medicine Office: Leichtag Building, 3A13 Meeting Dates AM AM- 11:50 change of venue to Leichtag 205 AM-11:50 change of venue to Leichtag 205

Purpose Preparation for future practice Must be able to critically evaluate new protocols as they arise. Must evaluate the efficacy of the drugs for non-standard uses. Opportunity to practice oral presentation Oral communication is essential for interacting with patients. Future steps require the ability to present your case orally to your peers. Preparation for the questions of future patients An effective health care provider must be able to answer patient questions which arise from popular media or their own research.

Requirements One oral presentation Attendance at each session (contact instructor if you cannot attend) Participation in class discussions

Course Objectives Recognize that ongoing advances in medicine will necessitate life-long learning Critically evaluate biomedical literature, and effectively present their conclusions Maintain a healthy skepticism about interpretations Understand the necessity of using evidence-based studies Communicate the implications of new research to non- experts, such as colleagues or patients

Structure First Meeting Introduction Assignment of papers Second and Third Meetings Two papers presented 35 minute talk per paper plus discussion 10 minute break between presentations Feedback will be in the form of evaluations from peers and Leader Food and Beverage bribes are welcome Discussion Prep Arranged meetings with leader prior to presentation

Requirements Each student must participate in an oral presentation Students must attend each meeting or contact the instructor ahead of time The content of the presentations/papers will be examined on quizzes and exams Learning objectives that will be tested are posted on the course website

The Papers Papers are drawn from the New England Journal of Medicine Reasonably accessible to the general reader Common audience of clinicians and researchers Editorials and perspective articles included to provide background and context Instructions for reading and presenting are posted on the course website 2-3 members will team up for each paper

Reading a Paper Abstract Will include the author’s major points You should understand the main point Introduction Places the research in context Develops the primary hypothesis You should learn why the work is important and what the central question is Results Describers the approach, design and outcomes of the tests or observations You should understand the logic and implementation of the study as well as outcomes Discussion Summarizes results and draws conclusions Addresses impact Makes predictions and indicates future directions You should form an opinion about the work Methods Should provide enough information for another expert to replicate the study You should determine if the methods were appropriate

Presenting a Paper Use Learning Objectives as a Guide Involve the Audience Question the audience and assess comprehension Introduction Provide Context, discuss why the study is important or of interest The Approach How the question is asked The Experiments Clearly State Question, describe the result, then conclusion Conclusions Give overall conclusions and your interpretation of it Implications Discuss future experiments or broad implications

References September 8, 2014: First paper and commentary: Cancer Vaccine Trial-Lizette, Mack, Toby FUTURE II Study Group. “Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.” NEJM 356: (2007). Finn, O.J., and R. P. Edwards. “Human Papillomavirus Vaccine for Cancer Prevention.” NEJM 361: (2009). Second paper and commentary: Molecular Medicine-Quan, Vi, Sarah Fong, P.C. et al. “Inhibition of Poly(ADP-Ribose) Polymerase in Tumors from BRCA Mutation Carriers.” NEJM 361: (2009). Editorial: Iglehart, J.D., and D. P. Silver. “Synthetic Lethality – A New Direction in Cancer-Drug Development.” NEJM 361: (2009).

References September 15, 2014: First paper and commentary: Personalized Medicine-Natalia, Shaddi Baselga, J., et al, “Pertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer,” NEJM 366: 109 (2012) EXCERPT from an Extension of Survival Analysis for Baselga et al: Swain, S.M. et al, “Overall Survival Benefit with Pertuzumab, Trastuzumab, and Docetaxel … Lancet Oncology 14: 461 (2013) Editorial: Gradishar, W.J., “HER2 Therapy - - An Abundance of Riches,” NEJM 366:176 (2012). Second paper and commentary: Molecular Medicine-Michael, Jonathan, Jinnie Chapman, P.B., et al, “Improved Survival with Vemurafenib in melanoma with BRAF V600E Mutation,” NEJM 364:2507 (2011). Editorial for a previous, related paper: Smalley, K.S.M, and Sondak, V.K., “Melanoma – An Unlikely Poster Child for Personalized Cancer Therapy,” NEJM 363:876 (2010). Editorial: Ernstoff, M.S., “Been There, not Done That – Melanoma in the Age of Molecular Therapy,” NEJM 364:2547 (2011).

Introductions Assignment of Papers

Assignments: