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

Research output: Contribution to journalArticle

Original languageEnglish
Pages (from-to)700-710
Number of pages11
JournalAnnals of Surgery
Volume267
Issue number4
Early online date10 Mar 2017
DOIs
DateAccepted/In press - 10 Mar 2017
DateE-pub ahead of print - 10 Mar 2017
DatePublished (current) - Apr 2018

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.

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  • Full-text PDF (accepted author manuscript)

    Rights statement: 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, 487 KB, PDF-document

  • Supplementary information PDF - Table 1

    Rights statement: 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, 213 KB, PDF-document

  • Supplementary information PDF - Table 2

    Rights statement: 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, PDF-document

  • Supplementary information PDF - Table 3

    Rights statement: 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, 376 KB, PDF-document

  • Supplementary information PDF - Table 4

    Rights statement: 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, 330 KB, PDF-document

  • Supplementary information PDF - Table 5

    Rights statement: 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, 279 KB, PDF-document

  • Supplementary information PDF - Table 6

    Rights statement: 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, PDF-document

  • Supplementary information PDF - Figure 1

    Rights statement: 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, PDF-document

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