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Validation of the Harefield Cleansing Scale: a tool for the evaluation of bowel cleansing quality in both research and clinical practice - 30/06/13

Doi : 10.1016/j.gie.2013.02.009 
Marc Halphen, MD 1, Denis Heresbach, MD, PhD 2, Hans-Jurgen Gruss, MD 3, Jonathan Belsey, MB, BS 4,
1 Norgine Ltd, United Kingdom 
2 Centre Hospitalier de Cannes, Cannes, France 
3 University of Witten-Herdecke, Germany 
4 JB Medical Ltd, Sudbury, United Kingdom 

Reprint requests: Jonathan Belsey, MB, BS, JB Medical, Ltd, The Old Brickworks, Chapel Lane, Little Cornard, Sudbury CO10 0PB, United Kingdom

Riassunto

Background

Variations in bowel cleansing quality before colonoscopy can cause confounding of results within clinical trials and inappropriate treatment decisions in clinical practice. A new tool—the Harefield Cleaning Scale—has been developed, which addresses the limitations of existing scales.

Objective

Validation exercise for the new cleansing scale.

Design

Retrospective validation study.

Setting

Various colonoscopy units in France.

Patients

Patients who had a total of 337 colonoscopies recorded.

Intervention

Video-recorded colonoscopy.

Main Outcome Measurements

Comparisons of 2 scoring systems to assess direct correlation, interrater reliability, internal consistency, and test-retest reliability, based on assessment of video recordings from 337 colonoscopies.

Results

Correlation analysis for expert scores by using the 2 scales yielded a Spearman correlation coefficient of 0.833. Similarly, the comparison of the segmental sum score revealed a Spearman correlation coefficient of -0.778. Cross-tabulation for successful colon cleansing was 92.88% versus unsuccessful colon cleansing in 7.12%. Reliability assessment indicated an acceptable internal consistency with a Cronbach alpha coefficient of 0.81. Test-retest reliability demonstrated an overall agreement of 0.639 (kappa statistic). Receiver operating characteristic analysis versus Aronchick Scale scores yielded an area under the curve of 0.945, with sensitivity of 99% and specificity of 83% at the optimum score cut-off point.

Limitations

Test-retest reliability was assessed by using a different patient population to the other measures. There were insufficient patient numbers to assess performance by using adenoma detection rate.

Conclusion

This validation analysis has demonstrated that the Harefield Cleansing Scale is a robust, reliable, and consistent tool that has the potential to improve the effective standardization of bowel preparation assessment in both clinical and research practice.

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Abbreviations : AUC, HCS, PEG


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 DISCLOSURE: M. Halphen is a full-time employee of Norgine, Ltd. D. Heresbach is a consultant for Norgine, Ltd, Aptalis, and MedPass and a speaker for Mauna Kea Technology and Wilson-Cook, France and received project sponsorship from Ferring SA. H.-J. Gruss and J. Belsey are consultants for Norgine, Ltd. No other financial relationships relevant to this publication were disclosed.
 If you would like to chat with an author of this article, you may contact Dr Belsey at jbelsey@jbmedical.com.


© 2013  American Society for Gastrointestinal Endoscopy. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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Vol 78 - N° 1

P. 121-131 - luglio 2013 Ritorno al numero
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