A systematic review of potential biomarkers for bacterial burden and treatment efficacy assessment in TB platform-based clinical trials.

Adaptive platform trials can be more efficient than classic trials for developing new treatments. Moving from culture-based to simpler- or faster-to-measure biomarkers as efficacy surrogates may enhance this advantage. We performed a systematic review of treatment efficacy biomarkers in adults with tuberculosis. Platform trials can span different development phases. We grouped biomarkers as: α, bacterial load estimates used in phase 2a trials; ß, early and end-of treatment endpoints, phase 2b-c trials; γ, post-treatment or trial-level estimates, phase 2c-3 trials. We considered as analysis unit (biomarker entry) each combination of biomarker, predicted outcome, and their respective measurement times or intervals. Performance metrics included: sensitivity, specificity, area under the receiver-operator curve (AUC), and correlation measures, ,and classified as poor, promising, or good. Eighty-six studies included 22864 participants. From 1356 biomarker entries, 318 were reported with the performance metrics of interest, with 103 promising and 41 good predictors. Group results: α, mycobacterial RNA and Lipoarabinomannan in sputum, and host metabolites in urine; ß, mycobacterial RNA and host transcriptomic or cytokine signatures for early treatment response; γ, host transcriptomics for recurrence. A combination of biomarkers from different categories could help designing more efficient platform trials. Efforts to develop efficacy surrogates should be better coordinated.

Living with long-term conditions: validation of a new instrument for family caregivers in a Spanish-speaking population.

INTRODUCTION: Optimising the management of chronicity has been a global challenge for decades. Individuals with long-term conditions (LTCs) and their families live with them for years. Thus, it is necessary to include both of their perspectives in the management and adaptation of the interventions proposed. The psychometric properties of the living with LTCs scale from the perspective of the family caregiver are unknown. The objective of the present study is to describe the psychometric properties of the EC-PC-Fam in a Spanish-speaking population. METHODS: An observational, cross-sectional study was performed with a retest of part of the sample. The fit of the model was optimised with a factorial analysis, and the psychometric properties were verified. RESULTS: A sample of 311 caregivers was recruited. Most of them were women (68.2%) and had a mean age of 58.29±9.91 years (range: 32-84 years). The initial version did not obtain acceptable fit scores. To improve the fit, different versions were tested, refining the distribution of the items until optimisation was reached in V.10 (19 items). Cronbach's alpha was 0.81 for the scale as a whole. The intraclass correlation coefficient was 0.77. The EC-PC-Fam scale is strongly and inversely correlated with a scale that measures the burden of the caregiver (rs=-0.46), and moderately related to the health-related quality of life (rs=0.373) and social support (rs=0.38). CONCLUSIONS: The EC-PC-Fam scale from a family perspective is defined as a promising tool for promoting personalised care and for optimising the management of LTCs, and a new approach that includes family caregivers is proposed for clinical practice. The scale is an instrument with a moderate fit and optimum psychometric properties to measure living with LTCs from the perspective of a family caregiver. New validation studies are recommended to verify the fit of the proposed factorial solution.

Grief Intervention in Suicide Loss Survivors through Cognitive-Behavioral Therapy: A Systematic Review.

Suicide is one of the leading causes of death worldwide, affecting numerous individuals close to the person who died by suicide, including family members, friends, and colleagues. Those affected by the suicide of someone are referred to as "suicide survivors", and the psychological consequences they face are particularly severe. One of these consequences is grief, which is more complicated in survivors of suicide compared with those grieving deaths from other causes, mainly because of the stigma that continues to surround them. Therefore, psychotherapeutic intervention for suicide loss survivors is crucial. This study examines the efficacy of cognitive-behavioral programs for addressing grief and other related variables in suicide loss survivors. The search was conducted in databases including Psycinfo, Academic Search Premier, Medline, APA PsycArticles, E-Journals, Scopus, and PubMed. Five randomized controlled trials were selected, one of which focused exclusively on minors. The results reveal that cognitive-behavioral therapy is effective, although the methodological quality of these studies is not adequate, and the representativeness of the samples is very low. More RCTs are needed on the application of cognitive-behavioral programs to treat grief in suicide loss survivors.

