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The Clinical and Translational Science Award (CTSA) Consortium and the National Center for Advancing Translational Science (NCATS) undertook a Common Metrics Initiative to improve research processes across the national CTSA Consortium. This was implemented by Tufts Clinical and Translational Science Institute at the 64 CTSA academic medical centers. Three metrics were collaboratively developed by NCATS staff, CTSA Consortium teams, and outside consultants for Institutional Review Board Review Duration, Careers in Clinical and Translational Research, and Pilot Award Publications and Subsequent Funding. The implementation program included training on the metric operational guidelines, data collection, data reporting system, and performance improvement framework. The implementation team provided small-group coaching and technical assistance. Collaborative learning sessions, driver diagrams, and change packages were used to disseminate best and promising practices. After 14 weeks, 84% of hubs had produced a value for one metric and about half had produced an initial improvement plan. Overall, hubs reported that the implementation activities facilitated their Common Metrics performance improvement process. Experiences implementing the first three metrics can inform future directions of the Common Metrics Initiative and other research groups implementing standardized metrics and performance improvement processes, potentially including other National Institutes of Health institutes and centers.
Mental disorders cause high burden in adolescents, but adolescents often underutilise potentially beneficial treatments. Perceived need for and barriers to care may influence whether adolescents utilise services and which treatments they receive. Adolescents and parents are stakeholders in adolescent mental health care, but their perceptions regarding need for and barriers to care might differ. Understanding patterns of adolescent-parent agreement might help identify gaps in adolescent mental health care.
A nationally representative sample of Australian adolescents aged 13–17 and their parents (N = 2310), recruited between 2013–2014, were asked about perceived need for four types of adolescent mental health care (counselling, medication, information and skill training) and barriers to care. Perceived need was categorised as fully met, partially met, unmet, or no need. Cohen's kappa was used to assess adolescent-parent agreement. Multinomial logistic regressions were used to model variables associated with patterns of agreement.
Almost half (46.5% (s.e. = 1.21)) of either adolescents or parents reported a perceived need for any type of care. For both groups, perceived need was greatest for counselling and lowest for medication. Identified needs were fully met for a third of adolescents. Adolescent-parent agreement on perceived need was fair (kappa = 0.25 (s.e. = 0.01)), but poor regarding the extent to which needs were met (kappa = −0.10 (s.e. = 0.02)). The lack of parental knowledge about adolescents' feelings was positively associated with adolescent-parent agreement that needs were partially met or unmet and disagreement about perceived need, compared to agreement that needs were fully met (relative risk ratio (RRR) = 1.91 (95% CI = 1.19–3.04) to RRR = 4.69 (95% CI = 2.38–9.28)). Having a probable disorder was positively associated with adolescent-parent agreement that needs were partially met or unmet (RRR = 2.86 (95% CI = 1.46–5.61)), and negatively with adolescent-parent disagreement on perceived need (RRR = 0.50 (95% CI = 0.30–0.82)). Adolescents reported most frequently attitudinal barriers to care (e.g. self-reliance: 55.1% (s.e. = 2.39)); parents most frequently reported that their child refused help (38.7% (s.e. = 2.69)). Adolescent-parent agreement was poor for attitudinal (kappa = −0.03 (s.e. = 0.06)) and slight for structural barriers (kappa = 0.02 (s.e. = 0.09)).
There are gaps in the extent to which adolescent mental health care is meeting the needs of adolescents and their parents. It seems important to align adolescents' and parents' needs at the beginning and throughout treatment and to improve communication between adolescents and their parents. Both might provide opportunities to increase the likelihood that needs will be fully met. Campaigns directed towards adolescents and parents need to address different barriers to care. For adolescents, attitudinal barriers such as stigma and mental health literacy require attention.
Individuals experiencing different medical conditions, as well as healthy volunteers, may often be interested in trial participation, and researchers similarly need to find participants to advance medical knowledge. The ResearchMatch (RM) Trials Today clinical trial searching tool leverages clinicaltrials.gov data to enable potential participants to look for trial opportunities relevant to their situation. To facilitate expanded use of this tool, we undertook a national digital public awareness campaign to increase awareness of Trials Today among members of the general public.
The awareness campaign promoted Trials Today using Facebook and digital banner messages in 2017, encompassing nine cities across the USA. The digital strategy was complemented by print media in several outlets. We employed descriptive statistics to summarize campaign metrics and site usage data during the campaign.
