Bias In Non-randomized Studies Research Articles

Population-Based Disease Odds for E-Cigarettes and Dual Use versus Cigarettes

BackgroundE-cigarettes are promoted as less harmful than cigarettes. There has not been a direct comparison of health effects of e-cigarettes or dual use (concurrently using e-cigarettes and cigarettes) with those of cigarettes in the general population.MethodsStudies in PubMed, EMBASE, Web of Science, and PsychINFO published through October 1, 2023, were pooled in a random-effects meta-analysis if five or more studies were identified with a disease outcome. We assessed risk of bias with Risk Of Bias In Non-randomized Studies of Exposure and certainty with Grading of Recommendations, Assessment, Development, and Evaluations. Outcomes with fewer studies were summarized but not pooled.ResultsWe identified 124 odds ratios (94 cross-sectional and 30 longitudinal) from 107 studies. Pooled odds ratios for current e-cigarette versus cigarette use were not different for cardiovascular disease (odds ratio, 0.81; 95% confidence interval, 0.58 to 1.14), stroke (0.73; 0.47 to 1.13), or metabolic dysfunction (0.99; 0.91 to 1.09) but were lower for asthma (0.84; 0.74 to 0.95), chronic obstructive pulmonary disease (0.53; 0.38 to 0.74), and oral disease (0.87; 0.76 to 1.00). Pooled odds ratios for dual use versus cigarettes were increased for all outcomes (range, 1.20 to 1.41). Pooled odds ratios for e-cigarettes and dual use compared with nonuse of either product were increased (e-cigarette range, 1.24 to 1.47; dual use, 1.49 to 3.29). All included studies were assessed as having a low risk of bias. Results were generally not sensitive to study characteristics. Limited studies of other outcomes suggest that e-cigarette use is associated with additional diseases.ConclusionsThere is a need to reassess the assumption that e-cigarette use provides substantial harm reduction across all cigarette-caused diseases, particularly accounting for dual use.

Integrating large language models in systematic reviews: a framework and case study using ROBINS-I for risk of bias assessment

Large language models (LLMs) may facilitate and expedite systematic reviews, although the approach to integrate LLMs in the review process is unclear. This study evaluates GPT-4 agreement with human reviewers...

The Effects of Cognitive Interventions in Individuals with Chronic Respiratory Diseases: A Systematic Review

Purpose: To evaluate the effects of cognitive interventions (CIs) on cognitive function, health-related quality of life (HRQoL), self-management, physical activity, physical function, and psychosocial outcomes among individuals with chronic respiratory diseases (CRDs). Methods: The methods adhered to the Cochrane Handbook for Systematic Review of Interventions for data analysis and synthesis guidelines. Additionally, the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines were followed for the reporting of data. Database searches were conducted from inception to May 2023 across Medline, Embase, Emcare, PsycINFO, Scopus, and CINAHL. Included studies evaluated the effects of cognitive training, cognitive behavioural therapy, and transcranial brain stimulation in adults with CRDs. Studies were evaluated using the Cochrane Risk of Bias 2 tool, Risk of Bias in Non-Randomized Studies of Interventions, and Grading of Recommendations, Assessment, Development, and Evaluation. Results: Five eligible studies with 347 participants were included and showed very low-quality evidence of inconsistent improvements in cognition and no difference between groups for HRQoL and self-management; low evidence for no difference between groups in physical function; moderate evidence for no difference between groups in physical activity and psychosocial outcomes. Conclusion: The effects of CIs on cognitive function in people with CRDs are inconclusive.

Effectiveness and safety of robot-assisted versus fluoroscopy-assisted cortical bone trajectory screw instrumentation in spinal surgery: a systematic review and meta-analysis.

