PROSPERO Registration Research Articles

Impact of Fatty Acid Supplementation on Migraine Outcomes: A Systematic Review and Meta-analysis.

Migraines are a prevalent neurological condition that significantly impacts the quality of life. Although narrative reviews and clinical trials suggest the potential effects of fatty acid supplementation as a promising approach for migraine prophylaxis, the findings remain inconsistent. The aim was to evaluate the efficacy of fatty acid supplementation on migraine clinical outcomes through a systematic review and meta-analysis. This systematic review and meta-analysis was conducted using electronic databases including Medline, Scopus, Web of Science, and CINAHL from their inception up to October 7, 2024. Studies meeting the PICOS criteria were included: adults diagnosed with migraine, dietary supplementation with fatty acids, assessing migraine clinical outcomes, and only randomized controlled trials. Methodological quality and risk of bias were assessed independently by 2 reviewers using the Cochrane Risk of Bias 2 tool. Meta-analyses were conducted using Review Manager software. A random-effects model was applied to account for heterogeneity among studies. A standardized mean difference (SMD) of 0.2, 0.5, and 0.8 was interpreted as small, moderate, and large effects, respectively. Six randomized controlled trials, including 407 participants with chronic migraines, were analyzed. Interventions varied, including omega-3 supplementation with or without omega-6 restriction, lasting from 8 to 16 weeks, and 1 trial assessing alpha-lipoic acid. The overall risk of bias was assessed as low. The pooled analysis demonstrated significant reductions in headache intensity (SMD = -1.77; 95% CI: -3.32 to -0.21; P = .03), headache duration (SMD = -0.77; 95% CI: -1.05 to -0.50; P < .00001), headache frequency (SMD = -1.91; 95% CI: -2.61 to -1.21; P < .00001), and HIT-6 score (SMD = -2.44; 95% CI: -4.13 to -0.76; P = .004). This meta-analysis provides moderate evidence that fatty acid supplementation, particularly omega-3, improves migraine clinical outcomes. Additional high-quality, randomized controlled trials are needed to confirm these findings, particularly for the promising effects of alpha-lipoic acid. PROSPERO registration no. CRD42024592084.

Effects of Supplementation With Different Specificities of Dietary Fiber on Health-Related Indicators in Adults With Overweight or Obesity: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Dietary fiber (DF) exhibits variations in its chemical and physical complexity, as well as in its utilization by the gut microbiota. However, the impact of these differences on the health status of adults with overweight or obesity remains unclear. This meta-analysis aimed to explore the varying effects of supplementing with different specificities of DF on the health of adults with overweight or obesity, providing guidance on selecting DF supplementation to improve health status. The literature search encompassed 4 electronic databases-PubMed, Cochrane Library, Web of Science, and EMBASE-and was conducted between January 1, 2012, and November 10, 2023. Randomized controlled trials comparing DF with placebo treatment, without energy restriction, were included. Two independent reviewers extracted data using a standardized form, resolving discrepancies through discussion. The data included study characteristics, participant demographics, DF specifications, and outcome measures. Random-effects models and the generic inverse variance method were used to analyze data, assuming varying outcomes based on DF specificity. Meta-regression assessed the impact of population, duration, and dosage. Publication bias was evaluated using funnel plots and Egger's and Begg's tests. The analysis included 34 trials (n = 1804) examining DF supplementation at 1.5 to 40 g/day for 3 to 16 weeks. DF supplementation significantly reduced glycated hemoglobin (HbA1c) by 0.13%, fasting insulin by 0.82 μIU/mL, and homeostatic model assessment of insulin resistance (HOMA-IR) by 0.33 in adults with overweight or obesity. Subgroup analyses based on DF specificity revealed differences in effects on HbA1c, fasting insulin, and systolic blood pressure. The low-specificity subgroup showed significant heterogeneity in body weight, body mass index, HbA1c, fasting insulin, and HOMA-IR, with a decrease in fasting insulin by 1.09 μIU/mL. The low-to-intermediate-specificity subgroup had reductions in HbA1c by 0.8%, fasting insulin by 2.08 μIU/mL, and HOMA-IR by 0.61. The intermediate-specificity subgroup experienced a 2.85-kg decrease in body weight and a 9.03-mg/dL increase in LDL cholesterol. The mixed subgroup showed an increase in systolic blood pressure by 3.85 mmHg. Supplementing with different specificities of DF may have distinct effects on health-related indicators in adults with overweight or obesity. Considering individuals' gut microbiota composition and specific health goals is recommended when selecting DF supplementation for adults with overweight or obesity. PROSPERO registration no. CRD42023432920.

