C12

A methodology for the evaluation of patient satisfaction by an Early Phase Cancer Clinical Trials Unit

Teresa Lockett

University of Oxford, UK

Background

The Early Phase Clinical Trials Unit has been audited several times in recent years by the Medicines and Healthcare Products Regulatory Authority, pharmaceutical partners and the host Trust, in order to determine whether the trials within the unit are being conducted according to ICH GCP (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice) guidelines and UK legislation. It was noted that whilst the Unit had been audited externally, there had been no internal audit to look at whether the service was meeting the needs of the patients.

Method

The clinical trials service offered to patients covers many areas including recruitment of patients, giving information, informed consent, organisation of appointments and ordering of treatments.

In order to decide the potential areas of concern a quality impact analysis (QIA) was done. This involved scoping the role of the research nurse and scoring the different aspects of the role within a matrix. The headings under which the scoring took place were; frequency, risk and concern. Each aspect of the research nurse role was put into one of the three categories and then scored according to the same three categories i.e booking appointments is a frequent aspect of the role and scored a total of six whereas having a private area for consultation is an aspect of the role for concern and this scored a nine in the QIA. From this matrix the ten highest scoring areas would be included in a patient satisfaction questionnaire.

Conclusion

The QIA was successful in providing a basis for the development of a patient satisfaction survey. Evidence of how the survey tool was designed using the QIA will be presented.