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PubMed2006

Epidemiology and early predictive factors of mortality and outcome in children with traumatic severe brain injury: experience of a French pediatric trauma center.

OBJECTIVE: To describe the results of an integrated pre- and in-hospital approach to critical care in a large population of children with severe traumatic brain injury and to identify the early predictors of their outcome. DESIGN: A 9-yr retrospective review of the data of a trauma data bank. SETTING: Level III pediatric trauma center. PATIENTS: All children (1 month to 15 yrs) with severe traumatic brain injury (Glasgow Coma Scale </=8) hospitalized in our trauma center and followed until death or for >/=6 months after discharge. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Univariate and further multivariate analyses were performed to determine independent predictive factors of death and outcome at discharge and 6 months later. The Glasgow Outcome Scale was used to evaluate outcome; a poor outcome referred to Glasgow Outcome Scale >/=3. Receiver operating characteristic curves were drawn to determine the threshold values of predictors of death and outcome. Analysis concerned 585 children (67% male and 33% female). Mean age was 7 +/- 5 yrs. Predominant mechanisms of injury were road traffic accidents and falls. Mean values for Glasgow Coma Scale, Pediatric Trauma Score, and Injury Severity Score were 6 (3-8), 3 (-4,10), and 28 (4-75), respectively. Mortality rate was 22%; Glasgow Outcome Scale was <3 in 53% of the cases at discharge and 60% at 6 months. Multivariate analysis identified Glasgow Coma Scale, Injury Severity Score, and hypotension on arrival as independent predictors of death and poor outcome at discharge and at 6 months. Threshold values for death were 28 for Injury Severity Score and 5 for Glasgow Coma Scale. The same values were found for poor outcome, except for outcome at 6 months where threshold value for the Glasgow Coma Scale was 6. CONCLUSIONS: Initial hypotension, Glasgow Coma Scale, and Injury Severity Score are independent predictors of outcome in children with traumatic brain injury. Threshold values can be calculated for predicting poor outcome. These variables can be easily and detected early in this population and used for quality assessment.

Adolescent↗

PubMedDate not supplied

Cosmetic outcome and incidence of infection with the MammoSite breast brachytherapy applicator.

We present our results regarding the cosmetic outcome achieved and the rate of infection using the MammoSite breast brachytherapy applicator to treat patients with partial breast irradiation. In addition, factors associated with cosmetic outcome and infection are analyzed. The study population consisted of 30 patients with early stage breast cancer treated using the MammoSite device from October 28, 2002, to February 13, 2004. Cosmetic outcome was analyzed for its association with the following parameters: volume of the balloon, balloon-to-skin distance, maximal skin point dose per fraction, V100 (percent of volume that received 100% of the prescription dose), V150 (percent of volume that received 150% of the prescription dose), and V200 (percent of volume that received 200% of the prescription dose). The occurrence of infection at the time of treatment and during follow-up was also recorded. At a median follow-up of 13 months (range 1-16 months), 53.3% of the patients (16/30) were reported to have an excellent cosmetic outcome and 40.0% (12/30) had a good cosmetic outcome. Excellent cosmetic outcome was associated with a greater mean balloon-to-skin distance compared to those who achieved a good cosmetic outcome (1.5 cm versus 1.2 cm) (p = 0.164). The mean V100, V150, and V200 of those in the excellent cosmetic outcome group were 92.1%, 34.5%, and 7.6% versus 93.0%, 34.7%, and 7.6% in the good cosmetic outcome group (p = 0.642, 0.926, and 0.853), The mean balloon volumes were 47.7 cm3 and 56.9 cm3, respectively (p = 0.063) in the excellent and good outcome groups. The mean maximal skin doses per fraction in the excellent and good outcome groups were 354.8 cGy and 422.3 cGy (p = 0.286), respectively. Infection occurred in 13.3% of the patients (4/30). An excellent or good cosmetic outcome was achieved in 93.3% of patients and infection occurred in 13.3% of patients treated with the MammoSite breast brachytherapy applicator. Excellent cosmetic outcome was associated with a greater balloon-to-skin distance, lower maximal skin dose per fraction, and smaller mean balloon volume; however, the results did not reach statistical significance.

Adult↗

PubMed2004

Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research.

BACKGROUND: The reporting of outcomes within published randomized trials has previously been shown to be incomplete, biased and inconsistent with study protocols. We sought to determine whether outcome reporting bias would be present in a cohort of government-funded trials subjected to rigorous peer review. METHODS: We compared protocols for randomized trials approved for funding by the Canadian Institutes of Health Research (formerly the Medical Research Council of Canada) from 1990 to 1998 with subsequent reports of the trials identified in journal publications. Characteristics of reported and unreported outcomes were recorded from the protocols and publications. Incompletely reported outcomes were defined as those with insufficient data provided in publications for inclusion in meta-analyses. An overall odds ratio measuring the association between completeness of reporting and statistical significance was calculated stratified by trial. Finally, primary outcomes specified in trial protocols were compared with those reported in publications. RESULTS: We identified 48 trials with 68 publications and 1402 outcomes. The median number of participants per trial was 299, and 44% of the trials were published in general medical journals. A median of 31% (10th-90th percentile range 5%-67%) of outcomes measured to assess the efficacy of an intervention (efficacy outcomes) and 59% (0%-100%) of those measured to assess the harm of an intervention (harm outcomes) per trial were incompletely reported. Statistically significant efficacy outcomes had a higher odds than nonsignificant efficacy outcomes of being fully reported (odds ratio 2.7; 95% confidence interval 1.5-5.0). Primary outcomes differed between protocols and publications for 40% of the trials. INTERPRETATION: Selective reporting of outcomes frequently occurs in publications of high-quality government-funded trials.

Canada↗

PubMed1996

Accuracy of the umbilical arteries Doppler flow velocity waveforms in detecting adverse perinatal outcomes in a high-risk population.

OBJECTIVE: To define the accuracy of the umbilical artery Doppler flow velocity waveforms, according to different cut-off values, in predicting adverse perinatal outcomes among fetuses at high risk of hypoxic complications. SUBJECTS: Two hundred and sixty-five pregnant women with diagnosis of small for gestational age fetus and/or pregnancy induced hypertension studied in four Italian ultrasound units. METHODS: Prospective study. Serial Doppler ultrasound measurements of the umbilical artery were performed. Results were not available for clinical management. Cut-off curves, corresponding to different age-specific centiles of the pulsatility index distribution among pregnancies resulting in healthy newborns, regardless of birthweight, were computed by regression methods. Sensitivity, specificity, positive predictive value and negative predictive value of such cut-off curves, and of absent/reverse end-diastolic flow, in predicting different adverse outcomes were estimated. The adverse outcomes were: perinatal or neonatal death (OUTCOME 1). Death or Apgar<7 at 5' or need for admission to intensive care unit or other hypoxic related abnormalities (OUTCOME 2). Either OUTCOME 2 or birthweight<l0th centile (OUTCOME 3). Both OUTCOME 2 and birthweight<10th centile (OUTCOME 4). RESULTS: The best accuracy was in predicting OUTCOMES 1 and 4. Positive predictive value increased strongly with higher cut-off curves while negative predictive value only decreased slightly. For absent/reverse end-diastolic flow, negative predictive value and positive predictive value were respectively 94% and 39% for death, and 81% and 72% respectively for OUTCOME 2. For the 95th centile curve the corresponding figures were 96%, 33% and 84%, 67%. The 60th centile curve had a 85% and 74% sensitivity value for death and OUTCOME 2 respectively, but the corresponding positive predictive values were 18% and 40% only. CONCLUSIONS: The findings of an absent end diastolic flow or of pulsatility index values above the 95th centile curve strongly suggest it is time to deliver the fetus. The 60th centile curve is the most suitable to recognize fetuses at risk for abnormal outcome, but early delivery should be avoided because of its low positive predictive value.

Apgar Score↗

PubMed1998

Design, testing, and results of an outcomes-managed approach to patients requiring prolonged mechanical ventilation.

