Risk Of Bias In Non-randomized Studies Research Articles

Application of Robotics in Orthodontics: A Systematic Review.

Robotics has various applications in dentistry, particularly in orthodontics, although the potential use of these technologies is not yet clear. This review aims to summarize the application of robotics in orthodontics and clarify its function and scope in clinical practice. Original articles addressing the application of robotics in any area of orthodontic practice were included, and review articles were excluded. PubMed, Google Scholar, Scopus, and DOAJ were searched from June to August 2023. The risk of bias was established using the risk of bias in non-randomized studies (ROBINS) and certainty assessment tools following the grading of recommendations, assessment, development, and evaluation (GRADE) guidelines. A narrative synthesis of the data was generated and presented according to its application in surgical and non-surgical orthodontics. The search retrieved 2,106 articles, of which 16 articles were selected for final data synthesis of research conducted between 2011 and 2023 in Asia, Europe, and North America. The application of robotics in surgical orthodontics helps guide orthognathic surgeries by reducing the margin of error, but it does not replace the work of a clinician. In non-surgical orthodontics, robotics assists in performing customized bending of orthodontic wires and simulating orthodontic movements, but its application is expensive. The articles collected for this synthesis exhibited a low risk of bias and high certainty, and the results indicated that the advantages of the application of robotics in orthodontics outweigh the disadvantages. This project was self-financed, and a previous protocol was registered at the PROSPERO site (registration number: CRD42023463531).

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

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

Iliac crest bone graft versus cell-based grafts to augment spinal fusion: a systematic review and meta-analysis.

Despite successful fusion rates with iliac crest bone graft (ICBG), donor-site morbidity and increased operating time remain a considerable limitation and drive the search for alternatives. In this systematic review, grafts with additional cellular supplementation were compared with ICBG for spinal arthrodesis. We compared safety, efficacy and long-term outcomes, thus providing the current and relevant evidence for orthopaedic surgeons to make informed choices regarding this rapidly developing field. An electronic literature search was conducted according to the PRISMA guidelines by two independent reviewers for articles published up to 1st March 2023 using PubMed, EMBASE and the Cochrane Central Register of Controlled Trial. Cellular allografts were not included. The following data were extracted: Number of patients, type of graft, fusion assessment method, follow-up duration, fusion rates, clinical outcomes and complications. The methodological quality of evidence (MQOE) was assessed using the Risk of Bias 2 (RoB-2) tool and Risk of Bias In Non-Randomised Studies (ROBINS) tool developed by Cochrane for evaluating bias in randomised and non-randomised studies. Ten studies fulfiled the inclusion criteria, including 465 patients. The mean number of patients per study was 43.8 (std dev. 28.81, range 12-100). Two studies demonstrated cell-based therapy to be significantly more successful in terms of fusion rates compared to ICBG. However, the remaining eight demonstrated equivocal results. No study found that cell-based therapy was inferior. No difference was seen between the two groups in three studies who focused on degenerative cohorts. No difference in functional outcome scores was seen between the groups. A number of different preparation techniques for cell-based grafts were used throughout the studies. Cell-based therapy offers a promising alternative to ICBG in spinal fusion surgery, which could help reduce the associated morbidity to patients. This review found that cell-based therapy is non-inferior to iliac crest bone graft and may offer patients an alternative treatment option with fewer complications and reduced post-operative pain. However, the literature to date is limited by heterogeneity of the cell preparation and grafting process. Future research with a unified approach to the cell preparation process is required to fully delineate the potential advantages of this technology.

Tranexamic acid administration for the prevention of periprosthetic joint infection and surgical site infection: a systematic review and meta-analysis.

