Prevalence of non-coeliac gluten sensitivity and assessment of the response to gluten-free diet in a cohort of patients with fibromyalgia.

OBJECTIVES: To establish the prevalence of non-coeliac gluten sensitivity (NCGS) in a cohort of fibromyalgia patients and to evaluate their clinical response to a six-week gluten-free diet (GFD), the improvement in their symptoms, the percentage of diet responders who did not fulfil the diagnostic criteria for NCGS and the baseline characteristics that were associated with diet response and diagnostic criteria fulfilment. METHODS: Uncontrolled prospective experimental study in a cohort of patients with fibromyalgia from a specialized hospital unit. The percentage of patients that fulfilled the Salerno Experts' Criteria, that responded to GFD, that improved their symptomatology and baseline characteristics associated with GFD response and diagnostic criteria fulfilment was analysed. RESULTS: In total, 142 patients were selected and a NCGS prevalence of 5.6% was observed. A total of 21.8% responded to GFD due to their improvement in intestinal symptoms. In total, 74.2% of the responders did not fulfil the Salerno Experts' Criteria. The presence of diarrhoea and intraepithelial lymphocytosis and lower levels of anxiety were predictive factors of GFD response. No predictive factors of NCGS criteria fulfilment were found due to the low number of discriminators between gluten and placebo. CONCLUSIONS: A NCGS prevalence similar to that estimated in the general population was found. A GFD cannot be systematically recommended to all patients with fibromyalgia, although it could be evaluated in those with diarrhoea or intraepithelial lymphocytosis to evaluate if there are improvements in their intestinal symptoms.

Health-related quality of life decline in clinically stable inflammatory bowel disease patients during the COVID-19 outbreak.

BACKGROUND AND AIMS: Inflammatory bowel disease (IBD) affects many aspects of a patient's life and impairs their health-related quality of life (HRQoL). The COVID-19 outbreak has led to important mobility restrictions and a dramatic re-adjustment of social habits and health systems. This study aimed to assess the influence of the outbreak and mobility restrictions on the HRQoL of IBD patients with stable clinical remission on biologic treatment. Their self-perceived stress scores during the outbreak were also assessed. METHODS: A prospective, observational study was performed in IBD patients on biologic treatment with stable clinical remission. Patients with both Crohn's disease and Ulcerative Colitis patients were included. Patients filled in the IBDQ9 and the Perceived stress scale (PSS) electronically. To determine any changes, the results of the IBDQ9 during the outbreak were compared with the last IBDQ9 before the outbreak. RESULTS: 106 patients in clinical remission were included, with a median age of 42 year, 42% were female and 77% had CD. Median preCOVID-19 IBDQ9 was 72.1[66.5-80.12] and decreased to 69.2 [63.1-77.10] during the outbreak (p<0.001). The median PSS score was 12 [9-19]. There was a significant negative correlation between the PSS and the outbreak IBDQ9 (r=-0.66, p< 0.001). Regression analysis showed that the PSS score was associated with a lower IBDQ-9 during the outbreak(p<0.001) Conclusion: There was a negative impact of the COVID19 outbreak on the HRQoL of IBD patients in remission, with higher self-perceived stress scores associated with a lower QoL. The COVID-19 outbreak may have long-term implications for the HRQoL in these patients.

Severe and refractory gastrointestinal toxicity due to immune checkpoint inhibitors: clinical experience in a tertiary referral hospital.