BACKGROUND: Outcomes management that uses critical pathways may decrease costs while improving outcomes for patients who require prolonged mechanical ventilation. OBJECTIVE: To study the efficacy of an outcomes-managed approach to weaning patients from prolonged (more than 3 days) mechanical ventilation. METHODS: A method of multidisciplinary care delivery was designed that included an outcomes manager, a care pathway for patients receiving mechanical ventilation, and weaning protocols. Data collection consisted of three parts: a retrospective review of 124 patients who required prolonged ventilation during a 1-year period before implementation of the care model, a 6-month prospective study in which 91 patients were alternately assigned by month to an outcomes-managed approach or a non-outcomes-managed approach, and a 6-month prospective study of 90 patients in which an outcomes-managed approach without alternate-month assignment was used. RESULTS: Outcomes management had no significant effect on total duration of mechanical ventilation or length of stay in the hospital, days of mechanical ventilation without tracheostomy, days of mechanical ventilation with tracheostomy, or outcome (weaned, withdrawal from mechanical ventilation, death, or transfer without weaning). However, duration of mechanical ventilation was 1.3 days shorter, length of stay in the hospital was 2.1 days shorter, and the cost per case was $ 3341 less for patients in the outcomes-managed group than for patients in the non-outcomes-managed group. CONCLUSION: Outcomes-managed care did not have a significant effect on duration of ventilation, length of stay in the hospital, or outcome in patients receiving long-term mechanical ventilation.

Adult↗

PubMed1998

The long-term mechanically ventilated patient. An outcomes management approach.

As noted previously, prior to permanently instituting an outcomes approach, we compared the effects of such a model to a nonoutcomes-managed approach. The positive trend noted during the study interval has been sustained 2 years later, and the variables of cost, LOS, and ventilator duration (median = 9 days for DRG 475, 483 combined) for these patients continue to be favorably affected (see Figure 2). In addition, the outcomes-management model has been well accepted by all members of the health care team. The outcomes manager is a respected and valued member of the team and is central to the ongoing success of the approach. Although the clinical pathway is an essential tool for focusing and delineating multidisciplinary best-practice, the pathway (and processes of care contained within) must be continually evaluated and changed as needed. The pathway cannot be static if care is to be progressive. Essential to the process is a method of collecting and processing data in a timely way. Further, it is important that data collection, while important, not be the focus of the role of outcomes manager. Instead, the focus is the delivery of timely and effective care. Our current outcomes model applies to management of patients beyond the boundaries of the MICU or pulmonary suite. In other words, once weaned and transferred to a regular floor the outcomes manager no longer manages the patients (although she does track selected outcomes). Management of patients throughout hospitalization is a future goal, but we are convinced that this cannot be accomplished by a single outcomes manager. Although we are aware that other outcomes models do follow patients throughout the continuum of hospitalization and beyond, our highly clinically interactive model precludes that possibility. We are currently considering other similar unit-based positions to provide the desired continuity following discharge from the MICU or pulmonary suite. Despite our enthusiasm for the outcomes-management model, we recognize that other models may also result in comparable, favorable outcomes. It is important that those who adopt similar models of care delivery for managing patients requiring prolonged ventilation be scientific in their approach. Long-term studies of the efficacy of these models are essential if we are to truly provide quality care for our patients in the future. Unfortunately, as noted earlier, bias will be hard to overcome. Hospitals vested in rapidly establishing a stable financial bottom-line are likely to embrace quick applications. Projects with a true experimental design to evaluate efficacy, such as this one, will be rare in these organizations. Finally, it is critical that variables of interest be inclusive of specific quality indicators such as ventilator duration and complications rather than global institutional markers such as LOS. Standardization of variables of interest is imperative if outcomes are to be compared. For example, patients requiring long-term mechanical ventilation are identified by the AACN's Third National Study Group on weaning as those who require mechanical ventilation for more than 3 days. If we are to compare other variables of interest such as total ventilator duration, such as definition is essential or we will be comparing apples and oranges in the future. Provision of quality, cost-effective care for patients requiring prolonged ventilation is a true clinical challenge. Outcomes management is a multidisciplinary method of care delivery that is systematic and comprehensive in approach. Although little science exists related to the application of the model for patients requiring prolonged ventilation, preliminary reports are promising and warrant future applications and evaluation of the same.

Benchmarking↗

PubMed2005

Outcomes generated by patients with rheumatoid arthritis: how important are they?

