Mortality Risk Using a Pediatric Quick Sequential (Sepsis-Related) Organ Failure Assessment Varies With Vital Sign Thresholds.

OBJECTIVES: We evaluated adapting the quick Sequential (Sepsis-Related) Organ Failure Assessment score (fast respiratory rate, altered mental status, low blood pressure) for pediatric use by selecting thresholds from three commonly used definitions: Pediatric Logistic Organ Dysfunction 2, Pediatric Advanced Life Support, and International Pediatric Sepsis Consensus Conference. We examined their respective performance in identifying children who had a discharge diagnosis of infection at high risk of mortality using PICU registry data, with additional focus on the influence of age on performance. DESIGN: Analysis of retrospective data obtained from the Virtual Pediatric Systems PICU database. The performance in predicting observed mortality was assessed for the three candidate approaches using receiver operating characteristics analysis, including age group effects. SETTING: The Virtual Pediatric Systems database contains data on diagnosis, clinical markers, and outcomes in prospectively collected clinical records from 130 participating PICUs in the United States and Canada. PATIENTS: Children who had a discharge diagnosis of infection in a participating PICU between 2009 and 2014, for which all required data were available. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Data from 40,228 children revealed an overall mortality of 4.22%. Area under the receiver operating characteristics curve (95% CI) was 0.760 (0.749-0.771) for Pediatric Logistic Organ Dysfunction 2 with mechanical ventilation, 0.700 (0.689-0.712) for Pediatric Advanced Life Support, and 0.709 (0.696-0.721) for International Pediatric Sepsis Consensus Conference. When split by age group, the performance of Pediatric Logistic Organ Dysfunction 2 with mechanical ventilation was lowest in the youngest neonates (under 1 wk old), with an area under the receiver operating characteristics curve (95% CI) of 0.724 (0.656-0.791), and in the teenagers (13-18 yr), with an area under the receiver operating characteristics curve of 0.710 (0.682-0.738), yet it still outperformed Pediatric Advanced Life Support and International Pediatric Sepsis Consensus Conference in both groups. CONCLUSIONS: Among critically ill children who had a discharge diagnosis of infection in the PICU, quick Sequential (Sepsis-Related) Organ Failure Assessment score performs best when using the Pediatric Logistic Organ Dysfunction 2 age thresholds with mechanical ventilation, while all definitions performed worse at extremes of pediatric age. Thus, mortality risk varies with vital sign thresholds, and although Pediatric Logistic Organ Dysfunction 2 with mechanical ventilation performed marginally better, it is unlikely to be of use to clinicians. More work is needed to develop a robust and relevant pediatric sepsis risk score.

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial.

BACKGROUND: We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. METHODS/DESIGN: Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) or four weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. DISCUSSION: The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through five years among enrolled women. We highlight considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion.

Minimal clinically important difference for 7 measures of fatigue in patients with systemic lupus erythematosus.

OBJECTIVE: To determine the minimal clinically important difference (MCID) for 7 measures of fatigue in patients with systemic lupus erythematosus (SLE). METHODS: Study subjects completed 7 fatigue instruments [Fatigue Severity Scale (FSS), Multidimensional Assessment of Fatigue (MAF), Multidimensional Fatigue Inventory (MFI), Vitality scale of the MOS-SF-36, Chalder Fatigue Scale (CFS), Functional Assessment of Chronic Illness Therapy-Fatigue, and a global Rating Scale (RS)] and then participated in a series of interviews with other study participants comparing their fatigue with one another. Each interview participant rated the difference in their fatigue levels on a 7-point transition scale. The MCID was estimated from the mean difference in fatigue scores between each pair of interview participants based on their subjective rating of fatigue contrast. The MCID was also estimated using linear regression modeling. RESULTS: Eighty patients with SLE participated. Patients reported significant levels of fatigue [mean normalized (0 = none, 100 = maximum) fatigue scores for the 7 instruments ranged from 49.8 (CFS) to 71.1 (FSS)]. The MCID of "a little more" fatigue tended to be greater than the MCID for a "little less fatigue" and differed significantly for FSS and MAF. The MCID of normalized scores estimated by linear regression ranged from 7.0 (CFS) to 14.3 (MFI). CONCLUSION: Fatigue is a common and debilitating component of SLE. Estimates of MCID will help to interpret changes observed in a fatigue score and will be critical in estimating sample size requirements for clinical trials including fatigue as an outcome.

Effects of an enhanced secondary prevention program for patients with heart disease: a prospective randomized trial.

