Objective
The aim of the present study is to identify factors associated with patient empowerment in people living with type 2 diabetes mellitus (T2DM) in the Canary Islands (Spain).
Methods
...Secondary cross‐sectional analysis was carried out of data obtained in the INDICA study: A 24‐month cluster randomized‐controlled trial evaluating the effectiveness of educational interventions supported by new technology decision tools for T2DM patients. Sociodemographic variables, clinical data (years since diagnosis, glycated haemoglobin level, creatine, triglycerides, waist hip index, body mass index and number of comorbidities), diabetes knowledge (DIATEK), affective outcomes (Beck Depression Inventory‐II, the State subscale of the State‐Trait Anxiety Inventory and The Diabetes Distress Scale) and diabetes‐related quality of life (The Audit of Diabetes‐Dependent Quality of life) were assessed as potential correlates of patient empowerment, assessed using the Diabetes Empowerment Scale‐Short Form. Multilevel mixed linear regression models on patient empowerment were developed.
Results
The analysis included the baseline data of 2334 patients. Results showed that age (B = −0.14; p < .001), diabetes knowledge (B = 0.61; p < .001) and state‐anxiety (B = −0.09; p < .001) are significantly associated with patient empowerment. Sex, education level, living alone, employment status, country of birth, time since diagnosis, number of comorbidities, glycated haemoglobin level, depression and distress were not independently associated with patient empowerment in the multivariate analyses.
Conclusion
Younger age, lower state‐anxiety and greater diabetes‐specific knowledge are important correlates of patient empowerment. In line with the results of the INDICA study, interventions based on patient‐centred care might be effective in improving patient empowerment in adults with T2DM. Understanding the factors associated with empowerment may help clinicians and policymakers to identify high‐risk groups, prioritize resources and target evidence‐based interventions to better support people with T2DM to be actively involved in their own care.
Patient or Public Contribution
Patients with T2DM were actively involved in the design of the INDICA study. Two patient associations were included as part of the research team and actively participated in designing the interventions and selecting outcome measures.
Eating disorders (EDs) are mental health illnesses with a multifactorial origin. At present, no review of indexed publications studying their prevalence in Spain is available.
A scoping review ...(PROSPERO -CRD42019140884-) was carried out through systematic searches (MEDLINE, EMBASE and PsycINFO) until January 2022. Papers published in Spanish/English analysing the prevalence of EDs in Spain (population < 65 years) were selected.
A total of 766 articles were identified (186 eliminated as duplicates). A total of 580 articles were analysed on the basis of title and abstract, and 67 articles were selected for full-text analysis. A total of 37 studies analysed the prevalence of EDs in Spain.
This is the first scoping review to analyse the prevalence of EDs in Spain. Puberty and adolescence are the most extensively studied stages. There is a high heterogeneity in the use of ED screening tools and a paucity of information on diagnostic tools.
OBJECTIVE: Respiratory disease is the major cause of morbidity and mortality in patients with alpha-1 antitrypsin deficiency, mainly in homozygous PI*ZZ individuals. However, this association is ...uncertain in subjects with other deficiency genotypes. The objective of this study was to assess, in the context of alpha-1 antitrypsin deficiency, the existence of further risk factors that have been associated with respiratory diseases. MATERIAL AND METHODS: Lung function was assessed by spirometry in a sample of 1334 patients with a known genotype for the SERPINA1 gene whose serum alpha-1 antitrypsin levels had been previously determined. Patients with a normal genotype (PI*MM) were compared to 389 patients carrying a deficiency allele. RESULTS: Statistically significant associations were detected between (i) PI*ZZ genotype and abnormal FEV, values (chi square = 26.45; P < .0002), FEV.sub.1/FVC (chi square = 14.8; P < .02) or forced mid-expiratory flow 25%-75% (chi square=22.66; P < .0009); (ii) chronic obstructive pulmonary disease and PI*ZZ odds ratio: 26.5; 95% CI: (2.6-265.9); P < .005 and or PI*SS genotype odds ratio: 9; 95% CI: (2- 40.1); P< .004; (iii) prevalence of COPD in PI*MZ subjects and smoking habit (P < .01), low body weight (P < .01) or older age (P < .0001). CONCLUSION: The PI*ZZ and PI*SS genotypes seem to be associated with the prevalence of chronic obstructive pulmonary disease. Tobacco use, low body weight, and older age are risk factors that increase the probability of prevalence of chronic obstructive pulmonary disease by up to 70% in PI*MZ individuals. KEYWORDS: Alpha-1 antitrypsin deficiency, spirometry, lung function, chronic obstructive pulmonary disease, respiratory disease
Background
Subcutaneous implantable cardioverter‐defibrillator (S‐ICD) is gaining in popularity for primary and secondary prevention of sudden cardiac death. The objective was to evaluate the safety ...and clinical effectiveness of the S‐ICD for prevention of sudden cardiac death compared to transvenous cardioverter‐defibrillator (TV‐ICD).
