The effect of physical multimorbidity,mental health conditions and socioeconomic deprivation on unplanned admissions to hospital: a retrospective cohort study

Background:

Multimorbidity, the presence of more than 1 long-term disorder, is associated with increased use of health services, but unplanned admissions to hospital may often be undesirable. Furthermore, socioeconomic deprivation and mental health comorbidity may lead to additional unplanned admissions. We examined the association between unplanned admission to hospital and physical multimorbidity, mental health and socioeconomic deprivation.

Methods:

We conducted a retrospective cohort study using data from 180 815 patients aged 20 years and older who were registered with 40 general practices in Scotland. Details of 32 physical and 8 mental health morbidities were extracted from the patients’ electronic health records (as of Apr. 1, 2006) and linked to hospital admission data. We then recorded the occurrence of unplanned or potentially preventable unplanned acute (nonpsychiatric) admissions to hospital in the subsequent 12 months. We used logistic regression models, adjusting for age and sex, to determine associations between unplanned or potentially preventable unplanned admissions to hospital and physical multimorbidity, mental health and socioeconomic deprivation.

Results:

We identified 10 828 (6.0%) patients who had at least 1 unplanned admission to hospital and 2037 (1.1%) patients who had at least 1 potentially preventable unplanned admission to hospital. Both unplanned and potentially preventable unplanned admissions were independently associated with increasing physical multimorbidity (for ≥ 4 v. 0 conditions, odds ratio [OR] 5.87 [95% confidence interval (CI) 5.45–6.32] for unplanned admissions, OR 14.38 [95% CI 11.87–17.43] for potentially preventable unplanned admissions), mental health conditions (for ≥ 1 v. 0 conditions, OR 2.01 [95% CI 1.92–2.09] for unplanned admissions, OR 1.80 [95% CI 1.64–1.97] for potentially preventable unplanned admissions) and socioeconomic deprivation (for most v. least deprived quintile, OR 1.56 [95% CI 1.43–1.70] for unplanned admissions, OR 1.98 [95% CI 1.63–2.41] for potentially preventable unplanned admissions).

Interpretation:

Physical multimorbidity was strongly associated with unplanned admission to hospital, including admissions that were potentially preventable. The risk of admission to hospital was exacerbated by the coexistence of mental health conditions and socioeconomic deprivation.Multimorbidity — usually defined as the presence of more than 1 long-term disorder — is becoming the norm rather than the exception as populations age.^1,2 A recent study found that most people older than 65 years of age had multimorbidity, and the mean number of comorbidities per person increased with age;¹ however, multimorbidity is not confined to older adults.³Multimorbidity is associated with a range of adverse outcomes. People with multimorbidity have worse physical, social and psychological quality of life⁴ and increased mortality.⁵ Mental health conditions often accompany and exacerbate long-term physical conditions, leading to poor health outcomes, reduced quality of life and increased costs.^1,6,7 Furthermore, health services are largely organized to provide care for single diseases, particularly in hospitals or under specialist care. Indeed, many aspects of care are poor for patients with multimorbidity.^8–10 This situation may be further aggravated among patients who are socioeconomically disadvantaged, because they often have poorer health and higher health care needs, while also experiencing poorer provision of services, than their more advantaged counterparts.¹¹ A lack of social and personal resources, coupled with multiple stresses, makes coping difficult for these patients,¹² and the multiplicity of physical, psychological and social problems means that family physicians sometimes struggle to support patients with multimorbidity in deprived settings.¹³Multimorbidity is associated with increased use of health services; however, whereas high use of primary and specialist ambulatory care may be seen as an appropriate response to multimorbidity, frequent unplanned admissions to hospital will often be undesirable.¹⁴ Unfortunately, there are relatively few large studies that have examined the association between multimorbidity and unplanned hospital admissions.^15–17 Moreover, such studies did not separately examine physical and mental health morbidity and did not account for the additional effect of socioeconomic deprivation — shortcomings we hope to have addressed. Using linked routine clinical primary care and hospital data, we sought to determine the association between unplanned admissions to hospital and physical multimorbidity, as well as any additional effect of mental health morbidity and socioeconomic deprivation.     

Health care experiences of people with dementia and their caregivers: a meta-ethnographic analysis of qualitative studies

Background:

Understanding the health care experience of people with dementia and their caregivers is becoming increasingly important given the growing number of affected individuals. We conducted a systematic review of qualitative studies that examined aspects of the health care experience of people with dementia and their caregivers to better understand ways to improve care for this population.

Methods:

We searched the electronic databases MEDLINE, Embase, PsychINFO and CINAHL to identify relevant articles. We extracted key study characteristics and methods from the included studies. We also extracted direct quotes from the primary studies, along with the interpretations provided by authors of the studies. We used meta-ethnography to synthesize the extracted information into an overall framework. We evaluated the quality of the primary studies using the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist.

Results:

In total, 46 studies met our inclusion criteria; these involved 1866 people with dementia and their caregivers. We identified 5 major themes: seeking a diagnosis; accessing supports and services; addressing information needs; disease management; and communication and attitudes of health care providers. We conceptualized the health care experience as progressing through phases of seeking understanding and information, identifying the problem, role transitions following diagnosis and living with change.

Interpretation:

The health care experience of people with dementia and their caregivers is a complex and dynamic process, which could be improved for many people. Understanding these experiences provides insight into potential gaps in existing health services. Modifying existing services or implementing new models of care to address these gaps may lead to improved outcomes for people with dementia and their caregivers.The global prevalence of Alzheimer disease and related dementias is estimated to be 36 million people and is expected to double in the next 20 years.¹ Several recent strategies for providing care to patients with dementia have highlighted the importance of coordinated health care services for this growing population.^2–5 Gaps in the quality of care for people with dementia have been identified,^6–8 and improving their quality of care and health care experience has been identified as a priority area.^2–5Incorporating the health care experience of patients and caregivers in health service planning is important to ensure that their needs are met and that person-centred care is provided.⁹ The health care experience of people with dementia and their caregivers provides valuable information about preferences for services and service delivery.¹⁰ Matching available services to patient treatment preferences leads to improved patient outcomes^11,12 and satisfaction without increasing costs.¹³ Qualitative research is ideally suited to exploring the experiences and perspectives of patients and caregivers and has been used to examine these experiences for other conditions.¹⁴ We performed a systematic review and meta-ethnographic synthesis of qualitative studies exploring the health care experience of people with dementia and their caregivers in primary care settings, and we propose a conceptual framework for understanding and improving these health care experiences.     

Characteristics of primary care practices associated with high quality of care

Background:

No primary practice care model has been shown to be superior in achieving high-quality primary care. We aimed to identify the organizational characteristics of primary care practices that provide high-quality primary care.

