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This qualitative research is to assess the validity of the stool symptom screener that will be used in patients with chronic opioid-induced constipation to determine the adequacy of their response to laxatives.
Assessing the Content Validity of a Stool Symptom Screener in Patients with Chronic Opioid-Induced Constipation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with opioid induced constipation |
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| Measure | Description | Time Frame |
|---|---|---|
| Semi-structured discussion guide | Using a semi-structured discussion guide during a single one-on-one interview, qualitative information will be collected from subjects that relates to their experience with Opioid Induced Constipation symptoms and to their understanding and perception of a verbally-administered stool symptom screener. | Data will be collected at ONE time point from each patient using a semi-structured interview guide (up to 5 months) |
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Inclusion Criteria:
Exclusion Criteria:
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multi-speciality medical clinics ( family practice, neurology, internal medicine, pain management)
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sostek, MD | AstraZeneca | Study Director |
| Karin S Coyne, PHD, MPH | United BioSource | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10522604 | Background | Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327. | |
| 15914049 | Background | Slappendel R, Simpson K, Dubois D, Keininger DL. Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain. Eur J Pain. 2006 Apr;10(3):209-17. doi: 10.1016/j.ejpain.2005.03.008. |
| Label | URL |
|---|---|
| D3820C00028\_statement\_of\_no\_CSR\_Synopsis.pdf | View source |
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| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |