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1.  Understanding the Canadian adult CT head rule trial: use of the theoretical domains framework for process evaluation 
Background
The Canadian CT Head Rule was prospectively derived and validated to assist clinicians with diagnostic decision-making regarding the use of computed tomography (CT) in adult patients with minor head injury. A recent intervention trial failed to demonstrate a decrease in the rate of head CTs following implementation of the rule in Canadian emergency departments. Yet, the same intervention, which included a one-hour educational session and reminders at the point of requisition, was successful in reducing cervical spine imaging rates in the same emergency departments. The reason for the varied effect of the intervention across these two behaviours is unclear. There is an increasing appreciation for the use of theory to conduct process evaluations to better understand how strategies are linked with outcomes in implementation trials. The Theoretical Domains Framework (TDF) has been used to explore health professional behaviour and to design behaviour change interventions but, to date, has not been used to guide a theory-based process evaluation. In this proof of concept study, we explored whether the TDF could be used to guide a retrospective process evaluation to better understand emergency physicians’ responses to the interventions employed in the Canadian CT Head Rule trial.
Methods
A semi-structured interview guide, based on the 12 domains from the TDF, was used to conduct telephone interviews with project leads and physician participants from the intervention sites in the Canadian CT Head Rule trial. Two reviewers independently coded the anonymised interview transcripts using the TDF as a coding framework. Relevant domains were identified by: the presence of conflicting beliefs within a domain; the frequency of beliefs; and the likely strength of the impact of a belief on the behaviour.
Results
Eight physicians from four of the intervention sites in the Canadian CT Head Rule trial participated in the interviews. Barriers likely to assist with understanding physicians’ responses to the intervention in the trial were identified in six of the theoretical domains: beliefs about consequences; beliefs about capabilities; behavioural regulation; memory, attention and decision processes; environmental context and resources; and social influences. Despite knowledge that the Canadian CT Head Rule was highly sensitive and reliable for identifying clinically important brain injuries and strong beliefs about the benefits for using the rule, a number of barriers were identified that may have prevented physicians from consistently applying the rule.
Conclusion
This proof of concept study demonstrates the use of the TDF as a guiding framework to design a retrospective theory-based process evaluation. There is a need for further development and testing of methods for using the TDF to guide theory-based process evaluations running alongside behaviour change intervention trials.
doi:10.1186/1748-5908-8-25
PMCID: PMC3585785  PMID: 23433082
2.  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.
doi:10.1136/bmj.b4146
PMCID: PMC2770593  PMID: 19875425
3.  A matched-pair cluster design study protocol to evaluate implementation of the Canadian C-spine rule in hospital emergency departments: Phase III 
Background
Physicians in Canadian emergency departments (EDs) annually treat 185,000 alert and stable trauma victims who are at risk for cervical spine (C-spine) injury. However, only 0.9% of these patients have suffered a cervical spine fracture. Current use of radiography is not efficient. The Canadian C-Spine Rule is designed to allow physicians to be more selective and accurate in ordering C-spine radiography, and to rapidly clear the C-spine without the need for radiography in many patients. The goal of this phase III study is to evaluate the effectiveness of an active strategy to implement the Canadian C-Spine Rule into physician practice. Specific objectives are to: 1) determine clinical impact, 2) determine sustainability, 3) evaluate performance, and 4) conduct an economic evaluation.
Methods
We propose a matched-pair cluster design study that compares outcomes during three consecutive 12-months "before," "after," and "decay" periods at six pairs of "intervention" and "control" sites. These 12 hospital ED sites will be stratified as "teaching" or "community" hospitals, matched according to baseline C-spine radiography ordering rates, and then allocated within each pair to either intervention or control groups. During the "after" period at the intervention sites, simple and inexpensive strategies will be employed to actively implement the Canadian C-Spine Rule. The following outcomes will be assessed: 1) measures of clinical impact, 2) performance of the Canadian C-Spine Rule, and 3) economic measures. During the 12-month "decay" period, implementation strategies will continue, allowing us to evaluate the sustainability of the effect. We estimate a sample size of 4,800 patients in each period in order to have adequate power to evaluate the main outcomes.
Discussion
Phase I successfully derived the Canadian C-Spine Rule and phase II confirmed the accuracy and safety of the rule, hence, the potential for physicians to improve care. What remains unknown is the actual change in clinical behaviors that can be affected by implementation of the Canadian C-Spine Rule, and whether implementation can be achieved with simple and inexpensive measures. We believe that the Canadian C-Spine Rule has the potential to significantly reduce health care costs and improve the efficiency of patient flow in busy Canadian EDs.
doi:10.1186/1748-5908-2-4
PMCID: PMC1802999  PMID: 17288613
4.  Theory of planned behaviour can help understand processes underlying the use of two emergency medicine diagnostic imaging rules 
Background
Clinical decision rules (CDRs) can be an effective tool for knowledge translation in emergency medicine, but their implementation is often a challenge. This study examined whether the Theory of Planned Behaviour (TPB) could help explain the inconsistent results between the successful Canadian C-Spine Rule (CCR) implementation study and unsuccessful Canadian CT Head Rule (CCHR) implementation study. Both rules are aimed at improving the accuracy and efficiency of emergency department radiography use in clinical contexts that exhibit enormous inefficiency at the present time. The rules were prospectively derived and validated using the same methodology demonstrating high sensitivity and reliability. The rules subsequently underwent parallel implementations at 12 Canadian hospitals, yet only the CCR was observed to significantly reduce radiography ordering rates, while the CCHR failed to have any significant impact at all. The drastically different results are unlikely to be the result of differences in implementation strategies or the decision rules.
Methods
Physicians at the 12 participating Canadian hospitals were randomized to CCR or CCHR TPB surveys that were administered during the baseline phases of the implementation studies, before any intervention had taken place. The collected baseline survey data were linked to concurrent baseline physician and patient-specific imaging data, and subsequently analyzed using mixed effects linear and logistic models.
Results
A total of 223 of the 378 eligible physicians randomized to a TPB survey completed their assigned baseline survey (CCR: 122 of 181; CCHR: 101 of 197). Attitudes were significantly associated with intention in both settings (CCR: ß = 0.40; CCHR: ß = 0.30), as were subjective norms (CCR: ß = 0.26; CCHR: ß = 0.73). Intention was significantly associated with actual image ordering for CCR (OR = 1.79), but not CCHR.
Conclusions
The TPB can be used to better understand processes underlying use of CDRs. TPB constructs were significantly associated with intention to perform both imaging behaviours, but intention was only associated with actual behaviour for CCR, suggesting that constructs outside of the TPB framework may need to be considered when seeking to understand use of CDRs.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0088-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0088-x
PMCID: PMC4243777  PMID: 25099167
Clinical decision rules; Canadian C-Spine Rule; Canadian CT-Head Rule; Theory of planned behaviour; Emergency physicians; Implementation study
5.  Effect of the Low Risk Ankle Rule on the frequency of radiography in children with ankle injuries 
Background:
The Low Risk Ankle Rule is a validated clinical decision rule that has the potential to safely reduce radiography in children with acute ankle injuries. We performed a phased implementation of the Low Risk Ankle Rule and evaluated its effectiveness in reducing the frequency of radiography in children with ankle injuries.
Methods:
Six Canadian emergency departments participated in the study from Jan. 1, 2009, to Aug. 31, 2011. At the 3 intervention sites, there were 3 consecutive 26-week phases. In phase 1, no interventions were implemented. In phase 2, we activated strategies to implement the ankle rule, including physician education, reminders and a computerized decision support system. In phase 3, we included only the decision support system. No interventions were introduced at the 3 pair-matched control sites. We examined the management of ankle injuries among children aged 3–16 years. The primary outcome was the proportion of children undergoing radiography.
Results:
We enrolled 2151 children with ankle injuries, 1055 at intervention and 1096 at control hospitals. During phase 1, the baseline frequency of pediatric ankle radiography at intervention and control sites was 96.5% and 90.2%, respectively. During phase 2, the frequency of ankle radiography decreased significantly at intervention sites relative to control sites (between-group difference −21.9% [95% confidence interval [CI] −28.6% to −15.2%]), without significant differences in patient or physician satisfaction. All effects were sustained in phase 3. The sensitivity of the Low Risk Ankle Rule during implementation was 100% (95% CI 85.4% to 100%), and the specificity was 53.1% (95% CI 48.1% to 58.1%).
Interpretation:
Implementation of the Low Risk Ankle Rule in several different emergency department settings reduced the rate of pediatric ankle radiography significantly and safely, without an accompanying change in physician or patient satisfaction. Trial registration: ClinicalTrials.gov, no. NCT00785876.
doi:10.1503/cmaj.122050
PMCID: PMC3796622  PMID: 23939215
6.  Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: study protocol for a multicenter randomized trial 
Trials  2014;15:253.
Background
Blunt head trauma is a common cause of death and disability in children worldwide. Cranial computed tomography (CT), the reference standard for the diagnosis of traumatic brain injury (TBI), exposes children to ionizing radiation which has been linked to the development of brain tumors, leukemia, and other cancers. We describe the methods used to develop and test the effectiveness of a decision aid to facilitate shared decision-making with parents regarding whether to obtain a head CT scan or to further observe their child at home.
Methods/Design
This is a protocol for a multicenter clinician-level parallel randomized trial to compare an intervention group receiving a decision aid, ‘Head CT Choice’, to a control group receiving usual care. The trial will be conducted at five diverse emergency departments (EDs) in Minnesota and California. Clinicians will be randomized to decision aid or usual care. Parents visiting the ED with children who are less than 18-years-old, have experienced blunt head trauma within 24 hours, and have one or two risk factors for clinically-important TBI (ciTBI) from the Pediatric Emergency Care Applied Research Network head injury clinical prediction rules will be eligible for enrollment. We will measure the effect of Head CT Choice on: (1) parent knowledge regarding their child’s risk of ciTBI, the available diagnostic options, and the risks of radiation exposure associated with a cranial CT scan (primary outcome); (2) parent engagement in the decision-making process; (3) the degree of conflict parents experience related to feeling uninformed; (4) patient and clinician satisfaction with the decision made; (5) the rate of ciTBI at seven days; (6) the proportion of patients in whom a cranial CT scan is obtained; and (7) seven-day healthcare utilization. To capture these outcomes, we will administer parent and clinician surveys immediately after each clinical encounter, obtain video recordings of parent-clinician discussions, administer parent healthcare utilization diaries, analyze hospital billing records, review the electronic medical record, and conduct telephone follow-up.
Discussion
This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes, safety, and healthcare utilization in parents of children with minor head trauma in five diverse EDs.
Trial registration
ClinicalTrials.gov registration number: NCT02063087. Registration date February 13, 2014.
doi:10.1186/1745-6215-15-253
PMCID: PMC4081461  PMID: 24965659
7.  Evaluation of the safety of C-spine clearance by paramedics: design and methodology 
Background
Canadian Emergency Medical Services annually transport 1.3 million patients with potential neck injuries to local emergency departments. Less than 1% of those patients have a c-spine fracture and even less (0.5%) have a spinal cord injury. Most injuries occur before the arrival of paramedics, not during transport to the hospital, yet most patients are transported in ambulances immobilized. They stay fully immobilized until a bed is available, or until physician assessment and/or X-rays are complete. The prolonged immobilization is often unnecessary and adds to the burden of already overtaxed emergency medical services systems and crowded emergency departments.
Methods/Design
The goal of this study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients using a validated clinical decision rule, the Canadian C-Spine Rule, in order to determine the need for immobilization during transport to the emergency department.
This cohort study will be conducted in Ottawa, Canada with one emergency medical service. Paramedics with this service participated in an earlier validation study of the Canadian C-Spine Rule. Three thousand consecutive, alert, stable adult trauma patients with a potential c-spine injury will be enrolled in the study and evaluated using the Canadian C-Spine Rule to determine the need for immobilization. The outcomes that will be assessed include measures of safety (numbers of missed fractures and serious adverse outcomes), measures of clinical impact (proportion of patients transported without immobilization, key time intervals) and performance of the Rule.
Discussion
Approximately 40% of all very low-risk trauma patients could be transported safely, without c-spine immobilization, if paramedics were empowered to make clinical decisions using the Canadian C-Spine Rule. This safety study is an essential step before allowing all paramedics across Canada to selectively immobilize trauma victims before transport. Once safety and potential impact are established, we intend to implement a multi-centre study to study actual impact.
Trial Registration
ClinicalTrials.gov NCT01188447
doi:10.1186/1471-227X-11-1
PMCID: PMC3040719  PMID: 21284880
8.  Multicentre trial to introduce the Ottawa ankle rules for use of radiography in acute ankle injuries. Multicentre Ankle Rule Study Group. 
BMJ : British Medical Journal  1995;311(7005):594-597.
OBJECTIVE--To assess the feasibility and impact of introducing the Ottawa ankle rules to a large number of physicians in a wide variety of hospital and community settings over a prolonged period of time. DESIGN--Multicentre before and after controlled clinical trial. SETTING--Emergency departments of eight teaching and community hospitals in Canadian communities (population 10,000 to 3,000,000). SUBJECTS--All 12,777 adults (6288 control, 6489 intervention) seen with acute ankle injuries during two 12 month periods before and after the intervention. INTERVENTION--More than 200 physicians of varying experience were taught to order radiography according to the Ottawa ankle rules. MAIN OUTCOME MEASURES--Referral for ankle and foot radiography. RESULTS--There were significant reductions in use of ankle radiography at all eight hospitals and within a priori subgroups: for all hospitals combined 82.8% control v 60.9% intervention(P < 0.001); for community hospitals 86.7% v 61.7%; (P < 0.001); for teaching hospitals 77.9% v 59.9%; (P < 0.001); for emergency physicians 82.1% v 61.6%; (P < 0.001); for family physicians 84.3% v 60.1%; (P < 0.001); and for housestaff 82.3% v 60.1%; (P < 0.001). Compared with patients without fracture who had radiography during the intervention period those who had no radiography spent less time in the emergency department (54.0 v 86.9 minutes; P < 0.001) and had lower medical charges ($70.20 v $161.60; P < 0.001). There was no difference in the rate of fractures diagnosed after discharge from the emergency department (0.5 v 0.4%). CONCLUSIONS--Introduction of the Ottawa ankle rules proved to be feasible in a large variety of hospital and community settings. Use of the rules over a prolonged period of time by many physicians of varying experience led to a decrease in ankle radiography, waiting times, and costs without an increased rate of missed fractures. The multiphase methodological approach used to develop and implement these rules may be applied to other clinical problems.
PMCID: PMC2550661  PMID: 7663253
9.  A prospective observational study to assess the diagnostic accuracy of clinical decision rules for children presenting to emergency departments after head injuries (protocol): the Australasian Paediatric Head Injury Rules Study (APHIRST) 
BMC Pediatrics  2014;14:148.
Background
Head injuries in children are responsible for a large number of emergency department visits. Failure to identify a clinically significant intracranial injury in a timely fashion may result in long term neurodisability and death. Whilst cranial computed tomography (CT) provides rapid and definitive identification of intracranial injuries, it is resource intensive and associated with radiation induced cancer. Evidence based head injury clinical decision rules have been derived to aid physicians in identifying patients at risk of having a clinically significant intracranial injury. Three rules have been identified as being of high quality and accuracy: the Canadian Assessment of Tomography for Childhood Head Injury (CATCH) from Canada, the Children’s Head Injury Algorithm for the Prediction of Important Clinical Events (CHALICE) from the UK, and the prediction rule for the identification of children at very low risk of clinically important traumatic brain injury developed by the Pediatric Emergency Care Applied Research Network (PECARN) from the USA. This study aims to prospectively validate and compare the performance accuracy of these three clinical decision rules when applied outside the derivation setting.
Methods/design
This study is a prospective observational study of children aged 0 to less than 18 years presenting to 10 emergency departments within the Paediatric Research in Emergency Departments International Collaborative (PREDICT) research network in Australia and New Zealand after head injuries of any severity. Predictor variables identified in CATCH, CHALICE and PECARN clinical decision rules will be collected. Patients will be managed as per the treating clinicians at the participating hospitals. All patients not undergoing cranial CT will receive a follow up call 14 to 90 days after the injury. Outcome data collected will include results of cranial CTs (if performed) and details of admission, intubation, neurosurgery and death. The performance accuracy of each of the rules will be assessed using rule specific outcomes and inclusion and exclusion criteria.
Discussion
This study will allow the simultaneous comparative application and validation of three major paediatric head injury clinical decision rules outside their derivation setting.