INTRODUCTION: immune checkpoint inhibitors (ICI) are increasingly used to treat several types of cancer. These drugs lead to a wide range of toxicities. Immune-related gastrointestinal adverse events are common and potentially severe. In this manuscript, we recount the real clinical experience in a tertiary center. METHODS: a retrospective and observational study was conducted in adult patients under ICI treatment. Included patients had been referred to the Gastrointestinal Service of Hospital Universitario Vall d'Hebron for evaluation of severe toxicities, from January 2017 to January 2020, for whom the clinical, epidemiological and evolutive data were collected. RESULTS: a total of 18 patients were included. Fifty-five percent received anti-programmed cell death protein 1 (PD-1)/anti-programmed death-ligand 1 (anti PD-L1), 11 % received anti-cytotoxic T lymphocyte antigen 4 (CTLA-4) and 33 % received both treatments. The toxicities were manifested as enterocolitis, microscopic colitis and gastritis. Upper gastrointestinal endoscopy was performed in seven patients; all were proved to have histological changes on duodenum biopsies. Treatment was stopped in all patients and steroids were initiated. Sixty-six per cent achieved clinical remission with steroids. Five patients received anti-TNF treatment (infliximab). Only one of the five had responded. Two anti-TNF refractory patients received ustekinumab, with an appropriate clinical response. One patient received apheresis granulocyte as concomitant treatment. A patient with a steroid-dependent course started vedolizumab. Three patients had other immune-related adverse events. CONCLUSION: gastrointestinal immune-related adverse events are acquiring a higher profile in daily practice and gastroenterologists play an even greater role in the management of these patients.

Alterations in Gut Microbiome in Cirrhosis as Assessed by Quantitative Metagenomics: Relationship With Acute-on-Chronic Liver Failure and Prognosis.

BACKGROUND AND AIMS: Cirrhosis is associated with changes in gut microbiome composition. Although acute-on-chronic liver failure (ACLF) is the most severe clinical stage of cirrhosis, there is lack of information about gut microbiome alterations in ACLF using quantitative metagenomics. We investigated the gut microbiome in patients with cirrhosis encompassing the whole spectrum of disease (compensated, acutely decompensated without ACLF, and ACLF). A group of healthy subjects was used as control subjects. METHODS: Stool samples were collected prospectively in 182 patients with cirrhosis. DNA library construction and sequencing were performed using the Ion Proton Sequencer (ThermoFisher Scientific, Waltham, MA). Microbial genes were grouped into clusters, denoted as metagenomic species. RESULTS: Cirrhosis was associated with a remarkable reduction in gene and metagenomic species richness compared with healthy subjects. This loss of richness correlated with disease stages and was particularly marked in patients with ACLF and persisted after adjustment for antibiotic therapy. ACLF was associated with a significant increase of Enterococcus and Peptostreptococcus sp and a reduction of some autochthonous bacteria. Gut microbiome alterations correlated with model for end-stage liver disease and Child-Pugh scores and organ failure and was associated with some complications, particularly hepatic encephalopathy and infections. Interestingly, gut microbiome predicted 3-month survival with good stable predictors. Functional analysis showed that patients with cirrhosis had enriched pathways related to ethanol production, γ-aminobutyric acid metabolism, and endotoxin biosynthesis, among others. CONCLUSIONS: Cirrhosis is characterized by marked alterations in gut microbiome that parallel disease stages with maximal changes in ACLF. Altered gut microbiome was associated with complications of cirrhosis and survival. Gut microbiome may contribute to disease progression and poor prognosis. These results should be confirmed in future studies.

Adherence improvement in patients with ulcerative colitis: a multidisciplinary consensus document.

OBJECTIVES: a) to analyze the evidence available about poor adherence/non-adherence, including prevalences, associated factors, and interventions in ulcerative colitis (UC) patients; b) to provide a framework to improve poor adherence/non-adherence. METHODS: a qualitative approach was used. A literature review was performed using Medline. Primary searches were performed with Mesh and free texts to identify articles that analyzed prevalence, causes, associated factors, and interventions designed to improve poor adherence/non-adherence in UC patients. Study quality was evaluated using the Oxford scale. The results were presented and discussed in a nominal group meeting comprising a multidisciplinary committee of six gastroenterologists, one psychologist, one nurse, and one patient. Several overarching principles and recommendations were generated. A consensus procedure was implemented via a Delphi process, during which each committee member produced a score ranging from 0 = totally disagree to 10 = totally agree. Agreement was considered when at least 70 % of participants had voted ≥ 7. RESULTS: the literature review included 75 articles. Non-adherence rates ranged from 7 % to 72 %. We found a great variability in the methods employed to assess adherence, associated factors, and interventions designed to improve adherence. Overall, eight overarching principles and six recommendations were generated, all of them achieving the pre-established agreement level, including, among others, the identification, classification, and management of non-adherence. CONCLUSIONS: Poor adherence/non-adherence are common in UC patients, this being a relevant clinical concern. Health professionals should address this issue and actively involve their patients in implementing effective, individualized interventions to improve adherence.

