Risk Of Bias In Studies Research Articles

Clinical effectiveness of Lactobacillus reuteri in the treatment of peri-implant diseases: a systematic review and meta-analysis.

In the last decades, the presence of peri-implant diseases (PD) has increased. One of the therapies currently used is probiotics with Lactobacillus reuteri (LR). The aim of this article is to determinate, through a systematic review and meta-analysis, the clinical effectiveness of LR in the treatment of PD. We searched the literature until January 2021, in the biomedical databases: Pubmed, Embase, Scielo, Science Direct, Scopus, SIGLE, LILACS, Google Scholar and Cochrane Central Registry of Clinical Trials. The selection criteria of the studies were: randomized controlled clinical trials, without language and time restriction, reporting the clinical effects (depth to probing, plaque index and bleeding index) of the LR in the PD treatment. The risk of study bias was analyzed through the Cochrane tool for randomized studies using Review Manager software. The search strategy resulted in 6 articles of which four investigated peri-implantitis and three peri-implant mucositis. All studies reported that there was a difference in the depth of the probing in the treatment of PD, in favor of the group using LR, though not always achieving significance. The use of LR can be clinically effective in terms of pocket depth reduction in the treatment of PD.

Band ligation versus sham or no intervention for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis.

Band ligation versus sham or no intervention for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis.

Psychometric properties of chronic low back pain diagnostic classification systems: a systematic review.

To identify and critically appraise studies evaluating psychometric properties of functionally oriented diagnostic classification systems for Non-Specific Chronic Low Back Pain (NS-CLBP). This review employed methodology consistent with PRISMA guidelines. Electronic databases and journals: (PubMed, EMBASE, Cochrane, PEDro, CINAHL, Index to chiropractic literature, ProQuest, Physical Therapy, Journal of Physiotherapy, Canadian Physiotherapy and Physiotherapy Theory and Practice) were searched from inception until January 2020. Included studies evaluated the validity and reliability of NS-CLBP diagnostic classification systems in adults. Risk of bias was assessed using a Critical Appraisal Tool. Twenty-two studies were eligible: Five investigated inter-rater reliability, and 17 studies analyzed validity of O'Sullivan's classification system (OCS, n = 15), motor control impairment (MCI) test battery (n = 1), and Pain Behavior Assessment (PBA, n = 1). Evidence from multiple low risk of bias studies demonstrates that OCS has moderate to excellent inter-rater reliability (kappa > 0.4). Also, two low risk of bias studies support of OCS-MCI subcategory. Three tests within the MCI test battery show acceptable inter- and intra-rater reliability for clinical use (the "sitting knee extension," the "one leg stance," and the "pelvic tilt" tests). Evidence for the reliability and validity of the PBA is limited to one high bias risk study. Multiple low risk of bias studies demonstrate strong inter-rater reliability for OCS classification specifically OCS-MCI subcategory. Future studies with low risk of bias are needed to evaluate reliability and validity of the MCI test battery and the PBA.

Serum bilirubin and chronic obstructive pulmonary disease (COPD): a systematic review

BackgroundBilirubin is a potent antioxidant and higher serum bilirubin levels have been associated with improved COPD outcomes. We performed a systematic review to evaluate the association between serum bilirubin levels and lung function (FEV1), prevalence/incidence of COPD, acute exacerbations of COPD, respiratory health status, and mortality.MethodsMEDLINE® and Embase were searched using Ovid® (search updated October 1st, 2019). We included studies that measured serum bilirubin levels and outcomes of interest in adults with or without underlying lung disease. We excluded studies of those with liver disease or drug-induced elevations in bilirubin. We used the Newcastle–Ottawa scale to assess individual study risk of bias (ROB) and the US Agency for Healthcare Research and Quality—Evidence Based Practice tool to assess overall strength of evidence (SOE). Two authors independently determined eligibility, performed data abstraction, assessed ROB, and determined SOE.ResultsThirteen studies (5 low risk of bias, 3 moderate and 5 high risk) were included. We found low strength of evidence for the association between higher bilirubin levels and lower risk of acute exacerbations of COPD (2 studies), mortality (3 studies), COPD diagnosis (4 studies), and lung function (FEV1) (8 studies). We found insufficient evidence on the relationship between serum bilirubin and respiratory health status/exercise capacity (1 study) and airflow obstruction (FEV1/FVC ratio) (4 studies).ConclusionHigher bilirubin levels may be associated with lower mortality and improved COPD outcomes. Randomized trials are needed to evaluate the effect of medications that raise serum bilirubin on COPD outcomes.PROSPERO registration: CRD42019145747.

