TY - JOUR
T1 - Baseline Predictors of Longitudinal Changes in Symptom Severity and Quality of Life in Patients With Suspected Gastroparesis
AU - Lee, Allen A.
AU - Rao, Krishna
AU - Parkman, Henry P.
AU - McCallum, Richard W.
AU - Sarosiek, Irene
AU - Nguyen, Linda A.
AU - Wo, John M.
AU - Schulman, Michael I.
AU - Moshiree, Baharak
AU - Rao, Satish
AU - Kuo, Braden
AU - Hasler, William L.
N1 - Funding Information:
The authors thank Dr Richard Krause for his assistance with recruiting subjects for this study. Allen Lee, MD (Data curation: Equal; Formal analysis: Lead; Investigation: Equal; Methodology: Supporting; Project administration: Equal; Supervision: Equal; Visualization: Lead; Writing – original draft: Lead; Writing – review & editing: Lead), Krishna Rao, MD, MS (Formal analysis: Supporting; Methodology: Equal; Writing – review & editing: Equal), Henry Parkman, MD (Data curation: Equal; Investigation: Equal; Methodology: Supporting; Project administration: Equal; Supervision: Equal; Writing – review & editing: Equal), Richard McCallum, MD (Data curation: Equal; Investigation: Equal; Methodology: Supporting; Project administration: Equal; Supervision: Equal; Writing – review & editing: Equal), Irene Sarosiek, MD (Data curation: Equal; Investigation: Equal; Methodology: Supporting; Project administration: Equal; Supervision: Equal; Writing – review & editing: Equal), Linda Nguyen, MD (Data curation: Equal; Investigation: Equal; Methodology: Supporting; Project administration: Equal; Supervision: Equal; Writing – review & editing: Equal), John Wo, MD (Data curation: Equal; Investigation: Equal; Methodology: Supporting; Project administration: Equal; Supervision: Equal; Writing – review & editing: Equal), Michael Schulman, MD (Data curation: Equal; Investigation: Equal; Methodology: Supporting; Project administration: Equal; Supervision: Equal; Writing – review & editing: Equal), Baharak Moshiree, MD (Data curation: Equal; Investigation: Equal; Methodology: Supporting; Project administration: Equal; Supervision: Equal; Writing – review & editing: Equal), Satish Rao, MD (Data curation: Equal; Investigation: Equal; Methodology: Supporting; Project administration: Equal; Supervision: Equal; Writing – review & editing: Equal), Braden Kuo, MD, MS (Conceptualization: Equal; Data curation: Equal; Formal analysis: Supporting; Funding acquisition: Equal; Investigation: Equal; Methodology: Supporting; Project administration: Equal; Supervision: Equal; Writing – original draft: Supporting; Writing – review & editing: Equal), William Hasler, MD (Conceptualization: Equal; Data curation: Equal; Formal analysis: Supporting; Funding acquisition: Equal; Investigation: Equal; Methodology: Supporting; Project administration: Equal; Supervision: Equal; Writing – original draft: Equal; Writing – review & editing: Equal) Conflicts of interest These authors disclose the following: AL, HP, RM, LN, JW, MS, BM, SR, BK, and WH received funding from Covidien to conduct this study. BK is a consultant for Gelesis, Ironwood Pharmaceuticals, Takeda, Alpha Waserman, Neurogastrx, Arena Pharmaceuticals, and CinRx Pharma and received research support from Vanda, Genzyme, and Covidien. The remaining authors disclose no conflicts. Funding The parent study supporting the data and analyses included in this article was funded by Covidien. Covidien did not participate in study design, data interpretation, writing support, or other preparation assistance for this article. Grant support was also provided by the NIH grants KL2TR002241 (to AL) and AI124255 (to KR).
Funding Information:
Funding The parent study supporting the data and analyses included in this article was funded by Covidien. Covidien did not participate in study design, data interpretation, writing support, or other preparation assistance for this article. Grant support was also provided by the NIH grants KL2TR002241 (to AL) and AI124255 (to KR).
