Background
Health care‐associated infection is a major cause of morbidity and mortality. Hand hygiene is regarded as an effective preventive measure. This is an update of a previously published ...review.
Objectives
To assess the short‐ and long‐term success of strategies to improve compliance to recommendations for hand hygiene, and to determine whether an increase in hand hygiene compliance can reduce rates of health care‐associated infection.
Search methods
We conducted electronic searches of the Cochrane Register of Controlled Trials, PubMed, Embase, and CINAHL. We conducted the searches from November 2009 to October 2016.
Selection criteria
We included randomised trials, non‐randomised trials, controlled before‐after studies, and interrupted time series analyses (ITS) that evaluated any intervention to improve compliance with hand hygiene using soap and water or alcohol‐based hand rub (ABHR), or both.
Data collection and analysis
Two review authors independently screened citations for inclusion, extracted data, and assessed risks of bias for each included study. Meta‐analysis was not possible, as there was substantial heterogeneity across studies. We assessed the certainty of evidence using the GRADE approach and present the results narratively in a 'Summary of findings' table.
Main results
This review includes 26 studies: 14 randomised trials, two non‐randomised trials and 10 ITS studies. Most studies were conducted in hospitals or long‐term care facilities in different countries, and collected data from a variety of healthcare workers. Fourteen studies assessed the success of different combinations of strategies recommended by the World Health Organization (WHO) to improve hand hygiene compliance. Strategies consisted of the following: increasing the availability of ABHR, different types of education for staff, reminders (written and verbal), different types of performance feedback, administrative support, and staff involvement. Six studies assessed different types of performance feedback, two studies evaluated education, three studies evaluated cues such as signs or scent, and one study assessed placement of ABHR. Observed hand hygiene compliance was measured in all but three studies which reported product usage. Eight studies also reported either infection or colonisation rates. All studies had two or more sources of high or unclear risks of bias, most often associated with blinding or independence of the intervention.
Multimodal interventions that include some but not all strategies recommended in the WHO guidelines may slightly improve hand hygiene compliance (five studies; 56 centres) and may slightly reduce infection rates (three studies; 34 centres), low certainty of evidence for both outcomes.
Multimodal interventions that include all strategies recommended in the WHO guidelines may slightly reduce colonisation rates (one study; 167 centres; low certainty of evidence). It is unclear whether the intervention improves hand hygiene compliance (five studies; 184 centres) or reduces infection (two studies; 16 centres) because the certainty of this evidence is very low.
Multimodal interventions that contain all strategies recommended in the WHO guidelines plus additional strategies may slightly improve hand hygiene compliance (six studies; 15 centres; low certainty of evidence). It is unclear whether this intervention reduces infection rates (one study; one centre; very low certainty of evidence).
Performance feedback may improve hand hygiene compliance (six studies; 21 centres; low certainty of evidence). This intervention probably slightly reduces infection (one study; one centre) and colonisation rates (one study; one centre) based on moderate certainty of evidence.
Education may improve hand hygiene compliance (two studies; two centres), low certainty of evidence.
Cues such as signs or scent may slightly improve hand hygiene compliance (three studies; three centres), low certainty of evidence.
Placement of ABHR close to point of use probably slightly improves hand hygiene compliance (one study; one centre), moderate certainty of evidence.
Authors' conclusions
With the identified variability in certainty of evidence, interventions, and methods, there remains an urgent need to undertake methodologically robust research to explore the effectiveness of multimodal versus simpler interventions to increase hand hygiene compliance, and to identify which components of multimodal interventions or combinations of strategies are most effective in a particular context.
The use of the stepped-wedge cluster randomised trial (SW-CRT) is on the increase, and although there are still relatively few SW-CRTs currently published its use is bound to show an increase in the ...near future. An extension of the CONSORT reporting guideline for SW-CRTs has recently been developed. By making reporting guidelines for this innovative design available relatively early in its development, it is possible that the methodological conduct and reporting of future SW-CRTs will not be at the same risk of low-quality of reporting as is the case with many other study designs. We provide a brief overview of this reporting guideline and encourage authors to use it appropriately; and for journal editors to endorse its use.
In clinical trials it is not uncommon to face a multiple testing problem which can have an impact on both type I and type II error rates, leading to inappropriate interpretation of trial results. ...Multiplicity issues may need to be considered at the design, analysis and interpretation stages of a trial. The proportion of trial reports not adequately correcting for multiple testing remains substantial. The purpose of this article is to provide an introduction to multiple testing issues in clinical trials, and to reduce confusion around the need for multiplicity adjustments. We use a tutorial, question-and-answer approach to address the key issues of why, when and how to consider multiplicity adjustments in trials. We summarize the relevant circumstances under which multiplicity adjustments ought to be considered, as well as options for carrying out multiplicity adjustments in terms of trial design factors including Population, Intervention/Comparison, Outcome, Time frame and Analysis (PICOTA). Results are presented in an easy-to-use table and flow diagrams. Confusion about multiplicity issues can be reduced or avoided by considering the potential impact of multiplicity on type I and II errors and, if necessary pre-specifying statistical approaches to either avoid or adjust for multiplicity in the trial protocol or analysis plan.
Use of patient-reported outcomes (PROs) and patient and public engagement are critical ingredients of pragmatic trials, which are intended to be patient centered. Engagement of patients and members ...of the public in selecting the primary trial outcome and determining the target difference can better ensure that the trial is designed to inform the decisions of those who ultimately stand to benefit. However, to the best of our knowledge, the use and reporting of PROs and patient and public engagement in pragmatic trials have not been described. The objectives of this study were to review a sample of pragmatic trials to describe (1) the prevalence of reporting patient and public engagement; (2) the prevalence and types of PROs used; (3) how its use varies across trial characteristics; and (4) how sample sizes and target differences are determined for trials with primary PROs.
This was a methodological review of primary reports of pragmatic trials. We used a published electronic search filter in MEDLINE to identify pragmatic trials, published in English between January 1, 2014 and April 3, 2019; we identified the subset that were registered in ClinicalTrials.gov and explicitly labeled as pragmatic. Trial descriptors were downloaded from ClinicalTrials.gov; information about PROs and sample size calculations were extracted from the manuscript. Chi-squared, Cochran-Armitage, and Wilcoxon rank sum tests were used to examine associations between trial characteristics and use of PROs. Among 4,337 identified primary trial reports, 1,988 were registered in CT.gov, of which 415 were explicitly labeled as pragmatic. Use of patient and public engagement was identified in 39 (9.4%). PROs were measured in 235 (56.6%): 144 (34.7%) used PROs as primary outcomes and 91 (21.9%) as only secondary outcomes. Primary PROs were symptoms (64; 44%), health behaviors (36; 25.0%), quality of life (17; 11.8%), functional status (16; 11.1%), and patient experience (10; 6.9%). Trial characteristics with lower prevalence of use of PROs included being conducted exclusively in children or adults over age 65 years, cluster randomization, recruitment in low- and middle-income countries, and primary purpose of prevention; trials conducted in Europe had the highest prevalence of PROs. For the 144 trials with a primary PRO, 117 (81.3%) reported a sample size calculation for that outcome; of these, 71 (60.7%) justified the choice of target difference, most commonly, using estimates from pilot studies (31; 26.5%), standardized effect sizes (20; 17.1%), or evidence reviews (16; 13.7%); patient or stakeholder opinions were used to justify the target difference in 8 (6.8%). Limitations of this study are the need for trials to be registered in ClinicalTrials.gov, which may have reduced generalizability, and extracting information only from the primary trial report.
In this study, we observed that pragmatic trials rarely report patient and public engagement and do not commonly use PROs as primary outcomes. When provided, target differences are often not justified and rarely informed by patients and stakeholders. Research funders, scientific journals, and institutions should support trialists to incorporate patient engagement to fulfill the mandate of pragmatic trials to be patient centered.
The use of a validated tool for risk assessment to inform hospital discharge, combined with rapid follow-up, led to a lower risk of death or hospitalization for cardiovascular causes within 30 days ...among patients with acute heart failure.
