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Bhattacharya S, Middleton LJ, Tsourapas A, et al.; the International Heavy Menstrual Bleeding Individual Patient Data Meta-analysis Collaborative Group. Hysterectomy, Endometrial Ablation and Mirena® for Heavy Menstrual Bleeding: A Systematic Review of Clinical Effectiveness and Cost-Effectiveness Analysis. Southampton (UK): NIHR Journals Library; 2011 Apr. (Health Technology Assessment, No. 15.19.)

5Interpretation of available evidence and consensus regarding treatment

Data from the IPD meta-analysis suggest that more women are dissatisfied following first-generation EA than hysterectomy. However, it is important to note that dissatisfaction rates are low after all treatments and hysterectomy is associated with an increased hospital stay and recovery period. In the absence of head-to-head trials, indirect estimates suggest hysterectomy is also preferable to second-generation EA in terms of patient satisfaction. In terms of cost-effectiveness, hysterectomy is considered the best strategy, but it carries a higher risk of complications and is perceived as a final option by gynaecological experts and consumers. Dissatisfaction rates were comparable between first- and second-generation techniques, although second-generation techniques were cheaper, quicker and associated with a faster recovery and fewer complications. There are few comparisons of Mirena versus more invasive procedures. The few data available suggest that Mirena is potentially cheaper and more effective than first-generation ablation techniques, with rates of satisfaction similar to those of second-generation techniques. Owing to small, imprecise trials with relatively high levels of non-compliance, the evidence to suggest that hysterectomy is preferable to Mirena is currently so limited that definitive conclusions cannot yet be made.

Observational data indicate that at 7 years a quarter of women face further gynaecological surgery after EA while an initial hysterectomy for HMB is more likely to lead to further surgery for stress urinary incontinence. The incidence of endometrial cancer following EA is reassuringly low at 0.02%. The type of hysterectomy has an influence on future risk of surgery, with vaginal hysterectomy associated with a higher chance of further surgery for urinary incontinence and pelvic floor prolapse than hysterectomy carried out through the abdominal route.

A summary of the results on effectiveness and cost-effectiveness was sent electronically to 15 national experts (minimal-access gynaecological surgeons) along with a short questionnaire (see Appendix 9) to encourage a rapid response. After two mailings, responses were received from 10 clinicians. Their responses are summarised in Table 22. Mirena was offered as first-line treatment and second-generation EA as second-line treatment by 9 out of 10 responders, while hysterectomy was considered the final port of call for women with HMB in the absence of demonstrable organic pathology. It is also clear from the responses that such a simplistic approach was not considered appropriate by some of the clinicians, who felt that often the choice of treatment depended on which intervention had been used before. As Table 22 suggests, some of the clinicians were also keen to incorporate the patients' own preferences. One in particular (Clinician G) indicated that patients should choose any one of the three options in the context of first-line treatment for HMB.

TABLE 22. Clinicians' responses to queries regarding the treatment of women with HMB with failed oral medical treatment and no obvious clinical abnormalities.

TABLE 22

Clinicians' responses to queries regarding the treatment of women with HMB with failed oral medical treatment and no obvious clinical abnormalities.

The letter to the clinicians along with a summary of their views was sent electronically to three consumers. All three agreed with the order in which the three treatments were prioritised by the clinicians. Two of them made further comments highlighting potential problems associated with a rigid clinical algorithm and pointed out other factors such as age and fertility status which could have a bearing on the choice of treatments. Both argued for a degree of flexibility in order to accommodate the needs and preferences of individual women (Table 23).

TABLE 23. Consumer responses to clinician comments.

TABLE 23

Consumer responses to clinician comments.

Conclusion

An IPD meta-analysis of randomised trials as well as the results of a cost-effectiveness analysis favour hysterectomy in women with HMB. Interpretation of these results needs to take into account a number of issues. The limited evidence on the effectiveness of Mirena, concerns about the long-term consequences of hysterectomy and individual preferences of women and gynaecologists are factors that influence the choice of treatment. While hysterectomy results in significantly fewer women being dissatisfied than those undergoing EA, it is worth noting that rates of satisfaction were very high for all treatment modalities. Although economic models used suggest that hysterectomy is the most cost-effective treatment option for HMB, any decision to promote this procedure must balance the morbidity associated with it against the ease of Mirena insertions in the community, and the ability to perform second-generation ablative procedures outwith the traditional theatre setting. The latter could potentially free up theatre time in secondary care which could be used for other procedures. A key reason for the higher success rates associated with hysterectomy is the definitive nature of the procedure. Failure rates for Mirena remain to be formally established, but those associated with EA are well known. Around a quarter of all women who undergo EA will require subsequent gynaecological surgery, with just under a fifth requiring a hysterectomy. Endometrial cancer rates following EA are very low, although longer term follow-up will be necessary to confirm this. Mirena protects against endometrial hyperplasia and hence endometrial cancer rates should be low. It is clear that clinical experts and consumers considered ease of access to treatment, degree of invasiveness, long-term consequences and patient autonomy to be important determinants. Expert clinical opinion favours offering the least invasive treatment, that is, Mirena first, followed by ablation, with hysterectomy reserved for women in whom the first two options have failed. This approach is endorsed by lay consumers, although they are anxious that women have the opportunity to choose the option that is best for them.

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Cover of Hysterectomy, Endometrial Ablation and Mirena® for Heavy Menstrual Bleeding: A Systematic Review of Clinical Effectiveness and Cost-Effectiveness Analysis
Hysterectomy, Endometrial Ablation and Mirena® for Heavy Menstrual Bleeding: A Systematic Review of Clinical Effectiveness and Cost-Effectiveness Analysis.
Health Technology Assessment, No. 15.19.
Bhattacharya S, Middleton LJ, Tsourapas A, et al.; the International Heavy Menstrual Bleeding Individual Patient Data Meta-analysis Collaborative Group.
Southampton (UK): NIHR Journals Library; 2011 Apr.

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