Testing a tool for assessing the risk of bias for nonrandomized studies showed moderate reliability and promising validity

Assessment of the risk of bias is an essential component of any systematic review. This is true for both nonrandomized studies and randomized trials, which are the main study designs of systematic reviews. The Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) was developed in 2013 and has gained wide usage as a risk-of-bias assessment tool for nonrandomized studies. Four risk-of-bias assessment experts revised it by reviewing existing assessment tools and user surveys. The main modifications included additional domains of selection and detection bias susceptible to nonrandomized studies of interventions, a more detailed consideration of the comparability of participants, and more reliable and valid outcome measurements. A psychometric assessment of the revised RoBANS (RoBANS 2) revealed acceptable inter-rater reliability (weighted kappa, 0.25 to 0.49) and construct validity in which intervention effects of studies with an unclear or high risk of bias were overestimated. The RoBANS 2 has acceptable feasibility, fair-to-moderate reliability, and construct validity. It provides a comprehensive framework for allowing authors to assess and understand the plausible risk of bias in nonrandomized studies of interventions.

BackgroundThe objective of this study is to evaluate current literature on the association between cognitive dysfunction and nocturia.MethodsA systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was conducted through MEDLINE, EMBASE and COCHRANE databases and completed in November 2019. Randomized and non-randomized studies were included if they assessed the association between cognitive dysfunction and nocturia in older participants with or without neurological diseases. The quality of included studies was evaluated using the Risk of Bias Assessment tool for Non-randomized Studies (RoBANS).ResultsA total of 8 cross-sectional studies conducted in older patient populations met the criteria for inclusion. A statistically significant association was identified in 6 studies on univariate analysis, which persisted in 2 studies after controlling for confounding factors. The association between cognitive dysfunction and nocturia was positive for all 6 significant analyses. The overall risk of bias was unclear.ConclusionA significant positive association between cognitive dysfunction and nocturia was identified. However, research has been limited to cross-sectional studies, which precludes identification of causality between cognitive dysfunction and nocturia. Heightened awareness of the complex interplay between cognition and nocturia would allow professionals involved in the care of cognitively impaired patients with concomitant nocturia to more effectively manage these symptoms.

IntroductionInvolvement of a chemokine known as C-X-C motif chemokine ligand 10 or CXCL10 in the immunopathology of leprosy has emerged as a possible immunological marker for leprosy diagnosis and needed to be investigate further. The purpose of this systematic review is to assess CXCL10’s potential utility as a leprosy diagnostic tool and evaluation of therapy.MethodsThis systematic review is based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020. A thorough search was carried out to find relevant studies only in English and limited in humans published up until September 2023 using PubMed, Scopus, Science Direct, and Wiley Online Library database with keywords based on medical subject headings (MeSH) and no exclusion criteria. The Newcastle-Ottawa Scale (NOS) was utilized for quality assessment, while the Risk of Bias Assessment tool for Non-randomized Studies (RoBANS) was utilized for assessing the risk of bias. Additionally, a narrative synthesis was conducted to provide a comprehensive review of the results.ResultsWe collected a total of 115 studies using defined keywords and 82 studies were eliminated after titles and abstracts were screened. We assessed the eligibility of the remaining 26 reports in full text and excluded four studies due to inappropriate study design and two studies with incomplete outcome data. There were twenty included studies in total with total of 2.525 samples. The included studies received NOS quality evaluation scores ranging from 6 to 8. The majority of items in the risk bias assessment, using RoBANS, across all included studies yielded low scores. However, certain items related to the selection of participants and confounding variables showed variations. Most of studies indicate that CXCL10 may be a helpful immunological marker for leprosy diagnosis, particularly in leprosy reactions as stated in seven studies. The results are better when paired with other immunological markers. Its effectiveness in field-friendly diagnostic tools makes it one of the potential biomarkers used in diagnosing leprosy patients. Additionally, CXCL10 may be utilized to assess the efficacy of multidrug therapy (MDT) in leprosy patients as stated in three studies.ConclusionThe results presented in this systematic review supports the importance of CXCL10 in leprosy diagnosis, particularly in leprosy responses and in tracking the efficacy of MDT therapy. Using CXCL10 in clinical settings might help with leprosy early diagnosis. Yet the findings are heterogenous, thus more investigation is required to determine the roles of CXCL10 in leprosy while taking into account for additional confounding variables.

