PubMed Health⌕ Search

Biomedical subjects

J Verter

Publications and source records attributed to J Verter.

40 records · Page 3Linked to original sources

Sickle cell anaemia trial.

The major cause of death in sickle cell anaemia is from infection, especially infection caused by Streptococcus pneumoniae. Meningitis, pneumonia and septicaemia caused by this organism are the primary types of infection leading to death. Children under three years of age are at highest risk. We have known for over twenty years that approximately 30 per cent of the infants born with sickle cell anaemia will become infected in the first three years of life and one-third can be expected to die from the infection. These data were the reason that we conducted the Prophylactic Penicillin Study (PROPS), a trial to investigate the effectiveness of oral prophylactic penicillin in preventing severe infection due to S. pneumoniae. This investigation was a very efficient, cost effective study because of its timeliness and its conduct within the framework of an ongoing study. Moreover, the question being answered was simple and focused with up-to-date data that permitted accurate estimates of sample size and incidence.

Anemia, Sickle Cell↗

How much data should we collect in a randomized clinical trial?

Multicentre randomized controlled clinical trials are usually designed to answer a specific question. In accomplishing this they often collect a large quantity of data during screening, baseline and follow-up visits. These data are not all necessarily related to the main study question. This collection impacts on the overall recruitment process and the participants' time. During the planning phase of the trial we need to consider the reasons for collecting data and the use of that data for the current study as well as its potential use in future investigations. We discuss briefly some of the possible reasons that data may be collected: screening or determining eligibility; conducting a run-in or dose titration phase; assessing group comparability; aiding patient management; evaluating the natural history of the disease; monitoring the study; testing the study hypotheses; evaluating adherence; estimating side effects and the use of other therapies; analysis of other study questions.

Data Collection↗