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Background: As patients with immune conditions were excluded from COVID-19 vaccine clinical trials, it is important to accumulate realworld data in this setting, particularly to identify those who would benefit from repeated doses. Method(s): Effectiveness and Safety of COVID-19 Vaccine in Patients with Inflammatory Bowel Disease (IBD) Treated with Immunomodulatory or Biological Drugs (ESCAPE) is a prospective, multicentre, observational study assessing effectiveness and safety of COVID-19 vaccines in patients with IBD (ClinicalTrials.gov ID: NCT04769258). Here we present data on the rate of breakthrough SARS-CoV-2 infections in the timeframe between 14 days after the second dose and the third dose of COVID-19 vaccine (or a maximum of 9 months from the second dose). The risk factors for SARS-CoV-2 infection, including lack of seroconversion (cut-off for IgG anti-SARS-CoV-2: OD 0.28) and IgG anti-SARS-CoV-2 levels after 8 weeks from the second dose, and treatment for IBD, were assessed. Result(s): Out of the 1076 patients with IBD enrolled in the ESCAPE study, data on breakthrough SARS-CoV-2 infection were available in 953 cases. Most of the patients received homologous, doubledose mRNA-based vaccines (BNT162b2 or mRNA-1273: 99.2%). Seroconversion was reported in 92.7% of cases (median OD 1.60 [IQR 0.8-3.6]), while SARS-CoV-2 infection was documented in 95 patients (10.0%), of whom 9 died. At multivariable regression analyses, age (OR 0.97, 95% CI 0.96-0.99;p<0.001) being former smoker (OR 2.23, 95% CI 1.26-3.88;p=0.005), and lack of seroconversion (OR 0.42, 95% CI 0.20-0.99;p=0.034) were independent predictors of SARS-CoV-2 infection. Conversely, none of the treatments for IBD was associated with breakthrough SARS-CoV-2 infection. Notably, all 9 patients who died had reported seroconversion after the second dose. Conclusion(s): IBD patients without seroconversion after COVID-19 vaccines are at increased risk for SARS-CoV-2 infection, while medications for IBD had no impac.
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OBJECTIVE: Telemedicine (TM) has had a powerful impact in recent years, particularly on managing chronic diseases such as inflammatory bowel disease (IBD). Knowing patients' expectations and concerns is essential to increase their confidence in this mode of medical care. PATIENTS AND METHODS: We interviewed a large cohort of IBD patients enrolled at two Italian tertiary referral centers to investigate their trust in TM. RESULTS: A total of 376 patients completed the survey and were included in the study: 293 (77.9%) considered TM valuable for managing their disease, and 307 (85%) wanted to have TM service at their center. However, only 99 patients (26.3%) believed that TM guarantees the same level of care as the in-person visit. Among the socio-demographic variables, those independently associated with trust in TM were the higher education qualification (p=0.02) and the level of competence in information and communication technologies (ICT) (p=0.03). CONCLUSIONS: Our findings highlighted the importance of equipping IBD patients with basic ICT skills to utilize TM services and increase their confidence in ICT with the help of caregivers. Additionally, to improve the perceived value of TM, it will be helpful to use additional tools such as telemonitoring of disease activity using patients' reported outcomes or remote measurement of fecal calprotectin.
Subject(s)
COVID-19 , Inflammatory Bowel Diseases , Telemedicine , Humans , Pandemics , Cross-Sectional Studies , Trust , Inflammatory Bowel Diseases/diagnosis , Inflammatory Bowel Diseases/therapy , Inflammatory Bowel Diseases/epidemiology , Chronic Disease , Leukocyte L1 Antigen ComplexABSTRACT
Background: Telemedicine is becoming a necessary tool for chronic disease management. Thanks to the wide diffusion of devices connecting to the World Wide Web, a large part of the population are now able to access to telemedicine services.Telemedicine is becoming a necessary tool for chronic disease management. Thanks to the wide diffusion of devices connecting to the World Wide Web, a large part of the population are now able to access to telemedicine services. The aim of this survey was to explore the willingness and hesitancy of patients with inflammatory bowel disease (IBD) to the use of telemedicine during COVD-19 outbreak. Methods: A paper-and-pencil questionnaire was proposed to all consecutive patients observed at our tertiary IBD center in San Giovanni Rotondo (Italy) from February to May 2021. The survey investigated 20 items that can be grouped into 5 areas: socio-demographic data, clinical data, informatics competence, devices and network utilized for the internet connection, attitude to the telemedicine, and the impact of COVID-19 pandemic. Results: A total of 156 patients completed the questionnaire (100 males). One hundred forthy-three patients (91.7%) were under 65 years and only 15 (9.6%) were graduates. Forthy-seven patients (30%) were single, 101 married (65%). Eighteen patients (11.5%) felt they had no IT skills. Eight patients (5.1%) had a previous experience of telemedicine. One hundred twenty-three patients (78.8%) consider the support of telemedicine useful for the management of their pathology and 134 (85.9%) would like the Center where they are followed up to have the possibility of offering a telemedicine service. One hundred three patients (66.0%) would like to have a teleconsultation with figures other than the Gastroenterologist. Ninety-seven patients (62.2%) agree that the ongoing coronavirus pandemic has a major impact on the need to implement telemedicine. Regarding the confidence with telemedicine, 106 patients (67.9%) were partially or totally agreeing telemedicine can properly resolve health problems, and 98 (62.8%) agree that technologies guarantee the privacy of the health data. One hundred twenty-five patients (80%) agree that telemedicine should be developed independently of the pandemic, however only 48 patients (31%) believe that telemedicine guarantee the same level of assistance of visit in presence. Conclusion: Italian IBD patients showed a positive attitude towards telemedicine and consider that useful for the management of their disease. The majority of patients would like the center where they are followed up offering a telemedicine service, regardless of the ongoing pandemic. However only one third of patients believe that telemedicine can offer the same level of assistance of in-presence visit.
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Background: Telemedicine is one of the major changes that clinicians have encountered over the past decade;in particular during the COVID-19 pandemic, televisits were rapidly implemented to guarantee patients' assistance, with the intention of Health Care Providers (HCPs) to continue to use them beyond the pandemic. The aim of our national survey was to evaluate the current usage of telemedicine for IBD patients from their perspective, investigating patients' impressions about telemedicine and factors affecting them through a Machine Learning (ML) analysis. Methods: In March 2021, the Italian IBD patients' association (AMICI Onlus) distributed to their members -through its mailing list and on social media platforms -an anonymous online questionnaire investigating the use of telemedicine. Socio-demographic and IBD characteristics were collected;the usage, patients' satisfaction and trust of telemedicine were assessed through Likert scales. ML tools -Decision Trees (DT) and Random Forest (RF) -were applied to identify the determinants of patient's perceptions about telemedicine;the produced RF ranking displays two indicators: %IncMSE and IncNodePurity. Results: Nine hundred and seventy-eight IBD patients (women 58.9%) from every Italian region completed the questionnaire. Among the respondents, 87 (8.9%) personally had a telemedicine experience;153 reported that their Centre performed a telemedicine service during the COVID-19 pandemic (24.2% televisits, 39.2% e-mails, 24.8% phone-calls, 3.9 % dedicated website, 7.9% others). Overall, 707 (72.3%) would trust a telemedicine service, 760 (77.7%) would like to have it also with another HCP (e.g., nutritionist, psychologist) and 778/961 (81%) would like to use telemedicine in the future (17 did not answer to this specific question);792 (81%) stated they thought useful to have the possibility to use telemedicine and 847 (86.6%) would like their Centre to offer them this facility. Considering this last question as the output at the DT, the variable which have been found to influence the most this patients' willingness is patient's perception of the usefulness of telemedicine in treating their disease, since it represented the root of the tree explaining the results. The RF rankings confirmed that this variable influenced the most patients' perception with the highest levels of %IncMSE and IncNodePurity(Figure 1). Conclusion: The practice of telemedicine in the management of IBD patients has not been very relevant throughout Italy so far (less than 10%), but more than four every five respondents would like to use telemedicine. Machine learning analysis shows that the perceived usefulness of telemedicine service is the key point for patients who would like it was a part of usual clinical practice.
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Background: Coronavirus disease 2019 (COVID-19), had two pandemic waves in 2020, respectively in April and November. In the general population, the first wave has been characterized by a higher prevalence in Northern Italy and a higher mortality rate compared to the second one. The aim of this study was to compare the characteristics of IBD patients and negative outcomes of COVID-19 (pneumonia, hospitalization, ventilatory support, death) between the two pandemic waves in Italy. Methods: Prospective observational cohort study. Patients with diagnosis of IBD and confirmed SARS-CoV-2 infection were enrolled. Differences between first and second wave were tested for significance using the Student's t test and Fisher's test, as appropriate. A two-tailed p value <0.05 was indicative of statistical significance. Results: We enrolled 937 IBD patients from 47 participating IBD centres across Italy (219 in the first wave, 718 in the second wave). There were no significant differences between the first and the second wave in terms of age (46.3 ± 16.0 vs. 44.1 ± 15.5 years, p=0.06) and gender (female 45.7% vs. 48.2%, p= 0.54). In the first wave, a lower percentage of patients was affected by Crohn's disease (CD): 92 (42.0%) vs. 399 (55.6%) (p<0.001) while no differences were observed for disease clinical activity: 97/219 (44.3%) vs. 280/718 (38.9%) in the first and second wave, respectively (p=0.18). Regarding biologic therapy, the percentage of patients on biologics in the two waves was similar: 119/219 (54.3%) vs. 393/718 (54.7%) (p=0.94), without differences in anti-TNFalpha, anti-integrins and anti-IL12/23 distribution. During the first wave, a significantly higher percentage of patients were from Northern Italy compared to Central-Southern Italy: 171/219 (78.1%) vs. 387/718 (53.9%), respectively (p<0.001). Overall, COVID-19 negative outcomes were significantly higher in the first wave compared to the second one: 110 (50.2%) vs. 95 (13.2%), respectively (p<0.001). Also the single negative outcomes were significantly higher in the first wave: 61/219 (27.8%) vs. 84/718 (11.7%) had pneumonia, 62/219 (28.3%) vs. 76/718 (10.6%) required hospitalization, 26/219 (11.9%) vs. 39/718 (5.4%) required ventilatory support, and 12/219 (5.5%) vs. 13/718 (1.8%) died (Figure 1). Conclusion: IBD patients had higher number of COVID-19 negative outcomes in the first wave than in second wave. In the first wave, a significantly higher percentage of patients were from Northern Italy, but no significant differences in negative outcomes were observed in comparison with those from Central- Southern Italy. Overall, findings in IBD population are coherent with those observed in the general population. (Table Presented).
