METHODS: We systematically searched PubMed, Cochrane Library, Medline & CINAHL, Turning Research into Practice (TRIP), ProQuest Theses & Dissertations Databases, and China National Knowledge Infrastructure (CNKI) from inception till March 15, 2021. The primary outcome measure was a reduction in respiratory illness; decrease in frequency, symptoms, and duration. Random-effects model was used to estimate the odds ratio (OR) and 95% confidence interval (CI). We used Cochrane's RoB-2 to appraise the risk of bias of included RCTs.
RESULTS: A total of nine RCTs were eligible for this review, of which six were included in the meta-analysis. Overall, two studies demonstrated a high risk of bias. The meta-analysis revealed a significantly reduced odds of developing respiratory infections with the use of Lf relative to the control (pooled odds ratio = 0.57; 95% confidence interval 0.44 to 0.74, n = 1,194), with sufficient evidence against the hypothesis of 'no significant difference' at the current sample size.
CONCLUSIONS: The administration of Lf shows promising efficacy in reducing the risk of RTIs. Current evidence also favours Lf fortification of infant formula. Lf may also have a beneficial role in managing symptoms and recovery of patients suffering from RTIs and may have potential for use as an adjunct in COVID-19, however this warrants further evidence from a large well-designed RCT.
METHODS AND FINDINGS: A randomised clinical trial involving 146 Sudanese TB patients will be conducted at the Abu Anga hospital in Khartoum. The participants will be randomly assigned to the intervention and control groups. A 2-hour session will be offered to the intervention group in a one-day TB educational intervention course. The same educational materials will also be provided to the control group after the randomised controlled trial (RCT). Data will be collected at baseline, one month, and four months after the intervention. The primary outcome of interest is TB treatment adherence, while secondary outcomes include quality of life score, tuberculosis knowledge, and health belief domains. Generalised estimating equations (GEE) in SPSS software version 25.0 will be utilised to evaluate the changes over time.
CONCLUSIONS: This trial will provide information that could be used in improving TB control strategies to achieve better results in the adherence of healthcare services to the norms of the National Program and patient adherence to the disease treatment and cure.
TRIAL REGISTRATION: This study is registered at TCTR: (TCTR20210607006).
OBJECTIVES: To summarize and synthesize evidence on the utility and methodological quality of cognitive-based interventions on cognitive performance and associated secondary outcomes among healthy older adults in Asia, as well as novel, culture-specific components of cognitive interventions across the region.
DATA SOURCES: The PubMed/Medline, Web of Science, Scopus, and ScienceDirect databases were searched through May 2020.
ELIGIBILITY: Studies including individuals aged 60 years and above, who had no previous history of physical and/or mental illness. Few restrictions placed on intervention design, duration and mode of delivery, provided that participants were randomized to study conditions, and intervention included components addressing at least one cognitive domain.
RESULTS: A total of 17 studies from six countries met the eligibility criteria and were included in the final review. Evidence from those studies indicated that cognitive interventions may be most effective when the design and aims were directed towards improvement in specific cognitive domains, but evidence regarding long-term effectiveness in preventing progression to clinical-level cognitive deficits is still unclear. Several studies highlighted culture-specific activities as components of their interventions, though these will need to be further outlined and standardized clearly in future research.
METHODS: A systematic search was conducted through MEDLINE (PubMed), EBSCO, and SCOPUS databases to collect full English articles related to school-based CSA intervention programs published from 2000 to 2021.
RESULTS: A total of 29 studies from randomized control trial and quasi-experimental from several countries was analyzed. Comparisons within group of pre-post intervention for knowledge, skills, and attitude were measured by standardized mean difference (SMD) and 95% CI of -1.06 (95% CI: -1.29, -0.84), -0.91 (95% CI: -1.2, -0.61), and -0.51 (95% CI: -3.61, 0.58), respectively. Meanwhile for between intervention and control group comparisons, the SMD of knowledge was 0.9 (95% CI: 0.63, 1.18), skills was 0.39 (95% CI: 0.07, 0.71), and attitude was 1.76 (95% CI: 0.46, 3.07).