Rapidity of clinical response to adalimumab and improvement of quality of life in luminal Crohn's disease: RAPIDA study.

OBJECTIVE: No studies evaluating the rapidity of response to biological therapies are available for Crohn's disease (CD). The aim of this study was to evaluate rapidity of onset of clinical response and impact on quality of life (QoL) of adalimumab therapy in adult anti-TNF-naïve patients with moderately-to-severely active CD. PATIENTS AND METHODS: RAPIDA was an open-label, single-arm, prospective, multicenter clinical trial. Adult patients with moderately-to-severely active luminal CD, anti-TNF-naïve, and unresponsive to conventional therapy were treated with adalimumab. Clinical disease activity, QoL and inflammatory biomarkers were measured at day 4, and weeks 1, 2, 4, and 12 after treatment initiation. RESULTS: Eighty-six patients were included in the intention-to-treat (ITT) analyses. Clinical disease activity was reduced from a median of 9.0 points to 6.0 points at day 4. Clinical response (≥ 3-point reduction in the Harvey-Bradshaw Index, HBI) was achieved by 61.6% (d4) and 75.6% (w1) of patients in the ITT population (median 2.5 days) and with non-responder imputation (NRI), by 55.8% and 53.4%, respectively. The proportion of patients in clinical remission (HBI<5) at weeks 2 and 4 in the ITT population was 54.7% and 62.8%, respectively (median 7.0 days), and 38.4% and 45.3% in the NRI population. All QoL scores significantly improved and inflammatory biomarkers significantly decreased from day 4 onwards (p<0.0001). CONCLUSION: Rapid clinical response and remission, improvement in QoL and fatigue, and a reduction of inflammatory biomarkers were achieved with adalimumab as early as day 4 in adult anti-TNF-naïve patients with moderately-to-severely active CD.

Normalization of long-term quality of life in Crohn's disease patients receiving ustekinumab.

BACKGROUND AND AIM: ustekinumab is a fully human monoclonal antibody against IL-12/23, approved for induction and maintenance treatment of Crohn's disease (CD). Real-life data shows its true effectiveness in terms of clinical and endoscopic response. However, there is little information regarding health-related quality of life (HRQoL) in CD patients receiving ustekinumab. The main aim of this study was to define long-term clinical remission and HRQoL normalization. The clinical predictive factors of clinical remission were investigated as a secondary aim. METHODS: a retrospective, observational study was performed in CD patients under ustekinumab treatment in the Hospital Vall d'Hebron, between January 2009 and January 2019. Clinical remission was defined using the Crohn's Disease Activity Index (CDAI) and HRQoL normalization was defined by the 36-item Inflammatory Bowel Disease Questionnaire (IBDQ). RESULTS: thirty-three patients were included. The average disease evolution was eleven years (standard deviation [SD]: 8), perianal disease was present in 13 patients (39 %), 30 patients (91 %) had previously been treated with alfa tumor necrosis factor antagonists (anti-TNF) agents and 22 patients (67 %) had a history of intestinal resection. Twenty-four patients (73 %) had undergone one year of treatment. Seventeen patients (51 %) reached clinical remission and six (18 %) restored the HRQoL. No predictors of clinical remission were identified. CONCLUSIONS: ustekinumab shows clinical effectiveness in real-life conditions similar to previous data. Normalization of HRQoL is low compared to clinical remission, which may be due to the inaccuracy of the indicator and the severe disease course. Such normalization is a challenge for physicians dealing with inflammatory bowel diseases.

