Impact of symptom severity in patients with diarrhoea-predominant irritable bowel syndrome (IBS-D): results from two separate surveys of HCPs and patients with IBS-D.

BACKGROUND: Management of diarrhoea-predominant irritable bowel syndrome (IBS-D) is generally based on patient-reported symptoms; however, limited information on symptom severity exists. The objective of the study was to assess the impact of IBS-D severity on patient burden and patient and healthcare professional attitudes towards IBS. METHODS: We conducted two web-based surveys of healthcare professionals and patients from Australia, Canada and Europe. We analysed patient characteristics and attitudes by IBS-D severity, which was assessed retrospectively using a composite of four variables: worst abdominal pain, IBS symptom frequency, Bristol Stool Form Scale and quality of life. RESULTS: Of 679 healthcare professional respondents, one-third routinely classified patients by severity. The patient survey was completed by 513 patients with mild (26%), moderate (33%) and severe (41%) IBS-D, classified using the composite scale. Age, sex and treatment satisfaction did not change with severity; however, 19% of patients classified with severe IBS-D agreed with the statement: 'When my IBS is bad, I wish I was dead' versus 4 and 7% of patients with mild and moderate IBS-D, respectively (p < 0.05). Significantly more patients classified with severe IBS-D reported medication use versus mild IBS-D. CONCLUSION: Compared with milder symptoms, severe IBS-D was associated with increased medication use and a negative perspective of IBS-D. This highlights the need for a validated severity scale to inform treatment decisions.

Neurogenic bowel dysfunction in patients with multiple sclerosis: prevalence, impact, and management strategies.

Bowel dysfunction in patients with multiple sclerosis (MS) is highly prevalent. Constipation and fecal incontinence can coexist and alternate, impacting on the patient's quality of life and social interactions, as well as burdening the caregivers. The cost for the health care providers is also significant, with increased number of hospital admissions, treatment-related costs, and hospital appointments. The origin is multifactorial, and includes alteration of neurological pathways, polypharmacy, behavioral elements, and ability to access the toilet. Every patient with MS should be sensitively questioned about bowel function, and red flag symptoms should prompt adequate investigations. Manipulation of life style factors and establishment of a bowel regime should be attempted in the first place, and if this fails, other measures such as biofeedback and transanal irrigation should be included. A stoma can improve quality of life, and is not necessarily a last-ditch option. Antegrade colonic enemas can also be an effective option, whilst neuromodulation has not proved its role yet. Effective treatment of bowel dysfunction improves quality of life, reduces incidence of urinary tract infection, and reduces health care costs.

Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT.

BACKGROUND: Between 50% and 80% of people with multiple sclerosis (PwMS) experience neurogenic bowel dysfunction (NBD) (i.e. constipation and faecal incontinence) that affects quality of life and can lead to hospitalisation. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of abdominal massage plus advice on bowel symptoms on PwMS compared with advice only. A process evaluation investigated the factors that affected the clinical effectiveness and possible implementation of the different treatments. DESIGN: A randomised controlled trial with process evaluation and health economic components. Outcome analysis was undertaken blind. SETTING: The trial took place in 12 UK hospitals. PARTICIPANTS: PwMS who had 'bothersome' NBD. INTERVENTION: Following individualised training, abdominal massage was undertaken daily for 6 weeks (intervention group). Advice on good bowel management as per the Multiple Sclerosis Society advice booklet was provided to both groups. All participants received weekly telephone calls from the research nurse. MAIN OUTCOME MEASURES: The primary outcome was the difference between the intervention and control groups in change in the NBD score from baseline to week 24. Secondary outcomes were measured via a bowel diary, adherence diary, the Constipation Scoring System, patient resource questionnaire and the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). RESULTS: A total of 191 participants were finalised, 189 of whom were randomised (two participants were finalised in error) (control group, n = 99; intervention group, n = 90) and an intention-to-treat analysis was performed. The mean age was 52 years (standard deviation 10.83 years), 81% (n = 154) were female and 11% (n = 21) were wheelchair dependent. Fifteen participants from the intervention group and five from the control group were lost to follow-up. The change in NBD score by week 24 demonstrated no significant difference between groups [mean difference total score -1.64, 95% confidence interval (CI) -3.32 to 0.04; p = 0.0558]; there was a significant difference between groups in the change in the frequency of stool evacuation per week (mean difference 0.62, 95% CI 0.03 to 1.21; p = 0.039) and in the number of times per week that participants felt that they emptied their bowels completely (mean difference 1.08, 95% CI 0.41 to 1.76; p = 0.002), in favour of the intervention group. Of participant interviewees, 75% reported benefits, for example less difficulty passing stool, more complete evacuations, less bloated, improved appetite, and 85% continued with the massage. A cost-utility analysis conducted from a NHS and patient cost perspective found in the imputed sample with bootstrapping a mean incremental outcome effect of the intervention relative to usual care of -0.002 quality-adjusted life-years (QALYs) (95% CI -0.029 to 0.027 QALYs). In the same imputed sample with bootstrapping, the mean incremental cost effect of the intervention relative to usual care was £56.50 (95% CI -£372.62 to £415.68). No adverse events were reported. Limitations include unequal randomisation, dropout and the possibility of ineffective massage technique. CONCLUSION: The increment in the primary outcome favoured the intervention group, but it was small and not statistically significant. The economic analysis identified that the intervention was dominated by the control group. Given the small improvement in the primary outcome, but not in terms of QALYs, a low-cost version of the intervention might be considered worthwhile by some patients. FUTURE WORK: Research is required to establish possible mechanisms of action and modes of massage delivery. TRIAL REGISTRATION: Current Controlled Trials ISRCTN85007023 and NCT03166007. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 58. See the NIHR Journals Library website for further project information.