Methods:

We performed a cross-sectional observational study involving a stratified random sample of 37 primary care practices from 3 regions of Quebec. We recruited 1457 patients who had 1 of 2 chronic care conditions or 1 of 6 episodic care conditions. The main outcome was the overall technical quality score. We measured organizational characteristics by use of a validated questionnaire and the Team Climate Inventory. Statistical analyses were based on multilevel regression modelling.

Results:

The following characteristics were strongly associated with overall technical quality of care score: physician remuneration method (27.0; 95% confidence interval [CI] 19.0–35.0), extent of sharing of administrative resources (7.6; 95% CI 0.8–14.4), presence of allied health professionals (15.3; 95% CI 5.4–25.2) and/or specialist physicians (19.6; 95% CI 8.3–30.9), the presence of mechanisms for maintaining or evaluating competence (7.7; 95% CI 3.0–12.4) and average organizational access to the practice (4.9; 95% CI 2.6–7.2). The number of physicians (1.2; 95% CI 0.6–1.8) and the average Team Climate Inventory score (1.3; 95% CI 0.1–2.5) were modestly associated with high-quality care.

Interpretation:

We identified a common set of organizational characteristics associated with high-quality primary care. Many of these characteristics are amenable to change through practice-level organizational changes.A health care system is only as strong as its primary care sector,¹ which provides “entry into the system for all new needs and problems, provides person-focused (not disease-oriented) care over time, provides care for all but very uncommon or unusual conditions …”² Patient enrolment, team-based care, information technology, and funding and remuneration schemes that foster comprehensiveness and collaboration are key characteristics of effective primary care systems.³ None can be singled out as the most determining, but how they are clustered defines a limited set of organizational models that have been associated with a variety of outcomes.⁴ Canadian provinces have implemented different primary care models with different scopes of changes.⁵ Research has not yet identified a “winning” model. For example, in Ontario, community health centres deliver better chronic illness care⁶ but have less accessibility than fee-for-service enrolment models,⁷ and no model provided more comprehensive preventive care.⁸ Walk-in clinics achieved better quality scores than did family medicine clinics for treatment of a set of acute problems.⁹ How the work is organized may be as important, if not more important, than what the model is called.These observations suggest that the challenges associated with providing high-quality services differ depending on the nature of care considered.^9–11 Even if chronic illness is a major challenge, the quality of care must not be improved at the expense of accessibility, preventive or good episodic care, which are all essential components of primary care.In this study, we report the results of the quantitative component of a multimethod observational study conducted in Quebec to determine which organizational characteristics of primary care practices are associated with high-quality care. We sought to find a quality measure of care that would encompass the comprehensive nature of primary care (episodic, chronic and preventive care), and we explored how the contribution of organizational characteristics varied based on the type of care provided.     

Utility of prior screening for methicillin-resistant Staphylococcus aureus in predicting resistance of S. aureus infections

Background:

Screening for methicillin-resistant Staphylococcus aureus (MRSA) is intended to reduce nosocomial spread by identifying patients colonized by MRSA. Given the widespread use of this screening, we evaluated its potential clinical utility in predicting the resistance of clinical isolates of S. aureus.

Methods:

We conducted a 2-year retrospective cohort study that included patients with documented clinical infection with S. aureus and prior screening for MRSA. We determined test characteristics, including sensitivity and specificity, of screening for predicting the resistance of subsequent S. aureus isolates.

Results:

Of 510 patients included in the study, 53 (10%) had positive results from MRSA screening, and 79 (15%) of infecting isolates were resistant to methicillin. Screening for MRSA predicted methicillin resistance of the infecting isolate with 99% (95% confidence interval [CI] 98%–100%) specificity and 63% (95% CI 52%–74%) sensitivity. When screening swabs were obtained within 48 hours before isolate collection, sensitivity increased to 91% (95% CI 71%–99%) and specificity was 100% (95% CI 97%–100%), yielding a negative likelihood ratio of 0.09 (95% CI 0.01–0.3) and a negative predictive value of 98% (95% CI 95%–100%). The time between swab and isolate collection was a significant predictor of concordance of methicillin resistance in swabs and isolates (odds ratio 6.6, 95% CI 1.6–28.2).

Interpretation:

A positive result from MRSA screening predicted methicillin resistance in a culture-positive clinical infection with S. aureus. Negative results on MRSA screening were most useful for excluding methicillin resistance of a subsequent infection with S. aureus when the screening swab was obtained within 48 hours before collection of the clinical isolate.Antimicrobial resistance is a global problem. The prevalence of resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), has reached high levels in many countries.^1–3 Methicillin resistance in S. aureus is associated with excess mortality, hospital stays and health care costs,^3,4 possibly owing to increased virulence or less effective treatments for MRSA compared with methicillin-sensitive S. aureus (MSSA).⁵The initial selection of appropriate empirical antibiotic treatment affects mortality, morbidity and potential health care expenditures.^6–8 The optimal choice of antibiotics in S. aureus infections is important for 3 major reasons: β-lactam antibiotics have shown improved efficacy over vancomycin and are the ideal treatment for susceptible strains of S. aureus;⁶ β-lactam antibiotics are ineffective against MRSA, and so vancomycin or other newer agents must be used empirically when MRSA is suspected; and unnecessary use of broad-spectrum antibiotics (e.g., vancomycin) can lead to the development of further antimicrobial resistance.⁹ It is therefore necessary to make informed decisions regarding selection of empirical antibiotics.^10–13 Consideration of a patient’s previous colonization status is important, because colonization predates most hospital and community-acquired infections.^10,14Universal or targeted surveillance for MRSA has been implemented widely as a means of limiting transmission of this antibiotic-resistant pathogen.^15,16 Although results of MRSA screening are not intended to guide empirical treatment, they may offer an additional benefit among patients in whom clinical infection with S. aureus develops.Studies that examined the effects of MRSA carriage on the subsequent likelihood of infection allude to the potential diagnostic benefit of prior screening for MRSA.^17,18 Colonization by MRSA at the time of hospital admission is associated with a 13-fold increased risk of subsequent MRSA infection.^17,18 Moreover, studies that examined nasal carriage of S. aureus after documented S. aureus bacteremia have shown remarkable concordance between the genotypes of paired colonizing and invasive strains (82%–94%).^19,20 The purpose of our study was to identify the usefulness of prior screening for MRSA for predicting methicillin resistance in culture-positive S. aureus infections.     

Effectiveness of disseminating consensus management recommendations for ulcer bleeding: a cluster randomized trial

Background:

International guidelines for the management of nonvariceal upper gastrointestinal bleeding have not been widely adopted in clinical practice. We sought to determine whether a national, multifaceted intervention could improve adherence to guidelines, especially for patients at high risk of nonvariceal upper gastrointestinal bleeding.

Methods:

In this randomized trial, we stratified hospitals by region and size and allocated sites to either the control or experimental group. Health care workers in the experimental group were given published guidelines, generic algorithms, stratification scoring systems and written reminders and attended multidisciplinary guideline education groups and case-based workshops. These interventions were implemented over a 12-month period after randomization, with performance feedback and benchmarking. The primary outcome of adherence rates to key guidelines in endoscopic and pharmacologic management, determined by chart review, was adjusted according to site characteristics and possible within-site dependencies. We also report the rates of adherence to other recommendations.

Results:

Forty-three sites were randomized to the experimental (n = 21) or control (n = 22) groups. In our primary analysis, we compared patients before (experimental group: n = 402 patients; control group: n = 424 patients) and after (experimental group: n = 361 patients; control group: n = 389 patients) intervention. Patient-level analysis revealed no significant difference in adherence rates to the guidelines after the intervention (experimental group: 9.8%; control group: 4.8%; p = 0.99) after adjustment for the rate of adherence before the intervention (experimental group: 13.2%; control group: 7.1%). The adherence rates to other guidelines were similar and decreased over time, varying between 5% and 93%.

Interpretation:

This national knowledge translation–based trial suggests poor adherence to guidelines on nonvariceal upper gastrointestinal bleeding. Adherence was not improved by an educational intervention, which highlights both the complexity and poor predictability of attempting to alter the behaviour of health care providers (Trial registration: ClinicalTrials.gov, no. MCT-88113).The care of patients with nonvariceal upper gastrointestinal bleeding has evolved dramatically over the past 10 years, with international consensus recommendations being issued in 2003.¹ National benchmarking initiatives^2,3 suggest that widespread variations in practice persist,^4,5 with poor adherence to published recommendations.⁶ In this randomized knowledge-translation trial, we aimed to assess the effectiveness of a nation-wide active strategy to improve adoption of evidence-based consensus recommendations on nonvariceal upper gastrointestinal bleeding.     

Effectiveness of training family physicians to deliver a brief intervention to address excessive substance use among young patients: a cluster randomized controlled trial

Background:

Brief interventions delivered by family physicians to address excessive alcohol use among adult patients are effective. We conducted a study to determine whether such an intervention would be similarly effective in reducing binge drinking and excessive cannabis use among young people.

Methods:

We conducted a cluster randomized controlled trial involving 33 family physicians in Switzerland. Physicians in the intervention group received training in delivering a brief intervention to young people during the consultation in addition to usual care. Physicians in the control group delivered usual care only. Consecutive patients aged 15–24 years were recruited from each practice and, before the consultation, completed a confidential questionnaire about their general health and substance use. Patients were followed up at 3, 6 and 12 months after the consultation. The primary outcome measure was self-reported excessive substance use (≥ 1 episode of binge drinking, or ≥ 1 joint of cannabis per week, or both) in the past 30 days.

Results:

Of the 33 participating physicians, 17 were randomly allocated to the intervention group and 16 to the control group. Of the 594 participating patients, 279 (47.0%) identified themselves as binge drinkers or excessive cannabis users, or both, at baseline. Excessive substance use did not differ significantly between patients whose physicians were in the intervention group and those whose physicians were in the control group at any of the follow-up points (odds ratio [OR] and 95% confidence interval [CI] at 3 months: 0.9 [0.6–1.4]; at 6 mo: 1.0 [0.6–1.6]; and at 12 mo: 1.1 [0.7–1.8]). The differences between groups were also nonsignificant after we re stricted the analysis to patients who reported excessive substance use at baseline (OR 1.6, 95% CI 0.9–2.8, at 3 mo; OR 1.7, 95% CI 0.9–3.2, at 6 mo; and OR 1.9, 95% CI 0.9–4.0, at 12 mo).

Interpretation:

Training family physicians to use a brief intervention to address excessive substance use among young people was not effective in reducing binge drinking and excessive cannabis use in this patient population. Trial registration: Australian New Zealand Clinical Trials Registry, no. ACTRN12608000432314.Most health-compromising behaviours begin in adolescence.¹ Interventions to address these behaviours early are likely to bring long-lasting benefits.² Harmful use of alcohol is a leading factor associated with premature death and disability worldwide, with a disproportionally high impact on young people (aged 10–24 yr).^3,4 Similarly, early cannabis use can have adverse consequences that extend into adulthood.^5–8In adolescence and early adulthood, binge drinking on at least a monthly basis is associated with an increased risk of adverse outcomes later in life.^9–12 Although any cannabis use is potentially harmful, weekly use represents a threshold in adolescence related to an increased risk of cannabis (and tobacco) dependence in adulthood.¹³ Binge drinking affects 30%–50% and excessive cannabis use about 10% of the adolescent and young adult population in Europe and the United States.^10,14,15Reducing substance-related harm involves multisectoral approaches, including promotion of healthy child and adolescent development, regulatory policies and early treatment interventions.¹⁶ Family physicians can add to the public health messages by personalizing their content within brief interventions.^17,18 There is evidence that brief interventions can encourage young people to reduce substance use, yet most studies have been conducted in community settings (mainly educational), emergency services or specialized addiction clinics.^1,16 Studies aimed at adult populations have shown favourable effects of brief alcohol interventions, and to some extent brief cannabis interventions, in primary care.^19–22 These interventions have been recommended for adolescent populations.^4,5,16 Yet young people have different modes of substance use and communication styles that may limit the extent to which evidence from adult studies can apply to them.Recently, a systematic review of brief interventions to reduce alcohol use in adolescents identified only 1 randomized controlled trial in primary care.²³ The tested intervention, not provided by family physicians but involving audio self-assessment, was ineffective in reducing alcohol use in exposed adolescents.²⁴ Sanci and colleagues showed that training family physicians to address health-risk behaviours among adolescents was effective in improving provider performance, but the extent to which this translates into improved outcomes remains unknown.^25,26 Two nonrandomized studies suggested screening for substance use and brief advice by family physicians could favour reduced alcohol and cannabis use among adolescents,^27,28 but evidence from randomized trials is lacking.²⁹We conducted the PRISM-Ado (Primary care Intervention Addressing Substance Misuse in Adolescents) trial, a cluster randomized controlled trial of the effectiveness of training family physicians to deliver a brief intervention to address binge drinking and excessive cannabis use among young people.     

Emergency health care use and follow-up among sociodemographic groups of children who visit emergency departments for mental health crises

Background:

Previous studies of differences in mental health care associated with children’s sociodemographic status have focused on access to community care. We examined differences associated with visits to the emergency department.

Methods:

We conducted a 6-year population-based cohort analysis using administrative databases of visits (n = 30 656) by children aged less than 18 years (n = 20 956) in Alberta. We measured differences in the number of visits by socioeconomic and First Nations status using directly standardized rates. We examined time to return to the emergency department using a Cox regression model, and we evaluated time to follow-up with a physician by physician type using a competing risks model.