Methods
A systematic review with meta‐analyses was performed. The electronic databases MEDLINE, EMBASE, SCI, and Cochrane Central Register of Controlled Trials were consulted in March 2018 with no restrictions on publication date. Predefined criteria were used to determine inclusion of studies and to assess their methodologic quality.
Results
Ten longitudinal‐observational studies with comparison group presenting moderate methodologic flaws were included (N = 7820). The combination of results indicates that health‐related quality of life is not significantly different between S‐ICD and TV‐ICD groups (Physical health: MD = 2.90; 95% CI = −3.88, 9.68/Mental health: MD = 0.13; 95% CI = −2.11, 2.37). Mortality occurred in 4.4% of S‐ICD patients and 5.9% of TV‐ICD patients died (OR = 0.79; 95% CI = 0.50, 1.24). The incidence of infections (OR = 1.79; 95% CI = 0.93, 3.43) and inappropriate shocks (OR = 1.28, 95% CI = 0.91, 1.78) is not significantly different between both groups. The S‐ICD reduces complications related to electrodes/leads (OR = 0.13, 95% CI = 0.05, 0.29) and has lower electrodes/leads movement compared with TV‐ICD (OR = 0.26; 95% CI 0.10, 0.67). In contrast, pneumothorax is more likely in TV‐ICD than S‐ICD (OR = 0.17; 95% CI = 0.03, 0.97).
Conclusions
S‐ICD reduces electrodes/leads movement, electrodes/leads related complications, and pneumothorax. Our study did not demonstrate a statistically significant difference in mortality, health‐related quality of life, and infection rate between S‐ICD and TV‐ICD.
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Eating disorders (EDs) develop more frequently in young females. Following the COVID-19 pandemic, there has been evidence of an increase in children and adolescents, with an earlier ...onset and a worse body weight and nutritional status. The aim of this study was to determine whether this trend has also been observed in our region over the past 6 years.
We conducted a retrospective and descriptive cohort study in paediatric patients with a diagnosis of ED, referred during the 3 years preceding and following the declaration of the state of alarm due to the pandemic. We analysed and compared clinical, anthropometric and laboratory variables and bioelectrical impedance and bone density data.
Of the 129 patients in the sample, 28 were referred before the lockdown period and 101 after. When we compared these groups, we found a longer time elapsed from onset to the initial assessment (mean delay, 11.87 SD, 6.75 vs. 6.64 SD, 4.36 months), a greater hospitalization rate (14.1% vs. 10.1%), and lower vitamin D values (mean level, 28.19 SD, 9.95 vs. 34.39 SD, 11.87 ng/mL) in the post-lockdown group. We also found a greater frequency of self-harm suicide attempts in these patients.
This study confirms the increasing trend in EDs in children and adolescents in our area. Moreover, we found differences in the clinical characteristics and time elapsed to diagnosis compared to the patients referred to the hospital before the pandemic.
Los trastornos de la conducta alimentaria (TCA) se presentan con mayor frecuencia en personas jóvenes de sexo femenino. Tras la pandemia por COVID-19, se ha descrito su incremento en niños y adolescentes, con presentación a edades más tempranas y peor estado ponderal y nutricional. Este estudio pretende constatar si esa tendencia se cumple también en nuestro medio.
Se realizó un estudio de cohortes descriptivo, retrospectivo en el que se incluye a los pacientes pediátricos con diagnóstico de TCA, remitidos durante los tres años previos y posteriores a la declaración del estado de alerta por la pandemia. Se analizaron y compararon parámetros clínicos, antropométricos, analíticos, bioimpedancia eléctrica y densitometría ósea.
