There are huge shortcomings in the way that evidence based medicine operates today: bad quality research, evidence that is withheld, piecemeal dissemination, a failure to respect patients’ priorities, and more. There is also a long history of people, and organisations, trying to fix these problems. We want to pull together a clear set of achievable goals, and a strong overview of the strategies that work best, to help deliver change better, and faster. This is the EBM manifesto.
Whilst the amount of research, funded and published, has grown enormously, there is little to suggest increased outputs have led to real improvements in patient care. Equally worrying, the growth and volume of evidence 1 has been accompanied by a corrosion in the quality of evidence, 2 which has compromised medicine’s ability to provide affordable, effective, high value care.
Disquiet about the lack of high quality evidence cannot be dismissed as the grumblings of a disgruntled few. 2 Serious systematic bias,3 error, 3 and wastage 4 are now too well documented in all areas of medicine 5 and across the entire research ecosystem, from research to implementation.
Problems include: poorly managed commercial and academic vested interests,6 bias in the research agenda, failure to take account of the patient perspective in research questions and outcomes, 7 poor research design, 4 the rising use of surrogate outcomes,8 lack of transparency, lack of independent scrutiny, ghost authorship,9 publication bias,10 reporting bias 11 including under-reporting of harms, 12 trials that fail to follow their protocols 13 or are stopped too early,14 and over-interpretation and misuse of the results of research, 15 uncorrected errors, 16 and undetected fraud. 17 5 These are just some ways in which our flawed system generates evidence that has reached the wrong result, or conclusions that don’t matter to real world patients.18 studies suggest that most published research (including a range of study designs) is more likely to be false than true. 16
As medical research activity has intensified over the past 50 years, so too have these problems, aggravated by major structural problems with guideline production,19 significant regulatory failings,5 and significant delays in the withdrawal of harmful drugs.20 All of this contributes to escalating costs of treatment,21 medical excess,22 and avoidable harm. 20 Add to this the unmanageable volume of evidence,1 the prohibitive cost of doing research, 23 and the lack of evidence to support shared decision making,24 and it is clear that we have a major structural problem with the current production and use of evidence.2 If left unaddressed, these inherent problems may become entrenched and unsolvable.
Our aim is to facilitate the creation of a manifesto developed by people engaged at all points in the research ecosystem who want to engage in fixing the problem, including above all patients and the public who indirectly fund but are directly affected by the outputs of the current system. This first draft is an extension of the critique and solutions first reported in The BMJ article, “Evidence based medicine: a movement in crisis” 25 and the editorial, “How medicine is broken, and how we can fix it.” 26
Following the principle of “release early, and release often!” we have set out some of the key problems facing medicine today, and the changes we think are necessary. We are running a series of seminars, round-tables, and online consultations, with partners around the world. If you would like to be involved, or lead a part of the process, please get in touch. To be clear: this is political work, but this manifesto is not a project to control activity. We hope to establish clear shared goals; to map where change is already being delivered; and to help discussions that shine light on new approaches that might work faster.
Fixing EBM is a vast project that is led, and will be led, by disparate groups around the globe. We hope to focus global attention on the most effective tools and strategies we can use to deliver that change, so that we can all work together.
We will gather your feedback and ideas in as many ways as we can: through online dissemination that allows your comments to be captured, and through small group and roundtable discussions in various venues around the world over the next six months. A final version of the manifesto will be published in The BMJ, and the development of an action plan will be main the focus of discussion at Evidence Live 2017.
Carl Heneghan, Kamal R. Mahtani, Ben Goldacre, CEBM Fiona Godlee, Helen Macdonald, BMJ Rosamund Snow BMJ Patient Editor. http://evidencelive.org/manifesto/ V1.5 2nd Dec 2016 Conflict of interest statement
To create effective long term change for better healthcare we propose the need to:
– Develop tools for practice that support and serve patient choice.
– Promote the uptake of accurate, impartial evidence to empower patient decision making.
– Expand the role of patients in the co-design of all types of research
– Use rigorous research methods and stick to them.
– Eradicate publication and reporting bias.
– Reduce excessive costs of trials, promote independent replication and trial outcomes that matter.
– Use informative systematic reviews and stick to them.
– Determine the appropriate uses of routinely collected data for genuine patient benefit.
– Educate decision makers to generate informative transparent evidence-based healthcare policy.
– Establish guideline recommendations from only high quality evidence.
– Improve the research ecosystem to support regulators and regulatory decisions.
– Reduce unwarranted variation, overdiagnosis and unnecessary medicalisation.
– Declare and manage conflicts of interests to reduce their impact on critical decision making.
– Cultivate skills of health professionals to deal with uncertainty, recognise poor quality evidence & deliver great healthcare.
– Grow the next generation of leaders in evidence-based methods.
We want to focus on solutions, and help offer a structure for people to coordinate positive action. We want to map what is currently being done. We want to formulate clear goals, so that we can work back from these, to inform the interventions that are deployed. We want your help to achieve Better Evidence for Better Healthcare.