Tranexamic acid (TXA) has been widely utilized to reduce blood loss and allogeneic transfusions in patients who undergo lower limb arthroplasty. In recent years, there have been several articles reporting the incidence of periprosthetic joint infection (PJI) as a primary outcome of TXA administration, but no meta-analysis has been conducted to date. The present systematic review and meta-analysis evaluated the efficacy of TXA administration in preventing PJI and surgical site infection (SSI). Pubmed, CINAHL, and the Cochrane Library bibliographic databases were searched for studies published by May 24, 2022, that evaluated the effects of TXA on PJI and SSI. Two researchers screened the identified studies based on the PRISMA flow diagram. The quality of each randomized clinical trial was assessed using Version 2 of the Cochrane risk-of-bias tool for randomized trials (ROB2.0), and the quality of cohort and case-control studies was assessed by risk of bias for nonrandomized studies (ROBANS-I). Of the 2259 articles identified from the database search, 31 were screened and selected. Treatment with TXA significantly reduced the incidence of overall infection, including PJI, SSI, and other infections (OR 0.55; 95% CI 0.49-0.62) (P < 0.00001), and that of PJI alone (OR 0.53; 95% CI 0.47-0.59) (P < 0.00001). TXA reduced the incidence of overall infection in patients who underwent total hip arthroplasty (THA; OR 0.51; 95% CI: 0.35-0.75) (P = 0.0005) and total knee arthroplasty (TKA; OR 0.55; 95% CI: 0.43-0.71) (P < 0.00001). Intravenous administration of TXA reduced the incidence of overall infection (OR 0.59; 95% CI 0.47-0.75) (P < 0.0001), whereas topical administration did not. Intravenous administration of TXA reduces the incidence of overall infection in patients undergoing both THA and TKA. Level III.

Efficacy and Safety of Indwelling Catheter for Malignant Pleural Effusions Related to Timing of Cancer Therapy: A Systematic Review

IntroductionTo compare the efficacy and safety of indwelling pleural catheters (IPC) in relation with the timing of systemic cancer therapy (SCT) (i.e., before, during, or after SCT) in patients with malignant pleural effusion (MPE). MethodsSystematic review of randomized controlled trials (RCT), quasi-controlled trials, prospective and retrospective cohorts, and case series of over 20 patients, in which the timing of IPC insertion in relation to that of SCT was provided. Medline (via PubMed), Embase, and Cochrane Library were systematically searched from inception to January 2023. The risk of bias was assessed using the Cochrane Risk of Bias (ROB) tool for RCTs and the ROB in non-randomized studies of interventions (ROBINS-I) for non-randomized designs. ResultsTen studies (n=2907 patients; 3066 IPCs) were included. Using SCT while the IPC was in situ decreased overall mortality, increased survival time, and improved quality-adjusted survival. Timing of SCT had no effect on the risk of IPC-related infections (2.85% overall), even in immunocompromised patients with moderate or severe neutropenia (relative risk 0.98 [95%CI: 0.93–1.03] for patients treated with the combination of IPC and SCT). The inconsistency of the results or the lack of analysis of all outcome measures in relation to the SCT/IPC timing precluded drawing solid conclusions about time to IPC removal or need of re-interventions. ConclusionsBased on observational evidence, the efficacy and safety of IPC for MPE does not seem to vary depending on the IPC insertion timing (before, during, or after SCT). The data most likely support early IPC insertion.

Treatment Effectiveness of Clear Aligners in Correcting Complicated and Severe Malocclusion Cases Compared to Fixed Orthodontic Appliances: A Systematic Review.

This systematic review aimed to critically assess the available evidence regarding the effectiveness and efficiency of clear aligners in the comprehensive treatment of complex cases accompanied by premolars extraction. An electronic literature search by two reviewers was independently done on 27 February 2023 in the following databases without time and language limitations: Pubmed®, Scoups®, Google Scholar, Cochrane Library database, Web of Science™, and Proquest Database Open. Randomized controlled trials (RCTs) of any type, non-randomized clinical trials (CCT), cohort studies, and prospective, retrospective, and cross-sectional studies were reviewed. The risk of bias in included studies was assessed using the Risk of Bias (RoB 2.0) tool for randomized trials and the Risk of Bias in Non-randomized Studies (ROBINS-I) tool for non-randomized studies. After carefully searching the literature, six trials were included in this systematic review, three RCTs, two retrospective cohort studies, and one CCT. Two hundred eighty-three patients were included (186 females, 97 males). Three studies found that there were no differences between the clear aligners and fixed appliances when evaluations were done using the American Board of Orthodontists Objective Grading System (ABO-OGS) or the Peer Assessment Rating (PAR) index. Two studies found that there were some differences between predicted and achieved tooth movements when clear aligners were used in premolars extraction cases. Based on the included studies, the duration of treatment was shorter with fixed appliances than the clear aligners when applied to orthodontic extraction cases. Both clear aligners and fixed appliances were found effective in the orthodontic treatment of premolar extraction-based cases. Fixed appliances have the advantage of achieving better buccolingual inclination and occlusal contacts in a shorter treatment duration. Treatment with clear aligners might be associated with differences between predicted and achieved tooth movements. Therefore, the characteristics of these techniques should be considered when making a treatment decision.

