Risk Of Bias In Non-randomized Studies Of Interventions Research Articles

P082 Nephrolithiasis associated with uricosuric therapies for the treatment of gout: a systematic review

Abstract Background/Aims Uric acid nephrolithiasis is a recognised side-effect of uricosuric therapies and a contraindication to their use. The objective of this systematic review was to assess the incidence and risk of nephrolithiasis in people with gout receiving uricosuric therapy. Methods A systematic review was undertaken using MEDLINE, Embase, Cochrane Library, Web of Science and Clinical Trials electronic databases from inception to 16th May 2023. Pre-specified search terms relating to ‘gout’, ‘uricosuric drugs’ and ‘nephrolithiasis’ and their synonyms were used. Title/abstract and full-text screening and data extraction were undertaken independently by two reviewers. Randomised controlled trials (RCTs) and observational cohort studies assessing the incidence and risk of nephrolithiasis in adults with gout treated with uricosuric therapies were included (with or without a non-uricosuric urate-lowering therapy (ULT) comparator group). The Cochrane Risk of Bias (RoB)-2 for randomised trials and the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tools were used to assess the quality of included RCTs and cohort studies respectively. Results 507 articles were identified, of which 22 studies (8 RCTs, 14 cohort studies) were eligible for inclusion. The mean age of participants ranged from 51.2 years (standard deviation (SD) 10.9) to 66.8 years (SD 9.1). Participants were predominantly male (range 69-100%). Length of follow-up ranged from three months to 10 years. Eleven studies included participants with a prior history of nephrolithiasis. Ten studies assessed Benzbromarone monotherapy, five Lesinurad plus xanthine oxidase inhibitor (XOI), four Probenecid, three Sulfinpyrazone and one Lesinurad monotherapy (total 3091 participants). Ten studies included a non-uricosuric comparator group(s) (five placebo plus XOI, four XOI only, and one placebo only (total 1386 participants)), whereas 12 had no comparator group. Most studies assessed nephrolithiasis through clinical adverse event reporting rather than systematic assessment. The incidence of nephrolithiasis ranged from 0.0% to 11.8% in people receiving uricosuric therapy (four studies reported no stone events; incidence 0.1%-5% in seven studies, 5.1-10% in 9, and >10% in two). The incidence of nephrolithiasis ranged from 0.0% to 4.2% in those not receiving uricosurics. No studies calculated the risk of nephrolithiasis between uricosuric-treated and untreated groups. Few studies documented renal stone composition or reported the severity of clinical presentation of nephrolithiasis events. Conclusion Nephrolithiasis is a common side-effect of uricosuric therapy for gout. Future studies should provide risk estimates between uricosuric-treated and untreated groups, describe clinical presentation of stone events and, where possible, assess stone composition. Disclosure C. Dahanayake: None. R. Bajpai: Other; Dr Bajpai is a member of the Versus Arthritis College of Experts. K.M. Jordan: Other; Dr Jordan is a Trustee of the UK Gout Society. M. Lambie: Honoraria; Dr Lambie has received speakers honoraria from Baxter Healthcare and Fresenius Medical Care. Grants/research support; Dr Lambie has received an unrestricted research grant from Baxter Healthcare. E. Roddy: None.

Evaluation of the External Soft Tissue Changes Following the Correction of Class II Skeletal Malocclusion in the Adolescence Period Using Removable and Fixed Functional Appliances: A Systematic Review and Meta-Analysis.

