Use of digital health tools in inflammatory bowel disease. / Uso de herramientas digitales en salud en enfermedad inflamatoria intestinal.

OBJECTIVE: To analyse the characteristics and use of digital health tools (DHT) in inflammatory bowel disease (IBD). METHODS: We performed a qualitative study based on a narrative literature review, a questionnaire and on the opinion of 3 expert gastroenterologists. Several searches were carried out until September 2022 through Medline to identify articles on the use of DHT in IBD by healthcare professionals. A structured questionnaire was designed to be answered by health professionals involved in the care of patients with IBD. The experts generated a set of recommendations. RESULTS: There are multiple DHT for IBD with different characteristics and contents. We received 29 questionnaires. Almost 50% of the participants were 41-50 years old, the majority were women (83%) and 90% were gastroenterologists. A total of 96% reported the use of several DHT, but 20% used them occasionally or infrequently. Web pages were found the most used (62%). DHT are mostly used to get information (80%), followed by clinical practice issues (70%) and educational purposes (62%). G-Educainflamatoria website is the best known and most used HDS (96% and 64%, respectively). The main barriers to the use of DHT in IBD were the lack of time (55%), doubts about the benefit of DHT (50%) and the excess of information (40%). CONCLUSIONS: Healthcare professionals involved in the care of patients with to IBD frequently use DHT, although actions are needed to optimize their use and to guarantee their efficient and safe use.

Medical consultation in ulcerative colitis: Key elements for improvement.

Ulcerative colitis (UC) is a chronic inflammatory disease with a high impact. In order to improve patient outcomes, the clinician-patient relationship in daily practice is critical. Clinical guidelines provide a framework for UC diagnosis and treatment. However, standard procedures and the medical content focused upon medical consultations in UC patients has not yet been defined. Moreover, UC is a complex disease, given that patient characteristics and patient needs have been proven to vary during clinical consultation since establishing the diagnosis and upon the course of the disease. In this article, we have discussed the key elements and specific objectives to consider in medical consultation, such as diagnosis, first visits, follow-up visits, active disease patients, patients on topical therapies, new treatment initiation, refractory patients, extra-intestinal manifestations, as well as challenging situations. The key elements have been mentioned to comprise effective communication techniques, motivational interviewing (MI), as well as information and educational aspects, or organizational issues. The key elements to be implemented in daily practice were reported to comprise several general principles like duly prepared consultations, in addition to honesty and empathy with patients, as well as effective communication techniques, MI, information and educational points, or organizational issues. The role of other healthcare professionals such as specialized nurses, psychologists, or the use of checklists was also discussed and commented on.

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)

Cost-effectiveness analysis of using innovative therapies for the management of moderate-to-severe ulcerative colitis in Spain.

BACKGROUND: To evaluate the cost-effectiveness of tofacitinib in comparison to vedolizumab for the treatment of moderate-to-severe ulcerative colitis (UC) after failure or intolerance to conventional therapy (bio-naive) or first-line biologic treatment (bio-experienced), from the Spanish National Health System (NHS) perspective. METHODS: A lifetime Markov model with eight-week cycles was developed including five health states: remission, response, active UC, remission after surgery, and death. Response and remission probabilities (for induction and maintenance periods) were obtained from a multinomial network meta-analysis. Drug acquisition - biosimilar prices included - (ex-factory price with mandatory deductions), administration, surgery, patient management, and adverse event management costs (€, year 2019) were considered. A 3% discount rate (cost/outcomes) was applied. Probabilistic and deterministic sensitivity analyses (PSA) were conducted. RESULTS: Tofacitinib was dominant versus vedolizumab (both in bio-naive and bio-experienced patients) entailing total cost savings of €23,816 (bio-naïve) and €11,438 (bio-experienced). Differences in quality-adjusted life-year (QALY) were smaller than 0.1 for both populations. PSA results showed that tofacitinib has a high probability of being cost-effective (bio-naïve: 82.5%; bio-experienced: 90.6%) versus vedolizumab. CONCLUSIONS: From the Spanish NHS perspective, tofacitinib could be a dominant treatment (less costly and more effective) in comparison to vedolizumab, with relevant cost savings and similar QALY gains.

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.

Consensus document on the management preferences of patients with ulcerative colitis: points to consider and recommendations.