Human rights violations are associated with forcibly displaced population’s mental health—a systematic review and meta-analysis

BackgroundLittle is known about the mental health consequences of human rights violations in forcibly displaced populations. Objective: The objectives of this systematic review are to examine: (1) the prevalence of mental health conditions among forcibly displaced persons; (2) to investigate methodological factors contributing to mental health conditions; and (3) associations between mental health conditions and human rights violations.MethodsWe conducted a systematic review with meta-analyses on the prevalence of anxiety, depression, and posttraumatic stress disorder among forcibly displaced populations and factors contributing to it by searching in databases MEDLINE (Ovid), Embase, Web of Science Core Collection (Clarivate), PsycINFO (EBSCO), Sociological Abstracts (ProQuest), and PTSDPubs (ProQuest). Additionally, we assessed the Global Peace Index. Pooled associations were calculated using a random-effects meta-analysis model. Subgroup analyses were performed for the Global Peace Index, sampling methodology, also we assessed risk of bias.ResultsOf the 4,175 records screened, 55 with n = 31,573 participants met the inclusion criteria (n = 15,714 males, females, n = 15,859 females). Most studies were cross-sectional (n = 49). The pooled prevalence rates were 38.90% (95% CI: 29.63; 48.17) for anxiety, 38.16% (95% CI: 32.16; 44.15) for depression and 39.62% (95% CI: 32.87; 46.36) for posttraumatic stress disorder. Analyses by level of human rights violations show anxiety, and depression prevalence rates were higher in countries with low Global Peace Index than countries with high, moderate and low Global Peace Index (39.84% vs. 16.09%; 41.07% vs. 26.67%). Analyses by risk of bias indicate that the prevalence rate of PTSD was higher in studies with a high risk of bias compared to those with a very high risk of bias (49.27% vs. 29.79%). For anxiety, the prevalence rate was greater with random sampling compared to convenience sampling (44.71% vs. 36.87%). Depression and PTSD prevalence rates were higher with convenience sampling than with random sampling (38.67% vs. 37.70%; 42.83% vs. 35.50%).ConclusionOur review suggests that systematic continuous human rights violations are associated with mental health conditions in forcibly displaced persons. To prevent mental health conditions, it is necessary to reduce exposure to human rights violations in the countries forcibly displaced persons come from.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42017076535, PROSPERO registration: CRD42017076535.

Circulating fibroblast growth factor 21 levels in gestational diabetes mellitus and preeclampsia: a systematic review and meta-analysis

BackgroundThe connection between fibroblast growth factor 21 (FGF21) and the likelihood of gestational diabetes mellitus (GDM) or preeclampsia (PE) has received more attention recently. Based on published articles, meta-analysis were conducted to explore the differences in FGF21 levels in GDM or PE compared to control groups.MethodsArticles published before April 5, 2024 were searched across four databases: PubMed, Web of Science, Embase, and Cochrane Library, and studies exploring the association of FGF21 levels and GDM or PE were collected. Additionally, ClinicalTrials.gov was also searched for completed and ongoing trials. (Prospero Registration CRD42024504738). The standardized mean differences (SMDs) and 95% confidence intervals (CIs) were utilized to determine FGF21 levels among different groups.ResultsThis analysis incorporated a total of 16 articles, with 714 GDM and 701 non-GDM in the control group. The GDM-affected pregnant women had greater levels of circulating FGF21 than the control group (SMD = 0.529, 95% CI: 0.168 ~ 0.890, p = 0.004). Moreover, the PE case group covered 120 while the control group contained 134. The findings indicated that pregnant women with PE had significantly greater levels of circulating FGF21 than healthy expectant mothers (SMD = 0.743, 95% CI: 0.527 ~ 0.958, p = 0.000).ConclusionsOur study found that FGF21 has the potential to serve as a diagnostic marker for GDM or PE. However, due to the limited number of studies and the fact that most data were from the second and third trimesters of pregnancy, more large-scale prospective studies are needed to validate these conclusions, investigate the potential of FGF21 in enabling early diagnosis, and further examine the role of FGF21 in the development and progression of GDM/PE.Trial registrationNot applicable.

