Description of the condition
While infections in both community and healthcare settings have been a concern of healthcare providers, organisations and governments for centuries, there has been an increased focus on the prevention and control of healthcare-associated infections (HAIs) in the past few decades. Global estimates of the prevalence of HAIs are not available, but it has been estimated that over four million patients in Europe and 1.7 million in the US develop an infection each year, with higher prevalence in developing countries (Allegranzi 2011; WHO 2011). HAIs are associated with increased length of stay, excess mortality, billions of dollars in associated hospital costs, as well as psychosocial and economic impacts on the people involved, their families and their communities (Andersson 2010; WHO 2011).
HAIs can occur when susceptible patients are exposed to infectious microorganisms during their stay in the healthcare setting. Patients in hospitals and long-term care facilities are frequently more susceptible to infections than those in the community because of their illness, use of immunosuppressive therapy, exposure to invasive procedures, or contact with others who have infections. Infectious agents are most frequently spread by direct contact with contaminated hands, or indirect contact via contaminated objects, such as patient care equipment, healthcare workers' uniforms, or environmental surfaces.
In 1996, the Centers for Disease Control and Prevention in the US introduced guidelines, called 'Standard Precautions', which summarise strategies to be used to prevent transmission of microorganisms in healthcare settings. Standard Precautions replaced previously used guidelines such as 'Universal Precautions' (introduced in 1985) and 'Body Substance Isolation' (introduced in 1987). These previously used guidelines had varied in terms of strategies used and the conditions to which they applied, whereas Standard Precautions recommends strategies to be used on all patients at all times in all settings. Standard Precautions are based on the assumption that all patients carry transmissible microorganisms although the patients may be asymptomatic.
Strategies included in Standard Precautions include: 1) Appropriate hand hygiene (handwashing with soap and water or use of an alcohol-based hand rub) and appropriate use of gloves to disrupt the spread of microorganisms from one patient to another by healthcare workers' contaminated hands (Armstrong-Evans 1999; Johnson 1990; Tenorio 2001); 2) use of gowns to disrupt transmission of microorganisms carried on healthcare workers' uniforms; 3) appropriate cleaning and disinfection of patient care equipment and environment surfaces to reduce transmission by the indirect contact route; 4) use of appropriate facial protection (e.g. masks (Health Canada 1999; Siegel 2007; Wong 2004) and goggles (Siegel 2007; Wong 2004)) or an N95 respirator to reduce exposure of healthcare workers to infectious agents spread by the droplet or airborne route; 5) management of used needles and other sharp objects to prevent exposure from percutaneous injury; 6) management of clinical waste and used linen to reduce environmental contamination; and 7) cough etiquette to reduce droplet transmission and contamination of the environment. All of these strategies protect patients in the setting or healthcare workers from exposure to infectious agents, or both.
Standard Precautions guidelines also include specific transmission-based precautions to be taken when patients are known or suspected to have an infection. There are three categories of transmission-based precautions: airborne, contact and droplet. They involve additional strategies to those of Standard Precautions that are based on the route of transmission of the known or presumed causative microorganism.
Standard Precautions have been adopted worldwide, with periodic updates since they were first released. In Canada, a similar system, called 'Routine Practices and Additional Precautions', has been in place since 1999 (Public Health Agency of Canada 2012). While multiple guidelines have been published for the control of specific microorganisms, such as Clostridium difficile or norovirus, they build on, rather than replace, Standard Precautions.
In spite of widespread adoption of Standard Precautions by organisations, there are gaps in their implementation by healthcare workers (Clock 2010; Gammon 2008). The barriers reported by the healthcare professionals include inadequate infrastructure such as lack of handwashing facilities; lack of information about transmission and insufficient personal protective equipment (Oliveira 2010). Interventions have, therefore, been used to promote implementation of Standard Precautions as the basis for infection prevention and control.
Description of the intervention
Interventions can be categorised into three approaches: educational, behavioural, or technical. While these categories differ from the Cochrane Effective Practice and Organisation of Care (EPOC)'s usual taxonomy of professional, financial, organisational and structural interventions (EPOC 2012), they are more reflective of the actual interventions implemented with respect to promoting Standard Precautions. Educational approaches, one aspect of professional interventions, include educational campaigns, instruction and training, use of pamphlets and posters, and audits with feedback. Education may be provided to individuals or directed to groups. Behavioural interventions, also reflective of professional interventions, include raising risk awareness, or providing penalties or rewards for the desired behaviours. Financial interventions may also be used to influence behaviour. Technical interventions illustrate both organisational and structural interventions; examples include provision and placement of materials required to implement Standard Precautions and eliminating barriers to their use.
