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INTRODUCTION/AIMS: Laboratory and clinical data suggest a link between neurologically mediated inflammation and psoriasis, but the risk and features of peripheral neuropathy in psoriasis or psoriatic arthritis remain unknown. The aim of this exploratory study was to evaluate the risk and to describe the features of peripheral neuropathy in patients with psoriasis and psoriatic arthritis. METHODS: One hundred patients with psoriasis and/or psoriatic arthritis and 100 control subjects were consecutively enrolled. Diagnostic confirmation included electrophysiological examination, skin biopsy, and nerve ultrasound for confirmed polyneuropathy. RESULTS: Nine patients were diagnosed with confirmed polyneuropathy, while none of the control subjects had the condition (relative risk [RR] = 19.00, 95% confidence interval [CI] = 1.12-322.11). Specific relative risks for polyneuropathy were 22.09 (95% CI = 1.17-416.43) in psoriasis patients and 18.75 (95% CI = 1.07-327.62) in psoriatic arthritis patients. The observed polyneuropathy in all nine patients was length-dependent, symmetrical, and predominantly sensory, with minimal or no disability. Comorbidities and exposure to therapies known to increase the risk of polyneuropathy were more frequent in psoriasis and/or psoriatic arthritis patients compared to controls (42% vs. 4%, p = .0001). Analyzing data after excluding possible contributory causes, the risk of polyneuropathy in patients with psoriasis and/or psoriatic arthritis was not significant. DISCUSSION: Psoriasis and psoriatic arthritis appear to be associated with an increased risk of polyneuropathy. This increased risk seems to be linked to the higher prevalence of contributing factors for polyneuropathy, rather than a direct increase in neuropathy risk specifically related to psoriasis and psoriatic arthritis.
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Artritis Psoriásica , Enfermedades del Sistema Nervioso Periférico , Psoriasis , Humanos , Femenino , Masculino , Artritis Psoriásica/complicaciones , Artritis Psoriásica/epidemiología , Persona de Mediana Edad , Psoriasis/complicaciones , Psoriasis/epidemiología , Enfermedades del Sistema Nervioso Periférico/epidemiología , Enfermedades del Sistema Nervioso Periférico/etiología , Adulto , Estudios Prospectivos , Anciano , Estudios de Cohortes , Factores de RiesgoRESUMEN
In patients with cardiovascular, pulmonary, muscular and neurological diseases, cardiopulmonary exercise testing (CPET) is a valuable tool providing clinically-relevant diagnostic and prognostic information by evaluation of exercise response. CPET requires to be performed in dedicated centers able to correctly carry out the examination and to carefully evaluate the results. CPET analyzes functional capacity revealing both symptomatic and asymptomatic intolerance to exercise. One of the most important advantages for clinicians derived by the use of CPET, beyond standard exercise electrocardiography testing, is the capability not only to grade the severity of the disease, but also to distinguish between different causes of dyspnea and exercise impairment. Indications for CPET use in clinical practice are increasing in the last decades, evolving beyond the routine use as a training tool in athletes. In fact, CPET represents an important step in the management of patients with heart failure or pulmonary hypertension, as suggested by international guidelines. CPET role in helping for the selection of patients candidate to heart transplantation is also well known. Beyond its clinical usefulness, scientific interest in CPET is constantly expanding, mainly due to the safety of the exam and to the huge size of the pathophysiological information that it offers. The aim of this paper is to simply explain everyday applications and potential further purposes of CPET in clinical practice. Our review is intended both for physicians approaching CPET for the first time and for clinicians with an interest in expanding their knowledge in this field.
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Prueba de Esfuerzo , Humanos , Prueba de Esfuerzo/métodos , Cardiólogos , Tolerancia al Ejercicio/fisiología , Disnea/diagnóstico , Disnea/fisiopatología , Disnea/etiología , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/fisiopatología , Enfermedades Cardiovasculares/diagnóstico , Pronóstico , Electrocardiografía/métodos , Trasplante de CorazónRESUMEN
Advances in the understanding of cytokines have revolutionized mechanistic treatments for chronic inflammatory and autoimmune diseases, as exemplified by rheumatoid arthritis. We conducted a systematic literature review on the role of cytokines and chemokines in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN). Ovid Medline, EMBASE and Web of Science were searched until August 31, 2022 for human studies investigating cytokines levels in CIDP or MMN. Fifty-five articles on 1061 CIDP patients and 86 MMN patients were included, with a median of 18 patients per study (range 3-71). Studies differed in the inclusion criteria, type of assay, manufacturer, control subjects, and tested biological material. Only a minority of studies reported data on disease activity. Interleukin (IL)-6, IL-17, CXCL10, and tumor necrosis factor alpha (TNF-α), were elevated in CIDP compared to controls in most of the studies. IL-6 and TNF-α levels are also correlated with disability. In MMN patients, IL-1Ra was elevated in the majority of the reports. While acknowledging the challenges in comparing studies and the various limitations of the studies, including small patient numbers, particularly in MMN, our review suggests that IL-6, IL-17, CXCL10, and TNF-α might play a role in CIDP pathogenesis. Larger studies are needed in MMN.
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Citocinas , Polirradiculoneuropatía Crónica Inflamatoria Desmielinizante , Humanos , Quimiocinas/sangre , Citocinas/sangre , Polineuropatías/fisiopatología , Polineuropatías/sangre , Polineuropatías/inmunología , Polirradiculoneuropatía Crónica Inflamatoria Desmielinizante/fisiopatología , Polirradiculoneuropatía Crónica Inflamatoria Desmielinizante/sangreRESUMEN
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.
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Terapia de Aceptación y Compromiso , Comparación Transcultural , Esclerosis Múltiple , Psicometría , Humanos , Esclerosis Múltiple/psicología , Esclerosis Múltiple/terapia , Femenino , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Encuestas y Cuestionarios/normas , Adulto , Análisis Factorial , Calidad de Vida/psicología , Alemania , España , Italia , AncianoRESUMEN
BACKGROUND: Postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery being associated with poorer outcomes. Revealing before the operation of left atrial subtle structural/functional abnormalities may help to identify patients at increased risk of POAF. We investigated the role of left atrial strain parameters by preoperative speckle tracking echocardiography as independent predictors of POAF in patients undergoing coronary artery bypass graft. METHODS: Consecutive patients undergoing isolated coronary artery bypass graft were prospectively enrolled at three Italian centers. All patients underwent transthoracic echocardiography before the operation. The occurrence of POAF up to discharge was monitored. RESULTS: Overall, a total of 310 patients were included. POAF was demonstrated in 103 patients (33%). At receiver operating characteristic curve analysis, lower global peak atrial longitudinal strain (PALS) values significantly predicted the risk of POAF (area under the curve, 0.74; P<0.001). The optimal cutoff value for the arrhythmia prediction was a global PALS value <28%, with a specificity of 86% and a sensitivity of 36%. The incidence of POAF was 51% in patients with global PALS <28% versus 14% in those with PALS ≥28% (P<0.001), with a POAF-free survival at Kaplan-Meier analysis of 45.4% and 85.7%, respectively (P<0.001). At multivariate analysis, a global PALS <28% carried a 3.6-fold higher risk of POAF (hazard ratio, 3.6 [95% CI, 2.2-5.9]; P<0.001). The risk increase was even higher when PALS <28% was associated with age ≥70 years (adjusted hazard ratio, 11.2 [4.7-26.6], P<0.001). CONCLUSIONS: A presurgery global PALS <28% is a specific parameter to stratify patients at increased risk of POAF after coronary artery bypass graft. This assessment can be useful to identify patients at higher arrhythmic risk in whom perioperative preventive strategies and stricter monitoring aimed at early diagnosing and treating POAF may be applied.
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Apéndice Atrial , Fibrilación Atrial , Humanos , Anciano , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/etiología , Atrios Cardíacos/diagnóstico por imagen , Puente de Arteria Coronaria/efectos adversos , Ecocardiografía , Complicaciones Posoperatorias/diagnóstico por imagen , Complicaciones Posoperatorias/epidemiología , Factores de Riesgo , Estudios RetrospectivosRESUMEN
PURPOSE: To perform a detailed psychometric Rasch analysis of the Prosthesis Embodiment Scale (PEmbS) administered in adults with lower limb amputation (LLA). METHODS: A convenience sample of German-speaking adults with LLA (n = 150), recruited from German state agencies' databases, was asked to complete the PEmbS, a 10-item patient-reported scale assessing prosthesis embodiment. RESULTS: The local dependency between two items was resolved by keeping for the global score only the lower score of these two items (#9 and #10). Collapsing the seven response categories to four (two expressing disagreement and two agreement) eliminated disordered thresholds. After that, the PEmbS demonstrated unidimensionality, acceptable item fit, and good reliability indices. A keyform plot was created to transform raw scores into linear measures of prosthesis embodiment, making it possible to compare the individual's item responses with those expected by the Rasch model, and to manage missing responses. CONCLUSIONS: The PEmbS is useful for assessing prosthesis embodiment in people with LLA, both for research and clinical purposes. We propose a revised version of the PEmbS for lower limb amputees; its appropriateness in other LLA contexts requires further investigation.
Prosthesis embodiment has been empirically related to positive clinical outcomes in limb amputees.The Prosthesis Embodiment Scale (PEmbS) is a patient-reported scale that has been recently recommended for use in research on prosthesis embodiment.Rasch analysis showed that the revised version of the German PEmbS is a psychometrically sound instrument for the assessment of prosthesis embodiment in lower limb amputees.The PEmbS thus also allows reliable and valid diagnosis of prosthesis embodiment in clinical and rehabilitation contexts.
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Amputados , Miembros Artificiales , Adulto , Humanos , Reproducibilidad de los Resultados , Extremidad Inferior/cirugía , Amputación Quirúrgica , Psicometría , Encuestas y CuestionariosRESUMEN
BACKGROUND: To investigate the utility of regular serum VEGF (sVEGF) levels assessment in the monitoring of POEMS syndrome. METHODS: We retrospectively reviewed data of 30 patients with POEMS syndrome whose sVEGF was tested regularly every 6 months. sVEGF levels after treatment were measured and correlated with disability (Overall Neuropathy Limitations Scale, ONLS), clinical impairment (measured with the modified Clinical Response Evaluation Scale, mCRES), and relapse-free survival. The ability of sVEGF to predict disease flares during remission and refractory disease was also analysed. RESULTS: Patients with normalised serum VEGF levels (< 1000 pg/ml) at 6 months showed prolonged relapse-free survival (at 3-year 94% for complete VEGF response, 57% partial, 0% none, p < 0.001) and greater later clinical improvement (median ΔmCRES complete VEGF response -5 vs partial -4, p = 0.019, and vs no VEGF response -2, p = 0.006). After remission, the sensitivity of 6-month sVEGF monitoring in predicting clinical relapse was 58% with a specificity of 100%. In patients refractory to treatment, the sensitivity in predicting further clinical worsening was 15%. In addition, in 25% of the patients in remission and 16% of those refractory to therapy, sVEGF levels only increased at the time of relapse. CONCLUSIONS: Regular sVEGF assessment is a valid biomarker in the prediction of disease reactivation in POEMS syndrome and was particularly useful during the phase of remission.
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Síndrome POEMS , Factor A de Crecimiento Endotelial Vascular , Humanos , Síndrome POEMS/diagnóstico , Estudios Retrospectivos , RecurrenciaRESUMEN
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.
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Planificación Anticipada de Atención , Esclerosis Múltiple Crónica Progresiva , Esclerosis Múltiple , Humanos , Femenino , Persona de Mediana Edad , Esclerosis Múltiple/terapia , Folletos , Investigación Cualitativa , ItaliaRESUMEN
The present study investigates the ecotoxicity of 7 biofertilizers, including biowaste-derived organic matrices. Real-field tests were conducted to assess the impacts of soil fertilization with sewage sludge digestate from high-solid thermophilic anaerobic digestion (HSTAD) compared to those obtained on non-amended and urea-fertilized soils. The physical-chemical and ecotoxic impact of HSTAD digestate on soil was monitored for 12 months, at 5 time points and 2 soil depths, on a maize field divided in 3 portions (non-treated, fertilized with urea, amended with digestate). The chemical and physical characteristics of the soil were previously analyzed for 3 years to provide a long-term outlook of the impacts of biofertilizer application. Seven bioindicators were utilized for direct (on whole soil) and indirect (on soil elutriates) ecotoxicological tests on fertilizers and amended soils, including plant seeds (Lepidium sativum, Sorghum saccharatum, and Sinapsis alba), the aquatic organism Daphnia magna, the alga Raphidocelis subcapitata, the luminescent bacterium Aliivibrio fischeri, and the Nematode Caenorhabditis elegans. No serious negative effects on soil fertilized with HSTAD digestate were evidenced. Conversely, bioassays rather showed positive effects, encouraging the utilization of HSTAD digestate in agriculture, considering the proper concentrations of use. The obtained data were interpolated and a test battery integrated index was generated, confirming the absence of ecotoxicological risk for the soils amended with the applied fertilizers. The long-term evolution of the physical-chemical soil characteristics (including the concentrations of potential contaminants) was similar for both HSTAD digestate and urea application as well as for non-fertilized soil, indicating no negative effects due to digestate application on land. On the contrary, digestate application improved the content of stabilized organic matter and nutrients in soil. This study proposes a more correct approach to ecotoxicity assessment of fertilized soils for biofertilizer evaluation and demonstrates the long-term safe application of HSTAD digestate on agricultural soil.
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Fertilizantes , Suelo , Suelo/química , Fertilizantes/análisis , Agricultura , Aguas del Alcantarillado/química , Fertilización , UreaRESUMEN
Resistance to cucumber mosaic virus (CMV) strain LS in melon is controlled by the gene cmv1, which restricts phloem entry. In nature, CMV is commonly found in mixed infections, particularly with potyviruses, where a synergistic effect is frequently produced. We have explored the possibility that this synergism could help CMV-LS to overcome cmv1-mediated resistance. We demonstrate that during mixed infection with a potyvirus, CMV-LS is able to overcome cmv1-controlled resistance and develop a systemic infection and that this ability does not depend on an increased accumulation of CMV-LS in mechanically inoculated cotyledons. Likewise, during a mixed infection initiated by aphids, the natural vector of both cucumoviruses and potyviruses that can very efficiently inoculate plants with a low number of virions, CMV-LS also overcomes cmv1-controlled resistance. This indicates that in the presence of a potyvirus, even a very low amount of inoculum, can be sufficient to surpass the resistance and initiate the infection. These results indicate that there is an important risk for this resistance to be broken in nature as a consequence of mixed infections, and therefore, its deployment in elite cultivars would not be enough to ensure a long-lasting resistance.
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Coinfección , Cucumovirus , Cucurbitaceae , Infecciones por Citomegalovirus , Potyvirus , Cucumovirus/genética , Enfermedades de las PlantasRESUMEN
The first observation of ultraviolet surface-enhanced Raman scattering (UV-SERS) was 20 years ago, yet the field has seen a slower development pace than its visible and near-infrared counterparts. UV excitation for SERS offers many potential advantages. These advantages include increased scattering intensity, higher spatial resolution, resonance Raman enhancement from organic, biological, and semiconductor analytes, probing UV photoluminescence, and mitigating visible photoluminescence from analytes or substrates. One of the main challenges is the lack of readily accessible, effective, and reproducible UV-SERS substrates, with few commercial sources available. In this review, we evaluate the reported UV-SERS substrates in terms of their elemental composition, substrate morphology, and performance. We assess the best-performing substrates with regard to their enhancement factors and limits of detection in both the ultraviolet and deep ultraviolet regions. Even though aluminum nanostructures were the most reported and best-performing substrates, we also highlighted some unique UV-SERS composition and morphology substrate combinations. We address the challenges and potential opportunities in the field of UV-SERS, especially in relation to the development of commercially available, cost-effective substrates. Lastly, we discuss potential application areas for UV-SERS, including cost-effective detection of environmentally and militarily relevant analytes, in situ and operando experimentation, defect engineering, development of materials for extreme environments, and biosensing.
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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.
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Pruebas Adaptativas Computarizadas , Esclerosis Múltiple , Calidad de Vida , Pruebas Adaptativas Computarizadas/métodos , Simulación por Computador , Esclerosis Múltiple/diagnóstico , Encuestas y Cuestionarios , Humanos , Adolescente , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , PsicometríaRESUMEN
BACKGROUND: Since multiple sclerosis (MS) is often diagnosed in young women, pregnancy is a common topic for women with MS (wwMS). The study aimed to assess the measurement properties of two patient-reported outcome measures on motherhood choice in MS, and to explore the information and support needs of wwMS concerning motherhood. METHODS: We conducted an anonymous web-based survey to validate the motherhood/pregnancy choice and worries questionnaire (MPWQ, 31 items plus up to 3 additional items) and the motherhood choice knowledge questionnaire (MCKQ, 16 items). We used mailing lists and social media for nationwide recruitment in Germany, and included women of childbearing age with relapsing-remitting MS, clinically isolated syndrome or suspected MS who were considering pregnancy or were pregnant. For the MPWQ, we assessed item difficulty, discriminatory power, and internal consistency (Cronbach's alpha; CA). We analysed construct validity using the Leipzig Questionnaire of Motives to have a Child, the Decisional Conflict Scale, the Hospital Anxiety and Depression Scale, and the Pregnancy-Related Anxiety Questionnaire-revised 2. We studied the structural validity using exploratory factor analysis (EFA). The MCKQ was evaluated descriptively. We explored the information and support needs of wwMS on motherhood descriptively. We examined correlations between MCKQ, MPWQ and clinical characteristics and performed exploratory group comparisons considering the following binary variables: having children and being pregnant. RESULTS: 325 wwMS started the survey; 232 wwMS met our inclusion criteria and were analysed. Their mean age was 30 years (SD 5). Most women had relapsing-remitting MS (n = 218; 94%), 186 (80%) had no children, and 38 (16%) were pregnant. Internal consistency was good for the worries subscale (CA>0.8), while it was unsatisfactory for the attitude and coping subscales (CA<0.7). The EFA did not support the three-scale structure (coping, attitude, and worries). Due to these findings, we decided to keep the worries scale without any subscale. The items from the coping scale and attitude scale could be assessed as additional descriptive items. Convergent and divergent construct validity of the MPWQ was satisfactory. 206 wwMS (89%) completed the MCKQ. On average, 9 of 16 (56%) items were answered correctly (range 2-15), and the questionnaire showed a good balance between easy and difficult items. Questions on immunotherapy, disease activity, and breastfeeding were the most challenging. WwMS were confident in getting pregnant and raising a child (n = 222; 96%). Most wwMS were worried about postpartum relapses (n = 200; 86%) and the long-term effects of pregnancy on disease evolution (n = 149; 64%). About half of the wwMS (n = 124; 54%) did not know where to find professional help and 127 (55%) had no strategies to cope with future impairments so that they could take care of a child. CONCLUSION: Our results support the suitability and acceptability of both questionnaires as potential patient-reported measures for assessment of knowledge and worries around motherhood/pregnancy in MS. The survey results highlight the need for evidence-based information on motherhood in MS to increase knowledge, reduce worries and support wwMS in making informed decisions.
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Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Niño , Embarazo , Humanos , Femenino , Adulto , Estudios Transversales , Ansiedad , Medición de Resultados Informados por el Paciente , Encuestas y Cuestionarios , Reproducibilidad de los Resultados , PsicometríaRESUMEN
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.
