Overall Risk Of Bias Research Articles

Effectiveness of psychological interventions in endometriosis: a systematic review with meta-analysis

IntroductionEndometriosis is a chronic gynecological disease associated with chronic debilitating pain, poor mental health and quality of life. The objective of this paper is to evaluate the effectiveness of psychological interventions aimed at improving the pain, quality of life and mental health of women with endometriosis.MethodsA systematic review (SR) of the literature with meta-analysis (MA) was carried out. MEDLINE, Embase, PsycINFO and CENTRAL were searched to locate Randomized Controlled Trials (RCTs). The risk of bias assessment of each study was conducted using the Cochrane Collaboration’s RoB 2.0 tool.ResultsSeven RCTs were included (N = 757). The data obtained suggest that psychological interventions reduce dyspareunia [standardized mean difference (SMD): -0.54, 95% CI: −0.86, −0.22] and dyschezia [mean difference (MD): -2.90, 95% CI: −4.55, −1.26] and increase mental health levels (SMD: 0.70, 95% CI: 0. 42, 0.99); they also point to a large reduction in levels of trait anxiety (MD: -6.63, 95% CI: −8.27, −4.99) and depression (MD: -2.49, 95% CI: −3.20, −1.79), and a likely reduction in state anxiety (MD: -9.72, 95% CI: −13.11, −6.33) experienced by women with endometriosis. It was also identified that psychological interventions probably slightly reduce pelvic pain and may increase physical health. However, most of the included studies have a high overall risk of bias or have certain concerns, which limit conclusions about the certainty of the evidence.DiscussionThe available evidence indicates that psychological interventions are effective in improving the pain, quality of life and mental health variables of women with endometriosis.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, CRD42024516100.

Effects of Yi Jin Jing on enhancing muscle strength and physical performance in older individuals: a systematic review and meta-analysis

BackgroundThe aging population is rapidly increasing, leading to physical decline and higher risks of chronic diseases, including sarcopenia, which adversely affects muscle quality and strength. Yi Jin Jing (YJJ), a traditional Chinese exercise method, can enhance flexibility and strength, but evidence regarding its effectiveness in older adults is conflicting. This meta-analysis aims to systematically evaluate the effects of YJJ on muscle strength and physical performance in this demographic.MethodsWe searched seven electronic databases: China National Knowledge Infrastructure, Wanfang Data, Sinomed, Web of Science, PubMed, Cochrane Library, and EMBASE to identify randomized controlled trials (RCTs). Following PRISMA guidelines, we quantified the effects of YJJ on muscle strength (grip strength, isokinetic strength) and physical performance (chair sit-to-stand, squatting-to-standing, shoulder flexibility, sit-and-reach tests). Treatment effects were calculated using Hedges’g. The Cochrane tool assessed risk of bias, the PEDro scale evaluated methodological quality, and the GRADE method assessed evidence quality. Data analysis was conducted using Stata 17.0 software, utilizing standardized mean differences (SMD) and 95% confidence intervals (CIs).ResultsThis meta-analysis included 10 RCTs involving 590 participants. The overall risk of bias was assessed to be low. The methodological quality of these studies was generally moderate, and the quality of the main results varied from low to moderate. The findings revealed that YJJ had considerable effects on the chair sit-to-stand test (Hedges’g = 1.06), squatting-to-standing test (Hedges’g = 1.08), and small to moderate effects on handgrip strength (Hedges’g = 0.25), 60°/s extensor peak torque (Hedges’g = 0.47), 60°/s extensor average power (Hedges’g = 0.31), 60°/s extensor total work (Hedges’g = 0.29), 60°/s flexor peak torque (Hedges’g = 0.42), 60°/s flexor average power (Hedges’g = 0.37), and 180°/s extensor peak torque (Hedges’g = 0.29), and left shoulder flexibility (Hedges’g = 0.4). However, there were no significant improvement effects in 180°/s extensor average power (Hedges’g = 0.19), 180°/s extensor total work (Hedges’g = 0.11), 180°/s flexor peak torque (Hedges’g = 0.01), 180°/s flexor average power (Hedges’g = −0.08), right shoulder flexibility (Hedges’g = 0.09), and sit-and-reach test (Hedges’g = 0.15).ConclusionYJJ significantly enhances specific aspects of physical performance, particularly chair sit-to-stand and squatting-to-standing tests, while showing small and moderate improvements in handgrip strength and knee muscle strength. However, it had no significant effects on other metrics, including shoulder flexibility and sit-and-reach tests.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024530487, Registration number: CRD42024530487.

Predicting Biochemical Recurrence of Prostate Cancer Post-Prostatectomy Using Artificial Intelligence: A Systematic Review

Background/Objectives: Biochemical recurrence (BCR) after radical prostatectomy (RP) is a significant predictor of distal metastases and mortality in prostate cancer (PCa) patients. This systematic review aims to evaluate the accuracy of artificial intelligence (AI) in predicting BCR post-RP. Methods: Adhering to PRISMA guidelines, a comprehensive literature search was conducted across Medline, Embase, Web of Science, and IEEE Xplore. Studies were included if they utilised AI to predict BCR in patients post-RP. Studies involving patients who underwent radiotherapy or salvage RP were excluded. This systematic review was registered on PROSPERO (International prospective register of systematic reviews) under the ID CRD42023482392. Results: After screening 9764 articles, 24 met the inclusion criteria. The included studies involved 27,216 patients, of whom 7267 developed BCR. AI algorithms developed using radiological parameters demonstrated higher predictive accuracy (median AUROC of 0.90) compared to algorithms based solely on pathological variables (median AUROC of 0.74) or clinicopathological variables (median AUROC of 0.81). According to the Prediction Model Risk of Bias Assessment Tool (PROBAST), the overall risk of bias was unclear in three studies due to ambiguous inclusion criteria and the exclusion of many patients because of missing follow-up data. In seven studies, the developed AI outperformed or was at least equivocal to traditional methods of BCR prediction. Conclusions: AI shows promise in predicting BCR post-RP, particularly when radiological data were used in its development. However, the significant variability in AI performance and study methodologies highlights the need for larger, standardised prospective studies with external validation prior to clinical application.

Efficacy of an erector spinae plane block for renal colic: a systematic review and meta-analysis

Background and aimThe passage of kidney stones through the ureter creates renal colic, a severe visceral abdominal pain. Renal colic is typically managed with non-steroidal anti-inflammatory drugs and opioids. Yet,...

Effectiveness of Acupuncture in Improving Quality of Life for Patients with Advanced Cancer: A Systematic Review and Meta-Analysis.

To investigate the effect of acupuncture on advanced cancer patients by meta-analysis. Nine databases (the Cochrane Central Register of Controlled Trials, MEDLINE, Web of Science, Embase, China National Knowledge Infrastructure, the Cumulative Index to Nursing and Allied Health Literature, Chinese Biomedical Literature Database, China Science and Technology Journal Database, and WanFang Data) were searched for randomized controlled trials (RCTs) on acupuncture in advanced cancer patients published from inception to February 13, 2023 and updated to June 1, 2023. Primary outcomes were quality of life (QOL), while secondary outcomes were pain, fatigue, and adverse events (side effects). Data synthesis was performed using RevMan V.5.3 to calculate pooled effect sizes. RoB-2 was used for the risk of bias, and the quality of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool. Totally 17 RCTs involving 1,178 participants were included, 15 of which were pooled for meta-analysis. Most studies demonstrated some concern for the overall risk of bias. The pooled data indicated that acupuncture was associated with improved QOL [mean difference (MD)=6.67, 95% confidence interval (CI): 5.09 to 8.26], pain (MD=-1.18, 95% CI -2.28 to -0.08), and adverse events (risk ratio=0.30, 95% CI: 0.26 to 0.57) compared with control groups. Fatigue outcome was not included. Heterogeneity was substantial, and GRADE evidence was very low for both QOL and pain. Acupuncture could benefit patients with advanced cancer and is considered safe compared with usual care. However, the evidence regarding QOL and pain outcomes requires further validation. It is crucial to encourage the development of high-quality studies to strengthen this evidence. (Registry No. CRD42023423539).

Vitamin D serum levels and temporomandibular disorders: A systematic review and meta-analysis

ObjectiveThis systematic review evaluates the connection between vitamin D serum levels, deficiency, and temporomandibular disorders (TMD), offering a meta-analysis of the existing evidence in this domain. DesignThe Scopus, ISI Web of Science, and Pubmed databases were searched for human studies concerning the connection between vitamin D and TMD comprising a control group. A random-effect model with forest plots was used for vitamin D serum levels mean difference (MD), vitamin D deficiency odds ratio (OR), and risk difference (RD) between subjects with and without TMD. Subgroup analysis was conducted based on ethnicity, overall risk of bias, TMD diagnosis method, and study designs. A p-value lower than 0.05 was considered significant. The certainty of the meta-evidence was evaluated according to the GRADE approach. ResultsOf the 2621 identified unique records, 15 studies were included in the study, eight of which were considered for the meta-analysis. The meta-analysis revealed a significant vitamin D deficiency OR (3.85; 95 % CI: 2.35 – 5.43; Certainty: Low) and RD (22 %; 95 % CI: 11 % - 32 %; Certainty: Very low), and vitamin D serum levels MD (-5.03 ng/mL; 95 % CI: −9.92 – −0.13; Certainty: Very low) between subjects with and without TMD. Among subgroup analyses, only the difference in vitamin D MD between Middle Eastern and European patients was significant (P < 0.01). ConclusionConsidering the low to very low certainty of the evidence, vitamin D serum levels are significantly lower, and vitamin D deficiency is significantly more prevalent in TMD patients.

