Risk Of Bias In Non-randomized Studies Research Articles

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.

Evaluation of the risk of bias in non-randomized studies of interventions (ROBINS-I) and the ‘target experiment’ concept in studies of exposures: Rationale and preliminary instrument development

Assessing the risk of bias (RoB) of individual studies is a critical part in determining the certainty of a body of evidence from non-randomized studies (NRS) that evaluate potential health effects due to environmental exposures. The recently released RoB in NRS of Interventions (ROBINS-I) instrument has undergone careful development for health interventions. Using the fundamental design of ROBINS-I, which includes evaluating RoB against an ideal target trial, we explored developing a version of the instrument to evaluate RoB in exposure studies. During three sequential rounds of assessment, two or three raters (evaluators) independently applied ROBINS-I to studies from two systematic reviews and one case-study protocol that evaluated the relationship between environmental exposures and health outcomes. Feedback from raters, methodologists, and topic-specific experts informed important modifications to tailor the instrument to exposure studies. We identified the following areas of distinction for the modified instrument: terminology, formulation of the ideal target randomized experiment, guidance for cross-sectional studies and exposure assessment (both quality of measurement method and concern for potential exposure misclassification), and evaluation of issues related to study sensitivity. Using the target experiment approach significantly impacts the process for how environmental and occupational health studies are considered in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence-synthesis framework.

Critical appraisal of nonrandomized studies-A review of recommended and commonly used tools.

When randomized controlled trial data are limited or unavailable, or to supplement randomized controlled trial evidence, health technology assessment (HTA) agencies may rely on systematic reviews of nonrandomized studies (NRSs) for evidence of the effectiveness of health care interventions. NRS designs may introduce considerable bias into systematic reviews, and several methodologies by which to evaluate this risk of bias are available. This study aimed to identify tools commonly used to assess bias in NRS and determine those recommended by HTA bodies. Appraisal tools used in NRS were identified through a targeted search of systematic reviews (January 2013-March 2017; MEDLINE and EMBASE [OVID SP]). Recommendations for the critical appraisal of NRS by expert review groups and HTA bodies were reviewed. From the 686 studies included in the narrative synthesis, 48 critical appraisal tools were identified. Commonly used tools included the Newcastle-Ottawa Scale, the methodological index for NRS, and bespoke appraisal tools. Neither the Cochrane Handbook nor the Centre for Reviews and Dissemination recommends a particular instrument for the assessment of risk of bias in NRS, although Cochrane has recently developed their own NRS critical appraisal tool. Among HTA bodies, only the Canadian Agency for Drugs and Technologies in Health recommends use of a specific critical appraisal tool-SIGN 50 (for cohort or case-control studies). Several criteria including reporting, external validity, confounding, and power were examined. There is no consensus between HTA groups on the preferred appraisal tool. Reviewers should select from a suite of tools on the basis of the design of studies included in their review.

Effectiveness of Interventions for Workplace Bullying among Nurses: A Systematic Review

Purpose: The aim of this study was to evaluate the effectiveness of interventions for workplace bullying among nurses. Methods: First, risk factors of workplace bullying were categorized in order to create analysis criteria. A search of 8 databases, and manual searching resulted in the identification of 3,096 relevant articles. Three of the authors did article selection, data extraction, and quality assessment using the Risk of Bias (RoB) and the Risk of Bias for Nonrandomized studies (ROBANS). Results: Interventions in workplace bullying were classified as individual, interactions, and organizational approach. Twelve intervention studies (10 individual interventions, 1 team approach, 1 multi-level approach) were selected. Four of the individual interventions decreased bullying, but three had no effect. One multi-level intervention reported that bullying did not occur. Individual interventions improved bullying awareness in four articles, decreased turnover intention in two articles, and increased skill and knowledge of bullying management in five articles. One team approach increased nurse interactions and group cohesion. The quality of selected articles was low overall. Conclusion: Individual interventions have a possibility to improve awareness and knowledge about bullying, but there is a lack of evidence on preventing bullying. Further research is required on multi-levels interventions with well-designed controlled trials.

