Demonstrating responsiveness of the pediatric cardiac quality of life inventory in children and adolescents undergoing arrhythmia ablation, heart transplantation, and valve surgery.

PURPOSE: Pediatric Cardiac Quality of Life Inventory (PCQLI) is a disease-specific pediatric cardiac health-related quality of life (HRQOL) instrument that is reliable, valid, and generalizable. We aim to demonstrate PCQLI responsiveness in children undergoing arrhythmia ablation, heart transplantation, and valve surgery before and after cardiac intervention. METHODS: Pediatric cardiac patients 8-18 years of age from 11 centers undergoing arrhythmia ablation, heart transplantation, or valve surgery were enrolled. Patient and parent-proxy PCQLI Total, Disease Impact and Psychosocial Impact subscale scores were assessed pre- and 3-12 months follow-up. Patient clinical status was assessed by a clinician post-procedure and dichotomized into markedly improved/improved and no change/worse/much worse. Paired t-tests examined change over time. RESULTS: We included 195 patient/parent-proxies: 12.6 ± 3.0 years of age; median follow-up time 6.7 (IQR = 5.3-8.2) months; procedural groups - 79 (41%) ablation, 28 (14%) heart transplantation, 88 (45%) valve surgery; clinical status - 164 (84%) markedly improved/improved, 31 (16%) no change/worse/much worse. PCQLI patient and parent-proxies Total scores increased (p ≤ 0.013) in each intervention group. All PCQLI scores were higher (p < 0.001) in the markedly improved/improved group and there were no clinically significant differences in the PCQLI scores in the no difference/worse/much worse group. CONCLUSION: The PCQLI is responsive in the pediatric cardiac population. Patients with improved clinical status and their parent-proxies reported increased HRQOL after the procedure. Patients with no improvement in clinical status and their parent-proxies reported no change in HRQOL. PCQLI may be used as a patient-reported outcome measure for longitudinal follow-up and interventional trials to assess HRQOL impact from patient and parent-proxy perspectives.

It is important to have quality of life (QOL) measures that are sensitive to change in QOL before and after procedures and to be sensitive to change over time. The Pediatric Cardiac Quality of Life Inventory (PCQLI) is a QOL measure specifically developed for children with cardiac disease. This study assessed the responsiveness of the PCQLI to detect change in QOL over time. QOL in Children and adolescents who were being treated for abnormal heart rhythms, heart transplantation, and aortic, pulmonary, or mitral valve surgery were assessed before and after their procedure. Children and adolescents with improved clinical status post-procedure, and their parents, reported better QOL after the procedure. Patients with no improvement from a cardiac standpoint and their parents reported no change in QOL after their procedure. The PCQLI may be used to assess QOL before and after cardiac procedures or medical treatment and follow QOL over time.

Long-Term Quality of Life in Congenital Heart Disease Surgical Survivors: Multicenter Retrospective Study of Surgical and ICU Explanatory Factors.

OBJECTIVES: Greater congenital heart disease (CHD) complexity is associated with lower health-related quality of life (HRQOL). There are no data on the association between surgical and ICU factors and HRQOL in CHD survivors. This study assess the association between surgical and ICU factors and HRQOL in child and adolescent CHD survivors. DESIGN: This was a corollary study of the Pediatric Cardiac Quality of Life Inventory (PCQLI) Testing Study. SETTING: Eight pediatric hospitals participating in the PCQLI Study. PATIENTS: Patients in the study had the Fontan procedure, surgery for tetralogy of Fallot (TOF), and transposition of the great arteries (TGAs). MEASUREMENTS AND MAIN RESULTS: Surgical/ICU explanatory variables were collected by reviewing the medical records. Primary outcome variables (PCQLI Total patient and parent scores) and covariates were obtained from the Data Registry. General linear modeling was used to create the multivariable models. There were 572 patients included: mean ± sd of age 11.7 ± 2.9 years; CHD Fontan 45%, TOF/TGA 55%; number of cardiac surgeries 2 (1-9); and number of ICU admissions 3 (1-9). In multivariable models, lowest body temperature on cardiopulmonary bypass (CPB) was negatively associated with patient total score (p < 0.05). The total number of CPB runs was negatively associated with parent-reported PCQLI Total score (p < 0.02). Cumulative days on an inotropic/vasoactive drug in the ICU was negatively associated with all patient-/parent-reported PCQLI scores (p < 0.04). Neurological deficit at discharge was negatively associated with parent-reported PCQLI total score (p < 0.02). The variance explained by these factors ranged from 24% to 29%. CONCLUSIONS: Surgical/ICU factors, demographic, and medical care utilization variables explain a low-to-moderate amount of variation in HRQOL. Research is needed to determine whether modification of these surgical and ICU factors improves HRQOL, and to identify other factors that contribute to unexplained variability.

