Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation

Charles E Argoff, Michael J Brennan, Michael Camilleri, Andrew Davies, Jeffrey Fudin, Katherine E Galluzzi, Jeffrey Gudin, Anthony Lembo, Steven P Stanos, Lynn R Webster, Charles E Argoff, Michael J Brennan, Michael Camilleri, Andrew Davies, Jeffrey Fudin, Katherine E Galluzzi, Jeffrey Gudin, Anthony Lembo, Steven P Stanos, Lynn R Webster

Abstract

Objective: Aims of this consensus panel were to determine (1) an optimal symptom-based method for assessing opioid-induced constipation in clinical practice and (2) a threshold of symptom severity to prompt consideration of prescription therapy.

Methods: A multidisciplinary panel of 10 experts with extensive knowledge/experience with opioid-associated adverse events convened to discuss the literature on assessment methods used for opioid-induced constipation and reach consensus on each objective using the nominal group technique.

Results: Five validated assessment tools were evaluated: the Patient Assessment of Constipation-Symptoms (PAC-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL), Stool Symptom Screener (SSS), Bowel Function Index (BFI), and Bowel Function Diary (BF-Diary). The 3-item BFI and 4-item SSS, both clinician administered, are the shortest tools. In published trials, the BFI and 12-item PAC-SYM are most commonly used. The 11-item BF-Diary is highly relevant in opioid-induced constipation and was developed and validated in accordance with US Food and Drug Administration guidelines. However, the panel believes that the complex scoring for this tool and the SSS, PAC-SYM, and 28-item PAC-QOL may be unfeasible for clinical practice. The BFI is psychometrically validated and responsive to changes in symptom severity; scores range from 0 to 100, with higher scores indicating greater severity and scores >28.8 points indicating constipation.

Conclusions: The BFI is a simple assessment tool with a validated threshold of clinically significant constipation. Prescription treatments for opioid-induced constipation should be considered for patients who have a BFI score of ≥30 points and an inadequate response to first-line interventions.

Keywords: Bowel Function Index; Chronic Pain; Lubiprostone; Methylnaltrexone; Naloxegol; PAMORAs.

Wiley Periodicals, Inc.

Figures

Figure 1
Figure 1
The BFI assessment tool and instructions for use. Abbreviation: BFI, Bowel Function Index. Reproduced with permission from: Rentz AM, Yu R, Müller‐Lissner S, Leyendecker P. Validation of the Bowel Function Index to detect clinically meaningful changes in opioid‐induced constipation. J Med Econ 2009;12:371–83. Copyright 2009 Informa Healthcare.
Figure 2
Figure 2
Relative cumulative frequencies of BFI scores for the reference and OIC populations. The reference population comprised nonconstipated patients with chronic pain who were treated with WHO step I and II analgesics; the OIC population comprised patients with chronic pain who had been pretreated with WHO step III opioids and laxative regimens and who reported constipation caused or aggravated by an opioid; 95% of the reference population and 7.9% of the OIC population had a BFI score ≤28.8 points. Abbreviations: BFI, Bowel Function Index; OIC, opioid‐induced constipation; WHO, World Health Organization. Adapted with permission from: Ueberall MA, Müller‐Lissner S, Buschmann‐Kramm C, Bosse B. The Bowel Function Index for evaluating constipation in pain patients: definition of a reference range for a non‐constipated population of pain patients. J Int Med Res 2011;39:41–50. Copyright 2011 SAGE Publications.

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