AI Article Synopsis

  • The study analyzed the effectiveness of patient-reported outcome measures for chronic constipation (CC) in clinical trials of linaclotide, highlighting that previous measures fell short of FDA standards.
  • Using data from multiple trials, the researchers assessed the measurement properties of CC Symptom Severity Measures, confirming their reliability and validity through various statistical analyses.
  • Results showed that linaclotide significantly improved both abdominal and bowel symptoms in CC patients, supporting the effectiveness of the analyzed measures for evaluating treatment outcomes in clinical studies.

Article Abstract

Background: Measures assessing treatment outcomes in previous CC clinical trials have not met the requirements described in the US Food and Drug Administration's guidance on patient-reported outcomes.

Aim: Psychometric analyses using data from one Phase IIb study and two Phase III trials of linaclotide for the treatment of chronic constipation (CC) were conducted to document the measurement properties of patient-reported CC Symptom Severity Measures.

Study Methods: Each study had a multicenter, randomized, double-blind, placebo-controlled, parallel-group design, comparing placebo to four doses of oral linaclotide taken once daily for 4 weeks in the Phase IIb dose-ranging study (n=307) and to two doses of linaclotide taken once daily for 12 weeks in the Phase III trials (n=1,272). The CC Symptom Severity Measures addressing bowel function (Bowel Movement Frequency, Stool Consistency, Straining) and abdominal symptoms (Bloating, Abdominal Discomfort, Abdominal Pain) were administered daily using interactive voice-response system technology. Intraclass correlations, Pearson correlations, factor analyses, F-tests, and effect sizes were computed.

Results: The CC Symptom Severity Measures demonstrated satisfactory test-retest reliability and construct validity. Factor analyses indicated one factor for abdominal symptoms and another for bowel symptoms. Known-groups F-tests substantiated the discriminating ability of the CC Symptom Severity Measures. Responsiveness statistics were moderate to strong, indicating that these measures are capable of detecting change.

Conclusion: In large studies of CC patients, linaclotide significantly improved abdominal and bowel symptoms. These psychometric analyses support the reliability, validity, discriminating ability, and responsiveness of the CC Symptom Severity Measures for evaluating treatment outcomes in the linaclotide clinical studies.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4186570PMC
http://dx.doi.org/10.2147/CEG.S64713DOI Listing

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