BACKGROUND: It has been shown previously that patients with rheumatoid arthritis (RA) can generate a wide range of outcomes that they consider important in treatment. It is not known if these outcomes are generally important in the wider RA patient community. OBJECTIVES: (1) To examine whether recent patient-generated outcomes are generalizable within a wider RA population; (2) to assess the relative importance of each outcome; and(3) to explore whether any important outcomes have been omitted. METHODS: A questionnaire, listing 23 outcomes previously generated by RA patients, was distributed through three rheumatology centres in the UK. Patients gave an importance score to each outcome (0-3), selected their top three most important outcomes, and then listed any outcomes of personal importance that were missing. RESULTS: 323 questionnaires were returned (65%). All outcomes were deemed important. Independence, pain, and mobility were most frequently selected by patients in their top three outcomes but were not chosen by 61-66% of patients. The next most commonly chosen outcomes related to feeling well and fatigue. Factor analysis revealed six reasonably distinct groupings: general well-being (11.9% explained variance), day-to-day functioning(10.6%), emotional and psychological well-being (10.6%), social role and confidence (10%), physical symptoms (9.5%) and medication issues (7.9%). CONCLUSION: Outcomes generated by patients as important in RA, are generalizable and inclusive. The most important (independence, pain and mobility) are routinely treated and measured. The next most important (feeling well, fatigue) are infrequently addressed and deserve urgent consideration for measurement, treatment and research.

Journal Article↗

PubMed2000

Analysis of patients with poor outcome of rectocele repair.

PURPOSE: The aim of the present study was to analyze the prognostic value of clinical data and physiologic tests in patients undergoing rectocele repair for obstructed defecation. METHODS: Between 1988 and 1996, 89 consecutive female patients with obstructed defecation caused by a rectocele were enrolled in the study. Median age at time of presentation was 55 (range, 35-81) years. All patients underwent a combined transvaginal and transanal rectocele repair. End evaluation to assess long-term results was performed by an independent observer after a median duration of follow up of 52 (range, 12-92) months. The presence of the following five symptoms was evaluated: prolonged and unsuccessful straining at stool, feelings of incomplete evacuation, manual assistance during defecation, false urge to defecate, and a stool frequency of less than three times per week. When none or just one of these symptoms was present, outcome of rectocele repair was considered successful. The outcome was considered as a failure when two or more of these symptoms were recorded. Furthermore, all patients were asked to score the outcome of their operations as excellent, good, moderate, or poor. Clinical data and the results of physiologic tests obtained in patients with a poor outcome of surgery were compared with those obtained in patients with a successful outcome. RESULTS: Objective outcome of rectocele repair, based on the presence of symptoms, was found to be successful in 63 (71 percent) patients. Sixty-one patients considered outcome of surgery excellent or good (69 percent). Graded subjective outcomes between the two groups showed significantly better grades in cases of success. Duration of symptoms, number of symptoms, age, parity, and previous hysterectomy had no influence on the final outcome of surgery. Defecographic parameters, such as size of the rectocele, barium trapping in the rectocele, poor rectal evacuation, or intussusception, had no prognostic value. Signs of anismus based on defecography, electromyography, and balloon-expulsion studies did not influence outcome of surgery. The presence of symptoms such as defecation frequency, manual assistance, severe straining, false urge to defecate, or feelings of incomplete evacuation had no impact on the outcome. However, in patients without a daily urge to defecate or with a stool frequency of less than once per week, results of rectocele repair were significantly worse than in patients with a daily urge to defecate or a defecation frequency of more than once per week or both. In 14 of 26 patients with a poor outcome, colonic transit studies were performed. A delayed passage was observed throughout the entire colon in seven patients, in the left part of the colon and the rectosigmoid colon in four patients, and in the rectosigmoid colon in one patient. In two patients colonic transit was normal. CONCLUSIONS: Combined transvaginal and transanal rectocele repair is beneficial for the majority of patients with obstructed defecation. In patients without a daily urge to defecate or a stool frequency of less than once per week, indicating colonic malfunctioning, the outcome of rectocele repair seems to be poor.

Adult↗

PubMed1995

Somatosensory evoked potentials for prediction of outcome in acute severe brain injury.

