Satisfaction With Life in IBS Is Associated With Psychological Burden Rather than Gastrointestinal Symptom Severity.

INTRODUCTION: Irritable bowel syndrome (IBS) has a major impact on emotional, social, and professional life. This study aimed to evaluate general life satisfaction, a subjective measure of well-being, in IBS patients, and to determine which factors are associated with higher life satisfaction. METHODS: IBS patients (n = 195, mean age 51.4 ± 16.5 years, 73.8% female) recruited from primary and secondary/tertiary care completed questionnaires regarding gastrointestinal symptoms, quality of life, psychological factors, and life satisfaction (Satisfaction With Life Scale, 5 items, range 5-35). A finite mixture model analysis was performed to identify latent classes. Multivariable linear regression was used to identify variables associated with life satisfaction. RESULTS: Overall, 71.3% of the patients were satisfied about their life (Satisfaction With Life Scale-score ≥21). Three latent subgroups could be identified with significantly higher life satisfaction in the subgroup with higher mental quality of life, fewer anxiety and depressive symptoms, lower gastrointestinal specific anxiety, and lower gastrointestinal symptom severity, compared with the other 2 groups. Multivariable linear regression showed that higher physical quality of life (B0.168, P < 0.001) and higher mental quality of life (B0.199, P < 0.001) were associated with higher life satisfaction. Using multivariable regression, no significant association was found between gastrointestinal symptom severity and life satisfaction. DISCUSSION: Higher physical and mental quality of life, but not gastrointestinal symptom severity, were independently associated with higher general life satisfaction in IBS. These findings reinforce the clinical need in IBS treatment to focus on the full extent of the disorder and not merely on gastrointestinal symptom improvement. ClinicalTrials.gov Identifier: NCT00775060.

Real-time Symptom Assessment in Patients With Endometriosis: Psychometric Evaluation of an Electronic Patient-Reported Outcome Measure, Based on the Experience Sampling Method.

BACKGROUND: The experience sampling method (ESM) holds advantages over traditional retrospective questionnaires including a high ecological validity, no recall bias, the ability to assess fluctuation of symptoms, and the ability to analyze the temporal relationship between variables. OBJECTIVE: This study aimed to evaluate the psychometric properties of an endometriosis-specific ESM tool. METHODS: This is a short-term follow-up prospective study, including patients with premenopausal endometriosis aged ≥18 years who reported dysmenorrhea, chronic pelvic pain, or dyspareunia between December 2019 and November 2020. An ESM-based questionnaire was sent out by a smartphone application 10 times a day during 1 week on randomly chosen moments. Additionally, patients completed questionnaires concerning demographics, end-of-day pain scores, and end-of-week symptom scores. The psychometric evaluation included compliance, concurrent validity, and internal consistency. RESULTS: Twenty-eight patients with endometriosis completed the study. Compliance for answering the ESM questions was as high as 52%. End-of-week pain scores were higher than ESM mean scores and showed peak reporting. ESM scores showed strong concurrent validity when compared with symptoms scored by the Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome, 7-item Generalized Anxiety Disorders Scale, 9-question Patient Health Questionnaire, and the majority of questions of the 30-item Endometriosis Health Profile. Cronbach α coefficients demonstrated a good internal consistency for abdominal symptoms, general somatic symptoms, and positive affect, and an excellent internal consistency for negative affect. CONCLUSIONS: This study supports the validity and reliability of a newly developed electronic instrument for the measurement of symptoms in women with endometriosis, based on momentary assessments. This ESM patient-reported outcome measure has the advantage of providing a more detailed view on individual symptom patterns and offers the possibility for patients to have insight in their symptomatology, leading to more individualized treatment strategies that can improve the quality of life of women with endometriosis.

Systematic review on sleeve gastrectomy or Roux-en-Y gastric bypass surgery for refractory gastroparesis.

Management of refractory gastroparesis is challenging after diet, prokinetics, and long-term nutritional support have failed. In this review, the efficacy and safety of surgical interventions (sleeve gastrectomy and Roux-en-Y gastric bypass surgery) are evaluated systematically in patients with refractory gastroparesis. The PubMed, Embase, and Scopus databases were searched to identify relevant studies published up to June 2021. Outcome of interest was symptom improvement and gastric emptying. Nineteen studies with 222 refractory gastroparesis patients (147 Roux-en-Y gastric bypass, 39 sleeve gastrectomy, and 36 subtotal gastrectomy) were included. All studies reported symptom improvement postoperatively, particularly vomiting and nausea. Gastric emptying improved postoperatively in 45% up to 67% for sleeve gastrectomy and 87% for Roux-en-Y gastric bypass. The findings of our systematic review suggest that sleeve gastrectomy and Roux-en-Y gastric bypass surgery improve symptoms and gastric emptying in patients with refractory gastroparesis. Surgery may be effective as treatment for a small group of patients when all other therapies have failed.

Antroduodenal motility recording identifies characteristic patterns in gastroparesis related to underlying etiology.

BACKGROUND: Gastroparesis (GP) is a gastrointestinal disorder associated with significant morbidity and healthcare costs. GP patients form a heterogeneous population with diverse etiology, and treatment is often challenging due to a poorly understood underlying pathophysiology. The aim of the present study was to assess antroduodenal motility patterns among the different GP etiologies. METHODS: We reviewed antroduodenal manometry (ADM) recordings of patients with confirmed GP between 2009 and 2019. ADM measurements were evaluated for fed period duration, number of phase III contractions and migrating motor complexes (MMCs), motility index (MI), and presence of neuropathic patterns. KEY RESULTS: A total of 167 GP patients (142 women, median age 45 [31-57]) were included. The following etiologies were identified: idiopathic n = 101; post-surgery n = 36; and diabetes n = 30. Fed period duration was significantly longer in idiopathic (p < 0.01) and diabetic GP patients (p < 0.05) compared with post-surgery GP patients. Furthermore, the number and duration of phase III contractions and the number of MMCs were significantly lower in idiopathic and diabetic patients compared with post-surgery GP patients (p < 0.01). Likewise, absence of MMCs during 6-h recording was more often observed in idiopathic and diabetes GP patients compared with post-surgery GP patients (resp. p < 0.01 and p < 0.05). CONCLUSIONS AND INFERENCES: Antroduodenal motility patterns are different among GP etiologies. A dysmotility spectrum was identified with different patterns ranging from post-surgery GP to idiopathic and diabetic GP.

Using a Patient Hotel: Perceptions of the Quality of Care by Patients Undergoing Analysis for Gastrointestinal Motility Disorders in the Netherlands.

There is growing demand to improve healthcare services for patients. Patient hotel models can be applied to allow shorter inpatient stays, however, whether this improves patient satisfaction and quality of care is unknown. All consecutive patients referred for analysis of gastrointestinal (GI) motility disorders at Maastricht UMC, the Netherlands, who stayed overnight in the patient hotel (June 2017-July 2018), were asked to complete a questionnaire on patient satisfaction and quality of care. On a 4-point Likert scale, most patients reported they were largely to absolutely satisfied with the quality of care, regarding coordination, information, courtesy of nurses and staff, and privacy. Cost savings between 48,433 and 74,613 euros for 1 year were achieved, amounting to 613-944 euros per patient. Positive patient satisfaction and perception of quality of care with the patient hotel model were achieved. We show that moving overnight stays from inpatient to an outpatient hotel provides substantial financial savings for hospitals, healthcare providers, and insurance companies.

The Interplay Between Stress and Fullness in Patients With Functional Dyspepsia and Healthy Controls: An Exploratory Experience Sampling Method Study.

OBJECTIVE: Fullness is a cardinal symptom in functional dyspepsia (FD). The use of real-time symptom assessment might provide more insight into factors, such as daily stress, that can influence fullness. Therefore, this study aimed to use the experience sampling method (a real-time, repeated-measurement method making use of repeated questionnaires available at random moments for a limited amount of time) to assess the association between stress and fullness in patients with FD and healthy controls (HCs). METHODS: Thirty-five patients with FD (25 female, mean age = 44.7 years) and 34 HCs (24 female, mean age = 44.1 years) completed the experience sampling method (a maximum of 10 random moments per day) for 7 consecutive days. Stress and fullness were rated on an 11-point Numeric Rating Scale. Data between patients with FD and HCs were statistically compared using a Student samples t test and linear mixed-effects models with repeated measures (level 1) nested within participants (level 2). RESULTS: Average fullness scores were 2.23 (standard error = 0.37) points higher in patients with FD compared with HCs (p < .001). Average stress scores were 1.37 (standard error = 0.30) points higher in patients with FD compared with HCs (p = .002).In FD, fullness scores increased with 0.14 for every 1-point increase in concurrent stress scores (p = .010). Fullness scores at t = 0 increased with 0.12 for every 1-point increase in stress scores at t = -1 (p = .019). T = 0 stress scores were not associated with change in t = -1 fullness scores. No associations between concurrent symptom scores were found for HCs. CONCLUSIONS: Concurrent and preceding stress scores are positively associated with fullness scores in patients with FD, but not in HCs. These findings indicate that increased levels of stress may precede feelings of fullness in patients with FD. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04204421.

Patient-Reported Outcome Measure for Real-time Symptom Assessment in Women With Endometriosis: Focus Group Study.

BACKGROUND: Symptoms related to endometriosis have a significant impact on the quality of life, and symptoms often recur. The experience sampling method (ESM), a digital questioning method characterized by randomly repeated momentary assessments, has several advantages over traditionally used measurements, including the ability to assess the temporal relationship between variables such as physical, mental, and social factors. OBJECTIVE: The aim of this study is to develop an ESM tool for patients with endometriosis to accurately measure symptoms and their course over time, allowing for personalized treatment and adequate monitoring of treatment efficacy in individual patients. METHODS: On the basis of international guidelines, items from validated questionnaires were selected through a literature review and during focus groups and multidisciplinary expert meetings. Data analysis was conducted using ATLAS.ti (ATLAS.ti Scientific Software Development GmbH). The feasibility and usability of the newly developed momentary assessment tool were tested for 28 consecutive days in 5 patients with endometriosis-related pain symptoms. RESULTS: Momentary assessment items contained questions concerning endometriosis symptoms, general somatic symptoms, psychological symptoms, contextual information, and the use of food and medication. A morning questionnaire on sleep and sexuality was included. In a pilot study, the patients considered the tool easy to use but time consuming. The average compliance rate of momentary assessments was 37.8% (106/280), with the highest completion rate during the first week (39/70, 56%). Therefore, it is advisable to use the ESM for a maximum of 7 days. CONCLUSIONS: A new digital tool for endometriosis symptom assessment was developed using the ESM, which may help overcome the limitations of current retrospective questionnaires. After validation and testing, future studies will be planned to evaluate the use of this tool in a clinical setting in order to propose a personalized treatment plan for women with endometriosis.

Psychometric evaluation of an experience sampling method-based patient-reported outcome measure in functional dyspepsia.

