The needs of clinicians predominate throughout the text, but these needs overlap with those of researchers especially in chapters covering randomized controlled trials. For readers to assess trials accurately they need to understand relevant guidelines on the conduct of trials that are emerging from methodological research. In presenting these discussions to clinicians these chapters will help researchers who also do randomized trials and provide a methodological background that enhances the quality and quantity of their research productivity.
Enables clinicians to read the medical literature more critically
Chapters cover: descriptive studies, cohort studies, case control studies, bias, and screening tests
Five chapters dedicated to randomized controlled trials
An overview of clinical research: the lay of the land. Descriptive studies: what they can and cannot do. Bias and causal associations in observational research. Cohort studies: marching towards outcome. Case-control studies: research in reverse. Generation of allocation sequences in randomized trials: chance, not choice. Allocation concealment in randomized trials: defending against deciphering. Sample size slippages in randomized trials: exclusions and the lost and wayward. Blinding in randomized trials: hiding who got what. Uses and abuses of screening tests. Unequal group sizes in randomized trials: guarding against guessing. Sample size calculations in randomized trials: mandatory and mystical. Compared to what? Finding controls for case-control studies. Refining clinical diagnosis with likelihood ratios. Multiplicity in randomized trials I: endpoints and treatments. Multiplicity in randomized trials II: subgroup and interim analyses.
By Kenneth Schulz, PhD, MBA, Vice President of Quantitative Sciences, Family Health International, Research Triangle Park, North Carolina, and Clinical Professor, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, North Carolina, USA; and David A. Grimes, MD, Vice President of Biomedical Affairs, Family Health International, Research Triangle Park, North Carolina, and Clinical Professor, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA