Characterization of Chronic Graft-versus-host Disease After Haploidentical Stem Cell Transplantation With Posttransplant Cyclophosphamide: A Study on Behalf of GETH-TC.

BACKGROUND: Chronic graft-versus-host disease (cGVHD) is a cause of late morbidity and nonrelapse mortality (NRM) after allogenic hematopoietic stem cell transplantation (allo-HSCT). Although studies evaluating haploidentical allo-HSCT (haplo-HSCT) using posttransplant cyclophosphamide (PTCy) demonstrate lower cGVHD rates, comprehensive data describing the clinical profile, risk factors, or outcomes of cGVHD within this platform are scarce. METHODS: We conducted a retrospective multicenter analysis of 389 consecutive patients who underwent haplo-HSCT PTCy in 7 transplant centers of the Spanish Group Grupo Español de Trasplante Hematopoyético y Terapia Celular (GETH-TC) between 2008 and 2020 describing incidence, clinical profile, risk factors, and cGVHD outcomes. RESULTS: Ninety-five patients of 389 developed cGVHD. Our data revealed that the incidence and severity of cGVHD are lower than those reported for HLA-identical transplantation with conventional prophylaxis and that the strongest predictor for cGVHD was previous acute GVHD (P = 0.031). Also, recipient age ≥60 y (P = 0.044) was protective against cGVHD. Moreover, patients with moderate cGVHD had longer event-free survival at 3 y than other patients (P = 0.016) and a lower relapse rate at 3 y (P = 0.036). CONCLUSIONS: Our results support the fact that the incidence and severity of cGVHD are lower than those reported for HLA-identical transplantation with conventional prophylaxis. In this series, patients who develop moderate cGVHD after haplo-HSCT PTCy had a higher overall survival and event-free survival, and lower relapse, suggesting higher graft-versus-leukemia effect. Although this is the largest series focused on characterizing cGVHD in haplo-HSCT PTCy, further prospective studies are needed to confirm the findings.

Analysis of Psychological Well-Being from a Compositional Data Analysis Perspective: A New Approach.

Well-being is a widely studied construct in psychology. In 1989, Carol Ryff proposed the "Scale of Psychological Well-Being (SPWB)", which has been validated in multiple languages. The instrument assesses six dimensions of psychological well-being: Self-acceptance, Positive Relationships with Others, Autonomy, Environmental Mastery, Purpose in Life, and Personal Growth. In this article, we propose to enrich the traditional approach of directly interpreting the raw scores in each dimension by incorporating Compositional Data Analysis. This new approach aims to identify "what proportion" of each dimension constitutes well-being, which will allow us to analyze the interactions between the different dimensions of well-being and balance among them. To achieve this, we introduce two position ratios (PR1 and PR2) and a general adjustment indicator called the General Indicator of Subjective Psychological Well-Being (GISPW), which characterizes individuals in a compositional manner, providing a fresh perspective in the interpretation of psychological test results, specifically those related to PWB. The proposal is illustrated with three cases taken from a study involving 628 university students who completed the psychological well-being scale questionnaire. The results show that the GISPW, PR1, and PR2 obtained offer relevant information about the overall balance of each case in the different dimensions.

Kinesiotape effectiveness in mechanical low back pain: A randomized clinical trial.

BACKGROUND: Low back pain (LBP) is the most common musculoskeletal disorder work-related health problem in Europe, affecting millions of workers. It is estimated that 60-80% of the population will suffer at least one episode of mechanical LBP during their life. OBJECTIVE: To evaluate the kinesiotape (KT) effectiveness in mechanical LBP. METHODS: This was a double blinded, randomized-controlled clinical trial. Twenty-eight nursing and cleaning auxiliaries from Salamanca received a manual therapy program and a bandage of KT or false kinesiotape (FKT). They received two sessions a week for three weeks and a follow-up one month after the last session. Pain, range of motion and function were measured at baseline, at the end of each session and a month after the last session. RESULTS: Work-related musculoskeletal disorders and LBP are responsible for a high prevalence of sick-leave and absenteeism. Manual therapy and KT has demonstrated to reduce pain and to increase range of motion and function being effective in this population. There are statistically significant results in both groups in all measurements for all variables. KT seems to be superior, however, both have a positive effect on LBP. Although benefits decrease, long-term treatments focusing on pain alleviation and functional recovery is needed to maintain the benefits achieved. CONCLUSION: KT was an effective complement for this treatment. Although both show improvements, KT is recommended. Future studies are needed to demonstrate KT properties, to establish a treatment protocol to prevent chronic LBP and to avoid sick leave and absenteeism.

Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple myeloma ineligible for autologous transplant: a randomized trial.

Although case-control analyses have suggested an additive value with the association of clarithromycin to continuous lenalidomide and dexamethasone (Rd), there are not phase III trials confirming these results. In this phase III trial, 286 patients with MM ineligible for ASCT received Rd with or without clarithromycin until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). With a median follow-up of 19 months (range, 0-54), no significant differences in the median PFS were observed between the two arms (C-Rd 23 months, Rd 29 months; HR 0.783, p = 0.14), despite a higher rate of complete response (CR) or better in the C-Rd group (22.6% vs 14.4%, p = 0.048). The most common G3-4 adverse events were neutropenia [12% vs 19%] and infections [30% vs 25%], similar between the two arms; however, the percentage of toxic deaths was higher in the C-Rd group (36/50 [72%] vs 22/40 [55%], p = 0.09). The addition of clarithromycin to Rd in untreated transplant ineligible MM patients does not improve PFS despite increasing the ≥CR rate due to the higher number of toxic deaths in the C-Rd arm. Side effects related to overexposure to steroids due to its delayed clearance induced by clarithromycin in this elderly population could explain these results. The trial was registered in clinicaltrials.gov with the name GEM-CLARIDEX: Ld vs BiRd and with the following identifier NCT02575144. The full trial protocol can be accessed from ClinicalTrials.gov. This study received financial support from BMS/Celgene.

Eficacia del Programa de reducción de estrés basado en atención plena (REBAP) aplicado a familiares de jugadores patológicos / No disponible

La adicción al juego conlleva situaciones de estrés para quienes sufren este trastorno y su entorno social próximo. 33 familiares voluntarios de jugadores en rehabilitación participaron en una intervención grupal de autoayuda (GAA), tras la cual iniciaron un Programa de reducción de estrés basado en atención plena (REBAP), de ocho semanas. Sus niveles de estrés fueron evaluados antes y después de cada intervención y en tres seguimientos (1, 3 y 6 meses). Mientras que el GAA no reducía significativamente el estrés de los familiares, el protocolo REBAP producía cambios de gran magnitud (η2= 0,88) y conseguía disminuir el estrés, desde niveles inicialmente moderados a bajos. Los efectos se mantuvieron en los tres seguimientos, durante los cuales se observaron niveles elevados de práctica de atención plena. No obstante, en el seguimiento a los 6 meses se apreció una disminución de la práctica, lo cual sugeriría la necesidad de introducir sesiones de refuerzo. Los resultados muestran la utilidad del programa REBAP en la intervención con familiares de personas con adicción al juego

Gambling addiction may lead to stressful situations for the gambler and their proximal social environment. 33 close relatives of disordered gamblers volunteered to attend a self-help group; afterwards, they participated in the Mindfulness-Based Stress Reduction (MBSR) program for 8 weeks. The participants' perceived stress was assessed before and after each treatment condition, and at 1-month, 3-months, and 6-months follow-ups. Participating in the self-help group did not significantly reduce the stress levels of pathological gamblers' relatives, whereas the MBSR training produced changes of great magnitude (η2= 0.88), decreasing stress levels from initially moderate scores to low values. Changes in stress levels were maintained at low levels throughout follow-ups, with participants reporting overall strong engagement with the practice of mindfulness. However, a decrease in practice (number of individuals practicing, frequency and time of exercises) was observed at 6-months follow-up, which suggest that including sessions to strengthen practice could be advisable. The MBSR program may be a useful protocol to reduce stress in pathological gamblers' families

Construct Validity of the Spanish Versions of the Memorial Symptom Assessment Scale Short Form and Condensed Form: Rasch Analysis of Responses in Oncology Outpatients.

CONTEXT: The Memorial Symptom Assessment Scale (MSAS) is a self-rating instrument for the assessment of symptom distress in cancer patients. The Spanish version of the MSAS has recently been validated. However, we lack evidence of the internal construct validity of the shorter versions (short form [MSAS-SF] and condensed form [CMSAS]). In addition, rigorous testing of these scales with modern psychometric methods is needed. OBJECTIVES: The aim of this study was to evaluate the internal construct validity and reliability of the Spanish versions of the MSAS-SF and CMSAS in oncology outpatients using Rasch analysis. METHODS: Data from a convenience sample of oncology outpatients receiving chemotherapy (n = 306; mean age 60 years; 63% women) at a university hospital were analyzed. The Rasch unidimensional measurement model was used to examine response category functioning, item hierarchy, targeting, unidimensionality, reliability, and differential item functioning by age, gender, and marital status. RESULTS: The response category structure of the symptom distress items was improved by collapsing two categories. The scales were adequately targeted to the study patients, showed overall Rasch model fit (mean Infit MnSq ranged from 0.98 to 1.05), met criteria for unidimensionality, and the reliability of scores was good (person reliability > 0.80), except for the CMSAS prevalence scale. Only four items showed differential item functioning. CONCLUSION: The present study demonstrated that the Spanish versions of the MSAS-SF and CMSAS have adequate psychometric properties to evaluate symptom distress in oncology outpatients. Additional studies of the CMSAS are recommended.

Reliability and Validity of the Spanish Version of the Memorial Symptom Assessment Scale in Oncology Patients.

CONTEXT: Memorial Symptom Assessment Scale (MSAS) is a multidimensional tool developed to evaluate frequency, severity, and distress of common symptoms present in cancer patients. OBJECTIVE: To translate the original English version of MSAS and prove the reliability and validity of the Spanish version. METHODS: MSAS scale was translated into Spanish and administered to 246 cancer patients aged between 18 and 85 years. They attended the Day Hospital to receive chemotherapy. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 and Rotterdam Symptom Checklist were used to test criterion validity. RESULTS: TOTAL MSAS, Physical Symptom Subscale (PHYS), Psychological Symptom Subscale (PSYCH), and Global Distress Index (GDI) reported high internal consistency: 0.891, 0.801, 0.825, 0.813, respectively. Exploratory factor analysis identified two-factors structure and confirmatory factor analysis showed good adjustment rates. The emotional functioning subscale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 highly correlated with PSYCH (r = -0.868; P < 0.001) and GDI (r = -0.810; P < 0.001), whereas social functioning subscale correlated with PSYCH (r = -0.704; P < 0.001) and GDI (r = -0.624; P < 0.001). The PHYS of Rotterdam Symptom Checklist correlated with PHYS (r = 0.876; P < 0.001) and the PSYCH with PSYCH (r = 0.872; P < 0.001). CONCLUSION: The Spanish version of MSAS was determined to be a valid and reliable scale in cancer patients.

Measurement of the severity of disability in community-dwelling adults and older adults: interval-level measures for accurate comparisons in large survey data sets.

OBJECTIVES: To (1) create a single metric of disability using Rasch modelling to be used for comparing disability severity levels across groups and countries, (2) test whether the interval-level measures were invariant across countries, sociodemographic and health variables and (3) examine the gains in precision using interval-level measures relative to ordinal scores when discriminating between groups known to differ in disability. DESIGN: Cross-sectional, population-based study. SETTING/PARTICIPANTS: Data were drawn from the Survey of Health, Ageing and Retirement in Europe (SHARE), including comparable data across 16 countries and involving 58 489 community-dwelling adults aged 50+. MAIN OUTCOME MEASURES: A single metric of disability composed of self-care and instrumental activities of daily living (IADLs) and functional limitations. We examined the construct validity through the fit to the Rasch model and the know-groups method. Reliability was examined using person separation reliability. RESULTS: The single metric fulfilled the requirements of a strong hierarchical scale; was able to separate persons with different levels of disability; demonstrated invariance of the item hierarchy across countries; and was unbiased by age, gender and different health conditions. However, we found a blurred hierarchy of ADL and IADL tasks. Rasch-based measures yielded gains in relative precision (11-116%) in discriminating between groups with different medical conditions. CONCLUSIONS: Equal-interval measures, with person-invariance and item-invariance properties, provide epidemiologists and researchers with the opportunity to gain better insight into the hierarchical structure of functional disability, and yield more reliable and accurate estimates of disability across groups and countries. Interval-level measures of disability allow parametric statistical analysis to confidently examine the relationship between disability and continuous measures so frequent in health sciences (eg, cholesterol, blood pressure, C reactive protein).

Effects of exposure to food images on physiological reactivity and emotional responses in women with bulimia nervosa / Efecto de la exposición a imágenes de comida sobre la reactividad psicofisiológica y las reacciones emocionales en mujeres con bulimia nerviosa

Background: The aim of this study is to compare the effectiveness of two exposure procedures on habituation of emotional responses to food stimuli: (a) exposure to external cues (food images) without eating forbidden food (CE) and (b) exposure to external cues eating forbidden food (with purge prevention). The influence of craving-trait and mood state on the habituation process is also studied. Method: Emotional modulation of the defense startle reflex was assessed in 26 women at risk of bulimia nervosa. After four exposure trials, changes in the following variables were measured: (a) food craving-state; (b) physiological measures: hearth rate (HR) and skin conductance response (SCR); (c) motivational patterns towards food (defense startle response); and (d) valence, arousal and dominance of the emotional response to food images. Results: After treatment, subjects tended to show non-significant lower SCR and heart orientation responses (vs. defense responses); defense startle response was also significantly lower. Conclusions: The exposure procedure, the induced emotional state and the number of exposure trials are analyzed (AU)

Antecedentes: en este estudio comparamos la eficacia de dos procedimientos de exposición sobre la habituación de reacciones emocionales a alimentos: a) claves externas (imágenes de comida) sin ingerir alimentos prohibidos, y b) claves externas en personas que sí los han ingerido (impidiendo que se produzca el vómito). Además consideramos la influencia de la intensidad del craving rasgo y del estado de ánimo. Evaluamos la modulación emocional del reflejo defensivo de sobresalto motor (RMS) en 26 mujeres con riesgo de padecer bulimia nerviosa. Método: tras cuatro bloques de exposición, se midieron los cambios en: a) craving estado por la comida; b) tasa cardíaca (TC) y respuesta electrodérmica de conductancia (SCR); c) patrones motivacionales ante la comida (RMS); y d) estimaciones afectivas de valencia, arousal y dominancia de las emociones producidas por las imágenes de los alimentos. Resultados: como consecuencia del tratamiento los sujetos tendían a mostrar de forma estadísticamente no significativa menores SCRs y una tendencia de cambio de patrón de respuesta de defensa cardíaca (RD) a respuesta de orientación (RO); sí se apreciaban diferencias significativas en RMS. Conclusiones: se comenta el papel desempeñado por el tipo de exposición utilizado, los estados emocionales inducidos y el número de ensayos de exposición (AU)

Effects of exposure to food images on physiological reactivity and emotional responses in women with bulimia nervosa.

BACKGROUND: The aim of this study is to compare the effectiveness of two exposure procedures on habituation of emotional responses to food stimuli: (a) exposure to external cues (food images) without eating forbidden food (CE) and (b) exposure to external cues eating forbidden food (with purge prevention). The influence of craving-trait and mood state on the habituation process is also studied. METHOD: Emotional modulation of the defense startle reflex was assessed in 26 women at risk of bulimia nervosa. After four exposure trials, changes in the following variables were measured: (a) food craving-state; (b) physiological measures: hearth rate (HR) and skin conductance response (SCR); (c) motivational patterns towards food (defense startle response); and (d) valence, arousal and dominance of the emotional response to food images. RESULTS: After treatment, subjects tended to show non-significant lower SCR and heart orientation responses (vs. defense responses); defense startle response was also significantly lower. CONCLUSIONS: The exposure procedure, the induced emotional state and the number of exposure trials are analyzed.

Evaluación de la reactividad emocional ante imágenes de comida en bulimia nerviosa / Assessment of emotional reactivity to food images in bulimia nervosa

En este estudio evaluamos la influencia de la intensidad del craving rasgo, efecto de estado de ánimo y restricción de comida sobre la reacción ante imágenes de alimentos. Se evalúa la modulación emocional del reflejo defensivo de sobresalto motor (RMS) en 26 mujeres con riesgo de padecer bulimia nerviosa; fueron asignadas a dos grupos en base a la intensidad del craving rasgo. En cada uno de estos dos grupos se generó estado de ánimo positivo o negativo y los sujetos ingirieron o no alimentos antes del comienzo de la prueba. Se registra el electromiograma del músculo orbicular del ojo tras un estímulo auditivo, SCR, medidas de autoinforme para evaluar el deseo de comer (craving estado y rasgo) y emociones ante las imágenes de alimentos (SAM). Los resultados indican que el estado de ánimo negativo hace que las imágenes de comida sean valoradas como más desagradables, generadoras de emociones más intensas y de pérdida de control; además provocan mayores SCRs. Estos dos últimos efectos se produjeron en los grupos no deprivados. Las personas con bajos niveles en el FCQ-T disminuyeron su RMS ante imágenes de comida como consecuencia de experimentar emociones positivas; cuando las emociones eran negativas, su RMS se incrementaba (AU)

The aim of the study was to assess the influence on reactivity to food images of the following variables: craving-trait, positive or negative mood state, and food restriction. Emotional modulation of the defense startle reflex (RMS) was assessed in 26 women at risk of suffering from bulimia nervosa; they were assigned one of to two groups: high craving-trait and low craving-trait. Before the test, positive or negative mood and restriction vs. non-restriction states were induced in each of the groups. Skin conductance response (SCR) and electromyogram activity from the orbiculari oculi region were recorded after the auditory stimuli; questionnaires such as Food Craving Trait Questionnaire (FCQ-T) and the Self-assessment Manikin (SAM) were used. Results showed that negative affect produced a negative valence of food images, more arousal, and more loss of control, as well as higher SCRs. Subjects with low FCQ-T levels reduced their RMS to food images as a consequence of experiencing positive emotions; when emotions were negative, their RMS increased (AU)