Cross-cultural adaptation, reliability and validity of the Spanish version of the long-term quality of life questionnaire.

Purpose: The aim of this study was to translate, culturally adapt, and evaluate the psychometric properties of the Spanish Long-Term Quality of Life (LTQL) questionnaire. Methods: The LTQL was initially translated into Spanish and cross-culturally adapted based on established guidelines. The Spanish LTQL was administered to patients with breast cancer who had completed their initial treatment 5 years earlier, along with other self-report measures: Quality of Life in Adult Cancer Survivors (QLACS), Hospital Anxiety and Depression Scale (HADS) and EORT-QLQ-BR23. Reliability was evaluated using internal consistency and test-retest. Convergent and known-groups validity were examined. Structural validity as determined by confirmatory factor analysis (CFA) and Rasch analyses was used to assess the unidimensionality and item-functioning of the LTQL domains. Results: Cronbach's alpha were above 0.7 in all domains. Test-retest coefficients were between 0.72 to 0.96 for LTQL domains. LTQL total score was correlated with others total scores of other measures: QLACS (r=-0.39), HADS depression (r=-0.57), HADS anxiety (-0.45) and EORTC-QLQ-BR23 (r=-0.50). CFA provided satisfactory fit indices, with RMSEA value of 0.077 and TLI and CFI values of 0.901 and 0.909, respectively. All factor loadings were higher than 0.40 and statistically significant (P<0.001). Rasch analysis showed that Somatic Concerns domain had 4 misfitting items, and Philosophical/Spiritual View of Life and social Support domains only 1 misfit item. However, unidimensionality was supported for the four domains. Conclusion: The findings support the validity and reliability of the Spanish version of LTQL questionnaire to be used in long-term cancer female survivors.

Percutaneous ethanol injection in thyroid nodular pathology and metastatic cervical adenopathies: A systematic review, meta-analysis and economic evaluation.

BACKGROUND: Percutaneous ethanol injection (PEI) has been shown to be a valuable treatment for thyroid nodular pathology and metastatic cervical adenopathies. OBJECTIVE: To evaluate the effectiveness, safety, and cost-effectiveness of PEI in thyroid nodular pathology and metastatic cervical adenopathies. METHODS: A systematic review (SR) using meta-analysis was conducted on the effectiveness and safety of PEI. A SR on cost-effectiveness was also performed. The SRs were conducted according to the methodology developed by the Cochrane Collaboration with reporting in accordance with the PRISMA statement. A cost-minimization analysis was carried out using a decision tree model. Assuming equal effectiveness between two minimally invasive techniques (PEI and radiofrequency ablation (RFA)), the model compared the costs of the alternatives with a horizon of six months and from the perspective of the Spanish National Health System. RESULTS: The search identified three RCTs (n=157) that evaluated PEI versus RFA in patients diagnosed with benign thyroid nodules: ninety-six patients with predominantly cystic nodules and sixty-one patients with solid nodules. No evidence was found on other techniques or thyroid nodular pathology. No statistically significant differences were observed between PEI and RFA in volume reduction (%), symptom score, cosmetic score, therapeutic success and major complications. No economic evaluations were identified. The cost-minimization analysis estimated the cost per patient of the PEI procedure at €326 compared to €4781 for RFA, which means an incremental difference of -€4455. CONCLUSIONS: There are no differences between PEI and RFA regarding their safety and effectiveness, but the economic evaluation determined that the former option is cheaper.

Ethical, Legal, Organisational and Social Issues of Teleneurology: A Scoping Review.

BACKGROUND: Neurological disorders are the leading cause of disability and the second leading cause of death worldwide. Teleneurology (TN) allows neurology to be applied when the doctor and patient are not present in the same place, and sometimes not at the same time. In February 2021, the Spanish Ministry of Health requested a health technology assessment report on the implementation of TN as a complement to face-to-face neurological care. METHODS: A scoping review was conducted to answer the question on the ethical, legal, social, organisational, patient (ELSI) and environmental impact of TN. The assessment of these aspects was carried out by adapting the EUnetHTA Core Model 3.0 framework, the criteria established by the Spanish Network of Health Technology Assessment Agencies and the analysis criteria of the European Validate (VALues In Doing Assessments of healthcare TEchnologies) project. Key stakeholders were invited to discuss their concerns about TN in an online meeting. Subsequently, the following electronic databases were consulted from 2016 to 10 June 2021: MEDLINE and EMBASE. RESULTS: 79 studies met the inclusion criteria. This scoping review includes 37 studies related to acceptability and equity, 15 studies developed during COVID and 1 study on environmental aspects. Overall, the reported results reaffirm the necessary complementarity of TN with the usual face-to-face care. CONCLUSIONS: This need for complementarity relates to factors such as acceptability, feasibility, risk of dehumanisation and aspects related to privacy and the confidentiality of sensitive data.

Telemedicine for neurological diseases: A systematic review and meta-analysis.