Robot-assisted (RA) technology has been shown to be a safe aid in spine surgery, this meta-analysis aims to compare surgical parameters and clinical indexes between robot-assisted cortical bone trajectory (CBT) and fluoroscopy-assisted (FA) cortical bone trajectory in spinal surgery. We searched databases such as PubMed, Web of Science, the Cochrane Library, and the China National Knowledge Infrastructure. The study selection process was guided by the PICOS (Patient/Problem, Intervention, Comparison, Outcome, Study Design) strategy. The risk of bias in non-randomized comparative studies was assessed using the risk of bias in non-randomized studies of interventions (ROBINS-I) tool. We performed this meta-analysis using RevMan 5.3 software (Cochrane Collaboration, Copenhagen, Denmark), and the level of statistical significance was set at P < 0.05. Six articles involving 371 patients and 1535 screws were included in this meta-analysis. RA-CBT outperformed FA-CBT in terms of various parameters, such as accuracy of pedicle screw position (both Gertzbein-Robbins scale and Ding scale), avoidance of superior facet joint violation (FJV), and reduction of neurological injury. Our meta-analysis offered a thorough evaluation of the efficacy and safety of RA-CBT in spinal surgery. The findings revealed that RA-CBT produced statistically significant results in terms of pedicle screw position accuracy and superior facet joint violation prevention. In terms of surgical parameters and clinical indexes, future research and clinical practice should investigate the efficacy of RA-CBT further. The study was registered in the PROSPERO (CRD42023466280).

Dutasteride in the treatment of frontal fibrosing alopecia: Systematic review and meta-analysis.

Frontal fibrosing alopecia (FFA) is a scarring alopecia with fronto-temporo-parietal hairline recession. Although no proven treatment for FFA exists, dutasteride has been suggested as a potential treatment option. We aimed to evaluate the therapeutic response of oral dutasteride in FFA patients. The identification and selection of studies were conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis 2020 criteria. To assess the risk of bias for each study, we used the Cochrane's risk of bias in non-randomized studies of interventions (ROBINS-I) assessment tool. A random effects model meta-analysis was performed. Estimated proportion of stabilization for eligible studies was calculated to evaluate the effectiveness of dutasteride for treating FFA. Among patients who achieved stabilization, subgroup analysis was conducted on those showing improvement. Seven studies including 366 patients who received oral dutasteride were identified. The estimated proportion of patients who experienced stabilization of FFA with oral dutasteride was 0.628 (95% CI: 0.398-0.859). In subgroup analyses of patients who experienced improvement, the estimated proportion of improvement was 0.356 (95% CI: 0.163-0.549). In this systematic review and meta-analysis, oral dutasteride revealed to be a good treatment option for disease stabilization or improvement in patients with FFA.

Impact of minimally invasive surgical procedures for Male Lower Urinary Tract Symptoms due to benign prostatic hyperplasia on ejaculatory function: a systematic review.

Surgical treatments for lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) are affected by potentially bothersome side effects on sexual, and, above all, ejaculatory function. Several minimally invasive techniques have been proposed in the last years in order to overcome these consequences. Our aim is to summarize and evaluate the efficacy on LUTS relieve and the impact on sexual/ejaculatory function of Rezum, prostate artery embolization (PAE), implantation of a prostatic urethral lift (PUL) and the temporary implantable nitinol device (TIND). A systematic review of the English-language literature was conducted using the MEDLINE, Embase, and Web of Science databases from January 2000 to October 2022, according to the PRISMA guidelines (PROSPERO ID: CRD42023466515). Randomized controlled trials(RCTs), prospective studies and non-comparative or comparative studies assessing the impact on functional and ejaculatory function after minimally invasive surgical therapies for Male LUTS were evaluated. Risk of bias assessment was performed according to the Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) tool for comparative studies, and the revised Cochrane risk-of-bias tool for randomized trials (RoB 2) for RCTs. Overall, 47 studies were included (n = 4 for TIND; n = 9 for Rezum; n = 13 for PUL; n = 21 for PAE). Most studies relied on prospective patient cohorts and were rated as low risk of bias. Across studies assessing the efficacy of Rezum, a significant improvement in terms of IPSS (ranging from -47% to -56%) and Qmax (ranging from +39% to +87%) was reported. On the other hand, according to IIEF-5 score, Rezum had a minimal impact on sexual function (ranging from -1% to -3%). PUL showed a positive impact on IPSS (ranging from -35% to -58.2%) and Qmax (ranging from +49.9% to +114.7%) and sexual function. Finally, PAE showed encouraging functional results with IPSS score reducing from -12.8% to 63.3% and Qmax improving from +8% to 114.9% but the available evidence regarding the potential impact of PAE on sexual outcomes were limited. Rezum, PAE, PUL and TIND are safe and feasible techniques associated with a significant functional improvement. While available data suggest a minimal impact of Rezum and PUL on ejaculatory function, the evidence after PAE and TIND are still limited. Therefore, our review lays the foundation for further research aiming to identify the criteria to select best candidates for uMIST to tailor the management in light of specific patient- and disease- factors.