Alternative Biologic Therapy in Children Failing Conventional TNFα Inhibitors for Refractory, Noninfectious, Chronic Anterior Uveitis.

PURPOSE: A significant number of children with noninfectious, chronic anterior uveitis (CAU) fail to respond to conventional therapy; however, successful alternative biologic treatments (ABT) have not been well described. This study aims to review the clinical and treatment characteristics of children with CAU who require ABT. DESIGN: Retrospective, nonrandomized clinical study. METHODS: Setting: Tertiary center. STUDY POPULATION: Children with noninfectious CAU. OBSERVATION PROCEDURES: Clinical characteristics, uveitis course, complications, and treatment were compared among patients treated with methotrexate (MTX) monotherapy, conventional TNFα inhibitors (cTNFi), and ABT for >3 months. MAIN OUTCOME MEASURE: Success of ABT (abatacept, tocilizumab, and/or golimumab) in children failing conventional treatment. RESULTS: Of the 52 children with CAU, 75% had juvenile idiopathic arthritis. CAU was controlled in 15 children receiving MTX monotherapy, 28 receiving cTNFi, and 9 receiving ABT (n = 1, abatacept; n = 3, tocilizumab; n = 5, golimumab). Patients in the ABT group had a greater number of total ocular complications per person before ABT than those in the control groups (3.4 vs 0.7 [MTX], P < .001, and 1.5 [cTNFi], P < .001, respectively). In all 9 children on ABT, treatment led to control of CAU and topical glucocorticoids tapered to ≤2 drops/d with no new ocular complications. CONCLUSIONS: In this study, alternative biologics (abatacept, golimumab, and tocilizumab) were useful for treating CAU in children who fail MTX and cTNFi therapy. Patients who were controlled on ABT had more disease activity, ocular complications, and anti-cTNFi neutralizing antibodies (before ABT) than those managed with conventional therapy. Larger studies are required to confirm these findings.

Fontan Geometry and Hemodynamics Are Associated With Quality of Life in Adolescents and Young Adults.

BACKGROUND: Despite favorable short-term outcomes, Fontan palliation is associated with comorbidities and diminished quality of life (QOL) in the years after completion. We hypothesized that poor Fontan hemodynamics and ventricular function are associated with worse QOL. METHODS: This was a single-center study of Fontan survivors aged more than 12 years. Subjects completed a cardiac magnetic resonance scan and QOL questionnaire. Cardiac magnetic resonance-derived variables included Fontan geometry, and hemodynamics. Computational fluid dynamics simulations quantified power loss, pressure drop, and total cavopulmonary connection resistance across the Fontan. Quality of life was assessed by completion of the Pediatric Quality of Life Inventory. Longitudinal and cross-sectional comparisons were made between cardiac magnetic resonance and computational fluid dynamics parameters with patient-reported QOL. RESULTS: We studied 77 Fontan patients, median age 19.7 years (interquartile range, 17.1 to 23.6), median time from Fontan completion 16 years (interquartile range, 13 to 20). Longitudinal data were available for 48 patients; median time between cardiac magnetic resonance and QOL was 8.1 years (interquartile range, 7 to 9.4). Median patient-reported Pediatric Quality of Life Inventory total score was 80 (interquartile range, 67.4 to 88). Greater power loss and smaller left pulmonary artery diameter at baseline were associated with worse QOL at follow-up. Greater pressure drop was associated with worse QOL at the same time point. CONCLUSIONS: For Fontan survivors, measures of computational fluid dynamics hemodynamics and geometry are associated with worse QOL. Interventional strategies targeted at optimizing the Fontan may improve QOL.

