Implementation of an evidence-based management algorithm for patients with chronic pancreatitis (COMBO trial): study protocol for a stepped-wedge cluster-randomized controlled trial

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Abstract

Background

Chronic pancreatitis (CP) is an inflammatory disease that may be complicated by abdominal pain, pancreatic dysfunction, nutritional deficiencies, and diminished bone density. Importantly, it is also associated with a substantially impaired quality of life and reduced life expectancy. This may partly be explained by suboptimal treatment, in particular the long-term management of this chronic condition, despite several national and international guidelines. Standardization of care through a structured implementation of guideline recommendations may improve the level of care and lower the complication rate of these patients. Therefore, the aim of the present study is to evaluate to what extent patient education and standardization of care, through the implementation of an evidence-based integrated management algorithm, improve quality of life and reduce pain severity in patients with CP .

Methods

The COMBO trial is a nationwide stepped-wedge cluster-randomized controlled trial. In a stepwise manner, 26 centers, clustered in 6 health regions, cross-over from current practice to care according to an evidence-based integrated management algorithm. During the current practice phase, study participants are recruited and followed longitudinally through questionnaires. Individual patients contribute data to both study periods. Co-primary study endpoints consist of quality of life (assessed by the PANQOLI score) and level of pain (assessed by the Izbicki questionnaire). Secondary outcomes include process measure outcomes, clinical outcomes (e.g., pancreatic function, nutritional status, bone health, interventions, medication use), utilization of healthcare resources, (in) direct costs, and the level of social participation. Standard follow-up is 35 months from the start of the trial.

Discussion

This is the first stepped-wedge cluster-randomized controlled trial to investigate whether an evidence-based integrated therapeutic approach improves quality of life and pain severity in patients with CP as compared with current practice.

Trial registration

ISRCTN, ISRCTN13042622. Registered on 5 September 2020.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-022-07044-8.

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Most cited references 22

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2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2019

(2018)

The American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" includes ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations, please refer to the Standards of Care Introduction Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

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United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (HaPanEU)

J.-Matthias Löhr, Juan Domínguez-Muñoz, Jonas Rosendahl … (2017)

Background There have been substantial improvements in the management of chronic pancreatitis, leading to the publication of several national guidelines during recent years. In collaboration with United European Gastroenterology, the working group on ‘Harmonizing diagnosis and treatment of chronic pancreatitis across Europe’ (HaPanEU) developed these European guidelines using an evidence-based approach. Methods Twelve multidisciplinary review groups performed systematic literature reviews to answer 101 predefined clinical questions. Recommendations were graded using the Grading of Recommendations Assessment, Development and Evaluation system and the answers were assessed by the entire group in a Delphi process online. The review groups presented their recommendations during the 2015 annual meeting of United European Gastroenterology. At this one-day, interactive conference, relevant remarks were voiced and overall agreement on each recommendation was quantified using plenary voting (Test and Evaluation Directorate). After a final round of adjustments based on these comments, a draft version was sent out to external reviewers. Results The 101 recommendations covered 12 topics related to the clinical management of chronic pancreatitis: aetiology (working party (WP)1), diagnosis of chronic pancreatitis with imaging (WP2 and WP3), diagnosis of pancreatic exocrine insufficiency (WP4), surgery in chronic pancreatitis (WP5), medical therapy (WP6), endoscopic therapy (WP7), treatment of pancreatic pseudocysts (WP8), pancreatic pain (WP9), nutrition and malnutrition (WP10), diabetes mellitus (WP11) and the natural course of the disease and quality of life (WP12). Using the Grading of Recommendations Assessment, Development and Evaluation system, 70 of the 101 (70%) recommendations were rated as ‘strong' and plenary voting revealed ‘strong agreement' for 99 (98%) recommendations. Conclusions The 2016 HaPanEU/United European Gastroenterology guidelines provide evidence-based recommendations concerning key aspects of the medical and surgical management of chronic pancreatitis based on current available evidence. These recommendations should serve as a reference standard for existing management of the disease and as a guide for future clinical research.

