Title |
Outcome based subgroup analysis: a neglected concern
|
---|---|
Published in |
Trials, May 2009
|
DOI | 10.1186/1745-6215-10-33 |
Pubmed ID | |
Authors |
Karim F Hirji, Morten W Fagerland |
Abstract |
A subgroup of clinical trial subjects identified by baseline characteristics is a proper subgroup while a subgroup determined by post randomization events or measures is an improper subgroup. Both types of subgroups are often analyzed in clinical trial papers. Yet, the extensive scrutiny of subgroup analyses has almost exclusively attended to the former. The analysis of improper subgroups thereby not only flourishes in numerous disguised ways but also does so without a corresponding awareness of its pitfalls. Comparisons of the grade of angina in a heart disease trial, for example, usually include only the survivors. This paper highlights some of the distinct ways in which outcome based subgroup analysis occurs, describes the hazards associated with it, and proposes a simple alternative approach to counter its analytic bias. |
X Demographics
Geographical breakdown
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Unknown | 2 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 2 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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United States | 1 | 2% |
Unknown | 58 | 98% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Master | 15 | 25% |
Researcher | 11 | 19% |
Student > Ph. D. Student | 6 | 10% |
Professor | 5 | 8% |
Student > Bachelor | 3 | 5% |
Other | 6 | 10% |
Unknown | 13 | 22% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 21 | 36% |
Agricultural and Biological Sciences | 6 | 10% |
Mathematics | 6 | 10% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 3% |
Psychology | 2 | 3% |
Other | 8 | 14% |
Unknown | 14 | 24% |