Effect of Plant Versus Animal Protein on Muscle Mass, Strength, Physical Performance, and Sarcopenia: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Dietary protein is recommended for sarcopenia-a debilitating condition of age-related loss of muscle mass and strength that affects 27% of older adults. The effects of protein on muscle health may depend on protein quality. The aim was to synthesize randomized controlled trial (RCT) data comparing plant with animal protein for muscle health. Forty-three eligible RCTs were sourced from Medline, Embase, Scopus, Web of Science, and CENTRAL databases. Four reviewers (R.J.R.-M., S.F.B., N.A.W., D.L.) extracted data from RCTs (study setting, population, intervention characteristics, outcomes, summary statistics) and conducted quality assessment using the Cochrane Risk of Bias 2.0. Standardized mean differences (SMDs) (95% CIs) were combined using a random-effects meta-analysis and forest plots were generated. I2 statistics were calculated to test for statistical heterogeneity. Thirty RCTs (70%) were eligible for meta-analysis and all examined muscle mass outcomes. Compared with animal protein, plant protein resulted in lower muscle mass following the intervention (SMD = -0.20; 95% CI: -0.37, -0.03; P = .02), with stronger effects in younger (<60 years; SMD = -0.20; 95% CI: -0.37, -0.03; P = .02) than in older (≥60 years; SMD = -0.05; 95% CI: -0.32, 0.23; P = .74) adults. There was no pooled effect difference between soy and milk protein for muscle mass (SMD = -0.02; 95% CI: -0.20, 0.16; P = .80) (n = 17 RCTs), yet animal protein improved muscle mass compared with non-soy plant proteins (rice, chia, oat, and potato; SMD = -0.58; 95% CI: -1.06, -0.09; P = .02) (n = 5 RCTs) and plant-based diets (SMD = -0.51; 95% CI: -0.91, -0.11; P = .01) (n = 7 RCTs). No significant difference was found between plant or animal protein for muscle strength (n = 14 RCTs) or physical performance (n = 5 RCTs). No trials examined sarcopenia as an outcome. Animal protein may have a small beneficial effect over non-soy plant protein for muscle mass; however, research into a wider range of plant proteins and diets is needed. PROSPERO registration no. CRD42020188658.

Alcohol use among populations with autism spectrum disorder: narrative systematic review.

Alcohol use in autism spectrum disorder (ASD) is under-researched. Previous reviews have explored substance use as a whole, but this neglects individual characteristics unique to different substances. Alcohol use in non-clinical samples is associated with diverse responses. To advance practice and policy, an improved understanding of alcohol use among people with ASD is crucial to meet individual needs. This was a narrative systematic review of the current literature on the association between alcohol use and ASD, focusing on aetiology (biological, psychological, social and environmental risk factors) and implications (consequences and protective factors) of alcohol use in autistic populations who utilise clinical services. We sought to identify priority research questions and offer policy and practice recommendations. PROSPERO Registration: CRD42023430291. The search was conducted across five databases: CINAHL, EMBASE, MEDLINE, PsychINFO and Global Health. Included studies explored alcohol use and ASD within clinical samples. A total of 22 studies was included in the final review. The pooled prevalence of alcohol use disorder in ASD was 1.6% and 16.1% in large population registers and clinical settings, respectively. Four components were identified as possible aetiological risk factors: age, co-occurring conditions, gender and genetics. We identified ten implications for co-occurring alcohol use disorder in ASD, summarised as a concept map. Emerging trends in the literature suggest direction and principles for research and practice. Future studies should use a standardised methodological approach, including psychometrically validated instruments and representative samples, to inform policy and improve the experience for autistic populations with co-occurring alcohol use.

Paediatric sedation with intranasal dexmedetomidine: Protocol for a systematic review and meta-analysis.

Sedation ensures a child remains motionless during a procedure and decreases anxiety. Several pharmacologic regimes exist for paediatric sedation. However, often, intravenous cannulation is required, causing distress for the child. Creating a low-stress environment for children during medical procedures is crucial. Intranasal dexmedetomidine offers a promising alternative by either removing the need for intravenous cannulation or significantly reducing stress and anxiety when cannulation is necessary. We aim to investigate the safety and efficiency of sedating children with intranasal dexmedetomidine. We will systematically search MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCO), CENTRAL, Clinicaltrials.gov, and the WHO ICTRP portal. We will include all randomized controlled trials (RCT) that investigate the use of intranasal dexmedetomidine compared to alternative sedatives for premedication or sedation of children. Two researchers will independently screen title/abstract and full-text articles for eligibility using Covidence. Our primary outcome is sedation success rate. RCTs that meet the inclusion criteria will form the unit of analysis. Data extracted from each study will be presented in table format (S2 Table). Information on parameters that describe safety and efficiency outcomes will be extracted and analysed. Outcome data will be reported as risk ratios and 95% confidence intervals (CI) for dichotomous outcomes or mean and standardized mean differences with 95% CI for continuous outcomes. The assessment of statistical heterogeneity will be examined using Chi2- and I2-statistics. PROSPERO registration number CRD42024532993. Sedation with intranasal dexmedetomidine is not common practice in all countries, though the medicament has the potential to provide a child-friendly approach to sedation and premedication. Reviews on the area are conflicting, and new RCT studies have been published. Our systematic review aims to comprehensively assess intranasal paediatric sedation, focusing on dexmedetomidine and guiding clinicians in daily decision-making for optimal paediatric sedation.

