Design and implementation of a mobile app for the pharmacotherapeutic follow-up of patients diagnosed with immune-mediated inflammatory diseases: eMidCare (Preprint)

2022 ◽  
Author(s):  
Rosa Romero-Jimenez ◽  
Vicente Escudero-Vilaplana ◽  
Esther Chamorro-de-Vega ◽  
Arantza Ais-Larisgoitia ◽  
Maria Elena Lobato Matilla ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthcare Professionals ◽  
Biological Therapy ◽  
Inflammatory Diseases ◽  
Injection Site Reaction ◽  
Mobile App ◽  
Biological Therapies ◽  
Patient Profile ◽  
Immune Mediated

BACKGROUND Pharmacotherapeutic management of immune-mediated inflammatory diseases (IMID) has become more complex due to the development of new treatments, such as biological therapies. Mobile health, especially apps, can provide IMID patients with greater autonomy and facilitate communication with healthcare professionals. OBJECTIVE Our objective was to design and implement an app for remote monitoring and communication with IMID patients. We also assessed the usability of and satisfaction with the app. METHODS A multidisciplinary group comprising pharmacists, dermatologists, rheumatologists, gastroenterologists, and nurses was created to design and develop an app for IMID patients in a tertiary hospital. The app functionalities were identified through a focus group with IMID patients and through an observational, cross-sectional, descriptive study of all available apps for IMID patients at App Store and Play Store platforms. Once the app was designed and developed, we started offering the app to all IMID patients who initiated a new biological therapy. We performed an observational, longitudinal study of patients followed using the app to assess the tool's impact on safety, communication, satisfaction, and usability. The inclusion period was from December 2020 to August 2021. The inclusion criteria were age ≥ 18 years, diagnosis of an IMID, and ownership of a Smartphone. Patients with language barriers were excluded. RESULTS We designed an app (eMidCare®) with the following modules: My Medication, My Questionnaires, Adverse Events, Useful Information, Messages, and Patient Profile. A total of 86 patients were installed with the app (the median age was 48.3 [18.1-79.4] years and 62.4 were female). The median (range) follow-up time for app use was 123 (5-270) days. In the My Medication module, 100% of patients registered their biological therapy and 25.9% also used this module to record each dose of medication administered. A total of 82 adverse events (AEs) were registered. Thirty-two percent of the patients registered at least 1 AE. The most frequent AEs were fatigue, injection site reaction, headache, and nausea. Fifty-two percent of patients used the Messages module to communicate with healthcare professionals. The most frequent messages concerned doubts about managing AEs (26.2%) and drug interactions (18.9%). The satisfaction survey yielded a median (range) score of 9.1 (7-10) out of 10. The app sections that patients browsed for the longest time were Messages (21.9%), Start screen (20.9%), My questionnaires (20.4%), My medication (8.8%), and Adverse events (7.1%). CONCLUSIONS We developed an app, eMidCare®, which reminds patients to take their medication, enables them to record AEs, and helps them communicate with healthcare professionals. Approximately one-third of the patients registered the administration of the biological therapies and registered at least 1 AE. The most used and most satisfactory functionality was communication with health professionals. Patient satisfaction and retention were very high.

scholarly journals Management of Patients under Treatment with Monoclonal Antibodies and New Biological Therapies

2021 ◽  
Vol 11 (11) ◽  
pp. 4865
Author(s):  
Marta Amigo-Basilio ◽  
Covadonga Álvarez-González ◽  
Carlos Cobo-Vázquez ◽  
Isabel Leco-Berrocal ◽  
Luis Miguel Sáez-Alcaide ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Conservative Treatment ◽  
Adverse Effects ◽  
Adverse Events ◽  
Oral Cavity ◽  
Study Design ◽  
Biological Therapy ◽  
Design Analysis ◽  
Biological Therapies ◽  
Analysis Of Cases

