Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

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Abstract

Background

There is substantial variation in how menopausal vasomotor symptoms are reported and measured among intervention studies. This has prevented meaningful comparisons between treatments and limited data synthesis.

Objectives

To review systematically the outcome reporting and measures used to assess menopausal vasomotor symptoms from randomised controlled trials of treatments.

Search strategy

We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from inception to May 2018.

Selection criteria

Randomised controlled trials with a primary outcome of menopausal vasomotor symptoms in women and a sample size of at least 20 women per study arm.

Data collection and analysis

Data about study characteristics, primary vasomotor‐related outcomes and methods of measuring them.

Main results

The search identified 5591 studies, 214 of which were included. Forty‐nine different primary reported outcomes were identified for vasomotor symptoms and 16 different tools had been used to measure these outcomes. The most commonly reported outcomes were frequency (97/214), severity (116/214), and intensity (28/114) of vasomotor symptoms or a composite of these outcomes (68/214). There was little consistency in how the frequency and severity/intensity of vasomotor symptoms were defined.

Conclusions

There is substantial variation in how menopausal vasomotor symptoms have been reported and measured in treatment trials. Future studies should include standardised outcome measures which reflect the priorities of patients, clinicians, and researchers. This is most effectively achieved through the development of a Core Outcome Set. This systematic review is the first step towards development of a Core Outcome Set for menopausal vasomotor symptoms.

Tweetable summary

Menopausal hot flushes and night sweats have been reported in 49 different ways in clinical research. A core outcome set is urgently required.

Tweetable summary

Menopausal hot flushes and night sweats have been reported in 49 different ways in clinical research. A core outcome set is urgently required.

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Most cited references 227

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How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

Cecilia Prinsen, Sunita Vohra, Michael Rose … (2016)

Background In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a “Core Outcome Set” (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. Methods Informed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed. Results Of the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %). Conclusions This study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1555-2) contains supplementary material, which is available to authorized users.

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MOMENT – Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Nicola L Harman, Iain Bruce, Peter Callery … (2013)

Background Cleft palate (CP) has an incidence of approximately 1 in 700. Children with CP are also susceptible to otitis media with effusion (OME), with approximately 90% experiencing nontrivial OME. There are several approaches to the management of OME in children with CP. The Management of Otitis Media with Effusion in Children with Cleft Palate (MOMENT) study is a feasibility study that includes the development of a core outcome set for use in future trials of the management of OME in children with CP. Methods/Design The MOMENT study will include a systematic review of the literature to identify a list of outcomes that have previously been reported. This list of outcomes will be used in a Delphi study with cleft clinicians. The Delphi study is anticipated to include three rounds. The first round will ask clinicians to score the outcome list and to add any outcomes they think are relevant. The second round involves presentation of scores according to stakeholder group and the opportunity for participants to rescore outcomes. To ensure that the opinion of parents and children are sought, qualitative interviews will be completed with a purposive sample in parallel. In the final round of the Delphi process, participants will be shown the distribution of scores, for each outcome, for all stakeholder groups separately as well as a summary of the results concerning outcomes from the qualitative interviews with parents. A final consensus meeting will be held with all stakeholders, including parents and children, to review outcomes. Discussion A core outcome set represents the minimum that should be measured in a clinical trial for a particular condition. The MOMENT study will aim to identify a core outcome set that can be used in future trials of the management of OME, improving the consistency of research in this clinical area.

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Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial

Eleanor Mann, Melanie J Smith, Jennifer Hellier … (2012)

