Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial): A clinical and economic analysis

Abimbola O. Famuyide, Shannon K Laughlin-Tommaso, Sherif A. Shazly, Kirsten Hall Long, Daniel M. Breitkopf, Amy L. Weaver, Michaela E. McGree, Sherif A. El-Nashar, Maureen A. Lemens, Matthew R. Hopkins

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Radiofrequency endometrial ablation (REA) is currently a second line treatment in women with heavy menstrual bleeding (MHB) if medical therapy (MTP) is contraindicated or unsatisfactory. Our objective is to compare the effectiveness and cost burden of MTP and REA in the initial treatment of HMB. Methods: We performed a randomized trial at Mayo Clinic Rochester, Minnesota. The planned sample size was 60 patients per arm. A total of 67 women with HMB were randomly allocated to receive oral contraceptive pills (Nordette ®) or Naproxen (Naprosyn®) (n = 33) or REA (n = 34). Primary 12-month outcome measures included menstrual blood loss using pictorial blood loss assessment chart (PBLAC), patients’ satisfaction, and Menorrhagia Multi-Attribute Scale (MMAS). Secondary outcomes were total costs including direct medical and indirect costs associated with healthcare use, patient out-of-pocket costs, and lost work days and activity limitations over 12 months. Results: Compared to MTP arm, women who received REA had a significantly lower PBLAC score (median [Interquartile range, IQR]: 0 [0–4] vs. 15 [0–131], p = 0.003), higher satisfaction rates (96.8%vs.63.2%, p = 0.003) and higher MMAS (median [IQR]: 100 [100–100] vs. 100 [87–100], p = 0.12) at 12 months. Direct medical costs were higher for REA ($5,331vs. $2,901, 95% confidence interval (CI) of mean difference:$727,$4,852), however, when indirect costs are included, the difference did not reach statistical significance ($5,469 vs. $3,869, 95% CI of mean difference:-$339, $4,089). Conclusion: For women with heavy menstrual bleeding, initial radiofrequency endometrial ablation compared to medical therapy offered superior reduction in menstrual blood loss and improvement in quality of life without significant differences in total costs of care. Clinical trial registration: NCT01165307.

Original languageEnglish (US)
Article numbere0188176
JournalPLoS One
Volume12
Issue number11
DOIs
StatePublished - Nov 1 2017

Fingerprint

Endometrial Ablation Techniques
Economic analysis
Ablation
economic analysis
hemorrhage
Economics
Clinical Trials
Hemorrhage
therapeutics
blood
Costs and Cost Analysis
Blood
Menorrhagia
Costs
confidence interval
Naproxen
oral contraceptives
work schedules
Ethinyl Estradiol-Norgestrel Combination
Therapeutics

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

Cite this

Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial) : A clinical and economic analysis. / Famuyide, Abimbola O.; Laughlin-Tommaso, Shannon K; Shazly, Sherif A.; Long, Kirsten Hall; Breitkopf, Daniel M.; Weaver, Amy L.; McGree, Michaela E.; El-Nashar, Sherif A.; Lemens, Maureen A.; Hopkins, Matthew R.

In: PLoS One, Vol. 12, No. 11, e0188176, 01.11.2017.

Research output: Contribution to journalArticle

Famuyide, Abimbola O. ; Laughlin-Tommaso, Shannon K ; Shazly, Sherif A. ; Long, Kirsten Hall ; Breitkopf, Daniel M. ; Weaver, Amy L. ; McGree, Michaela E. ; El-Nashar, Sherif A. ; Lemens, Maureen A. ; Hopkins, Matthew R. / Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial) : A clinical and economic analysis. In: PLoS One. 2017 ; Vol. 12, No. 11.
@article{fc4461e339f141468c861e12d7fa180f,
title = "Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial): A clinical and economic analysis",
abstract = "Background: Radiofrequency endometrial ablation (REA) is currently a second line treatment in women with heavy menstrual bleeding (MHB) if medical therapy (MTP) is contraindicated or unsatisfactory. Our objective is to compare the effectiveness and cost burden of MTP and REA in the initial treatment of HMB. Methods: We performed a randomized trial at Mayo Clinic Rochester, Minnesota. The planned sample size was 60 patients per arm. A total of 67 women with HMB were randomly allocated to receive oral contraceptive pills (Nordette {\circledR}) or Naproxen (Naprosyn{\circledR}) (n = 33) or REA (n = 34). Primary 12-month outcome measures included menstrual blood loss using pictorial blood loss assessment chart (PBLAC), patients’ satisfaction, and Menorrhagia Multi-Attribute Scale (MMAS). Secondary outcomes were total costs including direct medical and indirect costs associated with healthcare use, patient out-of-pocket costs, and lost work days and activity limitations over 12 months. Results: Compared to MTP arm, women who received REA had a significantly lower PBLAC score (median [Interquartile range, IQR]: 0 [0–4] vs. 15 [0–131], p = 0.003), higher satisfaction rates (96.8{\%}vs.63.2{\%}, p = 0.003) and higher MMAS (median [IQR]: 100 [100–100] vs. 100 [87–100], p = 0.12) at 12 months. Direct medical costs were higher for REA ($5,331vs. $2,901, 95{\%} confidence interval (CI) of mean difference:$727,$4,852), however, when indirect costs are included, the difference did not reach statistical significance ($5,469 vs. $3,869, 95{\%} CI of mean difference:-$339, $4,089). Conclusion: For women with heavy menstrual bleeding, initial radiofrequency endometrial ablation compared to medical therapy offered superior reduction in menstrual blood loss and improvement in quality of life without significant differences in total costs of care. Clinical trial registration: NCT01165307.",
author = "Famuyide, {Abimbola O.} and Laughlin-Tommaso, {Shannon K} and Shazly, {Sherif A.} and Long, {Kirsten Hall} and Breitkopf, {Daniel M.} and Weaver, {Amy L.} and McGree, {Michaela E.} and El-Nashar, {Sherif A.} and Lemens, {Maureen A.} and Hopkins, {Matthew R.}",
year = "2017",
month = "11",
day = "1",
doi = "10.1371/journal.pone.0188176",
language = "English (US)",
volume = "12",
journal = "PLoS One",
issn = "1932-6203",
publisher = "Public Library of Science",
number = "11",

