Impact of diabetes on outcomes in hypertrophic cardiomyopathy: a GRADE meta-analysis.

Evidence Evaluation Process and Management of Potential Conflicts of Interest: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations.

To evaluate the association between left atrial appendage volume (LAAV) and atrial fibrillation (AF) recurrence after catheter ablation (CA) and explore the potential mechanism. Systematic review and meta-analysis. PubMed, EMBASE, Web of Science and Cochrane Library databases were searched systematically from inception through 28 September 2024 to identify relevant studies. Observational studies that estimated the association between LAAV and AF recurrence. Two independent investigators screened studies for inclusion and extracted data. Statistical heterogeneity was assessed using the Cochrane Q-test and I², with p<0.1 or I² > 50% indicating significant heterogeneity. This study used a random-effects model to account for potential heterogeneity. The quality of the included studies was assessed using the Newcastle-Ottawa Scale (NOS), Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I tool) and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Publication bias was examined through funnel plots and Egger's test. Seventeen studies (3078 patients) were included. Meta-analysis of 11 studies suggested that LAAV was significantly associated with the risk of AF recurrence in both univariate (HR 1.06, 95%CI 1.04 to 1.08, p<0.01; I2=49.7%) and multivariate analyses (HR 1.10, 95%CI 1.05 to 1.16, p<0.01; I2=77.4%). The relationship between LAAV and recurrence of persistent AF (HR 1.11, 95% CI 1.03 to 1.20, p<0.05; I² = 73.0%) was significant. However, no significant association was found for paroxysmal AF (HR 1.01, 95% CI 0.94 to 1.07, p>0.05; I² = 0%). Meta-analysis of 13 studies suggested that patients with recurrence had larger LAAV values than those without recurrence (standardised mean difference (SMD) 0.54, 95% CI 0.36 to 0.71, p<0.01; I2=67.9%), and persistent AF patients had larger LAAV values than paroxysmal AF (SMD 0.29, 95% CI 0.02 to 0.57, p=0.05; I2=60.6%). Sensitivity analyses did not change these results. Subgroup analyses largely aligned with the overall findings, though study design and sample size contributed to heterogeneity. The mean NOS scores indicated moderate to high study quality; ROBINS-I assessments showed that most studies had a low to moderate overall risk of bias; and the GRADE approach rated the certainty of outcome evidence as low. Our study suggests that LAAV may be a significant predictor of AF recurrence after CA. Incorporating LAAV into pre-ablation screening may enhance risk stratification, guiding tailored follow-up and treatment strategies. CRD42022339910.

A risk of bias instrument for non-randomized studies of exposures: A users' guide to its application in the context of GRADE

BackgroundSleep disturbances are common among older adults, affecting up to 50% of this population and significantly impacting quality of life and health outcomes. Music therapy has been proposed as a non-pharmacological intervention to improve sleep quality in this population, but evidence regarding its effectiveness remains inconsistent across individual studies. Therefore, this systematic review and meta-analysis aims to synthesize available evidence on the effectiveness of music therapy interventions for improving sleep quality in elderly adults..MethodsWe conducted a systematic review and meta-analysis following PRISMA guidelines. Major databases were searched for studies evaluating music interventions for sleep quality in adults aged 50 + years. Randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) were included. Risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB 2) tool for RCTs and the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool for non-RCTs. Standardized mean differences (SMDs) with 95% confidence intervals (CIs) were calculated using both common effect and random effects models. The certainty of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.ResultsThe initial search retrieved 473 articles from electronic databases. After removing duplicates and screening, 10 studies (6 RCTs, 4 non-RCTs) published between 2010 and 2023 with 602 participants met inclusion criteria and were included in the meta-analysis. The random effects model showed significant improvement in sleep quality with music therapy (SMD: −0.79; 95% CI, −1.25 to −0.33; P < .001). Substantial heterogeneity was observed (I² = 79%; Q = 42.54; P < .001). Subgroup analysis revealed significant benefits in RCTs (SMD: −0.59; 95% CI, −1.11 to −0.07) but not in non-RCTs (SMD: −1.08; 95% CI, −2.36 to 0.19). Sensitivity analyses confirmed the robustness of findings, and no publication bias was detected. GRADE assessment indicated very low certainty of evidence for both RCTs and non-RCTs due to risk of bias concerns and substantial heterogeneity.ConclusionsMusic therapy demonstrates significant improvement in sleep quality among older adults; however, the very low certainty of evidence based on GRADE assessment suggests caution in clinical recommendations. Future research should address methodological limitations, particularly regarding bias in outcome measurement and intervention implementation, to provide more definitive evidence for clinical practice guidelines.

Unconditional cash transfers (UCTs) through social programs or direct cash transfers (DCTs) may address drivers of pregnancy-related morbidity and mortality. To summarize evidence on UCTs and postpartum outcomes in the United States. PubMed, Embase, Web of Science, Social Science Research Network, and structured internet searches through 28 January 2025. Primary research reporting associations between UCTs and postpartum outcomes (0 to 2 years after delivery) in the United States. Dual data extraction with predefined outcomes: infant or child care, reproductive health, substance use, other mental health outcomes, and other outcomes. Study quality was assessed using the Cochrane Risk of Bias 2 and ROBINS-I (Risk Of Bias In Non-randomised Studies - of Interventions) tools. Strength of evidence (SOE) was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Eleven reports from 6 studies were identified. Four quasi-experimental (QE) studies examined 3 different social programs, 2 of which targeted populations with low incomes. Seven reports from 2 randomized controlled trials (RCTs) examined DCTs to postpartum persons with low incomes. The evidence on UCTs showed an increase in breastfeeding (high SOE [2 RCTs, 2 QE studies]), little or no difference in postpartum mood (high SOE [1 RCT, 2 QE studies]), and low SOE or insufficient evidence for all other associations. Unpublished studies and those not published in English may have been missed. Nonrandomized studies were subject to reporting or recall bias, reducing SOE. Study heterogeneity prevented meta-analysis. Unconditional cash transfers increase breastfeeding in diverse settings and populations and result in little or no difference in postpartum mood specifically in persons with low incomes. No studies examined DCTs given during pregnancy. More evidence is needed on associations between UCTs and key clinical outcomes, such as postpartum maternal morbidity and mortality. None. (Registered on Open Science Framework [https://osf.io/4c3nx]).

Evaluation of the risk of bias in non-randomized studies of interventions (ROBINS-I) and the ‘target experiment’ concept in studies of exposures: Rationale and preliminary instrument development

Introduction: The Risk Of Bias in Non-randomized Studies – of Interventions (ROBINS-I) tool evaluates internal validity (risk of bias) in non-randomized studies of interventions in comparison to an ideal (hypothetical) randomized trial. The use of ROBINS-I in studies dealing with exposures or interventions in environmental health has not yet been explored. This study evaluated the usability and applicability of ROBINS-I in studies of environmental health (EH) exposure. Methods: Three researchers in sequential rounds applied ROBINS-I to three systematic reviews of EH exposures: bisphenol-A and obesity; perfluorooctanoic acid and birth weight; and polybrominated diphenyl ethers and thyroid function. We began by providing instructions for application of ROBINS-I to EH studies, including possible confounders and co-exposures specific to the exposures considered in the three reviews. For the first two rounds of testing, two reviewers independently applied ROBINS-I and provided feedback on usability of the tool. Barriers and facilitators to the appropriateness of ROBINS-I for environmental health were identified and modifications made to the tool, as necessary. For the third round of testing, three reviewers independently applied the tool and came to consensus on item-level and overall study risk of bias. Results: Suggested modifications ranged from syntax and wording to conceptual changes to the tool. The term “intervention” was replaced with “exposure” throughout the document. Additional instructions were provided to address assessment of cross-sectional studies. Fields to collect information on measurement of exposures and outcomes of interest was added to the project protocol. Additional granularity was added to the measurement of interventions/exposure domain. Conclusion: Modifications made to the risk of bias tool to tailor it to studies of EH exposure increased understanding and application of the tool, as well as consistency in responses.

The concept of bad posture being a dominant driver of pain is commonly held belief in the society. This may explain the significant attention supportive clothing such as posture-correcting shirts has recently gained in Scandinavia and the USA. The aim of this scoping review was to present an overview and synthesis of the available evidence for the use of posture-correcting shirts aimed at reducing pain or postural discomfort and optimising function/posture. A systematic search was conducted for literature investigating the effect of posture-correcting shirts on musculoskeletal pain or function. PubMed, Embase, CINAHL, PEDro and the Cochrane Library were searched for relevant literature. Results of the searches were evaluated by two independent reviewers in three separate steps based on title, abstract and full text. For data synthesis, the population, intervention, comparator and outcome were extracted. The quality of the literature was evaluated using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies and the risk of bias was assessed using the Risk Of Bias In Non-randomized Studies - of Interventions (ROBINS-I) assessment tool or the RoB 2.0 tool for individually randomized, parallel group trials. The overall confidence in the literature was determined using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). A total of 136 articles were identified and six of these were included in the review. These studies were heterogeneous with regards to aims, outcomes and methods, presenting contrasting results. The overall findings were that posture-correcting shirts change posture and subjectively have a positive effect on discomfort, energy levels and productivity. The quality of the included literature was poor to fair with only one study being of good quality. The risk of bias was serious or critical for the included studies. Overall, this resulted in very low confidence in available evidence. An important limitation of all studies was that they were conducted in pain-free individuals. The contrasting findings and the low quality of current literature, questions the intended effect of posture-correcting shirts and whether the changes it creates are in fact useful for clinical practice. Moreover, the findings are contrasted by the available evidence regarding posture and pain with a particular focus on whether this management strategy may have a detrimental effect on people living with musculoskeletal pain. A major limitation to the existing literature on the effect of posture-correcting shirts is that no studies have investigated their effect in clinical populations. Based on the available literature and the major limitation of no studies investigating clinical populations, there is no good quality evidence to support recommendation of posture-correcting shirts as a management strategy for musculoskeletal pain. Promotion of this product may reinforce the inaccurate and unhelpful message that poor posture leads to pain. The efficacy of such garments should be tested in clinical populations and not only in pain-free individuals, to assess whether there is any meaningful benefit of this management approach. Until then, the use of posture-correcting shirts for musculoskeletal pain is not supported by current evidence.

Negative pressure wound therapy (NPWT) has been used because of its perceived advantages in reducing surgical site infections, wound complications, and the need for further surgery. The purpose of this study was to assess the infection rates, wound complications, length of stay, and financial burden associated with NPWT use in primary and revision total knee arthroplasty (TKA). We performed a PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) systematic review of the existing literature on using NPWT in primary and revision TKA. PubMed, Embase, Science Direct, and the Cochrane Library were utilized. The risk of bias was evaluated using the ROBINS-I (Risk Of Bias In Non-randomised Studies - of Interventions) tool, and the quality of evidence was evaluated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria. Twelve articles that evaluated 1,403 primary TKAs and 279 revision TKAs were reviewed. NPWT significantly reduced complication rates in revision TKA. However, there was no significant difference in infection rates between NPWT and regular dressings in primary or revision TKA. NPWT use in primary TKA significantly increased the risk of blistering, although no increase in reoperations was noted. The analysis showed a possible reduction in length of stay associated with NPWT use for both primary and revision TKA, with overall health-care cost savings. Based on a meta-analysis of the existing literature, we do not recommend the routine use of NPWT. However, in high-risk revision TKA and selected primary TKA cases, NPWT reduced wound complications and may have health-care cost savings. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Thrombolytic Therapy for Venous Thromboembolism in the Pediatric Population: A Systematic Review and Meta-Analysis

Effective medical education must balance clinical service demands for institutions and learning needs of trainees. The question of whether these are competing demands or can serve complementary roles has profound impacts on graduate medical education, ranging from funding decisions to the willingness of community-based hospitals and physicians to include learners at their clinical sites. Our objective in this article was to systematically review the evidence on the impact of medical trainees on productivity and efficiency in the emergency department (ED). We queried PubMed, Embase, Scopus, and Web of Science from earliest available dates to March 2023. We identified all studies evaluating the impact of medical students and/or residents in the ED on commonly used productivity and efficiency metrics. Only studies in EDs in the United States were included. No additional filters were used. We assessed the risk of bias of included studies using the Risk of Bias in Non-randomized Studies - of Interventions (ROBINS-I) tool. Certainty of evidence was rated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Study findings were combined in a narrative synthesis and reported according to PRISMA guidelines. The literature search yielded 3,390 unique articles for abstract screening. Eighty-one abstracts were identified as relevant to our PICO question (population, intervention, control, and outcomes), 76 of which had retrievable full-text articles and the themes of which were discussed in a narrative synthesis. We selected 13 of the full-text articles for final inclusion in a systematic review. Studies were roughly split between observational (6) and quasi-experimental (7) designs. The majority of studies (11) were single-site studies. Only two studies could be graded as low risk of bias per the ROBINS-I tool. Low-GRADE evidence suggests that students and residents decrease ED efficiency by a statistically small effect size of debatable clinical importance. Residents provide a moderate boost to ED productivity. Students do not produce a statistically or clinically significant impact on ED productivity. Residents increase emergency department relative value units revenue by $26.30 an hour, while students have no impact. Both types of learners decrease efficiency.

BackgroundRheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease that affects approximately 0.5% to 1% of the population in the United States and Northern Europe. Interstitial lung disease (ILD) is the most common and severe pulmonary manifestation of RA, collectively referred to as RA-associated ILD (RA-ILD). RA-ILD contributes significantly to morbidity and mortality and often presents with a variable clinical course. Although corticosteroids and disease-modifying antirheumatic drugs (DMARDs) remain the cornerstone of RA management, their role in RA-ILD is less clearly defined. In contrast, antifibrotic therapies such as pirfenidone and nintedanib, initially developed for idiopathic pulmonary fibrosis, are now being explored for their potential in treating fibrosing variants of RA-ILD. Despite increasing clinical use, no systematic review has comprehensively compared the safety and efficacy of antifibrotic versus anti-inflammatory therapies in chronic RA-ILD.ObjectiveThis study aims to compare the impact of antifibrotic and anti-inflammatory therapies on lung function, radiologic progression, clinical outcomes, and safety in patients with chronic RA-ILD.MethodsThis study will follow PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and is registered with PROSPERO (CRD42024583847). A comprehensive search of PubMed, Embase, and the Cochrane Library will be conducted for studies published between January 1991 and August 2024. Eligible studies will include adult patients (aged ≥18 years) with a diagnosis of RA and confirmed ILD based on radiological or histopathological findings who have been treated with either antifibrotic or anti-inflammatory therapies. The PECOS (Population, Exposure, Comparator, Outcome, Study Design) framework will be used to define inclusion criteria. The primary outcomes assessed in this review will include the following pulmonary function parameters: forced vital capacity, forced expiratory volume in 1 second, and diffusing capacity of the lungs for carbon monoxide. Anti-inflammatory therapies will be stratified into corticosteroids, conventional synthetic DMARDs, and biologic DMARDs to account for heterogeneity. The Cochrane Risk of Bias 2 (RoB 2) and Risk of Bias in Non-randomized Studies - of Interventions (ROBINS-I) tools will be used for quality assessment, and GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology will be used to evaluate the certainty of evidence.ResultsThe literature search and screening commenced in August 2024, and data extraction is underway. The final results are expected by December 2025.ConclusionsThis systematic review and meta-analysis will provide a comprehensive comparison of antifibrotic and anti-inflammatory therapies in the treatment of chronic RA-ILD. The findings will help inform clinical decision-making, support evidence-based treatment selection, and identify gaps in current research. By addressing both efficacy and safety, this review aims to guide future studies and improve patient outcomes for this complex and debilitating condition.Trial RegistrationPROSPERO CRD42024583847; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024583847International Registered Report Identifier (IRRID)DERR1-10.2196/73219

This study aims to systematically review the effect of mobile applications (apps) in supporting individuals with cerebral palsy (CP) and their caregivers. Five databases were searched for articles published between 2013 and 2023. Included studies were original with full available text that assessed the effectiveness of mobile apps to support the daily life of individuals with CP and their caregivers. The Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) tool was used to assess the risk of bias, and quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Six studies, encompassing 91 individuals with CP, were included. Included studies were mostly experimental (3/6, 50.0%). Predominantly focused on children with CP, the studies covered various areas, such as assistance with speech impairment, intervention mapping with gamification, athletics, relaxation, and educational apps for individuals with CP. Among all, one study focused on caregivers. Out of six studies, two were found to be serious (33.3%), and four (66.7%) had a moderate risk of bias. Quality assessments revealed that grades were low (4/6, 66.7%) and very low quality (2/6, 33.3%). The limited available studies indicate the need for future research on the potential of integrating technological solutions, such as mobile apps, in addressing various facets of management and care of individuals with CP.