The campaign was successful in increasing visits to Trials Today, with 142,303 sessions logged during its run, as compared to pre-campaign data indicating 104,688 total sessions during the entire 2-year period since the site’s inception. The city-specific click-through rate for all digital impressions, combining Facebook and banner messaging, ranged from 0.50% to 1.09%, resulting in a cost-per-click range of $0.69–$1.15. In addition, visitors conducted 29,697 searches and viewed individual trial records 173,512 times.
The public awareness campaign was successful in increasing use of the RM Trials Today clinical trial searching tool. Our findings support the value of digital media messaging as a cost-effective vehicle for promoting clinical trial awareness, especially for chronic ailments.
The COllaborative project of Development of Anthropometrical measures in Twins (CODATwins) project is a large international collaborative effort to analyze individual-level phenotype data from twins in multiple cohorts from different environments. The main objective is to study factors that modify genetic and environmental variation of height, body mass index (BMI, kg/m2) and size at birth, and additionally to address other research questions such as long-term consequences of birth size. The project started in 2013 and is open to all twin projects in the world having height and weight measures on twins with information on zygosity. Thus far, 54 twin projects from 24 countries have provided individual-level data. The CODATwins database includes 489,981 twin individuals (228,635 complete twin pairs). Since many twin cohorts have collected longitudinal data, there is a total of 1,049,785 height and weight observations. For many cohorts, we also have information on birth weight and length, own smoking behavior and own or parental education. We found that the heritability estimates of height and BMI systematically changed from infancy to old age. Remarkably, only minor differences in the heritability estimates were found across cultural–geographic regions, measurement time and birth cohort for height and BMI. In addition to genetic epidemiological studies, we looked at associations of height and BMI with education, birth weight and smoking status. Within-family analyses examined differences within same-sex and opposite-sex dizygotic twins in birth size and later development. The CODATwins project demonstrates the feasibility and value of international collaboration to address gene-by-exposure interactions that require large sample sizes and address the effects of different exposures across time, geographical regions and socioeconomic status.
We used a survey to characterize contemporary infection prevention and antibiotic stewardship program practices across 64 healthcare facilities, and we compared these findings to those of a similar 2013 survey. Notable findings include decreased frequency of active surveillance for methicillin-resistant Staphylococcus aureus, frequent active surveillance for carbapenem-resistant Enterobacteriaceae, and increased support for antibiotic stewardship programs.
Regional to global high-resolution correlation and timing is critical when attempting to answer important geological questions, such as the greenhouse to icehouse transition that occurred during the Eocene–Oligocene boundary transition. Timing of these events on a global scale can only be answered using correlation among many sections, and multiple correlation proxies, including biostratigraphy, lithostratigraphy, geochemistry and geophysical methods. Here we present litho- and biostratigraphy for five successions located in the southeastern USA. To broaden the scope of correlation, we also employ carbon and oxygen stable isotope and magnetic susceptibility (χ) data to interpret these sections regionally, and correlate to the Global Boundary Stratotype Section and Point (GSSP) near Massignano in central Italy. Our results indicate that approaching the Eocene–Oligocene boundary, climate warmed slightly, but then δ18O data exhibit an abrupt c. +5 ‰ positive shift towards cooling that reached a maximum c. 1 m below the boundary at St Stephens Quarry, Alabama. This shift was accompanied by a c. −3 ‰ negative shift in δ13C interpreted to indicate environmental changes associated with the onset of the Eocene–Oligocene boundary planktonic foraminiferal extinction event. The observed cold pulse may be responsible for the final extinction of Hantkeninidae, used to define the beginning of the Rupelian Stage. Immediately preceding the boundary, Hantkeninidae species dropped significantly in abundance and size (pre-extinction dwarfing occurring before the final Eocene–Oligocene extinctions), and these changes may be the reason for inconsistencies in past Eocene–Oligocene boundary placement in the southeastern USA.
Members of online bipolar disorder forums often report experiences of mood-stabilisation on the ketogenic diet, which has traditionally been used in the treatment of epilepsy. We examined the nature and extent of such reports.
To investigate associations between a ketogenic diet and mood stabilisation among individuals with bipolar disorder.
We undertook an observational analytic study of free-text comments in online forums about mood effects of dietary interventions (ketogenic, omega-3 enriched or vegetarian) classified by a priori categories of change in mood stabilisation in 274 people with bipolar disorder.
There were 141 (85.5%) free-text comments on ketogenic diets that reported a positive impact on mood stabilisation. Reports of significant mood stabilisation or remission of symptoms over a period were substantially higher for a ketogenic diet than for other diets (93/165, 56.4%, 95% CI 48.4–64.1) v. 14/94, 14.9%, 95% CI 8.4–23.7), odds ratio 7.4, 95% CI 3.8–14.1, P < 0.0001), many with detailed reports of the improvements experienced and several lasting for extended periods (months to years). Other reported associations included fewer episodes of depression (in 41.2%, 95% CI 30.6–52.4 of individuals); improved clarity of thought and speech (28.2%, 95% CI 19.0–39.0); increased energy (25.9, 95% CI 17.0–36.5); and weight loss (25.9%, 95% CI 17.0–36.5).
Despite the inherent limitations of the observational data based on self-reports posted online, the association strength and reports of sustained benefit support a hypothesis of a ketogenic diet being associated with beneficial effects on mood stabilisation. Caution should be exercised in interpreting this data until a controlled trial can be carried out to examine this hypothesis. These preliminary observations are generally consistent with a mitochondrial dysfunction component to bipolar disorder aetiology with ketones bypassing a block between glycolysis and the tricarboxylic acid cycle.
Less than half of stool samples from people symptomatic with infectious intestinal disease (IID) will identify a causative organism. A secondary data analysis was undertaken to explore whether symptomology alone could be used to make inferences about causative organisms. Data were utilised from the Second Study of Infectious Intestinal Disease in the Community. A total of 844 cases were analysed. Few symptoms differentiated individual pathogens, but grouping pathogens together showed that viral IID was more likely when symptom onset was in winter (odds ratio (OR) 2.08, 95% confidence interval (CI) 1.16–3.75) or spring (OR 1.92, 95% CI 1.11–3.33), the patient was aged under 5 years (OR 3.63, 95% CI 2.24–6.03) and there was loss of appetite (OR 2.19, 95% CI 1.29–3.72). The odds of bacterial IID were higher with diarrhoea in the absence of vomiting (OR 3.54, 95% CI 2.37–5.32), diarrhoea which persisted for >3 days (OR 2.69, 95% CI 1.82–3.99), bloody diarrhoea (OR 4.17, 95% CI 1.63–11.83) and fever (OR 1.67, 95% CI 1.11–2.53). Symptom profiles could be of value to help guide clinicians and public health professionals in the management of IID, in the absence of microbiological confirmation.
The Lung Cam expanded stratigraphic succession in Vietnam is correlated herein to the Meishan D section in China, the GSSP for the Permian–Triassic boundary. The first appearance datum of the conodont Hindeodus parvus at Meishan defines the Permian–Triassic boundary, and using published graphic correlation, the Permian–Triassic boundary level has been projected into the Lung Cam section. Using time-series analysis of magnetic susceptibility (χ) data, it is determined that H. parvus arrived at Lung Cam ∼18 kyr before the Permian–Triassic boundary. Data indicate that the Lung Cam section is expanded by ∼90 % relative to the GSSP section at Meishan. Given the expanded Lung Cam section, it is possible to resolve the timing of significant events during the Permian–Triassic transition with high precision. These events include major stepped extinctions, beginning at ∼135 kyr and ending at ∼110 kyr below the Permian–Triassic boundary, with a duration of ∼25 kyr, followed by deposition of Lung Cam ash Bed + 13, which is equivalent to Siberian Traps volcanism is graphically correlated to a precession Time-series model, placing onset of this major volcanic event at ~242 kyr before the PTB. The Meishan Beds 25 and 26, at ∼100 kyr before the Permian–Triassic boundary. In addition, the elemental geochemical, carbon and oxygen isotope stratigraphy, and magnetostratigraphy susceptibility datasets from Lung Cam allow good correlation to other Permian–Triassic boundary succession. These datasets are helpful when the conodont biostratigraphy is poorly known in sections with problems such as lithofacies variability, or is undefined, owing possibly to lithofacies exclusions, anoxia or for other reasons. The Lung Pu Permian–Triassic boundary section, ∼45 km from Lung Cam, is used to test these problems.
Failure of the Fontan circulation is not a well-understood clinical phenomena.For some patients, a gradual increase in pulmonary vascular resistance (PVR) and structural changes in the pulmonary artery may be an important causative factor. To further investigate this issue, we employed optical coherence tomography (OCT) to evaluate structural changes within the pulmonary arteries of Fontan patients and compared to those with a normal pulmonary circulation.
Materials and Methods:
Pulmonary artery OCT was performed, without complications, in 12 Fontan and 11 control patients. Wall thickness and wall:vessel cross-sectional area (CSA) ratio were calculated after image acquisition, using digital planimetry.