Psychosocial functioning of parents of children with heart disease-describing the landscape.

The aim was to describe the psychological functioning of parents of school-age children with heart disease (HD) in a large-scale, transnational evaluation of parent dyads across the spectrum of cardiac diagnoses and a range of psychosocial domains. Parents of children with HD attending routine out-patient cardiology follow-up visits completed questionnaires assessing their mental health, coping, and family functioning. Parents (1197 mothers and 1053 fathers) of 1214 children (mean age: 12.6 years; S.D. 3.0 years; median time since last surgery: 8.9 years) with congenital or acquired HD from three centers each in the UK and the USA participated (80% response rate). Parents of children with milder HD demonstrated few differences from healthy norms and had significantly lower scores on measures of illness-related stress and post-traumatic stress than parents of children with single ventricle conditions or cardiomyopathy. Parents in these latter two diagnostic sub-groups had significantly higher levels of anxiety and depression than healthy norms but did not differ on other measures of family functioning and coping skills. There were few differences between parents from the UK and the USA. Agreement between mothers and fathers within a dyad was highest for the measure of frequency of illness-related stressors (ICC = 0.67) and lowest for anxiety (ICC = 0.12).Conclusion: Our results suggest two different pathways for the long-term psychological well-being of parents of children with HD: on the one hand, more complex HD is associated with poorer long-term psychosocial outcomes; in contrast, there are also grounds for optimism, particularly for parents of children with less complex conditions, with better psychological outcomes noted for some groups of parents compared to previously reported early psychosocial outcomes. Future work needs to identify factors other than disease severity which might explain poorer (or better) functioning in some parents of children with more complex HD. What is Known: • Parents of children with congenital heart disease report elevated levels of anxiety, depression, and stress after cardiac surgery in infancy. • Maternal mental health problems can have an adverse impact on the psychological adjustment of the child with congenital heart disease. What is New: • Parents of children with milder forms of heart disease do not differ from healthy norms in the longer term and psychological outcomes are better than might be expected from early findings. • More complex diagnoses, particularly functional single ventricle conditions and cardiomyopathy, are associated with poorer long-term psychosocial outcomes for parents.

Impaired cerebral autoregulation and elevation in plasma glial fibrillary acidic protein level during cardiopulmonary bypass surgery for CHD.

BACKGROUND: Cerebrovascular reactivity monitoring has been used to identify the lower limit of pressure autoregulation in adult patients with brain injury. We hypothesise that impaired cerebrovascular reactivity and time spent below the lower limit of autoregulation during cardiopulmonary bypass will result in hypoperfusion injuries to the brain detectable by elevation in serum glial fibrillary acidic protein level. METHODS: We designed a multicentre observational pilot study combining concurrent cerebrovascular reactivity and biomarker monitoring during cardiopulmonary bypass. All children undergoing bypass for CHD were eligible. Autoregulation was monitored with the haemoglobin volume index, a moving correlation coefficient between the mean arterial blood pressure and the near-infrared spectroscopy-based trend of cerebral blood volume. Both haemoglobin volume index and glial fibrillary acidic protein data were analysed by phases of bypass. Each patient's autoregulation curve was analysed to identify the lower limit of autoregulation and optimal arterial blood pressure. RESULTS: A total of 57 children had autoregulation and biomarker data for all phases of bypass. The mean baseline haemoglobin volume index was 0.084. Haemoglobin volume index increased with lowering of pressure with 82% demonstrating a lower limit of autoregulation (41±9 mmHg), whereas 100% demonstrated optimal blood pressure (48±11 mmHg). There was a significant association between an individual's peak autoregulation and biomarker values (p=0.01). CONCLUSIONS: Individual, dynamic non-invasive cerebrovascular reactivity monitoring demonstrated transient periods of impairment related to possible silent brain injury. The association between an impaired autoregulation burden and elevation in the serum brain biomarker may identify brain perfusion risk that could result in injury.

