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      Consensus Recommendations on Initiating Prescription Therapies for Opioid‐Induced Constipation

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          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.

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          Most cited references 61

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          The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.

          In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included. The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity. The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient > or = .70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe. These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.
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            Functional bowel disorders.

            Employing a consensus approach, our working team critically considered the available evidence and multinational expert criticism, revised the Rome II diagnostic criteria for the functional bowel disorders, and updated diagnosis and treatment recommendations. Diagnosis of a functional bowel disorder (FBD) requires characteristic symptoms during the last 3 months and onset > or =6 months ago. Alarm symptoms suggest the possibility of structural disease, but do not necessarily negate a diagnosis of an FBD. Irritable bowel syndrome (IBS), functional bloating, functional constipation, and functional diarrhea are best identified by symptom-based approaches. Subtyping of IBS is controversial, and we suggest it be based on stool form, which can be aided by use of the Bristol Stool Form Scale. Diagnostic testing should be guided by the patient's age, primary symptom characteristics, and other clinical and laboratory features. Treatment of FBDs is based on an individualized evaluation, explanation, and reassurance. Alterations in diet, drug treatment aimed at predominant symptoms, and psychotherapy may be beneficial.
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              Core outcome measures for chronic pain clinical trials: IMMPACT recommendations.

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                Author and article information

                Journal
                Pain Med
                Pain Med
                10.1111/(ISSN)1526-4637
                PME
                Pain Medicine: The Official Journal of the American Academy of Pain Medicine
                John Wiley and Sons Inc. (Hoboken )
                1526-2375
                1526-4637
                19 November 2015
                December 2015
                : 16
                : 12 ( doiID: 10.1111/pme.v16.12 )
                : 2324-2337
                Affiliations
                [ 1 ]The American Academy of Pain Medicine Foundation and Comprehensive Pain Center, Albany Medical Center Albany New YorkUSA
                [ 2 ]The Pain Center of Fairfield Fairfield ConnecticutUSA
                [ 3 ] Division of Gastroenterology and HepatologyMayo Clinic College of Medicine Rochester MinnesotaUSA
                [ 4 ] Supportive and Palliative CareRoyal Surrey County Hospital and St. Luke's Cancer Centre SurreyUK
                [ 5 ] Remitigate, LLC, and Department of PharmacyStratton Veterans Affairs Medical Center Albany New YorkUSA
                [ 6 ] Department of GeriatricsPhiladelphia College of Osteopathic Medicine Philadelphia PennsylvaniaUSA
                [ 7 ] Pain Management and Palliative CareEnglewood Hospital and Medical Center Englewood New JerseyUSA
                [ 8 ] Division of GastroenterologyBeth Israel Deaconess Medical Center Boston MassachusettsUSA
                [ 9 ] Pain and Headache CenterSwedish Medical Center Seattle WashingtonUSA
                [ 10 ] Scientific AffairsPRA Health Sciences Salt Lake City UtahUSA
                Author notes
                [* ] Reprint requests to: Lynn R. Webster, MD, 3838 South 700 East, Suite 202, Salt Lake City, UT 84106, USA. Tel: 801‐892‐5140, Fax: 801‐269‐9427; E‐mail: lrwebstermd@ 123456gmail.com .
                Article
                PME12937
                10.1111/pme.12937
                4738423
                26582720
                © 2015 The Authors Pain Medicine published by Wiley Periodicals, Inc. on behalf of American Academy of Pain Medicine

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                Page count
                Pages: 14
                Product
                Categories
                Opioids, Substance Abuse & Addictions Section
                OPIOIDS, SUBSTANCE ABUSE & ADDICTIONS SECTION
                Review Article
                Custom metadata
                2.0
                pme12937
                December 2015
                Converter:WILEY_ML3GV2_TO_NLMPMC version:4.7.5 mode:remove_FC converted:28.01.2016

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