Cochrane Central Register Of Controlled Trials Research Articles

Rationale, completeness and quality of evidence for the use of ursodeoxycholic acid in neonatal hyperbilirubinemia

Background. Systematic reviews are considered the highest evidence of the effectiveness and safety of treatment methods used in clinical practice. The veracity of a results and conclusions of systematic reviews is directly related to their quality. The aim of the study is an assessment of the currency, completeness and methodological quality of published systematic reviews on the evaluation of the effectiveness of ursodeoxycholic acid (UDCA) for the treatment of neonatal hyperbilirubinemia. Materials and methods. A meta-epidemiological methodological study was conducted. The search for evidence sources was performed in November 2023 in the specialized databases MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR), LILACS, CNKI, LENS.ORG, еLibrary.Ru, in registers ClinicalTrials.gov, ICTRP, ISRCTN, PROSPERO, as well as in the Google Academy and Google search engines. Additionally, the lists of references and citations of selected publications have been reviewed. Only systematic reviews and randomized clinical trials are included in the study. The search was carried out to assess the currency and completeness of systematic reviews. A systematic review is considered currency if the most recent studies are included in its analysis. A systematic review is considered complete if its analysis includes all identified studies that meet the inclusion criteria set by the review authors and are published no later than the date of the last search conducted by the review authors. The methodological quality of the systematic reviews was assessed using the AMSTAR-2 tool. Results. As a result of the search, 4 systematic reviews and 23 randomized trials were identified. All reviews evaluated the effect of UDCA in combination with phototherapy on the level of total serum bilirubin, the duration of phototherapy and the frequency of adverse events (for example, loose stools, vomiting, rash) compared with phototherapy alone and/or placebo. All systematic reviews have been published over the past two years, but have already lost their currency. There are missing studies and/or outcomes in each review. The methodological quality of the reviews was found to be extremely low. Conclusion. Given the listed shortcomings of systematic reviews, their results and conclusions should be treated with caution. In order to obtain the most accurate and reliable evidence, a new systematic review is needed.

Effects of automatic heel lancet on invasiveness in neonates: A systematic review and meta-analysis.

We conducted a meta-analysis comparing the invasiveness of automatic lancet devices, which can collect adequate amount of blood at shallow puncture depths, with conventional manual lance devices (lancet or needle) to statistically identify less invasive instruments for neonatal heel lance. We searched PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, and Ichushi databases for studies comparing the invasiveness between automatic lancet and manual lancet or needle in term and preterm neonates in neonatal intensive care unit. This review included 9 out of 449 searched articles, with 673 neonates. Automatic lancet had significantly lower pain scores (standardised mean difference: -2.0, 95% confidence interval: -3.3 to -0.7), heart rate (mean difference: -8.0, 95% confidence interval: -13.8 to -2.1), cry duration (mean difference: -21.5, 95% confidence interval: -32.5 to -10.4), number of punctures (mean difference: -0.6, 95% confidence interval: -1.1 to -0.2), and duration of procedures (mean difference: -37.7, 95% confidence interval: -75.2 to -0.2) than manual lancet or needle. Furthermore, peripheral oxygen saturation was significantly higher in automatic lancet than in manual lancet or needle (mean difference: 4.5, 95% confidence interval: 0.5-8.5). Automatic heel lancet devices were less invasive than manual heel lance devices (lancet or needle).

Chlorhexidine is not effective at any concentration in preventing ventilator-associated pneumonia: a systematic review and network meta-analysis

IntroductionOral chlorhexidine has been widely used for ventilator-associated pneumonia prevention in the critical care setting; however, previous studies and evidence synthesis have generated inconsistent findings. Our study aims to investigate if different concentrations of oral chlorhexidine may be effective in preventing such complication in intensive care unit patients.MethodsAfter pre-registration (Open Science Framework: 8CUKF), we conducted a network meta-analysis with the following PICOS: adult patients (age > 18 years old) undergoing invasive mechanical ventilation admitted in ICU (P); any concentration of chlorhexidine used for oral hygiene (I); placebo, sham intervention, usual care, or no intervention (C); rate of VAP (primary outcome), mechanical ventilation length, ICU length of stay (LOS), hospital LOS, mortality (secondary outcomes) (O); randomized controlled trials (S). We used the following database: PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, and EMBASE without any limitation in publication date or language.ResultsChlorhexidine did not demonstrate any significant advantage over the control group in preventing ventilator-associated pneumonia or reducing mortality, duration of mechanical ventilation, length of stay in the intensive care unit, or overall mortality.ConclusionsChlorhexidine oral decontamination does not reduce the rate of ventilator-associated pneumonia in critically ill adult patients and its routine use could not be recommended.Trial registrationRegistration number: Open Science Framework: 8CUKF.

