Original Study: Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials

Alexander Harris; James Butterworth; Piers R Boshier; Hugh MacKenzie; Masanori Tokunaga; Hideki Sunagawa; Stella Mavroveli; Melody Ni; Sameh Mikhail; Chi-Chuan Yeh; Natalie S Blencowe; Kerry N L Avery; Richard Hardwick; Arnulf Hoelscher; Manuel Pera; Giovanni Zaninotto; Simon Law; Donald E Low; Jan J B van Lanschot; Richard ChM Berrisford; Jane M Blazeby; George Hanna; Christopher Paul Barham

Original Study: Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials

Alexander Harris, James Butterworth, Piers R Boshier, Hugh MacKenzie, Masanori Tokunaga, Hideki Sunagawa, Stella Mavroveli, Melody Ni, Sameh Mikhail, Chi-Chuan Yeh, Natalie S Blencowe, Kerry N L Avery, Richard Hardwick, Arnulf Hoelscher, Manuel Pera, Giovanni Zaninotto, Simon Law, Donald E Low, Jan J B van Lanschot, Richard ChM BerrisfordJane M Blazeby, George Hanna^*, Christopher Paul Barham

^*Corresponding author for this work

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

77 Downloads (Pure)

Abstract

Objective:

The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts.

Summary of Background Data:

There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence.

Methods:

Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory.

Results:

Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall G-coefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700.

Conclusions:

A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials.

Ethical approval:

11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.

Trial registration number: ISRCTN59036820, ISRCTN10386621.

Original language	English
Pages (from-to)	399-597, e21-e101
Number of pages	10
Journal	Annals of Surgery
Volume	271
Issue number	3
Publication status	Published - 27 Mar 2020

Keywords

esophageal cancer
esophagectomy
surgical quality assurance

Access to Document

Full-text PDF (author’s accepted manuscript)
This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Lippincott, Williams & Wilkins at https://journals.lww.com/annalsofsurgery/toc/2020/03000 . Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 360 KB

https://journals.lww.com/annalsofsurgery/toc/2020/03000

Handle.net

Persistent link

Dr Natalie S Blencowe
- Natalie.Blencowebristol.acuk
- Bristol Medical School (PHS) - Associate Professor in Surgery
- Cancer
Person: Academic , Member

Cite this

Harris, A., Butterworth, J., Boshier, P. R., MacKenzie, H., Tokunaga, M., Sunagawa, H., Mavroveli, S., Ni, M., Mikhail, S., Yeh, C.-C., Blencowe, N. S., Avery, K. N. L., Hardwick, R., Hoelscher, A., Pera, M., Zaninotto, G., Law, S., Low, D. E., van Lanschot, J. J. B., ... Barham, C. P. (2020). Original Study: Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials. Annals of Surgery, 271(3), 399-597, e21-e101. https://journals.lww.com/annalsofsurgery/toc/2020/03000

@article{5282eba753484fb4816a055cd18fbe99,

title = "Original Study: Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials",

abstract = "Objective: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts.Summary of Background Data: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence.Methods: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory.Results: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall G-coefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700.Conclusions: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials.Ethical approval: 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.Trial registration number: ISRCTN59036820, ISRCTN10386621.",

keywords = "esophageal cancer, esophagectomy, surgical quality assurance",

author = "Alexander Harris and James Butterworth and Boshier, {Piers R} and Hugh MacKenzie and Masanori Tokunaga and Hideki Sunagawa and Stella Mavroveli and Melody Ni and Sameh Mikhail and Chi-Chuan Yeh and Blencowe, {Natalie S} and Avery, {Kerry N L} and Richard Hardwick and Arnulf Hoelscher and Manuel Pera and Giovanni Zaninotto and Simon Law and Low, {Donald E} and {van Lanschot}, {Jan J B} and Berrisford, {Richard ChM} and Blazeby, {Jane M} and George Hanna and Barham, {Christopher Paul}",

year = "2020",

month = mar,

day = "27",

language = "English",

volume = "271",

pages = "399--597, e21--e101",

journal = "Annals of Surgery",

issn = "0003-4932",

publisher = "Lippincott Williams and Wilkins",

number = "3",

}

Harris, A, Butterworth, J, Boshier, PR, MacKenzie, H, Tokunaga, M, Sunagawa, H, Mavroveli, S, Ni, M, Mikhail, S, Yeh, C-C, Blencowe, NS , Avery, KNL, Hardwick, R, Hoelscher, A, Pera, M, Zaninotto, G, Law, S, Low, DE, van Lanschot, JJB, Berrisford, RC, Blazeby, JM, Hanna, G & Barham, CP 2020, 'Original Study: Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials', Annals of Surgery, vol. 271, no. 3, pp. 399-597, e21-e101. <https://journals.lww.com/annalsofsurgery/toc/2020/03000>

TY - JOUR

T1 - Original Study

T2 - Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials

AU - Harris, Alexander

AU - Butterworth, James

AU - Boshier, Piers R

AU - MacKenzie, Hugh

AU - Tokunaga, Masanori

AU - Sunagawa, Hideki

AU - Mavroveli, Stella

AU - Ni, Melody

AU - Mikhail, Sameh

AU - Yeh, Chi-Chuan

AU - Blencowe, Natalie S

AU - Avery, Kerry N L

AU - Hardwick, Richard

AU - Hoelscher, Arnulf

AU - Pera, Manuel

AU - Zaninotto, Giovanni

AU - Law, Simon

AU - Low, Donald E

AU - van Lanschot, Jan J B

AU - Berrisford, Richard ChM

AU - Blazeby, Jane M

AU - Hanna, George

AU - Barham, Christopher Paul

PY - 2020/3/27

Y1 - 2020/3/27

N2 - Objective: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts.Summary of Background Data: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence.Methods: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory.Results: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall G-coefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700.Conclusions: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials.Ethical approval: 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.Trial registration number: ISRCTN59036820, ISRCTN10386621.

AB - Objective: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts.Summary of Background Data: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence.Methods: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory.Results: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall G-coefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700.Conclusions: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials.Ethical approval: 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.Trial registration number: ISRCTN59036820, ISRCTN10386621.

KW - esophageal cancer

KW - esophagectomy

KW - surgical quality assurance

M3 - Article (Academic Journal)

SN - 0003-4932

VL - 271

SP - 399-597, e21-e101

JO - Annals of Surgery

JF - Annals of Surgery

IS - 3

ER -

Original Study: Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials

Abstract

Keywords

Access to Document

Handle.net

Fingerprint

Profiles

Dr Natalie S Blencowe

Cite this