MONOVISION VERSUS MULTIFOCAL INTRAOCULAR LENS IMPLANTATION IN CATARACT PATIENTS:A SYSTEMATIC REVIEW AND META-ANALYSIS

Objective: With the aim to increase spectacle independence, recent approaches to repair cataracts include the implantation of premium intraocular lenses (IOLs), such as multifocals. Another approach is monovision techniques achieved by monofocal IOL implantation, which is more cost-effective, although it has the same good outcome as multifocal IOLs. This meta-analysis aimed to compare monovision versus multifocal IOL implantation in cataract patients.&#x0D; Method: Systematic search was performed in April 2023 on six databases (Medline, SCOPUS, Proquest, EBSCO, Embase, and PubMed). Studies were extracted for the following outcome of interest: monovision, multifocal intraocular lens, spectacles independence, visual acuity. All studies published up to April 2023 were reviewed. Cochrane risk of bias tool (RoB 2) and The Risk Of Bias In Non-randomized Studies – of Interventions (ROBINS-I) was used to screen studies for risk of bias where appropriate. A meta-analysis was done to quantify any reported quantitative data.&#x0D; Result: Ten studies satisfying the inclusion criteria were included. Pooling analysis for BCVA and BNVA showed no difference between monovision vs multifocal IOL (95% CI at -0,10 to 0,73; I2=79% (p=0,14) and 95% CI at -0,27 to 1,37; I2=94% (p=0,19), respectively). Spectacle independence showed monovision was inferior to multifocal IOL (RR 0,53; 95% CI at 0,34 to 0,82; I² 83% (p=0,004)).&#x0D; Conclusion: Current evidence showed monovision was comparable to multifocal IOL in terms of visual acuity. While multifocal IOL achieved more spectacle-free patients than monovision, many patients in the monovision group also achieved spectacle-free condition.&#x0D; Keywords: cataract, monovision, multifocal intraocular lens, visual acuity, spectacle independence.

Functional alignment in robotic-assisted total knee arthroplasty: a systematic review.

The present study systematically reviewed current evidence on functional alignment (FA) in robotic total knee arthroplasty (TKA), discussing advantages and limitations, possible pitfalls, and prospects. This study was conducted according to the 2020 PRISMA statement. In August 2023, the following databases were accessed: PubMed, Web of Science, Google Scholar, and Embase with no additional filters or time constraints. All the clinical studies investigating functional alignment in robotic TKA were accessed. Only studies published in peer-reviewed journals were considered. The risk of bias was evaluated following the guidelines in the Cochrane Handbook for Systematic Reviews of Interventions. Non-randomized controlled trials (non-RCTs) were evaluated using the Risk of Bias in Nonrandomised Studies of Interventions (NRSI) (ROBINS-I) tool. Data from 1198 patients (seven studies) were retrieved. The mean length of the follow-up was 17.1 ± 6.4months. The mean age was 67.2 ± 5.4years, and the mean BMI was 30.9 ± 2.7kg/m2. FA might improve resection accuracy, implant alignment, and gap balancing in TKA, and additional high-quality clinical trials are necessary to properly establish the superiority of FA to other alignment techniques in TKA. Long-term clinical trials are needed to investigate the impact of FA on implant survivorship. Level IV, systematic review and meta-analysis.

