Displaying publications 81 - 100 of 492 in total

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  1. Osland EJ, Yunus RM, Khan S, Memon MA
    Surg Laparosc Endosc Percutan Tech, 2020 Dec;30(6):542-553.
    PMID: 32658120 DOI: 10.1097/SLE.0000000000000834
    BACKGROUND: Laparoscopic vertical sleeve gastrectomy (LVSG) has overtaken the laparoscopic Roux-en-Y gastric bypass (LRYGB) as the most frequently performed bariatric surgical procedure. To date little has been reported on the long-term outcomes of the LVSG procedure comparative to the traditionally favoured LRYGB. We undertook a systematic review and meta-analysis to review the 5-year outcomes of comparing LVSG and LRYGB. We undertook a systematic review and meta-analysis to compare 5-year weight loss outcomes of randomized controlled trials comparing LVSG to LRYGB.

    MATERIALS AND METHODS: Searches of electronic databases (PubMed, Embase, CINAHL, Cochrane) were undertaken for randomized controlled trials describing weight loss outcomes in adults at 5 years postoperatively. Where sufficient data was available to undertake meta-analysis, the Hartung-Knapp-Sidik-Jonkman estimation method for random effects model was utilized. The review was registered with PROSPERO and reported following in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

    RESULTS: Five studies met the inclusion criteria totaling 1028 patients (LVSG=520, LRYGB=508). Moderate but comparable levels of bias were observed within studies. Statistically significant body mass index loss ranged from -11.37 kg/m (range: -6.3 to -15.7 kg/m) in the LVSG group and -12.6 kg/m (range: -9.5 to -15.4 kg/m) for LRYGB at 5 years (P<0.001). Systematic review suggested that LRYGB produced a greater weight loss expressed as percent excess weight and percent excess body mass index loss than LVSG: this was not corroborated in the meta-analysis.

    CONCLUSIONS: Five year weight loss outcomes suggest both LRYGB and LVSG are effective in achieving significant weight loss at 5 years postoperatively, however, differences in reporting parameters limit the ability to reliably compare the outcomes using statistical methods. Furthermore, results may be impacted by large dropout rates and per protocol analysis of the 2 largest included studies. Further long-term studies are required to contradict or validate the results of this meta-analysis.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  2. Ismail NA, Hashim HA, Ahmad Yusof H
    Games Health J, 2022 Feb;11(1):1-17.
    PMID: 34851732 DOI: 10.1089/g4h.2021.0104
    Recently, exergames have been widely applied as exercise platforms among older adults. However, studies on the influence of exergames on older adults' physical activity remain scarce. The review article highlights the potential benefit of exergames as a physical activity tool for older adults. The literature search followed the PRISMA guidelines on databases PubMed (Public/Publisher MEDLINE), CINAHL (Cumulative Index to Nursing and Allied Health Literature), Cochrane, and Scopus. The literature included studies that evaluated the influence of exergames on older adults' physical activity. Articles were excluded if the mixed intervention was used, emphasizing specific limbs, improving specific tasks, or not mentioning intervention. The review article identified 25 studies that reported on 855 older adults 55 years of age and older. In addition, the common exergaming technology platforms examined were Microsoft Kinect™, Nintendo® Wii™, cybercycling, and interactive video dance games. Meanwhile, 11 studies used a pretest/post-test design and randomized controlled trial design in 14 studies. The review found that exergames significantly impacted the older adults' physical activity level as participants experienced improved balance and cognitive function, and enjoyed playing exergame, thus prolonging their game engagement. Although research on exergames is still new, current evidence showed a significant potential benefit of exergames as a physical activity tool for older adults. To overcome the limitation on various parameters that showed different effects and outcomes of exergames, the study recommends implementing randomized controlled trials with long-term observation using a mixed-method approach. Moreover, a multidisciplinary method involving exercise and neuromotor control experts could determine potential mechanisms of action that benefited from the exercises.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  3. Kow CS, Ramachandram DS, Hasan SS
    J Infect Chemother, 2022 Feb;28(2):257-265.
    PMID: 34840039 DOI: 10.1016/j.jiac.2021.11.008
    OBJECTIVE: We aimed to perform a meta-analysis to summarize the overall evidence from randomized controlled trials related to higher-intensity anticoagulation in hospitalized patients with COVID-19.

    METHODS: A systematic literature search was performed in electronic databases to identify randomized controlled trials comparing the clinical outcomes between intermediate/ therapeutic anticoagulation and prophylactic anticoagulation. Meta-analyses with random-effects models were used to estimate the pooled odds ratio (OR) for outcomes of interest at a 95% confidence interval (CI).

    RESULTS: Eight randomized controlled trials were included, with a total of 5405 hospitalized patients with COVID-19. The meta-analysis revealed no statistically significant difference in the odds of mortality (pooled OR = 0.92; 95% CI 0.71-1.19) but a statistically significant reduction in the odds of development of thrombotic events (pooled OR = 0.55; 95% CI 0.42-0.72), and significantly increased odds of development of major bleeding (pooled OR = 1.81; 95% CI 1.20-2.72) with the use of intermediate/therapeutic anticoagulation, relative to prophylactic anticoagulation. Subgroup analysis in patients with a severe course of COVID-19 observed a statistically significant reduction in the odds of development of thrombotic events (pooled OR = 0.66; 95% CI 0.45-0.98) but no significant difference in the odds of development of major bleeding events (pooled OR = 1.37; 95% CI 0.74-2.56), with the use of intermediate/therapeutic anticoagulation, relative to prophylactic anticoagulation.

