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THE SECTION ON Evidence Based Health Care OF THE NEW YORK ACADEMY OF MEDICINE. 2014 TEACH Workshop. Simple. Scientifically Informed Medical Practice and Learning. Suzana Alves da Silva, MD, MSc, PhD, FNYAM. Clinical Problems. P. I. C. O. What we know?.

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Simple

THE SECTION ON

Evidence Based Health Care

OF THE NEW YORK ACADEMY OF MEDICINE

2014 TEACH Workshop

Simple.

Scientifically Informed Medical Practice and Learning

Suzana Alves da Silva, MD, MSc, PhD, FNYAM


What we know

Clinical Problems

P

I

C

O

What we know?

Chatterji, M; Graham, M; Wyer, P. Mapping Cognitive Overlaps Between Practice-Based Learning and Improvement and Evidence-Based Medicine: An Operational Definition for Assessing Resident Physician Competence.2009


What is new

Frequency of outcome

Prediction of outcome

Impact

on outcome

What is new?

Silva, S and Wyer P. The Roadmap: a blueprint for evidence literacy within a Scientifically Informed Medical Practice and Learning Model. 2012


Why this is so important

Why this is so important?


Likelihood issue on therapy

Likelihood issue on therapy

This scenario converges on an issue of the absolute probability of survival given maximal, evidence-based, interventions.

An elderly man is brought to the emergency room from a nursing home. He is febrile, hypotensive, anuric, minimally responsive. Medical and nursing staffs are preparing to implement an advanced protocol for sepsis care when the patient’s daughter arrives. The daughter wants to know “So, if you give him the most intense treatment, how likely is it that he will survive? It doesn’t make sense if he is likely to die anyway!”


Utility issue on prognosis

Utility issue on prognosis

This scenario involves a trade-off between risks versus benefits of sharing the results of a prognostic information.

A 40 year old woman is seeing her primary care physician. Her mother has recently been diagnosed with Alzheimer’s disease. She is concerned about the possibility that it could happen to her. The physician advises that there is a genetic test that could eliminate that likelihood. However, the woman expresses ambivalence, saying, “I am not sure I want to know.”


Performance issue on therapy

Performance issue on therapy

This scenario involves predicting the likelihood of benefit from a treatment if the predictor is present. It calls for information regarding the predictive performance of criteria such as a biomarker in modifying the probability of benefit from a therapeutic option.

A medical director of a health care organization is considering inclusion of BRCA1 within a panel of molecular biomarkers for optimization of individualized care of women with diagnosed breast cancer with respect to hormonal therapy, immune-therapy or chemo-therapy. His first question is what is the accuracy of BRCA1 mutation to predict that a women with cancer will in fact respond to a specific therapeutic regimen.


Simple

Levels of efficacy of Dx imaging tests

Phases of novel cardiac markers

diagnostic accuracy, sensitivity, and specificity associated with interpretation of the test.

whether the information produces change in the referring physician’s diagnostic thinking.

effect of the information on the patient management plan and on patient outcomes.

societal costs and benefits of a diagnostic imaging technology.

Performance

Utility

Likelihood

Performance

Utility

  • 1. Proof of concept—Do novel marker levels differ between subjects with and without outcome?

  • 2. Prospective validation—Does the novel marker predict development of future outcomes?

  • 4. Clinical utility—Does the novel risk marker change predicted risk sufficiently to change recommended therapy and to improve clinical outcomes?

  • 6. Cost-effectiveness—Does use of the marker justify additional costs of testing and treatment?

Fryback and Thornbury. 1991

Hlatky. AHA 2009


Simple

= Randomized Trials


Simple

“My doctors estimated that I had an 87 percent risk of breast cancer and a 50 percent risk of ovarian cancer… Once I knew that this was my reality, I decided to be proactive and to minimize the risk as much as I could.”


Scenario

HMOs being pressured for the inclusion of BRCA mutation testing for screening of women with high risk of breast cancer.

Chief Medical Executive

Physician

Healthy Patient

Many patients with family history of cancer want to be tested for BRCA mutation. Many wonder about preventive surgery or chemotherapy on top of surveillance.

Many primary care physicians are ordering BRCA mutation testing to their patients or referring them for genetic counseling without knowing exactly what to do with it.

Scenario


Brca1 for screening

BRCA1 for screening


Brca1 for screening1

BRCA1 for screening


Simple

Breast Cancer || Ovarian Cancer

Women in general

Preventive surgery will drop the risk of cancer by ~ 90%

Little info about the effect of chemoprevention or close surveillance

Little info about impact on death

Source: 1. Senkus. European Society of Medical Oncology.2014. 2. Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer: U.S. Preventive Services Task Force Recommendation. 2013. 3. Berliner. National Society of Genetic Counselors 2013


Why this is so important1

Why this is so important?

Recognition of questions of importance to patients, managers and policy makers in a fashion that facilitates the use of clinical research to inform the corresponding decisions.

Provide guidance regarding how to explore and interpret patient and stakeholder expressions of the concerns that will maximally inform decisions.

Categorization of clinical research designs in relationship to different types of clinical questions in a way that embraces the full spectrum of clinically relevant research.


Why this is so important2

Why this is so important?


Thank you

Thank you!


Simple

Therapy Utility

Therapy Frequency


Simple

Prognosis Utility

Prognosis Frequency


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