Andrea Giordano

Background: Multiple sclerosis (MS) significantly affects individuals’ health-related quality of life (HRQoL). Ideally, HRQoL assessment tools for MS should be patient-centered, ensuring that each item meaningfully contributes to measurement precision. The present study has three main objectives: (1) a review of the literature to identify key HRQoL domains by examining existing instruments; (2) confirmation and integration of HRQoL domains based on stakeholders’ input; (3) systematic comparison of the categories and subcategories identified by the stakeholders with the domains identified in the literature review. Methods: Findings from the literature review were discussed in four focus group meetings (FGMs) with key stakeholders, including people with MS (PwMS) and healthcare professionals (HPs). Participants were purposively sampled to ensure diversity in geographic location, gender, education, and (for PwMS) disease severity. FGMs were audio-recorded, transcribed verbatim, and analyzed using qualitative content analysis by two independent researchers. The categories and subcategories generated from the qualitative analysis were then systematically compared with the items of the MS-specific HRQoL instruments identified in the literature review, by two independent researchers. Results: Out of 5190 references, 308 records related to 9 instruments were included in the literature review. The main HRQoL domains were then extracted and discussed with the steering committee, and informed the FGM grids. The results validated the HRQoL domains identified in literature and provided deeper insights into their complexity. Conclusion: This study confirmed and added granularity to the existing HRQoL domains relevant to PwMS, identifying key areas for inclusion in future research. The findings contribute to the development of a more comprehensive, patient-centered HRQoL assessment tool, which could inform targeted interventions to enhance quality of life in PwMS.

Background: The Benefit Finding Scale (BFS) is a 17-item measure assessing the perception of positive contributions to one’s life deriving from stressful and life-threatening conditions such as illnesses. We aimed to investigate construct validity (structural validity, measurement invariance between sub-samples, and convergent/divergent validity) and reliability (internal consistency) of the Italian version of the BFS in persons with multiple sclerosis (PwMS) and their caregivers. Methods: We used confirmatory factor analysis (CFA) to assess structural validity in terms of the proposed three-factor structure of the BFS. We performed multi-group CFA to assess measurement invariance between PwMS and their caregivers. To assess convergent/divergent validity, we calculated correlations of the BFS subscales with instruments measuring affect (PANAS), life satisfaction (SWLS), social support (MSPSS), depression (BDI-II), and quality of life (SF-36 and MSQoL-54). To appraise internal consistency, we calculated Cronbach’s alpha. Results: A total of 1359 PwMS and their caregivers completed the study. The three-factor structure of the BFS showed good fit (RMSEA 0.06; CFI 0.92; SRMR 0.05). Configural, metric and scalar invariance were confirmed. Convergent/divergent validity was supported. The BFS showed good internal consistency for ‘Acceptance and adjustment’ (alpha 0.82), ‘Family relations and sense of connectedness’ (alpha 0.84) and ‘Personal growth and authenticity’ (alpha 0.85). Conclusions: Results support the BFS as a valid and invariant three-factor measure of benefit finding among Italian PwMS and their caregivers. This scale use in clinical practice could help health professionals track participants’ experience of positive changes under adverse circumstances, as assets in managing stress and promoting illness adjustment.

Background: Patients undergoing elective endovascular treatment for cerebrovascular diseases (CBVD) may face mental health challenges that impact their quality of life (QoL). However, this issue is still rarely addressed in neuro-endovascular research literature and clinical practice. Our single center ongoing project ONIRIC aims to assess anxiety and depressive symptoms, coping, and QoL in CBVD patients treated via endovascular approaches. Methods: We prospectively enrolled a cohort of patients undergoing elective endovascular procedures over a 6-month period. Patients completed the State-Trait Anxiety Inventory (STAI-S and STAI-T), the Beck Depression Inventory-version II (BDI-II), the Brief Coping Orientation to Problems Experienced Inventory (Brief-Cope), the Euro-QoL 5D-5L, and the World Health Organization Disability Assessment Schedule (WHODAS 2.0) questionnaires at the baseline, and at discharge. Results: We included 25 patients (13 females): mean age 60 ± 12.5 years. There was a significant improvement in state anxiety and depressive symptom scores at discharge: the BDI-II scores significantly differed from the ones at baseline ( p < .01), as well as the STAI-S scores ( p < .01). The coping and QoL scores did not show any changes. Conclusions: To our knowledge, this research represents one of the few prospective studies examining the psychological and neuropsychological outcomes associated with elective neuro-endovascular treatment of CBDV. Despite the small sample size, our preliminary findings, are consistent with recent literature in related fields, contributing valuable insights to the broader understanding of how these factors influence clinical management. Future directions include the collection of follow-up data, essential for deepening our understanding of this complex and sensitive issue.