De los 129 pacientes de la muestra, 28 se derivaron en periodo pre-confinamiento y 101 tras el mismo. En comparación, el segundo grupo presentó mayor tiempo de evolución hasta su primera valoración (11,87 ± 6,75 frente a 6,64 ± 4,36 meses), más hospitalizaciones (14,1% frente a 10,1%), y una reducción de los valores de vitamina D (28,19 ± 9,95 frente a 34,39 ± 11,87 ng/mL). Asimismo, estos pacientes asociaban con más frecuencia autolesiones e intentos de suicidio.
Se comprobó la tendencia creciente de los TCA en niños y adolescentes en nuestro medio. Además, se observaron diferencias en algunas de sus características clínicas, en su gravedad, y en el tiempo de evolución hasta el diagnóstico, en comparación con los pacientes remitidos antes de la pandemia.
Background and objective The EuroQol 5 dimensions 5 levels (EQ-5D-5L) is the new version of EQ-5D, developed to improve its discriminatory capacity. This study aims to evaluate the construct validity ...of the Spanish version and provide index and dimension population-based reference norms for the new EQ-5D-5L. Methods Data were obtained from the 2011/2012 Spanish National Health Survey, with a representative sample (n = 20,587) of non-institutionalized Spanish adults (≥ 18 years). The EQ-5D-5L index was calculated by using the Spanish value set. Construct validity was evaluated by comparing known groups with estimators obtained through regression models, adjusted by age and gender. Sampling weights were applied to restore the representativeness of the sample and to calculate the norms stratified by gender and age groups. We calculated the percentages and standard errors of dimensions, and the deciles, percentiles 5 and 95, means, and 95% confidence intervals of the health index. Results All the hypotheses established a priori for known groups were confirmed (P< 0.001). The EQ-5D-5L index indicated worse health in groups with lower education level (from 0.94 to 0.87), higher number of chronic conditions (0.96-0.79), probable psychiatric disorder (0.94 vs 0.80), strong limitations (0.96-0.46), higher number of days of restriction (0.93-0.64) or confinement to bed (0.92-0.49), and hospitalized in the previous 12 months (0.92 vs 0.81). Conclusions The EQ-5D-5L is a valid instrument to measure perceived health in the Spanish-speaking population. The representative population-based norms provided here will help improve the interpretation of results obtained with the new EQ-5D-5L.
To assess the safety and effectiveness of immediately sequential (ISBCS) versus delayed sequential (DSBCS) bilateral cataract surgery.
Multiple clinics, Canary Islands, Spain.
Multicenter randomized ...clinical trial.
Patients with cataracts requiring bilateral surgery were randomized to ISBCS or DSBCS. Outcome measures were the incidence of intraoperative and postoperative surgical complications, corrected and uncorrected visual acuities, and self-perceived visual function (VF-14 questionnaire). All outcomes were measured 30 days postoperatively. Self-perceived visual function was also assessed after 1 year. Data were analyzed with repeated measures to assess temporal effects on surgical complications, visual acuity, and function. Effect size was also estimated for self-perceived visual function.
There were no differences in intraoperative or postoperative surgical complications, visual acuity 30 days postoperatively, or self-perceived visual function after 1 year between the 2 techniques. Effect size for visual function 30 days postoperatively was moderate in the ISBCS group (n = 834) and small in the DSBCS group (n = 780). This difference disappeared at 1-year follow-up after second-eye surgery in the delayed group.
There were no relevant surgical complications in 1614 operated eyes and no significant difference in surgical complications, visual acuity, or long-term self-perceived visual function between ISBCS and DSBCS. These safety and effectiveness outcomes were related to careful patient selection, surgical expertise, and the systematic use of standardized surgical guidelines to ensure aseptic and independent surgery in each eye.
The Spanish five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) valuation study was the first to use the EuroQol Valuation Technology protocol, including composite time trade-off (C-TTO) and ...discrete choice experiments (DCE). In this study, its investigators noticed that some interviewers did not fully explain the C-TTO task to respondents. Evidence from a follow-up study in 2014 confirmed that when interviewers followed the protocol, the distribution of C-TTO responses widened.
To handle the data quality issues in the C-TTO responses by estimating a hybrid interval regression model to produce a Spanish EQ-5D-5L value set.
Four different models were tested. Model 0 integrated C-TTO and DCE responses in a hybrid model and models 1 to 3 altered the interpretation of the C-TTO responses: model 1 allowed for censoring of the C-TTO responses, whereas model 2 incorporated interval responses and model 3 included the interviewer-specific protocol violations. For external validation, the predictions of the four models were compared with those of the follow-up study using the Lin’s concordance correlation coefficient.