The incidence of secondary neoplasms in retinoblastoma survivors who underwent radiation therapy: A systematic review and meta-analysis

Abstract: Secondary neoplasms are a significant cause of mortality among retinoblastoma survivors, particularly when exposed to radiation. This systematic review aims to investigate the association between radiation exposure and the incidence of secondary neoplasms in retinoblastoma survivors. A comprehensive literature search was conducted using PubMed, ProQuest, and EBSCOhost databases to gather relevant studies. Studies written in English about the incidence of secondary neoplasms in retinoblastoma patients who underwent radiotherapy were included. Retinoblastoma patients who did not receive radiotherapy were regarded as the control group. Studies involving animals and those without a control group were excluded. No date restrictions were applied. The last search was performed on April 6, 2022. The study selection process was presented in a flow diagram following the Preferred Reporting Items of Systematic reviews Meta-Analysis 2020 guidelines. The risk of bias was evaluated using the Risk of Bias in nonrandomized Studies of Interventions tool. Statistical analysis was performed using the Cochrane RevMan software (version 5.4.1). Five studies comprising a total of 3324 retinoblastoma patients were included. Of these, 290 (8.72%) patients developed secondary neoplasms, with 250 (86.21%) receiving radiotherapy. The results indicated that retinoblastoma patients who received radiotherapy had a higher risk of developing secondary neoplasms, with a pooled risk ratio of 5.12 (95% confidence interval 3.56–7.36, I 2 = 14%). The findings of this review highlight the importance of considering the risk of developing secondary neoplasms when treating retinoblastoma. Regular medical surveillance for secondary neoplasms should be a standard part of care for retinoblastoma survivors, particularly those exposed to radiation.

Effects of cardiopulmonary resuscitation training on mortality rates after out-of-hospital cardiac arrest: protocol for a systematic review and meta-analysis

IntroductionAn out-of-hospital cardiac arrest occurs at a rate of 67–170 cases per 100 000 inhabitants per year in Europe. The early recognition of the occurrence of a cardiac arrest, placing...

Cancer inequalities experienced by people with disability: a systematic review protocol

IntroductionCancer is a leading cause of death and has a significant impact on individuals, families and society. Emerging evidence shows that people with disability face challenges in accessing services which...

Personal strategies to reduce the effects of landscape fire smoke on asthma-related outcomes: a protocol for systematic review and meta-analysis

IntroductionLandscape fire smoke (LFS) contains several hazardous air pollutants that are known to be detrimental to human health. People with asthma are more vulnerable to the health impact of LFS...

Comparing prostatic artery embolization to surgical and minimally invasive procedures for the treatment of benign prostatic hyperplasia: a systematic review and meta-analysis

BackgroundTo summarize current evidence to report a comparative systematic review and meta-analysis of prostatic artery embolization (PAE) with transurethral resection of the prostate (TURP) and open simple prostatectomy (OSP) for the treatment of benign prostatic hyperplasia (BPH).MethodsA systematic literature search was performed to identify studies published from inception until August 2021. The search terms used were (prostate embolization OR prostatic embolization) AND (prostatic hyperplasia OR prostatic obstruction) as well as the abbreviations of PAE and BPH. Risk of bias was assessed using the Cochrane Risk of Bias tool for randomized controlled trials (RCTs) and the Risk of Bias in Non-randomized Studies—of Interventions (ROBINS-I) tool for observational studies. Random-effects meta-analysis was performed using Revman 5.4.ResultsSeven studies were included with 810 patients: five RCTs and one observational study compared PAE with TURP, and one observational study compared PAE with OSP. The included studies had considerable risk of bias concerns. TURP and OSP were associated with more statistically significant improvements in urodynamic measures and BPH symptoms compared to PAE. However, PAE seems to significantly improve erectile dysfunction compared to OSP and improve other outcome measures compared to TURP, although not significantly. PAE appeared to reduce adverse events and report more minor complications compared with TURP and OSP, but it is unclear whether PAE is more effective in the long-term.ConclusionPAE is an emerging treatment option for patients with symptomatic BPH who cannot undergo surgery or have undergone failed medical therapy. Overall, PAE groups reported fewer adverse events. Future ongoing and longer-term studies are needed to provide better insight into the benefit of PAE compared to other treatment options.

