Discrete Choice Experiment Reveals Strong Preference for Dietary Treatment Among Patients With Irritable Bowel Syndrome.

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is a highly prevalent, chronic disorder of the gut-brain interaction that significantly affects quality of life. Several treatments, with comparable clinical efficacy, are available. Patient preferences can therefore be an important determinant of an effective management strategy. Treatment preferences of patients regarding decision making remain unclear. We aimed to examine these preferences and estimate trade-offs between different attributes. METHODS: A total of 427 patients from the Maastricht IBS cohort were invited to participate. A labeled discrete choice experiment survey, containing 9 scenarios with each 3 alternatives (medication, diet, psychotherapy), was developed in order to estimate preferences. The treatment scenarios were based on 6 attributes: effectiveness, time to response, time until recurrence, side effects, time required, and frequency of appointments. The preference weights and relative importance were analyzed using a mixed logit model. RESULTS: A total of 185 (43.3%) of 427 potential respondents completed the questionnaire (mean age 49.51 years, 69.2% female). The most preferred treatment was dietary intervention (48.1%), followed by pharmacotherapy (29.2%) and psychotherapy (22.7%). IBS patients preferred a higher effectiveness, shorter time interval to response, longer time interval until recurrence, no severe side effects, and frequent appointments when attending psychotherapy. Younger patients (≤50 years of age) preferred dietary interventions and a long period until recurrence, whereas older patients (>50 years of age) were more inclined to choose pharmacotherapy and the period until recurrence was not important. CONCLUSIONS: Dietary interventions were the most preferred IBS therapy. Identifying patients' treatment preferences during shared decision making will provide more optimal management strategies and could be the best approach to diminish disease burden.

The estimation of a preference-based single index for the IBS-QoL by mapping to the EQ-5D-5L in patients with irritable bowel syndrome.

PURPOSE: The Irritable Bowel Syndrome Quality of Life (IBS-QoL) questionnaire is a commonly used and validated IBS-specific QoL instrument. However, this questionnaire is in contrast to the EQ-5D-5L, not preference-based and as such does not allow calculation of QALYs. The objective of this study was to describe the convergent- and known-group validity of both questionnaires and to develop a mapping algorithm from EQ-5D-5L which enable IBS-QoL scores to be transformed into utility scores for use in economic evaluations. METHODS: We used data from two multicenter randomized clinical trials, which represented the estimation and external validation dataset. The convergent validity was investigated by examining correlations between the EQ-5D-5L and IBS-QoL and the known-group validity by calculating effect sizes. Ordinary least squares (OLS), censored least absolute deviations (CLAD), and mixture models were used in this mapping approach. RESULTS: 283 IBS patients were included (n = 189 vs. n = 84). Mean IBS-QoL score was 71.13 (SD 15.66) and mean EQ-5D-5L utility score was 0.73 (SD 0.19). The overall sensitivity of the IBS-QoL and EQ-5D-5L to discriminate between patient and disease characteristics was similar. CLAD model 4, containing the total IBS-QoL score and squared IBS-SSS (IBS severity scoring system), was chosen as the most appropriate model to transform IBS-QoL scores into EQ-5D-5L utility scores. CONCLUSION: This study reports the development of an algorithm where the condition-specific questionnaire IBS-QoL can be used to calculate utility values for use in economic evaluations. Including a clinical measure, IBS-SSS, in the model improved the performance of the algorithm.

Do Patients' and Physicians' Perspectives Differ on Preferences for Irritable Bowel Syndrome Treatment?

Irritable bowel syndrome (IBS) is a highly prevalent disorder of gut-brain interaction and poses a significant burden to patients. Pharmacotherapy, diet, and psychotherapy all have largely comparable clinical efficacy. Therefore, factors outside efficacy can have an important impact in determining preferences for a specific therapeutic entity. The aim of this study was to compare the patient and physician perspectives and identify important treatment characteristics regarding the management of IBS. Semistructured interviews were performed among IBS patients (n = 8), fulfilling the Rome IV criteria, and surveys were sent to physicians involved in IBS care (n = 15). Nine important treatment characteristics were revealed: effectiveness, time until response, cessation of response, side effects, location, waiting period, treatment burden, frequency of healthcare appointments, and willingness to pay. Time to response, location, and waiting time were less important for patients compared to physicians. This study assessed important IBS treatment characteristics and provided context to preferences from a patient and physician perspective. These data could be relevant during shared decision-making in clinical practice.