Effectiveness of psychological interventions for reducing depressive symptomatology and overload and improving quality of life in informal caregivers of non-institutionalized dependent elderly: a systematic review.

Introduction: The phenomenon of aging is distinguished by profound life transformations, with the most dependent group being constituted by elderly individuals. The responsibility for their care primarily falls on the figure of the informal caregiver. The scarcity of time, the stress associated with caregiving, the financial, work-related, and personal difficulties it entails, make it a collective with high probabilities of experiencing various psychological disorders. Interventions that have shown the best results are those of multiple components, composed of various techniques that seek to adapt to the reality of the informal caregiver. Method: The purpose of this study is a systematic review of effective interventions on depressive symptoms, emotional wellbeing, burden, or quality of life in informal caregivers of non-institutionalized dependents from 2018 to the present. A search was conducted in November 2023, on Pubmed, Pubmed Central, Proquest, and Scielo. The final review was conducted on 11 articles. Results: The results indicate that multiple component interventions including cognitive behavioral techniques and psychoeducation in combination with stress coping techniques and social support are more effective on depressive symptoms, burden, quality of life, and increasing the social support network. Discussion: Results on web-based programs demonstrate their efficacy and effectiveness, but require a greater number of trials to adjust their methodological quality and content to the idiosyncrasies of the informal caregiver.

Attitudes toward death and burnout syndrome in geriatrics and gerontology healthcare personnel.

INTRODUCTION: Geriatric and gerontology healthcare workers are associated with a series of psychosocial risks such as death, bereavement and illness, and this implies a significant emotional and work overload, which can lead to negative attitudes toward death. OBJECTIVE: The aims of this study were to assess attitudes toward death, the level of burnout and the relationship between geriatrics and gerontology professionals. METHOD: A correlational, cross-sectional study was conducted, in which the 42 participants in the sample completed an online questionnaire including the Revised Profile of Attitudes to Death (PAM-R) and the Maslach Burnout Inventory-Human Services Survey (MBI-HSS). RESULTS: The results obtained show that the predominant attitude toward death in the sample is that of neutral acceptance, and with regard to burnout syndrome, moderate average levels are found in the dimensions of emotional exhaustion and personal accomplishment, but a low level of depersonalisation. CONCLUSION: Healthcare workers with attitudes of greater fear of death or acceptance of escape tend to experience higher levels of emotional exhaustion and depersonalisation, as do those with an attitude of death avoidance, who also have lower personal fulfillment.

Predictors of Health Satisfaction in Spanish Physically Active Older Adults: A Cross-Sectional Observational Study.

Studies that analyze the predictors of satisfaction with the health of the elderly are scarce. That is the reason why the objective of this study is to analyze whether the physical-psychological state, sports practice, and the use of socio-health resources are factors that predict satisfaction with health status in physically active elderly people. The Physical Activity and Quality of Life questionnaires were applied to a sample of 397 elderly people in this cross-sectional observational study. The data have been analyzed using Student's t-test chi-square test, Cohen's d, Phi Coefficient and Cramer's V. The results have shown that the lack of physical illnesses (OR = 3.920; p < 0.001) and psychological problems (OR = 1.940; p = 0.032), practicing a high level of physical activity (OR = 2.049; p = 0.001), having high scores in functional skills (OR = 8.059; p < 0.001) and using little social and health services (OR = 2.595; p < 0.001) are all predictors of being highly satisfied with one's health. In conclusion, predictors associated with high health satisfaction of active older people have been found, such as functional abilities, the existence of physical illness, psychological problems, level of physical activity, frequency of use of health and social services and satisfaction with health and social services; but it is not associated with gender or age of participants.

