Impact of Screening for Sexual Trauma in a Gynecologic Oncology Setting.

OBJECTIVES: Sexual trauma poses a significant concern and is associated with heightened stress, negative health repercussions, and adverse economic effects. A history of abuse may increase a woman's risk of developing cancer, in particular cervical cancer. We analyzed the impact of screening for sexual abuse in a gynecologic oncology population. METHODS: Patients were screened for sexual trauma in a gynecologic oncology clinic over 5 and a half years (April 1, 2011, to September 30, 2016) in this cohort study. The screening questions were selected by behavioral oncology physicians and integrated into the gynecologic history component of the new patient assessment. Patients who screened positive for a history of sexual abuse or intimate partner violence were offered a behavioral oncology referral. Providers were also questioned about the effect of screening on their practice. RESULTS: Of the 1,423 consecutive patients screened for sexual trauma, a total of 164 patients (12%) disclosed a history of sexual abuse. Of the 133 patients who specified their age at the sexual trauma, the majority (107 [80%]) responded that they were a young child or early teen. Most patients (92%) declined counseling. Among individuals presenting with cancer, the distribution of cancer type was statistically different between those patients with and without a sexual trauma history (p = 0.0001). CONCLUSION: Screening for sexual trauma in a gynecologic oncologic population serves as a valuable opportunity to uncover a history of abuse that may increase a woman's susceptibility to cancer. This study demonstrates that screening for sexual abuse in a gynecologic oncology setting may be integrated into new patient interviews with minimal disruption. Identification of an undisclosed sexual trauma history allows for an opportunity to offer counseling and minimize the emotional distress that may be precipitated by treatment and exams.

Who's Watching the Children? Caregiver Features Associated with Physical Child Abuse versus Accidental Injury.

OBJECTIVE: To compare caregiver features and caregiving arrangements of children with physical abuse vs accidental injuries. STUDY DESIGN: Data came from a prospective, observational, multicenter study investigating bruising and psychosocial characteristics of children younger than 4 years of age. Using logistic regression, we examined how abuse vs accidental injury and severity of injury were associated with caregiver sex, relation to the child, whether caregiving arrangements were different than usual at the time of injury, and length of the main caregiver's relationship with his/her partner. RESULTS: Of 1615 patients, 24% were determined to have been physically abused. Abuse was more likely when a male caregiver was present (OR 3.31, 95% CI 2.38-4.62). When the male was the boyfriend of the mother (or another female caregiver), the odds of abuse were very high (OR 169.2, 95% CI 61.3-614.0). Severe or fatal injuries also were more likely when a male caregiver was present. In contrast, abuse was substantially less likely when a female caregiver was present (OR 0.25, 95% CI 0.17-0.37) with the exception of a female babysitter (OR 3.87, 95% CI 2.15-7.01). Caregiving arrangements that were different than usual and caregiver relationships <1 year were also associated with an increased risk of abuse. CONCLUSIONS: We identified caregiver features associated with physical abuse. In clinical practice, questions regarding caregiver features may improve recognition of the abused child. This information may also inform future abuse prevention strategies.

Standardized warfarin monitoring decreases adverse drug reactions.

BACKGROUND: While warfarin is the most commonly prescribed medication to prevent thromboembolic disorders, the risk of adverse drug reactions (ADR) poses a serious concern. This prospective study evaluated how primary care providers (PCP) and cardiologists at our Institution managed patients treated with warfarin with the goal of decreasing the number of warfarin ADRs. METHODS: A multidisciplinary anticoagulation task force was established at our Institution in 2014 to standardize warfarin monitoring and management. Between 2013 and 2017, we analyzed patients who were prescribed warfarin by their PCP or cardiologist upon hospital discharge and in the ambulatory setting to determine the international normalized ratio (INR) within 5, 10, and 30 days after discharge, time in therapeutic range (TTR), number of severe warfarin ADRs, and total and average cost reduction of all severe warfarin ADRs to determine whether there was an organizational cost savings following the implementation of standardized warfarin care. RESULTS: The warfarin ADR rate significantly decreased over the 5-year period, from 3.8 to 0.98% (p < 0.0001). The proportion of warfarin prescriptions out of all anticoagulants significantly decreased, from 72.2 to 42.1% (p < 0.001). The proportion of individuals who received an INR at 5, 10, and 30 days after hospital discharge compared to the total number of patients prescribed warfarin significantly increased (p < 0.001). The total cost of severe warfarin ADRs decreased by 57.6% between 2013 and 2017. CONCLUSIONS: This study serves as a model to reduce the number of severe warfarin ADRs by the following tactics: (1) educating PCPs and cardiologists about evidence-based guidelines for warfarin management, (2) increasing the use of our Institution's electronic warfarin module, and (3) enhancing patient compliance with obtaining INR.