Growing political attention to antimicrobial resistance (AMR) offers a rare opportunity for achieving meaningful action. Many governments have developed national AMR action plans, but most have not ...yet implemented policy interventions to reduce antimicrobial overuse. A systematic evidence map can support governments in making evidence-informed decisions about implementing programs to reduce AMR, by identifying, describing, and assessing the full range of evaluated government policy options to reduce antimicrobial use in humans.
Seven databases were searched from inception to January 28, 2019, (MEDLINE, CINAHL, EMBASE, PAIS Index, Cochrane Central Register of Controlled Trials, Web of Science, and PubMed). We identified studies that (1) clearly described a government policy intervention aimed at reducing human antimicrobial use, and (2) applied a quantitative design to measure the impact. We found 69 unique evaluations of government policy interventions carried out across 4 of the 6 WHO regions. These evaluations included randomized controlled trials (n = 4), non-randomized controlled trials (n = 3), controlled before-and-after designs (n = 7), interrupted time series designs (n = 25), uncontrolled before-and-after designs (n = 18), descriptive designs (n = 10), and cohort designs (n = 2). From these we identified 17 unique policy options for governments to reduce the human use of antimicrobials. Many studies evaluated public awareness campaigns (n = 17) and antimicrobial guidelines (n = 13); however, others offered different policy options such as professional regulation, restricted reimbursement, pay for performance, and prescription requirements. Identifying these policies can inform the development of future policies and evaluations in different contexts and health systems. Limitations of our study include the possible omission of unpublished initiatives, and that policies not evaluated with respect to antimicrobial use have not been captured in this review.
To our knowledge this is the first study to provide policy makers with synthesized evidence on specific government policy interventions addressing AMR. In the future, governments should ensure that AMR policy interventions are evaluated using rigorous study designs and that study results are published.
PROSPERO CRD42017067514.
Interrupted time series (ITS) designs are frequently used in public health to examine whether an intervention or exposure has influenced health outcomes. Few reviews have been undertaken to examine ...the design characteristics, statistical methods, and completeness of reporting of published ITS studies.
We used stratified random sampling to identify 200 ITS studies that evaluated public health interventions or exposures from PubMed (2013–2017). Study characteristics, details of statistical models and estimation methods used, effect metrics, and parameter estimates were extracted. From the 200 studies, 230 time series were examined.
Common statistical methods used were linear regression (31%, 72/230) and autoregressive integrated moving average (19%, 43/230). In 17% (40/230) of the series, we could not determine the statistical method used. Autocorrelation was acknowledged in 63% (145/230) of the series. An estimate of the autocorrelation coefficient was given for only 1% of the series (3/230). Measures of precision were reported for 63% of effect measures (541/852).
Many aspects of the design, methods, analysis, and reporting of ITS studies can be improved, particularly description of the statistical methods and approaches to adjust for and estimate autocorrelation. More guidance on the conduct and reporting of ITS studies is needed to improve this study design.
Interrupted time series (ITS) studies are frequently used to evaluate the effects of population-level interventions or exposures. However, examination of the performance of statistical methods for ...this design has received relatively little attention.
We simulated continuous data to compare the performance of a set of statistical methods under a range of scenarios which included different level and slope changes, varying lengths of series and magnitudes of lag-1 autocorrelation. We also examined the performance of the Durbin-Watson (DW) test for detecting autocorrelation.
All methods yielded unbiased estimates of the level and slope changes over all scenarios. The magnitude of autocorrelation was underestimated by all methods, however, restricted maximum likelihood (REML) yielded the least biased estimates. Underestimation of autocorrelation led to standard errors that were too small and coverage less than the nominal 95%. All methods performed better with longer time series, except for ordinary least squares (OLS) in the presence of autocorrelation and Newey-West for high values of autocorrelation. The DW test for the presence of autocorrelation performed poorly except for long series and large autocorrelation.