Real-time ultrasound for umbilical venous catheter insertion in neonates- a systematic review and meta-analysis.

There has been an increase in real-time ultrasonography use in central venous catheterisation. This systematic review and meta-analysis aimed to assess the role of real-time ultrasound use in umbilical venous catheterisation in neonates. PubMed, Embase, Web of Science and Cochrane Library were searched on July 11, 2024. We followed the Cochrane Handbook for Systematic Reviews of Interventions (for study conduct), GRADE methodology (for certainty of evidence), and PRISMA guidelines (for reporting). All randomised controlled trials/RCTs and non-randomised studies of interventions/NRSIs comparing real-time ultrasound with the conventional technique of umbilical venous catheterisation were included. The outcomes of interest were malposition rates, procedure duration, mortality, sepsis, and cost. Data extraction and quality assessment were done in duplicate. Six studies (three RCTs and three NRSI), including 863 participants, were included. Data were analysed separately for RCTs and NRSIs. The RCTs were at low risk of bias, but NRSIs were at moderate to serious risk. The pooled estimates from RCTs showed a decrease in malposition rates (2 studies, 165 participants, risk ratio/RR 0.45, 95% confidence interval/CI 0.23, 0.90) and procedure duration (3 studies, 196 participants, mean difference -6.1min, 95% CI -8.4, -3.8min) with real-time ultrasound use. There was no reduction in sepsis. Mortality was not reported. The certainty of evidence was low for malposition rates and procedure duration. The data from NRSIs showed a reduction in malposition rates (3 studies, 667 participants, risk ratio/RR 0.10, 95% confidence interval/CI 0.07, 0.14) without an impact on procedure duration and sepsis. However, these findings did not improve the evidence. Low certainty evidence suggests that using real-time ultrasound for umbilical venous catheterisation reduces malposition rates. There is a clinically insignificant reduction in procedure duration. There is no sufficient data to come to a conclusion on the critical outcomes of sepsis and mortality. PROSPERO registration number: CRD42024567895.

Meta-Analysis of Palmitoylethanolamide in Pain Management: Addressing Literature Gaps and Enhancing Understanding.

Chronic pain is a debilitating condition that affects a significant proportion of the population. Palmitoylethanolamide (PEA), a naturally occurring fatty acid amide derived from omega-7 fatty acids, has emerged as a safe and effective alternative for pain management and exerts its effects by interacting with the endocannabinoid system, modulating inflammation, and regulating immune responses. A comprehensive meta-analysis was conducted to evaluate the efficacy of PEA in alleviating pain across various pathologies, considering the nociceptive, neuropathic, or nociplastic nature of pain. A systematic search was conducted of 4 databases: PubMed, Embase, Scopus, and Cochrane Collaboration Library. Randomized clinical trials were selected for analysis. This meta-analysis included 18 studies involving 1196 patients. Continuous variables were assessed using a standard mean difference (SMD). Heterogeneity was evaluated using the χ2 test and I2 statistics. Pain was significantly reduced in the PEA group at 6 weeks (SMD, -0.9; 95% CI, -1.60 to -0.31), 8 weeks (SMD, -0.98; 95% CI, -1.61 to -0.36), and 24-26 weeks (SMD, -1.16; 95% CI, -2.15 to -0.17). Quality of life, including pain-related items, was significantly higher in the PEA group (SMD, -0.61; 95% CI, -0.93 to -0.30). Significant differences in favor of PEA were observed at 4 (SMD, -0.36; 95% CI, -0.65 to -0.07) and 8 weeks (SMD, -0.66; 95% CI, -1.15 to -0.17). Palmitoylethanolamide was effective for all pain types: nociceptive (SMD, -0.74; 95% CI, -1.42 to -0.06), neuropathic (SMD, -0.97; 95% CI, -1.54 to -0.39), and nociplastic (SMD, -0.59; 95% CI, -1.15 to -0.03). This meta-analysis confirmed that PEA effectively reduces pain and enhances quality of life, with significant benefits observed within 4-6 weeks of treatment. Palmitoylethanolamide is a promising alternative to chronic opioid analgesics, potentially reducing the risk of opioid abuse and dependency. PROSPERO registration no. CRD42024550546.