Results:

First Nations children aged 15–17 years had the highest rate of visits for girls (7047 per 100 000 children) and boys (5787 per 100 000 children); children in the same age group from families not receiving government subsidy had the lowest rates (girls: 2155 per 100 000 children; boys: 1323 per 100 000 children). First Nations children (hazard ratio [HR] 1.64; 95% confidence interval [CI] 1.30–2.05), and children from families receiving government subsidies (HR 1.60, 95% CI 1.30–1.98) had a higher risk of return to an emergency department for mental health care than other children. The longest median time to follow-up with a physician was among First Nations children (79 d; 95% CI 60–91 d); this status predicted longer time to a psychiatrist (HR 0.47, 95% CI 0.32–0.70). Age, sex, diagnosis and clinical acuity also explained post-crisis use of health care.

Interpretation:

More visits to the emergency department for mental health crises were made by First Nations children and children from families receiving a subsidy. Sociodemographics predicted risk of return to the emergency department and follow-up care with a physician.Emergency departments are a critical access point for mental health care for children who have been unable to receive care elsewhere or are in crisis.¹ Care provided in an emergency department can stabilize acute problems and facilitate urgent follow-up for symptom management and family support.^1,2Race, ethnic background and socioeconomic status have been linked to a crisis-oriented care patterns among American children.^3,4 Minority children are less likely than white children to have received mental health treatment before an emergency department visit,^3,4 and uninsured children are less likely to receive an urgent mental health evaluation when needed.⁴ Other studies, however, have shown no relation between sociodemographic status and mental health care,^5,6 and it may be that different health system characteristics (e.g., pay-for-service, insurance coverage, publicly funded care) interact with sociodemographic status to influence how mental health resources are used. Canadian studies are largely absent in this discussion, despite a known relation between lower income and poorer mental health status,⁷ nationwide documentation of disparities faced by Aboriginal children,^8–10 and government-commissioned reviews that highlight deficits in universal access to mental health care.¹¹We undertook the current study to examine whether sociodemographic differences exist in the rates of visits to emergency departments for mental health care and in the use of post-crisis health care services for children in Alberta. Knowledge of whether differences exist for children with mental health needs may help identify children who could benefit from earlier intervention to prevent illness destabilization and children who may be disadvantaged in the period after the emergency department visit. We hypothesized that higher rates of emergency department use, lower rates of follow-up physician visits after the initial emergency department visit, and a longer time to physician follow-up would be observed among First Nations children and children from families receiving government social assistance.     

Concordance of effects of medical interventions on hospital admission and readmission rates with effects on mortality

Background:

Many clinical trials examine a composite outcome of admission to hospital and death, or infer a relationship between hospital admission and survival benefit. This assumes concordance of the outcomes “hospital admission” and “death.” However, whether the effects of a treatment on hospital admissions and readmissions correlate to its effect on serious outcomes such as death is unknown. We aimed to assess the correlation and concordance of effects of medical interventions on admission rates and mortality.

Methods:

We searched the Cochrane Database of Systematic Reviews from its inception to January 2012 (issue 1, 2012) for systematic reviews of treatment comparisons that included meta-analyses for both admission and mortality outcomes. For each meta-analysis, we synthesized treatment effects on admissions and death, from respective randomized trials reporting those outcomes, using random-effects models. We then measured the concordance of directions of effect sizes and the correlation of summary estimates for the 2 outcomes.

Results:

We identified 61 meta-analyses including 398 trials reporting mortality and 182 trials reporting admission rates; 125 trials reported both outcomes. In 27.9% of comparisons, the point estimates of treatment effects for the 2 outcomes were in opposite directions; in 8.2% of trials, the 95% confidence intervals did not overlap. We found no significant correlation between effect sizes for admission and death (Pearson r = 0.07, p = 0.6). Our results were similar when we limited our analysis to trials reporting both outcomes.

Interpretation:

In this metaepidemiological study, admission and mortality outcomes did not correlate, and discordances occurred in about one-third of the treatment comparisons included in our analyses. Both outcomes convey useful information and should be reported separately, but extrapolating the benefits of admission to survival is unreliable and should be avoided.Health care decisions often rely on effects of interventions described using rates of admission or readmission to hospital.^1,2 These outcomes are typically regarded as indicators of insufficient quality of care and inefficient spending of health care resources;^1,2 however, whether they can predict other serious clinical outcomes, such as death, is unknown.Although effects on admission or readmission rates are often analyzed using large sets of routinely collected data, such as from administrative databases and electronic health records, many randomized controlled trials (RCTs) also collect data on admission rates, and some RCTs collect mortality data. Moreover, some trials combine death and admission to hospital as the primary composite outcome³ to increase the study’s power to detect significant differences and reduce the required study size.⁴ However, the interpretation of such a combination is difficult when the treatment effects on the 2 components are not concordant,⁵ for example, when more patients survive but rates of admission increase. In such cases, composite outcomes may dilute or obscure clinically significant treatment effects on important individual components,^4,6 and incomplete disclosure of individual effects may mislead the interpretation of the results.⁴We investigated systematic reviews of treatment comparisons that included meta-analyses of RCTs assessing effects on both rates of admission and mortality. We used the reported trial data to assess whether effects on admission rates were concordant with effects on mortality or whether it was possible to identify interventions and diseases in which these 2 outcomes would provide differing pictures of the merits of the tested interventions.     

Effect of a provincial system of stroke care delivery on stroke care and outcomes

Background:

Systems of stroke care delivery have been promoted as a means of improving the quality of stroke care, but little is known about their effectiveness. We assessed the effect of the Ontario Stroke System, a province-wide strategy of regionalized stroke care delivery, on stroke care and outcomes in Ontario, Canada.

Methods:

We used population-based provincial administrative databases to identify all emergency department visits and hospital admissions for acute stroke and transient ischemic attack from Jan. 1, 2001, to Dec. 31, 2010. Using piecewise regression analyses, we assessed the effect of the full implementation of the Ontario Stroke System in 2005 on the proportion of patients who received care at stroke centres, and on rates of discharge to long-term care facilities and 30-day mortality after stroke.

Results:

We included 243 287 visits by patients with acute stroke or transient ischemic attack. The full implementation of the Ontario Stroke System in 2005 was associated with an increase in rates of care at stroke centres (before implementation: 40.0%; after implementation: 46.5%), decreased rates of discharge to long-term care facilities (before implementation: 16.9%; after implementation: 14.8%) and decreased 30-day mortality for hemorrhagic (before implementation: 38.3%; after implementation: 34.4%) and ischemic stroke (before implementation: 16.3%; after implementation: 15.7%). The system’s implementation was also associated with marked increases in the proportion of patients who received neuroimaging, thrombolytic therapy, care in a stroke unit and antithrombotic therapy.

