A grading scale to evaluate colon cleansing for the PillCam COLON capsule: a reliability study

Background and study aims: The PillCam COLON capsule (Given Imaging, Ltd., Yoqneam, Israel) is an emerging technology for colon visualization. The aim of this prospective study was to assess the interobserver agreement of a new grading scale to evaluate colon cleansing for capsule use.

Patients and methods: Healthy volunteers underwent colon preparation and ingested a PillCam COLON capsule. A RAPID 5 (Given Imaging, Ltd.) video was generated and de-identified, and the colon was divided into five segments. Two cleanliness grading scales were compared: a 2-point scale (adequate and inadequate) and a 4-point grading scale (poor, fair, good, and excellent). For assessment of interobserver variability, two experienced gastroenterologists independently rated the cleansing level for each colon segment and for the entire video. Investigators participated in a calibration session prior to reading the study videos.

Results: A total of 40 individuals (aged 40 – 74 years) completed the study. A total of 196 colon video segments were evaluated. Per segment, κ values for the 2-point and 4-point scales were 0.754 and 0.619, respectively, representing good interobserver agreement. For the overall grade of the 40 videos, κ values for the 2-point and 4-point scales were 0.647 and 0.44, respectively.

Conclusions: This new cleanliness grading scale showed good interobserver agreement and may be used with the PillCam COLON capsule to assess preparation quality.

References

• 1 Eliakim R, Fireman Z, Gralnek I M et al. Evaluation of the PillCam colon capsule in the detection of colonic pathology: results of the first multicenter, prospective, comparative study.  Endoscopy. 2006;  38 963-970
• 2 Schoofs N, Deviere J, Van Gossum A. PillCam colon capsule endoscopy compared with colonoscopy for colorectal tumor diagnosis: a prospective pilot study.  Endoscopy. 2006;  38 971-977
• 3 Lewis B, Rex D, Leiberman D. Capsule colonoscopy: an interim report of a pilot 3 arm, blinded trial of capsule colonoscopy, virtual colonoscopy and colonoscopy [abstract].  Am J Gastroenterol. 2006;  101 S559
• 4 Van Gossum A, Navas M M, Fernandez-Urien I et al. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer.  N Engl J Med. 2009;  361 264-270
• 5 Aronchick C A, Lipshutz W H, Wright S H et al. Validation of an instrument to assess colon cleansing [abstract].  Am J Gastroenterol. 1999;  94 2667
• 6 Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality.  Gastrointest Endosc. 2004;  59 482-486
• 7 Bitoun A, Ponchon T, Barthet M et al. Results of a prospective randomised multicentre controlled trial comparing a new 2-L ascorbic acid plus polyethylene glycol and electrolyte solution vs. sodium phosphate solution in patients undergoing elective colonoscopy.  Aliment Pharmacol Ther. 2006;  24 1631-1642
• 8 Rex D K, Schwartz H, Goldstein M et al. Safety and colon-cleansing efficacy of a new residue-free formulation of sodium phosphate tablets.  Am J Gastroenterol. 2006;  101 2594-2604
• 9 Szklo M, Nieto F J. Epidemiology: beyond the basics.. Gaithersburg, MD: Aspen Publications; 2000
• 10 Ell C, Fischbach W, Keller R et al. A randomized, blinded, prospective trial to compare the safety and efficacy of three bowel-cleansing solutions for colonoscopy (HSG-01*).  Endoscopy. 2003;  35 300-304
• 11 Brotz C, Nandi N, Conn M et al. A validation study of 3 grading systems to evaluate small-bowel cleansing for wireless capsule endoscopy: a quantitative index, a qualitative evaluation, and an overall adequacy assessment.  Gastrointest Endosc. 2009;  69 262-270

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