Correlates of cognitive functioning in independent elderly patients discharged home from the emergency department after a minor injury.

BACKGROUND: The objective of this study was to explore correlates of cognitive functioning of older adults visiting the emergency department (ED) after a minor injury. METHODS: These results are derived from a large prospective study in three Canadian EDs. Participants were aged ≥ 65 years and independent in basic activities of daily living, visiting the ED for minor injuries and discharged home within 48 hours (those with known dementia, confusion, and delirium were excluded). They completed the Montreal Cognitive Assessment (MoCA). Potential correlates included sociodemographic and injury variables, and measures of psychological and physical health, social support, mobility, falls, and functional status. RESULTS: Multivariate analyses revealed that male sex, age ≥ 85 years, higher depression scores, slower walking speed, and self-reported memory problems were significantly associated with lower baseline MoCA scores. CONCLUSIONS: These characteristics could help ED professionals identify patients who might need additional cognitive evaluations or follow-ups after their passage through the ED. Obtaining information on these characteristics is potentially feasible in the ED context and could help professionals alter favorably elderly's trajectory of care. Since a significant proportion of elderly patients consulting at an ED have cognitive impairment, the ED is an opportunity to prevent functional and cognitive decline.

Functional Impact of a Minor Thoracic Injury: An Investigation of Age, Delayed Hemothorax, and Rib Fracture Effects.

OBJECTIVE: To investigate whether minor thoracic injuries (MTIs) relate to subsequent functional limitations. BACKGROUND: Approximately 75% of patients with an MTI are discharged after an emergency department (ED) visit, whereas significant functional limitations can occur in the weeks that follow. METHODS: A 19 months' prospective cohort study with a 90-day follow-up was conducted at 4 university-affiliated EDs. Patients 16 years and older with an MTI were assessed at initial ED visit, 7, 14, 30, and 90 days after injury. Functional outcome was measured using the SF-12 scale. General linear model were used to assess outcome. RESULTS: A total of 482 patients were included, of whom 127 (26.3%) were 65 or older. Overall, 147 patients (30.5%) presented with at least 1 rib fracture and 59 subjects (12.2%) with delayed hemothorax. At 90 days, 22.8% of patients still had severe or moderate disabilities on global physical health score. Patients with solely delayed hemothorax and no rib fracture had the lowest global physical health score (46.4 vs 61.1, P < 0.01, effect size =  -2.60) than patients with simple MTI. Generally, functional limitations also increase with increments of number of rib fracture detected on radiograph. Outcomes were not different among patients 65 years or older when compared to their younger counterparts. CONCLUSIONS: In this prospective study of MTIs, severe to moderate disabilities were present in nearly 1 patient out of 5 at 90 days. The presence of delayed hemothorax and the number of rib fracture were associated with increased functional limitations after a MTI.

Influence of the family cluster effect on psychosocial variables in families undergoing BRCA1/2 genetic testing for cancer susceptibility.

OBJECTIVE: This study evaluated the influence of the family cluster effect on behavioral and psychological variables among individuals undergoing BRCA1/2 genetic testing for cancer susceptibility. METHODS: French-Canadian women (n = 552) and men (n = 104) from 140 different families undergoing BRCA1/2 testing between years 1998 and 2004 completed a self-administered questionnaire on a wide range of behavioral and psychological variables. The impact of the family cluster effect on 29 variables was assessed using the intraclass correlation coefficient (ICC) as computed from multilevel random-effect models. RESULTS: ICC values were statistically significant for 22 of the 29 variables. Overall, the mean ICC value was 0.10. The ICC values for knowledge about hereditary breast and ovarian cancer and frequency of alcohol consumption were 0.25. The ICC value for the Impact of Event Scale, which is a commonly used measure of cancer-specific distress, was 0.14. CONCLUSIONS: Our results suggest that the family cluster effect influences the majority of behavioral and psychosocial variables. When studying psychosocial aspects of genetic testing for cancer susceptibility, the family cluster effect should be routinely accounted for when determining sample size and statistical methods.