Risk Prediction Models for Adverse Drug Reactions and Adverse Drug Events in Older Adults – A Systematic Review and Meta-analysis

Abstract Background Adverse drug reactions (ADRs) and adverse drug events (ADEs) are common and result in significant morbidity, mortality and healthcare costs. As the world’s population ages, the consumption of medications and healthcare will increase. Models predicting ADR risks in older adults have previously been found to lack reliability and validity. The aim of this systematic review and meta-analysis is to provide an updated, comprehensive quality assessment and analysis of ADR-risk prediction tools in older adults. Methods Standard computerised-databases and citations were searched (2012 to 2023) to identify relevant peer-reviewed studies. Studies which developed and/or validated an ADR/ADE prediction model for use in older adults were included. Four studies from a previous systematic review were also included. The TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) guidelines were used to evaluate each of the included studies. Random effects models were used to derive a pooled discrimination estimate (area under the receiver operation curve; AUROC) for model development studies and model validation studies. The prediction model risk of bias assessment tool (PROBAST) was applied to evaluate bias. Results Five out of 11,481 titles, plus four previous studies, met all inclusion criteria and underwent TRIPOD evaluation. Meta-analysis resulted in a favourable pooled AUROC 0.75 (95% CI 0.57, 0.87; I-squared= 96.65%) for model development studies and 0.70 (95% CI 0.57, 0.80; I-squared= 90.53%) for model validation studies but there was substantial heterogeneity. Studies had poor adherence (range 32-50%; median 44%; IQR 11.5%) to TRIPOD guidelines. The overall risk of bias was high for all included studies. Conclusion Seven risk prediction models were identified, all exhibiting poor adherence to TRIPOD guidelines which may question the investigational rigor of the studies and their usability. This underscores the need for the development of a validated, robust and reliable tool worthy of implementation and testing in a real-world setting.

Integrating randomized controlled trials and non-randomized studies of interventions to assess the effect of rare events: a Bayesian re-analysis of two meta-analyses

BackgroundThere is a growing trend to include non-randomised studies of interventions (NRSIs) in rare events meta-analyses of randomised controlled trials (RCTs) to complement the evidence from the latter. An important consideration when combining RCTs and NRSIs is how to address potential bias and down-weighting of NRSIs in the pooled estimates. The aim of this study is to explore the use of a power prior approach in a Bayesian framework for integrating RCTs and NRSIs to assess the effect of rare events.MethodsWe proposed a method of specifying the down-weighting factor based on judgments of the relative magnitude (no information, and low, moderate, serious and critical risk of bias) of the overall risk of bias for each NRSI using the ROBINS-I tool. The methods were illustrated using two meta-analyses, with particular interest in the risk of diabetic ketoacidosis (DKA) in patients using sodium/glucose cotransporter-2 (SGLT-2) inhibitors compared with active comparators, and the association between low-dose methotrexate exposure and melanoma.ResultsNo significant results were observed for these two analyses when the data from RCTs only were pooled (risk of DKA: OR = 0.82, 95% confidence interval (CI): 0.25–2.69; risk of melanoma: OR = 1.94, 95%CI: 0.72–5.27). When RCTs and NRSIs were directly combined without distinction in the same meta-analysis, both meta-analyses showed significant results (risk of DKA: OR = 1.50, 95%CI: 1.11–2.03; risk of melanoma: OR = 1.16, 95%CI: 1.08–1.24). Using Bayesian analysis to account for NRSI bias, there was a 90% probability of an increased risk of DKA in users receiving SGLT-2 inhibitors and an 91% probability of an increased risk of melanoma in patients using low-dose methotrexate.ConclusionsOur study showed that including NRSIs in a meta-analysis of RCTs for rare events could increase the certainty and comprehensiveness of the evidence. The estimates obtained from NRSIs are generally considered to be biased, and the possible influence of NRSIs on the certainty of the combined evidence needs to be carefully investigated.

Cognitive behavioural therapy for fatigue in patients with multiple sclerosis: A systematic review and meta-analysis

BackgroundTreatment of fatigue is important for many patients with multiple sclerosis (MS). While pharmacological options have not shown consistent benefit, psychological interventions offer another avenue of treatment. Cognitive behavioural therapy (CBT) involves strategies to change maladaptive cognition and illness behaviours that modulate how patients with MS respond to fatigue. The aim of this study was to perform a systematic review and meta-analysis to determine the effectiveness of CBT for the treatment of fatigue in patients with MS. MethodsFive databases (Cochrane Central Register of Controlled Trials, MEDLINE/PubMed, Embase, Emcare and PsycINFO) were searched up until 31 July 2023. Randomised controlled trials involving adult patients with MS and fatigue, comparing CBT with another intervention or usual treatment were included. Studies were required to measure fatigue severity and/or the impact of fatigue as the primary outcome(s). Each study was assessed for bias using the Cochrane Risk of Bias tool version 2. Studies with sufficient data were used for meta-analysis to quantify the short- and long-term effects of CBT on MS-related fatigue. The level of certainty provided by the body of evidence was evaluated using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework. ResultsEight studies were included in the review and six studies contributed to the meta-analysis. Most studies had a low overall risk of bias. CBT interventions differed in the number, duration and frequency of sessions, mode of delivery and therapist. There were significant short- (standardised mean difference (SMD) -0.58, 95% confidence interval (95%CI) -0.85 to -0.31, P-value < 0.0001) and long-term (SMD -0.36, 95%CI -0.52 to -0.19, P-value < 0.0001) effects supporting CBT. The evidence provided a low level of certainty for the short-term effect because of heterogeneity of results and possible publication bias, while there was high certainty for the long-term result. ConclusionThe study provides secondary evidence that CBT has moderate short-term and small long-term effects in reducing fatigue in patients with MS. CBT should be regarded as a viable evidence-based intervention, particularly in the absence of established alternatives. Future research should identify the ideal characteristics of a fatigue-specific CBT intervention, patient factors that predict treatment response and strategies to maintain initial improvements over time.

Assistive technologies, including orthotic devices, for the management of contractures in adults after a stroke.

Contractures (reduced range of motion and increased stiffness of a joint) are a frequent complication of stroke. Contractures can interfere with function and cause cosmetic and hygiene problems. Preventing and managing contractures might improve rehabilitation and recovery after stroke. To assess the effects of assistive technologies for the management of contractures in adults after a stroke. We searched CENTRAL, MEDLINE, Embase, five other databases, and three trials registers in May 2022. We also searched for reference lists of relevant studies, contacted experts in the field, and ran forward citation searches. Randomised controlled studies (RCTs) that used electrical, mechanical, or electromechanical devices to manage contractures in adults with stroke were eligible for inclusion in this review. We planned to include studies that compared assistive technologies against no treatment, routine therapy, or another assistive technology. Three review authors (working in pairs) selected all studies, extracted data, and assessed risk of bias. The primary outcomes were passive joint range of motion (PROM) with and without standardised force, and indirect measures of PROM. The secondary outcomes included hygiene. We also wanted to evaluate the adverse effects of assistive technology. Effects were expressed as mean differences (MDs) or standardised mean differences (SMDs) with 95% confidence intervals (CIs). Seven studies fulfilled the inclusion criteria. Five of these were meta-analysed; they included 252 adults treated in acute and subacute rehabilitation settings. All studies compared assistive technology with routine therapy; one study also compared assistive technology with no treatment, but we were unable to obtain separate data for stroke participants. The assistive technologies used in the studies were electrical stimulation, splinting, positioning using a hinged board, and active repetitive motor training using a non-robotic device with electrical stimulation. Only one study applied stretching to end range. Treatment duration ranged from four to 12 weeks. The overall risk of bias was high for all studies. We are uncertain whether: • electrical stimulation to wrist extensors improves passive range of wrist extension (MD -7.30°, 95% CI -18.26° to 3.66°; 1 study, 81 participants; very low-certainty evidence); • a non-robotic device with electrical stimulation to shoulder flexors improves passive range of shoulder flexion (MD -9.00°, 95% CI -25.71° to 7.71°; 1 study; 50 participants; very low-certainty evidence); • assistive technology improves passive range of wrist extension with standardised force (SMD -0.05, 95% CI -0.39 to 0.29; four studies, 145 participants; very low-certainty evidence): • a non-robotic device with electrical stimulation to elbow extensors improves passive range of elbow extension (MD 0.41°, 95% CI -0.15° to 0.97°; 1 study, 50 participants; very low-certainty evidence). One study reported the adverse outcome of pain when using a hinged board to apply stretch to wrist and finger flexors, and another study reported skin breakdown when using a thumb splint. No studies reported hygiene or indirect measures of PROM. Only seven small RCTs met the eligibility criteria of this review, and all provided very low-certainty evidence. Consequently, we cannot draw firm conclusions on the effects of assistive technology compared with routine therapy or no therapy. It was also difficult to confirm whether there is a risk of harm associated with treatment using assistive technology. Future studies should apply adequate treatment intensity (i.e. magnitude and the duration of stretch) and use valid and reliable outcome measures. Such studies might better identify the role of assistive technology in the management of contractures in adults after a stroke.

