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Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study).
Aznar-Lou, I, Zabaleta-Del-Olmo, E, Casajuana-Closas, M, Sánchez-Viñas, A, Parody-Rúa, E, Bolíbar, B, Iracheta-Todó, M, Bulilete, O, López-Jiménez, T, Pombo-Ramos, H, et al
The international journal of behavioral nutrition and physical activity. 2021;(1):88
Abstract
BACKGROUND Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. METHODS An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. RESULTS The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (- 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. CONCLUSION The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. TRIAL REGISTRATION Clinicaltrials.gov NCT03136211 . Registered 02 May 2017 - Retrospectively registered.
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Effectiveness and equity of continuous subcutaneous insulin infusions in pediatric type 1 diabetes: A systematic review and meta-analysis of the literature.
Dos Santos, TJ, Donado Campos, JM, Argente, J, Rodríguez-Artalejo, F
Diabetes research and clinical practice. 2021;:108643
Abstract
AIMS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCT) and non-randomized studies (NRS) to assess the effectiveness and equity of continuous subcutaneous insulin infusions (CSII) versus multiple-daily injections (MDI) on glycemic outcomes. METHODS Searches were conducted between 2000 and 2019 in MEDLINE, CENTRAL, EMBASE and HTA. Included studies compared the CSII vs MDI in children and young people (CYP) ≤ 20 years with type 1 diabetes. Two independent reviewers screened the articles, extracted the data, assessed the risk of bias, evaluated the quality of evidence, and identified equity data. Results were pooled with a random-effects model. RESULTS Of the 578 articles screened, 16 RCT (545 CYP on CSII) and 70 NRS (73253 on CSII) were included in the meta-analysis. There was moderate-level evidence that the CSII lower HbA1c in RCT (pooled mean difference [MD]: -0.22%; 95% confidence interval [CI]: -0.33, -0.11%; I2:34%) and insufficient in NRS (pooled MD: -0.45%; 95%CI: -0.52, -0.38%; I2:99%). The pooled incidence rate ratio of severe hypoglycemia on CSII vs MDI in RCT was 0.87 (95%CI: 0.55, 1.37; I2:0%; low-level evidence), and 0.71 (95%CI: 0.63, 0.81; I2:57%, insufficient evidence) in NRS. Health-related quality of life presented insufficient evidence. Equity data were scarcely reported. CONCLUSIONS CSII modestly lower HbA1c when compared with MDI. Current literature does not provide adequate data on other glycemic outcomes. Future assessment on diabetes technology should include individual and area-level socioeconomic data. The study protocol was pre-registered in PROSPERO (CRD42018116474).
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QOLEC2: a randomized controlled trial on nutritional and respiratory counseling after esophagectomy for cancer.
Pinto, E, Nardi, MT, Marchi, R, Cavallin, F, Alfieri, R, Saadeh, L, Cagol, M, Baldan, I, Saraceni, E, Parotto, M, et al
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(2):1025-1033
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Abstract
BACKGROUND Esophagectomy for cancer strongly impairs quality of life. The aim of this trial was to evaluate the effect of the nutritional and respiratory counseling on postoperative quality of life. METHODS At hospital discharge, patients were randomized into four groups receiving respectively: nutritional and respiratory counseling, nutritional counseling alone, respiratory counseling alone, or standard care. The main endpoint was the impairment in quality of life in the first month after surgery. Linear mixed effect models were estimated to assess mean score differences (MDs) in quality of life scores. RESULTS Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery. Dyspnea was similar between patients receiving vs. those not receiving respiratory counseling (MD - 3.1, 95% CI - 10.8 to 4.6). Global quality of life was clinically similar between patients receiving vs. those not receiving nutritional counseling over time (MD 0.9, 95% CI - 5.5 to 7.3), as well as in patients receiving vs. those not receiving respiratory counseling over time (MD 0.7, 95% CI - 5.9 to 7.2). CONCLUSIONS Intensive postoperative care does not affect global quality of life even if nutritional counseling reduced appetite loss.
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Protein intake, weight loss, dietary intervention, and worsening of quality of life in older patients during chemotherapy for cancer.