What happens after randomised controlled trials? Uterine fibroids and ulipristal acetate: systematic review and meta-analysis of "real-world" data

"Real-world" data incorporates studies performed outside of controlled environments, allowing for a better understanding of the effects of treatment in routine clinical practice. We, therefore, performed a systematic review to summarise available "real-world studies" reporting on the use of ulipristal acetate (UPA) for management of uterine fibroids. We designed a prospective protocol according to PRISMA guidelines and registered it with PROSPERO (ID: CRD42019151393). We searched all major databases for relevant citations until 20th September 2019. Our screen included studies for risk of bias using an adapted structured quality assessment tool. Random-effects meta-analysis was used to calculate proportion estimates for each outcome including 95% confidence interval. Reported heterogeneity was assessed using I2. Initial search yielded 755 studies and 13 were included in the final synthesis. Administration of UPA resulted in reduction in the size of fibroids in 56.5% of women, improved menorrhagia in 83% of women, improved perception of pain in 80.1% of women and lead to an improvement in global symptom scores in 85.2% of women. Mean reduction in surgical blood loss and surgical time with use of UPA was 59.85ml and 12.47min, respectively. Qualitative analysis suggested that there was no difference in overall surgical experience for patients treated with UPA compared to those without pre-treatment. Our findings are consistent with previously reported data that UPA is an acceptable management option for women with fibroids. However, it provides limited benefits when used as a pre-operative adjunct, in terms of blood loss and surgical time.

Psychometric properties of burnout measures: a systematic review

Occupational Burnout (OB) is currently measured through several Patient-Reported Outcome Measures (PROMs) and some of them have become widely used in occupational health research and practice. We, therefore, aimed to review and grade the psychometric validity of the five OB PROMs considered as valid for OB measure in mental health professionals (the Maslach Burnout Inventory (MBI), the Pines' Burnout Measure (BM), the Psychologist Burnout Inventory (PBI), the OLdenburg Burnout Inventory (OLBI) and the Copenhagen Burnout Inventory (CBI)). We conducted systematic literature searches in MEDLINE, PsycINFO and EMBASE databases. We reviewed studies published between January 1980 and September 2018 following a methodological framework, in which each step of PROM validation, the reference method, analytical technics and result interpretation criteria were assessed. Using the COnsensus-based Standards for the selection of health Measurement Instruments we evaluated the risk of bias in studies assessing content and criterion validity, structural validity, internal consistency, reliability, measurement error, hypotheses testing and responsiveness of each PROM. Finally, we assessed the level of evidence for the validity of each PROM using the GRADE approach. We identified 6541 studies, 19 of which were included for review. Fifteen studies dealt with MBI whereas BM, PBI, OLBI and CBI were each examined in only one study. OLBI had the most complete validation, followed by CBI, MBI, BM and PBI, respectively. When examining the result interpretation correctness, the strongest disagreement was observed for MBI (27% of results), BM (25%) and CBI (17%). There was no disagreement regarding PBI and OLBI. For OLBI and CBI, the quality of evidence for sufficient content validity, the crucial psychometric property, was moderate; for MBI, BM and PBI, it was very low. To be validly and reliably used in medical research and practice, PROM should exhibit robust psychometric properties. Among the five PROMs reviewed, CBI and, to a lesser extent, OLBI meet this prerequisite. The cross-cultural validity of these PROMs was beyond the scope of our work and should be addressed in the future. Moreover, the development of a diagnostic standard for OB would be helpful to assess the sensitivity and specificity of the PROMs and further reexamine their validity.The study protocol was registered in PROSPERO (CRD 42019124621).

