Evidence map›Paper›PMID 33385464›Full record

ArticleGastrointestinal endoscopy2021

Development and validation of a patient-reported scale for tolerability of endoscopic procedures using conscious sedation.

Nauzer Forbes, Millie Chau, Hannah F Koury, B Cord Lethebe, Zachary L Smith, Sachin Wani, Rajesh N Keswani, B Joseph Elmunzer, John T Anderson, Steven J Heitman and 1 more

2 registry-linked trialsOpen access · greenAbstract read
In one paragraph

Article in Gastrointestinal endoscopy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
4.0field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07600073 recruitingnot on this mapstarted 2026, after this paper: background citation

Tolerability of Sedation With Remimazolam Versus Midazolam in Outpatients Undergoing Upper GI or Biliopancreatic Endoscopic Ultrasound in a Non-Anesthesiologist Setting: A Prospective Observational Study (REM-EUS Study)

TypeobservationalSponsorAzienda Socio Sanitaria Territoriale di LeccoRan2026 to 2026Enrolled126ConditionsSedation During GI Endoscopy
NCT07699731 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

The Effect of Pre-procedural Anxiety Level on Procedure Tolerability and Quality of ERCP in Consciously Sedated Patients

TypeobservationalSponsorMandip RaiRan2026 to 2027Enrolled200ConditionsAnxiety, Biliary and Pancreatic Diseases, ERCPArmsNot applicable- observational study
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 3 countries.

Nauzer ForbesDepartment of Medicine, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.
Millie ChauDepartment of Medicine, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada.
Hannah F KouryCumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
B Cord LethebeCumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Zachary L SmithDepartment of Medicine, Division of Gastroenterology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Sachin WaniDivision of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Denver, Colorado, USA.
Rajesh N KeswaniDivision of Gastroenterology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
B Joseph ElmunzerDivision of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA.
John T AndersonDepartment of Gastroenterology, Gloucestershire Hospitals NHSFT, Gloucester, UK.
Steven J HeitmanDepartment of Medicine, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.
Robert J HilsdenDepartment of Medicine, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.
University of Calgary · CAGloucestershire Hospitals NHS Foundation Trust · GBMedical College of Wisconsin · USMedical University of South Carolina · USNorthwestern University · USUniversity of Colorado Anschutz Medical Campus · US

Funding

Proteomics CoreP30DK123704 · NIDDK · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI DON C. ROCKEY · 2020 to 2026
$8.8M
NIDDK NIH HHS P30 DK123704
6 · The paper itself

Abstract

BACKGROUND AND

aimsPatient-reported experience measures (PREMs) assessing the tolerability of endoscopic procedures are scarce. In this study, we designed and validated a PREM to assess tolerability of endoscopy using conscious sedation.

methodsThe patient-reported scale for tolerability of endoscopic procedures (PRO-STEP) consists of questions within 2 domains and is administered to outpatients at discharge from the endoscopy unit. Domain 1 (intraprocedural) consists of 2 questions regarding discomfort/pain and awareness, whereas domain 2 (postprocedural) consists of 4 questions on pain, nausea, distention, and either throat or anal pain. All questions are scored on a Likert scale from 0 to 10. Cronbach's alpha was used to measure internal consistency of the questions. Multivariable logistic regression was performed to assess predictors of higher scores, reported using adjusted odds ratios and confidence intervals.

resultsTwo hundred fifty-five patients (91 colonoscopy, 73 gastroscopy, and 91 ERCP) were included. Colonoscopy was the least tolerable procedure by recall, with mean intraprocedural awareness and discomfort scores of 5.1 ± 3.8, and 2.6 ± 2.7, respectively. Consistency between intraprocedural awareness and discomfort/pain yielded an acceptable Cronbach's alpha of .71 (95% confidence interval, .62-.78). Higher use of midazolam during colonoscopy was inversely associated with an intraprocedural awareness score of 7 or higher (per additional mg: adjusted odds ratio, .23; 95% confidence interval, .09-.54).

conclusionsPRO-STEP is a simple PREM that can be administered after multiple endoscopic procedures using conscious sedation. Future work should focus on its performance characteristics in adverse event prediction.

Indexed as

MidazolamProcedural SedationColonoscopyHumansHypnotics and SedativesPatient Reported Outcome MeasuresProspective StudiesHypnotics and SedativesMidazolam

Identifiers

PMID33385464
PMCPMC8761529
OpenAlexW3117979179

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.