Corso di clinical writing

What to expect today? Core modules IntroductionIntroduction Correction of abstracts submitted by participantsCorrection of abstracts submitted by participants Practical session 2 – Abstract draftingPractical session 2 – Abstract drafting Results draftingResults drafting Discussion draftingDiscussion drafting Tables and Figures draftingTables and Figures drafting Peer review and publicationPeer review and publication Synthetic example – database creation, analysis and Results draftingSynthetic example – database creation, analysis and Results drafting

Results What were the findings?

Results The answer is in the Results.

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

Results 1.Logically answer the research question 2.Begin with most important result 3.Correlate with the methods 4.Use data from this study only 5.Present all the representative data (with exact P values and confidence intervals) 6.Use tables, graphs, photographs, and drawings for data

Results  Show subject characteristics as n/N (%) and means± standard deviations (or median [interquartile range)  In an intervention: show pre-test means±SD as subject characteristics; show change-score means and SDs to give an impression of any individual responses; show differences in mean changes, with 95% confidence intervals; calculate any individual responses as a standard deviation

Results  Show scattergrams only for a good reason (outliers, non- uniformity of error, non-linear trend): be aware that they can unmask you!  Summarize multiple outcomes in a figure or table  (Almost) never show test statistics (t, F,  2 )  Try to show chances of clinical/practical substantiveness  Avoid repetition of outcomes in figures, tables, or text  MOST IMPORTANTLY: do not discuss the findings or interpret them qualitatively!

Results Supplement rather than repeat data in visuals and tables: –Data must agree within the section and with data given in other sections and visuals Avoid too much dryness and overwhelming the reader with data: –The mean BMI was 10% lower in the 30 tennis players than in the 20 control subjects (respectively 22.5±0.8 vs 24.9±0.7 mm Hg, P=0.035). Should be simply stated (past tense)

Patient and procedural data Zehetner et al, Surg Endosc 2005

Patient and procedural data O’Brien et al, Ann Intern Med 2006

Patient and procedural data Flum et al, JAMA 2005

Exclusions O’Brien et al, Ann Intern Med 2006

Early outcomes Nelson et al, NEJM 2004

Early outcomes O’Brien et al, Ann Intern Med 2006

Early outcomes Ceelen et al, Ann Surg 2003

Late outcomes Nelson et al, NEJM 2004

Late outcomes Ceelen et al, Ann Surg 2003

Late outcomes Nelson et al, NEJM 2004

Late outcomes Nelson et al, NEJM 2004

Do NOTs Use big words that you do not really mean –Attributable –Causality –Preferential –Significant (without statistical evidence) –Validity Mix incidence and prevalence Mix frequency, rate, proportion, ratio

Questions?

Take home messages 1.Results should provide a coincise yet poignant synthesis of what you, apparently undexpectedly and independently, have found 2.Results and Discussion should appear as written by two separate individuals!

And now let’s move to Discussion…