Thesis Outline 2

#EBM: Evolution, revolution or illusion

April 08 (a clean up of the old page: Thesis Outline )

- Informal abstract: A philosophical framework for EBM is yet to be provided. Worse. Piecing together what has been put forward as a justification for EBM (and its hierarchy) is inconsistent. I aim (i) to show that the framework provided by EBM proponents is inconsistent and (ii) provide a defensible philosophical framework for EBM (iii) show that the defensible framework provided in (ii) can’t do half of the things EBM proponents have suggested EBM can do; with special emphasis on the fact that it does NOT do well in informing therapeutic decisions (the very aim of EBM).

Colour guide: {[blue Blue is substantially complete (at least in draft, `paper’ form) ]} {[red Red is not touched ]}

[[red Introduction (Things That Need To Be In The Introduction) Lay out the approach, and the main problems I will address. Main problems to be addressed: (i) there is currently no defensible interpretation of the hierarchy; (ii) the intractable problems that exist for EBM if theory ( I E. basic science) is ignored and (iii) the dilemma of external validity. These are all interlinked. The intro will aim to tell this in a nice story. ]]

#Section 1 What is EBM?

[[blue Chapter 1: EBM can’t be (8,000) There is not an unambiguous interpretation of EBM provided in the clinical literature. As much as an interpretation is provided, however, proponents suggest a categorical interpretation. The categorical interpretation holds that all the results of randomised trials always trumps evidence from lower down the hierarchy when it comes to informing therapeutic decisions. I show that this interpretation can not hold. ]]

[[blue Chapter 2: EBM must be (10,000) This chapter explores the arguments that have been provided in the clinical literature. Consistent with other philosophical treatments it shows that the justifications provided in the clinical literature do not justify the ambitious claims made by EBM on behalf of the hierarchy. Given this finding, I change tack. I ask what claims are substantiated by the arguments provided in the clinical literature. In particular, I focus on the argument that EBM’s hierarchy can be defended by viewing it has a hierarchy of internal validity. I show that if the hierarchy is interpreted in this way the claims of EBM need to be limited to: therapeutic decisions, primary hypothesis tests and internal validity. This approach highlights the additional questions that need to be addressed before clinical research can inform therapeutic questions. ]]

[[blue Chapter 3: Why randomise (8,000) Here I look at more depth at a justification for randomisation in clinical trials. In particular, I argue against Worrall’s claim that providing the groups are adequately matched according to background knowledge, there is no epistemic distinction between randomised and non-randomised studies. ]]

[[blue Chapter 4: Therapeutic decisions, EBM, and the dilemma of external validity (7000) I introduce the challenge of external validity for EBM. I show that informing therapeutic questions are invariably questions of external validity. I highlight the intractable problem for EBM if the knowledge of the basic sciences is ignored. The `subgroup’ debate is introduced. I return to this debate after discussing the statistical inference in EBM. ]]

#Section 2: Statistical Inference in EBM

[[red Chapter 5: General Principles Approaches to statistical inference in clinical trials are introduced. In particular, Neyman Pearson theory, its benefits and counter-arguments. Suppes models of data' are introduced to provide the basis of a reply to theintractable problem of ignoring the basis sciences’. ]]

[[blue Chapter 6: The Rofecoxib Case (8-10,000) Rofecoxib is introduced as a case to highlight the challenges of forming inferences in clinical trials. Especially with regard to secondary endpoints, and subgroup analyses. ]]

#Section 3: A philosophical framework for EBM

[[red Chapter 7: Approaching the challenge of external validity The threads of the discussion are brought together to show how the interpretation of EBM provided in chapter 2, and the statistical framework adopted in section 3, provide an approach to informing therapeutic questions on the basis of data from clinical trials. ]]

[[red Chapter 8: Conclusion Sum up. ]]