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Web-Based Educational Intervention for Patients With Uninvestigated Dyspepsia Referred for Upper Gastrointestinal Tract EndoscopyA Randomized Clinical Trial

Educational Objective
To describe the effectiveness of a web-based educational intervention as a tool to reduce upper gastrointestinal (GI) tract endoscopy in uninvestigated dyspepsia.
1 Credit CME
Key Points

Question  Can dedicated health education for patients with uninvestigated dyspepsia reduce the number of upper gastrointestinal tract endoscopic procedures?

Findings  This open-label, multicenter, clinical trial randomized 119 patients between health education or usual care and found that educating patients on dyspepsia greatly and sustainably decreased the number of upper gastrointestinal tract endoscopic procedures (39% vs 82%).

Meaning  Educating patients with uninvestigated dyspepsia effectively decreases the need for upper gastrointestinal tract endoscopic procedures.

Abstract

Importance  Diagnostic yield of upper gastrointestinal (GI) tract endoscopy for uninvestigated dyspepsia is low, and its clinical implications are limited. There is an unmet need for better strategies to reduce the volume of upper GI tract endoscopic procedures for dyspepsia.

Objective  To study the effectiveness of a web-based educational intervention as a tool to reduce upper GI tract endoscopy in uninvestigated dyspepsia.

Design, Setting, and Participants  This open-label, multicenter, randomized clinical trial enrolled participants between November 1, 2017, and March 31, 2019, with follow-up 52 weeks after randomization, at 4 teaching hospitals in the Netherlands. Participants included patients with uninvestigated dyspeptic symptoms who were referred for upper GI tract endoscopy by their general health care clinician without prior consultation of a gastroenterologist. A total of 119 patients, aged 18 to 69 years, were included. Patients were excluded if any of the following red flag symptoms were present: (indirect) signs of upper GI tract hemorrhage (hematemesis, melena, hematochezia, or anemia), unintentional weight loss of 5% or higher of normal body weight during a period of 6 to 12 months, persistent vomiting, dysphagia, or jaundice.

Interventions  Patients were randomly assigned (1:1) to education (intervention) or upper GI tract endoscopy (control). Education consisted of a self-managed web-based educational intervention, containing information on gastric function, dyspepsia, and upper GI tract endoscopy.

Main Outcomes and Measures  Difference in the proportion of upper GI tract endoscopy procedures between those who received access to the web-based educational intervention and those who did not at 12 weeks and 52 weeks after randomization, analyzed in the intention-to-treat population. Secondary outcomes included quality of life (Nepean Dyspepsia Index) and symptom severity (Patient Assessment of Gastrointestinal Disorders Symptom Severity Index) measured at baseline and 12 weeks.

Results  Of 119 patients included (median age, 48 years [interquartile range, 37-56 years]; 48 men [40%]), 62 were randomized to web-based education (intervention) and 57 to upper GI tract endoscopy (control). Significantly fewer patients compared with controls underwent upper GI tract endoscopy after using the web-based educational intervention: 24 (39%) vs 47 (82%) (relative risk, 0.46; 95% CI, 0.33-0.64; P < .001). Symptom severity and quality of life improved equivalently in both groups. One additional patient in the intervention group required upper GI tract endoscopy during follow-up.

Conclusions and Relevance  Findings of this study indicate that web-based patient education is an effective tool to decrease the need for upper GI tract endoscopy in uninvestigated dyspepsia.

Trial Registration  ClinicalTrials.gov Identifier: NCT03205319

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Accepted for Publication: March 8, 2021.

Published Online: April 26, 2021. doi:10.1001/jamainternmed.2021.1408

Corresponding Author: Judith J. de Jong, MD (judith.dejong@radboudumc.nl), and Joost P. H. Drenth, MD, PhD, (joostphdrenth@cs.com), Department of Gastroenterology and Hepatology, Radboud University Medical Centre, PO Box 9101, 6500 HB Nijmegen, the Netherlands.

Author Contributions: Dr Drenth had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: de Jong, Lantinga, Tan, Scheffer, Uil, Keszthelyi, Westert, Masclee, Drenth.

Acquisition, analysis, or interpretation of data: de Jong, Lantinga, Tan, Aquarius, Scheffer, de Reuver, Keszthelyi, Westert, Drenth.

Drafting of the manuscript: de Jong, Scheffer, Masclee, Drenth.

Critical revision of the manuscript for important intellectual content: Lantinga, Tan, Aquarius, Scheffer, Uil, de Reuver, Keszthelyi, Westert, Drenth.

Statistical analysis: de Jong, Drenth.

Obtained funding: Lantinga, Drenth.

Administrative, technical, or material support: Tan, Aquarius, Drenth.

Supervision: Lantinga, Scheffer, de Reuver, Westert, Masclee, Drenth.

Conflict of Interest Disclosures: Dr de Jong reported receiving a grant from ZonMw through her institution during the conduct of the study. Dr Lantinga reported receiving grants from the National Health Care Institute (Zorginstituut Nederland) and grants from Jeroen Bosch Hospital outside the submitted work. Dr Keszthelyi reported receiving grants from Allergan, Grünenthal, MLDS, United European Gastroenterology, Will Pharma, and ZonMw outside the submitted work. Dr Masclee reported receiving grants from Bioactor, the Dutch Cancer Society, the Netherlands Organization for Health Research and Development, Pentax GmbH, Will Pharma, and ZonMw; and receiving personal fees from Bayer, Kyowa Kirin, and Takeda outside the submitted work. Dr Drenth reported receiving grants from the Dutch Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport; “Doen of laten? Terugdringen van onnodige zorg”) during the conduct of the study; receiving personal fees or research grants through Radboudumc from AbbVie, Gilead, Ipsen, Novartis, and Otsuka; and serving as member of the advisory board for AbbVie, Bristol Myers Squibb, Janssen, Gilead, Norgine, and Otsuka. No other disclosures were reported.

Funding/Support: This study was funded by grant 80-83920-98-400 from the Netherlands Organization for Health Research and Development.

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 3.

Additional Contributions: We thank all patients for their participation, their general health care professionals for their approval and efforts, and all the staff of participating centers, in particular those involved in upper gastrointestinal tract endoscopy planning. Reinier Akkermans, MSc, Radboud University Medical Center, provided independent statistical support.

Additional Information: Patient data that underlie results reported in this article are available from the corresponding author (joostphdrenth@cs.com) based on a methodologically sound proposal. Data may be used to achieve proposed aims or for individual patient data meta-analysis.

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