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1.  A knowledge translation intervention to improve tuberculosis care and outcomes in Malawi: a pragmatic cluster randomized controlled trial 
Lay health workers (LHWs) play a pivotal role in addressing the high TB burden in Malawi. LHWs report lack of training to be a key barrier to their role as TB care providers. Given the cost of traditional off-site training, an alternative approach is needed. Our objective was to evaluate the effectiveness of a KT intervention tailored to LHWs needs.
The study design is a pragmatic cluster randomized trial. The study was embedded within a larger trial, PALMPLUS, and compared three arms which included 28 health centers in Zomba district, Malawi. The control arm included 14 health centers randomized as controls in the larger trial and maintained as control sites. Seven of 14 PALMPLUS intervention sites were randomized to the LHW intervention (PALM/LHW intervention arm), and the remaining 7 PALMPLUS sites maintained as a PALM only arm. PALMPLUS intervention sites received an educational outreach program targeting mid-level health workers. LHW intervention sites received both the PALMPLUS intervention and the LHW intervention employing on-site peer-led educational outreach and a point-of-care tool tailored to LHWs identified needs. Control sites received no intervention. The main outcome measure is the proportion of treatment successes.
Among the 28 sites, there were 178 incident TB cases with 46/80 (0.58) successes in the control group, 44/68 (0.65) successes in the PALMPLUS group, and 21/30 (0.70) successes in the PALM/LHW intervention group. There was no significant effect of the intervention on treatment success in the univariate analysis adjusted for cluster randomization (p = 0.578) or multivariate analysis controlling for covariates with significant model effects (p = 0.760). The overall test of the intervention-arm by TB-type interaction approached but did not achieve significance (p = 0.056), with the interaction significant only in the control arm [RR of treatment success for pulmonary TB relative to non-pulmonary TB, 1.18, 95% CI 1.05–1.31].
We found no significant treatment effect of our intervention. Given the identified trend for effectiveness and urgent need for low-cost approaches to LHW training, further evaluation of tailored KT strategies as a means of LHW training in Malawi and other LMICs is warranted.
Trial registration NCT01356095.
PMCID: PMC4437452  PMID: 25890186
Lay health workers; Community health workers; Educational outreach; Reminders; TB; Cluster randomized trial
2.  Factors associated with physician follow-up among patients with chest pain discharged from the emergency department 
Many patients with chest pain do not receive follow-up from a physician after discharge from the emergency department despite significant survival benefit associated with follow-up care. Our objective was to evaluate factors associated with physician follow-up to understand this gap in practice.
We conducted an observational study involving patients at high risk who were assessed for chest pain and discharged from an emergency department in Ontario between April 2004 and March 2010. We used multivariable logistic regression to determine the association of clinical and nonclinical characteristics with physician follow-up.
We identified 56 767 patients, of whom 25.1% did not receive any follow-up by a physician, 69.0% were seen by their primary care physician, and 17.3% were seen by a cardiologist within 30 days. Patients who had medical comorbidities and cardiac conditions such as myocardial infarction or heart failure were less likely to have follow-up. In contrast, a previous visit to a primary care physician was associated with the highest odds of having physician follow-up (odds ratio [OR] 6.44, 95% confidence interval [CI] 5.91–7.01). Similarly, a previous visit to a cardiologist was strongly associated with follow-up by a cardiologist (OR 3.01, 95% CI 2.85–3.17). Patients evaluated in emergency departments with the highest tertile of chest pain volume were more likely to receive follow-up from any physician (OR 1.52, 95% CI 1.31–1.77) and from a cardiologist (OR 2.04, 95% CI 1.61–2.57).
Nonclinical factors are strongly associated with physician follow-up for patients with chest pain after discharge from the emergency department. However, patients with comorbidities and at higher risk for future adverse events are less likely to receive follow-up care.
PMCID: PMC4361126  PMID: 25712950
4.  Outcomes in patients with heart failure treated in hospitals with varying admission rates: population-based cohort study 
BMJ Quality & Safety  2014;23(12):981-988.
Study objectives
Hospital admission rates for patients with heart failure (HF) presenting for emergency department (ED) care vary, and the implications of direct discharge home from the ED are unknown. We examined whether patients treated in hospitals with low admission rates exhibit higher rates of repeat ED visits, hospital readmissions and death.
We divided EDs into low-, medium- and high-admission-rate tertiles by their standardised HF admission rate in Ontario, Canada. Among adults (≥18 years) with HF discharged from an ED between April 2004 and March 2010, we evaluated the primary outcomes of repeat ED visits or hospitalisations for HF, and secondary outcomes, which included death, within 30 days stratified by HF admission-rate tertile.
89 878 patients with HF presented to low- (n=29 929), medium- (n=30 900) or high- (n=29 049) admission-rate institutions, with hospitalisation rates of <67%, 67–75% and >75%, respectively. Among 28 175 ED-discharged patients, the multivariable-adjusted HR for repeat ED visit or hospitalisation for HF at low-admission-rate institutions was 1.18 (95% CI 1.07 to 1.29, p<0.001) compared with high-admission institutions. Similarly, the HR for repeat ED visits for HF was 1.28 (95% CI 1.14 to 1.44, p<0.001) at low-admission hospitals. Compared with discharged patients in the high-admission-rate tertile, adjusted HR for 30-day mortality was 1.19 (95% CI 0.95 to 1.47) at low-admission-rate hospitals. The HRs for all of the above outcomes were not significantly increased at medium-admission-rate hospitals.
