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  1. Ahmed A, Tanveer M, Dujaili JA, Chuah LH, Hashmi FK, Awaisu A
    AIDS Patient Care STDS, 2023 Jan;37(1):31-52.
    PMID: 36626156 DOI: 10.1089/apc.2022.0192
    People living with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS; PLWHA) frequently encounter antiretroviral (ARV) therapy-related problems. Clinical pharmacists with specialized training in ARV stewardship play an important role in managing these problems. However, there is a paucity of evidence to clarify the impact of clinical pharmacists' interventions on managing ARV therapy-related problems in PLWHA. Therefore, we aim to systematically review the literature to determine the nature and impact of pharmacists' interventions on managing medication-related problems in PLWHA. The review protocol was registered on International Prospective Register of Systematic Reviews (PROSPERO; CRD42020173078). Relevant records were identified from six electronic bibliographic databases (PubMed, Embase, EBSCOhost, ProQuest, Scopus, and the Cochrane Central Register) from their inception until September 2022. We included all randomized and nonrandomized interventional studies that were published in English. After the abstract and full-text screening, data were extracted from the selected studies, and the quality of the studies was assessed. The electronic database search and citation tracking identified two thousand and three citations. The review included 21 of these studies, involving 2998 PLWHA, published between 2014 and 2022. Pharmacists' interventions, working alone or in a multi-disciplinary team, comprised ARV medication review, management of adverse drug reactions (ADRs), therapeutic drug monitoring, prevention of drug interactions, and provision of drug information to PLWHA or the health care team. The pharmacist-involved interventions significantly reduced incorrect/incomplete ARV regimens, drug interactions, incorrect dosages, duplicate therapy, polypharmacy, administration errors, missing medication, wrong formulation, ADRs, and prescribing errors. Most studies reported that physicians usually accept more than 90% of the pharmacists' recommendations. ARV medication-related problems remain highly prevalent in PLWHA. Pharmacist-led interventions and stewardship significantly reduce ARV therapy-related problems in PLWHA and are widely accepted by physicians. Dedicated pharmacists with specialized training and credentialing in infectious diseases or HIV/AIDS have a great potential to improve health outcomes in PLWHA.
    Matched MeSH terms: Randomized Controlled Trials as Topic; Non-Randomized Controlled Trials as Topic
  2. Jadhav RA, Maiya GA, Hombali A, Umakanth S, Shivashankar KN
    Acta Diabetol, 2021 Apr;58(4):419-429.
    PMID: 33211181 DOI: 10.1007/s00592-020-01626-1
    AIMS: Inflammatory stage in prediabetes is associated with increase in level of adipokines and pro-inflammatory cytokines. Physical activity promotion considered as a first-line therapeutic strategy to treat prediabetes. We have conducted the systematic review and meta-analysis to strengthen the evidence on the impact of physical activity promotion on inflammatory markers in prediabetes.

    METHODS: Studies were identified using electronic search and manual search techniques by choosing keywords for prediabetes, physical activity and inflammatory marker. Randomized controlled trials on individuals diagnosed with prediabetes and provided intervention in the form of physical activity were included in this review. Adiponectin, leptin, C-reactive protein, interleukin-6 and tumour necrosis factor-α were the considered outcome measures.

    RESULTS: Our search retrieved 1,688 citations, 31 full-text articles assessed for eligibility of inclusion. Nine studies satisfied the pre-specified criteria for inclusion. Meta-analysis found that physical activity with or without dietary or lifestyle modification reduces level of leptin (MD-2.11 ng/mL, 95% CI -3.81 - -0.42) and interleukin-6 (MD -0.15 pg/mL, 95% CI -0.25--0.04). It has no effect on level of adiponectin (MD 0.26 µg/mL, 95% CI -0.42- 0.93), C-reactive protein (MD -0.05 mg/L, 95% CI -0.33-0.23) and tumour necrosis factor-α (MD 0.67 pg/mL, 95% CI -2.56-3.89).

    CONCLUSIONS: This review suggests that physical activity promotion with dietary and lifestyle modification may reduce the level of leptin and interleukin-6 but are uncertain if there is any effect on levels of adiponectin, C-reactive protein and tumour necrosis factor-α in the individuals with prediabetes.