Impact of the COVID-19 pandemic on the activity of advanced-practice nurses on a reference unit for inflammatory bowel disease.

OBJECTIVE: To report the impact of the COVID-19 pandemic on the activity of nurses working on an inflammatory bowel disease (IBD) unit and to identify reasons for telehealth care and its relationship to certain characteristics. BACKGROUND: The COVID-19 pandemic had led to an increase in demand for remote care in patients with inflammatory bowel disease who require monitoring and frequent access to health services. DESIGN - METHODS: A retrospective study of all activity (in person and by phone call or email) done on the unit during the acute phase of the pandemic at a reference hospital in Spain. Numbers of activities done by nurses, reasons for telehealth care and sociodemographic and clinical data were collected. Statistical analysis was performed using frequency, chi-squared and analysis of variance tests. RESULTS: A total of 1095 activities for 561 patients who received care were reported. Among them, 1042 (95.2%) were telemedicine activities, amounting to a 47.3% increase over the prior year. COVID-19-related activities numbered 588 (59.5%). Consultations due to disease flare-up numbered 134 (13.7%), representing a 145% increase compared to 2019. Significant differences were found between reasons for using telemedicine and diagnosis, occupational status, contact week and treatment. CONCLUSION: The acute phase of the pandemic has changed the activity managed by the nursing staff on the unit. Identifying and analysing these changes has yielded valuable information to achieve more efficient management and better care quality for patients in special situations.

Development and validation of the QUECOMIICAT questionnaire: a tool to assess disease-related knowledge in patients with inflammatory bowel disease.

INTRODUCTION: adequate knowledge of inflammatory bowel disease (IBD) is essential for a successful patient-centered management of IBD. OBJECTIVE: due to the scarcity of up-to-date tools for measuring IBD literacy, this single-center, prospective study aimed to develop and validate a new questionnaire to assess IBD-related knowledge. MATERIAL AND METHODS: the study included patients followed up at the Crohn-Colitis Care Unit (UACC) at the Hospital Vall d'Hebron (Barcelona, Spain). Patients admitted to the UACC for the first time were subsequently enrolled into a standard IBD educational program. A pilot questionnaire was developed and validated in 92 IBD patients by determining the internal consistency reliability (Cronbach's α test), feasibility, construct validity (correlation with the Crohn's and Colitis Knowledge [CCKNOW] questionnaire and a knowledge visual analog scale [VAS]) and sensitivity (score change before and after a standard IBD educational program). The questionnaire, named "Qüestionari Coneixements Malaltia Inflamatòria Intestinal Catalunya" (IBD-knowledge questionnaire Catalonia) (QUECOMIICAT) was written in Spanish and had 25 items addressing six dimensions: general concepts, clinic, treatment, surgery, habits and social context. RESULTS: the median (interquartile range) completion time was 15 (10-20) minutes and the floor and ceiling effects were 1.1% and 2.1%, respectively. The Cronbach's α coefficient was α = 0.75. QUECOMIICAT significantly correlated with the VAS (rho = 0.34, p < 0.01) and CCKNOW questionnaires (rho = 0.74, p < 0.01). Patient knowledge significantly increased 24 hours after attending a standard IBD educational program and remained statistically significant one month later (Pearson's test-retest correlation coefficient r = 0.81, p < 0.001). CONCLUSION: in conclusion, the QUECOMIICAT questionnaire is a new up-to-date tool to assess IBD-related knowledge with good feasibility and validation results for use in the routine clinical practice.

Consensus document on exclusion diets in irritable bowel syndrome (IBS).