Patients seeking care at institutions with lower rates of HF admission showed higher rates of repeat ED visits or hospitalisations after previous ED discharge.
PMCID: PMC4255669  PMID: 25078104
Health Services Research; Emergency Department; Quality Improvement
5.  Supporting middle-cadre health care workers in Malawi: lessons learned during implementation of the PALM PLUS package 
BMC Health Services Research  2014;14(Suppl 1):S8.
The government of Malawi is committed to the broad rollout of antiretroviral treatment in Malawi in the public health sector; however one of the primary challenges has been the shortage of trained health care workers. The Practical Approach to Lung Health Plus HIV/AIDS in Malawi (PALM PLUS) package is an innovative guideline and training intervention that supports primary care middle-cadre health care workers to provide front-line integrated primary care. The purpose of this paper is to describe the lessons learned in implementing the PALM PLUS package.
A clinical tool, based on algorithm- and symptom-based guidelines was adapted to the Malawian context. An accompanying training program based on educational outreach principles was developed and a cascade training approach was used for implementation of the PALM PLUS package in 30 health centres, targeting clinical officers, medical assistants, and nurses. Lessons learned were identified during program implementation through engagement with collaborating partners and program participants and review of program evaluation findings.
Key lessons learned for successful program implementation of the PALM PLUS package include the importance of building networks for peer-based support, ensuring adequate training capacity, making linkages with continuing professional development accreditation and providing modest in-service training budgets. The main limiting factors to implementation were turnover of staff and desire for financial training allowances.
The PALM PLUS approach is a potential model for supporting mid-level health care workers to provide front-line integrated primary care in low and middle income countries, and may be useful for future task-shifting initiatives.
PMCID: PMC4108880  PMID: 25080192
training; educational outreach; task-shifting; continuing professional development; antiretroviral treatment; integrated primary care; nurses; clinical officers; medical assistants; health surveillance assistants; guideline; train-the-trainer; south-south collaboration; formation; sensibilisation; délégation de tâches; formation continue; soins primaires intégrés; personnel infirmier; personnel clinique; auxiliaires médicaux; adjoints à la surveillance sanitaire; lignes directrices; formation des formateurs; collaboration Sud-Sud
6.  Wait times in the emergency department for patients with mental illness 
It has been suggested that patients with mental illness wait longer for care than other patients in the emergency department. We determined wait times for patients with and without mental health diagnoses during crowded and noncrowded periods in the emergency department.
We conducted a population-based retrospective cohort analysis of adults seen in 155 emergency departments in Ontario between April 2007 and March 2009. We compared wait times and triage scores for patients with mental illness to those for all other patients who presented to the emergency department during the study period.
The patients with mental illness (n = 51 381) received higher priority triage scores than other patients, regardless of crowding. The time to assessment by a physician was longer overall for patients with mental illness than for other patients (median 82, interquartile range [IQR] 41–147 min v. median 75 [IQR 36–140] min; p < 0.001). The median time from the decision to admit the patient to hospital to ward transfer was markedly shorter for patients with mental illness than for other patients (median 74 [IQR 15–215] min v. median 152 [IQR 45–605] min; p < 0.001). After adjustment for other variables, patients with mental illness waited 10 minutes longer to see a physician compared with other patients during noncrowded periods (95% confidence interval [CI] 8 to 11), but they waited significantly less time than other patients as crowding increased (mild crowding: −14 [95% CI −12 to −15] min; moderate crowding: −38 [95% CI −35 to −42] min; severe crowding: −48 [95% CI −39 to −56] min; p < 0.001).
Patients with mental illness were triaged appropriately in Ontario’s emergency departments. These patients waited less time than other patients to see a physician under crowded conditions and only slightly longer under noncrowded conditions.
PMCID: PMC3519154  PMID: 23148052
7.  The Challenge of Heart Failure Discharge from the Emergency Department 
Current Heart Failure Reports  2012;9(3):252-259.
Acute decompensated heart failure is a common reason for presentation to the emergency department and is associated with high rates of admission to hospital. Distinguishing between higher-risk patients needing hospitalization and lower-risk patients suitable for discharge home is important to optimize both cost-effectiveness and clinical outcomes. However, this can be challenging and few validated risk stratification tools currently exist to help clinicians. Some prognostic variables predict risks broadly in those who are admitted or discharged from the emergency department. Risk stratification methods such as the Emergency Heart Failure Mortality Risk Grade and Acute Heart Failure Index clinical decision support tools, which utilize many of these predictors, have been found to be accurate in identifying low-risk patients. The use of observation units may also be a cost-effective adjunctive strategy that can assist in determining disposition from the emergency department.
