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PurposeIn conservative early onset scoliosis treatment, interest in bracing is growing because repeated general anaesthesia (required by casting) has been questioned for possible brain damages. We aimed to check the results in the medium term of bracing, comparing idiopathic (IIS) to secondary (SIS) infantile scoliosis.MethodsWe performed a retrospective study in a consecutive prospective cohort. Inclusion criteria were: discovery of scoliosis and bracing below age 3; exclusion criteria: previous spine surgery, less than three consultations. We considered the following results: full (< 20° Cobb) and partial (< 30°) success; hold-up (progression < 5° but curve > 29°); partial (progression > 5°) and full (fusion) failure; statistics: ANOVA for repeated measures; linear mixed effect model with Cobb angle (dependent), time and diagnosis (independent) variables.ResultsWe included 34 infants (16 IIS and 18 SIS) of age 1·10 ± 0·10 (years·months), 44 ± 17° curves, 27 ± 10° rib vertebral angle difference, average observation 5·05 ± 3·03 years. We found progressive improvement of IIS and stability of SIS patients. Six IIS (37.5%) and one SIS (6%) reached brace weaning before puberty with 13 ± 5° (improvement 61 ± 15%, p < 0.001), after 4·11 ± 3·07 years of treatment. Three patients were fused, one IIS (6%) and two SIS (11%). Two IIS patients also reached end-of-growth with 18° (start 40° at 1·03 years) and 20° (start 32° at 2·12 years), respectively.ConclusionBracing shows promising results in the medium term for high-degree IIS, with very few hold-ups (19%) and failures (12%). Conversely, failures prevail for SIS (full 11%), even if the partial failure (39%) is still a time-buying strategy.

PurposeAdult scoliosis is sometimes associated with back pain and severe curves can progress over time. Despite scoliosis has been estimated to affect up to 68% of the population over 60, there is scant literature about conservative treatment for adult scoliosis. Recently, we tested a new brace designed to alleviate pain for adult patients with chronic pain secondary to scoliosis. The study aims to test the efficacy of a prefabricated brace in reducing pain in adult scoliosis patients.MethodsTwenty adults (age 67.8 ± 10.5, curve 61.9 ± 12.6° Cobb) with chronic low back pain (cLBP) secondary to Idiopathic Scoliosis (IS) were included. Patients were evaluated at baseline immediately before starting with the brace and after 6 months. Outcome measures were GRS, Oswestry Disability Index (ODI), Roland Morris Questionnaire (RM), COMI. The paired t test, ANOVA and Wilcoxon tests were used for statistical analysisResultsAt six months, worst pain, leg pain and back pain were significantly improved: from 7.15 to 5.60, from 5.65 to 4.35 and from 6.55 to 5.25 (p < 0.05). Sixty-five percent of patients achieved the minimal clinically important difference of 2 points for worst pain and leg pain, 55% for back pain. RM and COMI improved (p < 0.05), no differences for ODI.ConclusionThe prefabricated brace showed a significant improvement at 6 months of worst, leg and back pain in most patients in a group of adult women with IS and cLBP. The quality of life didn’t change in a clinically significant way even if the patients reported satisfaction with the treatment. Trial registration number and date of registration: ClinicalTrials.gov Identifier: NCT02643290, December 31, 2015.

Background:The efficacy of belimumab in reducing disease activity in Systemic Lupus Eythematosus (SLE) has been extensively explored across clinical trials and real-life studies (1, 2). However, few studies have evaluated its efficacy upon stratification for different skin and joint phenotypes.Objectives:To assess potential disparity in efficacy of belimumab on different skin and joint manifestations from a multicentre nation-wide cohort (BeRLiSS).Methods:Adult SLE patients treated with belimumab (intravenous 10 mg/kg monthly or subcutaneous 200 mg weekly) included in the pre-existing BeRLiSS cohort (1, 2) were retrospectively analysed. Participating centres were asked to enrich the old BeRLiSS database with these new variables: skin (acute, subacute, chronic, skin vasculitis, alopecia/lupus hair, livedo reticularis, ulcer/chilblain) and joint involvement (non-deforming non-erosive arthritis – NDNE -, Jaccoud’s arthropathy, and rhupus). These different subtypes were assessed for variation in DAS28, CLASI-A (Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity), SRI-4 (SLE responder Index-4) and SLEDAI-2K scores at baseline, 12 and 24 months. Parametric and non-parametric tests were used as appropriate.Results:A total of 312 patients was recruited, 284 females and 28 males, F:M ratio 9.9:1, mean age at diagnosis 29.1±12.7 years, mean treatment duration 52.2±38.0 months. At belimumab initiation 213 patients with joint manifestations (68.3%) were identified: 174 NDNE (55.8%), 22 Jaccoud’s arthropathy (7.1%) and 17 rhupus (5.5%). Skin manifestations were found in 167 patients (53.5%): 88 acute (28.2%), 46 subacute (14.7%), and 11 chronic (3.5%) phenotype, 38 skin vasculitis (12.2%), 17 livedo reticularis (5.4%), 62 alopecia/lupus hair (19.7%) and 46 ulcer/chilblain (14.7%). Achievement of response as measured by SRI-4 was significant in patients with either articular or cutaneous manifestations, albeit independent of joint (p = 0.75; p = 0.63) and skin subtype (p = 0.24; p= 0.37) at 12 and 24 months, respectively. Similarly, SLEDAI-2K reduction was significant in both groups (p < 0.001), regardless of joint (p=0.80) and skin phenotype (p=0.14). Organ-specific measures such as DAS28 and CLASI-A decreased from baseline at 12 and 24 months across all phenotypes (Table 1 and 2). A statistically significant decrease in DAS28 from baseline at 12 and 24 months was observed for NDNE (baseline-12 months: p < 0.001; baseline-24 months: p < 0.001), Jaccoud’s arthropathy (baseline-12 months: p = 0.015; baseline-24 months: p = 0.006) and rhupus (baseline-12 months: p = 0.034; baseline-24 months: p = 0.045). However, by ANOVA rhupus did not show improvement, possibly due to insufficient sample size. Comparison of CLASI-A variation from baseline at 12 and 24 months for the acute (baseline-12 months: p = 0.001; baseline-24 months: p < 0.001) and subacute subtype (baseline-12 months: p < 0.001; baseline-24 months p < 0.001) resulted to be significant. On the other hand, for the chronic subtype it only appeared to become significant at 24 months (p = 0.033). Variation of CLASI-A was not significant among different timepoints in patients with SLE-nonspecific skin manifestations.Conclusion:In our cohort of SLE patients, belimumab was effective in patients with joint and skin manifestations with no significant difference in DAS28, SRI-4 or SLEDAI-2K variation across the various joint involvement subtypes. On the other hand, the acute and subacute skin phenotypes were associated with an earlier response to belimumab on CLASI-A than the chronic phenotype. Finally, a clear response to belimumab was not found in patients with SLE-nonspecific skin manifestations alone.REFERENCES:[1] Zen M, et al. J Pers Med. 2023;13(4):691.[2] Gatto M, et al. Arthritis Rheumatol. 2020;72(8):1314-1324.Acknowledgements:NIL.Disclosure of Interests:Luca Iaccarino LI received honoraria (speaker fee) from GSK., Marisol Bracalenti: None declared, Margherita Zen MZ received honoraria (speaker fee) from GSK., Martina Tizian: None declared, Elena Ruffato: None declared, Alberto Cauli: None declared, Rossella De Angelis: None declared, Roberto Gerli: None declared, Marcello Govoni: None declared, Renato Lo Gullo: None declared, Simone Negrini: None declared, Luca Quartuccio: None declared, Carlo Salvarani: None declared, Angelo Vacca: None declared, Andrea Doria AD received honoraria (speaker fee) from GSK.

