Choice of primary and secondary outcomes in randomised controlled trials evaluating treatment for uterine fibroids: a systematic review.
Core outcome sets
fibroids
leiomyomas
outcomes
Journal
BJOG : an international journal of obstetrics and gynaecology
ISSN: 1471-0528
Titre abrégé: BJOG
Pays: England
ID NLM: 100935741
Informations de publication
Date de publication:
Feb 2022
Feb 2022
Historique:
accepted:
12
08
2021
pubmed:
19
9
2021
medline:
27
1
2022
entrez:
18
9
2021
Statut:
ppublish
Résumé
Core outcome sets aim to reduce research heterogeneity and standardise reporting, allowing meaningful comparisons between studies. To report on outcomes used in randomised controlled trials (RCTs) investigating uterine fibroid treatments, towards the development of a core outcome set for fibroid research. Database search of MEDLINE, PubMed, EMBASE and CINAHL (inception to July 2021) for all English-language RCTs involving surgical or radiological fibroid treatments. A total of 1885 texts were screened for eligibility by two reviewers independently according to PRISMA methodology. JADAD and Management of Otitis Media with Effusion in Cleft Palate (MOMENT) scores were used to assess methodological and outcome reporting quality of studies, respectively. Outcomes were mapped to nine domains. Non-parametric tests for correlation and to compare group medians were undertaken. There were 23 primary outcomes (23 outcome measures) and 173 secondary outcomes (95 outcome measures) reported in 60 RCTs (5699 participants). The domains with highest frequency of primary outcomes reported were bleeding and quality of life (QoL). The most frequent primary outcomes were postoperative pain, QoL and menstrual bleeding. No primary outcomes were mapped to fertility domains. Median MOMENT outcome score was 5 (interquartile range 3). There was correlation between MOMENT outcome score and JADAD scores (r = 0.491, P = 0.0001), publishing journal impact factor (r = 0.419, P = 0.008) and publication year (r = 0.332, P = 0.01). There is substantial variation in the outcomes reported in fibroid RCTs. There is a need for a core outcome set for fibroid research, to allow improved understanding regarding the effects of different treatments. There is substantial variation in outcomes reported in uterine fibroid randomised controlled trials.
Sections du résumé
BACKGROUND
BACKGROUND
Core outcome sets aim to reduce research heterogeneity and standardise reporting, allowing meaningful comparisons between studies.
OBJECTIVES
OBJECTIVE
To report on outcomes used in randomised controlled trials (RCTs) investigating uterine fibroid treatments, towards the development of a core outcome set for fibroid research.
SELECTION STRATEGY
UNASSIGNED
Database search of MEDLINE, PubMed, EMBASE and CINAHL (inception to July 2021) for all English-language RCTs involving surgical or radiological fibroid treatments.
DATA COLLECTION AND ANALYSIS
METHODS
A total of 1885 texts were screened for eligibility by two reviewers independently according to PRISMA methodology. JADAD and Management of Otitis Media with Effusion in Cleft Palate (MOMENT) scores were used to assess methodological and outcome reporting quality of studies, respectively. Outcomes were mapped to nine domains. Non-parametric tests for correlation and to compare group medians were undertaken.
MAIN RESULTS
RESULTS
There were 23 primary outcomes (23 outcome measures) and 173 secondary outcomes (95 outcome measures) reported in 60 RCTs (5699 participants). The domains with highest frequency of primary outcomes reported were bleeding and quality of life (QoL). The most frequent primary outcomes were postoperative pain, QoL and menstrual bleeding. No primary outcomes were mapped to fertility domains. Median MOMENT outcome score was 5 (interquartile range 3). There was correlation between MOMENT outcome score and JADAD scores (r = 0.491, P = 0.0001), publishing journal impact factor (r = 0.419, P = 0.008) and publication year (r = 0.332, P = 0.01).
CONCLUSION
CONCLUSIONS
There is substantial variation in the outcomes reported in fibroid RCTs. There is a need for a core outcome set for fibroid research, to allow improved understanding regarding the effects of different treatments.
TWEETABLE ABSTRACT
CONCLUSIONS
There is substantial variation in outcomes reported in uterine fibroid randomised controlled trials.
Identifiants
pubmed: 34536313
doi: 10.1111/1471-0528.16933
doi:
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
345-355Informations de copyright
© 2021 John Wiley & Sons Ltd.
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