BACKGROUND: Due to important biases, conventional end-of-day and end-of-week assessment methods of gastrointestinal symptoms in functional dyspepsia (FD) are considered suboptimal. Real-time symptom assessment based on the experience sampling method (ESM) could be a more accurate measurement method. This study aimed to evaluate validity and reliability of an ESM-based patient-reported outcome measure (PROM) for symptom assessment in FD. METHODS: Thirty-five patients with FD (25 female, mean age 44.7 years) completed the ESM-based PROM (a maximum of 10 random moments per day) and an end-of-day symptom diary for 7 consecutive days. On day 7, end-of-week questionnaires were completed including the Nepean Dyspepsia Index (NDI) and Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM). KEY RESULTS: Experience sampling method and corresponding end-of-day scores for gastrointestinal symptoms were significantly associated (ICCs range 0.770-0.917). However, end-of-day scores were significantly higher (Δ0.329-1.031) than mean ESM scores (p < 0.05). Comparing ESM with NDI and PAGI-SYM scores, correlations were weaker (Pearson's r range 0.467-0.846). Cronbach's α coefficient was good for upper gastrointestinal symptoms (α = 0.842). First half-week and second half-week scores showed very good consistency (ICCs range 0.913-0.975). CONCLUSION AND INFERENCES: Good validity and reliability of a novel ESM-based PROM for assessing gastrointestinal symptoms in FD patients was demonstrated. Moreover, this novel PROM allows to evaluate individual symptom patterns and can evaluate interactions between symptoms and environmental/contextual factors. ESM has the potential to increase patients' disease insight, provide tools for self-management, and improve shared decision making. Hence, this novel tool may aid in the transition toward personalized health care for FD patients.

Examining the optimal cutoff values of HADS, PHQ-9 and GAD-7 as screening instruments for depression and anxiety in irritable bowel syndrome.

BACKGROUND: Self-rating scales are frequently used to screen for anxiety and depression in patients with irritable bowel syndrome (IBS). Different cutoff values are recommended in literature, and guidelines have suggested the use of other screening instruments over time. The aim of this study was to assess the correlation between the most commonly used psychological screening instruments for anxiety and depression in IBS and to compare custom cutoff scores for these instruments. METHODS: Irritable bowel syndrome patients (n = 192) completed several questionnaires including the Hospital Anxiety and Depression Scale (HADS, HADS-A and HADS-D subscale), Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7). Agreement at different cutoff points, for depressive and anxiety disorder, was assessed by use of the Gwet AC1 coefficient. KEY RESULTS: Hospital Anxiety and Depression Scale (HADS)-D and PHQ-9 scores, and HADS-A and GAD-7 scores showed high correlations (rs  = 0.735 and rs  = 0.805, respectively). For depressive disorder, a Gwet AC1 value of 0.829 was found when recommended cutoff points from literature were compared (PHQ-9 cutoff ≥10, HADS-D cutoff ≥8). For anxiety disorder, a Gwet AC1 value of 0.806 was found when recommended cutoff points from literature were compared (GAD-7 cutoff ≥10, HADS-A cutoff ≥8). Even higher agreements were found when higher HADS cutoff values were chosen, with impact on sensitivity and specificity. CONCLUSIONS & INFERENCES: Custom cutoff values deem the HADS subscales (HADS-D and HADS-A) concordant to PHQ-9 and GAD-7 scores. The choice of a cutoff value has substantial impact on sensitivity/specificity and is dependent on patient population, setting, and the purpose of use.

Symptom-network dynamics in irritable bowel syndrome with comorbid panic disorder using electronic momentary assessment: A randomized controlled trial of escitalopram vs. placebo.

INTRODUCTION: Momentary ecological assessment indicated alleviated abdominal pain in escitalopram treatment of irritable bowel syndrome (IBS) with comorbid panic disorder. Hitherto, little is known about symptom formation, i.e., how psychological impact physical symptoms, and vice versa, and about the effect of SSRI-treatment on symptom formation. OBJECTIVE: To investigate how psychological and somatic symptoms co-vary over time in IBS patients with comorbid panic disorder and how they are affected by escitalopram treatment. METHODS: Experience sampling data from 14 IBS patients with panic disorder were obtained from a single-centre, double-blind, parallel-group, randomized controlled trial on escitalopram versus placebo. At baseline, after three and six months, multilevel time-lagged linear regression analysis was used to construct symptom networks. Network connections represented coefficients between various affect and gastrointestinal items. RESULTS: Connectivity increased up to 3 months in both groups. Between 3 and 6 months, connectivity decreased for placebo and further increased in the escitalopram group. Additionally, a steep increase in node strength for negative affect nodes was observed in the escitalopram network and the opposite for positive affect nodes. Over time, group symptom networks became increasingly different from each other. Anxious-anxious and enthusiastic-relaxed became significantly different between groups at 6 months. The connection that changed significantly in all analyses was anxious-anxious. CONCLUSIONS: Escitalopram treatment was associated with changes in the symptom networks in IBS patients with panic disorder. While mood and physical symptoms improve over time, mainly connectivity between mood nodes changed, possibly pointing towards a healthier emotion regulation resulting in alleviation of physical symptoms.