Background: Health-related quality of life (HRQoL) has emerged as a meaningful outcome measure in clinical trials and healthcare interventions in children with cerebral palsy (CwCP). We assessed the construct validity and internal consistency of the Italian version of the Paediatric QoL inventory (PedsQL^TM) 4.0 Generic Core Scales (GCS) and PedsQL^TM 3.0 Cerebral Palsy Module (CPM). Methods: A total of 125 CwCP and their parents were enrolled. Participants completed both the GCS and the CPM modules, and the results were compared to those of a sample of 121 healthy peers and their parents. The dimensionality of the two modules was assessed through exploratory factor analysis. Construct validity was assessed by a known-groups method evaluating the differences between CwCP and healthy sample. Results: Only a few GCS subscales were unidimensional, while all CPM subscales proved to be unidimensional, except for the Speech and Communication subscales of child self-reports. GCS internal consistency was good for all subscales of the parent proxy-reports, as well as for the Physical Activities and Psychosocial Health subscales of child self-reports. CPM internal consistency was good for both parent proxy-reports and—with a few exceptions—child self-reports. As for the PedsQL^TM validity, the GCS proved effective in discriminating between CwCP and healthy participants; the CPM showed a significant association between lower neurofunctional abilities and lower HRQoL. Parent–child concordance shows that child self-report scores were always higher than the those of the proxy-reports for both the GCS and CPM modules. Conclusions: The present study confirms the internal consistency and construct validity of the Italian version of both PedsQL^TM modules. In CwCP, greater functional disability resulted in lower HRQoL scores, and there was significant discrepancy between the parent and child ratings.

Purpose The Comprehensive assessment of Acceptance and Commitment Therapy (CompACT) is a 23-item questionnaire measuring psychological flexibility, a quality of life protective factor. An 18-item version was recently produced. We assessed validity and reliability of CompACT, and equivalence of paper and electronic (eCompACT) versions in people with multiple sclerosis (PwMS) in Italy, Germany and Spain. Methods We used confirmatory factor analysis and assessed CompACT-23 and CompACT-18 measurement invariance between the three language versions. We assessed construct validity (Spearman's correlations) and internal consistency (Cronbach’s alpha). Test–retest reliability (intraclass correlation coefficient, ICC) and equivalence of paper and eCompACT (ICC and linear regression model for repeated measures) were assessed in subsamples of PwMS. Results A total of 725 PwMS completed the study. The three-factor structure of the CompACT-23 showed poor fit (RMSEA 0.07; CFI 0.82; SRMR 0.08), while the fit of the CompACT-18 was good (RMSEA 0.05; CFI 0.93; SRMR 0.05). Configural and partial metric invariance were confirmed, as well as partial scalar invariance (reached when five items were allowed to vary freely). The CompACT-18 showed good internal consistency (all alpha ≥ 0.78); and test–retest reliability (all ICCs ≥ 0.86). Equivalence between paper and eCompACT was excellent (all ICCs ≥ 0.86), with no mode, order, or interaction effects. Conclusion Results support using the refined CompACT-18 as a three-factor measure of psychological flexibility in PwMS. Paper and eCompACT-18 versions are equivalent. CompACT-18 can be used cross-culturally, but sub-optimal scalar invariance suggests that direct comparison between the three language versions should be interpreted with caution.

