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Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study
  1. Enrique de-Madaria1,
  2. Claudia Sánchez-Marin1,2,
  3. Irene Carrillo3,
  4. Santhi Swaroop Vege4,
  5. Serge Chooklin5,
  6. Andriy Bilyak5,
  7. Rafael Mejuto6,
  8. Violeta Mauriz6,
  9. Peter Hegyi7,8,
  10. Katalin Márta7,8,
  11. Ayesha Kamal9,
  12. Eugenia Lauret-Braña10,
  13. Sorin T Barbu11,
  14. Vitor Nunes12,
  15. M Lourdes Ruiz-Rebollo13,
  16. Guillermo García-Rayado14,
  17. Edgard E Lozada-Hernandez15,
  18. Jorge Pereira16,
  19. Ionut Negoi17,
  20. Silvia Espina18,
  21. Marcus Hollenbach19,
  22. Andrey Litvin20,
  23. Federico Bolado-Concejo21,
  24. Rómulo D Vargas22,
  25. Isabel Pascual-Moreno23,
  26. Vikesh K Singh9,
  27. José J Mira3,24
  1. 1Pancreatic Unit, Gastroenterology Department, Alicante University General Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, Spain
  2. 2Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, Santander, Spain
  3. 3Department of Health Psychology, Universidad Miguel Hernández, Elche, Spain
  4. 4Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
  5. 5Department of Surgery, Lviv Regional Clinical Hospital, Lviv, Ukraine
  6. 6Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain
  7. 7Institute for Translational Medicine, Szentágothai Research Centre, University of Pécs Medical School, Pécs, Hungary
  8. 8First Department of Medicine, University of Pécs Medical School, Pécs, Hungary
  9. 9Division of Gastroenterology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  10. 10Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain
  11. 11Department of Surgery, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
  12. 12Department of Surgery, Professor Doutor Fernando Fonseca Hospital, Amadora, Portugal
  13. 13Department of Gastroenterology, University Clinical Hospital of Valladolid, Valladolid, Spain
  14. 14Department of Gastroenterology, Lozano Blesa University Clinic Hospital, Aragon Health Research Institute (IIS Aragón), Zaragoza, Spain
  15. 15Department of Surgery, Hospital Regional de Alta Especialidad del Bajío, León, Mexico
  16. 16General Surgery Department 1, Tondela-Viseu Hospital Centre, Viseu, Portugal
  17. 17Department of General Surgery, Emergency Hospital of Bucharest, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania
  18. 18Gastroenterology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain
  19. 19Medical Department II (Gastroenterology, Hepatology, Infectious Diseases, Pulmonology), University of Leipzig Medical Center, Leipzig, Germany
  20. 20Department of Surgical Disciplines, Immanuel Kant Baltic Federal University, Regional Clinical Hospital, Kaliningrad, Russian Federation
  21. 21Department of Gastroenterology, Complejo Hospitalario de Navarra, Pamplona, Spain
  22. 22Gastroenterology Department, Hospital Universitario San Ignacio/Universidad Javeriana, Bogota, Colombia
  23. 23Department of Gastroenterology, Hospital Clínico Universitario de Valencia. Universidad de Valencia, Valencia, Spain
  24. 24Hospital Provincial-Pla Health Center, Alicante-Sant Joan Health District, Alicante, Spain
  1. Correspondence to Dr Enrique de-Madaria, Pancreatic Unit, Gastroenterology Department, Alicante University General Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante 03010, Spain; madaria{at}hotmail.com

Abstract

Objective This study aimed to develop and validate a patient-reported outcome measure (PROM) in acute pancreatitis (AP) as an endpoint centred on the patient.

Design A PROM instrument (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis, an international proSpEctive cohort study, PAN-PROMISE scale) was designed based on the opinion of patients, professionals and an expert panel. The scale was validated in an international multicentre prospective cohort study, describing the severity of AP and quality of life at 15 days after discharge as the main variables for validation. The COSMIN (COnsensus-based Standards for the selection of health status Measurement INstruments) methodology was applied. Both the design and validation stages considered the content and face validity of this new instrument; the metric properties of the different items, reliability (reproducibility and internal consistence), the construct, structural and criterion validity, responsiveness and interpretability of this scale.

Results PAN-PROMISE consists of a seven-item scale based on the symptoms that cause the most discomfort and concern to patients with AP. The validation cohort involved 15 countries, 524 patients. The intensity of symptoms changed from higher values during the first 24 hours to lower values at discharge and 15 days thereafter. Items converged into a unidimensional ordinal scale with good fit indices. Internal consistency and split-half reliability at discharge were adequate. Reproducibility was confirmed using test–retest reliability and comparing the PAN-PROMISE score at discharge and 15 days after discharge. Evidence is also provided for the convergent-discriminant and empirical validity of the scale.

Conclusion The PAN-PROMISE scale is a useful tool to be used as an endpoint in clinical trials, and to quantify patient well-being during the hospital admission and follow-up.

Trial registration number NCT03650062

  • acute pancreatitis
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Footnotes

  • Ed-M and CS-M are joint first authors.

  • Twitter @DeMadaria, @DraClauS

  • Presented at 1) preliminary results: European Pancreatic Club Meeting, Bergen, Norway (June 2019); 2) final results: United European Gastroenterology week, Barcelona, Spain (October 2019)

  • Collaborators Chuklin Serhii; Shershen Gennadiy; Tudor Cerciu; Sergiu Matei; Víctor Jiménez-Beltrán; Rita V. Martins; Rosa Matias; Antonio Gomes; Daniel Abad-Baroja; José P. Pinto; Ana C. Afonso; Cezar Ciubotaru; Bogdan Stoica; Vanesa Bernal; Eduardo Bajador-Andreu; Carlos Marra-López; Juliana Mantilla-Carreño; Claudia Zuluaga-Serna; Anita Gasiorowska; Natalia Fabisiak; László Czakó; Dóra Illés; Ainhoa Abando-Zurimendi; María Fraile; Young Koog Cheon; Konstantinos Triantafyllou; Polychronis Gatos-Gatopoulos; Rubén Piqué; Iván Guerra; Juan A. Rodríguez-Oballe; Beatriz Romero-Mosquera; Giulia De Marchi; Yonko Georgiev; Aurora Mula.

  • Contributors All authors were involved in data acquisition in phase I and/or II (except SSV), interpretation of the data and critical revision of the manuscript. Study concept and design: Ed-M and JJM. Primary analysis of the data: JJM, Ed-M, CS-M and IC. External review and assessment: SSV. Initial draft of the manuscript: JJM, Ed-M, PH, CS-M and SSV. Study supervision: CS-M. All authors have approved the final version of the manuscript.

  • Funding This study received no funding. The Spanish Association of Gastroenterology (AEG) provided access to a tool to develop the electronic case report form (REDCap) free of charge, with the sole aim of promoting independent investigator-driven research.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Ethics approval The study was initially approved on 09/01/2017 by the Ethic Committee of Clinical Research of the Alicante University General Hospital (Alicante, Spain), project identification code PI2016/69, and later by the Institutional Review Boards of all collaborating centres.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request. Study data are available to our collaborators to perform collateral studies.

  • Author note In loving memory of João Conde.

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