P - Adult Patients with Central Lines
I- Use of Disinfecting Caps
C- Manual Disinfection
O- Preventing Central Line Associated Bloodstream Infection
In adult patients with central lines (P) does the use of disinfecting caps (I) manual disinfection only (C) prevents central line associated bloodstream infections?
META-ANALYSIS 1: Antiseptic barrier caps in central line-associated bloodstream infections: A systematic review and meta-analysis
By: Tejada et al. (2022)
Section A: Is the basic study design valid for a systematic review?
1. Did the systematic review address a clearly formulated research question?
- Yes. The systematic review of Tejada et al. (2022) have clearly formulated their research question with a focus of comparing if the use of antiseptic barrier cap (of any brand) has an effect on the reduction of Central Line Associated Bloodstream Infections (CLABSIs) compared to the usual manual disinfection of the needleless connection hub of the central venous devices (CVD) in hospitalized patients. However, the population of the analysis includes subgroups such as ICU patients, non-ICU patients, adults, and pediatrics.
2. Did the researchers search for appropriate study design(s) to answer the research question?
- Can’t Tell. Although the researchers of the meta-analysis have used randomized controlled trials which is considered as a gold standard when it comes to evaluating the efficacy of interventions, observational and cohort studies are also used. Among the total 566 studies identified in the databases only fourteen were included in the qualitative analysis. Among the 14, only two are RCTs.
Section B: Is the systematic review methodologically sound?
3. Were all the relevant primary research studies likely to have been included in the systematic review?
a) Searching for primary research studies
- Yes. The meta-analysis has practiced a comprehensive search using multiple bibliographic databases. Two of the reviewers of the study have performed a search through PubMed, Cochrane Library database, and Web of Science database from 2011 to 2021. In addition to that, they also identify ongoing clinical trials through clinicaltrials.gov, and clinicaltrialsregister.eu. No filters were used with regards to the language of publication.
b)Screening primary research studies from the search
- Can’t Tell. The researchers have clearly defined their inclusion criteria with the following: RCT and observational (as design), hospitalized patients of any age with central line (as population), the use of antiseptic barrier cap in preventing CLABSI regardless of brand (as intervention), manual disinfection (as comparator), CLABSI rate per 1000 line days and number of CLABSI per patient (as primary outcome), compliance with the antiseptic cap use, length of stay, and economic differences (as secondary outcomes). However, no clear exclusion criteria was mentioned in the study.
c)Selecting primary research studies to include in the systematic review
- Yes. During the selection process, two of the researchers work independently in assessing the abstract and full text of the studies that have been retrieved during the selection process. When a disagreement between the two arises, a third reviewer was consulted in order to reach consensus. Although the level agreement using the kappa statistic was not reported in the paper, the process described indicates that the selection of studies was conducted in a methodologically rigorous manner.
d) Summarising the search and its outputs
- Yes. The researchers of the study have used the PRISMA flow diagram which presents the study selection process, including the number of duplicate studies removed, studies screened, excluded, and studies included in the systematic review.
4. Did the researchers assess the validity or methodological rigour of the primary research studies included in the systematic review?
- Yes. In order to validate or assess the methodological rigor of the Non-RCTs and observational studies the Newcastle Ottawa Scale was used which evaluated the selection of study groups, comparability, and quality of determining the outcome of interest of the study. On the other hand, the Cochrane Handbook of SR of Interventions and Cochrane Risk of Bias Tool was used to assess the RCTs.
5. Did the researchers extract, and present information from the individual primary research studies appropriately and transparently
a) Extraction of data
- Yes. During the extraction of data, two of the researchers work independently. When a disagreement between the two arises, a third reviewer was consulted in order to reach consensus. The study design, number and type of participants, settings, length of intervention phase, sample size, type of line, CLABSI rate and reduction rate, were the data extracted in the primary studies.
(b)Presentation of data
- Yes. The researchers of the study have presented the characteristics of included primary studies, and the population. The study used a table to clearly summarize the information. The results of primary studies were presented also in forest plot which shows the effect sizes, confidence intervals, and p-values for individual studies, as well as the overall meta-analysis result
Section C: Are the results of the systematic review trustworthy?
6. Did the researchers analyse the pooled results of the individual primary research studies appropriately?
- Yes. The researchers have conducted a rigorous meta-analysis using appropriate statistical tools in order to analyze the pooled results from the included primary studies. All statistical analyses were performed using RevMan v5.3 where they report risk ratios with 95% confidence intervals to measure the effect of the intervention on the reduction of CLABSI rate. In addition, subgroup analyses were also performed in order to have a comparison of effect in ICU vs non-ICU patients, and adults vs pediatric populations which may help in the identification of the outcomes across. The publication biases were assessed using Egger’s test and funnel plot.
