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1.  Diabetic status and the relation of the three domains of glycemic control to mortality in critically ill patients: an international multicenter cohort study 
Critical Care  2013;17(2):R37.
Introduction
Hyperglycemia, hypoglycemia, and increased glycemic variability have each been independently associated with increased risk of mortality in critically ill patients. The role of diabetic status on modulating the relation of these three domains of glycemic control with mortality remains uncertain. The purpose of this investigation was to determine how diabetic status affects the relation of hyperglycemia, hypoglycemia, and increased glycemic variability with the risk of mortality in critically ill patients.
Methods
This is a retrospective analysis of prospectively collected data involving 44,964 patients admitted to 23 intensive care units (ICUs) from nine countries, between February 2001 and May 2012. We analyzed mean blood glucose concentration (BG), coefficient of variation (CV), and minimal BG and created multivariable models to analyze their independent association with mortality. Patients were stratified according to the diagnosis of diabetes.
Results
Among patients without diabetes, mean BG bands between 80 and 140 mg/dl were independently associated with decreased risk of mortality, and mean BG bands >140 mg/dl, with increased risk of mortality. Among patients with diabetes, mean BG from 80 to 110 mg/dl was associated with increased risk of mortality and mean BG from 110 to 180 mg/dl with decreased risk of mortality. An effect of center was noted on the relation between mean BG and mortality. Hypoglycemia, defined as minimum BG <70 mg/dl, was independently associated with increased risk of mortality among patients with and without diabetes and increased glycemic variability, defined as CV >20%, was independently associated with increased risk of mortality only among patients without diabetes. Derangements of more than one domain of glycemic control had a cumulative association with mortality, especially for patients without diabetes.
Conclusions
Although hyperglycemia, hypoglycemia, and increased glycemic variability is each independently associated with mortality in critically ill patients, diabetic status modulates these relations in clinically important ways. Our findings suggest that patients with diabetes may benefit from higher glucose target ranges than will those without diabetes. Additionally, hypoglycemia is independently associated with increased risk of mortality regardless of the patient's diabetic status, and increased glycemic variability is independently associated with increased risk of mortality among patients without diabetes.
See related commentary by Krinsley, http://ccforum.com/content/17/2/131
See related commentary by Finfer and Billot, http://ccforum.com/content/17/2/134
doi:10.1186/cc12547
PMCID: PMC3733432  PMID: 23452622
2.  Enhancing breast milk production with Domperidone in mothers of preterm neonates (EMPOWER trial) 
Background
The use of mother’s own breast milk during initial hospitalization has a positive impact not only in reducing potential serious neonatal morbidities but also contribute to improvements in neurodevelopmental outcomes. Mothers of very preterm infants struggle to maintain a supply of breast milk during their infants’ prolonged hospitalization. Galactogogues are medications that induce lactation by exerting its effects through oxytocin or prolactin enhancement. Domperidone is a potent dopamine D2 receptor antagonist which stimulates the release of prolactin. Small trials have established its ability in enhancing breast milk production. EMPOWER was designed to determine the safety and efficacy of domperidone in mothers experiencing an inadequate milk supply.
Methods/design
EMPOWER is a multicenter, double masked, randomized controlled phase-II trial to evaluate the safety and effectiveness of domperidone in those mothers identified as having difficulty in breast milk production. Eligible mothers will be randomized to one of two allocated groups: Group A: domperidone 10 mg orally three times daily for 28 days; and Group B: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days. The primary outcome will be determined at the completion of the first 2-week period; the second 2-week period will facilitate answering the secondary questions regarding timing and duration of treatment. To detect an estimated 30% change between the two groups (from 40% to 28%, corresponding to an odds ratio of 0.6), a total sample size of 488 mothers would be required at 80% power and alpha = 0.05. To account for a 15% dropout, this number is increased to 560 (280 per group). The duration of the trial is expected to be 36–40 months.
Discussion
The use of a galactogogue often becomes the measure of choice for mothers in the presence of insufficient breast milk production, particularly when the other techniques are unsuccessful. EMPOWER is designed to provide valuable information in guiding the practices for this high-risk group of infants and mothers. The results of this trial will also inform both mothers and clinicians about the choices available to increase and maintain sufficient breast milk.
