Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population
Background: To evaluate the psychometric properties of the newly developed seven-item Irritable Bowel Syndrome – Diarrhea predominant (IBS-D) Daily Symptom Diary and four-item Event Log using phase II clinical trial safety and efficacy data in patients with IBS-D. This instrument measures diarrhea (...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2017-09-01
|
| Series: | Therapeutic Advances in Gastroenterology |
| Online Access: | https://doi.org/10.1177/1756283X17726018 |
| _version_ | 1818306938362920960 |
|---|---|
| author | Leticia Delgado-Herrera Kathryn Lasch Bernhardt Zeiher Anthony J. Lembo Douglas A. Drossman Benjamin Banderas Kathleen Rosa Christopher Lademacher Rob Arbuckle |
| author_facet | Leticia Delgado-Herrera Kathryn Lasch Bernhardt Zeiher Anthony J. Lembo Douglas A. Drossman Benjamin Banderas Kathleen Rosa Christopher Lademacher Rob Arbuckle |
| author_sort | Leticia Delgado-Herrera |
| collection | DOAJ |
| description | Background: To evaluate the psychometric properties of the newly developed seven-item Irritable Bowel Syndrome – Diarrhea predominant (IBS-D) Daily Symptom Diary and four-item Event Log using phase II clinical trial safety and efficacy data in patients with IBS-D. This instrument measures diarrhea (stool frequency and stool consistency), abdominal pain related to IBS-D (stomach pain, abdominal pain, abdominal cramps), immediate need to have a bowel movement (immediate need and accident occurrence), bloating, pressure, gas, and incomplete evacuation. Methods: Psychometric properties and responsiveness of the instrument were evaluated in a clinical trial population [ ClinicalTrials.gov identifier: NCT01494233]. Results: A total of 434 patients were included in the analyses. Significant differences were found among severity groups ( p < 0.01) defined by IBS Patient Global Impression of Severity (PGI-S) and IBS Patient Global Impression of Change (PGI-C). Severity scores for each Diary and Event Log item score and five-item, four-item, and three-item summary scores were calculated. Between-group differences in changes over time were significant for all summary scores in groups stratified by changes in PGI-S ( p < 0.05), two of six Diary items, and three of four Event Log items; a one-grade change in PGI-S was considered a meaningful difference with mean change scores on all Diary items −0.13 to −0.86 [standard deviation (SD) 0.79–1.39]. Similarly, for patients who reported being ‘slightly improved’ (considered a clinically meaningful difference) on the PGI-C, mean change scores on Diary items ranged from −0.45 to −1.55 (SD 0.69–1.39). All estimates of clinically important change for each item and all summary scores were small and should be considered preliminary. These results are aligned with the previous standalone psychometric study regarding reliability and validity tests. Conclusions: These analyses provide evidence of the psychometric properties of the IBS-D Daily Symptom Diary and Event Log in a clinical trial population. |
| first_indexed | 2024-12-13T06:50:26Z |
| format | Article |
| id | doaj.art-bfd1101049874f3cba6d93c94820cdff |
| institution | Directory Open Access Journal |
| issn | 1756-283X 1756-2848 |
| language | English |
| last_indexed | 2024-12-13T06:50:26Z |
| publishDate | 2017-09-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Gastroenterology |
| spelling | doaj.art-bfd1101049874f3cba6d93c94820cdff2022-12-21T23:56:10ZengSAGE PublishingTherapeutic Advances in Gastroenterology1756-283X1756-28482017-09-011010.1177/1756283X17726018Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study populationLeticia Delgado-HerreraKathryn LaschBernhardt ZeiherAnthony J. LemboDouglas A. DrossmanBenjamin BanderasKathleen RosaChristopher LademacherRob ArbuckleBackground: To evaluate the psychometric properties of the newly developed seven-item Irritable Bowel Syndrome – Diarrhea predominant (IBS-D) Daily Symptom Diary and four-item Event Log using phase II clinical trial safety and efficacy data in patients with IBS-D. This instrument measures diarrhea (stool frequency and stool