Objectives: To investigate psychological correlates in women referred with suspected ovarian cancer via the fast-track pathway, explore how anxiety and distress levels change 12 months post-testing and report cancer conversion rates by age and referral pathway. Design: Single arm prospective cohort study Setting: Multicentre. Secondary care including outpatient clinics and emergency admissions. Participants: 2596 newly presenting symptomatic women with a raised CA125 level, abnormal imaging or both. Methods: Women completed anxiety and distress questionnaires at recruitment and at 12 months for those who had not undergone surgery or a biopsy within 3 months of recruitment. Main outcome measures: Anxiety and distress levels measured using STAI-6 and IES-r questionnaires. OC conversion rates by age, menopausal status and referral pathway. Results: 1355/2596 (52.1%) and 1781/2596 (68.6%) experienced moderate-to-severe distress and anxiety at recruitment. Younger age and emergency presentations had higher distress levels. Clinical category for anxiety and distress remained unchanged/worsened in 76% at 12 months despite a non-cancer diagnosis. OC rates by age were 1.6% (95% CI 0.5 to 5.9) under 40 and 10.9 % (95% CI 8.7 to 13.6) over 40 years. In women referred through fast-track pathways, 3.3% (95% CI 1.9 to 5.7) of pre- and 18.5% (95% CI 16.1 to 21.0) of postmenopausal women were diagnosed with OC. Conclusions: Women undergoing diagnostic testing display severe anxiety and distress. Younger women are especially vulnerable and should be targeted for support. Women under 40 have low conversion rates and we advocate reducing testing in this group to reduce harms of testing.

Objective. To externally validate the M6 risk model and the two-step triage strategy (2ST) to triage pregnancies of unknown location (PUL), and compare performance with the M4 model and beta human chorionic gonadotropin (BhCG) ratio cut-offs. Design. Model validation study. Setting. Eight UK hospitals with early pregnancy assessment units. Population. Women presenting with a PUL and BhCG >25 IU/L. Methods. Women were managed using the 2ST protocol: step 1 classifies PUL as low risk of ectopic pregnancy (EP) if presenting progesterone ≤2 nmol/L, M6 is used as step 2 in the remaining cases. We validated 2ST and M6 alone (with and without progesterone as a predictor: M6P and M6NP). M6 and M4 require the BhCG ratio over two days. Based on these models, we classified PUL as high risk for EP when the risk was ≥5%. We meta-analysed centre-specific results. Main outcome measures. Discrimination, calibration and clinical utility (decision curve analysis) for predicting EP. Results. Of 2899 eligible women, the main analysis excluded 297 (10%) women that were lost to follow-up. 16% (95% confidence interval 12-20) of women had presenting progesterone ≤2 nmol/L. The area under the ROC curve for EP was 0.88 (0.86-0.90) for 2ST and 0.89 (0.86-0.91) for M6P. Sensitivity for EP was 94% (89%-97%) for 2ST and 96% (91%-98%) for M6P. Both approaches had good overall calibration, with modest variability between centres. M4 and BhCG ratio cut-offs had inferior performance and lower clinical utility. Conclusions. The 2ST and M6P alone are the best approaches to triage PUL.