Algorithm-Based Care for Treating Chronic Pancreatitis: A Nationwide Stepped-Wedge Cluster Randomized Controlled Trial
The American Journal of Gastroenterology
Abstract
INTRODUCTION: Chronic pancreatitis strongly impairs patients' quality of life through pain and functional insufficiencies, which may be improved by implementing an evidence-based management algorithm. This study aimed to improve quality of life and reduce pain by increasing guideline adherence, using an evidence-based management algorithm, addressing exocrine and endocrine pancreatic insufficiency, nutritional status, bone health, pain management, and lifestyle. METHODS: A nationwide stepped-wedge cluster-randomized controlled trial was performed across 26 Dutch centers collaborating in the Dutch Pancreatitis Study Group, representing 6 healthcare regions. Current practice was compared with evidence-based management algorithm-guided care. Patients with a definite diagnosis of chronic pancreatitis, who were actively receiving care from a gastroenterologist or surgeon at the time of algorithm implementation, were included during the current practice phase and followed longitudinally. Coprimary endpoints were pain severity (Izbicki Pain Score) and quality of life (Pancreatitis Quality-of-Life Instrument score), with a clinically relevant effect threshold defined as 10% of the maximum score, based on an expert consensus Delphi meeting. Analyses were performed according to intention-to-treat. Secondary outcomes included protocol adherence and several clinical outcomes. Total study duration was 35 months. RESULTS: Overall, 418 patients with chronic pancreatitis were included. Evidence-based management algorithm-guided care improved Izbicki Pain Scores (estimate: -1.72, 97.5% CI: -3.02 to -0.41, P < 0.001), without reaching the predefined threshold. No significant change in Pancreatitis Quality-of-Life Instrument score was observed (estimate: 0.42, 97.5% CI: -0.44 to 1.27, P = 0.27). Median protocol adherence in patients who completed the follow-up period was 68.8% (IQR, 56.1-83.9). Stratified analyses by baseline scores and adherence did not yield clinically relevant improvements. DISCUSSION: We found no superiority of an evidence-based management algorithm over standard practice in improving quality of life or pain severity in all patients with chronic pancreatitis. However, by subgroup analyses, increased protocol adherence led to significantly better outcomes, especially in those with severe pain or low quality of life at baseline. These findings highlight both the complexity of, and the need for, dedicated protocol adherence in chronic pancreatitis management.
Authors 41
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Florence E.M. de Rijk corresponding
Erasmus MC · St. Antonius Ziekenhuis · Erasmus University Rotterdam
Affiliation as printed
Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands;
Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands;
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N.D.E. Thierens corresponding
Radboud University Nijmegen · Radboud University Medical Center · St. Antonius Ziekenhuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands;
Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands;
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St. Antonius Ziekenhuis · Amsterdam University Medical Centers · Amsterdam Gastroenterology Endocrinology Metabolism · University of Amsterdam
Affiliation as printed
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, the Netherlands;
Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands;
Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands;
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Affiliation as printed
Department of Research and Development, St. Antonius Hospital, Nieuwegein, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Sint Franciscus Hospital, Rotterdam, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Haga Hospital, The Hague, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, Ede, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, the Netherlands;
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Spaarne Ziekenhuis · Spaarne Gasthuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Spaarne Gasthuis, Hoofddorp, the Netherlands;
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Radboud University Nijmegen · Radboud University Medical Center
Affiliation as printed
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, the Netherlands;
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Leiden University Medical Center
Affiliation as printed
Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Zuyderland Medical Center, Sittard, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Bravis Hospital, Roosendaal, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, OLVG, Amsterdam, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Isala, Zwolle, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Reinier de Graaf Gasthuis, Delft, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Amphia Hospital, Breda, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Maxima Medical Center, Veldhoven, the Netherlands;
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Canisius-Wilhelmina Ziekenhuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Martini Hospital, Groningen, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Bravis Hospital, Roosendaal, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Medical Spectrum Twente, Enschede, the Netherlands;
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University Medical Center Utrecht
Affiliation as printed
Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands;
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Amsterdam University Medical Centers · University of Amsterdam
Affiliation as printed
Department of Gastroenterology and Hepatology, Amsterdam, University Medical Center, University of AmsterdamAmsterdam, the Netherlands;
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Amsterdam University Medical Centers · Amsterdam Gastroenterology Endocrinology Metabolism · Vrije Universiteit Amsterdam · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, the Netherlands;
Department of Gastroenterology and Hepatology, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, Ede, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands;
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Amsterdam University Medical Centers · Amsterdam Gastroenterology Endocrinology Metabolism · University of Amsterdam
Affiliation as printed
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, the Netherlands;
Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands;
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Amsterdam University Medical Centers · University of Amsterdam
Affiliation as printed
Department of Gastroenterology and Hepatology, Amsterdam, University Medical Center, University of AmsterdamAmsterdam, the Netherlands;
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Leiden University Medical Center
Affiliation as printed
Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, the Netherlands;
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University Medical Center Utrecht · St. Antonius Ziekenhuis
Affiliation as printed
Department of Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands;
Department of Surgery, University Medical Center Utrecht, Utrecht, the Netherlands;
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Utrecht University · University Medical Center Utrecht
Affiliation as printed
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
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Erasmus MC · Erasmus University Rotterdam
Affiliation as printed
Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands;
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Erasmus MC · Erasmus University Rotterdam
Affiliation as printed
Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands;
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Affiliation as printed
Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands;
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Affiliation as printed
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