    CONCLUSION: There could be net clinical benefits with higher-intensity dosing of anticoagulation relative to prophylactic-dosing of anticoagulation among hospitalized patients with severe COVID-19.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  4. Kow CS, Burud IAS, Hasan SS
    Pancreas, 2022 Aug 01;51(7):752-755.
    PMID: 36395399 DOI: 10.1097/MPA.0000000000002112
    OBJECTIVES: We aimed to perform a systematic review and meta-analysis of randomized controlled trials to summarize the overall association between the choice of fluid (lactated Ringer's [LR] or normal saline [NS]) and clinical outcomes in patients with acute pancreatitis.

    METHODS: A systematic literature search was performed in electronic databases to identify eligible randomized controlled trials. Meta-analyses with the random-effects and IVhet models were used to estimate the pooled odds ratio (OR) for outcomes of interest with the administration of LR relative to NS, at 95% confidence intervals (CIs).

    RESULTS: There was a significant reduction in the odds of intensive care unit admission and development of local complications, respectively, with the administration of LR among hospitalized patients with acute pancreatitis relative to administration of NS (pooled ORs, 0.33 [95% CI, 0.13-0.81] and 0.43 [95% CI, 0.21-0.89], respectively).

    CONCLUSIONS: Our findings are able to assist clinicians in the navigation of the proper choice of fluid in patients with acute pancreatitis.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  5. Peng S, Yuan F, Othman AT, Zhou X, Shen G, Liang J
    PMID: 36612643 DOI: 10.3390/ijerph20010318
    Insufficient physical activity (PA) and excessive sedentary behavior (SB) are detrimental to physical and mental health. This systematic review and meta-analysis aimed to identify whether e-health interventions are effective for improving PA and SB in college students. Five electronic databases, including Medline, Web of Science, Embase, Cochrane Library, and ProQuest, were searched to collect relevant randomized controlled trials up to 22 June 2022. In total, 22 trials (including 31 effects) with 8333 samples were included in this meta-analysis. The results showed that e-health interventions significantly improved PA at post-intervention (SMD = 0.32, 95% CI: 0.19, 0.45, p < 0.001) compared with the control group, especially for total PA (SMD = 0.34, 95% CI: 0.10, 0.58, p = 0.005), moderate to vigorous PA (SMD = 0.17, 95% CI: 0.01, 0.32, p = 0.036), and steps (SMD = 0.75, 95% CI: 0.23, 1.28, p < 0.001. There were no significant effects for both PA at follow-up (SMD = 0.24, 95% CI: − 0.01, 0.49, p = 0.057) and SB (MD = −29.11, 95% CI: −70.55, 12.32, p = 0.17). The findings of subgroup analyses indicated that compared to the control group, interventions in the group of general participants (SMD = 0.45, 95% CI: 0.27, 0.63, p < 0.001), smartphone apps (SMD = 0.46, 95% CI: 0.19, 0.73, p = 0.001), and online (SMD = 0.23, 95% CI: 0.04, 0.43, p < 0.001) can significantly improve PA at post-intervention. Moreover, the intervention effects were significant across all groups of theory, region, instrument, duration, and female ratio. At follow-up, interventions in groups of developing region (SMD = 1.17, 95% CI: 0.73, 1.62, p < 0.001), objective instrument (SMD = 0.83, 95% CI: 0.23, 1.42, p = 0.007), duration ≤ 3-month (SMD = 1.06, 95% CI: 0.72, 1.39, p < 0.001), and all female (SMD = 0.79, 95% CI: 0.02, 1.56, p = 0.044) can significantly improve PA. The evidence of this meta-analysis shows that e-health interventions can be taken as promising strategies for promoting PA. The maintenance of PA improvement and the effect of interventions in reducing SB remain to be further studied. Educators and health practitioners should focus on creating multiple e-health interventions with individualized components.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  6. Yadee J, Bangpan M, Thavorn K, Welch V, Tugwell P, Chaiyakunapruk N
    Int J Equity Health, 2019 05 06;18(1):64.
    PMID: 31060570 DOI: 10.1186/s12939-019-0970-x
    BACKGROUND: Everyone has the right to achieve the standard of health and well-being. Migrants are considered as vulnerable populations due to the lack of access to health services and financial protection in health. Several interventions have been developed to improve migrant population health, but little is known about whether these interventions have considered the issue of equity as part of their outcome measurement.

    OBJECTIVE: To assess the evidence of health interventions in addressing inequity among migrants.

    METHODS: We adopted a two-stage searching approach to ensure the feasibility of this review. First, reviews of interventions for migrants were searched from five databases: PubMed, Cochrane, CINAHL, PsycINFO, and EMBASE until June 2017. Second, full articles included in the identified reviews were retrieved. Primary studies included in the identified reviews were then evaluated as to whether they met the following criteria: experimental studies which include equity aspects as part of their outcome measurement, based on equity attributes defined by PROGRESS-Plus factors (place of residence, race/ethnicity, occupation, gender, religion, education, socio-economic status, social capital, and others). We analysed the information extracted from the selected articles based on the PRISMA-Equity guidelines and the PROGRESS-Plus factors.

