Multicentric and collaborative study of Spanish neurosurgical management of pediatric craniopharyngiomas: S-PedCPGco / Estudio multicéntrico colaborativo del manejo neuroquirúrgico del craneofaringioma pediátrico en España: S-PedCPGco

Purpose To present a descriptive analysis of pediatric craniopharyngiomas (PedCPG) treated in various Spanish hospitals, defining factors related to recurrence and performing a critical analysis of the results. Methods We undertook a multicenter retrospective review of PedCPG treated between 2000 and 2017. Data collected included epidemiological variables, clinical and radiological characteristics, goal of first surgery, rate of recurrence and its approach, adjuvant treatment, complications and permanent morbidity. Associations were studied between progression and number of progressions and independent variables. Results The study involved 69 children from 8 Spanish hospitals. Most of the tumors invaded several intracranial compartments at diagnosis, with the hypothalamus involved in 41.3% of cases. The first treatment strategy was usually gross total resection (GTR) (71%), with some patients treated with radiotherapy or intracystic chemotherapy. The progression rate after first surgery was 53% in a mean follow-up of 88.2 months (range 7–357). In the GTR group 38.8% of tumors recurred, 40% in the group of subtotal resection or biopsy and 93.3% in the cyst fenestration±Ommaya reservoir group. Mortality was 7.2%. Follow-up period, size of the tumor and goal of first surgery were significantly related with progression. Conclusions Our results in terms of disease control, hormonal or visual impairment and mortality were acceptable, but there are several areas for improvement. Our short-term goals should be to create a national register of PedCPG, reach a consensus about a treatment algorithm, and improve diagnosis of hypothalamic dysfunction to avoid preventable morbidity (AU)

Objetivo Presentar un análisis descriptivo de los craneofaringiomas pediátricos tratados en varios hospitales españoles, definiendo los factores relacionados con la recurrencia y realizando un análisis crítico de los resultados. Métodos Estudio retrospectivo multicéntrico de los craneofaringiomas pediátricos tratados entre 2000-2017. Se recogieron variables epidemiológicas, clínicas y radiológicas, el objetivo de la primera cirugía, la tasa de recurrencia y su abordaje, los tratamientos adyuvantes, así como las complicaciones y la morbilidad permanente. Se estudió la relación estadística entre la progresión y el número de progresiones con las variables independientes. Resultados Se incluyeron 69 niños tratados en 8 hospitales españoles. La mayoría de los tumores se extendían por varios compartimentos intracraneales al diagnóstico, con invasión hipotalámica en el 41,3%. Habitualmente, la primera estrategia de tratamiento fue la resección radical (71%), con algunos pacientes tratados con radioterapia o quimioterapia intraquística. La tasa de progresión tras la primera cirugía fue del 53% en un seguimiento medio de 88,2 meses (rango 7-357). En el grupo de resección radical recurrieron un 38,8% de los tumores, un 40% en el de resección subtotal o biopsia y un 93,3% en el de fenestración quística±reservorio Ommaya. La mortalidad fue de un 7,2%. Las variables relacionadas de forma significativa con progresión fueron el tiempo de seguimiento, el tamaño del tumor y el objetivo de la primera cirugía. Conclusiones Los resultados obtenidos fueron aceptables en control de la enfermedad, secuelas hormonales o visuales y mortalidad, aunque hay varias áreas susceptibles de mejora. Nuestros objetivos a corto plazo deberían estar orientados a crear un registro nacional de craneofaringiomas pediátricos, alcanzar un consenso respecto al algoritmo de tratamiento y mejorar el diagnóstico de la disfunción hipotalámica para evitar morbilidad (AU)

Sense of coherence, resilience, and habitual optimism in cancer patients

Background/Objective: The aim of this study was to investigate whether the three resource variables sense of coherence, resilience, and dispositional optimism become impaired when people are ill with cancer, whether there are sex and age differences in these variables, and how these variables are associated with quality of life (QoL). Method: A sample of 1108 patients with mixed cancer diagnoses were examined using the Sense of Coherence Scale-3 (SOC-3), the Brief Resilience Scale (BRS), the Life Orientation Test (LOT-R), and the QoL questionnaire EORTC QLQ-C30. Results: The three resource variables showed somewhat lower levels in the patients’ sample in comparison with general population controls, with effect sizes between −0.10 and −0.23. While there were only small sex differences in the resource variables, significant age differences were found in these variables, with stronger detriments in younger patients. The correlations among the resource variables ranged between .53 and .61. Sense of coherence was more strongly correlated with QoL than resilience and optimism. Conclusions: Cancer patients with low levels of personal resources adapt to their disease more poorly than patients with high levels. In addition to limitations in QoL, health care professionals should also consider patients’ resources for coping with the disease. Special attention should be given to young cancer patients. (AU)

