In EBP, epidemiologic evidence-sources over-estimated as useful evidence in clinical practice clinical practice

Ekeland claims that the evidence-sources in EBP have limited usefulness in clinical practice. He argues for this in two ways. Firstly, he addresses the problem of usefulness by attending to what he views as the “context-free ideal” of scientific knowledge in EBP.

Secondly, he addresses specific challenges of external validity with regard to application of RCTs.

133 It is not further specified what other kinds of evidence that are included. In light of Ekeland’s attention to “context-free methods”, it seems reasonable to interpret Ekeland’s view as implying that methods in EBP consist of biomedical (including epidemiologic) methods only, and excludes, at the very least, qualitative methods.

191

 Context-free research knowledge has limited usefulness in clinical practice

As a consequence of EBPs narrow scope of evidence, with its biomedical research ideal of context-free research-evidence, Ekeland maintains that there is minimal attention to contextual understanding in EBP. He demonstrates this by addressing the lack of attention to external validity in the hierarchical ranking of evidence in EBP, which in Ekeland’s view is representative of the ideal of context-free evidence-sources, such as the RCT). Thus, the evidence hierarchy of EBP ignores the fact that every research method exhibits unique strengths and weaknesses regarding research questions and different contexts (cf. ibid., 157f).

Without attention to context, biomedical research evidence is considered problematical with regard to its usefulness in individual clinical practice. He admits that the scientific ideal of a universal or context-free medicine has provided great progress within biomedical research, through which drugs can be tested without regard for the complexity and character of clinical interventions. The problem, however, Ekeland states, is that there is no context-free treatment in clinical practice (ibid., 164f).

In particular, Ekeland states that the RCT is not suited for psychotherapy, because the RCT-design will “[s]uppress essential elements in psychotherapy as a phenomenon, such as the idea that the individual variation is categorized as systematic errors [feilvarians]” (cf. ibid., 160). Rather than basing psychotherapy on epidemiologic evidence, psychotherapy must be understood as a “contextual medicine”. ‘Contextual science’ refers to any practice in which the methodological and technical aspects of an intervention cannot be separated from its relational aspects e.g., conversations with the patient (cf. ibid.). Ekeland stresses that such contextual knowledge should be considered equally important evidence as scientific knowledge. In EBP, however, Ekeland claims, there is strikingly little interest in such knowledge (cf. ibid., 165). In this way, the context-free ideals of EBP is highly problematical with regard to application of research in contextual clinical practice.

192

 In EBP, the RCT is over-estimated as useful evidence in clinical practice

Ekeland also provides more specific arguments against the usefulness of RCTs, from a methodological perspective, attending to inherent limitations regarding external validity and usefulness due to their design. In particular, Ekeli identifies three problems with regard to external validity:

Firstly, internal validity does not imply external validity nor clinical usefulness (cf. ibid., 155f). According to Ekeland, many proponents seem to misunderstand this issue, and interpret internally valid RCT-results as being externally valid and useful in each individual case (cf. ibid., 156ff).

Secondly, the statistical documentation provided by RCTs is often incorrectly interpreted as prediction of that the effect of the intervention under testing will be reproduced in the future. Ekeland states that the statistical models used in RCTs do not account for such conclusions (156), and that such predictions can only be interpreted in light of theories about the (pathophysiologic) mechanisms (i.e., its causal inference) that generate the effect of the outcome in the first place.

In contrast, knowledge provided from RCTs supports knowledge of the association between intervention and outcome. On basis of such knowledge, statistical (probabilistic) predictions are made with regard to how a clinical intervention is likely to have effect when recommending a certain intervention to individual or groups of patients, regardless of knowledge of the causal mechanism.¹³⁴ The core of Ekeli’s claim here is that EBP clinician conflate these two different kinds of predictions.¹³⁵

134 This is discussed in the sections 1.2.1. above.

135 The description of predictions based on RTCs (which in turn is based on outcome-based research) is my explanation of Ekeland’s line of argument. In Ekeli’s text there are no reference to predictions based on RCTs.

193 Thirdly, RCTs provides knowledge of the average effect of an intervention in one test-population, compared to the average effect of an alternative intervention (or placebo treatment) in another test-population. Such knowledge, Ekeland claims, is characterized by a one-sided attention to outcome-based methods, or to “what works” – at the expense of understanding “in relation to what” (cf. ibid., 149). Ekeland considers this one-sided attention to “what works” to be less problematical in medicament treatment¹³⁶ but is highly problematic in other fields of health care, such as social services and psychiatry (cf.

ibid., 147ff). In non-medical fields, Ekeland continues, such objective, context-free knowledge is less central, and questions of effect and outcome will not necessarily be as useful in clinical practices.

According to Ekeland, the central point is that there is different ways in which knowledge is used. “For example”, Ekeland claims, “there is an essential difference between recommendations on population-level and clinical practice” (cf. ibid., 158). In other words, outcome-based methods (and RCTs in particular) are only considered useful to the

“average patient” on population-level, not on the level of the individual.

What does this more specifically entail? On the one hand, Ekeland addresses “drug-treatment” and then contrasts between “population-level” and “clinical practice” on the other. It seems that what Ekeland has in mind when referring to “drug treatment”, is recommendations for public health interventions (e.g., vaccination programs), where the intervention is provided to a group as a whole (cf. Frohlich 2014). Thus, Ekeland seems to imply that epidemiologic research knowledge is useful only within clinical practices that

136 It is not entirely clear what Ekeland means by “less problematical in drug treatment” [medikamentell behandling] (ibid., 158). He states that “[i]t may be seemingly unproblematic to define baseline or criteria for “positive effect” in medical treatment […]” (cf. ibid., 147; italics mine), which seems like a heavily qualified claim concerning whether or not attention to “what works” is considered useful. Presumably, Ekeland implies that it seems unproblematic only at the outset. As I will discuss immediately in the following, Ekeland argues that the relevance of knowledge about “what works” (i.e., on basis of population-based data on average effect of clinical interventions) is limited to population-level exclusively.