Methodology
PROBE
Patient Reported Outcome Based Evaluation
Patients Direct system, PROBE is used to obtain naturalistic patient data. It consists of a web-based system supplemented by telephone reporting. The web-based method requires patients to log on to a secure website and give electronic consent to participate before proceeding to answer a series of questionnaires at baseline. While one-off surveys are a useful way to gather data, maximum value will usually be achieved by longitudinal data collection at more than one time point.
The online layout is easy to navigate, uses simple screen designs, and efficiently moves through the bespoke questionnaires, thus reducing patient response times. By allowing quality control checks to be programmed in at the point of entry, data quality is improved by giving alerts against an inconsistent entry.
The telephone system allows a more representative population to be obtained by including patients not having internet access or who prefer this method. It improves data quality with trained personnel (clinical trial nurses) based at Patients Direct entering data and by dealing with any queries arising during web-based completion.
Each of our projects is specifically designed for each client, so that the data builds into a “Prospective patient registry”.
Recruitment - Patient recruitment is tailored to attract patients of interest with a conscious effort to reduce bias and population selection issues. Core recruitment methods include social networking sites, search engine and website optimisation, healthcare professionals, pharmacists, wholesalers, distributors, marketing authorisation holders, patient groups, public affairs articles and traditional methods of publicity. Special focus can be given to groups of interest such as children if appropriate and recruitment monitored to ensure sufficient numbers in each cohort. This is important so that the observed number of events of specific interest is sufficient and consistent with that of previous literature for example if the incidence of adverse events of specific interest is thought to be low.