How the intervention might work
Educational interventions can increase healthcare workers' knowledge of what strategies to use to reduce transmission of microorganisms, when to use these strategies, and how to implement them correctly. Behavioural interventions might increase awareness of specific individual behaviours and their consequences, and provide motivation for change, such as inducing shame if not adhering to guidelines or pride if adherence is appropriate. Technical interventions, such as ensuring availability of personal protective equipment or adequate housekeeping staff, may reduce barriers that prevent optimal adherence to Standard Precautions. By promoting knowledge of, and belief in, the value of Standard Precautions guidelines or enabling their application, or both, adherence can be improved.
We have not identified a systematic review of interventions to improve adherence to Standard Precautions although there is a review of interventions to improve hand hygiene (Gould 2010).
Why it is important to do this review
The results will be useful to provide healthcare professionals involved in healthcare settings with evidence of the best approach (educational, behavioural, technical, or a combination of these) to improve adherence to Standard Precautions in the provision of care.
To evaluate the effectiveness of interventions to improve adherence to Standard Precautions in patient care.
Criteria for considering studies for this review
Types of studies
We will include the following types of studies:
- randomised controlled trials (RCTs) of individuals and cluster-randomised controlled trials;
- non-randomised controlled trials (non-RCTs) (studies in which investigators allocated participants to the different groups that are being compared using a method that is not random, but at least two groups with different interventions are followed);
- controlled before-and after-studies (CBAs) (with at least two intervention sites and two control sites);
- interrupted time-series (ITS) (with at least three observations available before the intervention and further three available after the intervention).
See the EPOC checklist for definition of designs (EPOC).
Types of participants
Any healthcare professional (e.g. doctors, nurses, or pharmacists) with responsibility for patient care in any hospital, long-term care or community setting, or artificial setting, such as a classroom or learning laboratory.
Types of interventions
We will consider any intervention intended to improve adherence to Standard Precautions or transmission-based precautions, or both:
- educational interventions, including professional interventions (such as distribution of educational materials, educational meetings, patient-mediated interventions, reminders);
- behavioural interventions (such as audit and feedback, social marketing) including financial interventions (such as rewards or benefits or loss thereof tied to specific actions);
- technical interventions including organisational interventions (such as administrative support or policies) and structural interventions (such as changes to the setting/site of service delivery; changes in physical structure, facilities, and equipment; presence and organisation of quality monitoring mechanisms).
We will include studies if they relate to Standard Precautions or transmission-based precautions in general, or both, or to a particular type of transmission-based precautions, such as contact precautions. We will also include studies that only evaluate one component of Standard Precautions or transmission-based precautions, or both, such as use of gowns or gloves.
Older studies will have examined existing systems of precautions, rather than Standard Precautions. We will, therefore, also consider studies of interventions to improve adherence to universal precautions, category-specific precautions, body substance isolation precautions, and routine practices and additional precautions. These systems are all sufficiently similar in goals and issues that it is reasonable to assume that interventions for increasing adherence to one system will be relevant to another system.
We will exclude studies that evaluate only hand hygiene as this was already covered by another review (Gould 2010).
We will compare interventions against each other or no intervention.
Types of outcome measures
We will only include studies if they address the primary outcome.
- Rates of observed Standard Precautions or transmission-based precautions (SP*) adherence or a proxy indicator of SP adherence (e.g. increased use of SP guidelines as policy; volume of glove use; number of patients put on contact precautions), or a combination of these. The definition of adherence may vary across studies and adherence may be assessed using observational methods.
- Rates of healthcare-associated infection.
Search methods for identification of studies
Search strategies will be written by M. Fiander, EPOC Trials Search Co-ordinator (TSC), in consultation with the authors. The TSC will search the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects (DARE) for related systematic reviews and the following databases for primary studies.