Classifying Injuries in Young Children as Abusive or Accidental: Reliability and Accuracy of an Expert Panel Approach.

OBJECTIVE: To assess interrater reliability and accuracy of an expert panel in classifying injuries of patients as abusive or accidental based on comprehensive case information. STUDY DESIGN: Data came from a prospective, observational, multicenter study investigating bruising characteristics of children younger than 4 years. We enrolled 2166 patients with broad ranges of illnesses and injuries presenting to one of 5 pediatric emergency departments in whom bruises were identified during examination. We collected comprehensive data regarding current and past injuries and illnesses, and provided deidentified, standardized case information to a 9-member multidisciplinary panel of experts with extensive experience in pediatric injury. Each panelist classified cases using a 5-level ordinal scale ranging from definite abuse to definite accident. Panelists also assessed whether report to child protective services (CPS) was warranted. We calculated reliability coefficients for likelihood of abuse and decision to report to CPS. RESULTS: The interrater reliability of the panelists was high. The Kendall coefficient (95% CI) for the likelihood of abuse was 0.89 (0.87, 0.91) and the kappa coefficient for the decision to report to CPS was 0.91 (0.87, 0.94). Reliability of pairs and subgroups of panelists were similarly high. A panel composite classification was nearly perfectly accurate in a subset of cases having definitive, corroborated injury status. CONCLUSIONS: A panel of experts with different backgrounds but common expertise in pediatric injury is a reliable and accurate criterion standard for classifying pediatric injuries as abusive or accidental in a sample of children presenting to a pediatric emergency department.

Comparison of two equivalent model for end-stage liver disease scores for hepatocellular carcinoma patients using data from the United Network for Organ Sharing liver transplant waiting list registry.

Patients with hepatocellular carcinoma (HCC) have been advantaged on the liver transplant waiting list within the United States, and a 6-month delay and exception point cap have recently been implemented to address this disparity. An alternative approach to prioritization is an HCC-specific scoring model such as the MELD Equivalent (MELDEQ ) and the mixed new deMELD. Using data on adult patients added to the UNOS waitlist between 30 September 2009 and 30 June 2014, we compared projected dropout and transplant probabilities for patients with HCC under these two models. Both scores matched actual non-HCC dropout in groups with scores <22 and improved equity with non-HCC transplant probabilities overall. However, neither score matched non-HCC dropout accurately for scores of 25-40 and projected dropout increased beyond non-HCC probabilities for scores <16. The main differences between the two scores were as follows: (i) the MELDEQ assigns 6.85 more points after 6 months on the waitlist and (ii) the deMELD gives greater weight to tumor size and laboratory MELD. Post-transplant survival was lower for patients with scores in the 22-30 range compared with those with scores <16 (P = 0.007, MELDEQ ; P = 0.015, deMELD). While both scores result in better equity of waitlist outcomes compared with scheduled progression, continued development and calibration is recommended.

Changes in blood pressure and heart rate during sedation with ketamine in the pediatric ED.