    RESULTS: Forty-nine reviews involving 1145 primary studies met the first-stage inclusion criteria. After exclusion of 764 studies, the remaining 381 experimental studies were assessed. Thirteen out of 381 experimental studies (3.41%) were found to include equity attributes as part of their outcome measurement. However, although some associations were found none of the included studies demonstrated the effect of the intervention on reducing inequity. All studies were conducted in high-income countries. The interventions included individual directed, community education and peer navigator-related interventions.

    CONCLUSIONS: Current evidence reveals that there is a paucity of studies assessing equity attributes of health interventions developed for migrant populations. This indicates that equity has not been receiving attention in these studies of migrant populations. More attention to equity-focused outcome assessment is needed to help policy-makers to consider all relevant outcomes for sound decision making concerning migrants.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  7. Osland EJ, Yunus RM, Khan S, Memon MA
    Surg Laparosc Endosc Percutan Tech, 2023 Jun 01;33(3):241-248.
    PMID: 37058440 DOI: 10.1097/SLE.0000000000001156
    BACKGROUND: Laparoscopic vertical sleeve gastrectomy (LVSG) is now the most commonly performed bariatric procedure; however, it remains to be elucidated if it delivers equivalent long-term comorbid disease resolution outcomes similar to the longer established laparoscopic Roux-en-Y gastric bypass (LRYGB). We undertook a systematic review and meta-analysis of randomized controlled trials (RCTs) to investigate the comparative 5-year outcomes of both procedures.

    METHODS: Electronic databases (Pubmed, EMBASE, CINAHL) were searched for RCTs conducted in adults (>18y) that compared the 5-year- outcomes of LVSG to LRYGB and described comorbidity outcomes were included. Where data allowed, effect sizes were calculated using the Hartung-Knapp-Sidik-Jonkman estimation method for random effects model. Presence of bias was assessed with Cochrane Risk of Bias 2.0 and funnel plots, and certainty of evidence evaluated by GRADE. The study prospectively registered with PROSPERO (CRD42018112054).

    RESULTS: Three RCTs (LVSG=254, LRYGB=255) met inclusion criteria and reported on chronic disease outcomes. Improvement and/or resolution of hypertension favoured LRYGB (odds ratio 0.49, 95% CI 0.29, 0.84; P =0.03). Trends favoring LRYGB were seen for type 2 diabetes and dysplidemia, and LVSG for sleep apnea and back/joint conditions ( P >0.05). The certainty of evidence associated with each assessed outcome ranged from low to very low, in the setting of 'some' to 'high' bias assessed as being present.

    CONCLUSION: Both LRYGB and LVSG are effective in providing long-term improvements in commonly experienced obesity-related comorbidities; however, the limited certainty of the evidence does not allow for strong clinical conclusions to be made at this time regarding benefit of one procedure over the other.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  8. Xu F, Soh KG, Chan YM, Bai XR, Qi F, Deng N
    PLoS One, 2023;18(9):e0287035.
    PMID: 37768953 DOI: 10.1371/journal.pone.0287035
    BACKGROUND: Tai Chi is good for improving the physical fitness of older adults. But few studies have reported the effects of Tai Chi on the postural balance and quality of life of older adults with gait disorders.

    OBJECTIVE: This review aimed to assess the influence of tai chi on postural stability and quality of life in older adults with abnormal gait.

    METHOD: According to the literature retrieval principles, the works published from the inception date to May 2023 were retrieved, including the following databases: PubMed, Scopus, Web of Science, China National Knowledge Infrastructure, EBSCOhost, and Google Scholar. Subsequently, literature screening and quality assessment were performed.

    RESULTS: A total of 16 randomized controlled trials were included in this study, Tai Chi intervention can affect populations with Parkinson's disease (PD), no exercise, mild cognitive impairment (MCI), chronic stroke, sedentary, fear of falling, or history of falling. Postural instability is associated with balance, gait, the Unified Parkinson's Disease Rating Scale Motor Subscale 3 (UPDRS III), mobility, lower body strength, and falls. Only two articles looked at quality of life. The Yang style is the most commonly used in the intervention. Nonetheless, most studies were performed on female participants, hence, more research on older male populations is needed.

    CONCLUSION: Tai Chi intervention benefits postural balance in patients with gait disorders. 12 weeks is the most common intervention period for patients with gait disorders. The frequency of intervention is seven articles twice a week, and the intervention time is about 60 minutes. The Tai Chi intervention methods in this study involve Yang Style, Sun Style, Taoist Tai Chi, and Health Qigong Tai Chi, but the Yang Style Tai Chi intervention is the most widely used.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  9. Radonjić NV, Bellato A, Khoury NM, Cortese S, Faraone SV
    CNS Drugs, 2023 May;37(5):381-397.
    PMID: 37166701 DOI: 10.1007/s40263-023-01005-8
    BACKGROUND: For some adults with Attention-Deficit/Hyperactivity Disorder (ADHD), nonstimulants need to be considered either as a monotherapy or as an adjunct to stimulants.