Interpretation:

The implementation of an organized system of stroke care delivery was associated with improved processes of care and outcomes after stroke.Stroke is a leading cause of death and disability worldwide.^1,2 Guidelines recommend that eligible patients receive care in a stroke unit, undergo neuroimaging and receive thrombolytic therapy, antithrombotic agents and screening for carotid stenosis.^3–6 Many of these interventions require specialized resources, including clinicians with expertise in stroke care and rapid access to brain and vascular imaging; however, wide interfacility variations exist in the availability of such resources.^7–10To address regional disparities in resources and care, organizations such as the Canadian Stroke Network and the American Stroke Association have recommended the implementation of organized systems of stroke care delivery.^11,12 Such systems are designed to facilitate access to optimal stroke care across an entire region and to promote the use of evidence-based therapies.¹¹ However, little is known about the effect of stroke systems of care on outcomes in patients with stroke.The province of Ontario was the first large jurisdiction in Canada, and in North America, to implement an integrated regional system of stroke care delivery. A system of coordinated stroke care, known as the Ontario Stroke System, was launched in 2000 and fully implemented in 2005, resulting in a major transformation in the delivery of stroke care across the province.¹³ We used population-based administrative and clinical data to evaluate the effect of the system’s implementation on stroke care and outcomes.     

Development of guidelines for recently arrived immigrants and refugees to Canada: Delphi consensus on selecting preventable and treatable conditions

Background:

Setting priorities is critical to ensure guidelines are relevant and acceptable to users, and that time, resources and expertise are used cost-effectively in their development. Stakeholder engagement and the use of an explicit procedure for developing recommendations are critical components in this process.

Methods:

We used a modified Delphi consensus process to select 20 high-priority conditions for guideline development. Canadian primary care practitioners who care for immigrants and refugees used criteria that emphasize inequities in health to identify clinical care gaps.

Results:

Nine infectious diseases were selected, as well as four mental health conditions, three maternal and child health issues, caries and periodontal disease, iron-deficiency anemia, diabetes and vision screening.

Interpretation:

Immigrant and refugee medicine covers the full spectrum of primary care, and although infectious disease continues to be an important area of concern, we are now seeing mental health and chronic diseases as key considerations for recently arriving immigrants and refugees.Canada consistently receives more than 239 000 immigrants yearly, up to 35 000 of whom are refugees.¹ Many arrive with similar or better self-reported health than the general Canadian population reports, a phenomenon described as the “healthy immigrant effect.”^2–6 However, subgroups of immigrants, for example refugees, face health disparities and often a greater burden of infectious diseases.^7,8 These health issues sometimes differ from the general population because of differing disease exposures, vulnerabilities, social determinants of health and access to health services before, during and after migration. Cultural and linguistic differences combined with lack of evidence-based guidelines can contribute to poor delivery of services.^9,10Community-based primary health care practitioners see most of the immigrants and refugees who arrive in Canada. This is not only because Canada’s health system centres on primary care practice, but also because people with lower socioeconomic status, language barriers and less familiarity with the system are much less likely to receive specialist care.¹¹Guideline development can be costly in terms of time, resources and expertise.¹² Setting priorities is critical, particularly when dealing with complex situations and limited resources.¹³ There is no standard algorithm on who should and how they should determine top priorities for guidelines, although burden of illness, feasibility and economic considerations are all important.¹⁴ Stakeholder engagement to ensure relevance and acceptability, and the use of an explicit procedure for developing recommendations are critical in guideline development.^15–17 We chose primary care practitioners, particularly those who care for immigrants and refugees, to help the guideline committee select conditions for clinical preventive guidelines for immigrants and refugees with a focus on the first five years of settlement.     

Effect of a fixed-ratio (1:1:1) transfusion protocol versus laboratory-results–guided transfusion in patients with severe trauma: a randomized feasibility trial

Background:

Hemorrhage coupled with coagulopathy remains the leading cause of preventable in-hospital deaths among trauma patients. Use of a transfusion protocol with a predefined ratio of 1:1:1 (1 each of red blood cells [RBC], frozen plasma [FP] and platelets) has been associated with improved survival in retrospective studies in military and civilian settings, but such a protocol has its challenges and may increase the risk of respiratory complications. We conducted a randomized controlled trial to assess the feasibility of a 1:1:1 transfusion protocol and its effect on mortality and complications among patients with severe trauma.

Methods:

We included 78 patients seen in a tertiary trauma centre between July 2009 and October 2011 who had hypotension and bleeding and were expected to need massive transfusion (≥ 10 RBC units in 24 h). We randomly assigned them to either the fixed-ratio (1:1:1) transfusion protocol (n = 40) or to a laboratory-results–guided transfusion protocol (control; n = 38). The primary outcome, feasibility, was assessed in terms of blood product ratios and plasma wastage. Safety was measured based on 28-day mortality and survival free of acute respiratory distress syndrome.

Results:

Overall, a transfusion ratio of 1:1:1 was achieved in 57% (21/37) of patients in the fixed-ratio group, as compared with 6% (2/32) in the control group. A ratio of 1:1 (RBC:FP) was achieved in 73% (27/37) in the fixed-ratio group and 22% (7/32) in the control group. Plasma wastage was higher with the intervention protocol (22% [86/390] of FP units v. 10% [30/289] in the control group). The 28-day mortality and number of days free of acute respiratory distress syndrome were statistically similar between the groups.

Interpretation:

The fixed-ratio transfusion protocol was feasible in our study, but it was associated with increased plasma wastage. Larger randomized trials are needed to evaluate the efficacy of such a protocol in trauma care. Trial registration: ClinicalTrials.gov, no. {"type":"clinical-trial","attrs":{"text":"NCT00945542","term_id":"NCT00945542"}}NCT00945542A fixed-ratio (1:1:1) transfusion strategy is a resuscitation strategy for trauma patients that promotes the transfusion of red blood cells (RBC), plasma and platelets (PLT) at a 1:1:1 ratio while minimizing crystalloid infusion.¹ This balanced transfusion strategy aims to correct both the early coagulopathy of trauma and the volume status of patients in hemorrhagic shock, thus targeting preventable hemorrhage-related deaths.^2,3 Retrospective studies of the 1:1:1 transfusion protocol reported marked reductions in mortality based on retrospectively calculated ratios of plasma:PLT:RBC.^4–6 Methodologic limitations, particularly survivorship bias (where higher mortality was associated with low ratios of plasma and PLT to RBC in unsalvageable patients who died before 1:1:1 transfusion could be achieved), preclude any definitive conclusion on the potential benefit of a 1:1:1 transfusion strategy in terms of efficacy and safety.^7–10The 1:1:1 transfusion strategy has been widely adopted by trauma centres worldwide^11,12 and is being increasingly used in prehospital care and in the care of patients without traumatic injuries.^13–15 Widespread adoption of the strategy has significant resource and safety implications. Its full implementation requires access to thawed type AB plasma, which is chronically in short supply.¹⁶ In addition, because of the difficulty in predicting the need for massive transfusion (commonly defined as ≥ 10 RBC units in 24 h), the 1:1:1 transfusion protocol may lead to unnecessary exposure to blood components and an increased risk of acute respiratory distress syndrome, sepsis and multiple organ dysfunction.¹⁷We conducted a pilot randomized controlled trial comparing a 1:1:1 transfusion strategy with the standard of care at our institution (laboratory-results–guided transfusion; laboratory results are available for transfusion decisions throughout resuscitation) in trauma patients predicted to need massive transfusion. Our primary objective was to assess the feasibility and safety of the fixed-ratio protocol in patients with severe trauma.     