Reporting standards in randomized controlled trials involving neuro-oncology caregivers: A systematic review report from the RANO-Cares working group

Abstract BACKGROUND Family caregivers in neuro-oncology (e.g., spouse, family member, friend to a patient) have high unmet support needs, yet intervention trials and effective support options are scarce. The Response Assessment in Neuro-Oncology (RANO-) Cares working group investigated the methodological quality of neuro-oncology caregiver outcomes reporting in randomized controlled trials (RCTs). METHODS A systematic review was performed to evaluate to what extent RCTs assessing outcomes of caregivers of adult primary brain tumor patients adhere to minimum reporting standards. A 33-item checklist (23 applicable to secondary analysis reports) based on the International Society for Quality of Life Research (ISOQOL) criteria for patient-reported outcome (PRO) reporting was used. Risk of bias was assessed per RCT. RESULTS Fifteen publications from 11 unique RCTs included 676 neuro-oncology caregivers, with low overall risk of bias. Ten publications (66%) reported on caregiver outcomes as a primary aim, of which eight (80%) satisfied ≥2/3 of the key methodological criteria. Of the five secondary analysis reports (33%) two (40%) met ≥2/3 of applicable key criteria. Criteria often not reported adequately included sample size calculations (reported adequately in n=8, 53%), participant flow (n=9, 60%) window for data collection (n=1, 6%), and extent of (n=10, 66%), reasons for (n=9, 60%), and statistical approaches in dealing with (n=4, 26%) missing data. CONCLUSION Whilst there are opportunities to enhance reporting standards, RCTs that include neuro-oncology caregiver outcomes generally adhere to high quality reporting standards, and have low risk of bias, indicating good potential to impact clinical practice.

Comparing the effectiveness and safety of videolaryngoscopy and direct laryngoscopy for endotracheal intubation in the paediatric emergency department: a systematic review and meta-analysis.

Endotracheal intubation is an uncommon procedure for children in the emergency department but can be technically difficult and cause significant adverse effects. Videolaryngoscopy (VL) offers improved first-pass success rates over direct laryngoscopy (DL) for both adults and children undergoing elective surgery. This systematic review was designed to evaluate current evidence regarding how the effectiveness and safety of VL compares to DL for intubation of children in emergency departments. Four databases (MEDLINE, Embase, CENTRAL and Web of Science) were searched on 11th May 2023 for studies comparing first-pass success of VL and DL for children undergoing intubation in the emergency department. Studies including adult patients or where intubation occurred outside of the emergency department were excluded. Quality assessment of included studies was carried out using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool. Meta-analysis was undertaken for first-pass success and adverse event rate. Ten studies met the inclusion criteria representing 5,586 intubations. All included studies were observational. Significantly greater first-pass success rate was demonstrated with VL compared to DL (OR 1.64, 95% CI [1.21-2.21], p = 0.001). There was no significant difference in risk of adverse events between VL and DL (OR 0.79, 95% CI [0.52-1.20], p = 0.27). The overall risk of bias was moderate to serious for all included studies. VL can offer improved first-pass success rates over DL for children intubated in the emergency department. However, the quality of current evidence is low and further randomised studies are required to clarify which patient groups may benefit most from use of VL. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=415039, Identifier CRD42023415039.

Sarcopenia interventions in long-term care facilities targeting sedentary behaviour and physical inactivity: A systematic review.