There was no difference in wall thickness between both groups. Median wall thickness for Fontan patients was 0.12 mm (IQR, 0.10–0.14) and for controls was 0.11 mm (IQR, 0.10–0.12; p = 0.62). Wall:vessel CSA ratio for Fontan patients was 0.13 (IQR, 0.12–0.16) and for controls was 0.13 (IQR, 0.11–0.15) (p = 0.73). There was no association between wall thickness and ventricle morphology, age at catheterisation, age at Fontan, years since Fontan completion, pulmonary artery pressure, and PVR. The vessel media was more readily visualised in control patients.
OCT of the pulmonary arteries in Fontan patients is safe and feasible. Our OCT findings suggest that during childhood, pulmonary artery wall dimensions are normal in Fontan children with reassuring hemodynamics. Further evaluation of Fontan patients with abnormal hemodynamics and serial evaluation into adulthood are required to conclude on the utility of OCT for identifying early pulmonary artery structural changes.
To ascertain opinions regarding etiology and preventability of hospital-onset bacteremia and fungemia (HOB) and perspectives on HOB as a potential outcome measure reflecting quality of infection prevention and hospital care.
Hospital epidemiologists and infection preventionist members of the Society for Healthcare Epidemiology of America (SHEA) Research Network.
A web-based, multiple-choice survey was administered via the SHEA Research Network to 133 hospitals.
A total of 89 surveys were completed (67% response rate). Overall, 60% of respondents defined HOB as a positive blood culture on or after hospital day 3. Central line-associated bloodstream infections and intra-abdominal infections were perceived as the most frequent etiologies. Moreover, 61% thought that most HOB events are preventable, and 54% viewed HOB as a measure reflecting a hospital’s quality of care. Also, 29% of respondents’ hospitals already collect HOB data for internal purposes. Given a choice to publicly report central-line–associated bloodstream infections (CLABSIs) and/or HOB, 57% favored reporting either HOB alone (22%) or in addition to CLABSI (35%) and 34% favored CLABSI alone.
Among the majority of SHEA Research Network respondents, HOB is perceived as preventable, reflective of quality of care, and potentially acceptable as a publicly reported quality metric. Further studies on HOB are needed, including validation as a quality measure, assessment of risk adjustment, and formation of evidence-based bundles and toolkits to facilitate measurement and improvement of HOB rates.
OBJECTIVES/SPECIFIC AIMS: To explore rural African American parents’ and their community advisors’ perspectives on the Safety Baby Shower’s acceptability, feasibility, and adaptability. METHODS/STUDY POPULATION: Collaborating with a local community organization, we explored community advisors’ and expectant women’s SBS experiences to understand intervention delivery and adoption in a rural underserved community (RUC). The Consolidated Framework for Implementation Research guided our data collection and analysis using focus groups and key informant interviews. We used directed content analysis to generate themes and sub codes. RESULTS/ANTICIPATED RESULTS: Five focus groups (21 participants) and one key informant interview were conducted. Identified barriers that hinder feasibility and acceptability included resources, time/ flexibility, intervention location, cultural norms and beliefs, and the lack of a birthing hospital in the county. “Baby proofing”, “reinforcement products” and “teaching sleep safety on the same day as infant clinical appointment” are expectant mothers’ exemplars for what comes to their minds when asked to think about safety baby showers. To improve feasibility, both community advisors and expectant mothers suggested adaptations ranging from decentralizing or rotating intervention location, using different delivery sites such as churches, scheduling intervention outside business hours, to incorporating intervention into school health fairs and barbeque events. Social media emerged as a facilitator, and integrating safe sleep education into personal baby showers emerged as an implementation strategy. DISCUSSION/SIGNIFICANCE OF IMPACT: The community advisors and expectant mothers identified a wide spectrum of potential adaptations that have potential to improve safe sleep knowledge and practices. In the next study phase, identified themes will inform intervention adaptation and suggested implementation strategies will support uptake of the adapted SBS. Identifying transformative implementation strategies and conducting a community-informed SBS adaptation using a collective decision-making process between intervention experts and local community partners will support improved safety baby shower delivery, adoption and sustainability in RUCs.
To enhance enrollment into randomized clinical trials (RCTs), we proposed electronic health record-based clinical decision support for patient–clinician shared decision-making about care and RCT enrollment, based on “mathematical equipoise.”
