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Pharmacological and non-pharmacological interventions for irritability in autism spectrum disorder: a systematic review and meta-analysis with the GRADE assessment.
Choi, H, Kim, JH, Yang, HS, Kim, JY, Cortese, S, Smith, L, Koyanagi, A, Dragioti, E, Radua, J, Fusar-Poli, P, et al
Molecular autism. 2024;(1):7
Abstract
BACKGROUND Numerous interventions for irritability in autism spectrum disorder (ASD) have been investigated. We aimed to appraise the magnitude of pharmacological and non-pharmacological interventions for irritability in ASD without any restrictions in terms of eligible interventions. METHODS We systematically searched PubMed/MEDLINE, Scopus, and Web of Science until April 15, 2023. We included randomized controlled trials (RCTs) with a parallel design that examined the efficacy of interventions for the treatment of irritability in patients of any age with ASD without any restrictions in terms of eligible interventions. We performed a random-effects meta-analysis by pooling effect sizes as Hedges' g. We classified assessed interventions as follows: pharmacological monotherapy, risperidone plus adjuvant therapy versus risperidone monotherapy, non-pharmacological intervention, and dietary intervention. We utilized the Cochrane tool to evaluate the risk of bias in each study and the GRADE approach to assess the certainty of evidence for each meta-analyzed intervention. RESULTS Out of 5640 references, we identified 60 eligible articles with 45 different kinds of interventions, including 3531 participants, of which 80.9% were males (mean age [SD] = 8.79 [3.85]). For pharmacological monotherapy, risperidone (Hedges' g - 0.857, 95% CI - 1.263 to - 0.451, certainty of evidence: high) and aripiprazole (Hedges' g - 0.559, 95% CI - 0.767 to - 0.351, certainty of evidence: high) outperformed placebo. Among the non-pharmacological interventions, parent training (Hedges' g - 0.893, 95% CI - 1.184 to - 0.602, certainty of evidence: moderate) showed a significant result. None of the meta-analyzed interventions yielded significant effects among risperidone + adjuvant therapy and dietary supplementation. However, several novel molecules in augmentation to risperidone outperformed risperidone monotherapy, yet from one RCT each. LIMITATIONS First, various tools have been utilized to measure the irritability in ASD, which may contribute to the heterogeneity of the outcomes. Second, meta-analyses for each intervention included only a small number of studies and participants. CONCLUSIONS Only risperidone, aripiprazole among pharmacological interventions, and parent training among non-pharmacological interventions can be recommended for irritability in ASD. As an augmentation to risperidone, several novel treatments show promising effects, but further RCTs are needed to replicate findings. Trial registration PROSPERO, CRD42021243965.
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A pragmatic, open-label, randomized controlled trial of Plasma-Lyte-148 versus standard intravenous fluids in children receiving kidney transplants (PLUTO).
Hayes, WN, Laing, E, Brown, R, Silsby, L, Smith, L, Thomas, H, Kaloyirou, F, Sharma, R, Griffiths, J, Hume-Smith, H, et al
Kidney international. 2024;(2):364-375
Abstract
Acute electrolyte and acid-base imbalance is experienced by many children following kidney transplant. This is partly because doctors give very large volumes of artificial fluids to keep the new kidney working. When severe, fluid imbalance can lead to seizures, cerebral edema and death. In this pragmatic, open-label, randomized controlled trial, we randomly assigned (1:1) pediatric kidney transplant recipients to Plasma-Lyte-148 or standard of care perioperative intravenous fluids (predominantly 0.45% sodium chloride and 0.9% sodium chloride solutions). We then compared clinically significant electrolyte and acid-base abnormalities in the first 72 hours post-transplant. The primary outcome, acute hyponatremia, was experienced by 53% of 68 participants in the Plasma-Lyte-148 group and 58% of 69 participants in the standard fluids group (odds ratio 0·77 (0·34 - 1·75)). Five of 16 secondary outcomes differed with Plasma-Lyte-148: hypernatremia was significantly more frequent (odds ratio 3·5 (1·1 - 10·8)), significantly fewer changes to fluid prescriptions were made (rate ratio 0·52 (0·40-0·67)), and significantly fewer participants experienced hyperchloremia (odds ratio 0·17 (0·07 - 0·40)), acidosis (odds ratio 0·09 (0·04 - 0·22)) and hypomagnesemia (odds ratio 0·21 (0·08 - 0·50)). No other secondary outcomes differed between groups. Serious adverse events were reported in 9% of participants randomized to Plasma-Lyte-148 and 7% of participants randomized to standard fluids. Thus, perioperative Plasma-Lyte-148 did not change the proportion of children who experienced acute hyponatremia compared to standard fluids. However fewer fluid prescription changes were made with Plasma-Lyte-148, while hyperchloremia and acidosis were less common.