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Chronic pancreatitis

Georg Beyer, Aida Habtezion, Jens Werner … (2020)

Chronic pancreatitis is a multifactorial, fibroinflammatory syndrome in which repetitive episodes of pancreatic inflammation lead to extensive fibrotic tissue replacement, resulting in chronic pain, exocrine and endocrine pancreatic insufficiency, reduced quality of life, and a shorter life expectancy. The incidence and prevalence of chronic pancreatitis is rising and no curative treatment is available. Using novel diagnostic algorithms, definitive chronic pancreatitis can be diagnosed by imaging criteria alone, whereas probable chronic pancreatitis requires clinical features and imaging criteria. Criteria for the diagnosis of early chronic pancreatitis are still under discussion and need prospective validation in clinical trials. Cross-sectional imaging should be used first; endoscopic ultrasound is needed only when CT or MRI are inconclusive or to plan therapeutic interventions. Management of chronic pancreatitis requires an interdisciplinary approach including primary care practitioners, gastroenterologists, surgeons, radiologists, pain specialists, and nutritional therapists. Patients with chronic pancreatitis should be seen at least once a year and re-evaluated for causal risk factors, symptom control, and complications such as malnutrition, pancreatic exocrine insufficiency, and diabetes; refer to a specialised centre if symptoms are poorly controlled or there is risk of deterioration. Scoring systems to monitor disease progression have been developed and validated internationally. Interventional treatments for pain or cholestasis should be done by specialists only, and early discussion of treatment approaches should include all medical disciplines involved in care. Throughout this Seminar, we address research needs such as staging of pancreatitis, aspects of malnutrition and pain, and cancer surveillance, to help improve the care of patients.

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Author and article information

Contributors

Florence E. M. de Rijk:

ORCID: http://orcid.org/0000-0002-5315-2230

f.derijk@erasmusmc.nl

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 7 January 2023

Publication date PMC-release: 7 January 2023

Publication date Collection: 2023

Volume: 24

Electronic Location Identifier: 18

Affiliations

[1 ]GRID grid.5645.2, ISNI 000000040459992X, Department of Gastroenterology and Hepatology, , Erasmus University Medical Center, ; Doctor Molewaterplein 40, 3015 GD Rotterdam, The Netherlands

[2 ]GRID grid.415960.f, ISNI 0000 0004 0622 1269, Department of Research and Development, , St. Antonius Hospital, ; Nieuwegein, The Netherlands

[3 ]GRID grid.509540.d, ISNI 0000 0004 6880 3010, Department of Surgery, , Amsterdam UMC, Location University of Amsterdam, ; Amsterdam, The Netherlands

[4 ]Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands

[5 ]GRID grid.10419.3d, ISNI 0000000089452978, Department of Gastroenterology and Hepatology, , Leiden University Medical Center, ; Leiden, The Netherlands

[6 ]GRID grid.415960.f, ISNI 0000 0004 0622 1269, Department of Surgery, , St. Antonius Hospital, ; Nieuwegein, The Netherlands

[7 ]GRID grid.7692.a, ISNI 0000000090126352, Department of Surgery, , University Medical Center Utrecht, ; Utrecht, The Netherlands

[8 ]GRID grid.10417.33, ISNI 0000 0004 0444 9382, Department of Gastroenterology and Hepatology, , Radboud University Medical Center, ; Nijmegen, The Netherlands

[9 ]GRID grid.7692.a, ISNI 0000000090126352, Julius Center for Health Sciences and Primary Care, ; Utrecht, The Netherlands

[10 ]GRID grid.415960.f, ISNI 0000 0004 0622 1269, Department of Gastroenterology and Hepatology, , St. Antonius Hospital, ; Nieuwegein, The Netherlands

Author information

Florence E. M. de Rijk http://orcid.org/0000-0002-5315-2230

Article

Publisher ID: 7044

DOI: 10.1186/s13063-022-07044-8

PMC ID: 9824955

PubMed ID: 36611202

SO-VID: b9bc485d-6f68-4689-af82-4eefd04fa8a5

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 2 June 2022

Date accepted : 19 December 2022

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100016259, Mylan;

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ScienceOpen disciplines: Medicine

Keywords: chronic pancreatitis,management algorithm,integrated care,evidence-based,quality of life,pain severity,stepped-wedge,randomized controlled trial,combo

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ScienceOpen disciplines: Medicine

Keywords: chronic pancreatitis, management algorithm, integrated care, evidence-based, quality of life, pain severity, stepped-wedge, randomized controlled trial, combo

Implementation of an evidence-based management algorithm for patients with chronic pancreatitis (COMBO trial): study protocol for a stepped-wedge cluster-randomized controlled trial

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Abstract

Background

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Trial registration

Supplementary Information

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Herbal Medicines Journal (Herb Med J)

Most cited references 22

2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2019

United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (HaPanEU)

Chronic pancreatitis

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