1. Corso di clinical writing

2. What to expect today? Core modules IntroductionIntroduction General principlesGeneral principles Specific techniquesSpecific techniques Title/Abstract draftingTitle/Abstract drafting Finding out relevant literature, and Introduction draftingFinding out relevant literature, and Introduction drafting Nuts & bolts of statistics and Methods draftingNuts & bolts of statistics and Methods drafting Practical session 1 – Appraisal of a published articlePractical session 1 – Appraisal of a published article

3. What is your goal in preparing an article Let’s think backwards…

4. What is your goal in preparing an article The main goals in preparing a manuscript are full reporting and disclosure of relevant aspects of your study Is there any risk of bias? What are the findings? Do your findings apply to the my current clinical problem?

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

6. 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?

7. First tip to effective writing

8. Read a lot…

9. First tip to effective writing Read a lot… To learn something, you must see how it should be done, and how it should NOT be done!

10. Second tip to effective writing

11. What is the message you want to sell?

12. Second tip to effective writing What is the message you want to sell? It may be the core message, or the corollary/cosmetic message of your paper

13. Third tip to effective writing

14. Who is the audience?

15. Third tip to effective writing Who is the audience? You have to adjust your message, tailor your style, and prepare yourself for potential criticisms based on the target audience…

16. Fourth tip to effective writing

17. No matter what, keep clear writing!

18. Fourth tip to effective writing No matter what, keep clear writing! “Clear writing that is incapable of being misunderstood” Quintilian, I AD

19. Fifth tip to effective writing

20. Do not mistake the tree for the forest!!!

21. Fifth tip to effective writing Do not mistake the tree for the forest!!! The goal is the forest, of course

22. IMRAD IMRAD algorithm Introduction (± Aim) Methods Results And Discussion

23. Expanded IMRAD Expanded IMRAD algorithm Introduction Background Limitations of current evidence Study hypothesis Methods Design Patients Procedures Follow-up End-points Additional analyses Statistical analysis Results Baseline and procedural data Early outcomes Mid-to-long term outcomes Additional analyses Discussion Summary of study findings Current research context Implications of the present study Avenues for further research Limitations of the present study Conclusions

24. CONSORT guidelines for RCT

25. CONSORT statement Moher et al, JAMA 2001

26. CONSORT statement Moher et al, JAMA 2001

27. QUOROM statement for RCT meta-analyses

28. MOOSE guidelines for non-RCT meta-analyses

29. MOOSE guidelines Stroup et al, JAMA 2000

30. MOOSE guidelines

31. General tips Use “men” and “women,” not “males” and “females” (except when male and female are used as adjectives, e.g., male patients) Use “died,” not “expired” Use “humanely killed” or “killed” for animal studies, not “sacrificed” Replace “prior to” with “before” Patients are not implanted, i.e., “Patients who had the Jarvik 2000 implanted,” not “The implanted patients…” Be careful of “due to” and “because of.” Use “due to” only when you could substitute “caused by” –Recovery of brisk flow was due to thrombectomy. –Because of thrombectomy, recovery of brisk flow occurred. Consult the AMA Style Manual

32. Never throw away a good sentence “There is no good writing…… only good re-writing” Rationale: We are better at editing than writing Methods of conserving sentences: –Write about the same thing –Use similar methods –Dictation

33. General tips Include one thought per sentence, one idea per paragraph Use active voice whenever possible Keep words simple Be as succinct as possible Avoid adjectives, too much description Keep sentences short (< 22 words) and clear Use subject-verb-object constructions: –Of the 22 patients, 5 (22.7%) reported rectal bleeding

34. General tips Use transitions and key words Outline Consult a statistician Install spell-check software Consult grammar and writing websites Buy the AMA Manual of Style Hire an editor Remember the question

35. Tips for better writing: words Simple words are better than long ones Concrete terms are better than abstract ones Specific terms are better than general ones

36. Tips for better writing: grammar Avoid wordiness Know when to use active & passive voice Avoid faulty parallelism Paragraphs should hang together Paragraphs should have transitions

37. Phrases “The device, with long-term durability and reliability, is enhanced by the simplicity of its design and the clinical quality of its implantable platform. The ease of the prosthesis implantation in all patients, that enables avoidance of recoil, with the superior elastic properties and the extreme biocompatibility, are unique to this technology.”

38. Phrases “The device, with long-term durability and reliability, is enhanced by the simplicity of its design and the clinical quality of its implantable platform. The ease of prosthesis implantation in all patients, that enables avoidance of recoil, with the superior elastic properties and the extreme biocompatibility, are unique to this technology.” NO!

39. Phrases “The simplicity of its design and the clinical quality of its implantable platform enhance the durability and reliability of the device. The prosthesis is easy to implant in all patients. Moreover, it effectively prevents recoil, has superior elastic properties and is extremely biocompatible. All these characteristics make this novel stent unique among the others” NO!

40. Format Double space Each section on a separate page Use subheadings (in Methods, Results) Page numbers on the right (bottom..or top) Make sure font size and type consistent Format the documents 2.0 to 3.0 mm form the top, bottom, sides

41. Tense in scientific English Present tense - previously published information accepted as fact –Spatial resolution of MR microscopy can reach 3 microns [ref]. Present tense - refer to other parts of your document –Figure 4 shows a diffusion-weighted image. Past tense - methods and results/actions –Rats were anesthetized with isoflurane. –All animals exhibited significantly diminished learning capacity... Past perfect - action that happened before other past action –Group 2 rats had been housed individually prior to the beginning of the study Present perfect - action recently completed or continuing to the present –Since 1991, researchers at the Montefiore Medical Center have collaborated with more than thirty investigators at other institutions.

42. Editing 1.Does it make sense? 2.Is the writing clear? 3.Are there obvious factual errors? 4.Check for vague or ambiguous statements 5.Check for wordiness 6.Check for errors in grammar, spelling, punctuation, capitalization, and follow the journal’s rules

43. Questions?

44. Take home messages 1.When designing and drafting your manuscript, remember to plan in advance and revise many times 2.Keep it simple and active 3.Avoid jargon and try to sell your message/product in every sentence or paragraph

45. And now the Title and Abstract…