CONCLUSION: The programs were found to be effective in improving the knowledge, skills, and attitude of the students from pre-intervention to post-intervention and between the intervention and control groups.Systematic Review Registration: www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022312383, identifier: CRD42022312383.
METHODS: This is a systematic review protocol describing essential reporting items based on the PRISMA for systematic review protocols (PRISMA-P) (Registration number: CRD42020220636). We aim to review the effectiveness, tolerability, and safety of hf-rTMS at DLPFC in randomised controlled trials (RCTs) as migraine prophylactic treatment. We will search Scopus, Cumulative Index to Nursing and Allied Health Literature Plus, PubMed, Cochrane Central Register of Controlled Trials and Biomed Central for relevant articles from randomised controlled clinical trials that used hf-rTMS applied at DLPFC for the treatment of migraine. The risk of bias will be assessed using the version 2 "Risk of bias" tool from Cochrane Handbook for Systematic Reviews of Interventions Version 6.1. We will investigate the evidence on efficacy, tolerability and safety and we will compare the outcomes between the hf-rTMS intervention and sham groups.
DISCUSSION: This systematic review will further determine the efficacy, safety, and tolerability of hf-rTMS applied at DLPFC for migraine prophylaxis. It will provide additional data for health practitioners and policymakers about the usefulness of hf-rTMS for migraine preventive treatment.
METHODS: Sleep clinic patients were 3,965 consecutive adults diagnosed with OSA by in-laboratory polysomnography from 2006 to 2010 at a tertiary hospital sleep clinic. Characteristics of these patients were compared with participants of five recent RCTs examining the effect of CPAP on adverse CV events in OSA. The percentage of patients with severe (apnea-hypopnea index, [AHI] ≥ 30 events/h) or any OSA (AHI ≥ 5 events/h) who met the eligibility criteria of each RCT was determined, and those criteria that excluded the most patients identified.
RESULTS: Compared to RCT participants, sleep clinic OSA patients were younger, sleepier, more likely to be female and less likely to have established CV disease. The percentage of patients with severe or any OSA who met the RCT eligibility criteria ranged from 1.2% to 20.9% and 0.8% to 21.9%, respectively. The eligibility criteria that excluded most patients were preexisting CV disease, symptoms of excessive sleepiness, nocturnal hypoxemia and co-morbidities.
CONCLUSIONS: A minority of sleep clinic patients diagnosed with OSA meet the eligibility criteria of RCTs of CPAP on adverse CV events in OSA. OSA populations in these RCTs differ considerably from typical sleep clinic OSA patients. This suggests that the findings of such OSA treatment-related RCTs are not generalizable to sleep clinic OSA patients.Randomized Intervention with Continuous Positive Airway Pressure in CAD and OSA (RICCADSA) trial, https://clinicaltrials.gov/ct2/show/NCT00519597, ClinicalTrials.gov number, NCT00519597.Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients with a First Ever Stroke and Sleep Apnea Syndrome, https://clinicaltrials.gov/ct2/show/NCT00202501, ClinicalTrials.gov number, NCT00202501.Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients with Sleep Apnea and no Daytime Sleepiness, https://clinicaltrials.gov/ct2/show/NCT00127348, ClinicalTrials.gov number, NCT00127348.Continuous Positive Airway Pressure (CPAP) in Patients with Acute Coronary Syndrome and Obstructive Sleep Apnea (OSA) (ISAACC), https://clinicaltrials.gov/ct2/show/NCT01335087, ClinicalTrials.gov number, NCT01335087.
DESIGN: We carried out a systematic review and meta-analysis according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).
METHODS: Databases of MEDLINE, EMBASE, and CENTRAL were searched from their inception date until May 2023. Randomized clinical trials (RCT) comparing intraperitoneal lidocaine and placebo in adults undergoing surgery were included.
