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Existing Bowel Preparation Quality Scales Are Reliable in the Setting of Centralized Endoscopy Reading

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Abstract

Background

Development of bowel preparation products has been based upon colon cleansing rating by a local endoscopist. It is unclear how bowel preparation scales perform when centrally evaluated.

Aims

To evaluate the reliability of bowel preparation quality scales when assessed by central readers.

Methods

Four central readers evaluated 52 videos in triplicate, 2 weeks apart, during the entire endoscopic procedure (insertion/withdrawal of the colonoscope) and exclusively on colonoscope withdrawal using the Boston Bowel Preparation Scale (BBPS), Chicago Bowel Preparation scale, Harefield Cleansing Scale, Ottawa Bowel Preparation Quality Scale (OBPQS), Aronchick score, a visual analogue scale, and additional items proposed in a modified Research and Development/University of California Los Angeles appropriateness process. Reliability was assessed with intraclass correlation coefficients.

Results

Intraclass correlation coefficients (95% confidence interval) for inter-rater reliability of the quality scales ranged from 0.51 to 0.65 (consistent with moderate to substantial inter-rater reliability) during the entire procedure. Corresponding intraclass correlation coefficients for intra-rater reliability ranged from 0.69 to 0.77 (consistent with substantial intra-rater reliability). Reliability was highest in the right colon and lowest in the left colon. No differences were observed in reliability when assessed for the procedure overall (insertion/withdrawal) relative to assessment on withdrawal alone.

Conclusion

All five bowel preparation quality scales had moderate to substantial inter-rater reliability. Panelists considered the Aronchick score too simplistic for clinical trials and recognized that assessment of residual fluid in the Ottawa Bowel Preparation Quality Scale was not amenable to central assessment.

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Data availability

All de-identified data from this analysis is available upon request.

Abbreviations

ANOVA:

Analysis of variance

BBPS:

Boston Bowel Preparation Scale

B-Clear:

Boston Classification of Excrement and Residue

BP:

Bowel preparation

CBPS:

Chicago Bowel Preparation Scale

CI:

Confidence interval

CRC:

Colorectal cancer

FDA:

United States Food and Drug Administration

HCS:

Harefield Cleansing Scale

ICC:

Intraclass correlation coefficients

MBPC:

Marden Bowel Preparation Classification

OBPQS:

Ottawa Bowel Preparation Quality Scale

RAND/UCLA:

Research and Development University of California Los Angeles

RCT:

Randomized controlled trial

SD:

Standard deviation

SES:

Standardized effect size

VAS:

Visual analogue scale

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Acknowledgments

The authors acknowledge Norgine Ltd who provided images used in the assessment of reliability.

Funding

JEE is funded by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health.

Author information

Authors and Affiliations

  1. Department of Gastroenterology and Hepatology, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands

    Jurij Hanzel

  2. Faculty of Medicine, University of Ljubljana, University Medical Centre Ljubljana, Zaloška Cesta 7, 1000, Ljubljana, Slovenia

    Jurij Hanzel

  3. Alimentiv Inc, 100 Dundas St Suite 200, London, ON, Canada

    Jurij Hanzel, Christopher Ma, John W. D. McDonald, Tanja Van Viegen, Lisa M. Shackelton, Brian G. Feagan & Vipul Jairath

  4. Division of Gastroenterology, Department of Medicine, Western University & London Health Sciences Centre, University Hospital, 1151 Richmond St, Room A10-219, London, ON, Canada

    Michael Sey, Brian G. Feagan & Vipul Jairath

  5. Lawson Health Research Institute, London Health Sciences Centre-Victoria Hospital, 800 Commissioners Rd E, London, ON, Canada

    Michael Sey

  6. Division of Gastroenterology & Hepatology, Departments of Medicine and Community Health Sciences, Cumming School of Medicine, University Calgary, 2500 University Dr NW, Calgary, AB, Canada

    Christopher Ma

  7. Department of Epidemiology and Biostatistics, Western University, 1151 Richmond St, London, ON, Canada

    Guangyong Zou, Brian G. Feagan & Vipul Jairath

  8. Translational Gastroenterology Unit, Experimental Medicine Division, Nuffield Department of Medicine, John Radcliffe Hospital, University of Oxford, Oxford, OX1 2JD, UK