Daratumumab and antineoplastic therapy versus antineoplastic therapy only for adults with newly diagnosed multiple myeloma ineligible for transplant.

Multiple myeloma (MM) is a haematological malignancy that is characterised by proliferation of malignant plasma cells in the bone marrow. For adults ineligible to receive high-dose chemotherapy and autologous stem cell transplant, the recommended treatment combinations in first-line therapy generally consist of combinations of alkylating agents, immunomodulatory drugs, and proteasome inhibitors. Daratumumab is a CD38-targeting, human IgG1k monoclonal antibody recently developed and approved for the treatment of people diagnosed with MM. Multiple myeloma cells uniformly over-express CD-38, a 46-kDa type II transmembrane glycoprotein, making myeloma cells a specific target for daratumumab. To determine the benefits and harms of daratumumab in addition to antineoplastic therapy compared to antineoplastic therapy only for adults with newly diagnosed MM who are ineligible for transplant. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, EU Clinical Trials Register, ClinicalTrials.gov, WHO ICTRP, and conference proceedings from 2010 to September 2023. We included randomised controlled trials that compared treatment with daratumumab added to antineoplastic therapy versus the same antineoplastic therapy alone in adult participants with a confirmed diagnosis of MM. We excluded quasi-randomised trials and trials with less than 80% adult participants, unless there were subgroup analyses of adults with MM. Two review authors independently screened the results of the search strategies for eligibility. We documented the process of study selection in a flowchart as recommended by the PRISMA statement. We evaluated the risk of bias in included studies with RoB 1 and assessed the certainty of the evidence using GRADE. We followed standard Cochrane methodological procedures. We included four open-label, two-armed randomised controlled trials (34 publications) involving a total of 1783 participants. The ALCYONE, MAIA, and OCTANS trials were multicentre trials conducted worldwide in middle- and high-income countries. The AMaRC 03-16 trial was conducted in one high-income country, Australia. The mean age of participants was 69 to 74 years, and the proportion of female participants was between 40% and 54%. All trials evaluated antineoplastic therapies with or without daratumumab. In the ALCYONE and OCTANS trials, daratumumab was combined with bortezomib and melphalan-prednisone. In the AMaRC 03-16 study, it was combined with bortezomib, cyclophosphamide, and dexamethasone, and in the MAIA study, it was combined with lenalidomide and dexamethasone. None of the included studies was blinded (high risk of performance and detection bias). One study was published as abstract only, therefore the risk of bias for most criteria was unclear. The other three studies were published as full texts. Apart from blinding, the risk of bias was low for these studies. Overall survival Treatment with daratumumab probably increases overall survival when compared to the same treatment without daratumumab (hazard ratio (HR) 0.64, 95% confidence interval (CI) 0.53 to 0.76, 2 studies, 1443 participants, moderate-certainty evidence). After a follow-up period of 36 months, 695 per 1000 participants survived in the control group, whereas 792 per 1000 participants survived in the daratumumab group (95% CI 758 to 825). Progression-free survival Treatment with daratumumab probably increases progression-free survival when compared to treatment without daratumumab (HR 0.48, 95% CI 0.39 to 0.58, 3 studies, 1663 participants, moderate-certainty evidence). After a follow-up period of 24 months, progression-free survival was reached in 494 per 1000 participants in the control group versus 713 per 1000 participants in the daratumumab group (95% CI 664 to 760). Quality of life Treatment with daratumumab may result in a very small increase in quality of life after 12 months, evaluated on the EORTC QLQ-C30 global health status scale (GHS), when compared to treatment without daratumumab (mean difference 2.19, 95% CI -0.13 to 4.51, 3 studies, 1096 participants, low-certainty evidence). The scale is from 0 to 100, with a higher value indicating a better quality of life. On-study mortality Treatment with daratumumab probably decreases on-study mortality when compared to treatment without daratumumab (risk ratio (RR) 0.72, 95% CI 0.62 to 0.83, 3 studies, 1644 participants, moderate-certainty evidence). After the longest follow-up available (12 to 72 months), 366 per 1000 participants in the control group and 264 per 1000 participants in the daratumumab group died (95% CI 227 to 304). Serious adverse events Treatment with daratumumab probably increases serious adverse events when compared to treatment without daratumumab (RR 1.18, 95% CI 1.02 to 1.37, 3 studies, 1644 participants, moderate-certainty evidence). After the longest follow-up available (12 to 72 months), 505 per 1000 participants in the control group versus 596 per 1000 participants in the daratumumab group experienced serious adverse events (95% CI 515 to 692). Adverse events (Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3) Treatment with daratumumab probably results in little to no difference in adverse events (CTCAE grade ≥ 3) when compared to treatment without daratumumab (RR 1.01, 95% CI 0.99 to 1.02, 3 studies, 1644 participants, moderate-certainty evidence). After the longest follow-up available (12 to 72 months), 953 per 1000 participants in the control group versus 963 per 1000 participants in the daratumumab group experienced adverse events (CTCAE grade ≥ 3) (95% CI 943 to 972). Treatment with daratumumab probably increases the risk of infections (CTCAE grade ≥ 3) when compared to treatment without daratumumab (RR 1.52, 95% CI 1.30 to 1.78, 3 studies, 1644 participants, moderate-certainty evidence). After the longest follow-up available (12 to 72 months), 224 per 1000 participants in the control group versus 340 per 1000 participants in the daratumumab group experienced infections (CTCAE grade ≥ 3) (95% CI 291 to 399). Overall analysis of four studies showed a potential benefit for daratumumab in terms of overall survival and progression-free survival and a slight potential benefit in quality of life. Participants treated with daratumumab probably experience increased serious adverse events. There were likely no differences between groups in adverse events (CTCAE grade ≥ 3); however, there are probably more infections (CTCAE grade ≥ 3) in participants treated with daratumumab. We identified six ongoing studies which might strengthen the certainty of evidence in a future update of this review.

Rhythm vs Rate Control Strategy for Atrial Fibrillation: A Meta-Analysis of Randomized Controlled Trials.

Rhythm control, either with antiarrhythmic drugs or catheter ablation, and rate control strategies are the cornerstones of atrial fibrillation (AF) management. Despite the increasing role of rhythm control over the past few years, it remains inconclusive which strategy is superior in improving clinical outcomes. This study summarizes the total and time-varying evidence regarding the efficacy of rhythm- vs rate-control strategies in the management of AF. We systematically perused the MEDLINE, CENTRAL (Cochrane Central Register of Controlled Trials), and Web of Science databases for randomized controlled trials from inception to November 2023. We included studies that compared the efficacy of rhythm control (ie, antiarrhythmic drugs classes Ia, Ic, or III, AF catheter ablation, and electrical cardioversion) and rate control (ie, beta-blocker, digitalis, or calcium antagonist) strategies among patients with nonvalvular AF. The primary outcome was cardiovascular (CV) death, whereas secondary outcomes included all-cause death, stroke, hospitalization for heart failure (HF), sinus rhythm at the end of the follow-up, and rhythm control-related adverse events. A cumulative meta-analysis to assess temporal trends and a meta-regression analysis using the percentage of ablation use was performed. We identified 18 studies with a total of 17,536 patients (mean age: 68.6 ± 9.7 years, 37.9% females) and a mean follow-up of 28.5months. Of those, 31.9% had paroxysmal AF. A rhythm control strategy reduced CV death (HR: 0.78; 95%CI: 0.62-0.96), stroke (HR: 0.801; 95%CI: 0.643-0.998), and hospitalization for HF (HR: 0.80; 95%CI: 0.69-0.94) but not all-cause death (HR: 0.86; 95%CI: 0.73-1.02) compared with a rate control strategy. This benefit was driven by contemporary studies, whereas more ablation use within the rhythm control arm was associated with improved outcomes, except stroke. In patients with AF, a contemporary rhythm control strategy leads to reduced CV mortality, HF events, and stroke compared with a rate control strategy.

In the new era of psychedelic assisted therapy: A systematic review of study methodology in randomized controlled trials.

Recent years have seen a resurgence in randomized, placebo controlled trials (RCTs) utilizing non-classical psychedelics (e.g. 3,4-methyl enedioxy methamphetamine [MDMA]), and classical psychedelics (e.g. psilocybin, lysergic acid diethylamide [LSD], and N,N-dimethyltryptamine [DMT/ayahuasca]) in conjunction with assisted therapy (AT) for psychiatric disorders. A notable methodological challenge in psychedelic AT, however, is the complexity of blinding procedures. The lack of efficacious blinding can introduce considerable response bias, reduce internal validity, and compromise participant retention. This systematic review examines design and blinding techniques in RCTs utilizing psychedelics and placebo for the treatment of psychiatric disorders. The aim of this work is to identify factors that may inform future RTC design for conducting psychedelics research. We conducted a systematic review of PubMed, MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Psycinfo, Embase, and Web of Science Core Collection to examine: (1) placebo selection, (2) study design, and (3) integrity of blinding measures. Sixteen publications were identified as meeting the criteria for a systematic review.Our findings suggest that traditional placebo administration is insufficient to control for expectancy confounds. Consequently, experimental methodology that limits personnel unblinding and the use of an active placebo are important considerations when designing prospective clinical studies involving psychedelics.

Psychosocial and medication interventions to stop or reduce alcohol consumption during pregnancy.