Objective: The aim of this study is to know the biological therapy drugs that are related to adverse events, what dental treatments are associated with the appearance of these events, their severity, and how they are resolved. Study design: Analysis of cases described in the literature on patients undergoing treatment with biological therapies who have developed adverse effects associated with these drugs. Results: Of the 62 articles reviewed, 49 describe 68 cases of MRONJ, most of which appeared in the jaw and received surgical and/or conservative treatment. Conclusions: Biological therapies can potentially develop adverse effects in the oral cavity, so strict monitoring by the dentist is necessary.

scholarly journals Sixth report of adverse events with biological treatments in Argentina. BIOBADASAR registry report

2019 ◽  
pp. 4-9
Author(s):  
G. Gómez ◽  
G. Pons-Estel ◽  
G. Citera ◽  
E. Soriano ◽  
V. Saurit ◽  
...  
Keyword(s):  
Adverse Events ◽  
Treatment Interruption ◽  
Biological Therapies ◽  
Biological Treatments ◽  
Registry Report

Objective: update the results of the BIOBADASAR registry on safety, duration and causes of treatment interruption after 8 years of follow-up. Methods: BIOBADASAR is a safety record of biological therapies established by the Argentine Society of Rheumatology. The description of BIOBADASAR 3.0 is presented, a cohort of 53 centers in Argentina followed prospectively from August 2010 to January 2018.

scholarly journals P374 Safety and drug survival of methotrexate versus tioguanine after failure of conventional thiopurines in patients with Crohn’s disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S390-S391
Author(s):  
E Savelkoul ◽  
M Maas ◽  
A Bourgonje ◽  
F Crouwel ◽  
M Russel ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Events ◽  
Biological Treatment ◽  
Biological Therapy ◽  
Secondary Outcome ◽  
Multi Centre Study ◽  
Drug Survival ◽  
Elevated Liver Enzymes

Abstract Background Both methotrexate (MTX) and tioguanine (TG) can be considered as viable treatment options before initiating biological therapy following failure of conventional thiopurines for Crohn’s disease. It is unclear how safety and effectiveness compare for both therapies. This study aimed to compare tolerability and drug survival of MTX and TG therapy after failure of conventional thiopurines in patients with Crohn′s disease. Methods We conducted a retrospective, multi-centre study in five Dutch hospitals, including patients initiating MTX or TG for Crohn’s disease after failure (all causes) of conventional thiopurines. Patients with prior MTX or TG use, MTX or TG not primarily prescribed for Crohn’s disease, or patients receiving concomitant biological treatment at baseline were excluded. Follow-up duration from starting treatment was 104 weeks or until treatment discontinuation. Primary outcome was therapy discontinuation rate due to adverse events (AE). Secondary outcome was ongoing treatment without initiation of biological treatment. Results In total, 221 patients with failure of conventional thiopurines and subsequent therapy with either MTX (n=106) or TG (n=115) were included. Median follow-up was 89 weeks (IQR 28-104). Previous biological failure was present in 28 (26%) MTX and 17 (15%) TG treated patients (p=0.044). Sixty-four (29%) patients (MTX 41.5%, TG 17.4%, p<0.001) discontinued their treatment due to AE during follow-up (Figure 1). Median time until discontinuation due to AE was 16.5 weeks (IQR 8.0–39.0) for MTX and 17.5 weeks (IQR 1.3–69.8) for TG (p=0.925). MTX use was associated with a significantly higher risk of treatment failure due to AE (OR 3.37 [95% CI 1.82–6.25] p<0.001). Previous biological failure was not predictive for MTX or TG failure due to AE (OR 1.086, p=0.828). The most frequent discontinuation reasons were nausea for MTX (n=11) and abdominal pain for TG (n=4). In both groups, 8 (MTX 8%, TG 7%) serious adverse events (SAE) occurred. Infections comprised the majority of all SAE, 4 (50%) for MTX and 7 (88%) for TG. Discontinuation because of elevated liver enzymes occurred in 5 (11%) MTX and 4 (20%) TG treated patients. There were no cases of histological nodular regenerative hyperplasia, liver fibrosis, or cirrhosis. Initiation of concomitant biological therapy was not significantly different (MTX: n=26, TG: n=30, p=0.877). Total monotherapy drug survival after 104 weeks was 46% for TG and 25% for MTX (p<0.001). Conclusion Forty-two percent of MTX, compared to 17% of TG treated patients, discontinued therapy due to AE in patients with Crohn’s disease with prior failure of conventional thiopurines. These data may aid in the selection of subsequent therapy after failure of conventional thiopurine therapy.