Prevalence of and factors associated with head impact during falls in older adults in long-term care

Background:

Falls cause more than 60% of head injuries in older adults. Lack of objective evidence on the circumstances of these events is a barrier to prevention. We analyzed video footage to determine the frequency of and risk factors for head impact during falls in older adults in 2 long-term care facilities.

Methods:

Over 39 months, we captured on video 227 falls involving 133 residents. We used a validated questionnaire to analyze the mechanisms of each fall. We then examined whether the probability for head impact was associated with upper-limb protective responses (hand impact) and fall direction.

Results:

Head impact occurred in 37% of falls, usually onto a vinyl or linoleum floor. Hand impact occurred in 74% of falls but had no significant effect on the probability of head impact (p = 0.3). An increased probability of head impact was associated with a forward initial fall direction, compared with backward falls (odds ratio [OR] 2.7, 95% confidence interval [CI] 1.3–5.9) or sideways falls (OR 2.8, 95% CI 1.2–6.3). In 36% of sideways falls, residents rotated to land backwards, which reduced the probability of head impact (OR 0.2, 95% CI 0.04–0.8).

Interpretation:

Head impact was common in observed falls in older adults living in long-term care facilities, particularly in forward falls. Backward rotation during descent appeared to be protective, but hand impact was not. Attention to upper-limb strength and teaching rotational falling techniques (as in martial arts training) may reduce fall-related head injuries in older adults.Falls from standing height or lower are the cause of more than 60% of hospital admissions for traumatic brain injury in adults older than 65 years.^1–5 Traumatic brain injury accounts for 32% of hospital admissions and more than 50% of deaths from falls in older adults.^1,6–8 Furthermore, the incidence and age-adjusted rate of fall-related traumatic brain injury is increasing,^1,9 especially among people older than 80 years, among whom rates have increased threefold over the past 30 years.¹⁰ One-quarter of fall-related traumatic brain injuries in older adults occur in long-term care facilities.¹The development of improved strategies to prevent fall-related traumatic brain injuries is an important but challenging task. About 60% of residents in long-term care facilities fall at least once per year,¹¹ and falls result from complex interactions of physiologic, environmental and situational factors.^12–16 Any fall from standing height has sufficient energy to cause brain injury if direct impact occurs between the head and a rigid floor surface.^17–19 Improved understanding is needed of the factors that separate falls that result in head impact and injury from those that do not.^1,10 Falls in young adults rarely result in head impact, owing to protective responses such as use of the upper limbs to stop the fall, trunk flexion and rotation during descent.^20–23 We have limited evidence of the efficacy of protective responses to falls among older adults.In the current study, we analyzed video footage of real-life falls among older adults to estimate the prevalence of head impact from falls, and to examine the association between head impact, and biomechanical and situational factors.     

Incidence of neurologic death among patients with brain injury: a cohort study in a Canadian health region

Background:

Hospital mortality has decreased over time for critically ill patients with various forms of brain injury. We hypothesized that the proportion of patients who progress to neurologic death may have also decreased.

Methods:

We performed a prospective cohort study involving consecutive adult patients with traumatic brain injury, subarachnoid hemorrhage, intracerebral hemorrhage or anoxic brain injury admitted to regional intensive care units in southern Alberta over a 10.5-year period. We used multivariable logistic regression to adjust for patient age and score on the Glasgow Coma Scale at admission, and to assess whether the proportion of patients who progress to neurologic death has changed over time.

Results:

The cohort consisted of 2788 patients. The proportion of patients who progressed to neurologic death was 8.1% at the start of the study period, and the adjusted odds of progressing to neurologic death decreased over the study period (odds ratio [OR] per yr 0.92, 95% confidence interval [CI] 0.87–0.98, p = 0.006). This change was most pronounced among patients with traumatic brain injury (OR per yr 0.87, 95% CI 0.78–0.96, p = 0.005); there was no change among patients with anoxic injury (OR per yr 0.96, 95% CI 0.85–1.09, p = 0.6). A review of the medical records suggests that missed cases of neurologic death were rare (≤ 0.5% of deaths).

Interpretation:

The proportion of patients with brain injury who progress to neurologic death has decreased over time, especially among those with head trauma. This finding may reflect positive developments in the prevention and care of brain injury. However, organ donation after neurologic death represents the major source of organs for transplantation. Thus, these findings may help explain the relatively stagnant rates of deceased organ donation in some regions of Canada, which in turn has important implications for the care of patients with end-stage organ failure.Mortality has decreased among critically ill patients with various forms of brain injury in Canada and around the world.^1–10 There have also been changes in the incidence of stroke and the rate of admission to hospital for traumatic brain injury, especially among younger people and those whose injuries are related to motor vehicle or bicycle crashes.^5,6,10–13Some countries have noted a possible decline in the total number of patients with neurologic death.^14,15 Neurologic death (“brain death”) may occur when patients with brain injury experience progressive cerebral edema, complicated by transtentorial herniation. It is defined by the irreversible cessation of cerebral and brainstem functions, including respiration.¹⁶ Circulation and gas exchange persist only because of the use of mechanical ventilation. National guidelines exist for the diagnosis of neurologic death.^17,18 We hypothesized that the proportion of patients with acute brain injury who progress to neurologic death may have decreased over time.     

Prevalence estimates of chronic kidney disease in Canada: results of a nationally representative survey

Background:

Chronic kidney disease is an important risk factor for death and cardiovascular-related morbidity, but estimates to date of its prevalence in Canada have generally been extrapolated from the prevalence of end-stage renal disease. We used direct measures of kidney function collected from a nationally representative survey population to estimate the prevalence of chronic kidney disease among Canadian adults.

Methods:

We examined data for 3689 adult participants of cycle 1 of the Canadian Health Measures Survey (2007–2009) for the presence of chronic kidney disease. We also calculated the age-standardized prevalence of cardiovascular risk factors by chronic kidney disease group. We cross-tabulated the estimated glomerular filtration rate (eGFR) with albuminuria status.

