The Dyspepsia Educational Tool As a Novel Aid in Dyspepsia Management

Summary

This protocol describes the development process of a digital dyspepsia educational tool. Assessment of unmet needs and literature, content development, and building of the tool are presented. The methodology can be used as a guide for future development of digital educational tools.

Abstract

Digital educational tools have a well-established role in current healthcare. In particular, disorders that are managed non-pharmacologically benefit from this development, as it enables patient engagement in self-management. Dyspepsia is a condition thought to arise from gastric and duodenal perturbations, brain-gut axis disturbances, and dietary factors. Behavioral interventions are a major part of dyspepsia treatment, hence patient engagement and motivation through education is essential. Protocols that describe the development process of such educational tools are scarce. We provide a methodology describing development of a dyspepsia educational tool. Assessment of users' needs is the first step, followed by a literature search. The content is developed based on the main themes and entered into a content management system, to build the program. Final adjustments are made after a pilot test of the tool. The presented protocol can be used as a guide for development of a digital dyspepsia educational tool or as a tool for similar situations.

Introduction

Patient education is an important component of healthcare, enabling active engagement of patients in responsible management of their health¹. To improve efficacy and appropriate use of healthcare resources, contemporary and disease-specific measures are needed to facilitate patient engagement.

Nowadays, digital tools increasingly replace paper versions of patient education, benefiting from their sustainability, effective distribution, and potential to visualize information. For chronic illnesses that lack curative treatment and biological substrate, education is essential for motivation of patients to engage in self-management^2,3. Dyspepsia is a condition that often causes long-term complaints. Exact origin of symptoms remains unclear, although evidence indicates three main pathophysiological mechanisms, including 1) hypersensitivity to gastric distension, 2) impaired gastric accommodation, causing inadequate distension in reaction to a meal, and 3) delayed gastric emptying⁴. Additionally, duodenal perturbations, brain-gut disturbances, and dietary factors have been suggested to play a role⁵. Main symptoms comprise post-prandial fullness, epigastric pain, early satiety, and epigastric burning. Upper gastrointestinal (GI) endoscopy in dyspeptic patients reveals no cause of symptoms in over 70%; these cases are referred to as functional dyspepsia. Pharmacological treatment options for dyspepsia are limited, often inciting patients to resolve to complementary and alternative therapies^6,7. Quality of life in dyspepsia patients is often reduced as dyspepsia is associated with concomitant issues, such as impaired sleep quality and loss of work productivity⁸. Dyspepsia management benefits from active patient engagement, as behavioral interventions are a main component of dyspepsia treatment^9,10. These interventions require a significant effort from patients, which may be facilitated by personalized and interactive support.

Correct management of dyspepsia is essential to improve healthcare outcomes and prevent overuse of medical resources. Upper gastrointestinal (GI) endoscopy for dyspepsia is a well-known form of overuse as its diagnostic yield is limited¹¹. Several methods have been proposed to reduce the number of upper GI endoscopies, mostly focused on physician education or drug-based symptom reduction¹². Uncertainty about the cause of dyspepsia is often unsatisfactory for patients, and diagnostic tests may be performed in excess as a consequence. Consequently, education of patients about pathogenesis, treatment options, and conservative management would be an effective strategy to reduce the number of upper GI endoscopies.

While digital tools potentially provide an excellent platform for patient education, several functionalities of a digital tool are required, in order to maximize patient adoption and subsequent patient engagement in disease management¹³. The expected success of digital education mainly depends on its development process and measures taken to optimize information transfer. However, development processes of digital educational tools are infrequently published, impairing reproduction, progression, and evaluation of the validity and safety^1,14.

There is need for a detailed description and evaluation of development of a patient-centered digital educational tool. We describe the development of our dyspepsia educational tool, to serve as a template for future educational tool development.

Protocol

All procedures described in this protocol were approved by the Radboud university medical center Institutional Review Board (file no. 2016-3074).

