Come presentare i dati di uno studio clinico

Transcription

1 Come presentare i dati di uno studio clinico ANGELO CIGNARELLI Metodologia degli studi clinici in diabetologia DIPARTIMENTO DELL EMERGENZA E DEI TRAPIANTI DI ORGANI SEZIONE DI MEDICINA INTERNA, ENDOCRINOLOGIA, ANDROLOGIA E MALATTIE METABOLICHE SID ACADEMY Bologna, 20 marzo 2018

2 DATA 40% Prevalence young middle old 20% 40%

3 CONSORT 2010 STATEMENT GUIDELINES FOR REPORTING PARALLEL GROUP RANDOMISED TRIALS We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomized trials, non-inferiority and equivalence trials, nonpharmacological treatments, herbal interventions, and pragmatic trials.

4 Flow diagram of the progress through the phases of a parallel randomised trial of two groups

5 CONSORT 2010 checklist of information to include when reporting a randomized trial

6 CONSORT 2010 checklist of information to include when reporting a randomized trial

7 CONSORT 2010 checklist of information to include when reporting a randomized trial

8 Do you present yourself like this?

9 So why would you present your data like this? A1c >7 A1c <

10 Effective presentation For all communication formats it is important to ensure that there is: Consistency Font, Colors, Punctuation, Terminology, Line/ Paragraph Spacing An appropriate amount of information Less is more Appropriate content and format for audience Scientific community, Journalist, Politicians

11 Tables Summarizing data Simplest way to summarize data Data is presented as absolute numbers or percentages Charts and graphs Visual representation of data Usually data is presented using percentages

12 Ensure graphic has a title Points to remember Label the components of your graphic Indicate source of data with date Provide number of observations (n=xx) as a reference point Add footnote if more information is needed

13 Tips for Presenting Data in PowerPoint All text should be readable Use sans serif fonts Gill Sans (sans serif) Times New Roman (serif) Keep slides simple Limit animations and special effects Use high contrast text and backgrounds

14 How to present data Tables Continue boxplot N, frequency histogram excel % pie excel Survival curves line plot excel

15 Tables Ludvik B et al. Lancet Diabetes Endocrinol Feb 23. pii: S (18)

16 Tables N Engl J Med Sep 28;377(13):

17 Continue variables

18 Visual display of continuous variables 0 Sample.1 Sample.2 Sample.3 Sample.4 Sample.5

19 Visual display of continuous variables Upper whisker 3rd quartile Sample. Sample. 1 2 Sample. 3 Sample. 4 Sample Median st quartile Lower whisker

20 N Histogram A1c >7 A1c <7 0

21 N Histogram N of patients according to glyco-metabolic control 45 0 Country 1 Country 2 Country 3 Country A1c >7 A1c <7

22 CREATING GOOD CHARTS Good charts should focus on getting your message across, rather than creating fancy, and distracting, images. Remember: Do not use graphs just for the sake of it. Effect of NiceGlu on A1c level 93% 7% A1c >7 A1c <7 in some cases simply expressing the data as x/n (y%) is sufficient.

23 Visual Display of Same Data Poor Better 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr treatment control 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr treatment control 23

24 EFFECTS OF CHANGES IN FAT, FISH, AND FIBRE INTAKES ON DEATH AND MYOCARDIAL REINFARCTION: DIET AND REINFARCTION TRIAL (DART) % survival days Riduzione della mortalità 29% w/o treatment w/ treatment Burr et al. Volume 334, Issue 8666, 30 September 1989, Pages

25 EFFECTS OF CHANGES IN FAT, FISH, AND FIBRE INTAKES ON DEATH AND MYOCARDIAL REINFARCTION: DIET AND REINFARCTION TRIAL (DART) % survival days Mortalità dal 12,8% al 9,3% ARR: 3,5% NNT: 29 w/o treatment w/ treatment Burr et al. Volume 334, Issue 8666, 30 September 1989, Pages

26 Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes Holman R.R., Bethel M.A., Mentz R.J., et al. N Engl J Med 2017; 377:

27 Short- and long-acting angiotensin-converting enzyme inhibitors: A randomized trial of lisinopril versus captopril in the treatment of congestive heart failure % increase Mean change in ejection fraction 0,8 Captopril Lisinopril 4,1 % increase Mean change in ejection fraction 0,8 Captopril Lisinopril 4,1 Giles et al. J Am Coll Cardiol May;13(6):

28 Short- and long-acting angiotensin-converting enzyme inhibitors: A randomized trial of lisinopril versus captopril in the treatment of congestive heart failure % increase Mean change in ejection fraction 30 30, ,2 Captopril Basal Post treatment Lisinopril Adapted from Giles et al. J Am Coll Cardiol May;13(6):

29 Consumo di alcool procapite (litri) The relationship of alcohol consumption to atherosclerotic heart disease Alcool consumption Mortalità Consumo di alcool procapite (litri) Alcool consumption Mortalità LaPorte RE, Cresanta JL, Kuller LH. Prev Med Jan;9(1):22-40.

30 A1c What s wrong here? A1c 0 NiceGlu Placebo Yes No Number of patients (n) Number of patients on target for HbA1c according to drug assumption N=50

31 Summary Considerare se sia realmente necessario rappresentare graficamente I dati Considerare quale tipo di grafico possa trasferire il messaggio nella maniera più chiara possibile Accertarsi che il grafico non alteri il significato dei risultati Evitare di ingombrare

32 Thank you for your attention