This paper summarizes the contents of a consensus document on exclusion diets in irritable bowel disease that was developed by a task force from SEPD, FEAD, SENPE, FESNAD, SEÑ, SEEN, SEGHNP, SEDCA and ADENYD. The complete document is available at the SEPD website. Irritable bowel syndrome is a highly prevalent functional digestive disorder where, in addition to drugs, therapy includes diet and acquisition of healthy habits as basic elements for its control. In order to facilitate dietary counseling for these patients in daily practice, the present consensus document on the role of exclusion diets was developed. To this end, consensus opinions were collected from various experts in the national scientific societies aiming at establishing recommendations applicable to the health care of patients with irritable bowel syndrome.

Recommendations of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) and the Association of Crohn's Disease and Ulcerative Colitis Patients (ACCU) in the management of psychological problems in Inflammatory Bowel Disease patients. / Recomendaciones del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) y de la Confederación de Asociaciones de Enfermedad de Crohn y Colitis Ulcerosa (ACCU) para el manejo de los aspectos psicológicos en la enfermedad inflamatoria intestinal.

AIMS: To establish recommendations for the management of psychological problems affecting patients with inflammatory bowel disease (IBD). METHODS: A meeting of a group of IBD experts made up of doctors, psychologists, nurses and patient representatives was held. The following were presented: 1) Results of a previous focal group, 2) Results of doctor and patient surveys, 3) Results of a systematic review of tools for detecting anxiety and depression. A guided discussion was then held about the most important psychological and emotional problems associated with IBD, appropriate referral criteria and situations to be avoided. The validated instrument most applicable to clinical practice was selected. A recommendations document and a Delphi survey were designed. The survey was sent to the group and to a scientific committee of the GETECCU group in order to establish the level of agreement with these recommendations. RESULTS: Fifteen recommendations were established linked to 3 key processes: 1) What steps should be taken to identify psychological problems at an IBD appointment; 2) What are the criteria for referring patients to a mental health specialist; 3) How to approach psychological problems. CONCLUSIONS: Resources should be made available to healthcare professionals so that they can treat these problems during consultations, identify the disorders which could affect the clinical course of the disease and determine their impact on the patient's life in order that these can be treated and followed up by the most suitable professional. These recommendations could serve as a basis for redesigning IBD services or processes and as justification for the training of healthcare personnel.

A microbial signature for Crohn's disease.

OBJECTIVE: A decade of microbiome studies has linked IBD to an alteration in the gut microbial community of genetically predisposed subjects. However, existing profiles of gut microbiome dysbiosis in adult IBD patients are inconsistent among published studies, and did not allow the identification of microbial signatures for CD and UC. Here, we aimed to compare the faecal microbiome of CD with patients having UC and with non-IBD subjects in a longitudinal study. DESIGN: We analysed a cohort of 2045 non-IBD and IBD faecal samples from four countries (Spain, Belgium, the UK and Germany), applied a 16S rRNA sequencing approach and analysed a total dataset of 115 million sequences. RESULTS: In the Spanish cohort, dysbiosis was found significantly greater in patients with CD than with UC, as shown by a more reduced diversity, a less stable microbial community and eight microbial groups were proposed as a specific microbial signature for CD. Tested against the whole cohort, the signature achieved an overall sensitivity of 80% and a specificity of 94%, 94%, 89% and 91% for the detection of CD versus healthy controls, patients with anorexia, IBS and UC, respectively. CONCLUSIONS: Although UC and CD share many epidemiologic, immunologic, therapeutic and clinical features, our results showed that they are two distinct subtypes of IBD at the microbiome level. For the first time, we are proposing microbiomarkers to discriminate between CD and non-CD independently of geographical regions.

Enterotypes of the human gut microbiome.