Validación de un cuestionario específico de calidad de vida en sialoadenitis obstructiva crónica (CSOC) / Validation of a Spanish chronic obstructive sialadenitis quality of life questionnaire (CSOC)

Antecedentes y objetivos: El interés en la sialoadenitis obstructiva crónica está aumentando con la introducción de la sialoendoscopia. Es necesario contar con un instrumento para evaluar la calidad de vida en los pacientes con sialoadenitis obstructiva crónica que permita mejorar el manejo clínico y apoyar la investigación. Los objetivos del presente trabajo son diseñar un cuestionario en español para evaluar la calidad de vida en los pacientes con sialoadenitis obstructiva crónica, denominado CSOC, y evaluar su fiabilidad, validez y viabilidad.Material y métodosEstudio prospectivo, multicéntrico, observacional, en el que se incluyeron pacientes con diagnóstico de sialoadenitis obstructiva crónica. Se realizaron una búsqueda bibliográfica y entrevistas con pacientes para la generación de las preguntas del cuestionario. A continuación, un panel de expertos evaluó la validez de contenido. La validez de constructo fue evaluada en una muestra de 120 pacientes y 100 controles. Los pacientes contestaron un CSOC, un short form-36 (SF-36) versión en español y una escala visual analógica (EVA). Se evaluó la viabilidad, la fiabilidad, la consistencia interna, la validez de constructo y la sensibilidad al cambio.ResultadosTodos los pacientes encontraron comprensible el instrumento. El tiempo requerido para completar el CSOC pre y postsialoendoscopia fue de 5,7 y 4,5min, respectivamente. El coeficiente α de Cronbach fue muy alto para el CSOC pre y postsialoendoscópico (0,90 y 0,94, respectivamente). La correlación con las dimensiones del SF-36 fue negativa y positiva con la EVA. La puntuación media del CSOC en el grupo con sialoadenitis fue de 28,63 (antes de la sialoendoscopia) y de 8,33 (después de la sialoendoscopia). En el grupo control la puntuación media del CSOC fue de 1,31.ConclusionesEl CSOC es comprensible, factible, fiable y representativo de la calidad de vida en pacientes con sialoadenitis obstructiva crónica.

Background and objectives: Interest in chronic obstructive sialadenitis is increasing with the introduction of sialendoscopy. A self-administered instrument to assess quality of life in patients with chronic obstructive sialadenitis is needed to improve clinical management and support research. The objectives of this study are to design a Spanish questionnaire to assess quality of life in chronic obstructive sialadenitis, named CSOC and assess its reliability, validity and feasibility.Material and methodsA prospective, multicentre, observational study was conducted. Patients with diagnosis of chronic obstructive sialadenitis were included in the study. The item generation process included a review of published data as well as interviews with patients. An expert panel then tested the content validity of the instrument, and the construct validity was tested in 120 patients and 100 controls. Patients completed a self-administered CSOC questionnaire, a Short Form-36 and a Visual Analogue Scale. Feasibility, reliability, internal consistency, construct validity and responsiveness were assessed.ResultsAll the patients found the instrument understandable. Cronbach α coefficient was high (0.85). The time required to fill out was 5.7 and 4.5min for pre and postsialendoscopy CSOC respectively. Cronbach α coefficient was very high for both pre and postsialendoscopy CSOC (0.90 and 0.94, respectively). The correlation with the SF-36 dimensions was negative and positive with the VAS. The mean score of CSOC was 28.63 and 8.33 for pre and postsialendoscopy. In the control group the mean score of CSOC was 1.31.ConclusionsThe CSOC questionnaire is understandable, feasible, reliable and representative of quality of life in chronic obstructive sialadenitis. (AU)

Herramientas para la evaluación integral de la función sexual en pacientes con esclerosis múltiple / Tools for comprehensive evaluation of sexual function in patients with multiple sclerosis

Introducción: La esclerosis múltiple (EM) es una enfermedad desmielinizante del sistema nervioso central (SNC) que afecta a adultos jóvenes, ocasionando una variedad de síntomas (motores, visuales, control de esfínteres, alteraciones de la marcha) que impactan la funcionalidad del paciente; sin embargo, otros síntomas, como la disfunción sexual (DS), también pueden tener un efecto sobre la calidad de vida.DesarrolloLa DS puede presentarse en cualquier momento del curso de la enfermedad, su prevalencia varía entre 50 y 90%, puede ser secundaria a lesiones desmielinizantes en médula espinal y/o cerebro, ocasionada por síntomas que no incluyen directamente el sistema nervioso —fatiga, aspectos psicológicos, sociales y culturales—. Si bien se ha logrado establecer su prevalencia y su impacto sobre la calidad de vida, la DS todavía es una condición frecuentemente subestimada, razón por la cual en este artículo se revisan las diferentes escalas que ayudan a evaluar la presencia o la severidad de esta para dar un manejo multidisciplinario temprano, según corresponda.ConclusiónCinco cuestionarios han sido evaluados y/o diseñados para pacientes con EM, los cuales podrían identificar la presencia de DS, su etiología y, con esto, determinar posibilidades de tratamiento. La EM debe ser comprendida como una enfermedad compleja que abarca y compromete diferentes aspectos de la salud de los pacientes, y va más allá de solo medir escalas de discapacidad. (AU)