The purpose of this study was to evaluate prospectively short-latency somatosensory evoked potentials (SEPs) as a predictor of outcome in acute, severe brain injury, and to compare this with the predictive power of the motor component of the Glasgow Coma Scale score and computed tomographic scan. Outcome was measured with the Glasgow Outcome Scale at a minimum of 6 months after injury. We studied 109 patients (aged 0.1 to 16.8 years) with SEPs within 4 days of the onset of coma. Four patients had absent SEPs and a favorable outcome by the Glasgow Outcome Scale (full recovery or moderate disability); two of these patients had meningitis with bilateral subdural effusions, one had a midbrain hemorrhage, and one had a decompressive craniectomy for uncontrolled intracranial hypertension. Normal SEPs had a positive predictive value for favorable outcome of 93% (95% confidence interval (CI), 77% to 99%), and absent SEPs had a positive predictive value for unfavorable outcome by the Glasgow Outcome Scale (severe disability, survival in a persistent vegetative state, or death) of 92% (95% CI, 80% to 98%). If the above identifiable clinical situations in which a physical barrier existed to impede cutaneous reception of the electrical impulse were excluded, the positive predictive value of absent SEPs for poor outcome reached 100% (95% CI, 92% to 100%). An absent motor response to painful stimulus also had 100% positive predictive value (95% CI, 84% to 100%) for unfavorable outcome; however, 23% of patients could not be evaluated because of the effects of muscle relaxants or sedatives. In patients with traumatic brain injury, results of computed tomography did not reliably predict outcome. Of the 59 patients with unfavorable outcome, 76% could be identified with SEPs compared with 36% with examination of motor function. We suggest that SEPs be performed in children with acute severe brain injury because they add an important tool to the physician's prognostic armamentarium. We conclude that in the absence of the above mentioned identifiable clinical situations, absent SEPs predict 100% unfavorable outcome, and this finding may warrant consideration of withdrawal of treatment in children with brain injuries.

Acute Disease↗

PubMed2003

Modeling and predicting hearing aid outcome.

Following a brief tutorial on the application of factor analysis to hearing aid outcome measures, three studies of hearing aid outcome measures in elderly adults are presented and analyzed. Two of the studies were completed at Indiana University (IU-1 and IU-2), and one was a collaborative multisite study by the Veterans Administration and the National Institute of Deafness and other Communication Disorders (NIDCD/VA). IU-1 measured hearing aid outcome in 173 elderly wearers of single-channel, linear, in-the-ear hearing aids with output-limiting compression, whereas IU-2 obtained the same extensive set of outcome measures from 53 elderly wearers of two-channel, wide-dynamic-range compression, in-the-canal hearing aids. In the NIDCD/VA study, 333 to 338 participants wore three single-channel circuits in succession, with each circuit housed within an in-the-ear shell. The three circuits included in that study and in this analysis were: (1) linear with peak clipping, (2) linear with output-limiting compression, and (3) single-channel, wide-dynamic-range compression. Evaluation of the many outcome measures completed in each study using principal components factor analysis revealed that from three (both IU studies) to five (NIDCD/VA study) principal components captured the individual differences in hearing aid outcome. This was independent of hearing aid type (in-the-ear or in-the-canal) and circuitry. Subsequent multiple regression analyses of individual differences in performance along each dimension of hearing aid outcome revealed that these individual differences could be accounted for reasonably well by various prefit variables for some dimensions of outcome, but not others. In general, measures of speech recognition performance were well accounted for by prefit measures, with the best predictors being hearing loss, cognitive performance, and age. Measures of hearing aid usage were less well accounted for by prefit measures, with the most accurate predictor of current hearing aid use being prior hearing aid use. The outcome dimension accounted for most poorly was that associated with hearing aid satisfaction, with subjective measures of aided sound quality being the best predictor of performance along this dimension of hearing aid outcome. Additional multicenter, large-scale studies are needed to develop more complete models of hearing aid outcome and to identify the variables that influence various aspects of hearing aid outcome. It is only through this additional research that it will be possible to optimize outcome for hearing aid wearers.

Journal Article↗

PubMed2003

Predicting outcome in pediatric near-drowning.

BACKGROUND: Near-drowning is common in children and has a high mortality rate. Some survivors remain in a vegetative state after the accident and are a great burden to their family and society. OBJECTIVES: To find out whether outcomes on near drowning can be reliably identified early in the course of illness. METHOD: Medical records of 72 children admitted to Queen Sirikit National Institute of Child Health, Bangkok, Thailand, for treatment of near drowning from January 1993 to December 2001 were retrospectively studied. Stepwise multivariate discriminant analysis was used to identify the power of variables achieving highest overall accuracy in minimizing errors for predicting poor outcome in intact survivors. RESULTS: The patients were identified into three groups: functionally intact, vegetative and dead groups, it was found that a combination of physical examination in the emergency department (ED), the need for cardiopulmonary (CPR) in the ED, amount of adrenaline given during CPR, and high blood sugar achieved an overall accuracy of 83 per cent. When categorizing patients into good outcome versus poor outcome (the combination of the vegetative and dead group were the poor outcome group). The variables mentioned above achieved an overall accuracy of 98 per cent. Good outcome survivors could be correctly predicted with no error, but error occurred when poor outcome survivors were predicted to be good outcome in 3 per cent. Glasgow coma score > or = 5, the need for CPR in the ED and blood sugar > 300 mg/dl were selected clinical variables found to have optimum predictive abilities with an overall accuracy of 96 per cent, but showed an error of 6 per cent in predicting poor outcome from functional intact survivors (unpredicted good outcome). CONCLUSION: From the present study discrimination analysis cannot accurately separate all intact survivors from the vegetative groups, but can prospectively differentiate unpredicted good outcome from vegetative or dead groups. When using only simple clinical classification systems, unpredicted good outcome patients are detected. Since outcome cannot be accurately predicted in the ED, all near drowning victims should receive vigorous and aggressive treatment in the early course of illness and need close monitoring for respiratory complications and neurological signs.

