Strategic analysis and recommendations of the Sociedad Española de Patología Digestiva (SEPD) regarding population-based screening programs for colorectal cancer in Spain.

INTRODUCTION: population-based screening programs are effective to reduce colorectal cancer-related mortality and incidence. However, given their complex development, sound organization and design do not warrant success. This study provides a strategic analysis of the Spanish programs, as well as recommendations in an attempt to contribute to their optimization. METHODS: a multidisciplinary panel of researchers, supported by the Sociedad Española de Patología Digestiva (SEPD), has performed a SWOT (strengths, weaknesses, opportunities and threats) analysis, from which a proposal of recommendations was developed; their adequacy was judged using an adapted version of the RAND/UCLA method. RESULTS: 5 weaknesses, 3 threats, 5 strengths and 5 opportunities were identified, and a total of 15 recommendations were developed emphasizing aspects with room for improvement in program orientation, particularly the need to increase participation, fight variability and inequities, improve information processes and systems quality, ensure specific, adequate funding, and evaluate health results. CONCLUSION: promoting an operational collaboration framework between all the public health and care levels involved should facilitate effective communication with society regarding the benefits of taking part in population screening programs while persuading decision and policy makers of the critical importance of taking an active, determined stance regarding its implementation.

Activity of Spanish gastroenterology units before and after the COVID-19 pandemic: an assessment using the EFIC_AD tool, developed by the Sociedad Española de Patología Digestiva (SEPD).

INTRODUCTION: the COVID-19 pandemic had a strong impact on the healthcare model. The Sociedad Española de Patología Digestiva (SEPD) offered gastroenterology care units (UAAD) an instrument (EFIC_AD) to record and analyze their efficacy and efficiency. Thus, the impact of the pandemic on the activity of UAAD was assessed. METHODS: A descriptive study, based on the EFIC_AD registry for the period 2019-2021, of activity regarding admissions, clinic visits, and endoscopic as well as non-endoscopic tests, and endoscopy room performance. RESULTS: data were collected from up to 42 hospitals (22 with ≥ 500 beds). Overall, activity during 2020 compared to 2019 decreased by 12.30 % for admissions and 40 % for pH-metries (16.70 % for new clinic visits; 14.34 % for referrals from primary care; 24.70 % for gastroscopies; 32.50 % for colonoscopies; 31.00 % for endoscopic ultrasounds; 18.20 % for endoscopic retrograde cholangiopancreatography (ERCPs); 38.00 % for manometries; 23.60 % for abdominal ultrasounds; 36.17 % for liver transient elastographies [Fibroscan®]). The levels achieved during 2019 were not fully recovered during 2021 except for digestive motility studies, and virtually for endoscopy room performance rate (88.15 % in 2019; 67.77 % in 2020; 85.93 % in 2021). CONCLUSIONS: during 2020 the COVID-19 pandemic led to a markedly decreased in specific activities at UAAD, which was not fully recovered in 2021 despite endoscopy room performance return to normal.

Consensus document of the Spanish Society of Digestives Diseases and the Spanish Society of Thrombosis and Haemostasis on massive nonvariceal gastrointestinal bleeding and direct-acting oral anticoagulants.

INTRODUCTION: there is limited experience and understanding of massive nonvariceal gastrointestinal bleeding during therapy with direct-acting oral anticoagulants. OBJECTIVES: to provide evidenced-based definitions and recommendations. METHODS: a consensus document developed by the Spanish Society of Digestives Diseases and the Spanish Society of Thrombosis and Haemostasis using modified Delphi methodology. A panel was set up of 24 gastroenterologists with experience in gastrointestinal bleeding, and consensus building was assessed over three rounds. Final recommendations are based on a systematic review of the literature using the GRADE system. RESULTS: panelist agreement was 91.53 % for all 30 items as a group, a percentage that was improved during rounds 2 and 3 for items where clinical experience is lower. Explicit disagreement was only 1.25 %. A definition of massive nonvariceal gastrointestinal bleeding in patients on direct-acting oral anticoagulants was established, and recommendations to optimize this condition's management were developed. CONCLUSION: the approach to these critically ill patients must be multidisciplinary and protocolized, optimizing decisions for an early identification of the condition and patient stabilization according to the tenets of damage control resuscitation. Thus, consideration must be given to immediate anticoagulation reversal, preferentially with specific antidotes (idarucizumab for dabigatran and andexanet alfa for direct factor Xa inhibitors); hemostatic resuscitation, and bleeding point identification and management.