    Matched MeSH terms: Randomized Controlled Trials as Topic/statistics & numerical data
  3. Voon PT, Lee ST, Ng TKW, Ng YT, Yong XS, Lee VKM, et al.
    Adv Nutr, 2019 Jul 01;10(4):647-659.
    PMID: 31095284 DOI: 10.1093/advances/nmy122
    It is not clear whether a saturated fatty acid-rich palm olein diet has any significant adverse effect on established surrogate lipid markers of cardiovascular disease (CVD) risk. We reviewed the effect of palm olein with other oils on serum lipid in healthy adults. We searched in MEDLINE and CENTRAL: Central Register of Controlled Trials from 1975 to January 2018 for randomized controlled trials of ≥2 wk intervention that compared the effects of palm olein (the liquid fraction of palm oil) with other oils such as coconut oil, lard, canola oil, high-oleic sunflower oil, olive oil, peanut oil, and soybean oil on changes in serum lipids. Nine studies were eligible and were included, with a total of 533 and 542 subjects on palm olein and other dietary oil diets, respectively. We extracted and compared all the data for serum lipids, such as total cholesterol (TC), LDL cholesterol, HDL cholesterol, triglyceride, and TC/HDL cholesterol ratio. When comparing palm olein with other dietary oils, the overall weighted mean differences for TC, LDL cholesterol, HDL cholesterol, triglycerides, and the TC/HDL cholesterol ratio were -0.10 (95% CI: -0.30, 0.10; P = 0.34), -0.06 (95% CI: -0.29,0.16; P = 0.59), 0.02 (95% CI: -0.01, 0.04; P = 0.20), 0.01 (95% CI: -0.05, 0.06; P = 0.85), and -0.15 (95% CI: -0.43, 0.14; P = 0.32), respectively. Overall, there are no significant differences in the effects of palm olein intake on lipoprotein biomarkers (P > 0.05) compared with other dietary oils. However, dietary palm olein was found to have effects comparable to those of other unsaturated dietary oils (monounsaturated fatty acid- and polyunsaturated fatty acid-rich oils) but differed from that of saturated fatty acid-rich oils with respect to the serum lipid profile in healthy adults.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  4. 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
  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. Kord-Varkaneh H, Rinaldi G, Hekmatdoost A, Fatahi S, Tan SC, Shadnoush M, et al.
    Ageing Res Rev, 2020 01;57:100996.
    PMID: 31816443 DOI: 10.1016/j.arr.2019.100996
    BACKGROUND: Inconsistencies exist with regard to influence of vitamin D supplementation on IGF-1 levels. The inconsistencies could be attributed to several factors, such as dosage and duration of intervention, among others. To address these inconsistencies, this study was conducted to determine the impact of vitamin D supplementation on IGF-1 levels through a systematic review and meta-analysis of randomized controlled trials (RCTs).

    METHODS: A comprehensive systematic search was carried out in PubMed/MEDLINE, Web of Science, SCOPUS and Embase for RCTs that investigated the impact of vitamin D intake on circulating IGF-1 levels from inception until June 2019. Weighted mean difference (WMD) with the 95 % CI were applied for estimating combined effect size. Subgroup analysis was performed to specify the source of heterogeneity among studies.

    RESULTS: Pooled results from eight studies demonstrated an overall non-significant increase in IGF-1 following vitamin D supplementation (WMD: 4 ng/ml, 95 % CI: -4 to 11). However, a significant degree of heterogeneity among studies was observed (I2 = 66 %). The subgroup analyses showed that vitamin D dosage of ≤1000 IU/day (WMD: 10 ng/ml) significantly increased IGF-1 compared to the vitamin D dosage of <1000 IU/day (WMD: -1 ng/ml). Moreover, intervention duration ≤12 weeks (WMD: 11 ng/ml) significantly increased IGF-1 compared to intervention duration <12 weeks (WMD: -3 ng/ml). In the epidemiological cohort study, participants under 60 years of age with a higher dietary vitamin D intake had significantly higher IGF-1 levels when compared to those with lower dietary vitamin D intake in second categories.

    CONCLUSION: The main results indicate a non-significant increase in IGF-1 following vitamin D supplementation. Additionally, vitamin D dosages of <1000 IU/day and intervention durations of <12 weeks significantly raised IGF-1 levels.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  7. Viecelli AK, O'Lone E, Sautenet B, Craig JC, Tong A, Chemla E, et al.
    Am J Kidney Dis, 2018 03;71(3):382-391.
    PMID: 29203125 DOI: 10.1053/j.ajkd.2017.09.018
    BACKGROUND: Many randomized controlled trials have been performed with the goal of improving outcomes related to hemodialysis vascular access. If the reported outcomes are relevant and measured consistently to allow comparison of interventions across trials, such trials can inform decision making. This study aimed to assess the scope and consistency of vascular access outcomes reported in contemporary hemodialysis trials.