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Planificación Anticipada de Atención , Comparación Transcultural , Humanos , Comunicación , Encuestas y Cuestionarios , Italia , PsicometríaRESUMEN
BACKGROUND AND PURPOSE: The aim was to evaluate the risk of relapse after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination, and its safety and tolerability, in patients with chronic inflammatory neuropathies. METHODS: In this multicenter, cohort and case-crossover study, the risk of relapse associated with SARS-CoV-2 vaccination was assessed by comparing the frequency of relapse in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) patients who underwent or did not undergo vaccination. Frequency of relapse in the 3 months prior to and after vaccination, and safety and tolerability of SARS-CoV-2 vaccination, were also assessed. RESULTS: In all, 336 patients were included (278 CIDP, 58 MMN). Three hundred and seven (91%) patients underwent SARS-CoV-2 vaccination. Twenty-nine patients (9%) did not undergo vaccination. Mild and transient relapses were observed in 16 (5%) patients (13 CIDP, 3 MMN) after SARS-CoV-2 vaccination and in none of the patients who did not undergo vaccination (relative risk [RR] 3.21, 95% confidence interval [CI] 0.19-52.25). There was no increase in the specific risk of relapse associated with type of vaccine or diagnosis. Comparison with the 3-month control period preceding vaccination revealed an increased risk of relapse after vaccination (RR 4.00, 95% CI 1.35-11.82), which was restricted to CIDP patients (RR 3.25, 95% CI 1.07-9.84). The safety profile of SARS-CoV-2 vaccination was characterized by short-term, mild-to-moderate local and systemic adverse events. CONCLUSIONS: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in CIDP and MMN patients does not seem to be associated with an increased risk of relapse at the primary end-point, although a slightly increased risk in CIDP patients was found compared to the 3 months before vaccination.
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COVID-19 , Polineuropatías , Polirradiculoneuropatía Crónica Inflamatoria Desmielinizante , Humanos , Polirradiculoneuropatía Crónica Inflamatoria Desmielinizante/diagnóstico , Vacunas contra la COVID-19/efectos adversos , SARS-CoV-2 , Estudios Cruzados , COVID-19/prevención & control , Vacunación/efectos adversos , RecurrenciaRESUMEN
The influence of pregnancy on the course of multiple sclerosis (MS) has long been controversial. While historical evidence suggests a substantial decline in relapse rates during pregnancy followed by a rebound in the postpartum period, more recent work yielded equivocal results. We performed a systematic review and meta-analysis on data from cohort studies to determine whether women with MS experience increased relapse rates after delivery. A systematic literature search was conducted in the databases MEDLINE and Epistemonikos on the topic 'motherhood choice in MS' in March 2022. We included cohort studies assessing the association between pregnancy and MS relapse activity defined by the annualised relapse rate after 3, 6, 9 and 12 months post partum. Furthermore, information about disease-modifying therapies (DMT) and breast feeding was considered, if available. 5369 publications were identified. Of these, 93 full-text articles on MS relapse activity during the postpartum period were screened. 11 studies including 2739 pregnancies were eligible. Women with MS showed a significantly increased relapse rate in the first 6 months post partum, compared with preconception with the incidence rate ratio (IRR) almost doubled in the first 3 months post partum (1.87, 95% CI 1.40 to 2.50). However, at 10-12 months post partum, the IRR decreased significantly (0.81, 95% CI 0.67 to 0.98). Subanalysis on influencing parameters suggested that preconceptional DMTs (IRR for highly-effective DMTs 2.76, 95% CI 1.34 to 5.69) and exclusive breast feeding (risk ratio 0.39, 95% CI 0.18 to 0.86) significantly influenced postpartum relapse risk. Increased postpartum annualised relapse rate and possible modifiers should be considered in counselling women with MS who are considering pregnancy.
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Esclerosis Múltiple , Complicaciones del Embarazo , Embarazo , Femenino , Humanos , Esclerosis Múltiple/complicaciones , Complicaciones del Embarazo/epidemiología , Periodo Posparto , Estudios de Cohortes , Enfermedad Crónica , RecurrenciaRESUMEN
Highly stabilized digestate from sewage sludge and digestate-derived ammonium sulphate (RFs), were used in a comparison with synthetic mineral fertilizers (SF) to crop maize in a three-year plot trial in open fields. RFs and SF were dosed to ensure the same amount of mineral N (ammonia-N). In doing so, plots fertilized with digestate received much more N (+185 kg ha-1 of organic N) because digestate also contained organic N. The fate of nitrogen was studied by measuring mineral and organic N in soil at different depths, ammonia and N2O emissions, and N uptake in crops. Soil analyses indicated that at one-meter depth there was no significant difference in nitrate content between RF, SF and Unfertilized plots during crop season indicating that more N dosed with digestate did not lead to extra nitrate leaching. Ammonia emissions and N content in plants and grains measured were also similar for both RF and SF. Measuring denitrification activity by using gene makers resulted in a higher denitrification activity for RF than SF. Nevertheless, N2O measurements showed that SF emitted more N2O than RF (although it was not statistically different) (7.59 ± 3.2 kgN ha-1 for RF and 10.3 ± 6.8 kgN ha-1 for SF), suggesting that probably the addition of organic matter with digestate to RF, increased the denitrification efficiency so that N2 production was favoured. Soil analyses, although were not able detecting N differences between SF and Rf after three years of cropping, revealed a statistical increasing of total carbon, suggesting that dosing digestate lead to carbon (and maybe N) accumulation in soil. Data seem to suggest that N2O/N2 emission and organic N accumulation in soil can explain the fate of the extra N dosed (organic-N) in RF plots.