RECALAD. Patient care at National Health System Digestive Care Units - A pilot study, 2015.

OBJECTIVES: To reach a situation diagnosis on the status of patient management at digestive care units (DCUs) in Spain. MATERIAL AND METHODS: A cross-sectional descriptive study across DCUs in general acute care hospitals within the Spanish National Health System (data referred to 2015). The study variables were collected with a questionnaire including items on structure, services portfolio, activity, education, research, and good practice. Hospital discharge rates for digestive diseases were also assessed using the minimum basic data set (2005-2014). RESULTS: Two hundred and nine hospitals invited, 55 responders (26.3%). Average discharges from hospital were 1,139 ± 653 per DCU/year, and 100 ± 66 per year per dedicated gastroenterologist. In 2014, admission rate to DCUs per 1,000 population and year was 280, with a mean stay of 7.4 days. The analysis of the MBDS for 2005-2014 reveals a progressive increase in the number of discharges (37% more in 2014 versus 2005), with a 28% decrease in hospital gross mortality rate (3.7% in 2014) and a slightly reduced (14%) mean stay (7.6 days in 2014). Considerable variability may be seen in structure, activity, and results indicators. Mortality and readmission rates, as well as mean stay, vary more than 100% amongst DCUs, and major dispersions also exist in frequentation and results amongst autonomous communities. CONCLUSIONS: The RECALAD 2015 survey unveiled relevant aspects related to DCUs organization, structure, and management. The notable variability encountered likely reflects relevant differences in efficiency and productivity, and thus points out there is ample room for improvement.

Incidence of advanced neoplasia during surveillance in high- and intermediate-risk groups of the European colorectal cancer screening guidelines.

Background and study aims: The European guidelines for quality assurance in colorectal cancer (CRC) screening have established high-risk (≥ 5 adenomas or an adenoma ≥ 20 mm) and intermediate-risk (3 - 4 adenomas or at least one adenoma 10 - 19 mm in size, or villous histology, or high grade dysplasia) groups with different endoscopic surveillance intervals. The aim of this study was to evaluate the difference in the incidence of advanced neoplasia (advanced adenoma or CRC) between the two risk groups. Patients and methods: This retrospective group study included patients meeting high- or intermediate-risk criteria for adenomas detected in CRC screening programs and the COLONPREV study before European guidelines were adopted in Spain (June 2011) with a 3-year surveillance recommendation according to Spanish guidelines. The primary outcome measure was the incidence of advanced neoplasia in patients undergoing surveillance. The secondary outcome measure was the CRC incidence. We used an adjusted proportional hazards regression model to control confounding variables. Results: The study included 5401 patients (3379 intermediate risk, 2022 high risk). Endoscopic surveillance was performed in 65.5 % of the patients (2.8 ±â€Š1 years). The incidence of advanced neoplasia in the high- and intermediate-risk groups was 16.0 % (59.0 cases/1000 patient-years) and 12.3 % (41.2 cases/1000 patient-years), respectively. The CRC incidence was 0.5 % (1.4 cases/1000 patient-years) and 0.4 % (1 case/1000 patient-years), respectively. The advanced neoplasia and CRC attributable risk to the high risk group was of 3.7 % and 0.1 %, respectively. In the proportional hazards analysis, the risk of advanced neoplasia was greater in the high-risk group (hazard ratio [HR] 1.5, 95 % confidence interval [CI] 1.2 - 1.8), with no significant differences in the CRC incidence (HR 1.6, 95 %CI 0.6 - 3.8). Conclusions: Patients meeting high-risk criteria have a higher incidence of advanced neoplasia during endoscopic surveillance. No differences were found in the CRC incidence at a 3-year surveillance recommendation.

Killer immunoglobulin-like receptor repertoire analysis in a Caucasian Spanish cohort with inflammatory bowel disease.

Immunological molecules are implicated in inflammatory disorders, including inflammatory bowel disease (IBD; Crohn disease [CD] and ulcerative colitis [UC]). Killer cell immunoglobulin-like receptors (KIRs) are also genetically variable proteins involved in immune function. They are expressed by NK cells and certain T lymphocytes, regulate specificity and function by interaction with HLA Class I molecules, may be either inhibitory or activating and are polymorphic both in terms of alleles and haplotype gene content. Genetic associations between activating KIRs and certain autoimmune and inflammatory diseases have been reported; however, a possible association between KIR and IBD remains unclear. The aim of this study was to determine the relationship between KIR repertoire and IBD pathologies in a Spanish cohort. KIR variability was analyzed using PCR-sequence specific oligonucleotide probes (SSOP). Inhibitory KIR2DL5 was found more frequently in UC and IBD patient groups than in healthy controls (P = 0.028 and P = 0.01, respectively), as was activating KIR2DS1 (P = 0.02, Pc > 0.05, UC vs. Controls; P = 0.001, Pc = 0.01, IBD vs Controls; P = 0.01, Pc > 0.05, Controls vs CR), KIR2DS5 (P = 0.0028, Pc = 0.04, Controls vs UC; P = 0.0001, Pc = 0.0017, Controls vs IBD; P = 0.01, Pc > 0.05, Controls vs CD) and KIR3DS1 (P = 0.012, Pc > 0.05, Controls vs IBD). Our data suggest that imbalance between activating and inhibitory KIR may partially explain the different pathogeneses of these IBDs and that there is a hypothetical role for the telomeric B region (which contains both KIR2DS5 and KIR2DS1) in these diseases.

Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening.

BACKGROUND: Colonoscopy and fecal immunochemical testing (FIT) are accepted strategies for colorectal-cancer screening in the average-risk population. METHODS: In this randomized, controlled trial involving asymptomatic adults 50 to 69 years of age, we compared one-time colonoscopy in 26,703 subjects with FIT every 2 years in 26,599 subjects. The primary outcome was the rate of death from colorectal cancer at 10 years. This interim report describes rates of participation, diagnostic findings, and occurrence of major complications at completion of the baseline screening. Study outcomes were analyzed in both intention-to-screen and as-screened populations. RESULTS: The rate of participation was higher in the FIT group than in the colonoscopy group (34.2% vs. 24.6%, P<0.001). Colorectal cancer was found in 30 subjects (0.1%) in the colonoscopy group and 33 subjects (0.1%) in the FIT group (odds ratio, 0.99; 95% confidence interval [CI], 0.61 to 1.64; P=0.99). Advanced adenomas were detected in 514 subjects (1.9%) in the colonoscopy group and 231 subjects (0.9%) in the FIT group (odds ratio, 2.30; 95% CI, 1.97 to 2.69; P<0.001), and nonadvanced adenomas were detected in 1109 subjects (4.2%) in the colonoscopy group and 119 subjects (0.4%) in the FIT group (odds ratio, 9.80; 95% CI, 8.10 to 11.85; P<0.001). CONCLUSIONS: Subjects in the FIT group were more likely to participate in screening than were those in the colonoscopy group. On the baseline screening examination, the numbers of subjects in whom colorectal cancer was detected were similar in the two study groups, but more adenomas were identified in the colonoscopy group. (Funded by Instituto de Salud Carlos III and others; ClinicalTrials.gov number, NCT00906997.).

A randomized trial to compare the efficacy and tolerability of sodium picosulfate-magnesium citrate solution vs. 4 L polyethylene glycol solution as a bowel preparation for colonoscopy.

PURPOSE: The purpose of this study is to compare the efficacy and acceptability of an evening-before regimens of sodium picosulfate/magnesium citrate (SPMC) and polyethylene glycol (PEG) as bowel cleansers and to explore the results of a same-day regimen of SPMC. METHODS: Multicenter, randomized, observer-blinded, parallel study carried out in subjects who were 18-80 years old and were undergoing diagnostic colonoscopy for the first time. The primary outcome was treatment success, which was a composite outcome defined by (1) the evaluation of the overall preparation quality as "excellent" or "good" by two blinded independent evaluators with the Fleet(®) Grading Scale for Bowel Cleansing and (2) a subject's acceptability rating of "easy to take" or "tolerable." The primary outcome was analyzed using a logistic regression with site, gender, and age group (age ≥65 years and <65 years) as factors. RESULTS: Four hundred ninety subjects were included in the efficacy evaluation. Although treatment success was significantly higher in subjects assigned to the evening-before regimen of SPMC vs. subjects assigned to the evening-before PEG, when evaluating the two individual components for treatment success, there were significant differences in the ease of completion but not in the quality of preparation. The same-day SPMC regimen was superior to both the evening-before regimen of SPMC and PEG in terms of the quality of preparation, especially regarding the proximal colon. CONCLUSIONS: An evening-before regimen of SPMC is superior to an evening-before regimen of PEG in terms of subject's acceptability. The same-day SPMC regimen provides better cleansing levels in the proximal colon.

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.

Rate of detection of advanced neoplasms in proximal colon by simulated sigmoidoscopy vs fecal immunochemical tests.

BACKGROUND & AIMS: We compared the ability of biennial fecal immunochemical testing (FIT) and one-time sigmoidoscopy to detect colon side-specific advanced neoplasms in a population-based, multicenter, nationwide, randomized controlled trial. METHODS: We identified asymptomatic men and women, 50-69 years old, through community health registries and randomly assigned them to groups that received a single colonoscopy examination or biennial FIT. Sigmoidoscopy yield was simulated from results obtained from the colonoscopy group, according to the criteria proposed in the UK Flexible Sigmoidoscopy Trial for colonoscopy referral. Patients who underwent FIT and were found to have ≥75 ng hemoglobin/mL were referred for colonoscopy. Data were analyzed from 5059 subjects in the colonoscopy group and 10,507 in the FIT group. The main outcome was rate of detection of any advanced neoplasm proximal to the splenic flexure. RESULTS: Advanced neoplasms were detected in 317 subjects (6.3%) in the sigmoidoscopy simulation group compared with 288 (2.7%) in the FIT group (odds ratio for sigmoidoscopy, 2.29; 95% confidence interval, 1.93-2.70; P = .0001). Sigmoidoscopy also detected advanced distal neoplasia in a higher percentage of patients than FIT (odds ratio, 2.61; 95% confidence interval, 2.20-3.10; P = .0001). The methods did not differ significantly in identifying patients with advanced proximal neoplasms (odds ratio, 1.17; 95% confidence interval, 0.78-1.76; P = .44). This was probably due to the lower performance of both strategies in detecting patients with proximal lesions (sigmoidoscopy detected these in 19.1% of patients and FIT in 14.9% of patients) vs distal ones (sigmoidoscopy detected these in 86.8% of patients and FIT in 33.5% of patients). Sigmoidoscopy, but not FIT, detected proximal lesions in lower percentages of women (especially those 50-59 years old) than men. CONCLUSIONS: Sigmoidoscopy and FIT have similar limitations in detecting advanced proximal neoplasms, which depend on patients' characteristics; sigmoidoscopy underperforms for women 50-59 years old. Screening strategies should be designed on the basis of target population to increase effectiveness and cost-effectiveness. ClinicalTrials.gov number: NCT00906997.

Participation and detection rates by age and sex for colonoscopy versus fecal immunochemical testing in colorectal cancer screening.

PURPOSE: To compare two strategies for colorectal cancer screening: one-time colonoscopy versus fecal immunochemical testing (FIT) (and colonoscopy for positive) every 2 years, in order to determine which strategy provides the highest participation and detection rates in groups of sex and age. METHODS: This analysis was performed with data from the first screening round within the COLONPREV study, a population-based, multicenter, nationwide trial carried out in Spain. Several logistic regression models were applied to identify the influence of the screening test on participation rates and detection of proximal and distal neoplasms, as well to identify the influence of age and sex: women aged 50-59 years, women aged 60-69 years, men aged 50-59 years, and men aged 60-69 years. RESULTS: Participation was higher in women than in men, especially among women aged 50-59 years (25.91 % for colonoscopy and 35.81 % for FIT). Crossover from colonoscopy to FIT was higher among women than men, especially among those aged 60-69 years (30.37 %). In general, detection of any neoplasm and advanced adenoma was higher with colonoscopy than with FIT, but no significant differences were found between the two strategies for colorectal cancer detection. Detection of advanced adenoma in both arms was lower in women [specifically in women aged 50-59 years (OR 0.31; 95 % CI 0.25-0.38) than in men aged 60-69 years]. Women aged 50-59 years in the colonoscopy arm had a higher probability of detection of advanced adenoma (OR 4.49; 95 % CI 3.18-6.35), as well as of detection of neoplasms in proximal and distal locations (proximal OR 19.34; 95 % CI 12.07-31.00; distal OR 11.04; 95 % CI 8.13-15.01) than women of the same age in the FIT arm. These differences were also observed in the remaining groups but to a lesser extent. CONCLUSION: Women were more likely to participate in a FIT-based strategy, especially those aged 50-59 years. The likelihood of detection of any neoplasm was higher in the colonoscopy arm for all the population groups studied, especially in women aged 50-59 years. Distinct population groups should be informed of the benefits of each screening strategy so that they may take informed decisions.