BACKGROUND AND PURPOSE: The aim was to systematically review the effectiveness and safety of telemedicine combined with usual care (in-person visits) compared to usual care for the therapeutic management and follow-up assessment of neurological diseases. METHODS: The electronic databases MEDLINE, Embase, Web of Science and Cochrane Central Register of Controlled Trials were searched (June 2021). Randomized controlled trials (RCTs) on patients of any age with neurological diseases were considered. Two reviewers screened and abstracted data in duplicate and independently and assessed risk of bias using the Cochrane risk-of-bias tool for randomized trials (RoB 2). When possible, pooled effect estimates were calculated. RESULTS: Of a total of 3018 records initially retrieved, 25 RCTs (n = 2335) were included: 11 (n = 804) on stroke, four (n = 520) on Parkinson's disease, three (n = 110) on multiple sclerosis, two (n = 320) on epilepsy, one (n = 63) on dementia, one (n = 23) on spina bifida, one (n = 40) on migraine, one (n = 22) on cerebral palsy and one (n = 433) on brain damage. Types of telemedicine assessed were online visits (11 studies), tele-rehabilitation (seven studies), telephone calls (three), smartphone apps (two) and online computer software (two). The evidence was quite limited except for stroke. Compared to usual care alone, telemedicine plus usual care was found to improve depressive symptoms, functional status, motor function, executive function, generic quality of life, healthcare utilization and healthy lifestyle in patients in post-stroke follow-up. CONCLUSIONS: Well-designed and executed RCTs are needed to confirm our findings on stroke and to have more scientific evidence available for the other neurological diseases.

Information needs and research priorities in long-term survivorship of breast cancer: Patients and health professionals' perspectives.

OBJECTIVE: The objective of this work is to identify unmet information needs of long-term-survivors of breast cancer (BC) and future research needs from the perspectives of patients and health care professionals. METHODS: Two online Delphi surveys were conducted. Participants in Survey 1 were patients. Participants in Survey 2 were health care professionals from both primary and secondary care involved in BC care. Both surveys included three successive rounds. The first round aimed to identify research and information needs; the second round aimed to rank the relative importance of those needs; the third round aimed to find consensus. RESULTS: The most important information needs were self-management recommendations of common health problems after treatment and complications of breast reconstruction after 5 years. The most important research priorities were related to interventions and tools to increase information provision by professionals about certain tests, diet, and coordinated action between primary and specialised care during follow-up, and indications and safety issues of pregnancy in survivors. CONCLUSIONS: Two fundamental ideas were identified: (1) Patients request information about self-management common health problems after treatment and breast reconstruction complications. (2) Health care professionals emphasise the need for a standardised approach based on protocols, recommendations, and coordinated actions in the provision of information. IMPLICATIONS FOR CANCER SURVIVORS: Given the increasing number of BC survivors, it is essential to identify information and research needs to improve their care and health outcomes.

Effectiveness of Mantra-Based Meditation on Mental Health: A Systematic Review and Meta-Analysis.

BACKGROUND: Meditation is defined as a form of cognitive training that aims to improve attentional and emotional self-regulation. This systematic review aims to evaluate the available scientific evidence on the effectiveness and safety of mantra-based meditation techniques (MBM), in comparison to passive or active controls, or other active treatment, for the management of mental health symptoms. METHODS: MEDLINE, EMBASE, Cochrane Library, and PsycINFO databases were consulted up to April 2021. Randomised controlled trials regarding meditation techniques mainly based on the repetition of mantras, such as transcendental meditation or others, were included. RESULTS: MBM, compared to control conditions, was found to produce significant small-to-moderate effect sizes in the reduction of anxiety (g = -0.46, IC95%: -0.60, -0.32; I2 = 33%), depression (g = -0.33, 95% CI: -0.48, -0.19; I2 = 12%), stress (g = -0.45, 95% CI: -0.65, -0.24; I2 = 46%), post-traumatic stress (g = -0.59, 95% CI: -0.79, -0.38; I2 = 0%), and mental health-related quality of life (g = 0.32, 95% CI: 0.15, 0.49; I2 = 0%). CONCLUSIONS: MBM appears to produce small-to-moderate significant reductions in mental health; however, this evidence is weakened by the risk of study bias and the paucity of studies with psychiatric samples and long-term follow-up.

[Content validation of the spanish version of the Long-term Quality of Life Instrument for long-term female breast cancer survivors.] / Validación de contenido de la versión en castellano del instrumento Long-term Quality of Life Instrument para mujeres supervivientes de cáncer de mama de larga duración.