Publisher Copyright:
© 2022 AGA Institute
PY - 2022/3
Y1 - 2022/3
N2 - Background & Aims: Whether gastric emptying tests predict longitudinal outcomes in patients with symptoms of gastroparesis is unclear. We aimed to determine whether baseline gastric emptying tests and gut motility parameters could impact longitudinal symptom(s) and quality of life (QOL) in a prospective, observational cohort study of patients with symptoms of gastroparesis. Methods: One hundred fifty patients with gastroparesis symptoms underwent simultaneous scintigraphy (GES) and wireless motility capsule (WMC) measurement of gastric emptying and other motility parameters. Patient Assessment of Upper Gastrointestinal Symptoms and Quality of Life were administered at baseline, and 3 and 6 months after testing. Multivariable generalized linear marginal models were fit to determine which baseline parameters predict longitudinal changes in symptoms and QOL. Results: Overall upper GI symptoms and QOL scores were moderate in severity at baseline and significantly improved over 6 months. Clinical variables, including female gender, harder stools by Bristol stool form score, and presence of functional dyspepsia (FD) by Rome III criteria, were predictive of more severe upper GI symptoms. Even after controlling for these clinical factors, delayed gastric emptying by GES or WMC was associated with worse symptom severity and QOL scores. Low gastric and elevated small bowel contractile parameters by WMC were also independently associated with more severe upper GI symptoms and worse QOL scores. Conclusions: Baseline features, including demographic and clinical variables, delayed gastric emptying and abnormal gastrointestinal contractility, were independent predictors of more severe longitudinal symptoms and worse quality of life outcomes. These factors may help to risk stratify patients and guide treatment decisions. ClinicalTrials.gov no: NCT02022826.
AB - Background & Aims: Whether gastric emptying tests predict longitudinal outcomes in patients with symptoms of gastroparesis is unclear. We aimed to determine whether baseline gastric emptying tests and gut motility parameters could impact longitudinal symptom(s) and quality of life (QOL) in a prospective, observational cohort study of patients with symptoms of gastroparesis. Methods: One hundred fifty patients with gastroparesis symptoms underwent simultaneous scintigraphy (GES) and wireless motility capsule (WMC) measurement of gastric emptying and other motility parameters. Patient Assessment of Upper Gastrointestinal Symptoms and Quality of Life were administered at baseline, and 3 and 6 months after testing. Multivariable generalized linear marginal models were fit to determine which baseline parameters predict longitudinal changes in symptoms and QOL. Results: Overall upper GI symptoms and QOL scores were moderate in severity at baseline and significantly improved over 6 months. Clinical variables, including female gender, harder stools by Bristol stool form score, and presence of functional dyspepsia (FD) by Rome III criteria, were predictive of more severe upper GI symptoms. Even after controlling for these clinical factors, delayed gastric emptying by GES or WMC was associated with worse symptom severity and QOL scores. Low gastric and elevated small bowel contractile parameters by WMC were also independently associated with more severe upper GI symptoms and worse QOL scores. Conclusions: Baseline features, including demographic and clinical variables, delayed gastric emptying and abnormal gastrointestinal contractility, were independent predictors of more severe longitudinal symptoms and worse quality of life outcomes. These factors may help to risk stratify patients and guide treatment decisions. ClinicalTrials.gov no: NCT02022826.
KW - Gastric Emptying
KW - Gastrointestinal Motility
KW - Longitudinal Outcomes
KW - Scintigraphy
KW - Wireless Motility Capsule
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U2 - 10.1016/j.cgh.2020.09.032
DO - 10.1016/j.cgh.2020.09.032
M3 - Article
C2 - 32971231
AN - SCOPUS:85099574597
SN - 1542-3565
VL - 20
SP - e407-e428
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 3
ER -