Qualitative assessment of the symptoms and impact of Pancreatic Exocrine Insufficiency (PEI) to inform the development of a Patient-Reported Outcome (PRO) instrument
Qualitative assessment of the symptoms and impact of Pancreatic Exocrine Insufficiency (PEI) to inform the development of a Patient-Reported Outcome (PRO) instrument
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.
615-628
Johnson, Colin D.
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Arbuckle, Rob
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Bonner, Nicola
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Connett, Gary
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Dominguez-Munoz, Enrique
d450177b-5e74-4a1c-a549-01e9ec207c66
Levy, Philippe
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Staab, Doris
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Williamson, Nicola
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Lerch, Markus M.
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1 October 2017
Johnson, Colin D.
e50aa9cd-8c61-4fe3-a0b3-f51cc3a6c74a
Arbuckle, Rob
f1adc5b1-8dd5-48ae-b6cc-181f69553ba7
Bonner, Nicola
6c06af83-823c-498d-8415-c1d589553966
Connett, Gary
55d5676c-90d8-46bf-a508-62eded276516
Dominguez-Munoz, Enrique
d450177b-5e74-4a1c-a549-01e9ec207c66
Levy, Philippe
7d70c43f-0c15-4602-b3ad-59356c1d0383
Staab, Doris
639e84ad-6068-4f69-86db-b9f34313186f
Williamson, Nicola
c5d37726-7681-4c55-a551-75aff495a419
Lerch, Markus M.
4a50f26f-3b2e-493d-baba-66143ac02037
Johnson, Colin D., Arbuckle, Rob, Bonner, Nicola, Connett, Gary, Dominguez-Munoz, Enrique, Levy, Philippe, Staab, Doris, Williamson, Nicola and Lerch, Markus M.
(2017)
Qualitative assessment of the symptoms and impact of Pancreatic Exocrine Insufficiency (PEI) to inform the development of a Patient-Reported Outcome (PRO) instrument.
Patient, 10 (5), .
(doi:10.1007/s40271-017-0233-0).
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.
Text
10.1007%2Fs40271-017-0233-0
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Accepted/In Press date: 1 January 2017
e-pub ahead of print date: 22 March 2017
Published date: 1 October 2017
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Local EPrints ID: 419049
URI: http://eprints.soton.ac.uk/id/eprint/419049
ISSN: 1178-1653
PURE UUID: bc4719b3-80e6-4743-b31b-ef84169cfe95
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Date deposited: 28 Mar 2018 16:30
Last modified: 18 Mar 2024 03:46
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Author:
Rob Arbuckle
Author:
Nicola Bonner
Author:
Gary Connett
Author:
Enrique Dominguez-Munoz
Author:
Philippe Levy
Author:
Doris Staab
Author:
Nicola Williamson
Author:
Markus M. Lerch
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