Cost-Effectiveness Analysis of Transanal Irrigation for Managing Neurogenic Bowel Dysfunction in Japan.

BACKGROUND: Neurogenic bowel dysfunction (NBD) is a common sequela in Spinal Cord Injury (SCI) patients. Bowel dysfunction symptoms have a significant negative impact on quality of life (QOL) and are often socially disabling. Transanal irrigation (TAI) is a bowel management procedure that significantly mitigates NBD symptoms in patients refractory to standard bowel care (SBC) by reducing the incidence of fecal incontinence, ameliorating constipation, and improving QOL. TAI devices are used across many countries such as the United Kingdom, Germany, and France, and introduction of the devices is being considered in Japan. In this context, a cost-effectiveness analysis specific to Japanese settings is relevant. OBJECTIVES: To analyze the cost-effectiveness of TAI for bowel management of SCI patients with NBD in a Japanese clinical setting. METHODS: A modified version of a previously developed and published Markov model was used to evaluate the cost-effectiveness of TAI. In the model, SCI patients using TAI due to NBD were compared with SCI patients not responding to TAI and continuing with SBC. Quality-adjusted Life Years (QALYs) were used as the primary effectiveness measure, and the analysis was conducted from the payer's perspective. RESULTS: The model predicts a lifetime incremental cost of TAI to be 3 198 687 yen compared with SBC. TAI provided an additional 0.8 QALY, which leads to an incremental cost-effectiveness ratio (ICER) of TAI vs SBC of 4 016 287 yen/QALY. CONCLUSIONS: An ICER of 4 million yen falls within the range of reported willingness to pay (WTP) per QALY gain (5-6.7 million yen) in Japan, and TAI is therefore found to be a cost-effective treatment strategy compared to SBC. The result should be further corroborated in future Japanese trials of TAI.

Long-Term Cost-Effectiveness of Transanal Irrigation in Patients with Neurogenic Bowel Dysfunction.

BACKGROUND: People suffering from neurogenic bowel dysfunction (NBD) and an ineffective bowel regimen often suffer from fecal incontinence (FI) and related symptoms, which have a huge impact on their quality of life. In these situations, transanal irrigation (TAI) has been shown to reduce these symptoms and improve quality of life. AIM: To investigate the long-term cost-effectiveness of initiating TAI in patients with NBD who have failed standard bowel care (SBC). METHODS: A deterministic Markov decision model was developed to project the lifetime health economic outcomes, including quality-adjusted life years (QALYs), episodes of FI, urinary tract infections (UTIs), and stoma surgery when initiating TAI relative to continuing SBC. A data set consisting of 227 patients with NBD due to spinal cord injury (SCI), multiple sclerosis, spina bifida and cauda equina syndrome was used in the analysis. In the model a 30-year old individual with SCI was used as a base-case. A probabilistic sensitivity analysis was applied to evaluate the robustness of the model. RESULTS: The model predicts that a 30-year old SCI patient with a life expectancy of 37 years initiating TAI will experience a 36% reduction in FI episodes, a 29% reduction in UTIs, a 35% reduction in likelihood of stoma surgery and a 0.4 improvement in QALYs, compared with patients continuing SBC. A lifetime cost-saving of £21,768 per patient was estimated for TAI versus continuing SBC alone. CONCLUSION: TAI is a cost-saving treatment strategy reducing risk of stoma surgery, UTIs, episodes of FI and improving QALYs for NBD patients who have failed SBC.