Adolescent↗

PubMed2005

Outcomes in hypertensive black and nonblack patients treated with chlorthalidone, amlodipine, and lisinopril.

CONTEXT: Few cardiovascular outcome data are available for blacks with hypertension treated with angiotensin-converting enzyme (ACE) inhibitors or calcium channel blockers (CCBs). OBJECTIVE: To determine whether an ACE inhibitor or CCB is superior to a thiazide-type diuretic in reducing cardiovascular disease (CVD) incidence in racial subgroups. DESIGN, SETTING, AND PARTICIPANTS: Prespecified subgroup analysis of ALLHAT, a randomized, double-blind, active-controlled, clinical outcome trial conducted between February 1994 and March 2002 in 33,357 hypertensive US and Canadian patients aged 55 years or older (35% black) with at least 1 other cardiovascular risk factor. INTERVENTIONS: Antihypertensive regimens initiated with a CCB (amlodipine) or an ACE inhibitor (lisinopril) vs a thiazide-type diuretic (chlorthalidone). Other medications were added to achieve goal blood pressures (BPs) less than 140/90 mm Hg. MAIN OUTCOME MEASURES: The primary outcome was combined fatal coronary heart disease (CHD) or nonfatal myocardial infarction (MI), analyzed by intention-to-treat. Secondary outcomes included all-cause mortality, stroke, combined CVD (CHD death, nonfatal MI, stroke, angina, coronary revascularization, heart failure [HF], or peripheral vascular disease), and end-stage renal disease. RESULTS: No significant difference was found between treatment groups for the primary CHD outcome in either racial subgroup. For amlodipine vs chlorthalidone only, HF was the only prespecified clinical outcome that differed significantly (overall: relative risk [RR], 1.37; 95% confidence interval [CI], 1.24-1.51; blacks: RR, 1.46; 95% CI, 1.24-1.73; nonblacks: RR, 1.32; 95% CI, 1.17-1.49; P<.001 for each comparison) with no difference in treatment effects by race (P = .38 for interaction). For lisinopril vs chlorthalidone, results differed by race for systolic BP (greater decrease in blacks with chlorthalidone), stroke, and combined CVD outcomes (P<.001, P = .01, and P = .04, respectively, for interactions). In blacks and nonblacks, respectively, the RRs for stroke were 1.40 (95% CI, 1.17-1.68) and 1.00 (95% CI, 0.85-1.17) and for combined CVD were 1.19 (95% CI, 1.09-1.30) and 1.06 (95% CI, 1.00-1.13). For HF, the RRs were 1.30 (95% CI, 1.10-1.54) and 1.13 (95% CI, 1.00-1.28), with no significant interaction by race. Time-dependent BP adjustment did not significantly alter differences in outcome for lisinopril vs chlorthalidone in blacks. CONCLUSIONS: In blacks and nonblack subgroups, rates were not lower in the amlodipine or lisinopril groups than in the chlorthalidone group for either the primary CHD or any other prespecified clinical outcome, and diuretic-based treatment resulted in the lowest risk of heart failure. While the improved outcomes with chlorthalidone were more pronounced for some outcomes in blacks than in nonblacks, thiazide-type diuretics remain the drugs of choice for initial therapy of hypertension in both black and nonblack hypertensive patients.

Aged↗

PubMed2000

Outcomes research in surgical oncology.

