Development and validation of the Bowel Cleansing Impact Review (BOCLIR).

OBJECTIVE: Acceptability and tolerability of bowel cleansers influence whether patients are able to complete the prescribed dose and, consequently, the quality of the cleansing achieved. No standardised means of assessing patients' experience of using bowel cleansing is currently available. The aim of the study was to develop the Bowel Cleansing Impact Review (BOCLIR) to assess patient response to bowel cleansing products. DESIGN: Content was derived from qualitative interviews. Face and content validity were assessed via cognitive-debriefing interviews. Finally, patients completed the BOCLIR and a demographic questionnaire. Item response theory (Rasch analysis) was employed for item reduction and assessment of unidimensionality. Internal consistency and construct validity were also assessed. RESULTS: Analysis of 40 interviews resulted in the production of three scales; patient satisfaction, symptomatic impact and activity limitations. Scales were designed to be used alone or together. 19 debriefing interviews demonstrated BOCLIR acceptability, relevance and ease of completion. The validation survey involved 166 patients (52% male, mean (SD) age 54.3 (15.2) years). After misfitting and redundant items were removed all scales fit the Rasch model confirming their unidimensionality. Cronbach's α-coefficients were high (0.77-0.94) indicating good internal consistency. Scores on the BOCLIR were related to patients' willingness to use the product in future and ease of drinking the full preparation (p<0.01 for each scale). CONCLUSIONS: The BOCLIR is a new measure consisting of three unidimensional scales (satisfaction, symptoms and activity limitations) with good psychometric and scaling properties. The BOCLIR will allow accurate assessment of patients' response to bowel cleansing preparations.

Treatment of faecal impaction with polyethelene glycol plus electrolytes (PGE + E) followed by a double-blind comparison of PEG + E versus lactulose as maintenance therapy.

OBJECTIVES: To assess the efficacy of polyethylene glycol 3350 plus electrolytes (PEG + E; Movicol) as oral monotherapy in the treatment of faecal impaction in children, and to compare PEG + E with lactulose as maintenance therapy in a randomised trial. PATIENTS AND METHODS: An initial open-label study of PEG + E in the inpatient treatment of faecal impaction (phase 1), followed by a randomised, double-blind comparison between PEG + E and lactulose for maintenance treatment of constipation over a 3-month period (phase 2) in children aged 2 to 11 years with a clinical diagnosis of faecal impaction. RESULTS: Disimpaction on PEG + E was achieved in 58 (92%) of 63 of children (89% of 2-4 year olds and 94% of 5-11 year olds) without additional interventions. A maximum dose of 4 sachets (for 2-4 year olds) or 6 sachets (for 5-11 year olds) was required; median time to disimpaction was 6 days (range, 3-7 days). Seven children (23%) reimpacted whilst taking lactulose, whereas no children reimpacted while taking PEG + E (P = 0.011). The total incidence rate of adverse events seen was higher in the lactulose group (83%) than in the PEG + E group (64%). CONCLUSIONS: PEG + E is safe and highly effective in the management of childhood constipation. It allows a single orally administered laxative to be used for disimpaction without recourse to invasive interventions. It is significantly more effective than lactulose as maintenance therapy, both in efficacy in treating constipation and efficacy in preventing the recurrence of faecal impaction.

Evaluation of polyethylene glycol plus electrolytes in the treatment of severe constipation and faecal impaction in adults.