The Artificial Bowel Sphincter in the Treatment of Fecal Incontinence, Long-term Complications.

BACKGROUND: Fecal incontinence is a common and debilitating condition, of which the prevalence increases with age. Several medical and minimally invasive treatment modalities are available. However, for patients with greater sphincter defects, these treatments are often not sufficient. For these patients, the artificial bowel sphincter could be an alternative to colostomy. The artificial bowel sphincter has proven to be effective in the short term. Less is known whether the benefits sustain over time. OBJECTIVE: The aim of this study was to assess the long-term outcome of the artificial bowel sphincter in patients with refractory fecal incontinence. DESIGN: A retrospective record review was conducted in conjunction with questionnaires. SETTING: This study was conducted in a tertiary hospital setting. MAIN OUTCOME MEASURES: The primary end point was any complication. The secondary end point was fecal loss. PATIENTS: The patients included were adults experiencing severe fecal incontinence treated with artificial bowel sphincter, operated on between 1997 and 2014. RESULTS: Sixty-three patients were included in this study. After a median follow-up of 57 months (range, 1-198), the device had been explanted in 31 patients (49.2%; 95% CI, 36.5-62.0). In total, 101 reoperations were conducted, ranging from 1 to 6 reoperations per patient. The main reasons for revision were device failure and infection. At 5 years follow-up, 80% of the cohort had experienced a complication requiring surgery. Twenty-two (35%) patients had restored continence. LIMITATIONS: This study was limited by its retrospective design and subjective secondary outcome. CONCLUSION: Patients with severe end-stage fecal incontinence can benefit from artificial bowel sphincter, but this requires a large number of reoperations, and at least 20% of patients will eventually have a colostomy. Therefore, careful patient selection and the involvement of patients in decision making regarding the potential benefits and limitations of this technique are paramount. See Video Abstract at http://links.lww.com/DCR/B242. EL ESFÍNTER INTESTINAL ARTIFICIAL EN EL TRATAMIENTO DE LA INCONTINENCIA FECAL, COMPLICACIONES A LARGO PLAZO: La incontinencia fecal es una condición común y debilitante, cuya prevalencia aumenta con la edad. Se encuentran disponibles varias modalidades de tratamiento médico y mínimamente invasivo. Sin embargo, para pacientes con defectos del esfínter mayores, estos tratamientos a menudo no son suficientes. Para estos pacientes, el esfínter intestinal artificial (ABS) podría ser una alternativa a la colostomía. El esfínter intestinal artificial demostró ser efectivo a corto plazo. Se sabe menos si los beneficios se mantienen a lo largo del tiempo.El objetivo de este estudio fue evaluar el resultado a largo plazo del esfínter intestinal artificial en pacientes con incontinencia fecal refractaria.Se realizó una revisión retrospectiva de los registros junto con los cuestionarios.Realizado en un entorno de hospital de tercel nivel.El punto final primario fue cualquier complicación, el punto final secundario fue la pérdida fecal.Los pacientes incluidos fueron adultos que padecían incontinencia fecal severa tratados con esfínter intestinal artificial, operados entre 1997 y 2014.Sesenta y tres pacientes fueron incluidos en este estudio. Después de una mediana de seguimiento de 57 meses (rango 1-198), el dispositivo había sido explantado en 31 pacientes (49.2%; 95CI 36.5-62.0). En total, se realizaron 101 reoperaciones, que oscilaron de una a seis reoperaciones por paciente. Las principales razones para la revisión fueron la falla del dispositivo y la infección. A los cinco años de seguimiento, el 80% de la cohorte había experimentado una complicación que requería cirugía. 22 pacientes habían recuperado la continencia (35%).Diseño retrospectivo y resultado secundario subjetivo.Los pacientes con incontinencia fecal grave en etapa terminal pueden beneficiarse del esfínter intestinal artificial, pero esto requiere una gran cantidad de reoperaciones y al menos el 20% de los pacientes eventualmente tendrán una colostomía. Por lo tanto, la selección cuidadosa del paciente y la participación de los pacientes en la toma de decisiones con respecto a los posibles beneficios y limitaciones de esta técnica es primordial. Consulte Video Resumen en http://links.lww.com/DCR/B242.