Trial registration
The study is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR)- ACTRN12614000463673 (registered 2 May 2014).
doi:10.1186/1471-2431-14-148
PMCID: PMC4074143  PMID: 24927811
Head injury; Clinical decision rule; Computed tomography; Validation
10.  Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial 
Trials  2014;15:281.
Background
Mild head injuries commonly present to emergency departments. The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury, and which patients can safely be sent home. Traumatic brain injuries may exist with subtle symptoms or signs, but can still lead to adverse outcomes. Despite the existence of several high quality clinical practice guidelines, internationally and in Australia, research shows inconsistent implementation of these recommendations. The aim of this trial is to test the effectiveness of a targeted, theory- and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients (18 years of age or older) who present following mild head injuries (concussion), compared with passive dissemination of these recommendations. The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed.
Methods/design
The design of this study is a cluster randomised trial. We aim to include 34 Australian 24-hour emergency departments, which will be randomised to an intervention or control group. Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries. The intervention group will receive an implementation intervention based on an analysis of influencing factors, which include local stakeholder meetings, identification of nursing and medical opinion leaders in each site, a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3 month period of time. Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2 month period following intervention delivery (patient level outcomes). In consenting hospitals, eligible patients will be recruited for a follow-up telephone interview conducted by trained researchers. A cost-effectiveness analysis and process evaluation using mixed-methods will be conducted. Sample size calculations are based on including 30 patients on average per department. Outcome assessors will be blinded to group allocation.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12612001286831 (date registered 12 December 2012).
doi:10.1186/1745-6215-15-281
PMCID: PMC4107995  PMID: 25012235
Mild traumatic brain injury; Cluster trial; Emergency department
11.  Evaluation of the impact of the Canadian CT head rule on British practice 
Emergency Medicine Journal : EMJ  2004;21(4):426-428.
Background: The Canadian CT head rule has been developed to identify which adults with minor head injuries require computed tomography (CT). This is hoped will reduce the number of CT scans performed for minor head injury in North America. It was unclear whether applying the rule would reduce or even increase the number of CT scans requested in UK emergency departments.
Methods: A retrospective evaluation was conducted of all adults who presented after minor head injuries to Addenbrooke's emergency department. Clinical information about patients with head injuries is collected on standardised forms. A dataset was constructed to predict how many patients would require head CT scans if the Canadian CT rule was applied.
Results: 1489 adults presented after minor head injury over a seven month period. Seventy four of these had CT scans for head injury, applying the Canadian CT head rule would have resulted in 132 CT scans being requested. This is significantly more (p>0.001). This would have resulted in a 68% increase in costs.
Interpretation: The Canadian CT head rule would result in an increase in the number of CT scans requested for minor head injuries. This increased cost must be considered against the 488 skull radiographs that were requested during the study period.
PMCID: PMC1726365  PMID: 15208223
12.  CATCH: a clinical decision rule for the use of computed tomography in children with minor head injury 
Background
There is controversy about which children with minor head injury need to undergo computed tomography (CT). We aimed to develop a highly sensitive clinical decision rule for the use of CT in children with minor head injury.
Methods
For this multicentre cohort study, we enrolled consecutive children with blunt head trauma presenting with a score of 13–15 on the Glasgow Coma Scale and loss of consciousness, amnesia, disorientation, persistent vomiting or irritability. For each child, staff in the emergency department completed a standardized assessment form before any CT. The main outcomes were need for neurologic intervention and presence of brain injury as determined by CT. We developed a decision rule by using recursive partitioning to combine variables that were both reliable and strongly associated with the outcome measures and thus to find the best combinations of predictor variables that were highly sensitive for detecting the outcome measures with maximal specificity.
Results
Among the 3866 patients enrolled (mean age 9.2 years), 95 (2.5%) had a score of 13 on the Glasgow Coma Scale, 282 (7.3%) had a score of 14, and 3489 (90.2%) had a score of 15. CT revealed that 159 (4.1%) had a brain injury, and 24 (0.6%) underwent neurologic intervention. We derived a decision rule for CT of the head consisting of four high-risk factors (failure to reach score of 15 on the Glasgow coma scale within two hours, suspicion of open skull fracture, worsening headache and irritability) and three additional medium-risk factors (large, boggy hematoma of the scalp; signs of basal skull fracture; dangerous mechanism of injury). The high-risk factors were 100.0% sensitive (95% CI 86.2%–100.0%) for predicting the need for neurologic intervention and would require that 30.2% of patients undergo CT. The medium-risk factors resulted in 98.1% sensitivity (95% CI 94.6%–99.4%) for the prediction of brain injury by CT and would require that 52.0% of patients undergo CT.
Interpretation
The decision rule developed in this study identifies children at two levels of risk. Once the decision rule has been prospectively validated, it has the potential to standardize and improve the use of CT for children with minor head injury.
doi:10.1503/cmaj.091421
PMCID: PMC2831681  PMID: 20142371
13.  Predicting Outcome after Traumatic Brain Injury: Development and International Validation of Prognostic Scores Based on Admission Characteristics 
PLoS Medicine  2008;5(8):e165.
Background
Traumatic brain injury (TBI) is a leading cause of death and disability. A reliable prediction of outcome on admission is of great clinical relevance. We aimed to develop prognostic models with readily available traditional and novel predictors.
Methods and Findings
Prospectively collected individual patient data were analyzed from 11 studies. We considered predictors available at admission in logistic regression models to predict mortality and unfavorable outcome according to the Glasgow Outcome Scale at 6 mo after injury. Prognostic models were developed in 8,509 patients with severe or moderate TBI, with cross-validation by omission of each of the 11 studies in turn. External validation was on 6,681 patients from the recent Medical Research Council Corticosteroid Randomisation after Significant Head Injury (MRC CRASH) trial. We found that the strongest predictors of outcome were age, motor score, pupillary reactivity, and CT characteristics, including the presence of traumatic subarachnoid hemorrhage. A prognostic model that combined age, motor score, and pupillary reactivity had an area under the receiver operating characteristic curve (AUC) between 0.66 and 0.84 at cross-validation. This performance could be improved (AUC increased by approximately 0.05) by considering CT characteristics, secondary insults (hypotension and hypoxia), and laboratory parameters (glucose and hemoglobin). External validation confirmed that the discriminative ability of the model was adequate (AUC 0.80). Outcomes were systematically worse than predicted, but less so in 1,588 patients who were from high-income countries in the CRASH trial.
Conclusions
Prognostic models using baseline characteristics provide adequate discrimination between patients with good and poor 6 mo outcomes after TBI, especially if CT and laboratory findings are considered in addition to traditional predictors. The model predictions may support clinical practice and research, including the design and analysis of randomized controlled trials.
Ewout Steyerberg and colleagues describe a prognostic model for the prediction of outcome of traumatic brain injury using data available on admission.
Editors' Summary
Background.
Traumatic brain injury (TBI) causes a large amount of morbidity and mortality worldwide. According to the Centers for Disease Control, for example, about 1.4 million Americans will sustain a TBI—a head injury—each year. Of these, 1.1 million will be treated and released from an emergency department, 235,000 will be hospitalized, and 50,000 will die. The burden of disease is much higher in the developing world, where the causes of TBI such as traffic accidents occur at higher rates and treatment may be less available.
Why Was This Study Done?
Given the resources required to treat TBI, a very useful research tool would be the ability to accurately predict on admission to hospital what the outcome of a given injury might be. Currently, scores such as the Glasgow Coma Scale are useful to predict outcome 24 h after the injury but not before.
Prognostic models are useful for several reasons. Clinically, they help doctors and patients make decisions about treatment. They are also useful in research studies that compare outcomes in different groups of patients and when planning randomized controlled trials. The study presented here is one of a number of analyses done by the IMPACT research group over the past several years using a large database that includes data from eight randomized controlled trials and three observational studies conducted between 1984 and 1997. There are other ongoing studies that also seek to develop new prognostic models; one such recent study was published in BMJ by a group involving the lead author of the PLoS Medicine paper described here.
What Did the Researchers Do and Find?