}

TY - JOUR

T1 - Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial)

T2 - A clinical and economic analysis

AU - Famuyide, Abimbola O.

AU - Laughlin-Tommaso, Shannon K

AU - Shazly, Sherif A.

AU - Long, Kirsten Hall

AU - Breitkopf, Daniel M.

AU - Weaver, Amy L.

AU - McGree, Michaela E.

AU - El-Nashar, Sherif A.

AU - Lemens, Maureen A.

AU - Hopkins, Matthew R.

PY - 2017/11/1

Y1 - 2017/11/1

N2 - Background: Radiofrequency endometrial ablation (REA) is currently a second line treatment in women with heavy menstrual bleeding (MHB) if medical therapy (MTP) is contraindicated or unsatisfactory. Our objective is to compare the effectiveness and cost burden of MTP and REA in the initial treatment of HMB. Methods: We performed a randomized trial at Mayo Clinic Rochester, Minnesota. The planned sample size was 60 patients per arm. A total of 67 women with HMB were randomly allocated to receive oral contraceptive pills (Nordette ®) or Naproxen (Naprosyn®) (n = 33) or REA (n = 34). Primary 12-month outcome measures included menstrual blood loss using pictorial blood loss assessment chart (PBLAC), patients’ satisfaction, and Menorrhagia Multi-Attribute Scale (MMAS). Secondary outcomes were total costs including direct medical and indirect costs associated with healthcare use, patient out-of-pocket costs, and lost work days and activity limitations over 12 months. Results: Compared to MTP arm, women who received REA had a significantly lower PBLAC score (median [Interquartile range, IQR]: 0 [0–4] vs. 15 [0–131], p = 0.003), higher satisfaction rates (96.8%vs.63.2%, p = 0.003) and higher MMAS (median [IQR]: 100 [100–100] vs. 100 [87–100], p = 0.12) at 12 months. Direct medical costs were higher for REA ($5,331vs. $2,901, 95% confidence interval (CI) of mean difference:$727,$4,852), however, when indirect costs are included, the difference did not reach statistical significance ($5,469 vs. $3,869, 95% CI of mean difference:-$339, $4,089). Conclusion: For women with heavy menstrual bleeding, initial radiofrequency endometrial ablation compared to medical therapy offered superior reduction in menstrual blood loss and improvement in quality of life without significant differences in total costs of care. Clinical trial registration: NCT01165307.

AB - Background: Radiofrequency endometrial ablation (REA) is currently a second line treatment in women with heavy menstrual bleeding (MHB) if medical therapy (MTP) is contraindicated or unsatisfactory. Our objective is to compare the effectiveness and cost burden of MTP and REA in the initial treatment of HMB. Methods: We performed a randomized trial at Mayo Clinic Rochester, Minnesota. The planned sample size was 60 patients per arm. A total of 67 women with HMB were randomly allocated to receive oral contraceptive pills (Nordette ®) or Naproxen (Naprosyn®) (n = 33) or REA (n = 34). Primary 12-month outcome measures included menstrual blood loss using pictorial blood loss assessment chart (PBLAC), patients’ satisfaction, and Menorrhagia Multi-Attribute Scale (MMAS). Secondary outcomes were total costs including direct medical and indirect costs associated with healthcare use, patient out-of-pocket costs, and lost work days and activity limitations over 12 months. Results: Compared to MTP arm, women who received REA had a significantly lower PBLAC score (median [Interquartile range, IQR]: 0 [0–4] vs. 15 [0–131], p = 0.003), higher satisfaction rates (96.8%vs.63.2%, p = 0.003) and higher MMAS (median [IQR]: 100 [100–100] vs. 100 [87–100], p = 0.12) at 12 months. Direct medical costs were higher for REA ($5,331vs. $2,901, 95% confidence interval (CI) of mean difference:$727,$4,852), however, when indirect costs are included, the difference did not reach statistical significance ($5,469 vs. $3,869, 95% CI of mean difference:-$339, $4,089). Conclusion: For women with heavy menstrual bleeding, initial radiofrequency endometrial ablation compared to medical therapy offered superior reduction in menstrual blood loss and improvement in quality of life without significant differences in total costs of care. Clinical trial registration: NCT01165307.

UR - http://www.scopus.com/inward/record.url?scp=85034052405&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85034052405&partnerID=8YFLogxK

U2 - 10.1371/journal.pone.0188176

DO - 10.1371/journal.pone.0188176

M3 - Article

C2 - 29141040

AN - SCOPUS:85034052405

VL - 12

JO - PLoS One

JF - PLoS One

SN - 1932-6203

IS - 11

M1 - e0188176

ER -