    OBJECTIVES: The objectives of this systematic review and meta-analysis were to assess the efficacy, acceptability, and tolerability of nonstimulants in adults with ADHD.

    METHODS: Data sources, searches, and study selection were based on a previously published network meta-analysis of randomized clinical trials (RCTs) by Cortese at al. (Lancet Psychiatry 5(9):727-738, 2018), which we updated in March 2022. Specifically, we searched PubMed, BIOSIS Previews, CINAHL, the Cochrane Central Register of Controlled Trials, EMBASE, ERIC, MEDLINE, PsycINFO, OpenGrey, Web of Science Core Collection, ProQuest Dissertations and Theses (UK and Ireland), ProQuest Dissertations and Theses (abstracts and international), and the WHO International Trials Registry Platform, including ClinicalTrials.gov for double-blind RCTs with a placebo arm, lasting at least one week, including adults with a diagnosis of ADHD based on DSM-III, DSM-III-R, DSM-IV(TR), DSM-5 or ICD-9- or 10, and reporting data on efficacy, tolerability (drop-out due to side effects) and acceptability (drop-out due to any cause) of guanfacine, clonidine, or atomoxetine. Additionally, we searched for RCTs of viloxazine extended release (ER), approved for ADHD in 2021. Random-effects meta-analyses were conducted, and the risk of bias for individual RCTs was assessed using the Cochrane Risk of Bias tool.

    RESULTS: We included 18 studies in the meta-analyses (4308 participants) plus one additional study in the narrative synthesis (374 participants). The meta-analysis showed that atomoxetine (15 RCTs) (Hedge's g = - 0.48, 95% CI [- 0.64; - 0.33]), guanfacine (two RCTs) (Hedge's g = - 0.66, 95% CI [- 0.94; - 0.38]) and viloxazine ER (one RCT) were significantly more efficacious than placebo. Atomoxetine was less well tolerated than placebo, while tolerability of guanfacine and viloxazine ER could not be meta-analysed, since only one study, for each medication, reported on it.

    CONCLUSIONS: All investigated nonstimulants were more efficacious in the treatment of ADHD in adults, than placebo, while the placebo had better acceptability and tolerability.

    PROTOCOL: https://osf.io/5vnmt/?view_only=2bf87ed12ba94645babedceeee4c0120 .

    Matched MeSH terms: Randomized Controlled Trials as Topic
  10. Cheok YC, Mohd Shariff Z, Chan YM, Ng OC, Lee PY
    PLoS One, 2023;18(9):e0284337.
    PMID: 37729132 DOI: 10.1371/journal.pone.0284337
    INTRODUCTION: The incidence of type 2 diabetes mellitus is increasing worldwide. The literature suggests that acupuncture is a possible complementary therapy for type 2 diabetes mellitus. This study aims to determine the effectiveness of acupuncture as an adjunctive therapy on homeostasis model assessment-insulin resistance (HOMA-IR), and health-related quality of life (HRQoL) in patients with type 2 diabetes mellitus.

    MATERIALS AND METHODS: This randomized, double-blind, placebo controlled, and parallel design trial will be carried out in a public university teaching hospitals in Malaysia. Eligible type 2 diabetes mellitus subjects will be randomly assigned to receive either acupuncture (n = 30) or a placebo (n = 30). The intervention is carried out using press needle or press placebo on abdomen area (10 sessions of treatment). Both groups will continue with their routine diabetes care. Primary outcome of HOMA-IR will be measured at the time of recruitment (-week 0), and after completion of 10 sessions (week 7) of the treatment. Additionally, secondary outcome of HRQoL will be measured at the time of recruitment (-week 0), after completion of 5 sessions (week 3/4), and 10 sessions (week 7) of the treatment. Any adverse event will be recorded at every visit.

    DISCUSSION: The findings of this study will provide important clinical evidence for the effect of acupuncture as adjunctive therapy on HOMA-IR, adiposity and HRQoL of type 2 diabetes mellitus.

    TRIAL REGISTRATION NUMBER: NCT04829045.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  11. Hung Tsan S, Viknaswaran N, Lau J, Cheong C, Wang C
    Anaesthesiol Intensive Ther, 2022;54(5):413-424.
    PMID: 36734452 DOI: 10.5114/ait.2022.123197
    Preoxygenation during endotracheal intubation is important to ensure the safety of the procedure. This systematic review and meta-analysis aimed to evaluate the efficacy of preoxygenation in the head-elevated position as compared to the supine position. The Medline, PubMed, Scopus, Embase, and CENTRAL databases were searched systematically from inception of the study until 29 June 2021. Only randomized controlled trials (RCTs) were included. The Cochrane Risk of Bias Assessment Tool and GRADE assessment of certainty of evidence were used. Seven RCTs (n = 508) were analysed, of which 6 were included in the meta-analysis (n = 227). Six studies were carried out in the operating theatre (OT), while one was performed in the critical care (ICU) setting. Compared to the supine position, the head-elevated position significantly increased the duration of the safe apnoea period (mean difference 61.99 s; 95% confidence interval 42.93-81.05 s; P < 0.00001; I2 = 30%; certainty of evidence = high). This improvement was seen in both the obese and non-obese population (I2 = 0%). No differences were seen between both groups with regard to recovery time after apnoea, arterial oxygen tension after preoxygenation, and the incidence of adverse events. In the ICU setting, no difference was found between groups for the incidence of hypoxaemia and the lowest oxygen saturation between induction and after intubation. This meta-analysis demonstrated that the head-elevated position significantly improved the efficacy of preoxygenation during elective intubation in the OT. Clinicians should consider the head-elevated position as a starting intubating position for all patients undergoing anaesthesia in view of its many benefits and the lack of proven adverse consequences. Protocol Registration: This systematic review was registered prospectively in PROSPERO (CRD42019128962).
    Matched MeSH terms: Randomized Controlled Trials as Topic
  12. Junli A, Isa SNI, Ibrahim FS
    Nurse Educ Pract, 2023 May;69:103617.
    PMID: 36996552 DOI: 10.1016/j.nepr.2023.103617
    BACKGROUND: The retention of cardiopulmonary resuscitation skills among healthcare providers is critical to ensure the delivery of effective treatment to patients who experience cardiac arrest. However, the factors influencing cardiopulmonary resuscitation skills retention among healthcare providers have yet to be well studied.

