Core Set of Patient-reported Outcomes in Pancreatic Cancer (COPRAC): An International Delphi Study Among Patients and Health Care Providers.

OBJECTIVE To establish an international core set of patient-reported outcomes (PROs) selected by both patients and healthcare providers (HCPs) from the United States (US), Europe, and Asia. SUMMARY BACKGROUND DATA PROs are increasingly recognized in pancreatic cancer studies. There is no consensus on which of the many available PROs are most important. METHODS A multicenter Delphi study among patients with pancreatic cancer (curative- and palliative-setting) and HCPs in 6 pancreatic centers in the US (Baltimore, Boston), Europe (Amsterdam, Verona), and Asia (Mumbai, Seoul) was performed. In round 1, participants rated the importance of 56 PROs on a 1 to 9 Likert scale. PROs rated as very important (scores 7-9) by the majority (≥80%) of curative- and/or palliative-patients as well as HCPs were included in the core set. PROs not fulfilling these criteria were presented again in round 2, together with feedback on individual and group ratings. Remaining PROs were ranked based on the importance ratings. RESULTS In total 731 patients and HCPs were invited, 501 completed round 1, and 420 completed both rounds. This included 204 patients in curative-setting, 74 patients in palliative-setting, and 142 HCPs. After 2 rounds, 8 PROs were included in the core set: general quality of life, general health, physical ability, ability to work/do usual activities, fear of recurrence, satisfaction with services/care organization, abdominal complaints, and relationship with partner/family. CONCLUSIONS This international Delphi study among patients and HCPs established a core set of PROs in pancreatic cancer, which should facilitate the design of future pancreatic cancer trials and outcomes research.

[1]  K. Whale,et al.  Development of a Core Outcome Set for Clinical Effectiveness Trials in Esophageal Cancer Resection Surgery , 2017, Annals of surgery.

[2]  L. Collette,et al.  Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards. , 2016, The Lancet. Oncology.

[3]  T. Conroy,et al.  FOLFIRINOX for locally advanced pancreatic cancer: a systematic review and patient-level meta-analysis. , 2016, The Lancet. Oncology.

[4]  M. Porter,et al.  Standardizing Patient Outcomes Measurement. , 2016, The New England journal of medicine.

[5]  M. Koopman,et al.  Developing a core set of patient-reported outcomes in pancreatic cancer: A Delphi survey. , 2015, European journal of cancer.

[6]  A. Carrato,et al.  A Systematic Review of the Burden of Pancreatic Cancer in Europe: Real-World Impact on Survival, Quality of Life and Costs , 2015, Journal of Gastrointestinal Cancer.

[7]  J. Cameron,et al.  Two thousand consecutive pancreaticoduodenectomies. , 2015, Journal of the American College of Surgeons.

[8]  D. Moher,et al.  Putting patients at the heart of health-care research , 2015, The Lancet.

[9]  D. Sealy,et al.  Contextual factors influencing health-related quality of life in African American and Latina breast cancer survivors , 2015, Journal of Cancer Survivorship.

[10]  D. Altman,et al.  The COMET Initiative database: progress and activities from 2011 to 2013 , 2014, Trials.

[11]  P. Fayers,et al.  Overcoming barriers to the implementation of patient-reported outcomes in cancer clinical trials: the PROMOTION Registry , 2014, Health and Quality of Life Outcomes.

[12]  Benjamin D. Smith,et al.  Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. , 2014, Cancer research.

[13]  Roma Maguire,et al.  What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. , 2014, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[14]  T. Gardner,et al.  The FDA and Prescription Pancreatic Enzyme Product Cost , 2014, The American Journal of Gastroenterology.

[15]  J. Custers,et al.  The Cancer Worry Scale: Detecting Fear of Recurrence in Breast Cancer Survivors , 2014, Cancer nursing.

[16]  M. de Vries,et al.  Domains of quality of life: results of a three-stage Delphi consensus procedure among patients, family of patients, clinicians, scientists and the general public , 2013, Quality of Life Research.

[17]  David Goldstein,et al.  Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. , 2013, The New England journal of medicine.

[18]  Jack Chen,et al.  A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting , 2013, BMC Health Services Research.

[19]  Heiko A. von der Gracht,et al.  Consensus measurement in Delphi studies , 2012 .

[20]  Jeffrey E. Lee,et al.  Fear of Cancer Recurrence after Curative Pancreatectomy: A Cross-sectional Study in Survivors of Pancreatic and Periampullary Tumors , 2012, Annals of Surgical Oncology.

[21]  Pierre Michel,et al.  FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. , 2011, The New England journal of medicine.

[22]  P. Goodwin,et al.  Quality-of-life measurement in randomized clinical trials in breast cancer: an updated systematic review (2001-2009). , 2011, Journal of the National Cancer Institute.

[23]  P. Williamson,et al.  Using the Delphi Technique to Determine Which Outcomes to Measure in Clinical Trials: Recommendations for the Future Based on a Systematic Review of Existing Studies , 2011, PLoS medicine.

[24]  D. Litwin,et al.  Perioperative Mortality for Pancreatectomy: A National Perspective , 2007, Annals of surgery.

[25]  Chia-Chien Hsu,et al.  The Delphi Technique: Making Sense of Consensus , 2007 .

[26]  S. Schraub,et al.  An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32). , 2005, European journal of cancer.

[27]  J. Thumboo,et al.  Do health-related quality-of-life domains and items in knee and hip osteoarthritis vary in importance across social-cultural contexts? A qualitative systematic literature review. , 2005, Seminars in arthritis and rheumatism.

[28]  Julian de Meyrick,et al.  The Delphi method and health research , 2003 .

[29]  H. Friess,et al.  Development of a disease specific quality of life (QoL) questionnaire module to supplement the EORTC core cancer QoL questionnaire, the QLQ-C30 in patients with pancreatic cancer. EORTC Study Group on Quality of Life. , 1999, European journal of cancer.

[30]  A. Zbrozek,et al.  The Validity and Reproducibility of a Work Productivity and Activity Impairment Instrument , 1993, PharmacoEconomics.

[31]  D. Osoba,et al.  The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. , 1993, Journal of the National Cancer Institute.

[32]  M. Crowe Conjoint marital therapy: a controlled outcome study , 1978, Psychological Medicine.

[33]  Heiko A. Gracht Consensus measurement in Delphi studies Review and implications for future quality assurance Technological Forecasting & Social Change , 2015 .

[34]  D. Doran,et al.  Core domains for a person-focused outcome measurement system in cancer (PROMS-Cancer Core) for routine care: a scoping review and Canadian Delphi Consensus. , 2013, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.