RESULTS: Our systematic review included 24 RCTs (n = 1824). The intraperitoneal lidocaine group was significantly associated with lower postoperative pain scores at rest (MD, -0.87, 95% CI, -1.04 to -0.69) and at movement (MD, -0.50, 95% CI, -0.93 to -0.08) among adult patients after surgery. Its administration also significantly decreased morphine consumption (MD, -6.42 mg, 95% CI, -11.56 to -1.27) and lowered the incidence of needing analgesia (OR, 0.22, 95% CI, 0.14 to 0.35). Intraperitoneal lidocaine statistically reduced time to resume regular diet (MD, 0.16 days; 95% CI, -0.31 to -0.01) and lowered postoperative incidence of nausea and vomiting (OR, 0.54, 95% CI, 0.39 to 0.75).
CONCLUSIONS: In this review, our findings should be interpreted with caution. Future studies are warranted to determine the optimal dose of administering intraperitoneal lidocaine among adult patients undergoing surgery.
METHODS: For this SRMA of randomized controlled trials (RCT), electronic databases (MEDLINE, EMBASE, CENTRAL) were searched systematically from inception to January 2024 and updated in June 2024. Trials investigating clinical effects of fiber-supplemented EN versus placebo or usual care in adult critically ill patients were selected. Two independent reviewers extracted data and assessed the risk of bias of the included studies. Random-effect meta-analysis and trial sequential analysis (TSA) were conducted. The primary outcome was overall mortality, and one of the secondary outcomes was diarrhea incidence. Subgroup analyses were also performed for both outcomes.
RESULTS: Twenty studies with 1405 critically ill patients were included. In conventional meta-analysis, fiber-supplemented EN was associated with a significant reduction of overall mortality (RR 0.66, 95% CI 0.47, 0.92, p = 0.01, I2 = 0%; 12 studies) and diarrhea incidence (RR 0.70, 95% CI 0.51, 0.96, p = 0.03, I2 = 51%; 11 studies). However, both outcomes were assessed to have very serious risk of bias, and, according to TSA, a type-1 error cannot be ruled out. No subgroup differences were found for the primary outcome.
CONCLUSION: Very low-certainty evidence suggests that fiber-supplemented EN has clinical benefits. High-quality multicenter RCTs with large sample sizes are needed to substantiate any firm recommendation for its routine use in this group of patients. PROSPERO registration number: CRD42023492829.
METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) of vitamin C versus comparative interventions in patients with COVID-19. The outcome of interest was all-cause mortality.
RESULTS: The meta-analysis of eleven trials using a random-effects model revealed significant reduction in the risk of all-cause mortality with the administration of vitamin C among patients with COVID-19 relative to no vitamin C (pooled odds ratio = 0.53; 95% confidence interval 0.30-0.92). Subgroup analysis of studies that included patients with severe COVID-19 also produced findings of significant mortality reduction with the administration of vitamin C relative to no vitamin C (pooled odds ratio = 0.47; 95% confidence interval 0.26-0.84).
CONCLUSION: Overall, evidence from RCTs suggests a survival benefit for vitamin C in patients with severe COVID-19. However, we should await data from large-scale randomized trials to affirm its mortality benefits.
METHODS: The databases of CENTRAL, EMBASE, Web of Science, and the Cochrane Library were used to conduct a literature search, supplemented by internet search engines and manual searches. Publications released between January 2009 and October 2023 was identified, reviewed, and data extracted.
RESULTS: The review encompasses six studies involving 712 patients, comprising two randomized controlled trials (RCTs), two prospective studies, and two retrospective cohort studies. Three studies prescribed IMN perioperatively; two pre-operatively and one post-operatively. Four out of six studies reported less post-operative infection and complications. Two studies reported shorter hospitalization using the IMN formula. One study reported a longer hospitalization with IMN supplementation. Overall survival showed no significant difference in the two studies. Four studies reported positive modulation of inflammatory markers and lymphocytes as outcomes, with IMN formulas.
