Long-term psychosocial impact of alternative management policies in women with low-grade abnormal cervical cytology referred for colposcopy: a randomised controlled trial

Abstract

Background: The debate continues regarding the best management for women with low-grade abnormal cervical cytology attending colposcopy. We compared psychosocial outcomes of alternative management policies in these women.

Methods: In all, 989 women, aged 20-59 years, with low-grade abnormal cytology, were randomised to immediate large loop excision (LLETZ) or two to four targeted punch biopsies taken immediately with recall for LLETZ if these showed cervical intra-epithelial neoplasia 2/3. At 6 weeks after the last procedure, women completed the hospital anxiety and depression scale (HADS) and the impact of event scale (IES). At 12, 18, 24 and 30 months post recruitment, women completed the HADS and process outcome specific measure (POSM). Prevalence of significant depression (≥ 8), significant anxiety (≥ 11) and distress (≥ 9) and median POSM scores were compared between arms. Multivariate odds ratios (ORs) for immediate LLETZ vs biopsy and recall were computed.

Results: Over the entire follow-up, there was no significant difference between arms in cumulative prevalence or risk of significant depression (OR=0.78, 95% CI 0.52-1.17) or significant anxiety (OR=0.83, 95% CI 0.57-1.19). At 6 weeks post procedure, distress did not differ significantly between arms. At later time points, 8-11% had significant depression and 14-16% had significant anxiety but with no differences between arms. The POSM scores did not differ between the arms.

Conclusions: There is no difference in long- or short-term psychosocial outcomes of immediate LLETZ and punch biopsies with selective recall.

Figure 1

Timing of events and psychosocial assessments, and instruments included. EPQ, Eysenck personality questionnaire; HADS, hospital anxiety and depression scale; IES, impact of event scale; MHLCS, multi-dimensional health locus of control scale; POSM, process outcome specific measure, STAI, Spielberger state–trait anxiety inventory. ¹At 6 weeks after colposcopy, punch biopsy(ies) or LLETZ, whichever took place last. For women with a normal transformation zone at colposcopy, those who had immediate loop excision, and those who had punch biopsies which showed CIN0/1, this was 6 weeks after the initial (and only) colposcopy; for those women who had punch biopsies which showed CIN2/3 and were recalled for LLETZ, this was 6 weeks after the treatment appointment. ²All administered at colposcopy appointment, before examination and randomisation.

Figure 2

Numbers of women randomised and included in the psychosocial (PS) comparison.

Figure 3

Prevalence of significant depression (HADS depression sub-scale score of ⩾8), with odds ratios (ORs), 95% confidence intervals (CIs), and P-values, by randomisation arm. ¹Significant depression at any of the outcome assessment points, A3–A7. ²Adjusted for randomisation minimisation variables (age group, trial centre, high-risk HPV status and recruitment cytology status). ³Adjusted for minimisation variables, and the following: 6 weeks, ever had children, HADS depression pre-colposcopy, HADS anxiety pre-colposcopy, EPQ neuroticism, MHLCS chance; 12-months, ever had children, HADS depression pre-colposcopy, HADS anxiety pre-colposcopy, EPQ neuroticism; 18 months, HADS depression pre-colposcopy, EPQ neuroticism smoking status; 24-months, ever had children, HADS depression pre-colposcopy, HADS anxiety pre-colposcopy, EPQ neuroticism; 30 months, HADS depression pre-colposcopy, HADS anxiety pre-colposcopy, smoking status; cumulative, HADS anxiety pre-colposcopy, HADS depression pre-colposcopy, EPQ neuroticism, smoking status, ever had children, ethnic group, employment status. ⁴Likelihood ratio test P-value for randomisation arm, from multivariate model.

Figure 4

Prevalence of significant anxiety (HADS depression sub-scale score of ⩾11), with odds ratios (ORs), 95% confidence intervals (CIs), and P-values, by randomisation arm. ¹Significant anxiety at any of the outcome assessment points, A3–A7. ²Adjusted for randomisation minimisation variables (age group, trial centre, high-risk HPV status and recruitment cytology status). ³Adjusted for minimisation variables, and the following: 6 weeks, ever had children, HADS anxiety pre-colposcopy, EPQ neuroticism, MHLCS chance; 12-months, ever had children, deprivation category, HADS depression pre-colposcopy, HADS anxiety pre-colposcopy, STAI pre-colposcopy, EPQ neuroticism; 18 months, HADS anxiety pre-colposcopy, HADS depression pre-colposcopy, STAI pre-colposcopy, EPQ neuroticism; 24-months, smoking status, HADS depression pre-colposcopy, HADS anxiety pre-colposcopy, STAI pre-colposcopy, EPQ neuroticism; 30 months, ever had children, HADS anxiety pre-colposcopy, EPQ neuroticism, MHLCS chance; cumulative, HADS anxiety pre-colposcopy, HADS depression pre-colposcopy, EPQ neuroticism, ever had children, employment status. ⁴Likelihood ratio test P-value for randomisation arm, from multivariate model.

Figure 5

The POSM median scores, with P-values, by randomisation arm. IQR, interquartile range.