    STUDY DESIGN: Systematic review.

    SETTING & POPULATION: Adults requiring maintenance hemodialysis.

    SELECTION CRITERIA: All randomized controlled trials and trial protocols reporting vascular access outcomes identified from ClinicalTrials.gov, Embase, MEDLINE, and the Cochrane Kidney and Transplant Specialized Register from January 2011 to June 2016.

    INTERVENTIONS: Any hemodialysis-related intervention.

    OUTCOMES: The frequency and characteristics of vascular access outcome measures were analyzed and classified.

    RESULTS: From 168 relevant trials, 1,426 access-related outcome measures were extracted and classified into 23 different outcomes. The 3 most common outcomes were function (136 [81%] trials), infection (63 [38%]), and maturation (31 [18%]). Function was measured in 489 different ways, but most frequently reported as "mean access blood flow (mL/min)" (37 [27%] trials) and "number of thromboses" (30 [22%]). Infection was assessed in 136 different ways, with "number of access-related infections" being the most common measure. Maturation was assessed in 44 different ways at 15 different time points and most commonly characterized by vein diameter and blood flow. Patient-reported outcomes, including pain (19 [11%]) and quality of life (5 [3%]), were reported infrequently. Only a minority of trials used previously standardized outcome definitions.

    LIMITATIONS: Restricted sampling frame for feasibility and focus on contemporary trials.

    CONCLUSIONS: The reporting of access outcomes in hemodialysis trials is very heterogeneous, with limited patient-reported outcomes and infrequent use of standardized outcome measures. Efforts to standardize outcome reporting for vascular access are critical to optimizing the comparability, reliability, and value of trial evidence to improve outcomes for patients requiring hemodialysis.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  8. 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*
  9. Ismail SB, Noor NM, Hussain NHN, Sulaiman Z, Shamsudin MA, Irfan M
    Am J Mens Health, 2019 12 5;13(6):1557988319892735.
    PMID: 31795911 DOI: 10.1177/1557988319892735
    Erectile dysfunction is common in adult men, particularly those with hypertension and diabetes. The present study determines the effectiveness of angiotensin receptor blocker (ARB) drugs on erectile function in hypertensive male adults. For this purpose, CENTRAL and MEDLINE and reference lists of the articles were searched. The randomized controlled trials (RCTs) were selected that compared ARBs with conventional therapy or no treatment in men of any ethnicity who were presented with hypertension and/or diabetes. A total four trials that had 2,809 men were included. Three trials reported adequate random sequence allocation, two reported adequate blinding. Attrition bias is low in one of the included studies. All three studies are of low risk of selective reporting bias. There was an improvement in sexual activity with ARBs (valsartan) (mean difference (MD): 0.71, 95% Confidence Interval (CI) 0.66 to 0.76, I2 statistic = 0%). However, the erectile functions did not increase significantly in ARBs (losartan or telmisartan) treated men as compared to control or placebo (n = 203 vs n = 232; MD: 1.36; 95% CI: -0.97 to -3.69; I2 statistic = 80%). These results suggested that ARBs significantly improved sexual activity among hypertensive men. However, the erectile function was not significantly improved in ARBs treated men as compared to the control or placebo-treated. There were limited studies available. Hence, additional studies are needed to support findings from this review. ARBs should be considered when prescribing antihypertensive drugs to men.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  10. Armijo-Olivo S, Mohamad N, Sobral de Oliveira-Souza AI, de Castro-Carletti EM, Ballenberger N, Fuentes J
    Am J Phys Med Rehabil, 2022 Sep 01;101(9):864-878.
    PMID: 35978455 DOI: 10.1097/PHM.0000000000001893
    Bias is a systematic error that can cause distorted results leading to incorrect conclusions. Intervention bias (i.e., contamination bias, cointervention bias, compliance bias, and performance bias) and detection bias are the most common biases in rehabilitation research. A better understanding of these biases is essential at all stages of research to enhance the quality of evidence in rehabilitation trials. Therefore, this narrative review aims to provide insights to the readers, clinicians, and researchers about contamination, cointervention, compliance, performance, and detection biases and ways of recognizing and mitigating them. The literature selected for this review was obtained mainly by compiling the information from several reviews looking at biases in rehabilitation. In addition, separate searches by biases and looking at reference lists of selected studies as well as using Scopus forward citation for relevant references were used.This review provides several strategies to guard against the impact of bias on study results. Clinicians, researchers, and other stakeholders are encouraged to apply these recommendations when designing and conducting rehabilitation trials.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  11. Li S, Shaharudin S, Abdul Kadir MR
    Am J Phys Med Rehabil, 2021 Apr 01;100(4):337-344.
    PMID: 33727516 DOI: 10.1097/PHM.0000000000001567
    BACKGROUND: Due to the pain caused by knee injuries, low-load resistance training with blood flow restriction (L-BFR) may be a potential adjuvant therapeutic tool in the rehabilitation of knee injuries. This review aimed to analyze the effectiveness of L-BFR training modality in knee rehabilitation.