The role of meal timing in appetitive responses to acute exercise in adolescents with and without obesity: A systematic review and meta-analysis.

Physical activity has been shown to improve various aspects of metabolic health and is frequently applied as an intervention in the management and prevention of overweight/obesity. Chrono-exercise can be studied in relation to time of day and timing in relation to a meal, which encompasses chronology and duration of the temporal interval, but the latter has received limited attention to date. This brief review and meta-analysis investigates whether the timing of a meal subsequent to acute exercise, in children and adolescents with and without overweight/obesity, moderates eating behaviour and appetite. A quantitative synthesis of 28 controlled trials with 51 distinct conditions (N = 575; median sample size = 15, median age = 13 years, n = 297 overweight/obesity) was performed using multilevel random-effects meta-regressions and restricted splines to test the linear and non-linear relationships between mean differences in energy intake between exercise and control conditions and the duration of the exercise-test meal interval, and if this moderated by participant weight status or exercise characteristics (i.e., intensity, duration, and modality). Commencement of meals occurred from immediately to 3 hours after cessation of exercise (Median = 30 minutes, interquartile range = 8 minutes). The meal interval was not associated with effect sizes overall in the linear and spline analysis (ps = .576 and .971, respectively). Although there was only an interaction with weight status present in the linear analysis (p < .001), the meal interval significantly moderated effect sizes within study arms with lean participants (ps = .006 and .019, respectively), but not in those with overweight/obesity (ps = .070 and .620, respectively) in both analyses. Exercise characteristics did not have an impact on this relationship. Taken together, prescriptions for meal timing may depend on the individual phenotype when seeking to optimise potential anorexigenic effects of acute exercise. PROSPERO REGISTRATION NUMBER: CRD42021287838 (https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=287838).

The prevalence of frailty among older adults with maintenance hemodialysis: a systematic

BackgroundTo evaluate the epidemiological data on the prevalence of frailty and prefrailty in individuals aged 60 years or older on MHD patients.MethodsPubMed, Web of Science, Embase, CNKI, WanFang, CBM, and VIP were searched from inception to February 2023 using combinations of subject words and free words. The methodological quality of all the selected studies was assessed using the Joanna Briggs Institute Critical Appraisal of Epidemiological Studies Checklist and Newcastle‒Ottawa Cohort Quality Assessment Scale. Random effects meta-analysis was used to pool estimates from different studies. Subgroup analysis and meta-regression were performed to explore potential sources of heterogeneity.ResultsOf the 4,190 documents retrieved, 16 observational studies involving 2,446 participants from 8 countries were included in this systematic review. Among older adults receiving MHD, the overall prevalence of frailty and prefrailty was 41% (95% CI = 34–49%) and 37% (95% CI = 26–48%), respectively, with considerable heterogeneity. The pooled prevalence of frailty was greater among individuals aged > 70 years (45%) than among those aged ≤ 70 years (37%). However, subgroup analyses indicated that the confidence intervals for the age group overlap substantially.ConclusionOur research showed that the prevalence of frailty and prefrailty in older patients with MHD are high.Trial registrationThe PROSPERO registration number for this study was CRD42023442569.

The Efficacy and Safety of Non-Biologic and Biologic Treatments in Palmoplantar Pustular Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Network Meta-Analysis.