1. Preliminary research

1. Focus groups to assess unmet needs in dyspepsia management
   1. Create a structure for a focus group with dyspeptic patients and with general practitioners.
   2. Conduct a focus group. Keep conducting additional focus groups until saturation of information is reached.
      NOTE: For this study two focus groups were conducted.
      1. Recruit participants from patient organization platforms and the gastroenterology outpatient clinic.
      2. Recruit general practitioners through local general practitioner networks.
      3. Provide all participants with a patient information form, explaining the concept and goal of the focus group. Do not present the questions of the focus group in the information form.
      4. Obtain written informed consent from all participants.
         ​NOTE: Informed consent was obtained from all participants in this study.
      5. Conduct the focus groups with two researchers. Appoint a moderator and an observer. As a moderator, emphasize that there are no wrong answers, ensure all participants have the opportunity to express their views, and monitor the time. As an observer, observe and take notes of the group dynamics and body language of participants.
      6. Start the recording of the session using a voice recorder.
      7. Present each question to the group and encourage discussion about varying views. Ask the following questions; 'Could you describe the symptoms you feel?', 'How do the symptoms influence your day-to-day life?', 'What measures have you taken yourself to relieve your symptoms?', 'Where did you get most information about your disease?', and 'Which elements lacked in the management of your disease?'.
      8. Transcribe the voice recording. Process the focus groups and interviews using the qualitative data analysis software (e.g., ATLAS.ti version 8.3.16).
      9. Highlight and connect topics and views that overlap. Use the observer notes for interpretation of discussion and opposite views of participants.
      10. Extract the main themes resulting from the focus group to form the structure of the tool.
2. Existing scientific evidence
   1. Based on the main outlines that resulted from assessment of needs, make an overview of the topics that should be supported by literature. Examples are pathophysiology of dyspepsia, dietary interventions, pharmacological treatment, and (the value of) diagnostics.
   2. Use the online databases Medline and EMBASE to search for recent literature. To build a search, MeSH terms (Medline) or Emtree terms (EMBASE) should be combined with free text words.
   3. Select the most relevant articles to use as scientific background in the tool.
   4. Find local and national guidelines related to dyspepsia management. Make a selection of recommendations most relevant to the target audience.
   5. Summarize existing national patient information on dyspepsia. Use approved primary and secondary care information, as well as government supported web-based information.

2. Content development

1. Software development partner
   1. Select a partner for software production to involve in the development. Make a selection based on available products, such as 3D visualization, video recording, user friendly content management system, and possibilities to do adjustments after pilot test.
      ​NOTE: For this study, Medify Media B.V. was contracted for software development.
2. Organization of data
   1. Combine all collected data in one file and merge related topics. Create a clear overview of all items that should be addressed in the tool.
   2. Categorize the information into manageable chapters.
   3. Organize the items into a logical flow that will be maintained in the tool, for example by drawing up a flowchart illustrating the flow and content of each chapter and interconnection between chapters.
   4. Organize the chapters in a nonlinear structure, allowing completion of chapters in random order.
3. Process session
   1. Organize a process session with all stakeholders, including involved researchers, doctors, software developers, and visual designers.
   2. Within the process session, identify all elements that can be visualized through real-life videos or animation or should appear as text.
4. Creation of content
   1. Start every chapter with an overview of the chapter, introduce important items and terms.
   2. At the end of every chapter, give a chapter summary. Refrain from giving redundant information that may distract attention.
   3. Highlight essential information using bullet points and/or bold text.
   4. Use plain language writing when writing texts.
      1. Clearly consider the target audience and write from that perspective.
      2. Maintain a 7^th to 8^th grade reading level.
      3. Use active rather than passive sentences, writing in a conversational style, including the frequent use of questions and personal pronouns (e.g., 'do you regularly feel full after a normal sized meal? Try to avoid fatty foods.', rather than 'if a full feeling after a normal sized meal is regularly encountered, avoiding fatty foods may be tried.').
      4. Limit the amount of text per paragraph to a maximum of 10 sentences.
   5. For the videos:
      1. Make a list of people needed for the real-life videos (e.g., patients, doctors, dieticians).
      2. Write detailed scripts and log files for all videos.
      3. Select an entourage for shooting of the videos, appropriate to the subject of the video, and with reduced noise level.
   6. For 3D visualization of elements of the content:
      1. Use visual references for each step of the desired 3D animation.
      2. Split animations into clips of 8−12 s. Before and after a clip, provide text blocks with information about the clip.

3. Building the digital educational tool

1. Add all the content to a content management system to adjust the order and appearance.
   NOTE: In this study, the Medify B.V. content management system was used.
2. Add all the text and the videos to panels. Choose a background image or a 3D visualization. Add customized questionnaires.
3. Check whether everything is correctly incorporated in the tool.
4. When all content is built into the content management system, create a pilot version of the educational tool.

4. User experience and validation

1. Administer the pilot educational tool to two patients and two general practitioners and ask for feedback on lay-out, content, and user friendliness.
2. Adjust the tool based on the test comments.
3. Validate the efficacy and usability of the educational tool in a randomized controlled trial.

Results

Results of focus groups

Five patients, recruited through patient networks (n = 2) or at the outpatient clinic (n = 3), were invited to join a focus group. All focus group patients were diagnosed with dyspepsia based on the opinion of a gastroenterologist. Characteristics of included patients are presented in Table 1.

Most participants ...

Discussion

The digital dyspepsia educational tool, developed using the abovementioned protocol, is a novel multimedia educational tool to assist patients and physicians in management of dyspepsia. This tool may be deployed to stimulate patient engagement, and improve health outcomes while curtailing inappropriate use of medical resources.

A similar procedure has been described for development of a fibromyalgia app¹⁵. As with dyspepsia, management of fibromyalgia focuses initially ...

Materials

Name	Company	Catalog Number	Comments
Dyspepsia e-learning	Dyspepsia e-learning		Digital educational tool for dyspepsia management
Paper Food Diary	Any		Schedule to record food consumption and symptoms
Computer	Any		A computer or tablet should be used to complete the e-learning
Medify Content Management System	Medify BV		A content management system to process the e-learning content