Eligibility criteria in randomized phase II and III adjuvant and neoadjuvant breast cancer trials: not a significant barrier to enrollment.

BACKGROUND: Clinical trial recruitment can be impeded by eligibility criteria being too numerous or too restrictive. PURPOSE: This study's principal objective was to determine whether a specific category of eligibility criteria could be identified as a major barrier to patient enrollment. METHODS: Nine phase II or III clinical trials, opened between June 2004 and July 2008, were selected. A retrospective cohort of women diagnosed with invasive, nonmetastatic breast cancer and potentially eligible for these clinical trials was used. All eligibility criteria were sorted into the following categories: definition of disease, precision, safety, ethical and legal, or administrative. A total of 985 patient-trials were evaluated, defined as the experimental unit since one patient could be eligible to more than one trial. Proportions of cases with 'not met' eligibility criteria were assessed for each category in each trial. RESULTS: Two clinical trials had a 'not met' subcategory criterion of over 20%. 'Pathology' and 'consent' subcategory criteria were 'not met' in 24.2% and 92.7% of cases for the NEOCAN and NCIC CTG MA.27 trials, respectively. NCIC CTG MA.27 had the highest proportion of 'not met' subcategory due to an inclusion criterion requiring participation to two companion studies. National Surgical Adjuvant Breast and Bowel Project (NSABP) B-38 had a proportion of 18.8% of cases 'not meeting' the receptor status subcategory criterion. All other subcategories of eligibility criteria assessed were 'not met' by less than 15% of patients. Overall, few subcategories had over 10% of ineligible patients. LIMITATIONS: Many eligibility criteria were considered 'nonevaluable' because the information evaluated would have required additional procedures not performed as part of the general practice. CONCLUSION: The subjects from the study population are not precluded from entry in a trial because of stringent eligibility criteria. Eligibility criteria should reflect as much as possible the whole population to whom the treatment will be offered, with the exception of drugs targeting a specific receptor or pathway where only a subpopulation is hypothesized to benefit from the therapy. In the breast cancer clinical trials evaluated for the present study, no criterion precluding recruitment was shared by many or all trials and no specific eligibility criterion was consistently the reason for patients' ineligibility.

The potential cost-effectiveness of vaccination against herpes zoster and post-herpetic neuralgia.

A clinical trial has shown that a live-attenuated varicella-zoster virus vaccine is effective against herpes zoster (HZ) and post-herpetic neuralgia (PHN). The aim of this study was to examine the cost-effectiveness of vaccination against HZ and PHN in Canada. A cohort model was developed to estimate the burden of HZ and the cost-effectiveness of HZ vaccination, using Canadian population-based data. Different ages at vaccination were examined and probabilistic sensitivity analysis was performed. The economic evaluation was conducted from the ministry of health perspective and 5% discounting was used for costs and benefits. In Canada (population = 30 million), we estimate that each year there are 130,000 new cases of HZ, 17,000 cases of PHN and 20 deaths. Most of the pain and suffering is borne by adults over the age of 60 years and is due to PHN. Vaccinating 65-year-olds (HZ efficacy = 63%, PHN efficacy = 67%, no waning, cost/course = $150) is estimated to cost $33,000 per QALY-gained (90% CrI: 19,000-63,000). Assuming the cost per course of HZ vaccination is $150, probabilistic sensitivity analysis suggest that vaccinating between 65 and 75 years of age will likely yield cost-effectiveness ratios below $40,000 per Quality-Adjusted Life-Year (QALY) gained, while vaccinating adults older than 75 years will yield ratios less than $70,000 per QALY-gained. These results are most sensitive to the duration of vaccine protection and the cost of vaccination. In conclusion, results suggest that vaccinating adults between the ages of 65 and 75 years is likely to be cost-effective and thus to be a judicious use of scarce health care resources.

Health behaviors and psychological distress in women initiating BRCA1/2 genetic testing: comparison with control population.

The study objective was to compare breast cancer screening practices, lifestyle behaviors and psychological distress among 640 women initiating BRCA1/2 testing to those among 9,498 similarly-aged women from the general population. Health behaviors and psychological distress were reported in a self-administered questionnaire at pre-test genetic counseling. Regression analyses indicate that high-risk women were more frequently performing breast cancer screening and, in the case of those previously diagnosed with cancer, were more likely to be non-smokers and physically active than women from general population. However, women initiating BRCA1/2 testing were significantly more distressed than controls. Globally, high-risk women seemed to be well informed about recommendations for women who are at high risk and to have access to screening adapted to their risk level. Given their significant psychological distress, providing minimal psychosocial support to all women undergoing BRCA1/2 testing at pre-test genetic counseling is relevant.

Decline in activities of daily living after a visit to a Canadian emergency department for minor injuries in independent older adults: are frail older adults with cognitive impairment at greater risk?

OBJECTIVES: To compare functional decline in activities of daily living (ADLs) of older adults visiting emergency departments (EDs) for minor injuries according to frailty and cognitive status. DESIGN: Prospective cohort study. SETTING: Seven Canadian EDs. PARTICIPANTS: Individuals aged 65 and older who were independent in ADLs at baseline were recruited between March 2011 and March 2013 (N=1,114). MEASUREMENTS: The Older American Resources and Services (OARS) questionnaire was completed during the ED visit or within 7 days and 3 and 6 months after a minor injury to ascertain functional decline (≥1-point drop in ADL score). Participants were considered frail based on the Canadian Study of Health and Aging Clinical Frailty Scale (≥Level 4, vulnerable). Cognitive impairment was defined as performing below cutoffs on the Montreal Cognitive Assessment (<23/30) or Telephone Interview for Cognitive Status (≤31/50). Four subgroups were created: frail with cognitive impairment, frail without cognitive impairment, nonfrail with cognitive impairment, nonfrail without cognitive impairment. Sociodemographic and health data were also collected. RESULTS: Information on OARS, frailty, and cognitive impairment were available for 850 at 3 months and 728 at 6 months; 19.9% of participants showed declining function at 3 months and 25.3% at 6 months. After adjusting for age, number of comorbidities, and instrumental activity of daily living disability at baseline, frail participants with cognitive impairment were at significantly greater risk of functional decline at 3 (adjusted risk ratio (aRR)=1.89; 95% confidence interval (CI)=1.38-2.59) and 6 (aRR=2.09; 95% CI=1.45-3.00) months than nonfrail participants without cognitive impairment. CONCLUSION: Easy-to-administer frailty and cognitive screening tools should be included in ED assessments to identify independent older adults at high risk of functional decline after minor injury so that appropriate services may be provided to prevent deterioration in ADLs.

Evaluation of eligibility and recruitment in breast cancer clinical trials.

Objectives of the study were to measure recruitment rates in clinical trials and to identify patients, physicians or trials characteristics associated with higher recruitment rates. Among patients who had a clinical trial available for their cancer, 83.5% (345/413) met the eligibility criteria to at least one clinical trial. At least one trial was proposed to 33.1% (113/341) of the eligible patients and 19.7% (68/345) were recruited. Overall recruitment was 16.5% (68/413). In multivariate analyses, trial proposal and enrollment were lower for elderly patients and higher in high cancer stages. Trials from pharmaceutical industry had higher recruitment rates and trials testing hormonal therapy enrolled more patients. Breast cancer patients' accrual to a clinical trial could be improved by trying to systematically identify all eligible patients and propose a trial to those eligible and to whom the treatment is planned to be equivalent to the standard arm of the trial.

Is cognitive function a concern in independent elderly adults discharged home from the emergency department in Canada after a minor injury?