Arginine-vasopressin therapy in hypotensive neonates and infants after cardiac surgery: response is unrelated to baseline ventricular function.

We hypothesised that infants with ventricular dysfunction after cardiac surgery have impaired haemodynamic response to arginine-vasopressin therapy. We retrospectively reviewed the medical records of neonates and infants treated with arginine-vasopressin within 48 hours of corrective or palliative cardiac surgery who underwent echocardiographic assessment of ventricular function before initiation of therapy. Patients were classified as "responders" if their systolic blood pressure increased by ⩾10% without increase in catecholamine score or if it was maintained with decreased catecholamine score. Response was assessed 1 hour after maximum upward titration of arginine-vasopressin. A total of 36 children (15 neonates) were reviewed (17 male). The median (interquartile) age was 10.4 weeks (1.1-26.9), and the median weight was 4.3 kg (3.2-5.8). Diagnoses included single ventricle (eight), arch abnormalities (five), atrioventricular septal defect (four), double-outlet right ventricle (three), tetralogy of Fallot (three), and others (13). In all, 12 patients (33%) had ventricular dysfunction. Only 15 (42%) responded favourably according to our definition 1 hour after the "target" arginine-vasopressin dose was achieved. Ventricular dysfunction was not associated with poor response. The overall mortality was 25%, but mortality in patients with ventricular dysfunction was 42%. Favourable response was associated with shorter ICU stay (9.5 days versus 19.5 days, p=0.01). We conclude that arginine-vasopressin fails to increase blood pressure in ~50% of hypotensive children after cardiac surgery. The response rate does not increase with duration of therapy. Ventricular function does not predict haemodynamic response. The mortality in this group is very high. Prospective comparison of vasopressin with other vasoactive agents and/or inotropes is warranted.

Impact of Surgical Complexity on Health-Related Quality of Life in Congenital Heart Disease Surgical Survivors.

BACKGROUND: Surgical complexity and related morbidities may affect long-term patient quality of life (QOL). Aristotle Basic Complexity (ABC) score and Risk Adjustment in Congenital Heart Surgery (RACHS-1) category stratify the complexity of pediatric cardiac operations. The purpose of this study was to examine the relationship between surgical complexity and QOL and to investigate other demographic and clinical variables that might explain variation in QOL in pediatric cardiac surgical survivors. METHODS AND RESULTS: Pediatric Cardiac Quality of Life (PCQLI) study participants who had undergone cardiac surgery were included. The PCQLI database provided sample characteristics and QOL scores. Surgical complexity was defined by the highest ABC raw score or RACHS-1 category. Relationships among surgical complexity and demographic, clinical, and QOL variables were assessed using ordinary least squares regression. A total of 1416 patient-parent pairs were included. Although higher ABC scores and RACHS-1 categories were associated with lower QOL scores (P<0.005), correlation with QOL scores was poor to fair (r=-0.10 to -0.29) for all groups. Ordinary least squares regression showed weak association with R(2)=0.06 to R(2)=0.28. After accounting for single-ventricle anatomy, number of doctor visits, and time since last hospitalization, surgical complexity scores added no additional explanation to the variance in QOL scores. CONCLUSIONS: ABC scores and RACHS-1 categories are useful tools for morbidity and mortality predictions prior to cardiac surgery and quality of care initiatives but are minimally helpful in predicting a child's or adolescent's long-term QOL scores. Further studies are warranted to determine other predictors of QOL variation.