BACKGROUND AND AIMS: Our objective was to define, describe and organize (on the basis of consensus) the patient's preferences in the management of ulcerative colitis (UC), in order to further incorporate them in daily practice and improve patients satisfaction, adherence to the treatment and quality of care. METHODS: Qualitative study. A narrative literature review in Medline using Mesh and free-text terms was conducted to identify articles on UC patient preferences as well as clinical scenarios that may influence the preferences. The results were presented and discussed in a multidisciplinary nominal group meeting composed of six gastroenterologists, one primary care physician, one nurse practitioner and one expert patient. Key clinical scenarios and patient preferences were then defined, generating a series of points to consider and recommendations. The level of agreement with the final selection of preferences was established following a Delphi process. RESULTS: The narrative review retrieved 69 articles of qualitative design and moderate quality. The following key clinical scenarios were identified: diagnosis, follow-up, surgery, and special situations/patients profiles such as adolescents or women. Patient preferences were classified into information, treatment (pharmacological and non-pharmacological), follow-up, relations with health professionals, relations with the health system and administration. Finally, 11 recommendations on patient preferences for UC in relation to its management reached the level of agreement established. CONCLUSION: The consensual description of patient's preferences contribute to identify different areas for improvement in healthcare practice.

Disease features associated with a low disease impact in patients with psoriatic arthritis: results of a cross-sectional multicenter study.

BACKGROUND: Patient-reported outcomes measures, such as those provided by the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire, have been found to be a reliable indicator of change during treatment, predictive of long-term outcomes, and the impact of psoriatic arthritis (PsA) on patients' lives. The objective of the study was to describe the demographic and clinical characteristics of PsA patients with a low disease impact and to analyze predictive factors for that state. METHODS: Post hoc analysis of a cross-sectional multicenter study that included 223 consecutive patients. PsAID questionnaire was used to estimate disease impact. Patients with a PsAID < 4 were considered in low disease impact. Minimal disease activity (MDA) response and the Health Assessment Questionnaire (HAQ) were also assessed. The degree of agreement between the different outcomes was addressed by Cohen's kappa index. RESULTS: One hundred and twenty-two (54.7%) patients reached a PsAID < 4. Among them, 52.0% and 68.0% presented articular or skin remission, respectively. Almost 75% of patients were in MDA state and 85.2% presented a low disability state according to the HAQ. A moderate concordance between HAQ ≤ 0.5 and PsAID < 4 (k = 0.53), fair between MDA and PsAID < 4 (k = 0.36), and moderate between DAPSA remission and PsAID < 4 (k = 0.46) was observed. Multivariate logistic regression analysis showed that patients with distal interphalangeal joint (DIP) disease (OR 0.40, 95%CI, 0.20-0.79, p = 0.009), family history of PsA (OR 0.25, 95%CI, 0.09-0.72, p = 0.010), and higher C-reactive protein (OR 0.92, 95%CI, 0.85-0.99, p = 0.036) were significantly less likely to reach a PsAID < 4. CONCLUSIONS: There is certain discrepancy between disease activity measures and a low impact of disease in PsA. Clinical features (DIP joint involvement), biologic activity, and genetic factors (familial history) seem to be associated with lower odds of reaching a low disease impact.

Very Low Disease Activity, DAPSA Remission, and Impact of Disease in a Spanish Population with Psoriatic Arthritis.

OBJECTIVE: To examine the grade of agreement between very low disease activity (VLDA) and Disease Activity Index for Psoriatic Arthritis (DAPSA) remission, as well as their association with the effect of the disease as assessed by the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire in patients with psoriatic arthritis in routine clinical practice. METHODS: Posthoc analysis of data from a cross-sectional multicenter study. Patients were included who fulfilled the Classification for Psoriatic Arthritis (CASPAR) criteria with at least 1 year of disease duration and were treated with biological and/or conventional synthetic disease-modifying antirheumatic drugs according to routine clinical practice in Spain. Patients were considered in VLDA if they met 7/7 of the minimal disease activity criteria. DAPSA and clinical (c)DAPSA score ≤ 4 identified remissions. RESULTS: Of the 227 patients included in the original study, 26 (11.5%), 52 (22.9%), and 65 (28.6%) were in VLDA, DAPSA remission, and cDAPSA remission, respectively. There was a moderate agreement between VLDA and DAPSA remission (κ = 0.52) or cDAPSA remission (κ = 0.42). Patients with VLDA had less effect of the disease as measured by PsAID [mean total score (SD): VLDA 1.1 (1.2); DAPSA remission 1.3 (1.5); cDAPSA remission 1.7 (1.6)]. There was a moderate agreement between DAPSA remission or cDAPSA remission and PsAID < 4 (κ = 0.46 and κ = 0.58 respectively), while poor agreement (κ = 0.18) was found between VLDA and PsAID < 4. CONCLUSION: VLDA criteria seem to be more stringent for assessing a status of remission; however, DAPSA remission shows better correlation with a patient-acceptable symptoms state than VLDA does.