Proteomics for heart failure risk stratification: a systematic review

BackgroundHeart failure (HF) is a complex clinical syndrome with persistently high mortality. High-throughput proteomic technologies offer new opportunities to improve HF risk stratification, but their contribution remains to be clearly defined. We aimed to systematically review prognostic studies using high-throughput proteomics to identify protein signatures associated with HF mortality.MethodsWe searched four databases and two clinical trial registries for articles published from 2012 to 2023. HF proteomics studies measuring high numbers of proteins using aptamer or antibody-based affinity platforms on human plasma or serum with outcomes of all-cause or cardiovascular death were included. Two reviewers independently screened articles, extracted data, and assessed the risk of bias. A third reviewer resolved conflicts. We assessed the risk of bias using the Risk Of Bias In Non-randomized Studies—of Exposure tool.ResultsOut of 5131 unique articles identified, nine articles were included in the review. The nine studies were observational; three used the aptamer platform, and six used the antibody platform. We found considerable heterogeneity across studies in measurement panels, HF definitions, ejection fraction categorization, follow-up duration, and outcome definitions, and a lack of risk estimates for most protein associations. Hence, we proceeded with a systematic review rather than a meta-analysis. In two comparable aptamer studies in patients with HF with reduced ejection fraction, 21 proteins were identified in common for the association with all-cause death. Among these, one protein, WAP four-disulfide core domain protein 2 was also reported in an antibody study on HFrEF and for the association with CV death. We proposed standardized reporting criteria to facilitate the interpretation of future studies.ConclusionsIn this systematic review of nine studies evaluating the association of proteomics with mortality in HF, we identified a limited number of proteins common across several studies. Heterogeneity across studies compromised drawing broad inferences, underscoring the importance of standardized approaches to reporting.

Overuse of computed tomography for mild head injury: A systematic review and meta-analysis.

Computed tomography (CT) scan is a common imaging technique used to evaluate the severity of a head injury. The overuse of diagnostic interventions in the health system is a growing concern worldwide. Objectives: The aim of this systematic review is to investigate the rate of CT scan overuse in cases of mild head injury. Eligibility criteria: We encompassed observational studies-either designed as cohort, case-control, or cross-sectional investigations-that reported on CT scan overuse rates for mild head injuries. Studies had to be published in peer-reviewed, English-language sources and provide full content access Information sources: Web of Sciences, Scopus, Medline via PubMed, the Cochrane Library and Embase were searched from inception until April 1, 2023. Studies were included if reporting the overuse of CT scans for mild head injuries using validated criteria. Risk of bias: We used the Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) tool to evaluate the risk bias assessment of included studies. Two independent reviewers evaluated the eligibility of studies, extracted data, and assessed study quality by using the Newcastle-Ottawa Scale. Synthesis of results: Overuse estimates were calculated using a random-effects model. Subgroup analyses were performed to investigate any sources of heterogeneity. Point rate of overuse of CT scans for mild head injuries was the main outcome measured as percentage point estimates with corresponding 95% CIs. Included studies: Of the 913 potentially relevant studies identified, eight studies were selected for the final analysis. Synthesis of results: The pooled rate of CT scan overuse in patients with mild head injury was found to be 27% [95% CI: 16-43; I2 = 99%]. The rate of CT scan overuse in mild head injury cases varied depending on the criteria used. The rate of CT scan overuse was 37% [95% CI: 32-42; I2 = 0%] with the Glasgow Coma Scale (GCS), 30% [95% CI: 16-49; I2 = 99%] with the Canadian computed tomography head rule, and 10% [95% CI: 8-14; I2 = 0%] with the Pediatric Emergency Care Applied Research Network criterion (PERCAN). Based on subgroup analyses, the rate of CT scan overuse in mild head injury cases was observed to be 30% with the Canadian computed tomography head rule criterion, 43% with the National Institute for Health and Clinical Excellence criterion, and 18% with the New Orleans criterion. Limitations of evidence: The restricted number of included studies may impact generalizability. High heterogeneity was observed, leading to subgroup analyses based on age, assessment criteria, and study region. Absent data on overuse causes hinders drawing conclusions on contributing factors. Furthermore, this study solely addressed overuse rates, not associated harm or benefits. Interpretation: The overuse of CT scans in mild head injury patients is concerning, as it can result in unnecessary radiation exposure and higher healthcare costs. Clinicians and policymakers should prioritize the implementation of guidelines to reduce unnecessary radiation exposure, healthcare costs, and potential harm to patients. The study protocol of this review was registered in PROSPERO under the identification code CRD42023416080. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023416080.