As an example, we created the Knee Osteoarthritis Mathematical Equipoise Tool (KOMET) to determine the presence of patient-specific equipoise between treatments for the choice between total knee replacement (TKR) and nonsurgical treatment of advanced knee osteoarthritis.
With input from patients and clinicians about important pain and physical function treatment outcomes, we created a database from non-RCT sources of knee osteoarthritis outcomes. We then developed multivariable linear regression models that predict 1-year individual-patient knee pain and physical function outcomes for TKR and for nonsurgical treatment. These predictions allowed detecting mathematical equipoise between these two options for patients eligible for TKR. Decision support software was developed to graphically illustrate, for a given patient, the degree of overlap of pain and functional outcomes between the treatments and was pilot tested for usability, responsiveness, and as support for shared decision-making.
The KOMET predictive regression model for knee pain had four patient-specific variables, and an r2 value of 0.32, and the model for physical functioning included six patient-specific variables, and an r2 of 0.34. These models were incorporated into prototype KOMET decision support software and pilot tested in clinics, and were generally well received.
Use of predictive models and mathematical equipoise may help discern patient-specific equipoise to support shared decision-making for selecting between alternative treatments and considering enrollment into an RCT.
A robust biomedical informatics infrastructure is essential for academic health centers engaged in translational research. There are no templates for what such an infrastructure encompasses or how it is funded. An informatics workgroup within the Clinical and Translational Science Awards network conducted an analysis to identify the scope, governance, and funding of this infrastructure. After we identified the essential components of an informatics infrastructure, we surveyed informatics leaders at network institutions about the governance and sustainability of the different components. Results from 42 survey respondents showed significant variations in governance and sustainability; however, some trends also emerged. Core informatics components such as electronic data capture systems, electronic health records data repositories, and related tools had mixed models of funding including, fee-for-service, extramural grants, and institutional support. Several key components such as regulatory systems (e.g., electronic Institutional Review Board [IRB] systems, grants, and contracts), security systems, data warehouses, and clinical trials management systems were overwhelmingly supported as institutional infrastructure. The findings highlighted in this report are worth noting for academic health centers and funding agencies involved in planning current and future informatics infrastructure, which provides the foundation for a robust, data-driven clinical and translational research program.
The role that vitamin D plays in pulmonary function remains uncertain. Epidemiological studies reported mixed findings for serum 25-hydroxyvitamin D (25(OH)D)–pulmonary function association. We conducted the largest cross-sectional meta-analysis of the 25(OH)D–pulmonary function association to date, based on nine European ancestry (EA) cohorts (n 22 838) and five African ancestry (AA) cohorts (n 4290) in the Cohorts for Heart and Aging Research in Genomic Epidemiology Consortium. Data were analysed using linear models by cohort and ancestry. Effect modification by smoking status (current/former/never) was tested. Results were combined using fixed-effects meta-analysis. Mean serum 25(OH)D was 68 (sd 29) nmol/l for EA and 49 (sd 21) nmol/l for AA. For each 1 nmol/l higher 25(OH)D, forced expiratory volume in the 1st second (FEV1) was higher by 1·1 ml in EA (95 % CI 0·9, 1·3; P<0·0001) and 1·8 ml (95 % CI 1·1, 2·5; P<0·0001) in AA (Prace difference=0·06), and forced vital capacity (FVC) was higher by 1·3 ml in EA (95 % CI 1·0, 1·6; P<0·0001) and 1·5 ml (95 % CI 0·8, 2·3; P=0·0001) in AA (Prace difference=0·56). Among EA, the 25(OH)D–FVC association was stronger in smokers: per 1 nmol/l higher 25(OH)D, FVC was higher by 1·7 ml (95 % CI 1·1, 2·3) for current smokers and 1·7 ml (95 % CI 1·2, 2·1) for former smokers, compared with 0·8 ml (95 % CI 0·4, 1·2) for never smokers. In summary, the 25(OH)D associations with FEV1 and FVC were positive in both ancestries. In EA, a stronger association was observed for smokers compared with never smokers, which supports the importance of vitamin D in vulnerable populations.
Planning mental health carer services requires information about the number of carers, their characteristics, service use and unmet support needs. Available Australian estimates vary widely due to different definitions of mental illness and the types of carers included. This study aimed to provide a detailed profile of Australian mental health carers using a nationally representative household survey.
