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INFORMED CONSENT

PATIENT PARTICIPATION IN HEALTH CARE

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ADVANTAGES OF INFORMED CONSENT I

BOND OF MUTUAL TRUST BETWEEN PATIENT AND PHYSICIAN.

OPENING IMPORTANT PATHWAYS OF COMMUNICATION.

PATIENTS TAKE A GREATER MEASURE OF RESPONSIBILITY.

MORE EXTENSIVE KNOWLEDGE OF THEIR CONDITION. IMPACT ON PERSONAL LIFESTYLE.

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ADVANTAGES OF INFORMED CONSENT II

MORE EFFECTIVE CARING FOR PATIENTS. INFORMATION ABOUT PATIENTS. VALUE BASIS FOR GRANTING OR WITHHOLDING CONSENT.

REDUCES LIABILITY EXPOSURE.MAINTAIN AVENUES OF COMMUNICATION WHEREBY CONFLICTS CAN BE RESOLVED WITHIN THE RELATIONSHIP WITHOUT THE COURTS.

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GENERAL COMPONENTS OF INFORMED CONSENT I

CONDITION.DIAGNOSIS.PROGNOSIS.AVAILABLE TREATMENTS.

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GENERAL COMPONENTS OF INFORMED CONSENT II

PROPOSED TREATMENT.NATURE.PURPOSE.RISKS.BENEFITS.REASONABLE ALTERNATIVES.COST???

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INFORMED CONSENT CONSIDERATIONS I:President’s Commission (1982)

INTEGRAL PART OF A PLURALISTIC SOCIETY WITH MULTIPLE VIEWS OF THE “GOOD LIFE.”

BASIC VALUES UNDERLYING INFORMED CONSENT.

PERSONAL WELL-BEING.SELF-DETERMINATION.SHARED DECISION MAKING --- MUTUAL RESPECT.

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INFORMED CONSENT CONSIDERATIONS II:President’s Commission (1982)

PRESUMPTION OF CAPACITY TO MAKE DECISIONS.

CAPCITY IS SPECIFIC TO EACH DECISION.

CONSULTATION IN CASES OF INCAPACITY.

INFORMATIVE BUT NOT DETERMINATIVE.

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LEVELS OF RECEIVING INFORMATION

FACTS.PATIENT IS MERELY ACQUAINTED WITH A BODY OF FACTUAL KNOWLEDGE WHICH MAY BE FAIRLY DISCRETE AND UNRELATED.

UNDERSTANDING.PATIENT HAS MASTERED THE FACTS AND IS ABLE TO SEE THE RELATIONS BETWEEN THEM “AT A DISTANCE.”

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LEVELS OF RECEIVING INFORMATION

PROCESSING.PATIENT HAS INTEGRATED FACTS INTO HIS/HER VALUE CONTEXT.

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EXCHANGE OF POWER

INFORMATION EMPOWERS THE PATIENT.CONSENT EMPOWERS THE PHYSICIAN.

DYNAMICS OF NEGOTIATION ARE ESSENTIAL TO RELATIONSHIPS OF POWER.

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SURROGATE STANDARDS:SUBSTITUTED JUDGMENT I

DECISION THAT THE INCAPACITATED PERSON WOULD MAKE IF HE/SHE WERE ABLE TO MAKE A CHOICE.DECISION THROUGH THE “VALUE EYES” OF THE INCAPACITATED PERSON.

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SURROGATE STANDARDS:SUBSTITUTED JUDGMENT II

BASED UPON:DIRECT STATEMENTS BY PATIENT.INFERENCES FROM VALUE CHOICES OF PATIENT.

GROUNDED IN THE PRINCIPLE OF AUTONOMY.SUBSTITUTED JUDGMENT STANDARD IS PREFERABLE BUT BEST INTEREST STANDARD IS PERMITTED AND OFTEN NECESSARY.

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SURROGATE STANDARDS:BEST INTEREST I

“OBJECTIVE STANDPOINT.”

PROMOTE PATIENT’S GOOD. REFERENCE TO THE INCAPACITATED PATIENT’S ACTUAL OR SUPPOSED PREFERENCES.