Exeporfinium chloride (XF-73) nasal gel dosed over 24 hours prior to surgery significantly reduced Staphylococcus aureus nasal carriage in cardiac surgery patients: Safety and efficacy results from a randomized placebo-controlled phase 2 study.

We studied 83 cardiac-surgery patients with nasal S. aureus carriage who received 4 intranasal administrations of XF-73 nasal gel or placebo <24 hours before surgery. One hour before surgery, patients exhibited a S. aureus nasal carriage reduction of 2.5 log10 with XF-73 compared to 0.4 log10 CFU/mL for those who received placebo (95% CI, -2.7 to -1.5; P < .0001).

Community engagement in tuberculosis research: the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) experience.

OBJECTIVES: Community representatives are key to ensuring that tuberculosis (TB) research is relevant, culturally sensitive, and appropriate. For all trials (new drugs or treatment regimens, diagnostics, or vaccines) this can result in improvement of recruitment, retention, and adherence to the trial schedule. The early engagement of the community will, later in time, support the process of implementation of new policies designed for successful products. We aim at developing a structured protocol for the early engagement of TB community representatives developed in the context of the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) project. DESIGN: The EU-PEARL Innovative Medicine Initiative 2 (IMI2) project TB work package has developed a community engagement (CE) framework to ensure fair and efficient participation of the community in the design and implementation of TB clinical platform trials. RESULTS: We showed that early engagement of the EU-PEARL community advisory board highly contributes to the process of development of a community-acceptable Master Protocol Trial and Intervention-Specific Appendixes. We identified capacity building and training as major gaps in advancing CE in the TB field. CONCLUSION: Developing strategies to address these needs can contribute to preventing tokenism and increase the acceptability and appropriateness of TB research.

Cognitive Stimulation Program Presented Through New Technologies in a Group of People with Moderate Cognitive Impairment.

BACKGROUND: Cognitive stimulation is one of the non-pharmacological therapies recommended for intervention in dementia, consisting of activities involving different cognitive domains and involving brain activation. New technologies can be very useful in this field, favoring intervention tasks. OBJECTIVE: The objective of this work is to test the effectiveness of a cognitive stimulation intervention mediated with new technologies on a group of people with moderate dementia. METHODS: This is a quantitative, quasi-experimental study with a control and treatment group, with three measurement times (pre, post, and follow-up months after the end of the intervention). Ninety-eight subjects with moderate dementia were randomly assigned to the treatment group (N = 50) and the control group (N = 48). The treatment group received 16 intervention sessions including attention, executive function, and memory tasks, which were presented using new technologies and the activity was conducted in a group setting. Control group remained on a waiting list. The evaluators did not know which group each subject belonged to. All participants were assessed with a battery of neuropsychological tests. RESULTS: The results show an improvement in post-intervention outcomes in the treatment group compared to the control group on cognitive variables. No differences were found in mood depression. These results fade overtime after a few months without intervention. CONCLUSION: This type of intervention is useful to maintain cognitive functioning using new technologies and in a group setting, which favors the intervention. The improvements of the intervention disappear at follow-up, which would indicate the need to maintain the intervention over time.

Cognitive Stimulation in Moderate Alzheimer's Disease.

Cognitive stimulation is one of the non-pharmacological therapies recommended for dementia intervention. The present study evaluated the efficacy of an intervention based on cognitive stimulation in people with moderate Alzheimer's disease. Fifty-nine subjects with moderate dementia were randomly assigned to the stimulation group (N = 36) and the control group (N = 35). The treatment group received 16 intervention sessions cognitive tasks. All participants were evaluated with a battery of neuropsychological tests at three time points (pre, post, and follow-up). The treatment group showed significant increases in the three domains studied (memory, attention, and executive functions), although some of these effects were not maintained at follow-up. The control group progressively worsened. Cognitive stimulation was found to be an effective intervention for people with moderate Alzheimer's disease because it helped to maintain memory function, executive functions, and attention. However, the effects were minimized at the 3-month follow-up.