7. Did the researchers report any limitations of the systematic review and, if so, do the limitations discussed cover all the issues you identified during critical appraisal?
- Yes. The researchers have explicitly acknowledged that the limited number of RCTs in the menta-analysis might have affected the ability to detect a statistically significant effect since it is mostly based on observational studies. In terms of heterogeneity, they have conducted a subgroup analysis whereas in ICU vs Non-ICU patients have a significantly reduced CLABSI rate per 1000 line-days both in favour of antiseptic barrier caps, and adult vs pediatrics. The Non-RCT and observational studies was assessed for risk of bias using newcastle ottawa scale tool where eight of the primary studies showed moderate quality and four with low which is ndue to issues in the selection with inability to show ascertainment of exposure and lack of demonstration that the outcome of interest was not present at the start of the study. On the other hand, RCTs were assessed by cochrane risk for bias tool resulting in high which is mainly due to comparability and outcome reporting.
8. Would the benefits of intervention outweigh any potential disadvantages, harms and/or additional demand for resources associated with acting on the results?
- Can’t Tell. The research have explained the benefits of the interventions such as reduction of CLABSI incidence, cost savings, and improved patient outcomes. However, no potential disadvantages were clearly stated in the research.
9. Can the results of the systematic review be applied to your local population/in your local setting or context?
- The findings of the study suggests that the intervention to ICU and adult patients are the population that geared the most benefits. Although the meta-analysis have subgroups, it is applicable to be applied in practice to our local setting since our unit caters critically ill (Level III to Level IV) adult patients.
10. If actioned, would the findings from the systematic review represent greater or additional value for the individuals or populations for whom you are responsible?
- Due to the high benefit and cost effectiveness, ease in the implementation, and minimal training requirement, this is a valuable intervention for improving our patient outcomes in the ICU setting. By doing so, the findings from this meta-analysis would provide a substantial value to both patients and healthcare systems
META-ANALYSIS 2: Antiseptic barrier cap effective in reducing central line-associated bloodstream infections: A systematic review and meta-analysis
By: Voor in ’t holt et al (2017)
Section A: Is the basic study design valid for a systematic review?
1. Did the systematic review address a clearly formulated research question?
- Yes. The systematic review of Voor in ’t holt et al (2017) have clearly addressed their research question utilizing the PICO framework. Their population are hospitalized patients with central line catheters, the use of antiseptic barrier caps as their interventions, the comparator is the manual disinfection of catheter needleless hubs, and the outcome is the incidence of CLABSI per 1000 catheter days.
2. Did the researchers search for appropriate study design(s) to answer the research question?
- Can’t Tell. No RCTs were included in the meta-analysis which might not be rigorous in assessing the causality of the result. The researchers have used quasi-experimental before-after studies which might lack randomization.
Section B: Is the systematic review methodologically sound?
3. Were all the relevant primary research studies likely to have been included in the systematic review?
a) Searching for primary research studies
- Yes. The researchers have implemented a comprehensive search which included databases such as Medline ovid, embase, web of science, CINAHL EBSCO, Cochrane Library, PubMed, and Google Scholar without restrictions when it comes in country, and language.
b)Screening primary research studies from the search
- Yes. The researchers only have three inclusion criteria in screening the primary studies. Studies shall be conducted at the hospital setting, antiseptic barrier was used in the hubs of central lines, and reporting of CLABSI per 1000 catheter days with the use of the intervention compared to manual disinfection. Unlike the first journal article, the researchers have clearly stated their exclusion criteria. The exclusion criteria being: reviews, studies about the barrier cap used on feeding tubes or used for other purposes without access to the bloodstream, conference abstracts, letters to the editor and abstracts only, studies with missing information about CLABSIs per 1000 catheter-days after contacting the corresponding author.
c)Selecting primary research studies to include in the systematic review
- Can’t Tell. The researchers have used a robust selection process. The selection of primary studies were performed independently by multiple reviewers. A third reviewer is tasked with reviewing until consensus is reached if disagreements arise.
d)Summarising the search and its outputs
- Yes. The researchers also utilized the PRISMA flow diagram which represents the study selection process. Compared to the first journal, the diagram used in this meta-analysis is easier to understand since they have included when and where the primary studies are excluded and its reason for exclusion.
4. Did the researchers assess the validity or methodological rigour of the primary research studies included in the systematic review?
- Can’t Tell. The researchers have used the Downs and Black checklist to assess the methodological rigour of the primary studies. They have categorized thereafter the studies based on their scores as low, moderate, and high quality.
5. Did the researchers extract, and present information from the individual primary research studies appropriately and transparently
a) Extraction of data
- Yes. The researchers have used a robust selection process. The selection of primary studies were performed independently by multiple reviewers. A third reviewer is tasked with reviewing until consensus is reached if disagreements arise.