scholarly journals Prevalence of Hospital PCR Confirmed COVID-19 Cases in Patients with Chronic Inflammatory and Autoimmune Rheumatic Diseases

2020 ◽  
Author(s):  
José L. Pablos ◽  
Lydia Abasolo-Alcázar ◽  
José M. Álvaro-Gracia ◽  
Francisco J. Blanco ◽  
Ricardo Blanco ◽  
...  
Keyword(s):  
Rheumatic Diseases ◽  
Lupus Erythematosus ◽  
Inflammatory Diseases ◽  
Age Distribution ◽  
Reference Population ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Immune Mediated ◽  
Specific Factors

ABSTRACTBackgroundThe susceptibility of patients with rheumatic diseases, and the risks or benefits of immunosuppressive therapies for COVID-19 are unknown.MethodsWe performed a retrospective study with patients under follow-up in rheumatology departments from seven hospitals in Spain. We matched updated databases of rheumatology patients with SARS-CoV-2 positive PCR tests performed in the hospital to the same reference populations. Rates of PCR+ confirmed COVID-19 were compared among groups.ResultsPatients with chronic inflammatory diseases had 1.32-fold higher prevalence of hospital PCR+ COVID-19 than the reference population (0.76% vs 0.58%). Systemic autoimmune or immune mediated diseases (AI/IMID) patients showed a significant increase, whereas inflammatory arthritis (IA) or systemic lupus erythematosus (SLE) patients did not. COVID-19 cases in some but not all diagnostic groups had older ages than cases in the reference population. IA patients on targeted-synthetic or biological disease-modifying antirheumatic drugs (ts/bDMARD), but not those on conventional-synthetic (csDMARD), had a greater prevalence despite a similar age distribution.ConclusionPatients with AI/IMID show a variable risk of hospital diagnosed COVID-19. Interplay of aging, therapies, and disease specific factors seem to contribute. These data provide a basis to improve preventive recommendations to rheumatic patients and to analyze the specific factors involved in COVID-19 susceptibility.

scholarly journals A Brazilian Cohort of Patients With Immuno-Mediated Chronic Inflammatory Diseases Infected by SARS-CoV-2 (ReumaCoV-Brasil Registry): Protocol for a Prospective, Observational Study

10.2196/24357 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e24357
Author(s):  
Claudia Marques ◽  
Adriana Maria Kakehasi ◽  
Ana Paula Monteiro Gomides ◽  
Eduardo Dos Santos Paiva ◽  
Edgard Torres dos Reis Neto ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Inflammatory Diseases ◽  
Progression Rate ◽  
Immune Mediated ◽  
Increased Risk ◽  
Observational Cohort ◽  
And Function ◽  
The Impact ◽  
Brazilian Cohort

Background Patients with immune-mediated rheumatic diseases (IMRD) are at increased risk of infections, including significant morbidity and high mortality. Considering the potential for unfavorable outcomes of SARS-CoV-2 infection in patients with IMRD, several questions were raised regarding the impact of COVID-19 at the start of the pandemic. Objective This paper presents the protocol of a study that aims to prospectively evaluate patients with IMRD and a confirmed COVID-19 diagnosis (using criteria provided by the Brazilian Ministry of Health). Methods The study comprised a prospective, observational cohort (patients with IMRD and COVID-19) and a comparison group (patients with only IMRD), with a follow-up time of 6 months to evaluate differences in health outcomes. The primary outcomes will be changes in IMRD disease activity after SARS-CoV-2 infection at 4 time points: (1) at baseline, (2) within 4-6 weeks after infection, (3) at 3 months after the second assessment (±15 days), and (4) at 6 months (±15 days). The secondary outcomes will be the progression rate to moderate or severe forms of COVID-19, need for intensive care unit admission and mechanical ventilation, death, and therapeutic changes related to IMRD. Two outcomes—pulmonary and thromboembolic events in patients with both IMRD and SARS-CoV-2 infection—are of particular interest and will be monitored with close attention (clinical, laboratory, and function tests as well as imaging). Results Recruitment opened in May 2020, with 1300 participants recruited from 43 sites as of November 2020. Patient recruitment will conclude by the end of December 2020, with follow-up occurring until April 2021. Data analysis is scheduled to start after all inclusion data have been collected, with an aim to publish a peer-reviewed paper in December 2020. Conclusions We believe this study will provide clinically relevant data on the general impact of COVID-19 on patients with IMRD. Trial Registration Brazilian Registry of Clinical Trials RBR-33YTQC; http://www.ensaiosclinicos.gov.br/rg/RBR-33ytqc/ International Registered Report Identifier (IRRID) DERR1-10.2196/24357

