Translation and validation in Italian of the methotrexate intolerance severity score for children and adults with arthritis.

OBJECTIVES: Methotrexate (MTX) is the most used drug to treat children and adults with arthritis and its use is burdened by adverse effects. The MTX intolerance severity score (MISS) was developed in English to identify patients who are intolerant to MTX. The aim of this study was to translate and validate the MISS in Italian. METHODS: The Italian version of the MISS was developed following the "guidelines for process of cross-cultural adaptation of self-reported measures". The Italian version of the MISS was validated in 125 patients with juvenile idiopathic arthritis (JIA) followed at the Rheumatology Unit of Bambino Gesù Children Hospital. We assessed the construct validity and calculated the internal consistency of the Italian MISS. We performed ROC analysis to assess the overall performance of the Italian MISS. RESULTS: We translated and adapted the MISS to the Italian language. The Italian MISS showed a very good internal consistency as shown by a Cronbach α of 0.87 (95% CI, 0.84-0.90) and a composite reliability of 0.89 (95% CI, 0.83-0.91).The Cohen's κ was 0.81 (95% CI, 0.71-0.91), suggesting a very good construct validity. The ROC analysis showed an area under the curve (AUC) of 0.97 (95% CI, 0.93-0.99). A threshold of 6 to define intolerant patients, showed a sensitivity of 98.3% and specificity of 81.2%. CONCLUSIONS: We developed the Italian version of the MISS and showed its validity and reliability to identify patients intolerant to MTX in clinical practice and in a research setting.

Childhood traumatic events, alexithymia and perceived stress in patients with rheumatoid arthritis during the COVID-19 pandemic.

Rheumatoid arthritis (RA) is a chronic inflammatory disease, causing joint-swelling and pain. International literature highlights that patients with RA are more likely to report high levels of alexithymia, adverse childhood events (ACEs) and stress, but studies investigating the association between these dimensions are lacking. The general aim of the present study is to investigate the association between alexithymia, ACEs, and stress in RA patients and to highlight possible predictors of greater perceived stress. One hundred and thirty-seven female patients with RA (mean age = 50.74; SD = 10.01) participated in an online survey between April and May 2021. Participants completed a questionnaire for the collection of sociodemographic and clinical information, the 20-item Toronto Alexithymia Scale, the Adverse Childhood Events questionnaire and the 10-item Perceived Stress Scale. The correlational analysis highlighted several significant associations between the dimensions evaluated. Regression analyses showed that alexithymia, ACEs and the perceived health status have a predictive effect on the perceived stress of RA patients. More specifically, the role of difficulty in identifying feelings, and the physical and emotional neglect, has been highlighted. ACEs and high levels of alexithymia are common in RA clinical populations and seem to affect the wellbeing of these patients. The use of a biopsychosocial approach to RA treatment appears essential in achieving a better quality of life and illness control in this specific clinical population.

Patient Experience of Integrated Care: Findings from a Cross-Sectional Study Involving People with Rheumatic and Musculoskeletal Diseases.

Introduction: Although the patient experience of integrated care has been documented for several chronic conditions, little is known in the context of rheumatic and musculoskeletal diseases (RMDs). This study provides a first overview of the patient experience of integrated care according to the perspective of people living with RMDs in Italy. Methods: A cross-sectional survey was administered to 433 participants who reported their experiences together with the importance assigned to different attributes of integrated care. Explorative factor analysis (EFA) and non-parametric ANOVA and ANCOVA statistical tests were employed to account for the differences in the answers provided by sample subgroups. Results: Two factors (namely, "Person-centred care" and "Health service delivery") were extracted in the EFA. Participants attributed high importance to both of them. Overall positive experiences were reported only for Person-centred care. The delivery of health services instead received a poor evaluation. Significantly worse experiences were observed for women and people that were either older, unemployed, with comorbidities or lower self-reported health, or less engaged in their healthcare management. Conclusions: Italians with RMDs described integrated care as an important approach to care. However, further effort is needed to allow them to perceive an actual benefit from integrated care practices. Specific attention should be paid to disadvantaged and/or frail population groups.

A consensus-based approach on the management of patients with both psoriasis and psoriatic arthritis in the dermatological and rheumatological settings in Italy: The ADOI PSO-Amore Project.

Psoriasis is a complex disease often needing a multidisciplinary approach. In particular, the collaboration between dermatologist and rheumatologist is crucial for the management of patients suffering from both psoriasis (PSO) and psoriatic arthritis (PsA). Here we report a series of recommendations from a group of experts, as a result of a Consensus Conference, defining the circumstances in which it is preferable or even mandatory, depending on the available settings, to rely on the opinion of the two specialists, jointly or in a deferred manner. Indications are given on how to organize a 3rd level joint Dermatology- Rheumatology care unit, in connection with 1st and 2nd level clinicians of both specialties, GPs, and other specialists involved in the management of psoriasis. A potential patient journey is suggested, that can be used as a basis for future design and validation of national and/or local diagnostic therapeutic and assistance pathways.

Position paper of Italian rheumatologists on the use of biosimilar drugs.

The recent availability of biosimilars as a result of the expiry of the patents of first-generation biotechnological drugs may theoretically reduce the direct costs of such treatments, making their use accessible to a larger number of patients. However, the currently available clinical data refer to a relatively small number of patients, and do not provide sufficient information concerning long-term efficacy and safety or the frequency of rare adverse events. Given the importance of the introduction of biosimilar drugs and the limitations of our current knowledge of their efficacy and safety profiles, we believe it is mandatory to draw up a position paper for Italian Rheumatologists. Moreover, in order to guarantee their safety, it is mandatory to indicate behavioural rules for the involved specialists and competent authorities, and perform ad hoc clinical trials and appropriate drug surveillance.