Introduction: Multiple sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that affects young adults, causing a variety of symptoms (motor alterations, visual alterations, loss of sphincter control, gait alterations) that impair the patient's functional status. However, other symptoms, such as sexual dysfunction, can also have an effect on quality of life.DevelopmentSexual dysfunction can occur at any time during the course of the disease; its prevalence varies between 50% and 90%, and it can be secondary to demyelinating lesions in the spinal cord and/or brain or caused by symptoms that do not directly involve the nervous system (fatigue; psychological, social, and cultural factors; etc.). Although its prevalence and impact on quality of life are well known, sexual dysfunction is still frequently underestimated. Therefore, in this article we review the different scales for assessing presence or severity of sexual dysfunction, in order to offer early multidisciplinary management.ConclusionWe evaluated 5 questionnaires that could identify the presence of sexual dysfunction in patients with MS and determine its aetiology, assisting in treatment decision making. MS must be understood as a complex disease that encompasses and compromises different aspects of patients’ health, and goes beyond simply measuring disability. (AU)

Efficacy of Mesotherapy for Pain, Function and Quality of Life in Patients with Mild and Moderate Knee Osteoarthritis: A Randomized Controlled Trial.

OBJECTIVE: To investigate the effects of mesotherapy in patients with mild to moderate knee osteoarthritis (KOA). METHODS: The study included 43 patients (56 knees) who were randomly assigned to either the mesotherapy group (MG, n=28) or the saline group (SG, n=28) and received a total of 4 weekly mesotherapy (MG) or saline injections (SG). Pain, functional status and quality of life were evaluated by a Visual Analogue Scale (VAS), the Western Ontario Universities Osteoarthritis Index (WOMAC) and the Short Form-36 (SF-36) subscales at baseline and at 8 and 16 weeks of follow-up. RESULTS: A total of 39 patients (52 knees) completed the study. Eight weeks after treatment, a significant improvement was found in VAS pain scores, WOMAC scores and physical component scores (PCS) of the SF-36 in both groups compared to baseline (p<0.05). The VAS activity pain score, WOMAC-pain, WOMAC-physical function and WOMAC-total scores were found to have decreased significantly in the MG compared to the SG (p<0.001) at both 8 weeks and 16 weeks. The PCS scores significantly improved in the MG compared to the SG at 8- and 16-week follow-ups (p<0.001 and p<0.001, respectively). CONCLUSIONS: Mesotherapy is a well-tolerated, safe and effective alternative treatment option in patients with mild and moderate KOA.

Long-term psychological outcome of patients with moderate-to-severe atopic dermatitis continuously treated with Dupilumab: Data up to 3 years.

Dupilumab effectiveness and safety in treating moderate-to-severe atopic dermatitis (AD) have been demonstrated in open-label studies up to 4 years. Evidence about long-term psychological outcome is lacking. This study evaluates the long-term psychological outcome of moderate-to-severe AD patients continuously treated with Dupilumab up to 3 years. A prospective observational real-life study was conducted at an Italian tertiary centre from January 2019 to September 2022. Measures of disease severity and psychological outcomes were assessed at baseline, after 4, 8, 12, 24 and 36 months. A total of 382 moderate-to-severe AD patients were included. After 36 months, EASI-75 and EASI-90 were achieved by 91.8% and 77.2% of participants. Significant improvement (p < 0.001; ω2  = 0.18-0.84) in objective and patient-reported measures of disease severity and in the psychological condition were observed after 4 months of treatment and maintained up to 36 months. Longitudinal analysis of interactions of demographic and clinical features found subgroups of patients who did not reported psychological improvement over the study period notwithstanding the positive clinical response. Long-term improvement in the psychological outcome of moderate-to-severe AD patients continuously treated with Dupilumab is confirmed up to 3 years, supporting its wide use in this population. Between-subject differences in the psychological outcome irrespective of clinical response observed in this study foster the biopsychosocial approach in the clinical management of these patients.

Longitudinal changes in mental health outcomes after COVID-19 hospitalization: A prospective study.