BACKGROUND: Ketamine is commonly used in the emergency department for short, painful procedures. We describe changes in blood pressure (BP) and heart rate (HR) during procedural sedation with ketamine, as these changes have not been well described in children. METHODS: We performed a secondary analysis of a prospective, observational study involving children aged 8 to 18 years who received procedural sedation with ketamine in a pediatric emergency department. Serial vital signs and sedation scores were recorded from baseline until recovery from ketamine procedural sedation. Time of orthopedic manipulation was also recorded. Linear mixed-effect models were used to evaluate changes in systolic BP (SBP), diastolic BP (DBP), and HR using 3 sedation strata: presedation (baseline), sedated (ketamine administered and patient deeply sedated), and recovery (ketamine administered with patient minimally sedated), controlling for age and weight. RESULTS: Sixty children were enrolled; 10 were excluded due to missing manipulation time. A total of 394 observations were recorded. Mean sedated SBP, DBP, and HR were 8 mm Hg, 4 mm Hg, and 13 beats/min higher than presedation SBP (P<.001), DBP (P<.01), and HR (P<.001), respectively. Mean sedated SBP and DBP were 3 and 4 mm Hg higher than SBP (P=.006) and DBP (P<.01) during recovery. Manipulation increased mean SBP by 5 mm Hg (P<.001), mean DBP by 7 mm Hg (P<.001), and mean HR by 1 beat/min (P=.35). CONCLUSIONS: Ketamine administered during procedural sedation for painful procedures causes a statistically significant but modest increase in SBP, DBP, and HR. Orthopedic manipulation further increases BP.

Projected outcomes of 6-month delay in exception points versus an equivalent Model for End-Stage Liver Disease score for hepatocellular carcinoma liver transplant candidates.

The United Network for Organ Sharing (UNOS) recently implemented a 6-month delay before granting exception points to liver transplantation candidates with hepatocellular carcinoma (HCC) to address disparity in transplantation access between HCC and non-HCC patients. An HCC-specific scoring scheme, the Model for End-Stage Liver Disease equivalent (MELDEQ ), has also been developed. We compared projected dropout and transplant probabilities and posttransplant survival for HCC and non-HCC patients under the 6-month delay and the MELDEQ using UNOS data from October 1, 2009, to June 30, 2014, and multistate modeling. Overall (combined HCC and non-HCC) wait-list dropout was similar under both schemes and slightly improved (though not statistically significant) compared to actual data. Projected HCC wait-list dropout was similar between the MELDEQ and 6-month delay at 6 months but thereafter started to differ, with the 6-month delay eventually favoring HCC patients (3-year dropout 10.0% [9.0%-11.0%] for HCC versus 14.1% [13.6%-14.6%]) for non-HCC) and the MELDEQ favoring non-HCC patients (3-year dropout 16.0% [13.2%-18.8%] for HCC versus 12.3% [11.9%-12.7%] for non-HCC). Projected transplant probabilities for HCC patients were substantially lower under the MELDEQ compared to the 6-month delay (26.6% versus 83.8% by 3 years, respectively). Projected HCC posttransplant survival under the 6-month delay was similar to actual, but slightly worse under the MELDEQ (2-year survival 82.9% [81.7%-84.2%] versus actual of 85.5% [84.3%-86.7%]). In conclusion, although the 6-month delay improves equity in transplant and dropout between HCC and non-HCC candidates, disparity between the 2 groups may still exist after 6 months of wait-list time. Projections under the MELDEQ , however, appear to disadvantage HCC patients. Therefore, modification to the exception point progression or refinement of an HCC prioritization score may be warranted. Liver Transplantation 22 1343-1355 2016 AASLD.

The Prevalence of Bruising Among Infants in Pediatric Emergency Departments.

STUDY OBJECTIVE: Bruising can indicate abuse for infants. Bruise prevalence among infants in the pediatric emergency department (ED) setting is unknown. Our objective is to determine prevalence of bruising, associated chief complaints, and frequency of abuse evaluations in previously healthy infants presenting to pediatric EDs. METHODS: We conducted a prospective, observational, multicenter study of infants aged 12 months or younger presenting to pediatric EDs. Structured sampling was used. Pediatric emergency medicine clinicians performed complete skin examinations to screen for bruising. Study investigators documented skin findings, date of visit, patient's age, chief complaint, and abuse evaluation. The primary outcome was prevalence of bruising. Secondary outcomes were prevalence of bruising based on chief complaint and frequency of abuse evaluation. Point estimates of bruise prevalence and differences in bruise prevalence between patient subgroups were calculated with 95% confidence intervals (CIs). RESULTS: Bruising was identified in 88 of 2,488 infants (3.5%; 95% CI 2.9% to 4.4%). Rates of bruising for infants 5 months and younger and older than 5 months were 1.3% and 6.4%, respectively (difference 5.1%; 95% CI 3.6% to 6.8%). For infants 5 months and younger, 83% of bruising was associated with a trauma chief complaint and only 0.2% of infants presenting with a medical chief complaint had bruising. Pediatric emergency medicine clinicians obtained abuse evaluations on 23% of infants with bruising, and that rate increased to 50% for infants 5 months and younger. CONCLUSION: Bruising prevalence in children 12 months and younger who were evaluated in pediatric EDs was low, increased within age strata, and was most often associated with a trauma chief complaint. Most bruised infants did not undergo an abuse evaluation.

