Efficacy and safety of robotic spine surgery: systematic review and meta-analysis.

BACKGROUND: Robotic surgery (RS) may offer benefits compared with freehand/conventional surgery (FS) in the treatment of patients with spinal disease. The aim of this study was to evaluate the efficacy and safety of RS versus FS in spinal fusion. METHODS: A systematic review and meta-analysis was performed. Data analysis and risk of bias assessment were analysed using REVMAN V5.3. RESULTS: We found 11 randomised clinical trials involving 817 patients (FS: 408, RS: 409). The main diagnosis was degenerative spine disease. SpineAssist, Renaissance (Mazor Robotics), Tianji Robot and TiRobot robots (TINAVI Medical Technologies) were used. Pedicle screw placement within the safety zone (grades A + B according to the Gertzbein and Robbins scale) ranged from 93% to 100% in FS versus 85-100% in RS (relative risk 1.01, 95% CI 1.00-1.03, p = 0.14). Regarding intervention time, the meta-analysis showed a mean difference (MD) of 6.45 min (95% CI -13.59 to 26.49, p = 0.53). Mean hospital stay was MD of -0.36 days (95% CI -1.03 to 0.31, p = 0.30) with no differences between groups. Contradictory results were found regarding fluoroscopy time, although there seems to be a lower radiation dose in RS versus FS (p < 0.05). Regarding safety, the studies included surgical revision frequency. CONCLUSIONS: No conclusive results were found suggesting that there are benefits in using RS over FS for spinal fusion. Further research with adequate patient selection, robot type and quality-of-life variables is needed. LEVEL OF EVIDENCE: level 1.

Efecto del soporte social en la salud mental de trabajadores inmigrantes: una revisión sistemática / Effect of social support on migrant workers' mental health: a systematic review

Introducción: Los trabajadores inmigrantes son una población especialmente vulnerable a desarrollar trastornos de la esfera psicosocial, en probable relación con las diferencias que este grupo de trabajadores presenta: barrera idiomática, dificultad para acceder al sistema, desconocimiento de recursos disponibles, falta y/o ausencia de una red de apoyo social estable y segura. Objetivo: Conocer la incidencia de trastornos psicosociales en trabajadores inmigrantes y la influencia del apoyo sociosanitario en el desarrollo o aparición de los mismos. Material y Métodos: Revisión de Revisiones Sistemáticas con búsqueda en Medline (Pubmed), Embase, Cochrane, Google Académico y Journal of Inmigrant and Minority Health. Se incluyeron revisiones sistemáticas publicadas entre 2003 y diciembre de 2021, en inglés y español. Se empleó AMSTAR2 para evaluar la calidad de los estudios incluidos. Resultados: Se incluyeron tres revisiones sistemáticas, de calidad intermedia. Los estudios mostraban que los trabajadores inmigrantes, presenta más riesgo de desarrollar depresión y hay una prevalencia mayor de ésta, debido a diversos factores como falta de apoyo social y familiar, la incertidumbre o el tipo de trabajo que desarrollan. En cuanto a ansiedad, también se vio un aumento del riesgo y la prevalencia en trabajadores inmigrantes, debido a los mismos factores. Conclusión: Es necesario desarrollar estrategias de prevención para la protección de la salud mental de los trabajadores inmigrantes, ya que por sus característica presentan un mayor riesgo psicosocial con aumento de prevalencia de enfermedades como depresión y ansiedad. Es importante conocer las características de los trabajadores, con el fin de poder emplear los recursos preventivos más acertados. (AU)

Introduction: Migrant workers are a special kind of group with notable vulnerability to develop more psychosocial disorders compared to native workers, which may be due to several disadvantages such as language, culture shock, lack of social support or lack of access to health care between others. There are few studies on the health of immigrant groups at present, therefore, it is necessary and vital to explore and identify mental health situation and social support related factors or conditions. Objectives: To have knowledge of the incidence of psychosocial disorders in migrant workers and perceive the influence of social and health support in their development or appearance. Material and Methods: This is a review of Systematic Reviews by searching in Medline (Pubmed), Embase, Cochrane, Google Scholar and Journal of Immigrant and Minority Health. Systematic reviews published between 2003 and December 2022 were included, both in English and Spanish. Results: Three systematic reviews, of intermediate quality according to the AMSTAR2 tool, were included. Regarding depression, they concluded that migrant workers, has a higher risk of developing depression due to some factors such as lack of social and family support, uncertainty, the type of work they develop, etc. Regarding anxiety, an increased risk and prevalence was also seen in migrant workers, also due to the same factors. Conclusion: Prevention strategies are required to protect migrant workers' mental health, as they are a remarkably vulnerable group with a higher psychosocial risk and an increased prevalence of diseases such as depression and anxiety. (AU)

Study designs for clinical trials applied to personalised medicine: a scoping review.

