Displaying publications 81 - 100 of 466 in total

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  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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
  11. Lee ZY, Dresen E, Lew CCH, Bels J, Hill A, Hasan MS, et al.
    Crit Care, 2024 Jan 06;28(1):15.
    PMID: 38184658 DOI: 10.1186/s13054-023-04783-1
    BACKGROUND: A recent large multicentre trial found no difference in clinical outcomes but identified a possibility of increased mortality rates in patients with acute kidney injury (AKI) receiving higher protein. These alarming findings highlighted the urgent need to conduct an updated systematic review and meta-analysis to inform clinical practice.

    METHODS: From personal files, citation searching, and three databases searched up to 29-5-2023, we included randomized controlled trials (RCTs) of adult critically ill patients that compared higher vs lower protein delivery with similar energy delivery between groups and reported clinical and/or patient-centred outcomes. We conducted random-effect meta-analyses and subsequently trial sequential analyses (TSA) to control for type-1 and type-2 errors. The main subgroup analysis investigated studies with and without combined early physical rehabilitation intervention. A subgroup analysis of AKI vs no/not known AKI was also conducted.

    RESULTS: Twenty-three RCTs (n = 3303) with protein delivery of 1.49 ± 0.48 vs 0.92 ± 0.30 g/kg/d were included. Higher protein delivery was not associated with overall mortality (risk ratio [RR]: 0.99, 95% confidence interval [CI] 0.88-1.11; I2 = 0%; 21 studies; low certainty) and other clinical outcomes. In 2 small studies, higher protein combined with early physical rehabilitation showed a trend towards improved self-reported quality-of-life physical function measurements at day-90 (standardized mean difference 0.40, 95% CI - 0.04 to 0.84; I2 = 30%). In the AKI subgroup, higher protein delivery significantly increased mortality (RR 1.42, 95% CI 1.11-1.82; I2 = 0%; 3 studies; confirmed by TSA with high certainty, and the number needed to harm is 7). Higher protein delivery also significantly increased serum urea (mean difference 2.31 mmol/L, 95% CI 1.64-2.97; I2 = 0%; 7 studies).

    CONCLUSION: Higher, compared with lower protein delivery, does not appear to affect clinical outcomes in general critically ill patients but may increase mortality rates in patients with AKI. Further investigation of the combined early physical rehabilitation intervention in non-AKI patients is warranted.

    PROSPERO ID: CRD42023441059.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  12. 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
  13. 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
  14. 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
  15. Cao W, Kadir AA, Tang W, Wang J, Yuan J, Hassan II
    BMC Med Inform Decis Mak, 2024 Jan 02;24(1):6.
    PMID: 38167316 DOI: 10.1186/s12911-023-02391-1
    BACKGROUND: Although smartphone usage is ubiquitous, and a vast amount of mobile applications have been developed for chronic diseases, mobile applications amongst stroke survivors remain unclear.

    OBJECTIVE: This systematic review and meta-analysis aimed to determine the effectiveness of mobile applications on medication adherence, functional outcomes, cardiovascular risk factors, quality of life and knowledge on stroke in stroke survivors.

    METHODS: A review of the literature was conducted using key search terms in PubMed, EMBASE, Cochrane and Web of Science databases until 16 March 2023 to identify eligible randomized controlled trials (RCTs) or controlled clinical trial (CCTs) of mobile application interventions among stroke survivors. Two reviewers independently screened the literature in accordance with the eligibility criteria and collected data from the articles included. Outcomes included medication adherence,functional outcomes,cardiovascular risk factors, quality of life,and knowledge of stroke.