Community-based interventions to prevent stroke in low and middle-income countries: A systematic review

BackgroundIt remains unclear how inpatient physical activity after major abdominal surgery affects outcomes. Accelerometer research may provide further evidence for postoperative mobilization.ObjectiveWe aimed to summarize the current literature evaluating the impact of accelerometer-measured postoperative physical activity on outcomes after major abdominal surgery.MethodsWe searched PubMed and Google Scholar in October 2021 to conduct a systematic review. Studies were included if they used accelerometers to measure inpatient physical behaviors immediately after major abdominal surgery, defined as any nonobstetric procedures performed under general anesthesia requiring hospital admission. Studies were eligible only if they evaluated the effects of physical activity on postoperative outcomes such as postoperative complications, return of gastrointestinal function, hospital length of stay, discharge destination, and readmissions. We excluded studies involving participants aged <18 years. Risk of bias was assessed using the risk-of-bias assessment tool for nonrandomized studies (RoBANS) for observational studies and the revised Cochrane risk-of-bias tool for randomized trials (RoB 2) for randomized controlled trials (RCTs). Findings were summarized by qualitative synthesis.ResultsWe identified 15 studies. Risk of bias was high in 14 (93%) of the 15 studies. Most of the studies (11/15, 73%) had sample sizes of <100. Of the 15 studies, 13 (87%) included the general surgery population, 1 (7%) was a study of patients who had undergone gynecologic surgery, and 1 (7%) included a mixed (abdominal, thoracic, gynecologic, and orthopedic) surgical population. Of the 15 studies, 12 (80%) used consumer-grade accelerometers to measure physical behaviors. Step count was the most commonly reported physical activity outcome (12/15, 80%). In the observational studies (9/15, 60%), increased physical activity during the immediate postoperative period was associated with earlier return of gastrointestinal function, fewer surgical and pulmonary complications, shorter hospital length of stay, and fewer readmissions. In the RCTs (6/15, 40%), only 1 (17%) of the 6 studies demonstrated improved outcomes (shorter time to flatus and hospital length of stay) when a mobility-enhancing intervention was compared with usual care. Notably, mobility-enhancing interventions used in 4 (67%) of the 6 RCTs did not result in increased postoperative physical activity.ConclusionsAlthough observational studies show strong associations between postoperative physical activity and outcomes after major abdominal surgery, RCTs have not proved the benefit of mobility-enhancing interventions compared with usual care. The overall risk of bias was high, and we could not synthesize specific recommendations for postoperative mobilization. Future research would benefit from improving study design, increasing methodologic rigor, and measuring physical behaviors beyond step counts to understand the impact of postoperative mobilization on outcomes after major abdominal surgery.

Many cancer patients experience poor pain control due to various factors, including misconceptions regarding the use of opioid analgesics. For management of cancer pain, interventions involving education of both patients and physicians have been attempted. This review aimed to assess the current evidence of the benefits of education for the management of cancer pain. We searched the Medline, EMBASE, Cochrane library, and major Korean databases to identify relevant studies. We included most study designs, but excluded case series. The primary outcomes were pain intensity and quality of life (QoL). Two reviewers assessed the risk of bias using the Cochrane's tool for RCT and Risk of Bias Assessment tool for Non-randomized Studies (RoBANS) for non-randomized studies, independently. After extensive searches, 3,324 publications were screened, and 32 studies were selected. The education interventions used in the included studies included a wide variety of education methods, but the most common method was a booklet produced for patients. Regardless of the education method used, the results of the meta-analysis were as follows. The SMDs of the most severe, average, and current pain in the RCTs were significant. The SMD of worst, average, and current pain were -0.34 (-0.55, -0.13), -0.40 (-0.64, -0.15), and -0.79 (-1.35, -0.23). In the non-randomized studies, the effects on average pain were significant, but those on worst and current pain were not. Education intervention reduced the pain of cancer patients. Therefore, patient education could be considered to be an effective method of cancer pain management. However, our data should be interpreted with caution, and studies using standardized protocols are needed to confirm these observations.