    OBJECTIVE: This scoping review aimed to map the factors influencing cardiopulmonary resuscitation skills retention among healthcare providers.

    METHODS: A literature search was conducted using the Web of Sciences, Scopus, Cochrane, Google Scholar and PubMed electronic databases. The inclusion criteria were original publications published during the last five years (2018 - 2022), availability of full texts in English and evidence of the retention of pertinent cardiopulmonary resuscitation in terms of knowledge and abilities.

    RESULTS: Three cross-sectional studies, two prospective studies, one each of prospective descriptive-analytical study, randomised controlled trial, intervention and prospective interventional study, prospective pre-post study, retrospective study, cluster randomised control trial and randomised education trial study comprise the 14 publications including in this study. The thematic analysis identified four major themes that influence the retention of cardiopulmonary resuscitation skills: experience, training type, training frequency and other factors. The final theme identified infrastructure access, evidence-based practice review meetings and healthcare providers' educational background.

    CONCLUSION: To retain skills in cardiopulmonary resuscitation, healthcare providers must be regularly updated and trained on the latest cardiopulmonary resuscitation guidelines.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  13. Schroeder M, Lim YMF, Savarese G, Suzart-Woischnik K, Baudier C, Dyszynski T, et al.
    Eur J Heart Fail, 2023 Jun;25(6):912-921.
    PMID: 37101398 DOI: 10.1002/ejhf.2868
    AIMS: In order to understand how sex differences impact the generalizability of randomized clinical trials (RCTs) in patients with heart failure (HF) and reduced ejection fraction (HFrEF), we sought to compare clinical characteristics and clinical outcomes between RCTs and HF observational registries stratified by sex.

    METHODS AND RESULTS: Data from two HF registries and five HFrEF RCTs were used to create three subpopulations: one RCT population (n = 16 917; 21.7% females), registry patients eligible for RCT inclusion (n = 26 104; 31.8% females), and registry patients ineligible for RCT inclusion (n = 20 810; 30.2% females). Clinical endpoints included all-cause mortality, cardiovascular mortality, and first HF hospitalization at 1 year. Males and females were equally eligible for trial enrolment (56.9% of females and 55.1% of males in the registries). One-year mortality rates were 5.6%, 14.0%, and 28.6% for females and 6.9%, 10.7%, and 24.6% for males in the RCT, RCT-eligible, and RCT-ineligible groups, respectively. After adjusting for 11 HF prognostic variables, RCT females showed higher survival compared to RCT-eligible females (standardized mortality ratio [SMR] 0.72; 95% confidence interval [CI] 0.62-0.83), while RCT males showed higher adjusted mortality rates compared to RCT-eligible males (SMR 1.16; 95% CI 1.09-1.24). Similar results were also found for cardiovascular mortality (SMR 0.89; 95% CI 0.76-1.03 for females, SMR 1.43; 95% CI 1.33-1.53 for males).