Hemorrhoid laser dearterialization: systematic review and meta-analysis.

Hemorrhoidal disease is a common and troublesome condition. Excisional hemorrhoidectomy can assure the best chance of cure but it is hampered by postoperative pain and potential long-term morbidity therefore minimally invasive techniques have been developed. Since 2009 a doppler-guided hemorrhoidal dearterialization with laser (the hemorrhoidal laser procedure; HeLP) has been proposed to control symptoms without significant sequelae. The aim of this systematic review is to analyze the benefits and disadvantages of HeLP for symptomatic hemorrhoids. The Medline/PubMed, Embase, and Cochrane library databases were searched from January 2010 to March 2022, language was restricted to English and documents to the full text. Randomized and non-randomized, prospective and retrospective cohort studies were included. Risk of bias assessment was performed using the Risk of bias for non-randomized studies (ROBINS-I) and the RoB2 Tool for randomized clinical trial. Primary outcome was to assess the efficacy of HeLP on symptoms' resolution. Secondary objectives were postoperative pain and complications, comparison with other interventional techniques, and evaluation of long-term recurrence. Whenever possible, a meta-analysis was conducted. The GRADE approach was employed to assess the certainty of evidence. We included six non-randomized and one randomized study. HeLP improved or resolved preoperative symptoms in 83.6 to 100% of patients during follow-up. In the randomized study symptoms resolved in 90% of patients after HeLP and 53.3% after rubber band ligation as comparator. Published data indicate that HeLP is effective, relatively safe, with limited recurrence rate, after a short to medium follow-up. The quality of evidence was however low. There is a paucity of studies assessing the benefits or harms of laser dearterialization for the treatment of hemorrhoids and randomized trials are furthermore rare, therefore trials with adequate power and proper design, assessing the advantages and disadvantages of HeLP versus other minimally invasive techniques, are needed. Furthermore, studies evaluating long-term follow-up are wanted.

Impact of intrawork rest breaks on doctors’ performance and well-being: systematic review

ObjectivesTo summarise evidence on intrawork breaks and their associated effect on doctors’ well-being and/or performance at work.DesignSystematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 statement guidelinesData...

A Systematic Review of Parent Training for Children with Communication Disorders in Korea

Objectives: The purpose of this study was to review the research trends in regards to parent training and the speech and language development of children with communication disorders in Korea, to evaluate the effectiveness of parent training for improvement of children’s communication skills, and to provide evidence-based directions for parent training.Methods: A search of 4 databases, and manual searching resulted in the identification of 1,222 relevant articles in domestic journals. The 19 articles published from 2001 to 2020 in domestic journals were selected according to the Participants, Intervention, Comparison, and Outcomes (PICO) criteria. Three authors did article selection, data extraction, and quality assessment using the Risk of Bias for Nonrandomized studies (ROBANS).Results: First, the quality of selected articles was high overall. Second, very few studies have empirically examined the effectiveness of parent training intervention on the speech and language development of children with communication disorders. Third, most programs have been provided for mothers and no program focused on supporting fathers. Most programs focused on infants, toddlers, and preschoolers with communication disorders. Fourth, regarding studies on research type and method of data collection; most studies were conducted by experimental study. Lastly, areas of measurement involved participant interactions, development, parent perceptions, and parent experiences. The research studies reported positive effects of parent training intervention on the speech and language development of children with communication disorders.Conclusion: Based on these results, we discussed the limitations of identified studies and limitations of the current systematic review are discussed, as well as implications of the findings for research and practice for children with communication disorders regarding parent training intervention.

Efficacy and Safety of Low Molecular Weight Heparin Versus Unfractionated Heparin for Prevention of Venous Thromboembolism in Trauma Patients: A Systematic Review and Meta-analysis.

Trauma patients are at high risk of VTE. We summarize the efficacy and safety of LMWH versus UFH for the prevention of VTE in trauma patients. We searched 6 databases from inception through March 12, 2021. We included randomized controlled trials (RCTs) or observational studies comparing LMWH versus UFH for thromboprophylaxis in adult trauma patients. We pooled effect estimates across RCTs and observational studies separately, using random-effects model and inverse variance weighting. We assessed risk of bias using the Cochrane tool for RCTs and the Risk of Bias in Non-Randomized Studies (ROBINS)-I tool for observational studies and assessed certainty of findings using Grading of Recommendations, Assessment, Development and Evaluations methodology. We included 4 RCTs (879 patients) and 8 observational studies (306,747 patients). Based on pooled RCT data, compared to UFH, LMWH reduces deep vein thrombosis (RR 0.67, 95% CI 0.50 to 0.88, moderate certainty) and VTE (RR 0.68, 95% CI 0.51 to 0.90, moderate certainty). As compared to UFH, LMWH may reduce pulmonary embolism [adjusted odds ratio from pooled observational studies 0.56 (95% CI 0.50 to 0.62)] and mortality (adjusted odds ratio from pooled observational studies 0.54, 95% CI 0.45 to 0.65), though based on low certainty evidence. There was an uncertain effect on adverse events (RR from pooled RCTs 0.80, 95% CI 0.48 to 1.33, very low certainty) and heparin induced thrombocytopenia [RR from pooled RCTs 0.26 (95% CI 0.03 to 2.38, very low certainty)]. Among adult trauma patients, LMWH is superior to UFH for deep vein thrombosis and VTE prevention and may additionally reduce pulmonary embolism and mortality. The impact on adverse events and heparin induced thrombocytopenia is uncertain.

Chemoresection by mitomycin C compared to transurethral resection of bladder tumor in patients with recurrent nonmuscle-invasive bladder cancer: A systematic review and meta-analysis.

Some studies suggest that chemoresection with mitomycin C (MMC) is comparable to transurethral resection of bladder tumor (TURBT) in the management of recurrent nonmuscle-invasive bladder cancer (NMIBC). In this meta-analysis, we compared the efficacy and safety of MMC and TURBT in recurrent NMIBC. A search was conducted for studies published in English in the electronic databases of MEDLINE/PubMed, the Cochrane Library, Scopus, Web of Science, Google Scholar, ProQuest, System for information on Grey Literature, and ClinicalTrials.gov, with no publication date restrictions. Risk of bias was assessed using the Risk of bias 2 tool for randomized controlled trials and Risk of Bias inNon-Randomized Studies of Interventions-I tool for observational studies. Data analysis was performed using the RevMan 5.4 software. Three studies were included in this systematic review(total participants is 291); two studieswere included in themeta-analysis. The rate of complete response was significantly lower in MMC group compared with TURBT (relative risk [RR]: 0.55, 95% confidence interval (CI): 0.45-0.67, P< .001). The rates of local adverse events were lower inMMC, with a statistical significance for dysuria (RR: 0.55, 95% CI: 0.36-0.84, P ¼ .006), urinary frequency (RR: 0.60, 95% CI: 0.43- 0.84, P¼ .003), cystitis (RR: 0.22, 95% CI: 0.06-0.81, P¼ .02), and incontinence (RR: 0.48, 95% CI: 0.24-0.96, P¼ .04). In terms of complete response, TURBT is superior to chemoresection withMMC. Currently, chemoresection withMMC should be restricted to patients unfit for surgery and in clinical trials. Future randomized controlled trials are recommended to confirm or refute the use ofMMC in treating recurrent NMIBC.

Intervention for Married Immigrant Women in Korea: A Systematic Review

Purpose: This study aimed to review the intervention programs designed for married immigrant women living in Korea.Methods: A total of 39 articles published from 2010 to 2020 were selected and analyzed using domestic and international web-based academic databases according to a systematic literature review procedure. The selected studies were evaluated for quality according to RoB (Risk of Bias) and RoBANS (Risk of Bias for Non-randomized studies). Additionally, intervention programs and outcome variables were based on the Nursing Intervention Classification (NIC) and Nursing Outcome Classification (NOC) system.Results: According to the NIC categories, 69.2% of the interventions were in the behavioral domain, and 23.1% were in the family domain. The outcome variables primarily measured in NOC categories were psychological well-being (45.8%), health knowledge (11.0%), and health belief (10.2%). The quality of the selected studies was low overall in random sequence generation, allocation concealment, blinding of participants and personnel, and blinding of outcome data in randomized controlled trials (RCT) studies and confounding variables, blinding of outcome data, and incomplete outcome bias in non-RCT studies.Conclusion: Based on the results of this study, future studies will have to consider the characteristics of the subjects, life cycle, daily life, or language limitations. In addition, it is necessary to develop high-quality programs through continuous research on currently and frequently used interventions and outcome variables and on other various mediations and to verify the outcome variables.

