Qualitative Assessment of the Symptoms and Impact of Pancreatic Exocrine Insufficiency (PEI) to Inform the Development of a Patient-Reported Outcome (PRO) Instrument

Colin D. Johnson, Rob Arbuckle, Nicola Bonner, Gary Connett, Enrique Dominguez-Munoz, Philippe Levy, Doris Staab, Nicola Williamson () and Markus M. Lerch
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Colin D. Johnson: University of Southampton and University Hospital Southampton NHS Foundation Trust
Rob Arbuckle: Adelphi Values, Adelphi Mill
Nicola Bonner: Adelphi Values, Adelphi Mill
Gary Connett: Southampton Children’s Hospital and University Hospital Southampton NHS Foundation Trust
Enrique Dominguez-Munoz: University Hospital of Santiago de Compostela
Philippe Levy: Université Denis Diderot-Paris VII Hôpital Beaujon
Doris Staab: Charité University Hospital
Nicola Williamson: Adelphi Values, Adelphi Mill
Markus M. Lerch: University Medicine Greifswald

The Patient: Patient-Centered Outcomes Research, 2017, vol. 10, issue 5, No 10, 615-628

Abstract: Abstract Background Pancreatic exocrine insufficiency (PEI) affects patients with chronic pancreatitis (CP) and cystic fibrosis (CF) who produce insufficient digestive pancreatic enzymes. Common symptoms include steatorrhoea, diarrhea, and abdominal pain. Objective The objective of the study was to develop and test the content validity of a patient-reported outcome (PRO) instrument assessing PEI symptoms and their impact on health-related quality of life. Methods Instrument development was supported by a literature review, expert physician interviews (n = 10: Germany 4, UK 3, France 3), and exploratory, qualitative, concept-elicitation interviews with patients with CF and CP with PEI (n = 61: UK 29, Germany 18, France 14) and expert physicians (n = 10). Cognitive debriefing of the draft instrument was then performed with patients with PEI (n = 37: UK 24, Germany 8, France 5), and feasibility was assessed with physicians (n = 3). For all interviews, verbatim transcripts were qualitatively analysed using thematic analysis methods and Atlas.ti computerized qualitative software. All themes were data driven rather than a priori. Results Patient interviews elicited symptoms and impacts not reported in the literature. Six symptom concepts emerged: pain, bloating, bowel symptoms, nausea/vomiting, eating problems, and tiredness/fatigue. Six impact domains were also identified. A 45-item instrument was developed in English, French, and German for testing in cognitive debriefing patient interviews. Following cognitive debriefing, 18 items were deleted. Conclusion Rigorous qualitative patient research and expert clinical input supported development of a PEI-specific PRO with the potential to aid management and monitoring of unmet needs among patients with PEI. The next step is to perform psychometric evaluation of the resulting instrument.

Keywords: Cystic Fibrosis; Chronic Pancreatitis; Pancreatic Exocrine Insufficiency; Cognitive Debriefing; Expert Physician (search for similar items in EconPapers)
Date: 2017
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DOI: 10.1007/s40271-017-0233-0

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