Core outcome sets (COS)
What is a core outcome set?
A COS is a minimum set of outcomes of specific importance that should be measured and reported in all clinical trials for a specific condition. COS are developed with the input of relevant stakeholders, and patient engagement is a central part in the process of COS development.
Why use core outcome sets?
Clinical trials evaluate the safety and efficacy of interventions, treatments, or care procedures. To this end, one intervention is compared against an alternative intervention, for example placebo, in a trial. The effect of the intervention is seen as the difference between the groups when measuring different outcomes. It is crucial that these outcomes are of therapeutic importance to relevant stakeholders, such as patients and clinicians.
To provide the best clinical evidence, clinical trials within a field are systematically collected, assessed, and synthesized in systematic reviews. Often it is not possible to synthesize results of individual studies because different outcomes were measured. This, in turn, lowers the certainty of the evidence for the specific intervention.
As a producer of systematic reviews, SBU uses information from clinical trials. As such, SBU has been involved as a participant in the development of COS. SBU endorses the usage of robustly developed COS in clinical trials and in systematic reviews.
SBU participation in development of COS
Transcription of manuscript for “SBU and core outcomes sets”
Prioritization of evidence gaps using the James Lind Alliance method
Why do we need to set priorities for evidence gaps?
The purpose of this type of project is to highlight the perspectives of patients and clinicians in discussions as to which research questions should be given priority. In this context, the opinions of researchers, research funders and commercial agents are often more self-evident. However, it is also important to ascertain which research questions matter most to patients and clinicians i.e., which topics are considered highly relevant by the end-users. In 2009, Chalmers et al. calculated that as much as 85 per cent of research funds awarded to practice-oriented research yields study results which are not applicable in practice for patients or healthcare personnel. One contributing factor is that questions which are important to these end-users are not given priority in research.
The method applied in these prioritisation projects is derived from the non-profit British organization James Lind Alliance (JLA) . It supports the process of convening patients and clinicians in joint research priority setting exercises or priority setting partnerships (PSP).
Briefly, these projects consist of the following steps:
- Identification of research questions through an open survey
- A two-round Delphi survey with relevant stakeholders (i.e., patients, professionals, and researchers)
- A final prioritization in a priority setting meeting, where the highest ranked questions from the Delphi survey are discussed
Figure 1. Schematic illustration of the design of the project
Published SBU reports involving prioritization of research questions
- Top 10 research priorities relating to treatments for ADHD
- Prioritised research areas within the fields of prevention, diagnosis and treatment of maternal birth injuries
- Priorities for research on social services – perspectives from users, policy-makers and practitioners
- Prioritisation of research questions about maternal birth injuries
- Priority setting of future research into long-term symptoms of Covid-19 infection (post-acute sequelae of Covid-19 or Long Covid)
- Prioritized knowledge- and development needs within child- and adolescent inpatient psychiatric care
- Prioritized research questions regarding pregnancy-related pelvic girdle pain