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Sarcopenia increases mortality risk in liver transplantation: a systematic review and meta-analysis.
Prokopidis, K, Affronti, M, Testa, GD, Ungar, A, Cereda, E, Smith, L, Pegreffi, F, Barbagallo, M, Veronese, N
Panminerva medica. 2024;(1):47-54
Abstract
INTRODUCTION Liver transplantation is an efficacious treatment option for those with liver cirrhosis. However, the prognostic role of sarcopenia in these patients is unknown. Given this background, we conducted a systematic review and meta-analysis of the impact of sarcopenia on mortality in patients listed, evaluated and undergoing liver transplantation. EVIDENCE ACQUISITION Several databases were searched from the inception to December 2022 for observational studies regarding sarcopenia in liver transplant and mortality. We calculated the risk of mortality in sarcopenia vs. no sarcopenia using the most adjusted estimate available and summarizing the data as risk ratios (RRs) with their 95% confidence intervals (CIs). A random-effect model was considered for all analyses. EVIDENCE SYNTHESIS Among 1135 studies initially considered, 33 articles were included for a total of 12,137 patients (mean age: 55.3 years; 39.4% females). Over a median of 2.6 years and after adjusting for a median of 3 covariates, sarcopenia increased the risk of mortality approximately 2-fold (RR: 2.01; 95% CI: 1.70-2.36). After accounting for publication bias, the re-calculated RR was 1.75 (95% CI: 1.49-2.06). The quality of the studies was generally low, as determined by the Newcastle Ottawa Scale. CONCLUSIONS Sarcopenia was significantly linked with an increased risk of mortality in patients listed, evaluated, and undergoing a liver transplantation, indicating the need of interventional studies in this special population with the main aim to reverse this potential reversible condition and decrease mortality risk.
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Individual patient-centered target-driven intervention to improve clinical outcomes of diabetes, health literacy, and self-care practices in Nepal: A randomized controlled trial.
Pardhan, S, Upadhyaya, T, Smith, L, Sharma, T, Tuladhar, S, Adhikari, B, Kidd, J, Sapkota, R
Frontiers in endocrinology. 2023;:1076253
Abstract
PURPOSE To examine the effectiveness of a culturally and linguistically appropriate, patient-centered, target-driven lifestyle intervention with video education training in improving clinical outcomes, health literacy, and diabetic self-care practices in newly diagnosed patients in Nepal. METHODS A total of 110 participants with newly and consequently diagnosed Type 2 were randomly allocated into intervention (mean age = 45 ± 9.7 years) and control (mean age = 47 ± 12.5 years) groups. Intervention group participants were trained on a culturally and linguistically appropriate diabetic video education program and were given a customized dietary and physical activity plan with specific targets to practice at home. Participants' compliance was monitored weekly via telephone calls. Both groups received the usual treatment from their doctor and were followed up after three months. Outcome measures included changes in: i. diabetic health literacy, diet, and physical activity measured using self-reported questionnaires; and ii. blood glucose (glycated hemoglobin, HbA1c), cholesterol, blood pressure, body mass index, and visual acuity. Clinical outcome measures were blinded from randomization and intervention allocation. RESULTS After three months, HbA1c decreased to 6.1% from the baseline value of 7.2% in the intervention group compared to 6.6% in the control group from the baseline value of 7.1% (p <0.05). The intervention group had mean total cholesterol and low-density lipoprotein of 174 and 95.5 mg/dL, which were significantly lower than 186 and 107.5 mg/dL in the control group. Daily white rice consumption decreased by 36.5% in the intervention vs. 4% in the control group (p <0.05). After three months, the intervention group participants exercised more than the control group (p <0.05). All intervention group participants self-initiated retinal screening checks since the baseline visit among which 13% showed early diabetic retinopathy signs compared to 0% in the control group. Health literacy improvement in the intervention group was found to be sustained after three months too. CONCLUSIONS A culturally appropriate, target-driven lifestyle intervention with video education training is effective in improving clinical outcomes, health literacy, and self-care practice in newly diagnosed diabetic patients in Nepal, i.e., at a time period when effective diabetes control is vital to prevent further complications. The training intervention could be rolled out nationwide in order to reduce the risk of diabetic-related complications and improve people's quality of life and productivity.