Despite the known harms, alcohol consumption is common in pregnancy. Rates vary between countries, and are estimated to be 10% globally, with up to 25% in Europe. To assess the efficacy of psychosocial interventions and medications to reduce or stop alcohol consumption during pregnancy. We searched the Cochrane Drugs and Alcohol Group Specialised Register (via CRSLive), Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, Web of Science, and PsycINFO, from inception to 8 January 2024. We also searched for ongoing and unpublished studies via ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). All searches included non-English language literature. We handsearched references of topic-related systematic reviews and included studies. We included randomised controlled trials that compared medications or psychosocial interventions, or both, to placebo, no intervention, usual care, or other medications or psychosocial interventions used to reduce or stop alcohol use during pregnancy. Our primary outcomes of interest were abstinence from alcohol, reduction in alcohol consumption, retention in treatment, and women with any adverse event. We used standard Cochrane methodological procedures. We included eight studies (1369 participants) in which pregnant women received an intervention to stop or reduce alcohol use during pregnancy. In one study, almost half of participants had a current diagnosis of alcohol use disorder (AUD); in another study, 40% of participants had a lifetime diagnosis of AUD. Six studies took place in the USA, one in Spain, and one in the Netherlands. All included studies evaluated the efficacy of psychosocial interventions; we did not find any study that evaluated the efficacy of medications for the treatment of AUD during pregnancy. Psychosocial interventions were mainly brief interventions ranging from a single session of 10 to 60 minutes to five sessions of 10 minutes each. Pregnant women received the psychosocial intervention approximately at the end of the first trimester of pregnancy, and the outcome of alcohol use was reassessed 8 to 24 weeks after the psychosocial intervention. Women in the control group received treatment as usual (TAU) or similar treatments such as comprehensive assessment of alcohol use and advice to stop drinking during pregnancy. Globally, we found that, compared to TAU, psychosocial interventions may increase the rate of continuously abstinent participants (risk ratio (RR) 1.34, 95% confidence interval (CI) 1.14 to 1.57; I2 =0%; 3 studies; 378 women; low certainty evidence). Psychosocial interventions may have little to no effect on the number of drinks per day, but the evidence is very uncertain (mean difference -0.42, 95% CI -1.13 to 0.28; I2 = 86%; 2 studies; 157 women; very low certainty evidence). Psychosocial interventions probably have little to no effect on the number of women who completed treatment (RR 0.98, 95% CI 0.94 to 1.02; I2 = 0%; 7 studies; 1283 women; moderate certainty evidence). None of the included studies assessed adverse events of treatments. We downgraded the certainty of the evidence due to risk of bias and imprecision of the estimates. Brief psychosocial interventions may increase the rate of continuous abstinence among pregnant women who report alcohol use during pregnancy. Further studies should be conducted to investigate the efficacy and safety of psychosocial interventions and other treatments (e.g. medications) for women with AUD. These studies should provide detailed information on alcohol use before and during pregnancy using consistent measures such as the number of drinks per drinking day. When heterogeneous populations are recruited, more detailed information on alcohol use during pregnancy should be provided to allow future systematic reviews to be conducted. Other important information that would enhance the usefulness of these studies would be the presence of other comorbid conditions such as anxiety, mood disorders, and the use of other psychoactive substances.

Systematic assessment of the influence of quality of studies on mistletoe in cancer care on the results of a meta-analysis on overall survival

PurposeMistletoe treatment in cancer patients is controversial, and a Cochrane review concluded that due to heterogeneity, performing a meta-analysis was not suitable. However, several systematic reviews included meta-analyses in favor of mistletoe. The aim of this work was to assess the influence of the methodological quality of controlled studies on the results of a meta-analysis regarding overall survival.MethodsBetween April and August 2022, Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, CINAHL and Web of Science were systematically searched. In addition, reference lists of previously published meta-analyses were checked for relevant publications. A random effects meta-analysis with clustering was performed. The risk of bias within the studies was assessed using ROB 2.0 and ROBINS-I.ResultsThe search identified 4685 hits, and 28 publications reporting on 28 298 patients were included in the quantitative analysis. Overall, the analysis led to a significant result in favor of mistletoe therapy (overall HR = 0.61 with 95% CI [0.53;0.7]). According to our subgroup analysis of randomized studies, studies of higher quality (lower risk of bias) did not lead to a significant result in favor of mistletoe therapy (HR = 0.78; CI = [0.30; 2.00]).ConclusionsIn the case of mistletoe therapy, the results of the meta-analysis strongly depended on the methodological quality of the included studies. Calculating meta-analyses that include low-quality studies may lead to severe misinterpretation of the data.

Comparison of the coverage and rotation of asymmetrical and symmetrical tibial components: a systematic review and meta-analysis

BackgroundAn optimized fit of the tibial component to the resection platform and correct rotational alignment are critical for successful total knee arthroplasty (TKA). However, there remains controversy regarding the superiority of symmetric tibial component versus asymmetric tibial component. The objective of this systematic review and meta-analysis was to evaluate the current evidence for comparing the coverage and rotation of asymmetrical and symmetrical tibial component.MethodsWe searched potentially relevant studies form PubMed, Web of science, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and China National Knowledge Infrastructure (CNKI), up to 1 March 2023. Data extraction and quality assessment were performed by two independent reviewers. Meta-analysis was conducted using Review Manager 5.4.ResultsSixteen articles were identified. Compared to symmetric tibial component, asymmetric tibial component increased the coverage of the proximal tibial cut surface (MD, -2.87; 95%CI, -3.45 to -2.28; P < 0.00001), improved the prevalence of tibial baseplate underhang (OR, 0.16; 95%CI, 0.07 to 0.33; P < 0.00001) and malrotation (OR, 0.13; 95%CI, 0.02 to 0.90; P = 0.04), and reduced the degree of tibial component rotation (MD, -3.11; 95%CI, -5.76 to -0.47; P = 0.02). But there was no statistical significance for improving tibial baseplate overhang (OR, 0.58; 95%CI, 0.08 to 3.97; P = 0.58). Additionally, no revision had occurred for the two tibial components in the included studies.ConclusionThe current evidence shows asymmetric tibial component offer advantages in terms of coverage and rotation compared with symmetric tibial component in TKA.

Complications of Nasal Tip Stabilizing Grafts with Autologous Versus Irradiated Homologous Costal Cartilage in Septorhinoplasty: A Systematic Review.

Background: Complications associated with the use of autologous and homologous costal cartilage for nasal tip stabilizing grafts in septorhinoplasty are not well understood. Objective: The authors review current literature to evaluate complications associated with autologous and irradiated homologous costal cartilage (IHCC) used for septal extension and columellar strut grafts in rhinoplasty. Method: A comprehensive literature search was conducted in PubMed, Embase, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov. Articles that used autologous or IHCC for either septal extension or columellar strut grafts in patients undergoing septorhinoplasty were included. The primary outcomes analyzed were postoperative complications. Results: A total of 14 studies representing 1358 patients were included. The pooled complication rate was 4.7%. IHCC grafts were associated with a higher incidence of complications (n = 21, 5.0% vs. n = 44, 4.6%, p = 0.01). Resorption was the most common complication in the IHCC group and occurred significantly more frequently than in the autologous costal cartilage (ACC) group (n = 10, 2.4% vs. n = 5, 0.49%, p = 0.002). Deviation/warping was the most common complication in the ACC group (n = 16, 1.7%). Conclusion: Autologous and irradiated homologous costal rhinoplasties remain safe procedures. The increased incidence of resorption associated with IHCC grafts should be considered during preoperative planning.

Quantitative ultrasound radiomics analysis to evaluate lymph nodes in patients with cancer: a systematic review.

This systematic review aims to evaluate the role of ultrasound (US) radiomics in assessing lymphadenopathy in patients with cancer and the ability of radiomics to predict metastatic lymph node involvement. A systematic literature search was performed in the PubMed (MEDLINE), Cochrane Central Register of Controlled Trials (CENTRAL), and EMBASE (Ovid) databases up to June 13, 2023. 42 articles were included in which the lymph node mass was assessed with a US exam, and the analysis was performed using radiomics methods. From the survey of the selected articles, experimental evidence suggests that radiomics features extracted from US images can be a useful tool for predicting and characterizing lymphadenopathy in patients with breast, head and neck, and cervical cancer. This noninvasive and effective method allows the extraction of important information beyond mere morphological characteristics, extracting features that may be related to lymph node involvement. Future studies are needed to investigate the role of US-radiomics in other types of cancers, such as melanoma.

The effect of extracorporeal shock-wave therapy on pain in patients with various tendinopathies: a systematic review and meta-analysis of randomized control trials

ObjectivesTendinopathy is a common condition that affects the body’s tendon structures, causing discomfort, restricted movement, and reduced functionality. In this study, we looked at how extracorporeal shock wave therapy (ESWT) affected pain levels in individuals with various forms of tendinopathy around the world.DesignThis study is a comprehensive review and meta-analysis of previously published randomized controlled trials. To gather relevant data, the researchers performed keyword searches in international databases, including PubMed (Medline), Scopus, Web of Sciences, Cochrane Central Register of Controlled Trials (CENTRAL), Research Registers of ongoing trials (ClinicalTrials.gov), as well as Embase. The search was conducted up until March 2023. The quality of the selected articles was assessed using the Cochrane risk-of-bias method for randomized trials (RoB2).ResultsBased on the results of the meta-analysis, which included 45 clinical studies, the use of ESWT was found to have a significant impact on reducing pain in various conditions. The standardized mean difference (SMD) in patients with plantar fasciitis (PF) was reduced by 1.63 (SMD: -1.63, 95% CI: -3.04, -0.21; I2: 77.36%; P heterogeneity: 0.0001). For lateral epicondylitis (LE), the SMD was 0.63 (SMD: -0.63, 95% CI: -1.11, -0.16; I2: 67.50%; P heterogeneity: 0.003). In the case of chronic Achilles tendinopathy, the SMD was 1.38 (SMD: -1.38, 95% CI: -1.66, -1.10; I2: 96.44%; P heterogeneity: 0.0001). Additionally, in individuals with rotator cuff tendinopathy, the SMD for pain reduction was 2.37 units (SMD: -2.37, 95% CI: -3.58, -1.15; I2: 98.46%; P heterogeneity: 0.0001).ConclusionThis study suggests that ESWT can be a highly effective therapy option for relieving pain in people with tendinopathy. Nonetheless, it is encouraged to make additional recommendations based on high-quality clinical research and more accurate information in order to define the optimal therapeutic options for each type of tendinopathy.

Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis.

Evidence suggests that MDMA-assisted psychotherapy (MDMA-AP) has therapeutic potential for treatment of psychiatric illness. We conducted the first comprehensive systematic review and meta-analysis of the side effects of MDMA-AP across indications. We also assessed the quality of side effects-reporting in published trials of MDMA-AP. PubMed, EMBASE, PsycINFO, MEDLINE and Cochrane Central Register of Controlled Trials (CENTRAL) were systematically searched. Phase 2 and 3 MDMA-AP studies were included; Phase 1 studies, which assessed MDMA without psychotherapy, were not. Quality of side effects-reporting was assessed against the CONSORT Harms 2022 guidelines. We also compared numbers of adverse events reported in publications to those recorded in ClinicalTrial.gov registers. Thirteen studies were included, with eight contributing to the meta-analysis. In Phase 2 studies, MDMA-AP was associated with increased odds of any side effect during medication sessions (OR = 1.67, 95%CI (1.12, 2.49)) and in the 7 days following (OR = 1.59, 95%CI (1.12, 2.24)) relative to control conditions. In Phase 3 studies, MDMA-AP was associated with increased odds of any adverse event during the treatment period relative to placebo-assisted psychotherapy (OR = 3.51, 95%CI (2.76, 4.46)). The majority of RCTs were rated as having high risk of bias. Certainty of the evidence was rated as very low to moderate according to the GRADE framework. No included RCT had adequate adherence to the CONSORT Harms 2022 recommendations and reporting rates were also low. Compared to placebo, MDMA-AP was associated with increased odds of side effects, which were largely transient and mild or moderate in severity. However, identified limitations in existing evidence indicate that further investigation is needed to better characterize the safety profile of MDMA-AP and guide implementation.

Umeclidinium plus vilanterol versus fluticasone propionate plus salmeterol for chronic obstructive pulmonary disease: a meta-analysis of randomized, controlled trials.

Umeclidinium plus vilanterol (UMEC/VI) is an inhaled long-acting muscarinic antagonist/long-acting beta2-agonist (LAMA/LABA), recently approved as once-daily maintenance therapy for chronic obstructive pulmonary disease (COPD). This meta-analysis aims to assess the efficacy and safety of UMEC/VI compared with fluticasone propionate plus salmeterol (FP/SAL). A systematic search was conducted by a trained medical research librarian across MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and Chinese Biomedical Literature Database (CBM) for randomized controlled trials comparing UMEC/VI with FP/SAL in COPD patients. Two reviewers independently assessed the risk of bias and extracted data. The primary outcome was 0-24h weighted mean (wm) forced expiratory volume in the first second (FEV1), trough FEV1. The secondary outcomes were other lung functions, symptoms, quality of life, and safety. Three studies with 2119 patients were included in the meta-analysis. UMEC/VI showed improvement in 0-24h wm FEV1 (mean difference (MD) 0.08L, 95% confidence interval (CI) 0.06 to 0.10, P < 0.01, moderate quality) and trough FEV1 (MD 0.09L, 95% CI 0.07 to 0.11, P < 0.01, moderate quality) in comparison with FP/SAL. UMEC/VI statistically significantly improved all other lung functions compared with FP/SAL. However, there were no significant differences between UMEC/VI and FP/SAL in rescue-medication use, symptomatic endpoints, and health outcomes. UMEC/VI also demonstrated fewer drug-related adverse effects (risk ratio 0.47, 95% CI 0.27 to 0.82, P = 0.01, low quality). UMEC/VI, when compared with FP/SAL, demonstrated significant improvements in lung functions with fewer drug-related adverse effects. However, the conclusion was limited by the scarcity of studies and long-term trials.

