Sharp, L., Cotton, S., Gray, N., Avis, M., Russell, I., Walker, L., . . . TOMBOLA Group. (2011). Long-term psychosocial impact of alternative management policies in women with low-grade abnormal cervical cytology referred for colposcopy: A randomised controlled trial. British Journal of Cancer, 104, 255-264. 

To compare the psychosocial outcomes of two different approaches for management of women undergoing colposcopy: immediate large loop excision versus punch biopsies with recall

In a larger study, women had been randomly assigned to cytological surveillance or colposcopy for low-grade abnormal cervical cytology. Women having colposcopy then were randomly assigned to either immediate large loop excision or to a group having punch biopsies and selective recall. Assessments were done at baseline, at six weeks post-procedure, and at 12,18, 24, and 30 months.

• N (sample size) = 966 completed six-week assessments, and 594 completed 30-month assessments.
• AGE: Mean and range were not provided. All patients were younger than 60 years; 71.6% were younger than 40 years.
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: 37.6% were high risk based on initial cytology.
• OTHER KEY SAMPLE CHARACTERISTICS: 76.6% were employed full- or part-time.

• SITE: Mutli-site   
• SETTING TYPE: Outpatient
• LOCATION: United Kingdom

PHASE OF CARE: Diagnostic

Randomized controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• Profile of Mood States (POMS) 
• Spielberger State Trait Anxiety Inventory

There were no differences between groups in prevalence of significant depression at any study time-point. In all patients, the median POMS score fell significantly from recruitment to 12 months (p < .001) and remained stable thereafter. There were no significant differences in average scores at any time-point. In all patients, anxiety fell significantly from baseline to six weeks post-procedure (p < .001) and remained stable thereafter. There were no significant differences between groups at any time point in the study.

There were no differences in symptoms of anxiety and depression based on the type of management examined here for women undergoing colposcopy. In all patients, anxiety and depression declined significantly shortly after the procedure and then remained stable over the next 24 months. However, the prevalence of significant depression (HADS depression subscale ≥ 8 ) increased from 6% precolcoscopy to 9.6% at 30 months.

• No subgroup analysis was performed based upon whether or not patient had clinically relevant anxiety or depression at baseline.
• No information is provided regarding use of medications or any other interventions aimed at these symptoms.
• The study fails to take into consideration the many variables that can impact changes in anxiety and depression symptoms over time.

Findings suggest that the specific approach to management with colposcopy does not significantly impact anxiety and depression in women with low-risk abnormal cervical cytology. The timing of depression increase seen here might suggest that extended follow-up after colposcopy and treatment may be associated with depression for some women. Which of the strategies examined here offers the best balance between benefits and harms is a matter of continuing debate.