The authors analyzed data that had been collected prospectively on individual patients from the 11 studies included in the database and derived models to predict mortality and unfavorable outcome at 6 mo after injury for the 8,509 patients with severe or moderate TBI. They found that the strongest predictors of outcome were age, motor score, pupillary reactivity, and characteristics on the CT scan, including the presence of traumatic subarachnoid hemorrhage. A core prognostic model could be derived from the combination of age, motor score, and pupillary reactivity. A better score could be obtained by adding CT characteristics, secondary problems (hypotension and hypoxia), and laboratory measurements of glucose and hemoglobin. The scores were then tested to see how well they predicted outcome in a different group of patients—6,681 patients from the recent Medical Research Council Corticosteroid Randomisation after Significant Head Injury (MRC CRASH) trial.
What Do These Findings Mean?
In this paper the authors show that it is possible to produce prognostic models using characteristics collected on admission as part of routine care that can discriminate between patients with good and poor outcomes 6 mo after TBI, especially if the results from CT scans and laboratory findings are added to basic models. This paper has to be considered together with other studies, especially the paper mentioned above, which was recently published in the BMJ (MRC CRASH Trial Collaborators [2008] Predicting outcome after traumatic brain injury: practical prognostic models based on large cohort of international patients. BMJ 336: 425–429.). The BMJ study presented a set of similar, but subtly different models, with specific focus on patients in developing countries; in that case, the patients in the CRASH trial were used to produce the models, and the patients in the IMPACT database were used to verify one variant of the models. Unfortunately this related paper was not disclosed to us during the initial review process; however, during PLoS Medicine's subsequent consideration of this manuscript we learned of it. After discussion with the reviewers, we took the decision that the models described in the PLoS Medicine paper are sufficiently different from those reported in the other paper and as such proceeded with publication of the paper. Ideally, however, these two sets of models would have been reviewed and published side by side, so that readers could easily evaluate the respective merits and value of the two different sets of models in the light of each other. The two sets of models are, however, discussed in a Perspective article also published in PLoS Medicine (see below).
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050165.
This paper and the BMJ paper mentioned above are discussed further in a PLoS Medicine Perspective article by Andrews and Young
The TBI Impact site provides a tool to calculate the scores described in this paper
The CRASH trial, which is used to validate the scores mentioned here, has a Web site explaining the trial and its results
The R software, which was used for the prognostic analyses, is freely available
The MedlinePlus encyclopedia has information on head injury
The WHO site on neurotrauma discusses head injury from a global perspective
The CDC's National Center for Injury Prevention and Control gives statistics on head injury in the US and advice on prevention
doi:10.1371/journal.pmed.0050165
PMCID: PMC2494563  PMID: 18684008
14.  Application of the Canadian CT head rules in managing minor head injuries in a UK emergency department: implications for the implementation of the NICE guidelines 
Emergency Medicine Journal : EMJ  2004;21(4):420-425.
Objective: : In 2002 a new protocol was introduced based on the Canadian CT rules. Before this the Royal College of Surgeons "Galasko" report guidelines had been followed. This study evaluates the effects of the protocol and discusses the impact of the implementation of the NICE head injury guidelines—also based on the Canadian CT rules.
Methods: A "before and after" study was undertaken, using data from accident and emergency cards and hospital notes of adult patients with head injuries presenting to the emergency department over seven months in 2001 and nine months in 2002. The two groups were compared to see how rates of computed tomography (CT), admission for observation, discharge, and skull radiography had changed after introduction of the protocol.
Results: : Head CT rates in patients with minor head injuries (MHI) increased significantly from 47 of 330 (14%) to 58 of 267 (20%) (p<0.05). There were also significantly increased rates of admission for observation, from 111 (34%) to 119 (45%). Skull radiography rates fell considerably from 33% of all patients with head injuries in 2001 to 1.6% in 2002, without any adverse effect.
Conclusions: This study shows that it is possible to replace the current practice in the UK of risk stratification of adult MHI based on skull radiography, with slightly modified versions of the Canadian CT rule/NICE guidelines. This will result in a large reduction in skull radiography and will be associated with modest increases in CT and admissions rates. If introduction of the NICE guideline is to be realistic, the study suggests that it will not be cost neutral.
doi:10.1136/emj.2003.011353
PMCID: PMC1726397  PMID: 15208222
15.  Racial disparities in health care—emergency department management of minor head injury 
Background/aim
International research has demonstrated disparities in the Emergency Department care of patients of certain racial or ethnic backgrounds. The management of minor head injuries requires a careful clinical assessment to determine the requirement of a CT scan of the head. The aim of this study was to determine if there was any disparity, based on race, in the management of minor head injury.
Methods
This was a retrospective, structured, medical record review of patients presenting to The Townsville Hospital Emergency Department, between September 2004 and April 2007, with minor head injury. The main outcome measure was whether or not patients received a CT head scan when clinically indicated. The Canadian CT Head Rule was considered the standard for clinical indication for a CT head scan. Secondary outcome measures included triage category, waiting time, level of care provider, disposition and serum ethanol.
Results
A total of 270 patients (73 indigenous and 196 non-indigenous) were enrolled. There was no statistically significant difference in ordering CT head scans when clinically indicated between indigenous and non-indigenous patients. However, a trend indicating that indigenous patients were less likely to receive a CT head scan when clinically indicated (OR 0.35; 95% CI = 0.07 to 1.77) was noted. Indigenous patients had a mean waiting time of 44.6 min (SD 49.6) compared to non-indigenous with 31.1 min (SD 36.4; p = 0.02).
Conclusion
This study concluded that there was no statistically significant disparity based upon race in the management of minor head injuries with regard to decision to perform a CT head scan. There is some evidence that indigenous patients waited longer to be seen. A multi-centre prospective study is necessary to confirm these findings.
doi:10.1007/s12245-009-0124-9
PMCID: PMC2760704  PMID: 20157466
Racial disparity; Head injury; Emergency department
16.  Automated Detection of Infectious Disease Outbreaks in Hospitals: A Retrospective Cohort Study 
PLoS Medicine  2010;7(2):e1000238.
Susan Huang and colleagues describe an automated statistical software, WHONET-SaTScan, its application in a hospital, and the potential it has to identify hospital infection clusters that had escaped routine detection.
Background
Detection of outbreaks of hospital-acquired infections is often based on simple rules, such as the occurrence of three new cases of a single pathogen in two weeks on the same ward. These rules typically focus on only a few pathogens, and they do not account for the pathogens' underlying prevalence, the normal random variation in rates, and clusters that may occur beyond a single ward, such as those associated with specialty services. Ideally, outbreak detection programs should evaluate many pathogens, using a wide array of data sources.
Methods and Findings
We applied a space-time permutation scan statistic to microbiology data from patients admitted to a 750-bed academic medical center in 2002–2006, using WHONET-SaTScan laboratory information software from the World Health Organization (WHO) Collaborating Centre for Surveillance of Antimicrobial Resistance. We evaluated patients' first isolates for each potential pathogenic species. In order to evaluate hospital-associated infections, only pathogens first isolated >2 d after admission were included. Clusters were sought daily across the entire hospital, as well as in hospital wards, specialty services, and using similar antimicrobial susceptibility profiles. We assessed clusters that had a likelihood of occurring by chance less than once per year. For methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococci (VRE), WHONET-SaTScan–generated clusters were compared to those previously identified by the Infection Control program, which were based on a rule-based criterion of three occurrences in two weeks in the same ward. Two hospital epidemiologists independently classified each cluster's importance. From 2002 to 2006, WHONET-SaTScan found 59 clusters involving 2–27 patients (median 4). Clusters were identified by antimicrobial resistance profile (41%), wards (29%), service (13%), and hospital-wide assessments (17%). WHONET-SaTScan rapidly detected the two previously known gram-negative pathogen clusters. Compared to rule-based thresholds, WHONET-SaTScan considered only one of 73 previously designated MRSA clusters and 0 of 87 VRE clusters as episodes statistically unlikely to have occurred by chance. WHONET-SaTScan identified six MRSA and four VRE clusters that were previously unknown. Epidemiologists considered more than 95% of the 59 detected clusters to merit consideration, with 27% warranting active investigation or intervention.
