Validation of the PAC‐SYM questionnaire for opioid‐induced constipation in patients with chronic low back pain

Slappendel, R.; Simpson, Karen H.; Dubois, Dominique; Keininger, Dorothy L.

doi:10.1016/j.ejpain.2005.03.008

Cited by 111 publications

(90 citation statements)

References 26 publications

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“…30 The composite mean score of PAC-SYM along with other domains was high in both subtypes but was significantly higher in IBS-C compared to FC patients. Our results were analogous to a previously US population-based survey where the frequency of each of abdominal and bowel symptoms were significantly higher in patients with IBS-C against FC.…”

Section: Discussionmentioning

confidence: 99%

Prevalence of functional constipation and constipation-predominant irritable bowel syndrome in Indian patients with constipation

Rooprai

Bhat

Sainani³

et al. 2017

Int J Basic Clin Pharmacol

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Background: Evaluate prevalence of functional constipation (FC) and irritable bowel syndrome-constipation (IBS-C) in Indian constipated patients and assess their demographic/socio-economic/clinical characteristics.Methods: Patients (≥18 years) who visited their general physician with symptoms of constipation (Rome III criteria for FC or IBS-C as per physician assessment) and willing to participate were enrolled in this prospective, clinical-epidemiological study. Demographic, socioeconomic status, lifestyle and dietary habits, comorbid conditions, treatment history, concomitant medications, stool form (Bristol stool form scale), severity of constipation (constipation scoring system [CSS]), constipation-related symptoms (patient assessment of constipation symptoms [PAC-SYM]) and quality of life (patient assessment of constipation-quality of life questionnaire [PAC-QoL]) were recorded.Results: Out of 925 constipated patients, 75.6% were diagnosed with FC against 24.4% with IBS-C (P < 0.0001). Patients of both subtypes had high average scores of PAC-SYM (FC: 27.1 ± 6; IBS-C: 30.1 ± 4.9) and CSS (FC: 8.4 ± 3.1; IBS-C: 11.2 ± 3), leading to high PAC-QoL score (FC: 38.1 ± 16.8; IBS-C: 42.2 ± 13.6). Hypertension (16%) and diabetes (10%) in patients with FC while acid peptic disorders (21.7%) amongst IBS-C patients were the most common comorbid conditions observed. Laxatives were the most common medication used; osmotic (32.6% versus 40.7%) and bulk laxatives (22.8% versus 37.4%) were the commonest laxatives. However, about 1/5th patients of FC were using home remedies.Conclusions: There was a higher prevalence of FC over IBS-C in Indian constipated patients; both subtypes had high frequency and severity of constipation-related symptoms and poor QoL.

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Section: Discussionmentioning

confidence: 99%

Prevalence of functional constipation and constipation-predominant irritable bowel syndrome in Indian patients with constipation

Rooprai

Bhat

Sainani³

et al. 2017

Int J Basic Clin Pharmacol

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“…The subjects were asked to answer 4 validated GI questionnaires (1) BFI, 10 (2) gastrointestinal symptom rating scale (GSRS), 21 (3) PAC-SYM, 9,22 and (4) BSFS. 11 The BFI and GSRS were administered on day 1 and day 5, whilst the PAC-SYM and BSFS were used to assess the dynamic changes of the general bowel function of the healthy volunteers and thus assessed daily.…”

Section: Questionnairesmentioning

confidence: 99%

“…6 Current assessments of OIBD typically rely on self-assessed questionnaires primarily focusing on constipation. 7,8 The most commonly used questionnaires include assessment of number of spontaneous bowel movements (SBMs), the patient assessment of constipation symptoms (PAC-SYM) questionnaire, 9 the bowel function index (BFI), 10 and the Bristol stool form scale (BSFS). 11 Despite elaborate focus on constipation, which is often defined as a reduction in number of SBMs, infrequent bowel movement ranks number 5 in self-assessed constipation symptoms, whereas symptoms such as gas, straining, and abdominal discomfort are far more prevalent.…”