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Background and aim: Vaccine hesitancy, the delay in acceptance or refusal of vaccination despite its availability, threatens the control of infectious diseases. COVID-19 vaccination has been recommended by national and international organizations in patients with Inflammatory Bowel Diseases (IBD). The aim of the study was to evaluate COVID-19 vaccine hesitancy in a population of Italian patients with IBD. Materials and methods: In February 2021 an online questionnaire focused on COVID-19 vaccine was proposed to a representative sample of Italian IBD patients. Socio-demographic characteristics, IBD features, lifestyle, perception of COVID-19, general attitude towards vaccinations and to COVID-19 vaccines were investigated. Patients were divided into willing, hesitant and refusive towards COVID-19 vaccine. The hesitation reasons were investigated. The associations between baseline characteristics and willingness (determinants) were evaluated by calculating crude and adjusted Odds Ratio (AdjOR) with 95% confidence intervals (CI). Results: A total of 1252 surveys were collected. 1005 (80.3%), 222 (18.1%) and 33 (2.63%) patients were defined as willing, hesitant and refusive, respectively. The baseline characteristics are shown below. Concerns for vaccine adverse effects constituted the main reason for refusal (73.4%) (Figure). 49.1% of hesitant patients reported that presence of IBD exerted an influence on their answer. Among the patients willing to be vaccinated whenever possible, 78.2% (786) thought that their IBD represented a valid motivation to access vaccination with priority. Willingness to COVID-19 vaccine was significantly associated with adherence to previous vaccinations (AdjOR 17.6;95% CI: 11.4-27.2), male gender (1.68 95%;CI: 1.16-2.43), graduation degree (1.48;95%;CI: 1.03-2.13), perceived higher risk of COVID-19 becaues of IBD (1.47;95% CI: 1.05-2.08), alcohol intake (1.69;95% CI: 1.16-2.45). Conversely, the hesitancy was significantly associated with complementary and alternative medicine use (0.58;95% CI: 0.36-0.92). 54.5% of patients were under the impression to have a higher risk of COVID-19 and 31.8% to have a more severe course due to their IBD. (figure presented) Conclusions: Most IBD patients would accept COVID-19 vaccines, although one in five was hesitant, primarily due to fear of adverse events. Knowledge of determinants and reasons for COVID-19 vaccination acceptance or refusal could be key in developing targeted communication strategies to fight vaccine hesitancy, also in the future for general vaccinations.
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OBJECTIVE: From September 2020, a second wave of COVID-19 pandemic started. We aimed at exploring the impact of SARS-CoV-2 infection in IBD patients during the two waves. PATIENTS AND METHODS: All IBD patients with a confirmed diagnosis of SARS-CoV-2 infection were enrolled. They were sorted into two groups (those infected before September 2020, and those from September 2020 to January 2021) and compared by demographic and clinical data. RESULTS: Twenty-five patients (out of about 600 with a follow-up visit) were infected with SARS-CoV-2 (4.1%). Sixteen were male and the mean age was 46.5 ± 14.3 years (range 24-74). Six were smokers and 11 had comorbidities; 2 were on steroids and 17 on immunosuppressants or biologics. Three patients (12%) needed hospitalization and other three patients were treated with azithromycin, steroids and LMWH, all of them during the second wave. No patient died or developed any sequelae. Two subjects were infected during the first wave (0.3 vs. 3.83, p<0.0001). Non-significant differences were found between the two groups. CONCLUSIONS: A higher number of IBD patients were infected during the second wave. No patient developed a severe form of pneumonia, even those treated with immunosuppressants or biologics. No risk factor for hospitalization was found.