Time trends in the epidemiology and outcome of perianal fistulizing Crohn's disease in a population-based cohort.

OBJECTIVE: Perianal disease is a debilitating condition that frequently occurs in Crohn's disease (CD) patients. It is currently unknown whether its incidence has changed in the era of frequent immunomodulator use and biological availability. We studied the incidence and outcome of perianal and rectovaginal fistulas over the past two decades in our population-based Inflammatory Bowel Disease South-Limburg cohort. PATIENTS AND METHODS: All 1162 CD patients registered in the Inflammatory Bowel Disease South-Limburg registry were included. The cumulative probabilities of developing a perianal and rectovaginal fistula were compared between three eras distinguished by the year of CD diagnosis: 1991-1998, 1999-2005 and 2006-2011. Second, clinical risk factors and the risk of fistula recurrence were determined. RESULTS: The cumulative 5-year perianal fistula rate was 14.1% in the 1991-1998 era, 10.4% in the 1999-2005 era and 10.3% in the 2006-2011 era, P=0.70. Colonic disease was associated with an increased risk of developing perianal disease, whereas older age was associated with a decreased risk (both P<0.01). Over time, more patients were exposed to immunomodulators or biologicals before fistula diagnosis (18.5 vs. 32.1 vs. 52.1%, respectively, P=0.02) and started biological therapy thereafter (18.6 vs. 34.1 vs. 54.0%, respectively, P<0.01). The cumulative 5-year perianal fistula recurrence rate was not significantly different between eras (19.5 vs. 25.5 vs. 33.1%, P=0.28). In contrast, the cumulative 5-year rectovaginal rate attenuated from 5.7% (the 1991-2005 era) to 1.7% (the 2006-2011 era), P=0.01. CONCLUSION: Over the past two decades, the risk of developing a perianal fistula was stable, as well as its recurrence rate, underlining the lasting need for improving treatment strategies for this invalidating condition.

Sacral neuromodulation in children and adolescents with chronic constipation refractory to conservative treatment.

PURPOSE: Functional constipation in children and adolescents is a common and invalidating condition. In a minority of patients, symptoms persist despite optimal conservative therapy. The aim of this study was to evaluate whether the short-term effects of sacral neuromodulation (SNM) in children and adolescents with constipation are sustained over prolonged period of time. METHODS: Patients aged 10-20 years, with refractory constipation, fulfilling the Rome III criteria, were included in our study. If SNM test treatment showed >50 % improvement in defecation frequency, a permanent stimulator was implanted. Primary outcome measure was defecation frequency during 3 weeks. Secondary endpoints were abdominal pain and Wexner score. To assess sustainability of treatment effect, a survival analysis was performed. Cross-sectional quality of life was assessed using the EQ-5D VAS score. RESULTS: Thirty girls, mean age 16 (range 10-20), were included. The mean defecation frequency increased from 5.9 (SD 6.5) in 21 days at baseline to 17.4 (SD 11.6) after 3 weeks of test treatment (p < 0.001). During test treatment, abdominal pain and Wexner score decreased from 3.6 to 1.5 and 18.6 to 8.5 (p < 0.001), respectively. Improvement of symptoms sustained during a median follow-up of 22.1 months (12.2-36.8) in 42.9 % of patients. On a scale from 0 to 100, quality of life was 7 points lower than the norm score (mean 70 vs. 77). CONCLUSION: SNM is a therapeutic option for children with chronic constipation not responding to intensive oral and/or laxative therapy, providing benefits that appear to be sustained over prolonged period of time.