consistency), abdominal pain related to IBS-D (stomach pain, abdominal pain, abdominal cramps), immediate need to have a bowel movement (immediate need and accident occurrence), bloating, pressure, gas, and incomplete evacuation. Methods: Psychometric properties and responsiveness of the instrument were evaluated in a clinical trial population [ ClinicalTrials.gov identifier: NCT01494233]. Results: A total of 434 patients were included in the analyses. Significant differences were found among severity groups ( p < 0.01) defined by IBS Patient Global Impression of Severity (PGI-S) and IBS Patient Global Impression of Change (PGI-C). Severity scores for each Diary and Event Log item score and five-item, four-item, and three-item summary scores were calculated. Between-group differences in changes over time were significant for all summary scores in groups stratified by changes in PGI-S ( p < 0.05), two of six Diary items, and three of four Event Log items; a one-grade change in PGI-S was considered a meaningful difference with mean change scores on all Diary items −0.13 to −0.86 [standard deviation (SD) 0.79–1.39]. Similarly, for patients who reported being ‘slightly improved’ (considered a clinically meaningful difference) on the PGI-C, mean change scores on Diary items ranged from −0.45 to −1.55 (SD 0.69–1.39). All estimates of clinically important change for each item and all summary scores were small and should be considered preliminary. These results are aligned with the previous standalone psychometric study regarding reliability and validity tests. Conclusions: These analyses provide evidence of the psychometric properties of the IBS-D Daily Symptom Diary and Event Log in a clinical trial population.https://doi.org/10.1177/1756283X17726018 |
| spellingShingle | Leticia Delgado-Herrera Kathryn Lasch Bernhardt Zeiher Anthony J. Lembo Douglas A. Drossman Benjamin Banderas Kathleen Rosa Christopher Lademacher Rob Arbuckle Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population Therapeutic Advances in Gastroenterology |
| title | Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population |
| title_full | Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population |
| title_fullStr | Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population |
| title_full_unstemmed | Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population |
| title_short | Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population |
| title_sort | evaluation and performance of a newly developed patient reported outcome instrument for diarrhea predominant irritable bowel syndrome in a clinical study population |
| url | https://doi.org/10.1177/1756283X17726018 |
| work_keys_str_mv | AT leticiadelgadoherrera evaluationandperformanceofanewlydevelopedpatientreportedoutcomeinstrumentfordiarrheapredominantirritablebowelsyndromeinaclinicalstudypopulation AT kathrynlasch evaluationandperformanceofanewlydevelopedpatientreportedoutcomeinstrumentfordiarrheapredominantirritablebowelsyndromeinaclinicalstudypopulation AT bernhardtzeiher evaluationandperformanceofanewlydevelopedpatientreportedoutcomeinstrumentfordiarrheapredominantirritablebowelsyndromeinaclinicalstudypopulation AT anthonyjlembo evaluationandperformanceofanewlydevelopedpatientreportedoutcomeinstrumentfordiarrheapredominantirritablebowelsyndromeinaclinicalstudypopulation AT douglasadrossman evaluationandperformanceofanewlydevelopedpatientreportedoutcomeinstrumentfordiarrheapredominantirritablebowelsyndromeinaclinicalstudypopulation AT benjaminbanderas evaluationandperformanceofanewlydevelopedpatientreportedoutcomeinstrumentfordiarrheapredominantirritablebowelsyndromeinaclinicalstudypopulation AT kathleenrosa evaluationandperformanceofanewlydevelopedpatientreportedoutcomeinstrumentfordiarrheapredominantirritablebowelsyndromeinaclinicalstudypopulation AT christopherlademacher evaluationandperformanceofanewlydevelopedpatientreportedoutcomeinstrumentfordiarrheapredominantirritablebowelsyndromeinaclinicalstudypopulation AT robarbuckle evaluationandperformanceofanewlydevelopedpatientreportedoutcomeinstrumentfordiarrheapredominantirritablebowelsyndromeinaclinicalstudypopulation |