OBJECTIVE: Personalised medicine (PM) allows treating patients based on their individual demographic, genomic or biological characteristics for tailoring the 'right treatment for the right person at the right time'. Robust methodology is required for PM clinical trials, to correctly identify groups of participants and treatments. As an initial step for the development of new recommendations on trial designs for PM, we aimed to present an overview of the study designs that have been used in this field. DESIGN: Scoping review. METHODS: We searched (April 2020) PubMed, Embase and the Cochrane Library for all reports in English, French, German, Italian and Spanish, describing study designs for clinical trials applied to PM. Study selection and data extraction were performed in duplicate resolving disagreements by consensus or by involving a third expert reviewer. We extracted information on the characteristics of trial designs and examples of current applications of these approaches. The extracted information was used to generate a new classification of trial designs for PM. RESULTS: We identified 21 trial designs, 10 subtypes and 30 variations of trial designs applied to PM, which we classified into four core categories (namely, Master protocol, Randomise-all, Biomarker strategy and Enrichment). We found 131 clinical trials using these designs, of which the great majority were master protocols (86/131, 65.6%). Most of the trials were phase II studies (75/131, 57.2%) in the field of oncology (113/131, 86.3%). We identified 34 main features of trial designs regarding different aspects (eg, framework, control group, randomisation). The four core categories and 34 features were merged into a double-entry table to create a new classification of trial designs for PM. CONCLUSIONS: A variety of trial designs exists and is applied to PM. A new classification of trial designs is proposed to help readers to navigate the complex field of PM clinical trials.

Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.

The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.

The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS).

Earlier activities on health technology assessment (HTA) started in Spain around 1984, with the creation of a National Advisory Board on HTA, and the development of national and regional HTA organizations in the early 1990s. In 2012, the Spanish Health Ministry established the Spanish Network for Health Technology Assessment of the National Health System (RedETS); funded at national level and including all public HTA organizations at national and regional levels. RedETSis focused on the assessment of nondrug health technologies to inform the revision (approval and funding or disinvestment) of the Benefit Portfolio of the Spanish NHS. In parallel with European Network for Health Technology Assessment (EUnetHTA), RedETS has been setting-up and sharing common procedures and methodological guidelines to ensure effective cooperation and mutual recognition of the scientific and technical production in HTA. The output of RedETS is fifty to sixty annual reports, including the production of full HTA reports, Clinical Practice Guidelines, methodological guidance reports, relative effectiveness assessments, tools to support shared decision making between patients and healthcare professionals, and monitoring studies. The HTA assessments requested by the Regional Health Authorities are the biggest component of the annual RedETS working plan. These assessment needs are identified according to a yearly process and prioritized by a Commission composed of representatives from all Spanish regions with the aid of the PRITEC tool. The objectives of this study are to report and update the normative and organizational state of HTA in Spain; describing noteworthy advances witnessed over the past 10 years, as well as discussing existing challenges.

Development and validation of a risk stratification model for prediction of disability and hospitalisation in patients with heart failure: a study protocol.

BACKGROUND: Chronic heart failure (CHF) reduces quality of life and causes hospitalisation and death. Identifying predictive factors of such events may help change the natural history of this condition. AIM: To develop and validate a stratification system for classifying patients with CHF, according to their degree of disability and need for hospitalisation due to any unscheduled cause, over a period of 1 year. METHODS AND ANALYSIS: Prospective, concurrent, cohort-type study in two towns in the Madrid autonomous region having a combined population of 1 32 851. The study will include patients aged over 18 years who meet the following diagnostic criteria: symptoms and typical signs of CHF (Framingham criteria) and left ventricular ejection fraction (EF)<50% or structural cardiac lesion and/or diastolic dysfunction in the presence of preserved EF (EF>50%).Outcome variables will be(a) Disability, as measured by the WHO Disability Assessment Schedule V.2.0 Questionnaire, and (b) unscheduled hospitalisations. The estimated sample size is 557 patients, 371 for predictive model development (development cohort) and 186 for validation purposes (validation cohort). Predictive models of disability or hospitalisation will be constructed using logistic regression techniques. The resulting model(s) will be validated by estimating the probability of outcomes of interest for each individual included in the validation cohort. ETHICS AND DISSEMINATION: The study protocol has been approved by the Clinical Research Ethics Committee of La Princesa University Teaching Hospital (PI-705). All results will be published in a peer-reviewed journal and shared with the medical community at conferences and scientific meetings.