OBJECTIVES: To describe the cognitive functioning of independent community-dwelling elderly adults visiting the emergency department (ED) for minor injuries and at 3- and 6-month follow-up assessments and to document the occurrence of falls, return to the ED, and hospital visits over time according to cognitive level. DESIGN: Prospective cohort study. SETTING: Three Canadian EDs. PARTICIPANTS: Individuals aged 65 and older who were independent in basic activities of daily living, visiting the ED for minor injuries, and discharged home within 48 hours (N = 320). MEASUREMENTS: Participants completed the Montreal Cognitive Assessment (MoCA). New falls involving pain and ED or hospital visits were documented at 3 and 6 months. RESULTS: At baseline, 62.4% of participants scored below the recommended cutoff of 26 on the MoCA, suggesting cognitive dysfunction, and 22.9% scored below a more-stringent cutoff of 21. MoCA scores had improved significantly at 3 and 6 months. Items showing the most improvement were delayed recall and verbal fluency. Persons with MoCA scores of less than 21 reported significantly more new falls and hospital visits 3 to 6 months after injury. CONCLUSION: Cognition is not optimal in many community-dwelling elderly adults visiting an ED for a minor injury, which may affect their capacity to comprehend, recall, and adhere to medical recommendations after their injury and put them at risk of further negative health events such as falls.

Cumulative incidence of functional decline after minor injuries in previously independent older Canadian individuals in the emergency department.

OBJECTIVES: To estimate the cumulative incidence of functional decline in independent older adults 3 and 6 months after a minor injury treated in the emergency department (ED) and to identify predictors of this functional decline. DESIGN: Prospective cohort study. SETTINGS: Three Canadian teaching EDs. PARTICIPANTS: Individuals aged 65 and older who were independent in basic activities of daily living before their injury and were evaluated in the ED for minor injuries (N = 335). MEASUREMENTS: Functional decline was defined as a loss of 2 or more out of 28 points on the self-reported Older Americans Resources Services scale. Sociodemographic, mobility, and clinical risk factors for functional decline in non-ED studies were measured at the ED visit and 3 and 6 months after the injury. Generalized linear mixed models were used to explore differences in functional decline between groups determined according to the different factors. RESULTS: The cumulative incidence of decline was 14.9% (95% confidence interval (CI) = 7.6-29.1%) at 3 months and 17.3% (95% CI = 9.7-30.9%) at 6 months. Predictors of functional decline were occasional use of a walking aid (relative risk (RR)=2.4, 95% CI = 1.4-4.2), needing help in instrumental activities of daily living (IADLs) before the injury (RR = 3.1, 95% CI=1.7-5.5), taking five or more daily medications (RR = 1.8, 95% CI = 1.0-3.2), and the emergency physicians' assessment of functional decline (RR = 2.8, 95% CI = 1.5-5.3). CONCLUSION: Minor injuries in independent older adults treated in EDs are associated with a 15% cumulative incidence of functional decline 3 months after the injury that persisted 6 months later. Simple-to-measure factors such as occasional use of a walking aid, daily medication, need for help with IADLs, and physician assessment of decline may help identify independent older adults at risk of functional decline during their consultation. These results confirm the need to improve risk assessment and management of this population in EDs.

Risk factors of significant pain syndrome 90 days after minor thoracic injury: trajectory analysis.

OBJECTIVES: The objective was to identify the risk factors of clinically significant pain at 90 days in patients with minor thoracic injury (MTI) discharged from the emergency department (ED). METHODS: A prospective, multicenter, cohort study was conducted in four Canadian EDs from November 2006 to November 2010. All consecutive patients aged 16 years or older with MTI were eligible at discharge from EDs. They underwent standardized clinical and radiologic evaluations at 1 and 2 weeks, followed by standardized telephone interviews at 30 and 90 days. A pain trajectory model characterized groups of patients with different pain evolutions and ascertained specific risk factors in each group through multivariate analysis. RESULTS: In this cohort of 1,132 patients, 734 were eligible for study inclusion. The authors identified a pain trajectory that characterized 18.2% of the study population experiencing clinically significant pain (>3 of 10) at 90 days after a MTI. Multivariate modeling found two or more rib fractures, smoking, and initial oxygen saturation below 95% to be predictors of this group of patients. CONCLUSIONS: To the authors' knowledge, this is the first prospective study of trajectory modeling to detect risk factors associated with significant pain at 90 days after MTI. These factors may help in planning specific treatment strategies and should be validated in another prospective cohort.