BACKGROUND: The long-term trends of COVID-19 mental sequelae remain unknown. Thus, this study aimed to survey the one-year temporal trends of PTSD and health-related quality of life of COVID-19 survivors. METHODS: Patients hospitalized with COVID-19 were followed up at three, six, and 12 months after discharge. Patients with COVID-19 who were able to communicate and complete the questionnaires were included in the study. All participants were asked to complete the Medical Outcomes Study 36-Item Short-Form Health (SF-36) survey and the Impact of Event Scale-Revised (IES-R). The cutoff point of 24/25 of IES-R was defined as preliminary PTSD. Patients exhibiting PTSD symptoms at six months or later were regarded as "delayed patients," while those exhibiting PTSD symptoms at all the time points were "persistent patients." RESULTS: Of the 98 patients screened between June and November 2020, 72 participated in the study. A total of 11 (15.3%) had preliminary PTSD at three months, 10 (13.9%) at six months, and 10 (13.9%) at 12 months; delayed and persistent patients were four patients (7.54%) each. Patients with preliminary PTSD had lower mental summary scores in SF-36; 47 (IQR 45, 53) for patients with preliminary PTSD and 60 (49, 64) without preliminary PTSD at three months, 50 (45, 51) and 58 (52, 64) at six months, and 46 (38, 52) and 59 (52, 64) at 12 months. CONCLUSION: Healthcare providers should care about the courses of PTSD in COVID-19 survivors and be aware that patients with PTSD symptoms may have a lower health-related quality of life.

Evaluation of oral mucositis, candidiasis, and quality of life in patients with head and neck cancer treated with a hypofractionated or conventional radiotherapy protocol: a longitudinal, prospective, observational study.

BACKGROUND: Due to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, recently, Radiotherapy (RT) protocols requiring fewer sessions (hypofractionated) have been used to shorten RT treatment and minimize patient exposure to medical centers, and decrease the risk of SARS-CoV-2 infection. METHODS: This longitudinal, prospective, observational study aimed to compare the quality of life (QoL) and the incidence of oral mucositis and candidiasis in 66 patients with head and neck cancer (HNC) who undergo a hypofractionated RT protocol (GHipo), total of 55 Gy for 4 weeks, or a conventional RT protocol (GConv), total of 66 - 70 Gy for 6 - 7 weeks. PURPOSE: To assess the incidence and severity of oral mucositis, the incidence of candidiasis, and QoL were evaluated using the World Health Organization scale, clinical evaluation, and the QLC-30 and H&N-35 questionnaires, respectively, at the beginning and the end of RT. RESULTS: The incidence of candidiasis did not show differences between the two groups. However, at the end of RT, mucositis had a higher incidence (p < 0.01) and severity (p < 0.05) in GHipo. QoL was not markedly different between the two groups. Although mucositis worsened in patients treated with hypofractionated RT, QoL did not worsen for patients on this regimen. CONCLUSIONS: Our results open perspectives for the potential use of RT protocols for HNC with fewer sessions in conditions that require faster, cheaper, and more practical treatments.

Dual-task versus single-task gait rehabilitation after stroke: the protocol of the cognitive-motor synergy multicenter, randomized, controlled superiority trial (SYNCOMOT).

BACKGROUND: Gait disorders and cognitive impairments are prime causes of disability and institutionalization after stroke. We hypothesized that relative to single-task gait rehabilitation (ST GR), cognitive-motor dual-task (DT) GR initiated at the subacute stage would be associated with greater improvements in ST and DT gait, balance, and cognitive performance, personal autonomy, disability, and quality of life in the short, medium and long terms after stroke. METHODS: This multicenter (n=12), two-arm, parallel-group, randomized (1:1), controlled clinical study is a superiority trial. With p<0.05, a power of 80%, and an expected loss to follow-up rate of 10%, the inclusion of 300 patients will be required to evidence a 0.1-m.s-1 gain in gait speed. Trial will include adult patients (18-90 years) in the subacute phase (0 to 6 months after a hemispheric stroke) and who are able to walk for 10 m (with or without a technical aid). Registered physiotherapists will deliver a standardized GR program (30 min three times a week, for 4 weeks). The GR program will comprise various DTs (phasic, executive function, praxis, memory, and spatial cognition tasks during gait) in the DT (experimental) group and gait exercises only in the ST (control) group. The primary outcome measure is gait speed 6 months after inclusion. The secondary outcomes are post-stroke impairments (National Institutes of Health Stroke Scale and the motor part of the Fugl-Meyer Assessment of the lower extremity), gait speed (10-m walking test), mobility and dynamic balance (timed up-and-go test), ST and DT cognitive function (the French adaptation of the harmonization standards neuropsychological battery, and eight cognitive-motor DTs), personal autonomy (functional independence measure), restrictions in participation (structured interview and the modified Rankin score), and health-related quality of life (on a visual analog scale). These variables will be assessed immediately after the end of the protocol (probing the short-term effect), 1 month thereafter (the medium-term effect), and 5 months thereafter (the long-term effect). DISCUSSION: The main study limitation is the open design. The trial will focus on a new GR program applicable at various stages after stroke and during neurological disease. TRIAL REGISTRATION: NCT03009773 . Registered on January 4, 2017.