Palmoplantar pustular psoriasis (PPPP), or palmoplantar pustulosis (PPP), is a type of psoriasis that affects the skin on the palms and soles. It is characterised by dermatosis and small sterile pustules and is considered a significant burden on patients' quality of life, as there is currently no gold standard treatment or cure. This network meta-analysis (NMA) compares the efficacy and safety of biologic and non-biologic medications for PPPP and PPP. Medline, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched. The efficacy and safety of all medications were assessed through a frequentist NMA using a random-effects model. Treatments were ranked using the net rank function, yielding P scores. Fourteen RCTs with 1056 participants were included. Guselkumab 100 mg was the most effective for improving PPPGA scores (p = 0.72, RR = 1.31, CI: 0.31-5.57). Guselkumab 100 mg was ranked the highest for achieving PPPASI-75 (RR = 5.4, CI: 1.26-23.2, p = 0.023). Oral cyclosporine 1 mg/kg/day was ranked the highest for PPPASI-50 (RR = 2.10, CI: 0.65-6.82). Etretinate 1 mg/kg/day had the highest rate of adverse events (RR = 1.78, CI: 0.92-3.44). Secukinumab 300 mg was associated with the highest rate of serious adverse events (RR = 1.58, CI: 0.21-12.02). Based on the P-scores from our NMA, guselkumab 100 mg was the most effective for PPPGA improvement, guselkumab 100 mg for PPPASI-75, oral cyclosporine 1 mg/kg/day for PPPASI-50, etretinate 1 mg/kg/day had the most adverse events, and secukinumab 300 mg was associated with the highest rate of serious adverse events. TRIAL REGISTRATION: PROSPERO registration number: CRD42023460842.

The Beneficial Effects of Lactobacillus Strains on Gut Microbiome in Alzheimer's Disease: A Systematic Review.

Growing evidence suggests that the gut-brain axis influences brain function, particularly the role of intestinal microbiota in modulating cognitive processes. Probiotics may alter brain function and behavior by modulating gut microbiota, with implications for neurodegenerative diseases like Alzheimer's disease (AD). The purpose of this review is to systematically review the current literature exploring the effects of probiotic supplementation on gut microbiota and cognitive function in AD and mild cognitive impairment (MCI). A comprehensive literature search was conducted across PubMed/Medline, Embase, and Scopus to identify relevant randomized controlled trials (RCTs) from inception to 20 August 2024. The search focused on comparing outcomes between intervention and control/placebo groups. Data searches, article selection, data extraction, and risk of bias assessment were performed in accordance with Cochrane guidelines. PROSPERO registration no: CRD42023446796. Data from four RCTs involving 293 Individuals (AD and MCI patients) receiving mainly Lactobacillus and Bifidobacterium strains showed some beneficial effects on cognitive function, altered gut microbiota composition, and positively affected metabolic biomarkers. However, variability in microbiota assessment across studies limits the interpretation of results. The limited number and quality of the existing studies make it difficult to draw definitive conclusions from the data. Additional high-quality research is clearly needed. Probiotics show promise as an adjunctive intervention for cognitive decline, but larger, long-term trials are needed to confirm their efficacy and clinical applicability in neurodegenerative diseases like AD.

Research Participants’ Engagement and Retention in Digital Health Interventions Research: Protocol for Mixed Methods Systematic Review

Background Digital health interventions have become increasingly popular in recent years, expanding the possibilities for treatment for various patient groups. In clinical research, while the design of the intervention receives close attention, challenges with research participant engagement and retention persist. This may be partially due to the use of digital health platforms, which may lack adequacy for participants. Objective This systematic literature review aims to investigate the relationship between digital health platforms and participant engagement and retention in clinical research. It will map and analyze key definitions of engagement and retention, as well as identify design characteristics that influence them. Methods We will carry out a mixed methods systematic literature review, analyzing qualitative and quantitative studies. The search strategy includes the electronic databases PubMed, IEEE Xplore, CINAHL, Scopus, Web of Science, APA PsycINFO, and the ACM Digital Library. The review will encompass studies published between January 2018 and June 2024. Criteria for inclusion will be the presence of digital health care interventions conducted through digital health platforms like websites, web and mobile apps used by patients, and informal caregivers as research participants. The main outcome will be a narrative analysis with key findings on the definitions of participant engagement and retention and critical factors that affect them. Quality assessment and appraisal will be done through the Mixed-Methods Assessment Tool. Data analysis and synthesis will follow the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 flow diagram. Quantitative data will be qualified and integrated into qualitative data, which will be analyzed using thematic analysis and synthesis. Results The study expects to map and summarize critical definitions of participant engagement and retention, and the characteristics of digital health platforms that influence them. The systematic review is expected to be completed in June 2025. Conclusions This systematic review will contribute to the growing discussion on how the design of digital health intervention platforms can promote participant engagement and retention in clinical research. Trial Registration PROSPERO CRD42024561650; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=561650 International Registered Report Identifier (IRRID) PRR1-10.2196/65099

The Effectiveness of Cervical Sensorimotor Control Training for the Management of Chronic Neck Pain Disorders: A Systematic Review and Meta-Analysis