OBJECTIVE: The quality of life of women affected by breast cancer diagnosed 5 or more years ago has been relatively unexplored in Spain; there are no instruments for its measurement validated. The objective of the study is to translate into Spanish, culturally adapt and examine the content validity of the Spanish version of the Long-Term Quality of Life Instrument (LTQL). METHODS: The initial translation was performed by two translators with Spanish as their mother tongue carried out the translation of the questionnaire, obtaining two initial versions in Spanish (T1 and T2). An analysis of the results and elaboration of a single preliminary version in Spanish (T-1-2) were performed. The retro-translation was performed by two translators with English as their mother tongue not familiar with the original version translated the joint version (T-1-2) back into the original language (RT1 and RT2) to identify inconsistencies. Finally, a final version of the questionnaire was obtained. For content validation a committee of experts (seven women affected by breast cancer) assessed the degree of clarity, accuracy and understanding of each of the items in the questionnaire translated into Spanish, and calculated the content validity index (CVI) of the questionnaire according to Lawshe and Tristán. RESULTS: The LTQL questionnaire was translated into Spanish with a low discrepancy between translators. An adequate CVI higher than 0.58 was obtained in clarity (0.95), precision (0.93), comprehension (0.91) and relevance (0.72). CONCLUSIONS: The LTQL is a useful questionnaire in the health field for the assessment of quality of life of women survivors of long-term breast cancer.

OBJETIVO: La calidad de vida de mujeres afectadas de cáncer de mama diagnosticadas hace 5 o más años ha sido relativamente poco explorada en España, no existen instrumentos para su medida validados. El objetivo del estudio fue traducir al castellano, adaptar culturalmente y examinar la validez de contenido del cuestionario Long-Term Quality of Life Instrument (LTQL). METODOS: La traducción inicial fue realizada por dos traductores con castellano como lengua materna que tradujeron independientemente el cuestionario (versiones T1 y T2). Se realizó un análisis de los resultados y se elaboró una única versión preliminar en castellano (T-1-2). La retrotraducción se realizó por dos traductores con inglés como lengua materna que tradujeron independientemente la versión conjunta (T-1-2) al idioma original (RT1 y RT2) para identificar inconsistencias. Finalmente, se obtuvo una versión final del cuestionario. Para la validación de contenido se constituyó un comité de expertas (siete mujeres afectadas de cáncer de mama) que valoró el grado de claridad, precisión, comprensión y relevancia de cada uno de los ítems del cuestionario traducido al castellano y se calculó el índice de validez de contenido (CVI) del cuestionario según Lawshe y Tristán. RESULTADOS: Se tradujo el cuestionario LTQL al castellano con una baja discrepancia entre los traductores. Se obtuvo un CVI adecuado mayor de 0,58 en claridad (0,95), precisión (0,93), comprensión (0,91) y relevancia (0,72). CONCLUSIONES: El LTQL en un cuestionario de utilidad en el campo de la salud para la evaluación de la calidad de vida de mujeres supervivientes de cáncer de mama de larga duración.

Validación de contenido de la versión en castellano del instrumento Long-term Quality of Life Instrument para mujeres supervivientes de cáncer de mama de larga duración / Content validation of the spanish version of the Long-term Quality of Life Instrument for long-term female breast cancer survivors

Fundamentos: La calidad de vida de mujeres afectadas de cáncer de mama diagnosticadas hace 5 o másaños ha sido relativamente poco explorada en España, no existen instrumentos para su medida validados. El objetivo del estudio fue traducir al castellano, adaptar culturalmente y examinar la validez de contenido del cuestionario Long-Term Quality of Life Instrument (LTQL Métodos: La traducción inicial fue realizada por dos traductores con castellano como lengua materna que tradujeron independientemente el cuestionario (versiones T1 y T2). Se realizó un análisis de los resultados y se elaboró una única versión preliminar en castellano (T-1-2). La retrotraducción se realizó por dos traductores con inglés como lengua materna que tradujeron independientemente la versión conjunta (T-1-2) al idioma original (RT1 y RT2) para identificar inconsistencias. Finalmente, se obtuvo una versión final del cuestionario. Para la validación de contenido se constituyó un comité de expertas (siete mujeres afectadas de cáncer de mama) que valoró el grado de claridad, precisión, comprensión y relevancia de cada uno de los ítems del cuestionario traducido al castellano y se calculó el índice de validez de contenido (CVI) del cuestionario según Lawshe y Tristán. Resultados: Se tradujo el cuestionario LTQL al castellano con una baja discrepancia entre los traductores. Se obtuvo un CVI adecuado mayor de 0,58 en claridad (0,95), precisión (0,93), comprensión (0,91) y relevancia (0,72). Conclusiones: El LTQL en un cuestionario de utilidad en el campo de la salud para la evaluación de la calidad de vida de mujeres supervivientes de cáncer de mama de larga duración.(AU)

