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Influence of methodology upon the identification of potential core outcomes: recommendations for core outcome set developers are needed

Influence of methodology upon the identification of potential core outcomes: recommendations for... Primary outcomes for treatment of heavy menstrual bleeding Influence of methodology upon the identification of potential core outcomes: recommendations for core outcome set developers are needed JMN Duffy, RJ McManus Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK Linked article: This is a mini commentary on MC Herman et al., pp. 1593–1598 in this issue. To view this article visit http://dx.doi.org/10.1111/1471-0528.14054. Published Online 18 July 2016. The linked study by Herman and col- menstrual bleeding trials. Core out- decisions that are rarely justified. It is leagues mapped the availability of come sets are agreed minimum sets of interesting to consider the potential outcomes in studies of heavy men- outcomes that can be measured in a effect on a subsequent outcome set of strual bleeding, identifying widespread standardised manner and reported limiting a systematic review to pri- variation including 12 different pri- consistently in the final publication. A mary outcomes as has been done in mary outcomes, measured by an array core outcome set is developed in the linked study. of different definitions and instru- three broad stages: (1) identifying Including women-orientated out- ments (Herman et al. BJOG;123:1593– potential core outcomes; (2) deter- comes is vital. Amenorrhoea is not 8). They found the most commonly mining core outcomes using robust necessarily a desirable outcome for reported primary outcome, blood loss, consensus methods engaging key women with heavy menstrual bleed- to be measured in five different stakeholders; and (3) determining ing. Quality of life — potentially rel- domains and by eight different meth- how core outcomes should be mea- evant for all — was reported by less ods. This heterogeneity would doubt- sured (Williamson et al. Trials than a tenth of included studies. Fur- less be worse had around 40% of 2012;13:132). In our speciality, the thermore, no harms or adverse trials initially identified not have been Core Outcomes in Women’s and events were reported as primary out- excluded for a lack of primary out- Newborn Health (CROWN) initiative, comes, limiting a healthcare profes- come or power calculation. a consortium of 76 women’s health sional or patient’s ability to The primary outcome should be journals, encourages healthcare pro- considering the trade-offs between the outcome of greatest therapeutic fessionals, researchers, and patients to benefits and harms of therapeutic importance (Schulz et al. BMJ develop such outcome sets (Khan. interventions. 2010;340:c332). Researchers may need BJOG 2014;121:1181-2). Given the uncertainty in core to make pragmatic decisions when However, to our knowledge, there outcome set development methods, designing trials. Funding and time is limited guidance for the most further methodological research is limitations may mean outcomes with appropriate methods to develop core urgently required. A research higher event rates that are easy to outcome sets (Williamson et al. Trials agenda could be designed through measure are more attractive, increas- 2012;13:132). For example, in the the CROWN initiative to ensure ing the statistical power of the trial at absence of a standardised approach, that future core outcome sets devel- the expense of relevance for patients. different researchers have designed oped across our speciality are Researchers may be unable to select their systematic review using different robust. otherwise appropriate outcomes methods, perhaps limiting the search because of the lack of objective defini- Disclosure of interests strategy by date or language, limiting tions or validated instruments. included studies by size or method- Full disclosure of interests available The authors advocate the develop- ological quality, or only extracting to view online as supporting infor- ment of a core outcome set for heavy primary outcomes from trial reports, mation. & ª 2016 Royal College of Obstetricians and Gynaecologists 1599 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png BJOG An International Journal of Obstetrics & Gynaecology Wiley

Influence of methodology upon the identification of potential core outcomes: recommendations for core outcome set developers are needed

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Publisher
Wiley
Copyright
Copyright © 2016 Royal College of Obstetricians and Gynaecologists
ISSN
1470-0328
eISSN
1471-0528
DOI
10.1111/1471-0528.14219
Publisher site
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Abstract

Primary outcomes for treatment of heavy menstrual bleeding Influence of methodology upon the identification of potential core outcomes: recommendations for core outcome set developers are needed JMN Duffy, RJ McManus Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK Linked article: This is a mini commentary on MC Herman et al., pp. 1593–1598 in this issue. To view this article visit http://dx.doi.org/10.1111/1471-0528.14054. Published Online 18 July 2016. The linked study by Herman and col- menstrual bleeding trials. Core out- decisions that are rarely justified. It is leagues mapped the availability of come sets are agreed minimum sets of interesting to consider the potential outcomes in studies of heavy men- outcomes that can be measured in a effect on a subsequent outcome set of strual bleeding, identifying widespread standardised manner and reported limiting a systematic review to pri- variation including 12 different pri- consistently in the final publication. A mary outcomes as has been done in mary outcomes, measured by an array core outcome set is developed in the linked study. of different definitions and instru- three broad stages: (1) identifying Including women-orientated out- ments (Herman et al. BJOG;123:1593– potential core outcomes; (2) deter- comes is vital. Amenorrhoea is not 8). They found the most commonly mining core outcomes using robust necessarily a desirable outcome for reported primary outcome, blood loss, consensus methods engaging key women with heavy menstrual bleed- to be measured in five different stakeholders; and (3) determining ing. Quality of life — potentially rel- domains and by eight different meth- how core outcomes should be mea- evant for all — was reported by less ods. This heterogeneity would doubt- sured (Williamson et al. Trials than a tenth of included studies. Fur- less be worse had around 40% of 2012;13:132). In our speciality, the thermore, no harms or adverse trials initially identified not have been Core Outcomes in Women’s and events were reported as primary out- excluded for a lack of primary out- Newborn Health (CROWN) initiative, comes, limiting a healthcare profes- come or power calculation. a consortium of 76 women’s health sional or patient’s ability to The primary outcome should be journals, encourages healthcare pro- considering the trade-offs between the outcome of greatest therapeutic fessionals, researchers, and patients to benefits and harms of therapeutic importance (Schulz et al. BMJ develop such outcome sets (Khan. interventions. 2010;340:c332). Researchers may need BJOG 2014;121:1181-2). Given the uncertainty in core to make pragmatic decisions when However, to our knowledge, there outcome set development methods, designing trials. Funding and time is limited guidance for the most further methodological research is limitations may mean outcomes with appropriate methods to develop core urgently required. A research higher event rates that are easy to outcome sets (Williamson et al. Trials agenda could be designed through measure are more attractive, increas- 2012;13:132). For example, in the the CROWN initiative to ensure ing the statistical power of the trial at absence of a standardised approach, that future core outcome sets devel- the expense of relevance for patients. different researchers have designed oped across our speciality are Researchers may be unable to select their systematic review using different robust. otherwise appropriate outcomes methods, perhaps limiting the search because of the lack of objective defini- Disclosure of interests strategy by date or language, limiting tions or validated instruments. included studies by size or method- Full disclosure of interests available The authors advocate the develop- ological quality, or only extracting to view online as supporting infor- ment of a core outcome set for heavy primary outcomes from trial reports, mation. & ª 2016 Royal College of Obstetricians and Gynaecologists 1599

Journal

BJOG An International Journal of Obstetrics & Gynaecology – Wiley

Published: Sep 1, 2016

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