Our knowledge of species and functional composition of the human gut microbiome is rapidly increasing, but it is still based on very few cohorts and little is known about variation across the world. By combining 22 newly sequenced faecal metagenomes of individuals from four countries with previously published data sets, here we identify three robust clusters (referred to as enterotypes hereafter) that are not nation or continent specific. We also confirmed the enterotypes in two published, larger cohorts, indicating that intestinal microbiota variation is generally stratified, not continuous. This indicates further the existence of a limited number of well-balanced host-microbial symbiotic states that might respond differently to diet and drug intake. The enterotypes are mostly driven by species composition, but abundant molecular functions are not necessarily provided by abundant species, highlighting the importance of a functional analysis to understand microbial communities. Although individual host properties such as body mass index, age, or gender cannot explain the observed enterotypes, data-driven marker genes or functional modules can be identified for each of these host properties. For example, twelve genes significantly correlate with age and three functional modules with the body mass index, hinting at a diagnostic potential of microbial markers.

Health-related quality of life and determinant factors in celiac disease. A population-based analysis of adult patients in Spain.

BACKGROUND: Celiac disease (CD) has a negative impact on the health-related quality of life (HRQL) of affected patients. Although HRQL and its determinants have been examined in Spanish CD patients specifically recruited in hospital settings, these aspects of CD have not been assessed among the general Spanish population. METHODS: An observational, transversal study of a non-randomized, representative sample of adult celiac patients throughout all of Spain's Autonomous Regions. Subjects were recruited through celiac patient associations. A Spanish version of the self-administered Celiac Disease-Quality of Life (CD-QOL) questionnaire was used. Determinant factors of HRQL were assessed with the aid of multivariate analysis to control for confounding factors. RESULTS: We analyzed the responses provided by 1,230 patients, 1,092 (89.2%) of whom were women. The overall mean value for the CD-QOL index was 56.3 ± 18.27 points. The dimension that obtained the most points was dysphoria, with 81.3 ± 19.56 points, followed by limitations with 52.3 ± 23.43 points; health problems, with 51.6 ± 26.08 points, and inadequate treatment, with 36.1 ± 21.18 points. Patient age and sex, along with time to diagnosis, and length of time on a gluten-free diet were all independent determinant factors of certain dimensions of HRQL: women aged 31 to 40 expressed poorer HRQL while time to diagnosis and length of time on a gluten-free diet were determinant factors for better HRQL scores. CONCLUSIONS: The HRQL of adult Spanish celiac subjects is moderate, improving with the length of time patients remain on a gluten-free diet.

[Efficacy and effectiveness of biologic therapy in inflammatory bowel disease. EFIFECT study]. / Eficacia y efectividad de la terapia biológica en la Enfermedad Inflamatoria Intestinal. Estudio EFIFECT.

INTRODUCTION: Randomized controlled trials provide the best scientific evidence for the efficacy of biological drugs in inflammatory bowel disease (IBD). However, findings obtained from these trials might not be reproducible in clinical practice. This study aimed to estimate the percentage of patients with IBD treated with biologics who would have been eligible for randomized controlled trials, and to compare the theoretical efficacy of biological drugs with their effectiveness in clinical practice. METHODS: We performed a retrospective multicenter study in 375 patients with IBD treated with anti-TNF agents and followed-up for 1 year. The eligibility criteria for the trial were taken from the ACCENT, SONIC, ACT, CLASSIC and CHARM trials. Eligible patients were included in a second analysis to compare results in clinical practice versus those hypothetically obtained if the patient had been included in a trial. RESULTS: Only 45.6% of 375 patients would have been eligible for pivotal trials. One-year clinical benefit (remission or response) was similar for eligible and non-eligible cohorts (68.4% vs. 68.6%, P=.608). The clinical benefit was greater for current clinical practice than for a hypothetical trial situation (68.4% vs. 44.4%, P<.001) in eligible patients. CONCLUSION: More than half of patients with IBD treated with biologic drugs would not be represented in pivotal trials. The effectiveness of anti-TNF drugs in clinical practice exceeds their theoretical efficacy.

Predictive value of early restoration of quality of life in Crohn's disease patients receiving antitumor necrosis factor agents.