PMCID: PMC3406314  PMID: 22798046
Heart failure; Emergency department; Risk stratification; Hospitalization; Hospital discharge
9.  Evaluating a streamlined clinical tool and educational outreach intervention for health care workers in Malawi: the PALM PLUS case study 
Nearly 3 million people in resource-poor countries receive antiretrovirals for the treatment of HIV/AIDS, yet millions more require treatment. Key barriers to treatment scale up are shortages of trained health care workers, and challenges integrating HIV/AIDS care with primary care.
The research
PALM PLUS (Practical Approach to Lung Health and HIV/AIDS in Malawi) is an intervention designed to simplify and integrate existing Malawian national guidelines into a single, simple, user-friendly guideline for mid-level health care workers. Training utilizes a peer-to-peer educational outreach approach. Research is being undertaken to evaluate this intervention to generate evidence that will guide future decision-making for consideration of roll out in Malawi. The research consists of a cluster randomized trial in 30 public health centres in Zomba District that measures the effect of the intervention on staff satisfaction and retention, quality of patient care, and costs through quantitative, qualitative and health economics methods.
Results and outcomes
In the first phase of qualitative inquiry respondents from intervention sites demonstrated in-depth knowledge of PALM PLUS compared to those from control sites. Participants in intervention sites felt that the PALM PLUS tool empowered them to provide better health services to patients. Interim staff retention data shows that there were, on average, 3 to 4 staff departing from the control and intervention sites per month. Additional qualitative, quantitative and economic analyses are planned.
The partnership
Dignitas International and the Knowledge Translation Unit at the University of Cape Town Lung Institute have led the adaptation and development of the PALM PLUS intervention, using experience gained through the implementation of the South African precursor, PALSA PLUS. The Malawian partners, REACH Trust and the Research Unit at the Ministry of Health, have led the qualitative and economic evaluations. Dignitas and Ministry of Health have facilitated interaction with implementers and policy-makers.
Challenges and successes
This initiative is an example of South-South knowledge translation between South Africa and Malawi, mediated by a Canadian academic-NGO hybrid. Our success in developing and rolling out PALM PLUS in Malawi suggests that it is possible to adapt and implement this intervention for use in other resource-limited settings.
PMCID: PMC3247831  PMID: 22166125
10.  Prediction of Emergent Heart Failure Death by Semi-Quantitative Triage Risk Stratification 
PLoS ONE  2011;6(8):e23065.
Generic triage risk assessments are widely used in the emergency department (ED), but have not been validated for prediction of short-term risk among patients with acute heart failure (HF). Our objective was to evaluate the Canadian Triage Acuity Scale (CTAS) for prediction of early death among HF patients.
We included patients presenting with HF to an ED in Ontario from Apr 2003 to Mar 2007. We used the National Ambulatory Care Reporting System and vital statistics databases to examine care and outcomes.
Among 68,380 patients (76±12 years, 49.4% men), early mortality was stratified with death rates of 9.9%, 1.9%, 0.9%, and 0.5% at 1-day, and 17.2%, 5.9%, 3.8%, and 2.5% at 7-days, for CTAS 1, 2, 3, and 4–5, respectively. Compared to lower acuity (CTAS 4–5) patients, adjusted odds ratios (aOR) for 1-day death were 1.32 (95%CI; 0.93–1.88; p = 0.12) for CTAS 3, 2.41 (95%CI; 1.71–3.40; p<0.001) for CTAS 2, and highest for CTAS 1: 9.06 (95%CI; 6.28–13.06; p<0.001). Predictors of triage-critical (CTAS 1) status included oxygen saturation <90% (aOR 5.92, 95%CI; 3.09–11.81; p<0.001), respiratory rate >24 breaths/minute (aOR 1.96, 95%CI; 1.05–3.67; p = 0.034), and arrival by paramedic (aOR 3.52, 95%CI; 1.70–8.02; p = 0.001). While age/sex-adjusted CTAS score provided good discrimination for ED (c-statistic = 0.817) and 1-day (c-statistic = 0.724) death, mortality prediction was improved further after accounting for cardiac and non-cardiac co-morbidities (c-statistics 0.882 and 0.810, respectively; both p<0.001).
A semi-quantitative triage acuity scale assigned at ED presentation and based largely on respiratory factors predicted emergent death among HF patients.
PMCID: PMC3154275  PMID: 21853068
11.  From PALSA PLUS to PALM PLUS: adapting and developing a South African guideline and training intervention to better integrate HIV/AIDS care with primary care in rural health centers in Malawi 
Only about one-third of eligible HIV/AIDS patients receive anti-retroviral treatment (ART). Decentralizing treatment is crucial to wider and more equitable access, but key obstacles are a shortage of trained healthcare workers (HCW) and challenges integrating HIV/AIDS care with other primary care. This report describes the development of a guideline and training program (PALM PLUS) designed to integrate HIV/AIDS care with other primary care in Malawi. PALM PLUS was adapted from PALSA PLUS, developed in South Africa, and targets middle-cadre HCWs (clinical officers, nurses, and medical assistants). We adapted it to align with Malawi's national treatment protocols, more varied healthcare workforce, and weaker health system infrastructure.