Age-Related Decrease in Abdominal Pain and Associated Structural- and Functional Mechanisms: An Exploratory Study in Healthy Individuals and Irritable Bowel Syndrome Patients.

Introduction: The world population is ageing, resulting in increased prevalence of age-related comorbidities and healthcare costs. Limited data are available on intestinal health in elderly populations. Structural and functional changes, including altered visceroperception, may lead to altered bowel habits and abdominal symptoms in healthy individuals and irritable bowel syndrome (IBS) patients. Our aim was to explore age-related changes in gastrointestinal symptoms and underlying mechanisms. Methods: In total, 780 subjects (IBS patients n = 463, healthy subjects n = 317) from two separate studies were included. Subjects were divided into different age groups ranging from young adult to elderly. Demographics and gastrointestinal symptom scores were collected from all participants using validated questionnaires. A subset of 233 IBS patients and 103 controls underwent a rectal barostat procedure to assess visceral hypersensitivity. Sigmoid biopsies were obtained from 10 healthy young adults and 10 healthy elderly. Expression of the visceral pain-associated receptors transient receptor potential (TRP) Ankyrin 1 (TRPA1) and Vanilloid 1 (TRPV1) genes were investigated by quantitative RT-PCR and immunofluorescence. Results: Both elderly IBS and healthy individuals showed significantly lower scores for abdominal pain (p < 0.001) and indigestion (p < 0.05) as compared to respective young adults. Visceral hypersensitivity was less common in elderly than young IBS patients (p < 0.001). Relative TRPA1 gene transcription, as well as TRPA1 and TRPV1 immunoreactivity were significantly lower in healthy elderly versus healthy young adults (p < 0.05). Conclusions: Our findings show an age-related decrease in abdominal pain perception. This may in part be related to decreased TRPA1 and/or TRPV1 receptor expression. Further studies are needed to reveal precise underlying mechanisms and the associations with intestinal health.

Network approach of mood and functional gastrointestinal symptom dynamics in relation to childhood trauma in patients with irritable bowel syndrome and comorbid panic disorder.

OBJECTIVE: Irritable bowel syndrome (IBS) has a high comorbidity with mental disorders. The present paper aims to visualise the interplay between IBS and affect (anxiety and mood) in daily life. Furthermore, this interplay may be different depending on risk factors such as childhood trauma. METHODS: Using momentary assessment (Experience Sampling Method), data of 24 individuals diagnosed with both IBS and panic disorder were analysed (15 non-trauma and 9 low-trauma-score patients). Networks were constructed, based on multilevel time-lagged linear regression analysis. Regression coefficients present network connections including three negative affect items (down, irritated, rushed), three positive affect items (happy, enthusiastic, cheerful), three abdominal complaints (abdominal pain, bloating, nausea) and one social item (feeling lonely). Those networks were stratified by levels of childhood trauma based on the Childhood Trauma Questionnaire. RESULTS: Connections within the group of mood items and within the group of abdominal complaints were more frequent than between abdominal complaints and mood items. When data were stratified by childhood trauma, networks were different. In addition, node strengths were stronger in low-trauma than in non-trauma, although only one was significantly different (enthusiastic). Overall, there were mainly non-significant connections and a clear pattern was not visible. CONCLUSIONS: A time-lagged network provides additional insight in connections between abdominal complaints and affective complaints, in patients with IBS and panic disorder, with different levels of childhood trauma. More research is needed to gain a better understanding of symptom formation and the impact of variation in context on individual symptom experiences in IBS with affective comorbidity. Baseline data of a clinical trial: NCT01551225 (http://www.clinicaltrials.gov).