화병의 한의학적 치료에 대한 연구동향

Objectives: To determine the general characteristics of clinical studies about Hwabyung and assess their limitations and alternatives. Methods: Clinical studies that examined the effects of traditional Korean medicine intervention on Hwabyung were included in this study. A systematic search of English, Chinese, Japanese, and Korean databases was performed. The characteristics of included articles were described and those articles were assessed by Risk of Bias (RoB) tool or Risk of Bias for Nonrandomized Studies (RoBANS) tool. Results: Sixteen articles were selected from 1,826 articles. Most clinical studies about Hwabyung were published in Korea. The number of conducted trials was insufficient. The prevailing study design was randomized controlled trial. Traditional Korean medicine intervention used in the trials were acupuncture, herbal medicine, counselling, meditation, emotional freedom technique (EFT), music therapy, art therapy, and multi intervention program. Herbal medicine study used placebo as control while non-pharmacological intervention study mostly used no treatment as control. Most of the trials were supported by the government. Therefore, financial conflict of interest might not exist for results. We judged that some studies had a high risk of bias. In general, most of the studies with a high risk of bias were non-pharmacological intervention studies, and the risk of bias was mainly due to lack of blinding. Conclusions: More clinical studies of Hwabyung are needed. There are some issues about a suitable comparison and effective blinding strategy for non-pharmacological study. Improving methodological quality is required.

Samaritan Hospital Ovariotomy and Antiseptics

<h3>Abstract</h3> <h3>Objective</h3> To 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 with acute and chronic conditions. <h3>Design</h3> Systematic review of randomised and non-randomised controlled trials. <h3>Data sources</h3> Medline, ISI of Knowledge, Cochrane Central Register of Controlled Trials, Science Direct, Scopus, American Psychological Association PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and Latin American and Caribbean Health Sciences Literature. <h3>Study selection</h3> Randomised and non-randomised controlled trials were peer reviewed using the following eligibility criteria: children and adolescents who were admitted to hospital for acute conditions or chronic disorders, studies comparing use of hospital clowns with standard care, and studies evaluating the effect of hospital clowns on symptom management of inpatient children and adolescents as a primary outcome. <h3>Data extraction and synthesis</h3> Two investigators independently screened studies, extracted data, and appraised the risk of bias. Methodological appraisal was assessed by two investigators independently using the Jadad scale, the revised Cochrane risk-of-bias tool for randomised controlled trials (RoB 2), and the risk of bias in non-randomised studies (ROBINS-I) tool for non-randomised controlled trials. <h3>Results</h3> 24 studies (n=1612) met the inclusion criteria for data extraction and analysis. Most studies were randomised controlled trials (n=13). Anxiety was the most frequently analysed symptom (n=13), followed by pain (n=9), psychological and emotional responses and perceived wellbeing (n=4), stress (n=4), cancer related fatigue (n=3), and crying (n=2). Five studies used biomarkers, mainly cortisol, to assess stress or fatigue outcome following hospital clowns. Most of the randomised controlled trials (n=11; 85%) were rated as showing some concerns, and two trials were rated with a high risk of bias. Most non-randomised controlled trials (n=6; 55%) were rated with a moderate risk of bias according to ROBINS-I tool. Studies showed that children and adolescents who were in the presence of hospital clowns, either with or without a parent present, reported significantly less anxiety during a range of medical procedures, as well as improved psychological adjustment (P&lt;0.05). Three studies that evaluated chronic conditions showed favourable results for the intervention of hospital clowns with significant reduction in stress, fatigue, pain, and distress (P&lt;0.05). <h3>Conclusions</h3> These findings suggest that the presence of hospital clowns during medical procedures, induction of anaesthesia in the preoperative room, and as part of routine care for chronic conditions might be a beneficial strategy to manage some symptom clusters. Furthermore, hospital clowns might help improve psychological wellbeing in admitted children and adolescents with acute and chronic disorders, compared with those who received only standard care. <h3>Systematic review registration</h3> PROSPERO CRD42018107099.