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Publication Scholarship: The Manuscript Reviewer & Teaching Journal Club Henry Cohen, BS, MS, PharmD, FCCM, BCPP, CGP Professor of Pharmacy Practice Arnold & Marie Schwartz College of Pharmacy and Health Sciences of Long Island University and Chief Pharmacotherapy Officer Director of Pharmacy Residency Programs (PGY-1 & PGY-2) Departments of Pharmacy and Medicine Kingsbrook Jewish Medical Center Brooklyn, New York Scholarship Defined The creation, discovery, advancement, or transformation of knowledge Composed in a manner that is subject to peer review and effective communication Assessed for quality by peer review and made public If an activity cannot be evaluated using universally recognized criteria, it will not be universally valued Standards to Assess Scholarship Clear goals Adequate preparation Appropriate methods Significant Results Effective presentation Reflective critique Relevance of Publication Scholarship Pharmacy Requirement of a healthcare profession Advance and improve patient care Societal contribution Clinical Pharmacists Establish & improve relationships with medical and nursing staff Funding opportunities for department and hospital – Fellowships, new equipment, stipends Enhance job satisfaction Relevance of Publication Scholarship Academicians Requirement for reappointment, promotion and tenure – Tenure track faculty – Nontenure track faculty – Research positions Collaborative opportunities with other pharmacy disciplines Research and practice opportunities at university-based medical centers Teaching Opportunities – Undergraduate and graduate Advantages of Serving as a Peer Reviewer for a Journal Ensure robust, fair, non-bias, safe contributions to the literature Critique can enhance the manuscript and increase relevance Controversial publications Review cutting edge research Apply data to practice Provide ideas for research endeavors Advantages of Serving as a Peer Reviewer for a Journal Scholarly activity Job requirement for reappointment promotion Professional notoriety Professional satisfaction Provides new opportunities Journal Editorial Board Member Journal Editor Publishing Educational What credentials do I need to be a Peer Reviewer? Training in area of expertise PharmD or advanced degree General Residency and Specialty Residency Practice in area of expertise Experience in area of expertise 3 – 5 Years minimum Research in area of expertise Fellowship Board Certified What credentials do I need to be a Peer Reviewer? Publish manuscripts Publish in peer reviewed journals Chapters in text books Web Chapters Lecture in area of expertise Invited presentations Board certification review courses Notoriety in area of expertise How can I be appointed to become a Peer Reviewer? Choose an area that you are competent Respond to peer review in a timely fashion Do not be an offensive Abstract reviewer Answer Journal “call” for peer reviewers Ask the Journal Editor Ask Journal Editorial Board Members for recommendations After publishing an article – ask if opportunities exist How to Critically Evaluate Published Drug Therapy & Drug-Induced Case Reports Introduction – relevance and brief literature review Establish a temporal and causal relationship Detect confounding variables Medications, OTCs, CAM, recreational drugs Doses of concomitant medications Medication compliance measurements Drug serum levels and laboratory data Drug and food interactions Nutrition status and compliance Comorbid diseases How to Critically Evaluate Published Drug Therapy & Drug-Induced Case Reports Was a comprehensive literature review provided? Focus on similarities and differences to the case report Was a summary table with salient data provided? Was the case validated with established criteria Naranjo’s Algorithm Conclusion Is the conclusion valid based on the case report? How can I apply the data from the report to my practice? Provide a prospectus to answer unanswered questions How to Critically Evaluate Published Drug-Related Clinical Trials Hypothesis Objectives How many and are they attainable? Methodology Sample size – was a power analysis completed? Blinding Length of study Exclusion criteria Medication source – generic or brand Confounding variables (similar as with case reports) Compliance statistics How to Critically Evaluate Published Drug-Related Clinical Trials Results & Discussion Do the results answer the objectives Did the author’s compare and contrast the results with similar trials, and provide explanations for the differences Conclusion Is the conclusion is based on study objectives and results? How can I apply the trial conclusions to my practice? Provide a prospectus to answer unanswered questions Reviewing Submitted Manuscripts as a Referee Vs Reviewing Published Articles Minor flaws are acceptable Major flaws Fatal Recoverable Acceptable Uncontrollable Are the conclusions accurate? Do the conclusions have any value in advancing present practice? Correcting Diction, Grammar, and Spelling Diction Choice of words; clear, correct and effective Grammar Syntax Spelling Reject based on poor diction, grammar, or spelling Choppy, lengthy, redundant, awkward sentencing Do not correct use of english Request medical writer to edit and rewrite List the different Forest Classes for GI Bleeding List the troponin and CPK levels that were noted in patients who did develop an acute coronary syndrome In the clinical course section, sentence 1, shorter duration of symptoms refers to MI or GI symptoms – please clarify? What medications were used to treat patients with GI bleed? Did patients receive medications prior to endoscopy? When providing mortality data – provide the number in addition to the percentage. What strength