Trial registration
Clinical Trials.gov Identifier: NCT01512225
doi:10.1186/1471-2393-12-87
PMCID: PMC3532128  PMID: 22935052
Domperidone; Galactogogues; Mothers of preterm infants; Breast milk
3.  Emergency department length of stay for patients requiring mechanical ventilation: a prospective observational study 
Background
Recommendations for acceptable emergency department (ED) length of stay (LOS) vary internationally with ≤ 8 h generally considered acceptable. Protracted ED LOS may place critically ill patients requiring mechanical ventilation at increased risk of adverse events as most EDs are not resourced for longitudinal delivery of critical care. Our objective was to quantify the ED LOS for mechanically ventilated patients (invasive and/or non-invasive ventilation [NIV]) and to explore patient and system level predictors of prolonged ED LOS. Additionally, we aimed to describe delivery and monitoring of ventilation in the ED.
Methods
Prospective observational study of ED LOS for all patients receiving mechanical ventilation at four metropolitan EDs in Toronto, Canada over two six-month periods in 2009 and 2010.
Results
We identified 618 mechanically ventilated patients which represented 0.5% (95% CI 0.4%–0.5%) of all ED visits. Of these, 484 (78.3%) received invasive ventilation, 118 (19.1%) received NIV; 16 received both during the ED stay. Median Kaplan-Meier estimated duration of ED stay for all patients was 6.4 h (IQR 2.8–14.6). Patients with trauma diagnoses had a shorter median (IQR) LOS, 2.5 h (1.3–5.1), compared to ventilated patients with non-trauma diagnoses, 8.5 h (3.3–14.0) (p <0.001). Patients requiring NIV had a longer ED stay (16.6 h, 8.2–27.9) compared to those receiving invasive ventilation exclusively (4.6 h, 2.2–11.1) and patients receiving both (15.4 h, 6.4–32.6) (p <0.001). Longer ED LOS was associated with ED site and lower priority triage scores. Shorter ED LOS was associated with intubation at another ED prior to transfer.
Conclusions
While patients requiring mechanical ventilation represent a small proportion of overall ED visits these critically ill patients frequently experienced prolonged ED stay especially those treated with NIV, assigned lower priority triage scores at ED presentation, and non-trauma patients.
doi:10.1186/1757-7241-20-30
PMCID: PMC3466156  PMID: 22494785
Mechanical ventilation; Emergency department; Non-invasive ventilation, critical illness; Acute respiratory failure
4.  Genetic predictors of response to treatment with citalopram in depression secondary to traumatic brain injury 
Brain injury : [BI]  2010;24(7-8):959-969.
Objectives
To determine which serotonergic system-related single nucleotide polymorphisms (SNPs) predicted variation in treatment response to citalopram in depression following a traumatic brain injury (TBI).
Methods
Ninety (50 M/40 F, aged 39.9, SD = 18.0 years) post-TBI patients with a major depressive episode (MDE) were recruited into a 6-week open-label study of citalopram (20 mg/day). Six functional SNPs in genes related to the serotonergic system were examined: serotonin transporter (5HTTLPR including rs25531), 5HT1A C-(1019)G and 5HT2A T-(102)C, methylene tetrahydrofolate reductase (MTHFR) C-(677)T, brain-derived neurotrophic factor (BDNF) val66met and tryptophan hydroxylase-2 (TPH2) G-(703)T. Regression analyses were performed using the six SNPs as independent variables: Model 1 with response (percentage Hamilton Depression (HAMD) change from baseline to endpoint) as the dependent variable and Model 2 with adverse event index as the dependent variable (Bonferroni corrected p-value <0.025).
Results
MTHFR and BDNF SNPs predicted greater treatment response (R2= 0.098, F = 4.65, p = 0.013). The 5HTTLPR predicted greater occurrence of adverse events (R2= 0.069, F = 5.72, p = 0.020).