PurposeThis study aims to propose and validate a new unified “Risser+” grade that combines the North American (NA) and European (EU) variants of the classic Risser score. The “Risser+ ” grade can effectively combine the North American and European Risser Classifications for skeletal maturity with adequate intra-rater/inter-rater reliability and agreement.MethodsAgreement and reliability were evaluated for 6 raters (3-NA, 3-EU) who assessed 120 pelvic radiographs from the BrAIST trial, all female, average age 13.4 (range 10.1–16.5 years). Blinded raters reviewed x-rays at two time-points. Intra- and inter-rater agreement (RA) were established with Krippendorff’s alpha (k-alpha), while intra- and inter-rater reliability (RR) were established with intraclass correlation coefficients (ICC). Acceptable agreement and reliability were set a priori at 0.80.ResultsInter-RA for the second reading met study requirements (k-alpha = 0.86 [0.81–0.90]) compared to the first reading (0.72 [0.63–0.79]) while combined readings was close to target agreement (0.79 [0.74–0.84]). Removal of 20 readings demonstrating outlier tendencies increased agreement for the first, second, and combined reads (k-alpha = 0.85, 0.89, 0.87, respectively). Intra-RA was sufficient for 4 out of 6 raters (k-alpha > 0.80) and one rater from EU and NA presented subpar intra-RA (k-alpha = 0.64 and 0.74, respectively). Inter-RR met study requirements overall reads (ICC = 0.96 [0.95–0.97]) including the first (0.94 [0.92–0.95]) and second (0.97 [0.97–0.98]) reads, independently.ConclusionsThe Risser+ system showed excellent reliability across multiple reads and raters and demonstrated 79% agreement overall reads and ratings. Agreement increased to over 85% when raters could distinguish Risser 0 + from Risser 5.Graphical abstractThese slides can be retrieved from electronic supplementary material.

BackgroundSystemic sclerosis (SSc) is a complex disease characterised by immune abnormalities, vascular damage and fibrosis. Human leukocyte antigen-G (HLA-G) is a non-classic class I major histocompatibility complex (MHC) molecule expressed on different cell lineages in both physiological and pathological conditions and detectable in soluble forms (sHLA-G1 and HLA-G5 shed and secreted isoform, respectively). Several immunomodulatory functions have been attributed to both membrane-bound and soluble HLA-G molecules. HLA-G is expressed on extravillous cytotrofoblast, in placenta but also in a few normal tissues, solid tumours, transplanted organs and virally infected cells. Soluble form (sHLA-G) derives from shedding of cleaved surface isoforms (sHLA-G1) or secretion of soluble isoforms (HLA-G5). Immunosuppressive functions have been attributed to both membrane HLA-G (mHLA-G) and sHLA-G.ObjectivesThe aims of the present study were: 1) to determine the serum levels of sHLA-G molecules in a cohort of SSc patients with the limited or diffuse form of the disease; 2) to correlate sHLA-G levels with TGF-β; 3) to evaluate the expression of HLA-G in peripheral blood mononuclear cells (PBMC).MethodsThirtyfive patients (28 females/7 males, age 40–89 years) with diffuse SSc (dSSc, n. 12) or limited SSc (lSSc, n. 23) and 40 healthy sex and age matched controls were enrolled. Plasma sHLA-G, sHLA-G1 and HLA-G5 levels were determined by immunoenzymatic assays. mHLA-G expression in peripheral blood mononuclear cells (PBMC) was evaluated by flow cytometry.ResultsThe plasma levels of sHLA-G were higher in SSc patients (444.27±304.84 U/ml) compared to controls (16.74±20.58 U/ml) (p<0.0001). The plasma levels of TGF-β were higher in SSc patients (18937±15217 pg/ml) compared to controls (11099±6081 pg/ml; p=0.003) and a significant correlation was found between TGFβ and the plasma levels of total sHLA-G (r: 0.65; p<0.01), sHLA-G1 (r: 0.60; p=0.003) and HLA-G5 (r: 0.47; p=0.02). The percentage of HLA-G-positive monocytes (0.98±1.72), CD4+ (0.37±0.68), CD8+ (2.05±3.74) and CD4 +CD8+double positive cells (14.53±16.88) was higher in SSc patients than in controls (0.11±0.08, 0.01±0.01, 0.01±0.01 and 0.39±0.40, respectively) (p<0.0001). A high percentage of HLA-G +cells (30.47±26.75) was detectable on CD4dullCD8high cells from SSc patients only.ConclusionsThese data indicate that in SSc secretion and/or shedding of sHLA-G and mHLA-G are clearly elevated and involved in immune dysregulation.References[1] Gabrielli A, Avvedimento EV, Krieg T. Scleroderma. N Engl J Med2009;360:1989–2003.[2] Negrini S, Fenoglio D, Parodi A, Kalli F, Battaglia F, Nasi G, et al. Phenotypic Alterations Involved in CD8+ Treg Impairment in Systemic Sclerosis. Front Immunol2017;8:18.[3] Parel Y, Aurrand-Lions M, Scheja A, Dayer JM, Roosnek E, Chizzolini C. Presence of CD4+CD8+ double-positive T cells with very high interleukin-4 production potential in lesional skin of patients with systemic sclerosis. Arthritis Rheum2007;56:3459–67.AcknowledgementsThis work was supported by “Gruppo Italiano Lotta alla Sclerodermia” (GILS). The sponsor had no role in study design, in the collection, analysis and interpretation of data, in the writing of the report, and in the decision to submit the article for publication.Disclosure of InterestNone declared