Regueme, SC, Echeverria, I, Monéger, N, Durrieu, J, Becerro-Hallard, M, Duc, S, Lafargue, A, Mertens, C, Laksir, H, Ceccaldi, J, et al
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(2):687-696
Abstract
Decreased health-related quality of life (HRQoL) is common in patients with cancer. We investigated the effects of dietary intervention and baseline nutritional status on worsening of HRQoL in older patients during chemotherapy. In this randomized control trial assessing the effect on mortality of dietary advice to increase dietary intake during chemotherapy, this post hoc analysis included 155 patients with cancer at risk of malnutrition. The effects of dietary intervention, baseline Mini Nutritional Assessment item scores, weight loss, and protein and energy intake before treatment on the worsening of HRQoL (physical functioning, fatigue) and secondary outcomes (Timed Up and Go test, one-leg stance time, depressive symptoms, basic (ADL), or instrumental (IADL) activities of daily living) were analyzed by multinomial regressions. Dietary intervention increased total energy and protein intake but had no effect on any examined outcomes. Worsening of fatigue and ADL was predicted by very low protein intake (< 0.8 g kg-1 day-1) before chemotherapy (OR 3.02, 95% CI 1.22-7.46, p = 0.018 and OR 5.21, 95% CI 1.18-22.73, p = 0.029 respectively). Increase in depressive symptomatology was predicted by 5.0-9.9% weight loss before chemotherapy (OR 2.68, 95% CI 1.10-6.80, p = 0.038). Nutritional intervention to prevent HRQoL decline during chemotherapy should focus on patients with very low protein intake along with those with weight loss.
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New Frontiers in the Prevention, Diagnosis, and Treatment of Alzheimer's Disease.
Guzman-Martinez, L, Calfío, C, Farias, GA, Vilches, C, Prieto, R, Maccioni, RB
Journal of Alzheimer's disease : JAD. 2021;(s1):S51-S63
Abstract
One of the major puzzles in medical research and public health systems worldwide is Alzheimer's disease (AD), reaching nowadays a prevalence near 50 million people. This is a multifactorial brain disorder characterized by progressive cognitive impairment, apathy, and mood and neuropsychiatric disorders. The main risk of AD is aging; a normal biological process associated with a continuum dynamic involving a gradual loss of people's physical capacities, but with a sound experienced view of life. Studies suggest that AD is a break from normal aging with changes in the powerful functional capacities of neurons as well as in the mechanisms of neuronal protection. In this context, an important path has been opened toward AD prevention considering that there are elements of nutrition, daily exercise, avoidance of toxic substances and drugs, an active social life, meditation, and control of stress, to achieve healthy aging. Here, we analyze the involvement of such factors and how to control environmental risk factors for a better quality of life. Prevention as well as innovative screening programs for early detection of the disease using reliable biomarkers are becoming critical to control the disease. In addition, the failure of traditional pharmacological treatments and search for new drugs has stimulated the emergence of nutraceutical compounds in the context of a "multitarget" therapy, as well as mindfulness approaches shown to be effective in the aging, and applied to the control of AD. An integrated approach involving all these preventive factors combined with novel pharmacological approaches should pave the way for the future control of the disease.
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Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial.
Díaz-García, A, González-Robles, A, García-Palacios, A, Fernández-Álvarez, J, Castilla, D, Bretón, JM, Baños, RM, Quero, S, Botella, C
Journal of medical Internet research. 2021;(2):e21335
Abstract
BACKGROUND Emotional disorders (EDs) are among the most prevalent mental disorders. Existing evidence-based psychological treatments are not sufficient to reduce the disease burden of mental disorders. It is therefore essential to implement innovative solutions to achieve a successful dissemination of psychological treatment protocols, and in this regard, the use of information and communication technologies such as the internet can be very useful. Furthermore, the literature suggests that not everyone with an ED receives the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which attempts to address the underlying processes common to EDs. Most of these transdiagnostic interventions focus primarily on downregulating negative affectivity (NA), and less attention has been paid to strengths and the upregulation of positive affectivity, despite its importance for well-being and mental health. OBJECTIVE This study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample. METHODS A 3-armed randomized controlled trial was conducted. A total of 216 participants were randomly assigned to a transdiagnostic internet-based protocol (TIBP), a TIBP+ positive affect (PA) component, or a waiting list (WL) control group. The treatment protocol contained core components mainly addressed to downregulate NA (ie, present-focused emotional awareness and acceptance, cognitive flexibility, behavioral and emotional avoidance patterns, and interoceptive and situational exposure) as well as a PA regulation component to promote psychological strengths and enhance well-being. Data on depression, anxiety, quality of life, neuroticism and extraversion, and PA/NA before and after treatment were analyzed. Expectations and opinions of treatment were also analyzed. RESULTS Within-group comparisons indicated significant pre-post reductions in the two experimental conditions. In the TIBP+PA condition, the effect sizes were large for all primary outcomes (d=1.42, Beck Depression Inventory [BDI-II]; d=0.91, Beck Anxiety Inventory [BAI]; d=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; d=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (d=1.19) and PANAS-N (d=1.28) and medium effect sizes for BAI (d=0.63) and PANAS-P (d=0.69). Between-group comparisons revealed that participants who received one of the two active treatments scored better at posttreatment than WL participants. Although there were no statistically significant differences between the two intervention groups on the PA measure, effect sizes were consistently larger in the TIBP+PA condition than in the standard transdiagnostic protocol. CONCLUSIONS Overall, the findings indicate that EDs can be effectively treated with a transdiagnostic intervention via the internet, as significant improvements in depression, anxiety, and quality of life measures were observed. Regarding PA measures, promising effects were found, but more research is needed to study the role of PA as a therapeutic component. TRIAL REGISTRATION ClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-017-1297-z.