Relationship of colonoscopy-detected serrated polyps with synchronous advanced neoplasia in average-risk individuals.

BACKGROUND: Serrated cancers account for 10% to 20% of all colorectal cancers (CRC) and more than 30% of interval cancers. The presence of proximal serrated polyps and large (≥10 mm) serrated polyps (LSP) has been correlated with colorectal neoplasia. OBJECTIVE: To evaluate the prevalence of serrated polyps and their association with synchronous advanced neoplasia in a cohort of average-risk population and to assess the efficacy of one-time colonoscopy and a biennial fecal immunochemical test for reducing CRC-related mortality. This study focused on the sample of 5059 individuals belonging to the colonoscopy arm. DESIGN: Multicenter, randomized, controlled trial. SETTING: The ColonPrev study, a population-based, multicenter, nationwide, randomized, controlled trial. PATIENTS: A total of 5059 asymptomatic men and women aged 50 to 69 years. INTERVENTION: Colonoscopy. MAIN OUTCOME MEASUREMENTS: Prevalence of serrated polyps and their association with synchronous advanced neoplasia. RESULTS: Advanced neoplasia was detected in 520 individuals (10.3%) (CRC was detected in 27 [0.5%] and advanced adenomas in 493 [9.7%]). Serrated polyps were found in 1054 individuals (20.8%). A total of 329 individuals (6.5%) had proximal serrated polyps, and 90 (1.8%) had LSPs. Proximal serrated polyps or LSPs were associated with male sex (odds ratio [OR] 2.08, 95% confidence interval [CI], 1.76-4.45 and OR 1.65, 95% CI, 1.31-2.07, respectively). Also, LSPs were associated with advanced neoplasia (OR 2.49, 95% CI, 1.47-4.198), regardless of their proximal (OR 4.15, 95% CI, 1.69-10.15) or distal (OR 2.61, 95% CI, 1.48-4.58) locations. When we analyzed subtypes of serrated polyps, proximal hyperplasic polyps were related to advanced neoplasia (OR 1.61, 95% CI, 1.13-2.28), although no correlation with the location of the advanced neoplasia was observed. LIMITATIONS: Pathology criteria for the diagnosis of serrated polyps were not centrally reviewed. The morphology of the hyperplasic polyps (protruded or flat) was not recorded. Finally, because of the characteristics of a population-based study carried out in average-risk patients, the proportion of patients with CRC was relatively small. CONCLUSION: LSPs, but not proximal serrated polyps, are associated with the presence of synchronous advanced neoplasia. Further studies are needed to determine the risk of proximal hyperplastic polyps.

Modifiable endoscopic factors that influence the adenoma detection rate in colorectal cancer screening colonoscopies.

BACKGROUND: Adenoma detection rate (ADR) has become the most important quality indicator for colonoscopy. OBJECTIVE: The aim of this study was to investigate which modifiable factors, directly related to the endoscopic procedure, influenced the ADR in screening colonoscopies. DESIGN: Observational, nested study. SETTING: Multicenter, randomized, controlled trials. PATIENTS: Asymptomatic people aged 50 to 69 years were eligible for a multicenter, randomized, controlled trial designed to compare colonoscopy and fecal immunochemical testing in colorectal cancer screening. A total of 4539 individuals undergoing a direct screening colonoscopy were included in this study. INTERVENTION: Colonoscopy. MAIN OUTCOME MEASUREMENTS: Bowel cleansing, sedation, withdrawal time in normal colonoscopies, and cecal intubation were analyzed as possible predictors of adenoma detection by using logistic regression analysis, adjusted for age and sex. RESULTS: In multivariate analysis, after adjustment for age and sex, factors independently related to the ADR were a mean withdrawal time longer than 8 minutes (odds ratio [OR] 1.51; 95% CI, 1.17-1.96) in normal colonoscopies and split preparation (OR 1.26; 95% CI, 1.01-1.57). For advanced adenomas, only withdrawal time maintained statistical significance in the multivariate analysis. For proximal adenomas, withdrawal time and cecal intubation maintained independent statistical significance, whereas only withdrawal time longer than 8 minutes and a <10-hour period between the end of preparation and colonoscopy showed independent associations for distal adenomas. LIMITATIONS: Only endoscopic variables have been analyzed. CONCLUSION: Withdrawal time was the only modifiable factor related to the ADR in colorectal cancer screening colonoscopies associated with an increased detection rate of overall, advanced, proximal, and distal adenomas.

