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Essential guide for all those involved in the planning, conduct and interpretation of clinical research.
Edited by Anthony Keech, Val Gebski and Rhana Pike of the NHMRC Clinical Trials Centre in Sydney, this book explains and expands upon each of the items in the CONSORT checklist to elucidate how best to undertake and learn from clinical trials.
• Randomised controlled trials: elements of a good study
• Introducing the report of a randomised controlled trial: the title, abstract, scientific background and rationale
• Selecting participants for clinical trials
• Specifying interventions in a clinical trial
• Specifying objectives and outcomes for clinical trials
• Determining the sample size in a clinical trial
• Managing the resource demands of a large sample size in clinical trials: can you succeed with fewer subjects?
• Randomisation in clinical trials
• Allocation concealment and blinding: when ignorance is bliss
• Statistical methods in clinical trials
• Flow of participants in randomised studies
• Recruitment to randomised studies
• Baseline data in clinical trials
• Inclusion of patients in clinical trial analysis: the intention-to-treat principle
• Making sense of trial results: outcomes and estimation
• Subgroup analysis in clinical trials
• Applying subgroup analysis to individual patient decisions
• Multiple analyses in clinical trials: sound science or data dredging?
• Balancing the outcomes: reporting harms (adverse events)
• Interpreting the results of a clinical trial
• Generalising the results of trials to clinical practice
• Putting results of a clinical trial into perspective