Search

Your search keyword '"Evans, Stephen Jw"' showing total 2 results
Start Over Author "Evans, Stephen Jw" Topic research design
2 results on '"Evans, Stephen Jw"'

1. Design choices for observational studies of the effect of exposure on disease incidence.

Author

Gail MH, Altman DG, Cadarette SM, Collins G, Evans SJ, Sekula P, Williamson E, and Woodward M

Subjects
Case-Control Studies, Cohort Studies, Disease, Humans, Incidence, Risk, Observational Studies as Topic methods, Research Design
Abstract

The purpose of this paper is to help readers choose an appropriate observational study design for measuring an association between an exposure and disease incidence. We discuss cohort studies, sub-samples from cohorts (case-cohort and nested case-control designs), and population-based or hospital-based case-control studies. Appropriate study design is the foundation of a scientifically valid observational study. Mistakes in design are often irremediable. Key steps are understanding the scientific aims of the study and what is required to achieve them. Some designs will not yield the information required to realise the aims. The choice of design also depends on the availability of source populations and resources. Choosing an appropriate design requires balancing the pros and cons of various designs in view of study aims and practical constraints. We compare various cohort and case-control designs to estimate the effect of an exposure on disease incidence and mention how certain design features can reduce threats to study validity., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2019
Full Text
View/download PDF

2. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement

Author

Piaggio, Gilda, Elbourne, Diana R, Altman, Douglas G, Pocock, Stuart J, Evans, Stephen JW, and CONSORT Group

Subjects
Publishing, Quality Control, Therapeutic Equivalency, Research Design, General Medicine, Letters to the Editor, Randomized Controlled Trials as Topic
Abstract

The CONSORT (Consolidated Standards of Reporting Trials) Statement, including a checklist and a flow diagram, was developed to help authors improve their reporting of randomized controlled trials. Its primary focus was on individually randomized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another but is now being extended to other trial designs. Noninferiority and equivalence trials have methodological features that differ from superiority trials and present particular difficulties in design, conduct, analysis, and interpretation. Although the rationale for such trials occurs frequently, those designed and described specifically as noninferiority or equivalence trials appear less commonly in the medical literature. The quality of reporting of those that are published is often inadequate. In this article, we present an adapted CONSORT checklist for reporting noninferiority and equivalence trials and provide illustrative examples and explanations for those items amended from the original CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the validity of their results and conclusions.

Published
2016

Catalog

Books, media, physical & digital resources
See catalog results