Patient-Specific Stress-Abdominal Pain Interaction in Irritable Bowel Syndrome: An Exploratory Experience Sampling Method Study.

INTRODUCTION: Gastrointestinal symptoms in irritable bowel syndrome (IBS) have been correlated with psychological factors using retrospective symptom assessment. However, real-time symptom assessment might reveal the interplay between abdominal and affective symptoms more reliably in a longitudinal perspective. The aim was to evaluate the association between stress and abdominal pain, using the Experience Sampling Method (ESM) as a real-time, repeated measurement method. METHODS: Thirty-seven patients with IBS (26 women; mean age 36.7 years) and 36 healthy controls (HC; 24 women; mean age 31.1 years) completed an electronic ESM during 7 consecutive days. Abdominal pain and stress were scored on an 11-point Numeric Rating Scale at a maximum of 10 random moments each day. RESULTS: Abdominal pain scores were 2.21 points higher in patients with IBS compared with those in HC (P < 0.001), whereas stress levels did not differ significantly (B: 0.250, P = 0.406). In IBS, a 1-point increase in stress was associated with, on average, 0.10 points increase in abdominal pain (P = 0.017). In HC, this was only 0.02 (P = 0.002). Stress levels at t = -1 were not a significant predictor for abdominal pain at t = 0 in both groups, and vice versa. DISCUSSION: Our results demonstrate a positive association between real-time stress and abdominal pain scores and indicate a difference in response to stress and not a difference in experienced stress per se. Furthermore, an in-the-moment rather than a longitudinal association is suggested. This study underlines the importance of considering the individual flow of daily life and supports the use of real-time measurement when interpreting potential influencers of abdominal symptoms in IBS.

Normal colonic transit time predicts the outcome of colonic manometry in patients with chronic constipation-an exploratory study.

PURPOSE: Colonic manometry (CM) can be of additive value in the diagnostic workup of colonic motility in chronic constipated patients. However, it is claimed that colonic motor disturbances occur in normal-transit constipation (NTC) and slow-transit (STC) constipation, as measured using a radio-opaque marker study, and therefore, the relationship between colonic motor disturbances on CM and colonic transit time (CTT) remains unclear. Our aim was to compare results from colonic marker study with the outcome of CM in patients with treatment-refractory chronic constipation (CC). METHOD: Eighty-seven CC patients and 12 healthy volunteers, undergoing both a CTT study and a 24-h CM in a Dutch tertiary referral center, were included. CTT was measured using radio-opaque markers (X-ray at day 4 after ingestion of 20 markers at day 0). CM was performed using a catheter with 6 solid-state pressure sensors, endoscopically clipped to the mucosa in the right colon. CM was defined as normal when at least three high-amplitude propagating contractions (HAPCs), i.e., propagating waves with amplitude ≥ 80 mmHg over at least three sensors, were identified. RESULTS: In total, 70 patients showed STC on CTT, of which 21 (30%) showed normal CM. All 17 NTC patients and healthy volunteers showed normal CM. The negative predictive value of CTT for normal CM was 100%. CONCLUSION: Colonic manometry should be considered in therapy-refractory STC patients in order to further delineate colonic motility. However, in this exploratory study, for patients presenting with NTC on a radio-opaque marker study, colonic manometry does not appear to have added value.