(b)Presentation of data
- Yes. The researchers of the meta-analysis have used a table to present the characteristics of primary studies. The table summarizes the author, country and year of publication, setting, brand of antiseptic barrier caps, type of central line, pre and intervention period, CLABSI rate, compliance rate, and quality score.
Section C: Are the results of the systematic review trustworthy?
6. Did the researchers analyse the pooled results of the individual primary research studies appropriately?
- Yes. The study has analyzed the pooled results by using a suitable effect measure with a 95% CI. The researchers also used random-effects models for clinical heterogeneity of the primary studies. A subgroup analysis and bias investigation was done using Egger and Behh- Mazumdar test along with funnel plots.
7. Did the researchers report any limitations of the systematic review and, if so, do the limitations discussed cover all the issues you identified during critical appraisal?
- Yes. The researchers have explicitly disclosed possible limitations of the meta-analysis. First being the study’s heterogeneity wherein they have seen variability of the population group. Moreover, they have stated that in their funnel plots, publication bias is present. Another limitation disclosed is that the primary studies involved are quasi-experimental before-after studies rather than RTCs which might have an effect on the results of the intervention.
8. Would the benefits of intervention outweigh any potential disadvantages, harms and/or additional demand for resources associated with acting on the results?
- Yes. With regards to the adult patients, no potential disadvantages were seen in using antiseptic barrier caps. However, the researchers do note a concern in using antiseptic caps to neonates since a study highlighted that one type of barrier cap might inject significant amounts of alcohol. On the other hand, the evidence in the meta-analysis supported a strong recommendation in adult patients.
9. Can the results of the systematic review be applied to your local population/in your local setting or context?
- Yes. While concern was raised in the paper compared to the first reviewed journal, it is still applicable in our locale. The findings suggest that the use of antiseptic barriers can lower the rate of CLABSI and is also cost-effective and saving.
10. If actioned, would the findings from the systematic review represent greater or additional value for the individuals or populations for whom you are responsible?
- Due to the high benefit and cost effectiveness, ease in the implementation, and minimal training requirement, this is a valuable intervention for improving our patient outcomes in the ICU setting.
Reflection to Practice:
Both of the meta-analyses from Tejada et.al (2022) and Voor in’t Holt et al. (2017) have provided evidence that the use of antiseptic barrier caps in adult patients with central lines can significantly help reduce the incidences of CLABSI. In my current practice where the majority of the patients' access are CVDs, this will help not just the reduction of infection but also to the improvement of patient outcome, prevention of further complications, and the costs from the two.
While using disinfecting caps in our unit in my current workplace is practiced most of the time, it is a good thing to take a look at this evidence. Since the use of it is not included to our standards of care or CLABSI bundles of care, the use of it is practically inconsistent. The consistency of findings in the adult population highlighted its applicability to my current practice since our unit caters only adult patients. With minimal added cost to patients, training to staff, it definitely outweighs the potential effects of reducing nosocomial infections from CVDs.
However, while doing the critical appraisal activity to these two journals I have seen some gaps that are worth pondering on when this practice was applied. First being a gap in the reporting of the exclusion criteria and the details in the study selection process. While the two studies have good and robust inclusion criteria, the lack of clearly defined exclusion criteria makes it difficult to assess whether the primary studies are appropriately filtered out. Another limitation that I have seen is the lack of details of when the barrier cap will be changed.
In conclusion, the evidence from these two meta-analyses can support the implementation of it to my locale. However, more random clinical trials should be done regarding this matter since it is considered as a golden standard when it comes to evaluation of intervention efficacy.
References:
Brice, R. (2024, April 17). CASP Checklist: Systematic Reviews with Meta-Analysis of Randomised Controlled Trials (RCTs). CASP - Critical Appraisal Skills Programme. https://casp-uk.net/casp-tools-checklists/systematic-reviews-meta-analysis-rcts/
Tejada, S., Leal-dos-Santos, M., Peña-López, Y., Blot, S., Emine Alp, & Rello, J. (2022). Antiseptic barrier caps in central line-associated bloodstream infections: A systematic review and meta-analysis. European Journal of Internal Medicine, 99, 70–81. https://doi.org/10.1016/j.ejim.2022.01.040
Voor in ’t holt, A. F., Helder, O. K., Vos, M. C., Schafthuizen, L., Sülz, S., van den Hoogen, A., & Ista, E. (2017). Antiseptic barrier cap effective in reducing central line-associated bloodstream infections: A systematic review and meta-analysis. International Journal of Nursing Studies, 69(69), 34–40. https://doi.org/10.1016/j.ijnurstu.2017.01.007