The international research team included the developers of the PALSA PLUS program, key Malawi-based team members and personnel from national and district level Ministry of Health (MoH), professional associations, and an international non-governmental organization. The PALSA PLUS guideline was extensively revised based on Malawi national disease-specific guidelines. Advice and input was sought from local clinical experts, including middle-cadre personnel, as well as Malawi MoH personnel and representatives of Malawian professional associations.
An integrated guideline adapted to Malawian protocols for adults with respiratory conditions, HIV/AIDS, tuberculosis, and other primary care conditions was developed. The training program was adapted to Malawi's health system and district-level supervision structure. PALM PLUS is currently being piloted in a cluster-randomized trial in health centers in Malawi (ISRCTN47805230).
The PALM PLUS guideline and training intervention targets primary care middle-cadre HCWs with the objective of improving HCW satisfaction and retention, and the quality of patient care. Successful adaptations are feasible, even across health systems as different as those of South Africa and Malawi.
PMCID: PMC3162564  PMID: 21791048
12.  Association between waiting times and short term mortality and hospital admission after departure from emergency department: population based cohort study from Ontario, Canada 
Objective To determine whether patients who are not admitted to hospital after attending an emergency department during shifts with long waiting times are at risk for adverse events.
Design Population based retrospective cohort study using health administrative databases.
Setting High volume emergency departments in Ontario, Canada, fiscal years 2003-7.
Participants All emergency department patients who were not admitted (seen and discharged; left without being seen).
Outcome measures Risk of adverse events (admission to hospital or death within seven days) adjusted for important characteristics of patients, shift, and hospital.
Results 13 934 542 patients were seen and discharged and 617 011 left without being seen. The risk of adverse events increased with the mean length of stay of similar patients in the same shift in the emergency department. For mean length of stay ≥6 v <1 hour the adjusted odds ratio (95% confidence interval) was 1.79 (1.24 to 2.59) for death and 1.95 (1.79 to 2.13) for admission in high acuity patients and 1.71 (1.25 to 2.35) for death and 1.66 (1.56 to 1.76) for admission in low acuity patients). Leaving without being seen was not associated with an increase in adverse events at the level of the patient or by annual rates of the hospital.
Conclusions Presenting to an emergency department during shifts with longer waiting times, reflected in longer mean length of stay, is associated with a greater risk in the short term of death and admission to hospital in patients who are well enough to leave the department. Patients who leave without being seen are not at higher risk of short term adverse events.
PMCID: PMC3106148  PMID: 21632665
13.  The effect of a charted history of depression on emergency department triage and outcomes in patients with acute myocardial infarction 
Patients with acute myocardial infarction may have worse outcomes if they also have a history of depression. The early management of acute myocardial infarction is known to influence outcomes, and patients with a coexisting history of depression may be treated differently in the emergency department than those without one. Our goal was to determine whether having a charted history of depression was associated with a lower-priority emergency department triage score and worse performance on quality-of-care indices.
We conducted a retrospective population-based cohort analysis involving patients with acute myocardial infarction admitted to 96 acute care hospitals in the province of Ontario from April 2004 to March 2005. We calculated the adjusted odds of low-priority triage (Canadian Emergency Department Triage and Acuity Scale score of 3, 4 or 5) for patients with acute myocardial infarction who had a charted history of depression. We compared these odds with those for patients having a charted history of asthma or chronic obstructive pulmonary disease (COPD). Secondary outcome measures were the odds of meeting benchmark door-to-electrocardiogram, door-to-needle and door-to-balloon times.
Of 6784 patients with acute myocardial infarction, 680 (10.0%) had a past medical history of depression documented in their chart. Of these patients, 39.1% (95% confidence interval [CI] 35.3%–42.9%) were assigned a low-priority triage score, as compared with 32.7% (95% CI 31.5%–33.9%) of those without a charted history of depression. The adjusted odds of receiving a low-priority triage score with a charted history of depression were 1.26 (p = 0.01) versus 0.88 (p = 0.23) with asthma and 1.12 (p = 0.24) with COPD. For patients with a charted history of depression, the median door-to-electrocardiogram time was 20.0 minutes (v. 17.0 min for the rest of the cohort), median door-to-needle time was 53.0 (v. 37.0) minutes, and median door-to-balloon time was 251.0 (v. 110.0) minutes. The adjusted odds of missing the benchmark time with a charted history of depression were 1.39 (p < 0.001) for door-to-electrocardiogram time, 1.62 (p = 0.047) for door-to-needle time and 9.12 (p = 0.019) for door-to-balloon time.
Patients with acute myocardial infarction who had a charted history of depression were more likely to receive a low-priority emergency department triage score than those with other comorbidities and to have worse associated performance on quality indicators in acute myocardial infarction care.
PMCID: PMC3071386  PMID: 21398248
14.  Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial 
Trials  2010;11:118.
In low-income countries, only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) patients eligible for anti-retroviral treatment currently receive it. Providing decentralized treatment close to where patients live is crucial to a faster scale up, however, a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services (e.g. tuberculosis, malaria, respiratory conditions). This study will test an adapted primary care health care worker training and guideline intervention, Practical Approach to Lung Health and HIV/AIDS Malawi (PALM PLUS), on staff retention and satisfaction, and quality of patient care.
