Objective: The objective of the study was to evaluate the inter-rater and intercenter reliability, usability, and utility of A MeaSurement Tool to Assess systematic Reviews (AMSTAR), AMSTAR 2, and Risk Of Bias In Systematic reviews (ROBIS).Study Design and Setting: This is a prospective evaluation using 30 systematic reviews of randomized trials, undertaken at three international centers.Results: Reviewers completed AMSTAR, AMSTAR 2, and ROBIS in median (interquartile range) 15.7 (11.3), 19.7 (12.1), and 28.7 (17.4) minutes and reached consensus in 2.6 (3.2), 4.6 (5.3), and 10.9 (10.8) minutes, respectively. Across all centers, inter-rater reliability was substantial to almost perfect for 8/11 AMSTAR, 9/16 AMSTAR 2, and 12/24 ROBIS items. Intercenter reliability was substantial to almost perfect for 6/11 AMSTAR, 12/16 AMSTAR 2, and 7/24 ROBIS items. Intercenter reliability for confidence in the results of the review or overall risk of bias was moderate (Gwet's first-order agreement coefficient (AC1) 0.58, 95% confidence intervals [CI]: 0.30 to 0.85) to substantial (AC1 0.74, 95% CI: 0.30 to 0.85) for AMSTAR 2 and poor (AC1 À0.21, 95% CI: À0.55 to 0.13) to moderate (AC1 0.56, 95% CI: 0.30 to 0.83) for ROBIS. It is not clear whether using the appraisals of any tool as an inclusion criterion would alter an overview's findings.Conclusions: Improved guidance may be needed to facilitate the consistent interpretation and application of the newer tools (especially ROBIS).

Because VPT could be measured over a wide range with the Maxivibrometer, it was demonstrated that loss of sensation in diabetic neuropathy can progress far beyond the maximum VPT value of the Biothesiometer. The wide measurement range and the excellent reliability make the Maxivibrometer a valuable research tool to quantify loss of sensation, particularly in the presence of severe neuropathy and to record changes over time. Diabet. Med. 18, 469-475 (2001)

The efficacy and safety of icodextrin versus glucose-only peritoneal dialysis (PD) regimens is unclear. The aim of this study was to compare once-daily long-dwell icodextrin versus glucose among patients with kidney failure undergoing PD. Study Design: Systematic review of randomized controlled trials (RCTs), enriched with unpublished data from investigator-initiated and industry-sponsored studies. Setting & Study Populations: Individuals with kidney failure receiving regular PD treatment enrolled in clinical trials of dialysate composition. Selection Criteria for Studies: Medline, Embase, CENTRAL, Ichushi Web, 10 Chinese databases, clinical trials registries, conference proceedings, and citation lists from inception to November 2018. Further data were obtained from principal investigators and industry clinical study reports. Data Extraction: 2 independent reviewers selected studies and extracted data using a prespecified extraction instrument. Analytic Approach: Qualitative synthesis of demographics, measurement scales, and outcomes. Quantitative synthesis with Mantel-Haenszel risk ratios (RRs), Peto odds ratios (ORs), or (standardized) mean differences (MDs). Risk of bias of included studies at the outcome level was assessed using the Cochrane risk-of-bias tool for RCTs. Results: 19 RCTs that enrolled 1,693 participants were meta-analyzed. Ultrafiltration was improved with icodextrin (medium-term MD, 208.92 [95% CI, 99.69-318.14] mL/24 h; high certainty of evidence), reflected also by fewer episodes of fluid overload (RR, 0.43 [95% CI, 0.24-0.78]; high certainty). Icodextrin-containing PD probably decreased mortality risk compared to glucose-only PD (Peto OR, 0.49 [95% CI, 0.24-1.00]; moderate certainty). Despite evidence of lower peritoneal glucose absorption with icodextrin-containing PD (medium-term MD, −40.84 [95% CI, −48.09 to −33.59] g/ long dwell; high certainty), this did not directly translate to changes in fasting plasma glucose (−0.50 [95% CI, −1.19 to 0.18] mmol/L; low certainty) and hemoglobin A 1c levels (−0.14% [95% CI, −0.34% to 0.05%]; high certainty). Safety outcomes and residual kidney function were similar in both groups; health-related quality-of-life and pain scores were inconclusive. Limitations: Trial quality was variable. The followup period was heterogeneous, with a paucity of assessments over the long term. Mortality results are based on just 32 events and were not corroborated using time-to-event analysis of individual patient data. Conclusions: Icodextrin for once-daily long-dwell PD has clinical benefit for some patients, including those not meeting ultrafiltration targets and at risk for fluid overload. Future research into patient-centered outcomes and costeffectiveness associated with icodextrin is needed. T he prevalence of kidney replacement therapy is expected to increase steeply. 1 Approximately 15% of dialysis patients globally use peritoneal dialysis (PD), and this proportion is increasing. 2 PD is probably associated with the same survival as hemodialysis (HD) 3-6 but pre...

Innovations into clinical practice should be introduced with the highest possible grade of safety for the patient (nil nocere: do no harm). The recommendations can contribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.

BackgroundSystematic reviews (SRs) of randomised controlled trials (RCTs) can provide the best evidence to inform decision-making, but their methodological and reporting quality varies. Tools exist to guide the critical appraisal of quality and risk of bias in SRs, but evaluations of their measurement properties are limited. We will investigate the interrater reliability (IRR), usability, and applicability of A MeaSurement Tool to Assess systematic Reviews (AMSTAR), AMSTAR 2, and Risk Of Bias In Systematic reviews (ROBIS) for SRs in the fields of biomedicine and public health.MethodsAn international team of researchers at three collaborating centres will undertake the study. We will use a random sample of 30 SRs of RCTs investigating therapeutic interventions indexed in MEDLINE in February 2014. Two reviewers at each centre will appraise the quality and risk of bias in each SR using AMSTAR, AMSTAR 2, and ROBIS. We will record the time to complete each assessment and for the two reviewers to reach consensus for each SR. We will extract the descriptive characteristics of each SR, the included studies, participants, interventions, and comparators. We will also extract the direction and strength of the results and conclusions for the primary outcome. We will summarise the descriptive characteristics of the SRs using means and standard deviations, or frequencies and proportions. To test for interrater reliability between reviewers and between the consensus agreements of reviewer pairs, we will use Gwet’s AC1 statistic. For comparability to previous evaluations, we will also calculate weighted Cohen’s kappa and Fleiss’ kappa statistics. To estimate usability, we will calculate the mean time to complete the appraisal and to reach consensus for each tool. To inform applications of the tools, we will test for statistical associations between quality scores and risk of bias judgments, and the results and conclusions of the SRs.DiscussionAppraising the methodological and reporting quality of SRs is necessary to determine the trustworthiness of their conclusions. Which tool may be most reliably applied and how the appraisals should be used is uncertain; the usability of newly developed tools is unknown. This investigation of common (AMSTAR) and newly developed (AMSTAR 2, ROBIS) tools will provide empiric data to inform their application, interpretation, and refinement.Electronic supplementary materialThe online version of this article (10.1186/s13643-018-0746-1) contains supplementary material, which is available to authorized users.

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