    CONCLUSION: Generalizability of HFrEF RCTs differed substantially between the sexes, with females having lower trial participation and female trial participants having lower mortality rates compared to similar females in the registries, while males had higher than expected cardiovascular mortality rates in RCTs compared to similar males in registries.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  14. Ayat Ali AS, Lim SK, Tang LY, Rashid AA, Chew BH
    Sci Prog, 2021;104(2):368504211026159.
    PMID: 34143698 DOI: 10.1177/00368504211026159
    The complexity of chronic kidney disease (CKD) and its treatments have made self-management behaviors inevitably challenging. However, supplementing education with self-management skills may improve numerous health outcomes in people with nondialysis CKD. This study protocol describes a randomized controlled trial (RCT) aimed to evaluate the effects of a nurse-led self-management support program as an intervention for kidney disease knowledge and CKD self-management behaviors among people with pre-dialysis CKD. In Phase 1, people with CKD stage 3-4 and their family members are involved in co-designing, development and pilot testing of a theory-based self-management intervention. In Phase 2, we perform a cross-cultural adaptation of the Kidney Disease Knowledge Survey, CKD Self-Management and Self-efficacy for Managing Chronic Disease questionnaires. In Phase 3, a parallel RCT will be conducted to evaluate the intervention where 154 participants with CKD stage 3-4 will be randomly assigned to either the intervention (n = 77) or control group (n = 77). The intervention group will receive 6-week self-management program from a nurse-coach in addition to standard usual care, while the control group will receive only standard usual care. Outcome measures include kidney disease knowledge, CKD self-management behavior, self-efficacy, quality of life, blood pressure control and adherence to CKD diet as indicated by 24-h urine urea nitrogen, 24-h urine sodium and net endogenous acid production. Data will be collected at baseline and 12-week post-baseline. The between- and within-group intervention effects will be estimated using the Generalized Estimating Equations. The self-management intervention offers strategies to delay CKD progression and to encourage motivation to better self-manage at home. This study integrates self-management education and psychosocial support with culturally relevant scenarios, and evaluates important self-reported and objective outcomes.Clinical Trials Registration: www.ClinicalTrials.gov, identifier: NCT03974646.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  15. Chang WH, Kim TW, Kim HS, Hanapiah FA, Kim DH, Kim DY
    BMJ Open, 2023 Aug 11;13(8):e065298.
    PMID: 37567748 DOI: 10.1136/bmjopen-2022-065298
    INTRODUCTION: The purpose of this study is to determine the effect of overground gait training using an exoskeletal wearable robot (exoskeleton) on the recovery of ambulatory function in patients with subacute stroke. We also investigate the assistive effects of an exoskeleton on ambulatory function in patients with subacute stroke.

    METHODS AND ANALYSIS: This study is an international, multicentre, randomised controlled study at five institutions with a total of 150 patients with subacute stroke. Participants will be randomised into two groups (75 patients in the robot-assisted gait training (RAGT) group and 75 patients in the control group). The gait training will be performed with a total of 20 sessions (60 min/session); 5 sessions a week for 4 weeks. The RAGT group will receive 30 min of gait training using an exoskeleton (ANGEL LEGS M20, Angel Robotics) and 30 min of conventional gait training, while the control group will receive 60 min conventional gait training. In all the patients, the functional assessments such as ambulation, motor and balance will be evaluated before and after the intervention. Follow-up monitoring will be performed to verify whether the patient can walk without physical assistance for 3 months. The primary outcome is the improvement of the Functional Ambulatory Category after the gait training. The functional assessments will also be evaluated immediately after the last training session in the RAGT group to assess the assistive effects of an exoskeletal wearable robot. This trial will provide evidence on the effects of an exoskeleton to improve and assist ambulatory function in patients with subacute stroke.

    ETHICS AND DISSEMINATION: This protocol has been approved by the Institutional Review Board of each hospital and conforms to the Declaration of Helsinki. The results will be disseminated through publication.

    TRIAL REGISTRATION NUMBER: Protocol was registered at ClinicalTrials.gov (NCT05157347) on 15 December 2021 and CRIS (KCT0006815) on 19 November 2021.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  16. Patil PG, Seow LL
    J Indian Prosthodont Soc, 2021 11 24;21(4):375-382.
    PMID: 34810365 DOI: 10.4103/jips.jips_328_21
    Aim: Single implant-retained mandibular overdentures (1IMO) is a viable alternative to 2 implant-retained overdentures (2IMO) in edentulous patients. However, literature lacks in the quality of life (QoL) of these patients when treated with immediate loading protocols. The purpose of this study was to compare oral health-related QoL (OHRQoL) of patients using 1IMO or 2 IMO with immediate loading protocols at 1 month and 1 year.

    Settings and Design: Randomized Controlled Trial.

    Materials and Methods: Fifty-two edentulous participants treated with mandibular overdentures using either single implant (n = 26) or two implants (n = 26) with immediate loading protocol by a single operator. The low-profile stud-attachments (LOCATOR; Zest Anchors) were attached to the implants and female attachments were picked up within 0-7 days of implant placement. The OHRQoL was recorded using Oral Health Impact Profile-14 (OHIP-14) questionnaire either in English or in the Malay language before treatment and 1 month and 1 year after treatment.

    Statistical Analysis Used: Kruskal Wallis test was used to find out significant difference amongst 3 timepoints and 7 OHIP-14 domains and Mann-Whitney-U test to compare 1IMO or 2IMO groups.

    Results: Compared to baseline OHIP-14 scores, participants had a statistically significant decrease in total OHIP-14 at 1 month and 1 year after-treatment time points in both 1IMO and 2IMO groups (P < 0.05). The difference between 1 month and 1 year after-treatment total and subscale scores were also found to be statistically significant (P < 0.05). The overall QoL improvement was comparatively higher in 2IMO group than 1IMO group. The OHIP-14 scores were statistically different within seven domains (P < 0.05). Overall total scores between 1IMO and 2IMO groups were also found to be statistically significant (P < 0.05) at baseline and insignificant (P > 0.05) at 1 month and 1 year.

