Should We Require Informed Consent Forms for Risk Factor Treatment? John S. Yudkin Emeritus Professor of Medicine, University College London
Outline The nature of informed consent for prescribing Treatment for symptoms/disease versus treating risk factors The special case of diabetes disease or risk factor? Information for informed decision making What do physicians know? Ethics and the law
Benefits of Interventions to Reduce CVD Risk Gains in life expectancy estimated by 46 physicians Male T2DM 72yrs, smoker, BMI 30, SBP 155, HbA1c 8.8%, Chol 5.3 Intervention - stop smoking Female T2DM 65yrs, non-smoker, BMI 37, SBP 180, HbA1c 8.8%, Chol 3.7 Intervention SBP to 130 Price et al, 2009
Informed Decision Making A view of informed consent in which the emphasis is on a meaningful dialogue between physician and patient instead of a unidirectional, dutiful disclosure of alternatives, risks, and benefits by the physician. This expanded view is termed informed decision making. Braddock CH et al, JAMA. 1999;282:2313-2320
Informed Consent To Treatment
Informed Consent To Treatment
Case 1 Informed Decision Making
Informed Decision Making Case 1 Consent is implicit in patient s seeking treatment
Case 2 Informed Decision Making
Case 2 Informed Decision Making
THOUGHTS?
Case 2 Informed Decision Making
Case 2 Informed Decision Making
Case 3 Informed Decision Making
Case 3 Informed Decision Making
Informed Decision Making Case 3 Br J Gen Pract. 2015 Mar;65(632):e152-60. Grateful thanks to Dr Kingshuk Pal, Dept of Primary Care, UCL
Case 3 Informed Decision Making
Case 3 Informed Decision Making
Case 3 Informed Decision Making
Case 3 Informed Decision Making
Case 3 Informed Decision Making
Informed Decision Making Case 3 What about the HbA1c of 8.2%? Should we start you on insulin?
Events During UKPDS Post-Study Monitoring 250 (Mean age 62, Mean HbA1c 8.2%) Event rate per 1000 in 10 years 200 150 100 50 0 Myocardial Infarction Stroke Other IHD Amputation Heart Failure Blindness One Eye ESRF Leal et al, Diabetes Care 2013
Lifetime Impact of Metformin Treatment for a Newly Diagnosed Type 2 Diabetic Patient, HbA1c 8.5% 7.5% 1.2 Assumed metformin disutility = 0.00404 Quality- Adjusted Years of Life Gained 1 0.8 0.6 Disu>lity Quality- adjusted years gained 0.4 0.2 0 45 55 65 75 Age at Diagnosis Vijan et al, 2014
Lifetime Impact of Insulin Treatment for a Newly Diagnosed Type 2 Diabetic Patient, HbA1c 8.5% 7.5% 1.2 Assumed insulin disutility = 0.037 Quality- Adjusted Years of Life Gained 1 0.8 0.6 0.4 0.2 0-0.2-0.4 Age at Diagnosis 45 55 65 75 Vijan et al, 2014
Treating Risk Factors in Asymptomatic Patients Individual Benefit or Public Health?
US adults aged 40-75 CV Risk Threshold % on Statin Life Expectancy QALYs None (current pattern) 8% 81.24y 17.28y 15% 39% 81.32y 17.31y 5% 57% 81.37y 17.33y Treat all 100% 81.39y 17.33y JAMA 2015; 34: 142-150
Treating Risk Factors in Asymptomatic Patients Individual Benefit or Public Health? Other factors at play - quality measures - reimbursement (eg QOF)
Informed Consent Are patients being provided with accurate and complete information?
Benefits of Interventions to Reduce CVD Risk Gains in life expectancy estimated by 46 physicians Male T2DM 72yrs, smoker, BMI 30, SBP 155, HbA1c 8.8%, Chol 5.3 Intervention - stop smoking Female T2DM 65yrs, non-smoker BMI 37, SBP 180, HbA1c 8.8%, Chol 3.7 Intervention SBP to 130 Price et al, 2009
Benefits of Interventions to Reduce CVD Risk Gains in life expectancy estimated by 46 physicians Estimated Male T2DM 72yrs, smoker, BMI 30, SBP 155, HbA1c 8.8%, Chol 5.3 6.9y 11.5y Intervention - stop smoking Female T2DM 65yrs, non-smoker, 9.8y 17y BMI 37, SBP 180, HbA1c 8.8%, Chol 3.7 Intervention SBP to 130 Price et al, 2009
Benefits of Interventions to Reduce CVD Risk Gains in life expectancy estimated by 46 physicians Estimated Calculated Male T2DM 72yrs, smoker, BMI 30, SBP 155, HbA1c 8.8%, Chol 5.3 6.9y 11.5y 5.1y 5.9y Intervention - stop smoking Female T2DM 65yrs, non-smoker, 9.8y 17y 10.7y 10.9y BMI 37, SBP 180, HbA1c 8.8%, Chol 3.7 Intervention SBP to 130 Price et al, 2009
Optimism Bias Sharot T. Current Biology 2011
Informed Consent The ethical code General Medical Council The doctor s knowledge, experience and clinical judgment are important in outlining overall benefits, risks and burdens, but the pa#ent is the person who weighs up the informa=on, together with relevant non- clinical issues, and makes the decision.
Informed Consent The ethical code General Medical Council The UK legal requirement the Montgomery judgment Over- ruled the Bolam Test, which deemed doctor is not guilty of negligence if he has acted in accordance with a prac=ce accepted as proper by a responsible body of medical men (sic) skilled in that par=cular art. Now is duty of physician to provide pa=ent with all relevant informa=on to permit a pa=ent to decide on strategy.
Requirements Physician is able correctly to estimate benefits and risks of treatment in a variety of formats, eg relative and absolute risk reduction, gains in quality-years of life. To provide the doctor, and the patient, with the time, explanation, and decision tools to ensure that these are fully understood. This process needs to be fully documented.
Informed Consent To Treatment?
Conclusion For treatment of risk factors, most individual patients will not benefit The same is true for intensive glucose lowering in people with diabetes Physicians probably over-estimate the benefits of such treatments The process of informed consent requires greater precision This ethical requirement is also now encoded in UK law While conducted mainly for defensive reasons, a consent form may obligate physicians to enhance their understanding of risk