Zineb Cherkaoui1,2,3, Cristians González1,2, Taiga Wakabayashi4, Bastien Delattre5, Elodie Léost5, Sébastien Serra6, Jerôme Huppertz6, Francine Klein2, Marie Stéphan2, Jean-Michel Meyer7, Alain Schaff2, Elisa Martinis2, Elena Bangoura2, Sophie Kieffer2, Sophie Blanès2, Elham Haddad8, Gabrielle De Guio9, Emanuele Felli2, Sophie Pernot1, Jacques Marescaux1,4, Didier Mutter1,2,4, Constance Lugiez5, Patrick Pessaux10,11,12,13,14. 1. Institute of Image-Guided Surgery (IHU Strasbourg), Université de Strasbourg, Strasbourg, France. 2. Digestive and Endocrine Surgery Unit, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Strasbourg, France. 3. SSPC (Simplification of Surgical Patient Care), UR UPJV 7518, University of Picardie Jules Verne, Amiens, France. 4. Research Institute Against Digestive Cancer (IRCAD), Strasbourg, France. 5. Integrated Health Solutions (IHS), Medtronic France, Boulogne-Billancourt, France. 6. Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France. 7. CISS Alsace (Collectif Inter Associatif Sur la Santé), Strasbourg, France. 8. Oncology Unit, Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France. 9. Groupe Hospitalier Saint Vincent, Strasbourg, France. 10. Institute of Image-Guided Surgery (IHU Strasbourg), Université de Strasbourg, Strasbourg, France. patrick.pessaux@chru-strasbourg.fr. 11. Digestive and Endocrine Surgery Unit, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Strasbourg, France. patrick.pessaux@chru-strasbourg.fr. 12. Research Institute Against Digestive Cancer (IRCAD), Strasbourg, France. patrick.pessaux@chru-strasbourg.fr. 13. Hepatobiliary and Pancreatic Surgical Unit, Nouvel Hôpital Civil (NHC), Strasbourg, France. patrick.pessaux@chru-strasbourg.fr. 14. Unité Inserm UMR_S1110, Institut de Recherche sur les Maladies Virales et Hépatiques, Strasbourg, France. patrick.pessaux@chru-strasbourg.fr.
Abstract
BACKGROUND: Global health systems are shifting toward value-based health care to improve patient outcomes in the face of rising health care costs. The challenge is to identify standardized outcome measurements that allow optimal quality-of-care monitoring and comparison to optimize medical practices and patient pathways. A common outcomes definition is required, including medical results (Clinical Reported Outcomes Measurements [CROMs]) and quality-of-life components that matter most to patients (Patient-Reported Outcomes Measurements [PROMs]), which are particularly important for severe pathologies with short life expectancy such as pancreatic cancer. This study aimed to create standardized metrics that could be used for outcomes analysis of pancreatic cancer care. METHODS: A multidisciplinary working group (WG) was assembled. A systematic review was performed to collect the most used outcomes in clinical studies of pancreatic cancers. The study reviewed 570 studies published in the last 10 years. From these studies, 3370 outcomes, including CROMs, and PROMs, were listed and prioritized. The WG reached a consensus on key outcomes, proposed groupings for CROMs and PROMs, identified existing questionnaires that could be used for PROMs collection, and set the timeline for data collection. To refine and validate the final outcomes set, an international external committee completed a Delphi process (two rounds for both CROMS and PROMs). RESULTS: After the systematic literature review, the WG selected 102 outcomes (92 CROMs and 10 PROMs) for submission to the international Delphi vote committee. The committee retrained 89 outcomes (78 CROMs and 11 PROMs). For the PROMs, the WG and the international external committee chose a validated questionnaire, the Functional Assessment of Cancer Therapy-Hepatobiliary, which covers all of the 11 selected PROMs. CONCLUSIONS: A standardized set of outcome measures that need to be validated through international health outcome comparisons and quality-of-care assessments was built. Pilot projects are underway to test and optimize the approach in real-life conditions.
BACKGROUND: Global health systems are shifting toward value-based health care to improve patient outcomes in the face of rising health care costs. The challenge is to identify standardized outcome measurements that allow optimal quality-of-care monitoring and comparison to optimize medical practices and patient pathways. A common outcomes definition is required, including medical results (Clinical Reported Outcomes Measurements [CROMs]) and quality-of-life components that matter most to patients (Patient-Reported Outcomes Measurements [PROMs]), which are particularly important for severe pathologies with short life expectancy such as pancreatic cancer. This study aimed to create standardized metrics that could be used for outcomes analysis of pancreatic cancer care. METHODS: A multidisciplinary working group (WG) was assembled. A systematic review was performed to collect the most used outcomes in clinical studies of pancreatic cancers. The study reviewed 570 studies published in the last 10 years. From these studies, 3370 outcomes, including CROMs, and PROMs, were listed and prioritized. The WG reached a consensus on key outcomes, proposed groupings for CROMs and PROMs, identified existing questionnaires that could be used for PROMs collection, and set the timeline for data collection. To refine and validate the final outcomes set, an international external committee completed a Delphi process (two rounds for both CROMS and PROMs). RESULTS: After the systematic literature review, the WG selected 102 outcomes (92 CROMs and 10 PROMs) for submission to the international Delphi vote committee. The committee retrained 89 outcomes (78 CROMs and 11 PROMs). For the PROMs, the WG and the international external committee chose a validated questionnaire, the Functional Assessment of Cancer Therapy-Hepatobiliary, which covers all of the 11 selected PROMs. CONCLUSIONS: A standardized set of outcome measures that need to be validated through international health outcome comparisons and quality-of-care assessments was built. Pilot projects are underway to test and optimize the approach in real-life conditions.
Authors: Neil E Martin; Laura Massey; Caleb Stowell; Chris Bangma; Alberto Briganti; Anna Bill-Axelson; Michael Blute; James Catto; Ronald C Chen; Anthony V D'Amico; Günter Feick; John M Fitzpatrick; Steven J Frank; Michael Froehner; Mark Frydenberg; Adam Glaser; Markus Graefen; Daniel Hamstra; Adam Kibel; Nancy Mendenhall; Kim Moretti; Jacob Ramon; Ian Roos; Howard Sandler; Francis J Sullivan; David Swanson; Ashutosh Tewari; Andrew Vickers; Thomas Wiegel; Hartwig Huland Journal: Eur Urol Date: 2014-09-16 Impact factor: 20.096
Authors: Kimberley S Mak; Annelotte C M van Bommel; Caleb Stowell; Janet L Abrahm; Matthew Baker; Clarissa S Baldotto; David R Baldwin; Diana Borthwick; David P Carbone; Aileen B Chen; Jesme Fox; Tom Haswell; Marianna Koczywas; Benjamin D Kozower; Reza J Mehran; Franz M Schramel; Suresh Senan; Robert G Stirling; Jan P van Meerbeeck; Michel W J M Wouters; Michael D Peake Journal: Eur Respir J Date: 2016-07-07 Impact factor: 16.671
Authors: Patrick Michl; Matthias Löhr; John P Neoptolemos; Gabriele Capurso; Vinciane Rebours; Nuria Malats; Mathilde Ollivier; Luigi Ricciardiello Journal: United European Gastroenterol J Date: 2021-08-25 Impact factor: 6.866