Sedentary behaviour and physical inactivity are independent risk factors for sarcopenia for long-term care facility residents. Understanding the components, mechanisms and context of interventions that target change in these risk factors can help optimize sarcopenia management approaches. This study aimed to identify, appraise and synthesize the interventions targeting sedentary behaviour and physical inactivity, construct a Theory of Change logic model, inform complex sarcopenia intervention development and identify areas for improvement. Eight electronic databases, including Embase and Web of Science, were searched for eligible interventional studies from inception until February 2024. Narrative synthesis was used. The Theory of Change was applied to develop a logic model presenting the synthesized results. A Cochrane risk of bias assessment tool was used for quality appraisal. The study included 21 articles involving 1014 participants, with mean ages ranging from 72.5 to 90.4years. The proportion of female participants ranged from 8.0% to 100.0%. The applied sarcopenia diagnosis criteria varied, including those of the Asian Working Group for Sarcopenia and the European Working Group on Sarcopenia in Older People. The overall risk of bias in the included studies was moderate. Interventions primarily targeted physical inactivity, with resistance training being the most common intervention type. The reporting of intervention adherence was insufficient (only 11 out of 21 included studies provided adherence reports), and adherence overall and by intervention type was not possible to discern due to inconsistent criteria for high adherence across these studies. Four categories of intervention input were identified: educational resources; exercise equipment and accessories; monitoring and tailoring tools; and motivational strategies. Intervention activities fell into five categories: determining the intervention plan; educating; tailoring; organizing, supervising, assisting and motivating; and monitoring. While sarcopenia-related indicators were commonly used as desired outcomes, intermediate outcomes (i.e., sedentary time and physical activity level) and other long-term outcomes (i.e., economic outcomes) were less considered. Contextual factors affecting intervention use included participant characteristics (i.e., medical condition and education level) and intervention provider characteristics (i.e., trustworthiness). The findings led to the development of a novel logic model detailing essential components for interventions aimed at managing sarcopenia in long-term care facilities, with a focus on addressing sedentary behaviour and physical inactivity. Future sarcopenia interventions in long-term care facilities should fully attend to sedentary behaviour, enhance adherence to interventions through improved education, monitoring, tailoring and motivation and establish an agreed standard set of outcome measures.

Emulations of Oncology Trials Using Real-World Data: A Systematic Literature Review.

By evaluating published emulations of oncology RCTs studies in which both the active and comparator groups are sourced from RWD and target trial results are available for benchmarking, this systematic review aims to gain insight into factors related to emulation performance. Thirteen oncology emulation studies using various types of RWD were identified through an online database search of PubMed through 2022. Based on the ROBINS-I tool, most studies (N=8) had a serious risk of overall bias driven by risk of bias from confounding. Approximately half of the studies (N=6) fully proxied the RCT entry criteria. Of 11 RWD studies that provided sufficient detail to quantify emulation performance, the emulation HR estimate fell within the 95% CI of the trial estimate in 9 of the studies. There were no clear trends between risk of bias or degree to which the entry criteria were proxied and emulation performance. Findings may have been influenced by publication bias and researcher degrees of freedom, as only one emulation study pre-registered its protocol. Tools for comprehensively characterizing factors that affect emulation performance, including the real-world clinical context as it relates to the RCT research question, are needed to evaluate the feasibility of a RCT emulation.

Impact of Sodium-Glucose Cotransporter-2 Inhibitors on Heart Failure in Patients With Type 2 Diabetes Mellitus: A Systematic Review.

Type 2 diabetes mellitus (T2DM) is a major global health concern with a strong association with increased cardiovascular morbidity and mortality. The prevalence of heart failure is significantly higher in the T2DM population compared to non-diabetic individuals. Sodium-glucose cotransporter-2 (SGLT-2) inhibitors have emerged as a promising therapeutic class for managing T2DM, with potential cardioprotective effects.This systematic review aims to comprehensively evaluate the impact of SGLT-2 inhibitors on cardiovascular outcomes in adult patients with T2DM. A comprehensive electronic search was conducted across multiple databases and registries from May 8to June 6, 2024, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Studies published between January 2019 and June 6, 2024 that evaluated the effects of SGLT-2 inhibitors on cardiovascular outcomes in adults with T2DM were included. The risk of bias was assessed using appropriate tools based on thestudy design. A narrative synthesis was planned to summarize the findings. The search strategy identified 25 studies (22 randomized controlled trials, three cohort studies) for inclusion in the systematic review.Most of the included studies demonstrated a low overall risk of bias, although some observational studies had some limitations. The studies investigated the effects of various SGLT-2 inhibitors, including empagliflozin, canagliflozin, dapagliflozin, and others, on cardiovascular endpoints such as heart failure-related hospitalizations, mortality, cardiac structure and function, and biomarkers.The findings suggest that SGLT-2 inhibitors may have a beneficial impact on reducing the risk of heart failure-related hospitalizations and potentially improving other cardiovascular outcomes in patients with T2DM. This comprehensive systematic review provides valuable insights into the emerging role of SGLT-2 inhibitors in mitigating cardiovascular complications associated with T2DM. The findings have important clinical implications and may inform evidence-based guidelines and treatment strategies aimed at improving cardiovascular outcomes in this high-risk patient population.