    RESULTS: Twenty-three studies involving 2983 participants across nine countries were included in this review. Sixteen trials involved health care professionals in app use, and seven trials reported measures to ensure app-based intervention adherence. Mobile applications targeting stroke survivors primarily encompassed three areas: rehabilitation, education and self-care. The participants in the studies primarily included young and middle-aged stroke survivors. Meta-analysis results demonstrated that mobile application intervention significantly improved trunk control ability (mean differences [MD] 3.00, 95% CI [1.80 to 4.20]; P 

    Matched MeSH terms: Randomized Controlled Trials as Topic
  16. Jassim GA, Doherty S, Whitford DL, Khashan AS
    Cochrane Database Syst Rev, 2023 Jan 11;1(1):CD008729.
    PMID: 36628983 DOI: 10.1002/14651858.CD008729.pub3
    BACKGROUND: Breast cancer is the most common cancer affecting women worldwide. It is a distressing diagnosis and, as a result, considerable research has examined the psychological sequelae of being diagnosed and treated for breast cancer. Breast cancer is associated with increased rates of depression and anxiety and reduced quality of life. As a consequence, multiple studies have explored the impact of psychological interventions on the psychological distress experienced after a diagnosis of breast cancer. This review is an update of a Cochrane Review first published in 2015.

    OBJECTIVES: To assess the effect of psychological interventions on psychological morbidities and quality of life among women with non-metastatic breast cancer.  SEARCH METHODS: We searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov up to 16 March 2021. We also scanned the reference lists of relevant articles.

    SELECTION CRITERIA: Randomised controlled trials that assessed the effectiveness of psychological interventions for women with non-metastatic breast cancer.

    DATA COLLECTION AND ANALYSIS: Two review authors independently appraised, extracted data from eligible trials, and assessed risk of bias and certainty of the evidence using the GRADE approach. Any disagreement was resolved by discussion. Extracted data included information about participants, methods, the intervention and outcomes.

    MAIN RESULTS: We included 60 randomised controlled trials comprising 7998 participants. The most frequent reasons for exclusion were non-randomised trials and the inclusion of women with metastatic disease. The updated review included 7998 randomised women; the original review included 3940 women. A wide range of interventions was evaluated. Most interventions were cognitive- or mindfulness-based, supportive-expressive, and educational. The interventions were mainly delivered face-to-face (56 studies) and in groups (50 studies) rather than individually (10 studies). Most intervention sessions were delivered on a weekly basis with an average duration of 14 hours. Follow-up time ranged from two weeks to 24 months.  Pooled standardised mean differences (SMD) from baseline indicated that the intervention may reduce depression (SMD -0.27, 95% confidence interval (CI) -0.52 to -0.02; P = 0.04; 27 studies, 3321 participants, I2 = 91%, low-certainty evidence); anxiety (SMD -0.43, 95% CI -0.68 to -0.17; P = 0.0009; 22 studies, 2702 participants, I2 = 89%, low-certainty evidence); mood disturbance in the intervention group (SMD -0.18, 95% CI -0.31 to -0.04; P = 0.009; 13 studies, 2276 participants, I2 = 56%, low-certainty evidence); and stress (SMD -0.34, 95% (CI) -0.55 to -0.12; P = 0.002; 8 studies, 564 participants, I2 = 31%, low-certainty evidence). The intervention is likely to improve quality of life in the intervention group (SMD 0.78, 95% (CI) 0.32 to 1.24; P = 0.0008; 20 studies, 1747 participants, I2 = 95%, low-certainty evidence). Adverse events were not reported in any of the included studies.

    AUTHORS' CONCLUSIONS: Based on the available evidence, psychological intervention may have produced favourable effects on psychological outcomes, in particular depression, anxiety, mood disturbance and stress. There was also an improvement in quality of life in the psychological intervention group compared to control group. Overall, there was substantial variation across the studies in the range of psychological interventions used, control conditions, measures of the same outcome and timing of follow-up.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  17. Dapari R, Mahfot MH, Ahmad Zamzuri M'I, Md Isa Z, Hassan MR, Che Dom N, et al.
    PLoS One, 2024;19(1):e0295771.
    PMID: 38165964 DOI: 10.1371/journal.pone.0295771
    INTRODUCTION: The significant contribution of the food and beverage industry to Malaysia's Gross Domestic Product is projected to increase in the upcoming years. With the industry's expansion, the demand for workers on food premises would also continuously increase. The food industry workers are exposed to risks arising from physical, chemical, biological, ergonomic, and psychosocial hazards while performing their duties. Thus, it is essential for these workers to be equipped with proper knowledge, attitude, and practices (KAP) in safety and health.