Conclusion
Results suggest that polymorphisms in genes related to the serotonergic system may help predict short-term response to citalopram and tolerability to the medication in patients with MDE following a TBI.
doi:10.3109/02699051003789229
PMCID: PMC3142269  PMID: 20515362 CAMSID: cams1807
Traumatic brain injury; serotonin receptors; serotonin transporter; brain derived neurotrophic factor (BDNF); methylenetetrahydrofolate reductase (MTHFR); tryptophan hydroxylase (TPH)
5.  Anxiety As a Predictor of Treatment Outcome in Children and Adolescents with Depression 
Abstract
Objective
The aim of this study was to examine the impact of co-morbid illnesses on treatment outcomes in depressed children and adolescents aged 7–17 who were treated with fluoxetine.
Method
This data set was drawn from two large clinical trials involving children and adolescents with depression. Subjects with a diagnosis of major depressive disorder and depressive symptoms of at least moderate severity as defined by a Children's Depression Rating Score, Revised (CDRS-R) total score ≥40 and a Clinical Global Impressions–Severity (CGI-S) rating ≥4 were included. Subjects were randomized to receive fluoxetine or placebo over an 8-week period. Predictor analyses examining two primary outcomes were conducted: (1) Response based on Clinical Global Impressions–Improvement (CGI-I) score of 1 or 2, and (2) remission based on CDRS-R score of ≤28. Logistic regression models were run to assess whether anxiety disorders were a predictor of response or remission.
Result
A total of 309 study participants were included. The only factor found to influence response was treatment with fluoxetine (p = 0.022, odds ratio [OR] = 2.08, 95% confidence interval [CI] 1.30, 3.31). Several factors were found to influence remission: Treatment with fluoxetine (p < 0.0001, OR = 3.17, 95% CI 1.80, 5.57), gender (p = 0.024, OR = 1.90, 95% CI 1.09, 3.30), and number of co-morbid diagnoses (p = 0.026, OR 0.73, 95% CI 0.55, 0.96).
Conclusion
Anxiety disorders alone did not predict response or remission, but the total number of co-morbid illnesses was associated with remission in depressed children and adolescents treated with fluoxetine.
doi:10.1089/cap.2010.0006
PMCID: PMC2936256  PMID: 20578934
6.  Informed decision-making in elective major vascular surgery: analysis of 145 surgeon–patient consultations 
Canadian Journal of Surgery  2011;54(3):173-178.
Background
Prior studies show significant gaps in the informed decision-making process, a central goal of surgical care. These studies have been limited by their focus on low-risk decisions, single visits rather than entire consultations, or both. Our objectives were, first, to rate informed decision-making for major elective vascular surgery based on audiotapes of actual physician–patient conversations and, second, to compare ratings of informed decision-making for first visits to ratings for multiple visits by the same patient over time.
Methods
We prospectively enrolled patients for whom vascular surgical treatment was a potential option at a tertiary care outpatient vascular surgery clinic. We audio-taped all surgeon–patient conversations, including multiple visits when necessary, until a decision was made. Using an existing method, we evaluated the transcripts for elements of decision-making, including basic elements (e.g., an explanation of the clinical condition), intermediate elements (e.g., risks and benefits) and complex elements (e.g., uncertainty around the decision).
Results
We analyzed 145 surgeon–patient consultations. Overall, 45% of consultations contained complex elements, whereas 23% did not contain the basic elements of decision-making. For the 67 consultations that involved multiple visits, ratings were significantly higher when evaluating all visits (50% complex elements) compared with evaluating only the first visit (33% complex elements, p < 0.001.)
Conclusion
We found that 45% of consultations contained complex elements, which is higher than prior studies with similar methods. Analyzing decision-making over multiple visits yielded different results than analyzing decision-making for single visits.
doi:10.1503/cjs.047709
PMCID: PMC3104311  PMID: 21443835
7.  Feedback GAP: study protocol for a cluster-randomized trial of goal setting and action plans to increase the effectiveness of audit and feedback interventions in primary care 
Background
Audit and feedback to physicians is commonly used alone or as part of multifaceted interventions. While it can play an important role in quality improvement, the optimal design of audit and feedback is unknown. This study explores how feedback can be improved to increase acceptability and usability in primary care. The trial seeks to determine whether a theory-informed worksheet appended to feedback reports can help family physicians improve quality of care for their patients with diabetes and/or ischemic heart disease.
