Development and Validation of the Saint Paul's Endoscopy Comfort Scale (SPECS) for Colonoscopy and Upper Endoscopy

Completed

• Conditions: Patient Comfort

• Registration Number: NCT02443480
• Lead Sponsor: University of British Columbia

Brief Summary

The investigators created the St. Paul's Endoscopy Comfort Score (SPECS) which includes the frequency of verbal cues, body positioning and anxiety levels with descriptions for each of the variables. Our objective is to compare the SPECS, NAPCOMs, NPAT and GS amongst different observers and to determine any correlation with patient satisfaction.

Detailed Description

Colonoscopy is used for the diagnosis and treatment of colonic lesions as well as screening and follow up of patients at risk of developing colorectal cancer. With the increasing demand for colonoscopies, the number of procedures performed in recent years has increased dramatically (Bjorkman \& Popp Jr., 2006). Given that performance of a high quality colonoscopy is dependent on the expertise and technical skills of the endoscopist, quantitative and reliable methods for measurement of the quality of colonoscopy are needed. Although other colonoscopy quality indicators, such as adenoma detection rate, have been studied comprehensively (Rex, et al., 2006), patient comfort as a measure of endoscopic quality performance has not been thoroughly assessed.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-13
• Primary Completion: 2015-08
• Study Completion: 2016-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Age 19 years or older
• Outpatients referred to Saint Paul's Hospital for colonoscopy and upper endoscopy
• Capable of reading and understanding English

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Exclusion Criteria

• Patients who undergo colonoscopy and upper endoscopy in the same appointment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inter-observer reliability	15-30 minutes	To determine the inter-observer reliability for the SPECS amongst observers and the different comfort scores, NAPCOMS, GS and NPAT.
Correlation with patient's reported pain	10-15 minutes	To determine the correlation of SPECS, NAPCOMS, GS and NPAT with post-procedure patient reported pain and satisfaction controlling for sedation.

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada