1. Suzana Alves da Silva, MD, MSc, PhD, FNYAM Senior Researcher Amil Assistência Médica Internacional, Rio de Janeiro, Brazil PROBLEM DELINEATION

2. THE SIMPLE MODEL Scientifically Informed Medical Practice and Learning

3. DISCLOSURES Financial: none

4. Clinical Actions TDPH Study Designs RCT ✖ Cross Sectional ✖ Cohort ✖ Case Control ✖ SIMPLE. Things must be as simple as possible but not any simpler. Einstein David Sackett

5. Clinical Actions TDPH Study Designs RCT ✖✔✔✔ Cross Sectional ✔✖✔✔ Cohort ✔✔✖✔ Case Control ✔✔✖ SIMPLE. Things must be as simple as possible but not any simpler. Einstein SIMPLE.

6. Clinical Actions TDPH Enabling Skills Ask ✔✔✔✔ Acquire ✔✔✔✔ Appraise ✔✔✔✔ Apply ✔✔✔✔ SIMPLE. Things must be as simple as possible but not any simpler. Einstein SIMPLE. J Grad Med Educ. 2009 Dec;1(2):287-98

7. Acquire AppraiseApply AskAcquire AppraiseApply AskAcquire AppraiseApply AskAcquire AppraiseApply Ask Therapy Diagnosis PrognosisHarm

8. Acquire AppraiseApply Ask Therapy 80%

9. Acquire AppraiseApply Ask Therapy Need of Information Need of RCT 80% Indirectness of PICO

10. HISTORICAL PRECEDENTS Randomized Trials

11. THE NEED OF INFORMATION CREATED A RICH SOIL BASIS FOR THE RISE OF RANDOMIZED TRIALS J Eval Clin Pract. 2015 Jun;21(3):518-28.

12. PRECEDENTS FOR SIMPLE. EBM Workshops focused on the validity of study designs with emphasis on RCTs. Rio Workshops dealing with Brazilian Health Ministry issues: National Policies, Vertical Medical Centers and Regulations Explosion of legal injunctions related to barriers of access to both high cost procedures and healthcare services. Incorporation of new technologies and elaboration of recommendations for use done mostly on political grounds. NYAM initiatives showing that workshops in EBM do not equip participants to identify and answer questions requiring consideration of clinical research (Wyer, 2008) Clear perception that EBM curriculum was insufficient to empower learners to deal with their realities.

13. SIMPLE The Relational Field and The Information Literacy Field J Grad Med Educ. 2009 Dec;1(2):287-98 Silva SA, Charon R, Wyer PC. JECP. Aug 2011;17(4):585-593. Acquire AppraiseApply Ask

14. SIMPLE: THE RELATIONAL FIELD ValuesPreferences Priorities Silva SA, Charon R, Wyer PC. JECP. Aug 2011;17(4):585-593.

15. THE ROADMAP The concept of PACT

16. PACT: PROBLEM, ACTIONS, CHOICES AND TARGETS Frequency – Is it relevant? Performance – Is there any association? Utility – Does the use of the intervention worth?

17. CORONARY CALCIUM SCORE This test has been proposed to the National Agency of Health, which regulates the private health care system in Brazil, as a test that should be incorporated in the list of mandate coverage. The main assumption was that the Coronary Calcium Score performs better than the Framingham Risk Score to predict cardiovascular events in 10 years. Cohort studies published in high impact journals such as JAMA.  A – Therapeutic issue  B – Diagnostic issue  C – Prognostic issue  D – Harm issue  A – Utility issue  B – Performance issue  C – Frequency issue

18. DIAGNOSTIC PERFORMANCE OF CAC-CT FOR THE PREDICTION OF SIGNIFICANT STENOSIS ON CCTA Meyer 2012 Impact of Coronary Calcium Score on the Prevalence of Coronary Artery Stenosis on Dual Source CT Coronary Angiography in Symptomatic Caucasian Patients with an Intermediate Risk

19. COMPARISON OF NO-SCAN SUBJECTS AND SCAN SUBJECTS WITH A CAC SCORE OF 0 ParametersCACs = 0No Scan Rosansk. JACC 2011 Impact of Coronary Artery Calcium Scanning on Coronary Risk Factors and Downstream Testing The EISNER (Early Identification of Subclinical Atherosclerosis by Noninvasive Imaging Research) Prospective Randomized Trial

20. ISSUES THAT MAY RISE FROM DIFFERENT PERSPECTIVES PatientsPhysiciansManagers FrequencyWhat is my risk of dying if my test is positive? How many tests are expected to be performed yearly? How many of them will lead to interventions? PerformanceI have dyslipidemia, diabetes and family history of CAD. Will this test really decrease my risk of dying if it turns out to be negative? Does this test perform better than the Framingham Risk Score to predict outcomes? UtilityWill the radiation exposure increase my risk of cancer? Does it worth to start any specific primary prevention treatment if the test is positive? Does it worth to use this test in general practice compared to the Framingham risk score?

21. PACT PACT Frequency Consider what would happen -if submitted to a intervention or a behavioral or an environmental exposure -if a set of signs and symptoms or a clinical condition is present Estimate of frequency of important clinical outcomes PerformanceConsider a test, a predictor or a rule Consider a criterion assessment Estimate of effect on important outcomes UtilityConsider a intervention or a behavioral or an environmental exposure Consider Alternatives Estimate of magnitude of effect on important outcomes

22. FREQUENCY OF MODE OF BIRTH IN BRAZIL, 2011 Childbirth Private 90% C-Section 10% Natural birth Public 45% C-Section 55% Natural birth Cad. Saúde Pública, Rio de Janeiro, 30 Sup:S1-S16, 2014

23. FREQUENCY OF BEST PRACTICES DURING LABOR AND CHILDBIRTH IN BRAZIL, 2011 Paulo Freire, Pedagogy of Oppressed Cad. Saúde Pública, 30 Sup:S1-S31, 2014 Low-risk women (%) Women at risk (%) All women (%) Best practices during labor - Eating25.624.525.2 - Mobility46.341.144.3 - Pain relief strategies28.024.726.7 - Monitoring progress with a partograph44.236.941.4 Interventions during labor - Peripheral venous catheter73.876.774.9 - Oxytocin drip38.233.336.4 - Spinal/epidural analgesia31.537.833.9 - Amniotomy40.736.439.1 Practices that are not recommended during vaginal birth - Lithotomy91.791.891.7 - Uterine fundal pressure37.333.936.1 - Episiotomy56.148.653.5

24. WHAT IF WE ELIMINATED THE INFORMATION LITERACY FIELD? Lets keep the relational field only

25. AN EXAMPLE OF A GENERAL REALITY IN BRAZIL  Health policy largely divorced from systematic consideration of relevant research.  Policies determined by the play of social and financial interests without regard to health implication.  Health technology assessment unscientific due to lack of research literacy.  Guidelines imported from abroad with no consideration of local context.

26. Education is the practice of freedom, the means by which men and women deal critically and creatively with reality and discover how to participate in the transformation of their world. Paulo Freire, Pedagogy of Oppressed suzanasilva@me.com