Burden of Childhood Cancer and the Social and Economic Challenges in Adulthood

Significant advancements in pediatric oncology have led to a continuously growing population of survivors. Although extensive research is being conducted on the short-, medium-, and long-term somatic effects, reports on psychosocial reintegration are often conflicting; therefore, there is an urgent need to synthesize the evidence to obtain the clearest understanding and the most comprehensive answer. To provide a comprehensive review and analysis of the socioeconomic attainment of childhood cancer survivors (CCSs) compared with their unaffected peers. A systematic review and meta-analysis was conducted using data obtained from a comprehensive search of MEDLINE (via PubMed), Embase, and CENTRAL (Cochrane Central Register of Controlled Trials) databases on October 23, 2021; the search was updated until July 31, 2023. Eligible articles reported on educational attainment, employment, family formation, quality of life (QoL), or health-risk behavior-related outcomes of CCSs, and compared them with their unaffected peers. Study selection was performed in duplicate by 4 blinded independent coauthors. Data extraction was performed in duplicate by 4 independent authors following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Outcome measures were odds ratios (ORs) and mean differences with 95% CIs; data were pooled using a random-effects model. The search identified 43 913 articles, 280 of which were eligible for analysis, reporting data on a total of 389 502 survivors. CCSs were less likely to complete higher levels of education (OR, 0.69; 95% CI, 0.40-1.18), had higher odds of health-related unemployment (OR, 2.94; 95% CI, 1.90-4.57), and showed lower rates of marriage (OR, 0.72; 95% CI, 0.63-0.84) and parenthood (OR, 0.60; 95% CI, 0.49-0.74) compared with population-based controls. Study findings suggest that CCSs face several socioeconomic difficulties; as a result, the next goal of pediatric oncology should be to minimize adverse effects, as well as to provide lifelong survivorship support aimed at maximizing social reintegration.

Robot-assisted pedicle screw insertion versus navigation-based and freehand techniques for posterior spinal fusion in scoliosis: a systematic review and meta-analysis.

The role of robotics in spine surgery remains controversial, especially for scoliosis correction surgery. This study aims to assess the safety and efficacy of robotic-assisted (RA) surgery specifically for scoliosis surgery by comparing RA to both navigation systems (NS) and conventional freehand techniques (CF). As per the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, a systematic review and meta-analysis were conducted via an electronic search of the following databases: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL). All papers comparing RA to either NS or CF for posterior spinal fusion in scoliosis were included. Fixed and random effects models of analysis were utilised based on analysis heterogeneity. 10 observational studies were included in total. RA had significantly greater odds of accurate pedicle screw placement relative to both NS (OR = 2.02, CI = 1.52-2.67, p < 0.00001) and CF (OR = 3.06, CI = 1.79-5.23, p < 0.00001). The downside of RA was the significantly greater operation duration relative to NS (MD = 10.74, CI = 3.52-17.97, p = 0.004) and CF (MD = 40.27, CI = 20.90, p < 0.0001). Perioperative outcomes including estimated blood loss, radiation exposure, length of hospital stay, cobb angle correction rate, postoperative SRS score, VAS pain score, JOA score, as well as rates of neurological injury and revision surgery, were comparable between the groups (p > 0.05). RA offers significantly greater pedicle screw placement accuracy relative to NS and CF, however, surgery can take longer. In terms of perioperative outcomes, all three techniques are comparable.

Rehabilitation and Return to Play Protocols After Anterior Cruciate Ligament Reconstruction in Soccer Players: A Systematic Review.

Rehabilitation after anterior cruciate ligament ACL reconstruction (ACLR) is crucial for safe return to play (RTP) and reducing the chances of a reinjury. Yet, there is no consensus on the ideal functional tests to assess rehabilitation progress in soccer players after ACLR. The primary objective was to highlight the existing gap in the literature concerning the most effective standardized rehabilitation protocols and testing for facilitating successful RTP among soccer players. Systematic review; Level of evidence, 4. A systematic review using PubMed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) was conducted. Inclusion criteria encompassed original studies (level of evidence 1-4) that examined rehabilitation protocols, metrics of knee rehabilitation, and clinical outcomes after ACLR in soccer players. This review incorporated 23 studies, predominantly retrospective case series, with a total number of 874 soccer players who underwent ACLR and rehabiliation. 5 (21.7%) studies utilized an accelerated rehabilitation protocol, while 7 (30.4%) of studies utilized a criterion-based rehabilitation. A wide heterogeneity of data was extracted including functional tests of rehabilitation and RTP such as strength test batteries, hop test batteries, and movement quality assessments. Of the 23 selected studies, 2 (8.7%) used all 3 test batteries, 8 (34.8%) used 2 test batteries, 12 (52.2%) used 1 test battery, and 1 (4.3%) used 0 of the test batteries. The mean time between surgery and RTP ranged from 3 to 8 months with only 2 (8.7%) studies reporting complications after ACLR. Lastly, out of the total studies examined, 9 (39.1%) assessed patient-reported outcome measures (PROMs), all of which demonstrated significant improvement from the initial assessment to the final follow up. Soccer-specific rehabilitation after ACLR lacks standardization. Even though many studies have assessed protocols for optimal RTP and reduced secondary ACL injuries, there is a gap in the literature regarding the most effective protocols and RTP testing. The methodology reported by Kyritsis et al could serve as a foundation for future prospective randomized multicenter studies to establish a standard rehabilitation protocol and enable a successful return to soccer.

