‘ Introduction  – RCTa background Randomised controlled trials (RCTs) are largely consideredthe “gold standard” within evidence-based research (Grossman and Mackenzie 2005).They have been seen asholding the highest ranking in the ‘evidence hierarchy’ (blackwood). However, even the most zealous advocates of RCTs willadmit there are certain problematic elements of RCTs (Ibid).

Michael Rawlins, Chairman of theNational Institute for Health and Clinical Excellence (NICE) calls the attemptto place evidence in hierarchies ‘illusory’ and the placement of RCTs at thetop as ‘an undeserved pedestal’ (Rawlins, 2008). Often they can beethically questionable, due to the existence of the control group (Meldrum2000). Logistically carrying out a trial with real-world constrictions of costand time is not always feasible (O). Furthermore, the absence of external validity is often the most common criticism of RCTs(Rothwell 2006). To what extent can the results of a given study appliedto other groups is perhaps the greatest weakness of RCT’s (Rothwell 2005). RCT’s can be considered to haveanother weakness depending where you stand as a researcher, positivist orsocial constructivist. There are those who considered the positivistic natureof RCT’s prevents it from unpacking complex causal mechanisms, which can helpexplain why a given intervention has an effect (reference).

This essay hopesto address to what extent qualitative research methods used in conjunction with RCTs can help shed lightupon the causal mechanism and therefore is this the only way that RCTs shouldbe used by policy makers.   This essay will focus upon that debate about around RCT’sability to “unpack” complex interventions. There can be little debate aroundRCTs strength when dealing with pharmaceutical trails or certain medical trails(Feneck, 2009).

However, the current RCT debate that rages is it possible foran RCT, which is aware of its potential shortcomings has the ability to explainthe causal mechanisms of complex interventions (Porter and O’Halloran, 2012).  Complex interventions – a MRC framework There is now perhaps a conesus and awareness about thelimitations of RCT’s when it comes to understanding complex interventions (reference). As a result, the Medical ResearchCouncil (MRC) produced a framework that would attempt to address the complexityof developing and evaluating complex healthcare interventions, in an attempt toovercome some of the limitations of the RCT (Medical Research Council,2000, 2008). The framework provided a step-by-step guide as how toapproach and RCT addressing a complex intervention. There are 5 differentphases that the MRC guidelines suggest. Firstly, a sound hypothesis should beformed embedded in theory and evidence.

Following this step the researchersmust identify the components of the intervention. Determining how thesecomponent’s mechanisms will work. Both these first two stages may integratequalitative methods to describe component and their mechanisms. The third stageis the exploratory trial and the conduction of the RCT. There are a final twostages proposed by the MRC. Firstly, a definitive RCT is central step inevaluating the effectiveness of the complex intervention. Finally, a process evaluation,aiming to understand how local context influenced outcomes. This final stagehopes the address some of the external validity issues often associated withRCTs.

So the MRC is grappling with the issue of complexity in health servicesresearch by declaring that there is value to be achieved through using otherresearch methods, including qualitative strategies, to inform the developmentand evaluation of complex interventions. Critique of the MRC framework The question that we wish to address here is howsuccessfully does the MRC framework address the limitations of the RCT’s whendealing with complex interventions. The supplement RCTs with various qualitativemethods appears to be a neat solution to the epistemological difficulties presentedby complex interventions (Porter and O’Halloran, 2012). Nonetheless, there apotential issues with this MRC framework. One of the core challenges is that the MRC framework is thebridging the divide of positivism and realism (Denzin and Lincoln, 2000).Undoubtedly, there may be some difficulty in integrating qualitative methodswithin an RCT experimental design.

It could be argued that the schism ofpositivism and social constructivism are mutually exclusive. However, thisdichotomous viewpoint hides more than it illuminates (reference). Though there a core epistemological differencesin the theory that has developed these different methodological researchmethods moving past that divide will undoubtedly benefit research (reference). Though the MRC framework attempted to address the lack ofthe RCT’s ability to address the causal mechanisms of complex innervationsthere are those who still argue it was unsuccessful. The MRC framework couldperhaps benefit form the incorporation of what has been coined the ‘realistRCT’ (Bonnel et al 2012)     Realism to Realist RCTs  Realism has been argued as to be the panacea of RCT’sproblems in relation to complex interventions (Boneell etal 2008)(Pawson and Tilly ???). A realistRCT would look at the how multiple components interact, by looking at these componentsalone and together (Ibid). Factorial trials (Montgomery et al.

, 2003) could be usedto do this and there are a number of of this research projects that conductedthis (Dangour et al., 2007; Flay et al., 2004).  Secondly, a realist RCT advocates the use of additional strategic and synchronizedapproaches to test the effects of interventions. They also seek to understandhow the components of the RCT work in different contexts using consistentmeasures where possible eg (Breitenstein et al., 2010).

Perhaps thereare already elements of this in cluster RCT’s. Realist argued that it should bea core component of all RCT’s (Strange et al., 2002). Examples of RCTs attemptsto do this, are characterised and by the inconsistent measures of contexts (Armstronget al., 2011). More consistent measurement of context is recommended intheorization of hypotheses. The aspects of the context may be significant for theinterventions so that projects can be designed to examine these possibilities.(Bonnel et al 2012) Thirdly, realist RCTs should utilise both qualitative andquantitative research methods (Palinkas et al.

, 2010). Qualitative research cancultivate hypotheses around defining the most important intervention components,how they work and the context impact on implementation and effect.  Furthmore, realist RCTs would aim to explain the interactionof context and an intervention’s fundamental mechanisms produce outcomes. Theyalso should pay more attention to interaction of mechanisms with context(Connell & Kubisch, 1998; Patton, 2002; Weiss, 1995). Therefore, it is criticalthat interventions are a clearly enunciated within the theory of change(Connell & Kubisch, 1998).

Incorporating contextual factors within theoriesof change, would explicitly consider the circumstances in which an interventioncan be enhanced or fail. Optimising the targeting, application and structuralsupport. Realist RCT’s – an oxymoron RCT’sability to evaluate complex interventions by use of realist design (Bonell etal, 2012).

However, a realist design, which is fundamentally built upon apositivist epistemological position, cannot be adapted to be used from within arealist paradigm. The recommendations for “realist RCTs” do notsufficiently take into account important elements of complexity that pose majorchallenges for the RCT design. They also ignore key tenets of the realistevaluation approach.

We propose that the adjective ‘realist’ should continue tobe used only for studies based on a realist philosophy and whose analyticapproach follows the established principles of realist analysis. It seems morecorrect to call the approach proposed by Bonell and colleagues ‘theory informedRCT’, which indeed can help in enhancing RCTs. Conclusions – RCT’s with imbedded qualitative elements To conclude the RCT has much developed from its originalform (reference). The RCT framework suggested by the MRC has in it elements ofqualitative research. To what extent policy makers could use a RCT if I did nothave a quallative element much depends upon the question it seeks to answer.

RCT that deal with non comoplex intervetions don’t seemed to need qualativeelemnst. Howvere, if complex intervetions are invloved both the Realist RCT andthe RCT conducted in the MRC framework stress the need for qualative elelmenstwith the RCT itself. RCT’s should not be followed up by qualative research butinstead have qualative elements embed within its methdolcoallt structure. Thesequalative elements can be used to help    

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