Virtual reality (VR) is effective in several healthcare domains. As of date, there have been no systematic reviews investigating the efficacy of VR technology in episiotomy repair in women. This systematic review and meta-analysis examined the effects of using VR on pain, anxiety and satisfaction in women under episiotomy repair. For the original articles, six databases were searched using relevant keywords without restriction on time or languages until June 6, 2024. The Cochrane risk-of-bias tool for randomized trials (RoB) and the Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) were both used to assess the risk of bias in randomized and non-randomized studies, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) also determined the quality of our evidence. All analyses employed Comprehensive Meta-Analysis (CMA) V.2. Five randomized clinical trial and two quasi-experimental studies with poor-to high-quality met the inclusion criteria. The VR significantly decreased perineal pain during [MD (95% CI)=-1.622 (-2.598, -0.645), P=0.001], immediately after [MD (95% CI)=-1.931 (-2.785, -1.076), P<0.001], and one hour after [MD (95% CI)=-1.596 (-2.436, -0.765), P<0.001]. It also significantly decreased anxiety [SMD (95% CI)=-1.48 (-2.451, -0.509), P=0.003] after repair. VR group participants were significantly more satisfied than the control group. The quality of was moderate for perineal pain intensity one hour after episiotomy repair and anxiety after episiotomy repair. Given the efficacy of VR on pain, anxiety, and satisfaction, it is suggested that it be utilized as a novel modality to enhance the quality of maternity hospital care.

BackgroundPreterm labor (PTL) is a common and serious pregnancy disorder that can cause long-term neurological issues in the infant. There are conflicting studies concerning whether sildenafil citrate (SC) reduces preterm labor complications. Therefore, the meta-analysis aimed to examine the clinical outcomes in women with threatened PTL who received nifedipine plus SC therapy versus only nifedipine.MethodsFor the original articles, six databases were searched using relevant keywords without restriction on time or language until January 13, 2024. The Cochrane risk-of-bias tool for randomized trials (RoB) and the Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) were both used to assess the risk of bias in randomized and non-randomized studies, and GRADE determined the quality of our evidence. Meta-analysis of all data was carried out using Review Manager (RevMan) version 5.1.ResultsSeven studies with mixed quality were included in the meta-analysis. The study found that combining nifedipine and SC resulted in more prolongation of pregnancy (MD = 6.99, 95% CI: 5.32, 8.65, p < 0.00001), a lower rate of delivery in the 1st to 3rd days after hospitalization (RR = 0.62, 95% CI: 0.50, 0.76, p < 0.00001), a higher birth weight (252.48 g vs. nifedipine alone, p = 0.02), and the risk ratio of admission to the neonatal intensive care unit (NICU) was significantly lower (RR = 0.62, 95% CI: 0.50, 0.76, p < 0.00001) compared to nifidepine alone. The evidence was high for prolongation of pregnancy, delivery rate 24–72 h after admission, and NICU admission, but low for newborn birth weight.ConclusionsGiven the effectiveness of SC plus nifedipine in increased prolongation of pregnancy and birth weight, lower delivery in the 1st to 3rd days after hospitalization, and NICU admission, Gynecologists and obstetricians are suggested to consider this strategy for PTL management, although additional article rigor is required to improve the quality of the evidence.

BackgroundMost patients with advanced cancer have an inadequate understanding of their prognosis, and there are few interventions aimed at enhancing their prognostic understanding, with the effectiveness of these interventions remaining controversial.AimThe purpose of this systematic review is to identify interventions that have been effective at improving prognostic understanding in patients with advanced cancer.MethodsA systematic review was conducted in accordance with PRISMA guidelines. All relevant peer-reviewed articles published from 1990 and February 2025 were identified through an electronic search of four databases: Embase, Scopus, Pubmed, and Web of Science. Risk of bias was independently assessed by two reviewers using the Cochrane Risk of Bias Assessment Tool (CRBT) and Cochrane Risk of Bias Assessment Tool for Non-randomized Studies (RoBANS). Following this, a narrative synthesis of the findings was completed. Publications reporting on interventions delivered to patients with advanced cancer that included quantitative data on prognostic understanding were systematically reviewed.ResultsThirteen unique intervention studies involving 1,780 cancer patients were identified. Interventions tested included decision aids (DAs), prognostic discussions, advance care planning (ACP), and palliative care. Seven studies utilized a randomized controlled design. Five of these investigated DAs-based interventions and four examined prognostic discussions interventions, with the greatest empirical support found for these intervention types. However, most interventions fail to improve the prognostic understanding of patients with advanced cancer.ConclusionFurther research is needed to investigate the effects of interventions on prognostic understanding among patients with advanced cancers, using randomized controlled designs and adequately powered samples. This would enable the implementation of evidence-based recommendations for the most appropriate interventions in clinical practice.

