Terms of Reference

Terms of Reference

Approved Name

Here the British approved name (BAN) or generic drug name will be used throughout the text.

Reference Style

These will be presented in Vancouver style with the convention of citing the first 3 authors before the use of 'et al'.

Duration of Toxicities

The following descriptions of duration have been used when describing toxicities :

Severity of Toxicity

This is denoted using the 'plus' system where

+	Mild
+ +	Moderate
+ + +	Severe
+ + + (+)	Potentially life threatening

The use of parentheses after a one, two or three plus toxicity shows that sources are contradictory, eg. + (+) would be mild to moderate.

Levels of Evidence

These are based on the AHCPR 1992 citation, with subsequent modifications.

Level	Type of Evidence
Ia	Evidence obtained from the meta-analysis of randomised controlled trials
Ib	Evidence obtained from at least one randomised controlled trial
IIa	Evidence obtained from one well-conducted non-randomised phase III study, or a randomised phase II study
IIb	Evidence obtained from a well-designed study where randomisation may not have been appropriate. The study should be appropriately powered and the design explained. Good qualitative data will be level IIb
IIIa	Evidence obtained from well-designed non-experimental studies such as comparative/ audit studies, correlational studies or case control studies
IIIb	Evidence obtained from series of case studies reported by a single investigator or institute
IV	Evidence obtained from expert committees or concensus statements
V	Evidence obtained from a single case report.

Fetal Risk Following Drug Exposure During Pregnancy

The National Extravasation Information Service has used the US food and drug administration catagories of risk as defined below -

Category A	Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester ( and there is no evidence of a risk in later trimesters), and the possibility of fetal harm appears remote.
Category B	Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters)
Category C	Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should only be given if the potential benefit justifies the potential risk to the fetus.
Category D	There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg. if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Category X	Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs and possible benefit. The drug is contraindicated in women who are or may become pregnant.

This page last updated 06/01/2004