Study protocol training is one the highest impact factors to acquire quality medical imaging data in clinical trials. When a multi-year clinical trial receives data from many sites all over the globe, it is of paramount importance that the study protocol is followed closely so that when data is pooled at the end of the study, there is a minimum systematic error (variance) due to non-compliance of the protocol by the various sites. The concept of accuracy is probably of secondary importance to precision since in most clinical trials, it is the change of a measured parameter over a period of time that is the primary study outcome. Precision is the ability of a particular site to reliably make repeated measurements. This was discussed in greater detail in Chapter 12 of the book "Clinical Trials in Osteoporosis" by Springer, which I co-edited.
Several years ago, study protocol compliance for quality medical imaging was addressed initially by site training, usually by a physical visit by a trainer to each and every site. Occasionally site visits were not performed if the protocol was deemed to be more or less a standard of care procedure, and the imaging guidelines were simply sent to the site with the requirement that personnel involved with the data acquisition read it. Then on an ongoing basis, as data arrived at the imaging core lab, it was inspected and if there were issues, a Data Clarification Form (DCF) was generated and sent to the site for immediate resolution. The rate of issue of the DCF’s was an indication of how well the site training had been and how closely the protocol was being followed.
However, physical site visits are problematic from several viewpoints. First, they are a one-time occurrence and the individual being trained often is not involved in the study for the full duration, frequently several years. This necessitates additional training visits or reliance upon understanding of the training manual. Additionally, the cost of individual site visits can be prohibitively expensive and time-consuming for large multi-center studies.
CD and Web-Based Training Programs
Consequently, BioClinica introduced CD and web-based programs as viable alternatives to the site training visit in 2003. The primary objective was to create a media experience that added to the study imaging guidelines. The result was a 20-minute video that was easily understood, could be produced in the local language and assured compliance and understanding by the use of an included test, the results of which formed part of the site acceptance procedure. Although we investigated both CD and web-based presentations, we found that although the web format was attractive, in many countries around the world, many hospitals or clinics do not have or allow the clinical computers to be connected to the internet. However, the CD produced the same experience without the internet connection issue. As a result, we have focused on quality medical imaging training programs in a CD format. To date we have produced fully-narrated programs in over 20 languages which include a test to ensure understanding and the program is easily undertaken by site staff whenever there is a change. In fact, we have found that a 20 minute video is far MORE likely to be studied than a lengthy written manual and the test interaction provides immediate feedback.
One glowing example of this approach is the case where a client considered an x-ray procedure to be simple and straight forward, sufficiently so that site training was not requested and it was assumed that a paper manual would suffice. Unfortunately that decision resulted in a DCF rate of approximately 75%. This caused both a lack of precision and loss of time due to requests for repeat procedures. This directly translated into poor data and increased costs. BioClinica quickly produced a CD-based training program for this study with a test to ensure understanding of the material and requested that the sites have the appropriate personnel take the program. The result after sites completed the CD training was a 90% decrease in the DCF rate to less than 7%.
Today, BioClinica offers both CD and web-based training programs for clinical trials, available in multiple languages, with or without a test. This training format provides an excellent, cost-effective way to ensure protocol compliance while improving the precision of study data. This, in turn, either improves overall statistics and/or shortens the time required to detect significant change, thus reducing overall cost for sponsors.
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