Methods
Two-arm cluster trial was conducted with participating primary care practices allocated using minimization to simple feedback or enhanced feedback group. The simple feedback group receives performance feedback reports every six months for two years regarding the proportion of their patients with diabetes and/or ischemic heart disease who are meeting quality targets. The enhanced feedback group receives these same reports as well as a theory-informed worksheet designed to facilitate goal setting and action plan development in response to the feedback reports. Participants are family physicians from across Ontario who use electronic medical records; data for rostered patients are used to produce the feedback reports and for analysis.
Outcomes
The primary disease outcomes are the blood pressure (BP), and low-density lipoprotein cholesterol (LDL) levels. The primary process measure is a composite score indicating the number of recommended activities (e.g., tests and prescriptions) conducted by the family physicians for their patients with diabetes and/or ischemic heart disease within the appropriate timeframe. Secondary outcomes are the proportion of patients whose results meet targets for glucose, LDL, and BP as well as the percent of patients receiving relevant prescriptions. A qualitative process evaluation using semi-structured interviews will explore perceived barriers to behaviour change in response to feedback reports and preferences with regard to feedback design.
Analysis
Intention-to-treat approach will be used to analyze the trial. Analysis will be performed on patient-level variables using generalized estimating equation models to adjust for covariates and account for the clustered nature of the data. The trial is powered to show small, but clinically important differences of 7 mmHG in systolic BP and 0.32 mmol/L in LDL.
Trial Registration
ClinicalTrials.gov NCT00996645
doi:10.1186/1748-5908-5-98
PMCID: PMC3161381  PMID: 21167034
8.  Pan-Canadian Evaluation of Irreversible Compression Ratios (“Lossy” Compression) for Development of National Guidelines 
New technological advancements including multislice CT scanners and functional MRI, have dramatically increased the size and number of digital images generated by medical imaging departments. Despite the fact that the cost of storage is dropping, the savings are largely surpassed by the increasing volume of data being generated. While local area network bandwidth within a hospital is adequate for timely access to imaging data, efficiently moving the data between institutions requires wide area network bandwidth, which has a limited availability at a national level. A solution to address those issues is the use of lossy compression as long as there is no loss of relevant information. The goal of this study was to determine levels at which lossy compression can be confidently used in diagnostic imaging applications. In order to provide a fair assessment of existing compression tools, we tested and compared the two most commonly adopted DISCOM compression algorithms: JPEG and JPEG-2000. We conducted an extensive pan-Canadian evaluation of lossy compression applied to seven anatomical areas and five modalities using two recognized techniques: objective methods or diagnostic accuracy and subjective assessment based on Just Noticeable Difference. By incorporating both diagnostic accuracy and subjective evaluation techniques, enabled us to define a range of compression for each modality and body part tested. The results of our study suggest that at low levels of compression, there was no significant difference between the performance of lossy JPEG and lossy JPEG 2000, and that they are both appropriate to use for reporting on medical images. At higher levels, lossy JPEG proved to be more effective than JPEG 2000 in some cases, mainly neuro CT. More evaluation is required to assess the effect of compression on thin slice CT. We provide a table of recommended compression ratios for each modality and anatomical area investigated, to be integrated in the Canadian Association of Radiologists standard for the use of lossy compression in medical imaging.
doi:10.1007/s10278-008-9139-7
PMCID: PMC3043739  PMID: 18931879
Compression; JPEG2000; digital imaging; lossy compression; JPEG
9.  The health of homeless immigrants 
Background
This study examined the association between immigrant status and current health in a representative sample of 1,189 homeless people in Toronto, Canada.