Cough peak flow to predict extubation outcome: a systematic review and meta-analysis.

ObjetivoAvaliar a utilidade do pico de fluxo da tosse para predizer o desfecho da extubação em pacientes que obtiveram sucesso no teste de respiração espontânea.MétodosA busca cobriu as bases de dados científicos MEDLINE®, Lilacs, Ibecs, Cinahl, SciELO, Cochrane, Scopus, Web of Science e literatura cinzenta. Utilizaram-se os critérios Quality Assessment of Diagnostic Accuracy Studies para avaliar a qualidade da metodologia e o risco de viés dos estudos. A heterogeneidade estatística da razão de verossimilhança (LR) e razão de chance diagnóstica (RCD) do diagnóstico foram avaliadas com utilização de gráficos em floresta, teste Q de Cochran e um gráfico crosshair summary Receiver Operating Characteristic, utilizando um modelo com múltiplos pontos de corte.ResultadosInicialmente obteve-se, nas bases de dados, um total de 3.522 referências; dentre estas, selecionaram-se para análise qualitativa 12 estudos que incluíram 1.757 participantes. Muitos estudos apresentavam um risco de viés incerto em termos da seleção de pacientes e do fluxo e tempo. Dentre os 12 estudos incluídos, sete tinham alto risco e cinco risco incerto para o item padrão de referência. O desempenho diagnóstico do pico de fluxo da tosse para o resultado da extubação foi baixo a moderado quando se consideram os resultados de todos os estudos incluídos, com +LR de 1,360 (IC95% 1,240 - 1,530), -LR de 0,218 (IC95% 0,159 - 0,293) e razão de chance diagnóstica de 6,450 (IC95% 4,490 - 9,090). Uma análise de subgrupos que incluiu somente estudos com valores de corte entre 55 e 65 L/minuto demonstrou desempenho ligeiramente melhor, porém ainda moderado.ConclusãoA avaliação do pico de fluxo da tosse, considerando valor de corte entre 55 e 65 L/minuto, pode ser útil como medida complementar antes da extubação. São necessários estudos com melhor delineamento para elucidar o melhor método e equipamento para registrar o pico de fluxo da tosse, assim como o melhor ponto de corte.

Treatment of symptomatic postoperative pelvic lymphoceles: A systematic review

PurposeA broad range of therapeutic options exists for symptomatic postoperative lymphoceles. However, no consensus exists on what is the optimal therapy. In this study, we aimed to compare the efficacy of currently available radiologic interventions in terms of number of successful interventions, number of recurrences, and number of complications. MethodsA systematic review was conducted with a pre-defined search strategy for PubMed, EMBASE, and Cochrane databases from inception until September 2019. Quality assessment was performed using the ‘Risk Of Bias In Non-randomized Studies - of Interventions’ tool. Statistical heterogeneity was assessed using the I2 and χ2 test and a meta-analysis was considered for studies reporting on multiple interventions. Results37 eligible studies including 732 lymphoceles were identified. Proportions of successful interventions for percutaneous fine needle aspiration, percutaneous catheter drainage, percutaneous catheter drainage with delayed or instantaneous addition of sclerotherapy, and embolization were as follows: 0.341 (95% confidence interval [CI]: 0.185−0.542), 0.612 (95% CI: 0.490−0.722), 0.890 (95% CI: 0.781−0.948), 0.872 (95% CI: 0.710−0.949), 0.922 (95% CI: 0.731−0.981). Random-effects meta-analysis of seven studies revealed a pooled relative risk for percutaneous catheter drainage with delayed addition of sclerotherapy of 1.57 (95% CI: 1.17–2.10) when compared to percutaneous catheter drainage alone. The risk of bias in this study was severe. ConclusionsThis systematic review demonstrates that the success rates of percutaneous catheter drainage with sclerotherapy are more favorable when compared to percutaneous catheter drainage alone in the treatment of postoperative pelvic lymphoceles. Overall, percutaneous catheter drainage with delayed addition of sclerotherapy, and embolization showed the best outcomes.

