OBJECTIVE: To compare the cost-effectiveness of levonorgestrel intrauterine system (LNG-IUS) (Mirena; Schering Co., Turku, Finland) and thermal balloon ablation (Thermachoicetrade mark; Gynecare Inc., Menlo Park, CA, USA) for the treatment of heavy menstrual bleeding. DESIGN: An open, pragmatic, prospective randomised trial. SETTING:A menstrual disorders clinic at National Women's Hospital, Auckland, New Zealand. POPULATION: Seventy-nine women with self-defined heavy menstrual bleeding randomised to theLNG-IUS (40 women) or the thermal balloon ablation (39 women). METHODS: Decision tree modelling using primary source data was used to identify the incremental cost-effectiveness of the two treatments. MAIN OUTCOME MEASURES: Direct and indirect costs of medical treatment, including treatment costs, subsequent medical procedures, lost income and medical treatment for failed procedures. The change in quality of life as assessed by the Short Form-36 (SF-36) measured between time of treatment and 24 months was the primary outcome measure. Economic modelling examined the expected cost and outcome for a woman entering each treatment. Sensitivity analysis explored the robustness of the results. RESULTS: The expected cost of treatment was $NZ1241 ($US869) for the LNG-IUS and $NZ2418 ($US1693) for the thermal balloon ablation. The LNG-IUS was associated with an increase of 15 points on the SF-36 scale, compared with 12 points for the thermal balloon ablation. Sensitivity analysis indicates that the results are robust to a 25% decrease in the price of the primary cost drivers and to variations in the rates of failed treatment between the conditions. CONCLUSION: The LNG-IUS would appear to be cost-effective when compared with the thermal balloon ablation for treatment of heavy menstrual bleeding.
RCT Entities:
OBJECTIVE: To compare the cost-effectiveness of levonorgestrel intrauterine system (LNG-IUS) (Mirena; Schering Co., Turku, Finland) and thermal balloon ablation (Thermachoicetrade mark; Gynecare Inc., Menlo Park, CA, USA) for the treatment of heavy menstrual bleeding. DESIGN: An open, pragmatic, prospective randomised trial. SETTING: A menstrual disorders clinic at National Women's Hospital, Auckland, New Zealand. POPULATION: Seventy-nine women with self-defined heavy menstrual bleeding randomised to the LNG-IUS (40 women) or the thermal balloon ablation (39 women). METHODS: Decision tree modelling using primary source data was used to identify the incremental cost-effectiveness of the two treatments. MAIN OUTCOME MEASURES: Direct and indirect costs of medical treatment, including treatment costs, subsequent medical procedures, lost income and medical treatment for failed procedures. The change in quality of life as assessed by the Short Form-36 (SF-36) measured between time of treatment and 24 months was the primary outcome measure. Economic modelling examined the expected cost and outcome for a woman entering each treatment. Sensitivity analysis explored the robustness of the results. RESULTS: The expected cost of treatment was $NZ1241 ($US869) for the LNG-IUS and $NZ2418 ($US1693) for the thermal balloon ablation. The LNG-IUS was associated with an increase of 15 points on the SF-36 scale, compared with 12 points for the thermal balloon ablation. Sensitivity analysis indicates that the results are robust to a 25% decrease in the price of the primary cost drivers and to variations in the rates of failed treatment between the conditions. CONCLUSION: The LNG-IUS would appear to be cost-effective when compared with the thermal balloon ablation for treatment of heavy menstrual bleeding.
Authors: L J Middleton; R Champaneria; J P Daniels; S Bhattacharya; K G Cooper; N H Hilken; P O'Donovan; M Gannon; R Gray; K S Khan; J Abbott; J Barrington; S Bhattacharya; M Y Bongers; J-L Brun; R Busfield; M Sowter; T J Clark; J Cooper; K G Cooper; S L Corson; K Dickersin; N Dwyer; M Gannon; J Hawe; R Hurskainen; W R Meyer; H O'Connor; S Pinion; A M Sambrook; W H Tam; I A A van Zon-Rabelink; E Zupi Journal: BMJ Date: 2010-08-16
Authors: Ali M El Saman; Faten F AbdelHafez; Kamal M Zahran; Hazem Saad; Mohamed Khalaf; Mostafa Hussein; Ibrahim M A Hassanin; Saba M Shugaa Al Deen Journal: Minim Invasive Surg Date: 2015-07-30