Morbidity in children and adolescents after surgical correction of interrupted aortic arch.

Previous studies of outcome after operative correction of interrupted aortic arch (IAA) have focused on mortality and rates of reintervention. We sought to investigate the clinical status of children and adolescents after surgery for IAA. A cross-sectional study of subjects with IAA between the ages of 8 and 18 years was performed with the subjects undergoing simultaneous genetic testing, electrocardiogram, cardiac magnetic resonance imaging, cardiopulmonary exercise testing, and assessment of health status and health-related quality of life as well as concurrent retrospective cohort study reviewing their postoperative use of medical care, including operative and transcatheter reinterventions, noncardiac surgeries, and hospitalizations. Twenty-one subjects with IAA with median age of 9 years were studied. Reintervention rates were 38% for left-ventricular outflow tract, 33% for AA, and 24% for both. Rates of reintervention were highest in the first year of life and decreased in subsequent years. Left-ventricular ejection fraction was preserved (72 ± 6%). Maximal oxygen consumption, maximal work, and forced vital capacity were both significantly decreased from age and sex norms (p < 0.0001). Health status and quality of life were both severely decreased. Subjects with IAA demonstrate a significant burden of operative and transcatheter intervention and large magnitude deficits in exercise performance, health status, and health-related quality of life.

Oral risedronate sodium improves bone mineral density in non-ambulatory patients: a randomized, double-blind, placebo controlled trial.

AIMS: Investigate the efficacy of risedronate sodium (Procter and Gamble, Cincinnati, USA) for treating reduced lumbar spine (LS) bone mineral density (BMD) in non-ambulatory patients. METHODS: Nine (10-39 years, mean age 23.0 years, 7 males) in the risedronate arm and 10 (10-35 years, mean age 21.4 years, 8 males) in the placebo arm completed 24 months of therapy at baseline, 6, 12, 18, and 24 months. The primary outcome was change in LS BMD assessed by dual energy x-ray absorptiometry (DXA). Secondary outcomes included changes in serum bone markers, bone specific alkaline phosphatase, osteocalcin, and N-telopeptides. Mixed models examined group, time, and the group by time interaction for the 4 post-baseline time points. RESULTS: The change in LS BMD score from baseline to 24 months was 0.069 (95% CI 0.014 to 0.124) in risedronate participants compared to -0.015 (95% CI -0.073 to 0.042) (t Value = -2.40, P > t=0.03) in the controls. When controlling for baseline scores, the difference was consistent across four post-baseline time points tested (F=5.67, Pr > F=0.03). No differences in serum bone markers were observed. CONCLUSIONS: Risedronate increases LS BMD in non-ambulatory patients with minimal side effects.

Staged palliation of hypoplastic left heart syndrome: trends in mortality, cost, and length of stay using a national database from 2000 through 2009.

Staged surgical palliation has revolutionized the care of patients with hypoplastic left heart syndrome (HLHS), although the outcomes of survival and cost at a national level remain unclear. This study sought to evaluate (1) trends in HLHS surgical outcomes including in-hospital mortality, length of stay (LOS), and cost, and (2) patient and hospital risk factors associated with these outcomes. Hospitalizations for patients with HLHS, including stage I, II, and III palliations, were analyzed using the Kids' Inpatient Database from 2000 through 2009. Trends in mortality, LOS, and cost were analyzed and chi-squared tests were used to test association between categorical variables. Patient and hospital characteristics associated with death were analyzed using logistic regression and associations with LOS were analyzed using ordinary least squared regression. There were 16,923 hospital admissions in patients with HLHS of which 5,672 (34%) included surgical intervention. Total (3,201-5,102) and surgery-specific admissions (1,165-1,618) increased from 2000 to 2009. Mortality decreased 14% per year in stage III palliations (odds ratio [OR] 0.86; 95% confidence interval [CI]: 0.79-0.94) and 6% per year for stage I palliations (OR 0.94; 95% CI 0.90-0.99) but not for stage II palliations (OR 1.01; 95% CI; 0.89-1.14). Length of stay increased for stage I and II palliations; however, per-patient hospital cost decreased in 2009. In conclusion, recent decrease in per patient cost for staged surgical palliation for HLHS has correlated temporally with improved mortality.

