ABSTRACT: BACKGROUND:Cervical cancer screening will inevitably lead to unintentional harmful effects e.g. detection of indolent pathological conditions defined as overdetection or overdiagnosis. Overdiagnosis often leads to overutilisation, overtreatment, labelling and thereby negative psychosocial consequences. There is a lack of adequate psychosocial measures when it comes to measurement of the harms of medical screening. However, the Consequences of Screening questionnaire (COS) has been found relevant and comprehensive with adequate psychometric properties in breast and lung cancer screening. Therefore, the aim of the present study was to extend the Consequences of Screening Questionnaire for use in cervical cancer screening by testing for content coverage, dimensionality, and reliability. METHODS:In interviews, the suitability, content coverage, and relevance of the COS were tested on participants in cervical screening. The results were thematically analysed to identify the key consequences of abnormal screening results. Item Response Theory and Classical Test Theory were used to analyse data. Dimensionality, invariance, and reliability were established by item analysis, examining the fit between item responses and Rasch models. RESULTS:All COS items were found relevant by the interviewees and the ten COS constructs were confirmed each to be unidimensional in the Rasch models. Ten new themes specifically relevant for participants having abnormal cervical screening result were extracted from the interviews: 'Uncertainty about the screening result', 'Uncertainty about future pregnancy', 'Change in body perception', 'Change in perception of own age', 'Guilt', 'Fear and powerlessness', 'Negative experiences from the pelvic examination', 'Negative experiences from the examination', 'Emotional reactions' and 'Sexuality' Altogether, 50 new items were generated: 10 were single items. Most of the remaining 40 items were confirmed to fit Rasch models measuring ten different constructs. However, the two items in the scale 'Change in perception of own age' both possessed differential item functioning in relation to time, which can bias longitudinal repeated measurement. CONCLUSIONS:The reliability and the dimensionality of a condition-specific measure with high content validity for women having an abnormal cervical cancer screening results have been demonstrated. This new questionnaire called Consequences Of Screening in Cervical Cancer (COS-CC) covers in two parts the psychosocial experience in cervical cancer screening.