Push hard, push fast: quasi-experimental study on the capacity of elementary schoolchildren to perform cardiopulmonary resuscitation.

BACKGROUND: The optimal age to begin CPR training is a matter of debate. This study aims to determine if elementary schoolchildren have the capacity to administer CPR efficiently. METHODS: This quasi-experimental study took place in a Quebec City school. Eighty-two children 10 to 12 years old received a 6-hour CPR course based on the American Heart Association (AHA) Guidelines. A comparison group of 20 adults who had taken the same CPR course was recruited. After training, participants' performance was evaluated using a Skillreporter manikin. The primary outcome was depth of compressions. The secondary outcomes were compression rate, insufflation volume and adherence to the CPR sequence. Children's performance was primarily evaluated based on the 2005 AHA standards and secondarily compared to the adults' performance. RESULTS: Schoolchildren did not reach the lower thresholds for depth (28.1 +/- 5.9 vs 38 mm; one-sided p = 1.0). The volume of the recorded insufflations was sufficient (558.6 +/222.8 vs 500 ml; one-sided p = 0.02), but there were a significant number of unsuccessful insufflation attempts not captured by the Skillreporter. The children reached the minimal threshold for rate (113.9 +/-18.3 vs 90/min; one-sided p < 0.001). They did not perform as well as the adults regarding compression depth (p < 0.001), but were comparable for insufflation volume (p = 0.83) and CPR sequence. CONCLUSIONS: In this study, schoolchildren aged 10-12 years old did not achieve the standards for compression depth, but achieved adequate compression rate and CPR sequence. When attempts were successful at generating airflow in the Skillreporter, insufflation volume was also adequate.

Association between prodromal pain and the severity of acute herpes zoster and utilization of health care resources.

BACKGROUND: Herpes zoster results from the reactivation of the varicella-zoster virus, which is often accompanied by a prodrome of dermatomal pain. Little is known about the burden of prodromal pain. OBJECTIVES: (1) Describe the frequency, severity and duration of prodromal pain; (2) determine the relationship between prodromal pain and the characteristics of herpes zoster at recruitment and the utilization of health care resources. METHODS: Between 10/2005 and 07/2006, 251 subjects ≥ 50 years old, seeking care for herpes zoster within 14 days of rash onset, were recruited across Canada. Severity and duration of prodromal pain were measured retrospectively using the Initial Zoster Impact Questionnaire. The burden of prodromal pain was obtained by the product of pain severity and duration. The severity of acute herpes zoster pain was measured using the Zoster Brief Pain Inventory. RESULTS: The majority of participants reported prodromal pain (74%). Mean pain duration and severity were 4.7 days and 6/10, respectively. Subjects aged 61-70 years old were more likely to report prodromal pain (RR=1.14, p-value=0.02). The burden of prodromal pain was greater in subjects not working (p-value=0.02) or immunosuppressed (p-value=0.04). Prodromal pain was associated with more severe acute pain (6.2 vs. 4.3, p-value 0.0001). Compared to subjects who did not report prodromal pain, those with this pain were more likely to receive antivirals (RR=1.18, p-value=0.04) and to visit the emergency room (RR=2.56, p-value=0.04). CONCLUSION: The burden of prodromal pain is significant and should be considered when evaluating the overall benefit of herpes zoster vaccination.

Evaluation of factors associated with recruitment in hematological clinical trials: a retrospective cohort study.

