Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Center for Medical Technology Policy | UNKNOWN |
| Duke University | OTHER |
The purpose of this observational, retrospective database study of patients with uterine fibroids is to compare the durability of symptom relief after uterus-conserving treatments for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and subsequent procedures and evaluate the effect stakeholder participation had on the research process.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myomectomy | Women with uterine fibroids who underwent myomectomy as their index procedure as part of their routine clinical care |
| |
| Endometrial ablation | Women with uterine fibroids who underwent endometrial ablation as their index procedure as part of their routine clinical care |
| |
| Uterine artery embolization | Women with uterine fibroids who underwent uterine artery embolization as their index procedure as part of their routine clinical care |
| |
| MRI-guided focused ultrasound ablation | Women with uterine fibroids who underwent MRI-guided focused ultrasound ablation as their index procedure as part of their routine clinical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| myomectomy | Procedure | Myomectomy as part of routine clinical care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of uterine fibroids patients who experience new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation) | Minimum of two years after index procedure | |
| Time to new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation) | Minimum of two years after index procedure | |
| Number of uterine fibroids patients who experience a subsequent procedure after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation) | Minimum of two years after index procedure | |
| Time to a subsequent procedure after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation) | Minimum of two years | |
| Effect of stakeholder participation in the research process | From first stakeholder conference (April 2014) to final stakeholder conference (November 2015) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The patient population for the retrospective data analysis was uterine fibroid patients who have a record of at least 1 of the procedures of interest occurring during the time period of January 1, 2005 - December 31, 2011, with the first instance being designated as the index date. The study time period spanned from January 1, 2004 - December 31, 2013 to allow for 12 months pre-index for evaluating baseline demographic and clinical characteristics and 24 months post-index, ensuring a minimum of 2 years follow-up.
Not provided
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D063186 | Uterine Myomectomy |
| D055356 | Endometrial Ablation Techniques |
| D055357 | Uterine Artery Embolization |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D055011 | Ablation Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
| endometrial ablation |
| Procedure |
Endometrial ablation as part of routine clinical care |
|
| uterine artery embolization | Procedure | Uterine artery embolization as part of routine clinical care |
|
| MRI-guided focused ultrasound ablation | Procedure | MRI-guided focused ultrasound ablation as part of routine clinical care |
|
| D004621 | Embolization, Therapeutic |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |