Accuracy of Information given by ChatGPT for Patients with Inflammatory Bowel Disease in Relation to ECCO Guidelines.

BACKGROUND: As acceptance of artificial intelligence [AI] platforms increases, more patients will consider these tools as sources of information. The ChatGPT architecture utilizes a neural network to process natural language, thus generating responses based on the context of input text. The accuracy and completeness of ChatGPT3.5 in the context of inflammatory bowel disease [IBD] remains unclear. METHODS: In this prospective study, 38 questions worded by IBD patients were inputted into ChatGPT3.5. The following topics were covered: [1] Crohn's disease [CD], ulcerative colitis [UC], and malignancy; [2] maternal medicine; [3] infection and vaccination; and [4] complementary medicine. Responses given by ChatGPT were assessed for accuracy [1-completely incorrect to 5-completely correct] and completeness [3-point Likert scale; range 1-incomplete to 3-complete] by 14 expert gastroenterologists, in comparison with relevant ECCO guidelines. RESULTS: In terms of accuracy, most replies [84.2%] had a median score of ≥4 (interquartile range [IQR]: 2) and a mean score of 3.87 [SD: ±0.6]. For completeness, 34.2% of the replies had a median score of 3 and 55.3% had a median score of between 2 and <3. Overall, the mean rating was 2.24 [SD: ±0.4, median: 2, IQR: 1]. Though groups 3 and 4 had a higher mean for both accuracy and completeness, there was no significant scoring variation between the four question groups [Kruskal-Wallis test p > 0.05]. However, statistical analysis for the different individual questions revealed a significant difference for both accuracy [p < 0.001] and completeness [p < 0.001]. The questions which rated the highest for both accuracy and completeness were related to smoking, while the lowest rating was related to screening for malignancy and vaccinations especially in the context of immunosuppression and family planning. CONCLUSION: This is the first study to demonstrate the capability of an AI-based system to provide accurate and comprehensive answers to real-world patient queries in IBD. AI systems may serve as a useful adjunct for patients, in addition to standard of care in clinics and validated patient information resources. However, responses in specialist areas may deviate from evidence-based guidance and the replies need to give more firm advice.

Non-biological Complex Drugs (NBCDs): Complex Pharmaceuticals in Need of Individual Robust Clinical Assessment Before Any Therapeutic Equivalence Decision.

Non-Biological Complex Drugs (NBCDs) are complex non-biological drugs comprised of large high molecular weight molecules and, often, nanoparticular structures (including liposomes and block-copolymer micelles). In the case of NBCDs, the entire complex is the active pharmaceutical ingredient and its properties cannot be fully characterized by physicochemical analysis. Moreover, the manufacturing process is fundamental in creating the correct originator product. The same is true for generic versions of the product. A recent appraisal of approval procedures for NBCDs "follow-on products" approved in Europe shows a diversity of regulatory pathways. In fact, three different abridged application procedures, under European legislation, were used: the generic application procedure of Article 10(1), the hybrid application procedure of Article 10(3), and the biosimilar application procedure of Article 10(4). Three informed consent applications via Article 10(c) from innovator companies of glatiramer acetate and sevelamer carbonate were submitted shortly after the approval of the first follow-on products. Furthermore, a number of "well-established use" applications [via Article 10(a)] were approved for iron sucrose and iron dextran complexes. In order to protect patients from the increased risks of NBCD products and NBCD follow-on products, two complementary approaches should be considered: (i) improving the regulatory procedures and their guidance documents within the pre-registration phase, and (ii) not considering interchangeability whenever clinical data is not available. With regards to the latter, the need for adequate safety and efficacy data might also include risk management programmes within post-approval pharmacovigilance actions. This, however, would depend on a risk appraisal that must be considered for individual medicinal products, based on the nature of the submitted relevant set of safety/efficacy data.

Features of Fecal and Colon Microbiomes Associate With Responses to Biologic Therapies for Inflammatory Bowel Diseases: A Systematic Review.

BACKGROUND & AIMS: We performed a systematic review of changes in fecal and colon microbiomes of patients with inflammatory bowel diseases (IBDs) receiving treatment with monoclonal antibodies against tumor necrosis factor, integrins, or cytokines. We explored associations among microbiome composition and functions (at baseline and throughout the treatment) and therapy-related outcomes to determine whether colon or fecal microbiomes might be used as biomarkers of response to therapy. METHODS: We searched the PubMed, Web of Science, and Science Direct databases through February 2019 for studies of associations among the microbiomes of fecal or colon samples, biologic therapies, and IBDs. We used the critical appraisal skills program checklist to assess the quality of the study methods. RESULTS: From the 787 citations identified, 10 studies met the inclusion criteria. Changes in microbiomes of fecal or colon samples after treatment did not differ significantly among biologic agents; all produced decreases in relative abundances of Escherichia and Enterococcus and increases in genera that produce short-chain fatty acids. Fecal or colon microbiomes of patients who responded to therapy with antagonists of tumor necrosis factor or interleukins had higher α-diversity and increased relative abundances of different genera (Faecalibacterium, Roseburia, or Clostridium) from the Clostridiales order, either at baseline or during follow-up evaluation. Patients in remission after treatment with antibodies against integrins had decreased abundances of Roseburia. CONCLUSIONS: In a systematic review of 10 studies, we found evidence for consistent changes in microbiomes of fecal and colon samples from patients with IBD who responded to treatment with biologic agents. Prospective studies are needed to determine what changes are associated significantly with treatment, whether these changes are causes or effects of response, or whether the composition of the intestinal microbiome can be used to select treatments for patients with IBD.