BACKGROUND: There have been significant developments and advances in the area of outcomes research in the past 25 years. Unfortunately, many surgical oncologists may not have a clear concept of outcomes research and the methodology involved. METHODS: A literature-based review article was done that included an overview of outcomes research, and study design and types, outcome measures, outcome instruments, and sources of outcome data were examined. In addition, we reviewed small area variation/volume outcome analysis as well as quality-of-life studies and their applications in surgical oncology clinical investigation. Specific examples from surgical oncology were identified. RESULTS: As the costs of health care have increased, so has the emphasis on measuring outcomes of medical and surgical care to determine the quality and appropriateness of care. Marked variations in a variety of outcomes after oncological procedures have been attributed to individual surgeon and institution characteristics. Because much of the clinical surgical oncology literature deals only with the traditional mortality and morbidity outcomes, a more comprehensive examination of patient outcomes is required to fully evaluate the impact of patient management decisions. Health-related quality of life can be measured and analyzed in several ways and decisions regarding the use of such methodology are dependent on multiple factors. CONCLUSIONS: Surgical oncologists should recognize that the true value of their interventions requires systematic and comprehensive examination of patient outcomes.

Decision Making↗

PubMed1996

Clinical and biological markers for outcome in schizophrenia: a review of a longitudinal follow-up study in Uppsala schizophrenia research project.

During a 10-year period, 120 drugfree DSM-III-R schizophrenic patients were consecutively and unselectively admitted to a ward for young psychotic patients and subjected to a battery of examinations including symptomatology, cerebrospinal fluid (CSF)-biochemistry, computed tomography (CT)-scan, neurophysiologic and psychophysiologic (Electrodermal activity, EDA) parameters before antipsychotic treatment was initiated. After discharge, the patients were longitudinally followed with ratings of outcome (Strauss-Carpenters outcome scale) at years 1, 3, and 5 after index admission. The aim of the study was to find possible early markers for outcome in schizophrenia. At 5 years, 30% of the patients had a good outcome (total score > 13) and 15% a poor outcome (total score < 8). Poor premorbid adjustment and low level of education as well as negative schizophrenic symptomatology at index admission were associated with a poor outcome 5 years later. Positive symptomatology and a family history of schizophrenia did not predict outcome. Patients with a poor outcome (total score < 8) had a significantly more deviant CSF HVA/5-HIAA quotient than those with a very good outcome (total score > 15) as compared with healthy controls. Further, the CSF-peptides neuropeptide Y, dynorphin A, and CRF were predictable for outcome at the 5-year follow-up evaluation. Male schizophrenics who were "nonresponders" on the EDA test showed an almost 100% poor outcome, which was not found in females. In summary, several clinical and biological variables seem to have a predictable value for outcome in schizophrenia and, early identification of them might be a challenge for our future treatment strategies.

Biomarkers↗

PubMed2006

How many arterial grafts are enough? A population-based study of midterm outcomes.

OBJECTIVE: Current evidence suggests arterial grafting improves freedom from cardiac events after coronary artery bypass graft surgery. It has been shown that 2 arterial grafts provide improved outcome compared with 1 arterial graft. This population study seeks to understand trends in arterial graft use and midterm outcomes of patients receiving 1, 2, or 3 arterial grafts. METHODS: This study is a retrospective population-based cohort of 53,727 patients (47,214 with 1 arterial graft, 5466 with 2 arterial grafts, and 1047 with 3 arterial grafts) undergoing isolated coronary artery bypass graft surgery in Ontario (1991-2001). The patients were followed by using linked clinical and administrative data, with complete follow-up until December 31, 2003 (average patient years of follow-up: 6 years for those with 1 arterial graft, 5 years for those with 2 arterial grafts, and 4 years for those with 3 arterial grafts). Propensity matching was used to compare outcomes between patients receiving 1 versus 2 arterial grafts, 2 versus 3 arterial grafts, and 1 versus 2 or 3 arterial grafts. The outcomes included death, repeat revascularization (angioplasty or coronary artery bypass grafting), cardiac readmission (readmission for angina, heart failure, and myocardial infarction), and a composite comprising all of these outcomes. Cox proportional hazards models were used to compare outcomes for propensity-matched patients. Subgroup analyses of various patient risk categories defined by the tercile of predicted 30-day mortality risk were conducted between propensity-matched individuals. RESULTS: The use of multiple arterial grafts (defined as >1 arterial graft) increased mainly in the latter part of the study, from 4% in 1991 to 27% in 2001. Four thousand nine hundred sixty-eight patients were propensity matched (91% of patients receiving 2 arterial grafts) to compare outcomes with those of patients receiving 1 arterial graft. One thousand twenty-eight patients were propensity matched (98% of those receiving 3 arterial grafts) to compare outcomes with those of patients receiving 2 arterial grafts. Five thousand four hundred ninety-one patients were propensity matched (84% of those receiving 2 or 3 arterial grafts) to compare outcomes with those of patients receiving 1 arterial graft. Two arterial grafts were shown to be protective for cardiac readmission (0.8; 95% confidence interval, 0.76-0.92) and a composite outcome (0.9; 95% confidence interval, 0.72-0.95) compared with 1 arterial graft. Two or 3 arterial grafts were further found to improve survival (0.8; 95% confidence interval, 0.72-0.99). In all patient operative risk categories, 2 or 3 arterial grafts were protective for cardiac readmission (hazard ratio, 0.7-0.8) and the composite outcome (hazard ratio, 0.8). There was no difference in the Cox hazard ratios of propensity-matched patients in the comparison of the groups receiving 3 versus 2 arterial grafts. CONCLUSIONS: Few patients received more that 1 arterial graft in our region. There was a survival benefit in receiving 2 or 3 arterial grafts. Patients with low, moderate, and high operative risk receiving 2 or 3 arterial grafts had lower rates of cardiac readmission compared with patients receiving only 1 arterial graft. This suggests that the standard of care should include the use of at least 2 arterial bypasses in all categories of operative risk to allow for optimal midterm outcomes.

