The future for follow-up of gynaecological cancer in Europe. Summary of available data and overview of ongoing trials.

After completing treatment, most patients follow a pre-determined schedule of regular hospital outpatient appointments, which includes clinical examinations, consultations and routine tests. After several years of surveillance, patients are transferred back to primary care. However, there is limited evidence to support the effectiveness and efficiency of this approach. This paper examines the current rationale and evidence base for hospital-based follow-up after treatment for gynaecological cancer. We investigate what alternative models of care have been formally evaluated and what research is currently in progress in Europe, in order to make tentative recommendations for a model of follow-up. The evidence base for traditional hospital based follow-up is limited. Alternative models have been reported for other cancer types but there are few evaluations of alternative approaches for gynaecological cancers. We identified five ongoing European studies; four were focused on endometrial cancer patients and one feasibility study included all gynaecological cancers. Only one study had reached the reporting stage. Alternative models included nurse-led telephone follow-up and comparisons of more intensive versus less intensive regimes. Outcomes included survival, quality of life, psychological morbidity, patient satisfaction and cost effectiveness of service. More work is needed on alternative strategies for all gynaecological cancer types. New models will be likely to include risk stratification with early discharge from secondary care for early stage disease with fast track access to specialist services for suspected cancer recurrence or other problems.

Colposcopy training and assessment across the member countries of the European Federation for Colposcopy.

OBJECTIVES: Colposcopy training and assessment is not uniform across Europe with individual countries determining their own required standards and regulations. In light of the significant changes in colposcopic practice that have occurred over the past decade and the expansion of the European Federation for Colposcopy (EFC) membership, a study was conducted firstly, to assess the current requirements for training in each of the member countries and secondly, to review an EFC-approved core training curriculum for colposcopy. STUDY DESIGN: A questionnaire survey of the EFC representatives from all member countries investigating their country's current practices/requirements with regard to training, assessment and accreditation for colposcopy. A two-round Delphi consultation with representation from the full, associate and three potential member countries was conducted using a 5-point Likert scale for scoring opinions. The results were analysed with respect to each country's population size and World Bank economic classification. RESULTS: For the questionnaire survey, responses were received from 31/34 countries invited to participate. Training programmes were reported to be in place in 21 of the 31 countries but only 17 of the 21 countries had a committee overseeing the training programme. An assessment was part of the training programme in 20 countries with multiple choice questions and portfolios the most common assessment tools. Countries with a population size less than 2 million have a statistically significant lower probability of having a structured training/assessment programme, 1/5 compared to 20/26 for a populations greater than 2 million, p=0.013. For the Delphi study, responses were received from 34/39 countries invited to participate. Of the 51 competencies previously identified only 2 did not receive full support: 'perform bacterial swabs' and 'provide data to national body'. There was no significant difference in the responses given by member, associate member or potential member countries. CONCLUSIONS: There is considerable variation in colposcopy training and assessment across Europe. This study has enabled consensus opinion with the EFC on the contents of an EFC core curriculum. The revised curriculum has a mandate from the EFC member countries to be implemented across Europe as the standard for colposcopic training.

A questionnaire survey to study the effect of colposcopy training in Europe.

The objective of the study was to see if colposcopy training can provide a measurable effect. A questionnaire containing 10 clinical scenarios requiring colposcopy was completed by delegates attending three colposcopy training courses in Europe. A total of 128 and 132 questionnaires were returned pre- and post-training, respectively. The means and standard deviations for the number of correctly assessed scenarios were M = 4.21, SD = 1.71 at pre-training and M = 5.05, SD = 1.82 at post-training. The χ(2)-test showed a statistically significant difference in the proportions of correct answers at pre- and post-training for five questions. The two factor ANOVA showed that there is a statistically significant difference between the pre- and post-training measures (F((2,124)) = 17.13, p < 0.001) although the effect of training is not the same for all three locations. Trainees' results show that there is a positive effect of training. The questionnaire may be used as a quality tool for measuring the effectiveness of training for colposcopy.

Guidelines for gynecological cancer-an audit of current network documents in England and Wales.

The objective of this study was to assess the adequacy of network cancer guidelines paying particular attention to referral criteria, referral routes, tumor diagnosis, staging, and suggested management and care pathways for ovarian and endometrial cancer. Guidelines from 15 regions in England and Wales were analyzed quantitatively and qualitatively as a prospective audit of predefined data items and subsequently agreed management recommendations. Details of unit and center clinicians were included in a minority of documents (2 to 5/15). Multidisciplinary team membership was not usually offered (6/15). Among the least reported data items were histopathology minimum dataset for endometrial cancer and an algorithm for management or summary and clinical symptoms and signs for both cancers. Among the most reported data items were hysteroscopy and ultrasound scanning for endometrial cancer and CA125 and chemotherapy for ovarian cancer. Qualitative analysis revealed differing criteria for the use of endometrial biopsy and radiotherapy in endometrial cancer, for lymphadenectomy and management of recurrent disease in ovarian cancer, and for referral pathways and the use of computed tomography/magnetic resonance (MR) scanning in the assessment of either disease. This study concludes that consideration should be given to the development of national guidelines or templates to ensure consistency of management for gynecological malignancy in England and Wales.

Repeating cytology at initial colposcopy does not improve detection of high-grade abnormalities: a retrospective cohort study of 6595 women.

