2 Obstetrics and Gynecology, Amsterdam
University Medical Centers, Amsterdam, University of Amsterdam, The
Netherlands
The authors report no conflict of interest.
Title: Patient voice in Core Outcome Sets: Are we hearing but not
listening?
The article by Kgosidialwa O. et al. is a good example of the process of
uniformization of research1. In the absence of
unambiguous empirical evidence, a (modified) Delphi consensus procedure
is the method of choice to develop agreement on definitions, core
outcome sets, and other sets of relevant items. The Delphi procedure
taps into the contemporary knowledge and values of individual
participants, including lay experts and patient
representatives2. Patient involvement is advocated
because they are the primary stakeholders and best informed about what
outcomes are most important to them. An example: the perception of the
importance of breast feeding as an outcome of obstetric intervention
studies may differ between patients and health care providers.
The COMET initiative provides tools for COS development, and initiated a
working group for patient involvement (‘People and Patient
Participation, Involvement and Engagement (PoPPIE)’). A full
understanding of the concept of the COS itself for all stakeholders and
particularly for patients is of paramount importance and promoted by a
video explaining the COS concept for patients and other
stakeholders3.
It is important to actively counteract the effects of biases such as
heterogeneity in knowledge and numbers among stakeholder groups and
carefully balance participants between stakeholder groups in order to
allow for minority opinions and prevent attrition bias (thereby
overestimating agreement).
In our own experience in COS development procedures, several issues
complicate patient involvement. This is seen in many studies, including
the one by Kgosidialwa O. et al.1:
The patient group is typically smaller than the group of professional
experts. In the current study, 46/205 (22%) participants were
patients in the first round and 2/26 (8%) of the participants were in
the consensus meeting. Also, no stratified responses were analysed
(which would also pose challenges for semi anonymity). Thus, the
patient voice may not be sufficiently heard among other stakeholders.
We wonder: should the patient have a stronger voice than the other
stakeholders? The COMET methodology does not give guidance on
prioritized inclusion of outcomes that have a very high percentage
agreement (for example >90%) in specific predefined
stakeholder groups (like patients). To illustrate the point: of 21
outcomes scoring >90% among patients in the first round
only 5 were included in the COS and of 20 outcomes scoring
> 90% by the professionals 16 were included in the COS:
patient preferences are numerically undervalued.
In a consensus meeting, individuals from professional stakeholder
groups are all highly educated and experienced caregivers or
researchers. Patient participants, often recruited from patient
organisations, also have a selection towards higher education, but
their experience of the condition is usually personal. Given the
obvious difference in medical expertise means patients will be
influenced by the professional stakeholders. In the example above, 14
of 21 outcomes that scored >90% in the patient group
were excluded during the consensus meeting.
Consensus procedures clearly have the potential to bring research
forward in many areas. This has increased uniformity and fostered
collaboration. We applaud that it has become self-evident that
involvement of the primary stakeholders is key. However, in our view
this needs to be more than a pretence: it is time to evaluate if the
mechanics of these procedures adequately allow the perspective of what
patients find valuable to be incorporated.
1. Kgosidialwa O, Bogdanet D, Egan AM, et al. A core outcome set for the
treatment of pregnant women with pregestational diabetes: an
international consensus study. BJOG: An International Journal of
Obstetrics & Gynaecology. 2021.
2. Williamson PR, Altman DG, Bagley H, et al. The COMET Handbook:
version 1.0. Trials. 2017;18(Suppl 3):280.
3. COMET. The COMET Initiative’s Guide to Selecting Outcomes in Clinical
Trials. https://youtu.be/Hpmtk4v5xpA. Published 2018. Accessed.