Usability, user experience and acceptance evaluation of CAPACITY: a technological ecosystem for remote follow-up of frailty (Preprint)

2021 ◽  
Author(s):  
Rodrigo Pérez-Rodríguez ◽  
Elena Villalba-Mora ◽  
Myriam Valdés-Aragonés ◽  
Cristian Moral-Martos ◽  
Marta Mas-Romero ◽  
...  
Keyword(s):  
Adverse Events ◽  
User Experience ◽  
Older Persons ◽  
Research Work ◽  
Mobile App ◽  
Design Stage ◽  
Final Sample ◽  
System Usability Scale ◽  
Frail Older Persons

BACKGROUND Frailty is a highly prevalent condition that predisposes older persons to adverse events. According to the WHO, there is a pressing need to develop comprehensive community-based approaches, and to introduce interventions to prevent functional decline. In this regards, Information and Communication Technologies can play a crucial role to promote ageing in place, for instance by collecting fresh and periodic information on variables associated to poor health outcomes. The CAPACITY technological ecosystem tackles this problem, providing a means to remotely monitor variables with high predictive power for adverse events (ie, gait speed, muscle power and involuntary weight loss) that enable personalized early interventions aimed to prevent disability. OBJECTIVE This study aims to present a novel mobile app designed using a participatory methodology to be used by frail older persons to interact with the services offered by the CAPACITY technological ecosystem, Furthermore, this research work pursues evaluating its usability, user experience and acceptance. METHODS Usability, User Experience and acceptance were assessed at 3 different sampling points during 6 months of continued use of CAPACITY to receive a multicomponent intervention to prevent/reverse frailty. Usability was assessed using the System Usability Scale (SUS); User Experience using the User Experience Questionnaire (UEQ); and acceptance with the Technology Acceptance Model (TAM) and a customized quantitative questionnaire. Data were collected at baseline (recruitment), and after 3 and 6 months of use. RESULTS Forty-six participants used the technology for six months at their homes, and 9 dropped out during the follow-up, leaving a final sample of 37 subjects. All of them completed the questionnaires about usability, user experience and acceptance evaluation in the intermediate and final sample collection points; 25 subjects completed the whole evaluation set at baseline. Usability, measured as SUS reached a maximum averaged value of 83.68 after 6 months of use; no statistically significant values have been found to demonstrate that usability improves with use. User experience, measured as UEQ, obtained averages scores higher or very close to 2 in all 6 categories. Finally, acceptance in terms of TAM reached a maximum of 51.54 points, showing an improvement trend. CONCLUSIONS Results indicate the success of the participatory methodology, and support User Centered Design as the key methodology to follow when designing technologies for frail older persons. Involving potential end users and giving them voice during the design stage maximizes usability and acceptance.

