Evidence-Based Practice - King's College London - MBBS Stage 1

Evidence-Based Practice MBBS Stage 1 Genes, Behaviour and Environment Professor Patrick White School of Life Course and Population Sciences Learning objectives for this lecture The Cochrane Database of Systematic Reviews* Randomised controlled trials* Meta-analysis* Qualit...

Evidence-Based Practice MBBS Stage 1 Genes, Behaviour and Environment Professor Patrick White School of Life Course and Population Sciences Learning objectives for this lecture The Cochrane Database of Systematic Reviews* Randomised controlled trials* Meta-analysis* Quality Adjusted Life Years* Clinical Guidelines* The development of experimental evidence Experimental Evidence How we are managing evidence QALYs, NICE, Getting a quick, accurate, authoritative answer to a question on clinical evidence The development of experimental evidence Hippocrates – 460-370 BC I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone. I will not cut for stone even for patients in whom the disease is manifest; I will leave this operation to be performed by practitioners, specialists in this art. In every house where I come I will enter only for the good of my patients, keeping myself far from all intentional ill-doing and all seduction and especially from the pleasures of love with women or with men, be they free or slaves. All that may come to my knowledge in the exercise of my profession or in daily commerce with men, which ought not to be spread abroad, I will keep secret and will never reveal. Hippocrates – 460-370 BC I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone. I will not cut for stone even for patients in whom the disease is manifest; I will leave this operation to be performed by practitioners, specialists in this art. In every house where I come I will enter only for the good of my patients, keeping myself far from all intentional ill-doing and all seduction and especially from the pleasures of love with women or with men, be they free or slaves. All that may come to my knowledge in the exercise of my profession or in daily commerce with men, which ought not to be spread abroad, I will keep secret and will never reveal. Sir Austin Bradford-Hill : July 1897 – April 1991 English Epidemiologist and Statistician. Famous for criteria of causation Early exponent of the clinical trial Sir Archie Cochrane: Jan1909 – June 1988 Scottish doctor famous for his book – Effectiveness and Efficiency – Random Reflections on Health Services (Nuffield Provincial Hospitals Trust) 1972 BMJ review: "the hero of the book is the randomized control trial, and the villains are the clinicians in the "care" part of the National Health Service (NHS) who either fail to carry out such trials or succeed in ignoring the results if they do not fit in with their own preconceived ideas” Sir Archie Cochrane: Jan1909 – June 1988 Subsequent report in the BMJ (1978) of a study he made of 18 countries: “…the indices of health care are not negatively associated with mortality, and there is a marked positive association between the prevalence of doctors and mortality in the younger age groups. No explanation of this doctor anomaly has so far been found. Gross national product per head is the principal variable which shows a consistently strong negative association with mortality. ” doi:10.1136/jech.32.3.200 Sir Archie Cochrane: Jan1909 – June 1988 Subsequent report in the BMJ (1978) of a study he made of 18 countries: “…the indices of health care are not negatively associated with mortality, and there is a marked positive association between the prevalence of doctors and mortality in the younger age groups. No explanation of this doctor anomaly has so far been found. Gross national product per head is the principal variable which shows a consistently strong negative association with mortality. ” doi:10.1136/jech.32.3.200 Sir Archie Cochrane: Jan1909 – June 1988 Subsequent report in the BMJ (1978) of a study he made of 18 countries: “…the indices of health care are not negatively associated with mortality, and there is a marked positive association between the prevalence of doctors and mortality in the younger age groups. No explanation of this doctor anomaly has so far been found. Gross national product per head is the principal variable which shows a consistently strong negative association with mortality. ” doi:10.1136/jech.32.3.200 Sir Archie Cochrane: Jan1909 – June 1988 Subsequent report in the BMJ (1978) of a study he made of 18 countries: “…the indices of health care are not negatively associated with mortality, and there is a marked positive association between the prevalence of doctors and mortality in the younger age groups. No explanation of this doctor anomaly has so far been found. Gross national product per head is the principal variable which shows a consistently strong negative association with mortality. ” doi:10.1136/jech.32.3.200 Sir Ian Chalmers: b June 1943 Clinician and Health Researcher Oxford Database of Perinatal Trials (ODPT) 1986 Effective Care in Pregnancy and Childbirth 1989 Guide to Effective Care in Pregnancy and Childbirth. 