Displaying publications 101 - 120 of 473 in total

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  1. 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
  2. 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
  3. Faghfouri AH, Afrakoti LGMP, Kavyani Z, Nogourani ZS, Musazadeh V, Jafarlou M, et al.
    Inflammopharmacology, 2023 Oct;31(5):2253-2268.
    PMID: 37698776 DOI: 10.1007/s10787-023-01332-8
    OBJECTIVE: Despite the increasing evidence for probiotics' anti-inflammatory effects, the results of meta-analyses remain inconsistent. The present umbrella meta-analysis aimed to investigate the effects of probiotic supplementation on inflammatory biomarkers.

    METHODS: We performed a wide-ranging systematic search in several databases, including PubMed, Web of Science, Scopus, EMBASE, and Google Scholar up to April 2023. The overall effect sizes were calculated using effect size (ES) values and their corresponding confidence intervals (CI).

    RESULTS: Out of a total of 580 related articles, 39 studies were qualified for inclusion in the analysis. The results of the analysis revealed a significant reduction of C-reactive protein (CRP) (ES = -1.02; 95% CI: -1.23, -0.80, p 

    Matched MeSH terms: Randomized Controlled Trials as Topic
  4. Al-Haroni H, Nik Farid ND, Azanan MS
    PLoS One, 2024;19(1):e0289937.
    PMID: 38232100 DOI: 10.1371/journal.pone.0289937
    BACKGROUND: Among the most urgent public health challenges, of the twenty-first century, is obesity. This can be attributed to its relationship with several non-communicable diseases (NCDs), as well as premature mortality. Being overweight or obese is a major concern not only in high-income countries, but also in low-income and middle-income countries, particularly in urban areas. Several studies have highlighted the prevalence of obesity, among Middle Eastern-descent adolescents, studying in Arabic secondary schools, located in Malaysia. Intervention studies, directed at Middle Eastern adolescents in Malaysia, are limited. This paper, describes the protocol, for an integrated health education intervention process. Titled 'Healthy lifestyle', it is a primary prevention process, aimed at curbing obesity and disordered eating, among Middle Eastern secondary school adolescents, aged 13-14 years old, residing in Malaysia.

    METHODS AND ANTICIPATED RESULTS: A cluster randomized controlled study will be conducted, involving 250 Middle Eastern adolescents, in Arabic schools in Malaysia. The participants will be randomly assigned to the intervention and control groups. While the intervention group participates in six weeks of fortnightly six sessions (45 minutes per session), the control group will carry on with their regular curriculums, and normal physical activity routines. The variables which will be evaluated include anthropometric measurements, knowledge, attitude, daily routines, physical activity, sedentary behaviour, food assessment, eating attitudes test-26, and a structured questionnaire based on the HBM. Data will be collected from the intervention and control groups at baseline, post-intervention, and two months following the intervention. Data analysis will be performed by way of the SPSS Statistics software version 26. The generalized estimating equation (GEE) will be used, to test the effect of the intervention program, with regards to the selected variables (outcomes), between and within-group at baseline, as well as six weeks and two months following intervention, after adjusting for clustering. Outcomes will be assessed at each time point, along with a derived average over all three-time points; thus, ensuring that both the cumulative and overall effects are determined.

    CONCLUSIONS: This trial will provide useful information for improving the knowledge, attitude, and practices of Middle Eastern adolescents, with regards to body weight status, physical activity level, nutrition status (BMI and dietary intake), and disordered eating. This will go a long way, towards ensuring their adherence to appropriate physical activities, and a healthy diet, to keep non-communicable diseases at bay.

