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. 2023 Mar 28:14:1149604.
doi: 10.3389/fneur.2023.1149604. eCollection 2023.

The Gut Dysmotility Questionnaire for Parkinson's disease: Insights into development and pretest studies

Vanessa Raeder  1   2   3   4 , Lucia Batzu  2   3 , Robert Untucht  1 , Annekathrin Fehre  5 , Alexandra Rizos  2   3 , Valentina Leta  2   3 , Renate Schmelz  6 , Jochen Hampe  6 , Sevasti Bostantjopoulou  7 , Zoe Katsarou  7 , Alexander Storch  8   9 , Heinz Reichmann  1 , Björn Falkenburger  1 , K Ray Chaudhuri  2   3 , Lisa Klingelhoefer  1
Affiliations

The Gut Dysmotility Questionnaire for Parkinson's disease: Insights into development and pretest studies

Vanessa Raeder et al. Front Neurol. .

Abstract

Objective: A total of 48% of patients with Parkinson's disease (PD) present symptoms of gastrointestinal dysfunction, particularly constipation. Furthermore, gastrointestinal tract (GIT)-related non-motor symptoms (NMSs) appear at all stages of PD, can be prodromal by many years and have a relevant impact on the quality of life. There is a lack of GIT-focused validated tools specific to PD to assess their occurrence, progress, and response to treatment. The aim of this study was to develop and evaluate a novel, disease- and symptom-specific, self-completed questionnaire, titled Gut Dysmotility Questionnaire (GDQ), for screening and monitoring gastrointestinal dysmotility of the lower GIT in patients with PD.

Methods: In phase 1, a systematic literature review and multidisciplinary expert discussions were conducted. In phase 2, cognitive pretest studies comprising standard pretests, interviews, and evaluation questionnaires were performed in patients with PD (n = 21), age- and sex-matched healthy controls (HC) (n = 30), and neurologists (n = 11). Incorporating these results, a second round of cognitive pretests was performed investigating further patients with PD (n = 10), age- and sex-matched HC (n = 10), and neurologists (n = 5). The questionnaire was adapted resulting in the final GDQ, which underwent cross-cultural adaptation to the English language.

Results: We report significantly higher GDQ total scores and higher scores in five out of eight domains indicating a higher prevalence of gastrointestinal dysmotility in patients with PD than in HC (p < 0.05). Cognitive pretesting improved the preliminary GDQ so that the final GDQ was rated as relevant (100/100%), comprehensive (100/90%), easy to understand concerning questions and answer options (100/90%), and of appropriate length (80/100%) by neurologists and patients with PD, respectively. The GDQ demonstrated excellent internal consistency (Cronbach's alpha value of 0.94). Evidence for good construct validity is given by moderate to high correlations of the GDQ total score and its domains by intercorrelations (r s = 0.67-0.91; p < 0.001) and with validated general NMS measures as well as with specific items that assess gastrointestinal symptoms.

Interpretation: The GDQ is a novel, easy, and quick 18-item self-assessment questionnaire to screen for and monitor gastrointestinal dysmotility with a focus on constipation in patients with PD. It has shown high acceptance and efficacy as well as good construct validity in cognitive pretests.

Keywords: Parkinson's disease; bowel movement; cognitive pretest; constipation; gut; non-motor symptoms; questionnaire.

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Conflict of interest statement

RU has received a grant from the Stiftung Hochschulmedizin (medical university foundation) Dresden outside the present study. He was or is an investigator in pharmaceutical studies sponsored by Amylyx, Bial, Ferrer, Orion Pharma, and UCB outside the present study. AR has received salary support from the National Institute of Health Research (NIHR) Clinical Research Network (CRN) South London, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK and the International Parkinson and Movement Disorder Society (MDS), 555 East Wells Street, Suite 1100, Milwaukee, WI 53202-3823 USA outside the present study. VL reports honoraria for sponsored symposium from UCB, Bial, Invisio, Profile, AbbVie, and Britannia Pharmaceuticals, outside the submitted work. AS has received funding from the Deutsche Forschungsgemeinschaft (German Research Association) and the Helmholtz-Association outside the present study. He has received honoraria for presentations/advisory boards/consultations from Global Kinetics Corporation (manufacturer of the PKG®), Desitin, Lobsor Pharmaceuticals, STADA, Bial, RG Gesellschaft, Zambon, NovoNordisk and AbbVie outside the present study. He has received royalties from Kohlhammer Verlag and Elsevier Press. He serves as an editorial board member of Stem Cells International. HR was acting on Advisory Boards, gave lectures and received research grants from Abbott, Abbvie, Bayer Health Care, Bial, Boehringer/Ingelheim, Brittania, Cephalon, Desitin, Eisai, GSK, Lundbeck, Medtronic, Merck-Serono, Novartis, Orion, Pfizer, TEVA, UCB Pharma, Valeant, and Zambon. BF reports no funding related to the conduct of this study. Outside of the submitted work, he reports grants from the German Research Foundation (DFG) and speaker honoraria from AbbVie, Stadapharm, Desitin, Zambon and Bial. LK reports habilitation funding for women from the Medical Faculty of the Technical University (TU) Dresden, Germany. Further, the development of the GDQ was supported by the university of excellence of TU Dresden, funded by the excellence strategy of the federal and state governments (Str1911_038) without any influence on the scientific content. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flowchart summarizing the literature search.
Figure 2
Figure 2
Therapy of patients with Parkinson's disease included in phase 2a.
Figure 3
Figure 3
Gut Dysmotility Questionnaire (GDQ).
Figure 4
Figure 4
Instructions for administration and evaluation of the Gut Dysmotility Questionnaire (GDQ).
See this image and copyright information in PMC

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