A cluster-randomized trial design is being used to compare usual care with a standardized clinical guideline and training intervention, PALM PLUS. The intervention targets middle-cadre health care workers (nurses, clinical officers, medical assistants) in 30 rural primary care health centres in a single district in Malawi. PALM PLUS is an integrated, symptom-based and user-friendly guideline consistent with Malawian national treatment protocols. Training is standardized and based on an educational outreach approach. Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused (1-2 hours), intermittent, interactive sessions on-site in health centers. Primary outcomes are health care worker retention and satisfaction. Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS, tuberculosis, prevention-of-mother-to-child-transmission of HIV and other primary care conditions. Effect sizes and 95% confidence intervals for outcomes will be presented. Assessment of outcomes will occur at 1 year post- implementation.
The PALM PLUS trial aims to address a key problem: strengthening middle-cadre health care workers to support the broader scale up of HIV/AIDS services and their integration into primary care. The trial will test whether the PALM PLUS intervention improves staff satisfaction and retention, as well as the quality of patient care, when compared to usual practice.
Trial Registration
Current controlled Trials: ISRCTN47805230
PMCID: PMC3017521  PMID: 21129211
15.  A prospective cluster-randomized trial to implement the Canadian CT Head Rule in emergency departments 
The Canadian CT Head Rule was developed to allow physicians to be more selective when ordering computed tomography (CT) imaging for patients with minor head injury. We sought to evaluate the effectiveness of implementing this validated decision rule at multiple emergency departments.
We conducted a matched-pair cluster-randomized trial that compared the outcomes of 4531 patients with minor head injury during two 12-month periods (before and after) at hospital emergency departments in Canada, six of which were randomly allocated as intervention sites and six as control sites. At the intervention sites, active strategies, including education, changes to policy and real-time reminders on radiologic requisitions were used to implement the Canadian CT Head Rule. The main outcome measure was referral for CT scan of the head.
Baseline characteristics of patients were similar when comparing control to intervention sites. At the intervention sites, the proportion of patients referred for CT imaging increased from the “before” period (62.8%) to the “after” period (76.2%) (difference +13.3%, 95% CI 9.7%–17.0%). At the control sites, the proportion of CT imaging usage also increased, from 67.5% to 74.1% (difference +6.7%, 95% CI 2.6%–10.8%). The change in mean imaging rates from the “before” period to the “after” period for intervention versus control hospitals was not significant (p = 0.16). There were no missed brain injuries or adverse outcomes.
Our knowledge–translation-based trial of the Canadian CT Head Rule did not reduce rates of CT imaging in Canadian emergency departments. Future studies should identify strategies to deal with barriers to implementation of this decision rule and explore more effective approaches to knowledge translation. ( trial register no. NCT00993252)
PMCID: PMC2950184  PMID: 20732978
16.  Major Radiodiagnostic Imaging in Pregnancy and the Risk of Childhood Malignancy: A Population-Based Cohort Study in Ontario 
PLoS Medicine  2010;7(9):e1000337.
In a record-linkage study, Joel Ray and colleagues examine the association between diagnostic imaging during pregnancy and later childhood cancers.
The association between fetal exposure to major radiodiagnostic testing in pregnancy—computed tomography (CT) and radionuclide imaging—and the risk of childhood cancer is not established.
Methods and Findings
We completed a population-based study of 1.8 million maternal-child pairs in the province of Ontario, from 1991 to 2008. We used Ontario's universal health care–linked administrative databases to identify all term obstetrical deliveries and newborn records, inpatient and outpatient major radiodiagnostic services, as well as all children with a malignancy after birth. There were 5,590 mothers exposed to major radiodiagnostic testing in pregnancy (3.0 per 1,000) and 1,829,927 mothers not exposed. The rate of radiodiagnostic testing increased from 1.1 to 6.3 per 1,000 pregnancies over the study period; about 73% of tests were CT scans. After a median duration of follow-up of 8.9 years, four childhood cancers arose in the exposed group (1.13 per 10,000 person-years) and 2,539 cancers in the unexposed group (1.56 per 10,000 person-years), a crude hazard ratio of 0.69 (95% confidence interval 0.26–1.82). After adjusting for maternal age, income quintile, urban status, and maternal cancer, as well as infant sex, chromosomal or congenital anomalies, and major radiodiagnostic test exposure after birth, the risk was essentially unchanged (hazard ratio 0.68, 95% confidence interval 0.25–1.80).
Although major radiodiagnostic testing is now performed in about 1 in 160 pregnancies in Ontario, the absolute annual risk of childhood malignancy following exposure in utero remains about 1 in 10,000. Since the upper confidence limit of the relative risk of malignancy may be as high as 1.8 times that of an unexposed pregnancy, we cannot exclude the possibility that fetal exposure to CT or radionuclide imaging is carcinogenic.