    AIMS: This study aims to develop and evaluate the effectiveness of the safety and health programme TRIMOSH (Theory-Based Intervention Module on Occupational Safety and Health) in improving the knowledge, attitude, and practice among food industry workers.

    METHODS: TRIMOSH intervention study is a two-arm randomised, single-blinded, controlled, parallel trial that will be conducted among food industry workers in Selangor, Malaysia. In a partnership with Food Handler Training Schools in Selangor, 10 pairs of Food Handler Training Schools with 12 participants per group (n = 240) will be recruited for balanced randomisation intervention and control conditions. Furthermore, data collection of all participants was conducted at four time points: baseline (T0), immediately (T1), one month (T2), and three months (T3) post-intervention. Generalised Linear Mixed Model (GLMM) will be conducted to determine the effects of intervention within and between study groups. Subsequently, the primary outcomes increase the knowledge, attitude, and practice (KAP) of safety and health at food premises. Clinical Trial Registry registration was approved by the ClinicalTrials.gov committee on October 2022 with the ClinicalTrials.gov Identifier: NCT05571995. This study has also been approved by the Ethics Committee for Research Involving Human Subjects of Universiti Putra Malaysia (JKEUPM-2022-346). All participants are required to provide consent prior to participation.

    CONCLUSIONS: The characteristics of the respondents are expected to show no difference between the groups. It is hypothesised that TRIMOSH is effective in improving the knowledge, attitude, and practices of food industry workers in Selangor. The results will be reported and presented in international peer-reviewed journals, conferences, and other platforms. In addition, the TRIMOSH programme will be offered at the national level by the relevant authorities for the benefit of food industry workers.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  18. Mohammad A, Falahi E, Mohd Yusof BN, Hanipah ZN, Sabran MR, Mohamad Yusof L, et al.
    Clin Nutr ESPEN, 2021 Dec;46:66-72.
    PMID: 34857250 DOI: 10.1016/j.clnesp.2021.10.013
    OBJECTIVES: The effect of ginger supplements on inflammatory biomarkers and oxidative stress in patients with type 2 diabetes (T2DM) has been investigated, but findings are inconsistent. This systematic review and meta-analysis were conducted to determine the effects of ginger supplementation on inflammatory parameters (high-sensitivity C-reactive protein [hs-CRP], tumour necrosis factor-alpha [TNF-α], and interleukin-6 [IL-6]) in patients with T2DM.

    METHODS: We performed a systematic search using PubMed, Scopus, Cochrane Library, Web of Science for randomised controlled trials (RCTs), published until March 17, 2021. The quality assessment was carried out using the Cochrane Collaboration risk of bias tool. The Q-test and I 2 tests were used for the determination of heterogeneity of the included studies. Data were pooled using a random-effects model, and weighted mean difference (WMD) was used for the overall effect size.

    RESULTS: Pooled findings of the five RCTs demonstrated that ginger supplementations had significantly reduced hs-CRP (WMD -0.42 mg/L; 95% CI, -0.78, -0.05, P = 0.03), TNF-α (-2.13 pg/mL; 95% CI: -3.41, -0.86, P = 0.001), and IL-6 (WMD: -0.61 pg/mL; 95% CI: -0.92, -0.30, P = 0.001) levels in patients with T2DM. The quality assessment of the studies showed that all of the included studies were at high risk of bias.

    CONCLUSIONS: The meta-analysis shows that ginger supplementations reduced inflammatory parameters in patients with T2DM. Nonetheless, the reduction is relatively small, and its meaningful clinical effects are unknown. Future high-quality RCTs are needed to confirm the beneficial effects of ginger supplementation in patients with T2DM.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  19. Tomson PL, Vilela Bastos J, Jacimovic J, Jakovljevic A, Pulikkotil SJ, Nagendrababu V
    Int Endod J, 2023 Oct;56 Suppl 3:355-369.
    PMID: 36209498 DOI: 10.1111/iej.13844
    BACKGROUND: Pulpitis characterized by spontaneous pain can result in debilitating pain. Dogma has existed to offer only have two treatment options, namely root canal treatment (RCT) or extraction, although pulpotomy has always remained a potential treatment modality.