In this systematic review, we aimed to assess the current evidence regarding the effectiveness of functional treatment with both removable and fixed appliances to normalize the external soft tissue for skeletal class II adolescent individuals. We performed a broad electronic search to retrieve relevant studies from nine databases to identify randomized controlled trials (RCTs) and controlled clinical trials (CCTs) that investigated soft tissue changes following functional treatment and evaluated the changes using 2D lateral cephalometric radiographsand 3D-optical surface laser scanning. A total of three RCTs and eight CCTs were included. Ages ranged from 11 to 16 years with the fixed functional appliances, and from eight to 12 years with the removable ones, including 689 skeletal class II patients. Version 2 of Cochran's risk-of-bias (RoB2), and the risk of bias in non-randomized studies of interventions (ROBIN-I) were used to assess the risk of bias for the included papers. Of the 11 eligible studies, three studies were included in the meta-analysis to assess the upper and lower lip position in relation to the E-line (Ricketts's aesthetic line) in addition to the nasolabial angle. The meta-analysis showed that the upper lip retracted after functional treatment with Twin-block in relation to E-line (mean difference (MD) = -1.93; 95% CI: -2.37, -1.50; p < 0.00001; χ² = 5.43; p = 0.07; I2 = 63%), while the lower lip position did not change after functional treatment with Twin-block in relation to E-line (MD = 0.03; 95% CI: -0.56, 0.61; p = 0.92; χ² = 1.74; p = 0.42; I2 = 0%). The nasolabial angle increased after Twin-block treatment (MD = 5.75; 95% CI: 4.57, 6.93;p < 0.00001; χ² = 6.77; p = 0.03; I2 = 70%). The mentolabial angle and Z-angle also increased after functional therapy, where the facial convexity angle decreased, regardless of the functional devices used. On the other hand, using the 3D-optical surface laser scanning showed that the upper lip length and the commissural width did not change following therapy, but the lower lip increased in length, as well as the total face height. More high-quality RCTs are required to obtain accurate evidence in this field.

Systematic review of empiric studies on lockdowns, workplace closures, and other non-pharmaceutical interventions in non-healthcare workplaces during the initial year of the COVID-19 pandemic: benefits and selected unintended consequences

BackgroundWe conducted a systematic review aimed to evaluate the effects of non-pharmaceutical interventions within non-healthcare workplaces and community-level workplace closures and lockdowns on COVID-19 morbidity and mortality, selected mental disorders, and employment outcomes in workers or the general population.MethodsThe inclusion criteria included randomized controlled trials and non-randomized studies of interventions. The exclusion criteria included modeling studies. Electronic searches were conducted using MEDLINE, Embase, and other databases from January 1, 2020, through May 11, 2021. Risk of bias was assessed using the Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) tool. Meta-analysis and sign tests were performed.ResultsA total of 60 observational studies met the inclusion criteria. There were 40 studies on COVID-19 outcomes, 15 on anxiety and depression symptoms, and five on unemployment and labor force participation. There was a paucity of studies on physical distancing, physical barriers, and symptom and temperature screening within workplaces. The sign test indicated that lockdown reduced COVID-19 incidence or case growth rate (23 studies, p < 0.001), reproduction number (11 studies, p < 0.001), and COVID-19 mortality or death growth rate (seven studies, p < 0.05) in the general population. Lockdown did not have any effect on anxiety symptoms (pooled standardized mean difference = -0.02, 95% CI: -0.06, 0.02). Lockdown had a small effect on increasing depression symptoms (pooled standardized mean difference = 0.16, 95% CI: 0.10, 0.21), but publication bias could account for the observed effect. Lockdown increased unemployment (pooled mean difference = 4.48 percentage points, 95% CI: 1.79, 7.17) and decreased labor force participation (pooled mean difference = -2.46 percentage points, 95% CI: -3.16, -1.77). The risk of bias for most of the studies on COVID-19 or employment outcomes was moderate or serious. The risk of bias for the studies on anxiety or depression symptoms was serious or critical.ConclusionsEmpiric studies indicated that lockdown reduced the impact of COVID-19, but that it had notable unwanted effects. There is a pronounced paucity of studies on the effect of interventions within still-open workplaces. It is important for countries that implement lockdown in future pandemics to consider strategies to mitigate these unintended consequences.Systematic review registrationPROSPERO registration # CRD42020182660.

Treatment of women with vaginal laxity: systematic review with meta-analysis.