Summary Background Hot flushes and night sweats (HFNS) affect 65–85% of women after breast cancer treatment; they are distressing, causing sleep problems and decreased quality of life. Hormone replacement therapy is often either undesirable or contraindicated. Safe, effective non-hormonal treatments are needed. We investigated whether cognitive behavioural therapy (CBT) can help breast cancer survivors to effectively manage HFNS. Methods In this randomised controlled trial, we recruited women from breast clinics in London, UK, who had problematic HFNS (minimum ten problematic episodes a week) after breast-cancer treatment. Participants were randomly allocated to receive either usual care or usual care plus group CBT (1:1). Randomisation was done in blocks of 12–20 participants, stratifying by age (younger than 50 years, 50 years or older), and was done with a computer-generated sequence. The trial statistician and researchers collecting outcome measures were masked to group allocation. Group CBT comprised one 90 min session a week for 6 weeks, and included psycho-education, paced breathing, and cognitive and behavioural strategies to manage HFNS. Assessments were done at baseline, 9 weeks, and 26 weeks after randomisation. The primary outcome was the adjusted mean difference in HFNS problem rating (1–10) between CBT and usual care groups at 9 weeks after randomisation. Analysis of the primary endpoint was done by modified intention to treat. The trial is registered, ISRCTN13771934, and was closed March 15, 2011. Findings Between May 5, 2009, and Aug 27, 2010, 96 women were randomly allocated to group CBT (n=47) or usual care (n=49). Group CBT significantly reduced HFNS problem rating at 9 weeks after randomisation compared with usual care (mean difference −1·67, 95% CI −2·43 to −0·91; p<0·0001) and improvements were maintained at 26 weeks (mean difference −1·76, −2·54 to −0·99; p<0·0001). We recorded no CBT-related adverse events. Interpretation Group CBT seems to be a safe and effective treatment for women who have problematic HFNS after breast cancer treatment with additional benefits to mood, sleep, and quality of life. The treatment could be incorporated into breast cancer survivorship programmes and delivered by trained breast cancer nurses. Funding Cancer Research UK.

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Author and article information

Contributors

S Iliodromiti: s.iliodromiti@qmul.ac.uk

Journal

Journal ID (nlm-ta): BJOG

Journal ID (iso-abbrev): BJOG

Journal ID (doi): 10.1111/(ISSN)1471-0528

Journal ID (publisher-id): BJO

Title: Bjog

Publisher: John Wiley and Sons Inc. (Hoboken )

ISSN (Print): 1470-0328

ISSN (Electronic): 1471-0528

Publication date (Electronic): 13 November 2019

Publication date (Print): February 2020

Volume: 127

Issue: 3 ( doiID: 10.1111/bjo.v127.3 )

Pages: 320-333

Affiliations

[ ¹ ] Women’s Health Division Blizard Institute Queen Mary University London London UK

[ ² ] School of Medicine University of Glasgow Glasgow UK

[ ³ ] Department of Obstetrics Shanghai First Maternity and Infant Hospital Tongji University School of Medicine Shanghai China

[ ⁴ ] Institute of Psychiatry, Psychology and Neuroscience Kings College London London UK

[ ⁵ ] Women’s Health Research Program School of Public Health and Preventive Medicine Monash University Melbourne Australia

[ ⁶ ] Faculty of Medicine School of Public Health University of Queensland Brisbane Australia

[ ⁷ ] Department of Obstetrics and Gynaecology University of Melbourne and The Royal Women’s Hospital Victoria Australia

Author notes

[*] [* ] Correspondence: S Iliodromiti, Women’s Health Research Unit, Centre for Primary Care and Public Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London E1 2AB, UK. Email: s.iliodromiti@ 123456qmul.ac.uk

[†]

Joint first authors.

Article

Publisher ID: BJO15990

DOI: 10.1111/1471-0528.15990

PMC ID: 6972542

PubMed ID: 31621155

SO-VID: 73e3739a-dd42-485f-bffc-bb7a52c01c16

License:

This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

History

Date accepted : 10 October 2019

Page count

Figures: 1, Tables: 3, Pages: 14, Words: 12387

Funding

Funded by: Medical Research Council , open-funder-registry 10.13039/501100000265;

Award ID: Skills Development Fellowship MR/N015177/1 for SI

Funded by: National Health and Medical Research Council , open-funder-registry 10.13039/501100000925;

Award ID: APP 1058935

Award ID: APP1121844

Custom metadata

source-schema-version-number 2.0

cover-date February 2020

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:21.01.2020

ScienceOpen disciplines: Obstetrics & Gynecology

Keywords: core outcomes,menopause,randomised clinical trials,vasomotor symptoms

Data availability:

ScienceOpen disciplines: Obstetrics & Gynecology

Keywords: core outcomes, menopause, randomised clinical trials, vasomotor symptoms

Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

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Abstract

Background

Objectives

Search strategy

Selection criteria

Data collection and analysis

Main results

Conclusions

Tweetable summary

Tweetable summary

Related collections

Bioscientifica Reproduction

Most cited references 227

How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

MOMENT – Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial

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