The ability to reprogram adult cells into stem cells has raised hopes for novel therapies for many human diseases. Typical stem cell reprogramming protocols involve expression of a small number of genes in differentiated somatic cells with the c-Myc and Klf4 proto-oncogenes typically included in this mix. We have previously shown that expression of oncogenes leads to DNA replication stress and genomic instability, explaining the high frequency of p53 mutations in human cancers. Consequently, we wondered whether stem cell reprogramming also leads to genomic instability. To test this hypothesis, we examined stem cells induced by a variety of protocols. The first protocol, developed specifically for this study, reprogrammed primary mouse mammary cells into mammary stem cells by expressing c-Myc . Two other previously established protocols reprogrammed mouse embryo fibroblasts into induced pluripotent stem cells by expressing either three genes, Oct4 , Sox2 and Klf4 , or four genes, OSK plus c-Myc . Comparative genomic hybridization analysis of stem cells derived by these protocols revealed the presence of genomic deletions and amplifications, whose signature was suggestive of oncogene-induced DNA replication stress. The genomic aberrations were to a significant degree dependent on c-Myc expression and their presence could explain why p53 inactivation facilitates stem cell reprogramming.

Background: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that exhibits considerable diversity in terms of both clinical and immunological manifestations. Since its female-to-male ratio is around 9:1, it is well recognized that systemic lupus erythematosus mostly affects women, especially those of childbearing age. There is a greater susceptibility to infections in adult patients with systemic lupus erythematosus (SLE) compared to the general population. However, only a small number of studies have attempted to analyze this risk using real-life data, and even fewer have successfully assessed the influence of sex. Materials and Methods: A retrospective study was conducted, enrolling patients and dividing them into two groups based on their biological sex. Infectious episodes were identified from medical records and categorized by severity. Patients were stratified according to disease duration and treatment received. Logistic regression analysis was used to calculate the odds ratio (OR), with a 95% confidence interval (CI) for the assessment of risk factors. Multivariable logistic regression was performed to adjust for potential confounders. Model fit was evaluated using the Hosmer–Lemeshow test, and interactions between variables were tested. Sensitivity analyses were conducted to assess the robustness of the findings. Results: A total of 119 patients (107 females and 12 males) were included in the analysis. No significant difference in age was found between sexes (t = −0.715, p = 0.487), but disease duration was significantly shorter in males (t = 3.35, p = 0.003). Logistic regression showed a significant association between male sex and infection risk (β = 0.9426, p = 0.05), with males having an almost sixfold higher probability of infection compared to females (OR 5.675, 95% CI: 1.4479–22.2477, p = 0.0127). Disease duration (β = 0.0250, p = 0.102) and smoking status (β = 0.4529, p = 0.078) were not statistically significant. Lastly, correlation analysis revealed a significant association between SS-A antibodies and infection rate (r = 0.291, p = 0.003). Conclusions: This study highlights a significant sex-based disparity in the risk of infections among SLE patients, with males being at a higher risk compared to females. The differences in the distribution of infections, such as the higher prevalence of pneumonia in males and urinary tract infections in females, suggest that sex-specific factors, including immunological and hormonal differences, may influence infection susceptibility. Our findings emphasize the need for tailored clinical management, with increased vigilance for infections in male patients, to improve prevention strategies and targeted therapeutic interventions in this subgroup.

