1 Service de Gynécologie-Obstétrique, Université Paris-Sud, Hôpital Antoine Béclère (AP-HP), 157, Rue de la Porte de Trivaux, 92141 Clamart Cedex and 2 HDI France, 492 chemin des Laurens, 06530 Spéracèdes, France
3 To whom correspondence should be addressed. e-mail: herve.fernandez{at}abc.ap-hop-paris.fr
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Abstract |
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Key words: direct costs/endometrial ablation/hysterectomy/menorrhagia/thermo-coagulation
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Introduction |
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Several different surgical interventions for treatment of severe menorrhagia are routinely performed. They differ in their effectiveness and the rate of post-surgical complications (Overton et al., 1997; NHSCRD, 1995
), but also, as regards hysterectomy, in the burden of the procedure, in terms of surgery duration and hospital costs. In the current environment of limited resources, choices need to be made to allocate resources efficiently, and different treatment alternatives should therefore be compared in terms of clinical effectiveness, costs, and estimated cost-effectiveness.
The aim of this study was to compare vaginal hysterectomy, hysteroscopic endometrial ablation and endometrial thermo-coagulation (Thermachoice; GynCare Inc, MenloPark, CA, USA) for the treatment of dysfunctional uterine bleeding and to evaluate the direct medical costs for each of these three different procedures.
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Materials and methods |
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All patients included had only menorrhagia evaluated on a pictorial chart (>150 for Higham score; Higham et al., 1990). Patients with myomas were excluded from this study.
Every day of menstruation, the patients recorded the number of lightly, moderately or heavily soiled pads and the passage of clots and periods of flooding on a pictorial chart, which were then scored. The total numerical score for each pictorial chart showed the extent of menorrhagia. Usually a score 100 is taken to correlate with menorrhagia
80 ml. We included in this series patients with a score
150. Indeed, we decided to treat surgically only severe menorrhagia defined by this score
150. These women had either failed medical therapy with progestins or were unwilling or unable to carry on with medical treatment with an anamnesis of severe menorrhagia over 1 year.
The choice between the three procedures was based on patient preference: vaginal hysterectomy to obtain 100% of success and amenorrhoea, hysteroscopic endometrial ablation as usually performed in the department as primary conservative surgical treatment, endometrial thermo-coagulation when local anaesthesia was desired and when the device was in demonstration.
Patients were then contacted 2436 months later to collect data on the level of treatment success, on subsequent interventions, medical visits, and gynaecological problems if any, and to assess their satisfaction with the procedure. A questionnaire was mailed to 60 patients for each procedure and patients who had not answered after 1 month received a reminder.
Resource utilization and costs
Resource utilization for the interventions were collected from the hospital charts. These provided detailed data on primary intervention duration, occupation time of the operating theatre, staff present, product consumption and number of in-patient days. The number of out-patient visits after the intervention, which were related to the indication, were collected from patients.
Resources were valued from the point of view of society, i.e. all resources were valued at their opportunity cost as far as possible, regardless of who ultimately paid for the resource. Unit costs for resources in the hospital were obtained from hospital accounting. The cost of out-patient visits was based on tariffs of the national health insurance. Drug treatment was excluded from the analysis, as no detailed data were available.
The main analysis presents total costs based on hospitalization and out-patient procedures, including costs for re-interventions as reported by patients. As no detailed data on resource consumption for re-interventions were available, we based the cost on the average cost for out-patient procedures and the mean length of stay for in-patient procedures.
We also estimated the cost of the procedures alone (excluding hospitalization) from the hospital perspective, based on the average duration of the intervention, operating theatre use and staff, sterilization, devices and materials and post-surgical visits.
Table I shows the presence of different staff in the operating theatre as well as hourly staff costs. The rate for nurses obtained from the hospital administration appeared high compared with average costs in national accounting records. We therefore also present a sensitivity analysis using these national costs.
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This study was not set up to perform a cost-effectiveness analysis, particularly as outcome was assessed through patient questionnaires between 2 and 3 years after the intervention. Also, our scoring definition of the satisfaction level was not based on a validated questionnaire. Lastly, the re-intervention rates after thermo-coagulation may reflect the introduction of a new procedure, rather than current clinical practice. For illustrative purposes, we present the incremental cost effectiveness for hysterectomy based on the total number of failures (re-interventions and persistent severe menorrhagia).
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Results |
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Effectiveness
As expected, with our definition of success and failure, the proportion of patients considered in our analysis as successfully treated was highest for hysterectomy, followed by thermo-coagulation and endometrial ablation (Table III).
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The mean operating time was 2 h for hysterectomy,
1 h for ablation and 46 min for thermo-coagulation. Patients who had undergone thermo-coagulation had the highest number of follow-up visits, 5.9, explained by the fact that the procedure was new, compared with 3.9 for ablation and 2.2 for hysterectomy.
