| |
| |
| Acknowledgments | |
| |
| |
| Foreword | |
| |
| |
| Preface | |
| |
| |
| |
| Introduction | |
| |
| |
| |
| The philosophy of evidence-based medicine | |
| |
| |
| |
| What on earth was medicine based on before evidence-based medicine? | |
| |
| |
| |
| Scope of the book | |
| |
| |
| |
| How the claims of EBM will be examined | |
| |
| |
| |
| Structure of what is to come | |
| |
| |
| |
| What is EBM? | |
| |
| |
| |
| EBM as a self-proclaimed Kuhnian paradigm | |
| |
| |
| |
| The motivation for the birth of EBM: a sketch | |
| |
| |
| |
| Original definition of EBM | |
| |
| |
| |
| Reaction to criticism of the EBM system of evidence: more subtle, more or less the same | |
| |
| |
| |
| What is good evidence for a clinical decision? | |
| |
| |
| |
| Introduction | |
| |
| |
| |
| Evidence for clinical effectiveness | |
| |
| |
| |
| Strong evidence tells us what? | |
| |
| |
| |
| Do randomization, double masking, and placebo controls rule out more confounding factors than their alternatives? | |
| |
| |
| |
| Ruling out plausible rival hypotheses and confounding factors: a method | |
| |
| |
| |
| Resolving the paradox of effectiveness: when do observational studies offer the same degree of evidential support as randomized trials? | |
| |
| |
| |
| The paradox of effectiveness | |
| |
| |
| |
| Observational studies: definition and problems | |
| |
| |
| |
| Randomized trials to the rescue | |
| |
| |
| |
| Defending the EBM view that randomized trials provide better evidence than observational studies | |
| |
| |
| |
| Overcoming the paradox of effectiveness | |
| |
| |
| |
| Conclusion: a more subtle way to distinguish between high- and low-quality comparative clinical studies | |
| |
| |
| |
| types of restricted randomization | |
| |
| |
| |
| Worrall's arguments that randomization is required for classical hypothesis testing and establishing probabilistic causes | |
| |
| |
| |
| Questioning double blinding as a universal methodological virtue of clinical trials: resolving the Philip's paradox | |
| |
| |
| |
| The problems with double masking as a requirement for clinical trial validity | |
| |
| |
| |
| The many faces of double masking: clarifying the terminology | |
| |
| |
| |
| Confounders that arise from participant and caregiver knowledge | |
| |
| |
| |
| The importance of successful double masking | |
| |
| |
| |
| One (and a half) solutions to the Philip's paradox | |
| |
| |
| |
| The full solution to the Philip's paradox: challenging the view that double masking rules out confounding factors when treatments are evidently dramatic | |
| |
| |
| |
| Double masking is valuable unless the treatment effects are evidently dramatic, hence the Philip's paradox does not arise | |
| |
| |
| |
| Placebo controls: problematic and misleading baseline measures of effectiveness | |
| |
| |
| |
| The need to control the placebo | |
| |
| |
| |
| Legitimate placebo controls | |
| |
| |
| |
| How placebo controls often violate the first condition for legitimacy | |
| |
| |
| |
| How placebo controls often violate the second condition for legitimacy | |
| |
| |
| |
| Special problem for constructing placebos for complex treatments: case studies of exercise and acupuncture | |
| |
| |
| |
| Summary and solution to the problem with illegitimate placebo controls | |
| |
| |
| |
| Questioning the methodological superiority of "placebo" over "active" controlled trials | |
| |
| |
| |
| Epistemological foundations of the ethical debate over the use of placebo-controlled trials | |
| |
| |
| |
| Problems with the assay sensitivity arguments against ACTs | |
| |
| |
| |
| Problems with the first assay sensitivity argument against ACTs | |
| |
| |
| |
| The second assay sensitivity argument | |
| |
| |
| |
| Challenging the view that PCTs provide a measure of absolute effect size | |
| |
| |
| |
| Questioning the claim that PCTs require smaller sample sizes | |
| |
| |
| |
| Conclusion: a reassessment of the relative methodological quality of PCTs | |
| |
| |
| Appendix: more detailed explanation of why the second assay sensitivity argument fails | |
| |
| |
| |
| Examining the paradox that traditional roles for mechanistic reasoning and expert judgment have been up-ended by EBM | |
| |
| |
| |
| Transition to Part III | |
| |
| |
| |
| Summary of Part II | |
| |
| |
| |
| Introduction to Part III | |
| |
| |
| |
| A qualified defence of the EBM stance on mechanistic reasoning | |
| |
| |
| |
| A tension between proponents of mechanistic reasoning and EBM views | |
| |
| |
| |
| Clarifying the terminology: comparative clinical studies, mechanisms, and mechanistic reasoning | |
| |
| |
| |
| Why the strong view that mechanistic reasoning is necessary to establish causal claims is mistaken | |
| |
| |
| |
| Two epistemological problems with mechanistic reasoning | |
| |
| |
| |
| Why EBM proponents should allow a more prominent role for high-quality (valid and based on "complete" mechanisms) mechanistic reasoning in their evidence hierarchies | |
| |
| |
| |
| Mechanisms and other roles in clinical medicine | |
| |
| |
| |
| Recommending a (slightly) more important role for mechanistic reasoning in the EBM system | |
| |
| |
| Appendix: cases where mechanistic reasoning led to the adoption of therapies that were either useless or harmful according to well-conducted clinical research | |
| |
| |
| |
| Knowledge that versus knowledge how: situating the EBM position on expert clinical judgment | |
| |
| |
| |
| Controversies surrounding the EBM stance on expert clinical judgement | |
| |
| |
| |
| General clinical judgment belongs at the bottom of (or off) the hierarchy of evidence | |
| |
| |
| |
| Individual clinical judgment also belongs at the bottom of the hierarchy | |
| |
| |
| |
| The equally important non-evidential roles of expertise | |
| |
| |
| |
| Conclusion | |
| |
| |
| |
| Conclusions | |
| |
| |
| |
| Moving EBM forward | |
| |
| |
| |
| Summary of findings: the EBM philosophy is acceptable, but. . . | |
| |
| |
| |
| Two new frontiers for EBM | |
| |
| |
| References | |
| |
| |
| Index | |