Methodological and Evidence Synthesis Quality Evaluation of MetaAnalyses Assessing the Effect of Antibacterial Envelopes to Reduce CIEDRelated Infections

Received: 09-Feb-2022, Manuscript No. ijmrhs-22-55005 (M); Editor assigned: 10-Feb-2022, Pre QC No. ijmrhs-22-55005 (P); Reviewed: 20-Feb-2022, QC No. ijmrhs-22-55005 (Q); Revised: 21-Feb-2022, Manuscript No. ijmrhs-22-55005 (R); Published: 28-Feb-2022

Introduction

Infection is one of the most common side effects of treatment with Cardiovascular Implantable Electronic Devices (CIED), and it’s associated with a high mortality rate and substantial healthcare costs [1-4]. Cardiac implantables are approaches and treatments available to people at risk of life-threatening ventricular arrhythmias, and their efficacy and effectiveness have been demonstrated in several randomized controlled trials [5-12]. According to current statistics, an estimated 1.5 million persons worldwide receive cardiac implantables each year, according to recent statistics [13]. Despite this, infection is one of the most common reasons for implantation failure [14].

Despite the effectiveness of systemic antibiotics in reducing infections caused by implanted electronic devices, infection is widespread, and the frequency of infections is continuously increasing to alarming levels [11,15-19]. According to a consensus paper published by the European Heart Rhythm Association (EHRA) in 2020, the risk of implantable electronic heart device infection is of particular concern because it is linked to significant morbidity, increased hospitalizations, lower survival, and higher healthcare costs [20]. According to the findings of a study, the average cost of treating a patient with severe CIED-related infection is over $50,000, with an average hospital stay of 13 days [21]. According to reports, infection rates may increase faster than the implantation rate [17,18]. As a result, novel infection-prevention measures could help to improve the outcome of implantation therapy.

As previously indicated, preventative measures appear crucial, given the high cost of implanted electronic devicerelated infections to healthcare systems [22]. The Food and Drug Administration (FDA) approved the use of an Antibacterial Envelope (AE) to decrease the risk of infection during device installation to address these concerns [13]. Thanks to technological developments, this has been replaced by a single-use absorbable sheath [13]. Even though multiple meta-analyses have found antibacterial envelopes therapeutically effective in CIED patients, largescale research to examine the validity of the current evidence synthesis is still needed [23-27]. We studied systematic reviews comparing the use of an antibacterial envelope in patients undergoing electronic device implantation to assess the quality of the evidence on the efficacy of an antibacterial envelope in preventing CIED-related infections. Systematic flaws or deficiencies in the design or conduct of articles in the field may mislead the findings. As a result, the methodology and evidence synthesis quality assessments should help improve evidence-based therapeutic management of infections caused by implantation.

One of the tools created to assess the quality of evidence is the GRADE which has universal validity and acceptance acknowledged by the World Health Organization (WHO) and recommended in the Cochrane Handbook [28]. Evidence quality is divided into four categories by the GRADE system: high, moderate, low, and very low. While more studies are unlikely to affect our confidence in the effect estimate if the quality is high, we have very little confidence in the effect estimate if the quality is low [29]. As a result, this study aims to assess the overall quality of evidence derived from systematic reviews that provide a quantitative synthesis of the impact of an antibacterial envelope on CIEDrelated infection versus alternative therapies that do not use an antibacterial envelope. The current study provides a thorough assessment of the existing evidence on the effects of AE-based treatments in CIED patients.

Materials and Methods

Eligibility Criteria

English systematic reviews in the original full text published in peer-reviewed journals describing meta-analyses of the clinical effect of AE on CIED-related infection in human populations of both genders and any age group compared to other comparators without AE. This research did not include any animal-based studies. We did not confine our analysis to a particular period, clinical environment, or geographic location.

Search Strategy

We conducted a complete literature search from conception to September 27, 2021, using the electronic databases PubMed, Scopus, and Web of Science. On the 2nd of January 2022, we also updated our search. The final qualifying studies’ reference lists were also reviewed to see any additional potentially relevant studies. For further information on the search techniques used in each database, see Table 1.

