Corso di clinical writing

1. Corso di clinical writing

2. What to expect today? Core modules • Introduction • Correction of abstracts submitted by participants • Practical session 2 – Abstractdrafting • Resultsdrafting • Discussion drafting • Tables and Figuresdrafting • Peerreview and publication • Syntheticexample– database creation, analysis and Resultsdrafting

3. Discussion What do these findings mean?

4. Discussion What do these findings mean? The answer is in the Discussion.

5. Discussion vs Results Remember: Results and Discussion sections should appear as written by two different people!

6. Discussion

7. Discussion

8. Discussion Nepal's Maoists come out of the jungle, into the mainstream The New York Times FRIDAY, JUNE 2, 2006 The rebels are coming out of the bush. Ten years after waging war from their jungle redoubts in the hills, Nepal's Maoists are tiptoeing out onto mainstream political turf, raising hopes for an end to the deadly conflict but also clouds of uncertainty about the country's future. Maoist cadres are openly organizing meetings in town squares and trolling for "donations" for their party coffers. Senior leaders, who have spent most of the 10 years underground, are holding news conferences. A series of rallies across the country is scheduled to culminate with a giant gathering this Friday in the capital, Katmandu. For Nepal, the challenge of reintegrating the rebels could not be more important. The country stands on the brink of historic change and the rebels, in large measure, hold the key to whether it treads the path of war or peace. The rebels have already scored important victories. In late April, after three weeks of nationwide protests, King Gyanendra ceded

9. Discussion Dura replica del vicepresidente rossonero ad un articolo de «La Stampa» Galliani: «C'era solo il sistema Juve» «Cercano di far passare il concetto secondo cui il sistema Juve e il sistema Milan fossero la stessa cosa. Non è così» Corriere della Sera – 2 giugno 2006 VILLASIMIUS (CAGLIARI) - «Cercano di far passare il concetto secondo cui il sistema Juve e il sistema Milan fossero la stessa cosa. Non è così: c'era solo il sistema Juve, e tutti gli altri erano i danneggiati»: lo ha detto il vicepresidente rossonero, Adriano Galliani, parlando al workshop del Milan a Villasimius. TENTATIVO PROVENIENTE DA TORINO - È in atto un «tentativo proveniente da Torino» di coinvolgere il Milan nel calcioscandalo con l'intento di rendere meno pesante la situazione bianconera: ha spiegato Galliani, in risposta a un articolo della Stampa di Torino in cui si dà conto della intercettazione di una telefonata tra il collaboratore del Milan addetto agli arbitri, Leonardo Meani, e il direttore sportivo dell'Udinese, prima della partita Udinese-Milan, ultima del campionato 2004-2005, che terminò in parità sull'1-1. L'intercettazione lascerebbe intendere che tra le due società ci sarebbe stato un accordo per concludere la partita su un risultato di parità. «Non so di che telefonata si tratti - ha detto Galliani -. È evidente e ovvio, e appare chiaro anche a un bambino, che è in atto uno scorretto tentativo proveniente da Torino, attraverso anche i suoi quotidiani…

10. Expanded IMRADalgorithm IntroductionBackground Limitations of current evidence Study hypothesis MethodsDesign Patients Procedures Follow-up End-points Additional analyses Statistical analysis Results Baseline and procedural data Early outcomes Mid-to-long term outcomes Additional analyses DiscussionSummary of study findings Current research context Implications of the present study Avenues for further research Limitations of the present study Conclusions

11. Discussion • Present the principles, relationships, and generalizations shown by the Results • Briefly summarize the Results in the first sentences • But discuss — not thoroughly recapitulate — the Results • Include a beginning, middle, and end • Write in present tense, active voice─ except for the findings, which are described in past tense • Discuss this study only, in light of the others

12. Discussion • State the main finding, then discuss how technicalities might have impacted it • Interpret the magnitude of the main and any other findings qualitatively • Reconcile the finding with those in other articles: a qualitative mini meta-analysis if you will • Explain possible mechanisms and confounders • Devote space to discussion of a finding in proportion to the certainty of its magnitude • Introduce no new results! • Explain any major limitations

13. Discussion • Beginning: • Answer the research question • Begin with a signal • We found that • Blood pressure increased in patients who … • Give your conclusions, based on your results • Give your strongest result first! • May use the a), b), c) approach…

