Rights to social determinants of flourishing? A paradigm for disability and public health research and policy

The term evidence based medicine (EBM) was introduced in the early 1990s in clinical medicine to educate clinicans about how to assess the ‘credibility’ of research to ensure best treatments for their patients [1]. British Centres for Evidence were established and it was taken up into clinical training, textbooks and practice. EBM was also espoused as new paradigm in 2001 by the Cochrane Collaboration, which publishes rigourous methodological information about clinical randomised controlled trials (RCTs) [2]. It was hoped that the EBM paradigm would ensure that clinical practices would become ‘scientfic’, in the sense of giving assurances of quality of scientific background and emprical research to inform clinical decisions, as well as evidencing value for money by ensuring clinicians did not pursue treatments that did not work [3].

Djulbegovic and Guyatt [1] argue that there are three epistemological principles for EBM: firstly that evidence has to be trustworthy, credibly determined and based on controlled clinical observatons; secondly that the ‘totality’ of evidence should inform the truth of decisions; and thirdly, that ‘clinical decision-making requires consideration of patients’ values and preferences’. In order to assess such principles, evidence hierarchies began to appear; with critical appraisals assuming that clinical RCTs provided more certainty than uncontrolled emprical studies, while systematic reviews (using evidence synthesis) were developed to measure the ‘totality’ of evidence. Parallel systems in the United States (US) have also evolved and numerous standards and guidelines have been developed to ensure better evaluations, as well as designs for RCTs. There has been a focus on what ‘works’ in terms of RCTs and then understanding ‘why’ in terms of their evaluation. Robust methodological guides are now emphasised in checklists, like the Consolidated Standards of Reporting Trials (CONSORT) [4]. In the United Kingdom (UK), the EBM paradigm has been espoused through the National Institute for Health and Care Excellence (NICE), who highlight the improvement of health and social care through evidence-based guidance. Implementation science has also been advocated by the National Health Service (NHS) to try and close the gap between research and practice, by evaluating ‘why’ interventions work.

In times of neoliberalism and austerity, it can seem as if the EBM framework is becoming more diffuse and applied to a much broader range of decisions [5], in line with an increasing emphasis being placed on evidence for budget allocations and justfications of how funding is being spent. Trial evidence has, therefore, become especially attractive to policy makers as it seems to offer potential solutions to complex, expensive and increasing politically contested dilemmas facing health care, thereby meeting ‘a longing that this rational discourse can in Rousseauian fashion locate and unmask our suffering’ [6]. This explains why the principles of EBM have spread, from being used to weigh up evidence for health interventions in clinical practices, to wider realms such as public health, social prescribing and even economic policy making. For example, the UK’s What Works Network was formed in 2014 as a government intiative that promotes the use of robust evidence to faciliate policy making and service delivery, in areas as diverse as health, policing and development aid [7]. This means, for instance, the UK’s Department for International Development (DFID) has to ensure that their policy teams can illustrate how decision making is evidence-based and this is inclusive of business decision-making [7]. While Greenhalgh et al. [3] and Wieringa et al. [5] have been critical of the misappropriation of the EBM brand, they also offer solutions, viewing EBM as a ‘situated practice’ in terms of links to how cultural values and norms influence ‘evidence’. This points to a trickier issue, in that while the policy focus is on what ‘works’, its evaluation and ‘why’ an intervention works becomes more complex in different global contexts.

In terms of public health, Victora et al. [8] too warn that application of EBM to research means that we have to become more critical and think beyound simplistic RCT designs. Similarly, Mays et al. [9] note that despite the fact that policy-makers are under increasing pressure to adopt evidence-based decisions, Cochrane style reviews of evidence alone will not be enough and different approaches might have to be evaluated. This indicates that issues with EBM are not only located within research but also policy making, affecting interventions and the evaluation of research evidence [10], for example in terms of implementation science, as well as its further funding. In this paper, we want to focus on the links between RCTs and public health to see if any evidence-based innovations are possible in terms of disability research.

RCTs are currently regarded as the gold standard for scientific evidence in public health policy, with gaps between research and policy uptake still viewed as problematic [11, 12]. We accept that RCTs in public health have a crucial part to play in ensuring the health of people who have disabilities across the life-course. Evidence from RCTs can lead to interventions that can tackle underlying causes of ill-health and reduce health inequalities with the potential to transform lives and ensure rights to independent living [13]. Yet, in a letter in The Lancet, van der Marck et al. [14] note that the biggest challenge that clinicians will face in the next twenty-five years, is patients presenting with multi-morbidities across the life-course for whom evidence informed guidelines will not work and may cause harm. They argue that there is a ‘fundamental mismatch’ between evidence being produced and what will be needed to tackle disabilities [14]. We argue that this mismatch in terms of disability is also present in public health, and linked to the kind of research that is being funded and its evaluation. This raises broader challenges in how evidence is presented and interpreted.

First, evidence synthesis reinforces the clinical basis of medicine, to the relative neglect of social-economic, cultural and environmental conditions [15], while simultaneously struggling to engage with the meaning patients and practitioners’ accord to an intervention [16]. Consequently, key contextual factors contributing to the broader social determinants of health - and the success or otherwise of an intervention - are underplayed [14]. Second, synthesis often assumes the idealised integrity of trial methodology, rather than offer a critical account of how the trial was conducted, designed and reported [17, 18]. Over 50 % of trial interventions, for example, are inadequately described and over 50 % of planned study outcomes not reported, with negative results rarely getting published [19]. Moreover, randomisation rarely provides representative samples, specifically failing to address diversity, in terms of age, sexuality, ethnicity or disability [13]. Third, a narrow focus on trial evidence has meant equally valuable forms of insight, such as those offered by epidemiology, are neglected [20]. Epidemiology has a particularly strong tradition of reflecting the experience of those traditionally neglected by trial evidence [21], and is also able to embrace the challenges posed by future of epigenetics [22]. Finally, the focus of trials, can obscure the role of political decision-making and bias in determining the evidence available or what evidence is regarded as significant and/or put into practice [23].

Despite decades of research advocating synergies between public health and disability research [24, 25], we know little about how disabled people and disability theory are integrated into public health RCTs. Previous studies have mostly recorded exclusions and non-recruitment of disabled population groups most affected by health inequalities, for example, people with intellectual disabilities [26‐28]. We thus want to begin a critical theoretical and empirically informed discussion about the ways in which public health RCTs could better integrate disability. Furthermore, we argue that public health RCTs now need to take into account issues of policy impact, as well as health inequalities, which focus on ensuring not only that people can live well with disabilities but that they have a right to that health. This entails thinking more constructively, in practical terms, about how we are integrating human rights and social justice perspectives in inequalities research so we guarantee social flourishing with disabilities. Our approach is consistent - at least in spirt - to the intent of Doll & Bradford-Hill [29], who in establishing the scientific basis of current trial methodology, were suspicious of naïve descriptive empiricism, particularly when it was at the expense of more theoretically informed enquiry. We argue for a novel social determinants of flourishing, which is more consistent with how people experience disability, within an evidence-based framework that places an emphasis on RCTs and their evaluation. There are four ways in which this can be achieved by: 1) Rethinking theoretical connections between public health and disability; 2) Building ethics and equity into interventions through human rights; 3) Ensuring ethical inclusion through intersectionality; and 4) Evaluating policy and other social impacts. We explain each in turn.