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Iain K. Crombie
Evidence in Medicine
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Evidence in Medicine The Common Flaws, Why They Occur and How to Prevent Them
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CHAPTER 1 The Rationale for Treatment: A Brief History
THEORY AS JUSTIFICATION FOR TREATMENT
TESTING ON A SERIES OF PATIENTS
COMPARING GROUPS
COMPARING SIMILAR GROUPS
CASTING LOTS AND TREATMENT ALLOCATION
RANDOM NUMBERS FOR TREATMENT ALLOCATION
THE NEED FOR BLINDING
CONCLUSION
REFERENCES
CHAPTER 2 Sources of Bias in Randomised Controlled Trials
METHOD OF TREATMENT ALLOCATION
Generation of the Random Assignment
Importance of Concealed Allocation
Evidence that the Randomisation Process Is Subverted
Does Integrity of Allocation Concealment Matter?
PROBLEMS IN MEASURING THE OUTCOME
Switching Primary Outcomes
Blinding of Outcome Assessment
Reporting of Adverse Events
FOLLOW‐UP AND MISSING OUTCOMES
Extent of Loss to Follow‐up
Characteristics of Patients Lost
Bias from Loss to Follow‐up
MISSING OUTCOME DATA AND INTENTION TO TREAT
Methods of Imputation
Modified Intention to Treat
OTHER METHODOLOGICAL CONCERNS Unregistered Trials and Bias
Small Studies
Low Power
Industry‐Funded Trials
CONCLUSIONS
REFERENCES
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