Despite several treatments that have been used for women reporting vaginal laxity (VL), to our knowledge no systematic review is available on the topic so far. In this study, we sought to summarize the best available evidence about the efficacy and safety of interventions for treating VL, whether conservative or surgical. A comprehensive search strategy was performed in Medline, Embase, Scopus, Web of Science, and Cochrane Library for reports of clinical trials published from database inception to September 2022. Studies selected for inclusion were in the English language and were performed to investigate any type of treatment for VL, with or without a comparator, whether nonrandomized studies or randomized controlled trials (RCTs). Case reports and studies without a clear definition of VL were excluded. The outcomes were interventions (laser, radiofrequency, surgery, and topical treatment), adverse effects, sexual function, pelvic floor muscle (PFM) strength, and improvement of VL by the VL questionnaire (VLQ). From 816 records, 38 studies remained in the final analysis. Laser and radiofrequency (RF) were the energy-based treatment devices most frequently studied. Pooled data from eight observational studies have shown improved sexual function assessed by a Female Sexual Function Index score mean difference (MD) of 6.51 (95% CI, 5.61-7.42; i2 = 85%, P < .01) before and after intervention, whether by RF (MD,6.00; 95% CI, 4.26-7.73; i2 = 80%; P < .001) or laser (MD, 6.83; 95% CI, 5.01-8.65; i2 = 92%; P < .01). However, this finding was not shown when only 3 RCTs were included, even when separated by type of intervention (RF or laser). When RF treatment was compared to sham controls, VLQ scores did not improve (MD, 1.01; 95% CI, -0.38 to 2.40; i2 = 94%; P < .001). Patient PFM strength improved after interventions were performed (MD, 4.22; 95% CI, 1.02-7.42; i2 = 77%; P < .001). The ROBINS-I (Risk Of Bias In Nonrandomized Studies of Interventions) tool classified all non-RCTs at serious risk of bias, except for 1 study, and the risk of bias-1 analysis found a low and unclear risk of bias for all RCTs. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) certainty of the evidence was moderate for sexual function and the VLQ questionnaire and low for PFM strength. Sexual function in women with VL who underwent RF and laser treatment improved in observational studies but not in RCTs. Improvement in PFM strength was observed in women with VL after the intervention. Crucial issues were raised for the understanding of VL, such as lack of standardization of the definition and for the development of future prospective studies. A limitation of the study was that the heterogeneity of the interventions and different follow-up periods did not make it possible to pool all available data. Vaginal tightening did not improve sensation in women with VL after intervention, whereas RF and laser improved sexual function in women with VL according to data from observational studies, but not from RCTs. PFM strength was improved after intervention in women with VL.

Systematic review of survival following liver or lung metastasectomy for metastatic anal squamous cell carcinoma.

Metastatic anal squamous cell carcinoma (SCC) carries a poor prognosis and the evidence base for surgical resection of metastases remains limited. The aim of this study was to establish the survival outcomes for patients undergoing metastasectomy for anal SCC. A systematic review was performed using the MEDLINE®, Embase®, Cochrane and PubMed® databases. Studies were considered for inclusion in the review if they involved patients aged >18 years with a diagnosis of stageIV anal SCC who underwent metastasectomy for liver and/or lung metastases. The primary outcome measure was overall survival. Secondary outcome measures were disease free survival, early morbidity according to the Clavien-Dindo classification and quality of life, measured using a validated scoring tool. Risk of bias was assessed with the ROBINS-I (Risk Of Bias In Non-randomised Studies - of Interventions) tool. There were 10 studies with a total of 98 patients. There was heterogeneity in results reporting, with recurrence free survival the most reported outcome. For all studies reporting on liver metastasectomy, the one-year overall survival rate was 87%. In studies with adequate follow-up reported, the three and five-year overall survival rates were 53% and 38% respectively. Only one study reported on lung metastasectomy patients; the overall median survival was 24 months. None of the studies reported on quality of life measures. The ROBINS-I tool identified a critical risk of bias in six studies, a serious risk in one study and a moderate risk in three studies. The evidence base for metastasectomy in metastatic anal SCC is limited. Further information is required to inform future treatment methods and use of a standardised outcomes reporting method is needed to support this.

Indirect Effects of the COVID-19 Pandemic on Routine Childhood Vaccination in Low-Income Countries: A Systematic Review to Set the Scope for Future Pandemics.

The COVID-19 pandemic halted progress in global vaccine coverage and disrupted routine childhood vaccination practices worldwide. While there is ample evidence of the vaccination decline experienced during the pandemic, it is less clear how low-income countries were affected. We executed a systematic review to synthesize the current literature on the impacts of routine childhood vaccinations in low-income countries from 1 January 2020 to 8 February 2023. We collected data using an extraction form on Covidence and assessed the quality of studies included in the review using the Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) tool. Effect estimates for changes in vaccination during the pandemic were reported and summarized. Factors that influenced changes were grouped into descriptive themes. Thirteen studies, encompassing 18 low-income countries and evaluating 15 vaccines at varying doses, were included in the final review. We found that routine childhood vaccinations during the COVID-19 pandemic varied considerably by vaccine type, location, and phase of the pandemic. Nine different themes were identified as factors that influenced changes in vaccination. Documenting past experiences and lessons learned is crucial for informing preparedness efforts in anticipation of future public health emergencies. Failure to effectively address these things in the next public health emergency could result in a recurrence of declining routine childhood vaccinations.

The Impact of Health Care Algorithms on Racial and Ethnic Disparities : A Systematic Review.

There is increasing concern for the potential impact of health care algorithms on racial and ethnic disparities. To examine the evidence on how health care algorithms and associated mitigation strategies affect racial and ethnic disparities. Several databases were searched for relevant studies published from 1 January 2011 to 30 September 2023. Using predefined criteria and dual review, studies were screened and selected to determine: 1) the effect of algorithms on racial and ethnic disparities in health and health care outcomes and 2) the effect of strategies or approaches to mitigate racial and ethnic bias in the development, validation, dissemination, and implementation of algorithms. Outcomes of interest (that is, access to health care, quality of care, and health outcomes) were extracted with risk-of-bias assessment using the ROBINS-I (Risk Of Bias In Non-randomised Studies - of Interventions) tool and adapted CARE-CPM (Critical Appraisal for Racial and Ethnic Equity in Clinical Prediction Models) equity extension. Sixty-three studies (51 modeling, 4 retrospective, 2 prospective, 5 prepost studies, and 1 randomized controlled trial) were included. Heterogenous evidence on algorithms was found to: a) reduce disparities (for example, the revised kidney allocation system), b) perpetuate or exacerbate disparities (for example, severity-of-illness scores applied to critical care resource allocation), and/or c) have no statistically significant effect on select outcomes (for example, the HEART Pathway [history, electrocardiogram, age, risk factors, and troponin]). To mitigate disparities, 7 strategies were identified: removing an input variable, replacing a variable, adding race, adding a non-race-based variable, changing the racial and ethnic composition of the population used in model development, creating separate thresholds for subpopulations, and modifying algorithmic analytic techniques. Results are mostly based on modeling studies and may be highly context-specific. Algorithms can mitigate, perpetuate, and exacerbate racial and ethnic disparities, regardless of the explicit use of race and ethnicity, but evidence is heterogeneous. Intentionality and implementation of the algorithm can impact the effect on disparities, and there may be tradeoffs in outcomes. Agency for Healthcare Quality and Research.

Impact of pharmacist-supported transition of care services in the Middle East and North Africa: a systematic review and meta-analysis.

Transition of care (TOC) is associated with an increased risk of medication-related problems. Despite recent advancements in pharmacy practice and research in the Middle East and North Africa (MENA), the characteristics and impact of regional pharmacy-supported TOC interventions remain unclear.This systematic review and meta-analysis aimed to describe pharmacist-supported TOC interventions in the MENA region and evaluate their effectiveness. PubMed, CINAHL, EMBASE, Web of Science, World Health Organization's International Clinical Trials Registry Platform (ICTRP) were searched from their inception to March 9, 2023, for experimental studies published in English, comparing pharmacist-supported TOC interventions with usual care for adults (age ≥18 years) discharged from the hospital. The risk of bias was evaluated using Cochrane's risk-of-bias tool for randomised trials (ROB2) and the risk of bias in non-randomised studies of interventions (ROBINS-I) tool for randomised and non-randomised studies respectively. Narrative syntheses and meta-analysis methods were employed depending on the outcomes evaluated. Twelve studies (n = 2377 subjects), 10 randomised controlled trials and 2 quasi-experimental studies, were included. Most studies had high or serious risk of bias. The included studies were quite heterogeneous in terms of nature and the delivery of intervention, and assessment of outcome measures. Compared to the usual care group, pharmacist-led TOC interventions contributed to a significant reduction in preventable drug-related (N = 2) and cardiac-related healthcare utilisation (N = 1), a significant reduction in preventable adverse drug events (ADEs) (Odds ratio (OR) 0.34, 95% CI: 0.13-0.94) and an improvement in medication adherence. However, all-cause hospitalisation and medication discrepancies were not significantly reduced. Pharmacy-supported TOC interventions may improve patient outcomes in the MENA region. However, considering the limited quality of evidence and the variability in intervention delivery, future well-designed clinical trials are needed.