    TRIAL REGISTRATION: This study is registered at NCT: NCT05694143.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  5. Weaver C, Ahles S, Murphy KJ, Shyam S, Cade J, Plat J, et al.
    Adv Nutr, 2023 Nov 21.
    PMID: 37996044 DOI: 10.1016/j.advnut.2023.100154
    Creating effective dietary guidance requires a rigorous evidence base that is predominantly developed from robust clinical trials or large-scale cohort studies, with the quality of the data available depending on the completeness and accuracy of their reporting. An international group of academics from 14 institutions in 12 different countries and on 5 continents, working on behalf of the Federation of European Nutrition Societies within its "Improving Standards in the Science of Nutrition" initiative, reviewed the Consolidated Standards of Reporting Trials (CONSORT) statement checklist as it pertains to nutrition trials. This perspective piece documents the procedure followed to gain input and consensus on the checklist previously published by this group, including its presentation and interrogation at the International Union of Nutritional Sciences International Congress of Nutrition 2022 (IUNS-ICN 22), inputs from a survey of journal editors, and its piloting on 8 nutrition trials of diverse designs. Overall, the initiative has been met with considerable enthusiasm. At IUNS-ICN 22, refinements to our proposal were elicited through a World Café method discussion with participating nutrition scientists. The contributing journal editors provided valuable insights, and the discussion led to the development of a potential tool specific to assess adherence to the proposed nutrition extension checklist. The piloting of the proposed checklist provided evidence from real-life studies that reporting of nutrition trials can be improved. This initiative aims to stimulate further discussion and development of a CONSORT-nutrition-specific extension.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  6. Liu WY, Li HM, Jiang H, Zhang WK
    Pediatr Rheumatol Online J, 2024 Mar 04;22(1):33.
    PMID: 38438855 DOI: 10.1186/s12969-024-00967-3
    OBJECTIVE: Little is known about the efficacy and safety of exercise training on juvenile idiopathic arthritis (JIA). This study aims to investigate the effect of exercise on health, quality of life, and different exercise capacities in individuals with JIA.

    METHOD: A comprehensive search of Medline, Embase, Web of Science, and the Cochrane Library was conducted from database inception to October, 2023. Included studies were randomized controlled trials (RCTs) reporting the effects of exercise on JIA patients. Two independent reviewers assessed the literature quality using the Cochrane Collaboration's risk of bias tool. Standardized mean differences (SMD) were combined using random or fixed effects models. The level of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.

    RESULT: Five RCTs met the inclusion criteria, containing 216 female participants and 90 males. The meta-analysis results showed that exercise had no significant effect on JIA patients based on the Child Health Assessment Questionnaire (CHAQ) (SMD=-0.32, 95%CI: -0.83, 0.19; I2 = 73.2%, P = 0.011) and Quality of Life (QoL) (SMD = 0.27, 95%CI: -0.04, 0.58; I2 = 29.4%, P = 0.243) and no significant effect on peak oxygen uptake (VO2peak). However, exercise significantly reduced visual analog scale (VAS) pain scores in JIA patients (SMD = 0.50, 95%CI: -0.90, -0.10; I2 = 50.2%, P = 0.134). The quality of evidence assessed by GRADE was moderate to very low.

    CONCLUSION: Exercise does not significantly affect the quality of life and exercise capacity in JIA patients but may relieve pain. More RCTs are needed in the future to explore the effects of exercise on JIA.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  7. Moullaali TJ, Wang X, Woodhouse LJ, Law ZK, Delcourt C, Sprigg N, et al.
    BMJ Open, 2019 Jul 16;9(7):e030121.
    PMID: 31315876 DOI: 10.1136/bmjopen-2019-030121
    INTRODUCTION: Conflicting results from multiple randomised trials indicate that the methods and effects of blood pressure (BP) reduction after acute intracerebral haemorrhage (ICH) are complex. The Blood pressure in Acute Stroke Collaboration is an international collaboration, which aims to determine the optimal management of BP after acute stroke including ICH.

    METHODS AND ANALYSIS: A systematic review will be undertaken according to the Preferred Reporting Items for Systematic review and Meta-Analysis of Individual Participant Data (IPD) guideline. A search of Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE from inception will be conducted to identify randomised controlled trials of BP management in adults with acute spontaneous (non-traumatic) ICH enrolled within the first 7 days of symptom onset. Authors of studies that meet the inclusion criteria will be invited to share their IPD. The primary outcome will be functional outcome according to the modified Rankin Scale. Safety outcomes will be early neurological deterioration, symptomatic hypotension and serious adverse events. Secondary outcomes will include death and neuroradiological and haemodynamic variables. Meta-analyses of pooled IPD using the intention-to-treat dataset of included trials, including subgroup analyses to assess modification of the effects of BP lowering by time to treatment, treatment strategy and patient's demographic, clinical and prestroke neuroradiological characteristics.

    ETHICS AND DISSEMINATION: No new patient data will be collected nor is there any deviation from the original purposes of each study where ethical approvals were granted; therefore, further ethical approval is not required. Results will be reported in international peer-reviewed journals.