Clinical predictors of outcome following inflicted traumatic brain injury in children.

BACKGROUND: The study aimed to determine which acute injury variables were predictors of long-term functional outcome following inflicted traumatic brain injury (iTBI). METHODS: A retrospective case review of 35 children with iTBI was performed. After controlling for age at injury and time since injury, the generalized estimation equations method was used to identify acute injury variables that were significantly related to the Glasgow Outcome Scale scores at the initial follow-up assessments. When available, functional sequelae at these and longer-term follow-ups were also examined. RESULTS: In bivariate generalized estimation equations analyses, a low Glasgow Coma Scale (GCS) eye component score, a low GCS motor component score, a low GCS verbal component score, need for neurosurgical intervention, seizures in the first week after injury, need for mechanical ventilation for more than 10 days, length of intensive care unit stay of more than 10 days, initial hyperglycemia, and neuroimaging findings of cerebral edema or loss of gray-white matter differentiation were significantly (p ≤ 0.05) related to having a poor outcome, as defined by their Glasgow Outcome Scale score at the initial follow-up. In multivariable analyses, considering the significant predictors while controlling for age at injury and time since injury, the presence of cerebral edema on neuroimaging (odds ratio, 27.21; 95% confidence interval, 4.40-168.22), and length of intensive care unit stay of more than 10 days (odds ratio, 21.57; 95% confidence interval, 3.09-150.48) were significantly related to having a poor outcome. CONCLUSION: Early clinical data following iTBI help predict long-term functional outcome. Further research to support these findings may help delineate acutely after injury which children with iTBI are at risk for a poor prognosis and should be more closely followed up over time. LEVEL OF EVIDENCE: Prognostic study, level IV.

Trajectories of adherence to airway clearance therapy for patients with cystic fibrosis.

OBJECTIVE: Although cross-sectional studies have demonstrated poor adherence to airway clearance therapy (ACT) for patients with cystic fibrosis (CF), no studies have identified longitudinal patterns of adherence. The objective was to characterize and identify predictors of ACT adherence trajectories for individuals with CF. METHODS: Secondary data analyses were conducted for a randomized clinical trial examining differences in three ACTs. Participants (n = 153; M = 14.3 years, 55% male, 86% Caucasian, baseline FEV(1)% predicted: M = 86.7)/primary caregivers completed Daily Phone Diaries, an empirically supported adherence measure, every 4 months. RESULTS: Group-based trajectory modeling revealed the best-fitting solution was a three-group model: low-adherence (14%), medium-adherence (49%), and high-adherence (37%) groups. ACT type was the only significant predictor of adherence trajectories. DISCUSSION: Three trajectories of adherence to ACT for patients with CF were found. With the identification of trajectories, adherence interventions can be targeted for the subgroup at highest risk in order to prevent poor health outcomes.

Adherence to treatment among children with cardiac disease.

OBJECTIVE: Our purpose was to review the literature with respect to issues of adherence to treatment among children with congenital and acquired cardiac disease. MATERIALS AND METHODS: Databases used for this review included MEDLINE, Pub Med's Single Citation Manager, Cochrane Library, Cochrane Central Register of Controlled Trials, Scopus, and Google Scholar. We did not use any restrictions on date when locating peer-reviewed articles published worldwide through December of 2008. RESULTS: There exists a lack of published research regarding adherence to medical treatment for children with cardiac conditions. Of the few published studies, rates of adherence for children with congenital and acquired cardiac disease ranged from a high of 96% for an in-patient exercise programme, to a low of 33% among those who made all of their medical appointments. Risk factors for nonadherence included older age, one as opposed to two parents in the home, lack of emotional availability of parents, smoking, sedentary lifestyle, use of illicit drugs, presence of tattoos, and multiple body piercings. Clinical outcomes associated with non adherence in the population of children undergoing transplantation included mortality, acute episodes of rejection, lower levels of Cyclosporine A, and lower values for the International Normalised Ratio of prothrombin. CONCLUSIONS: For children with congenital and acquired heart disease, the challenges of adherence to treatment can often be overwhelming. Recommendations designed to maximize the impact and scientific rigour of future studies include obtaining quantitative and qualitative measures of adherence, identifying primary and secondary endpoints, emphasizing factors of interest, planning studies with sufficient power to impact on the adherence to treatment, and developing epidemiologic foundations.