BACKGROUND: Secondary prevention medications in cardiac patients improve outcomes. However, prescription rates for these drugs and long-term adherence are suboptimal. OBJECTIVE: To determine whether an enhanced secondary prevention program improves outcomes. METHODS: Hospitalized patients with indications for secondary prevention medications were randomly assigned to either usual care or an intervention arm, in which an intensive program was used to optimize prescription rates and long-term adherence. Follow-up was 19 months. RESULTS: A total of 2643 patients were randomly assigned in the study; 1342 patients were assigned to usual care and 1301 patients were assigned to the intervention arm. Prescription rates were near optimal except for lipid-lowering medications. Rehospitalization rates per 100 patients were 136.2 and 132.6 over 19 months in the usual care and intervention groups, respectively (P=0.59). Total days in hospital per patient were similar (10.9 days in the usual care group versus 10.2 days in the intervention group; P not significant). Crude mortality was 6.2% and 5.5% in the usual care and intervention groups, respectively, with no significant difference (P=0.15) in overall survival. Post hoc analysis suggested that after the study team became experienced, days in hospital per patient were reduced by the program (11.1+/-0.91 and 8.9+/-0.61 in the usual care and intervention groups, respectively; P<0.05). CONCLUSIONS: The intervention program failed to improve outcomes in the present study. One explanation for these results is the near optimal physician compliance with guidelines in both groups. It is also possible that a substantial learning curve for the staff was involved, as suggested by the reduction in total days in hospital in the intervention patients during the second part of the study.

Association of postoperative complications with hospital costs and length of stay in a tertiary care center.

BACKGROUND: Postoperative complications are a significant source of morbidity and mortality. There are limited studies, however, assessing the impact of common postoperative complications on health care resource utilization. OBJECTIVE: To assess the association of clinically important postoperative complications with total hospital costs and length of stay (LOS) in patients undergoing noncardiac surgery. METHODS: We determined total hospital costs and LOS in all patients admitted to a single tertiary care center between July 1, 1996 and March 31, 1998 using a detailed administrative hospital discharge database. Total hospital costs and LOS were adjusted for preoperative and surgical characteristics. RESULTS: Of 7,457 patients who underwent noncardiac surgery, 6.9% developed at least 1 of the postoperative complications. These complications increased hospital costs by 78% (95% confidence interval [CI]: 68% to 90%) and LOS by 114% (95% CI: 100% to 130%) after adjustment for patient preoperative and surgical characteristics. Postoperative pneumonia was the most common complication (3%) and was associated with a 55% increase in hospital costs (95% CI: 42% to 69%) and an 89% increase in LOS (95% CI: 70% to 109%). CONCLUSIONS: Postoperative complications consume considerable health care resources. Initiatives targeting prevention of these events could significantly reduce overall costs of care and improve patient quality of care.

Assessment of mental health and illness by telephone survey: experience with an Alberta mental health survey.

Mental health is an emerging priority for health surveillance. It has not been determined that the existing data sources can adequately meet surveillance needs. The objective of this project was to explore the use of telephone surveys as a means of collecting supplementary surveillance information. A computer-assisted telephone interview was administered to 5,400 subjects in Alberta. The interview included a set of brief, validated measures for evaluating mental disorder prevalence and related variables. The individual subject response rate was 78 percent, but a substantial number of refusals occurred at the initial household contact. The age and sex distribution of the study sample differed from that of the provincial population prior to weighting. Prevalence proportions did not vary substantially across administrative health regions. There is a potential role for telephone data collection in mental health surveillance, but these results highlight some associated methodological challenges. They also draw into question the importance of regional variation in mental disorder prevalence--which might otherwise have been a key advantage of telephone survey methodologies.

Automated assessment of blood pressure using BpTRU compared with assessments by a trained technician and a clinic nurse.

OBJECTIVE: To determine the accuracy and reproducibility of a new automated blood pressure manometer (BpTRU) relative to auscultatory blood pressure assessed by a research nurse and to that assessed by a clinic nurse. METHODS: Firefighters in a cohort study had blood pressure assessed on up to five occasions with BpTRU and by a trained research technician. Patients in an internal medicine clinic had blood pressure assessed by the clinic nurse and by BpTRU. The absolute values of blood pressure, reproducibility and effect on hypertension classification were compared with the different methods. RESULTS: The research technician readings were higher than the BpTRU readings at visit 1 (3.0/2.7 mmHg, P<0.0001) but the readings converged by visits 4-5 because of a greater reduction in the research nurse readings. The BpTRU readings had similar reproducibility and classification of hypertension as the research technician but did not exhibit terminal digit preference while the research technician readings did. The BpTRU had substantially lower readings (8/7 mmHg) and fewer hypertensive readings than those of the nurse in the internal medicine clinic. CONCLUSIONS: This preliminary study found that the BpTRU had desirable characteristics that suggest that it would be a suitable replacement for auscultatory assessment of blood pressure in clinical practice. A large confirmatory study performed in a usual clinic setting is required.

