Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Apr;267(4):700-710.
doi: 10.1097/SLA.0000000000002204.

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

Kerry N L Avery  1 , Katy A Chalmers  1 , Sara T Brookes  1 , Natalie S Blencowe  1 , Karen Coulman  1 , Katie Whale  1 , Chris Metcalfe  1   2 , Jane M Blazeby  1   3 ; ROMIO Study Group; CONSENSUS Esophageal Cancer Working Group
Affiliations

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

Kerry N L Avery et al. Ann Surg. 2018 Apr.

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.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Data sources and steps involved in the development of the core outcome set.
See this image and copyright information in PMC

References

    1. Revicki DA, Frank L. Pharmacoeconomic evaluation in the real world. Effectiveness versus efficacy studies. Pharmacoeconomics 1999; 15:423–434. - PubMed
    1. Singal AG, Higgins PDR, Waljee AK. A primer on effectiveness and efficacy trials. Clin Transl Gastroenterol 2014; 5:e45. - PMC - PubMed
    1. Gartlehner G, Hansen RA, Nissman D, Lohr KN, Carey TS. Criteria for distinguishing effectiveness from efficacy trials in systematic reviews. In: Technical Review. Agency for Healthcare Research and Quality; 2006. - PubMed
    1. Blencowe NS, Strong S, McNair AG, et al. Reporting of short-term clinical outcomes after esophagectomy: a systematic review. Ann Surg 2012; 255:658–666. - PubMed
    1. Macefield RC, Jacobs M, Korfage IJ, et al. Developing core outcome sets: methods for identifying and including patient-reported outcomes (PROs). Trials 2014; 15:49. - PMC - PubMed

Publication types