Please see later in the article for the Editors' Summary
Editors' Summary
In industrialized countries, childhood cancer (any form of cancer in a child aged 14 years or under) remains a major cause of death. With the exception of a few known risk factors, such as acquired genetic predisposition to cancer, which accounts for about 10% of all childhood cancers, the etiology of most childhood cancer remains unknown. There is thought to be an association between exposure to ionizing radiation in pregnancy and the subsequent risk of development of cancer in the exposed mother's child, but the evidence base to support this association is conflicting. For example, studies examining maternal exposure to plain radiographs in pregnancy and subsequent childhood cancer are inconsistent. Furthermore, although their use has dramatically increased over the past two decades, little is known about the cancer risk related to certain types of radiodiagnostic tests, such as CT and radionuclide imaging, both of which expose the fetus to considerably higher doses of radiation than plain radiographs administered at the same anatomical level.
Why Was This Study Done?
Many women could be exposed to major radiodiagnostic tests, such as those used in emergency situations, before they are aware that they are pregnant, as almost 50% of pregnancies are unplanned. This situation means that it is important to determine the subsequent cancer risk to any child exposed to maternal radiodiagnostic tests before birth.
What Did the Researchers Do and Find?
The researchers conducted a retrospective population-based cohort study of women who delivered a live infant in Ontario, Canada between April 1, 1992 and March 31, 2008. The basis of the research was an anonymized database for the whole province of Ontario, where universal health care, including prenatal care and radiodiagnostic testing, is available to all residents. Database characteristics allowed the researchers to link maternal radiation exposure (a major radiodiagnostic test performed on the mother up to one day before her delivery date) in a specific (index) pregnancy to a subsequent malignancy in the child. After birth, maternal-infant pairs were only followed up if the infant was delivered at term, weighed 2,500 g or more, and survived for at least 30 days.
The researchers were able to follow up 1,835,517 maternal-child pairs. The overall rate of exposure to major radiodiagnostic testing in pregnancy was 3.0 per 1,000 and occurred at an estimated mean gestational age of 15.7 weeks. A total of four childhood cancers occurred in the exposed group and 2,539 cancers in the unexposed group corresponding to a crude hazard ratio of 0.69, which did not significantly change after adjustments were made for potential confounding factors, such as maternal age, sex, and the presence of any chromosomal or congenital anomalies in the infant. The overall prevalence of childhood cancer following exposure to CT or radionuclide imaging in pregnancy is under 0.07%, giving an incidence rate of 1.13 per 10,000 person-years.
What Do These Findings Mean?
These findings can help inform clinicians and mothers about the risk of childhood malignancy following major radiodiagnostic testing in pregnancy. The absolute risk appears to be low, while the relative risk is not materially higher than that of unexposed controls. However, as the upper confidence limit of the relative risk of malignancy may be a maximum of 1.8 times that of an unexposed pregnancy, the possibility that fetal exposure to CT or radionuclide imaging is carcinogenic cannot be excluded. Because this finding means that a very slight risk may exist, beta hCG testing should continue to be done in all potentially pregnant women before undergoing major radiodiagnostic testing, and lead apron shielding used in all women of reproductive age, whether or not known to be pregnant. In addition, nonradiation-emitting imaging, such as MRI and ultrasonography, should be considered first, when clinically appropriate. However, some pregnant women will still be faced with the decision to undergo CT or nuclear imaging because the test is clinically warranted. The findings of this study suggest that when clinically indicated, major radiodiagnostic testing in pregnancy should be performed, along with brief counseling to help lessen the anxiety experienced by an expectant mother before and after the birth of her child.
Additional Information
Please access these Web sites via the online version of this summary at
For information for patients and caregivers on radiodiagnostic testing, see The Royal College of Radiologists
The National Cancer Institute provides information about childhood cancer
CureSearch for Children's Cancer provides additional information about research into childhood cancer
PMCID: PMC2935460  PMID: 20838660
17.  Implementation of the Canadian C-Spine Rule: prospective 12 centre cluster randomised trial 
Objective To evaluate the effectiveness of an active strategy to implement the validated Canadian C-Spine Rule into multiple emergency departments.
Design Matched pair cluster randomised trial.
Setting University and community emergency departments in Canada.
Participants 11 824 alert and stable adults presenting with blunt trauma to the head or neck at one of 12 hospitals.
Interventions Six hospitals were randomly allocated to the intervention and six to the control. At the intervention sites, active strategies were used to implement the Canadian C-Spine Rule, including education, policy, and real time reminders on radiology requisitions. No specific intervention was introduced to alter the behaviour of doctors requesting cervical spine imaging at the control sites.
Main outcome measure Diagnostic imaging rate of the cervical spine during two 12 month before and after periods.
Results Patients were balanced between control and intervention sites. From the before to the after periods, the intervention group showed a relative reduction in cervical spine imaging of 12.8% (95% confidence interval 9% to 16%; 61.7% v 53.3%; P=0.01) and the control group a relative increase of 12.5% (7% to 18%; 52.8% v 58.9%; P=0.03). These changes were significant when both groups were compared (P<0.001). No fractures were missed and no adverse outcomes occurred.
Conclusions Implementation of the Canadian C-Spine Rule led to a significant decrease in imaging without injuries being missed or patient morbidity. Final imaging rates were much lower at intervention sites than at most US hospitals. Widespread implementation of this rule could lead to reduced healthcare costs and more efficient patient flow in busy emergency departments worldwide.