    PROSPERO REGISTRATION NUMBER: CRD42019141136.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  8. Zhao Y, Soh KG, Saad HA, Liu C, Ding C
    Front Public Health, 2024;12:1320112.
    PMID: 38420024 DOI: 10.3389/fpubh.2024.1320112
    BACKGROUND: The purpose of this study was to critically review the existing literature on the effects of active video games (AVGs) on physical activity in overweight and obese college students to determine whether AVGs can promote and achieve recommended levels of physical activity. The results should provide constructive input for future research.

    METHODS: A total of five international databases including PubMed, SCOPUS, Web of Science, CINAHL Plus, and EBSCOhost were searched with keywords related to "active video games," "physical activity," and "obese college students" from July 2022. A systematic review was conducted using the PRISMA guidelines and randomised controlled trial (RCT) studies that met the inclusion criteria were included. Furthermore, the quality assessment of the studies was measured using the PEDro scale.

    RESULTS: One thousand and twenty-three articles were retrieved, of which eight randomised controlled trial studies met the inclusion criteria. AVGs can reduce sedentary behaviour and positively affect physical activity, time spent on moderate-to-vigorous physical activity (MVPA), positive psychological factors, and game attendance rate. Combining AVGs with other assistive devices (such as mini-trampolines and stationary bikes) can enhance the effects of AVGs and provide greater physiological stimulation. Different types of AVGs and game modes can achieve different emotional responses, physiological stimulation, and physical activity levels.

    CONCLUSION: The research findings prove that AVGs can be a viable intervention to increase physical activity in overweight or obese college students, ultimately reaching the recommended physical activity level(PAL). Physical activity can be further increased by incorporating assistive devices or using features supported by self-determination theory (SDT). As a new modality, AVGs could be a potential alternative to traditional physical activity.Systematic Review Registration:https://www.crd.york.ac.uk/prospero, identifier: CRD42022363993.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  9. Muhamad NA, Mohd Dali NS, Mohd Yacob A, Kassim MSA, Lodz NA, Abdul Wahid SF, et al.
    BMJ Open, 2020 Jun 15;10(6):e032503.
    PMID: 32540885 DOI: 10.1136/bmjopen-2019-032503
    INTRODUCTION: Acute myeloid leukaemia (AML) is a type of cancer in which the bone marrow makes abnormal myeloblasts (a type of white blood cell), red blood cells or platelets. Gemtuzumab ozogamicin (GO) holds promise as a new agent that also could be efficacious in newly diagnosed AML with acceptable toxicity. This paper describes the design of a protocol to conduct a systematic review of published studies assessing GO for the treatment of AML.

    METHOD AND ANALYSIS: We will conduct a systematic review of randomised controlled trials that investigate the effect and safety of GO for the treatment of patients with AML. We will search for any eligible articles from selected electronic databases. We will follow the Preferred Reporting Items for Systematic reviews and Meta-Analysis for study selection and reporting. We will use The Cochrane Handbook for Systematic Reviews of Interventions and Meta-Analysis as guidance to select eligible studies. All data will be extracted using a standardised data extraction form.

    ETHICS AND DISSEMINATION: There was no patient involved in this study, therefore no ethical consideration is needed. The findings of this study will be disseminated in a peer-reviewed journal and any relevant conference presentation.