Hip fracture surgery performed out-of-hours-A systematic review and meta-analysis.

. Early hip fracture surgery (<48 hours) has shown to improve mortality for geriatric patients and is recommended in national hip fracture guidelines. However, this may be at the expense of surgery being performed out-of-hours where concerns about mortality risk exist. A systematic review and meta-analysis were performed to determine the mortality risk for hip fracture surgery performed in-hours (IH) compared to out-of-hours (OH), and on weekdays (WD) compared to weekends (WE). . A systematic search of literature in the databases of MEDLINE, PubMed, Embase and Cochrane from the dates of inception was performed. All studies published in English were included. Risk of Bias in Non-randomised Studies (ROBINS-I) and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework were utilised. Relative risk (RR) was used for dichotomous outcomes, while mean difference (MD) was used for continuous variables, with 95% confidence intervals. Alpha was set at 0.05. . A total of 13 studies with 177,090 patients were included for analysis. Overall, there was no statistically significant difference for 30-day or inpatient mortality in IH vs OH groups (RR 0.93, p=0.46 and RR 1.16, p=0.63) and for WD vs WE groups (RR 0.98, p=0.73 and RR 0.76, p=0.67). There was no difference in length of stay between groups (p>0.05). The number of patients with American Society of Anaesthesiology (ASA) physical status classification ≥3 and male gender between the groups were similar (p>0.05). . Performing hip fracture surgery OH or on the WE does not appear to increase the risk of 30-day or inpatient mortality or post-operative complications. Consideration should be given to performing hip fracture surgery out-of-hours to meet national guidelines (<48 hours).

Cross-National Comparisons of Cognitive and Physical Health in Older Adults Across China, Japan, and Korea: A Systematic Review.

BackgroundCross-national studies are an emerging research area in public health. Specifically, cross-national health comparisons are important for understanding the factors driving the success or failure of public health policies. Therefore, this study systematically analyzed studies that compared health status (physical health and cognition) of the older adults using national panel data for three East Asian countries—China, Japan, and Korea.MethodsGoogle Scholar and PubMed were used for the literature search. The search strategy targeted papers published between 2005 and 2020, yielding a total of 2690 papers, of which seven were selected for the review. The Center for Evidence-Based Medicine (CEBM) criteria was used to assess study design quality. The risk of bias for non-randomized studies (RoBANS) tool, a quality assessment tool developed in Korea to evaluate non-randomized interventional studies, measured risk of bias.ResultsOf the seven included papers, two studies performed cognitive comparisons, four studies performed physical health comparisons, and one study compared both cognition and physical health. The studies selected for this study by CEBM criteria included four prospective cohort studies (Level 2B) and three expert opinions without explicit critical appraisal (Level 5). Risk of bias using the RoBANS tool found a risk of confounding variables in four out of seven papers. Finally, measurement items of cognitive and physical health differed across all three countries’ panel surveys.ConclusionThese results suggest that in order to compare East Asian health policies according to the aging society, it is necessary to develop consistent cognitive and physical health evaluation tools in the future.

Effectiveness of hospital clowns for symptom management in paediatrics: systematic review of randomised and non-randomised controlled trials

ObjectiveTo evaluate evidence from randomised controlled trials and non-randomised controlled trials on the effectiveness of hospital clowns for a range of symptom clusters in children and adolescents admitted to hospital...

The Effect of the Mediterranean Diet on Metabolic Health: A Systematic Review and Meta-Analysis of Controlled Trials in Adults.