The objectives of this study were to measure the recruitment, to study characteristics associated with recruitment, and to explore reasons for non-recruitment in clinical trials for malignant hematological diseases. Trials opened between 2002 and 2008 were selected. If the patient fulfilled the main criteria of the protocol, all eligibility criteria of the protocol were assessed. A total of 1394 patients-protocol were identified in 17 protocols (697 patients, since a patient could have been eligible for more than one protocol) and 195 patients-protocol (186 patients) of these fulfilled the main criteria of the protocol. Among the 195 patients-protocol, 133 (68·2%) fulfilled all the eligibility criteria and 45 (23·1%) were recruited. Patients, physicians, and protocol characteristics were not associated with recruitment. The most common reasons for not being recruited were as follow: 40·7%, not fulfilling all eligibility criteria; 31·3%, protocol not being proposed according to the chart; and 22·7%, patients' refusal.

Evaluation of the Prehospital Index, presence of high-velocity impact and judgment of emergency medical technicians as criteria for trauma triage.

OBJECTIVE: We sought to evaluate the performance of the Prehospital Index (PHI), the high velocity impact (HVI) criterion and emergency medical technician (EMT) judgment for the prehospital triage of injured patients. METHODS: The study population included all prehospital trauma patients transported by an emergency medical service to 2 level I trauma centres for adults. All prehospital run sheets were linked to trauma registry data. The main outcome was severe trauma, defined as death within 72 hours, admission to the intensive care unit within 24 hours or an Injury Severity Score greater than 15. We assessed sensitivity, specificity and rates of overtriage. RESULTS: Of 16,805 patients in the study population, 1113 (6.62%) had severe trauma. The combination of all 3 triage criteria (PHI score > or = 4, HVI presence and EMT judgment) performed best for identifying patients with severe trauma, with a sensitivity of 74.2% but with an overtriage rate of 85.1%. Alone, EMT judgment had the highest sensitivity and a PHI score of 4 or greater had the low est rate of overtriage. CONCLUSION: Although the combination of PHI score, HVI presence and EMT judgment offers the highest sensitivity for the identification of patients that could benefit from direct transport to a level I trauma centre, overall sensitivity remains low and over triage is high. More research is required to improve prehospital triage.

Predictors of postherpetic neuralgia among patients with herpes zoster: a prospective study.

UNLABELLED: Postherpetic neuralgia (PHN) is the most common complication of herpes zoster (HZ). The main objectives of this study were to: 1) estimate the severity and duration of PHN; and 2) identify the predictors of PHN. From October, 2005 to July, 2006, 261 outpatients with HZ, aged ≥ 50, were recruited within 14 days of rash onset during the routine clinical practice of 83 physicians across Canada. Physicians documented HZ characteristics, treatments, general health, functional, and immune status. HZ pain was measured at recruitment and on days 7, 14, 21, 30, 60, 90, 120, 150, and 180 following recruitment. PHN was defined as a worst pain ≥ 3 persisting or appearing more than 90 days after rash onset. Predictors of PHN were obtained by hierarchical log-binomial regression. Twenty-two percent of 249 immunocompetent subjects with HZ developed PHN. Median duration of PHN was 77 days. Independent predictors of PHN included: older age, limitation in performing usual activities prior to HZ, and pain severity at recruitment. This study confirms that older age and greater acute pain severity are predictors of PHN, while functional status emerges as a novel independent predictor of PHN that deserves further exploration. These findings will contribute to optimal use of the HZ vaccine and testing of new therapies that might prevent PHN. PERSPECTIVE: This study confirmed that older age and greater acute pain severity are robust predictors of PHN, whereas functional status emerged as a novel predictor. Despite the high proportion of subjects treated with antivirals, the burden of PHN remains considerable, suggesting that prevention and additional early interventions are needed to reduce the burden of HZ.

A prospective study of the herpes zoster severity of illness.

