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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
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.

1178-1653
615-628
Johnson, Colin D.
e50aa9cd-8c61-4fe3-a0b3-f51cc3a6c74a
Arbuckle, Rob
f1adc5b1-8dd5-48ae-b6cc-181f69553ba7
Bonner, Nicola
6c06af83-823c-498d-8415-c1d589553966
Connett, Gary
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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.
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), 615-628. (doi:10.1007/s40271-017-0233-0).

Record type: Article

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.

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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

Identifiers

Local EPrints ID: 419049
URI: http://eprints.soton.ac.uk/id/eprint/419049
ISSN: 1178-1653
PURE UUID: bc4719b3-80e6-4743-b31b-ef84169cfe95
ORCID for Gary Connett: ORCID iD orcid.org/0000-0003-1310-3239

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Date deposited: 28 Mar 2018 16:30
Last modified: 07 Oct 2020 02:20

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Contributors

Author: Rob Arbuckle
Author: Nicola Bonner
Author: Gary Connett ORCID iD
Author: Enrique Dominguez-Munoz
Author: Philippe Levy
Author: Doris Staab
Author: Nicola Williamson
Author: Markus M. Lerch

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