The number of mental health carers, characteristics of carers and their care recipients, caring hours and tasks provided, service use and unmet service needs were derived from the national 2012 Survey of Disability, Ageing and Carers. Co-resident carers of adults with a mental illness were compared with those caring for people with physical health and other cognitive/behavioural conditions (e.g., autism, intellectual disability, dementia) on measures of service use, service needs and aspects of their caring role.
In 2012, there were 225 421 co-resident carers of adults with mental illness in Australia, representing 1.0% of the population, and an estimated further 103 813 mental health carers not living with their care recipient. The majority of co-resident carers supported one person with mental illness, usually their partner or adult child. Mental health carers were more likely than physical health carers to provide emotional support (68.1% v. 19.7% of carers) and less likely to assist with practical tasks (64.1% v. 86.6%) and activities of daily living (31.9% v. 48.9%). Of co-resident mental health carers, 22.5% or 50 828 people were confirmed primary carers – the person providing the most support to their care recipient. Many primary mental health carers (37.8%) provided more than 40 h of care per week. Only 23.8% of primary mental health carers received government income support for carers and only 34.4% received formal service assistance in their caring role, while 49.0% wanted more support. Significantly more primary mental health than primary physical health carers were dissatisfied with received services (20.0% v. 3.2%), and 35.0% did not know what services were available to them.
Results reveal a sizable number of mental health carers with unmet needs in the Australian community, particularly with respect to financial assistance and respite care, and that these carers are poorly informed about available supports. The prominence of emotional support and their greater dissatisfaction with services indicate a need to better tailor carer services. If implemented carefully, recent Australian reforms including the Carer Gateway and National Disability Insurance Scheme hold promise for improving mental health carer supports.
Potential participants seek information about clinical trials for many reasons, but the process can be challenging. We analyzed 101,249 searches in ResearchMatch Trials Today, a free interface to recruiting trials from ClinicalTrials.gov. Searches from March 2015 to November 2016 included a broad range of conditions and healthy volunteer concepts, including 12,649 unique topics. Trials Today data indicate that it is being used to identify trials on a variety of topics.
Inefficiencies in the national clinical research infrastructure have been apparent for decades. The National Center for Advancing Translational Science—sponsored Clinical and Translational Science Award (CTSA) program is able to address such inefficiencies. The Trial Innovation Network (TIN) is a collaborative initiative with the CTSA program and other National Institutes of Health (NIH) Institutes and Centers that addresses critical roadblocks to accelerate the translation of novel interventions to clinical practice. The TIN’s mission is to execute high-quality trials in a quick, cost-efficient manner. The TIN awardees are composed of 3 Trial Innovation Centers, the Recruitment Innovation Center, and the individual CTSA institutions that have identified TIN Liaison units. The TIN has launched a national scale single (central) Institutional Review Board system, master contracting agreements, quality-by-design approaches, novel recruitment support methods, and applies evidence-based strategies to recruitment and patient engagement. The TIN has received 113 submissions from 39 different CTSA institutions and 8 non-CTSA Institutions, with projects associated with 12 different NIH Institutes and Centers across a wide range of clinical/disease areas. Already more than 150 unique health systems/organizations are involved as sites in TIN-related multisite studies. The TIN will begin to capture data and metrics that quantify increased efficiency and quality improvement during operations.
Ventilator bundles encompass practices that reduce the risk of ventilator complications, including ventilator-associated pneumonia. The impact of ventilator bundles on the risk of developing ventilator-associated events (VAEs) is unknown. We sought to determine whether decreased compliance to the ventilator bundle increases the risk for VAE development.
Nested case-control study.
This study was conducted at 6 adult intensive care units at an academic tertiary-care center in Tennessee.
In total, 273 patients with VAEs were randomly matched in a 1:4 ratio to controls by mechanical ventilation duration and ICU type.
Controls were selected from the primary study population at risk for a VAE after being mechanically ventilated for the same number of days as a specified case. Using conditional logistic regression analysis, overall cumulative compliance, and compliance with individual components of the bundle in the 3 and 7 days prior to VAE development (or the control match day) were examined.
Overall bundle compliance at 3 days (odds ratio [OR], 1.15; P=.34) and 7 days prior to VAE diagnosis (OR, 0.96; P=.83) were not associated with VAE development. This finding did not change when limiting the outcome to infection-related ventilator-associated complications (IVACs) and after adjusting for age and gender. In the examination of compliance with specific bundle components increased compliance with chlorhexidine oral care was associated with increased risk of VAE development in all analyses.
Ventilator bundle compliance was not associated with a reduced risk for VAEs. Higher compliance with chlorhexidine oral care was associated with a greater risk for VAE development.