This stepwise approach to modeling C-TTO and DCE responses improved the concordance between the valuation and follow-up studies (concordance correlation coefficient: 0.948 model 0, 0.958 model 1, 0.952 model 2, and 0.989 model 3). We recommend the estimates from model 3, because its hybrid interval regression model addresses the data quality issues found in the valuation study.
Protocol violations may occur in any valuation study; handling them in the analysis can improve external validity. The resulting EQ-5D-5L value set (model 3) can be applied to inform Spanish health technology assessments.
BACKGROUND // Alopecia is one of the most common adverse effects of chemotherapy, having a significant impact on the quality
of life of patients who suffer from it. Among the interventions available ...for its prevention, scalp cooling (SC) is the most widely used.
The aim of this study was to assess the efficacy and safety of the use of SC systems during chemotherapy sessions for the prevention
or the reduction of the extent of chemotherapy-induced alopecia.
METHODS // A systematic review of the literature published up to November 2021 was carried out. Randomized clinical trials were selected.
The main outcome measure was alopecia (hair loss>50%) during and after chemotherapy treatment. When possible, a quantitative synthesis
of the results was performed through meta-analysis using the Stata v.15.0 software. The risk ratio (RR) of the variable alopecia, was estimated
using a random effects model following the Mantel-Haenszel method. Statistical heterogeneity of the results was evaluated graphically and
through the test of heterogeneity χ2 and the Higgins I2 statistic. Sensitivity analyses and subgroup analyses were performed.
RESULTS // 13 studies were included, with a total of 832 participants (97.7% women). In most studies, the main chemotherapy treatment
applied was anthracyclines or the combination of anthracyclines and taxanes. The results obtained indicate that SC prevents
alopecia (loss>50%) by 43% compared to the control group (RR=0.57; 95% CI=0.46 to 0.69; k=9; n=494; I2=63.8%). No statistically
significant difference was found between the efficacy of automated and non-automated cooling systems (P=0.967). No serious shortor
medium-term adverse events related to SC were recorded.
CONCLUSIONS // The results suggest that scalp cooling contributes to the prevention of chemotherapy-induced alopecia.
FUNDAMENTOS // La alopecia es uno de los efectos adversos más comunes de la quimioterapia, con un impacto importante sobre
la calidad de vida de los/las pacientes que la padecen. Entre las intervenciones disponibles para su prevención, el enfriamiento del
cuero cabelludo (ECC) es la que cuenta con un uso más extendido. El objetivo de este estudio fue evaluar la eficacia y la seguridad
del uso de sistemas de ECC durante las sesiones de quimioterapia para la prevención o reducción de la extensión de la alopecia
secundaria a la quimioterapia.
MÉTODOS // Se llevó a cabo una revisión sistemática de la literatura publicada hasta noviembre de 2021. Se seleccionaron ensayos
clínicos aleatorizados. La medida de resultado principal fue la alopecia (pérdida de cabello superior al 50%) durante y posteriormente
al tratamiento de quimioterapia. Cuando fue posible, se realizó síntesis cuantitativa de los resultados mediante metanálisis con el
programa Stata v.15.0. Se estimó el riesgo relativo (RR) de la variable alopecia, utilizando un modelo de efectos aleatorios siguiendo
el método de Mantel-Haenszel. La heterogeneidad estadística de los resultados se evaluó gráficamente y mediante el test de la χ2 y
el estadístico I2 de Higgins. Se realizaron análisis de sensibilidad y análisis de subgrupos.
RESULTADOS // Se incluyeron 13 estudios con un total de 832 participantes (97,7% de mujeres). En la mayoría de los estudios, los
agentes quimioterapéuticos principales aplicados fueron las antraciclinas o la combinación de antraciclinas y taxanos. Los resultados
obtenidos indican que el ECC reduce la aparición de la alopecia un 43% frente al grupo control (RR=0,57; IC95%=0,46 a 0,69; k=9;
n=494; I2=63,8%). No se encontró una diferencia estadísticamente significativa entre la eficacia de sistemas de enfriamiento automatizados
y no automatizados (P=0,967). No se registraron eventos adversos graves a corto o medio plazo relacionados con el ECC.
CONCLUSIONES // Los resultados sugieren que el ECC contribuye a prevenir la alopecia secundaria a la quimioterapia.