Carbon dioxide insufflation safety in double-balloon enteroscopy: an experimental animal study.

AIM: The aim of the present study was to assess the safety and efficacy of CO(2) during double-balloon enteroscopy (DBE) in an experimental animal model study. In this study, insufflation with room air and with CO(2) was compared. METHODS: Twenty healthy swines were used. The animals were randomly allocated to two groups. The room air-DBE group was insufflated with room air, whereas the CO(2)-DBE group was insufflated with CO(2). Endoscopy duration was 90 min. The following parameters were measured during the study (basal, 30 min, 60 min, 90 min): invasive hemodynamic parameters, ventilatory parameters, arterial blood gases, exploration depth, as well as biochemical tests. Residual gas was evaluated at the end of DBE, at 180 min and 24 h after DBE. RESULTS: During the endoscopic exploration none of the animals showed hemodynamic, ventilatory or arterial blood gas alterations in the normal reference range for the swine species. The CO(2) group showed statistically significant differences over the room air group with lower post-procedure residual gas and greater depth of the small bowel explored. CONCLUSION: The use of CO(2) for insufflation during DBE was safe and no complications associated with CO(2) were observed. In addition, the use of CO(2) offers benefits over the use of room air for insufflation during DBE.

Linaclotide in the treatment of patients with irritable bowel syndrome and constipation - analysis of an opportunity.

Linaclotide is a secretagogue that provides a combined effect on visceral pain. The European Medicines Agency has authorized its indication for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation in adults. The purpose of this review is to discuss the clinical framework for linaclotide use in our setting, the drug´s characteristics and pre-clinical development, and the clinical studies supporting its use in order to establish relevant views regarding its validity and clinical applicability. The results suggest that the only -non-severe- adverse effect associated with this drug is diarrhea. As regards effectiveness, linaclotide consistently shows favorable, significant differences in absolute risk versus placebo for all objective outcome variables described by regulatory agencies, with a combined pain and constipation response between 12.6% and 22.8% according to the variable and trial under consideration. This response is sustained and drug-related, as it goes away upon discontinuation. To conclude, linaclotide has a safety and efficacy profile that, from a clinical perspective, warrants its use for patients meeting irritable bowel syndrome and constipation criteria, with significant symptoms that cannot be relieved with other less specific measures. In the absence of predictive rules for response, it is recommended that, should the patient fail to respond, he or she should be considered not eligible for linaclotide therapy, and both indication and treatment continuity should be reserved for objective responders alone.

An endoscopic technique for treating symptomatic distal jejunum obstruction by leaving the overtube in place.

Double balloon enteroscopy has a limitation for positioning an enteral stent in the distal jejunum through its long, narrow biopsy channel. When the distal end of its overtube is left in place close to the neoplasia with the enteroscope removed, if we push an enteral stent introduction system, it tends to form loops so the techniquecannot be performed with this instrument. However, the double balloon colonoscope has a shorter overtube length and using the same push-and-pull technique we can reach the distal jejunum with this instrument by inserting the delivery stent system without loops through its overtube. We present a patient with neoplastic obstruction in the distal jejunum with resolution of his symptoms after positioning an enteral stent.

Joint position statement by "Sociedad Española de Patología Digestiva" (Spanish Society of Gastroenterology) and "Sociedad Española de Farmacología" (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease.

Biological drugs or biopharmaceutical products, manufactured with or from living organisms using biotechnology, have represented a therapeutic revolution for the control of inflammatory bowel disease (IBD). At present, in this indication and in our country, only two biological are approved, infliximab (IFX) and adalimumab (ADA), both of them monoclonal antibodies against tumor necrosis factor alpha. Effectiveness data are strong for both therapies, with maximum levels of scientific evidence.The upcoming expiry date for these biologicals´ patents has allowed the potential marketing of so-called biosimilar agents for the IBD indication. While biosimilars are conceptually for biological what generics are for chemical drugs, the structural complexity of biosimilars and their biological and manufacturing variability lead to consider validation processes for these two types in humans as highly differential. Thus, in our setting, under the coverage of "Agencia Española del Medicamento y Productos Sanitarios (AEMPS)" (Spanish Agency of Medicines and Medical Devices), guidelines issued by the European Medicines Agency (EMA) are to be applied, which states that a number of stages or steps must be overcome in order to obtain approval for a biosimilar agent.However, despite the presence of these recommendations by EMA, which must be met by a biosimilar in order to be licensed in our marketplace, relevant uncertainties persist that only future decisions by EMA and AEMPS may clarify. The present stance by our task force is that biosimilar development should be undertaken according to established regulations, thus certifying their efficacy and safety. Similarly, this task force considers that results obtained from studies in rheumatoid arthritis (RA) should not be extrapolated to IBD since the biological variability of these complex structures will not ensure a lack of noticeable changes in efficacy and safety.

