Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Benefit and harm: Effectiveness and risk • Key concepts in therapeutics • Key issues in communication I Ralph Edwards Marie Lindquist With acknowledgements to Andrew Herxheimer 'Benefit' and its opposite 'Harm' There are individual and general definitions possible for benefit and harm "To be an advantage to" – Societal "Something that contributes to or increases one’s wellbeing" – Individual A BENEFIT TO SOCIETY MAY NOT BE A BENEFIT TO AN INDIVIDUAL AND VICE VERSA NEITHER IS HARM TO SOCIETY THE SAME AS HARM TO AN INDIVIDUAL AND VICE VERSA 'Benefit' in societal terms • Benefit – Increased overall population health • 'Fitter' working population – Decreased expenditure on health • Increased efficiency • Shift to less costly options • Harm – Increased longevity without health – More costly health care • Costs shifted or hidden • Diversion of funding from more 'effective' areas 'Benefit' in societal terms • Benefit – Measles vaccine – Total abolition of tobacco advertising – Discontinuation of the NSAIDS that cause the most GI bleeding • Effective only – The prolongation of life in diabetics – Treatment of HIV – The use of 'Viagra' •Which shows that decisions on health are not only based on public health BENEFIT but also EFFECTIVENESS ' Effectiveness' and 'risk' • Effectiveness is an indication that a drug works: this is not the same as benefit The true balanced concepts • Efficacy v. hazard – Pre-clinical/clinical study • Effectiveness v. risk – Post-marketing clinical use studies • Benefit v. harm – What is actually experienced by a patient or patients Perception of effectiveness and risk from medicines Mild stroke Hypertension 160/100 Insurance medical Hypertension 160/100 Difference? Treatment Same treatment Not only pathology, but also in PERCEPTIONS of what chances one will take Communication challenges • Different audiences: different perceptions – Doctors, patients, media, lawyers • How to express the effectiveness/ risk balance • How to compare between treatments • How to handle changes in knowledge – HRT - myocardial infarction – Blood pressure therapy (ALLHAT) Communication challenges • Expression of message – Retention of information: reference • Complexity – Impact • Confidentiality v. openness – Access – Information flow (Learned intermediary) • Seriousness of issue – speed of communication Effectiveness/risk communication • • • • The correct message To the right audience By the right medium Consequences – Message received? – Message understood? – Followed up? – Acted upon appropriately? Communication challenges Message sent ! New! Follow up Message received Message understood Message acted upon Studies More messages ! Action appropriate Benefit and harm from medicines Edwards, IR., Wiholm, B-E., Martinez C. (1996) "Concepts in Risk-Benefit Assessment" Drug Safety 15(1): 1-7 CIOMS 4 • Compare like-with-like – Principle of 3's • Disease; effect of drug; ADRs • Seriousness; duration; frequency • Three worst and three most frequent ADRs – Then consider cost...