Publication Scholarship The Manuscript Reviewer

1. Publication Scholarship The Manuscript Reviewer Henry Cohen, BS, MS, PharmD, FCCM, BCPP, CGP Associate 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

2. 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

3. 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

4. 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

5. The Peer Review Process • Unpaid healthcare professionals • Peer review is the major criteria for publication of credible and useful information • Throwaway journals or trade magazines • Editor appoints reviewers • Peer-review is conducted anonymously • Peer Reviewers do not review galley proofs

6. 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

7. 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

8. How can I be appointed to become a Peer Reviewer? • Choose an area that you are competent • Gain experience by reviewing Abstracts • 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 • Respond to peer review in a timely fashion

9. 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

10. 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 • Summary/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

11. 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

12. 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

13. Reviewing Submitted Manuscripts as a Referee • Minor flaws are acceptable • Major flaws • Fatal • Recoverable • Acceptable • Uncontrollable • Are the conclusions accurate? • Do the conclusions have any value in advancing present practice?

14. 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

16. Reviewer Comment’sGI Bleed Study • 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.

17. 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

18. 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

19. Reviewer’s Guidelines • Does the abstract reflect accurately what the manuscript says • Tables and Figures • Are they useful? • How many? • Are they redundant with the text • Is this journal the right place for this manuscript?

20. 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 or offensive • Judge each manuscript on its own merits • Avoid personal comments and opinions

21. 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

22. 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

23. List of Subjects Disease specific Organ specific Subject specific CNS Head Injury Stroke Parkinson’s Disease Pulmonary Pulmonary Edema Pulmonary Emboli Pulmonary Function Tests Gastrointestinal PUD/GERD Laxatives Pancreatic Disease How to choose expert subjects for review

24. Focus Areas for Reviewers • Publishing negative studies • Improves value of Meta-analysis • Avoid unnecessary duplication of ineffective therapies • Conflicts of interest • Reviewers from same department or institution • Reviewers should disclose and/or disqualify • Reviewer Certificate

25. Rules for Reviewers • Cannot make copies of the manuscript for their files • Should return or destroy the manuscript after review • Cannot discuss publicly the manuscript or it’s ideas • Reviewers’ comments should be shared by the reviewers’ of the same manuscript

26. Conclusions • The definition of a profession includes publication scholarship in peer reviewed journals • A Peer Reviewer is obligated to render an honest unbiased decision on whether a manuscript should be published • A Peer Reviewers comments should be constructive and improve the manuscript • Peer reviewers should have expertise in the subject that they serve as reviewers

27. ? ? ? ? ? ? ? ? Questions Questions Thanks!

28. 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

29. 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

30. 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

31. 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.

32. 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.

33. 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

34. 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

35. 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

38. Standards to Assess Scholarship • Clear goals • Adequate preparation • Appropriate methods • Significant Results • Effective presentation • Reflective critique