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

Kerry N L Avery; Katy A. Chalmers; Sara T. Brookes; Natalie S. Blencowe; Karen Coulman; Katie Whale; Chris Metcalfe; Jane M. Blazeby; the ROMIO Study Group

doi:10.1097/SLA.0000000000002204

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

Kerry N L Avery^*, Katy A. Chalmers, Sara T. Brookes, Natalie S. Blencowe, Karen Coulman, Katie Whale, Chris Metcalfe, Jane M. Blazeby, the ROMIO Study Group

^*Corresponding author for this work

Research output: Contribution to journal › Article (Academic Journal) › peer-review

43 Citations (Scopus)

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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.

Original language	English
Pages (from-to)	700-710
Number of pages	11
Journal	Annals of Surgery
Volume	267
Issue number	4
Early online date	10 Mar 2017
DOIs	https://doi.org/10.1097/SLA.0000000000002204
Publication status	Published - Apr 2018

Research Groups and Themes

Centre for Surgical Research
BRTC
BTC (Bristol Trials Centre)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1097/SLA.0000000000002204

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This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Wolters Kluwer at http://journals.lww.com/annalsofsurgery/Abstract/publishahead/Development_of_a_Core_Outcome_Set_for_Clinical.96178.aspx. Please refer to any applicable terms of use of the publisher.
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Supplementary information PDF - Table 1
This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Wolters Kluwer at http://journals.lww.com/annalsofsurgery/Abstract/publishahead/Development_of_a_Core_Outcome_Set_for_Clinical.96178.aspx. Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 214 KB
Supplementary information PDF - Table 2
This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Wolters Kluwer at http://journals.lww.com/annalsofsurgery/Abstract/publishahead/Development_of_a_Core_Outcome_Set_for_Clinical.96178.aspx. Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 219 KB
Supplementary information PDF - Table 3
This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Wolters Kluwer at http://journals.lww.com/annalsofsurgery/Abstract/publishahead/Development_of_a_Core_Outcome_Set_for_Clinical.96178.aspx. Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 377 KB
Supplementary information PDF - Table 4
This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Wolters Kluwer at http://journals.lww.com/annalsofsurgery/Abstract/publishahead/Development_of_a_Core_Outcome_Set_for_Clinical.96178.aspx. Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 331 KB
Supplementary information PDF - Table 5
This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Wolters Kluwer at http://journals.lww.com/annalsofsurgery/Abstract/publishahead/Development_of_a_Core_Outcome_Set_for_Clinical.96178.aspx. Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 280 KB
Supplementary information PDF - Table 6
This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Wolters Kluwer at http://journals.lww.com/annalsofsurgery/Abstract/publishahead/Development_of_a_Core_Outcome_Set_for_Clinical.96178.aspx. Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 178 KB
Supplementary information PDF - Figure 1
This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Wolters Kluwer at http://journals.lww.com/annalsofsurgery/Abstract/publishahead/Development_of_a_Core_Outcome_Set_for_Clinical.96178.aspx. Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 179 KB

https://eprints.soton.ac.uk/406434/

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@article{6594b6b4d81747f38dc5cdddc40bf569,

title = "Development of a Core Outcome Set for Clinical Effectiveness Trials in Esophageal Cancer Resection Surgery",

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.",

author = "Avery, {Kerry N L} and Chalmers, {Katy A.} and Brookes, {Sara T.} and Blencowe, {Natalie S.} and Karen Coulman and Katie Whale and Chris Metcalfe and Blazeby, {Jane M.} and {the ROMIO Study Group}",

year = "2018",

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doi = "10.1097/SLA.0000000000002204",

language = "English",

volume = "267",

pages = "700--710",

journal = "Annals of Surgery",

issn = "0003-4932",

publisher = "Lippincott Williams and Wilkins",

number = "4",

}

TY - JOUR

T1 - Development of a Core Outcome Set for Clinical Effectiveness Trials in Esophageal Cancer Resection Surgery

AU - Avery, Kerry N L

AU - Chalmers, Katy A.

AU - Brookes, Sara T.

AU - Blencowe, Natalie S.

AU - Coulman, Karen

AU - Whale, Katie

AU - Metcalfe, Chris

AU - Blazeby, Jane M.

AU - the ROMIO Study Group

PY - 2018/4

Y1 - 2018/4

N2 - 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.

AB - 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.

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U2 - 10.1097/SLA.0000000000002204

DO - 10.1097/SLA.0000000000002204

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AN - SCOPUS:85014991995

SN - 0003-4932

VL - 267

SP - 700

EP - 710

JO - Annals of Surgery

JF - Annals of Surgery

IS - 4

ER -

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

Abstract

Research Groups and Themes

UN SDGs

Access to Document

Handle.net

Other files and links

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NIHR BRC Surgical Innovation

ConDuCT-II

Dr Kerry N L Avery

Professor Jane Blazeby

Dr Natalie S Blencowe

Cite this

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

Abstract

Research Groups and Themes

UN SDGs

Access to Document

Handle.net

Other files and links

Fingerprint

Projects

NIHR BRC Surgical Innovation

ConDuCT-II

Profiles

Dr Kerry N L Avery

Professor Jane Blazeby

Dr Natalie S Blencowe

Cite this