Core Outcome Measures in Effectiveness Trials

Development of a Core Outcome Set for Clinical Effectiveness Trials in Esophageal Cancer Resection Surgery

General Information

Abstract:
OBJECTIVE: Development of a core outcome set (COS) for clinical effectiveness trials in esophageal cancer resection surgery.

BACKGROUND: Inconsistency and heterogeneity in outcome reporting after esophageal cancer resection surgery hampers comparison of trial results and undermines evidence synthesis. COSs provide an evidence-based approach to these challenges.

METHODS: A long list of clinical and patient-reported outcomes was identified and categorized into outcome domains. Domains were operationalized into a questionnaire and patients and health professionals rated the importance of items from 1 (not important) to 9 (extremely important) in 2 Delphi survey rounds. Retained items were discussed at a consensus meeting and a final COS proposed. Professionals were surveyed to request endorsement of the COS.

RESULTS: A total of 68 outcome domains were identified and operationalized into a questionnaire; 116 (91%) of consenting patients and 72 (77%) of health professionals completed round 1. Round 2 response rates remained high (87% patients, 93% professionals). Rounds 1 and 2 prioritized 43 and 19 items, respectively. Retained items were discussed at a patient consensus meeting and a final 10-item COS proposed, endorsed by 61/67 (91%) professionals and including: overall survival; in-hospital mortality; inoperability; need for another operation; respiratory complications; conduit necrosis and anastomotic leak; severe nutritional problems; ability to eat/drink; problems with acid indigestion or heartburn; and overall quality of life.

CONCLUSIONS: The COS is recommended for all pragmatic clinical effectiveness trials in esophageal cancer resection surgery. Further work is needed to delineate the definitions and parameters and explore best methods for measuring the individual outcomes.

Authors:
Kerry N. L. Avery, PhD, Katy A. Chalmers, PhD, Sara T. Brookes, PhD, Natalie S. Blencowe, PhD, Karen Coulman, PhD, Katie Whale, DHealthPsy, Chris Metcalfe, PhD, y and Jane M. Blazeby, MD z, on behalf of the ROMIO Study Group, the CONSENSUS Esophageal Cancer Working Group

Publication

Journal:
Annals of Surgery
Volume:
267
Issue:
4
Pages:
700 - 710
Year:
2017
DOI:
Further Study Information

Date:
January 2010 - April 2013
Funding source(s):
This study was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 10/50/65). This work was supported by the Medical Research Council ConDUCT-II (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures) Hub for Trials Methodology Research (MR/K025643/1) (http://www.bristol.ac.uk/social-community-medicine/centers/conduct2/). J.B. is an NIHR Senior Investigator.

Health Area

Disease Category
Cancer

Disease Name
Oesophageal cancer

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Consensus meeting
Delphi process
Interview
Systematic review

A long list of clinical and patient-reported outcomes was identified and categorized into outcome domains. Domains were operationalized into a questionnaire and patients and health professionals rated the importance of items from 1 (not important) to 9 (extremely important) in 2 Delphi survey rounds. Retained items were discussed at a consensus meeting and a final COS proposed. Professionals were surveyed to request endorsement of the COS.


Stakeholders Involved

Clinical experts
Consumers (patients)

Study Type

COS for clinical trials or clinical research

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