Von Willebrand Disease Epidemiology, Burden of Illness and Management: A Systematic Review.

Introduction: Although hereditary von Willebrand disease (VWD) is the most common bleeding disorder, its epidemiology is not well understood. A systematic review (PROSPERO CRD42020197674/CRD42021244374) on the epidemiology/burden of illness of VWD was conducted to better understand patients' unmet needs. Methods: Observational studies (published January 1, 2010 to April 14, 2021) were identified in MEDLINE and Embase databases, using free-text keywords and thesaurus terms for VWD and outcomes of interest. Pragmatic web-based searches of the gray literature, including conference abstracts, were performed, and reference lists of retained publications were manually searched for additional sources. Case reports and clinical trials (phase 1-3) were excluded. Outcomes of interest were incidence, prevalence, mortality, patient characteristics, burden of illness, and therapeutic management/treatments currently used for VWD. Results: Of the 3095 identified sources, 168 were included in this systematic review. Reported VWD prevalence (22 sources) ranged from 108.9 to 2200 per 100,000 in population-based studies and from 0.3 to 16.5 per 100,000 in referral-based studies. Reported times between first symptom onset and diagnosis (two sources; mean 669 days; median 3 years) highlighted gaps in timely VWD diagnosis. Bleeding events reported in 72-94% of the patients with VWD (all types; 27 sources) were mostly mucocutaneous including epistaxis, menorrhagia, and oral/gum bleeding. Poorer health-related quality of life (three sources) and greater health care resource utilization (three sources) were reported for patients with VWD than in general populations. Conclusion: Available data suggest that patients with VWD experience high disease burden in terms of bleeding, poor quality of life, and health care resource utilization.

Effectiveness of digital care platform CMyLife for patients with chronic myeloid leukemia: results of a patient-preference trial.

BACKGROUND: Two most important factors determining treatment success in chronic myeloid leukemia (CML) are adequate medication compliance and molecular monitoring albeit still being suboptimal. The CMyLife platform is an eHealth innovation, co-created with and for CML patients, aiming to improve their care, leading to an increased quality of life and the opportunity of hospital-free care. OBJECTIVE: To explore the effectiveness of CMyLife in terms of information provision, patient empowerment, medication compliance, molecular monitoring, and quality of life. METHODS: Effectiveness of CMyLife was explored using a patient-preference trial. Upon completion of the baseline questionnaire, participants actively used (intervention group) or did not actively use (questionnaire group) the CMyLife platform for at least 6 months, after which they completed the post-intervention questionnaire. Scores between the intervention group and the questionnaire group were compared with regard to the within-subject change between baseline and post-measurement using Generalized Estimating Equation models. RESULTS: At baseline, 33 patients were enrolled in the questionnaire group and 75 in the intervention group. Online health information knowledge improved significantly when actively using CMyLife and patients felt more empowered. No significant improvements were found regarding medication compliance and molecular monitoring, which were already outstanding. Self-reported effectiveness showed that patients experienced that using CMyLife improved their medication compliance and helped them to oversee their molecular monitoring. Patients using CMyLife reported more symptoms but were better able to manage these. CONCLUSIONS: Since hospital-free care has shown to be feasible in time of the COVID-19 pandemic, eHealth-based innovations such as CMyLife could be a solution to maintain the quality of care and make current oncological health care services more sustainable. TRIAL REGISTRATION: ClinicalTrials.gov NCT04595955 , 22/10/2020.

[Impact of the type of hematopoietic stem-cell transplant on quality of life and psychopathology]. / A haematopoeticus ossejt-transzplantáció hatása az életminoségre és a pszichés tünetekre.

Background and purpose:

Despite the decrease in transplant-related mortality, patients who receive hematopoietic stem-cell transplants often suffer from short-and long-term morbidities, poorer quality of life, and psychosocial functioning deficits. Several studies have compared the quality of life and affective symptoms of patients after undergoing autologous and allogeneic hematopoietic stem-cell transplants. Some studies have reported similar or greater quality of life impairments in allogeneic hematopoietic stem-cell recipients, but the findings have been inconsistent. Our purpose was to examine the influence of the type of hematopoietic stem-cell transplantation on the quality of life and affective symptoms of patients.