    James E. East

  9. Division of Gastroenterology and Hepatology, Mayo Clinic Healthcare, 15 Portland Pl, London, UK

    James E. East

  10. Section of Gastroenterology & Hepatology, Department of Medicine, Dartmouth-Hitchcock Medical Center, 1 Medical Center Dr, Lebanon, NH, USA

    Corey A. Siegel

  11. Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, 22254, Saudi Arabia

    Mahmoud Mosli

  12. Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria

    Walter Reinisch

  13. Inflammatory Bowel Disease Centre, Mount Sinai Hospital, 600 University Ave, Toronto, ON, Canada

    Mark S. Silverberg

  14. Norgine Ltd, Widewater Place Moorhall Road, Harefield, England, UK

    Lucy B. Clayton & Richard Ng Kwet Shing

  15. Division of Gastroenterology, Department of Medicine, St. Paul’s Hospital, University of British Columbia, 1081 Burrard St, Vancouver, BC, Canada

    Robert Enns & Jennifer J. Telford

  16. Division of Digestive Care & Endoscopy, Department of Medicine, Dalhousie University, 6299 South St, Halifax, NS, Canada

    Ian Epstein

  17. Departments of Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, 2500 University Dr NW, Calgary, AB, Canada

    Robert J. Hilsden

  18. Forzani & MacPhail Colon Cancer Screening Centre, Alberta Health Services, 3280 Hospital Dr NW, Calgary, AB, Canada

    Robert J. Hilsden

  19. Gastrointestinal Diseases Research Unit, Department of Medicine, Queen’s University, 99 University Ave, Kingston, ON, Canada

    Lawrence Hookey

  20. Department of Medicine, Max Rady College of Medicine, University of Manitoba, 66 Chancellors Cir, Winnipeg, Canada

    Dana C. Moffatt

  21. Division of Gastroenterology, Department of Medicine, Université de Montréal, 2900 Edouard Montpetit Blvd, Montreal, QC, Canada

    Daniel von Renteln

  22. Division of Gastroenterology, McGill University and McGill University Health Centre, 845 Sherbrooke St W, Montreal, QC, Canada

    Alan Barkun

Authors
  1. Jurij Hanzel
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  2. Michael Sey
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  3. Christopher Ma
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  4. Guangyong Zou
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  5. James E. East
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  6. Corey A. Siegel
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  7. Mahmoud Mosli
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  8. Walter Reinisch
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  9. John W. D. McDonald
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  10. Mark S. Silverberg
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  11. Tanja Van Viegen
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  12. Lisa M. Shackelton
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  13. Lucy B. Clayton
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  14. Robert Enns
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  15. Ian Epstein
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  16. Robert J. Hilsden
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  17. Lawrence Hookey
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  18. Dana C. Moffatt
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  19. Richard Ng Kwet Shing
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  20. Jennifer J. Telford
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  21. Daniel von Renteln
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  22. Brian G. Feagan
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  23. Alan Barkun
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  24. Vipul Jairath
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Contributions

Guarantor of the article: Dr. Vipul Jairath is acting as the article guarantor. VJ, GYZ, LC, RN: conception and design, GYZ, VJ: analysis and interpretation of the data, VJ, JH, LMS: Drafting of the article, all authors: critical revision of the article for important intellectual content, final approval of the article, GYZ: statistical methods. All authors have reviewed and approved the final version of this manuscript.

Corresponding author

Correspondence to Vipul Jairath.