Study Selection

The documents found during the searches were organized and entered into the Microsoft Excel program. DOI numbers were used to identify duplicates. The titles were utilized to identify duplication without a DOI number. Two reviewers separately evaluated the titles and abstracts of included articles based on the following criteria: Is this a study based on a systematic review? (yes/unsure, no) Is it an antibacterial envelope-based study (yes/unsure, no)? Studies with yes/unsure answers were eligible for the next round of the screening process (full-text screening). The reviewers then evaluated the studies using the following factors: Is this a study in English? (Yes, no) Is this a human study? (Yes, no) Is it a meta-analysis (yes, no)? Does the study explore the effect of the envelope on CIED infections? (Yes, or no.). We could find qualified systematic reviews by limiting “Yes” to all questions. Reviewers discussed disagreements throughout both titles/abstract and full-text screening to achieve a consensus. The PRISMA flowchart illustrates the screening findings and the selection of eligible research. Two reviewers worked individually to obtain data from the qualifying studies [30].

Data Items

In terms of data extraction, the following variables were collected by the reviewers from the studies: Year of publication, authors’ names, first author’s country using the ISO 3166-1 code, population, intervention, comparator, outcome, the total number of populations in each outcome, effect size, and confidence intervals.

The Methodological Quality of Systematic Reviews

Two reviewers independently assessed the quality of the eligible systematic reviews using the AMSTAR-2 instrument, which consists of 16 questions with answers of yes, partially yes, or no [31]. Disagreements in the ratings of the 16 items on the AMSTAR-2 checklist were addressed through debate and consensus. We utilized the following methodology to report the review’s methodological quality: 1 point for questions with a yes response, 0.5 points for questions with a partial yes answer, and 0 points for questions with a no answer.

Assessment of the Quality of Evidence

As previously stated, two reviewers independently assessed the quality of evidence for each outcome in meta-analyses using the GRADE tool, which evaluates the quality of synthesis of each outcome based on five domains: 1) risk of bias, 2) inconsistency, 3) imprecision, 4) publication bias, and 5) indirectness. The GRADE tool recommends 0, 1, or 2 downgrades depending on the severity of each domain. As a result, we used the techniques listed below [29]:

Concerning the risk of bias, if at least 75% of the included studies had a low risk of bias for each outcome, we did not assign any downgrade. Conversely, we set one downgrade to the outcome. We gave one downgrade if the risk of bias score was not reported in the reviews. When it comes to inconsistency, we considered the reported heterogeneity (I2 ) for each outcome. Accordingly, we assigned one downgrade if the calculated heterogeneity was reported to be at least 50% for each outcome, as according to the Cochrane handbook, the heterogeneity more than 50% may represent substantial heterogeneity [28]. Otherwise, we did not consider any downgrades. We also assigned one downgrade if no heterogeneity was reported [32]. We did not give a downgrade to any outcome if the pooled sample size was more than 2000 in line with imprecision, as recommended by the GRADE Handbook [29]. We assigned one downgrade if the pooled sample size was less than 200 [32]. Optimal information size was calculated when pooled sample sizes were between 200 and 2000. We gave one downgrading if the calculated optimal information size was more than the pooled sample size of the outcome [33]. Otherwise, there was no consideration for a downgrading. Stata software 16 and Power calculation were used to calculate optimal information size.

There is publication bias in a pooled estimate when only some of the publications that may be included are entered in the analysis. A bias in the meta-analysis may be shown visually using a funnel plot. Consequently, the funnel plot may not adequately identify publication bias and may lead to incorrect findings [34-37]. As a result, we used the trimand-fill approach of Duval and Tweedie to investigate publication bias [38]. The pooled effect size is calculated using the results of the imputed studies. We degrade the outcome if the imputation of the possibly missing study alters the meta-analysis results [39]. If there were discrepancies between included studies in terms of intervention, population, or comparator, we considered 1 or 2 downgrades, depending on the severity of the differences, to measure indirectness in each outcome. No downgrading was considered if the included studies were compatible with the review questions in each outcome and were coherent in terms of population, intervention, or comparator [36]. Finally, we graded the quality of every piece of evidence on a four-point scale: 0 downgrade equals high quality, 1-2 downgrades equal moderate quality. 3-4 and 5-6 downgrades also equal low and very low quality of evidence synthesis [32].