Predicting Serious Bacterial Infections Among Hypothermic Infants in the Emergency Department.

BACKGROUND: There is insufficient evidence to guide the initial evaluation of hypothermic infants. We aimed to evaluate risk factors for serious bacterial infections (SBI) among hypothermic infants presenting to the emergency department (ED). METHODS: We conducted a multicenter case-control study among hypothermic (rectal temperature <36.5°C) infants ≤90 days presenting to the ED who had a blood culture collected. Our outcome was SBI (bacteremia, bacterial meningitis, and/or urinary tract infection). We performed 1:2 matching. Historical, physical examination and laboratory covariables were determined based on the literature review from febrile and hypothermic infants and used logistic regression to identify candidate risk factors. RESULTS: Among 934 included infants, 57 (6.1%) had an SBI. In univariable analyses, the following were associated with SBI: age > 21 days, fever at home or in the ED, leukocytosis, elevated absolute neutrophil count, thrombocytosis, and abnormal urinalysis. Prematurity, respiratory distress, and hypothermia at home were negatively associated with SBI. The full multivariable model exhibited a c-index of 0.91 (95% confidence interval: 0.88-0.94). One variable (abnormal urinalysis) was selected for a reduced model, which had a c-index of 0.82 (95% confidence interval: 0.75-0.89). In a sensitivity analysis among hypothermic infants without fever (n = 22 with SBI among 116 infants), leukocytosis, absolute neutrophil count, and abnormal urinalysis were associated with SBI. CONCLUSIONS: Historical, examination, and laboratory data show potential as variables for risk stratification of hypothermic infants with concern for SBI. Larger studies are needed to definitively risk stratify this cohort, particularly for invasive bacterial infections.

Retinoids for preventing the progression of cervical intra-epithelial neoplasia.

BACKGROUND: Invasive cervical carcinoma is preceded by a precancerous phase, cervical intra-epithelial neoplasia (CIN), which can be detected on cervical smears and confirmed by colposcopy and biopsy. Moderate and severe cases of intra-epithelial neoplasia (CIN2 and CIN3) are treated mainly with surgery to prevent progression to invasive carcinoma. Medical methods of preventing the progression or inducing the regression of CIN are needed. Retinoids are potent modulators of epithelial cell growth and differentiation that may have potential for the treatment of CIN. OBJECTIVES: To ascertain whether retinoids can cause regression or prevent progression of CIN. SEARCH METHODS: We searched the Cochrane Gynaecological Cancer Review Group's Specialised Register and Non-Trials Database, the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 3, 2010), and MEDLINE and EMBASE (July 2010).For the 2013 update, the searches were re-run as follows: CENTRAL, Issue 3, 2013; MEDLINE, April, Week 2, 2013; and EMBASE, Week 16, 2013. SELECTION CRITERIA: Randomized controlled trials (RCTs) and non-RCTs of retinoids for treating CIN in women. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data from the trials. Adverse effects information was also collected from the trials. MAIN RESULTS: Five RCTs comparing the efficacy of four different retinoids were identified. Two studies examined the effects on CIN2 and CIN3 of the retinoids N-(4-hydroxyphenyl)retinamide (fenretinide) and 9-cis-retinoic acid (aliretinoin) given orally. Two examined the effect of all-trans-retinoic acid administered topically to the cervix. The fifth study investigated the use of 13-cis-retinoic acid (isotretinoin) given orally to human immunodeficiency virus (HIV)-positive participants with CIN1 and condyloma.Four studies reported no significant effect of retinoids on the progression to higher grades of CIN, and the fifth did not report data on progression. In all studies retinoids had no significant effect on regression of CIN3. Two studies reported that retinoids were associated with regression of CIN2. One reported a greater complete regression of CIN2 over that seen with placebo, which was of borderline statistical significance (odds ratio (OR) 0.5, 95% confidence interval (CI) 0.25 to 1.02). The other study reported a nonsignificant dose-related trend toward increased rates of complete and partial regression compared with placebo. One study reported significantly worse outcomes in women receiving retinoid (OR for regression 6.00, 95% CI 1.00 to 35.91). In general, the retinoid medications were well tolerated.In the 2010 review and in this update, no new studies were identified for inclusion. AUTHORS' CONCLUSIONS: The retinoids studied are not effective in causing regression of CIN3 but may have some effect on CIN2. The data on CIN1 are inadequate. Retinoids are not effective in preventing progression of CIN of any grade. At the doses given for the duration of treatment studied, the retinoids were reasonably well tolerated.

