Authors' objectives:

This study aimed to compare three outpatient methods of endometrial evaluation in terms of performance, patient acceptability and cost-effectiveness.

Authors' results and conclusions: Overall 67% of those approached about the study were recruited. Recruitment met the target for postmenopausal women (n = 200, 100% of target) and nearly met it for moderate-risk women (n = 326, 82%), but was unsuccessful for low-risk women (n = 157, 52.3%), mainly because of changes in referral patterns and in investigation practice for this group. Over 90% of women completed all their recruitment questionnaires, 82% completed all their randomised investigations and over 83% returned their review of the clinic visit. There were high rates of follow-up to 10 months (77%) and of case-note review (98%). Minor adverse events (e.g. shock, patient distress) did not occur for ultrasound, but occurred in 16% and 10% of women for hysteroscopy and biopsy procedures respectively. More women reported biopsy and hysteroscopy as markedly unpleasant, and for both these methods after-effects (bleeding and abdominal discomfort) were common. Nevertheless, the vast majority of women (87%) were reassured by their clinic visit and glad they had their investigation (94%), and overall 78% of women thought that their clinic visit was very or extremely worthwhile. There were only modest differences between investigations in these positive views. Women who had biopsy only expressed greater wish to have had more investigation. In high- and moderate-risk women, 15% intention to treat (ITT) of the Pipelle biopsies and 11% of hysteroscopies could not be undertaken for medical reasons, mainly failed insertion. Pipelle biopsy provided an acceptable endometrial sample for 79% of moderate-risk women, but only 43% of high-risk women. The Tao brush gave similar performance in moderate-risk women (77%), but was more successful than the Pipelle sampler in obtaining adequate samples in postmenopausal (high-risk) women (72%, p < 0.001). More women preferred the Tao brush than preferred the Pipelle sampler. Furthermore, adequate samples were more likely to be obtained if biopsy was undertaken at the time of hysteroscopy for both the Pipelle (p = 0.027) and Tao brush (p = 0.002). There were significantly more successful visualisations for ultrasound than for hysteroscopy in both the low-risk (97% vs 65%, intention to treat, p = 0.003) and the moderate-risk group (88% vs 77%, p = 0.002), and a similar but non-significant trend in the high-risk group. Ultrasound was significantly better than hysteroscopy at detecting fibroids (32% vs 13%, p = 0.006), but hysteroscopy significantly better for polyps (13% vs 4%, p < 0.001). At the 10-month follow-up, high-risk women who had been investigated by hysteroscopy (with biopsy) had the most positive views of their clinic experience, but this effect had largely disappeared by 24 months. In the moderate-risk group, the subgroup randomised to biopsy alone gave the most negative responses about their clinic experience and health now. Women wishing they had more investigation comprised 22% of moderate-risk women and 38% of low-risk women, but only 14% of postmenopausal women. At follow-up the moderate-risk women (with menstrual bleeding problems), compared with postmenopausal women, had much worse ratings for clinic experience and health now, in that less than half of them judged their symptoms much improved by 10 months and one-quarter reported that their problem had not been cured.

Authors' recommendations: This study has highlighted the complexity of the investigation pathways travelled by women referred for abnormal bleeding. Decision-making about investigation and understanding would be clarified if postmenopausal women were studied separately from premenopausal women with menstrual bleeding problems. For postmenopausal women exclusion of cancer is a main objective, so once investigation has been completed discharge follows, but in the woman with abnormal menstrual bleeding, even if serious pathology is excluded, the original presenting symptoms require management. About 60% of premenopausal women with abnormal bleeding reported that their symptoms were not much improved at 10 months. Research is needed to understand this phenomenon, and to explore ways to integrate patient factors into optimising evaluation and treatment in these cases. The significance of benign pathologies in this group also requires clarification. Given the relatively small differences observed in cost-effectiveness, there is justification for allowing other issues (such as clinician preferences and womens perspectives) to influence decisions as to the investigation method. The clinicians expressed interest in the Tao brush being made available for their use. Its introduction would have resource implications, in particular the training of pathology staff. The Tao brush is superior in obtaining adequate samples, so it should be considered the method of choice for postmenopausal women, or at least be readily available as a back-up technique where Pipelle sampling has failed. At the time of investigation ultrasound was much more acceptable to women than hysteroscopy and biopsy, but hysteroscopy was not more unpleasant to women than biopsy. Women having hysteroscopy were pleased to have had the investigation and women having this randomisation option were least likely to have wanted more investigation, whereas those having biopsy only wished that they had had more investigation. There is scope to make better use of patient factors to inform decisions as to the most efficient and acceptable method of investigation for an individual woman. Additional analyses, using data available as a result of this study, will contribute to this agenda.

Authors' methods: Randomised controlled trial

Project Status: Completed

URL for project: http://www.hta.ac.uk/1063

Year Published: 2004

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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