Background: The quality of life of women affected by breast cancer diagnosed 5 or more years ago has been relatively unexplored in Spain; there are no instruments for its measurement validated. The objective of the study is to translate into Spanish, culturally adapt and examine the content validity of the Spanish version of the LongTerm Quality of Life Instrument (LTQL). Methods: The initial translation was performed by two translators with Spanish as their mother tongue carried out the translation of the questionnaire, obtaining two initial versions in Spanish (T1 and T2). An analysis of the results and elaboration of a single preliminary version in Spanish (T-1-2) were performed. The retro-translation wasperformed by two translators with English as their mother tongue not familiar with the original version translated the joint version (T-1-2) back into the original language (RT1and RT2) to identify inconsistencies. Finally, a final version of the questionnaire was obtained. For content validation a committee of experts (seven women affected by breast cancer) assessed the degree of clarity, accuracy and understanding of each of the items in the questionnaire translated into Spanish, and calculated the content validity index (CVI) of the questionnaire according to Lawshe and Tristán.Results: The LTQL questionnaire was translated into Spanish with a low discrepancy between translators. An adequate CVI higher than 0.58 was obtained in clarity (0.95), precision (0.93), comprehension (0.91) and relevance (0.72). Conclusions: The LTQL is a useful questionnaire in the health field for the assessment of quality of life of women survivors of long-term breast cancer.(AU)

Aplicaciones móviles para mejorar la adherencia a la medicación: revisión y análisis de calidad / Mobile applications to improve drug adherence: Review and quality analysis

Objetivo: Revisar las aplicaciones móviles en español para mejorar la adherencia farmacológica y evaluar sus características y calidad con el fin de identificar aplicaciones de alta calidad. Médoto: Se ha hecho una revisión siguiendo un procedimiento por pasos similar a una revisión sistemática de la literatura. La fuente de los datos han sido plataformas de distribución digital de aplicaciones móviles Apple Apps Store y Google Play Store. Se han seleccionado aquellas aplicaciones dirigidas a apoyar la autogestión de los medicamentos, capaces de generar recordatorios, en español, actualizadas en los últimos 2 años y gratuitas. Los análisis de las aplicaciones se han hecho según un conjunto de características consideradas deseables y evaluación de la calidad con la herramienta Mobile App Rating Scale. Resultados: De 708 aplicaciones, se seleccionaron 3. Las aplicaciones Medisafe y Mytherapy presentaron el 89% y el 78% de las características deseables, respectivamente. La aplicación de Sergio Licea presentó el 56%. La mayor puntuación global de calidad la obtuvo MyTherapy (3,79/5; RIQ: 3-4), seguida de Medisafe (3,72/5; RIQ: 3-4) y, por último, Sergio Licea (2,87/5; RIQ: 2-4). La valoración de la calidad es coincidente con la hecha por los usuarios. Hay muchas aplicaciones disponibles, sin embargo, la mayoría no cumplieron los criterios de selección establecidos. Conclusiones: Através de un proceso sistemático por pasos, identificamos la aplicación de mayor calidad en español para que sea probada en un estudio futuro, que proporcionará evidencia sobre el uso de una intervención multicomponente para mejorar la adherencia a la medicación.(AU)

Objective: To review the mobile apps in the Spanish market to improve adherence to medications and evaluate their characteristics and quality to identify high-quality applications. Method: A review was carried out following a stepwise procedure similar to a systematic review of the scientific literature. Apple Apps Store and Google Play Store mobile application digital distribution platforms. Applications aimed at supporting self-management of treatment, which generate reminders, in Spanish, updated in the last 2 years and free. We evaluate the applications according to a set of characteristics considered desirable and the quality with the Mobile App Rating Scale tool. Results: Out of 708 applications, 3 applications were selected. The Medisafe and Mytherapy applications had 89% and 78% of the desirable characteristics, respectively. Sergio Licea's application only had 56%. The highest global quality score was obtained by the MyTherapy application (3.79/5, IQR: 3-4), followed by Medisafe (3.72/5, (IQR: 3-4) and, finally, Sergio Licea (2.87/5, IQR: 2-4). The quality assessment coincides with the user assessment. There are many available applications, however, most did not meet the selection criteria. Conclusions: A systematic stepwise process was able to identify the quality application to be tested in a future study that will provide evidence on the use of a multicomponent inter.(AU)

[Mobile applications to improve drug adherence: Review and quality analysis]. / Aplicaciones móviles para mejorar la adherencia a la medicación: revisión y análisis de calidad.

OBJECTIVE: To review the mobile apps in the Spanish market to improve adherence to medications and evaluate their characteristics and quality to identify high-quality applications. METHOD: A review was carried out following a stepwise procedure similar to a systematic review of the scientific literature. Apple Apps Store and Google Play Store mobile application digital distribution platforms. Applications aimed at supporting self-management of treatment, which generate reminders, in Spanish, updated in the last 2 years and free. We evaluate the applications according to a set of characteristics considered desirable and the quality with the Mobile App Rating Scale tool. RESULTS: Out of 708 applications, 3 applications were selected. The Medisafe and Mytherapy applications had 89% and 78% of the desirable characteristics, respectively. Sergio Licea's application only had 56%. The highest global quality score was obtained by the MyTherapy application (3.79/5, IQR: 3-4), followed by Medisafe (3.72/5, (IQR: 3-4) and, finally, Sergio Licea (2.87/5, IQR: 2-4). The quality assessment coincides with the user assessment. There are many available applications, however, most did not meet the selection criteria. CONCLUSIONS: A systematic stepwise process was able to identify the quality application to be tested in a future study that will provide evidence on the use of a multicomponent intervention to improve medication adherence.