Ethics declarations

Conflict of interest

JH has received speaker's fees from Abbvie, Janssen, and Takeda; consulting fees from Alimentiv, Inc. MS has received research grants and speaker’s fees from Pendopharm Inc.; consulting fees from Medtronic Inc. (consultant). CM has received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma Inc, Bristol Myers Squibb, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Takeda, Pendopharm, Pfizer, Roche; speaker's fees from AbbVie, Amgen, AVIR Pharma Inc, Alimentiv, Ferring, Janssen, Takeda, and Pfizer; research support from Pfizer. GYZ has received consulting fees from Alimentiv, Inc. JEE has served on clinical advisory boards for Lumendi, Boston Scientific, and Paion; has served on the clinical advisory board and owns share options in Satisfai Health; and reports speaker fees from Falk and Janssen. CAS has received consulting fees from Abbvie, BMS, Lilly, Janssen, Napo Pharmaceuticals, Pfizer, Prometheus, Takeda, Tellus Health; speaker fees for CME activities for Abbvie, Janssen, Pfizer, Takeda; grant support from Abbvie, Janssen, Pfizer and Takeda. Dr. Corey Siegel and Dr. Lori Siegel are co-founders of MiTest Health, LLC (software company). Technology developed by MiTest Health, LLC has been licensed to Takeda. Dr. Corey Siegel is a co-founder of ColonaryConcepts, LLC and has United States Patents on “Dietary Purgatives” and “Foods, Systems, Methods, and Kits for Providing Electrolyte Replacement.” MM has received speaker’s fees from Abbvie, Takeda, Janssen, Pfizer, Amgen, Novartis, Hikma, Ferring; grant/research support from Takeda, Pfizer, and Janssen. WR is a speaker for Abbott Laboratories, Abbvie, Aesca, Aptalis, Astellas, Centocor, Celltrion, Danone Austria, Elan, Falk Pharma GmbH, Ferring, Immundiagnostik, Mitsubishi Tanabe Pharma Corporation, MSD, Otsuka, PDL, Pharmacosmos, PLS Education, Schering-Plough, Shire, Takeda, Therakos, Vifor, Yakult; consultant for Abbott Laboratories, Abbvie, Aesca, Algernon, Amgen, AM Pharma, AMT, AOP Orphan, Arena Pharmaceuticals, Astellas, Astra Zeneca, Avaxia, Roland Berger GmBH, Bioclinica, Biogen IDEC, Boehringer-Ingelheim, Bristol-Myers Squibb, Cellerix, Chemocentryx, Celgene, Centocor, Celltrion, Covance, Danone Austria, DSM, Elan, Eli Lilly, Ernest & Young, Falk Pharma GmbH, Ferring, Galapagos, Genentech, Gilead, Grünenthal, ICON, Index Pharma, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, LivaNova, Mallinckrodt, Medahead, MedImmune, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Nash Pharmaceuticals, Nestle, Nippon Kayaku, Novartis, Ocera, OMass, Otsuka, Parexel, PDL, Periconsulting, Pharmacosmos, Philip Morris Institute, Pfizer, Procter & Gamble, Prometheus, Protagonist, Provention, Alimentiv Inc, Sandoz, Schering-Plough, Second Genome, Seres Therapeutics, Setpointmedical, Sigmoid, Sublimity, Takeda, Therakos, Theravance, Tigenix, UCB, Vifor, Zealand, Zyngenia, and 4SC; and advisory board member for Abbott Laboratories, Abbvie, Aesca, Amgen, AM Pharma, Astellas, Astra Zeneca, Avaxia, Biogen IDEC, Boehringer-Ingelheim, Bristol-Myers Squibb, Cellerix, Chemocentryx, Celgene, Centocor, Celltrion, Danone Austria, DSM, Elan, Ferring, Galapagos, Genentech, Grünenthal, Inova, Janssen, Johnson & Johnson, Kyowa Hakko, Kirin Pharma, Lipid Therapeutics, MedImmune, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Nestle, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Sandoz, Schering-Plough, Second Genome, Setpointmedical, Takeda, Therakos, Tigenix, UCB, Zealand, Zyngenia, and 4SC. JWDM has received consulting fees from Alimentiv, Inc. MSS has nothing relevant to disclose. TvV is an employee of Alimentiv, Inc. LMS has received consulting fees from Alimentiv, Inc. LC is an employee of Norgine Ltd. RE has nothing relevant to disclose. IE