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SURROGATE STANDARDS:BEST INTEREST II

WEIGHING BENEFITS AND BURDENS.“REASONABLE” PERSON LOOKING AT CLINICAL OUTCOMES.

SELF-REFLECTIVE.RELATIVELY UNBIASED.ATTEMPTING FACT-BASED OBJECTIVITY.SETTING ASIDE SELF-INTEREST.

GROUNDED IN THE PRINCIPLE OF BENEFICENCE.

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MODELS OF IMPLEMENTING INFORMED CONSENT:EVENT MODEL

DISCRETE ACT.MINIMAL LEGAL REQUIREMENT.CONSENT FORM AS A SYMBOL.HOW MUCH DO PATIENTS TRULY UNDERSTAND?

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MODELS OF IMPLEMENTING INFORMED CONSENT:PROCESS MODEL I

ACTIVE PATIENT PARTICIPATION IN DECISION MAKING.ROLE EXPECTATIONS OF PHYSICIANS AND PATIENTS.IMPORTANCE OF PATIENT’S PERSONAL AND VALUE HISTORY.

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MODELS OF IMPLEMENTING INFORMED CONSENT:PROCESS MODEL II

PATIENT RESPONSIBILITY.MUTUAL MONITORING.CONTINUAL DIALOGUE.CONTINUAL RUMINATION AND REORDERING OF KNOWLEDGE IN LIGHT OF NEW INFORMATION AND EXPERIENCE.

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STRATEGIES FOR PROCESS MODEL I

DEFINE PROBLEM.ESTABLISH RESPONSIBILITY.

PERSONAL AUTONOMY.NORMAL PART.

GETTING WELL.MANAGING A DISEASE.

SET GOALS FOR TREATMENT.SELECT APPROACH TO TREATMENT.

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STRATEGIES FOR PROCESS MODEL II

SET GOALS FOR TREATMENT.SELECT APPROACH TO TREATMENT. FOLLOW-UP IN EXTENDED TREATMENT.SOLICIT PATIENT REFLECTIONS.

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COMMUNICATION ANDINFORMED CONSENT I

ACCURATE INFORMATION.INFORMATION IN AN UNDERSTANDABLE WAY.PROCESSING INFORMATION WITHIN PATIENT’S VALUES AND GOALS.

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COMMUNICATION AND INFORMED CONSENT II

EXPLORING FEELINGS.SHARING RESPONSIBILITY.AVOIDING EUPHEMISMS AND DOUBLE MESSAGES.SUPPORTING PATIENT IN THE DECISION.

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PROBLEMS IN INFORMED CONSENT I

COMMUNICATION.TIME.

EFFICIENCY.

LANGUAGE.

UNCERTAINTIES.

PROBABILITIES.

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PROBLEMS ININFORMED CONSENT II

TRUST.

IN PHYSICIAN.

IN PATIENT.

PATIENT’S VALUE CONTEXT.

WHAT PATIENT CONSIDERS BENEFICIAL.

PATIENT’S TOLERANCE LEVEL FOR RISKS --- MORBIDITY, MORTALITY.

PATIENT’S FEAR LEVEL.

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PROBLEMS IN INFORMED CONSENT III

INEQUALITY OF PATIENT AND CAREGIVER.

KNOWLEDGE BASE.

VARIABILITY OF VALUES.

EXPERIENCE.

VULNERABILITY.

PRESUMING TOO MUCH KNOWLEDGE FROM PATIENT.

SPECIFICITY IN CONSENT FORM.

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PROBLEMS ININFORMED CONSENT IV

TESTING UNDERSTANDING.

REPEATING WORDS.

SIGNIFICANCE FOR LIFESTYLE.

ROLE OF SURROGATES.

DECISIONAL CAPACITY.

VARYING WISHES OF PATIENTS AND SURROGATES.

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PROBLEMS ININFORMED CONSENT V

ROLE OF CAREGIVERS.

PROVIDE INFORMATION.

PROCESS INFORMATION.

RESOURCE ISSUES.

STANDARDS.

REASONABLE PHYSICIAN.

REASONABLE PATIENT.