Methods
Multivariate regression analyses were performed to examine the relationship between immigrant status and current health status (assessed using the SF-12) among homeless recent immigrants (≤10 years since immigration), non-recent immigrants (>10 years since immigration), and Canadian-born individuals recruited at shelters and meal programs (response rate 73%).
Results
After adjusting for demographic characteristics and lifetime duration of homelessness, recent immigrants were significantly less likely to have chronic conditions (RR 0.7, 95% CI 0.5 to 0.9), mental health problems (OR 0.4, 95% CI 0.2 to 0.7), alcohol problems (OR 0.2, 95% CI 0.1 to 0.5), and drug problems (OR 0.2, 95% CI 0.1 to 0.4) compared to non-recent immigrants and Canadian-born individuals. Recent immigrants were also more likely to have better mental health status (+3.4 points, SE ±1.6) and physical health status (+2.2 points, SE ±1.3) on scales with a mean of 50 and a standard deviation of 10 in the general population.
Conclusion
Homeless recent immigrants are a distinct group who are generally healthier and may have very different service needs compared to other homeless people.
doi:10.1136/jech.2009.088468
PMCID: PMC2773541  PMID: 19654122
homelessness; migration and health
10.  Multidimensional Social Support and the Health of Homeless Individuals 
Homeless individuals often suffer from serious health problems. It has been argued that the homeless are socially isolated, with low levels of social support and social functioning, and that this lack of social resources contributes to their ill health. These observations suggest the need to further explore the relationship between social networks, social support, and health among persons who are homeless. The purpose of this study was to examine the association between multidimensional (cognitive/perceived and behavioral/received) social support and health outcomes, including physical health status, mental health status, and recent victimization, among a representative sample of homeless individuals in Toronto, Canada. Multivariate regression analyses were performed on social support and health outcome data from a subsample of 544 homeless adults, recruited from shelters and meal programs through multistage cluster sampling procedures. Results indicated that participants perceived moderately high levels of access to financial, emotional, and instrumental social support in their social networks. These types of perceived social supports were related to better physical and mental health status and lower likelihood of victimization. These findings highlight a need for more services that encourage the integration of homeless individuals into social networks and the building of specific types of social support within networks, in addition to more research into social support and other social contextual factors (e.g., social capital) and their influence on the health of homeless individuals.
doi:10.1007/s11524-009-9388-x
PMCID: PMC2729873  PMID: 19629703
Homelessness; Social support; Physical health; Mental health; Victimization; Canada
11.  Drug problems among homeless individuals in Toronto, Canada: prevalence, drugs of choice, and relation to health status 
BMC Public Health  2010;10:94.
Background
Drug use is believed to be an important factor contributing to the poor health and increased mortality risk that has been widely observed among homeless individuals. The objective of this study was to determine the prevalence and characteristics of drug use among a representative sample of homeless individuals and to examine the association between drug problems and physical and mental health status.
Methods
Recruitment of 603 single men, 304 single women, and 284 adults with dependent children occurred at homeless shelters and meal programs in Toronto, Canada. Information was collected on demographic characteristics and patterns of drug use. The Addiction Severity Index was used to assess whether participants suffered from drug problems. Associations of drug problems with physical and mental health status (measured by the SF-12 scale) were examined using regression analyses.
Results
Forty percent of the study sample had drug problems in the last 30 days. These individuals were more likely to be single men and less educated than those without drug problems. They were also more likely to have become homeless at a younger age (mean 24.8 vs. 30.9 years) and for a longer duration (mean 4.8 vs. 2.9 years). Marijuana and cocaine were the most frequently used drugs in the past two years (40% and 27%, respectively). Drug problems within the last 30 days were associated with significantly poorer mental health status (-4.9 points, 95% CI -6.5 to -3.2) but not with poorer physical health status (-0.03 points, 95% CI -1.3 to 1.3)).
Conclusions
Drug use is common among homeless individuals in Toronto. Current drug problems are associated with poorer mental health status but not with poorer physical health status.
doi:10.1186/1471-2458-10-94
PMCID: PMC2841106  PMID: 20181248
12.  The Toronto prehospital hypertonic resuscitation-head injury and multi organ dysfunction trial (TOPHR HIT) - Methods and data collection tools 
Trials  2009;10:105.