Trial registration Clinical trials NCT00290875.
PMCID: PMC2770593  PMID: 19875425
18.  Incidence and predictors of critical events during urgent air–medical transport 
Little is known about the risks of urgent air–medical transport used in regionalized health care systems. We sought to determine the incidence of intransit critical events and identify factors associated with these events.
We conducted a population-based, retrospective cohort study using clinical and administrative data. We included all adults undergoing urgent air–medical transport in the Canadian province of Ontario between Jan. 1, 2004, and May 31, 2006. The primary outcome was in-transit critical events, which we defined as death, major resuscitative procedure, hemodynamic deterioration, or inadvertent extubation or respiratory arrest.
We identified 19 228 patients who underwent air–medical transport during the study period. In-transit critical events were observed in 5.1% of all transports, for a rate of 1 event per 12.6 hours of transit time. Events consisted primarily of new hypotension or airway management procedures. Independent predictors of critical events included female sex (adjusted odds ratio [OR] 1.3, 95% confidence interval [CI] 1.1–1.5), assisted ventilation before transport (adjusted OR 3.0, 95% CI 2.3–3.7), hemodynamic instability before transport (adjusted OR 3.2, 95% CI 2.5–4.1), transport in a fixed-wing aircraft (adjusted OR 1.5, 95% CI 1.2–1.8), increased duration of transport (adjusted OR 1.02 per 10-minute increment, 95% CI 1.01–1.03), on-scene calls (adjusted OR 1.7, 95% CI 1.4–2.1) and type of crew (adjusted OR 0.6 for advanced care paramedics v. critical care paramedics, 95% CI 0.5–0.7).
Critical events occurred in about 1 in every 20 air–medical transports and were associated with multiple risk factors at the patient, transport and system levels. These findings have implications for the refinement of training of paramedic transport crews and processes for triage and transport.
PMCID: PMC2764752  PMID: 19752105
19.  Development of a minimization instrument for allocation of a hospital-level performance improvement intervention to reduce waiting times in Ontario emergency departments 
Rigorous evaluation of an intervention requires that its allocation be unbiased with respect to confounders; this is especially difficult in complex, system-wide healthcare interventions. We developed a short survey instrument to identify factors for a minimization algorithm for the allocation of a hospital-level intervention to reduce emergency department (ED) waiting times in Ontario, Canada.
Potential confounders influencing the intervention's success were identified by literature review, and grouped by healthcare setting specific change stages. An international multi-disciplinary (clinical, administrative, decision maker, management) panel evaluated these factors in a two-stage modified-delphi and nominal group process based on four domains: change readiness, evidence base, face validity, and clarity of definition.
An original set of 33 factors were identified from the literature. The panel reduced the list to 12 in the first round survey. In the second survey, experts scored each factor according to the four domains; summary scores and consensus discussion resulted in the final selection and measurement of four hospital-level factors to be used in the minimization algorithm: improved patient flow as a hospital's leadership priority; physicians' receptiveness to organizational change; efficiency of bed management; and physician incentives supporting the change goal.
We developed a simple tool designed to gather data from senior hospital administrators on factors likely to affect the success of a hospital patient flow improvement intervention. A minimization algorithm will ensure balanced allocation of the intervention with respect to these factors in study hospitals.
PMCID: PMC2706789  PMID: 19505308
20.  Users' guides to the medical literature: how to use an article about mortality in a humanitarian emergency 
The accurate interpretation of mortality surveys in humanitarian crises is useful for both public health responses and security responses. Recent examples suggest that few medical personnel and researchers can accurately interpret the validity of a mortality survey in these settings. Using an example of a mortality survey from the Democratic Republic of Congo (DRC), we demonstrate important methodological considerations that readers should keep in mind when reading a mortality survey to determine the validity of the study and the applicability of the findings to their settings.
PMCID: PMC2569008  PMID: 18826636
21.  Effect of widespread restrictions on the use of hospital services during an outbreak of severe acute respiratory syndrome 
Restrictions on the nonurgent use of hospital services were imposed in March 2003 to control an outbreak of severe acute respiratory syndrome (SARS) in Toronto, Ont. We describe the impact of these restrictions on health care utilization and suggest lessons for future epidemics.
We performed a retrospective population-based study of the Greater Toronto Area (hereafter referred to as Toronto) and unaffected comparison regions (Ottawa and London, Ont.) before, during and after the SARS outbreak (April 2001–March 2004). We determined the adjusted rates of hospital admissions, emergency department and outpatient visits, diagnostic testing and drug prescribing.
During the early and late SARS restriction periods, the rate of overall and medical admissions decreased by 10%–12% in Toronto; there was no change in the comparison regions. The rate of elective surgery in Toronto fell by 22% and 15% during the early and late restriction periods respectively and by 8% in the comparison regions. The admission rates for urgent surgery remained unchanged in all regions; those for some acute serious medical conditions decreased by 15%–21%. The rates of elective cardiac procedures declined by up to 66% in Toronto and by 71% in the comparison regions; the rates of urgent and semi-urgent procedures declined little or increased. High-acuity visits to emergency departments fell by 37% in Toronto, and inter-hospital patient transfers fell by 44% in the circum-Toronto area. Drug prescribing and primary care visits were unchanged in all regions.
