Page 115 - The diagnostic work-up of women with postmenopausal bleeding

Clinical outcomes
The primary outcome measure was the recurrence of PMB within a year after randomization. All women were contacted by telephone after one year to assess whether they had experienced recurrent bleeding. Although not registered as a secondary outcome in the protocol, pathology results of hysteroscopy showing the presence of a (pre) cancer were also registered. Since no hysteroscopy was performed in the group receiving expectant management, we assumed that the prevalence of (pre) cancer in this group was the same as in the group receiving a diagnostic work-up with hysteroscopy and a SIS due to the randomization principles.
Costs
Costs were assessed from a healthcare perspective and were derived from case
record forms. Direct health care costs directly after inclusion (diagnostic work-up)
in the study included visits to the outpatient clinic, costs for diagnostic or therapeutic hysteroscopy and costs for diagnosis and treatment of a (pre) cancer of the endometrium diagnosed with hysteroscopy after randomisation. Direct health care
costs during follow-up included visits to the outpatient clinic, transvaginal sonography
(TVS), diagnostic or therapeutic hysteroscopy and costs for diagnosis and treatment
of a (pre) cancer of the endometrium diagnosed during 12 months follow-up. Prices 6 were based on Dutch standard costs if available.18 In other cases, prices were obtained
from the financial administration of one of the participating academic hospitals.All costs were adjusted to the year 2012 using consumer price indices if necessary.19 Discounting was not necessary, because follow-up was limited to 12 months.Table 1 lists the cost categories and prices used in this economic evaluation.
Diagnostic work-up strategies
In this paper, we compared two strategies with expectant management: a strategy in which all women received a hysteroscopy without a SIS and a hypothetical strategy in which all women received a SIS and only those with a suspicion of an endometrial polyp or an inconclusive SIS underwent a hysteroscopy.
Cost-effectiveness
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