Drug immunogenicity in patients with inflammatory arthritis and secondary failure to tumour necrosis factor inhibitor therapies: the REASON study.

Objectives: The aims were to evaluate the prevalence of anti-drug antibodies (ADA) in patients with RA or SpA experiencing secondary failure to anti-TNF therapy and to correlate ADA presence with anti-TNF concentration and clinical response. Methods: This was a cross-sectional, observational study of patients with active RA or SpA experiencing secondary failure to etanercept (ETN), infliximab (INF) or adalimumab (ADL). Concomitant non-biologic DMARDs were permitted. Serum anti-TNF and ADA levels were measured with two-site ELISA. Results: Among 570 evaluable patients, those with RA (n = 276) were mostly female (80 vs 39%), older (56 vs 48 years), received concomitant DMARDs (83 vs 47%) and had maintained good clinical disease control for longer (202 vs 170 weeks) compared with patients with SpA (n = 294). ADA were found in 114/570 (20.0%) patients; 51/188 (27.1%) against INF and 63/217 (29.0%) against ADL; none against ETN. Of these 114 patients, 92 (81%) had no detectable serum drug concentrations. Proportionately more patients with SpA (31.3%) had anti-INF antibodies than those with RA (21.1%; P = 0.014). A significantly lower proportion of patients receiving concomitant DMARDs (16.5%) developed ADA than those on monotherapy (26.4%; P < 0.05). Conclusion: In patients with RA or SpA and secondary failure, the development of ADA against ADL or INF, but not ETN, appears to be one of the main reasons for secondary treatment failure, but not the only one. Further investigations are needed to determine other causes of anti-TNF failure.

Minimal disease activity and impact of disease in psoriatic arthritis: a Spanish cross-sectional multicenter study.

BACKGROUND: Patients with psoriatic arthritis (PsA) experience functional impairment and reduced quality of life, and thus patient global assessment in PsA is explained mainly by the physical, but also by the psychological, aspect of the disease. To assess the prevalence of minimal disease activity (MDA) in Spanish patients with PsA, we examined their characteristics and the association between MDA and the impact of the disease as assessed by the PsA Impact of Disease (PsAID) questionnaire. METHODS: A cross-sectional multicenter study was carried out in patients who fulfilled the Classification for Psoriatic Arthritis (CASPAR) criteria with at least 1 year of disease duration, and who were treated with biological or conventional synthetic (cs) disease-modifying anti-rheumatic drugs (DMARDs) according to routine clinical practice in Spain. Patients were considered in MDA if they met at least 5/7 of the MDA criteria. The association between MDA and the recently developed PsAID questionnaire was also recorded. RESULTS: Of 227 patients included, 133 (58.6%) were in the MDA state (52% with antitumor necrosis factor (anti-TNF)α monotherapy, 24% with csDMARD monotherapy, and 24% with anti-TNFα in combination with csDMARD). Using multivariate logistic regression analysis, male gender (odds ratio (OR) 2.74, p = 0.001), a sedentary lifestyle (OR 3.13, p = 0.002), familial history of PsA (OR 0.38, p = 0.036), C-reactive protein (CRP) level (OR 0.92, p = 0.010), and use of corticoids (OR 0.33, p = 0.007) were considered features related to MDA. MDA patients had a significantly lower impact of the disease according to PsAID (mean total score (SD): MDA 3.3 (3.1) vs. non-MDA 7.1 (5.2); p < 0.001). CONCLUSIONS: Nearly 60% of Spanish PsA patients achieve MDA in routine clinical practice. MDA remains one of the most useful therapeutic targets for PsA since patients who reached this state also had a significantly lower impact of disease according to PsAID.