The study sample comprised 121 patients with various hematological diseases who underwent hematopoietic stem-cell transplantation at St. István and St. László Hospitals, Budapest. The study had a cross-sectional design. Quality of life was evaluated using the Hungarian version of the Functional Assessment of Cancer Therapy–Bone Marrow Transplant scale (FACT-BMT). Anxiety and depressive symptoms were assessed using Spielberger’s State and Trait Anxiety Inventory (STAI) and the Beck Dep­ression Inventory (BDI), respectively. Basic sociodemographic and clinical variables were also recorded. Comparisons between autologous and allogeneic recipients were analyzed using a t-test when the variables were normally distributed and a Mann–Whitney U test otherwise. A stepwise multiple linear regression analysis was performed to identify the risk factors that contributed to the quality of life and the affective symptoms in each group.

Quality of life (p=0.83) and affective symptoms (pBDI=0.24; pSSTAI=0.63) were similar between the autologous and allogeneic transplant groups. The BDI scores of allogeneic transplant patients indicated mild depression, but their STAI scores were similar to those of the general population. Allogeneic transplant patients with symptoms of graft-versus-host disease (GVHD) experienced more severe clinical conditions (p=0.01), poorer functional status (p<0.01) and received more immunosuppressive treatment (p<0.01) than those without graft versus host disease. Patients suffering from graft versus host disease experienced more severe depression (p=0.01), and constant anxiety (p=0.03) than those without graft versus host disease. Quality of life was affected by depressive and anxiety symptoms and psychiatric comorbidity in both the alloge­neic and autologous groups.

Graft versus host disease-related severe somatic complaints seemed to influence the allogeneic transplant patients’ quality of life by inducing depressive and anxiety symptoms.

Five-year follow-up mortality prognostic index for colorectal patients.

PURPOSE: To identify 5-year survival prognostic variables in patients with colorectal cancer (CRC) and to propose a survival prognostic score that also takes into account changes over time in the patient's health-related quality of life (HRQoL) status. METHODS: Prospective observational cohort study of CRC patients. We collected data from their diagnosis, intervention, and at 1, 2, 3, and 5 years following the index intervention, also collecting HRQoL data using the EuroQol-5D-5L (EQ-5D-5L), European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30), and Hospital Anxiety and Depression Scale (HADS) questionnaires. Multivariate Cox proportional models were used. RESULTS: We found predictors of mortality over the 5-year follow-up to be being older; being male; having a higher TNM stage; having a higher lymph node ratio; having a result of CRC surgery classified as R1 or R2; invasion of neighboring organs; having a higher score on the Charlson comorbidity index; having an ASA IV; and having worse scores, worse quality of life, on the EORTC and EQ-5D questionnaires, as compared to those with higher scores in each of those questionnaires respectively. CONCLUSIONS: These results allow preventive and controlling measures to be established on long-term follow-up of these patients, based on a few easily measurable variables. IMPLICATIONS FOR CANCER SURVIVORS: Patients with colorectal cancer should be monitored more closely depending on the severity of their disease and comorbidities as well as the perceived health-related quality of life, and preventive measures should be established to prevent adverse outcomes and therefore to ensure that better treatment is received. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02488161.

Psychometric performance of the Chichewa versions of the EQ-5D-Y-3L and EQ-5D-Y-5L among healthy and sick children and adolescents in Malawi.

OBJECTIVES: The EuroQol Group has developed an extended version of the EQ-5D-Y-3L with five response levels for each of its five dimensions (EQ-5D-Y-5L). The psychometric performance has been reported in several studies for the EQ-5D-Y-3L but not for the EQ-5D-Y-5L. This study aimed to psychometrically evaluate the EQ-5D-Y-3L and EQ-5D-Y-5L Chichewa (Malawi) versions. METHODS: The EQ-5D-Y-3L, EQ-5D-Y-5L and PedsQL™ 4.0 Chichewa versions were administered to children and adolescents aged 8-17 years in Blantyre, Malawi. Both of the EQ-5D-Y versions were evaluated for missing data, floor/ceiling effects, and validity (convergent, discriminant, known-group and empirical). RESULTS: A total of 289 participants (95 healthy, and 194 chronic and acute) self-completed the questionnaires. There was little problem with missing data (< 5%) except in children aged 8-12 years particularly for the EQ-5D-Y-5L. Ceiling effects was generally reduced in moving from the EQ-5D-Y-3L to the EQ-5D-Y-5L. For both EQ-5D-Y-3L and EQ-5D-Y-5L, convergent validity tested with PedsQL™ 4.0 was found to be satisfactory (correlation ≥ 0.4) at scale level but mixed at dimension /sub-scale level. There was evidence of discriminant validity (p > 0.05) with respect to gender and age, but not for school grade (p < 0.05). For empirical validity, the EQ-5D-Y-5L was 31-91% less efficient than the EQ-5D-Y-3L at detecting differences in health status using external measures. CONCLUSIONS: Both versions of the EQ-5D-Y-3L and EQ-5D-Y-5L had issues with missing data in younger children. Convergent validity, discriminant validity with respect to gender and age, and known-group validity of either measures were also met for use among children and adolescents in this population, although with some limitations (discriminant validity by grade and empirical validity). The EQ-5D-Y-3L seems particularly suited for use in younger children (8-12 years) and the EQ-5D-Y-5L in adolescents (13-17 years). However, further psychometric testing is required for test re-test reliability and responsiveness that could not be carried out in this study due to COVID-19 restrictions.