Effectiveness of interventions for improving timely diagnosis of breast and cervical cancers in low and middle-income countries: a systematic review protocol

IntroductionBreast and cervical cancers pose a major public health burden globally, with disproportionately high incidence, morbidity and mortality in low- and middle-income countries (LMICs). The majority of women diagnosed with...

How effective are the non-conventional ovarian stimulation protocols in ART? A systematic review and meta-analysis.

To compare the effectiveness of starting the ovarian stimulation on the early follicular phase ("Conventional") with the newer range of non-conventional approaches starting in the luteal phase ("Luteal"), random-start, and studies implementing them in DuoStim ("Conventional"+"Luteal"). Systematic review. We searched CENTRAL, PubMed, and Embase, on March 2020. We included randomized and non-randomized controlled trials that compared "Luteal," random-start ovarian stimulation or DuoStim with "Conventional"; we analyzed them by subgroups: oocyte freezing and patients undergoing ART treatments, both, in the general infertile population and among poor responders. The following results come from a sensitivity analysis that included only the low/moderate risk of bias studies. When comparing "Luteal" to "Conventional," clinically relevant differences in MII oocytes were ruled out in all subgroups. We found that "Luteal" probably increases the COH length both, in the general infertile population (OR 2.00days, 95% CI 0.81 to 3.19, moderate-quality evidence) and in oocyte freezing cycles (MD 0.85days, 95% CI 0.53 to 1.18, moderate-quality evidence). When analyzing DuoStim among poor responders, we found that it appears to generate a higher number of MII oocytes in comparison with a single "Conventional" (MD 3.35, 95%CI 2.54-4.15, moderate-quality evidence). Overall, this systematic review of the available data demonstrates that in poor responders, general infertile population and oocyte freezing for cancer stimulation in the late follicular and luteal phases can be utilized in non-conventional approaches such as random-start and DuoStim cycles, offering similar outcomes to the conventional cycles but potentially with increased flexibility, within a reduced time frame. However, more well-designed trials are required to establish certainty.

A tool for assessment of risk of bias in studies of adverse effects of orthodontic treatment applied in a systematic review on external root resorption.

Systematic reviews (SRs) are considered to provide reliable estimates, but flaws in designs, methods of monitoring effects, and outcomes have the potential to bias results. There are several tools for assessing risk of bias (RoB), most of them designed for SRs of beneficial effects. To our knowledge, there is no tool that is adapted specifically to assess RoB in studies of adverse effects associated with orthodontic treatment. To address this, the aim of this study was first to introduce a tool for assessment of RoB in studies of adverse effects associated with orthodontic treatment and, second, to apply it in an SR of external root resorption (ERR) associated with orthodontic treatment with fixed appliance. The approach with domains supported by signalling questions was used for the tool. Domains and signalling questions were tailored to the review questions of the SR of studies of ERR after orthodontic treatment using periapical radiography or cone beam computed tomography. Duplicate study selection, data extraction, and RoB assessment using the tool, followed by meta-analyses, were performed. Using the tool for the assessment of RoB identified shortcomings and report deficiencies of primary studies concerning the presentation of orthodontic treatment, identification of ERR, and analysis of outcomes. RoB assessment resulted in 12 of 32 studies read in full text being included. Reported severe ERR varied across studies between 2 and 14 per cent for all incisors and 10 and 29 per cent for maxillary incisors. Results of ERR related to patients' age and sex, orthodontic diagnosis, and treatment were contradictory. Quality of evidence evaluated by GRADE was low due to study limitations, imprecision, and inconsistency of study results. As the tool and its application highlight important issues to consider when planning, conducting, and reporting research, the tool may have a valuable role for quality enhancement of future studies of outcomes of orthodontic treatment. The tool may also serve for authors when planning SRs. Our SR identified a need for studies that use rigorous methodology and transparent reporting. PROSPERO (ID = CRD42018084725).