    Conclusions: Mandibular single and 2IMO improve the QoL of elderly edentulous Malaysian participants at 1 month of immediate loading and 1 year of recall. 1IMO may provide comparable QoL with the elderly patients using 2 implants.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  17. Phang SCW, Ahmad B, Abdul Kadir K, M Palanisamy UD
    Adv Nutr, 2023 Sep;14(5):1159-1169.
    PMID: 37321474 DOI: 10.1016/j.advnut.2023.06.006
    There are a large number of studies that have reported benefits of tocotrienol-rich fraction (TRF) in various populations with different health status. To date, no systematic reviews have examined randomized controlled trials (RCTs) on the effect of TRF supplementations specifically in patients with type 2 diabetes mellitus (T2DM). This systematic review and meta-analysis aim to examine the changes in HbA1c (glycated hemoglobin), blood pressure, and serum Hs-CRP (C-reactive protein high sensitivity) levels at post-TRF supplementation. Online databases including PubMed, Scopus, OVID Medline, and Cochrane Central Register of Controlled Trials were searched from inception until March 2023 for RCTs supplementing TRF in patients with T2DM. A total of 10 studies were included in the meta-analysis to estimate the pooled effect size. The Cochrane Risk-of-Bias (RoB) Assessment Tool was utilized to evaluate the RoB in individual studies. The meta-analysis revealed that TRF supplementation at a dosage of 250-400 mg significantly decreased HbA1c (-0.23, 95% CI: -0.44, -0.02, P < 0.05, n = 754), particularly where the intervention duration is less than 6 mo (-0.47%, 95% CI: -0.90, -0.05, P < 0.05, n = 126) and where duration of diabetes is less than 10 y (-0.37, 95% CI: -0.68, -0.07, P < 0.05, n = 83). There was no significant reduction in systolic and diastolic blood pressure and serum Hs-CRP (P > 0.05). The present meta-analysis demonstrated that supplementing with TRF in patients with T2DM decreased HbA1c but does not decrease systolic and diastolic blood pressure and serum Hs-CRP.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  18. Luger T, Chu CY, Elgendy A, Ibrahim SBBK, Murashkin N, Ranjan S, et al.
    Eur J Dermatol, 2023 Oct 01;33(5):474-486.
    PMID: 38297923 DOI: 10.1684/ejd.2023.4556
    This systematic literature review (SLR) and meta-analysis assessed the efficacy and safety of pimecrolimus vs other topical treatments in patients with mild-to-moderate atopic dermatitis (AD), focusing on children and sensitive skin areas. An SLR was conducted in MEDLINE, Embase and Cochrane Library databases on January 15th, 2020, to identify randomized controlled trials (RCTs) with pimecrolimus as a study arm. Another SLR performed on October 5th, 2020 identified RCTs with a crisaborole study arm. Direct pair-wise meta-analysis was used to compare pimecrolimus with vehicle, tacrolimus or topical corticosteroids (TCS; n = 27 studies). Outcomes included Investigator's Global Assessment (IGA) score 0/1 up to week 6 and adverse events. Pimecrolimus was more efficacious than vehicle in achieving IGA 0/1 up to week 6 in children, and similar safety profiles were observed with pimecrolimus and vehicle in children and the mixed population, including on sensitive skin. No significant differences in efficacy and safety were observed between pimecrolimus and tacrolimus 0.03%. Efficacy and safety were similar for pimecrolimus and mild medium potency TCS; mildly potent steroids caused transient epidermal thinning in sensitive skin areas (not seen with pimecrolimus). Pimecrolimus can be considered as a first-line option for mild-to-moderate AD, particularly in children and sensitive skin areas.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  19. Arora A, Kumbargere Nagraj S, Khattri S, Ismail NM, Eachempati P
    Cochrane Database Syst Rev, 2022 Jul 27;7(7):CD012595.
    PMID: 35894680 DOI: 10.1002/14651858.CD012595.pub4
    BACKGROUND: In school dental screening, a dental health professional visually inspects children's oral cavities in a school setting and provides information for parents on their child's current oral health status and treatment needs. Screening at school aims to identify potential problems before symptomatic disease presentation, hence prompting preventive and therapeutic oral health care for the children. This review evaluates the effectiveness of school dental screening for improving oral health status. It is the second update of a review originally published in December 2017 and first updated in August 2019.

    OBJECTIVES: To assess the effectiveness of school dental screening programmes on overall oral health status and use of dental services.

    SEARCH METHODS: An information specialist searched four bibliographic databases up to 15 October 2021 and used additional search methods to identify published, unpublished and ongoing studies.

    SELECTION CRITERIA: We included randomised controlled trials (RCTs; cluster- or individually randomised) that evaluated school dental screening compared with no intervention, or that compared two different types of screening.

    DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane.

