Descriptive observational study on the use of virtual reality in patients with inflammatory bowel disease undergoing biological treatment.

BACKGROUND: Virtual reality (VR) is a neurosensory experience in which simulated spaces a person has the sensation of being able to function within them. Some patients with inflammatory bowel disease (IBD) receive intravenous biological treatments in an Adult Day Hospital (ADH) regime. VR has been used in some fields of medicine, demonstrating its usefulness in reducing negative symptoms. However, we do not have any literature showing the applicability in real clinical practice of VR in IBD. METHODS: Descriptive observational pilot study based on an initial cohort of 87 patients that were obtained from the ADH of the IBD Unit. Satisfaction and acceptance of VR through the use of 3D glasses and the reduction of negative symptoms during intravenous biological treatment in patients with IBD in ADH have been assessed. RESULTS: 43 patients (52.4%) used VR and completed the study. In the comparative analysis of the results of the questionnaires before and after the use of VR, a statistically significant improvement was observed in the patients' view on the ability of VR to achieve a reduction in stress (65% patients improve; p: 0.0021) and pain (VAS, 54% p. improve; p<0.05) during treatment. Likewise, with the applicability of VR in other areas of medicine (53%; p: 0.05) and with the possibility of improving well-being during the stay in the ADH (56%; p: 0.0014). No side effects were reported with the use of the 3D glasses. CONCLUSIONS: VR is a useful complementary tool to improve the stay of patients with IBD on ADH during intravenous treatment.

The Risk of Developing Disabling Crohn's Disease: Validation of a Clinical Prediction Rule to Improve Treatment Decision Making.

BACKGROUND: Crohn's disease (CD) is characterized by the development of complications over the course of the disease. It is crucial to identify predictive factors of disabling disease, in order to target patients for early intervention. We evaluated risk factors of disabling CD and developed a prognostic model. METHODS: In total, 511 CD patients were retrospectively analyzed. Univariate and multivariate logistic regression analyses were used to identify demographic, clinical, and biological risk factors. A predictive nomogram model was developed in a subgroup of patients with noncomplicated CD (inflammatory pattern and no perianal disease). RESULTS: The rate of disabling CD within 5 years after diagnosis was 74.6%. Disabling disease was associated with gender, location of disease, requirement of steroids for the first flare, and perianal lesions. In the subgroup of patients (310) with noncomplicated CD, the rate of disabling CD was 80%. In the multivariate analysis age at onset <40 years (OR = 3.46, 95% confidence interval [CI] = 1.52-7.90), extensive disease (L3/L4) (OR = 2.67, 95% CI = 1.18-6.06), smoking habit (OR = 2.09, 95% CI = 1.03-4.27), requirement of steroids at the first flare (OR = 2.20, 95% CI = 1.09-4.45), and albumin (OR = 0.59, 95% CI = 0.36-0.96) were associated with development of disabling disease. The developed predictive nomogram based on these factors presented good discrimination, with an area under the receiver operating characteristic curve of 0.723 (95% CI: 0.670-0.830). CONCLUSION: We identified predictive factors of disabling CD and developed an easy-to-use prognostic model that may be used in clinical practice to help identify patients at high risk and address treatment effectively.

Three-dimensional modelling as a novel interactive tool for preoperative planning for complex perianal fistulas in Crohn's disease.

AIM: The aim of this study is to demonstrate the added value of three-dimensional (3D) reconstruction models and artificial intelligence for preoperative planning in complex perianal Crohn's disease. MRI is the gold standard for diagnosis of complex perianal fistulas and abscess due to its high sensitivity, but it lacks high specificity values. This creates the need for better diagnostic models such as 3D image processing and reconstruction (3D-IPR) with artificial intelligence (AI) algorithms. METHOD: This is a prospective study evaluating the utility of 3D reconstruction models from MRI in four patients with perineal Crohn's disease (pCD). RESULTS: Four pCD patients had 3D reconstruction models made from pelvic MRI. This provided a more visual representation of perianal disease and made possible location of the internal fistula orifice, seton placement in fistula tracts and abscess drainage. CONCLUSION: Three-dimensional reconstruction in CD-associated complex perianal fistulas can facilitate disease interpretation, anatomy and surgical strategy, potentially improving preoperative planning as well as intraoperative assistance. This could probably result in better surgical outcomes to control perianal sepsis and reduce the number of surgical procedures required in these patients.

Mesalazine-induced esophageal ulcers. a rare adverse effect.

31-year-old woman. Diagnosis of ulcerative proctitis in February/2022. Calprotectin 1832 µg/g. Colonoscopy: erythematous, friable and erosive mucosa up to 10 cm from the anal margin. Pathology: compatible with ulcerative colitis with moderate activity. Start of oral mesalazine (3 gr/24 h granules) and topical (1 gr/24 h suppository). After three months, she achieved clinical remission. Calprotectin 57 µg/g. Two months later, she consulted for solid dysphagia, loss of 10 kg, and low-grade fever for a month. Fifteen days before, she went to an emergency room where Prednisone 50 mg/24 h was started. On the day of the assessment, she was receiving 30 mg with no improvement. The next day, gastroscopy showed 6-12 mm esophageal ulcers with non-confluent shallow geographic borders, biopsies were taken. Viral serologies and HLA B51 were requested. Given the severity of the symptoms, empirical treatment was started with Valaciclovir 1 g/12 h. Serologies: IgG for Ebstein Barr virus, cytomegalovirus and herpes virus with negative IgM. Cytomegalovirus viral load: <30 IU/ml. Pathology: acute extensively ulcerated esophagitis, inflammatory infiltrate and some eosinophils with negative histochemical staining for fungi, cytomegalovirus and herpes virus I and II. HLA B51 was negative. Valaciclovir and mesalazine are discontinued after seven days given the known relationship of the latter with low-grade fever and, exceptionally, with esophageal pathology. Three days later, the patient reported clear improvement in dysphagia from the day the mesalazine was discontinued. After eight months, she was still asymptomatic. Upon resolution of the symptoms, control gastroscopy was not performed, and mesalazine has not been reintroduced due to its probable causal association. Mesalazine has an excellent safety profile. Adverse effects include fever, headache, diarrhea and.

Optimizing treatment of mild to moderate ulcerative colitis: CU-forum Delphi consensus. / Optimización del tratamiento de la colitis ulcerosa leve a moderada: Consenso Delphi CU-Forum.

BACKGROUND AND OBJECTIVE: Ulcerative colitis (UC) clinical guidelines include the best available evidence, although not all clinical situations are answered, so their management can be controversial. The aim of this study is to identify the situations of mild to moderate UC susceptible to controversy and to evaluate the degree of agreement or disagreement with specific proposals. METHODS: Inflammatory bowel disease (IBD) expert discussion meetings were used to identify criteria, attitudes and opinions regarding the management of UC. A Delphi questionnaire was then developed with 60 items regarding antibiotics, salicylates and probiotics; local, systemic and topical corticosteroids; and immunosuppressants. RESULTS: Consensus was reached in 44 statements (73.3%); 32 in agreement (53.3%) and 12 in disagreement (20.0%). Some of them were: it is not necessary the systematic use of antibiotics despite the severity of the outbreak, being reserved when there is suspicion of infection or systemic toxicity; when faced with a mild-moderate outbreak of UC and in patients who do not respond to aminosalicylates, it is appropriate to use a dose of beclomethasone of 10mg/day for one month and 5mg/day for another month; it is advised that the dose of azathioprine be administered in a single dose. CONCLUSIONS: IBD experts agree on most of the proposals identified for managing mild to moderate UC and there is a need for scientific evidence in some specific situations where expert opinion may be helpful.

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.

Patient preferences in chronic immune-mediated inflammatory diseases potentially treated with biological drugs: discrete choice analysis using real-world data analysis.

OBJECTIVES: Immune-mediated inflammatory diseases (IMIDs) represent a high burden due to their chronicity, high prevalence, and associated comorbidities. Chronic patients' preferences must be considered in IMIDs treatment and follow-up. The objective of this study was to further understand patient's preferences in private settings. METHODS: A literature review was performed to choose the most relevant criteria for patients. A D-efficient discrete choice experiment was designed to elicit preferences of adult patients with IMIDs and potential biological treatment prescription. Participants were collected from private practices (rheumatology, dermatology, and gastroenterology) from February to May 2022. Patients chose between option pairs, characterized by six health-care attributes, as well as monthly out-of-pocket drug price. Responses were analyzed through a conditional logit model. RESULTS: Eighty-seven patients answered the questionnaire. The most frequent pathologies were Rheumatoid Arthritis (31%) and Psoriatic Arthritis (26%). The most relevant criteria were choosing the preferred physician (OR 2.25 [SD0.26]); reducing time until visit with specialist (OR 1.79 [SD0.20]), access through primary care (OR 1.60 [SD0.08]), and an increase in monthly out-of-pocket price from 100€ to 300€ (OR 0.55 [SD0.06]) and to 600€ (OR 0.08 [SD0.02]). CONCLUSIONS: Chronic IMIDs patients showed a preference toward a faster, personalized service, even with a trade-off in terms of out-of-pocket price.

[Severe tubulo-interstitial nephritis secondary to 5-ASA]. / Nefropatía tubulointersticial grave secundaria a 5-ASA.

We report a new case of chronic interstitial nephritis in a patient with ulcerative colitis diagnosed in 2002 who was originally treated with 5-ASA. Three years later deterioration of renal function was apparent with an increase in serum creatinine, which was normal before treatment. Withdrawal of 5-ASA led to partial improvement of renal function. In patients with a delayed diagnosis of kidney damage, recovery of renal function is incomplete and, in some cases, the patient even requires some form of renal replacement therapy. We stress the importance of monitoring renal function in patients diagnosed with inflammatory bowel disease treated with this drug.

[Impact of a registry on survival in familial adenomatous polyposis]. / Mejoría de la supervivencia de la poliposis adenomatosa familiar después del establecimiento de un registro.

BACKGROUND AND OBJECTIVE: Familial adenomatous polyposis (FAP) is an autosomal dominant inherited disease characterized by hundreds of adenomatous polyps in the large intestine. Almost all affected untreated patients will die from colorectal cancer (CRC) at the age of 40-50 years. The Balearic Islands Polyposis Registry was established in 1988. The aim of the present study was to evaluate changes in the prevalence of CRC and the prognosis of FAP, before and after the establishment of the registry. PATIENTS AND METHOD: The diagnosis of FAP was defined by history, clinical examination, histopathological assessment and/or genetic testing. In this study we compare the data of probands and call-up patients. To evaluate the impact of the registry, selected variables were calculated for the periods 1970-1987 and 1988-2005. RESULTS: At the end of 2005 the registry included information of 19 families with 52 affected members (19 probands, 33 call-up). Thirty-six patients were alive and 16 had died. The cumulative 15 years survival was 82% in call-up cases compared with 47% in probands (p < 0.05). The cumulative 15 years survival was 87% for the period 1988-2005, compared with 33% for the period 1970-1987 (p < 0.001). The frequency of CRC was 72% for the period 1970-1987 and 21% for the period 1988-2005 (p < 0.005). CONCLUSIONS: The survival of the call-up patients was significantly improved as compared to the probands. Since the establishment of the registry, the frequency of CRC has decreased considerably, and the prognosis has improved substantially in FAP patients.

[Ileal perforation secondary to intestinal endometriosis]. / Perforación ileal secundaria a endometriosis.

Endometriosis is defined as the presence of endometrial tissue outside the uterus. The bowel is not often affected. There are no specific clinical findings for intestinal endometriosis. It is typically asymptomatic, but sometimes can present with abdominal pain, diarrhoea, constipation or intestinal obstruction. Ileal perforation is a rare complication of intestinal endometriosis and only a few cases have been reported in the literature. Intestinal endometriosis can mimic many gastrointestinal diseases, such as irritable bowel syndrome, inflammatory bowel disease, infections and neoplasms. The diagnosis is made by laparoscopy or laparotomy. We present a case of a woman with intermittent abdominal pain and ileal perforation secondary to intestinal endometriosis.

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. (AU)

Optimización del tratamiento de la colitis ulcerosa leve a moderada: Consenso Delphi CU-Forum / Optimizing treatment of mild to moderate ulcerative colitis: CU-forum Delphi consensus

Antecedentes y objetivo: Las guías clínicas de colitis ulcerosa (CU) recogen la mejor evidencia disponible, aunque no todas las situaciones clínicas quedan respondidas, por lo que su manejo puede ser motivo de controversia. El objetivo de este estudio es identificar las situaciones de la CU leve a moderada susceptibles de controversia y evaluar el grado de acuerdo o desacuerdo a propuestas concretas. Métodos: Mediante reuniones de debate de expertos en enfermedad inflamatoria intestinal (EII) se identificaron criterios, actitudes y opiniones respecto al manejo de la CU. A continuación se elaboró un cuestionario Delphi con 60 aseveraciones relativas a antibióticos, salicilatos y probióticos, corticoides locales, sistémicos y tópicos e inmunosupresores. Resultados: Se alcanzó consenso en 44 aseveraciones (73,3%); 32 en el acuerdo (53,3%) y 12 en el desacuerdo (20,0%). Algunos de ellos fueron: no es necesario el uso sistemático de antibióticos a pesar de la gravedad del brote, quedando reservados ante la sospecha de infección o toxicidad sistémica; ante un brote leve-moderado de CU y en pacientes que no responden a aminosalicilatos es adecuado utilizar una dosis de beclometasona de 10mg/día durante un mes y 5mg/día durante otro mes; se aconseja que la dosis de azatioprina se administre en una única dosis. Conclusiones: Los expertos en EII coinciden en la mayoría de las propuestas identificadas para manejar la CU leve a moderada y se constata la necesidad de evidencia científica en algunas situaciones concretas en las que conocer la opinión de expertos puede resultar de ayuda. (AU)

Background and objective: Ulcerative colitis (UC) clinical guidelines include the best available evidence, although not all clinical situations are answered, so their management can be controversial. The aim of this study is to identify the situations of mild to moderate UC susceptible to controversy and to evaluate the degree of agreement or disagreement with specific proposals. Methods: Inflammatory bowel disease (IBD) expert discussion meetings were used to identify criteria, attitudes and opinions regarding the management of UC. A Delphi questionnaire was then developed with 60 items regarding antibiotics, salicylates and probiotics; local, systemic and topical corticosteroids; and immunosuppressants. Results: Consensus was reached in 44 statements (73.3%); 32 in agreement (53.3%) and 12 in disagreement (20.0%). Some of them were: it is not necessary the systematic use of antibiotics despite the severity of the outbreak, being reserved when there is suspicion of infection or systemic toxicity; when faced with a mild-moderate outbreak of UC and in patients who do not respond to aminosalicylates, it is appropriate to use a dose of beclomethasone of 10mg/day for one month and 5mg/day for another month; it is advised that the dose of azathioprine be administered in a single dose. Conclusions: IBD experts agree on most of the proposals identified for managing mild to moderate UC and there is a need for scientific evidence in some specific situations where expert opinion may be helpful. (AU)

Post-marketing health technology monitoring. The analysis of an experience from a clinical perspective.

INTRODUCTION: A system for monitoring the use of aphaeresis in the treatment of ulcerative colitis (UC), named system for monitoring aphaeresis in ulcerative colitis (SiMAC), was designed in 2006 in the Basque Country. In the present study, the opinion of the clinicians who participated in SiMAC was evaluated, in order to identify the barriers and gather suggestions that could improve implementation of this kind of system. METHODS: A mixed questionnaire was designed, in order to gather clinicians' assessments of the SiMAC monitoring system. RESULTS: The response rate was 73.9% (17/23). The data from 40.96% (159/388) of patients with UC treated with aphaeresis was recorded. The main reasons for not including the data from all treated patients were a lack of required data or not meeting the study inclusion criteria. Positive aspects of the SiMAC were identified, as the simplicity of data collection and its systematic, multi-center approach. The negative aspects mentioned were the use of a local computer application and the lack of time for health professionals to enter data. DISCUSSION: The use of monitoring systems helps to formalize the introduction of technologies of little-known effectiveness; involve clinicians and medical societies in coming to agreement and obtaining information about the safety, effectiveness or efficiency of new technologies; and provide relevant information to healthcare administrations for making decisions about the introduction of new technologies into healthcare practice. In order for a monitoring system to work, the process must be straightforward. A minimum set of key variables that are easy to collect must be selected, and an effort made to involve a range of stakeholders, especially institutions and scientific societies, to support the work group.

Medicamentos biosimilares: impacto, oportunidades y estrategias. Doce años de experiencia en Europa / Biosimilar medicines: impact, opportunities and strategies. Twelve years of experience in Europe

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