BACKGROUND AND AIM: Crohn's disease (CD) impairs patients' health-related quality of life (HRQoL), therefore a goal of treatment is to improve their health. Recently, a more ambitious therapeutic target has been proposed, to reestablish patients' HRQoL to normal standards. There is no information on long-term prognostic value of restoring the health of patients with CD. Our aim was to determine if early restoration of HRQoL with antitumor necrosis factor (anti-TNF) agents is associated with long-term clinical remission. METHODS: Retrospective longitudinal study in patients with active CD treated with anti-TNF agents. Patients completed the Inflammatory Bowel Disease Questionnaire (IBDQ)-36 at baseline and weeks 2, 6, 14, 28, and 52. Early restoration of health was defined as an IBDQ-36 score > 209 at week 14, and long-term clinical remission as a Cohn's disease activity index (CDAI) score < 150 maintained through week 52. RESULTS: Ninety-four patients were included. Sixty-three patients maintained long-term remission, with 47 (75%) of them achieving early restoration of HRQoL. Of the 31 patients who did not maintain long-term remission, only 4 (13%) restored their HRQoL early (P < 0.01). There was a strong negative correlation between the IBDQ-36 at week 14 and CDAI values at week 52 (rs = - 0.64, P < 0.01). Ninety-two percent of patients with early restoration of HRQoL maintained long-term remission versus 37% who did not restore their HRQoL (P < 0.01). To predict long-term remission, the cutoff point of 209 of the early IBDQ-36 had an area under the receiver operating characteristic (AUROC) curve of 0.87. CONCLUSION: Achieving early restoration of HRQoL with anti-TNF agents is associated with sustained long-term remission. This could be a therapeutic goal of treatment in clinical trials and daily practice.

The management of lactose intolerance among primary care physicians and its correlation with management by gastroenterologists: the SEPD-SEMG national survey.

INTRODUCTION AND AIMS: The understanding of lactose intolerance (LI) is limited in some professional settings. Sociedad Española de Patología Digestiva (SEPD) and Sociedad Española de Medicina General (SEMG) have developed a survey in order to: a) Analyze primary care physicians (PCPs) knowledge and clinical management; and b) to compare results with those of a previous survey of Spanish gastroenterologists (GEs). MATERIAL AND METHODS: An online questionnaire was sent to SEMG members with 27 items on various issues: Demographics, occupational characteristics, outlook on LI, diagnostic tests, treatment, and follow-up. Results were compared to those from a survey of GEs. RESULTS: A total of 456 PCPs responded, versus 477 GEs. PCPs had an older mean age and longer professional experience. Level of understanding of LI was similar, albeit a higher proportion of PCPs lacked epidemiological awareness (p < 0.01). GEs tended to consider LI a "minor" condition (71.3 vs. 40.1%; p > 0.001), and LI symptoms as overlapping those of irritable bowel syndrome (93.5 vs. 88.2%; p = 0.005), although symptoms perceived as suspicious of LI were similar in both groups. Dietary recommendations were recognized as the primary therapeutic approach. CONCLUSION: This study reveals the outlook of PCPs on LI, and allows comparison with that of GEs, as a basis for the development of strategies aimed at improving LI understanding, approach and management in our setting.

Treatment preferences of patients with Crohn's disease: Development of the IMPLICA questionnaire.