Derivation of a clinical prediction rule for pediatric abusive head trauma.

OBJECTIVES: Abusive head trauma is a leading cause of traumatic death and disability during infancy and early childhood. Evidence-based screening tools for abusive head trauma do not exist. Our research objectives were 1) to measure the predictive relationships between abusive head trauma and isolated, discriminating, and reliable clinical variables and 2) to derive a reliable, sensitive, abusive head trauma clinical prediction rule that-if validated-can inform pediatric intensivists' early decisions to launch (or forego) an evaluation for abuse. DESIGN: Prospective, multicenter, cross-sectional, observational. SETTING: Fourteen PICUs. PATIENTS: Acutely head-injured children less than 3 years old admitted for intensive care. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Applying a priori definitional criteria for abusive head trauma, we identified clinical variables that were discriminating and reliable, calculated likelihood ratios and post-test probabilities of abuse, and applied recursive partitioning to derive an abusive head trauma clinical prediction rule with maximum sensitivity-to help rule out abusive head trauma, if negative. Pretest probability (prevalence) of abusive head trauma in our study population was 0.45 (95 of 209). Post-test probabilities of abusive head trauma for isolated, discriminating, and reliable clinical variables ranged from 0.1 to 0.86. Some of these variables, when positive, shifted probability of abuse upward greatly but changed it little when negative. Other variables, when negative, largely excluded abusive head trauma but increased probability of abuse only slightly when positive. Some discriminating variables demonstrated poor inter-rater reliability. A cluster of five discriminating and reliable variables available at or near the time of hospital admission identified 97% of study patients meeting a priori definitional criteria for abusive head trauma. Negative predictive value was 91%. CONCLUSIONS: A more completeunderstanding of the specific predictive qualities of isolated, discriminating, and reliable variables could improve screening accuracy. If validated, a reliable, sensitive, abusive head trauma clinical prediction rule could be used by pediatric intensivists to calculate an evidence-based, patient-specific estimate of abuse probability that can inform-not dictate-their early decisions to launch (or forego) an evaluation for abuse.

Efficacy of extended-release 45 mg oral minocycline and extended-release 45 mg oral minocycline plus 15% azelaic acid in the treatment of acne rosacea.

Rosacea is one of the most commonly occurring dermatoses treated by dermatologists. There are multiple therapeutic options available for the treatment of papulopustular rosacea. Rosacea is an inflammatory condition, classically presenting with flushing and/or blushing along with erythema, edema, telangiectasia, papules, pustules, and nodules of the face. Minocycline, a member of the tetracycline family, has demonstrated benefit in the treatment of inflammatory lesions in patients with rosacea. This manuscript highlights the use of a new sustained-release low-dose minocycline 45 mg tablet, with or without azelaic acid, for the treatment of papulopustular rosacea.

Racial and Ethnic Disparities in Emergency Department Wait Times for Children: Analysis of a Nationally Representative Sample.