of epinephrine was used for endoscopic injection hemostasis? The tables are not referenced in the text. Define in every table in the key section, pre- and post- PES MI. Make some preventative recommendations – should beta blockers be considered at patients with CAD risk? Conclusions regarding the duration of endoscopic examination may be premature, the differences are small – please clarify. The author concludes that the method of hemostasis did not differ between patients who had an MI and those who did not there are too few patients in all groups to make this conclusion. Methods for Submitting Review Web-based programs Electronic copy submitted via mail, E-mail or fax Generally cannot write comments on the manuscript Not-blinded to editor Blinded to author Comments to editor and author Comments to editor that are not viewable by author Reviewer’s Guidelines Ensure ethical and humane study Ensure Institutional Review Board Approval Ensure HIPPA rules are followed Appropriate use of references Ensure that assays & scoring systems are validated Recommend review for statistical analysis Recommend “Editorial Reply” by an expert Recommend experts to the editor Reviewer’s Guidelines Critically review the manuscript Focus on scientific merit and value Provide constructive criticism Aim is to improve the quality Do not be destructive Judge each manuscript on its own merits Avoid personal comments and opinions Reviewer’s Guidelines The Final Decision Accept a manuscript Perfect manuscript Requires no changes Cannot accept but will reconsider if revisions are made Provide comments on scientific method Provide recommendations for substantive changes Reject Provide a paragraph describing the merits of your decision Reviewer’s Guidelines Choose only areas of expertise May ask a colleague to review Teaching tool for residents and new practitioners Inform editor that this is not your area of expertise Editors request 2 – 6 week deadlines Inform editor immediately when you cannot meet a deadline Review 2 – 6 manuscripts annually Estimated 20 – 50 hours per year Allow for busy-time, Vacations Recommend an alternative reviewer How to choose expert subjects for review List of Subjects Disease specific Organ specific Subject specific Pulmonary Edema Pulmonary Emboli Pulmonary Function Tests CNS Head Injury Cerebral Function Stroke Parkinson’s Disease Pulmonary Hepatic Hepatic Failure Hepatic Drug Metabolism Hepatic Function Tests How does drug literature evaluation enhance the skills necessary to publish case reports and clinical trials? Developing excellent drug literature evaluation skills spawns similar applicability and strategy to preparing case reports, and designing research protocols Case reports are an excellent start for beginners Comprehensive evaluation of clinical trials is an advanced skill, and integral to success Repetition and experience is important to master this skill Teaching Drug Literature Evaluation Skills to Pharmacy Students, Residents, and Pharmacists Journal Club Presentations Provide goals and objectives for evaluations and grading Present using slides, and a handout Teach a primer on basic presentation skills Encourage active participation from the audience Require the audience to read the article Teaching Drug Literature Evaluation Skills to Pharmacy Students, Residents, and Pharmacists Design an outline for the presentation Faculty should review the outline BEFORE the student proceeds with the preparation of the presentation Establish time limitations based on the outline Case reports 20 minutes + 20 minutes of Q&A Research Trials 30 – 40 minutes + 30 minutes of Q&A 1 or 2 presentations every 4 – 8 weeks of clerkship Journal Club Evaluation Criteria: Review of Article Accurately and concisely summarizes the introduction, study hypothesis, methodology, major points of results and discussion (if applicable) of the article. Accurately presents the conclusion of the study. Elaborates on any minor or major attributes or deficiencies of the study. If none are present, the presenter states such. Journal Club Evaluation Criteria: Ability to Answer Questions Answers questions in a logical fashion. Accurately answers and corresponds with the expected competency of the presenter. Thinks creatively and analytically. May theorize, if not sure of an answer, but identifies answer as such. Journal Club Evaluation Criteria: Presentation Skills Visual aids are appropriate handouts and slides Room setup Establishes eye contact Pronunciations are correct Speaks with enthusiasm Correct use of vocabulary Not verbose or redundant Appropriate use of pointer Teaching Drug Literature Evaluation Skills to Pharmacy Students, Residents, and Pharmacists Review and master the subject and background Read the article at least twice Provide a background to the subject matter Provide a checklist of plausible bias and confounding variables Verify the authors statistics or references Provide data from other case reports or trials beyond the data from the article Journal Club Evaluation Criteria: Evaluation with faculty Ask presenter to perform self evaluation first Areas of strengths and weakness What strategy will they employ to improve their weaknesses? Consider a standard grading system Provide constructive criticism, and methods for improvement Conclusions The definition of a profession includes publication scholarship in peer reviewed journals Publication scholarship validates the role of the pharmacist and medication management Peer reviewers should have expertise Establishing concise goals and objectives are necessary to teach drug literature evaluation Mastering drug literature evaluation skills is necessary to develop publication skills ? ? ? ? ? ? Questions Thanks! ? Questions ?