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Corso di clinical writing

This course provides an introduction to clinical writing, addressing general principles, specific techniques, and practical sessions on article appraisal and manuscript drafting. Learn how to analyze and critically evaluate published studies, understand bias, and apply findings to current clinical problems.

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Corso di clinical writing

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  1. Corso di clinical writing

  2. What to expect today? Core modules • Introduction • Generalprinciples • Specifictechniques • Title/Abstractdrafting • Finding out relevantliterature, and Introductiondrafting • Nuts & boltsofstatistics and Methodsdrafting • Practicalsession 1 – Appraisalof a publishedarticle

  3. Whichwere the authors’ goals? • The main goals in preparing a manuscript are full reporting and disclosure of • relevant aspects of the study • Isthereanyriskofbias? • What are the findings? • Do yourfindingsapplyto the mycurrentclinicalproblem?

  4. Case study Nelson et al, NEJM 2004

  5. Usefulappraisalapproaches The peer-reviewer approach The Cochrane Collaboration approach The EBM approach -> RECOMMENDED

  6. Focused, structured and analytic approach BMJ guidelines for peer-reviewers: 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

  7. Self-criticisism while “studying a study” BMJ scoringtool for peer-reviewers Schroter et al, JAMA 2006

  8. Internal validity appraisalaccording to The Cochrane Collaboration • 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 http://www.cochrane.org

  9. 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?

  10. EBM: Articlesabouttherapy • 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?

  11. EBM: Articlesabouttherapy • 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?

  12. Title RANDOMIZED? Nelson et al, NEJM 2004

  13. Abstract NON-INFERIORITY MARGIN? Nelson et al, NEJM 2004

  14. Introduction OK! Follows KUQE Brief but clear Nelson et al, NEJM 2004

  15. Methods OK! Explicit selection criteria Documentation of expertise Specific procedural protocol Centralized randomization Nelson et al, NEJM 2004

  16. Methods OK! Explicit follow-up criteria Independent adjudication Justification for sample size Clarification on non-inferiority Nelson et al, NEJM 2004

  17. Results OK! Trial profile Reasons for high drop-in (20%) BUT No details on non-enrolled pts Miss confidence intervals Lacks per protocol analysis Nelson et al, NEJM 2004

  18. Results OK! Trial profile Reasons for high drop-in (20%) BUT No details on non-enrolled pts Miss confidence intervals Lacks per protocol analysis Nelson et al, NEJM 2004

  19. Discussion/Conclusions OK! Comprehensive but concise Include disclosures of support BUT No conflicts of interest? Nelson et al, NEJM 2004

  20. Discussion/Conclusions OK! Comprehensive but concise Include disclosures of support BUT Cost implications? External validity? No conflicts of interest? Nelson et al, NEJM 2004

  21. Figures OK! Detailed but synthetic BUT Miss confidence intervals Nelson et al, NEJM 2004

  22. Questions?

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

  24. And now have a good dinner…

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