DISCUSSION AND CONCLUSION: Perioperative IMN emerge as a promising intervention, demonstrating notable benefits included shortened hospitalization as well and positive modulation of inflammatory markers.
OBJECTIVES: To assess the effectiveness of oral or intranasal aspirin desensitisation, as monotherapy or as adjunctive therapy, in adults with NSAID-exacerbated respiratory disease.
SEARCH METHODS: The Cochrane Ear Nose and Throat (ENT) Information Specialist searched the Cochrane ENT and Airways Trials Registers; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; International Clinical Trials Registry Platform and additional sources for published and unpublished trials. The date of the search was 10 February 2023.
SELECTION CRITERIA: Randomised controlled trials that compared ATAD with placebo were eligible. We included studies of adults with NSAID-exacerbated respiratory disease (i.e. intolerance to NSAID established, e.g. by aspirin challenge test), with chronic rhinosinusitis or asthma, or both. Participants had to be followed up for at least three months.
DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. The primary outcomes were health-related quality of life, asthma control, and significant serious and non-serious adverse events. The secondary outcomes were changes in airway assessments, nasal endoscopy score, medication use, symptom scores, and chronic rhinosinusitis and asthma exacerbations (description of exacerbation for which systemic corticosteroid or sinus surgery was needed). We used the GRADE approach to rate the certainty of the evidence.
MAIN RESULTS: We included five studies with a total of 211 participants (146 analysed). All studies compared oral ATAD at different dosages with placebo and were performed in tertiary care centres. All participants had a diagnosis of chronic rhinosinusitis with nasal polyps. In four studies, participants also had a confirmed diagnosis of asthma and two studies reported that participants had previous surgery for nasal polyps. Outcomes were analysed at six and 36 months follow-up. However, only one study reported data for 36 months follow-up. All but one study reported source of funding. Mid-term follow-up (six months, ATAD versus placebo) ATAD may improve health-related quality of life, assessed with Sino-Nasal Outcome Test (SNOT) scores (mean difference (MD) -0.54, 95% confidence interval (CI) -0.76 to -0.31; 3 studies, 85 participants; minimum clinically important difference (MCID) 9.0 points for total score; low-certainty evidence). In this analysis, SNOT-22 scores were divided by 22 and SNOT-20 scores were divided by 20. The mean reduction (11.9 points) in SNOT score (based on SNOT-22) is larger than the MCID. It is uncertain if asthma control may be improved after ATAD. Asthma control was measured using the Asthma Control Test (ACT) in one study and the Asthma Control Questionnaire (ACQ) in another study, so data were not pooled. The MD on the ACQ was -2.00 (total score 0 to 6) (95% CI -4.30 to 0.30; 1 study, 15 participants; MCID 0.5 points; very low-certainty evidence). The MD on the ACT was 5.90 (total score 5 to 25) (95% CI 2.93 to 8.87; 1 study, 30 participants; MCID 3 points; very low-certainty evidence). All but one study reported on adverse events. Seven participants in the active treatment group developed a gastrointestinal disorder and dropped out (129 participants, very low-certainty evidence). We are uncertain of the effect of ATAD on nasal airflow, measured by peak nasal inspiratory flow scores (MD 32.90 L/min, 95% CI -12.44 to 78.24; 1 study, 15 participants; very low-certainty evidence). It is uncertain if the dosage of intranasal or inhaled corticosteroids may be reduced with ATAD (inhaled corticosteroids: -1197.60 µg, 95% CI -1744.93 to -650.27; intranasal corticosteroids: -120.50 µg, 95% CI -206.49 to -34.51; 1 study; 15 participants; very low-certainty evidence). Symptom scores may not differ between ATAD and placebo, but the evidence is very uncertain (sneezing: MD -0.70, 95% CI -1.45 to 0.05; smell: MD -2.20, 95% CI -4.74 to 0.34; nasal blockage: MD -0.90, 95% CI -1.90 to 0.10; 1 study, very low-certainty evidence). No study assessed nasal endoscopy at this time point. Long-term follow-up (36 months, ATAD versus placebo) ATAD may improve quality of life, as measured with the Rhinosinusitis Disability Index (RSDI) score (MD-18.10, 95% CI -32.82 to -3.38; 1 study; 31 participants; low-certainty evidence). ATAD may result in little to no difference in the size of nasal polyps (MD -1.20, 95% CI -2.72 to 0.32; 1 study, 31 participants; very low-certainty evidence). No adverse events were reported in either group over the total study period of 36 months (1 study; 31 participants; very low-certainty evidence). Data on peak nasal inspiratory flow, changes in dosage of inhalation or intranasal corticosteroids and symptom scores were not reported at this time point.