OBJECTIVE: To evaluate the association of race and ethnicity with wait times for children in US emergency departments (ED). METHODS: We performed a cross-sectional study of ED encounters of children (<18 years) from 2014 to 2019 using a multistage survey of nonfederal US ED encounters. Our primary variable of interest was composite race and ethnicity: non-Hispanic White (NHW), non-Hispanic Black, Hispanic, and all others. Our outcome was ED wait time in minutes. We evaluated the association between race and ethnicity and wait time in Weibull regression models that sequentially added variables of acuity, demographics, hospital factors, and region/urbanicity. RESULTS: We included 163,768,956 survey-weighted encounters. In univariable analysis, Hispanic children had a lower hazard ratio (HR) of progressing to evaluation (HR 0.84, 95% confidence interval [CI] 0.76-0.93) relative to NHW children, indicating longer ED wait times. This association persisted in serial multivariable models incorporating acuity, demographics, and hospital factors. This association was not observed when incorporating variables of hospital region and urbanicity (HR 0.91, 95% CI 0.83-1.00). In subgroup analysis, Hispanic ethnicity was associated with longer wait times in pediatric EDs (HR 0.76, 95% CI 0.63-0.92), non-metropolitan EDs (HR 0.75, 95% CI 0.64-0.89), and the Midwest region (HR 0.77, 95% CI 0.69-0.87). No differences in wait times were observed for children of Black race or other races. CONCLUSIONS: Hispanic children experienced longer ED wait times across serial multivariable models, with significant differences limited to pediatric, metropolitan, and Midwest EDs. These results highlight the presence of disparities in access to prompt emergency care for children.

Longitudinal patterns of functional recovery in patients with incomplete spinal cord injury receiving activity-based rehabilitation.

OBJECTIVE: To model the progression of 3 functional outcome measures from patients with incomplete spinal cord injury (SCI) receiving standardized locomotor training. DESIGN: Observational cohort. SETTING: The NeuroRecovery Network (NRN), a specialized network of treatment centers providing standardized, activity-based therapy for SCI patients. PARTICIPANTS: Patients (N=337) with incomplete SCI (grade C or D on the International Standards for Neurological Classification of Spinal Cord Injury scale) who were enrolled in the NRN between February 2008 and March 2011. INTERVENTION: All enrolled patients received standardized locomotor training sessions, as established by NRN protocol, and were evaluated monthly for progress. MAIN OUTCOME MEASURES: Berg Balance Scale, 6-minute walk test, and 10-meter walk test. Progression over time was analyzed via the fitting of linear mixed effects models. RESULTS: There was significant improvement on each outcome measure and significant attenuation of improvement over time. Patients varied significantly across groups defined by recovery status and American Spinal Injury Association Impairment Scale (AIS) grade at enrollment with respect to baseline performance and rates of change over time. Time since SCI was a significant determinant of the rate of recovery for all measures. CONCLUSIONS: Locomotor training, as implemented in the NRN, results in significant improvement in functional outcome measures as treatment sessions accumulate. Variability in patterns of recovery over time suggest that time since SCI and patient functional status at enrollment, as measured by the Neuromuscular Recovery Scale, are important predictors of performance and recovery as measured by the targeted outcome measures.

Dynamic longitudinal evaluation of the utility of the Berg Balance Scale in individuals with motor incomplete spinal cord injury.

