Premium
Evaluating the Safety of Interventions for Prevention of Perinatal Transmission of HIV
Author(s) -
FLEMING THOMAS R.
Publication year - 2000
Publication title -
annals of the new york academy of sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.712
H-Index - 248
eISSN - 1749-6632
pISSN - 0077-8923
DOI - 10.1111/j.1749-6632.2000.tb05490.x
Subject(s) - psychological intervention , medicine , human immunodeficiency virus (hiv) , clinical trial , intensive care medicine , transmission (telecommunications) , randomized controlled trial , adverse effect , risk analysis (engineering) , medical physics , medical emergency , computer science , family medicine , surgery , pathology , nursing , telecommunications
A bstract : Efficient approaches are needed for obtaining reliable insights into the safety, in developing and developed country settings, of interventions for prevention of mother‐to‐child transmission (MCT) of HIV. A randomized trial designed with an appropriate sample size and adequate duration of follow‐up provides a powerful tool for obtaining causal evidence regarding the safety and efficacy of MTC prevention interventions. Such trials are ideal for detecting adverse effects (AEs) that occur in the short or moderate term and with moderate to high frequency. Passive and active surveillance procedures, where practical, can provide valuable insights regarding long‐term or rare AEs. Ideally, surveillance procedures should be carefully planned sufficiently early to allow prospective definition and uniform collection of important classes of AEs, enhancing the sensitivity and specificity of these surveillance data.