Patient interpretations of patient-reported outcome measures to assess bowel urgency: qualitative interviews in ulcerative colitis.

Vipul Jairath, Theresa Hunter Gibble, Richard Moses, Brittany Klooster, Leighann Litcher-Kelly, Marisa Walker, Madison C Bernstein, Kaelyn Rupinski, Megan McLafferty, Simon Travis, Marla Dubinsky
Author Information
  1. Vipul Jairath: Departments of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Canada.
  2. Theresa Hunter Gibble: Eli Lilly and Company, Indianapolis, IN, USA. hunter_theresa_marie@lilly.com.
  3. Richard Moses: Eli Lilly and Company, Indianapolis, IN, USA.
  4. Brittany Klooster: Adelphi Values LLC, Boston, MA, USA.
  5. Leighann Litcher-Kelly: Adelphi Values LLC, Boston, MA, USA.
  6. Marisa Walker: Adelphi Values LLC, Boston, MA, USA. marisa.walker@adelphivalues.com. ORCID
  7. Madison C Bernstein: Adelphi Values LLC, Boston, MA, USA.
  8. Kaelyn Rupinski: Adelphi Values LLC, Boston, MA, USA.
  9. Megan McLafferty: Adelphi Values LLC, Boston, MA, USA.
  10. Simon Travis: University of Oxford, Oxford, UK.
  11. Marla Dubinsky: Icahn School of Medicine, New York, NY, USA.

Abstract

OBJECTIVES: Bowel urgency is an impactful core symptom of ulcerative colitis (UC). Patient-reported outcome (PRO) questionnaires have been developed and used to assess the patient experience of this important symptom. The objective of this paper is to present evidence from qualitative research conducted to support the use and interpretation of select PRO questionnaires to assess bowel urgency related to the UC patient experience.
METHODS: Qualitative interviews were conducted with ten adults with a clinician-confirmed diagnosis of moderately to severely active UC. Interviews aimed to document patient interpretation of modified recall periods for the Urgency Numeric Rating Scale (Urgency NRS), two global assessments (i.e., the Patient Global Impression of Severity [PGIS] and Patient Global Impression of Change [PGIC]), and four items (Items 11, 16, 23, and 26) of the Inflammatory Bowel Disease Questionnaire (IBDQ), and explore the patient perspective of meaningful change on these questionnaires.
RESULTS: Both modified Urgency NRS versions (with 7-day or 3-day recall period) were interpreted as intended by most patients (≥ 88.9%), and slightly more than half of patients (60.0%) reported that the 7-day recall period was more relevant to their bowel urgency experience. Patients reported thinking of bowel urgency (≥ 80.0%) or bowel urgency-related accidents (70.0% of patients) when interpreting the global assessments and IBDQ items. Most patients reported a 1- to 3-point change as the smallest meaningful improvement that would be meaningful on the Urgency NRS (similar to findings on other questionnaires).
CONCLUSION: Adults with UC can understand and respond to the Urgency NRS with modified recall periods (i.e., 7-day or 3-day), interpret the conceptual content of the PGIS, PGIC, and select IBDQ items to be inclusive of bowel urgency and bowel urgency-related accidents, and select answers representing meaningful improvements on the Urgency NRS, PGIS, PGIC, and IBDQ item response scales. These results further contribute patient-centered data to existing UC and bowel urgency research.

References

  1. Crohns Colitis 360. 2022 Jun 03;4(3):otac016 [PMID: 36777426]
  2. Inflamm Bowel Dis. 2014 Mar;20(3):545-52 [PMID: 24407484]
  3. BMC Gastroenterol. 2012 Aug 15;12:108 [PMID: 22894661]
  4. J Patient Rep Outcomes. 2022 Apr 1;6(1):31 [PMID: 35362902]
  5. Gastroenterology. 1989 Mar;96(3):804-10 [PMID: 2644154]
  6. Gastroenterol Hepatol (N Y). 2022 Jul;18(7 Suppl 2):3-4 [PMID: 36756655]
  7. Patient Relat Outcome Meas. 2022 Dec 22;13:287-300 [PMID: 36582542]
  8. Inflamm Bowel Dis. 2024 Jun 3;30(6):939-949 [PMID: 37603837]
  9. Am J Gastroenterol. 2010 Mar;105(3):501-23; quiz 524 [PMID: 20068560]
  10. J Patient Rep Outcomes. 2019 Oct 30;3(1):66 [PMID: 31667633]
  11. Therap Adv Gastroenterol. 2020 Apr 28;13:1756284820915043 [PMID: 32523620]
  12. Aliment Pharmacol Ther. 2022 Dec;56(11-12):1570-1580 [PMID: 36225106]
  13. Gastroenterology. 2023 Nov;165(5):1197-1205.e2 [PMID: 37481117]
  14. Dig Dis Sci. 2021 Oct;66(10):3330-3342 [PMID: 33164146]
  15. BMJ Open. 2023 Mar 28;13(3):e065186 [PMID: 36977543]
  16. J Patient Rep Outcomes. 2022 Nov 5;6(1):114 [PMID: 36334163]
  17. Crohns Colitis 360. 2021 Jul 17;3(3):otab050 [PMID: 36776662]
  18. Crohns Colitis 360. 2021 Feb 24;3(2):otab013 [PMID: 34226891]
  19. J Pediatr Gastroenterol Nutr. 1999 Apr;28(4):S23-7 [PMID: 10204520]
  20. Value Health. 2011 Dec;14(8):978-88 [PMID: 22152166]
  21. Gastroenterol Hepatol (N Y). 2022 Apr;18(4 Suppl 1):7-8 [PMID: 35610995]
  22. Gastroenterol Res Pract. 2012;2012:106502 [PMID: 22778720]
  23. Lancet. 2018 Dec 23;390(10114):2769-2778 [PMID: 29050646]

Grants

  1. Eli Lilly and Company/Eli Lilly and Company

MeSH Term

Humans
Patient Reported Outcome Measures
Colitis, Ulcerative
Female
Male
Adult
Middle Aged
Qualitative Research
Surveys and Questionnaires
Severity of Illness Index
Interviews as Topic
Quality of Life
Aged

Word Cloud

Created with Highcharts 10.0.0bowelurgencyUrgencyUCNRSquestionnairespatientrecallIBDQmeaningfulpatientsassessexperienceselectmodifiedPatientitems7-day0%reportedBowelsymptomulcerativecolitisoutcomePROqualitativeresearchconductedinterpretationinterviewsperiodsglobalassessmentsieGlobalImpressionchange3-dayperiodurgency-relatedaccidentsPGISPGICOBJECTIVES:impactfulcorePatient-reporteddevelopedusedimportantobjectivepaperpresentevidencesupportuserelatedMETHODS:Qualitativetenadultsclinician-confirmeddiagnosismoderatelyseverelyactiveInterviewsaimeddocumentNumericRatingScaletwoSeverity[PGIS]Change[PGIC]fourItems11162326InflammatoryDiseaseQuestionnaireexploreperspectiveRESULTS:versionsinterpretedintended≥ 889%slightlyhalf60relevantPatientsthinking≥ 8070interpreting1-3-pointsmallestimprovementsimilarfindingsCONCLUSION:Adultscanunderstandrespondinterpretconceptualcontentinclusiveanswersrepresentingimprovementsitemresponsescalesresultscontributepatient-centereddataexistinginterpretationspatient-reportedmeasuresurgency:

Similar Articles

Cited By