OBJECTIVES: To examine the utility of the Berg Balance Scale among patients with motor incomplete spinal cord injuries (SCIs), to determine how the utility of the Berg Balance Scale changes over time with activity-based therapy, and to identify differences in scale utility across patient groups defined by status of recovery. DESIGN: Prospective observational cohort. SETTING: The NeuroRecovery Network (NRN), a network of clinical centers for patients with motor incomplete SCI. PARTICIPANTS: Patients with motor incomplete SCI (n=124) with American Spinal Injury Association Impairment Scale grade C or D, who were enrolled in the NRN between February 2008 and June 2009. INTERVENTION: Standardized locomotor training. MAIN OUTCOME MEASURE: The Berg Balance Scale items were examined with longitudinal principal components analyses. Patients were categorized by phase using the Neuromuscular Recovery Scale. RESULTS: In the full sample, the first principal component explained a large percentage of overall scale variance (77%), items were loaded homogeneously on the first principal component, and item scores were well correlated with first principal component scores. In subgroups of low and high functioning of patients, first principal component variance accounting was reduced (49%) and only a few of the simplest and most difficult items substantially loaded onto the first principal component. Item loading coefficients evolved over time as patients recovered, with simpler items becoming less important to the full scale and difficult items more important. CONCLUSIONS: The utility of the Berg Balance Scale in patients with motor incomplete SCI in early and advanced phases of recovery is limited. Specific item utility changes as patients recover. Thus, a more comprehensive and dynamic instrument is necessary to adequately measure balance across the spectrum of patients with motor incomplete SCI.

Cardiovascular status of individuals with incomplete spinal cord injury from 7 NeuroRecovery Network rehabilitation centers.

OBJECTIVE: To examine cardiovascular (CV) health in a large cohort of individuals with incomplete spinal cord injury (SCI). The CV health parameters of patients were compared based on American Spinal Injury Association Impairment Scale (AIS), neurologic level, sex, central cord syndrome, age, time since injury, Neuromuscular Recovery Scale, and total AIS motor score. DESIGN: Cross-sectional study. SETTING: Seven outpatient rehabilitation clinics. PARTICIPANTS: Individuals (N=350) with incomplete AIS classification C and D were included in this analysis. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Heart rate, systolic and diastolic blood pressure during resting sitting and supine positions and after an orthostatic challenge. RESULTS: CV parameters were highly variable and significantly differed based on patient position. Neurologic level (cervical, high and low thoracic) and age were most commonly associated with CV parameters where patients classified at the cervical level had the lowest resting CV parameters. After the orthostatic challenge, blood pressure was highest for the low thoracic group, and heart rate for the high thoracic group was higher. Time since SCI was negatively related to blood pressure at rest but not after orthostatic challenge. Men exhibited higher systolic blood pressure than women and lower heart rate. The prevalence of orthostatic hypotension (OH) was 21% and was related to the total motor score and resting seated blood pressures. Cervical injuries had the highest prevalence. CONCLUSIONS: Resting CV parameters of blood pressure and heart rate are affected by position, age, and neurologic level. OH is more prevalent in cervical injuries, those with lower resting blood pressures and who are lower functioning. Results from this study provide reference for CV parameters for individuals with incomplete SCI. Future research is needed on the impact of exercise on CV parameters.

Balance and ambulation improvements in individuals with chronic incomplete spinal cord injury using locomotor training-based rehabilitation.

OBJECTIVE: To evaluate the effects of intensive locomotor training on balance and ambulatory function at enrollment and discharge during outpatient rehabilitation after incomplete SCI. DESIGN: Prospective observational cohort. SETTING: Seven outpatient rehabilitation centers from the Christopher and Dana Reeve Foundation NeuroRecovery Network (NRN). PARTICIPANTS: Patients (N=196) with American Spinal Injury Association Impairment Scale (AIS) grade C or D SCI who received at least 20 locomotor training treatment sessions in the NRN. INTERVENTIONS: Intensive locomotor training, including step training using body-weight support and manual facilitation on a treadmill followed by overground assessment and community integration. MAIN OUTCOME MEASURES: Berg Balance Scale; Six-Minute Walk Test; 10-Meter Walk Test. RESULTS: Outcome measures at enrollment showed high variability between patients with AIS grades C and D. Significant improvement from enrollment to final evaluation was observed in balance and walking measures for patients with AIS grades C and D. The magnitude of improvement significantly differed between AIS groups for all measures. Time since SCI was not associated significantly with outcome measures at enrollment, but was related inversely to levels of improvement. CONCLUSIONS: Significant variability in baseline values of functional outcome measures is evident after SCI in individuals with AIS grades C and D and significant functional recovery can continue to occur even years after injury when provided with locomotor training. These results indicate that rehabilitation, which provides intensive activity-based therapy, can result in functional improvements in individuals with chronic incomplete SCI.