Background
Clinical trials evaluating the use of hypertonic saline in the treatment of hypovolemia and head trauma suggest no survival superiority over normal saline; however subgroup analyses suggest there may be a reduction in the inflammatory response and multiorgan failure which may lead to better survival and enhanced neurocognitive function. We describe a feasibility study of randomizing head injured patients to hypertonic saline and dextran vs. normal saline administration in the out of hospital setting.
Methods/Design
This feasibility study employs a randomized, placebo-controlled design evaluating normal saline compared with a single dose of 250 ml of 7.5% hypertonic saline in 6% dextran 70 in the management of traumatic brain injuries. The primary feasibility endpoints of the trial were: 1) baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial, 2) randomization compliance rate, 3) ease of protocol implementation in the out-of-hospital setting, and 4) adverse event rate of HSD infusion.
The secondary objectives include measuring the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulating the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome and clinical response to HSD intervention; evaluating effects of HSD on brain atrophy post-injury and neurocognitive and neuropsychological outcomes.
Discussion
We anticipate three aspects of the trial will present challenges to trial success; ethical demands associated with a waiver of consent trial, challenging follow up and comprehensive accurate timely data collection of patient identifiers and clinical or laboratory values. In addition all the data collection tools had to be derived de novo as none existed in the literature.
Trial registration number
NCT00878631
doi:10.1186/1745-6215-10-105
PMCID: PMC2788534  PMID: 19930566
13.  DreamTel; Diabetes risk evaluation and management tele-monitoring study protocol 
Background
The rising prevalence of type 2 diabetes underlines the importance of secondary strategies for the prevention of target organ damage. While access to diabetes education centers and diabetes intensification management has been shown to improve blood glucose control, these services are not available to all that require them, particularly in rural and northern areas. The provision of these services through the Home Care team is an advance that can overcome these barriers. Transfer of blood glucose data electronically from the home to the health care provider may improve diabetes management.
Methods and design
The study population will consist of patients with type 2 diabetes with uncontrolled A1c levels living on reserve in the Battlefords region of Saskatchewan, Canada. This pilot study will take place over three phases. In the first phase over three months the impact of the introduction of the Bluetooth enabled glucose monitor will be assessed. In the second phase over three months, the development of guidelines based treatment algorithms for diabetes intensification will be completed. In the third phase lasting 18 months, study subjects will have diabetes intensification according to the algorithms developed.
Discussion
The first phase will determine if the use of the Bluetooth enabled blood glucose devices which can transmit results electronically will lead to changes in A1c levels. It will also determine the feasibility of recruiting subjects to use this technology. The rest of the Diabetes Risk Evaluation and Management Tele-monitoring (DreamTel) study will determine if the delivery of a diabetes intensification management program by the Home Care team supported by the Bluetooth enabled glucose meters leads to improvements in diabetes management.
Trial Registration
Protocol NCT00325624
doi:10.1186/1472-6823-9-13
PMCID: PMC2689225  PMID: 19426530
14.  Homelessness and the Response to Emerging Infectious Disease Outbreaks: Lessons from SARS 
Journal of Urban Health   2008;85(3):402-410.
During the 2003 severe acute respiratory syndrome (SARS) outbreak in Toronto, the potential introduction of SARS into the homeless population was a serious concern. Although no homeless individual in Toronto contracted SARS, the outbreak highlighted the need to develop an outbreak preparedness plan that accounts for unique issues related to homeless people. We conducted key informant interviews with homeless service providers and public health officials (n = 17) and identified challenges specific to the homeless population in the areas of communication, infection control, isolation and quarantine, and resource allocation. Planning for future outbreaks should take into account the need to (1) develop systems that enable rapid two-way communication between public health officials and homeless service providers, (2) ensure that homeless service providers have access to infection control supplies and staff training, (3) prepare for possible homeless shelter closures due to staff shortages or high attack rates among clients, and (4) plan for where and how clinically ill homeless individuals will be isolated and treated. The Toronto SARS experience provided insights that are relevant to response planning for future outbreaks in cities with substantial numbers of homeless individuals.
doi:10.1007/s11524-008-9270-2
PMCID: PMC2329752  PMID: 18347991
Contact tracing; Disease outbreaks; Homeless persons; Human; Influenza; Patient isolation; Quarantine; Severe acute respiratory syndrome.