Conclusions
Automated statistical software identified hospital clusters that had escaped routine detection. It also classified many previously identified clusters as events likely to occur because of normal random fluctuations. This automated method has the potential to provide valuable real-time guidance both by identifying otherwise unrecognized outbreaks and by preventing the unnecessary implementation of resource-intensive infection control measures that interfere with regular patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Admission to a hospital is often a life-saving necessity—individuals injured in a road accident, for example, may need immediate medical and surgical attention if they are to survive. Unfortunately, many patients acquire infections, some of which are life-threatening, during their stay in a hospital. The World Health Organization has estimated that, globally, 8.7% of hospital patients develop hospital-acquired infections (infections that are identified more than two days after admission to hospital). In the US alone, 2 million people develop a hospital-acquired infection every year, often an infection of a surgical wound, or a urinary tract or lung infection. Infections are common among hospital patients because increasing age or underlying illnesses can reduce immunity to infection and because many medical and surgical procedures bypass the body's natural protective barriers. In addition, poor infection control practices can facilitate the transmission of bacteria—including meticillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE)—and other infectious agents (pathogens) between patients.
Why Was This Study Done?
Sometimes, the number of cases of hospital-acquired infections increases unexpectedly or a new infection emerges. Such clusters account for relatively few health care–associated infections, but, because they may arise from the transmission of a pathogen within a hospital, they need to be rapidly identified and measures implemented (for example, isolation of affected patients) to stop transmission if an outbreak is confirmed. Currently, the detection of clusters of hospital-acquired infections is based on simple rules, such as the occurrence of three new cases of a single pathogen in two weeks on the same ward. This rule-based approach relies on the human eye to detect infection clusters within microbiology data (information collected on the pathogens isolated from patients), it focuses on a few pathogens, and it does not consider the random variation in infection rates or the possibility that clusters might be associated with shared facilities rather than with individual wards. In this study, the researchers test whether an automated statistical system can detect outbreaks of hospital-acquired infections quickly and accurately.
What Did the Researchers Do and Find?
The researchers combined two software packages used to track diseases in populations to create the WHONET-SaTScan cluster detection tool. They then compared the clusters of hospital-acquired infection identified by the new tool in microbiology data from a 750-bed US academic medical center with those generated by the hospital's infection control program, which was largely based on the simple rule described above. WHONET-SaTScan found 59 clusters of infection that occurred between 2002 and 2006, about three-quarters of which were identified by characteristics other than a ward-based location. Nearly half the cluster alerts were generated on the basis of shared antibiotic susceptibility patterns. Although WHONET-SaTScan identified all the clusters previously identified by the hospital's infection control program, it classified most of these clusters as likely to be the result of normal random variations in infection rates rather than the result of “true” outbreaks. By contrast, the hospital's infection control department only identified three of the 59 statistically significant clusters identified by WHONET-SaTScan. Furthermore, the new tool identified six previously unknown MRSA outbreaks and four previously unknown VRE outbreaks. Finally, two hospital epidemiologists (scientists who study diseases in populations) classified 95% of the clusters detected by WHONET-SaTScan as worthy of consideration by the hospital infection control team and a quarter of the clusters as warranting active investigation or intervention.
What Do These Findings Mean?
These findings suggest that automated statistical software should be able to detect clusters of hospital-acquired infections that would escape detection using routine rule-based systems. Importantly, they also suggest that an automated system would be able to discount a large number of supposed outbreaks identified by rule-based systems. These findings need to be confirmed in other settings and in prospective studies in which the outcomes of clusters detected with WHONET-SaTScan are carefully analyzed. For now, however, these findings suggest that automated statistical tools could provide hospital infection control experts with valuable real-time guidance by identifying outbreaks that would be missed by routine detection methods and by preventing the implementation of intensive and costly infection control measures in situations where they are unnecessary.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000238.
The World Health Organization's Prevention of Hospital-Acquired Infections, A Practical Guide contains detailed information on all aspects of hospital-acquired infections
MedlinePlus provides links to information on infection control in hospitals (in English and Spanish)
The US Centers for Disease Control and Prevention also provides information on infectious diseases in health care settings (in English and Spanish)
The WHONET/Baclink software and the SatScan software, the two components of WHONET-SaTScan are both available on the internet (the WHONET-SaTScan cluster detection tool is freely available as part of the version of WHONET/BacLink released June 2009)
doi:10.1371/journal.pmed.1000238
PMCID: PMC2826381  PMID: 20186274
17.  Evaluating a streamlined clinical tool and educational outreach intervention for health care workers in Malawi: the PALM PLUS case study 
Background
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.
doi:10.1186/1472-698X-11-S2-S11
PMCID: PMC3247831  PMID: 22166125
18.  School Playground Surfacing and Arm Fractures in Children: A Cluster Randomized Trial Comparing Sand to Wood Chip Surfaces 
PLoS Medicine  2009;6(12):e1000195.
In a randomized trial of elementary schools in Toronto, Andrew Howard and colleagues show that granitic sand playground surfaces reduce the risk of arm fractures from playground falls when compared with wood fiber surfaces.
Background
The risk of playground injuries, especially fractures, is prevalent in children, and can result in emergency room treatment and hospital admissions. Fall height and surface area are major determinants of playground fall injury risk. The primary objective was to determine if there was a difference in playground upper extremity fracture rates in school playgrounds with wood fibre surfacing versus granite sand surfacing. Secondary objectives were to determine if there were differences in overall playground injury rates or in head injury rates in school playgrounds with wood fibre surfacing compared to school playgrounds with granite sand surfacing.
Methods and Findings
The cluster randomized trial comprised 37 elementary schools in the Toronto District School Board in Toronto, Canada with a total of 15,074 students. Each school received qualified funding for installation of new playground equipment and surfacing. The risk of arm fracture from playground falls onto granitic sand versus onto engineered wood fibre surfaces was compared, with an outcome measure of estimated arm fracture rate per 100,000 student-months. Schools were randomly assigned by computer generated list to receive either a granitic sand or an engineered wood fibre playground surface (Fibar), and were not blinded. Schools were visited to ascertain details of the playground and surface actually installed and to observe the exposure to play and to periodically monitor the depth of the surfacing material. Injury data, including details of circumstance and diagnosis, were collected at each school by a prospective surveillance system with confirmation of injury details through a validated telephone interview with parents and also through collection (with consent) of medical reports regarding treated injuries. All schools were recruited together at the beginning of the trial, which is now closed after 2.5 years of injury data collection. Compliant schools included 12 schools randomized to Fibar that installed Fibar and seven schools randomized to sand that installed sand. Noncompliant schools were added to the analysis to complete a cohort type analysis by treatment received (two schools that were randomized to Fibar but installed sand and seven schools that were randomized to sand but installed Fibar). Among compliant schools, an arm fracture rate of 1.9 (95% confidence interval [CI] 0.04–6.9) per 100,000 student-months was observed for falls into sand, compared with an arm fracture rate of 9.4 (95% CI 3.7–21.4) for falls onto Fibar surfaces (p≤0.04905). Among all schools, the arm fracture rate was 4.5 (95% CI 0.26–15.9) per 100,000 student-months for falls into sand compared with 12.9 (95% CI 5.1–30.1) for falls onto Fibar surfaces. No serious head injuries and no fatalities were observed in either group.
Conclusions
Granitic sand playground surfaces reduce the risk of arm fractures from playground falls when compared with engineered wood fibre surfaces. Upgrading playground surfacing standards to reflect this information will prevent arm fractures.
Trial Registration
Current Controlled Trials ISRCTN02647424
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Playgrounds and outdoor play equipment provide children with a place to let steam off, play creatively, socialize, and learn new skills. And, in a world where childhood obesity is a burgeoning problem, playgrounds provide a place where children can be encouraged to exercise. But playgrounds are not without hazards. Even in well-maintained and well-run facilities, children can hurt themselves by falling off climbing frames, monkey bars, and other equipment or by falling from standing height during playground games such as tag. In the US alone, more than 200,000 children are treated in emergency departments for injuries sustained in playgrounds every year and about 6,400 children are admitted to hospitals because of playground injuries, most of which are bone fractures (broken bones). In fact, playground injuries in the US are more severe and have a higher hospital admission rate than any other sort of child injury except those involving vehicles.
Why Was This Study Done?
Children who fall off playground equipment are nearly four times as likely to break a bone (often in an arm) as children who fall from standing height. To reduce the number of fractures that occur in playgrounds, some governments have limited the height of playground equipment. Some have also set standards for the type of surfaces installed in playgrounds and for the depth of sand or engineered wood fiber in loose fill surfaces. These standards are based on laboratory tests in which headforms (artificial heads) are dropped onto surfaces. However, these tests provide no information about the ability of different surfaces to prevent broken arms and other specific injuries in the real world. In this cluster randomized trial (a study in which groups of people are randomly assigned to receive different interventions), the researchers compare the rates of arm fractures in elementary (primary) school playgrounds in Toronto (Canada) that have wood fiber surfacing with the rates in playgrounds that have granite sand surfacing.