Assessment of functional improvement without compensation reduces variability of outcome measures after human spinal cord injury.

OBJECTIVE: To develop a scale (Neuromuscular Recovery Scale [NRS]) for classification of functional motor recovery after spinal cord injury (SCI) based on preinjury movement patterns that would reduce variability of the populations' level of function within each class, because assessment of functional improvement after SCI is problematic as a result of high variability of the populations' level of function and the insensitivity to change within the available outcome measures. DESIGN: Prospective observational cohort with longitudinal follow-up. SETTING: Seven outpatient rehabilitation centers from the Christopher and Dana Reeve Foundation NeuroRecovery Network (NRN). PARTICIPANTS: Individuals (N=95) with American Spinal Injury Association Impairment Scale (AIS) grade C or AIS grade D having received at least 20 locomotor training treatment sessions in the NRN. INTERVENTIONS: Intensive locomotor training including stepping on a treadmill with partial body weight support and manual facilitation and translation of skills into home and community activities. MAIN OUTCOME MEASURES: Berg Balance Scale, six-minute walk test, and ten-meter walk test. RESULTS: Individuals classified within each of the 4 phases of the NRS were functionally discrete, as shown by significant differences in the mean values of balance, gait speed, and walking endurance, and the variability of these measurements was significantly reduced by NRS classification. The magnitude of improvements in these outcomes was also significantly different among phase groups. CONCLUSIONS: Assessment with the NRS provides a classification for functional motor recovery without compensation, which reduces variability in performance and improvements for individuals with injuries classified as AIS grades C and D.

Ambulation and balance outcomes measure different aspects of recovery in individuals with chronic, incomplete spinal cord injury.

OBJECTIVE: To evaluate relationships among ambulation and balance outcome measures over time for incomplete spinal cord injury (SCI) after locomotor training, in order to facilitate the selection of effective and sensitive rehabilitation outcomes. DESIGN: Prospective observational cohort. SETTING: Outpatient rehabilitation centers (N=7) from the Christopher and Dana Reeve Foundation NeuroRecovery Network. PARTICIPANTS: Patients with incomplete SCI (N=182) American Spinal Injury Association Impairment Scale level C (n=61) and D (n=121). INTERVENTIONS: Intensive locomotor training, including step training using body weight support and manual facilitation on a treadmill followed by overground assessment and community integration. MAIN OUTCOME MEASURES: Six-minute and 10-meter walk tests, Berg Balance Scale, Modified Functional Reach, and Neuromuscular Recovery Scale collected at enrollment, approximately every 20 sessions, and on discharge. RESULTS: Walking and standing balance measures for all participants were strongly correlated (r≥.83 for all pairwise outcome correlations), standing and sitting balance measures were not highly correlated (r≤.48 for all pairwise outcome correlations), and walking measures were weakly related to sitting balance. The strength of relationships among outcome measures varied with functional status. Correlations among evaluation-to-evaluation changes were markedly reduced from performance correlations. Walk tests, when conducted with different assistive devices, were strongly correlated but had substantial variability in performance. CONCLUSIONS: These results cumulatively suggest that changes in walking and balance measures reflect different aspects of recovery and are highly influenced by functional status and the utilization of assistive devices. These factors should be carefully considered when assessing clinical progress and designing clinical trials for rehabilitation.

Marginal association measures for clustered data.

The use of correlation coefficients in measuring the association between two continuous variables is common, but regular methods of calculating correlations have not been extended to the clustered data framework. For clustered data in which observations within a cluster may be correlated, regular inferential procedures for calculating marginal association between two variables can be biased. This is particularly true for data in which the number of observations in a given cluster is informative for the association being measured. In this paper, we apply the principle of inverse cluster size reweighting to develop estimators of marginal correlation that remain valid in the clustered data framework when cluster size is informative for the correlation being measured. These correlations are derived as analogs to regular correlation estimators for continuous, independent data, namely, Pearson's ρ and Kendall's τ. We present the results of a simple simulation study demonstrating the appropriateness of our proposed estimators and the inherent bias of other inferential procedures for clustered data. We illustrate their use through an application to data from patients with incomplete spinal cord injury in the U.S.A.