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Risk factors for multimorbidity in adulthood: A systematic review.
Tazzeo, C, Zucchelli, A, Vetrano, DL, Demurtas, J, Smith, L, Schoene, D, Sanchez-Rodriguez, D, Onder, G, Balci, C, Bonetti, S, et al
Ageing research reviews. 2023;:102039
Abstract
BACKGROUND Multimorbidity, the coexistence of multiple chronic diseases in an individual, is highly prevalent and challenging for healthcare systems. However, its risk factors remain poorly understood. OBJECTIVE To systematically review studies reporting multimorbidity risk factors. METHODS A PRISMA-compliant systematic review was conducted, searching electronic databases (MEDLINE, EMBASE, Web of Science, Scopus). Inclusion criteria were studies addressing multimorbidity transitions, trajectories, continuous disease counts, and specific patterns. Non-human studies and participants under 18 were excluded. Associations between risk factors and multimorbidity onset were reported. RESULTS Of 20,806 identified studies, 68 were included, with participants aged 18-105 from 23 countries. Nine risk factor categories were identified, including demographic, socioeconomic, and behavioral factors. Older age, low education, obesity, hypertension, depression, low pysical function were generally positively associated with multimorbidity. Results for factors like smoking, alcohol consumption, and dietary patterns were inconsistent. Study quality was moderate, with 16.2% having low risk of bias. CONCLUSIONS Several risk factors seem to be consistently associated with an increased risk of accumulating chronic diseases over time. However, heterogeneity in settings, exposure and outcome, and baseline health of participants hampers robust conclusions.
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Body mass index and nutritional intake following Elexacaftor/Tezacaftor/Ivacaftor modulator therapy in adults with cystic fibrosis.
Caley, LR, Jarosz-Griffiths, HH, Smith, L, Gale, L, Barrett, J, Kinsey, L, Davey, V, Nash, M, Jones, AM, Whitehouse, JL, et al
Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society. 2023;(6):1002-1009
Abstract
BACKGROUND Elexacaftor/Tezacaftor/Ivacaftor (ETI) modulator therapy is often associated with increased body mass index (BMI) in people with cystic fibrosis (CF). This is thought to reflect improved clinical stability and increased appetite and nutritional intake. We explored the change in BMI and nutritional intake following ETI modulator therapy in adults with CF. METHODS Dietary intake, measured with myfood24®, and BMI were collected from adults with CF at baseline and follow-up as part of an observational study. Changes in BMI and nutritional intake in participants who commenced ETI therapy between time points were assessed. To contextualize findings, we also assessed changes in BMI and nutritional intake between study points in a group on no modulators. RESULTS In the pre and post ETI threapy group (n = 40), BMI significantly increased from 23.0 kg/m2 (IQR 21.4, 25.3) at baseline to 24.6 kg/m2 (IQR 23.0, 26.7) at follow-up (p<0.001), with a median of 68 weeks between time points (range 20-94 weeks) and median duration of ETI therapy was 23 weeks (range 7-72 weeks). There was a significant decrease in energy intake from 2551 kcal/day (IQR 2107, 3115) to 2153 kcal/day (IQR 1648, 2606), p<0.001. In the no modulator group (n = 10), BMI and energy intake did not significantly change between time points (p>0.05), a median of 28 weeks apart (range 20-76 weeks). CONCLUSIONS These findings tentatively suggest that the increase in BMI with ETI therapy may not simply be attributable to an increase in oral intake. Further exploration into the underlying aetiology of weight gain with ETI therapy is needed.