The who-when-why triangle of CAM use among Portuguese IBD patients.

BACKGROUND: The use of complementary and alternative medicines is increasing among chronic patients, particularly those afflicted with inflammatory bowel diseases. AIM: This study aimed to address the prevalence of complementary and alternative medicines use among Portuguese inflammatory bowel diseases' patients. METHODS: Patients were invited to fill an anonymous questionnaire concerning the use of complementary and alternative medicines. RESULTS: Thirty-one per cent of the patients reported having used complementary and alternative medicines in the past, whereas 12% were using them by the time the questionnaire was administered. Fifty-nine per cent of the users did not share this information with their physician, whereas 14% and 8% discontinued their medication and periodical examination, respectively. Steroids prescription (OR=2.880) and a higher instruction level (OR=3.669) were predictors of complementary and alternative medicines use in this cohort. CONCLUSIONS: Roughly a third of Portuguese IBD patients had used CAM. Steroid treatment and an academic degree are associated with CAM use. Given the potential side effects and interactions, patient information about the benefits and limitations of conventional and complementary treatments should be reinforced.

[Portuguese Consensus on the Diagnosis, Prevention and Treatment of Anaemia in Inflammatory Bowel Disease]. / Consenso Português sobre o Diagnóstico, Prevenção e Tratamento da Anemia na Doença Inflamatória Intestinal.

INTRODUCTION: Anaemia can be considered the most common extra-intestinal manifestation in inflammatory bowel disease. Nevertheless, anaemia is often under-diagnosed and under-treated both in adults and children with inflammatory bowel disease. Herein, we report the consensus statements on the management of anaemia in inflammatory bowel disease developed by the Portuguese Working Group on Inflammatory Bowel Disease (known as Grupo de Estudo da Doença Inflamatória Intestinal - GEDII) to aid clinicians in daily management of inflammatory bowel disease patients. MATERIAL AND METHODS: A comprehensive literature review was conducted in order to prepare consensus statements on the following topics: (1) prevalence and diagnosis of anaemia in inflammatory bowel disease, (2) iron supplementation for the prevention of anaemia in inflammatory bowel disease and (3) treatment of anaemia in inflammatory bowel disease. The final statements for each topic were discussed at a consensus meeting and rated according to the Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence. CONSENSUS: It was concluded that anaemia has a high incidence and prevalence in inflammatory bowel disease, particularly in those with active disease and hospitalised. Patients with anaemia had decreased quality of life and frequently complained of fatigue. Absolute indications for intravenous therapy should be considered: (1) moderate to severe anaemia (haemoglobin < 10.5 g/dL) or clearly symptomatic anaemia; (2) previous intolerance to oral iron supplements; (3) inappropriate response to oral iron; (4) active severe intestinal disease; (5) need for a quick therapeutic response (e.g. surgery in the short term); (6) concomitant therapy with erythropoiesis-stimulating agent; and (7) patient's preference.

Introdução: A anemia pode ser considerada a manifestação extra-intestinal mais comum na doença inflamatória intestinal. Ainda assim, a anemia é subdiagnosticada e subtratada tanto em adultos como em crianças com doença inflamatória intestinal. Assim, apresentamos o consenso alcançado pelo Grupo de Estudo da Doença Inflamatória Intestinal - GEDII relativamente à gestão da anemia na doença inflamatória intestinal, com o objetivo de facilitar o acompanhamento clínico dos doentes com doença inflamatória intestinal. Material e Métodos: Foi conduzida uma revisão exaustiva da literatura, por forma a preparar statements de consenso nos seguintes tópicos: (1) prevalência e diagnóstico de anemia na doença inflamatória intestinal, (2) ferro da prevenção da anemia na doença inflamatória intestinal e (3) tratamento da anemia na doença inflamatória intestinal. Os statements finais para cada tópico foram discutidos na reunião de consenso e classificados de acordo com os níveis de evidência definidos em 2011 pelo Oxford Centre for Evidence-Based Medicine. Consensos: Concluiu-se que a anemia tem elevada incidência e prevalência na doença inflamatória intestinal, particularmente entre pacientes com doença ativa e hospitalizados. Indicações absolutas para terapia intravenosa devem ser consideradas quando existe: (1) anemia moderada a severa (hemoglobina < 10,5 g/dL) ou anemia claramente sintomática; (2) intoler'ncia prévia à terapêutica com ferro por via oral; (3) resposta inadequada à terapêutica com ferro por via oral; (4) doença intestinal ativa severa; (5) necessidade de resposta terapêutica rápida (e.g. cirurgia a curto prazo); (6) terapêutica concomitante com agente estimulante da eritropoiese; e (7) preferência do paciente.

Histological Outcomes and Predictive Value of Faecal Markers in Moderately to Severely Active Ulcerative Colitis Patients Receiving Infliximab.

BACKGROUND AND AIMS: Histological healing has emerged as a promising therapeutic goal in ulcerative colitis. This is especially important in the context of biological therapies. The objectives of the present study were to investigate the ability of infliximab to induce histological remission in ulcerative colitis [UC] patients and to explore the utility of faecal calprotectin and lactoferrin in predicting histological activity. METHODS: Multi-centre, single-cohort, open-label, 52-week trial including moderately to severely biological-naïve UC patients receiving intravenous infliximab [5mg/kg]. The primary outcome was the proportion of patients with histological remission [Geboes index ≤ 3.0] after 8 weeks of treatment, scored by two independent pathologists. RESULTS: Twenty patients were included. The rate of histological remission increased from 5% at baseline to 15% and 35% at Week 8 and Week 52, respectively. At Week 8, 40% of patients were in clinical remission [Mayo ≤ 2] and 45% achieved mucosal healing [Mayo endoscopy subscore 0-1]. At Week 52, 25% of patients had clinical, endoscopic and histological remission. Faecal calprotectin and lactoferrin showed the highest correlation with histological activity at Week 8 (area under the curve [AUC] 94%, p = 0.017; and 96%, p = 0.013, respectively) and both markers revealed an excellent positive predictive value for this outcome at this time point [100%, p = 0.017; and 94%, p = 0.013, respectively]. CONCLUSIONS: Infliximab was able to induce histological remission. There was a good agreement between histology and faecal biomarkers. Faecal calprotectin and lactoferrin were good predictors of histological remission. Our data support inclusion of histology as a treatment target complementary to endoscopy in clinical trials when evaluating therapeutic response in UC.

Anaemia management in patients with inflammatory bowel disease: routine practice across nine European countries.

BACKGROUND AND OBJECTIVES: Anaemia and iron deficiency (ID) are common complications in inflammatory bowel disease (IBD). In patients undergoing iron therapy, intravenous iron supplementation is recommended in preference to oral therapy. This study evaluated routine practice in the management of IBD-associated anaemia and ID to verify implementation of international treatment guidelines. MATERIALS AND METHODS: Gastroenterologists from nine European countries (n=344) were surveyed about their last five IBD patients treated for anaemia (n=1404). Collected information included tests performed at anaemia diagnosis, haemoglobin (Hb) levels and iron status parameters, the anaemia treatment given and, if applicable, the iron administration route. RESULTS: Selection of diagnostic tests and treatment for IBD-associated anaemia varied considerably across Europe. Anaemia and iron status were mainly assessed by Hb (88%) and serum ferritin (75%). Transferrin saturation was only tested in 25% of patients. At diagnosis of anaemia, 56% presented with at least moderate anaemia (Hb<10 g/dl) and 15% with severe anaemia (Hb<8 g/dl). ID (ferritin<30 ng/ml) was detected in 76%. Almost all patients (92%) received iron supplementation; however, only 28% received intravenous iron and 67% oral iron. Management practice was similar in 2009 and 2011. CONCLUSION: In clinical practice, most IBD patients received oral iron even though this administration route may aggravate the disease, and despite international guidelines recommending intravenous administration as the preferred route. The high frequency of ID suggests insufficient monitoring of iron status in IBD patients. There is a need to increase awareness and implementation of international guidelines on iron supplementation in patients with IBD.

Clinical practice in Crohn's disease in bordering regions of two countries: different medical options, distinct surgical events.

UNLABELLED: Contemplating the multifactorial nature of Crohn's disease (CD), the purpose of this study was to compare two neighbouring CD populations from different nations and examine how clinical characteristics of patients can influence therapeutic strategies and consequently different surgical events in routine clinical practice. Cross-sectional study based on data of an on-line registry of patients with CD in northern Portugal and Galicia. Of the 1238 patients, all with five or more years of disease, 568 (46%) were male and 670 (54%) female. The Portuguese and Galician populations were similar regarding Montreal categories, age at diagnosis, and years of follow-up. Galician B2 patients were associated with immunosuppression (OR 3.6; CI 2.2-6.1) and biologic treatment (OR 1.8; CI 1.0-3.1). In both populations ileocolonic disease was associated with immunosuppression and biologic treatment and the penetrating group was linked to immunosuppression. In the north of Portugal 47% and 16% of patients, and in Galicia 63% and 33%, were treated with immunosuppressants and biologic treatment, respectively. In the north of Portugal 44% of patients classified as stricturing behavior were operated without immunomodulation, in contrast to 12% in Galicia. In the latter it was possible to maintain 16% of B2 patients and 40% of B3 patients without surgery with adequate immunosuppression and/or biologic treatment. The delta of surgeries in B2 patients was 8% and in B3 26%. CONCLUSIONS: Stratifying patients according to the Montreal classification identified similar clinical patterns in disparate geographic populations, and revealed that differing medical therapeutic practices may influence the occurrence of surgical events.