has received consulting fees from AbbVie. RJH has received grant support and advisory board fees from Exact Sciences, Inc. LH has received consulting fees from Pendopharm. DCM has nothing relevant to disclose. RN is an employee of Norgine Ltd. JJT has received consulting fees from Pendopharm. DvR has received research funding from Arm’s length, ERBE, Boston Scientific, Pendopharm, Pentax, Fuji; consulting fees from Boston Scientific, Pendopharm; and speaker’s honoraria from Boston Scientific, Pendopharm, ERBE. BGF has received grant/research support from AbbVie Inc., Amgen Inc., AstraZeneca/MedImmune Ltd., Atlantic Pharmaceuticals Ltd., Boehringer-Ingelheim, Celgene Corporation, Celltech, Genentech Inc/Hoffmann-La Roche Ltd., Gilead Sciences Inc., GlaxoSmithKline (GSK), Janssen Research & Development LLC., Pfizer Inc., Receptos Inc./Celgene International, Sanofi, Santarus Inc., Takeda Development Center Americas Inc., Tillotts Pharma AG, and UCB; consulting fees from Abbott/AbbVie, Akebia Therapeutics, Allergan, Amgen, Applied Molecular Transport Inc., Aptevo Therapeutics, Astra Zeneca, Atlantic Pharma, Avir Pharma, Biogen Idec, BioMx Israel, Boehringer-Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring Pharma, Roche/Genentech, Galapagos, GiCare Pharma, Gilead, Gossamer Pharma, GSK, Inception IBD Inc, JnJ/Janssen, Kyowa Kakko Kirin Co Ltd., Lexicon, Lilly, Lycera BioTech, Merck, Mesoblast Pharma, Millennium, Nestle, Nextbiotix, Novonordisk, Pfizer, Prometheus Therapeutics and Diagnostics, Progenity, Protagonist, Receptos, Salix Pharma, Shire, Sienna Biologics, Sigmoid Pharma, Sterna Biologicals, Synergy Pharma Inc., Takeda, Teva Pharma, TiGenix, Tillotts, UCB Pharma, Vertex Pharma, Vivelix Pharma, VHsquared Ltd., and Zyngenia; speakers bureau fees from Abbott/AbbVie, JnJ/Janssen, Lilly, Takeda, Tillotts, and UCB Pharma; is a scientific advisory board member for Abbott/AbbVie, Allergan, Amgen, Astra Zeneca, Atlantic Pharma, Avaxia Biologics Inc., Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Centocor Inc., Elan/Biogen, Galapagos, Genentech/Roche, JnJ/Janssen, Merck, Nestle, Novartis, Novonordisk, Pfizer, Prometheus Laboratories, Protagonist, Salix Pharma, Sterna Biologicals, Takeda, Teva, TiGenix, Tillotts Pharma AG, and UCB Pharma; and is the Senior Scientific Officer of Alimentiv Inc. AB has received speaking and consulting fees from Pendopharm, Inc (Canada). VJ has received consulting fees from AbbVie, Alimentiv Inc (formerly Robarts Clinical Trials), Arena pharmaceuticals, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Mylan, Pendopharm, Pfizer, Roche, Sandoz, Takeda, Topivert; speaker’s fees from, Abbvie, Ferring, Janssen, Pfizer, Shire, Takeda. Alimentiv Inc is an academic gastrointestinal contract research organization (CRO), operating under the Alimentiv Health Trust. Alimentiv Inc. provides comprehensive clinical trial services, precision medicine offerings, and centralized imaging solutions for endoscopy, histopathology, and other imaging modalities. The beneficiaries of the Alimentiv Health Trust are the employees of the enterprises it holds. CM, GYZ, LMS, BGF, and VJ are consultants to Alimentiv Inc.; they do not hold equity positions or shares in Alimentiv Inc. and CM, GYZ, BGF, and VJ have a primary academic appointment.

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The study was approved by the Western University Health Science Research Ethics Board (File Number: 108879).

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Hanzel, J., Sey, M., Ma, C. et al. Existing Bowel Preparation Quality Scales Are Reliable in the Setting of Centralized Endoscopy Reading. Dig Dis Sci 68, 1195–1207 (2023). https://doi.org/10.1007/s10620-022-07729-9

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