This systematic review and meta-analysis aimed to evaluate the effectiveness of cervical sensorimotor control training for the management of chronic neck pain (NP) disorders compared to no treatment, or other conservative or non-conservative treatments. The review was conducted following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines (PROSPERO registration number: CRD42022381714). A comprehensive database search was performed (until November 2023) for randomized controlled trials (RCTs) and clinical trials evaluating the effects of cervical sensorimotor control training on several subjective and objective outcomes in adults with chronic NP (traumatic or non-traumatic origin). Data on study and patient characteristics, outcome measures, and effects on primary and secondary outcomes were extracted. Seven RCTs (409 participants) were included, of which 6 qualified for meta-analysis. Low-certainty evidence suggests that cervical sensorimotor control training is more effective for reducing pain (standardized mean difference (SMD): 0.48; 95% confidence interval (CI): 0.07 to 0.89) and improving cervicocephalic kinesthesia at short term than no treatment, and for reducing kinesiophobia at intermediate term compared to other treatment modalities. No significant between-group differences were found for other outcomes and follow-ups (very low-to-moderate-certainty evidence). Considering the significant improvements in cervicocephalic kinesthesia, cervical sensorimotor control training could be an important element in the rehabilitation of patients with chronic NP disorders. However, the current evidence in the literature is scarce to draw conclusions regarding its effectiveness as a stand-alone rehabilitation program.

Telessaúde na assistência ao paciente por enfermeiros de prática avançada: revisão sistemática

Abstract Objective To analyze the results of application of telehealth in patient care by advanced practice nurses. Methos This is a systematic review of intervention studies, in accordance with recommendations from the JBI and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The search was conducted on August 23, 2023, using the descriptors “telemedicine”, “nurse practitioner”, “patient care” and related keywords. Seven databases were accessed, such as LILACS, PubMed®, CINAHL, Embase, Scopus, Cochrane Database of Systematic Reviews and Web of Science Core Collection. Clinical trials, randomized or not, pre-post testing or before and after studies, without restrictions on publication date or language, that answered the question/PICO “What is the result of the application of telehealth carried out by advanced practice nurses in patient care?”, were included. An analysis of methodological quality was carried out, only studies of moderate and high methodological quality were included, and it was not possible to perform a meta-analysis. Results A total of 15 articles were selected, with a population of adult patients, older adults and family members of children with chronic diseases. Interventions involved phone calls, combinations of different devices or programs for education, monitoring or counseling. In 12 studies, positive effects were identified for the primary outcomes: costs; self-management of care, caregiver satisfaction with health management; quality of life, comfort, adaptation to treatment, functional recovery, clinical indicators and vital signs. Conclusion The positive effects of using telehealth to obtain clinical data and care management and its safe use, evidenced in the present study, allow us to recommend it. PROSPERO Register: CRD42023465566

Prevalence of post-acute sequelae of SARS-CoV-2 infection in people living with HIV: a systematic review with meta-analysis

Given the chronic immune activation and inflammatory milieu associated with Long COVID and HIV, we assessed the prevalence of Long COVID in adults living with HIV; and investigated whether adults living with HIV were associated with increased chance of developing Long COVID compared to adults living without HIV. In this systematic review and meta-analysis, we searched Medline, EMBASE, CINHAL, PubMed and CENTRAL from inception until June 14th, 2024, for observational studies that measured the prevalence of Long COVID in adults living with HIV and the odds of developing Long COVID following a SARS-CoV-2 infection in people living with HIV compared to people living without HIV. Reviews, case reports, randomised control trials and editorials were excluded. The search was conducted without language restrictions. We performed meta-analysis of proportions to synthesise prevalence estimates using logit transformation and a sensitivity analysis using mixed-effects logistic regression. We used random-effects meta-analyses to summarize the odds ratio (OR) of developing Long COVID in adults living with HIV compared to adults living without HIV and conducted a sensitivity analysis including only studies with covariate-adjusted estimates that was planned a-priori. We used ROBINS-E for the risk of bias assessment and GRADE to rate the certainty of evidence. We identified statistical heterogeneity using Cochran's Q test and quantified it using the I2 statistic. For the Q test, a P<0.10 was considered statistically significant. PROSPERO registration: CRD42024577616. Our search returned 831 results, of which 8 studies (4489 participants) were deemed eligible for inclusion in the systematic review and meta-analysis. The prevalence of Long COVID in adults with HIV was 43% (95% CI: 32-54%, 8 studies; 1227 participants; low certainty, I2<0.0001). The association of HIV status with Long COVID was inconclusive, with wide confidence intervals (OR: 1.16, 95% CI: 0.58-2.29; 4 studies; 3556 participants, low certainty, I2=0.013). When the analysis was restricted to studies reporting covariate-adjusted estimates, adults living with HIV were associated with a higher odds of Long COVID than those not living with HIV (OR: 2.21, 95% CI: 1.12-4.36; 2 studies; 374 participants, low certainty, I2=0.51). Current evidence indicates that the prevalence of Long COVID in adults living with HIV may be high, suggesting the need for increased awareness and education of healthcare providers and policy makers. Evidence on whether HIV positivity increases the risk of Long COVID is limited and inconclusive, highlighting a need for further research to clarify this potential association. None.