Psychological treatments for temporomandibular disorder pain-A systematic review.

Temporomandibular disorders (TMD) are common. They affect abilities for carrying out daily tasks and influence different psychological aspects. In addition to standard treatment, psychological treatments have been suggested. The aim was to investigate the effects of psychological treatments on patients with painful TMD in a short- and long-term perspective. An electronic search was conducted in the databases MEDLINE, CINAHL, EMBASE, the Cochrane Central Registry of Controlled Trials (CENTRAL), and Web of Science for randomized clinical trials (RCTs) reporting psychological interventions for TMD. Registered beforehand in PROSPERO (CRD42022320106). In total, 18 RCTs were included; six RCTs that could be used in the meta-analysis, and all 18 RCTs were used in the narrative synthesis. Risk of bias was assessed by the Cochrane's tool for assessing risk of bias and certainty of evidence by GRADE. The narrative synthesis indicates that psychological treatment options seem equivalent to standard treatment for painful TMD. The meta-analysis showed that a combination of psychological treatment and standard treatment and manual treatment (very low-quality evidence) are significantly better in pain reduction than just counselling and standard treatments of TMD. This study indicates that psychological treatments seem to reduce pain intensity in individuals with painful TMD, and that the effect seems to be equally good as standard treatment. However, a combination of psychological treatments and standard treatments seems to have an even better effect. This indicates that psychological treatments are promising as an additional treatment approach for painful TMDs.

Nonpharmacological Interventions for Managing the Dyspnea-Fatigue-Physical/Role Functioning Symptom Cluster in Lung Cancer Patients: A Systematic Review

Objective. Lung cancer (LC) patients suffer from multiple cooccurring symptoms. Interventions that have the potential to impact more than one symptom within a symptom cluster should be identified. The aim of this review was to examine nonpharmacological interventions that were effective in the management of one or more of the following symptoms in LC patients: dyspnea, fatigue, physical functioning (PF), and role functioning (RF). Methods. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was used for reporting this systematic review. The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (using the PubMed interface), Embase (using the embase.com interface), and Web of Science were used as electronic databases. Randomized controlled studies were included if they assessed the effects of nonpharmacological interventions on dyspnea, fatigue, PF, and/or RF in patients with LC. Studies were evaluated with the Cochrane risk of bias tool, and relevant data were extracted and narratively summarized. Results and Conclusions. In total, 89 articles were included. Search results (until April 2023) show that most evidence was found for exercise interventions, followed by multicomponent, psychoeducational, diet, acupuncture, and other interventions. Studies that had an effect on multiple symptoms were observed to have the most frequent instances of positively affecting dyspnea, followed by PF, fatigue, and RF.

A systematic review of participant descriptors reported in studies of adhesive small bowel obstruction.

Reporting of participant descriptors in studies of adhesive small bowel obstruction (ASBO) can help identify characteristics associated with favourable outcomes and allow comparison with other studies and real-world clinical populations. The aim was to identify the pattern of participant descriptors reported in studies assessing interventions for ASBO. This systematic review was registered with PROSPERO (CRD42021281031) and reported in line with the PRISMA checklist. Systematic searches of Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were undertaken to identify studies assessing operative and non-operative interventions for adults with ASBO. Studies were dual screened for inclusion. Descriptors were categorised into conceptual domains by the research team. Searches identified 2648 studies, of which 73 were included. A total of 156 unique descriptors were identified. On average, studies reported 12 descriptors. The most frequently reported descriptors were sex, age, SBO aetiology, history of abdominal surgery, BMI and ASA classification. The highest number of descriptors in a single study was 34, compared to the lowest number of descriptors which was one. Pathway factors were the least frequently described domain. Overall, 37 descriptors were reported in just one study. There is a lack of consistency in participant descriptors reported in studies of SBO. Furthermore, a significant proportion of the descriptors were used infrequently. This makes it challenging to assess whether study participants are representative of the wider population. Further work is required to develop a Core Descriptor Set to standardise the reporting of patient characteristics and reduce heterogeneity between studies.