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Quality of life in people living with HIV-associated neurocognitive disorder: A scoping review study.
Alford, K, Daley, S, Banerjee, S, Vera, JH
PloS one. 2021;(5):e0251944
Abstract
Quality of life (QoL) is recognized as an essential end point in the disease management of chronic conditions such as HIV with calls to include good QoL as a 'fourth 90' in the 90-90-90 testing and treatment targets introduced by World Health Organization in 2016. Cognitive impairments impact a broad spectrum of experiences and are a common issue effecting people living with HIV (PLWH). Despite this, few studies have examined QoL in PLWH who also have a cognitive disorder. This study aimed to synthesize and describe what is known about QoL in those living with HIV-associated neurocognitive disorders (HAND). A scoping review of peer-reviewed literature was conducted to identify how QoL has been investigated and measured in PLWH with HAND, and how PLWH with HAND report and describe their QoL. We searched PsychInfo, Medline, Scopus, and Web of Science along with hand-searching reference lists from relevant studies found. Included studies were those published in English after 1st January 2003 which included PLWH with cognitive impairment not due to other pre-existing conditions. Fifteen articles met criteria for inclusion. Two studies measured QoL as a primary aim, with others including QoL assessment as part of a broader battery of outcomes. The MOS-HIV and SF-36 were the most commonly used measures of overall QoL, with findings generally suggestive of poorer overall QoL in PLWH with HAND, compared to PLWH without cognitive impairment. Studies which examined dimensions of QoL focused exclusively on functionality, level of independence, and psychological QoL domains. There is a considerable dearth of research examining QoL in PLWH with HAND. The initiatives which advocate for healthy aging and improved QoL in PLWH must be extended to include and understand the experiences those also living with cognitive impairment. Research is needed to understand the broad experiential impacts of living with these two complex, chronic conditions, to ensure interventions are meaningful to patients and potential benefits are not missed.
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A systematic review of self-care measures for adolescents with health needs.
Jiang, X, Walker, K, Topps, AK
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 2021;(4):967-981
Abstract
PURPOSE The current study sought to review instruments measuring self-care for adolescents with health needs to provide a summary of the tools available for conducting self-care research in this population. METHOD Studies were mainly identified through searches in three electronic bibliographic databases (i.e., PsycINFO, CINAHL, and PubMed) and additional sources to retrieve relevant articles. Studies were included if they focused on self-care measures, included samples of adolescents (ages 10-19), were published in English peer-reviewed journals, dissertations, and from the years 1980 through 2020. The COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN) was used to assess the methodological quality of each study and evaluate the measurement quality based on available studies. RESULTS A total of ten scales from 12 papers were identified to meet the search criteria and designed for adolescent patients with three types of health needs, including diabetes, cystic fibrosis, and others (female care and nutrition). There is a lack of a clear and comprehensive definition of self-care for different health needs. The dominant focus of the scales was the behavioral aspect of self-care (e.g., adherence to medication regimen), with only a few scales (e.g., female care) assessing the psychological aspect of self-care. The quality of the psychometric properties of the scales varied greatly. CONCLUSIONS Results highlighted the need for more research on developing and validating self-care measures for adolescents with health needs. The unique developmental characteristics of adolescents should be adequately considered, and the psychological aspect of self-care should be incorporated in measurement development.