Success rate of single versus multiple debridement, antibiotics, and implant retention (DAIR) in hip and knee periprosthetic joint infection: a systematic review and meta-analysis.

This systematic review aimed to compare outcomes between multiple and single debridement, antibiotics, and implant retention (DAIR) procedures for early periprosthetic joint infection (PJI) in hip and knee arthroplasty. Four databases were searched from inception till January 2024 for original studies investigating the outcomes of multiple DAIR in hip and knee PJI. The primary outcome was the success rate in eradicating joint infection. This review was conducted per PRISMA guidelines. A total of 9 observational studies with 1104 participants were included, with a mean age and BMI of 58.37years (95%CI: 25.77-90.98) and 31.43kg/m2 (95%CI: 28.89-34.98), respectively. The mean follow-up period was 58.37months (95%CI: 25.77-90.98), and the average MINORS score assigned to the review was 17.6 ± 3.46, indicating a low overall risk of bias. An equivalent success rate between single and double DAIR was observed, at 67% (95%CI: 64-71%) and 70% (95%CI: 48-86%), respectively, with no statistically significant difference between the two treatment modalities (p = 0.740). Additionally, the success rate for triple DAIR ranged from 50 to 60%. This study suggests that double DAIR is a valid treatment option for acute PJI after TKA and THA, with a success rate comparable to single DAIR (70% vs. 67%, p = 0.740). Triple DAIR achieved success rates ranging from 50 to 60%. However, caution is warranted when interpreting these results due to heterogeneity in host comorbidity factors, DAIR protocols, and antibiotic regimens. Therapeutic, Level III.

The effectiveness of autologous platelet-rich concentrates as an adjunct during nonsurgical periodontal therapy: a systematic review and meta-analysis of randomized controlled trials.

To evaluate the efficacy of autologous platelet concentrates (APC) on periodontal outcomes in nonsurgical therapy of periodontitis patients. Electronic search via Web of Science, MEDLINE via PubMed, Scopus, and Cochrane CENTRAL registry as well as manual search were done from June 2024 to July 2024 for relevant publication from inception until June 2024. The articles were assessed by 2 independent reviewers and deemed relevant when the interventional studies reported on periodontal outcomes after adjunctive APC were used in NSPT. The studies were excluded if it was not in English or unpublished. The risk of bias for each study was assessed using the Cochrane risk-of-bias tool (RoB 2). Fixed effect meta-analysis was conducted to measure the summary effect for change of periodontal pocket depth (PPD) and Clinical Attachment Level (CAL). The statistical heterogeneity between studies was also calculated using I2 test. A total of 607 records were found in the four electronic databases. Following the removal of duplicates and initial title screening, 16 full text articles from electronic search and 7 articles from manual search were assessed resulting in 13 studies included in the systematic review. The overall risk of bias showed most studies have moderate to high risk of bias. The fixed-effect meta-analysis showed summary effects favored the adjunctive use of APC in nonsurgical periodontal therapy but with high heterogeneity between the studies, particularly for CAL. The evidence on APC as adjunct in NSPT is limited by the small number of studies, moderate to high risk of bias in most studies and significant heterogeneity in the results.

Prevalence of pulmonary nodules detected incidentally on noncancer-related imaging: a review.

Pulmonary nodules are common incidental findings requiring surveillance. Follow-up recommendations vary depending on risk factors, size and solid or subsolid characteristics. This review aimed to evaluate the prevalence of clinically significant nodules detected on noncancer-dedicated imaging and the prevalence of part-solid and ground-glass nodules. We conducted a systematic search of literature and screened texts for eligibility. Clinically significant nodules were noncalcified nodules >4-6 mm. Prevalence estimates were calculated for all studies and risk of bias was assessed by one reviewer. Twenty-four studies were included, with a total of 30 887 participants, and 21 studies were cross-sectional in design. Twenty-two studies used computed tomography (CT) imaging with cardiac-related CT being the most frequent. Prevalence of significant nodules was highest in studies with large field of view of the chest and low size thresholds for reporting nodules. The prevalence of part-solid and ground-glass nodules was only described in two cardiac-related CT studies. The overall risk of bias was low in seven studies and moderate in 17 studies. While current literature frequently reports incidental nodules on cardiovascular-related CT, there is minimal reporting of subsolid characteristics. Unclear quantification of smoking history and heterogeneity of imaging protocol also limits reliable evaluation of nodule prevalence in nonscreening cohorts.

