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Strength of Evidence; Empirically Supported Treatments

Strength of Evidence; Empirically Supported Treatments. The Evidence Pyramid for Treatment Effectiveness Questions. Clinical Trials – Phases of Development.

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Strength of Evidence; Empirically Supported Treatments

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  1. Strength of Evidence;Empirically Supported Treatments

  2. The Evidence Pyramid for Treatment Effectiveness Questions

  3. Clinical Trials – Phases of Development • Phase I: 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 effects. • Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. • Phase III: 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 collect information that will allow the drug or treatment to be used safely. • Phase IV: 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 with long-term use.

  4. Strength of Evidence • Strength of research design: SR of homogeneous studies at the highest level; combines individual studies using a summary metric • RCT strongest single research design capable of demonstrating causation • Other key dimensions • Consistency of evidence • Specificity • Dose-response • Biological or psychological plausability • Common sense

  5. RCT Example - NRT

  6. RCT Example – Buproprion v. Placebo

  7. Case 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.

  8. Cohort Studies

  9. Case Control Studies The main advantages of case control studies are: They can be done quickly. Byaskingpatients 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.

  10. Empirically Supported Treatments in Psychology • Let’s take a look at the Division 12 website: • http://www.apa.org/divisions/div12/homepage.html

  11. Historical 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 other bonafide treatment • II: supported by at least one RCT showing superiority to a placebo or other bonafide treatment, or some other reasonably well-controlled situation • III: heterogeneous with low levels of evidence • Current state of website: http://www.apa.org/divisions/div12/est/chamble2.pdf • Criticisms of EST

  12. EST Criticisms • EST’s used inappropriately in managed care • Malpractice for failure to follow guidelines • Practice restriction/restraint of trade • EST data is flawed • RCTism • Rejects qualitative approach • Favors CBT • Manualization restricts generalization • Limits application to specific cases • Not the way it happens in real life • Limited effectiveness data (as opposed to efficacy)

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