Global small bowel motility: assessment with dynamic MR imaging.

PURPOSE: To assess the repeatability in human volunteers of software-quantified small bowel motility captured with magnetic resonance (MR) imaging and to test the ability to detect changes in motility induced by pharmacologic agents. MATERIALS AND METHODS: The study was approved by the Royal Free Research Ethics Committee, and all subjects gave full written informed consent. Twenty-one healthy volunteers (14 men, seven women; mean age, 28 years) underwent cine MR imaging with a three-dimensional balanced turbo field-echo sequence to capture small bowel motility. Volume blocks (15 cm thick) were acquired every second during a 20-second breath hold. A randomized, blinded, placebo-controlled crossover study of either 0.5 mg neostigmine or saline (n = 11) or 20 mg intravenous butylscopolamine or saline (n = 10) was performed with motility MR imaging at baseline and repeated at a mean of 4 weeks (range, 2-7 weeks). Two readers independently drew regions of interest around the small bowel, and motility was quantified by using a registration algorithm that provided a global motility metric in arbitrary units. Repeatability of the motility measurements at baseline was assessed by using Bland-Altman and within-subject coefficient of variation measures. Changes in mean motility measurements after drug administration were compared with those after placebo administration by using paired t testing. RESULTS: The repeatability between baseline measurements of motility was high; the Bland-Altman mean difference was -0.0025 (range, 0.28-0.4), the 95% limit of agreement was ±0.044 arbitrary units (au), and the within-subject coefficient of variation was 4.9%. Measured motility with neostigmine (mean, 0.39 au) was significantly higher than that with placebo (mean, 0.34 au; P < .001), whereas that with butylscopolamine (mean, 0.13 au) was significantly lower than that with placebo (mean, 0.30 au; P < .001). CONCLUSION: Quantification of small bowel motility with use of MR imaging in healthy volunteers is repeatable and sensitive to changes induced by means of pharmacologic manipulation. SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.13130151/-/DC1.

Assessment of gastrointestinal symptoms in patients with systemic sclerosis in a UK tertiary referral centre.

OBJECTIVES: The gastrointestinal tract (GIT) is affected in up to 90% of patients with SSc to a variable extent and severity. We aimed to establish the frequency and range of gastrointestinal (GI) symptoms in SSc patients at the Royal Free Hospital, a tertiary referral centre. METHODS: A 52-item, previously validated, questionnaire capturing SSc-related gut dysfunction was given to consecutive patients with SSc attending the rheumatology outpatient department. The questionnaire assesses the 'frequency' of five categories of symptoms and their 'impact' on social functioning and emotional well-being. Patients' notes were reviewed to establish disease subtype, autoantibody profile and other internal organ involvement. RESULTS: We collected 402 completed questionnaires (357 females; mean age 55). Sixty-nine per cent of patients had lcSSc and 30% dcSSc with mean disease duration of 11 years. Mean questionnaire scores showed that patients have a wide range of GI symptoms. Ninety-four per cent of patients reported upper and 79% lower GI symptoms, 3% of patients reported no symptoms and 10% reported daily symptoms. There was no association between disease subtype or autoantibody profile and GI symptoms. There was a positive correlation between diarrhoea scores (high scores = best health) and pulmonary fibrosis (r = 0.134, P = 0.0068). No other association between GI symptoms and other internal organ involvement was found. CONCLUSIONS: GI symptoms, both upper and lower, are common in patients with SSc. Patients should be asked specifically about GI symptoms as they may be under-reported and therefore under-treated. GI focused questionnaire is an effective way to assess gut symptoms and adjust treatment.