Methodological decisions influence the identification of potential core outcomes in studies related to pre-eclampsia: an analysis informing the development of recommendations for future core outcome set developers.
Core outcome sets
outcomes
pre-eclampsia
qualitative interviews
systematic review
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:
Nov 2019
Nov 2019
Historique:
accepted:
12
07
2019
pubmed:
31
7
2019
medline:
17
10
2019
entrez:
31
7
2019
Statut:
ppublish
Résumé
To quantify the effect of different methodological decisions on the identification of potential core outcomes to inform the development of recommendations for future core coutcome set developers. Mixed methods study. A core outcome set for pre-eclampsia was used as an exemplar. A long list of potential core outcomes was developed by undertaking a systematic review of pre-eclampsia trials and performing a thematic analysis of in-depth patient interviews. Specific methods used to generate long lists of potential core outcomes were evaluated. Different methodological decisions had a substantial impact on the identification of potential core outcomes. Extracting outcomes from published pre-eclampsia trials was an effective way of identifying 48 maternal, eight fetal, 25 neonatal outcomes, and eight patient-reported outcomes. Limiting the extraction of outcomes to primary outcomes or outcomes commonly reported in pre-eclampsia trials reduced the number and diversity of potential core outcomes identified. Thematic analysis of in-depth patient interviews ensured an additional five patient reported outcomes and six outcomes related to future child health were identified. Future core outcome set developers should use quantitative and qualitative methods when developing a long list of potential core outcomes. TWEETABLE ABSTRACT: @OfficialNIHR research published in @BJOGtweets informs new recommendations for future @coreoutcomes developers.
Identifiants
pubmed: 31359560
doi: 10.1111/1471-0528.15892
doi:
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1482-1490Subventions
Organisme : Department of Health
ID : DRF-2014-07-051
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/N008405/1
Pays : United Kingdom
Organisme : Department of Health
ID : NIHR-RP-02-12-015
Pays : United Kingdom
Organisme : National Institute for Health Research
ID : DRF-2014-07-051
Investigateurs
Mark Brown
(M)
Chris Gale
(C)
William Grobman
(W)
Ray Fitzpatrick
(R)
S Ananth Karumanchi
(SA)
Nuala Lucas
(N)
Laura Magee
(L)
Ben Mol
(B)
Michael Stark
(M)
Shakila Thangaratinam
(S)
Mathew Wilson
(M)
Janneke Van't Hooft
(J)
Peter von Dadelszen
(P)
Paula R Williamson
(PR)
Khalid S Khan
(KS)
Informations de copyright
© 2019 Royal College of Obstetricians and Gynaecologists.
Références
Townsend R, Duffy JMN, Khalil A. Increasing value and reducing research waste in obstetrics: towards woman-centred research. Ultrasound Obstet Gynecol 2019. https://doi.org/10.1002/uog.20294
Duffy JMN, Ziebland S, von DP, McManus RJ. Tackling poorly selected, collected, and reported outcomes in obstetrics and gynecology research. Am J Obstet Gynecol 2019;220:71.e1-.e4.
Wilkinson J, Bhattacharya S, Duffy J, Kamath M, Marjoribanks J, Repping S, et al. Reproductive medicine: still more ART than science? BJOG 2019;126:138-41.
Duffy J, Bhattacharya S, Herman M, Mol B, Vail A, Wilkinson J, et al. Reducing research waste in benign gynaecology and fertility research. BJOG 2017;124:366-9.
Sileo FG, Duffy JMN, Townsend R, Khalil A. Addressing the variation in outcome reporting in high risk twin studies: the key to reducing research waste and improving clinical care. Ultrasound Obstet Gynecol 2018;54:10-15.
Duffy JMN, Rolph R, Gale C, Hirsch M, Khan KS, Ziebland S, et al. Core outcome sets in women's and newborn health: a systematic review. BJOG 2017;124:1481-9.
Whitehouse KC, Kim CR, Ganatra B, Duffy JMN, Blum J, Brahmi D, et al. Standardizing abortion research outcomes (STAR): a protocol for developing, disseminating and implementing a core outcome set for medical and surgical abortion. Contraception 2017;95:437-41.
Khalil A, Duffy JMN, Perry H, Ganzevoort W, Reed K, Baschat AA, et al. Study protocol: developing, disseminating, and implementing a core outcome set for selective fetal growth restriction in monochorionic twin pregnancies. Trials 2019;20:35.
