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      Reporting Quality Assessment of Randomized Controlled Trials Published in Nephrology Urology Monthly Journal

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          Abstract

          Context:

          Randomized controlled trials (RCTs) are important tools for evidence-based health care decisions. It is, therefore, important that they be conducted and reported with the highest possible standards. The aim of this study was to evaluate the reporting quality of the RCTs published in nephrology urology monthly journal and to examine whether there was a change over time in the reporting quality.

          Evidence Acquisition:

          The quality of each report was assessed using the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement checklist and a 5-point quality assessment instrument, i.e. the Jadad scale.

          Results:

          Eighteen (14 Iranian and 4 non-Iranian) RCTs were published from 2012 to 2014 on topics including renal stone (16.6%), hemodialysis and transplantation (38.8%), and prostate conditions (11.1%). Interventions comprised surgery, drugs, and teaching method in 7 (38 %), 10 (55%), and 1 (5%) of them, respectively. According to the CONSORT checklist, the weakest reported items were registration number, identification as a randomized trial in the title, and settings and locations where the data were collected. The mean Jadad score of the reports was 2.72 ± 1.36 (54% of their maximum possible total score). According to the Jadad and CONSORT scales, there was an increase in the quality of reporting from 2012 to 2014.

          Conclusions:

          This assessment shows low reporting quality scores in reports. Training courses for researchers, using standard reporting tools (e.g. CONSORT 2010 Statement checklist), and consultation with methodologists can improve the quality of published RCTs.

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          Most cited references27

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          Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.

          To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects. An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects. Meta-analyses from the Cochrane Pregnancy and Childbirth Database. The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding. Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P < .001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P = .01), with odds ratios being exaggerated by 17%. This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials.
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            Improving the quality of reporting of randomized controlled trials. The CONSORT statement.

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              Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews.

              Lately, the number of systematic reviews published has increased substantially. Many systematic reviews exclude trials published in languages other than English. However, there is little empirical evidence to support this action. We looked for differences in the completeness of reporting between trials published in other languages and those published in English, to see whether the exclusion of trials published in other languages is justified. We compared completeness of reporting, design characteristics, and analytical approaches of 133 randomised controlled trials (RCTs) published in English between 1989 and 1994 and 96 published in French, German, Italian, or Spanish during the same time. RCTs were identified by hand searching of journals (seven in English and six in the other languages). We found no significant differences between trials published in English and other-language trials for any single item in the completeness of reporting scale (randomisation, double-blinding, withdrawals), or for the overall score (percentage of maximum possible score 51.0% for trials in English, 46.2% for trials in other languages; 95% CI for difference -1.1 to 10.5). Other-language trials were more likely than English-language trials to have adult participants, to use two or more interventions, and to compare two or more active treatments without an untreated control group. Trials in other languages were less likely to report a clearly prespecified primary outcome or any rationale for sample size estimation. These results provide evidence for inclusion of all trial reports, irrespective of the language in which they are published, in systematic reviews. Their inclusion is likely to increase precision and may reduce systematic errors. We hope that our findings will prove useful to those developing guidelines and policies for the conduct of reporting of systematic reviews.
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                Author and article information

                Journal
                Nephrourol Mon
                Nephrourol Mon
                10.5812/numonthly
                Kowsar
                Nephro-urology Monthly
                Kowsar
                2251-7006
                2251-7014
                01 July 2015
                July 2015
                : 7
                : 4
                : e28752
                Affiliations
                [1 ]Behavioral Sciences Research Center, Baqiyatallah University of Medical Sciences, Tehran, IR Iran
                [2 ]Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, IR Iran
                Author notes
                [* ]Corresponding author: Mahmood Salesi, Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, IR Iran. Tel/Fax: +98-9196805469, E-mail: smahmood1360@ 123456yahoo.com
                Article
                10.5812/numonthly.28752
                4623776
                0aa69fc6-119a-4cd4-a5ce-d4d6c6af7116
                Copyright © 2015, Nephrology and Urology Research Center.

                This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.

                History
                : 06 April 2015
                : 24 April 2015
                Categories
                Review Article

                nephrology,urology,randomized controlled trial,checklist

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