BackgroundPrognostic models are used widely in the oncology domain to guide medical decision-making. Little is known about the risk of bias of prognostic models developed using machine learning and the barriers to their clinical uptake in the oncology domain.MethodsWe conducted a systematic review and searched MEDLINE and EMBASE databases for oncology-related studies developing a prognostic model using machine learning methods published between 01/01/2019 and 05/09/2019. The primary outcome was risk of bias, judged using the Prediction model Risk Of Bias ASsessment Tool (PROBAST). We described risk of bias overall and for each domain, by development and validation analyses separately.ResultsWe included 62 publications (48 development-only; 14 development with validation). 152 models were developed across all publications and 37 models were validated. 84% (95% CI: 77 to 89) of developed models and 51% (95% CI: 35 to 67) of validated models were at overall high risk of bias. Bias introduced in the analysis was the largest contributor to the overall risk of bias judgement for model development and validation. 123 (81%, 95% CI: 73.8 to 86.4) developed models and 19 (51%, 95% CI: 35.1 to 67.3) validated models were at high risk of bias due to their analysis, mostly due to shortcomings in the analysis including insufficient sample size and split-sample internal validation.ConclusionsThe quality of machine learning based prognostic models in the oncology domain is poor and most models have a high risk of bias, contraindicating their use in clinical practice. Adherence to better standards is urgently needed, with a focus on sample size estimation and analysis methods, to improve the quality of these models.

Clinical features of endophthalmitis clusters after cataract surgery and practical recommendations to mitigate risk: systematic review.

Purpose The purpose of this study was to examine the effects of non-pharmacological interventions for preoperative anxiety in surgical patient. Methods The search included the following: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL EMBASE, and Korean electronic databases (2000 to November 2018). Risk of bias in randomized studies was assessed using the Cochrane’s Risk of Bias (RoB) tool for randomized studies and for non-randomized studies, the Risk of Bias Assessment tool for Non-randomized studies (RoBANS) was used. To estimate the effect size, meta-analysis of the studies was performed using the R program (version 3.5.1). Results Nineteen trials were included (1,685 participants). The non-pharmacological interventions for preoperative anxiety in surgical patient were music intervention, aromatherapy, and patient education. Specifically, the twelve studies showing the effect of music intervention on anxiety were heterogeneous (x2=23.42, p=.05, I2=40%). The effect size was -0.77 (95% CI:-0.93, -0.60). The four studies showing the effect of aromatherapy on anxiety were heterogeneous (x2=8.95, p=.03, I2=66%). The effect size was -0.83 (95% CI: -1.30, -0.36). The three studies measuring the effect of patient education on anxiety identified as homogeneous (x2=1.95, p=.38, I2=0%). The effect size was -2.85 (95% CI: -5.00, -0.71). Conclusion This meta-analysis indicates that non-pharmacological interventions including music intervention, aromatherapy and patient education may have a beneficial effect on preoperative anxiety. Therefore, the findings of this study provide evidence to incorporate various non-pharmacological interventions into nursing practice to reduce preoperative anxiety. 주요어: ìˆ˜ìˆ , 환자, 불안, 메타분석 Key words: Perioperative period, Patients, Anxiety, Meta-analysis