Efficacy and safety of implantable vascular support in the treatment of arteriovenous fistula: A single-arm meta-analyses.

VasQ (Laminate Medical Technologies, Israel) is an external support device for autologous arteriovenous fistula (AVF) designed to improve anastomotic blood flow and reduce neointimal hyperplasia. However, different studies have shown that the efficacy of the VasQ device in improving AVF is inconsistent. The purpose of this study was to conduct a meta-analysis to further evaluate the efficacy and safety of the VasQ device. Two reviewers independently searched studies published in PubMed, EMBASE, Cochrane, Web of Science, CNKI, and Wan Fang databases from inception to 2023. The Cochrane Systematic Evaluation Bias Risk Tool Version 1 was used to assess the risk of RCTS bias. The ROBINS-I tool was used to assess the risk of bias in non-randomized studies. A Single-arm meta-analysis was performed, and a random effects model was used for all analyses. We identified six trials involving 146 patients and conducted a meta-analysis. The results showed that after 6 months of VasQ device treatment, the primary patency rate of AVF was [76.4% (95%CI: 0.608-0.920), p < 0.01] while the secondary patency rate was [76.5% (95%CI: 0.572-0.958), p < 0.01]. The maturity rate of AVF 1 month after surgery was [88.5% (95%CI: 0.818-0.952), p = 0.46]. The incidence of anastomotic stenosis was [8.9% (95%CI: 0.015-0.163), p = 0.23], and the incidence of anastomotic venous thrombosis was [10% (95%CI: 0.035-0.179), p = 0.38]. Meta-analysis data of this study show that the VasQ device has a good effect in improving the patency rate of AVF and does not increase the occurrence of adverse events. However, due to the limitation of the number and quality of included studies, more high-quality studies are needed to confirm this in the future.

Effects of Physical Exercise on Telomere Length in Healthy Adults: Systematic Review, Meta-Analysis, and Meta-Regression.

Physical exercise is one of the main nonpharmacological treatments for most pathologies. In addition, physical exercise is beneficial in the prevention of various diseases. The impact of physical exercise has been widely studied; however, existing meta-analyses have included diverse and heterogeneous samples. Therefore, to our knowledge, this is the first meta-analysis to evaluate the impact of different physical exercise modalities on telomere length in healthy populations. In this review, we aimed to determine the effect of physical exercise on telomere length in a healthy population through a meta-analysis of randomized controlled trials. A systematic review with meta-analysis and meta-regression of the published literature on the impact of physical exercise on telomere length in a healthy population was performed. PubMed, Cochrane Library, SCOPUS, Web of Science, and Embase databases were searched for eligible studies. Methodological quality was evaluated using the Risk Of Bias In Nonrandomized Studies of Interventions and the risk-of-bias tool for randomized trials. Finally, the certainty of our findings (closeness of the estimated effect to the true effect) was evaluated using Grading of Recommendations, Assessment, Development, and Evaluations (GRADE). We included 9 trials that met the inclusion criteria with fair methodological quality. Random-effects model analysis was used to quantify the difference in telomere length between the exercise and sham groups. Meta-analysis showed that exercise did not significantly increase telomere length compared with the control intervention (mean difference=0.0058, 95% CI -0.05 to 0.06; P=.83). Subgroup analysis suggested that high-intensity interventional exercise significantly increased telomere length compared with the control intervention in healthy individuals (mean difference=0.15, 95% CI 0.03-0.26; P=.01). Furthermore, 56% of the studies had a high risk of bias. Certainty was graded from low to very low for most of the outcomes. The findings of this systematic review and meta-analysis suggest that high-intensity interval training seems to have a positive effect on telomere length compared with other types of exercise such as resistance training or aerobic exercise in a healthy population. PROSPERO CRD42022364518; http://tinyurl.com/4fwb85ff.

Efficacy of reinforcing sutures for prevention of anastomotic leakage after low anterior resection for rectal cancer: A systematic review and meta-analysis.