Risk factors associated with surgical site infection after pediatric posterior spinal fusion procedure.

OBJECTIVE: To identify risk factors associated with surgical site infection (SSI) after pediatric posterior spinal fusion procedure by examining characteristics related to the patient, the surgical procedure, and tissue hypoxia. DESIGN: Retrospective case-control study nested in a hospital cohort study. SETTING: A 475-bed, tertiary care children's hospital. METHODS: All patients who underwent a spinal fusion procedure during the period from January 1995 through December 2006 were included. SSI cases were identified by means of prospective surveillance using National Nosocomial Infection Surveillance system definitions. Forty-four case patients who underwent a posterior spinal fusion procedure and developed an SSI were identified and evaluated. Each case patient was matched (on the basis of date of surgery, +/-3 months) to 3 control patients who underwent a posterior spinal fusion procedure but did not develop an SSI. Risk factors for SSI were evaluated by univariate analysis and multivariable conditional logistic regression. Odds ratios (ORs), with 95% confidence intervals (CIs) and P values, were calculated. RESULTS: From 1995 to 2006, the mean annual rate of SSI after posterior spinal fusion procedure was 4.4% (range, 1.1%-6.7%). Significant risk factors associated with SSI in the univariate analysis included the following: a body mass index (BMI) greater than the 95th percentile (OR, 3.5 [95% CI, 1.5-8.3]); antibiotic prophylaxis with clindamycin, compared with other antibiotics (OR, 3.5 [95% CI, 1.2-10.0]); inappropriately low dose of antibiotic (OR, 2.6 [95% CI, 1.0-6.6]); and a longer duration of hypothermia (ie, a core body temperature of less than 35.5 degrees C) during surgery (OR, 0.4 [95% CI, 0.2-0.9]). An American Society of Anesthesiologists (ASA) score of greater than 2, obesity (ie, a BMI greater than the 95th percentile), antibiotic prophylaxis with clindamycin, and hypothermia were statistically significant in the multivariable model. CONCLUSION: An ASA score greater than 2, obesity, and antibiotic prophylaxis with clindamycin were independent risk factors for SSI. Hypothermia during surgery appears to provide protection against SSI in this patient population.

The identification of medical errors by family physicians during outpatient visits.

BACKGROUND: We wanted to describe errors and preventable adverse events identified by family physicians during the office-based clinical encounter and to determine the physicians' perception of patient harm resulting from these events. METHOD: We sampled Cincinnati area family physicians representing different practice locations and demographics. After each clinical encounter, physicians completed a form identifying process errors and preventable adverse events. Brief interviews were held with physicians to ascertain their perceptions of harm or potential harm to the patient. RESULTS: Fifteen physicians in 7 practices completed forms for 351 outpatient visits. Errors and preventable adverse events were identified in 24% of these visits. There was wide variation in how often individual physicians identified errors (3% to 60% of visits). Office administration errors were most frequently noted. Harm was believe to have occurred as a result of 24% of the errors, and was a potential in another 70%. Although most harm was believed to be minor, there was disagreement as to whether to include emotional discomfort and wasted time as patient harm. CONCLUSIONS: Family physicians identify errors and preventable adverse events frequently during patient visits, but there is variation in how some error categories are interpreted and how harm is defined.