Primary analysis by intention-to-treat: prevalence of worries at recruitment and during follow-up, overall and by management arm, with OR*, 95% CI and p values from likelihood ratio tests
| Type of worry | Recruitment | Follow-up | ||||
|---|---|---|---|---|---|---|
| 12 months | 18 months | 24 months | 30 months | Cumulative | ||
| T0 | T1 | T2 | T3 | T4 | T1–T4 | |
| Cervical cancer | ||||||
| Overall prevalence | 67.7 | 27.8 | 22.8 | 20.3 | 17.8 | 40.4 |
| By arm | ||||||
| Immediate loop excision | 67.8 | 27.0 | 22.2 | 18.8 | 16.3 | 38.6 |
| Punch biopsies & selective recall | 67.6 | 28.6 | 23.3 | 21.7 | 19.4 | 42.2 |
| OR†, 95% CI | – | 0.93 (0.69 to 1.25) | 0.92 (0.69 to 1.28) | 0.79 (0.56 to 1.13) | 0.78 (0.53 to 1.13) | 0.86 (0.67 to 1.10) |
| p Value | – | 0.634 | 0.632 | 0.199 | 0.190 | 0.232 |
| Sex | ||||||
| Overall prevalence | 27.9 | 14.1 | 12.7 | 11.6 | 11.7 | 25.7 |
| By arm | ||||||
| Immediate loop excision | 29.7 | 12.6 | 11.4 | 11.4 | 11.4 | 23.8 |
| Punch biopsies & selective recall | 26.1 | 15.7 | 14.0 | 11.8 | 11.9 | 27.6 |
| OR‡, 95% CI | – | 0.78 (0.54 to 1.14) | 0.81 (0.54 to 1.21) | 0.96 (0.62 to 1.49) | 0.84 (0.53 to 1.31) | 0.81 (0.61 to 1.07) |
| p Value | – | 0.199 | 0.302 | 0.859 | 0.437 | 0.402 |
| Future fertility | ||||||
| Primary analysis—all women | ||||||
| Overall prevalence | 24.4 | 16.9 | 14.7 | 12.5 | 12.0 | 24.3 |
| By arm | ||||||
| Immediate loop excision | 25.4 | 17.0 | 13.3 | 13.3 | 12.3 | 24.1 |
| Punch biopsies & selective recall | 23.5 | 16.9 | 16.0 | 11.8 | 11.7 | |
| OR§, 95% CI | – | 0.93 (0.62 to 1.39) | 0.70 (0.46 to 1.07) | 1.11 (0.69 to 1.79) | 0.86 (0.52 to 1.42) | 0.88 (0.63 to 1.25) |
| p Value | – | 0.717 | 0.098 | 0.670 | 0.553 | 0.486 |
| Secondary analysis—restricted to women planning to have a child in the future | ||||||
| Overall prevalence | 62.7 | 45.3 | 42.0 | 37.9 | 39.0 | 57.1 |
| By arm | ||||||
| Immediate loop excision | 62.2 | 43.5 | 38.2 | 38.8 | 38.1 | 55.6 |
| Punch biopsies & selective recall | 63.3 | 47.4 | 45.7 | 37.0 | 40.0 | 58.6 |
| OR¶, 95% CI | – | 0.85 (0.55 to 1.33) | 0.68 (0.43 to 1.08) | 1.09 (0.65 to 1.86) | 0.83 (0.47 to 1.45) | 0.92 (0.62 to 1.35) |
| p Value | – | 0.488 | 0.100 | 0.737 | 0.503 | 0.663 |
| General health | ||||||
| Overall prevalence | 68.9 | 36.1 | 36.8 | 36.5 | 35.0 | 59.9 |
| By arm | ||||||
| Immediate loop excision | 68.5 | 37.6 | 38.5 | 37.4 | 36.0 | 61.0 |
| Punch biopsies & selective recall | 69.3 | 34.5 | 35.0 | 35.7 | 33.9 | 58.8 |
| OR**, 95% CI | – | 1.17 (0.90 to 1.53) | 1.17 (0.88 to 1.54) | 0.99 (0.74 to 1.32) | 1.02 (0.76 to 1.37) | 1.06 (0.83 to 1.36) |
| p Value | – | 0.249 | 0.279 | 0.956 | 0.885 | 0.644 |
*OR for immediate loop excision versus punch biopsy and selective recall.
†Adjusted for minimisation variables, plus anxiety, MHLCS powerful others, worries about cancer at T0, feeling about self.
‡Adjusted for minimisation variables, plus anxiety, MHLCS powerful others, worries about sex at T0, ethnic group.
§Adjusted for minimisation variables (with age grouped as 20–29, 30–39, 40–59), plus anxiety, worries about fertility at T0, reproductive history.
¶Adjusted for minimisation variables, plus anxiety, worries about fertility at T0, reproductive history.
**Adjusted for minimisation variables, plus anxiety, depression, ethnic group, worries about general health at T0, and support received.
MHLCS, Multidimensional Health Locus of Control Scale.