Risk of tuberculosis in patients with immune-mediated diseases on biological therapies: a population-based study in a tuberculosis endemic region

Rheumatology ◽  
2018 ◽  
Vol 58 (5) ◽  
pp. 803-810 ◽  
Author(s):  
Xing Wang ◽  
Sunny H Wong ◽  
Xian-Song Wang ◽  
Whitney Tang ◽  
Chang-Qin Liu ◽  
...  
Keyword(s):  
General Population ◽  
Population Based ◽  
Hazard Ratio ◽  
Tnf Inhibitor ◽  
Biological Therapies ◽  
Standardized Incidence Ratio ◽  
Endemic Region ◽  
Immune Mediated ◽  
Increased Risk

Abstract Objective Real-world epidemiological data on the risk of tuberculosis (TB) in patients with immune-mediated diseases treated with biologics are scarce in TB endemic areas. We investigated the incidence of TB in a population-based setting and stratified the risk of TB among different biological therapies. Methods We collected medical data from a territory-wide computerized database in Hong Kong. We reported the incidence of TB in patients treated with various classes of biologics, and calculated standardized incidence ratio by comparing with the general population. Subgroup analyses were performed based on disease subtypes and biological drugs. Results Among 2485 subjects with immune-mediated diseases (82.5% rheumatology diseases; 10.6% IBD; 6.9% dermatology diseases), 54 subjects developed active TB during 6921 person-years of follow-up. The mean age (±s.d.) was 43 (14) years, and the median follow-up duration was 24.9 months (interquartile range 4.9–45.0). The overall standardized incidence ratio of TB was 10.91 (95% CI 8.00–13.82), and patients treated with infliximab had a nearly 26 times increased risk of TB compared with the general population (standardized incidence ratio 25.95; 95% CI 17.23–34.67). The risk of TB with TNF inhibitor was higher than with a non-TNF biologic (hazard ratio 4.34; 95% CI 1.31–14.39), while the risk of infliximab was higher than etanercept and adalimumab (hazard ratio: 4.10 and 2.08, respectively). Conclusion The risk of TB is much higher in patients with immune-mediated diseases on biological therapy compared with the general population, and infliximab is associated with the highest risk of TB among the biologics analysed.

Safety of Recombinant Zoster Vaccine: a Retrospective Study of 622 Rheumatology Patients

Rheumatology ◽  
2021 ◽  
Author(s):  
Tiphaine Lenfant ◽  
Yuxuan Jin ◽  
Elizabeth Kirchner ◽  
Rula A Hajj-Ali ◽  
Leonard H Calabrese ◽  
...  
Keyword(s):  
Inflammatory Diseases ◽  
Cox Model ◽  
Patient Portal ◽  
Single Center ◽  
Zoster Vaccine ◽  
Treatment Change ◽  
Immune Mediated ◽  
Recombinant Zoster Vaccine ◽  
Insight Into

Abstract Objectives To provide insight into the safety of Recombinant Zoster Vaccine (RZV) in patients with Immune-Mediated Inflammatory Diseases (IMID). Methods Patients who received RZV in a single center Rheumatology Department were retrospectively included. An IMID flare was defined as a) a documentation of flare in the office notes or patient portal communication or b) new prednisone prescription, in the 12 weeks after each dose. Results Six-hundred twenty-two patients were included (67% female, median age 67 years), 8.5% of them experienced AEs and HZ incidence was 0.6% after median follow-up of 36 weeks. Of 359 IMID patients: 88 had RA (25%), 50 vasculitis (14%), 29 PMR (8%). At vaccination, 35% were on glucocorticoids (GC). Fifty-nine patients (16%) experienced a flare, 18 flares occurred in temporal relation to a treatment change (31%). RA patients had the highest flare rate (n = 21, 24%), 25% of patients who flared required adjustment of immunosuppression. In a multivariate analysis, use of GC at time of vaccination was associated with flare after vaccination (OR 2.31 [1.3-4.1], p = 0.004). A time-to-flare survival analysis (Cox-model) showed that GC was a significant predictor of IMID flare after first RZV dose (HR 2.4 [1.3-4.5], p = 0.0039) and that a flare after the first dose was associated with flaring after the second RZV dose (HR 3.9 [1.7-9], p = 0.0015). Conclusion RZV administration in patients with IMIDs was generally well-tolerated, though mild flares were not uncommon in the first 12 weeks after vaccination. These data may provide useful information for patient education when considering RZV administration.

Sign in / Sign up

Export Citation Format

Share Document