AUTHORS' CONCLUSIONS: Aspirin treatment after desensitisation may improve health-related quality of life for people with N-ERD with a follow-up of six months. With respect to asthma control, adverse events, peak nasal inspiratory flow score, nasal endoscopy scores, changes in dosage of inhaled or intranasal corticosteroids, nasal and bronchial symptom scores, exacerbations or worsening of asthma and chronic rhinosinusitis (including the need for surgery), the evidence is inconclusive for the short-term and long-term. We did not find data on peak expiratory flow. It is difficult to interpret the results adequately, due to the potential influence of the use of any co-medications for chronic rhinosinusitis or asthma. Future research should emphasise longer duration of follow-up, report baseline disease characteristics and report on compliance and exacerbations for which additional medication or surgery is warranted.
METHODS AND FINDINGS: We included all prospective controlled studies (randomised and non-randomised) comparing rooming-in to nursery care that reported full or partial breastfeeding up to six months. We used the 2016 search results of the Cochrane review and updated the search to August 2018 using OVID MEDLINE. Duplicate data extraction and assessment of risk of bias were performed. Meta-analyses were performed using REVMAN 5. The GRADE approach was used to assess quality of evidence. Seven studies were included, five had 24-hour-per-day, one daytime only and one 8-hours-per-day rooming-in. Four studies had at least one additional co-intervention: Differences in delivery room management, and educational packages. All studies contributing to meta-analyses had 24-hour rooming-in. There was no difference in the proportion of infants on full breastfeeding at 3 months (RR 1.14; 95% CI 0.84 to 1.54; very-low-quality evidence), 4 months (RR 0.99; 95% CI 0.73 to 1.33; very-low-quality evidence) and 6 months (RR 0.95; 95% CI 0.57 to 1.58; low-quality evidence). The proportion of infants on partial breastfeeding at 3-4 months was higher with rooming-in (RR 1.31; 95% CI 1.06 to 1.61; very-low-quality evidence).
CONCLUSION: The addition of non-randomised prospective controlled studies to existing evidence did not add further information on the effects of rooming-in on breastfeeding duration but resulted in lower quality of evidence. Uncertainty about the effects of rooming-in on breastfeeding duration remains.
OBJECTIVES: We described the ROB profile of neonatal RCTs published since the 1950s.
METHODS: We analyzed individual studies within the Cochrane Neonatal reviews published up to December 2016. We extracted the reviewers' judgments on the ROB domains including random sequence generation, allocation concealment, blinding, incomplete outcome data, and selective reporting. We evaluated blinding of personnel in trials in which blinding was considered feasible.
RESULTS: We assessed 1980 RCTs published between 1952 and 2016 from 294 Cochrane Neonatal systematic reviews, with full ROB assessments performed in 848 trials (42.8%). Among the ROB domains, the highest proportion of trials (73%) were judged as satisfactory ("low risk") in handling incomplete outcome data, while fewest trials achieved blinding of outcome assessor (38.4%). In the last 6 decades, a progressive increase has been observed in the proportion of trials that were rated as low risk in random sequence generation, allocation concealment, and selective reporting. However, blinding was achieved in less than half of the trials with no clear improvement across decades (23-44% since the 1980s).
CONCLUSIONS: Despite steady improvement in the overall quality of neonatal RCTs over the last 6 decades, blinding remained unsatisfactory in the majority of the trials.