    PROSPERO REGISTRATION NUMBER: CRD42019123286.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  10. 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
  11. Nguyen-Nhon D, Nagendrababu V, Pulikkotil SJ, Rossi-Fedele G
    Aust Endod J, 2020 Aug;46(2):282-294.
    PMID: 31638301 DOI: 10.1111/aej.12380
    The purpose of this systematic review was to assess the effect of occlusal reduction on post-operative pain following root canal treatment and was performed in accordance with the PRISMA statement being registered in the PROSPERO database (CRD42018089941). Two reviewers independently conducted a systematic literature search in the PubMed (MEDLINE), Dentistry & Oral Sciences Source and the Cochrane Library databases. Seven studies were included, of which three were used to perform meta-analysis for 6 days post-operative and the rest for qualitative synthesis. Three studies were assessed as low risk of bias, three as some concern, and one as high risk of bias. Occlusal reduction diminishes the post-operative pain (SMD -1.10 (95%CI -2.06, -0.15) I2  = 96.9%) at 6 days for teeth diagnosed as irreversible pulpitis, and, overall, likely reduces post-operative pain for patients presenting with irreversible pulpitis and/or symptomatic apical periodontitis. Future high-quality clinical trials are needed to better understand the role of occlusal reduction.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  12. Morton SE, Chiew YS, Pretty C, Moltchanova E, Scarrott C, Redmond D, et al.
    Math Biosci, 2017 02;284:21-31.
    PMID: 27301378 DOI: 10.1016/j.mbs.2016.06.001
    Randomised control trials have sought to seek to improve mechanical ventilation treatment. However, few trials to date have shown clinical significance. It is hypothesised that aside from effective treatment, the outcome metrics and sample sizes of the trial also affect the significance, and thus impact trial design. In this study, a Monte-Carlo simulation method was developed and used to investigate several outcome metrics of ventilation treatment, including 1) length of mechanical ventilation (LoMV); 2) Ventilator Free Days (VFD); and 3) LoMV-28, a combination of the other metrics. As these metrics have highly skewed distributions, it also investigated the impact of imposing clinically relevant exclusion criteria on study power to enable better design for significance. Data from invasively ventilated patients from a single intensive care unit were used in this analysis to demonstrate the method. Use of LoMV as an outcome metric required 160 patients/arm to reach 80% power with a clinically expected intervention difference of 25% LoMV if clinically relevant exclusion criteria were applied to the cohort, but 400 patients/arm if they were not. However, only 130 patients/arm would be required for the same statistical significance at the same intervention difference if VFD was used. A Monte-Carlo simulation approach using local cohort data combined with objective patient selection criteria can yield better design of ventilation studies to desired power and significance, with fewer patients per arm than traditional trial design methods, which in turn reduces patient risk. Outcome metrics, such as VFD, should be used when a difference in mortality is also expected between the two cohorts. Finally, the non-parametric approach taken is readily generalisable to a range of trial types where outcome data is similarly skewed.
    Matched MeSH terms: Randomized Controlled Trials as Topic/statistics & numerical data*
  13. Loh SY, Lee SY, Quek KF, Murray L
    Asian Pac J Cancer Prev, 2012;13(12):6337-42.
    PMID: 23464455
    BACKGROUND: Clinical trials on cancer subjects have one of the highest dropout rates. Barriers to recruitment range from patient-related, through institutional-related to staff-related factors. This paper highlights the low response rate and the recruitment barriers faced in our Qigong exercises trial.

    MATERIALS AND METHOD: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197).

    RESULTS: Multiple barriers were identified, and were regrouped as patient- related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.

    Matched MeSH terms: Randomized Controlled Trials as Topic/methods*
  14. Khoo YS, Aziz Z
    J Clin Pharm Ther, 2009 Apr;34(2):133-45.
    PMID: 19250134 DOI: 10.1111/j.1365-2710.2008.00998.x
    Prevention of cardiovascular disease by modifying its major risk factors, including serum cholesterol levels, is an important strategy. Regular intake of garlic has been suggested, but its impact on cholesterol levels has been inconsistent.
    Matched MeSH terms: Randomized Controlled Trials as Topic/standards
  15. Parthiban N, Esterman A, Mahajan R, Twomey DJ, Pathak RK, Lau DH, et al.
    J Am Coll Cardiol, 2015 Jun 23;65(24):2591-2600.
    PMID: 25983009 DOI: 10.1016/j.jacc.2015.04.029
    BACKGROUND: Remote monitoring (RM) of implantable cardioverter-defibrillators (ICD) is an established technology integrated into clinical practice. One recent randomized controlled trial (RCT) and several large device database studies have demonstrated a powerful survival advantage for ICD patients undergoing RM compared with those receiving conventional in-office (IO) follow-up.

    OBJECTIVES: This study sought to conduct a systematic published data review and meta-analysis of RCTs comparing RM with IO follow-up.

    METHODS: Electronic databases and reference lists were searched for RCTs reporting clinical outcomes in ICD patients who did or did not undergo RM. Data were extracted from 9 RCTs, including 6,469 patients, 3,496 of whom were randomized to RM and 2,973 to IO follow-up.

