Electronic diary studies

Electronic Diary Cards are portable, hand-held systems designed to be programmed according to specific protocol requirements and are used by patients to record directly information on their condition and medication consumption during a particular study. They should be specified and designed so that they are highly prescriptive since they are used in a relatively uncontrolled environment (e.g., subject s home). Specific considerations for the validation of electronic diary cards are ... 

Although superficially attractive, there has not been the widespread take up of technology that many have predicted for the past 15 years. The use of electronic data capture (EDC) remains in its infancy. There are many suppliers, and most companies have conducted studies with EDC. However, the difficulties in training investigators and ensuring consistent technological support 24 hours a day, 365 days a year, in many different countries remain formidable. Ss internet access improves, electronic diaries may become more widely use for some particular types of studies, such as asthma and diabetes, where patients are accustomed to keeping diaries in any event. 

Contributions concerning psychological data, that is, the acquisition of behavioral measures, behavior ratings, and self-report data in the natural environment have been made in the literature on behavior assessment (cf de Vries, 1992 Nelson Hayes, 1986 Suen Aiy, 1989). The scope, however, is mostly clinical and new techniques, such as electronic diaries and physical activity monitoring, have been rarely employed in this context. Therefore, the development of computer-assisted methods suitable for ambulatory assessment studies are reviewed here in greater depth. 

Obviously, if the clinical mirror approach to bioequivalency testing gains momentum, we may expect to see more quantification of clinical response in bioequivalency studies. In some instances pharmacodynamic parameters that are amenable to precise quantification are easily identified. Thus, if we are working with an antihypertensive drug, measurement of blood pressure using an electronic sphygnomanometer is an obvious option. However, for many drugs there is no simple way to quantify pharmacodynamic response. In some cases we may have to rely, to some extent at least, on patient diaries [41]. Such techniques are open to criticism of subjectivity and imprecision. 

---