IntroductionMetallic and elastomeric ligatures are widely used in orthodontics to secure the archwire within the bracket slots, but elastomeric ligatures have traditionally been associated with increased microbial colonization, which could adversely affect periodontal health.AimThis systematic review compares the periodontal effects of elastomeric and steel ligatures used for orthodontic fixed appliances.MethodsUnrestricted literature search of 7 databases (MEDLINE, Scopus, Web of Science, Embase, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and Virtual Health Library) up to July 2023 were performed for randomized / non-randomized clinical studies on humans comparing the two ligation methods during fixed-appliance therapy. After duplicate study selection, data extraction, and risk-of-bias assessment with the Risk of Bias (RoB) 2 or the Risk Of Bias In Non-randomized Studies - of Interventions (ROBINS-I) tool, random-effects meta-analyses of Mean Differences (MD) or Standardized Mean Differences (SMD) and their 95% confidence intervals (CIs) were carried out, followed by assessment of certainty of existing evidence with the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach.ResultsA total of 11 studies (3 randomized / 8 non-randomized) with 354 patients (mean age 14.7 years and 42% male) were included. No statistically significant differences were seen for plaque index (5 studies; SMD = 0.48; 95% CI = -0.03 to 1.00; P = 0.07), gingival index (2 studies; MD = 0.01; 95% CI = -0.14 to 0.16; P = 0.89), probing pocket depth (2 studies; MD = 0; 95% CI = -0.17 to 0.16; P = 0.97), or Streptococcus mutans counts (4 studies; SMD = 0.40; 95% CI=-0.41 to 1.20; P = 0.21). Elastomeric ligatures were associated with moderately increased total bacterial load (3 studies; SMD = 0.43; 95% CI = 0.10 to 0.76; P = 0.03). Confidence in these estimates was low in all instances due to the inclusion of non-randomized studies with high risk of bias.ConclusionsExisting low quality evidence indicates that ligature method does not seem to influence the periodontal health during fixed treatment, even if elastomeric ligatures are associated with a moderate increase of bacterial load.RegistrationPROSPERO (CRD42023444383)

Beyond gynecological issues, women with endometriosis have a significant risk of cardiac outcomes. Despite this evidence, the extent and mechanisms of the association remain unclear. The aim of this study was to evaluate the association between endometriosis and the incidence of cerebro-cardiovascular disorders. Using preferred reporting items for systematic review and meta-analyses (PRISMA) guidelines, seven databases were searched as of October 14, 2024, for observational studies assessing the association between endometriosis and cerebro-cardiovascular disorders. The main outcome was major adverse cardiovascular and cerebrovascular event (MACCE) while the secondary outcomes included all-cause mortality, cerebrovascular accident (CVA), ischemic heart disease (IHD), myocardial infarction (MI), arrhythmia, and heart failure (HF). Bias was assessed with the risk of bias in non-randomized studies of exposures (ROBINS-E) tool. Odds ratios with 95% confidence interval (CI) were calculated using random-effects meta- analysis. Evidence certainty was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Robustness was assessed via sensitivity analyses and trial sequential analysis (TSA). Out of 3,141 studies, nine cohort studies encompassing 1,670,589 women (follow-up 7-28 years) were included. Endometriosis was associated with 24% higher odds of MACCE incidence (95%CI: 1.18-1.31, moderate certainty). In addition, having endometriosis increased the odds of CVA by 49% (95%CI: 1.20-1.85, high certainty), IHD by 64% (95%CI: 1.31-2.05, low certainty), MI by 53% (95%CI: 1.18-1.98, high certainty), arrhythmias by 24% (95%CI: 1.12-1.37, high certainty), and HF by 13% (95%CI: 1.03-1.25, high certainty). Endometriosis did not significantly associate with all-cause mortality. Sensitivity analyses and TSA reinforced all of these findings. In conclusion, endometriosis was significantly associated with increased odds of cerebro-cardiovascular disorders. Future research should clarify the underlying mechanisms and develop targeted prevention strategies.