THE SIMPLE MODEL OF INTEGRATION OF RESEARCH AND

THE SIMPLE MODEL OF INTEGRATION OF RESEARCH AND HEALTHCARE Suzana Alves da Silva, MD, MSc, Ph. D, FNYAM Senior Researcher HCOR, Sao Paolo / National Institute of Cardiology and Amil Assistência Médica Internacional, Rio de Janeiro, Brazil

Scientifically Informed Medical Practice and Learning THE SIMPLE MODEL

DISCLOSURES Financial: none Academic: many

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

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

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

Therapy Diagnosis Ask Acquire Apply Appraise Harm Prognosis Ask Acquire Apply Appraise

Therapy Ask Acquire 80% Apply Appraise

Therapy Ask Indirectne ss of PICO Acquire 80% Apply Appraise Need of Information Need of RCT

Randomized Trials HISTORICAL PRECEDENTS

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.

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.

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

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

The concept of PACT THE ROADMAP

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

CORONARY CALCIUM SCORE • This test has been proposed by the Brazilian Medical Association 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. q q A – Therapeutic issue B – Diagnostic issue C – Prognostic issue D – Harm issue q A – Utility issue q B – Performance issue q C – Frequency issue

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

PACT P A C 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 Performanc Consider a test, a Consider a e predictor or a rule criterion assessment T Utility Estimate of magnitude of effect on important Consider a intervention Consider or a behavioral or an Alternatives environmental exposure Estimate of frequency of important clinical outcomes Estimate of effect on important outcomes

FREQUENCY OF MODE OF BIRTH IN BRAZIL, 2011 90% Private C-Section 10% Natural birth Childbirth 45% Public C-Section 55% Natural birth Cad. Saúde Pública, Rio de Janeiro, 30 Sup: S 1 S 16, 2014

Cad. Saúde Pública, 30 Sup: S 1 -S 31, 2014 FREQUENCY OF BEST PRACTICES DURING LABOR AND CHILDBIRTH IN BRAZIL, 2011 Low-risk Women at women (%) risk (%) All women (%) - Eating 25. 6 24. 5 25. 2 - Mobility 46. 3 41. 1 44. 3 - Pain relief strategies 28. 0 24. 7 26. 7 - Monitoring progress with a partograph 44. 2 36. 9 41. 4 - Peripheral venous catheter 73. 8 76. 7 74. 9 - Oxytocin drip 38. 2 33. 3 36. 4 - Spinal/epidural analgesia 31. 5 37. 8 33. 9 - Amniotomy 40. 7 36. 4 39. 1 - Lithotomy 91. 7 91. 8 91. 7 - Uterine fundal pressure 37. 3 33. 9 36. 1 • Paulo Freire, Pedagogy of Oppressed Best practices during labor Interventions during labor Practices that are not recommended during vaginal birth

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

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.

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 Thank You! suzanasilva@me. com