Multicomponent Interventions for the Prevention of Delirium in Hospitalized Older People: A Meta-Analysis.

OBJECTIVES: To comprehensively assess the effects of multicomponent interventions for prevention of delirium in hospitalized older people. DESIGN: Systematic review with meta-analysis following Preferred Reporting Items for Systematic Reviews and Meta-Analyses methods. PARTICIPANTS: All randomized controlled trials were included. Included studies were conducted in hospitalized older people (aged ≥65 years). MEASUREMENTS: The electronic databases MEDLINE, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials were consulted (search date: 2015 to March 2019). Predefined criteria were used to determine inclusion of studies and to assess their methodologic quality. RESULTS: From 1,250 records identified, 10 randomized controlled trials were included (n = 2,850: 1355 medical patients, 1,243 surgical, and 160 intensive care unit). The multicomponent interventions, compared with usual care, reduced the incidence of delirium (risk ratio (RR) = 0.62; 95% confidence interval (CI) = 0.54-0.72; I2 = 0%; k = 10; n = 2,758), duration of delirium (RR = -1.18; 95% CI = -1.95 to -0.40; I2 = 45%; k = 6; n = 276), severity of delirium (standard mean difference = -0.98; 95% CI = -1.46 to -0.49; I2 = 0%; k = 3; n = 82), and pressure ulcers (RR = 0.48; 95% CI = 0.26-0.88; I2 = 0%; k = 2; n = 457). CONCLUSIONS: This meta-analysis suggests that multicomponent interventions to prevent delirium are effective in decreasing its incidence, duration, and severity; as well as the incidence of pressure ulcers in hospitalized older people. Therefore, multicomponent interventions hold great promise to impact in the most important and prevalent conditions affecting fragile older people during hospitalization.

Health status, lifestyle habits, and perceived social support in long-term cancer survivors: a cross-sectional study.

OBJECTIVE: To compare the presence of comorbidities and self-perceived health and social support between long-term cancer survivors and people without a history of cancer from a clinical trial examining the effects of a multiple risk behavior intervention. RESULTS: Of the 4259 people studied, 190 (4.46%) were cancer survivors. They had a mean ± SD age of 62.8 ± 7 years vs. 58.7 ± 8 years (P < 0.01) for non-cancer people and were more likely to be on long-term sick leave (11.9 vs. 3.5%, P < 0.001). No differences were observed for smoking, adherence to the Mediterranean diet, physical activity, obesity, or social support. Cancer survivors were more likely to have worse self-perceived health (OR 1.82; 95% CI 1.02-2.75), more comorbidities (OR 1.68; 95% CI 1.18-2.39), COPD (OR 2.17; 95% CI 1.25-3.78), and depression (OR 1.65; 95% CI 1.06-2.57). Older age and worse self-perceived health were independent predictors of survivorship in the adjusted analysis.

Pharmacologic interventions for prevention of delirium in hospitalized older people: A meta-analysis.

INTRODUCTION: To comprehensively assess the effects of pharmacologic interventions for prevention of delirium in hospitalized older people. MATERIALS AND METHODS: A systematic review with meta-analysis following Preferred Reporting Items for Systematic reviews and Meta-Analyses methodology was performed. Hospitalized people aged 65 and older, recruited to randomized controlled clinical trials. The electronic databases MEDLINE, EMBASE, WOS and Cochrane Central Register of Controlled Trials were consulted (March 2019). Predefined criteria were used to determine inclusion of studies and to assess their methodologic quality. RESULTS: 1855 records were identified in the database, and after removing the duplicates, the titles and abstracts evaluated were 1250 records. Finally, 25 randomized controlled trials contributed to meta-analysis (n = 5820): 1 anti-epileptics (n = 697), 2 anti-inflammatories (n = 615), 4 antipsychotics (n = 1193), 2 cholinesterase inhibitors (n = 87), 13 hypnotics/sedatives (n = 2909), 1 opioids (n = 52), 1 psychostimulants/nootropics (n = 81), 1 yokukansan (n = 186). Olanzapine (RR = 0.36; 95 %CI: 0.24, 0.52; k = 1; n = 400), rivastigmine (RR = 0.36; 95 %CI: 0.15, 0.87; k = 1; n = 62), dexmedetomidine (RR = 0.52; 95 %CI: 0.38, 0.71; I²â€¯= 55 %; k = 6; n = 2084), and ramelteon (RR = 0.09; 95 %CI: 0.01, 0.64; k = 1; n = 65) reduced the incidence of delirium compared to placebo/usual care. Only dexmedetomidine was also associated with a shorter duration of delirium (0.70 days reduction) and a lower consumption of psychotropic drugs (48 %). No effect was found in mortality, adverse events, urinary tract infections or post-operative complications. CONCLUSIONS: This meta-analysis suggests that dexmedetomidine is effective in reducing the incidence and duration of delirium in hospitalized older patients. Individual studies reveal effects of ramelteon, olanzapine and rivastigmine on the incidence of delirium but the evidence is insufficient to draw a robust conclusion.

