Systematic review: Disease‐specific instruments to assess gastrointestinal symptoms in functional dyspepsia

Smeets, Fabienne G.; Masclee, Ad; Conchillo, José M.; Keszthelyi, Dániel

doi:10.1111/nmo.13327

Cited by 8 publications

(13 citation statements)

References 67 publications

(140 reference statements)

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“…A conceptual framework of theoretical constructs was developed for assessment of symptoms in patients with functional dyspepsia. For development of this framework, an extensive systematic literature search was performed to obtain available retrospective questionnaires for selection of FD‐specific items . Moreover, ESM‐specific constructs (ie, psychological status, social, and contextual factors) were derived from previously used ESM questionnaires at the departments of Gastroenterology and Hepatology, and Psychiatry and Psychology of Maastricht University Medical Center (MUMC+) …”

Section: Methodsmentioning

confidence: 99%

“…Functional dyspepsia is a symptom‐based diagnosis, and patient‐reported outcome measures (PROMs) are used to assess treatment efficacy . In a recently published systematic review, 20 available retrospective outcome measures were described for the evaluation of dyspeptic symptoms . However, these outcome measures do not fulfill all criteria for adequate psychometric validation, as defined by regulatory authorities.…”

Section: Introductionmentioning

confidence: 99%

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Development of a real‐time patient‐reported outcome measure for symptom assessment in patients with functional dyspepsia using the experience sampling method

Smeets

Keszthelyi

Vork

et al. 2018

Neurogastroenterology Motil

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Background Patient‐reported outcome measures (PROMs) are used to assess symptoms in patients with functional dyspepsia (FD). Current end‐of‐day questionnaires have several limitations including sensitivity to recall and ecological bias. The experience sampling method (ESM) is characterized by random and repeated assessments across momentary states in daily life and therefore less sensitive to these limitations. This study describes the development of a novel PROM based on ESM technology. Methods An initial draft of the PROM was developed based on literature. Focus group interviews with FD patients according to Rome IV criteria, and an expert meeting with international opinion leaders in the field of functional gastrointestinal disorders were conducted in order to select items for the PROM. Cognitive interviews were performed to evaluate patients’ understanding of the selected items and to create the definitive PROM. Key results A systematic literature search revealed 59 items across four domains (ie, physical status; mood and psychological factors; context and environment; and nutrition, medication, and substance use). After patient focus group interviews and an international expert meeting, the number of items was reduced to 33. Cognitive interviews resulted in some minor linguistic changes in order to improve patients’ understanding. Conclusions and inferences A novel digital ESM‐based PROM for real‐time symptom assessment in patients with functional dyspepsia was developed. This novel PROM has the potential to identify individual symptom patterns and specific triggers for dyspeptic symptoms, and optimize treatment strategies.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development of a real‐time patient‐reported outcome measure for symptom assessment in patients with functional dyspepsia using the experience sampling method

Smeets

Keszthelyi

Vork

et al. 2018

Neurogastroenterology Motil

Self Cite

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show abstract

“…This might explain the clear discrimination between FD, IBS, and HV based on abdominal symptoms. Another advantage is that no detailed questionnaire needs to be completed to discriminate between FD/IBS patients and HV as it has been the case for previous patient‐reported outcome measures (PROM) . The test also meets the FDA criterion of a PROM representing a direct report from the patient without its interpretation by a clinician.…”

Section: Discussionmentioning

confidence: 99%

“…but also between FD and HV. Additionally, despite big efforts during the last years, no developed PROM is currently considered appropriate in FD patients . Considering this, we think that the LHBT as an instrument including subjective as well as objective measure represents a useful tool for diagnostic work‐up and to monitor and predict the therapeutic progress in FD patients in the future.…”

Section: Discussionmentioning

confidence: 99%

“…Another advantage is that no detailed questionnaire needs to be completed to discriminate between FD/IBS patients and HV as it has been the case for previous patient-reported outcome measures (PROM). [14][15][16][17] The test also meets the FDA criterion of a PROM representing a direct report from the patient without its interpretation by a clinician. In the past, tests with investigator-administered instruments were described to be limited as clinician's interpretation often underestimates symptom severity.…”

Section: Discussionmentioning

confidence: 99%

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Differentiation of functional gastrointestinal disorders from healthy volunteers by lactulose hydrogen breath test and test meal

Schindler

Giezendanner

Bütikofer

et al. 2018

J of Gastro and Hepatol

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Background and Aim Functional dyspepsia (FD) is a common disorder of gut–brain interaction with incompletely understood pathophysiology. Consequently, heterogeneous expert opinions on diagnostic tests and assessment of treatment efficacies exist. So far, no consensus about the most relevant diagnostic and outcome tool has been reached. In this study, we aimed to analyze the significance of a combined lactulose hydrogen breath test (LHBT) and liquid meal, yet representing a standardized test in irritable bowel syndrome (IBS), in FD. Methods We analyzed data of 146 FD, 204 IBS patients, and 50 healthy volunteers (HV). All patients underwent LHBT with a meal‐drink consisting of 30‐g Lactulose and 400‐mL Ensure®. Effect of abdominal symptom generation in FD/IBS compared with HV was assessed on a patient‐reported Likert‐scale. Results There was a significant difference between FD/IBS patients and HV in LHBT‐induced abdominal pain (odds ratio [OR] 246.9, 95% confidence interval [CI] 26.6–2290.7; OR 161.2, 95% CI 16.9–1534.8), abdominal bloating (OR 384.8, 95% CI 92.9–2135.4; OR 524.1, 95% CI 114.7–3432.3), borborygmi (OR 9.9, 95% CI 2.2–46.9; OR 17.7, 95% CI 4.7–67.4), nausea only in FD (OR 174.4, 95% CI 15.5–5375.5), and diarrhea in IBS only (OR 25.8, 95% CI 2.0–7012.6). Hydrogen production was not significantly different in FD/IBS and HV. Conclusions In this study, we demonstrated significant differences in postprandial symptom generation in FD and IBS compared with HV after LHBT. This does not only allow us to discriminate FD/IBS from HV but may also represent a diagnostic and monitoring tool for FD/IBS in the future, including monitoring of treatment effects.

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Efficacy and safety of spore-forming probiotics in the treatment of functional dyspepsia: a pilot randomised, double-blind, placebo-controlled trial

Wauters

Slaets

Paepe

et al. 2021

The Lancet Gastroenterology & Hepatology

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Systematic review: Disease‐specific instruments to assess gastrointestinal symptoms in functional dyspepsia

Cited by 8 publications

References 67 publications

Development of a real‐time patient‐reported outcome measure for symptom assessment in patients with functional dyspepsia using the experience sampling method

Development of a real‐time patient‐reported outcome measure for symptom assessment in patients with functional dyspepsia using the experience sampling method

Differentiation of functional gastrointestinal disorders from healthy volunteers by lactulose hydrogen breath test and test meal

Efficacy and safety of spore-forming probiotics in the treatment of functional dyspepsia: a pilot randomised, double-blind, placebo-controlled trial

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