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The effect of adherence to high-quality dietary pattern on COVID-19 outcomes: A systematic review and meta-analysis.
Rahmati, M, Fatemi, R, Yon, DK, Lee, SW, Koyanagi, A, Il Shin, J, Smith, L
Journal of medical virology. 2023;(1):e28298
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Abstract
Dietary quality and patterns may influence SARS-CoV-2 infection and outcomes, but scientific data and evidence to support such a role are lacking. Therefore, this meta-analysis aims to elucidate the effect of prepandemic diet quality on the risk of COVID-19 infection and hospitalization. PubMed/MEDLINE, CENTRAL, Scopus, and EMBASE were systematically searched for articles published up to September 1, 2022. A systematic review and meta-analysis were performed to calculate each outcome's risk ratio (RR) and 95% confidence interval (CI). Five studies including 4 023 663 individuals (3 149 784 high-quality diet individuals and 873 881 controls) were included in the present meta-analysis. The effectiveness of high-quality dietary pattern against SARS-CoV-2 infection and hospitalization was 28% (95% CI 19%-36%) and 62% (95% CI 25%-80%); respectively. Subgroup analysis based on different levels of diet quality showed no difference between middle and high levels of diet quality in reducing the risk of COVID-19 infection. Interestingly, subgroup analysis based on the different types of high-quality diets and the risk of COVID-19 infection revealed that the effectiveness of plant-based diet against SARS-CoV-2 infection was 50% (95% CI 30%-65%); while the effectiveness of Mediterranean diet against SARS-CoV-2 infection was 22% (95% CI 12%-31%). Adherence to a high-quality dietary pattern is associated with a lower risk of COVID-19 infection and hospitalization. More studies are required to confirm these findings, and future studies should determine the biological mechanisms underlying the association between diet quality and risk of COVID-19 infection.
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New-onset type 1 diabetes in children and adolescents as postacute sequelae of SARS-CoV-2 infection: A systematic review and meta-analysis of cohort studies.
Rahmati, M, Yon, DK, Lee, SW, Udeh, R, McEVoy, M, Kim, MS, Gyasi, RM, Oh, H, López Sánchez, GF, Jacob, L, et al
Journal of medical virology. 2023;(6):e28833
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in children and adolescents may increase risk for a variety of post-acute sequelae including new-onset type 1 diabetes mellitus (T1DM). Therefore, this meta-analysis aims to estimate the risk of developing new-onset type 1 diabetes in children and adolescents as post-acute sequelae of SARS-CoV-2 infection. PubMed/MEDLINE, CENTRAL, and EMBASE were systematically searched up to March 20, 2023. A systematic review and subsequent meta-analyses were performed to calculate the pooled effect size, expressed as risk ratio (RR) with corresponding 95% confidence interval (CI) of each outcome based on a one-stage approach and the random-effects estimate of the pooled effect sizes of each outcome were generated with the use of the DerSimonian-Laird method. Eight reports from seven studies involving 11 220 530 participants (2 140 897 patients with a history of diagnosed SARS-CoV-2 infection and 9 079 633 participants in the respective control groups) were included. The included studies reported data from four U.S. medical claims databases covering more than 503 million patients (IQVIA, HealthVerity, TriNetX, and Cerner Real-World Data), and three national health registries for all children and adolescents in Norway, Scotland, and Denmark. It was shown that the risk of new-onset T1DM following SARS-CoV-2 infection in children and adolescents was 42% (95% CI 13%-77%, p = 0.002) higher compared with non-COVID-19 control groups. The risk of developing new-onset T1DM following SARS-CoV-2 infection was significantly higher (67%, 95% CI 32 %-112%, p = 0.0001) in children and adolescents between 0 and 11 years, but not in those between 12 and 17 years (RR = 1.10, 95% CI 0.54-2.23, p = 0.79). We also found that the higher risk for developing new-onset T1DM following SARS-CoV-2 infection only exists in studies from the United States (RR = 1.70, 95% CI 1.37-2.11, p = 0.00001) but not Europe (RR = 1.02, 95% CI 0.67-1.55, p = 0.93). Furthermore, we found that SARS-CoV-2 infection was associated with an elevation in the risk of diabetic ketoacidosis (DKA) in children and adolescents compared with non-COVID-19 control groups (RR = 2.56, 95% CI 1.07-6.11, p = 0.03). Our findings mainly obtained from US medical claims databases, suggest that SARS-CoV-2 infection is associated with higher risk of developing new-onset T1DM and diabetic ketoacidosis in children and adolescents. These findings highlight the need for targeted measures to raise public health practitioners and physician awareness to provide intervention strategies to reduce the risk of developing T1DM in children and adolescents who have had COVID-19.