Background:Mepolizumab (MEPO) proved its efficacy in the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in the randomised controlled MIRRA trial. The ANCA-associated vasculitis patient-reported outcomes (AAV-PRO) questionnaire is a novel, disease-specific tool, validated with the aim of assessing the impact of the disease and its treatment on the patients’ perspectives.Objectives:To prospectively evaluate the impact and the rapidity of the effect of MEPO on the AAV-PRO score and patient global assessment (PtGA) in a multicentre cohort of patients with EGPA.Methods:Patients with EGPA satisfying the 2022 ACR/EULAR and/or MIRRA trial classification criteria and initiating treatment with MEPO were included. PtGA and AAV-PRO score were prospectively evaluated at MEPO initiation and after 7, 14, 30, 90 and 180 days of treatment. Predictors of improved AAV-PRO response during treatment with MEPO were also investigated.Results:Seventy patients were included in the study: female 54.3%, mean age at diagnosis 48.7±12.6 years, 20% ANCA-positive. Sixty-three patients (90%) had a history of relapsing disease. Forty-seven (67.1%) and 23 (32.9%) patients received MEPO 100 mg and 300 mg/4 weeks, respectively, with the main indication being refractory asthma and/or rhinosinusitis. Prednisone (PDN)-equivalent mean dose was 10.8±9.2 mg/day. At MEPO initiation, mean PtGA, AAV-PRO organ-specific symptoms, systemic symptoms, treatment side effects, social and emotional impact, concerns about the future and physical function domain 0-100 score were 59.1±21.2, 30.9±17.8, 25.5±18.6, 18.8±18.1, 32.6±21.9, 37.7±22.1 and 28.2±21.2, respectively. After 7 days, a statistically significant reduction of PtGA [ratio 0.87 (95% CI 0.87—0.95); Table 1] was observed. At 14 days, all AAV-PRO domains, except treatment side effects, showed a statistically significant improvement compared to baseline. Conversely, no relevant amelioration of the AAV-PRO domains was demonstrated between 30 and 180 days of follow-up (Figure 1). Previous history of vasculitic relapse, BVAS ≤3, C-reactive protein ≤5 mg/L and PDN-equivalent dose ≤10 mg/day at MEPO initiation were the main predictors of a better response of the AAV-PRO questionnaire during follow-up. MEPO 300 mg/4 weeks positively influenced organ-specific symptoms compared to MEPO 100 mg/4 weeks, although with a less significant improvement of the treatment side effects domain. Conversely, age, educational level and ANCA status at baseline had no impact on the AAV-PRO domains.Conclusion:MEPO allows a quick and remarkable improvement of several aspects of health-related quality of life in patients with refractory EGPA.Table 1. Comparison, at different timepoints, of the AAV-PRO domains 0-100 score, after log-normalization and adjustment for sex and age.OSS: organ-specific symptoms; SS: systemic symptoms; TSA: treatment side effects; SEI: social and emotional impact; CAF: concerns about the future; PF: physical function; PtGA: patient global assessment; 95% CI: 95% confidence interval.Figure 1.Temporal trend of the AAV-PRO specific domains 0-100 score during 6-month treatment with mepolizumab.OSS: organ-specific symptoms; SS: systemic symptoms; TSA: treatment side effects; SEI: social and emotional impact; CAF: concerns about the future; PF: physical function.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of Interests:Paolo Delvino: None declared, Luca Quartuccio: None declared, Joanna C Robson: None declared, Federico Alberici: None declared, Diego Bagnasco: None declared, Alvise Berti: None declared, Marco Caminati: None declared, Marta Camoni: None declared, Maria C. Cid Lecturing fees from GSK, AbbVie, and CSL-Vifor; participation in advisory boards for GSK, CSL-Vifor, AbbVie, and Astrazeneca, Consulting fees from GSK, AbbVie, CSL- Vifor, and AstraZeneca; royalties from UpToDate, Research grant and meeting travel support from Kiniksa Pharmaceuticals Corp, Edoardo Conticini: None declared, Giulia Costanzo: None declared, Claire de Moreuil: None declared, Stefano Del Giacco: None declared, Georgina Espigol-Frigole Speaker fees from VIFOR and GSK, Consulting fees from VIFOR and GSK, Grant research support from GSK, Virginia V. Ferretti: None declared, Franco Franceschini: None declared, Luca Iorio: None declared, Anna Kernder: None declared, Catherine Klersy: None declared, Alberto Lo Gullo: None declared, Laura Losappio: None declared, Elena Manna: None declared, Matteo Maule: None declared, Carlomaurizio Montecucco: None declared, Simone Negrini: None declared, Roberto Padoan: None declared, Francesca Regola: None declared, Luisa Ricciardi: None declared, Jan Schroeder: None declared, Benjamin Terrier: None declared, Paola Toniati: None declared, Elena Treppo: None declared, Maria Letizia Urban: None declared, Augusto Vaglio: None declared, Giacomo Emmi: None declared, Sara Monti: None declared.

