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EDITORIAL

From evidence-based practice to evidence-based research – Reaching research-worthy problems by applying an evidence-based approach

Nothing less than a revolution in clinical practice has taken place since the concept of evidence-based medicine (later broadened and called evidence-based practice or evidence-based healthcare) was first introduced in the early 1990s (Citation1). The idea was to compile all research within a given clinical area into systematic reviews and to formulate recommendations in clinical guidelines.

Scientists have strongly promoted evidence-based practice (EBP), but increasing evidence indicates that, as researchers, we need to put our own house in order first. If asked, any scientist would agree that new projects should always build on previous research results within the same field in accordance with for instance the CONSORT statement (Citation2). However, several studies clearly show that this is not the case.

During a period of 12 years, Mike Clarke, Iain Chalmers and colleagues showed only small improvements in searching for the systematic use of earlier research when designing clinical trials and/or discussing the results (Citation3–6), even in trials published in highly rated medical journals. Karen Robinson and Steven Goodman of Johns Hopkins University recently presented even more worrying results (Citation7). Based on analysis of 1523 randomized clinical trials, they found that about half the trials cite none or only one, no matter how many trials have been performed in a specific field. Other studies found similar results (Citation8–11). Furthermore, cumulative meta-analyses showed that several thousand patients have been included in randomized controlled trials after a definite effect of an intervention was established (Citation12). Following the publication from the Johns Hopkins University, one of the authors said to The New York Times: “As cynical as I am about such things, I didn't realize the situation was this bad” (Citation13).

When a group of physicians invented the concept of EBP, their first suggestion was to name it “research/science-based medicine”. However, their colleagues found it insulting to insinuate that the treatment they were offering was not research-based, and the word “evidence” was introduced instead. Today we have evidence showing that our own research is far from being systematically based on earlier research. What clinicians were blamed for in the 1990s still seems to apply to researchers today. Instead of building our research question on the totality of previous research, we typically do it the other way around. First, we formulate a research question, and then we retrospectively identify previous studies that can support the question.

Current evidence shows that several randomized controlled trials have been unnecessarily performed because a clear answer to the research question had already been established (Citation12,Citation14,Citation15). Just as EBP has identified gaps between research findings and clinical practice, the studies referred to above indicate a worrying gap between the recommended and the actual practice among researchers.

An international network group is presently being set up and suggests introducing the concept of evidence-based research. This could be defined as any research activity in which the research question, the discussion and the conclusion are based on a systematic review of all previous research.

The process of formulating a research question and designing research endeavoring to answer the question involves several aspects, such as the resources available, the patients’ perspectives and the researchers’ competencies. These factors are important in implementing both EBP and evidence-based research. By including the patients’ perspectives and the context, we acknowledge the complexity involved in formulating a research question, designing and conducting the study. Similarly to EBP, even though reality is complex and unpredictable, we should build our research program on the totality of earlier research. We owe that to our patients and to our limited research resources.

The evidence-based research network suggest that all PhD students, supervisors and senior researchers learn about and perform systematic reviews to anchor their own research questions and conclusions in all relevant earlier studies. Researchers would then have a much better foundation when arguing that their project is “research-worthy” and adds to existing knowledge. We support earlier suggestions that ethics committees only support evidence-based research (Citation16), that research funders focus their resources on evidence-based research (Citation1), and that editors and scientific journals reject manuscripts that do not systematically review previous research (Citation17).

For further information about the Evidence-Based Network, please contact Hans Lund, [email protected].

References

  • Boissel JP, Chalmers I, Flather MD, Franzosi M-G, Victor N. Controlled clinical trials. Strasbourg: European Science Foundation; 2001.
  • Moher D, Schulz KF, Altman DG. The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. J Am Podiatr Med Assoc. 2001;91:437–42.
  • Clarke M, Chalmers I. Discussion sections in reports of controlled trials published in general medical journals: islands in search of continents?JAMA. 1998;280:280–2.
  • Clarke M, Alderson P, Chalmers I. Discussion sections in reports of controlled trials published in general medical journals. JAMA. 2002;287:2799–801.
  • Clarke M, Hopewell S, Chalmers I. Reports of clinical trials should begin and end with up-to-date systematic reviews of other relevant evidence: A status report. J R Soc Med. 2007;100:187–90.
  • Clarke M, Hopewell S, Chalmers I. Clinical trials should begin and end with systematic reviews of relevant evidence: 12 years and waiting. Lancet. 2010;376:20–1.
  • Robinson KA, Goodman SN. A systematic examination of the citation of prior research in reports of randomized, controlled trials. Ann Intern Med. 2011;154:50–5.
  • Sheth U, Simunovic N, Tornetta P, 3rd, Einhorn TA, Bhandari M. Poor citation of prior evidence in hip fracture trials. J Bone Joint Surg Am. 2011;93:2079–86.
  • Goudie AC, Sutton AJ, Jones DR, Donald A. Empirical assessment suggests that existing evidence could be used more fully in designing randomized controlled trials. J Clin Epidemiol. 2010;63:983–91.
  • Jones AP, Conroy E, Williamson PR, Clarke M, Gamble C. The use of systematic reviews in the planning, design and conduct of randomised trials: A retrospective cohort of NIHR HTA funded trials. BMC Med Res Methodol. 2013;13:50.
  • Smith AJ, Goodman NW. The hypertensive response to intubation. Do researchers acknowledge previous work?Can J Anaesth. 1997;44:9–13.
  • Fergusson D, Glass KC, Hutton B, Shapiro S. Randomized controlled trials of aprotinin in cardiac surgery: Could clinical equipoise have stopped the bleeding?Clin Trials (London, England). 2005;2:218–29; discussion 29–32.
  • Kolata G. Trial in a vacuum: Study of studies shows few citations. The New York Times. 2011 January 17.
  • Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC. A comparison of results of meta-analyses of randomized control trials and recommendations of clinical experts. Treatments for myocardial infarction. JAMA. 1992;268:240–8.
  • Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F, Chalmers TC. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med. 1992;327:248–54.
  • Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically?Some suggestions for improving performance and accountability. BMJ. 1996;313:1390–3.
  • Young C, Horton R. Putting clinical trials into context. Lancet. 2005;366:107–8.

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