    DESIGN: A meta-analysis was conducted to determine the potential impact of blood flow restriction on patients with knee injuries. PubMed, EBSCO, and Web of Science databases were searched for eligible studies from January 2000 until January 2020. The mean differences of the data were analyzed using Revman 5.3 software with a 95% confidence interval.

    RESULTS: Nine studies fulfilled the inclusion criteria. These studies involved 179 patients who received L-BFR, 96 patients who underwent high-load resistance training, and another 94 patients who underwent low-load resistance training. The analysis of pooled data showed that patients in both the L-BFR (standardized mean difference, 0.83 [0.53, 1.14], P < 0.01) and high-load resistance training (standardized mean difference, -0.09 [-0.43, 0.24], P = 0.58) groups experienced an increase in muscle strength after the training. In addition, pain score was significantly reduced in the L-BFR group compared with the other two groups (standardized mean difference, -0.61 [-1.19, -0.03], P = 0.04).

    CONCLUSIONS: Muscle strength increased after L-BFR and high-load resistance training compared with low-load resistance training. Furthermore, pain score was significantly reduced after L-BFR. Hence, L-BFR is a potential intervention to be applied in rehabilitation of knee injuries.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  12. Roberts JA, Abdul-Aziz MH, Davis JS, Dulhunty JM, Cotta MO, Myburgh J, et al.
    Am J Respir Crit Care Med, 2016 Sep 15;194(6):681-91.
    PMID: 26974879 DOI: 10.1164/rccm.201601-0024OC
    RATIONALE: Optimization of β-lactam antibiotic dosing for critically ill patients is an intervention that may improve outcomes in severe sepsis.

    OBJECTIVES: In this individual patient data meta-analysis of critically ill patients with severe sepsis, we aimed to compare clinical outcomes of those treated with continuous versus intermittent infusion of β-lactam antibiotics.

    METHODS: We identified relevant randomized controlled trials comparing continuous versus intermittent infusion of β-lactam antibiotics in critically ill patients with severe sepsis. We assessed the quality of the studies according to four criteria. We combined individual patient data from studies and assessed data integrity for common baseline demographics and study endpoints, including hospital mortality censored at 30 days and clinical cure. We then determined the pooled estimates of effect and investigated factors associated with hospital mortality in multivariable analysis.

    MEASUREMENTS AND MAIN RESULTS: We identified three randomized controlled trials in which researchers recruited a total of 632 patients with severe sepsis. The two groups were well balanced in terms of age, sex, and illness severity. The rates of hospital mortality and clinical cure for the continuous versus intermittent infusion groups were 19.6% versus 26.3% (relative risk, 0.74; 95% confidence interval, 0.56-1.00; P = 0.045) and 55.4% versus 46.3% (relative risk, 1.20; 95% confidence interval, 1.03-1.40; P = 0.021), respectively. In a multivariable model, intermittent β-lactam administration, higher Acute Physiology and Chronic Health Evaluation II score, use of renal replacement therapy, and infection by nonfermenting gram-negative bacilli were significantly associated with hospital mortality. Continuous β-lactam administration was not independently associated with clinical cure.