Background. The European Journal of Physical and Rehabilitation Medicine (EJPRM) is listed in PubMed and Current Contents and in 2010 will have its first Impact Factor; the unofficial one in the last two years was around 1.00, coming from 0.04 in 2004; also the independent SCImago Journal Rate and Cites per Doc (2 years) have increased steadily since 2005. These results in the main bibliometric indexes are due to many reasons, including a careful internal audit to guarantee a continuous quality increase of the journal. The aim of this short paper is to report the results of this audit. Methods. We continuously register each step of our editorial work to check if there is any problem and where. The evolution of these indicators in the last five years is here analyzed using simple statistical tools. Results. The EJPRM receives today 12 papers per month and publishes more than 600 pages in 4 issues. The rejection rate is now around 60%, starting from 40% in 2005. The review and publication times are 1.54 (quartiles 0.57-2.79) and 8.4 (5.47-10.93) months, respectively: these parameters have decreased in these years, particularly the last one. Papers are mainly clinically oriented, original papers prevails with a 12% of RCTs, meta-analysis and Cochrane reviews in the last 5 years. The EJPRM has a well balanced coverage of different rehabilitation topics. Discussion. How these indices have been used to improve quality for the readers and authors is here discussed. The actual literature requires such a process, that is one of the main points for quality continuous improvement of scientific journals. Conclusion. The growth of the EJPRM in these years comes from the internal audit using the correct quality indicators and working to increase the actual standards. Together with this, also external factors (development of the specialty in our continent and region, European Society and Mediterranean Forum of PRM role, etc.) and other internal ones (e-Pub, Open Access, Special Sections, Awards, Cochrane reviews, collaboration with other journals, etc.) played for sure a role, but the last are in any case mainly led by, and checked through, our audit system.

Patient-orientated outcome questionnaires are essential for the assessment of treatment success in spine care. Standardisation of the instruments used is necessary for comparison across studies and in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders and is the recommended outcome instrument in the Spine Society of Europe Spine Tango Registry; currently, no validated Italian version exists. A cross-cultural adaptation of the COMI into Italian was carried out using established guidelines. 96 outpatients with chronic back problems (>3 months) were recruited from five practices in Switzerland and Italy. They completed the newly translated COMI, the Roland Morris disability (RM), adjectival pain rating, WHO Quality of Life (WHOQoL), EuroQoL-5D, and EuroQoL-VAS scales. Reproducibility was assessed in a subgroup of 63 patients who returned a second questionnaire within 1 month and indicated no change in back status on a 5-point Likert-scale transition question. The COMI scores displayed no floor or ceiling effects. On re-test, the responses for each individual domain of the COMI were within one category in 100% patients for “function”, 92% for “symptom-specific well-being”, 100% for “general quality of life”, 90% for “social disability”, and 98% for “work disability”. The intraclass correlation coefficients (ICC 2,1 ) for the COMI back and leg pain items were 0.78 and 0.82, respectively, and for the COMI summary index, 0.92 (95% CI 0.86–0.95); this compared well with 0.84 for RM, 0.87 for WHOQoL, 0.79 for EQ-5D, and 0.77 for EQ-VAS. The standard error of measurement (SEM) for COMI was 0.54 points, giving a ‘‘minimum detectable change’’ for the COMI of 1.5 points. The scores for most of the individual COMI domains and the COMI summary index correlated to the expected extent (0.4–0.8) with the corresponding full-length reference questionnaires ( r  = 0.45–0.72). The reproducibility of the Italian version of the COMI was comparable to that published for the German and Spanish versions. The COMI scores correlated in the expected manner with existing but considerably longer questionnaires suggesting adequate convergent validity for the COMI. The Italian COMI represents a practical, reliable, and valid tool for use with Italian-speaking patients and will be of value for international studies and surgical registries.