Skip to main content
Top
Published in: Annals of Surgical Oncology 2/2021

01-02-2021 | Care | Pancreatic Tumors

A Standard Set of Value-Based Patient-Centered Outcomes for Pancreatic Carcinoma: An International Delphi Survey

Authors: Zineb Cherkaoui, MD, Cristians González, MD, Taiga Wakabayashi, MD, Bastien Delattre, Elodie Léost, Sébastien Serra, MD, Jerôme Huppertz, MD, Francine Klein, Marie Stéphan, Jean-Michel Meyer, Alain Schaff, Elisa Martinis, Elena Bangoura, Sophie Kieffer, Sophie Blanès, Elham Haddad, Gabrielle De Guio, MD, Emanuele Felli, MD, Sophie Pernot, Jacques Marescaux, MD, FACS, Hon FRCS, Hon JSES, Hon FASA, Didier Mutter, MD, PhD, Constance Lugiez, Patrick Pessaux, MD, PhD, IHU-VBHC Working Group

Published in: Annals of Surgical Oncology | Issue 2/2021

Login to get access

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.
Literature
1.
go back to reference Bardou M, Le Ray I. Treatment of pancreatic cancer: a narrative review of cost-effectiveness studies. Best Pract Res Clin Gastroenterol. 2013;27:881–92.CrossRef Bardou M, Le Ray I. Treatment of pancreatic cancer: a narrative review of cost-effectiveness studies. Best Pract Res Clin Gastroenterol. 2013;27:881–92.CrossRef
2.
go back to reference Ilic M, Ilic I. Epidemiology of pancreatic cancer. World J Gastroenterol. 2016;22:9694–705.CrossRef Ilic M, Ilic I. Epidemiology of pancreatic cancer. World J Gastroenterol. 2016;22:9694–705.CrossRef
3.
go back to reference Neuzillet C, Gaujoux S, Williet N, Bachet JB, Bauguion L, Colson Durand L, et al; Thésaurus National de Cancérologie Digestive (TNCD); Société Nationale Française de Gastroentérologie (SNFGE); Fédération Francophone de Cancérologie Digestive (FFCD); Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR); Fédération Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Société Française de Chirurgie Digestive (SFCD); Société Française d’Endoscopie Digestive (SFED); Société Française de Radiothérapie Oncologique (SFRO); Association de Chirurgie Hépato-Bilio-Pancréatique et Transplantation (ACHBT); Association Française de Chirurgie (AFC). Pancreatic cancer: French clinical practice guidelines for diagnosis, treatment and follow-up (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, ACHBT, AFC). Dig Liver Dis. 2018;50:1257–71. Neuzillet C, Gaujoux S, Williet N, Bachet JB, Bauguion L, Colson Durand L, et al; Thésaurus National de Cancérologie Digestive (TNCD); Société Nationale Française de Gastroentérologie (SNFGE); Fédération Francophone de Cancérologie Digestive (FFCD); Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR); Fédération Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Société Française de Chirurgie Digestive (SFCD); Société Française d’Endoscopie Digestive (SFED); Société Française de Radiothérapie Oncologique (SFRO); Association de Chirurgie Hépato-Bilio-Pancréatique et Transplantation (ACHBT); Association Française de Chirurgie (AFC). Pancreatic cancer: French clinical practice guidelines for diagnosis, treatment and follow-up (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, ACHBT, AFC). Dig Liver Dis. 2018;50:1257–71.
4.
go back to reference Porter ME. A strategy for health care reform: toward a value-based system. N Engl J Med. 2009;361:109–12.CrossRef Porter ME. A strategy for health care reform: toward a value-based system. N Engl J Med. 2009;361:109–12.CrossRef
5.
go back to reference Pessaux P, Cherkaoui Z. Value-based healthcare: a novel approach to the evaluation of patient care. Hepatobiliary Surg Nutr. 2018;7:125–6.CrossRef Pessaux P, Cherkaoui Z. Value-based healthcare: a novel approach to the evaluation of patient care. Hepatobiliary Surg Nutr. 2018;7:125–6.CrossRef
7.
go back to reference Ong WL, Schouwenburg MG, van Bommel AC, et al. A standard set of value-based patient-centered outcomes for breast cancer: the international consortium for health outcomes measurement (ICHOM) initiative. JAMA Oncol. 2017;3:677–85.CrossRef Ong WL, Schouwenburg MG, van Bommel AC, et al. A standard set of value-based patient-centered outcomes for breast cancer: the international consortium for health outcomes measurement (ICHOM) initiative. JAMA Oncol. 2017;3:677–85.CrossRef
8.
go back to reference Zerillo JA, Schouwenburg MG, van Bommel ACM, et al. A standard set of value-based patient-centered outcomes for colon cancer: the international consortium for health outcomes measurement (ICHOM) initiative. JAMA Oncol. 2017;3:686–94.CrossRef Zerillo JA, Schouwenburg MG, van Bommel ACM, et al. A standard set of value-based patient-centered outcomes for colon cancer: the international consortium for health outcomes measurement (ICHOM) initiative. JAMA Oncol. 2017;3:686–94.CrossRef
11.