Subcutaneous implantable cardioverter-defibrillator in primary and secondary prevention of sudden cardiac death: A meta-analysis.

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.

Effectiveness and cost-effectiveness of a multicomponent intervention to improve medication adherence in people with depressive disorders - MAPDep: a study protocol for a cluster randomized controlled trial.

PURPOSE: Depression is a widespread mental disorder which can be treated effectively. However, low adherence to antidepressants is very common. The study of medication adherence in depression (MAPDep study) assesses the effectiveness and cost-effectiveness of a multicomponent strategy to enhance adherence toward medications in patients with depression. INTERVENTION: The intervention is a multicomponent one consisting of an educational program for psychiatrists and/or a collaborative care program for patients and relatives, plus a reminder system that works through the use of an already available high-quality medication reminder application. STUDY DESIGN: MAPDep study is an open, multicenter, four-arm cluster randomized controlled trial. The clusters are mental health units where psychiatrists are invited to participate. The clusters are randomly allocated to one of the three interventions or to usual care (control arm). Patients (18-65 years of age) diagnosed with depressive disorder, those taking antidepressant medication for an existing diagnosis of depression, and mobile phone users are selected. In group 1, only patients and relatives receive intervention; in group 2, only psychiatrists receive intervention; and in group 3, patients/relatives and psychiatrists receive intervention. The primary outcome is adherence to the antidepressant drug. The calculated sample size is 400 patients. To examine changes across time, generalized linear mixed model with repeated measures will be used. A cost-effectiveness analysis will be conducted. The effectiveness measure is quality-adjusted life years. Deterministic sensitivity analyses are planned. CONCLUSION: MAPDep study aims to assess a multicomponent strategy to improve adherence toward medications in patients with depression, based not only on clinical effectiveness but also on cost-effectiveness. This methodology will enhance the transferability of the expected results beyond mental health services (patients and psychiatrists) to health care policy decision making. CLINICAL TRIAL IDENTIFIER: NCT03668457.

The Vallecas Project: A Cohort to Identify Early Markers and Mechanisms of Alzheimer's Disease.

INTRODUCTION: Alzheimer's disease (AD) is a major threat for the well-being of an increasingly aged world population. The physiopathological mechanisms of late-onset AD are multiple, possibly heterogeneous, and not well understood. Different combinations of variables from several domains (i.e., clinical, neuropsychological, structural, and biochemical markers) may predict dementia conversion, according to distinct physiopathological pathways, in different groups of subjects. METHODS: We launched the Vallecas Project (VP), a cohort study of non-demented people aged 70-85, to characterize the social, clinical, neuropsychological, structural, and biochemical underpinnings of AD inception. Given the exploratory nature of the VP, multidimensional and machine learning techniques will be applied, in addition to the traditional multivariate statistical methods. RESULTS: A total of 1169 subjects were recruited between October 2011 and December 2013. Mean age was 74.4 years (SD 3.9), 63.5% of the subjects were women, and 17.9% of the subjects were carriers of at least one ε4 allele of the apolipoprotein E gene. Cognitive diagnoses at inclusion were as follows: normal cognition 93.0% and mild cognitive impairment (MCI) 7.0% (3.1% amnestic MCI, 0.1% non-amnestic MCI, 3.8% mixed MCI). Blood samples were obtained and stored for future determinations in 99.9% of the subjects and 3T magnetic resonance imaging study was conducted in 89.9% of the volunteers. The cohort is being followed up annually for 4 years after the baseline. CONCLUSION: We have established a valuable homogeneous single-center cohort which, by identifying groups of variables associated with high risk of MCI or dementia conversion, should help to clarify the early physiopathological mechanisms of AD and should provide avenues for prompt diagnosis and AD prevention.

Social robots in advanced dementia.

