Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia

Cumulative Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by the community pathologists during the two years of follow-up. The first community-based CIN2+ diagnosis was adjudicated to the participant (including the exit visit if none community-based CIN2+ during the two years of follow-up). This outcome is used for the effectiveness analysis of the three strategies.

Time frame: Two years since the enrolment to the exit visit (inclusive)

Population: Cumulative cases of CIN2+ diagnosed by the community pathologists from the healthcare institutions according to arm

This outcome was measured using the HPV Impact Profile (HIP) scale through the following five domains: concerns about cancer and loss of fertility; emotional impact (depression and anxiety); self-image; interaction with the medical staff (pain or discomfort during the visit); and impact upon the life and its control. The response to each domain was measured on a scale from 0 to 10 (0=not at all, 1-3=a little, 4-6=somewhat, 7-9=a great deal, 10=extremely) and was then transformed to a scale from 0 to 100. A total score was calculated by adding all the items. Values \<40 indicate no or little impact, between 40 and 70 moderate impact, and \>70 indicate high psychosocial impact. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.

Time frame: Two years between the enrolment and the exit visit

Population: This is a nested analysis that included 394 subjects of the ASCUS-COL trial (142 in COLPOSCOPY, 103 in CYTOLOGY, and 149 HPV) who accepted to participate and completed the follow-up of three measurements over time.

Cumulative Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by a panel of external experts obtained after histological review of biopsies emitted by the community pathologists. Biopsies obtained during the two years of follow-up and the exit visit were reviewed by a panel of two external experts and a final result was adjudicated to each participant based on the panel of experts and the community of pathologists. This outcome is used for the effectiveness analysis of the three strategies.

Time frame: Two years since the enrolment to the exit visit (inclusive)

Population: Cumulative cases of CIN2+ diagnosed by a panel of external expert pathologists according to arm

The outcome is defined as the number of cytologies, colposcopies, and histologies routinely performed during the two years of follow-up. Records were identified in databases or manually searched from clinical records. This outcome will be used for the analysis of the efficiency of the three strategies.

Time frame: Two years since the enrolment to before the exit visit (i.e., excluding clinical records collected at the exit visit)

Population: Utilization of cytology, colposcopy and histology during the routine follow-up of women with ASC-US cytology stratified by arm

Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by a panel of external experts after reviewing biopsies collected at the exit visit, two years after the enrolment. This outcome is an estimate of the remaining disease that was not detected by the strategies during the 2 years of follow-up. The outcome was obtained after the review of all the biopsies taken during the exit visit. Biopsies were taken using a standardized research protocol to ensure the completeness of the remaining disease. Basically, all women attending the exit visit were tested with HPV testing and Pap and referred to colposcopy if any HPV positive or abnormal cytology. The colposcopy was performed by a researcher of the study team who took up to two biopsies from the observed lesion plus one or two at random if none lesion was observed. All biopsies were reviewed by the external panel. This outcome is used for the efficiency analysis of the three strategies.

Time frame: Exit visit (two years after the enrolment)

Population: Exit-reviewed CIN2+ detected at the exit visit (2 years after the enrolment) of women with ASC-US cytology stratified by arm

Self-esteem corresponds to the self-assessment of a positive or negative evaluation toward oneself. This outcome was measured using the Rosenberg Scale through 10 Likert-type questions with scores varying between 1 and 4 (1=strongly agree, 2=agree, 3=disagree, 4=strongly disagree). Total values range between 10 and 40 where lower scores suggest lower self-esteem. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.

Time frame: Two years between the enrolment and the exit visit

Population: This is a nested analysis that included 394 subjects of the ASCUS-COL trial (142 in COLPOSCOPY, 103 in CYTOLOGY, and 149 HPV) who accepted to participate and completed the follow-up of three measurements over time.

State anxiety refers to the transitory tendency to experience negative emotions (such as fears, worries, and anxiety). This outcome was measured using the Spielberger State-Trait-Anxiety Inventory (STAI) through 20 Likert-type questions with scores varying between 0 and 3 (0=not at all, 1=somewhat, 2=moderately, 3=very much). Total values range between 0 and 60 where higher scores suggest higher levels of anxiety. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.

Time frame: Two years between the enrolment and the exit visit

Population: This is a nested analysis that included 394 subjects of the ASCUS-COL trial (142 in COLPOSCOPY, 103 in CYTOLOGY, and 149 HPV) who accepted to participate and completed the follow-up of three measurements over time.

Trait anxiety refers to the sustainable tendency to experience negative emotions (such as fears, worries, and anxiety) in various situations. This outcome was measured using the Spielberger State-Trait-Anxiety Inventory (STAI) through 20 Likert-type questions with scores varying between 0 and 3 (0=not at all, 1=somewhat, 2=moderately, 3=very much). Total values range between 0 and 60 where higher scores suggest higher levels of anxiety. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.

Time frame: Two years between the enrolment and the exit visit

Population: This is a nested analysis that included 394 subjects of the ASCUS-COL trial (142 in COLPOSCOPY, 103 in CYTOLOGY, and 149 HPV) who accepted to participate and completed the follow-up of three measurements over time.