Aptitude X treatment interactions: implications for patient education research.

Aptitude x treatment interaction (ATI) has been used only rarely in patient education research. This research paradigm incorporates individual differences (aptitudes) into experimental studies exploring differences in information strategies (treatments). ATI has great potential for applications to patient education research. It identifies patient characteristics and optimal instructional treatments, it is compatible with psychological theories and clinical approaches alike, and it offers a specific methodology for approaching existing problems in a new way. This article presents studies in which ATI has illuminated specific patient needs and treatments, and suggested further applications. Three studies (in addition to those reviewed) are examined in depth. One study determined general guidelines for designing instructional literature to accompany medication (drug package inserts), that would satisfy the requirements of a group of patients with varied reading ability. Another study examined the effect of patients' "prior knowledge" on their participation in a health education program. A third study explored the interaction between patients' view of self-control over their health and the use of different media for health-care instruction. Guidelines and considerations for conducting further ATI-based research are presented and discussed.

New indications for already-approved drugs: time trends for the new drug application review phase.

For 55 individual drugs, the time required for approval of the original new drug application (NDA) was compared with the time required for approval of supplemental NDAs. The mean time required for the original NDAs was 22.2 +/- 18.1 months; the mean for review of all 46 follow-on indications was similar (19.1 +/- 17.9 months). Since subsequent applications do not ordinarily require new assessment of clinical safety or animal toxicity studies, one would expect the subsequent applications to be processed more expeditiously. Such is not the case. The negative implications of these facts are discussed.