Resective epilepsy surgery and its impact on depression in adults: a systematic review, meta-analysis, and implications for future research

BackgroundHow epilepsy surgery influences the bidirectional relationship of epilepsy and depression remains poorly defined.MethodFor a better understanding of this question, we conducted a systematic review and meta-analysis of risk ratio...

Middle meningeal artery embolization as standalone treatment versus combined with surgical evacuation for chronic subdural hematomas: systematic review and meta-analysis.

Middle meningeal artery embolization (MMAE) is a novel treatment for chronic subdural hematomas (cSDHs) with high variability of use across practitioners and institutions. This study sought to investigate whether standalone MMAE may be an effective alternative to combined MMAE and surgery for select patients with cSDH. The authors searched the Medline and Embase databases for studies reporting outcomes specific to standalone MMAE and combined MMAE and surgery. The Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool was used to assess risk of bias in each included study. Patient characteristics were compared between cohorts, and rates of surgical recurrence of standalone MMAE and combined MMAE and surgery were pooled using random-effects models. Four hundred two unique patients (156 with standalone MMAE and 246 with combined MMAE and surgery) were identified across 8 studies. Overall, the subdural thickness for the standalone MMAE group was modestly but statistically significantly smaller (16.8 vs 18.8 mm, estimated p value 0.002), and the mean follow-up time was significantly longer for the standalone MMAE group (5.4 vs 2.3 months, estimated p value < 0.001); there were no significant differences between age, sex, and anticoagulant use. The surgical recurrence rates were not significantly different between the two groups (estimated p value 0.63). Using random-effects models, the surgical recurrence rates were estimated at 6.8% (95% CI 3.5%-11.2%) and 4.6% (95% CI 2.3%-7.7%) for standalone MMAE and combined MMAE and surgery, respectively. Standalone MMAE for cSDH may yield a low rate of surgical recurrence, which may be comparable to that of combined MMAE and surgery. However, studies in this systematic review and meta-analysis were primarily single-arm studies prone to treatment bias. Future studies are needed to further investigate whether standalone MMAE may be an effective alternative to combined MMAE and surgical treatment for cSDH in select patients.

Ayush [Indian System of Medicines] Prophylaxis Against COVID-19: A Living Systematic Review and Meta-Analysis (Second Update).

Background: Ayush (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy) system of medicine has been extensively used in India for the prevention and management of coronavirus disease 2019 (COVID-19). The present report is the second update of a living systematic review and meta-analysis and has been intended to assess the preventive potential and safety of Ayush drugs against COVID-19. Methods: A search of databases such as PubMed, the Cochrane central register of controlled trials, the World Health Organization (WHO) COVID-19 database, the clinical trial registry-India, the AYUSH research portal, and preprint repositories was performed till March 1, 2023. Randomized controlled trials or analytical observational studies were included. Incidences of COVID-19 infections and mortality were taken as primary outcome measures; and symptomatic severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection, incidences of hospital admissions, and adverse events were taken as secondary outcomes. The risk of bias was evaluated by version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB-2) and the Risk of Bias in Non-Randomized Studies-of Interventions (ROBINS-I) tool. Data were synthesized through the RevMan 5.4 tool, and the certainty of the evidence was ranked through the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results: Out of 2350 articles, 15 studies were included in the review. The pooled estimate of Guduchi [Tinospora cordifolia (Thunb.) Miers], Chyawanprasha, and Ayuraksha kit was obtained. Meta-analysis of the data suggested that Guduchi may reduce the incidences of COVID-19 infections (risk ratio [RR]: 0.67 [95% confidence interval, CI: 0.48-0.95]) and the symptom development among the infected (RR: 0.88 [95% CI: 0.73-1.08]), however, no change was observed in hospital admissions (RR: 0.96 [95% CI: 0.20-4.53]). It is uncertain that Chyawanprasha reduces the incidence of COVID-19 infection (RR: 0.28; [95% CI: 0.07-1.08]). Ayuraksha kit as chemoprophylaxis may reduce the incidences of COVID-19 infections (RR: 0.49; [95% CI: 0.32-0.77]). The certainty of the evidence was low to moderate mainly due to the serious risk of bias. Conclusion: Prophylactic use of Ayush medicines for populations at risk may help to prevent COVID-19 infection by reducing incidence and severity. However, considering the certainty and fewer studies, high-quality studies are still desired to confirm the efficacy and safety of Ayush chemoprophylaxis for COVID-19. Nevertheless, this update will serve as a torchbearer for policymakers, physicians, and other stakeholders for their decision-making through evidence-based medicine.