Reduction in IBS symptom severity is not paralleled by improvement in quality of life in patients with irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is a brain-gut disorder, of which the natural course varies between patients and is difficult to predict. This study aimed to evaluate symptom evolution over a 5-year follow-up period and to identify baseline predictors for symptom severity and quality of life (QoL) at follow-up. METHODS: Maastricht IBS cohort participants completed questionnaires upon inclusion regarding demographics and lifestyle, gastrointestinal (GI) symptoms, anxiety and depression, and QoL. The same questionnaires, in addition to others, were completed after 5 years. Rome criteria were confirmed face-to-face at initial enrollment and through telephonic interviews at follow-up. KEY RESULTS: At a mean follow-up of 4.7 years, 379 patients were approached of whom 203 (53.7%) responded. Of these, 161 were reached by telephone and analyzed; 49 (30.4%) did not fulfill the Rome III criteria at follow-up and had lower levels of GI symptoms and GI-specific anxiety compared to those remaining Rome III-positive (P < 0.001). However, Rome III-negative patients had comparable levels of QoL and life satisfaction, comorbid anxiety and depression, work absenteeism, and impaired productivity. No baseline predictors were found for being Rome III-positive or Rome III-negative. However, greater age and lower baseline physical QoL predicted lower physical QoL at follow-up (P < 0.005 and P < 0.01, respectively), while lower baseline mental QoL predicted lower mental QoL at follow-up (P = 0.005). Additionally, higher anxiety and depression scores at follow-up were associated with lower QoL and life satisfaction at follow-up (P < 0.001). CONCLUSIONS AND INFERENCES: Long-term QoL and general well-being might depend on concurrent psychological symptoms, rather than GI symptom improvement.

Therapeutic strategies in gastroparesis: Results of stepwise approach with diet and prokinetics, Gastric Rest, and PEG-J: A retrospective analysis.

BACKGROUND: Gastroparesis is characterized by abnormal gastric motor function with delayed gastric emptying in the absence of mechanical obstruction. In our tertiary referral center, patients are treated with a stepwise approach, starting with dietary advice and prokinetics, followed by three months of nasoduodenal tube feeding with "gastric rest." When not successful, a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) for long-term enteral feeding is placed. AIM: To evaluate the effect of this stepwise approach on weight and symptoms. METHODS: Analyses of data of all referred gastroparesis patients between 2008 and 2016. KEY RESULTS: A total of 86 patients (71% female, 20-87 years [mean 55.8 years]) were analyzed of whom 50 (58%) had adequate symptom responses to diet and prokinetics. The remaining 36 (decompensated gastroparesis) were treated with three months gastric rest. Symptom response rate was 47% (17/36). Significant weight gain was seen in all patients, independent of symptom response. In the remaining 19 symptom non-responders, the enteral feeding was continued through PEG-J. Treatment was effective (symptoms) in 37%, with significant weight gain in all. In 84% of patients, the PEG-J is still in use (mean duration 962 days). CONCLUSIONS AND INFERENCES: Following a stepwise treatment approach in gastroparesis, adequate symptom response was reached in 86% of all patients. Weight gain was achieved in all patients, independent of symptom response. Diet and prokinetics were effective with regard to symptoms in 58%, temporary gastric rest in 47%, and PEG-J as third step in 37% of patients.

Development of a real-time patient-reported outcome measure for symptom assessment in patients with functional dyspepsia using the experience sampling method.