Results:

The prevalence of chronic kidney disease during the period 2007–2009 was 12.5%, representing about 3 million Canadian adults. The estimated prevalence of stage 3–5 disease was 3.1% (0.73 million adults) and albuminuria 10.3% (2.4 million adults). The prevalence of diabetes, hypertension and hypertriglyceridemia were all significantly higher among adults with chronic kidney disease than among those without it. The prevalence of albuminuria was high, even among those whose eGFR was 90 mL/min per 1.73 m² or greater (10.1%) and those without diabetes or hypertension (9.3%). Awareness of kidney dysfunction among adults with stage 3–5 chronic kidney disease was low (12.0%).

Interpretation:

The prevalence of kidney dysfunction was substantial in the survey population, including individuals without hypertension or diabetes, conditions most likely to prompt screening for kidney dysfunction. These findings highlight the potential for missed opportunities for early intervention and secondary prevention of chronic kidney disease.Chronic kidney disease is defined as the presence of kidney damage or reduced kidney function for more than 3 months and requires either a measured or estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m², or the presence of abnormalities in urine sediment, renal imaging or biopsy results.¹ Between 1.3 million and 2.9 million Canadians are estimated to have chronic kidney disease, based on an extrapolation of the prevalence of end-stage renal disease.² In the United States, the 1999–2004 National Health and Nutrition Examination Survey reported a prevalence of 5.0% for stage 1 and 2 disease and 8.1% for stage 3 and 4 disease.^3,4Chronic kidney disease has been identified as a risk factor for death and cardiovascular-related morbidity and is a substantial burden on the health care system.^1,5 Hemodialysis costs the Canadian health care system about $60 000 per patient per year of treatment.¹ The increasing prevalence of chronic kidney disease can be attributed in part to the growing elderly population and to increasing rates of diabetes and hypertension.^1,6,7Albuminuria, which can result from abnormal vascular permeability, atherosclerosis or renal disease, has gained recognition as an independent risk factor for progressive renal dysfunction and adverse cardiovascular outcomes.^8–10 In earlier stages of chronic kidney disease, albuminuria has been shown to be more predictive of renal and cardiovascular events than eGFR.^4,9 This has prompted the call for a new risk stratification for cardiovascular outcomes based on both eGFR and albuminuria.¹¹A recent review advocated screening people for chronic kidney disease if they have hypertension, diabetes, clinically evident cardiovascular disease or a family history of kidney failure or are more than 60 years old.⁴ The Canadian Society of Nephrology published guidelines on the management of chronic kidney disease but did not offer guidance on screening.¹ The Canadian Diabetes Association recommends annual screening with the use of an albumin:creatinine ratio,¹² and the Canadian Hypertension Education Program guideline recommends urinalysis as part of the initial assessment of hypertension.¹³ Screening for chronic kidney disease on the basis of eGFR and albuminuria is not considered to be cost-effective in the general population, among older people or among people with hypertension.¹⁴The objective of our study was to use direct measures (biomarkers) of kidney function to generate nationally representative, population-based prevalence estimates of chronic kidney disease among Canadian adults overall and in clinically relevant groups.     

Naturopathic medicine for the prevention of cardiovascular disease: a randomized clinical trial

Background:Although cardiovascular disease may be partially preventable through dietary and lifestyle-based interventions, few individuals at risk receive intensive dietary and lifestyle counselling. We performed a randomized controlled trial to evaluate the effectiveness of naturopathic care in reducing the risk of cardiovascular disease.Methods:We performed a multisite randomized controlled trial of enhanced usual care (usual care plus biometric measurement; control) compared with enhanced usual care plus naturopathic care (hereafter called naturopathic care). Postal workers aged 25–65 years in Toronto, Vancouver and Edmonton, Canada, with an increased risk of cardiovascular disease were invited to participate. Participants in both groups received care by their family physicians. Those in the naturopathic group also received individualized care (health promotion counselling, nutritional medicine or dietary supplementation) at 7 preset times in work-site clinics by licensed naturopathic doctors. The body weight, waist circumference, lipid profile, fasting glucose levels and blood pressure of participants in both groups were measured 3 times during a 1-year period. Our primary outcomes were the 10-year risk of having a cardiovascular event (based on the Framingham risk algorithm) and the prevalence of metabolic syndrome (based on the Adult Treatment Panel III diagnostic criteria).Results:Of 246 participants randomly assigned to a study group, 207 completed the study. The characteristics of participants in both groups were similar at baseline. Compared with participants in the control group, at 52 weeks those in the naturopathic group had a reduced adjusted 10-year cardiovascular risk (control: 10.81%; naturopathic group: 7.74%; risk reduction −3.07% [95% confidence interval (CI) −4.35% to −1.78%], p < 0.001) and a lower adjusted frequency of metabolic syndrome (control group: 48.48%; naturopathic care: 31.58%; risk reduction −16.90% [95% CI −29.55% to −4.25%], p = 0.002).Interpretation:Our findings support the hypothesis that the addition of naturopathic care to enhanced usual care may reduce the risk of cardiovascular disease among those at high risk. Trial registration: ClinicalTrials.gov, no. NCT0071879.Cardiovascular disease is the second leading cause of death in Canada.¹ Observational studies, including a large international case–control study, have shown that several modifiable behavioural factors contribute to the risk of cardiovascular disease.² Metabolic syndrome, a cluster of modifiable risk factors for atherosclerotic cardiovascular disease, is strongly associated with increased risk of cardiovascular-related mortality.^3,4 Guidelines by the American Heart Association and the United States Preventive Services Task Force recommend lifestyle interventions as an important part of cardiovascular disease prevention.^5,6 Although the importance of lifestyle intervention is widely recognized, few individuals with, or at risk of, cardiovascular disease receive intensive dietary and lifestyle counselling.^7,8A variety of health care practitioners routinely deliver diet and health promotion advice to patients at risk of cardiovascular disease. Naturopathic doctors in North America are trained and regulated practitioners who emphasize this form of self-directed care. Several retrospective analyses have suggested that patients at risk of cardiovascular disease receive lifestyle counselling routinely as part of naturopathic care.^9–11 However, no rigorous studies have examined the effectiveness of these approaches. To evaluate the effectiveness of representative naturopathic approaches to reducing the risk of cardiovascular disease, we conducted a randomized clinical trial of a multimodality nutritional and physical activity intervention in a workplace setting.     