INTRODUCTION: Extreme and severe cases of constipation can lead to faecal impaction. Current therapies are often both ineffective and unpleasant. The objective of this trial was to evaluate the efficacy and safety of Movicol, a polyethylene glycol (PEG) + electrolyte solution (PEG+E), as treatment for severe constipation and faecal impaction. PATIENTS: 56 patients (aged 17 to 88 years) with a history of chronic constipation and presenting with no bowel movement for three to four days (severe constipation), or no bowel movement for at least five days (faecal impaction), were enrolled at three centres in Taiwan. Faecal loading was confirmed in all patients by abdominal and rectal examination or abdominal radiography. Patients were excluded from the study if they had a gastrointestinal obstruction, evidence of delayed gastric emptying, or if their constipation was secondary to severe inflammatory bowel disease. TREATMENT: All patients followed the same regimen: up to eight 13.8 g sachets of PEG+E (two at a time in 250 ml water; maximum of 1L/day) over a 4-6 h period each day, with 1-1.5 h between each dosing. Duration of treatment was for up to three days. EFFICACY ENDPOINTS AND RESULTS: Patients with either improvement (passage of a moderate to large volume of stool within four days of treatment initiation) or complete resolution (passage of moderate to large volumes of faecal matter plus the disappearance of palpable faecal masses in the abdomen and/or rectum) were considered responders. Based on bowel movement data recorded by the patients, an excellent response rate was obtained: 50/56 patients had a successful response to treatment (89.3%; 95% confidence intervals [CIs] 77.4% to 95.6%); there were 39 complete responders and 11 patients showed improvement. Investigator assessment of response was almost the same: 87.5% (95% CIs 75.3% to 94.4%). All bowel movement measurements (stool volume, number of evacuations, stool form and ease of evacuations) showed a positive improvement by Day 2. Median duration of treatment was two days. The incidence of adverse events was low, even for those side-effects such as abdominal pain and bloating, which are known undesirable consequences of PEG+E administration. No patient discontinued from the study because of an adverse event. CONCLUSION: PEG+E, administered orally at a dose equivalent to eight 13.8 g sachets (1 L) per day over three days, was a highly effective and well tolerated therapy for the treatment of severe constipation and faecal impaction.

A Randomised, Controlled Comparison of Low-Dose Polyethylene Glycol 3350 plus Electrolytes with Ispaghula Husk in the Treatment of Adults with Chronic Functional Constipation.

OBJECTIVE: To compare the efficacy and safety of polyethylene glycol (PEG) 3350 plus electrolytes (PEG+E; Movicol((R))) with that of ispaghula husk (psyllium; Konsyl((R))) in the treatment of constipation. PATIENTS: Male or female adults with chronic functional constipation. METHODS: This was a randomised, controlled, open-label, parallel-group trial. Study treatment was either PEG+E 13.8g/sachet dissolved in water twice daily or ispaghula husk 3.5g/sachet dissolved in water twice daily for a period of 2 weeks. Assessments were at baseline and after 1 and 2 weeks' therapy and by patient daily diary card. The primary outcome measures were weekly defaecation rate, stool consistency according to the Bristol Stool Form scale, time to first defaecation, and overall efficacy, which combined defaecation rate, stool consistency and difficulty on defaecation. Adverse effects were recorded and laboratory assessments were performed before and at the end of the treatment period. RESULTS: Sixty-three patients were randomised to each treatment group. Treatment was highly effective in 50/63 patients in the PEG+E group compared with 26/63 in the ispaghula husk group, and the overall efficacy rates were 92% and 73%, respectively (p = 0.005). PEG+E increased the mean weekly defaecation rate from 1.18 (SD 0.77) at baseline to 7.95 (SD 3.49) after 1 week and 8.48 (SD 3.55) after 2 weeks. In the ispaghula husk group the mean weekly defaecation rate increased from 1.33 (SD 0.68) at baseline to 5.33 (SD 2.81) after 1 week and to 5.71 (SD 2.49) after 2 weeks. The treatment differences for defaecation rates were all statistically significant (p < 0.001). Two weeks of treatment with PEG+E or ispaghula husk normalised stools in 55/63 (87.3%) and 42/63 (66.7%) of patients (p < 0.001). The incidence of adverse effects did not differ between groups and none were serious or required any treatment. Laboratory evaluations found no adverse effect from either treatment. CONCLUSION: The present study demonstrated that low-dose PEG 3350 plus electrolytes is more effective and more rapid in its onset of action than ispaghula husk, and is equally well tolerated.