1. Clinical Writing for Interventional Cardiologists

2. What you will learn - hopefully! Introduction General principles for clinical writing Specific techniques Practical session: critical review of a published article Writing the Title and the Abstract Bibliographic search and writing the Introduction Principles of statistics and writing the Methods Practical session: writing the Abstract Writing the Results Writing the Discussion Writing Tables and preparing Figures Principles of peer-review Principles of grant writing/regulatory submission Clinical writing at a glance Conclusions and take home messages

3. Which were the authors’ goals? The main goals in preparing a manuscript are full reporting and disclosure of relevant aspects of the study Is there any risk of bias? What are the findings? Do the findings apply to the my current clinical problem?

4. Case study Fajadet et al, Circulation 2006

5. There are at least 3 useful appraisal approaches to appraise a paper 1.The peer-reviewer approach 2.The Cochrane Collaboration approach 3.The EBM approach

6. There are at least 3 useful appraisal approaches to appraise a paper 1.The peer-reviewer approach 2.The Cochrane Collaboration approach 3.The EBM approach -> RECOMMENDED

7. The peer-reviewer approach: focused, structured and analytic BMJ guidelines for peer-reviewers (www.bmj.com) : 1 - What is the paper about? 2 - Why was the study done? 3 - What type of study was done? 4 - Was it primary research (RCT, cohort, case-control, cross-sectional, series)? 5 - Was it secondary research (overview, systematic review, meta-analysis, decision analysis, guidelines development, economic analysis)? 6 - Was the design appropriate (for study on treatment, diagnosis, screening, prognosis, or causation)? 7 - Was the study ethical? 8 - Is the design right? A - Does this treatment work? → systematic review, RCT B - How good is a diagnostic test? → (prospective) cohort study C - Should we screen? → RCT D - What causes this disease? → RCT, cohort, case/control (rare diseases) E - What did people think or do? → cohort, cross-sectional survey, qualitative study

8. Self-criticisism while “studying a study” BMJ scoring tool for peer-reviewers (www.bmj.com) : Schroter et al, JAMA 2006

9. Internal validity appraisal according to The Cochrane Collaboration http://www.cochrane.org 4 MAIN TYPES OF BIAS POTENTIALLY UNDERMINING STUDIES Ascertainment bias Non-uniform adjudication of events Attrition bias Non-uniform follow-up or compliance to treatment Performance bias Non-uniform performance of corollary treatments Selection bias The non-random allocation of pts one of the treatment groups

10. The EBM 3-step approach How your article should be appraised, in three steps: Step 1 – Are the results of the study (internally) valid? Step 2 – What are the results? Step 3 – How can I apply these results to patient care? Guyatt and Rennie, Users’ guide to the medical literature, 2002

11. Articles about therapy Are the results valid? Did experimental and control groups begin the study with a similar prognosis? Were pts randomized? Was randomization concealed? Were pts analyzed in the groups to which they were randomized? Were pts in the treatment and control groups similar with respect to known prognostic factors? Did experimental and control groups retain a similar prognosis after the study started? Were pts aware of group allocation? Were clinicians aware of group allocation? Were outcome assessors aware of group allocation? Was follow-up complete? Guyatt and Rennie, Users’ guide to the medical literature, 2002

12. Articles about therapy What are the results? How large was the treatment effect? How precise was the estimate of the treatment effect? How can I apply the results to patient care? Were the study patients similar to my patient? Were all clinically important outcomes considered? Are the likely treatment benefits worth the potential harm and costs? Guyatt and Rennie, Users’ guide to the medical literature, 2002

13. Title Fajadet et al, Circulation 2006 OK! Clear & detailed: thus following CONSORT rules

14. Fajadet et al, Circulation 2006 Abstract OK! Reports several results and outcomes BUT Poorly structured (Loscalzo’s fault) Lacks definitions of key-endpoints Only p values reported (no confidence intervals)

15. Introduction Fajadet et al, Circulation 2006 OK! Follow KUQE outline Brief & clear BUT Lacks explicit statement of study hypothesis

16. Methods OK! Explicit selection criteria Details on experimental devices Fajadet et al, Circulation 2006

17. OK! Centralized randomization Adjudication of events by independent committee Explicit and robust event definitions Standardized procedures Sound statistical plan Explicit sample size computation BUT No details on device appearance No details on means to generate randomization sequence Unclear if interim analysis was performed Methods

18. Results Fajadet et al, Circulation 2006 OK! Details on losses to follow-up Details and comparisons on baseline, procedural and outcome data BUT No CONSORT trial profile No per-protocol analysis No data on non-MACE serious adverse events

19. Discussion/Conclusions OK! Comprehensive but concise Compares results to other trials and devices Include disclosures of support Details on conflicts of interest BUT Cost implications? Long-term outcomes? Fajadet et al, Circulation 2006

20. Figures Fajadet et al, Circulation 2006 OK! Detailed with 95% CI Includes P value BUT Misses patients at risk

21. Questions?

22. Take home messages 1.Criticizing constructively even the apparently most rigorous study is a very useful exercise

23. Take home messages 1.Criticizing constructively even the apparently most rigorous study is a very useful exercise 2.As long as you apply the same constructive criticism to yourself, your writing skills will continue to improve with time and practice

24. And now a brief break…

25. For further slides on these topics please feel free to visit the metcardio.org website: http://www.metcardio.org/slides.html http://www.metcardio.org/slides.html