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A Cluster Randomized Controlled Trial of the Archena Infancia Saludable Project on 24-h Movement Behaviors and Adherence to the Mediterranean Diet among Schoolchildren: A Pilot Study Protocol.
López-Gil, JF, García-Hermoso, A, Smith, L, Gallego, A, Victoria-Montesinos, D, Ezzatvar, Y, Hershey, MS, Gutiérrez-Espinoza, H, Mesas, AE, Jiménez-López, E, et al
Children (Basel, Switzerland). 2023;(4)
Abstract
Objective: The aim of this paper is to describe the protocol of pilot cluster randomized controlled trial (RCT) that will evaluate the effects of a lifestyle-based intervention. The Archena Infancia Saludable project will have several objectives. The primary objective of this project is to determine the 6-month effects of a lifestyle-based intervention on adherence to 24-h movement behaviors and Mediterranean diet (MedDiet) in schoolchildren. The secondary objective of this project is to test the intervention effects of this lifestyle-based intervention on a relevant set of health-related outcomes (i.e., anthropometric measurements, blood pressure, perceived physical fitness, sleep habits, and academic performance). The tertiary objective is to investigate this intervention's "halo" effect on parents'/guardians' 24-h movement behaviors and adherence to the MedDiet. Methods: The Archena Infancia Saludable trial will be a cluster RCT submitted to the Clinical Trials Registry. The protocol will be developed according to SPIRIT guidelines for RCTs and CONSORT statement extension for cluster RCTs. A total of 153 eligible parents/guardians with schoolchildren aged 6-13 years will be randomized into an intervention group or a control group. This project focuses on two fundamental pillars: 24-h movement behaviors and MedDiet. It will mainly focus on the relationship between parents/guardians and their children. Behavior change strategies for dietary and 24-h movement behaviors in schoolchildren will be based on healthy lifestyle education for parents/guardians through infographics, video recipes, brief video clips, and videos. Conclusions: Most of the current knowledge on 24-h movement behaviors and adherence to the MedDiet is based on cross-sectional or longitudinal cohort studies, warranting a need to design and conduct RCTs to obtain more robust evidence on the effect of a healthy lifestyle program to increase 24-h movement behaviors and to improve adherence to the MedDiet in schoolchildren.
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Use of bioelectrical impedance analysis in centenarians: a systematic review.
Mandalà, C, Veronese, N, Dominguez, LJ, Candore, G, Accardi, G, Smith, L, Herrero, MT, Barbagallo, M
Aging clinical and experimental research. 2023;(1):1-7
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Abstract
BACKGROUND Centenarians often represent one of the best examples of aging successfully. However, the role of body composition or hydration status assessed with bioelectrical impedance analysis (BIA) is poorly explored in this population. Therefore, the aim of this systematic review was to better understand the use and the role of BIA for evaluating body composition and hydration status in centenarians. METHODS We conducted a systematic review of the literature up to the 1st of May, 2022 for published articles providing data on BIA to evaluate body composition parameters or hydration status in centenarians. Data were summarized descriptively because a meta-analysis was not possible due to the scarcity of available studies. RESULTS Among 2222 articles screened, four were eligible including 291 centenarians (mean age: 100.5 years) who were mainly women (88%). In one study, BIA overestimated fat-free mass and underestimated fat mass when compared to deuterium oxide dilution. Another study carried out in Italy including 14 centenarians found a significant correlation between BIA and fat-free mass evaluated using anthropometric tools. In one study, BIA showed a significant agreement with anthropometric measures of fat mass. In the same sample, sarcopenia and dehydration, evaluated with BIA, had a high prevalence. CONCLUSION BIA may be used for assessing body composition in centenarians, but research is limited to a few studies suggesting the need of future research in this area.