Quantitative assessment of thrombus burden predicts the outcome of treatment for venous thrombosis: a systematic review.

PURPOSE: Clot-burden change in patients receiving anticoagulant therapy, by predicting subsequent recurrent venous thromboembolism, may provide a clinically relevant surrogate endpoint of prognostic importance. The validity of this objective measure is yet to be established. METHODS: A PubMed search was performed to retrieve articles published up to December 2003. We identified 11 randomized trials reported from 1990 to 2003 that met our study identification and selection criteria. Anticoagulant therapy subsequently approved by regulatory affairs was assessed by clot-burden change and the validated outcome measure, long-term venous thromboembolism. Two additional randomized trials, partly meeting the inclusion criteria, were included in the sensitivity analysis. RESULTS: Individual studies suggested a predictive relationship between clot-burden change and likelihood of recurrent venous thromboembolism irrespective of the particular anticoagulant. The summary treatment effects strongly favored the therapy under evaluation and were in harmony for improved clot-burden (relative risk 0.82; 95% CI, 0.76-0.88; P <0.001) and for recurrent venous thromboembolism (relative risk 0.56; 95% CI, 0.42-0.76; P <0.001). The aggregate data show a striking predictive correlation for clot-burden change and subsequent recurrent venous thromboembolism using meta-regression analysis; (correlation = 0.81, P = 0.005) validating quantitative clot-burden assessment. CONCLUSION: Clot-burden change predicts long-term outcome, providing clinically relevant, patient-specific prognostic findings that may guide duration of anticoagulant therapy as well as provide a valid surrogate endpoint for clinical trials of innovative antithrombotic therapy, allowing more efficient trials exposing far fewer patients to the hazards of ineffective therapy than is required for outcome studies. Noninvasive assessment (duplex ultrasonography) of clot-burden change is currently being deployed for use in clinical trials.

Clinical usefulness of home oximetry compared with polysomnography for assessment of sleep apnea.

The practical purpose of diagnostic assessment in most cases of obstructive sleep apnea is to predict which patients have symptoms that will improve on treatment. We measured the accuracy with which clinicians make this prediction using polysomnography compared with oximeter-based home monitoring. Patients referred to a sleep center with suspicion of symptomatic obstructive sleep apnea were randomized to have polysomnography or home monitoring. Patients with comorbidity or physiologic consequences of sleep apnea were excluded. Sleep specialists estimated the likelihood of success of treatment as greater than 50% (predicted success) or less than 50% (predicted failure) on the basis of clinical data and test results. All patients were treated for 4 weeks with autoadjusting continuous positive airway pressure. Success was defined as an increase greater than 1.0 in Sleep Apnea Quality of Life Index. Correct prediction rates were compared. Two hundred eighty-eight patients were enrolled. Initial patient characteristics, compliance, and improvement in quality of life at 4 weeks were not different in the two groups. The correct prediction rate was 0.61 with polysomnography and 0.64 with home monitoring (not significant). We conclude that the ability of physicians to predict the outcome of continuous positive airway treatment in individual patients is not significantly better with polysomnography than with home oximeter-based monitoring.

A randomized trial of a single dose of oral dexamethasone for mild croup.

BACKGROUND: The benefits of dexamethasone treatment for moderate-to-severe croup are well established. However, most children with croup have mild symptoms, and it is unknown whether they would derive the same degree of benefit from dexamethasone treatment as children with more severe disease. METHODS: We conducted a double-blind trial at four pediatric emergency departments in which 720 children with mild croup were randomly assigned to receive one oral dose of either dexamethasone (0.6 mg per kilogram of body weight) or placebo. The children had mild croup, as defined by a score of < or =2 on the croup scoring system of Westley et al. The primary outcome was a return to a medical care provider for croup within seven days after treatment. The secondary outcome was the presence of ongoing symptoms of croup on days 1, 2, and 3 after treatment. Other outcomes included economic costs, hours of sleep lost by the child, and stress on the part of the parent in relation to the child's illness. RESULTS: Baseline clinical characteristics were similar in the two groups. Return to medical care was significantly lower in the dexamethasone group (7.3 percent vs. 15.3 percent, P<0.001). In the dexamethasone group, there was quicker resolution of croup symptoms (P=0.003), less lost sleep (P<0.001), and less stress on the part of the parent (P<0.001). CONCLUSIONS: For children with mild croup, dexamethasone is an effective treatment that results in consistent and small but important clinical and economic benefits. Although the long-term effects of this treatment are not known, our data support the use of dexamethasone in most, if not all, children with croup.