Objectives: Implementation of advance care planning (ACP) in people with progressive multiple sclerosis (PwPMS) is limited. We aimed to involve users (PwPMS, significant others, and healthcare professionals involved in PwPMS care) in the evaluation and refinement of a booklet to be used during the ACP conversations. Methods: This qualitative study consisted of cognitive interviews with PwPMS and significant others and a focus group with healthcare professionals from three Italian centers. We analyzed the interviews using the framework method and the focus group using thematic analysis. Results: We interviewed 10 PwPMS (3 women; median age 54 years; median Expanded Disability Status Scale score 6.0) and three significant others (2 women; 2 spouses and one daughter). The analysis yielded three themes: booklet comprehensibility and clarity, content acceptability and emotional impact, and suggestions for improvement. Twelve healthcare professionals (7 neurologists, 3 psychologists, one nurse, and one physiotherapist) participated in the focus group, whose analysis identified two themes: booklet’s content importance and clarity and challenges to ACP implementation. Based on analysis results, we revised the booklet (text, layout, and pictures) and held a second-round interviews with two PwPMS and one significant other. The interviewees agreed on the revisions but reaffirmed their difficulty in dealing with the topic and the need for a physician when using the booklet. Conclusions: Appraisal of the booklet was instrumental in improving its acceptability and understandability before using it in the ConCure-SM feasibility trial. Furthermore, our data reveal a lack of familiarity with ACP practice in the Italian context.

Background: The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is one of the most commonly-used MS-specific health-related quality of life (HRQOL) measures. It is a multidimensional, MS-specific HRQOL inventory, which includes the generic SF-36 core items, supplemented with 18 MS-targeted items. Availability of an adaptive short version providing immediate item scoring may improve instrument usability and validity. However, multidimensional computerized adaptive testing (MCAT) has not been previously applied to MSQOL-54 items. We thus aimed to apply MCAT to the MSQOL-54 and assess its performance.Methods: Responses from a large international sample of 3669 MS patients were assessed. We calibrated 52 (of the 54) items using bifactor graded response model (10 group factors and one general HRQOL factor). Then, eight simulations were run with different termination criteria: standard errors (SE) for the general factor and group factors set to different values, and change in factor estimates from one item to the next set at < 0.01 for both the general and the group factors. Performance of the MCAT was assessed by the number of administered items, root mean square difference (RMSD), and correlation.Results: Eight items were removed due to local dependency. The simulation with SE set to 0.32 (general factor), and no SE thresholds (group factors) provided satisfactory performance: the median number of administered items was 24, RMSD was 0.32, and correlation was 0.94.Conclusions: Compared to the full-length MSQOL-54, the simulated MCAT required fewer items without losing precision for the general HRQOL factor. Further work is needed to add/integrate/revise MSQOL-54 items in order to make the calibration and MCAT performance efficient also on group factors, so that the MCAT version may be used in clinical practice and research.

Background: Advance care planning (ACP) is influenced by several factors (e.g., patient’s readiness to engage, clinician’s skills, and the cultural environment). Availability of reliable and valid self-reported measures of the ACP domains is crucial, including cross-cultural equivalence. Aim: To culturally adapt into Italian the 19-item Quality of Communication (QOC) and the 4-item ACP Engagement (4-item ACP-E) questionnaires. Methods: We translated and culturally adapted the two questionnaires and produced a significant other (SO) version of the QOC (QOC-SO). Each questionnaire was field tested via cognitive interviews with users: nine patients (QOC, 4-item ACP-E) and three SOs (QOC-SO) enrolled at three palliative care services. Results: We made minor changes to 5/19 QOC items, to improve clarity and internal consistency; we changed the response option ‘didn’t do’ into ‘not applicable’. Finally, we slightly revised the QOC to adapt it to the paper/electronic format. QOC debriefing revealed that the section on end of life was emotionally challenging for both patients and SOs. We simplified the 4-item ACP-E layout, added a sentence in the introduction, and revised the wording of one item, to improve coherence with the Italian ACP legislation. ACP-E debriefing did not reveal any major issue. Conclusions: Results were satisfactory in terms of semantic, conceptual and normative equivalence of both questionnaires. Acceptability was satisfactory for the 4-item ACP-E, while findings of the QOC cognitive debriefing informed a major amendment of a pilot trial protocol on ACP in multiple sclerosis (ConCure-SM): use of the interviewer version only, in an adaptive form. Psychometric testing of both questionnaires on a large, independent sample will follow.