The restrictions achieved modest reductions in overall hospital admissions and substantial reductions in the use of elective services. Brief reductions occurred in admissions for some acute serious conditions, high-acuity visits to emergency departments and inter-hospital patient transfers suggesting that access to care for some potentially seriously ill patients was affected.
PMCID: PMC1891122  PMID: 17576979
22.  Results of the Recent Immigrant Pregnancy and Perinatal Long-term Evaluation Study (RIPPLES) 
People who immigrate to Western nations may experience fewer chronic health problems than original residents of those countries, which raises concerns about long-term environmental or lifestyle factors in those countries. We tested whether the “healthy immigrant effect” extends to the risk of placental dysfunction during the short interval of pregnancy.
We conducted a population-based retrospective cohort study of data for 796 105 women who had a first documented obstetric delivery in Ontario between 1995 and 2005. Recency of immigration was determined for each woman as the time from her enrolment in universal health insurance to her date of delivery, classified as less than 3 months, 3–5 months, 6–11 months, 12–23 months, 24–35 months, 36–47 months, 48–59 months and 5 years or more (the referent). The primary composite outcome was maternal placental syndrome (defined as a diagnosis of pre-eclampsia or eclampsia, placental abruption or placental infarction).
The mean age of the women was 28.8 years. Maternal placental syndrome occurred in 45 216 women (5.7%). The risk of this outcome was lowest among the women who had immigrated less than 3 months before delivery (3.8%) and highest among those living in Ontario at least 5 years (6.0%), for a crude odds ratio (OR) of 0.62 (95% confidence interval [CI] 0.54–0.71). After adjustment for maternal age, income status, pre-existing hypertension, diabetes mellitus, multiple gestation and receipt of prenatal ultrasonography, the risk of maternal placental syndrome was correlated with the number of months since immigration in a gradient manner (OR, 95% CI): less than 3 months (0.53, 0.47–0.61), 3–5 months (0.68, 0.61–0.76), 6–11 months (0.67, 0.63–0.71), 12–23 months (0.69, 0.66–0.73), 24–35 months (0.75, 0.70–0.79), 36–47 months (0.75, 0.70–0.80) and 48–59 months (0.82, 0.77–0.87).
There was a progressively lower risk of maternal placental syndromes associated with recency of immigration. The “healthy immigrant effect” may extend to common placental disorders, diminishes with the duration of residency and underscores the importance of nongenetic determinants of maternal health accrued over a brief period.
PMCID: PMC1863534  PMID: 17485694
24.  Emergency department overcrowding and ambulance transport delays for patients with chest pain 
Emergency department overcrowding sometimes results in diversion of ambulances to other locations. We sought to determine the resulting prehospital delays for cardiac patients.
Data on consecutive patients with chest pain who were transported to Toronto hospitals by ambulance were obtained for a 4-month period in 1997 and a 4-month period in 1999, which represented periods of low and high emergency department overcrowding respectively. Multivariate analyses were used to model 90th percentile system response (initiation of 9-1-1 call to arrival on scene), on-scene (arrival on scene to departure from scene) and transport (departure from scene to arrival at hospital) intervals. Predictor variables were study period (1997 or 1999), day of the week, time of day, geographic location of the patient, dispatch priority, case severity, return priority and number of other patients with chest pain transported within 2 hours of the index transport.
A total of 3609 patients (mean age 66.3 years, 50.3% female) who met the study criteria were transported by ambulance during the 2 study periods. There were no significant differences in patient characteristics between the 2 periods, despite the fact that more patients were transported during the second period (p < 0.001). The 90th percentile system response interval increased by 11.3% from the first to the second period (9.7 v. 10.8 min, p < 0.001), whereas the on-scene interval decreased by 8.2% (28.0 v. 25.7 min, p < 0.001). The longest delay was in the transport interval, which increased by 28.4% from 1997 to 1999 (13.4 v. 17.2 min, p < 0.001). In multivariate analyses, the study period (1997 v. 1999) remained a significant predictor of longer transport interval (p < 0.001) and total prehospital interval (p = 0.004).
An increase in overcrowding in emergency departments was associated with a substantial increase in the system response interval and the ambulance transport interval for patients with chest pain.
PMCID: PMC140469  PMID: 12566332
25.  Problems for clinical judgement: 4. Surviving in the report card era 
HEALTH CARE REPORT CARDS INVOLVE COMPARISONS of health care systems, hospitals or clinicians on performance measures. They are going to be an important feature of medical care in Canada in the new millennium as patients demand more information about their medical care. Although many clinicians are aware of this growing trend, they may not be prepared for all of its implications. In this article, we provide some historical background on health care report cards and describe a number of strategies to help clinicians survive and thrive in the report card era. We offer a number of tips ranging from knowing your outcomes first to proactively getting involved in developing report cards.
PMCID: PMC81159  PMID: 11450215

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