Evaluation of ocular and systemic endpoints after radiation of posterior uveal melanoma – A systematic review and meta-analysis

BackgroundDue to the large number of radiotherapeutic options for treatment of posterior uveal melanoma (UM), advantages of each option regarding important clinical endpoints have yet to be determined. Therefore, objective of this systematic review was to analyze the numerous pro- and retrospective cohort studies focusing on the efficacy of different radiotherapeutic options for UM in adults, considering local tumor control, overall survival, visual acuity, eye preservation, metastasis, radiation side effects and dose rates. MethodsThe Review was performed based on the Cochrane Handbook of Systematic Reviews. The PubMed database was searched for studies published from January 1st, 2000, up to December 31st, 2021. Research, study selection and critical appraisal was performed by two reviewers. The risk of bias assessment was performed through the revised Cochrane risk of bias tools RoB 2 and ROBINS-I. A meta-analysis of proportions was performed using R (R version 4.1.3, library: meta, procedure: metaprop). This systematic review was registered with Prospero (ID CRD42022311758). ResultsOf 4886 studies identified in the database, a total of 20 studies with 4979 participants were included in the qualitative synthesis. Through critical appraisal with ROBINS-I and RoB 2, studies received a ‘moderate’, ‘serious’ or ‘some concerns’ overall risk of bias. Heterogeneity analysis allowed for meta-analysis of proportion of 3 outcome-therapy combinations: local tumor control with I-125 Brachytherapy (proportion: 0.94, CI 95 %: 0.91–0.98), local tumor control with proton therapy (proportion: 0.96, CI 95 %: 0.92–1.00) and eye preservation with I-125 brachytherapy (proportion: 0.91, CI 95 %: 0.88–0.93). This shows local tumor control to be at 94 % with I-125 brachytherapy and at 96 % with proton therapy, as well as an eye preservation rate of 91 % with I-125 brachytherapy. DiscussionThe evaluation of outcomes of radiotherapy in UM is limited because of missing data on radiation doses as well as great heterogeneity of study protocols. Radiation therapy outcomes are so far not comparable. Therefore, we recommend for upcoming studies on this topic to provide the biological effective dose (BED) or the equivalent dose in 2 Gy fractions (EQD2) per eye structure, thereby enabling a comparison of outcomes of different forms of radiation therapy.

Oral Chinese herbal medicine combined with donepezil for mild cognitive impairment: A systematic review and meta-analysis.

This study aims to evaluate the add-on effects of oral Chinese herbal medicine (CHM) for mild cognitive impairment (MCI), when used in addition to donepezil compared to donepezil alone. Randomized controlled trials comparing these treatments across all types of MCI were identified from nine databases and three registers until August 2023. Outcome measures were Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and adverse events (AEs). Methodological quality was assessed using Cochrane risk-of-bias tool, and evidence certainty was evaluated using the GRADE method. Involving 1611 participants across 20 studies, meta-analysis results indicate that oral CHM combined with donepezil significantly improved cognitive function in MCI patients compared to donepezil alone, as evidenced by MMSE (1.88 [1.52, 2.24], I2 = 41%, 12 studies, 993 participants) and MoCA (MD: 2.01 [1.57, 2.44], I2 = 52%, 11 studies, 854 participants). Eleven studies reported details of AEs, identifying gastrointestinal symptoms and insomnia as the most common symptoms. No significant difference in AEs frequency was found between the groups (RR: 0.91 [0.59, 1.39], I2 = 4%, 11 studies, 808 participants). All 20 studies were evaluated as having "some concerns" regarding the overall risk of bias. The certainty of evidence for MMSE was "moderate" and "low" for MoCA. From frequently utilized herbs, two classical CHM formulae were identified: Kai xin san and Si wu decoction. The observed treatment effects of commonly used herbs may be exerted through multiple pharmacological mechanisms, including anti-inflammatory, anti-oxidative stress, anti-apoptotic actions, promotion of neuronal survival and modulation of the cholinergic system. The concurrent use of oral CHM and donepezil appears to be more effective than donepezil alone in improving the cognitive function of MCI, without leading to an increase in AEs. While recognizing concerns of overall methodological quality, this combined therapy should be considered as an alternative option for clinical practice.