Machine learning vs. conventional statistical models for predicting heart failure readmission and mortality

AimsThis study aimed to review the performance of machine learning (ML) methods compared with conventional statistical models (CSMs) for predicting readmission and mortality in patients with heart failure (HF) and to present an approach to formally evaluate the quality of studies using ML algorithms for prediction modelling.Methods and resultsFollowing Preferred Reporting Items for Systematic Reviews and Meta‐Analyses guidelines, we performed a systematic literature search using MEDLINE, EPUB, Cochrane CENTRAL, EMBASE, INSPEC, ACM Library, and Web of Science. Eligible studies included primary research articles published between January 2000 and July 2020 comparing ML and CSMs in mortality and readmission prognosis of initially hospitalized HF patients. Data were extracted and analysed by two independent reviewers. A modified CHARMS checklist was developed in consultation with ML and biostatistics experts for quality assessment and was utilized to evaluate studies for risk of bias. Of 4322 articles identified and screened by two independent reviewers, 172 were deemed eligible for a full‐text review. The final set comprised 20 articles and 686 842 patients. ML methods included random forests (n = 11), decision trees (n = 5), regression trees (n = 3), support vector machines (n = 9), neural networks (n = 12), and Bayesian techniques (n = 3). CSMs included logistic regression (n = 16), Cox regression (n = 3), or Poisson regression (n = 3). In 15 studies, readmission was examined at multiple time points ranging from 30 to 180 day readmission, with the majority of studies (n = 12) presenting prediction models for 30 day readmission outcomes. Of a total of 21 time‐point comparisons, ML‐derived c‐indices were higher than CSM‐derived c‐indices in 16 of the 21 comparisons. In seven studies, mortality was examined at 9 time points ranging from in‐hospital mortality to 1 year survival; of these nine, seven reported higher c‐indices using ML. Two of these seven studies reported survival analyses utilizing random survival forests in their ML prediction models. Both reported higher c‐indices when using ML compared with CSMs. A limitation of studies using ML techniques was that the majority were not externally validated, and calibration was rarely assessed. In the only study that was externally validated in a separate dataset, ML was superior to CSMs (c‐indices 0.913 vs. 0.835).ConclusionsML algorithms had better discrimination than CSMs in most studies aiming to predict risk of readmission and mortality in HF patients. Based on our review, there is a need for external validation of ML‐based studies of prediction modelling. We suggest that ML‐based studies should also be evaluated using clinical quality standards for prognosis research. Registration: PROSPERO CRD42020134867

Long-term outcomes of psychological interventions on children and young people's mental health: A systematic review and meta-analysis.

BackgroundOver 600 RCTs have demonstrated the effectiveness of psychosocial interventions for children and young people’s mental health, but little is known about the long-term outcomes. This systematic review sought to establish whether the effects of selective and indicated interventions were sustained at 12 months.MethodWe conducted a systematic review and meta-analysis focusing on studies reporting medium term outcomes (12 months after end of intervention).FindingsWe identified 138 trials with 12-month follow-up data, yielding 165 comparisons, 99 of which also reported outcomes at end of intervention, yielding 117 comparisons. We found evidence of effect relative to control at end of intervention (K = 115, g = 0.39; 95% CI: 0.30–0.47 I2 = 84.19%, N = 13,982) which was maintained at 12 months (K = 165, g = 0.31, CI: 0.25–0.37, I2 = 77.35%, N = 25,652) across a range of diagnostic groups. We explored the impact of potential moderators on outcome, including modality, format and intensity of intervention, selective or indicated intervention, site of delivery, professional/para-professional and fidelity of delivery. We assessed both risk of study bias and publication bias.ConclusionsPsychosocial interventions provided in a range of settings by professionals and paraprofessionals can deliver lasting benefits. High levels of heterogeneity, moderate to high risk of bias for most studies and evidence of publication bias require caution in interpreting the results. Lack of studies in diagnostic groups such as ADHD and self-harm limit the conclusions that can be drawn. Programmes that increase such interventions’ availability are justified by the benefits to children and young people and the decreased likelihood of disorder in adulthood.