AIMS: Pilot studies applying a humanoid robot (NAO), a pet robot (PARO) and a real animal (DOG) in therapy sessions of patients with dementia in a nursing home and a day care center. METHODS: In the nursing home, patients were assigned by living units, based on dementia severity, to one of the three parallel therapeutic arms to compare: CONTROL, PARO and NAO (Phase 1) and CONTROL, PARO, and DOG (Phase 2). In the day care center, all patients received therapy with NAO (Phase 1) and PARO (Phase 2). Therapy sessions were held 2 days per week during 3 months. Evaluation, at baseline and follow-up, was carried out by blind raters using: the Global Deterioration Scale (GDS), the Severe Mini Mental State Examination (sMMSE), the Mini Mental State Examination (MMSE), the Neuropsychiatric Inventory (NPI), the Apathy Scale for Institutionalized Patients with Dementia Nursing Home version (APADEM-NH), the Apathy Inventory (AI) and the Quality of Life Scale (QUALID). Statistical analysis included descriptive statistics and non-parametric tests performed by a blinded investigator. RESULTS: In the nursing home, 101 patients (Phase 1) and 110 patients (Phase 2) were included. There were no significant differences at baseline. The relevant changes at follow-up were: (Phase 1) patients in the robot groups showed an improvement in apathy; patients in NAO group showed a decline in cognition as measured by the MMSE scores, but not the sMMSE; the robot groups showed no significant changes between them; (Phase 2) QUALID scores increased in the PARO group. In the day care center, 20 patients (Phase 1) and 17 patients (Phase 2) were included. The main findings were: (Phase 1) improvement in the NPI irritability and the NPI total score; (Phase 2) no differences were observed at follow-up.

Fiabilidad y validez de la batería de evaluación del deterioro grave, versión abreviada (SIB-s), en pacientes con demencia en España / Reliability and validity of the Severe Impairment Battery, short form (SIB-s), in patients with dementia in Spain

Introducción. Las personas con demencia progresiva evolucionan hacia un estado donde los tests neuropsicológicos tradicionales dejan de ser eficaces. La batería de evaluación del deterioro grave, en su forma completa (SIB) y abreviada (SIB-s), se desarrolló para evaluar el estado cognitivo de pacientes con demencia avanzada. Objetivo. Evaluar los atributos psicométricos de la SIB-s en población española. Pacientes y métodos. Estudio transversal de 127 pacientes con demencia (86,6%, mujeres; edad media: 82,6 ± 7,5 años) evaluados con la SIB-s y las siguientes medidas: escala de deterioro global, miniexamen cognitivo (MEC), miniexamen del estado mental grave (sMMSE), índice de Barthel y escala del estado funcional. Resultados. La puntuación media total de la SIB-s fue de 19,1 ± 15,34 (rango: 0-48). Efectos suelo y techo < 20%. El análisis factorial identificó un único factor que explica el 68% de la varianza total de la escala. La consistencia interna fue alta (α de Cronbach: 0,96). La correlación ítem-total corregida osciló entre 0,27 y 0,83, y la homogeneidad de los ítems fue de 0,43. La fiabilidad test-retest e interevaluador fue satisfactoria (coeficiente de correlación intraclase: 0,96 y 0,95, respectivamente), así como la validez de constructo convergente con otras medidas cognitivas (MEC: 0,83; sMMSE: 0,9). La SIB-s mostró una correlación moderada con escalas cognitivas de dependencia funcional (índice de Barthel: 0,48; FAST: –0,74). El error estándar de la medida fue de 3,07 para el total de la escala. Conclusiones. La SIB-s es un instrumento fiable y válido, relativamente breve, para evaluar a pacientes con demencia avanzada en la población española (AU)

Introduction. People with progressive dementia evolve into a state where traditional neuropsychological tests are not effective. Severe Impairment Battery (SIB) and short form (SIB-s) were developed for evaluating the cognitive status in patients with severe dementia. Aim. To evaluate the psychometric attributes of the SIB-s in patients with severe dementia. Patients and methods. 127 institutionalized patients (female: 86.6%; mean age: 82.6 ± 7.5 years-old) with dementia were assessed with the SIB-s, the Global Deterioration Scale (GDS), Mini-Mental State Examination (MMSE), Severe Mini- Mental State Examination (sMMSE), Barthel Index and FAST. Results. SIB-s acceptability, reliability, validity and precision were analyzed. The mean total score for scale was 19.1 ± 15.34 (range: 0-48). Floor effect was 18.1%, only marginally higher than the desirable 15%. Factor analysis identified a single factor explaining 68% of the total variance of the scale. Cronbach’s α coefficient was 0.96 and the item-total corrected correlation ranged from 0.27 to 0.83. The item homogeneity value was 0.43. Test-retest and inter-rater reliability for the total score was satisfactory (ICC: 0.96 and 0.95, respectively). The SIB-s showed moderate correlation with functional dependency scales (Barthel Index: 0.48, FAST: –0.74). Standard error of measurement was 3.07 for the total score. Conclusions. The SIB-s is a reliable and valid instrument for evaluating patients with severe dementia in the Spanish population of relatively brief instruments (AU)

Quality of life across three groups of older adults differing in cognitive status and place of residence.