    RESULTS: In the RCT setting, RM demonstrated clinical outcomes comparable with office follow-up in terms of all-cause mortality (odds ratio [OR]: 0.83; p = 0.285), cardiovascular mortality (OR: 0.66; p = 0.103), and hospitalization (OR: 0.83; p = 0.196). However, a reduction in all-cause mortality was noted in the 3 trials using home monitoring (OR: 0.65; p = 0.021) with daily verification of transmission. Although the odds of receiving any ICD shock were similar in RM and IO patients (OR: 1.05; p = 0.86), the odds of inappropriate shock were reduced in RM patients (OR: 0.55; p = 0.002).

    CONCLUSIONS: Meta-analysis of RCTs demonstrates that RM and IO follow-up showed comparable overall outcomes related to patient safety and survival, with a potential survival benefit in RCTs using daily transmission verification. RM benefits include more rapid clinical event detection and a reduction in inappropriate shocks.

    Matched MeSH terms: Randomized Controlled Trials as Topic/methods
  16. Bermejo A, Veeken H
    Bull World Health Organ, 1992;70(3):293-6.
    PMID: 1638658
    Insecticide-impregnated bed nets act as a physical barrier to repel and kill mosquitos. Community intervention trials suggest that these nets are effective in preventing malaria-related mortality and morbidity--but not malaria infection--in areas of low and moderate transmission; the results from areas of high transmission are not so encouraging. Comparison of the results from these trials and their interpretation are difficult because of variations in the epidemiology of malaria and several methodological flaws. Problems such as defining appropriate health indicators, monitoring bed-net usage, introducing bed nets randomly, selecting adequate controls, performing statistical analysis, and comparing bed nets with other available interventions are considered. Further community intervention trials are needed, paying attention to the methods and to assessment of their impact on malaria.
    Matched MeSH terms: Randomized Controlled Trials as Topic/standards
  17. Pui Kei C, Mohd Nordin NA, Abdul Aziz AF
    Medicine (Baltimore), 2020 Nov 20;99(47):e23296.
    PMID: 33217861 DOI: 10.1097/MD.0000000000023296
    INTRODUCTION: Stroke survivors are commonly at risk of functional decline following discharge from rehabilitation, which increase their susceptibility to falls, dependency in activities of daily living and emotional disturbances. To combat these, continued therapy is important. Home-based therapy (HBT) has been shown to be useful in maintaining functional performance and quality of life of chronic stroke survivors. However, evidence on its effectiveness remains limited, while no studies are available to date which report the benefit of HBT on stroke survivors self-efficacy and emotional status. Therefore, this study aims to assess the effectiveness of post-discharge HBT in comparison to usual practice on functional outcome (mobility and gait speed), self-efficacy and anxiety level among stroke survivors.

    METHODS: This is an assessor-blinded randomized control trial comparing 2 types of intervention which are HBT (experimental group) and usual practice (UP) (control group). Based on sample size calculation using GPower, a total number of 42 participants will be recruited and allocated into either the HBT or the UP group. Participants in HBT group will receive a set of structured exercise therapy consisting of progressive strengthening, balance and task-related exercises. While participants in UP group will receive a usual "intervention" practised by rehabilitation professional prior to discharging stroke patients from their care. Both groups are advised to perform the given interventions for 3 times per week for 12 weeks under the supervision of their caregiver. Outcomes of interventions will be measured using timed up and go test (for mobility), ten-meter walk test (for gait speed), stroke self-efficacy questionnaire (for self-efficacy) and hospital anxiety and depression scale (for anxiety level). All data will be analyzed using descriptive and inferential statistics.

    DISCUSSION: This study will provide the information on the effectiveness of HBT in comparison to UP among stroke population who are discharged from rehabilitation. Findings from the study will enable rehabilitation professionals to design effective discharge care plan for stroke survivors in combating functional decline when no longer receiving hospital-based therapy.

    TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12619001182189 (last updated 22/11/2019).