The Mediterranean diet (MD) may provide metabolic benefits but no systematic review to date has examined its effect on a multitude of outcomes related to metabolic health. This systematic review with meta-analysis (International Prospective Register of Systematic Reviews, PROSPERO; number CRD42019141459) aimed to examine the MD’s effect on metabolic syndrome (MetSyn) incidence, components and risk factors (primary outcomes), and incidence and/or mortality from MetSyn-related comorbidities and receipt of pharmacologic treatment for MetSyn components and comorbidities (secondary outcomes). We searched Pubmed, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Web of Science for controlled trials published until June 2019, comparing the MD with no treatment, usual care, or different diets in adults. Studies not published in English and not promoting the whole MD were excluded. Two authors independently extracted data and assessed risk of bias using the Cochrane Collaboration’s and Risk of Bias in non-randomised studies (ROBINS-I) tools. Reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Random-effects meta-analyses, subgroup analyses and meta-regressions were performed, and heterogeneity was quantified using the I2 statistic. We identified 2654 reports and included 84 articles reporting 57 trials (n = 36,983). In random effects meta-analyses, the MD resulted in greater beneficial changes in 18 of 28 MetSyn components and risk factors (body weight, body mass index, waist circumference, systolic and diastolic blood pressure, glucose, insulin, homeostatic model assessment of insulin resistance (HOMA-IR) index, total-, low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, triglycerides, alanine transaminase, hepatic fat mass, C-reactive protein, interleukin-6, tumour necrosis factor-a, and flow-mediated dilatation) and lower risk of cardiovascular disease incidence (risk ratio (RR) = 0.61, 95% confidence intervals (CI) 0.42–0.80; I2 = 0%), and stroke (RR = 0.67, 95% CI 0.35–0.98; I2 = 0%). Only six studies reported effects on pharmacotherapy use, and pooled analysis indicated no differences between diet groups. Lack of consistency in comparator groups and other study characteristics across studies resulted in high heterogeneity for some outcomes, which could not be considerably explained by meta-regressions. However, a consistent direction of beneficial effect of the MD was observed for the vast majority of outcomes examined. Findings support MD’s beneficial effect on all components and most risk factors of the MetSyn, in addition to cardiovascular disease and stroke incidence. More studies are needed to establish effects on other clinical outcomes and use of pharmacotherapy for MetSyn components and comorbidities. Despite the high levels of heterogeneity for some outcomes, this meta-analysis enabled the comparison of findings across studies and the examination of consistency of effects. The consistent direction of effect, suggesting the MD’s benefits on metabolic health, supports the need to promote this dietary pattern to adult populations.

Can we rely on non-randomised studies? Findings from a meta-epidemiological review

Abstract Background Increasingly, health technology assessment (HTA) agencies must decide whether new medicines should be used routinely in the absence of randomised controlled trial (RCT) data, relying solely on non-randomised studies (NRS), which are at high risk of bias due to confounding. Against the background of increased availability and improved methods to analyse non-randomised data (e.g., propensity score methods and instrumental variables), it is important for decision-makers to have guidance on the analysis and interpretation of NRS to inform health economic evaluation. We therefore aimed to systematically and empirically assess the performance of NRS using different analytical methods as compared to RCTs and develop recommendations on the basis of our findings. Methods We conducted a large-scale meta-epidemiological review to obtain estimates of the discrepancy in treatment effects in matched RCTs and NRS of pharmacologic interventions from published meta-analyses indexed in MEDLINE and the Cochrane Database of Systematic Reviews. We also consulted with HTA bodies, regulators and academics from five European countries to learn from their experience with using non-randomised evidence. Results We compiled the largest dataset of clinical topics with matching RCTs and NRS using various analytical methods to date, covering &amp;gt;100 unique clinical questions. Incorporating information on direction of effect and effect size from &amp;gt;700 unique studies, the dataset can be used to evaluate discrepancies in treatment effects between study designs across a wide range of therapeutic areas. Conclusions An empirically based understanding of the risk of bias in NRS is required in order to promote the adequate use of non-randomised evidence as input for health economic decision-making.

A Meta-analysis of Clinical, Patient-Reported Outcomes and Cost of DIEP versus Implant-based Breast Reconstruction.