15.  Heart and Stroke Foundation of Ontario (HSFO) high blood pressure strategy's hypertension management initiative study protocol 
Background
Achieving control of hypertension prevents target organ damage at both the micro and macrovascular level and is a highly cost effective means of lowering the risk for heart attack and stroke particularly in people with diabetes. Clinical trials demonstrate that blood pressure control can be achieved in a large proportion of people. Translating this knowledge into widespread practice is the focus of the Hypertension Management Initiative, which began in 2004 with the goal of improving the management of this chronic health condition by primary care providers and patients in the community.
Methods
This study will test the effect of a systems change on the management of high blood pressure in real world practice in primary care in Ontario, Canada. The systems change intervention involves an interprofessional educational program bringing together physicians, nurses and pharmacists with tools for both providers and patients to facilitate blood pressure management. Each of two waves of subjects were enrolled over a 6 month period with the initial enrollment between waves separated by 9 months. Blood pressure will be measured with the BpTru ® automated blood pressure device. To determine the effectiveness of the intervention, a before and after analysis within all subjects will compare blood pressure at baseline to annual measurements for the three year study. To assess whether the intervention has an impact on blood pressure control independent of community trends, a betwen group comparison of baseline blood pressures in the delayed wave will be made with the immediate wave during the same time period, so that the immediate wave has experienced the intervention for at least 9 months. The total enrollment goal is 5,000 subjects. The practice locations include 10 Family Health Teams (FHTs) and 1 Community Health Centre (CHC) and approximately 49 primary care physicians, 15 nurse practitioners, 37 registered nurses and over 150 community pharmacists across the 11 communities throughout the province of Ontario. The 11 primary care sites will be divided into immediate and delayed groups based on geography and the use of an electronic versus a traditional chart patient record.
Discussion
Initial consideration was given to randomizing the groups, however, for a number of reasons, this was deemed to not be possible. In order to ensure that the sites in the immediate intervention and delayed intervention groups are not different from each other, the sites will be assigned to the intervention groups manually to ensure a distribution of the variables as evenly as possible.
Given that HSFO approached this particular group of health care providers to participate in a program relating to hypertension, this may have heightened their awareness of the issue and affected their management of patients with hypertension. Thus, data will be collected to allow an assessment of previous practice patterns and determine any impact of the Hawthorne Effect.
Trial registration
Clinicaltrials.gov NCT00425828
doi:10.1186/1472-6963-8-251
PMCID: PMC2627848  PMID: 19068141
16.  The effect of traumatic brain injury on the health of homeless people 
Background
We sought to determine the lifetime prevalence of traumatic brain injury and its association with current health conditions in a representative sample of homeless people in Toronto, Ontario.
Methods
We surveyed 601 men and 303 women at homeless shelters and meal programs in 2004–2005 (response rate 76%). We defined traumatic brain injury as any self-reported head injury that left the person dazed, confused, disoriented or unconscious. Injuries resulting in unconsciousness lasting 30 minutes or longer were defined as moderate or severe. We assessed mental health, alcohol and drug problems in the past 30 days using the Addiction Severity Index. Physical and mental health status was assessed using the SF-12 health survey. We examined associations between traumatic brain injury and health conditions.
Results
The lifetime prevalence among homeless participants was 53% for any traumatic brain injury and 12% for moderate or severe traumatic brain injury. For 70% of respondents, their first traumatic brain injury occurred before the onset of homelessness. After adjustment for demographic characteristics and lifetime duration of homelessness, a history of moderate or severe traumatic brain injury was associated with significantly increased likelihood of seizures (odds ratio [OR] 3.2, 95% confidence interval [CI] 1.8 to 5.6), mental health problems (OR 2.5, 95% CI 1.5 to 4.1), drug problems (OR 1.6, 95% CI 1.1 to 2.5), poorer physical health status (–8.3 points, 95% CI –11.1 to –5.5) and poorer mental health status (–6.0 points, 95% CI –8.3 to –3.7).