OBJECTIVE: MASTER, a multicenter prospective study, was conducted to provide a thorough understanding of the burden of herpes zoster (HZ) and postherpetic neuralgia (PHN). Objectives are to: (1) describe the herpes zoster severity-of-illness (HZSOI), a composite measure of pain duration and severity; and (2) to identify the characteristics at recruitment predictive of greater HZSOI at the different phases of HZ. METHODS: From October, 2005 to July, 2006, 261 outpatients with HZ, aged more than equal to 50 years, were recruited within 14 days of rash onset across Canada. The pain was measured by the Zoster Brief Pain Inventory at recruitment and 7, 14, 21, 30, 60, 90, 120, 150, and 180 days later. The HZSOI represents the area under the curve of pain severity over time and ranges from 0 (no pain) to 1800 (pain=10 for 180 d). RESULTS: Median pain duration was 32.5 days. The predictors of greater HZSOI varied according to the different phases of HZ. Higher pain severity at recruitment, more lesions, lower income, and being immunocompromised were the predictors of a greater acute HZSOI. Higher acute pain severity, lower income, being immunocompromised, older age, and not receiving antivirals were the predictors of greater postherpetic HZSOI. DISCUSSION: Using an informative measure capturing simultaneously the burden caused by pain duration and severity, we identified subgroups that suffer most during the different phases of HZ. It is interesting to note that, younger participants were as likely to suffer as the older ones during the acute phase of HZ. This information should aid in optimizing the treatment and prevention of HZ.

Identification of cancer care and protocol characteristics associated with recruitment in breast cancer clinical trials.

PURPOSE: It is estimated that only 5% of patients with cancer participate in a clinical trial. Barriers to participation may relate to available protocols, physicians, and patients, but few data exist on barriers related to cancer care environments and protocol characteristics. METHODS: The primary objective was to identify characteristics of cancer care environments and clinical trial protocols associated with a low recruitment into breast cancer clinical trials. Secondary objectives were to determine yearly recruitment fraction onto clinical trials from 1997 to 2002 in Ontario, Canada, and to compare recruitment fraction among years. Questionnaires were sent to hospitals requesting characteristics of cancer care environments and to cooperative groups/pharmaceutical companies for information on protocols and the number of patients recruited per hospital/year. Poisson regression was used to estimate the recruitment fraction. RESULTS: Questionnaire completion rate varied between 69% and 100%. Recruitment fraction varied between 5.4% and 8.5% according to year. More than 30% of patients were diagnosed in hospitals with no available trials. In multivariate analysis, the following characteristics were associated with recruitment: use of placebo versus not (relative risk [RR] = 0.80; P = .05), nonmetastatic versus metastatic trial (RR = 2.80; P < .01), and for nonmetastatic trials, protocol allowing an interval of 12 weeks or longer versus less than 12 weeks (from diagnosis, surgery, or end of therapy) before enrollment (RR = 1.36; P < .01). CONCLUSION: Allowable interval of 12 weeks or longer to randomly assign patients in clinical trials could help recruitment. In our study, absence of an available clinical trial represented the largest barrier to recruitment.

Statistical validation of the Glasgow Coma Score.

BACKGROUND: To validate the predictive value of the Glasgow Coma Score (GCS) and find the best way to model the score in a logistic regression model predicting mortality. METHODS: Analyses were based on 20,494 patients from the trauma registries of three urban Level I trauma centers in the province of Quebec, Canada. The predictive value of the GCS and its components was evaluated in logistic regression models predicting in-hospital mortality with measures of discrimination and calibration. The performance of the GCS with no transformation and as an ordered categorical variable was compared with two transformation techniques: fractional polynomials and spline regression. RESULTS: The GCS had excellent discrimination (area under Receiving Operator Characteristic Curve=0.833 95% confidence interval=0.820-0.846) but fairly poor calibration (Pearson's Chi-squared statistic=122 on 11 df). The eye component added no predictive information to the verbal and motor components in the whole sample but was important in certain sub-populations. Using the three components separately, rather than the sum, did not improve the predictive model. Fractional polynomial transformation of the GCS improved calibration and spline regression performed even better. GCS modeled as an ordered categorical variable performed badly both in terms of discrimination and calibration. CONCLUSIONS: The GCS in its present form is an efficient predictor of in-hospital mortality, which could benefit from statistical transformation in logistic regression models when the accuracy of estimated probabilities of mortality is important. The common use of GCS categories for modeling mortality leads to loss of information and should be discarded.