The Prevalence of Opioid Analgesic Use in People with Chronic Noncancer Pain: Systematic Review and Meta-Analysis of Observational Studies.

To review studies examining the proportion of people with chronic noncancer pain who report consuming opioids and characteristics associated with their use. Systematic review. We searched databases from inception to February 8, 2020, and conducted citation tracking. We included observational studies reporting the proportion of adults with chronic noncancer pain who used opioid analgesics. Opioids were categorized as weak (e.g., codeine) or strong (e.g., oxycodone). Study risk of bias was assessed, and Grading of Recommendations Assessment, Development and Evaluations provided a summary of the overall quality. Results were pooled using a random-effects model. Meta-regression determined factors associated with opioid use. Sixty studies (N=3,961,739) reported data on opioid use in people with chronic noncancer pain from 1990 to 2017. Of these 46, 77% had moderate risk of bias. Opioid use was reported by 26.8% (95% confidence interval [CI], 23.1-30.8; moderate-quality evidence) of people with chronic noncancer pain. The use of weak opioids (17.3%; 95% CI 11.9-24.4; moderate-quality evidence) was more common than the use of strong opioids (9.8%; 95% CI, 6.8-14.0; low-quality evidence). Meta-regression determined that opioid use was associated with geographic region (P=0.02; lower in Europe than North America), but not sampling year (P=0.77), setting (P=0.06), diagnosis (P=0.34), or disclosure of funding (P=0.77). Our review summarized data from over 3.9 million people with chronic noncancer pain reporting their opioid use. Between 1990 and 2017, one-quarter of people with chronic noncancer pain reported taking opioids, and this proportion did not change over time.

Sella Turcica Morphology in Patients With Genetic Syndromes: Protocol for a Systematic Review.

BackgroundThe sella turcica is an important anatomical reference used in orthodontics and the evaluation of craniofacial growth. Studies have found an association between variations in sella turcica morphology in patients with certain syndromes affecting the craniofacial complex. It is hypothesized that each related syndrome or pathological condition is associated with a specific pattern of malformation of the sella turcica.ObjectiveThis study outlines the protocol for a systematic review that aims to determine if genetic syndromes involving the craniofacial complex are associated with abnormal radiographic sella turcica morphology and if there is a pattern of malformation that is consistent with each syndrome.MethodsAn electronic database search was conducted using a planned search strategy to identify relevant studies. We included primary studies evaluating the morphology of the sella turcica based on imaging from a lateral view. Specifically, only studies with postnatal human participants with genetic syndromes involving the craniofacial complex were included in this review. We placed no restrictions on the language or time frame of these studies. Based on the search findings, studies were further screened for relevance and eligibility by two independent reviewers. Data were extracted from the selected studies. We assessed the selected studies for risk of bias and quality by using risk of bias tools from the Joanna Briggs Institute. We will provide a narrative synthesis of our findings and a structured summary based on prespecified themes.ResultsThe protocol is registered with PROSPERO (#CRD42019148060) and approved by the University of Western Cape Biomedical Science Research Ethics Committee (BM205/3). The literature search was conducted in September 2019 and updated in July 2020. The study was completed in August 2020, and the findings will be published in an open-access journal.ConclusionsThe results of this systematic review are expected to provide a comprehensive list of morphological variations of the sella turcica, which will aid in the identification of syndromes associated with the craniofacial complex. We also expect to identify patterns of sella turcica morphology that highlight genotype-phenotype correlations, thus adding to the body of evidence relating to genetics and craniofacial malformations.Trial RegistrationPROSPERO International Prospective Register of Systematic Reviews CRD42019148060; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=148060International Registered Report Identifier (IRRID)RR1-10.2196/16633

Environmental assessment of cytotoxic drugs in healthcare settings: protocol for a systematic review and meta-analysis