    MAIN RESULTS: The previous version of this review included seven RCTs, and our updated search identified one additional trial. Therefore, this update included eight trials (six cluster-RCTs) with 21,290 children aged 4 to 15 years. Four trials were conducted in the UK, two in India, one in the USA and one in Saudi Arabia. We rated two trials at low risk of bias, three at high risk of bias and three at unclear risk of bias.  No trials had long-term follow-up to ascertain the lasting effects of school dental screening. The trials assessed outcomes at 3 to 11 months of follow-up. No trials reported the proportion of children with treated or untreated oral diseases other than caries. Neither did they report on cost-effectiveness or adverse events. Four trials evaluated traditional screening versus no screening. We performed a meta-analysis for the outcome 'dental attendance' and found an inconclusive result with high heterogeneity. The heterogeneity was partly due to study design (three cluster-RCTs and one individually randomised trial). Due to this inconsistency, and unclear risk of bias, we downgraded the evidence to very low certainty, and we are unable to draw conclusions about this comparison. Two cluster-RCTs (both four-arm trials) evaluated criteria-based screening versus no screening, suggesting a possible small benefit (pooled risk ratio (RR) 1.07, 95% confidence interval (CI) 0.99 to 1.16; low-certainty evidence). There was no evidence of a difference when comparing criteria-based screening to traditional screening (RR 1.01, 95% CI 0.94 to 1.08; very low-certainty evidence). One trial compared a specific (personalised) referral letter to a non-specific letter. Results favoured the specific referral letter for increasing attendance at general dentist services (RR 1.39, 95% CI 1.09 to 1.77; very low-certainty evidence) and attendance at specialist orthodontist services (RR 1.90, 95% CI 1.18 to 3.06; very low-certainty evidence). One trial compared screening supplemented with motivation to screening alone. Dental attendance was more likely after screening supplemented with motivation (RR 3.08, 95% CI 2.57 to 3.71; very low-certainty evidence). One trial compared referral to a specific dental treatment facility with advice to attend a dentist. There was no evidence of a difference in dental attendance between these two referrals (RR 0.91, 95% CI 0.34 to 2.47; very low-certainty evidence). Only one trial reported the proportion of children with treated dental caries. This trial evaluated a post-screening referral letter based on the common-sense model of self-regulation (a theoretical framework that explains how people understand and respond to threats to their health), with or without a dental information guide, compared to a standard referral letter. The findings were inconclusive. Due to high risk of bias, indirectness and imprecision, we assessed the evidence as very low certainty.

    AUTHORS' CONCLUSIONS: The evidence is insufficient to draw conclusions about whether there is a role for school dental screening in improving dental attendance.  We are uncertain whether traditional screening is better than no screening (very low-certainty evidence). Criteria-based screening may improve dental attendance when compared to no screening (low-certainty evidence). However, when compared to traditional screening, there is no evidence of a difference in dental attendance (very low-certainty evidence). For children requiring treatment, personalised or specific referral letters may improve dental attendance when compared to non-specific referral letters (very low-certainty evidence). Screening supplemented with motivation (oral health education and offer of free treatment) may improve dental attendance in comparison to screening alone (very low-certainty evidence). We are uncertain whether a referral letter based on the 'common-sense model of self-regulation' is better than a standard referral letter (very low-certainty evidence) or whether specific referral to a dental treatment facility is better than a generic advice letter to visit the dentist (very low-certainty evidence). The trials included in this review evaluated effects of school dental screening in the short term. None of them evaluated its effectiveness for improving oral health or addressed possible adverse effects or costs.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  20. Molteni E, Canas LDS, Briand MM, Estraneo A, Font CC, Formisano R, et al.
    Neurology, 2023 Aug 08;101(6):e581-e593.
    PMID: 37308301 DOI: 10.1212/WNL.0000000000207473
    BACKGROUND AND OBJECTIVES: Comprehensive guidelines for the diagnosis, prognosis, and treatment of disorders of consciousness (DoC) in pediatric patients have not yet been released. We aimed to summarize available evidence for DoC with >14 days duration to support the future development of guidelines for children, adolescents and young adults aged 6 months-18 years.

    METHODS: This scoping review was reported based on Preferred Reporting Items for Systematic reviews and Meta-Analyses-extension for Scoping Reviews guidelines. A systematic search identified records from 4 databases: PubMed, Embase, Cochrane Library, and Web of Science. Abstracts received 3 blind reviews. Corresponding full-text articles rated as "in-scope" and reporting data not published in any other retained article (i.e., no double reporting) were identified and assigned to 5 thematic evaluating teams. Full-text articles were reviewed using a double-blind standardized form. Level of evidence was graded, and summative statements were generated.

    RESULTS: On November 9, 2022, 2,167 documents had been identified; 132 articles were retained, of which 33 (25%) were published over the past 5 years. Overall, 2,161 individuals met the inclusion criteria; female patients were 527 of 1,554 (33.9%) cases included, whose sex was identifiable. Of 132 articles, 57 (43.2%) were single case reports and only 5 (3.8%) clinical trials; the level of evidence was prevalently low (80/132; 60.6%). Most studies included neurobehavioral measures (84/127; 66.1%) and neuroimaging (81/127; 63.8%); 59 (46.5%) were mainly related to diagnosis, 56 (44.1%) to prognosis, and 44 (34.6%) to treatment. Most frequently used neurobehavioral tools included the Coma Recovery Scale-Revised, Coma/Near-Coma Scale, Level of Cognitive Functioning Assessment Scale, and Post-Acute Level of Consciousness scale. EEG, event-related potentials, structural CT, and MRI were the most frequently used instrumental techniques. In 29/53 (54.7%) cases, DoC improvement was observed, which was associated with treatment with amantadine.

    DISCUSSION: The literature on pediatric DoCs is mainly observational, and clinical details are either inconsistently presented or absent. Conclusions drawn from many studies convey insubstantial evidence and have limited validity and low potential for translation in clinical practice. Despite these limitations, our work summarizes the extant literature and constitutes a base for future guidelines related to the diagnosis, prognosis, and treatment of pediatric DoC.

    Matched MeSH terms: Randomized Controlled Trials as Topic
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