185 GENERAL DISCUSSION These are just two examples illustrating that RCTs are too often conducted in the same vital population and that almost no RCTs are performed in specific populations where the greatest need for evidence exists. Since the leading research questions receive little or no attention in high-quality RCTs, it is therefore justified to introduce the term ‘inverse research law’ analogous to the term ‘inverse care law’. As in clinical care, RCTs are often focused on populations that do not have the highest priority of unanswered and clinically relevant questions. This needs to change. The last part of this chapter presents some possible solutions for reversing the ‘inverse research law’. HOW TO REVERSE THE ‘INVERSE RESEARCH LAW’? Fortunately, good examples already exist. For instance, the Dutch Heart Foundation has put reversing the ‘inverse care law’ and the ‘inverse research law’ on their national cardiovascular agenda for 2024-2034 in order to reduce the cardiovascular burden on patients and society.35 Three of the seven key challenges on this agenda (i.e. care for all, attention to diversity, and tailored treatment) at least partly reflect the need to also provide evidence for patients who are often not included in research.36 It also acknowledges the importance to aim at achieving both health and research equity by focusing on underserved and difficult to reach populations, and the need to tailor medical care to the individual needs of these populations. The Dutch Heart Foundation should be complimented for this research agenda, which will hopefully inspire other funding bodies to follow this example. The obvious next question is how we (i.e. both society as a whole and the research community) can achieve reversing the ‘inverse research law’ described in such a research agenda. First, it is crucial to establish clarity regarding the specific population in which (additional) research is needed. In the example of frail older patients the concept of frailty is used to define accelerated biological decline, as well as functional decline and social isolation. However, a clear definition for frailty is currently not available, or at least not uniform. The lack of such a clear definition makes it impossible for physicians, researchers, guideline makers, policy makers and regulatory authorities to speak the same language and compare findings from different studies. A uniform and international definition helps determine the future research field and increases the number of RCTs in a specific population as illustrated in the following example. Before there was a uniform and international definition of irritable bowel syndrome, hardly any research was conducted on this highly prevalent functional gastrointestinal disorder. Following the publication of the authority-based diagnostic Rome I criteria in 1994, the number of RCTs on irritable bowel syndrome increased tremendously from 73 RCTs before 1994 to 797 RCTs from 1994 onwards based on a quick scoping search in PubMed using the search term ‘irritable bowel syndrome’ in the title (see Figure 1).37 After each update of the Rome criteria (in 1999, 2006 and 2016), the number of 9
RkJQdWJsaXNoZXIy MTk4NDMw