Anastomotic leakage is a serious complication following surgery for cancer of the rectum. It is not clear whether reinforcing sutures could prevent anastomotic leakage. Therefore, this study aims at evaluating the efficacy of reinforcing sutures on anastomotic leakage. We searched PubMed, Embase, and the Cochrane Library databases from inception to January 31, 2023. We included studies comparing anastomosis with reinforcing sutures to anastomosis without reinforcing sutures after low anterior resection. Risk of bias was assessed by the Cochrane tool for RCTs and the Risk of Bias in Non-Randomized Studies (ROBINS)-I tool for observational studies. The overall quality of evidence for primary outcome was assessed using Grading of Recommendations Assessment, Development, and Evaluations methodology. Two RCTs (345 patients) and four observational studies (783 patients) were included. Anastomotic leakage occurred in 4.4% (24 of 548) of patients with reinforcing sutures and 11.9% (69 of 580) of patients without reinforcing sutures. Meta-analysis showed a lower incidence of anastomotic leakage (RR, 0.41; 95% CI 0.25 to 0.66, low certainty) in patients with reinforcing sutures. Operative time (WMD, -3.66; 95% CI -18.58 to 11.25) and reoperation for anastomotic leakage (RR, 0.69; 95% CI 0.23 to 2.08) were similar between patients with reinforcing sutures and those without reinforcing sutures. While observational data suggest that, there is a clear benefit in terms of reducing the risk of anastomotic leakage with the use of reinforcing sutures, RCT data are less clear. Further large, prospective studies are warranted to determine whether a true clinically important benefit exists with this technique.

Immune checkpoint inhibitors for patients with microsatellite instability-high colorectal cancer: protocol of a pooled analysis of clinical trials.

Colorectal cancer (CRC) is the third most common cause of cancer and the second leading cause of cancer-related deaths worldwide. Microsatellite instability-high (MSI-H) is a distinct molecular subtype of CRC that occurs in approximately 15% of all cases. Recently, immune checkpoint inhibitors (ICIs) have emerged as a promising therapeutic approach for patients with MSI-H colorectal cancer, exhibiting higher response rates than standard chemotherapies. To assess the effectiveness and safety of ICIs for the treatment of patients with MSI-H CRC, we propose a comprehensive pooled analysis of clinical trial data. A systematic search of multiple electronic databases, including PubMed, EMBASE, Cochrane Library, and Clinicaltrials.gov, will be conducted from their inception until September, 2023 to identify eligible randomized controlled trials (RCTs) and non-randomized studies. Inclusion criteria comprise studies of adult patients with histologically confirmed MSI-H CRC treated with immune checkpoint inhibitors, with a comparison to a control group receiving conventional therapies. Outcomes of interest will be overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and incidence of treatment-related adverse events (AEs). The Cochrane Risk of Bias tool and the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool will be employed to evaluate the methodological quality of included studies. A random-effects model using the DerSimonian and Laird method will be applied for pooling the effect estimates, calculating hazard ratios (HRs) or risk ratios (RRs) with their corresponding 95% confidence intervals (CIs). Heterogeneity will be assessed using I² statistics, and subgroup analysis and meta-regression will be performed to explore potential effect modifiers in case of substantial heterogeneity. Publication bias will be evaluated with funnel plots and Egger's test. Sensitivity analysis will be conducted to assess the robustness of the results. This meta-analysis will synthesize available evidence from clinical trials on immune checkpoint inhibitors in treating MSI-H colorectal cancer. The findings will offer valuable information about the effectiveness and safety of ICIs in this patient population, contributing to the refinement of clinical guidelines and enhancing the decision-making process for healthcare providers, policy-makers, and patients. The comprehensive analysis of subgroups and sensitivity allows for an in-depth understanding of potential effect modification, providing essential directions for future research. This study will involve the use of published data; hence, ethical approval is not required. The results of the study will be disseminated through publications in peer-reviewed journals and presentations at relevant conferences. The findings will potentially impact clinical decision-making and contribute to the development of evidence-based treatment recommendations for patients with MSI-H colorectal cancer. Open Science Framework identifier, 10.17605/OSF.IO/ZHJ85.

Relationship between objectively measured physical activity and subclinical cardiovascular disease: a systematic review

IntroductionThe association of physical activity (PA) with subclinical cardiovascular disease (CVD) is unclear. Clarifying this relationship may inform cardiovascular prevention strategies.MethodsWe performed a systematic review (CRD42021226089) using Medline, Embase, CINAHL...