Interpretation
Prior traumatic brain injury is very common among homeless people and is associated with poorer health.
doi:10.1503/cmaj.080341
PMCID: PMC2553875  PMID: 18838453
17.  A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting 
Trials  2007;8:28.
Background
Medication errors, adverse drug events and potential adverse drug events are common and serious in terms of the harms and costs that they impose on the health system and those who use it. Errors resulting in preventable adverse drug events have been shown to occur most often at the stages of ordering and administration. This paper describes the protocol for a pragmatic trial of electronic prescribing to reduce prescription error. The trial was designed to overcome the limitations associated with traditional study design.
Design
This study was designed as a 65-week, cluster randomized, parallel study.
Methods
The trial was conducted within ambulatory outpatient clinics in an academic tertiary care centre in Ontario, Canada. The electronic prescribing software for the study is a Canadian electronic prescribing software package which provides physician prescription entry with decision support at the point of care. Using a handheld computer (PDA) the physician selects medications using an error minimising menu-based pick list from a comprehensive drug database, create specific prescription instructions and then transmit the prescription directly and electronically to a participating pharmacy via facsimile or to the physician's printer using local area wireless technology. The unit of allocation and randomization is by 'week', i.e. the system is "on" or "off" according to the randomization scheme and the unit of analysis is the prescription, with adjustment for clustering of patients within practitioners.
Discussion
This paper describes the protocol for a pragmatic cluster randomized trial of point-of-care electronic prescribing, which was specifically designed to overcome the limitations associated with traditional study design.
Trial Registration
This trial has been registered with clinicaltrials.gov (ID: NCT00252395)
doi:10.1186/1745-6215-8-28
PMCID: PMC2092426  PMID: 17915028
18.  Immediate angioplasty after thrombolysis: a systematic review 
Background
The role of immediate transfer for percutaneous coronary intervention (PCI) after thrombolysis for ST-segment elevation myocardial infarction remains controversial. We performed a systematic review of the related literature to determine whether thrombolysis followed by transfer for immediate or early PCI is safe, feasible and superior to conservative management.
Methods
A systematic literature search of MEDLINE, EMBASE, the Cochrane Database for Systematic Reviews and Cochrane Central Register of Controlled Trials, and the American Heart Association EndNote 7 Master Library databases, was performed to 2004 for relevant published studies. The level of evidence and the quality of the study design and methods were rated by 2 reviewers according to a standardized classification. A quantitative meta-analysis was performed to assess the effect at 6–12 months on mortality of immediate or early PCI after thrombolysis.
Results
We found 13 articles that were supportive of immediate or early PCI after thrombolysis and 16 that were neutral or provided evidence opposing it. The largest randomized trials and meta-analyses showed no benefit of routine PCI immediately or shortly after thrombolysis. The studies that were supportive were generally more recent and more frequently involved coronary stents. One large trial supported early PCI after thrombolysis for patients with myocardial infarction complicated by cardiogenic shock. Overall, the difference in mortality rates between the invasive strategy and conservative care was nonsignificant. The 3 stent-era trials showed a significantly lower mortality among patients randomly assigned to the invasive strategy (5.8% v. 10.0%, odds ratio 0.55, 95% confidence interval 0.32–0.92). Analysis of variance found a significant difference in treatment effect between stent-era and pre–stent-era trials.
Interpretation
At present, there is inadequate evidence to recommend routine transfer of patients for immediate or early PCI after successful thrombolysis. Results of recent trials using contemporary PCI techniques, including coronary stents, appear more favourable but need to be confirmed in large randomized trials, which are currently in progress. Transfer for immediate PCI is recommended for patients with cardiogenic shock, hemodynamic instability or persistent ischemic symptoms after thrombolysis.
doi:10.1503/cmaj.045278
PMCID: PMC1316164  PMID: 16330637

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