Webbe J, Brunton G, Ali S, Duffy JM, Modi N, Gale C. Developing, implementing and disseminating a core outcome set for neonatal medicine. BMJ Paediatrics Open. 2017;1:e000048.
Perry H, Duffy JMN, Reed K, Baschat A, Deprest J, Hecher K, et al. A core outcome set for the evaluation of treatments for twin-twin transfusion syndrome. Ultrasound Obstet Gynecol 2019;54:255-61.
Khalil A, Perry H, Duffy J, Reed K, Baschat A, Deprest J, et al. Twin-Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set. Trials. 2017;18:325.
Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, et al. The COMET handbook: version 1.0. Trials 2017;18(S3):280.
Duffy J, McManus R. Influence of methodology upon the identification of potential core outcomes: recommendations for core outcome set developers are needed. BJOG 2016;123:1599.
Duffy JMN, van ‘HJ, Gale C, Brown M, Grobman W, Fitzpatrick R, et al. A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia. Pregnancy Hypertens 2016;6:274-8.
Duffy JMN, Hirsch M, Kawsar A, Gale C, Pealing L, Plana MN, et al. Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia. BJOG 2017;124:1829-39.
Duffy JMN, Hirsch M, Gale C, Pealing L, Kawsar A, Showell M, et al. A systematic review of primary outcome and outcome measure reporting in randomized trials evaluating treatments for preeclampsia. International Journal of Gynecology and Obstetrics. 2017;139:262-7.
Duffy JMN, Thompson T, Hinton L, Salinas M, McManus RJ, Ziebland S. What outcomes should researchers select, collect, and report in pre-eclampsia research? A qualitative study exploring the views of women with lived experience of pre-eclampsia BJOG 2019;126:637-46.
Duffy J, Hirsch M, Pealing L, Showell M, Khan K, Ziebland S, et al. Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation. BJOG 2018;125:795-803.
Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials 1996;17:1-12.
Kingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. BJA Education. 2017;17:137-44.
Hirsch M, Duffy JMN, Barker C, Hummelshoj L, Johnson NP, Mol B, et al. Protocol for developing, disseminating and implementing a core outcome set for endometriosis. BMJ Open 2016;6:e013998.
van‘t Hooft J, Duffy JM, Daly M, Williamson PR, Meher S, Thom E, et al. A core outcome set for evaluation of interventions to prevent preterm birth. Obstet Gynecol 2016;127:49-58.
Duffy JMN, Bhattacharya S, Curtis C, Evers JLH, Farquharson RG, Franik S, et al. A protocol developing, disseminating and implementing a core outcome set for infertility. Hum Reprod Open 2018;2018:hoy007.
Meher S. Alfirevic Z. Choice of primary outcomes in randomised trials and systematic reviews evaluating interventions for preterm birth prevention: a systematic review. BJOG 2014;121:1188-94.
Hirsch M, Duffy JMN, Kusznir JO, Davis CJ, Plana MN, Khan KS. Variation in outcome reporting in endometriosis trials: a systematic review. Am J Obstet Gynecol 2016;214:452-64.
Perry H, Duffy JMN, Umadia O, Khalil A. Outcome reporting across randomized trials and observational studies evaluating treatments for twin-twin transfusion syndrome: systematic review. Ultrasound Obstet Gynecol 2018;52:577-85.
Pergialiotis V, Durnea C, Elfituri A, Duffy J, Doumouchtsis S, International Collaboration for Harmonising Outcomes R, et al. Do we need a core outcome set for childbirth perineal trauma research? A systematic review of outcome reporting in randomised trials evaluating the management of childbirth trauma BJOG 2018;125:1522-31.
Durnea CM, Pergialiotis V, Duffy JMN, Bergstrom L, Elfituri A, Doumouchtsis SK, et al. A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set. Int Urogynecol J 2018;29:1727-45.
de Mattos Lourenco TR, Pergialiotis V, Duffy JMN, Durnea C, Elfituri A, Haddad JM, et al. A systematic review on reporting outcomes and outcome measures in trials on synthetic mesh procedures for pelvic organ prolapse: urgent action is needed to improve quality of research. Neurourol Urodyn 2019;38:509-24.