Comparative safety of transvenous and leadless pacemakers in patients with cardiovascular diseases: A meta-analysis study.

Transvenous pacemakers (TVP) and leadless pacemakers (LP) are two reliable permanent modalities for the treatment of heart rhythm disorders. Several observational studies explored the safety and efficacy of the two devices. The aim of this meta-analysis study is to present a comparative analysis of the safety of leadless versus transvenous pacemakers. The study protocol was registered in PROSPERO registry (CRD42024520647). A comprehensive and systematic search was conducted across PubMed, Embase, Cochrane Library, Web of Science and ClinicalTrials.gov, spanning from inception until just before the final analysis. SPSS was used for statistical analysis. Relative risks (RR) and odds ratio (OR) were used to evaluate the outcomes with a 95% confidence interval (CI). Nineteen studies met the inclusion criteria and were analyzed, in which the overall effect estimate showed increased risk of major complications in the TVP group (LogOR=-0.27, 95% CI: [-0.63, 0.10]) compared to the LP group. Among the nineteen studies, seven studies showed that TVP significantly increase the risk of reintervention (LogOR=-0.73, 95% CI: [-1.15, -0.31]) and thirteen studies showed a higher risk of mortality among patients receiving TVP (Cohen's d=-0.11, 95% CI: [-0.22, 0.01]) compared to those receiving LP. Conversely, a higher risk of pericardial effusion or tamponade and thromboembolic events was among patients receiving LP with (LogOR=1.01, 95% CI: [0.55, 1.46]) and (LogOR=0.45, 95% CI: [-0.33, 1.23]) respectively. This study showed that leadless pacemakers tend to be safer compared to transvenous pacemakers, with reduced risks of major complications, reintervention, generator malfunction, device or lead dislodgement, pneumothorax and hemothorax, infections rates, and mortality. However, higher odds of cardiac perforation and tamponade and thromboembolic events were observed among patients receiving LP. The lack of both randomized clinical trials and long term follow up studies limits our assessment and emphasizes the need for ongoing investigation to understand the extended complications associated with these devices amidst advancing technology.

Diaper dermatitis and associated factors among children aged 0-24 months in low- and middle-income countries: A systematic review protocol.

Diaper dermatitis (DD, sometimes known as diaper rash or napkin dermatitis is one of the most prevalent skin infections that occur in the area covered by the diaper. Although diaper dermatitis can be seen in any patient wearing diapers, it is reported to be more common in infants aged 9-12 months. Approximately, 70% of infants and young children suffer from diaper dermatitis at some point during their diaper wearing years and up to 25% of children seek healthcare due to this case. A comprehensive literature search will be gathered from electronic databases such as PubMed, Embase, Hinari, Cochrane Library, African Journals Online (AJOL), and Google Scholar. The protocol followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses for Protocol (PRISMA-P) guideline. All studies conducted in low- and middle-income countries (LMICs) will be included regardless of their study design as long as these studies report the magnitude of the problem under study. Joanna Briggs Institute's (JBI) appraisal checklist will be used to assess the quality of individual studies. Heterogeneity will be checked using Cochrane Q test statistics and I2 test statistics, and a random-effects model will be employed to estimate the pooled prevalence of DD and its associated factors. Ethics committee approval or written informed consent will not be required to conduct this review, and meta-analysis for the review will be entirely based on published data. The result of this study will be submitted to a peer-reviewed journal, and it will also be presented at relevant research conferences. The present study will estimate the pooled prevalence of diaper dermatitis and their associated factors in low- and middle-income countries. PROSPERO registration number: CRD42024578550.

Systematic review of health and social outcomes among Indigenous People exposed to the child welfare system: a protocol

IntroductionThe link between parent-child separation through child welfare systems and negative health and social outcomes is well documented. In contrast, despite the over-representation of Indigenous children and youth in child...