OBJECTIVE: To determine if repeating a smear improves detection of high-grade pre-invasive or invasive disease of the cervix compared with women who do not have a repeat smear at the time of the initial colposcopic assessment for referral of an abnormal smear. DESIGN: Retrospective cohort study. SETTING: All Wales Colposcopy database. POPULATION: The cohort included women referred for colposcopy with an abnormal smear result, who were seen between 1st January 2002 and 31st December 2002. METHOD: The management of the group of women who had a repeat smear was compared with the group who did not have a repeat smear test at their first visit. Confidence interval analysis was used to compare results between the two groups. MAIN OUTCOME MEASURE: The positive predictive value and sensitivity of the repeat smear to predict outcome, compared to the referral smear in cases where a smear was not repeated at the colposcopy clinic. RESULTS: 3505 cases (54.0%) did not have a repeat smear at initial colposcopy, whereas 2990 (46%) did. There was a significantly higher rate of referral for low-grade dyskaryosis in the group who had repeat smear testing. The median time interval from the referral smear to the first colposcopy was 49 days for both groups. The specificity and positive predictive value for high-grade lesions were significantly higher in the repeat smear results. The sensitivity was significantly lower, and a high-grade lesion would have been missed with the repeat smear in 14.0% of all referrals. CONCLUSIONS: Colposcopists appeared more inclined to repeat smears for low-grade referrals. The time interval from the referral smear to colposcopy did not appear to influence this decision. A repeat smear test at the first colposcopy visit will detect less high-grade pre-invasive or invasive disease than the initial referral smear.

A retrospective review of magnetic resonance imaging in assessing the extent of myometrial infiltration for patients with endometrial carcinoma.

The surgical treatment of endometrial malignancy is based on pre-operative assessment of differentiation, myometrial and lymph node infiltration. Studies have reported the use of magnetic resonance imaging (MRI) with conflicting results. This study aims to review the pre-operative accuracy of MRI against the histology in endometrial cancer within a district hospital. A total of 112 women were identified from January 1997 to December 2004. The post-operative FIGO staging showed 76.2% Stage I, 7.6% Stage II, 14.3% Stage III and 1.7% Stage IV. A total of 57% (n = 60) had a pre-operative MRI. The myometrial infiltration was difficult to interpret in 31 MRIs. The time between hysteroscopy and MRI scan in those cases was shorter (Mean 3 weeks, SD +/- 1.5) than in reports with a clear interpretation (4.4 weeks, SD +/- 1.6). Sensitivity for MRI to detect deep myometrial infiltration was 35.7% (5/14) and specificity 50% (23/46). Accuracy was 46.6% (28/60). The presented data suggests a poor predictability of myometrial invasion by MRI but the numbers are small and MRI is a rapidly evolving modality. The conclusions must be treated with caution and cannot easily be applied to large gynaecological cancer units in general.

A study to determine the underlying reason for abnormal glandular cytology and the formulation of a management protocol.

A retrospective review is presented of 89 patients with glandular dyskaryosis in order to formulate a management protocol. Fifteen patients had cervical intraepithelial neoplasia (CIN) without glandular abnormality (17%). One patient had adenocarcinoma in situ of the cervix and one patient had vaginal intraepithelial neoplasia (VAIN) grade III. Twenty-two patients had endometrial carcinoma (24.5%) and 11 patients had cervical carcinoma (12.5%). Of the patients presenting with post-menopausal bleeding as well as having glandular dyskaryosis, 69% had a gynaecological malignancy. In conclusion, colposcopy and out-patient endometrial sampling are recommended in all cases. Patients with abnormal endometrial sampling require hysteroscopy. Cone biopsy is necessary to exclude occult glandular disease if cytology remains abnormal despite negative colposcopy and sampling.

Detection of fetal fibronectin as a predictor of preterm delivery in high risk asymptomatic pregnancies.

OBJECTIVE: The study was designed to determine whether fetal fibronectin would predict delivery before 37 weeks in women at high risk of preterm delivery. STUDY METHODS: Forty-three women considered at risk of preterm delivery were recruited antenatally into a blind longitudinal study. Quantitative assays of fetal fibronectin were obtained from sequential high vaginal swabs taken fortnightly from 24 to 34 weeks of gestation. Fibronectin concentrations of 0.05 microgram/ml or more were considered as positive. RESULTS: Results were calculated by swab and by subject. The sensitivity of an individual fibronectin swab in predicting preterm delivery within 14 days of testing was 71% and the specificity was 93%. The overall positive predictive value was 31% and the negative predictive value was 99%. The sensitivity of the fibronectin swab in predicting delivery before 37 weeks was 17% and the specificity was 93%. The positive predictive value was 50% and the negative predictive value was 73%. For a woman who has had a positive swab the sensitivity in predicting preterm delivery within 14 days of testing was 80% and the specificity was 83%; a woman was counted as positive only if the final swab was positive and preceded delivery by not more than 14 days. The positive predictive value was 36% and the negative predictive value was 97%. For a woman who has had a positive swab the sensitivity in predicting delivery before 37 weeks was 54%. The specificity, the positive predictive value and the negative predictive value were 85%, 64% and 79%, respectively. Women were counted as positive if any swab in the sampling sequence was positive. Fibronectin swabbing when calculated by patient did predict preterm delivery within 14 days of testing (P=0.01) and before 37 weeks (P=0.01). Analysis of the accuracy of predicting delivery from 7 to 28 days after sampling revealed that the best prediction for delivery was within the following 14 days. CONCLUSION: Serial fetal fibronectin assessment from 24 to 34 weeks of gestation anticipated preterm delivery within 14 days of testing and before 37 weeks for high risk asymptomatic women. Such testing should be performed every two weeks.