BACKGROUND: Patient-reported outcome measures (PROMs) are used to assess symptoms in patients with functional dyspepsia (FD). Current end-of-day questionnaires have several limitations including sensitivity to recall and ecological bias. The experience sampling method (ESM) is characterized by random and repeated assessments across momentary states in daily life and therefore less sensitive to these limitations. This study describes the development of a novel PROM based on ESM technology. METHODS: An initial draft of the PROM was developed based on literature. Focus group interviews with FD patients according to Rome IV criteria, and an expert meeting with international opinion leaders in the field of functional gastrointestinal disorders were conducted in order to select items for the PROM. Cognitive interviews were performed to evaluate patients' understanding of the selected items and to create the definitive PROM. KEY RESULTS: A systematic literature search revealed 59 items across four domains (ie, physical status; mood and psychological factors; context and environment; and nutrition, medication, and substance use). After patient focus group interviews and an international expert meeting, the number of items was reduced to 33. Cognitive interviews resulted in some minor linguistic changes in order to improve patients' understanding. CONCLUSIONS AND INFERENCES: A novel digital ESM-based PROM for real-time symptom assessment in patients with functional dyspepsia was developed. This novel PROM has the potential to identify individual symptom patterns and specific triggers for dyspeptic symptoms, and optimize treatment strategies.

The Experience Sampling Method-Evaluation of treatment effect of escitalopram in IBS with comorbid panic disorder.

BACKGROUND: Confirming treatment response in clinical trials for irritable bowel syndrome (IBS) is challenging, due to the lack of biomarkers and limitations of the currently available symptom assessment tools. The Experience Sampling Method (ESM) might overcome these limitations by collecting digital assessments randomly and repeatedly during daily life. This study evaluated differences in change in abdominal pain between real-time (ie, ESM) and retrospective (ie, Gastrointestinal Symptom Rating Scale [GSRS] and an end-of-day symptom diary) measurements, using data of an RCT on escitalopram vs placebo in patients with IBS and comorbid panic disorder. METHODS: Twenty-nine IBS patients with comorbid panic disorder were included in a 6-month RCT. The GSRS, diary, and ESM were completed at baseline (t = 0) and after 3 (t = 3) and 6 months (t = 6). Linear mixed models were used. KEY RESULTS: Experience Sampling Method analyses revealed a significant interaction between escitalopram and time, and ESM abdominal pain scores were 1.4 points lower in the escitalopram group compared to placebo at t = 6 (on a 1-to-7 scale; P = 0.021). When including the interaction with momentary anxiety, the reduction in abdominal pain scores in escitalopram vs placebo was even more pronounced for higher levels of anxiety. Average GSRS- and end-of-day abdominal pain scores were not significantly different between escitalopram and placebo at t = 3 and 6. CONCLUSIONS & INFERENCES: Real-time ESM has the potential to capture treatment response more sensitively compared to a retrospective end-of-day GI symptom diary and the GSRS, by taking into account day-to-day symptom variability as well as momentary factors that might moderate treatment effect, such as anxiety.

The development of a patient-reported outcome measure for real-time symptom assessment in a population with functional urologic complaints-A focus group study.

AIMS: In the current diagnostic process for overactive bladder syndrome (OAB), biased retrospective questionnaires are often used. There is a need for a new assessment tool that embraces the heterogeneity of the OAB complex. A momentary assessment tool, the Experience Sampling Method (ESM) is promising, capturing random repetitive measurements during the day in the context of daily life and is capable to measure potential contextual triggers and psychological aspects. A focus group study was set up to evaluate which items should be implemented in a urological ESM. METHODS: Focus group interviews were arranged, to assess the suitability and comprehensibility of a newly developed urological patient-reported outcome measurement (PROM), "Uromate." "Uromate" was created based on ESM literature. A multidisciplinary expert meeting was conducted to gain consensus on item relevance. RESULTS: The initial ESM questionnaire contained 58 items, but was eventually reduced to 39 items after focus group sessions and expert meeting. Thirty-seven items are repeated questions, including three gender-dependent items. Two items are one-time questions about the use of incontinence material. Additionally, a morning questionnaire was included. Depending on the symptom pattern, a minimum of 26 items and a maximum of 36 items will be repeatedly assessed with "Uromate." CONCLUSION: There is a need for a modern assessment tool for OAB which overcomes the limitations of today's retrospective questionnaires. Therefore, a urological ESM tool, the "Uromate," is being developed as a PROM, following the FDA PROM development guidelines, to measure real-time symptoms in the context of daily life.