What Did the Researchers Do and Find?
The researchers randomly assigned 37 elementary schools that had qualified for school board funding for replacement playground equipment to receive either wood fiber (19 schools) or granite sand surfacing (18 schools) in their playgrounds. 19 of the schools complied with their randomization (12 installed fiber and seven installed sand); two schools installed sand although they were randomized to install fiber and seven schools installed fiber instead of sand. The researchers evaluated the playgrounds and their surfaces several times during the 2.5-year study and collected data on how playground injuries happened and types of injuries from the schools, parents, and medical reports. Among the schools that complied with randomization, falls from height into sand resulted in 1.9 arm fractures per 100,000 student-months whereas falls into fiber resulted in 9.4 arm fractures per 100,000 student-months. Arm fracture rates and other injury rates were also higher for falls from height into fiber than into sand when all the schools that had installed new surfaces were considered. However, the rates of arm fracture and other injuries that did not involve a fall from height did not vary between surfaces.
What Do These Findings Mean?
The accuracy of these findings is limited by the small number of arm fractures that occurred during the trial—only 20 children who fell into fiber and two who fell into sand broke an arm. The accuracy of the findings may also be limited by the failure of many schools to comply with randomization although the researchers found no obvious differences between the schools that did and did not comply with randomization that might have affected the trial's outcome. However, even with these limitations, the findings of this real-world study indicate that granitic sand surfaces substantially reduce the risk of arm fractures and other injuries caused by falls from playground equipment when compared with wood fiber surfaces. Thus, because falls from playground equipment are more likely to cause a fracture than falls from standing height, if playground surfacing standards are adjusted to reflect the findings of this study (that is, if sand surfaces are recommended in preference to wood fiber surfaces), many arm fractures in children should be prevented.
Additional Information
Please access these Web sites via the online version of this summary at ttp://dx.doi.org/10.1371/journal.pmed.1000195.
Safe Kids Canada provides information about playground safety and other aspects of childhood safety (in English and French)
Safe Kids Worldwide is a global network of organizations whose mission is to prevent accidental childhood injury (in English and Spanish)
The Nemours Foundation, a nonprofit organization for child health, provides information for parents on playground safety
The Royal Society for the Prevention of Accidents provides information on the safety of indoor and outdoor play areas
The US Centers for Disease Control and Prevention provides fact sheets on playground injuries
The US Consumer Product Safety Commission also has information on playground safety, including resources designed for children such as The Further Adventures of Kidd Safety and Little Big Kids, a booklet on play safety written by children for children
doi:10.1371/journal.pmed.1000195
PMCID: PMC2784292  PMID: 20016688
19.  Derivation of the children's head injury algorithm for the prediction of important clinical events decision rule for head injury in children 
Archives of Disease in Childhood  2006;91(11):885-891.
Background
A quarter of all patients presenting to emergency departments are children. Although there are several large, well‐conducted studies on adults enabling accurate selection of patients with head injury at high risk for computed tomography scanning, no such study has derived a rule for children.
Aim
To conduct a prospective multicentre diagnostic cohort study to provide a rule for selection of high‐risk children with head injury for computed tomography scanning.
Design
All children presenting to the emergency departments of 10 hospitals in the northwest of England with any severity of head injury were recruited. A tailor‐made proforma was used to collect data on around 40 clinical variables for each child. These variables were defined from a literature review, and a pilot study was conducted before the children's head injury algorithm for the prediction of important clinical events (CHALICE) study. All children who had a clinically significant head injury (death, need for neurosurgical intervention or abnormality on a computed tomography scan) were identified. Recursive partitioning was used to create a highly sensitive rule for the prediction of significant intracranial pathology.
Results
22 772 children were recruited over 2½ years. 65% of these were boys and 56% were <5 years old. 281 children showed an abnormality on the computed tomography scan, 137 had a neurosurgical operation and 15 died. The CHALICE rule was derived with a sensitivity of 98% (95% confidence interval (CI) 96% to 100%) and a specificity of 87% (95% CI 86% to 87%) for the prediction of clinically significant head injury, and requires a computed tomography scan rate of 14%.
Conclusion
A highly sensitive clinical decision rule is derived for the identification of children who should undergo computed tomography scanning after head injury. This rule has the potential to improve and standardise the care of children presenting with head injuries. Validation of this rule in new cohorts of patients should now be undertaken.
doi:10.1136/adc.2005.083980
PMCID: PMC2082967  PMID: 17056862
20.  Multicentre prospective validation of use of the Canadian C-Spine Rule by triage nurses in the emergency department 
Objectives
The Canadian C-Spine Rule for imaging of the cervical spine was developed for use by physicians. We believe that nurses in the emergency department could use this rule to clinically clear the cervical spine. We prospectively evaluated the accuracy, reliability and acceptability of the Canadian C-Spine Rule when used by nurses.
Methods
We conducted this three-year prospective cohort study in six Canadian emergency departments. The study involved adult trauma patients who were alert and whose condition was stable. We provided two hours of training to 191 triage nurses. The nurses then assessed patients using the Canadian C-Spine Rule, including determination of neck tenderness and range of motion, reapplied immobilization and completed a data form.
Results
Of the 3633 study patients, 42 (1.2%) had clinically important injuries of the cervical spine. The kappa value for interobserver assessments of 498 patients with the Canadian C-Spine Rule was 0.78. We calculated sensitivity of 100.0% (95% confidence interval [CI] 91.0%–100.0%) and specificity of 43.4% (95% CI 42.0%–45.0%) for the Canadian C-Spine Rule as interpreted by the investigators. The nurses classified patients with a sensitivity of 90.2% (95% CI 76.0%–95.0%) and a specificity of 43.9% (95% CI 42.0%–46.0%). Early in the study, nurses failed to identify four cases of injury, despite the presence of clear high-risk factors. None of these patients suffered sequelae, and after retraining there were no further missed cases. We estimated that for 40.7% of patients, the cervical spine could be cleared clinically by nurses. Nurses reported discomfort in applying the Canadian C-Spine Rule in only 4.8% of cases.
Conclusion
Use of the Canadian C-Spine Rule by nurses was accurate, reliable and clinically acceptable. Widespread implementation by nurses throughout Canada and elsewhere would diminish patient discomfort and improve patient flow in overcrowded emergency departments.
doi:10.1503/cmaj.091430
PMCID: PMC2917929  PMID: 20457772
21.  Research on Implementation of Interventions in Tuberculosis Control in Low- and Middle-Income Countries: A Systematic Review 
PLoS Medicine  2012;9(12):e1001358.
Cobelens and colleagues systematically reviewed research on implementation and cost-effectiveness of the WHO-recommended interventions for tuberculosis.
Background
Several interventions for tuberculosis (TB) control have been recommended by the World Health Organization (WHO) over the past decade. These include isoniazid preventive therapy (IPT) for HIV-infected individuals and household contacts of infectious TB patients, diagnostic algorithms for rule-in or rule-out of smear-negative pulmonary TB, and programmatic treatment for multidrug-resistant TB. There is no systematically collected data on the type of evidence that is publicly available to guide the scale-up of these interventions in low- and middle-income countries. We investigated the availability of published evidence on their effectiveness, delivery, and cost-effectiveness that policy makers need for scaling-up these interventions at country level.
Methods and Findings
PubMed, Web of Science, EMBASE, and several regional databases were searched for studies published from 1 January 1990 through 31 March 2012 that assessed health outcomes, delivery aspects, or cost-effectiveness for any of these interventions in low- or middle-income countries. Selected studies were evaluated for their objective(s), design, geographical and institutional setting, and generalizability. Studies reporting health outcomes were categorized as primarily addressing efficacy or effectiveness of the intervention. These criteria were used to draw landscapes of published research. We identified 59 studies on IPT in HIV infection, 14 on IPT in household contacts, 44 on rule-in diagnosis, 19 on rule-out diagnosis, and 72 on second-line treatment. Comparative effectiveness studies were relatively few (n = 9) and limited to South America and sub-Saharan Africa for IPT in HIV-infection, absent for IPT in household contacts, and rare for second-line treatment (n = 3). Evaluations of diagnostic and screening algorithms were more frequent (n = 19) but geographically clustered and mainly of non-comparative design. Fifty-four studies evaluated ways of delivering these interventions, and nine addressed their cost-effectiveness.