BackgroundOccupational exposure to cytotoxic drugs is associated with various unfavorable health outcomes. This protocol reports a methodology for a systematic review and meta-analysis that aims to systematically review the published literature and quantify the level of environmental contamination of healthcare settings with cytotoxic drugs.MethodsThis protocol is developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol-2015 (PRISMA-P) guidelines. Six electronic databases (PubMed, Web of Science, Scopus, Cochrane Library, CINAHL, and EMBASE) will be searched with no restrictions on publication period. Eligible studies will be identified and data will be extracted using a predefined data extraction form by at least two independent reviewers following best practice. Eligible studies should report calculated or calculable estimates on the proportion of positive samples tested for cytotoxic drugs and/or estimates on the concentration of the cytotoxic drug(s) in the tested samples. Risk of bias (RoB) will be assessed by using the RoB in Studies estimating Prevalence of Exposure to Occupational risk factors (RoB-SPEO) tool, which developed by the World Health Organization (WHO) and International Labour Organization (ILO) for environmental and occupational health systematic reviews. The random-effects model will be used to perform meta-analyses.DiscussionOccupational exposure to cytotoxic drugs is associated with short- and long-term adverse health outcomes. Following this protocol, the review to be carried out will be the first to fill an evidence gap on the environmental contamination of healthcare settings with cytotoxic drugs. The findings of this review will help in the understanding of the risk of occupational exposure of healthcare workers to cytotoxic drugs and facilitate the identification of priority areas for specific interventions.Ethics and disseminationThe systematic review methodology does not require ethics approval due to the nature of the study design. The results of the systematic review will be published in a peer-reviewed journal and will be publicly available.Systematic review registrationPROSPERO CRD42020162780, dated July 14, 2020

Pubertal timing in boys and girls born to mothers with gestational diabetes mellitus: a systematic review.

ContextThe incidence of gestational diabetes mellitus (GDM) has been on the rise, driven by maternal obesity. In parallel, pubertal tempo has increased in the general population, driven by childhood obesity.ObjectiveTo evaluate the available evidence on pubertal timing of boys and girls born to mothers with GDM.Data sourcesWe searched MEDLINE, EMBASE, CINAHL Plus, Cochrane library and grey literature for observational studies up to October 2019.Study selection and extractionTwo reviewers independently selected studies, collected data and appraised the studies for risk of bias. Results were tabulated and narratively described as reported in the primary studies.ResultsSeven articles (six for girls and four for boys) were included. Study quality score was mostly moderate (ranging from 4 to 10 out of 11). In girls born to mothers with GDM, estimates suggest earlier timing of pubarche, thelarche and menarche although for each of these outcomes only one study each showed a statistically significant association. In boys, there was some association between maternal GDM and earlier pubarche, but inconsistency in the direction of shift of age at onset of genital and testicular development and first ejaculation. Only a single study analysed growth patterns in children of mothers with GDM, describing a 3-month advancement in the age of attainment of peak height velocity and a slight increase in pubertal tempo.ConclusionsPubertal timing may be influenced by the presence of maternal GDM, though current evidence is sparse and of limited quality. Prospective cohort studies should be conducted, ideally coupled with objective biochemical tests.

3D-printed navigation template in cervical spine fusion: a systematic review and meta-analysis.

To explore the effectiveness and advantage of three-dimensional (3D)-printed navigation templates (3DPN-template) assisted in cervical spine fusion (CSF) surgery as compared to conventional surgery. An electronic literature search in PubMed, Scopus, Web of Science, and Cochrane was conducted for studies of 3DPN-templates in CSF up to May 2020. Outcome measures as the accuracy rate, operation time, intra-operative blood loss, and fluoroscopy used, associated with CSF were extracted. Mean difference based on changes was quantified using Hedges' g. From 4414 potentially relevant studies, 61 full-text publications were screened. Thirteen studies comprising 330 cases with 1323 screw placements were eligible for inclusion. For template group, pooled estimates were as follows: 97.3% accuracy rate for screw placement, 144.7min for operating time, 273.6ml for blood loss, and 3.2min for fluoroscopic times. A significantly positive difference was observed between the template group compared to control group in terms of accuracy rate of screw placement (Z = 5.3), operation time (Z = 2.41), intra-operative blood loss (Z = 2.64), and fluoroscopic times (Z = 3.64) (all, P value < 0.0001). Risk of bias for studies under review was assessed using the Newcastle-Ottawa Scale (NOS), and 11 studies were found as having high quality. Overall, funnel plot and Begg's test did not indicate obvious publication bias. The 3D-printed navigation template in the cervical surgery can improve accuracy of pedicle screw placement and consequently improve outcomes. In future, multi-center efforts are needed to validate the relationships found in this review.