Section: Introductionmentioning

confidence: 99%

The Impact of Opioid Treatment on Regional Gastrointestinal Transit

Poulsen

Nilsson

Brock

et al. 2016

J Neurogastroenterol Motil

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Background/AimsTo employ an experimental model of opioid-induced bowel dysfunction in healthy human volunteers, and evaluate the impact of opioid treatment compared to placebo on gastrointestinal (GI) symptoms and motility assessed by questionnaires and regional GI transit times using the 3-dimensional (3D)-Transit system. MethodsTwenty-five healthy males were randomly assigned to oxycodone or placebo for 5 days in a double blind, crossover design. Adverse GI effects were measured with the bowel function index, gastrointestinal symptom rating scale, patient assessment of constipation symptom questionnaire, and Bristol stool form scale. Regional GI transit times were determined using the 3D-Transit system, and segmental transit times in the colon were determined using a custom Matlab ® graphical user interface. ResultsGI symptom scores increased significantly across all applied GI questionnaires during opioid treatment. Oxycodone increased median total GI transit time from 22.2 to 43.9 hours (P < 0.001), segmental transit times in the cecum and ascending colon from 5.7 to 9.9 hours (P = 0.012), rectosigmoid colon transit from 2.7 to 9.0 hours (P = 0.044), and colorectal transit time from 18.6 to 38.6 hours (P = 0.001). No associations between questionnaire scores and segmental transit times were detected. ConclusionsSelf-assessed GI adverse effects and increased GI transit times in different segments were induced during oxycodone treatment. This detailed information about segmental changes in motility has great potential for future interventional head-to-head trials of different laxative regimes for prevention and treatment of constipation.

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“…Although some evidence of invariance of PAC-SYM in different samples has been obtained in older adults in longterm care facilities [2] and in patients with low back pain and opioid-induced constipation [7], no attempts to replicate the factor structure, responsiveness to clinical change and construct validity of the PAC-SYM questionnaire have been carried out in patients with chronic constipation. Replication addresses how well factors generalize across samples drawn from the same population [8].…”

Section: Introductionmentioning

confidence: 99%

Confirmatory factor analysis of the Patient Assessment of Constipation-Symptoms (PAC-SYM) among patients with chronic constipation

2014

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Background and aim PAC-SYM is widely adopted to asses constipation severity. However, it has been validated in a small sample, few items have been included based on expert opinion and not on empirical grounds, and its factor structure has never been replicated. We aimed at evaluating the psychometric properties of PAC-SYM in patients with chronic constipation. Methods We enrolled 2,203 outpatients with chronic constipation in two waves. We used wave I sample to test the psychometric properties of the PAC-SYM and wave II sample to cross-validate its factor structure, to assess criterion validity, responsiveness to clinical change, and its minimal clinically important difference. Results Only a minority of patients reported any rectal tearing (38 %). Deletion of such item leads to a 11-item version (M:PAC-SYM). The remaining items in the rectal domain were moderately correlated with the stool domain. Exploratory factor analysis and confirmatory factor analysis revealed a bifactor structure with two subscales (stool and abdominal symptoms) and a general severity factor. The M:PAC-SYM demonstrated excellent reliability, moderate correlation with SF-12 and treatment satisfaction (r = 0.28-0.45), discrimination across Rome III criteria for functional constipation and abdominal pain, and responsiveness to clinical change (b = -0.49; x 2 = 0.25). M:PAC-SYM minimal clinically important difference was 0.24. Conclusion Our analysis shows that the rectal domain may not represent a relevant cluster of symptoms for patients with chronic constipation. We developed a modified version of the PAC-SYM which might better represent symptom severity of most patients seeking care in gastroenterology referral centers.

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Validation of the PAC‐SYM questionnaire for opioid‐induced constipation in patients with chronic low back pain

Abstract: PAC-SYM is a reliable, valid and responsive measure of the presence and severity of opioid-induced constipation symptoms.

Cited by 111 publications

References 26 publications

Prevalence of functional constipation and constipation-predominant irritable bowel syndrome in Indian patients with constipation

Prevalence of functional constipation and constipation-predominant irritable bowel syndrome in Indian patients with constipation

The Impact of Opioid Treatment on Regional Gastrointestinal Transit

Confirmatory factor analysis of the Patient Assessment of Constipation-Symptoms (PAC-SYM) among patients with chronic constipation

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