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The PAC-SYM questionnaire for chronic constipation: defining the minimal important difference.

Y Yiannakou1, J Tack2, H Piessevaux3

  • 1County Durham and Darlington NHS Foundation Trust, Durham, UK.

Alimentary Pharmacology & Therapeutics
|October 7, 2017
PubMed
Summary
This summary is machine-generated.

This study determined the minimal important difference for the Patient Assessment of Constipation-Symptoms (PAC-SYM) score, finding approximately -0.6 to be a key threshold for defining constipation symptom improvement.

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Area of Science:

  • Gastroenterology
  • Clinical Trials
  • Patient-Reported Outcomes

Background:

  • The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire is widely used in constipation clinical trials.
  • A formal appraisal of the PAC-SYM score reduction threshold for defining clinical response and its link to patient-perceived benefit is lacking.

Purpose of the Study:

  • To establish the minimal important difference (MID) for the PAC-SYM score.
  • To identify the optimal cut-off value for defining treatment responders in constipation studies.

Main Methods:

  • Utilized anchor- and distribution-based approaches with data from 2884 patients across six international Phase 3/4 trials of prucalopride for chronic constipation.
  • Employed five patient-reported outcome measures as anchors and conducted receiver operating characteristic (ROC) curve analyses for responder discrimination.

Main Results:

  • Anchor-based MID estimates ranged from -0.52 to -0.63, with consistently lower values for rectal symptoms.
  • Distribution-based estimates were lower than anchor-based estimates.
  • ROC analyses indicated optimal cut-off scores aligned with anchor-based MID estimates.

Conclusions:

  • Anchor-based methods consistently suggested an MID of approximately -0.6 for the PAC-SYM score.
  • This -0.6 threshold is close to ROC-determined optimal cut-off scores and can be considered for clinical practice.
  • A more conservative threshold (e.g., -0.75) may be beneficial in clinical trials to mitigate placebo effects.