Observational, nonintervention, multicenter study for validation of the bowel function index for constipation in european countries

Abstract

Objective:

Constipation is a common adverse event of treatment with opioids for chronic non-malignant pain and may result in a considerable reduction in health-related quality of life. The aim of this study was to assess the psychometric properties of the Bowel Function Index (BFI) in european patients suffering from constipation secondary to opioid analgesic treatment for chronic, non-malignant pain.

Methods:

This was a multinational study conducted at 15 clinical sites in the Czech Republic, Germany, Italy, and the United Kingdom. Patients suffering from constipation secondary to opioid analgesic treatment for chronic, non-malignant pain were recruited to complete a series of questionnaires including a socio-demographic form, the BFI, the Patient Assessment of Constipation – Symptoms (PAC-SYM), a global frequency item, and a clinical form.

Results:

A total of 131 patients were included in this study. Inter-item correlations of the BFI were statistically significant in the moderate to large range and the analysis indicated a strong degree of internal consistency (Cronbach’s alpha = 0.86). All correlations between the BFI and the global item were statistically significant in the moderate to high range (r = 0.59 to 0.69; p < 0.0001). Correlations between the BFI and the PAC-SYM were moderate and statistically significant (p < 0.01 to 0.0001).

Conclusions:

Although this study was limited by the relatively small sample size, it is a part of an extensive validation program. This study suggests that the BFI is a reliable and valid measure of constipation-related symptomatology in chronic pain patients. This measure may be a valuable indicator of patients’ experience of symptoms of opioid treatment of chronic pain in future trials.

Key words::

• Bowel Function Index
• Opioid-induced constipation
• Pain
• Patient-reported outcomes

Transparency

Declaration of funding

Funding for this project was provided by Mundipharma Research GmbH & Co KG.

Declaration of financial/other relationships

A.M.R. and P.V. have disclosed no financial conflict of interest with this study or its contents. P.L. and M.H. have disclosed that they are employees of Mundipharma Research. A.M.R. and P.V. have disclosed that they had complete access to the data and complete editorial control over the content. All authors made substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; have been involved in drafting the manuscript and revising it critically for important intellectual content; and have provided final approval of the version to be published.

Acknowledgements

The authors thank the following investigators for providing data for this study: Justin Turner, Amanda Hulme, and Marie Greenhalgh, Hope Hospital; Peter Harvey, Crouch Oak Family; David Haworth, Layton Medical Centre; Renato Vellucci and Mediati, Az Ospedaliera Careggi; Francesco Paoletti, Stefano Strappaghetti and Umberto Ripani, Azienda Ospedaliera Perugia; Antonio Gatti, Antonio Offeddu, Sarit Nahmias, Claudi de Polo, Naria Friso and Annalia Carveei, Azienda Universitaria; George Dahemen, Praxis fur klinische Studien; Axel Holst, Clinical Research Hamburg; Ulf Schutter, Praxis (Marl); Jiří Polivka, Neurology Department, University Hospital Plzen; Jiří Ceé and Marketa Ceé, Neurologicka ambulance; Marek Hakl, Radovan Hrib, and Iveta Senkerikova, Oddeleni intenzivni pece; Eva Lengálová, Centrum bolesti; Eva Dokoupilová and Dominika Krocilova, Revmatologicko; Petr Svoboda and Ilona Kantorova, Research Centre of Traumatology and Surgery. The authors also thank Adria Hunter, Pam Murray and Ren Yu for their assistance with this study; Julie Meilak for her help with proofreading and formatting the manuscript; and Yvonne von Coburg (Mundipharma Research) for editorial assistance.

Notes

* Copyright in the BFI is owned by Mundipharma Research 2002. The BFI is the subject of european Patent Application Publication No. EP 1 860 988 and corresponding patents and applications in other countries.