Impact of possible tardive dyskinesia on physical wellness and social functioning: results from the real-world RE-KINECT study.

BACKGROUND: Tardive dyskinesia (TD) is a persistent and potentially disabling movement disorder associated with antipsychotic use. Data from RE-KINECT, a real-world study of antipsychotic-treated outpatients, were analyzed to assess the effects of possible TD on patient health and social functioning. METHODS: Analyses were conducted in Cohort 1 (patients with no abnormal involuntary movements) and Cohort 2 (patients with possible TD per clinician judgment). Assessments included: EuroQoL's EQ-5D-5L utility (health); Sheehan Disability Scale (SDS) total score (social functioning); patient- and clinician-rated severity of possible TD ("none", "some", "a lot"); and patient-rated impact of possible TD ("none", "some", "a lot"). Regression models were used to analyze the following: associations between higher (worse) severity/impact scores and lower (worse) EQ-5D-5L utility (indicated by negative regression coefficients); and associations between higher (worse) severity/impact scores and higher (worse) SDS total score (indicated by positive regression coefficients). RESULTS: In Cohort 2 patients who were aware of their abnormal movements, patient-rated TD impact was highly and significantly associated with EQ-5D-5L utility (regression coefficient: - 0.023, P < 0.001) and SDS total score (1.027, P < 0.001). Patient-rated severity was also significantly associated with EQ-5D-5L utility (- 0.028, P < 0.05). Clinician-rated severity was moderately associated with both EQ-5D-5L and SDS, but these associations were not statistically significant. CONCLUSIONS: Patients were consistent in evaluating the impacts of possible TD on their lives, whether based on subjective ratings ("none", "some", "a lot") or standardized instruments (EQ-5D-5L, SDS). Clinician-rated severity of TD may not always correlate with patient perceptions of the significance of TD.

Evaluation of the Quality of Life and the Quality of Sleep of postmenopausal osteoporotic women, without evidence of an osteoporotic fracture, who attended an outpatient DXA scan service.

OBJECTIVES: The present study aimed to investigate whether impairment of health-related quality of life (HRQOL) and possibly, the quality of sleep (Sleep Quality - SQ), of osteoporotic women, may occur, even before the onset of an osteoporotic fracture. METHODS: The study included 109 women, divided (DXA) into two groups (age-matched): the Control Group (n=68; normal and osteopenic) and the Patient Group (n=41; osteoporotic). Review of medical history of the participants, was followed by evaluation of HRQOL and SQ with the EQ-5D-3L and the PSQI questionnaires, respectively. RESULTS: There was no significant difference between the two groups (Control vs. Patient) in terms of average HRQOL and SQ, as measured by the EQ-5D-3L Questionnaire (0.73 vs. 0.70, p>0.05) and the PSQI Index value (5.56 vs. 6.29, p>0.05), respectively. A high percentage of patients was estimated as having a poor SQ (52.9% of the Control Group and 46.3% of the Patient Group, p>0.05). Increasing age, with or without the presence of osteoporosis, seemed to lead to worst QoL (OR<1.00, p<0.05). CONCLUSIONS: Our study documented homogeneity in HRQOL and SQ, between the two study groups. The strongest predictor for the HRQOL was age (for each year of age increase, the probability of excellent HRQOL significantly decreased).

(Cost-)effectiveness of a personalized multidisciplinary eHealth intervention for knee arthroplasty patients to enhance return to activities of daily life, work and sports - rationale and protocol of the multicentre ACTIVE randomized controlled trial.