Effects of daily iron supplementation in primary-school–aged children: systematic review and meta-analysis of randomized controlled trials

Background:

Anemia is an important public health and clinical problem. Observational studies have linked iron deficiency and anemia in children with many poor outcomes, including impaired cognitive development; however, iron supplementation, a widely used preventive and therapeutic strategy, is associated with adverse effects. Primary-school–aged children are at a critical stage in intellectual development, and optimization of their cognitive performance could have long-lasting individual and population benefits. In this study, we summarize the evidence for the benefits and safety of daily iron supplementation in primary-school–aged children.

Methods:

We searched electronic databases (including MEDLINE and Embase) and other sources (July 2013) for randomized and quasi-randomized controlled trials involving daily iron supplementation in children aged 5–12 years. We combined the data using random effects meta-analysis.

Results:

We identified 16 501 studies; of these, we evaluated 76 full-text papers and included 32 studies including 7089 children. Of the included studies, 31 were conducted in low- or middle-income settings. Iron supplementation improved global cognitive scores (standardized mean difference 0.50, 95% confidence interval [CI] 0.11 to 0.90, p = 0.01), intelligence quotient among anemic children (mean difference 4.55, 95% CI 0.16 to 8.94, p = 0.04) and measures of attention and concentration. Iron supplementation also improved age-adjusted height among all children and age-adjusted weight among anemic children. Iron supplementation reduced the risk of anemia by 50% and the risk of iron deficiency by 79%. Adherence in the trial settings was generally high. Safety data were limited.

Interpretation:

Our analysis suggests that iron supplementation safely improves hematologic and nonhematologic outcomes among primary-school–aged children in low- or middle-income settings and is well-tolerated.An estimated 25% of school-aged children worldwide are anemic.¹ Iron deficiency is thought to account for about half of the global cases of anemia² and is associated with inadequate dietary iron and, in developing settings, hookworm and schistosomiasis.³ In developed settings, anemia is prevalent among disadvantaged populations, including newly arrived refugees, indigenous people⁴ and some ethnic groups (e.g., Hispanic people in the United States).^5,6 About 3% of primary-school–aged children in Canada are anemic.⁷ Programs to address anemia are constrained by concerns that iron supplements cause adverse effects, including an increased risk of infections such as malaria in endemic areas.⁸In observational studies, iron deficiency has been associated with impaired cognitive and physical development. It has been estimated that each 10 g/L decrement in hemoglobin reduces future intelligence quotient (IQ) by 1.73 points.⁹ However, observational data are susceptible to confounding,¹⁰ and a causal relation between iron deficiency and cognitive impairment has not been confirmed.¹¹ Randomized controlled trials should overcome confounding, but results of trials examining this question have not agreed.Optimizing cognitive and physical development in primary-school–aged children could have life-long benefits.¹² However, anemia-control recommendations must balance safety and efficacy. We performed a systematic review of the effects of daily iron supplementation, a commonly used strategy to combat anemia,² in primary-school–aged children. We examined cognitive, growth and hematologic outcomes and adverse effects across all settings.     

Efficacy of pain control with topical lidocaine–epinephrine–tetracaine during laceration repair with tissue adhesive in children: a randomized controlled trial

Background:

Some children feel pain during wound closures using tissue adhesives. We sought to determine whether a topically applied analgesic solution of lidocaine–epinephrine–tetracaine would decrease pain during tissue adhesive repair.

Methods:

We conducted a randomized, placebo-controlled, blinded trial involving 221 children between the ages of 3 months and 17 years. Patients were enrolled between March 2011 and January 2012 when presenting to a tertiary-care pediatric emergency department with lacerations requiring closure with tissue adhesive. Patients received either lidocaine–epinephrine–tetracaine or placebo before undergoing wound closure. Our primary outcome was the pain rating of adhesive application according to the colour Visual Analogue Scale and the Faces Pain Scale — Revised. Our secondary outcomes were physician ratings of difficulty of wound closure and wound hemostasis, in addition to their prediction as to which treatment the patient had received.

Results:

Children who received the analgesic before wound closure reported less pain (median 0.5, interquartile range [IQR] 0.25–1.50) than those who received placebo (median 1.00, IQR 0.38–2.50) as rated using the colour Visual Analogue Scale (p = 0.01) and Faces Pain Scale – Revised (median 0.00, IQR 0.00–2.00, for analgesic v. median 2.00, IQR 0.00–4.00, for placebo, p < 0.01). Patients who received the analgesic were significantly more likely to report having or to appear to have a pain-free procedure (relative risk [RR] of pain 0.54, 95% confidence interval [CI] 0.37–0.80). Complete hemostasis of the wound was also more common among patients who received lidocaine–epinephrine–tetracaine than among those who received placebo (78.2% v. 59.3%, p = 0.008).

Interpretation:

Treating minor lacerations with lidocaine–epinephrine–tetracaine before wound closure with tissue adhesive reduced ratings of pain and increased the proportion of pain-free repairs among children aged 3 months to 17 years. This low-risk intervention may benefit children with lacerations requiring tissue adhesives instead of sutures. Trial registration: ClinicalTrials.gov, no. PR 6138378804.Minor laceration repair with tissue adhesive, or “skin glue,” is common in pediatrics. Although less painful than cutaneous sutures,¹ tissue adhesives polymerize through an exothermic reaction that may cause a burning, painful sensation. Pain is dependent on the specific formulation of the adhesive used and the method of application. One study of different tissue adhesives reported 23.8%–40.5% of participants feeling a “burning sensation”,² whereas another study reported “pain” in 17.6%–44.1% of children.³ The amounts of adhesive applied, method of application and individual patient characteristics can also influence the feeling of pain.^3,4 Because tissue adhesives polymerize on contact with moisture,^4,5 poor wound hemostasis has the potential to cause premature setting of the adhesive, leading to less efficient and more painful repairs.⁶Preventing procedural pain is a high priority in pediatric care.⁷ Inadequate analgesia for pediatric procedures may result in more complicated procedures, increased pain sensitivity with future procedures⁸ and increased fear and anxiety of medical experiences persisting into adulthood.⁹ A practical method to prevent pain during laceration repairs with tissue adhesive would have a substantial benefit for children.A topically applied analgesic solution containing lidocaine–epinephrine–tetracaine with vasoconstrictive properties provides safe and effective pain control during wound repair using sutures.¹⁰ A survey of pediatric emergency fellowship directors in the United States reported that 76% of respondents use this solution or a similar solution when suturing 3-cm chin lacerations in toddlers.¹¹ However, in a hospital chart review, this solution was used in less than half of tissue adhesive repairs, the remainder receiving either local injection of anesthetic or no pain control.¹² Reluctance to use lidocaine–epinephrine–tetracaine with tissue adhesive may be due to the perception that it is not worth the minimum 20-minute wait required for the analgesic to take effect¹³ or to a lack of awareness that tissue adhesives can cause pain.We sought to investigate whether preapplying lidocaine–epinephrine–tetracaine would decrease pain in children during minor laceration repair using tissue adhesive.