Background Assessing the risk of bias (RoB) in included studies is one of the key methodological aspects of systematic reviews. Cochrane systematic reviews appraise RoB of randomised controlled trials (RCTs) with the Cochrane RoB tool. Detailed instructions for using the Cochrane RoB tool are provided in the Cochrane Handbook for Systematic Reviews of Interventions (The Cochrane Handbook). The purpose of this study was to analyse whether Cochrane authors use adequate judgments about the RoB for random sequence generation of RCTs included in Cochrane reviews. Methods We extracted authors’ judgments (high, low or unclear RoB) and supports for judgments (comments accompanying judgments which explain the rationale for a judgment) for random sequence generation of included RCTs from RoB tables of Cochrane reviews using automated data scraping. We categorised all supporting comments, analysed the number and type of various supporting comments and assessed adequacy of RoB judgment for randomisation in line with recommendations from the Cochrane Handbook. Results We analysed 10,103 RCTs that were included in 704 Cochrane reviews. For 5,706 RCTs, randomisation was not described, but for the remaining RCTs, it was indicated that randomisation was performed using computer/software/internet ( N = 2,850), random number table ( N = 883), mechanical method ( N = 359) or it was incomplete/inappropriate ( N = 305). Overall, 1,220/10,103 trials (12%) did not have a RoB judgment in line with Cochrane Handbook guidance about randomisation. The highest proportion of misjudgements was found for trials with high RoB (28%), followed by those with low (20%) or unclear (3%). Therefore, one in eight judgments for the analysed domain in Cochrane reviews was not in line with Cochrane Handbook, and one in four if the judgment was "high risk". Conclusion Authors of Cochrane reviews often make judgments about the RoB related to random sequence generation that are not in line with instructions given in the Cochrane Handbook, which compromises the reliability of the systematic reviews. Our results can help authors of both Cochrane and non-Cochrane reviews which use Cochrane RoB tool to avoid making common mistakes when assessing RoB in included trials. Electronic supplementary material The online version of this article (10.1186/s12874-019-0804-y) contains supplementary material, which is available to authorized users.

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BackgroundThe degree of pain caused by the implantation of cardiac electronic devices (CEDs) and the type of anesthesia or perioperative pain management used with the procedure have been insufficiently studied. The aim of this study was to analyze perioperative pain management, as well as intensity and location of pain among patients undergoing implantation of CED, and to compare the practice with published guidelines.Patients and methodsThis was a combined retrospective and prospective study conducted at the tertiary hospital, University Hospital Split, Croatia. The sample included 372 patients who underwent CED implantation. Perioperative pain management was analyzed retrospectively in 321 patients who underwent CED implantation during 2014. In a prospective study, intensity and location of pain before, during, and after the procedure were measured by using a numerical rating scale (NRS) ranging from 0 to 10 in 51 patients at the same institution from November 2014 to August 2015.ResultsA quarter of patients received analgesia or sedation before surgery. All the patients received local lidocaine anesthesia. After surgery, 31% of patients received pain medication or sedation. The highest pain intensity was observed during CED implantation with the highest NRS pain score being 8. Some patients reported severe pain (NRS >5) also at 1, 3, 6, 8, and 24 hours after surgery. The most common pain locations were surgical site, shoulder, and chest. Adherence to guidelines for acute perioperative pain management was insufficient.ConclusionPatients may experience severe pain during and after CED implantation. Perioperative pain management was suboptimal, and higher doses of sedation and intensive analgesia are required. Guidelines for acute perioperative pain management and anesthesia during CED implantation should be developed.

Aim: Adequate judging of risk of bias (RoB) for blinding of outcome assessors (detection bias) is important for supporting highest level of evidence. Materials & methods: Judgments and supporting comments for detection bias were retrieved from RoB tables reported in Cochrane reviews. We categorized comments, and then compared judgment and supporting comment with instructions from the Cochrane Handbook. Results: We analyzed 8656 judgments for detection bias from 7626 trials included in 575 reviews. Overall, 1909 judgments (22%) were not in line with the Cochrane Handbook. In 9% of trials, the authors split the detection bias domain according to outcomes. Here, prevalence of inadequate judgments was 19%. Conclusion: Interventions to improve RoB assessments in systematic reviews should be explored.