•Cochrane Central Register of Controlled Trials (CENTRAL), Wiley
•Health Technology Assessment Database, Cochrane Library, Wiley
•NHS Economic Evaluation Database, Cochrane Library, Wiley
•MEDLINE, 1950-, In-Process and other non-indexed citations, OvidSP
•EMBASE, 1947 - , OvidSP
•The Joanna Briggs Institute EBP Database, OVID SP
•PubMed Central http://www.ncbi.nlm.nih.gov/pmc/
•EPOC Group, Specialised Register
•ProQuest Dissertations & Theses Full Text
•ProQuest Dissertations & Theses: UK & Ireland
•Dissertations and Theses Database, 1861-, ProQuest
•Latin American and Caribbean Health Sciences database (LILACS), Virtual Health Library (VHL)
•Science Citation Index Expanded (SCI-EXPANDED) --1900-present (Web of Science)
•Conference Proceedings Citation Index- Science (CPCI-S) --1990-present (Web of Science)
•World Health Organization Library Information System (WHOLIS/IRIS), Virtual Health Library (VHL)
A draft search strategy for MEDLINE is provided in Appendix 1. This strategy will be tested by screening selected citations for relevance and validated using a selection of exemplar papers on the topic of this review. The finalized strategy will be presented in the review. The Medline strategy will be translated for other databases using appropriate syntax and vocabulary for those databases. Results will be limited by two methodological filters: the Cochrane Highly Sensitive Search Strategy (sensitivity- and precision-maximizing version - 2008 revision) to identify randomized trials, and an EPOC methodology filter to identify non-RCT designs. Neither date nor language limits will be used.
Searching other resources
We will conduct a grey literature search to identify studies not indexed in the databases listed above. Sources will include the sites listed below. Additional sources, if any, will be documented in the review.
Open Grey http://www.opengrey.eu/
Grey Literature Report (New York Academy of Medicine) http://greylit.org/
Agency for Healthcare Research and Quality (AHRQ) www.ahrq.gov/
National Institute for Health and Clinical Excellence (NICE) www.nice.org.uk/
We will search the following registries for ongoing and completed trials:
•International Clinical Trials Registry Platform (ICTRP), Word Health Organization (WHO) http://www.who.int/ictrp/en/
•ClinicalTrials.gov, US National Institutes of Health (NIH) http://clinicaltrials.gov/
We will also:
• Screen individual journals and conference proceedings (e.g. hand search).
• Review reference lists of all included studies, relevant systematic reviews and primary studies.
• Contact the authors of relevant studies or reviews to clarify reported published information or to seek unpublished results/data.
• Contact researchers with expertise relevant to the review topic or EPOC interventions.
• Conduct cited reference searches for all included studies in citations indexes.
We will handsearch the available conference proceedings from the UK Hospital Infection Society and the Infection Prevention Society, the American Association of Professionals in Infection Control, and the Canadian Community and Hospital Infection Control Association.
Data collection and analysis
Selection of studies
Two review authors (IC and DM) will independently assess the titles and abstracts of all reports. We will obtain full-text hard copies for studies that appear to meet the selection criteria and for studies where there is some doubt whether they fulfil the selection criteria. We will resolve any discrepancies with a third review author (RED). If consensus is still not reached, we will not include data from the trial in question unless and until the authors of the trial are able to resolve the contentious issues.
Data extraction and management
Two review authors (IC and DM) will independently extract data. We will resolve any discrepancies with a third review author (RED). We will use a standard data extraction form to extract the following information: characteristics of the study (design, methods of randomisation); participants; interventions; and outcomes (types of outcome measures, adverse events). We will then check for errors before entering the data into Review Manager 5 software (RevMan 2011).
Assessment of risk of bias in included studies
For the assessment of study quality, we will use the 'Risk of bias' approach for Cochrane reviews (Higgins 2011).
Both review authors (IC and DM) will independently assess each included study's risk of bias using a form with the standard criteria described by the EPOC Group (EPOC 2009). We will use the EPOC nine-point criteria for RCTs, non-RCTs, CBA studies and the seven-point criteria for ITS studies to determine the quality of all eligible studies. When information in the studies is not sufficient, we will attempt to contact the study authors to provide further details. We will report risk of bias for each study in the 'Characteristics of included studies' section. Studies will be categorised as 'low' risk if all risk of bias criteria are judged to be adequate. Studies will be categorised as 'moderate' risk of bias if one or two criteria are judged to be inadequate, and as 'high' risk of bias if more than two criteria are judged to be inadequate. We will record this information for each included trial in 'Risk of bias' tables in Review Manager 5 (RevMan 2011), and summarise the risk of bias for each study in a summary 'Risk of bias' figure and graph.
Measures of treatment effect
(a) Binary outcomes
For dichotomous data, we will use the risk ratio (RR) as the effect measure with 95% confidence intervals (CI).