Results

In PubMed, Scopus, and the Web of Science, we found 60, 77, and 105 documents, respectively. After removing duplicates, one hundred twenty-three studies were suitable for title/abstract screening. Five studies were eliminated because they did not focus on an antibacterial envelope, and 91 records were excluded because they were not systematic reviews. As a result, 32 studies were selected for full-text screening. Six systematic reviews that reported a metaanalysis of the impact of an antibacterial envelope as an intervention on CIED infection outcomes vs. non-antibacterial envelope fulfilled the inclusion criteria and were included in the final analysis. After checking the reference lists of the qualifying research, no further studies were discovered to be eligible (Figure 1).

Figure 1. PRISMA flowchart of study selection

Characteristics of the Included Systematic Reviews

Six systematic reviews published in 2017, 2018, 2019, and 2020 in the United States of America, India, and Indonesia satisfied the inclusion criteria, providing meta-analyses evaluating the influence of AE on CIED infections. There were 35 primary studies in all that were included in the reviews (Table 2) [23-27,40].

Methodological Quality Results

The average methodological quality score was approximately 8.2 out of 16 points; the highest score was 10.5, and the lowest was 6.5 [25,26]. All included systematic reviews achieved a critically low methodological quality score using the AMSTAR-2 tool guideline [31]. Although all included studies were able to meet the criteria of items 1, 11, and 14, i.e., the inclusion of components of PICO, use of appropriate methods for statistical combination of results, and satisfactory explanation of heterogeneity, five items were not met by the reviews, namely: item 2: registration of the protocol before the main review, item 7: Provision of a list of excluded studies and rationale for exclusions, Item 10: Indication of the source of funding of included studies, Item 12: Assessment of the potential impact of risk of bias in individual studies on the results of the meta-analysis and Item 13: Consideration of risk of bias in individual studies when interpreting/discussing the results of the review. The study designs for inclusion were explained in half of the reviews but not in the other three studies [23-27,40]. Most of the reviews employed double study selection [23-23]. Data extraction was also not duplicated in one document [27]. In addition, the characteristics of the included studies were not described in sufficient detail in one study [25]. The risk of bias in the included studies was only assessed in two reviews [26,27]. Only one systematic review did not mention potential sources of conflict of interest [24]. The likelihood of publication bias was not analyzed (Table 3) [24,25].

GRADE Results

The six reviews included in this study comprised fifteen outcomes. Although none of the reported outcomes (0%) had high-quality evidence synthesis, nine (60%) and six (40%) outcomes had low and moderate-quality evidence synthesis, respectively. Regarding the GRADE criteria, all outcomes were at risk of bias (n=15, 100%), followed by inconsistency (n= 12, 80%), and publication bias (n=10, 67%). In contrast, imprecision and indirectness were not found in the outcomes (Table 4).

Discussion

Methodological examination and appraisal of the quality of evidence are strongly advocated in evidence-based medicine before making medical decisions [42,43]. The most important sources of evidence that influence medical decision-making are systematic reviews of high methodological quality that provide a high degree of certainty [44,45]. To our knowledge, the current study is the first to analyze the methodological and evidence quality of systematic reviews providing meta-analyses on the effect of antibacterial envelopes on CIED-related infections. This is to help physicians, policymakers, and researchers to make better therapeutic decisions by revealing the methodological and evidence synthesis quality of systematic reviews. Six reviews were included in the final analysis based on the inclusion criteria. As the findings revealed, the included systematic reviews had critically low methodological quality, underlining the need for quality improvement. Most included reviews failed to meet the five criteria of the Amstar-2 tool. None of the included studies followed a published and registered protocol. According to the Cochrane Handbook, a protocol for systematic reviews should be registered to minimize bias in the results of systematic reviews [28]. Most authors of systematic reviews are unaware that a protocol for systematic reviews must be registered in advance, so a standard method is needed that requires authors to register protocols before conducting systematic reviews [46].