From the methods evaluated, OLS was the preferred method in series with fewer than 12 points, while in longer series, REML was preferred. The DW test should not be relied upon to detect autocorrelation, except when the series is long. Care is needed when interpreting results from all methods, given confidence intervals will generally be too narrow. Further research is required to develop better performing methods for ITS, especially for short series.
The Interrupted Time Series (ITS) is a quasi-experimental design commonly used in public health to evaluate the impact of interventions or exposures. Multiple statistical methods are available to ...analyse data from ITS studies, but no empirical investigation has examined how the different methods compare when applied to real-world datasets.
A random sample of 200 ITS studies identified in a previous methods review were included. Time series data from each of these studies was sought. Each dataset was re-analysed using six statistical methods. Point and confidence interval estimates for level and slope changes, standard errors, p-values and estimates of autocorrelation were compared between methods.
From the 200 ITS studies, including 230 time series, 190 datasets were obtained. We found that the choice of statistical method can importantly affect the level and slope change point estimates, their standard errors, width of confidence intervals and p-values. Statistical significance (categorised at the 5% level) often differed across the pairwise comparisons of methods, ranging from 4 to 25% disagreement. Estimates of autocorrelation differed depending on the method used and the length of the series.
The choice of statistical method in ITS studies can lead to substantially different conclusions about the impact of the interruption. Pre-specification of the statistical method is encouraged, and naive conclusions based on statistical significance should be avoided.
IMPORTANCE: Procedural sedation for children undergoing painful procedures is standard practice in emergency departments worldwide. Previous studies of emergency department sedation are limited by ...their single-center design and are underpowered to identify risk factors for serious adverse events (SAEs), thereby limiting their influence on sedation practice and patient outcomes. OBJECTIVE: To examine the incidence and risk factors associated with sedation-related SAEs. DESIGN, SETTING, AND PARTICIPANTS: This prospective, multicenter, observational cohort study was conducted in 6 pediatric emergency departments in Canada between July 10, 2010, and February 28, 2015. Children 18 years or younger who received sedation for a painful emergency department procedure were enrolled in the study. Of the 9657 patients eligible for inclusion, 6760 (70.0%) were enrolled and 6295 (65.1%) were included in the final analysis. EXPOSURES: The primary risk factor was receipt of sedation medication. The secondary risk factors were demographic characteristics, preprocedural medications and fasting status, current or underlying health risks, and procedure type. MAIN OUTCOMES AND MEASURES: Four outcomes were examined: SAEs, significant interventions performed in response to an adverse event, oxygen desaturation, and vomiting. RESULTS: Of the 6295 children included in this study, 4190 (66.6%) were male and the mean (SD) age was 8.0 (4.6) years. Adverse events occurred in 736 patients (11.7%; 95% CI, 6.4%-16.9%). Oxygen desaturation (353 patients 5.6%) and vomiting (328 5.2%) were the most common of these adverse events. There were 69 SAEs (1.1%; 95% CI, 0.5%-1.7%), and 86 patients (1.4%; 95% CI, 0.7%-2.1%) had a significant intervention. Use of ketamine hydrochloride alone resulted in the lowest incidence of SAEs (17 0.4%) and significant interventions (37 0.9%). The incidence of adverse sedation outcomes varied significantly with the type of sedation medication. Compared with ketamine alone, propofol alone (3.7%; odds ratio OR, 5.6; 95% CI, 2.3-13.1) and the combinations of ketamine and fentanyl citrate (3.2%; OR, 6.5; 95% CI, 2.5-15.2) and ketamine and propofol (2.1%; OR, 4.4; 95% CI, 2.3-8.7) had the highest incidence of SAEs. The combinations of ketamine and fentanyl (4.1%; OR, 4.0; 95% CI, 1.8-8.1) and ketamine and propofol (2.5%; OR, 2.2; 95% CI, 1.2-3.8) had the highest incidence of significant interventions. CONCLUSIONS AND RELEVANCE: The incidence of adverse sedation outcomes varied significantly with type of sedation medication. Use of ketamine only was associated with the best outcomes, resulting in significantly fewer SAEs and interventions than ketamine combined with propofol or fentanyl.
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