14. Discussion • Answer the question from the Introduction! • End of Introduction: • ". . . to test whether laparoscopic surgery for colon cancer, performed by experienced operators, provides equivalent early and long-term results to those of open surgical resection" • Beginning of the Discussion: • "This study, to the best of our knowledge for the first time, originally demonstrates that laparoscopic surgical resection of colon cancer, when performed by expert operators, was associated with non-inferior event-free and overall survival in comparison to open surgery “

15. Discussion • Middle: • Interpret your results • Discuss key studies — but only those relevant to your work • Compare your work with others’ work • Present ambiguous results and discrepancies with others objectively • Explain unexpected findings • Describe limitations • Use subheadings (most of the times helpful)

16. Discussion Introduce Points With Your Findings Example: “In this study, multivariate analysis revealed that laparoscopic surgery was an independent predictor of early hospital discharge…. Levy et al17 reported less striking differences …However, the retrospective nature of their study and the uneven distribution of baseline clinical characteristics in their patient population … could account for the relatively narrow difference in their results.”

17. Discussion • Compare With Earlier Work • Own work first: • “The fact that our study was prospective lends support to the evidence (1-3) of a causal role of ultrasonic microdissection on limiting local complications of thyroidectomy…” • Other’s work first: • “Previous studies on the clinical impact of ultrasonic microdissection on local complications during and after thyroidectomy … have reported conflicting and inconclusive results … Findings of this study further expand previous knowledge, showing that current state of the art ultrasonic dissection devices provides indeed major clinical benefits, …

18. Discussion • Why using a structured format for the Discussion: • Helps organizing your writing • Enhances readability • Shows off that you follow a structured approach in everything you do

19. Structuring the Discussion • The usual structure of the Discussion is: • Brief summary of the study findings (no need for heading) • Current research context (use as heading) • Implications of the present study (use as heading) • Avenues for further research (use as heading) • Limitations of the present study (use as heading) • Conclusions (may use as heading)

20. Discussion – Briefsummaryoffindings • In the first phrase(s) of the Discussion you may stress the main findings • Use plain language • Target the busy or non-expert reader • Emphasize the novelty of your data! (if this applies)

21. Discussion – Brief summary of findings Cosgrave et al, JACC 2006

22. Discussion – Historical perspective Nelson et al, NEJM 2004

23. Boldness, ifyou can! Biondi-Zoccai et al, Eur Heart J 2006

24. Discussion – Currentresearchcontext • Continue (from the Introduction) your brief review of current research evidence • This time, take into account your study • But keep emphasis on other studies

25. Discussion – Currentresearchcontext Biondi-Zoccai et al, Eur Heart J 2006

26. Discussion – Whatthisstudyadds • Introduce the clinical and research implications of your study • Do you want to suggest a change in clinical practice? • You can be moderately bold, here

27. Discussion – Whatthisstudyadds Biondi-Zoccai et al, Ital Heart J 2003

28. Discussion – Avenues for furtherresearch • In this section you may spell out what should be the target of new research • This is an important part of the manuscript, if you feel only a collaborative effort can achieve your goal • Remember not to disclose too much

29. Discussion – Avenues for furtherresearch Biondi-Zoccai et al, Ital Heart J 2003

30. Discussion - Limitations • Limitations: • Show yourself as a critical thinker • Do not overdo it; otherwise why did you do the stupid study • Complete the argument (think it through): many limitations may be true but they would not explain the results • Better to acknowledge a limitation in advance, than having to address it later because the referee raised this issue!

31. Discussion - Limitations Biondi-Zoccai et al, Ital Heart J 2003

32. Discussion - Limitations O’Brien et al, Ann Intern Med 2006

33. Discussion - Conclusions • End: • Write a strong conclusion • Begin with a signal • In summary; In conclusion • May briefly mention applications, implications, speculations • Use present tense except when making comparisons to previous studies or results

34. Conclusions • If the journal has such a section… • State the main findings and/or applications in plain language, without being too repetitious • It must stand alone; therefore… • cite no references • refer to no tables or figures. • Make no substantial new points of discussion • Avoid generalizations and "should"s that go beyond your findings

35. Conclusions Miccoli et al, AOHNS 2006

36. Questions?

37. Take home messages The Discussion is important but should include a few traps and distractors for reviewers In most cases, the busy reader will focus on Abstract, Methods and Results, and will just have a brief glance at the Introduction and Discussion

38. And now let’s move to Tables & Figures…