Strength of Evidence;Strength of Evidence;Empirically Supported Empirically Supported

TreatmentsTreatments

The Evidence Pyramid forThe Evidence Pyramid forTreatment Effectiveness QuestionsTreatment Effectiveness Questions

Clinical Trials – Phases of Clinical Trials – Phases of DevelopmentDevelopment

Phase I:Phase I: Researchers test a new drug or treatment in a small group of people for the Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side first time to evaluate its safety, determine a safe dosage range, and identify side effects.effects.

Phase II:Phase II: The drug or treatment is given to a larger group of people to see if it is The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.effective and to further evaluate its safety.

Phase III:Phase III: The drug or treatment is given to large groups of people to confirm its The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.collect information that will allow the drug or treatment to be used safely.

Phase IV:Phase IV: Studies are done after the drug or treatment has been marketed to gather Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated information on the drug's effect in various populations and any side effects associated with long-term use.with long-term use.

Strength of EvidenceStrength of Evidence Strength of research design: SR of Strength of research design: SR of

homogeneous studies at the highest level; homogeneous studies at the highest level; combines individual studies using a summary combines individual studies using a summary metricmetric

RCT strongest RCT strongest singlesingle research design capable of research design capable of demonstrating causationdemonstrating causation

Other key dimensionsOther key dimensions Consistency of evidenceConsistency of evidence SpecificitySpecificity Dose-responseDose-response Biological or psychological plausabilityBiological or psychological plausability Common senseCommon sense

RCT Example - NRTRCT Example - NRT

RCT Example – Buproprion v. RCT Example – Buproprion v. PlaceboPlacebo

Case Series and Case ReportsCase Series and Case Reports

A group or series of case reports involving patients who were given similar treatment. Reports of case series usually contain detailed information about the individual patients. This includes demographic information (for example, age, gender, ethnic origin) and information on diagnosis, treatment, response to treatment, and follow-up after treatment.

Cohort StudiesCohort Studies

Case Control StudiesCase Control Studies

The main advantages of case control studies are:   They can be done quickly. By asking patients about their past history, researchers can quickly discover

effects that otherwise would take many years to show themselves. Researchers don't need special methods, control groups, etc. They just take the people who show up at their institution with a particular

condition and ask them a few questions. The first study to suggest a new medical conclusion will often be a case control study, perhaps designed to check on a hypothesis suggested by a case series. If possible, researchers will generally try to confirm the results with a randomized controlled trial or a cohort study.

Empirically Supported Treatments Empirically Supported Treatments in Psychologyin Psychology

Let’s take a look at the Division 12 Let’s take a look at the Division 12 website:website:

http://www.apa.org/divisions/div12/http://www.apa.org/divisions/div12/homepage.htmlhomepage.html

Historical Aspects of ESTHistorical Aspects of EST TASK FORCE ON PROMOTION AND DISSEMINATION OF

PSYCHOLOGICAL PROCEDURES A Report Adopted by the Division 12 Board - October 1993

Categories of support: I: supported by at least two RCT’s showing superiority to a palcebo or I: supported by at least two RCT’s showing superiority to a palcebo or

other bonafide treatmentother bonafide treatment II: supported by at least one RCT showing superiority to a placebo or II: supported by at least one RCT showing superiority to a placebo or

other bonafide treatment, or some other reasonably well-controlled other bonafide treatment, or some other reasonably well-controlled situationsituation

III: heterogeneous with low levels of evidenceIII: heterogeneous with low levels of evidence Current state of website: Current state of website:

http://www.apa.org/divisions/div12/est/chamble2.pdfhttp://www.apa.org/divisions/div12/est/chamble2.pdf

Criticisms of ESTCriticisms of EST

EST CriticismsEST Criticisms EST’s used inappropriately in managed careEST’s used inappropriately in managed care Malpractice for failure to follow guidelinesMalpractice for failure to follow guidelines Practice restriction/restraint of tradePractice restriction/restraint of trade EST data is flawedEST data is flawed RCTismRCTism

Rejects qualitative approachRejects qualitative approach Favors CBTFavors CBT

Manualization restricts generalizationManualization restricts generalization Limits application to specific casesLimits application to specific cases Not the way it happens in real lifeNot the way it happens in real life

Limited effectiveness data (as opposed to efficacy)Limited effectiveness data (as opposed to efficacy)