INTRODUCTION AND OBJECTIVE: Patient preferences with respect to available therapies must be taken into account if the quality of care of patients with Crohn´s disease is to be improved. The objective was to develop the IMPLICA preferences questionnaire for Crohn´s disease patients treated with biological therapies. METHODS: As per standard methodology, the questionnaire was developed in Spanish language, in five stages: 1. Literature review to identify attributes related to biological therapies in Crohn´s disease; 2. Expert meeting to identify attributes most relevant for patients; 3. Scoring of the most relevant attributes and generation of scenarios; 4. Patient comprehension test for selection and validation of scenarios; and 5. Final list of scenarios and qualitative evaluation of those most accepted by patients. RESULTS: Three attributes related to various characteristics of biological treatments were selected: route of administration, place/duration of administration and person administering the treatment; a combination of them produced seven possible scenarios. The comprehension test gave rise to significant modifications in the instructions, text of the scenarios and response categories. CONCLUSION: IMPLICA is the first questionnaire to evaluate treatment preferences of Crohn´s disease patients receiving biological therapies. This questionnaire facilitates patient´s selection of the most appropriate real world treatment option and, therefore, it can be considered a useful tool when deciding the most appropriate and feasible treatment in normal clinical practice.

Inflammatory bowel disease patient's satisfaction with healthcare services received. Physicians' and nurses' perceptions.

BACKGROUND: patient satisfaction with healthcare services provided for inflammatory bowel diseases (IBD) is essential due to high resources use. OBJECTIVES: the study aimed to describe patient satisfaction with healthcare services using the CACHE questionnaire and to assess gastroenterologist and nurse perception on patients' satisfaction. METHODS: observational multicentric prospective study in 35 Spanish hospitals. Patients included had Crohn's disease or ulcerative colitis. The study was approved by the Hospital Universitari Vall d'Hebron Ethics Committee. Scheduled study visits: baseline (patient sociodemographics and clinical data were collected), 2-4 and 6-months. Patient satisfaction with healthcare was assessed by CACHE questionnaire at each visit; it scores from 0-least satisfaction to 100-highest satisfaction.Gastroenterologists and nurses answered once an adapted questionnaire. RESULTS: participating 290 patients (54.2 % males, 41.3 years old), 62 gastroenterologists and 47 nurses. At baseline mean (SD) CACHE score was 81.7 (10.9); satisfaction with clinician care was the highest, patient information the lowest. Scores did not change across study. Gastroenterologist global score was 72.5 (9.8); Staff Care satisfaction was the highest, patient information the lowest. All scores were significantly lower than patients'. Nurses' global score was 82.2 (8.5), clinician care satisfaction was the highest, centre facilities the lowest. Scores on satisfaction with clinician care, centre facilities, and patient information scored statistically lower than patients'. No relationship was found between patients' satisfaction and patients characteristics. conclusions: IBD patients are satisfied with healthcare services provided, even though the information may be improved. Nurses' perception is similar to that of patients, physicians have a lower perception.

Impact of orocecal transit time on patient´s perception of lactose intolerance.

BACKGROUND: symptoms attributed to the lactose intolerance are an important public health issue because of their prevalence and social relevance. Also because they may cause undue rejection of dairy products consume with potential health consequences. Transit time is a putative factor implied in the severity of symptoms associated with lactose. OBJECTIVES: to elucidate the relation between orocecal transit time (OCTT) and lactose intolerance symptoms. METHODS: observational study in patients referred to a lactose hydrogen breath test who showed an increase in breath H2 excretion higher than 25 ppm. OCTT was measured with the breath test and symptoms of lactose tolerance with a validated scale. Symptoms were measured twice: before receiving the lactose, inquiring about self perceived symptoms when patients consumed dairy products at home ("home symptoms"), and again after completing the lactose breath test ("test symptoms"). RESULTS: 161 patients were included. There was no correlation between OCTT and home symptoms (r = -0.1). When OCTT was faster than 60 minutes, intensity of "test symptoms" was similar to "home symptoms". However, in patients with normal or slow OCTT, the "home symptoms" were more intense than the "test symptoms" (p < 0.05). At home, symptoms were independent of OCTT but with the lactose test load the symptoms were proportionately more intense with faster OCTT. CONCLUSIONS: in lactose maldigesters, selfreported symptoms of lactose intolerance are more pronounced at home than after a high lactose challenge. Intolerance symptoms that patients attributed to lactose consume at home are due to factors other than fast OCTT.