Psychosocial and economic aspects of a trial of management of mild and borderline cervical abnormalities (TOMBOLA).
TOMBOLA is a randomized controlled trial to determine (a) the most effective and efficient management strategy for women with borderline or mildly dyskaryotic cervical smear results, and (b) the most appropriate treatment for women with abnormalities detected following colposcopy. This paper outlines the trial's psychosocial and economic protocol, and explains how TOMBOLA can provide detailed evidence on the psychosocial and economic impact of alternative management options and follow-up. This protocol has been developed in parallel with the clinical protocol, thereby offering the opportunity for the development of a type-specific outcome measure and detailed piloting of all instruments. The multi-disciplinary approach to TOMBOLA allows the combination of clinical outcomes with both generic and specific psychosocial and health-related quality of life measures. The convergent validity between these measures will be assessed, with a view to developing a specific utility index for the future assessment of cervical screening modalities.
Philips
Zoe
Z
Centre for Health Economics, University of York.
Gray
Nicola
N
Avis
Mark
M
Whynes
David K
DK