Lifestyle modification interventions for adults with intellectual disabilities: systematic review and meta-analysis at intervention and component levels.

Adults with intellectual disabilities (IDs) are susceptible to multiple health risk behaviours such as alcohol consumption, smoking, low physical activity, sedentary behaviour and poor diet. Lifestyle modification interventions can prevent or reduce negative health consequences caused by these behaviours. We aim to determine the effectiveness of lifestyle modification interventions and their components in targeting health risk behaviours in adults with IDs. A systematic review and meta-analysis were conducted. Electronic databases, clinical trial registries, grey literature and citations of systematic reviews and included studies were searched in January 2021 (updated February 2022). Randomised controlled trials and non-randomised controlled trials targeting alcohol consumption, smoking, low physical activity, sedentary behaviours and poor diet in adults (aged≥18years) with ID were included. Meta-analysis was conducted at the intervention level (pairwise and network meta-analysis) and the component-level (component network meta-analysis). Studies were coded using Michie's 19-item theory coding scheme and 94-item behaviour change taxonomies. Risk of bias was assessed using the Cochrane Risk of Bias (ROB) Version 2 and Risk of Bias in Non-randomised Studies of Interventions (ROBINS-I). The study involved a patient and public involvement (PPI) group, including people with lived experience, who contributed extensively by shaping the methodology, providing valuable insights in interpreting results and organising of dissemination events. Our literature search identified 12180 articles, of which 80 studies with 4805 participants were included in the review. The complexity of lifestyle modification intervention was dismantled by identifying six core components that influenced outcomes. Interventions targeting single or multiple health risk behaviours could have a single or combination of multiple core-components. Interventions (2 RCTS; 4 non-RCTs; 228 participants) targeting alcohol consumption and smoking behaviour were effective but based on limited evidence. Similarly, interventions targeting low physical activity only (16 RCTs; 17 non-RCTs; 1413 participants) or multiple behaviours (low physical activity only, sedentary behaviours and poor diet) (17 RCTs; 24 non-RCTs; 3164 participants) yielded mixed effectiveness in outcomes. Most interventions targeting low physical activity only or multiple behaviours generated positive effects on various outcomeswhile some interventions led to no change or worsened outcomes, which could be attributed to the presence of a single core-component or a combination of similar core components in interventions. The intervention-level meta-analysis for weight management outcomes showed that none of the interventions were associated with a statistically significant change in outcomes when compared with treatment-as-usual and each other. Interventions with core-components combination of energy deficit diet, aerobic exercise and behaviour change techniques showed the highest weight loss [mean difference (MD)=-3.61, 95% credible interval (CrI) -9.68 to 1.95] and those with core-components combination dietary advice and aerobic exercise showed a weight gain (MD 0.94, 95% CrI -3.93 to 4.91). Similar findings were found with the component network meta-analysis for which additional components were identified. Most studies had a high and moderate risk of bias. Various theories and behaviour change techniques were used in intervention development and adaptation. Our systematic review is the first to comprehensively explore lifestyle modification interventions targeting a range of single and multiple health risk behaviours in adults with ID, co-produced with people with lived experience. It has practical implications for future research as it highlights the importance of mixed-methods research in understanding lifestyle modification interventions and the need for population-specific improvements in the field (e.g., tailored interventions, development of evaluation instruments or tools, use of rigorous research methodologies and comprehensive reporting frameworks). Wide dissemination of related knowledge and the involvement of PPI groups, including people with lived experience, will help future researchers design interventions that consider the unique needs, desires and abilities of people with ID.