Conclusions
There are substantial gaps in published evidence for scale-up for five WHO-recommended TB interventions settings at country level, which for many countries possibly precludes program-wide implementation of these interventions. There is a strong need for rigorous operational research studies to be carried out in programmatic settings to inform on best use of existing and new interventions in TB control.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Tuberculosis (TB), caused by Mycobacterium tuberculosis, is curable and preventable, but according to the World Health Organization (WHO), in 2011, 8.7 million people had symptoms of TB (usually a productive cough and fever) and 1.4 million people—95% from low- and middle-income countries—died from TB. TB is also the leading cause of death in people with HIV worldwide, and in 2010 about 10 million children were orphaned as a result of their parents dying from TB. To help reduce the considerable global burden of TB, a global initiative called the Stop TB Partnership, led by WHO, has implemented a strategy to reduce deaths from TB by 50% by 2015—even greater than the target of Millennium Development Goal 6 (to reverse the increase in TB incidence by 2015).
Why Was This Study Done?
Over the past few years, WHO has recommended that countries implement several interventions to help control the spread of tuberculosis through measures to improve prevention, diagnosis, and treatment. Five such interventions currently recommended by WHO are: treatment with isoniazid to prevent TB among people who are HIV positive, and also among household contacts of people infected with TB; the use of clinical pathways (algorithms) for diagnosing TB in people accessing health care who have a negative smear test—the most commonly used diagnostic test, which relies on sputum samples—(“rule-in algorithms”); screening algorithms for excluding TB in people who have HIV (“rule-out algorithms”); and finally, provision of second-line treatment for multidrug-resistant tuberculosis (a form of TB that does not respond to the most commonly used drugs) under programmatic conditions. The effectiveness of these interventions, their costs, and the practicalities of implementation are all important information for countries seeking to control TB following the WHO guidelines, but little is known about the availability of this information. Therefore, in this study the researchers systematically reviewed published studies to find evidence of the effectiveness of each of these interventions when implemented in routine practice, and also for additional information on the setting and conditions of implemented interventions, which might be useful to other countries.
What Did the Researchers Do and Find?
Using a specific search strategy, the researchers comprehensively searched through several key databases of publications, including regional databases, to identify 208 (out of 11,489 found initially) suitable research papers published between January 1990 and March 2012. For included studies, the researchers also noted the geographical location and setting and the type and design of study.
Of the 208 included studies, 59 focused on isoniazid prevention therapy in HIV infection, and only 14 on isoniazid prevention therapy for household contacts. There were 44 studies on “rule-in” clinical diagnosis, 19 on “rule-out” clinical diagnosis, and 72 studies on second-line treatment for TB. Studies on each intervention had some weaknesses, and overall, researchers found that there were very few real-world studies reporting on the effectiveness of interventions in program settings (rather than under optimal conditions in research settings). Few studies evaluated the methods used to implement the intervention or addressed delivery and operational issues (such as adherence to treatment), and there were limited economic evaluations of the recommended interventions. Furthermore, the researchers found that in general, the South Asian region was poorly represented.
What Do These Findings Mean?
These findings suggest that there is limited evidence on effectiveness, delivery, and cost-effectiveness to guide the scale-up of five WHO recommended interventions to control tuberculosis in the countries and settings, despite the urgent need for such interventions to be implemented. The poor evidence base identified in this review highlights the tension between the decision to adopt the recommendation and its implementation adapted to local circumstances, and may be an important reason as to why these interventions are not implemented in many countries. This study also suggests creative thinking is necessary to address the gaps between WHO recommendations and global health policy on new interventions and their real-world implementation in country-wide TB control programs. Future research should focus more on operational studies, the results of which should be made publicly available, and researchers, donors, and medical journals could perhaps re-consider their priorities to help bridge the knowledge gap identified in this study.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001358.
WHO has a wide range of information about TB and research on TB, including more about the STOP TB strategy and the STOP TB Partnership
The UN website has more information about MDG 6
The Global Fund to Fight AIDS, Tuberculosis and Malaria has specific information about progress on TB control
doi:10.1371/journal.pmed.1001358
PMCID: PMC3525528  PMID: 23271959
22.  Efficacy of Canadian computed tomography head rule in predicting the need for a computed–axial tomography scans among patients with suspected head injuries 
Context:
The use of imaging modalities is crucial in the diagnostic field of critical medicine. However, the ethical and economic use of these techniques has become a major concern especially in resource-poor settings. The Canadian computed tomography Head Rule (CCHR) is being increasingly used all over the world to evaluate the necessity of a Computer-assisted Tomography (CT) scan in patients with suspected head injury.
Aim:
The aim of the current study is to evaluate the efficacy of CCHR to predict the occurrence of head injury, as evidenced radiologically by a CT Head, at a government tertiary care clinical setting in south India.
Setting and Design:
The design was that of a hospital-based cross-sectional survey conducted at the Medical College Hospital, Thiruvananthapuram (Kerala, India).
Materials and Methods:
The study subjects were patients with suspected head injury evaluated at the Surgical Casualty Department of the study setting. Fifty consecutive patients with suspected head injury were enrolled in the study.
Statistical Analysis:
The Chi-square test was used to assess the statistical significance of association between the outcome variable and the exposure characteristics. The diagnostic ability of the Glasgow Coma Scale (GCS) and CCHR were expressed in terms of sensitivity and specificity by considering CT diagnosed Head injury as the gold standard diagnostic tool.
Results:
Clinical manifestations as measured by a GCS score < 13 failed to significantly predict a head injury in the CT scan. However, the same became statistically significant when the CCHR was added to the GCS score as a predictor (P value < 0.001). The sensitivity of the tool in predicting a head injury rose from 23.3 to 96.7%.
Conclusion:
The current study suggested that the CCHR could act as an excellent decision rule to indicate the need of a CT scan. The need of a decision rule was warranted in the context of the growth of newer diagnostic imaging facilities in India.
doi:10.4103/2229-5151.100904
PMCID: PMC3500009  PMID: 23181211
Canadian CT head rule; canadian computed tomography Head Rule; computer-assisted tomography scan; canadian CT head rule in India; head injury
23.  The Effectiveness of Community Action in Reducing Risky Alcohol Consumption and Harm: A Cluster Randomised Controlled Trial 
PLoS Medicine  2014;11(3):e1001617.
In a cluster randomized controlled trial, Anthony Shakeshaft and colleagues measure the effectiveness of a multi-component community-based intervention for reducing alcohol-related harm.
Background
The World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community), and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT) of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data.
Methods and Findings
We conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000–20,000, were at least 100 km from an urban centre (population ≥ 100,000), and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI); feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department–based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001–2009) were obtained in 2010. Secondary outcomes based on pre- and post-intervention surveys (n = 2,977 and 2,255, respectively) were the following: long-term risky drinking, short-term high-risk drinking, short-term risky drinking, weekly consumption, hazardous/harmful alcohol use, and experience of alcohol harm. At the 5% level of statistical significance, there was insufficient evidence to conclude that the interventions were effective in the experimental, relative to control, communities for alcohol-related crime, traffic crashes, and hospital inpatient admissions, and for rates of risky alcohol consumption and hazardous/harmful alcohol use. Although respondents in the experimental communities reported statistically significantly lower average weekly consumption (1.90 fewer standard drinks per week, 95% CI = −3.37 to −0.43, p = 0.01) and less alcohol-related verbal abuse (odds ratio = 0.58, 95% CI = 0.35 to 0.96, p = 0.04) post-intervention, the low survey response rates (40% and 24% for the pre- and post-intervention surveys, respectively) require conservative interpretation. The main limitations of this study are as follows: (1) that the study may have been under-powered to detect differences in routinely collected data outcomes as statistically significant, and (2) the low survey response rates.