1989 Co-founder of the Cochrane Library of Systematic Reviews in 1993. British organisation running 53 review groups around the world with 30,000+ volunteers contributing their expertise. Invaluable resource of systematic reviews of randomised controlled trials. Cochrane Library The Cochrane library now has more than 7500 systematic reviews Experimental evidence Evidence-Based Practice What is it ? Evidence-based practice is a systematic approach to decision-making that involves using the best available evidence to inform decisions and actions Evidence-Based Medicine What is it ? Translation of uncertainty to an answerable question and includes critical questioning, study design and levels of evidence Systematic retrieval of the best evidence available Critical appraisal of evidence for internal validity that can be broken down into a range of aspects including…. Evaluation of performance Sicily Conference of Evidence-Based Health Care Teachers and Developers Systematic Review and Delphi Survey. doi:10.1001/jamanetworkopen.2018.0281 Hierarchy of Experimental Evidence What is a randomized controlled trial? A randomized controlled trial (RCT) is an experimental form of impact evaluation in which the population receiving the programme or policy intervention is chosen at random from the eligible population, and a control group is also chosen at random from the same eligible population. A randomized controlled trial is a form of scientific experiment used to control factors not under direct experimental control. What is a meta-analysis? A meta-analysis is the statistical integration of evidence from multiple studies that address a common research question. By extracting effect sizes and measures of variance, numerous outcomes can be combined to compute a summary effect size. Meta-analysis is a quantitative, formal, epidemiological study design used to systematically assess the results of previous research to derive conclusions about that body of research. Cochrane Library The Cochrane library now has more than 7500 systematic reviews Hierarchy of Experimental Evidence How can we manage evidence? Having defined what the evidence we need is, what next? Potentially unmanageable volume of evidence Evidence needs rationalizing Evidence has to be compatible with the clinical situations in which I find myself The solution has been provided in three places Clinical Guidelines National Institute of Health and Care Excellence BMJ Clinical Guideline Concise and similar Clinical Guidelines Made the volume of research manageable for the individual clinician Resolved clinicians’ disagreement on appropriate management Funding from special interest groups and government Expertise became available – specialist, generalist, the patient and public Adminstrative resource included to handle large volumes of research evidence Source of Guidelines Professional Societies and Associations – British Thoracic Society, European Respiratory Society, Medical Royal Colleges Stakeholder Associations - Asthma + Lung UK Government supported national bodies – SIGN, NICE Risk of Duplication – Consider Chronic Obstructive Pulmonary Disease - COPD NICE GOLD COPD British Thoracic Society European Respiratory Society American Thoracic Society All produce independent guidelines and some guideline committee participants sit on two or three committees Is there too much evidence? In 2019, 80 systematic reviews were published each day compared to 4 in 2000 and 14 in 2010 Thousands of RCTs are published every day. Impact of too much evidence Volume, especially of clinical guidelines becomes unmanageable Statistically significant benefits may not be clinically important The evidence may not apply to people with complex multimorbidity and may become unintelligible There needs to be continuing rationalization NICE, QALYs, Getting a quick, accurate, authoritative answer to a question on clinical evidence NICE Independent organisation funded by the Department of Health Provides national guidance on the promotion of good health, prevention and treatment of ill health. Established in 1999 as a NHS Special Authority. In 2013 it become the National Institute for Health and Care Excellence and now covers social care. It left the NHS to become a non-departmental public body. Why the need for NICE? Address inappropriate variations in clinical practice and “post-code” access to expensive treatments Support clinicians to keep up to date with relevant new evidence Assess the “value” (cost effectiveness) of new and existing treatments Encourage innovation Core principles of NICE Comprehensive Evidence Base Expert Input Public Patient and Carer Involvement Independent Advisory Committees Genuine Consultation Regular Review Open and Transparent Process Bringing cost into the equation QALYs – Quality Adjusted Life Years Two dimensions – added duration of life quality of that life quality from 0 - 1, 0 = no quality, 1 = full quality QALYS QALYS are assessed by health economists They combine the outcome measure in years of quality of life gained and the cost of that gain. NICE National Institute for Health Care Excellence Easy access to evidence? Clinical Evidence Concise BMJ publication Guidance on 158 conditions currently Includes a synopsis of guidance from a wide variety of sources – NICE Clinical Guidelines, Professional Group Guidelines, Stakeholder Guidelines, International Guidelines Integral to the working day of many junior doctors Integrating evidence with the clinical record Health informatics - linking evidence with the electronic patient record Learning health system - integrated AI in the electronic record EPR – Patient’s demographic data, biometric data, disease and treatment data, presenting history and examination data + Clinician’s action: – proposed diagnosis, proposed investigation; proposed treatment EPR + learning health system provides an integrated assessment