BACKGROUND: With the worldwide rising obesity epidemic and the aging population, it is essential to deliver (cost-)effective care that results in enhanced societal participation among knee arthroplasty patients. The purpose of this study is to describe the development, content, and protocol of our (cost-)effectiveness study that assesses a perioperative integrated care program, including a personalized eHealth app, for knee arthroplasty patients aimed to enhance societal participation post-surgery compared to care as usual. METHODS: The intervention will be tested in a multicentre randomized controlled trial with eleven participating Dutch medical centers (i.e., hospitals and clinics). Working patients on the waiting-list for a total- or unicompartmental knee arthroplasty with the intention to return to work after surgery will be included. After pre-stratification on medical centre with or without eHealth as usual care, operation procedure (total- or unicompartmental knee arthroplasty) and recovery expectations regarding return to work, randomization will take place at the patient-level. A minimum of 138 patients will be included in both the intervention and control group, 276 in total. The control group will receive usual care. On top of care as usual, patients in the intervention group will receive an intervention consisting of three components: 1) a personalized eHealth intervention called ikHerstel ('I Recover') including an activity tracker, 2) goal setting using goal attainment scaling to improve rehabilitation and 3) a referral to a case-manager. Our main outcome is quality of life, based on patient-reported physical functioning (using PROMIS-PF). (Cost-)effectiveness will be assessed from a healthcare and societal perspective. Data collection has been started in 2020 and is expected to finish in 2024. DISCUSSION: Improving societal participation for knee arthroplasty is relevant for patients, health care providers, employers and society. This multicentre randomized controlled trial will evaluate the (cost-)effectiveness of a personalized integrated care program for knee arthroplasty patients, consisting of effective intervention components based on previous studies, compared to care as usual. TRIAL REGISTRATION: Trialsearch.who.int; reference no. NL8525, reference date version 1: 14-04-2020.

Health-related quality of life and patient-reported outcome measurements in patients with cystinosis.

Nephropathic cystinosis is a rare autosomal recessive lysosomal storage disorder. With the availability of treatment and renal replacement therapy, nephropathic cystinosis has evolved from an early fatal disease to a chronic, progressive disorder with potentially high impairment. We aim to review the literature on the health-related quality of life and identify appropriate patient-reported outcome measurements to assess the health-related quality of life of patients with cystinosis. For this review, we conducted a literature search in PubMed and Web of Science in September 2021. Inclusion and exclusion criteria for the selection of articles were defined a priori. We identified 668 unique articles through the search and screened them based on title and abstract. The full texts of 27 articles were assessed. Finally, we included five articles (published between 2009 and 2020) describing the health-related quality of life in patients with cystinosis. All studies, apart from one, were conducted in the United States, and no condition-specific measurement was used. Patients with cystinosis reported a lower health-related quality of life (for certain dimensions) than healthy subjects. Few published studies address the health-related quality of life of patients with cystinosis. Such data must be collected standardized and follow the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. To gain a comprehensive understanding of the impact of this disorder on health-related quality of life, it is necessary to use generic and condition-specific instruments to measure this, preferably in large samples from longitudinal studies. A cystinosis-specific instrument for measuring health-related quality of life has yet to be developed.

Associations between post-traumatic stress symptoms and quality of life among psychiatric healthcare personnel in China during the COVID-19 pandemic: A network approach.

Background: Post-traumatic stress symptoms (PTSS) are commonly reported by psychiatric healthcare personnel during the coronavirus disease 2019 (COVID-19) pandemic and negatively affect quality of life (QOL). However, associations between PTSS and QOL at symptom level are not clear. This study examined the network structure of PTSS and its connection with QOL in psychiatric healthcare personnel during the COVID-19 pandemic. Methods: This cross-sectional study was carried out between March 15 and March 20, 2020 based on convenience sampling. Self-report measures including the 17-item Post-Traumatic Stress Disorder Checklist - Civilian version (PCL-C) and World Health Organization Quality of Life Questionnaire - Brief Version (WHOQOL-BREF) were used to measure PTSS and global QOL, respectively. Network analysis was used to investigate the central symptoms of PTSS and pattern of connections between PTSS and QOL. An undirected network was constructed using an extended Bayesian Information Criterion (EBIC) model, while a directed network was established based on the Triangulated Maximally Filtered Graph (TMFG) method. Results: Altogether, 10,516 psychiatric healthcare personnel completed the assessment. "Avoidance of thoughts" (PTSS-6), "Avoidance of reminders" (PTSS-7), and "emotionally numb" (PTSS-11) were the most central symptoms in the PTSS community, all of which were in the Avoidance and Numbing domain. Key bridge symptoms connecting PTSS and QOL were "Sleep disturbances" (PTSS-13), "Irritability" (PTSS-14) and "Difficulty concentrating" (PTSS-15), all of which were within the Hyperarousal domain. Conclusion: In this sample, the most prominent PTSS symptoms reflected avoidance while symptoms of hyper-arousal had the strongest links with QOL. As such, these symptom clusters are potentially useful targets for interventions to improve PTSS and QOL among healthcare personnel at work under pandemic conditions.