Conclusions
This RCT provides little evidence that community action significantly reduces risky alcohol consumption and alcohol-related harms, other than potential reductions in self-reported average weekly consumption and experience of alcohol-related verbal abuse. Complementary legislative action may be required to more effectively reduce alcohol harms.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12607000123448
Please see later in the article for the Editors' Summary
Editors' Summary
Background
People have consumed alcoholic beverages throughout history, but alcohol use is now an increasing global public health problem. According to the World Health Organization's 2010 Global Burden of Disease Study, alcohol use is the fifth leading risk factor (after high blood pressure and smoking) for disease and is responsible for 3.9% of the global disease burden. Alcohol use contributes to heart disease, liver disease, depression, some cancers, and many other health conditions. Alcohol also affects the well-being and health of people around those who drink, through alcohol-related crimes and road traffic crashes. The impact of alcohol use on disease and injury depends on the amount of alcohol consumed and the pattern of drinking. Most guidelines define long-term risky drinking as more than four drinks per day on average for men or more than two drinks per day for women (a “drink” is, roughly speaking, a can of beer or a small glass of wine), and short-term risky drinking (also called binge drinking) as seven or more drinks on a single occasion for men or five or more drinks on a single occasion for women. However, recent changes to the Australian guidelines acknowledge that a lower level of alcohol consumption is considered risky (with lifetime risky drinking defined as more than two drinks a day and binge drinking defined as more than four drinks on one occasion).
Why Was This Study Done?
In 2010, the World Health Assembly endorsed a global strategy to reduce the harmful use of alcohol. This strategy emphasizes the importance of community action–a process in which a community defines its own needs and determines the actions that are required to meet these needs. Although community action is highly acceptable to community members, few studies have looked at the effectiveness of community action in reducing risky alcohol consumption and alcohol-related harm. Here, the researchers undertake a cluster randomized controlled trial (the Alcohol Action in Rural Communities [AARC] project) to quantify the effectiveness of community action in reducing risky alcohol consumption and harms in rural communities in Australia. A cluster randomized trial compares outcomes in clusters of people (here, communities) who receive alternative interventions assigned through the play of chance.
What Did the Researchers Do and Find?
The researchers pair-matched 20 rural Australian communities according to the proportion of their population that was Aboriginal (rates of alcohol-related harm are disproportionately higher among Aboriginal individuals than among non-Aboriginal individuals in Australia; they are also higher among young people and males, but the proportions of these two groups across communities was comparable). They randomly assigned one member of each pair to the experimental group and implemented 13 interventions in these communities by negotiating with key individuals in each community to define and implement each intervention. Examples of interventions included general practitioner training in screening for alcohol use disorders and in implementing a brief intervention, and a school-based interactive session designed to reduce alcohol harm among young people. The researchers quantified the effectiveness of the interventions using routinely collected data on alcohol-related crime and road traffic crashes, and on hospital inpatient admissions for alcohol dependence or abuse (which were expected to increase in the experimental group if the intervention was effective because of more people seeking or being referred for treatment). They also examined drinking habits and experiences of alcohol-related harm, such as verbal abuse, among community members using pre- and post-intervention surveys. After implementation of the interventions, the rates of alcohol-related crime, road traffic crashes, and hospital admissions, and of risky and hazardous/harmful alcohol consumption (measured using a validated tool called the Alcohol Use Disorders Identification Test) were not statistically significantly different in the experimental and control communities (a difference in outcomes that is not statistically significantly different can occur by chance). However, the reported average weekly consumption of alcohol was 20% lower in the experimental communities after the intervention than in the control communities (equivalent to 1.9 fewer standard drinks per week per respondent) and there was less alcohol-related verbal abuse post-intervention in the experimental communities than in the control communities.
What Do These Findings Mean?
These findings provide little evidence that community action reduced risky alcohol consumption and alcohol-related harms in rural Australian communities. Although there was some evidence of significant reductions in self-reported weekly alcohol consumption and in experiences of alcohol-related verbal abuse, these findings must be interpreted cautiously because they are based on surveys with very low response rates. A larger or differently designed study might provide statistically significant evidence for the effectiveness of community action in reducing risky alcohol consumption. However, given their findings, the researchers suggest that legislative approaches that are beyond the control of individual communities, such as alcohol taxation and restrictions on alcohol availability, may be required to effectively reduce alcohol harms. In other words, community action alone may not be the most effective way to reduce alcohol-related harm.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001617.
The World Health Organization provides detailed information about alcohol; its fact sheet on alcohol includes information about the global strategy to reduce the harmful use of alcohol; the Global Information System on Alcohol and Health provides further information about alcohol, including information on control policies around the world
The US National Institute on Alcohol Abuse and Alcoholism has information about alcohol and its effects on health
The US Centers for Disease Control and Prevention has a website on alcohol and public health that includes information on the health risks of excessive drinking
The UK National Health Service Choices website provides detailed information about drinking and alcohol, including information on the risks of drinking too much, tools for calculating alcohol consumption, and personal stories about alcohol use problems
MedlinePlus provides links to many other resources on alcohol
More information about the Alcohol Action in Rural Communities project is available
doi:10.1371/journal.pmed.1001617
PMCID: PMC3949675  PMID: 24618831
24.  Long term effects of a home visit to prevent childhood injury: three year follow up of a randomized trial 
Injury Prevention  2005;11(2):106-109.
Objective: To assess the long term effect of a home safety visit on the rate of home injury.
Design: Telephone survey conducted 36 months after participation in a randomized controlled trial of a home safety intervention. A structured interview assessed participant knowledge, beliefs, or practices around injury prevention and the number of injuries requiring medical attention.
Setting: Five pediatric teaching hospitals in four Canadian urban centres.
Participants: Children less than 8 years of age presenting to an emergency department with a targeted home injury (fall, scald, burn, poisoning or ingestion, choking, or head injury while riding a bicycle), a non-targeted injury, or a medical illness.
Results: We contacted 774 (66%) of the 1172 original participants. A higher proportion of participants in the intervention group (63%) reported that home visits changed their knowledge, beliefs, or practices around the prevention of home injuries compared with those in the non-intervention group (43%; p<0.001). Over the 36 month follow up period the rate of injury visits to the doctor was significantly less for the intervention group (rate ratio = 0.74; 95% CI 0.63 to 0.87), consistent with the original (12 month) study results (rate ratio = 0.69; 95% CI 0.54 to 0.88). However, the effectiveness of the intervention appears to be diminishing with time (rate ratio for the 12–36 month study interval = 0.80; 95% CI 0.64 to 1.00).
Conclusions: A home safety visit was able to demonstrate sustained, but modest, effectiveness of an intervention aimed at improving home safety and reducing injury. This study reinforces the need of home safety programs to focus on passive intervention and a simple well defined message.
doi:10.1136/ip.2004.006791
PMCID: PMC1730192  PMID: 15805440
25.  Effect of bodychecking on rate of injuries among minor hockey players 
Open Medicine  2011;5(1):e57-e64.
Background
Bodychecking is a leading cause of injury among minor hockey players. Its value has been the subject of heated debate since Hockey Canada introduced bodychecking for competitive players as young as 9 years in the 1998/1999 season. Our goal was to determine whether lowering the legal age of bodychecking from 11 to 9 years affected the numbers of all hockey-related injuries and of those specifically related to bodychecking among minor hockey players in Ontario.
Methods
In this retrospective study, we evaluated data collected through the Canadian Hospitals Injury Reporting and Prevention Program. The study’s participants were male hockey league players aged 6–17 years who visited the emergency departments of 5 hospitals in Ontario for hockey-related injuries during 10 hockey seasons (September 1994 to May 2004). Injuries were classified as bodychecking-related or non-bodychecking-related. Injuries that occurred after the rule change took effect were compared with those that occurred before the rule’s introduction.
Results
During the study period, a total of 8552 hockey-related injuries were reported, 4460 (52.2%) of which were attributable to bodychecking. The odds ratio (OR) of a visit to the emergency department because of a bodychecking-related injury increased after the rule change (OR 1.26, 95% confidence interval [CI] 1.16–1.38), the head and neck (OR 1.52, 95% CI 1.26–1.84) and the shoulder and arm (OR 1.18, 95% CI 1.04–1.35) being the body parts with the most substantial increases in injury rate. The OR of an emergency visit because of concussion increased significantly in the Atom division after the rule change, which allowed bodychecking in the Atom division. After the rule change, the odds of a bodychecking-related injury was significantly higher in the Atom division (OR 2.20, 95% CI 1.70–2.84).
Interpretation
In this study, the odds of injury increased with decreasing age of exposure to bodychecking. These findings add to the growing evidence that bodychecking holds greater risk than benefit for youth and support widespread calls to ban this practice.
PMCID: PMC3205817  PMID: 22046222

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