    OBJECTIVE: This review aimed to answer the following research question: 'Does pulpotomy (partial or full) (I) result in better patient and clinical reported outcomes (O), compared with RCT (C) in permanent teeth with pulpitis characterized by spontaneous pain (P) evaluated at various time intervals?' (T).

    METHODS: Two authors independently performed study selection, data extraction and risk of bias assessment. The literature search was conducted in the following electronic databases: Clarivate Analytics' Web of Science, Scopus, PubMed and Cochrane Central Register of Controlled Trials. English language clinical trials comparing the patient and clinical reported outcomes between RCT and pulpotomy were included. The meta-analysis was performed on a fixed-effect model and the quality of evidence assessed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach.

    RESULTS: Two randomized clinical trials were included. Amongst two trials, one has published four reports at different time points involving the same cohorts. The meta-analysis revealed no difference in postoperative pain (Day 7) between RCT and pulpotomy (OR = 0.99, 95% CI 0.63-1.55, I2  = 0%) and quality of evidence was graded as 'High'. Clinical success was high at year 1, 98% for both interventions, however, decreased over time to 78.1% (pulpotomy) and 75.3% (RCT) at 5 years.

    DISCUSSION: Pulpotomy is a definitive treatment modality that is as effective as RCT. This could have a significant impact on treatment of such patients affording the advantages of retaining a vital pulp and preventing the need for RCT.

    CONCLUSION: This review could only include two trials, hence there is insufficient evidence to draw robust conclusions. The clinical data accumulated so far suggests no difference in pain between RCT and pulpotomy at Day 7 postoperatively and a single randomized control trial suggests that the clinical success rate for both treatment modalities is similar long term. There is a need for more well-designed trials by different research groups to develop a stronger evidence base in this area.

    REGISTRATION: PROSPERO database (CRD42021259744).

    Matched MeSH terms: Randomized Controlled Trials as Topic
  20. Tan TW, Tan HL, Hsu MF, Huang HL, Chung YC
    BMC Womens Health, 2023 Nov 14;23(1):606.
    PMID: 37964288 DOI: 10.1186/s12905-023-02749-7
    BACKGROUND: Sarcopenia is a chronic disease marked by gradual muscle system and functional decline. Prior research indicates its prevalence in those under 60 varies from 8 to 36%. There is limited evidence on the effectiveness of non-pharmacological interventions for sarcopenia prevention in menopausal women aged 40-60. This study examines the influence of such interventions for sarcopenia prevention on these women.

    METHODS: PubMed, EMBASE, Medline, Cochrane Library, CINAHL, PEDro, and Airiti Library were searched from inception until May 5, 2023. Randomized controlled trials that examined exercise, vitamin D and protein supplementation effects on muscle mass, strength, and physical function. Quality assessment used the Cochrane risk of bias tool, and analysis employed Comprehensive Meta-Analysis version 2.0.

    RESULTS: A total of 27 randomized controlled trials, involving 1,989 participants were identified. Meta-analysis results showed exercise improved lean body mass (SMD = 0.232, 95% CI: 0.097, 0.366), handgrip strength (SMD = 0.901, 95% CI: 0.362, 1.441), knee extension strength (SMD = 0.698, 95% CI: 0.384, 1.013). Resistance training had a small effect on lean body mass, longer exercise duration (> 12 weeks) and higher frequency (60-90 min, 3 sessions/week) showed small to moderate effects on lean body mass. Vitamin D supplementation improved handgrip strength (SMD = 0.303, 95% CI: 0.130, 0.476), but not knee extension strength. There was insufficient data to assess the impact of protein supplementation on muscle strength.

    CONCLUSIONS: Exercise effectively improves muscle mass, and strength in menopausal women. Resistance training with 3 sessions per week, lasting 20-90 min for at least 6 weeks, is most effective. Vitamin D supplementation enhances small muscle group strength. Further trials are needed to assess the effects of vitamin D and protein supplementation on sarcopenia prevention.

    REGISTRATION NUMBER: This review was registered on PROSPERO CRD42022329273.

    Matched MeSH terms: Randomized Controlled Trials as Topic
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