Water Sowing and harvesting application for water management on the slopes of a volcano.

The present study aims to elaborate a hydrogeological characterisation in the Water Sowing and Harvesting context. The study is focused on rural parishes in the Ecuadorian Andes that, despite their proximity to snow sources (Chimborazo glaciers), need more supply of this resource, to satisfy the demand of a population of 70,466 inhabitants. The study is based on hydrology and geomorphological analysis, a geophysical exploration, and a definition of water management strategies. The application of non-destructive geophysical methods and Geographic Information Systems support the hydrogeological study and the proposal of strategies for sustainable water management on the slopes of the Chimborazo volcano. An aquifer potential was identified (sand, gravel and fractured porphyritic andesites) with resistivity values between 51.3 and 157 Ω m at an approximate depth of 30 m from the geophysical characterisation addressed. This potential saturated zone is on the southern slope of the Chimborazo volcano within the hydrographic watershed, with favourable drainage networks for water accumulation. The aquifer shows a high-water saturation level but uncontrolled losses. As a consequence of these characteristics, alternatives for managing water resources are proposed, such as wells construction, using Water Sowing and Harvesting system methods ("camellones") based on Nature-Based Solutions, dam construction and environmental education. The different proposals are associated with the four sustainability axes of Brundtland (economic, social, environmental and cultural axis) and contribute to the sixth objective of the Sustainable Development Goal 2030 Agenda.

[The Alliance for the Prevention of Colorectal Cancer in Spain. A civil commitment to society]. / Alianza para la Prevención del Cáncer de Colon en España: un compromiso cívico con la sociedad.

Colorectal cancer (CRC) is the most common malignant tumor in Spain, when men and women are considered together, and the second leading cause of cancer death. Every week in Spain over 500 cases of CRC are diagnosed, and nearly 260 people die from the disease. Epidemiologic estimations for the coming years show a significant increase in the number of annual cases. CRC is a perfectly preventable tumor and can be cured in 90% of cases if detected in the early stages. Population-based screening programs have been shown to reduce the incidence of CRC and mortality from the disease. Unless early detection programs are established in Spain, it is estimated that in the coming years, 1 out of 20 men and 1 out of 30 women will develop CRC before the age of 75. The Alliance for the Prevention of Colorectal Cancer in Spain is an independent and non-profit organization created in 2008 that integrates patients' associations, altruistic non-governmental organizations and scientific societies. Its main objective is to raise awareness and disseminate information on the social and healthcare importance of CRC in Spain and to promote screening measures, early detection and prevention programs. Health professionals, scientific societies, healthcare institutions and civil society should be sensitized to this highly important health problem that requires the participation of all sectors of society. The early detection of CRC is an issue that affects the whole of society and therefore it is imperative for all sectors to work together.

A Bibliometric Analysis of the Scientific Research on Artisanal and Small-Scale Mining.

Mineral resource exploitation is one of the activities that contribute to economic growth and the development of society. Artisanal and small-scale mining (ASM) is one of these activities. Unfortunately, there is no clear consensus to define ASM. However, its importance is relevant in that it represents, in some cases, the only employment alternative for millions of people, although it also significantly impacts the environment. This work aims to investigate the scientific information related to ASM through a bibliometric analysis and, in addition, to define the new lines that are tending to this field. The study comprises three phases of work: (i) data collection, (ii) data processing and software selection, and (iii) data interpretation. The results reflect that the study on ASM developed intensively from 2010 to the present. In general terms, the research addressed focuses on four interrelated lines: (i) social conditioning factors of ASM, (ii) environmental impacts generated by ASM, (iii) mercury contamination and its implication on health and the environment, and (iv) ASM as a livelihood. The work also defines that geotourism in artisanal mining areas is a significant trend of the last decade, explicitly focusing on the conservation and use of the geological and mining heritage and, in addition, the promotion of sustainable development of ASM.