RESUMEN
BACKGROUND: Prostheses are a primary rehabilitative intervention for people after lower limb amputation. To appropriately measure the effectiveness of prosthetic interventions, valid and reliable measures of prosthetic mobility are required. The Prosthetic Limb Users Survey of Mobility (PLUS-M) is a promising instrument for measuring prosthesis users' mobility. However, German translations of the PLUS-M short forms have not yet been validated. OBJECTIVES: Rasch validation of the German translation of the PLUS-M short forms in people with lower limb amputation. STUDY DESIGN: This study is based on a cross-sectional survey of prosthesis-using lower limb amputees from a nation-wide cohort. METHODS: PLUS-M data (the 7-item and the 12-item shortforms; PLUS-M-7 and PLUS-M-12, respectively) from 194 lower limb prosthesis users were subjected to Rasch analysis, an advanced statistical method for assessing if the measurement properties of a questionnaire comply with a wide spectrum of psychometric requirements. RESULTS: Analysis showed appropriate rating scale functioning, good internal construct validity (item fit), unidimensionality, and good targeting of the PLUS-M-7 and PLUS-M-12 short forms. Moreover, the greater conditional measurement precision of PLUS-M-12 (regarding higher test information and lower standard error of mobility estimates) was quantified. CONCLUSIONS: Rasch analysis of the German translation of both PLUS-M short forms showed good psychometric qualities. In addition, our study showed that test scores from the PLUS-M-12 are more accurate. Therefore, the PLUS-M-12 is recommended for individual-level clinical applications (e.g., classification or change assessment).
Asunto(s)
Amputados , Miembros Artificiales , Humanos , Estudios Transversales , Amputación Quirúrgica , Extremidad Inferior/cirugía , Encuestas y Cuestionarios , Psicometría , Reproducibilidad de los ResultadosRESUMEN
The Short Physical Performance Battery (SPPB) is a commonly used tool to assess lower extremity function, composed of three assessments (standing balance, gait speed, and chair stand). While its validity for group-level decisions has been positively demonstrated, the measurement precision at the individual level needs more clarification. We aimed to examine the SPPB's psychometric characteristics including its conditional measurement precision with Rasch methods in a sample of elderly patients admitted to cardiac rehabilitation. We analyzed prospectively collected SPPB data from 637 patients aged ≥75 years, admitted to our cardiac rehabilitation department (January 2018-July 2019). After classical Rasch analysis, we calculated the test information function to examine the measurement precision of the SPPB along the score continuum. The mean SPPB score was 6.3 points (SD 3.4) (potential range 0-12). Our results confirmed the SPPB unidimensionality (variance attributable to the main factor: 84.8%), appropriate functioning of rating scale categories, internal construct validity (infit and outfit mean-square statistics: 0.90-1.09), and no item local dependence (residual correlations <0.2). However, the measurement precision at the individual level was quite limited (SE > 0.94 logits): the confidence intervals for true scores were, at best, about one-third of the score range (four points). This limited measurement precision increases the risk of inappropriate clinical decisions about individuals in diagnostic classification or change assessment. Therefore, further research of high methodological quality is warranted on this point. Moreover, a clearer distinction between group-level vs. individual-level indicators of change is necessary.