CEBM and BMJ logo

EBM Manifesto Themes

Informing and involving patients in decision making and co-design of research

it is increasingly clear that decisions on how to use evidence in clinical practice must include and inform patients:  one of the founding principles of evidence based medicine. Yet, a greater emphasis on evidence alone has lost some of the nuances that includes incorporating evidence into shared decision. Furthermore,  Research informed by and involving  patients and the public is more likely to be relevant and is an essential process by  which important research is identified, designed, and disseminated. Explicitly, we need to better understand the role of research done ON patients compared to research done BY or WITH patients. We therefore need to "Involve patients in priority setting in grant funding agencies to help drive the research agenda. The grants and priority areas often decide which topics and areas are researched." (Peter Gill)

Researchers, editors, journalists and press officers all have a role in communicating evidence to the public. Evidence can be misinterpreted, over hyped and inaccurate.   Poor quality or preliminary studies can be highlighted at the expense of research that matters to patients. Such practice may give rise to  false hope or harm. Therefore, high quality, important research that matters has to be understandable and informative to a wide audience. Yet , much of what is currently produced is not directed to a lay audience, is often poorly constructed and is underpinned by a lack of training and guidance in this area. To make fair and informed judgements on the value and relevance of evidence, people must have access to research. Currently, much of the evidence is inaccessible, held behind paywalls and only available to those that can afford to subscribe.

  • 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.

Promoting rigorous, robust, efficient research and trials that matter and are published in full

A trial might be conducted flawlessly, but this is in vain if the results are not fully reported as planned. For example, we do trials to detect modest differences, and spend vast amounts of money specifically to exclude bias, yet we allow that bias to flood back in through selective publication and reporting. This lets down participants, misleads patients and the public, and wastes money. Financial interests also control and overshadow most evidence from trials of drugs and devices, justifiably undermining confidence in the results.  Therefore to improve confidence in new technologies, and their uptake into practice, we need independent, transparent evaluations. Furthermore, "Often trials are conducted with narrowly defined populations that are not relevant to most patients in clinical practice (i.e. high internal validity but poor external validity). We need to focus more on pragmatic trials set in everyday clinical practice that focus more on effectiveness rather than efficacy."(Peter Gill)

Replication of trial results and reduction of uncertainty will only be possible if the cost of conducting trials is radically reduced. Furthermore, treatments are routinely approved in trials with surrogate and composite outcomes. Research that matters to patients should provide clinically important outcomes; It therefore makes sense that patients should be core to developing relevant  and generalisable outcomes. Furthermore, core outcomes sets  need to be further deployed to outline the important outcomes, which also facilitates cross comparison of interventions. Finally, too much research plagued by biases that are rooted in poor methods, leading to the wrong result and conclusions and preventing uptake into practice. "The problems are really well-documented. That's remarkable of itself. e.g., the no. references in the second section of the intro there. In my world, and probably other disciplines, it's 'obvious' that, say, research quality is a problem but nobody's ever looked at it properly - not even once." (Caroline Fiennes)

  • 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;

Evidence informed Synthesis

The synthesis of evidence through  has been essential to inform and underpin decision making in healthcare. However, greater access to evidence (or in some cases lack of access) and the use of more complex evidence, (such as  Clinical Study Reports, regulatory documents and Individual Patient Data) as in the case of Tamiflu, have highlighted the need to ensure that systematic reviews are based on assessment of all of the evidence and not just evidence from limited evidence sources such as journal publications. "The biggest issue is around evidence synthesis. We need to re-examine what is a systematic review (or technique for evidence synthesis). One that is nuanced enough to appreciate that the type of review is context specific. If you really need to know how good an intervention is you need a Tamiflu-style review – one that is significantly more costly than a standard – Cochrane style – systematic review. If, on the other hand, you’re happy with a ‘ball park’ figure then do it quickly." (Jon Brassey)

  • Use informative systematic reviews and stick to them;

 Evidence-Based Policy and regulatory approval

Policy has a long-lasting impact on healthcare, and should clearly be based on high quality evidence. However, this is often not the case, and scarce healthcare resources go to waste due to policy based on weak or poorly understood evidence, or in some cases no evidence at all.

Clinical practice guidelines have been produced at a rapid rate with contradictory advice and little information on the implementation for the individual. Clinical guideline development must be a completely transparent process, showing who has made the guideline, why they were involved, with what evidence, and why the recommendations were reached. Currently members of a clinical guideline development group may have conflicts of interest, so long as they are declared, which is insufficient for delivering unbiased recommendations.

To permit robust evaluations by regulatory agencies, such as the FDA and the European Medicine’s Agency (EMA), requires high quality evidence. However, a substantial number of approved drugs have significant problems, which could have been discovered and dealt with at the time of approval. To speed the uptake of new drugs into practice there is increasing pressure to lower the burden of evidence required for approval, putting patients at unnecessary risk.

  • 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;

Better use of large, routinely collected health data sets:

The use of routine data (Big data) has the potential to improve health but also appreciably worsen health if used in the wrong way. True informed decisions require a range of evidence, to inform their uptake into practice. "Every major medical conference now has a ‘big data’ session and optimistic claims are being made about the possibilities for research and diagnostics in the future. Many different tech sounding issues are confused and rolled together." (Sam Gallivan) We therefore need better use and understanding of the role of  qualitative, observational and quantitative research in informing  those decisions that matter.

  • Determine the appropriate uses of routinely collected data for genuine patient benefit;


Overdiagnosis and Too much medicine

Overuse of diagnostic tests and medicines has the potential to cause harm, increase costs and waste scarce resources. This is particularly so when benefits are uncertain, effects are small, or when the test leads to no net benefits. Diagnostics tests that offer no benefits to patients can lead to unwarranted anxiety and in some situations unwarranted interventions that can cause  harm.

    • Reduce unwarranted variation, overdiagnosis and unnecessary medicalisation;  

Individual Accountability

Declaration of conflicts of interest (financial and non-financial) is currently chaotic, inconsistent, and incomplete. Conflicts, however, become particularly salient when evidence is unclear or when there are significant rewards for an individual, an institution or a company in relation to research outcomes. This is particularity pertinent when it comes to policy and guideline production. Moreover, "professional organisations, particularly those who operate in the sphere of postgraduate medical education, postgraduate training/appraisal/revalidation/professional competence have a professional obligation to declare conflicts of interest in relation to Pharma/Contract Research Organisations." (Tom Fahey)

      • Declare and manage conflicts of interests to reduce their impact on critical decision making;

Clinical Expertise and training in EBM 

Clinical expertise is pivotal to effective evidence-based care. Furthermore dealing with uncertainty when applying evidence to individual patient care requires skills in assessing evidence and recognising poor quality evidence.  "Education that will long term lead to a change in behaviour and our society's approach to evidence based medicine. "It doesnt stop with education of medical professionals, but it is about education of the population."(Kasia Bera) To therefore deliver great healthcare we need a generation of applied healthcare leaders with skills in assessing, appraising and applying evidence to patient care. "Education in evidence-based medicine could be greatly improved by the development of high-quality, open-access educational materials suitable for the public, for trainees, and for practicing professionals." (Bill Cayley) Furthermore, "EBM seems to be forgotten about as we pass through post graduate education- we need to bring together the junior specialty associations."(Sam Gallivan)

    • Cultivate the skills of health professionals to deal with uncertainty, recognise poor quality evidence and deliver great healthcare;
    • Grow the next generation of leaders in evidence-based methods.

2017 Highlights