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...

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.

Edaravone for patients with amyotrophic lateral sclerosis: a systematic review and meta-analysis.

The effectiveness and long-term efficacy of edaravone, a recommended treatment for amyotrophic lateral sclerosis (ALS), has not been examined in real-world settings. This study aims to evaluate the effectiveness and long-term efficacy of edaravone. The OVID Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases were searched for articles published between January 1, 2000, and May 1, 2023. Two investigators independently screened the retrieved articles for randomized controlled trials (RCTs), cohort studies, or single-arm trials that evaluated the effect of edaravone on amyotrophic lateral sclerosis (ALS). The risk of bias was evaluated using the revised Cochrane Risk-of-Bias (RoB 2.0) tool for randomized controlled trials (RCTs) and the Risk-of-Bias In Non-randomized Studies of Interventions (ROBINS-I) tool for observational studies. The primary outcome was the ALSFRS-R score assessed at month 6, with secondary outcomes including the ALSFRS-R scores evaluated at months 9, 12, and 18, forced vital capacity (FVC), and adverse events. The certainty of evidence was assessed using the GRADE approach. The analysis included 16 studies with a total of 4828 participants. Among these, four were randomized controlled trials (RCTs) and 12 were observational studies. Of the RCTs, four were rated as having a low risk of bias, while six of the observational studies were rated as having a low risk of bias. Edaravone was associated with slightly slower progression in the reduction of ALSFRS-R score at month 6 compared to placebo (mean difference 1.01, 95%CI -0.87 to 3.09, p = 0.293), as shown by evidence from RCTs. However, observational studies did not show any benefit of adding edaravone to routine practice (mean difference 1.85, 95%CI -2.05 to 5.75, p = 0.352). The change from baseline in ALSFRS-R score was -2.1, -4.04, -7.5, -6.82, and -7.9 at months 3, 6, 9, 12, and 18, respectively. The GRADE assessment indicated moderate certainty for evidence from RCTs, while evidence from observational studies had very low certainty. Due to the limited number of studies and confounding issues in observational studies, further examination of the added benefits of edaravone to routine practice is necessary through RCTs, particularly regarding its long-term efficacy.

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.

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.

Nonpharmacological treatment of rumination syndrome in childhood: A systematic review of the literature.

Rumination syndrome (RS) is a complex functional disorder characterized by recurrent, repetitive regurgitation of recently swallowed food. RS may have medical and psychosocial implications, compromising the quality of life and causing high rates of school absenteeism. Pediatric RS has been poorly studied and little evidence regarding its treatment is available. This systematic review aims to evaluate the literature on the nonpharmacological treatment of RS in childhood. A systematic literature search was conducted on MEDLINE/PubMed, CINAHL, Cochrane Library, PsycINFO, and PEDro, from 2000 to 2023. The methodological quality of the publications was assessed by applying the guidelines proposed by the Equator network, according to the different designs of study, and the risk of bias was evaluated with the Risk Of Bias In Non-Randomized Studies of Interventions (ROBINS-I). Five hundred ninety-six studies were screened, and 7 studies were included in the review. Diaphragmatic breathing was the most used nonpharmacological treatment, and it was always combined with other therapeutic strategies. The vast heterogeneity of the physical or mental comorbidities and the methodology adopted in the publications did not allow a comparative analysis of the different treatments. Regardless of the type of treatment, high-intensity therapeutic programs and specific operators' training emerged as the most influencing factors for patients' outcomes. According to the available evidence, there is not enough high-quality evidence to suggest a defined therapeutic strategy. Large observational studies on selected patients accounting for possible confounders, with adequate follow-up times, and with clearly defined treatment regimens are needed to identify the best therapeutic approach.