Algorithm-Based Care for Treating Chronic Pancreatitis: A Nationwide Stepped-Wedge Cluster Randomized Controlled Trial.
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de Rijk F E M, Thierens N D E, van Veldhuisen C L, Aman B A, Anten M P G F, Bhalla A, Bos P R, Brink M A, Curvers W L, van Eijck B C, van Geenen E J M, Hadithi M, Inderson A, Kager L M, Keulemans Y L, Koehestanie P, Kuiken S D, Poen A C, Quispel R, Römkens T E H, Nicolaas J Sint, van der Schaar P J, Straathof J W A, Tan A C I T L, Thijs W J, Tielemans M M, Venneman N G, Vleggaar F P, Voermans R P, van Wanrooij R L J, Verlaan T, Zoutendijk R, Besselink M G, Drenth J P H, van Hooft J E, van Santvoort H C, van Werkhoven C H, de Jonge P J F, Bruno M J, Verdonk R C, Dutch Pancreatitis Study Group
Аннотация
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.