(b) Continuous outcomes
For continuous data, we will present the results as mean differences (MD) with 95% CI). When pooling data across studies, we will estimate the MD if the outcomes are measured in the same way between studies. We will use the standardised mean difference (SMD) to combine studies that measure the same outcome but use different methods.
(c) Change scores versus final values
We will also report both pre- and post-intervention values for studies where change has not been reported. The difference-in-scores may be compared using a t-test (if assuming scores are continuous).
We will present results from CBAs and ITS that were not analysed using appropriate methods in a separate table.
Unit of analysis issues
We will assess whether appropriate analysis was conducted to adjust for clustering in estimating precision of intervention effects in cluster RCTs and CBAs. Where clustering has not been accounted for, we will contact study authors, and, if possible, work with them to adjust the results using (standard) approaches incorporating measures of intracluster correlation coefficients (ICCs) (Higgins 2011). If adjustment is not possible (e.g. due to lack of estimates of ICCs), we will report effect sizes without measures of precision.
Where relevant data can be obtained, inappropriately analysed ITS will be re-analysed using time-series regression to account for secular trends and potential autocorrelation (in time) of data; the best fit pre-intervention and post-intervention line will be estimated using linear regression or autoregressive integrated moving average (ARIMA) techniques (Lagarde 2012; Ramsay 2003).
Dealing with missing data
We will attempt to contact authors of the primary studies to obtain relevant missing data.
An intention-to-treat analysis (ITT) is one in which all the participants in a trial are analysed according to the intervention to which they were allocated, whether they received the intervention or not. We will assume that participants who dropped out are non-respondents. For each trial, we will report whether or not the investigators stated if the analysis was performed according to the ITT principle. If participants were excluded after allocation, we will report any details provided in full. As we will consider the dropouts as non-respondents, we will treat the participants who are not included in the analysis as if they have presented a negative outcome (for dichotomous data) or no change in the rates of healthcare-associated infection for continuous data. Where trials report results for participants who complete the trial without specifying the numbers initially randomised per group, we will present only complete case data. For other outcomes, we will present data for all patients randomised where reported; otherwise we will base estimates on complete cases only.
Assessment of heterogeneity
We will look for clinical heterogeneity (e.g. community versus artificial setting; healthcare professional versus students; educational versus behavioural interventions), by examination of the study details then test for statistical heterogeneity between trial results using the Chi
Assessment of reporting biases
Apart from assessing the risk of selective outcome reporting considered under assessment of risk of bias in included studies, we will assess the likelihood of potential publication bias using funnel plots provided that there are at least eight trials. When small studies in a meta-analysis tend to show larger treatment effects, we will consider other causes including; selection biases, poor methodological quality, heterogeneity, artefactual, and chance.
Given the substantial heterogeneity of interventions and methods across studies, it will be not sensible to use meta-analyses to pool results if these differences are deemed statistically and clinically significant. Instead, we will present the results of studies in tabular form and make a qualitative assessment of the effects of studies, based on quality. However, we will consider combining the results of subsets of studies using meta-analysis (random-effects method) where between-study differences are considered unlikely to explain variability in treatment effects. For studies that are sufficiently homogenous in terms of setting, design and intervention, we will use a fixed-effect model.
Subgroup analysis and investigation of heterogeneity
In this review, we will perform subgroup analyses considering the different subtypes of:
- staff specialities (such as physicians versus nurses);
- professionals from intensive care units (ICUs) versus others units;
- different settings such as hospital versus primary care;
- low- versus middle- versus high-income countries.
We will perform subgroup analyses in Review Manager 5 (RevMan 2011).
We will perform a sensitivity analysis to examine the effects of different trials as follows:.
- excluding trials with high risk of bias;
- excluding trials with rates of withdrawal of 20% or greater.
We would also like to thank Alain D. Mayhew, Julia Worswick and Pierre Durieux (Cochrane Effective Practice and Organisation of Care Group) for their help during the preparation of this protocol.
Appendix 1. DRAFT Medline Strategy
Contributions of authors
Conceiving the protocol: Ione Corrêa (IC) and Regina El Dib (RED).
Co-ordinating the protocol: RED.
Writing the protocol: IC, Donna Moralejo (DM), Pasqual Barretti (PB) and RED
Guarantor for the protocol (one author): RED.
Reading and checking protocol before submission: IC, DM, PB and RED.
Declarations of interest
Sources of support
- No source, Brazil.
- No sources of support supplied