Core Outcome Measures in Effectiveness Trials

Development of a core outcome set for early phase studies of innovative invasive procedures

General Information

Unlike the stringent regulation that accompanies the introduction of new pharmaceutical products, methods for bringing new invasive (surgical) procedures into clinical practice are haphazard and largely ungoverned. Early phase studies where innovation of surgery is occurring are rare, poorly designed and infrequently reported. This means that surgeons often rely on flawed and biased case studies, or even their own preferences, to inform how they treat their patients, which may compromise patient safety and outcomes.
A significant barrier to the evaluation of surgical innovation are inconsistencies with the selection, measurement and reporting of benefit and harm outcomes in early phase surgical studies. Effective systems and mandatory requirements for surgeons to report their outcomes when developing or implementing a new type of surgery are lacking. Heterogeneity in outcome selection, measurement and reporting limits evidence syntheses and risks outcome reporting bias, potentially leading to overly-optimistic assessment of new surgical interventions and under reporting of harms. Innovative surgical procedures may therefore become standard clinical practice without an evidence base, the consequences of which can be severe. The development of a generic core outcome set, a minimum mandated set of outcomes to report in all studies of surgical innovation, would promote standardised outcome selection and reporting to ensure that new surgical innovations are introduced safely and efficiently.

Principal investigator: Kerry Avery, NIHR Bristol Biomedical Research Centre Surgical Innovation Theme, University of Bristol.
Contributors: Members of the NIHR Bristol Biomedical Research Centre Surgical Innovation Theme, University of Bristol.

Further Study Information

Current Stage:
November 2017 - March 2022
Funding source(s):
This study is supported by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The views expressed are those of the authors and not necessarily those of the UK National Health Service, National Institute for Health Research, or Department of Health

Health Area

Disease Category

Disease Name

Target Population

Age Range
18 - 100


Nature / type of Intervention


Consensus meeting
Delphi process
Literature review
Semi structured discussion

Semi structured discussion: roundtable
Semi structured discussion: meeting(s)
Semi structured discussion: workshop(s)

Stakeholders Involved

Clinical experts
Consumers (patients)
Journal editors
Patient/ support group representatives
Service providers
Service users

Study Type

COS for clinical trials or clinical research
COS for practice

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