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Effect of Dietary Coenzyme Q10 Plus NADH Supplementation on Fatigue Perception and Health-Related Quality of Life in Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.
Castro-Marrero, J, Segundo, MJ, Lacasa, M, Martinez-Martinez, A, Sentañes, RS, Alegre-Martin, J
Nutrients. 2021;(8)
Abstract
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a complex, multisystem, and profoundly debilitating neuroimmune disease, probably of post-viral multifactorial etiology. Unfortunately, no accurate diagnostic or laboratory tests have been established, nor are any universally effective approved drugs currently available for its treatment. This study aimed to examine whether oral coenzyme Q10 and NADH (reduced form of nicotinamide adenine dinucleotide) co-supplementation could improve perceived fatigue, unrefreshing sleep, and health-related quality of life in ME/CFS patients. A 12-week prospective, randomized, double-blind, placebo-controlled trial was conducted in 207 patients with ME/CFS, who were randomly allocated to one of two groups to receive either 200 mg of CoQ10 and 20 mg of NADH (n = 104) or matching placebo (n = 103) once daily. Endpoints were simultaneously evaluated at baseline, and then reassessed at 4- and 8-week treatment visits and four weeks after treatment cessation, using validated patient-reported outcome measures. A significant reduction in cognitive fatigue perception and overall FIS-40 score (p < 0.001 and p = 0.022, respectively) and an improvement in HRQoL (health-related quality of life (SF-36)) (p < 0.05) from baseline were observed within the experimental group over time. Statistically significant differences were also shown for sleep duration at 4 weeks and habitual sleep efficiency at 8 weeks in follow-up visits from baseline within the experimental group (p = 0.018 and p = 0.038, respectively). Overall, these findings support the use of CoQ10 plus NADH supplementation as a potentially safe therapeutic option for reducing perceived cognitive fatigue and improving the health-related quality of life in ME/CFS patients. Future interventions are needed to corroborate these clinical benefits and also explore the underlying pathomechanisms of CoQ10 and NADH administration in ME/CFS.
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Vitamin D Supplementation and Mental Health in Multiple Sclerosis Patients: A Systematic Review.
Głąbska, D, Kołota, A, Lachowicz, K, Skolmowska, D, Stachoń, M, Guzek, D
Nutrients. 2021;(12)
Abstract
Vitamin D has a promising role in multiple sclerosis (MS) management, and it has been found to be beneficial for patients' mental health, which is reduced in MS patients. The aim of the present study was to conduct a systematic review of the literature to assess the influence of vitamin D supplementation on mental health in MS patients. The systematic review was registered in the PROSPERO database (CRD42020155779) and it was conducted on the basis of the PRISMA guidelines. The search procedure was conducted using PubMed and Web of Science databases and it included studies published up until September 2021. Six studies were included in the systematic review. The risk of bias was analyzed using the Newcastle-Ottawa Scale (NOS). Within the included studies, there were two studies randomized against placebo and four other prospective studies. The studies presented vitamin D interventions randomized against placebo or not randomized, while supplementation was applied for various durations-from 4 weeks to 12 months, or the studies compared patients who applied vitamin D supplementation and those who did not apply it and verified the effect of the supplementation after a number of years. The mental health outcomes that were assessed included quality of life, depression/depressive symptoms, and fatigue as an additional element. The majority of studies supported the positive influence of vitamin D on the mental health of MS patients, including the study characterized as having the highest quality (randomized against placebo with the highest NOS score). All the studies that assessed the quality of life indicated the positive influence of vitamin D while the studies that did not find a positive influence of vitamin D were conducted for depression/depressive symptoms. In spite of the fact that only a small number of studies have been conducted so far, and only two studies were randomized against a placebo, some conclusions may be formulated. The systematic review allowed us to conclude that there may be a positive effect of vitamin D supplementation in MS patients, which was stated in all of the studies analyzing quality of life, as well as in one study analyzing depressive symptoms. Considering that vitamin D deficiency is common in MS patients, and the potential positive influence of supplementation on the quality of life, supplementation should be applied at least in doses that cover the recommended intake.