Hormone therapy for preventing cardiovascular disease in post-menopausal women.

BACKGROUND: Evidence from systematic reviews of observational studies suggest that hormone replacement therapy (HT) may have beneficial effects in reducing the incidence of cardiovascular disease (CVD) events in post-menopausal women. This is an updated version of a Cochrane review first published in 2005 (Gabriel-Sanchez 2005). OBJECTIVES: To assess the effects of HT for the prevention of CVD in post-menopausal women, and whether there are differential effects between use of single therapy alone compared to combination HT and use in primary or secondary prevention. SEARCH METHODS: We searched the following databases to April 2010: Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, MEDLINE, EMBASE and LILACS. SELECTION CRITERIA: Randomised controlled trials (RCTs) of women comparing orally administered HT with placebo with a minimum of six-months follow-up. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study quality and extracted data. Risk Ratios (RR) with 95% confidence intervals were calculated for each outcome. Results were combined using fixed-effect meta-analyses, and where possible, further stratified analyses conducted to assess the effect of time on treatment. Additionally, univariate meta-regression analyses were undertaken to assess whether length of trial follow-up, single or combination treatment, or whether treatment for primary or secondary prevention were potential predictors for a number of CVD outcomes in the trials. MAIN RESULTS: Four new trials were identified through the update; one trial included in the previous review was excluded. Therefore the review included 13 trials with a total of 38,171 post-menopausal women. Overall, single and combination HT in both primary and secondary prevention conferred no protective effects for all cause mortality, CVD death, non-fatal MI, or angina. There were no significant differences in the number of coronary artery by-pass procedures or angioplasties performed between the trial arms. However there was an increased risk of stroke for both primary and secondary prevention when combination and single HT was combined, RR 1.26 (95% CI 1.11 to 1.43), in venous thromboembolic events, RR 1.89 (95% CI 1.58 to 2.26) and in pulmonary embolism RR 1.84 (95% CI 1.42 to 2.37) relative to placebo. The associated numbers needed-to-harm (NNH) were 164, 109 and 243 for stroke, venous thromboembolism and pulmonary embolism respectively. AUTHORS' CONCLUSIONS: Treatment with HT in post-menopausal women for either primary or secondary prevention of CVD events is not effective, and causes an increase in the risk of stroke, and venous thromboembolic events. HT should therefore only be considered for women seeking relief from menopausal symptoms. Short-term HT treatment should be at the lowest effective dose, and used with caution in women with predisposing risk factors for CVD events.

A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project.

BACKGROUND: This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7-8 years. METHODS/DESIGN: This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7-8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30) will be randomly assigned to one of two groups: 1) Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2) Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children) was calculated for a comparison of proportions with an α of 0.05 and a ß of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. DISCUSSION: The intervention providing the best results could be recommended as part of health education for young schoolchildren. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01418872.

Efficacy of a strategy for implementing a guideline for the control of cardiovascular risk in a primary healthcare setting: the SIRVA2 study a controlled, blinded community intervention trial randomised by clusters.

UNLABELLED: This work describes the methodology used to assess a strategy for implementing clinical practice guidelines (CPG) for cardiovascular risk control in a health area of Madrid. BACKGROUND: The results on clinical practice of introducing CPGs have been little studied in Spain. The strategy used to implement a CPG is known to influence its final use. Strategies based on the involvement of opinion leaders and that are easily executed appear to be among the most successful. AIM: The main aim of the present work was to compare the effectiveness of two strategies for implementing a CPG designed to reduce cardiovascular risk in the primary healthcare setting, measured in terms of improvements in the recording of calculated cardiovascular risk or specific risk factors in patients' medical records, the control of cardiovascular risk factors, and the incidence of cardiovascular events. METHODS: This study involved a controlled, blinded community intervention in which the 21 health centres of the Number 2 Health Area of Madrid were randomly assigned by clusters to be involved in either a proposed CPG implementation strategy to reduce cardiovascular risk, or the normal dissemination strategy. The study subjects were patients ≥ 45 years of age whose health cards showed them to belong to the studied health area. The main variable examined was the proportion of patients whose medical histories included the calculation of their cardiovascular risk or that explicitly mentioned the presence of variables necessary for its calculation. The sample size was calculated for a comparison of proportions with alpha = 0.05 and beta = 0.20, and assuming that the intervention would lead to a 15% increase in the measured variables. Corrections were made for the design effect, assigning a sample size to each cluster proportional to the size of the population served by the corresponding health centre, and assuming losses of 20%. This demanded a final sample size of 620 patients. Data were analysed using summary measures for each cluster, both in making estimates and for hypothesis testing. Analysis of the variables was made on an intention-to-treat basis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01270022.