    CONCLUSIONS: Compared with intermittent dosing, administration of β-lactam antibiotics by continuous infusion in critically ill patients with severe sepsis is associated with decreased hospital mortality.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  13. Serebruany V, Tanguay JF, Benavides MA, Cabrera-Fuentes H, Eisert W, Kim MH, et al.
    Am J Ther, 2020 10 29;27(6):e563-e572.
    PMID: 33109913 DOI: 10.1097/MJT.0000000000001286
    BACKGROUND: Excess vascular deaths in the PLATO trial comparing ticagrelor to clopidogrel have been repeatedly challenged by the Food and Drug Administration (FDA) reviewers and academia. Based on the Freedom of Information Act, BuzzFeed won a court order and shared with us the complete list of reported deaths for the ticagrelor FDA New Drug Application (NDA) 22-433. This dataset was matched against local patient-level records from PLATO sites monitored by the sponsor.

    STUDY QUESTION: Whether FDA death data in the PLATO trial matched the local site records.

    STUDY DESIGN: The NDA spreadsheet contains 938 precisely detailed PLATO deaths. We obtained and validated local evidence for 52 deaths among 861 PLATO patients from 14 enrolling sites in 8 countries and matched those with the official NDA dataset submitted to the FDA.

    MEASURES AND OUTCOMES: Existence, precise time, and primary cause of deaths in PLATO.

    RESULTS: Discrepant to the NDA document, sites confirmed 2 extra unreported deaths (Poland and Korea) and failed to confirm 4 deaths (Malaysia). Of the remaining 46 deaths, dates were reported correctly for 42 patients, earlier (2 clopidogrel), or later (2 ticagrelor) than the actual occurrence of death. In 12 clopidogrel patients, cause of death was changed to "vascular," whereas 6 NDA ticagrelor "nonvascular" or "unknown" deaths were site-reported as of "vascular" origin. Sudden death was incorrectly reported in 4 clopidogrel patients, but omitted in 4 ticagrelor patients directly affecting the primary efficacy PLATO endpoint.

    CONCLUSIONS: Many deaths were inaccurately reported in PLATO favoring ticagrelor. The full extent of mortality misreporting is currently unclear, while especially worrisome is a mismatch in identifying primary death cause. Because all PLATO events are kept in the cloud electronic Medidata Rave capture system, securing the database content, examining the dataset changes or/and repeated entries, identifying potential interference origin, and assessing full magnitude of the problem are warranted.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  14. 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
  15. Jacka MJ, Guyatt G, Mizera R, Van Vlymen J, Ponce de Leon D, Schricker T, et al.
    Anesth Analg, 2018 04;126(4):1150-1157.
    PMID: 29369093 DOI: 10.1213/ANE.0000000000002804
    BACKGROUND: Perioperative β-blockade reduces the incidence of myocardial infarction but increases that of death, stroke, and hypotension. The elderly may experience few benefits but more harms associated with β-blockade due to a normal effect of aging, that of a reduced resting heart rate. The tested hypothesis was that the effect of perioperative β-blockade is more significant with increasing age.

    METHODS: To determine whether the effect of perioperative β-blockade on the primary composite event, clinically significant hypotension, myocardial infarction, stroke, and death varies with age, we interrogated data from the perioperative ischemia evaluation (POISE) study. The POISE study randomly assigned 8351 patients, aged ≥45 years, in 23 countries, undergoing major noncardiac surgery to either 200 mg metoprolol CR daily or placebo for 30 days. Odds ratios or hazard ratios for time to events, when available, for each of the adverse effects were measured according to decile of age, and interaction term between age and treatment was calculated. No adjustment was made for multiple outcomes.

    RESULTS: Age was associated with higher incidences of the major outcomes of clinically significant hypotension, myocardial infarction, and death. Age was associated with a minimal reduction in resting heart rate from 84.2 (standard error, 0.63; ages 45-54 years) to 80.9 (standard error, 0.70; ages >85 years; P < .0001). We found no evidence of any interaction between age and study group regarding any of the major outcomes, although the limited sample size does not exclude any but large interactions.