Comparison of risk-of-bias assessment approaches for selection of studies reporting prevalence for economic analyses.

ObjectivesWithin cost-effectiveness models, prevalence figures can inform transition probabilities. The methodological quality of studies can inform the choice of prevalence figures but no single obvious candidate tool exists for assessing quality of the observational epidemiological studies for selecting prevalence estimates. We aimed to compare different tools to assess the risk of bias of studies reporting prevalence, and develop and compare possible numerical scoring systems using these tools to set a threshold for inclusion of reports of prevalence in an economic analysis of neonatal hypoglycaemia.DesignAssessments of bias using two tools (Joanna Briggs Institute (JBI) Checklist for Prevalence Studies and a modified version of Risk Of Bias In Non-randomised Studies-of Interventions (ROBINS-I)) were compared for 18 studies relevant to a single setting (neonatal hypoglycaemia). Inclusions of studies for use in a decision analysis model were considered based on summary scores derived from these tools.ResultsBoth tools were considered easy to use and produced dispersed scores for each of the 40 study–outcome combinations. The modified ROBINS-I scores were more skewed than the JBI scores, particularly at higher thresholds. The studies selected for inclusion are generally the same using either tool; if 50% was used as the cut-off threshold using the Applicable Score both tools would yield the same results. However, the JBI tool is shorter and may be easier to interpret and apply to studies that do not involve a control group, while the modified ROBINS-I tool assesses more methodological detail in studies that include a control group.ConclusionBoth tools performed well for systematically assessing studies that report on outcome prevalence and provided similar discrimination between studies for risk of bias. This convergent validity supports use of both tools for the purpose of assessing risk of bias and selecting studies that report prevalence for inclusion in economic analyses.

Characterisation of the environmental presence of hepatitis A virus in low-income and middle-income countries: a systematic review and meta-analysis.

ObjectiveTo characterise the environmental presence of hepatitis A virus (HAV) in low- and middle-income countries (LMICs).DesignSystematic review and meta-analysis.Data sourcesEBSCOhost, PubMed, Scopus, ScienceDirect, Clinical Key and Web of Science were searched. Grey literature was sourced by searching the following electronic databases: Open Grey, National Health Research Database and Mednar.Eligibility criteria for including studiesCross-sectional and ecological studies reporting HAV environmental presence and conducted in LMICs between January 2005 and May 2019, irrespective of language of publication.Data extraction and data synthesisRelevant data were extracted from articles meeting the inclusion criteria, and two reviewers independently assessed the studies for risk of bias. High heterogeneity of the extracted data led to the results being reported narratively.ResultsA total of 2092 records were retrieved, of which 33 met the inclusion criteria. 21 studies were conducted in Tunisia, India and South Africa, and the rest were from Philippines, Pakistan, Morocco, Chad, Mozambique, Kenya and Uganda. In Tunisian raw sewage samples, the prevalence of HAV ranged from 12% to 68%, with an estimated average detection rate of 50% (95% CI 25 to 75), whereas HAV detection in treated sewage in Tunisia ranged from 23% to 65%, with an estimated average detection rate of 38% (95% CI 20 to 57). The prevalence of HAV detection in South African treated sewage and surface water samples ranged from 4% to 37% and from 16% to 76%, with an estimated average detection rates of 15% (95% CI 1 to 29) and 51% (95% CI 21 to 80), respectively. Over the review period, the estimated average detection rate of environmental HAV presence appeared to have declined by 10%.ConclusionThe quality of included studies was fair, but sampling issues and paucity of data limited the strength of the review findings.PROSPERO registration numberCRD42019119592.