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  • Ovid Technologies (Wolters Kluwer Health)  (3)
  • 1
    Online Resource
    Online Resource
    A core outcome set for genitourinary symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Menopause Vol. 28, No. 8 ( 2021-05-10), p. 859-866
    Details
    In: Menopause, Ovid Technologies (Wolters Kluwer Health), Vol. 28, No. 8 ( 2021-05-10), p. 859-866
    Abstract: Genitourinary symptoms, such as vaginal dryness and pain with sex, are commonly experienced by postmenopausal women. Comparing treatments for these genitourinary symptoms are restricted by the use of different outcome measures in clinical trials and the omission of outcomes, which may be relevant to women. The aim of this project was to develop a Core Outcome Set (COS) to be reported in clinical trials of treatments for genitourinary symptoms associated with menopause. Methods: We performed a systematic review of randomized controlled trials of treatments for genitourinary symptoms associated with menopause and extracted their outcomes. This list was refined and entered into a two-round modified Delphi survey, which was open to clinicians, researchers, and postmenopausal women from November 2019 to March 2020. Outcomes were scored on a nine-point scale from “not important” to “critically important.” The final COS was determined following two international consensus meetings. Results: A total of 26 unique outcomes were included in the Delphi process, which was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to the Delphi scores to categorize outcomes by importance, which informed the e consensus meetings, attended by 43 participants from 21 countries. The final COS includes eight outcomes: (1) pain with sex, (2) vulvovaginal dryness, (3) vulvovaginal discomfort or irritation, (4) discomfort or pain when urinating, (5) change in most bothersome symptom, (6) distress, bother or interference of genitourinary symptoms, (7) satisfaction with treatment, (8) side effects of treatment. Conclusion: These eight core outcomes reflect the joint priorities of postmenopausal women, clinicians, and researchers internationally. Standardized collection and reporting of these outcomes in clinical trials will facilitate the comparison of different treatments for genitourinary symptoms, advance clinical practice, and ultimately improve outcomes for symptomatic women. Video Summary: http://links.lww.com/MENO/A765.
    Type of Medium: Online Resource
    ISSN: 1530-0374
    URL: Article
    DOI: 10.1097/GME.0000000000001788
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 2071114-1
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  • 2
    Online Resource
    Online Resource
    Protocol for development of a core outcome set for menopausal symptoms (COMMA)
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Menopause Vol. 27, No. 12 ( 2020-09-4), p. 1371-1375
    Details
    In: Menopause, Ovid Technologies (Wolters Kluwer Health), Vol. 27, No. 12 ( 2020-09-4), p. 1371-1375
    Abstract: Menopause is the natural cessation of menstruation and may be accompanied by troublesome symptoms including hot flushes and night sweats (vasomotor symptoms) and genitourinary symptoms. Randomized trials evaluating the safety and effectiveness of interventions for these symptoms have reported a wide range of outcomes and used inconsistent measures. This variation precludes comparing and combining data from different trials. To overcome this limitation, we will develop a Core Outcome Set for Menopausal Symptoms. Methods: We will systematically review the literature to identify the outcomes reported in the interventional trials for vasomotor and genitourinary symptoms. This list will be entered into a two-round modified Delphi survey to be completed by clinicians, researchers, and consumers (women who have experienced menopause). Participants will score outcomes on a nine-point scale from “not important” to “critically important.” Representatives from each stakeholder group will then meet to discuss the results and finalize the Core Outcome Set. Ethics approval was not required as this was considered service evaluation and development. The study is registered with the Core Outcome Measures in Effectiveness Trials Initiative (http://www.comet-initiative.org/studies/details/917). Results: An agreed upon set of minimum outcomes and outcome measures will facilitate combining and comparing findings from future trials of treatments for menopausal symptoms. Conclusions: This Core Outcome Set will better enable women and clinicians to select effective treatments, improve the quality of trial reporting, reduce research wastage, and improve care for women with troublesome menopausal symptoms. Video Summary: http://links.lww.com/MENO/A633.
    Type of Medium: Online Resource
    ISSN: 1530-0374
    URL: Article
    DOI: 10.1097/GME.0000000000001632
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 2071114-1
    Location Call Number Limitation Availability
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    Online Resource
  • 3
    Online Resource
    Online Resource
    A core outcome set for vasomotor symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Menopause Vol. 28, No. 8 ( 2021-04-26), p. 852-858
    Details
    In: Menopause, Ovid Technologies (Wolters Kluwer Health), Vol. 28, No. 8 ( 2021-04-26), p. 852-858
    Abstract: Vasomotor symptoms (VMS) (hot flashes and night sweats) affect most women over the menopause transition. Comparing the safety and effectiveness of treatments for vasomotor symptoms is limited by the use of inconsistent outcome measures, and uncertainty as to which outcomes are most important to symptomatic women. To address this, we have developed a Core Outcome Set (COS) for use in clinical trials of treatments for VMS. Methods: We systematically reviewed the primary outcomes measured in randomized controlled trials of treatments for VMS. These were refined and entered into a two-round modified Delphi survey completed by clinicians, researchers, and postmenopausal women between November 2019 and March 2020. Outcomes were scored on a nine-point scale from “not important” to “critically important.” Two international consensus meetings were held to finalize the COS. Results: Based on the systematic review, 13 separate outcomes were included in the Delphi process. This was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to categorize importance scores obtained during Round 2 of the Delphi survey. These informed discussions at the consensus meetings which were attended by 56 participants from 28 countries. The final COS includes six outcomes: 1) frequency of VMS, 2) severity of VMS, 3) distress, bother or interference caused by VMS, 4) impact on sleep, 5) satisfaction with treatment, and 6) side-effects of treatment. Conclusion: Implementation of this COS will: better enable research studies to accurately reflect the joint priorities of postmenopausal women, clinicians and researchers, standardize outcome reporting, and facilitate combining and comparing results from different studies, and ultimately improve outcomes for women with bothersome VMS. Video Summary: http://links.lww.com/MENO/A763.
    Type of Medium: Online Resource
    ISSN: 1530-0374
    URL: Article
    DOI: 10.1097/GME.0000000000001787
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 2071114-1
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
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