The total cost for hysterectomy was, as expected, higher than for the other two procedures, due to the need for all patients to be hospitalized. The two other procedures were predominantly out-patient procedures and hence less costly. When the procedures alone are considered, excluding devices, thermo-coagulation had the lowest cost. When devices are included, ablation had the lowest cost.
Hospitalization cost was lowest for thermo-coagulation, as only four of 47 patients required an overnight stay, compared with 14 of 50 patients for ablation. Patients undergoing thermo-coagulation had slightly more follow-up visits than those undergoing ablation or hysterectomy.
Also, the cost of re-interventions was higher for thermo-coagulation than for ablation, as all seven re-interventions were hysterectomies, while the preferred intervention after failure of ablation was a second ablation. Thus, the total cost per patient was increased by €782 per patient for re-interventions after thermo-coagulation, but only by €165 after ablation (Table V).
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Discussion |
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This study illustrates very well the importance of such an analysis. Thermo-coagulation requires a rather costly single-use device, which makes the procedure expensive compared with, for example, ablation. However, the procedure is less resource-intensive and overnight stays are rarely required. Thus, when all costs relating to the primary procedure are included, thermo-coagulation has the lowest mean cost per patient (€922) followed by €1098 for ablation and by €5315 for hysterectomy. This ranking is changed when re-interventions or re-hospitalizations are included, and ablation has the lowest costs (€1263) followed by €1704 for thermo-coagulation and €5321 for hysterectomy.
The number of successes (no eumenorrhoea or less or no re-intervention for persistent bleeding) were, as expected, similar for thermo-coagulation and ablation, 80%. However, all patients, where thermo-coagulation was not successful, underwent hysterectomy, leading to a very high cost of re-intervention. As the procedure was new when this study was performed, it could be argued that as the procedure becomes more common, some patients may undergo a second thermo-coagulation when the first intervention fails. This hypothesis is supported by the pattern of re-interventions after ablation, where three of the six patients who required a re-intervention, had a second ablation.
The novelty of thermo-coagulation could explain the finding that only 74.5% of patients were fully satisfied by the procedure in spite of the fact that the pain reported was lower. Moreover, the subjectivity of pain might also explain the difference between the observed results.
Under such an assumption, where only 4050% of the failures would be treated with a hysterectomy, (compared with only 1 in 6 after ablation), the total costs for thermo-coagulation is reduced to a similar level as ablation, i.e. €1320. Thus, the two out-patient procedures would be equivalent both in terms of cost and effectiveness.
Overall satisfaction appeared slightly lower for thermo-coagulation, which was a new surgical technique in 1995 but far more patients reported pain after ablation. Thus, the two out-patient procedures are very comparable in terms of success rates, and choices will depend on budgetary considerations and patient preference.
This analysis has several shortcomings that must be considered. First, the database includes interventions performed in the years 19951997 and patient management patterns may have changed since then, particularly as far as in-patient stays are concerned. Second, the data concerning re-interventions and medical visits have been obtained from patients 23 years after the procedure and could therefore include a large recall bias. Third, it was not possible to include all costs relating to the procedures, such as follow-up treatments nor the cost of treating complications, which are more frequent after hysterectomy. Fourth, information on sick leave and other indirect costs of the treatments were not available and the analysis will thus underestimate the costs from a societal perspective, as patients in this cohort were rather young, particularly patients in the thermo-coagulation group. Lastly, the significant difference in age between the three groups introduces a bias in success rate estimation because the younger patients of the thermo-coagulation group have a longer time to menopause and thus a longer exposure to relapse risk than in the other two groups. An adjustment for age should be performed. However, the key issues for a comparison of different procedures (success and failure rates), as well as the main costs (in-patient and procedure costs) may give some guidance to investment decisions.
Moreover, not all gynaecologists will be able, for various reasons, to acquire skill in all procedures designed to treat menorrhagia. However, skill-intensive procedures such as vaginal hysterectomy or hysteroscopic endometrial ablation may well be replaced by the second generation of endometrial ablation such as Thermachoice that appears to require minimal training and experience for effective outcomes, less complications and obviously less cost.
This study reinforces the economic information included in trials comparing hysterectomy with endometrial ablation (Gannon et al., 1991; Dwyer et al., 1993
; Sculpher et al., 1993
, 1996; Pinion et al., 1994
; Croscignani et al., 1997
; Research Council, 1997
). Although our analysis cannot be directly applied to health care systems of other countries, it appears that in view of our results conservative out-patient surgery should be the preferred option in most cases.
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Acknowledgements |
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References |
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Submitted on June 10, 2002; resubmitted on September 24, 2002; accepted on December 3, 2002.