    CONCLUSIONS: The effect of perioperative β-blockade on the major outcomes studied did not vary with age. Resting heart rate decreases slightly with age. Our data do not support a recommendation for the use of perioperative β-blockade in any age subgroup to achieve benefits but avoid harms. Therefore, current recommendations against the use of β-blockers in high-risk patients undergoing noncardiac surgery apply across all age groups.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  16. Chiong XH, Wong ZZ, Lim SM, Ng TY, Ng KT
    Ann Card Anaesth, 2022;25(4):384-398.
    PMID: 36254901 DOI: 10.4103/aca.aca_149_21
    High prevalence of cerebral desaturation is associated with postoperative neurological complications in cardiac surgery. However, the evidence use of cerebral oximetry by correcting cerebral desaturation in the reduction of postoperative complications remains uncertain in the literature. This systematic review and meta-analysis aimed to examine the effect of cerebral oximetry on the incidence of postoperative cognitive dysfunction in cardiac surgery. Databases of MEDLINE, EMBASE, and CENTRAL were searched from their inception until April 2021. All randomized controlled trials comparing cerebral oximetry and blinded/no cerebral oximetry in adult patients undergoing cardiac surgery were included. Observational studies, case series, and case reports were excluded. A total of 14 trials (n = 2,033) were included in this review. Our pooled data demonstrated that patients with cerebral oximetry were associated with a lower incidence of postoperative cognitive dysfunction than the control group (studies = 4, n = 609, odds ratio [OR]: 0.15, 95% confidence interval [CI]: 0.04 to 0.54, P = 0.003, I2 = 88%; certainty of evidence = very low). In terms of postoperative delirium (OR: 0.75, 95%CI: 0.50-1.14, P = 0.18, I2 = 0%; certainty of evidence = low) and postoperative stroke (OR: 0.81 95%CI: 0.37-1.80, P = 0.61, I2 = 0%; certainty of evidence = high), no significant differences (P > 0.05) were reported between the cerebral oximetry and control groups. In this meta-analysis, the use of cerebral oximetry monitoring in cardiac surgery demonstrated a lower incidence of postoperative cognitive dysfunction. However, this finding must be interpreted with caution due to the low level of evidence, high degree of heterogeneity, lack of standardized cognitive assessments, and cerebral desaturation interventions.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  17. Goh SL, Persson MSM, Stocks J, Hou Y, Lin J, Hall MC, et al.
    Ann Phys Rehabil Med, 2019 Sep;62(5):356-365.
    PMID: 31121333 DOI: 10.1016/j.rehab.2019.04.006
    BACKGROUND: Exercise is an effective treatment for osteoarthritis. However, the effect may vary from one patient (or study) to another.

    OBJECTIVE: To evaluate the efficacy of exercise and its potential determinants for pain, function, performance, and quality of life (QoL) in knee and hip osteoarthritis (OA).

    METHODS: We searched 9 electronic databases (AMED, CENTRAL, CINAHL, EMBASE, MEDLINE Ovid, PEDro, PubMed, SPORTDiscus and Google Scholar) for reports of randomised controlled trials (RCTs) comparing exercise-only interventions with usual care. The search was performed from inception up to December 2017 with no language restriction. The effect size (ES), with its 95% confidence interval (CI), was calculated on the basis of between-group standardised mean differences. The primary endpoint was at or nearest to 8 weeks. Other outcome time points were grouped into intervals, from<1 month to≥18 months, for time-dependent effects analysis. Potential determinants were explored by subgroup analyses. Level of significance was set at P≤0.10.

    RESULTS: Data from 77 RCTs (6472 participants) confirmed statistically significant exercise benefits for pain (ES 0.56, 95% CI 0.44-0.68), function (0.50, 0.38-0.63), performance (0.46, 0.35-0.57), and QoL (0.21, 0.11-0.31) at or nearest to 8 weeks. Across all outcomes, the effects appeared to peak around 2 months and then gradually decreased and became no better than usual care after 9 months. Better pain relief was reported by trials investigating participants who were younger (mean age<60 years), had knee OA, and were not awaiting joint replacement surgery.

    CONCLUSIONS: Exercise significantly reduces pain and improves function, performance and QoL in people with knee and hip OA as compared with usual care at 8 weeks. The effects are maximal around 2 months and thereafter slowly diminish, being no better than usual care at 9 to 18 months. Participants with younger age, knee OA and not awaiting joint replacement may benefit more from exercise therapy. These potential determinants, identified by study-level analyses, may have implied ecological bias and need to be confirmed with individual patient data.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  18. Memon MA, Memon B, Yunus RM, Khan S
    Ann Surg, 2016 Feb;263(2):258-66.
    PMID: 26445468 DOI: 10.1097/SLA.0000000000001267
    The aim was to conduct a meta-analysis of randomized controlled trials (RCTs) comparing 2 methods of hiatal closure for large hiatal hernia and to evaluate their strengths and flaws.
    Matched MeSH terms: Randomized Controlled Trials as Topic
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