go back to reference Morgans AK, van Bommel AC, Stowell C, et al. Development of a standardized set of patient-centered outcomes for advanced prostate cancer: an international effort for a unified approach. Eur Urol. 2015;68:891–8.CrossRef Morgans AK, van Bommel AC, Stowell C, et al. Development of a standardized set of patient-centered outcomes for advanced prostate cancer: an international effort for a unified approach. Eur Urol. 2015;68:891–8.CrossRef
12.
go back to reference Macefield RC, Jacobs M, Korfage IJ, et al. Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs). Trials. 2014;15:49.CrossRef Macefield RC, Jacobs M, Korfage IJ, et al. Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs). Trials. 2014;15:49.CrossRef
14.
go back to reference Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5:649–55.CrossRef Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5:649–55.CrossRef
15.
go back to reference Charlson M, Szatrowski TP, Peterson J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994;47:1245–51.CrossRef Charlson M, Szatrowski TP, Peterson J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994;47:1245–51.CrossRef
16.
go back to reference Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien–Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250:187–96.CrossRef Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien–Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250:187–96.CrossRef
18.
go back to reference Bassi C, Marchegiani G, Dervenis C, et al. The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 years after. Surgery. 2017;161:584–91.CrossRef Bassi C, Marchegiani G, Dervenis C, et al. The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 years after. Surgery. 2017;161:584–91.CrossRef
19.
go back to reference Wente MN, Bassi C, Dervenis C, et al. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007;142:761–8.CrossRef Wente MN, Bassi C, Dervenis C, et al. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007;142:761–8.CrossRef
20.
go back to reference Wente MN, Veit JA, Bassi C, et al. Post pancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007;142:20–5.CrossRef Wente MN, Veit JA, Bassi C, et al. Post pancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007;142:20–5.CrossRef
21.
go back to reference Cella D, Butt Z, Kindler HL, et al. Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer. Qual Life Res. 2013;22:1105–12.CrossRef Cella D, Butt Z, Kindler HL, et al. Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer. Qual Life Res. 2013;22:1105–12.CrossRef
22.
go back to reference Carrato A, Falcone A, Ducreux M, et al. A systematic review of the burden of pancreatic cancer in Europe: real-world impact on survival, quality of life, and costs. J Gastrointest Cancer. 2015;46:201–11.CrossRef Carrato A, Falcone A, Ducreux M, et al. A systematic review of the burden of pancreatic cancer in Europe: real-world impact on survival, quality of life, and costs. J Gastrointest Cancer. 2015;46:201–11.CrossRef
23.
go back to reference Basch E, Deal AM, Dueck AC, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA. 2017;318:197–8.CrossRef Basch E, Deal AM, Dueck AC, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA. 2017;318:197–8.CrossRef
24.
go back to reference Desomer A, Van den Heede K, Triemstra M, Paget J, De Boer D, Kohn L, Cleemput I. L’utilisation des résultats et expériences rapportés par les patients (PROM/PREM) à des fins cliniques et de gestion—synthèse. Health Services Research (HSR). Bruxelles: Centre Fédéral d’Expertise des Soins de Santé (KCE). 2018. KCE Reports 303Bs. D/2018/10.273/38. Desomer A, Van den Heede K, Triemstra M, Paget J, De Boer D, Kohn L, Cleemput I. L’utilisation des résultats et expériences rapportés par les patients (PROM/PREM) à des fins cliniques et de gestion—synthèse. Health Services Research (HSR). Bruxelles: Centre Fédéral d’Expertise des Soins de Santé (KCE). 2018. KCE Reports 303Bs. D/2018/10.273/38.
Metadata
Title
A Standard Set of Value-Based Patient-Centered Outcomes for Pancreatic Carcinoma: An International Delphi Survey
Authors
Zineb Cherkaoui, MD
Cristians González, MD
Taiga Wakabayashi, MD
Bastien Delattre
Elodie Léost
Sébastien Serra, MD
Jerôme Huppertz, MD
Francine Klein
Marie Stéphan
Jean-Michel Meyer
Alain Schaff
Elisa Martinis
Elena Bangoura
Sophie Kieffer
Sophie Blanès
Elham Haddad
Gabrielle De Guio, MD
Emanuele Felli, MD
Sophie Pernot
Jacques Marescaux, MD, FACS, Hon FRCS, Hon JSES, Hon FASA
Didier Mutter, MD, PhD
Constance Lugiez
Patrick Pessaux, MD, PhD
IHU-VBHC Working Group
Publication date
01-02-2021
Publisher
Springer International Publishing
Published in
Annals of Surgical Oncology / Issue 2/2021
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-020-08679-0

Other articles of this Issue 2/2021

Annals of Surgical Oncology 2/2021 Go to the issue