BACKGROUND: Health-related quality of life (HRQOL) in older adults is determined by personal conditions, as well as by the social and physical environment. The purpose of the present study was to describe the factors related to health conditions and residential environment that influence HRQOL of older adults. METHODS: Data from 1815 cases came from three cross-sectional surveys on quality of life in older adults in Spain: non-institutionalized older adults (n = 1106), institutionalized older adults without dementia (n = 234) and institutionalized older adults with dementia (n = 475). Assessment instruments used were: Barthel Index, Short Portable Mental Status Questionnaire, Comorbidity Index, EQ-5D-3L (5 dimensions, EQ-index and EQ-VAS), and information about sociodemographic characteristics and social networks. Partial correlation and multivariate logistic regression analyses were carried out. RESULTS: In group comparisons, institutionalized older adults showed a higher percentage of problems in the EQ-5D-3L dimensions than the non-institutionalized ones. Also, older adults with dementia presented less pain/discomfort and anxiety/depression than the other groups, but showed more problems in mobility, self-care and usual activities. EQ-Index showed a high association with functional independence, perceived health status and comorbidity. According to the logistic regression models, the Barthel Index was the most common determinant for most of EQ-5D-3L dimensions in all groups. CONCLUSION: Institutionalized older adults with dementia presented lower HRQOL than the other groups. Functional independence, comorbidity and cognitive status were the main HRQOL determinants in all groups. Maintenance and improvement of the functional condition might be translated into a higher HRQOL of older adults.

[Reliability and validity of the Severe Impairment Battery, short form (SIB-s), in patients with dementia in Spain]. / Fiabilidad y validez de la bateria de evaluacion del deterioro grave, version abreviada (SIB-s), en pacientes con demencia en España.

INTRODUCTION: People with progressive dementia evolve into a state where traditional neuropsychological tests are not effective. Severe Impairment Battery (SIB) and short form (SIB-s) were developed for evaluating the cognitive status in patients with severe dementia. AIM: To evaluate the psychometric attributes of the SIB-s in patients with severe dementia. PATIENTS AND METHODS: 127 institutionalized patients (female: 86.6%; mean age: 82.6 ± 7.5 years-old) with dementia were assessed with the SIB-s, the Global Deterioration Scale (GDS), Mini-Mental State Examination (MMSE), Severe Mini-Mental State Examination (sMMSE), Barthel Index and FAST. RESULTS: SIB-s acceptability, reliability, validity and precision were analyzed. The mean total score for scale was 19.1 ± 15.34 (range: 0-48). Floor effect was 18.1%, only marginally higher than the desirable 15%. Factor analysis identified a single factor explaining 68% of the total variance of the scale. Cronbach's alpha coefficient was 0.96 and the item-total corrected correlation ranged from 0.27 to 0.83. The item homogeneity value was 0.43. Test-retest and inter-rater reliability for the total score was satisfactory (ICC: 0.96 and 0.95, respectively). The SIB-s showed moderate correlation with functional dependency scales (Barthel Index: 0.48, FAST: -0.74). Standard error of measurement was 3.07 for the total score. CONCLUSIONS: The SIB-s is a reliable and valid instrument for evaluating patients with severe dementia in the Spanish population of relatively brief instruments.

TITLE: Fiabilidad y validez de la bateria de evaluacion del deterioro grave, version abreviada (SIB-s), en pacientes con demencia en España.Introduccion. Las personas con demencia progresiva evolucionan hacia un estado donde los tests neuropsicologicos tradicionales dejan de ser eficaces. La bateria de evaluacion del deterioro grave, en su forma completa (SIB) y abreviada (SIB-s), se desarrollo para evaluar el estado cognitivo de pacientes con demencia avanzada. Objetivo. Evaluar los atributos psicometricos de la SIB-s en poblacion española. Pacientes y metodos. Estudio transversal de 127 pacientes con demencia (86,6%, mujeres; edad media: 82,6 ± 7,5 años) evaluados con la SIB-s y las siguientes medidas: escala de deterioro global, miniexamen cognitivo (MEC), miniexamen del estado mental grave (sMMSE), indice de Barthel y escala del estado funcional. Resultados. La puntuacion media total de la SIB-s fue de 19,1 ± 15,34 (rango: 0-48). Efectos suelo y techo < 20%. El analisis factorial identifico un unico factor que explica el 68% de la varianza total de la escala. La consistencia interna fue alta (alfa de Cronbach: 0,96). La correlacion item-total corregida oscilo entre 0,27 y 0,83, y la homogeneidad de los items fue de 0,43. La fiabilidad test-retest e interevaluador fue satisfactoria (coeficiente de correlacion intraclase: 0,96 y 0,95, respectivamente), asi como la validez de constructo convergente con otras medidas cognitivas (MEC: 0,83; sMMSE: 0,9). La SIB-s mostro una correlacion moderada con escalas cognitivas de dependencia funcional (indice de Barthel: 0,48; FAST: ­0,74). El error estandar de la medida fue de 3,07 para el total de la escala. Conclusiones. La SIB-s es un instrumento fiable y valido, relativamente breve, para evaluar a pacientes con demencia avanzada en la poblacion española.