Another criterion not met by the included studies is the justification for exclusions. One of the critical areas of the AMSTAR-2 tool is presenting the list of excluded studies in systematic reviews and the reasons for exclusion of each excluded study, as highlighted in the conduct of screening in systematic reviews [47]. Therefore, researchers are highly advised to justify the exclusion of studies in systematic reviews. Because most reasons for exclusions in systematic reviews are intervention, comparison group, randomized controlled trial design, and outcomes, reporting reasons for exclusions can minimize any likely bias in systematic reviews [48]. Another criterion of the AMSTAR-2 tool that was not met by all systematic reviews is assessing the effect of risk of bias on the pooled effect size and the discussion of this effect on the results in systematic reviews. The reliability of randomized trials depends on how well they are organized and how well bias is minimized. In a review, it is crucial to examine the possibility of bias in the results of individual studies [28]. Authors performing meta-analyses must consider the possibility of bias in the results of the included studies. Analyses and conclusions based on the results of all studies, even if errors are overlooked in measuring bias, are inappropriate. More caution should be exercised in analyzing and interpreting results, and the quality of the evidence should be rated lower if more studies contain bias [28]. To account for the effects of risk of bias on the pooled effect size, authors can employ several strategies. The most important are subgroup analyses that stratify by the risk of bias of the included studies and meta-regression or sensitivity analyses. Consequently, researchers should conduct optimal analyses in their systematic reviews to account for the risk of bias. The AMSTAR tool requires systematic reviews to report the funding sources of included studies, which was not done in the included reviews. Most systematic reviews do not report or explain the funding source for included papers [49]. The main reason funding sources affect study results is sponsor bias [49]. To make appropriate therapeutic treatment recommendations, it is necessary to analyze, disclose, and critically evaluate any sponsor bias in meta-analytic estimates [49]. Previous studies in spinal surgery, treatment of major depression in adults, dance therapy, exercise therapy for chronic low back pain, bariatrics, and child sexual abuse interventions also rated the methodological quality of most systematic reviews as critically low [50-55]. In contrast, the methodological quality of most systematic reviews in antibiotics in third molar surgeries was reported as moderate [56].

We also found that the calculated outcomes in the included systematic reviews had evidence synthesis of low and moderate quality, primarily due to risk of bias in the included studies, significant inconsistency between included studies in the meta-analyses, and publication bias, which means that we have moderate and low confidence in these calculated effect sizes. According to the Cochrane Handbook, including studies in meta-analyses with a high risk of bias reduces the certainty of pooled effect sizes. Including only studies with a low risk of bias or conducting subgroup or sensitivity analyses to uncover the effects of risk of bias on the measured effect size may help address this issue. Researchers should consider these guidelines and strategies in the future to minimize the impact of risk of bias on the quality of evidence synthesis, contributing to high-quality meta-analyses [28]. Inconsistency of included studies in meta-analyses decreases the quality of evidence synthesis, as the results of the current systematic review showed that the quality of most measured outcomes in this study decreased due to inconsistency. Therefore, researchers in this field are advised to identify the source of heterogeneity of included studies in meta-analyses by conducting subgroup analyses or meta-regression [57].

The following are some of our study’s strengths. We assessed the methodological quality and the quality of evidence synthesis of the literature using two well-validated techniques, namely AMSTAR-2, a new version of AMSTAR, and GRADE, which improved the research quality.

Conclusion

Our investigation includes six systematic reviews assessing the effect of antibacterial envelopes on CIED-related infection with 15 outcomes, all rated as having critically low methodological quality by the AMSTAR-2 instrument. The GRADE rating of the meta-analysis results in the included SRs revealed that all evidence was of low and moderate quality. Systematic flaws or shortcomings in the design or conduct of articles in this field may skew the results. Before making any medical decisions, the Cochrane Handbook strongly advises evaluating the quality of evidence synthesis. As a result, assessing methodology and evidence synthesis could improve evidence-based therapeutic management of infections induced by cardiac implantation. According to the results of this systematic review, some critical flaws should be considered before making any clinical decision making. According to the current study results, the actual effects of the antibacterial envelopes to reduce CIED-related infection might differ from the estimated effects in the analyzed outcomes. This recommends that cardiologists, healthcare policymakers, and clinicians consider the current study results before making any medical decisions. Moreover, researchers in the field should receive more training and use the AMSTAR 2 scale and GRADE to perform high-quality studies in the future. For CIED-related infections, this method will provide improved clinical therapy recommendations.

Declarations

Author Contributions

HMN, and AS did searching, screening, and data extracting. MM interpreted the data. The first draft of the manuscript was written by HMN. HMN did the statistical analysis and supervised the research. All authors reviewed the results and approved the final version of the manuscript.

Conflict of Interest

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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