The prevalence of mental disorders increases sharply during adolescence. Therefore, school teachers are in a good position to provide initial assistance to students with mental health problems. Although effects of a number of mental health literacy programs aimed at teachers have been reported, they have not yet been reviewed in a systematic manner. This study conducted a systematic review of the effectiveness of mental health literacy programs for teachers. PubMed, PsycINFO, CINAHL, ERIC, Web of Science and reference lists of included studies were searched in September 2018. Studies that quantitatively measured at least one of the main components of mental health literacy, including (a) knowledge of mental illnesses, (b) stigma towards mental illnesses, (c) confidence in helping students, and (d) behaviour of helping students, were included regardless of study design. Risk of bias was rated for each included study according to the Cochrane tool for randomized studies and the Cochrane tool, for raondomized studies, and the Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS), for nonrandomized studies. Sixteen studies met the inclusion criteria, including 1 randomized controlled trial (RCT), 2 cluster RCTs, 1 controlled before-and-after study and 12 case series. Most of the studies claimed significant improvement of knowledge, attitudes, behaviour and/or confidence. However, the overall quality for all outcomes was relatively low; 15 studies had high/unclear risk of bias due to lack of allocation concealment, not controlling for confounders, and/or inadequate analysis for attrition. More high quality evidence is required before the effectiveness of mental health literacy programs for teachers can be established.

Demodex mites are usually harmless but can contribute to inflammatory skin conditions like rosacea, blepharitis, and demodicosis. While new therapies like lotilaner, niclosamide, and berberine show promise against D. folliculorum, ivermectin remains widely used for its strong antiparasitic and anti-inflammatory effects. However, the direct effectiveness of ivermectin in reducing Demodex mite density in associated skin diseases is not fully quantified. A systematic review and meta-analysis were conducted following PRISMA guidelines. PubMed, Scopus, the Cochrane Library, and Google Scholar were searched for studies published between December 2014 and December 2024. Eligible studies have assessed the effect of topical ivermectin on Demodex mite number or density using standardized diagnostic methods. Risk of bias was evaluated using the Risk of Bias Assessment Tool for Non-randomized Studies (RoBANS) and the Cochrane Risk of Bias Tool. Data were pooled using a random-effects model where appropriate. A total of 2344 studies were identified, with five studies (n=180 participants) meeting the inclusion criteria. All studies reported significant reductions in Demodex mite count or density after daily application of topical ivermectin 1%. Meta-analyses demonstrated a mean reduction of 70.01 mites/cm2 and an 80% decrease in Demodex-positive (≥5 D/cm2) rates. A 16-week treatment duration was associated with a notable reduction, with effects sustained for up to 12weeks post-treatment. Only mild, localized adverse events were reported, with no systemic side effects observed. Topical ivermectin is effective and well-tolerated for reducing the number and density of Demodex mites. A 16-week treatment course significantly decreases mite burden and improves clinical outcomes with minimal adverse events. However, the potential for mite repopulation after treatment underscores the importance of ongoing monitoring. Study heterogeneity and the limited number of included trials warrant cautious interpretation of the findings.

Objective To summarize and produce aggregated evidence on the effect of simulation-based teaching on skill performance in the nursing profession. Simulation is an active learning strategy involving the use of various resources to assimilate the real situation. It enables learners to improve their skills and knowledge in a coordinated environment. Methods Systematic literature search of original research articles was carried out through Google Scholar, Medline, and Cochrane Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases. Studies conducted on simulation-based teaching and skill performance among nursing students or clinical nursing staff from 2010 to 2019, and published in the English language, were included in this study. Methodological quality was assessed by Joanna Briggs Institute, and the risk of bias was also assessed by Cochrane risk of bias and the risk of bias assessment tool for non-randomized studies (ROBINS-I) checklists. Results Initially, 638 titles were obtained from 3 sources, and 24 original studies with 2209 study participants were taken for the final analysis. Of the total studies, 14 (58.3%) used single group prep post design, 7 (29.1%) used high fidelity simulator (HFS), and 7 (29.1%) used a virtual simulator (VS). Twenty (83.3%) studies reported improved skill performance following simulation-based teaching. Simulation-based teaching improves skill performance among types of groups (single or double), study regions, high fidelity (HF), low fidelity (LF), and standard patient (SP) users. But the effect over virtual and medium fidelity simulators was not statistically significant. Overall, simulation-based teaching improves the skill performance score among the experimental group (d = 1.01, 95% confidence interval [CI] [0.69–1.33], Z = 6.18, P &lt; 0.01, 93.9%). Significant heterogeneity and publication bias were observed during the pooled analysis. Conclusions Simulation did improve skill performance among the intervention groups, but the conclusion is uncertain due to the significant heterogeneity. The large extent of difference among original research has necessitated the development of well-defined assessment methods for skills and standardized simulation set-up for proper assessment of their effects.