    Matched MeSH terms: Randomized Controlled Trials as Topic/methods*
  18. Sartini C, Lomivorotov V, Pieri M, Lopez-Delgado JC, Baiardo Redaelli M, Hajjar L, et al.
    J Cardiothorac Vasc Anesth, 2019 05;33(5):1430-1439.
    PMID: 30600204 DOI: 10.1053/j.jvca.2018.11.026
    The authors aimed to identify interventions documented by randomized controlled trials (RCTs) that reduce mortality in adult critically ill and perioperative patients, followed by a survey of clinicians' opinions and routine practices to understand the clinicians' response to such evidence. The authors performed a comprehensive literature review to identify all topics reported to reduce mortality in perioperative and critical care settings according to at least 2 RCTs or to a multicenter RCT or to a single-center RCT plus guidelines. The authors generated position statements that were voted on online by physicians worldwide for agreement, use, and willingness to include in international guidelines. From 262 RCT manuscripts reporting mortality differences in the perioperative and critically ill settings, the authors selected 27 drugs, techniques, and strategies (66 RCTs, most frequently published by the New England Journal of Medicine [13 papers], Lancet [7], and Journal of the American Medical Association [5]) with an agreement ≥67% from over 250 physicians (46 countries). Noninvasive ventilation was the intervention supported by the largest number of RCTs (n = 13). The concordance between agreement and use (a positive answer both to "do you agree" and "do you use") showed differences between Western and other countries and between anesthesiologists and intensive care unit physicians. The authors identified 27 clinical interventions with randomized evidence of survival benefit and strong clinician support in support of their potential life-saving properties in perioperative and critically ill patients with noninvasive ventilation having the highest level of support. However, clinician views appear affected by specialty and geographical location.
    Matched MeSH terms: Randomized Controlled Trials as Topic/methods*
  19. Irfan M, Ismail SB, Noor NM, Hussain NHN
    Am J Mens Health, 2020 10 29;14(5):1557988320969082.
    PMID: 33111628 DOI: 10.1177/1557988320969082
    One of the major causes of erectile dysfunction (ED) is an endothelial vascular disorder. This meta-analysis is performed to determine the efficacy of aspirin on erectile function in men with vasculogenic ED. For this purpose, CENTRAL, MEDLINE, and reference lists of articles up to November 2019 were searched. Randomized controlled trials (RCTs) were selected that compared aspirin with placebo in men of any ethnicity with vasculogenic ED. A total of 58 trials were retrieved. Finally, two trials of 214 men fulfilled our selection criteria. High selection and detection bias were identified for one trial. The participants showed a significant improvement in erectile function when they took aspirin (mean difference: 5.14, 95% CI [3.89, 6.40], and I2 = 0%). Although the present meta-analysis suggested that aspirin has a significant effect on the improvement of erectile function, there were limited RCTs available on this topic and doses of aspirin varied. Additional studies are needed to support findings from this meta-analysis. Aspirin needs to be considered by practitioners when prescribing drugs for vasculogenic ED.
    Matched MeSH terms: Randomized Controlled Trials as Topic*
  20. Puttarak P, Sawangjit R, Chaiyakunapruk N
    J Ethnopharmacol, 2016 Dec 24;194:316-323.
    PMID: 27620659 DOI: 10.1016/j.jep.2016.09.021
    ETHNOPHARMACOLOGICAL RELEVANCE: Derris scandens (Roxb.) Benth. has been used as active ingredient in Thai traditional medicine recipes for pain treatment. Dry stem powder and ethanolic extract also recommended in Thailand National List of Essential Medicines (NLEMs) for musculoskeletal pain treatment as herbal medicine. However, no summarization of clinical effect and safety has been evaluated.

    OBJECTIVE: Our study aimed to determine the clinical effects and safety of D. scandens for musculoskeletal pain treatment compared with standard regimen, nonsteroidal anti-inflammatory drugs (NSAIDs).

    METHODS: International and Thai databases were searched from inception through August 2015. Comparative randomized controlled trials investigating oral D. scandens for musculoskeletal pain were included. Outcomes of interest included level of pain and adverse event. Mean changes of the outcomes from baseline were compared between D. scandens and NSAIDs by calculating mean difference.

    RESULTS: From 42 articles identified, 4 studies involving a total of 414 patients were included for efficacy analysis. The effects of oral D. scandens on reducing pain score were no different from those of non-steroidal anti-inflammatory drugs at any time points (3, 7, 14 days and overall). The overall pain reduction in the D. scandens group was not inferior to treatment with NSAIDs (weighted mean difference 0.06; 95% CI: -0.20, 0.31) without evident of heterogeneity (I(2)=0.00%, p=0.768). When compared, the adverse events (AEs) of D. scandens showed no different relative risk with NSAIDs. The major adverse events were gastrointestinal symptoms.

    CONCLUSION: D. scandens may be considered as an alternative for musculoskeletal pain reduction.

    Matched MeSH terms: Randomized Controlled Trials as Topic*
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