Introduction:Comparative data on clinical outcomes and cost of deep inferior epigastric perforator (DIEP) and implant-based reconstruction (IBR) are limited. We conducted a Preferred Reporting Items for Systematic Review and Meta-analysis-compliant systematic review and meta-analysis to compare clinical, patient-reported outcomes (PROs) and cost.Methods:The protocol was published a priori on PROSPERO (CRD42017072557). EMBASE, MEDLINE, Google Scholar, Cochrane Controlled Register of Trials, Science Citation Index, and ClinicalTrials.gov were searched from January 1994 to August 2018. Two independent reviewers evaluated the articles for inclusion. Study quality was assessed using Grading of Recommendations Assessment, Development, and Evaluation, and risk of bias (RoB) was assessed using Cochrane’s RoB in Nonrandomized Studies of Interventions tool.Results:Out of 6,381 articles screened, 16 were included [unilateral 782 DIEPs, 376 implants; mean age 49 years, follow-up (months): DIEP 29.9; IBR 35.5]. Mean flap loss and fat necrosis rates were 3.97% (SD 4.90) and 9.67% (SD 17.0), respectively. There was no difference in mean length of stay {standard mean difference 0.63 [confidence interval (CI) −9.17 to 10.43]; P =0.90}. The number of reoperations for complications was significantly lower in DIEP versus IBR [SMD −0.29 (CI −0.48 to −0.09); P < 0.01]. There were no randomized controlled trials. Study quality was low with high RoB. One study reported $11,941/Quality-adjusted Life Year incremental cost-effectiveness ratio for DIEP, with higher breast Quality-adjusted Life Year (DIEP 19.5; IBR 17.7) using Breast Questionnaire; 3 studies evaluated cost, favoring DIEP. Two comparative studies evaluating PROs favored DIEP.Conclusions:DIEP reconstruction maybe more cost-effective and yield superior PROs. However, poor-quality, bias-ridden studies limit the findings. Adequate reporting of core outcome measures is required to minimize reporting bias and facilitate evidence synthesis. Prospective, multicenter, cohort studies using robust patient-reported outcome measures (PROMs) tools, evaluating cost-effectiveness and contributing to national/international registries, will facilitate national-level policy and shared decision-making.

Influence of increased body mass index on orthodontic tooth movement and related parameters in children and adolescents: A systematic review of longitudinal controlled clinical studies.

To assess the impact of increased body mass index (BMI) on orthodontic tooth movement (OTM) and related parameters in children and adolescents. A search of six electronic databases and manual searching were performed up to June 2019 without language and time restrictions. Eligibility criteria were as follows: (1) longitudinal controlled clinical studies; (2) children and adolescents undergoing orthodontic therapy (OT); (3) no systemic diseases; (4) experimental group: patients with increased BMI; and (5) control group: patients with normal BMI. Screening, study selection and data extraction were performed; bias within studies was assessed using the Risk of Bias In Non-randomised Studies (ROBINS-I) tool. Seven studies were included. One study showed that an increased BMI is associated with less wear-time of removable orthodontic appliances and one study found no significant association. One study showed that an increased BMI is associated with less cooperation during OT; however, not with the treatment results. One study reported higher pain experience during OT in adolescents with than without increased BMI. Two studies showed that increased BMI in adolescents is related to OTM, one with increased and one with decreased rates of OTM, respectively. One study reported an association between increased BMI and incidence of white spot lesions and gingivitis during OT. The ROBINS-I tool showed low to moderate risk of bias within studies. The influence of BMI on OTM and related parameters in children and adolescents remains debatable.

Effects of Arteriovenous Fistula on Blood Pressure in Patients With End-Stage Renal Disease: A Systematic Meta-Analysis.

BackgroundCentral arteriovenous fistula (AVF) creation is under investigation for treatment of severe hypertension. We evaluated the effects of AVF for initiation of hemodialysis on systolic, diastolic, and mean arterial blood pressure in patients with end‐stage renal disease.Methods and ResultsData search included PubMed, Web of Science, and the Cochrane Library. A systematic review and meta‐analysis of peer‐reviewed studies reporting the effects of the creation/ligation of an AVF on blood pressure in patients with end‐stage renal disease was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta‐Analysis), PRISMA‐P (PRISMA for systematic review protocols), and ROBINS‐I (Risk of Bias in Non‐Randomized Studies) criteria by the Cochrane Bias Methods Group. All studies in which the results could have been biased by hemodialysis were excluded. A total of 14 trials including 412 patients with end‐stage renal disease (AVF creation, n=185; AVF ligation, n=227) fulfilled the criteria and were subsequently analyzed. Average blood pressure in patients with no/closed AVF was 140.5/77.6 mm Hg with a mean arterial blood pressure of 96.1 mm Hg. Following creation of AVF, systolic blood pressure significantly decreased by 8.7 mm Hg (P<0.001), diastolic blood pressure by 5.9 mm Hg (P<0.001), and mean arterial blood pressure by 6.6 mm Hg (P=0.02), whereas after ligation systolic blood pressure increased by 5.2 mm Hg (P=0.07), diastolic blood pressure by 3.8 mm Hg (P=0.02), and mean arterial blood pressure by 3.7 mm Hg (P=0.07) during short‐ to long‐term follow‐up.ConclusionsCreation of AVF significantly decreases blood pressure in patients with end‐stage renal disease, whereas blood pressure tends to increase after ligation. These findings illustrate the hemodynamic consequences of AVF which are under investigation for severe hypertension.