Aged↗

PubMed2005

Characterizing psychosocial outcome trajectories following seizure surgery.

PURPOSE: We have developed a new approach to characterizing psychosocial outcome after seizure surgery that allows us to identify diverse individual trajectories as well as subgroups of patients with similar outcomes. METHODS: Eighty-nine anterior temporal lobectomy (ATL) patients were recruited through our Seizure Surgery Follow-up and Rehabilitation Program. The Austin CEP Interview was used to measure psychosocial adjustment presurgery, at discharge, and 1, 3, 6, 12, and 24 months postsurgery. Patient outcome trajectories were characterized across this time frame using a profile-focused form of dual clustering that leads to a lattice representation. RESULTS: Two major, distinct outcome subgroups were identified. Fifty-eight percent (58%) of patients reported good outcomes, characterized by improved family dynamics, enhanced vocational and social functioning, and driving by 24 months postsurgery. A range of trajectories led to these outcomes, including the experience of early postoperative adjustment difficulties. In contrast, 31% of patients perceived their outcomes as poor, reporting affective disturbance at 12 months and difficulties discarding sick role behaviors. Early anxiety served as a marker of poor outcomes, while resolution of early anxiety and vocational change at 12 months were indicators of good outcomes at 24 months. The remaining 11% of patients reported minimal adjustment features. CONCLUSIONS: For the majority of patients, seizure surgery gives rise to an evolving process of postoperative adjustment that leads to distinct outcome trajectories. Our approach questions the clinical sensitivity of health-related quality of life measures that average across patients to provide a unitary measure of outcome. Although preliminary, the findings have implications for postoperative treatment, including the identification of markers of longer-term outcomes.

Adaptation, Psychological↗

PubMed2002

C-tau biomarker of neuronal damage in severe brain injured patients: association with elevated intracranial pressure and clinical outcome.

Following traumatic brain injury, the neuronally-localized intracellular protein MAP-tau is proteolytically cleaved (C-tau) and gains access to cerebrospinal fluid (CSF) and serum. The present study compared initial CSF C-tau levels, initial Glasgow Coma Scale (GCS) scores and elevated intracranial pressure (ICP) as predictors of clinical outcome. In this preliminary, prospective study of consecutive severe traumatic brain injured patients (TBI) clinical outcome was quantified with the Glasgow Outcome Scale (GOS) at discharge (n=28). Sensitivity and specificity of initial C-tau levels and initial GCS scores as predictors of clinical outcome is reported. To assess disease specificity C-tau levels were compared between TBI patients and neurologic (n=87) and non-neurologic control patients (n=67). Initial CSF C-tau levels were elevated 40,000 fold in TBI patients compared to either neurologic or non-neurologic control patients (P<0.001). Initial C-tau levels were correlated with clinical outcome (P=0.006) and were a significant predictor of dichotomized clinical outcome (P=0.011) demonstrating a sensitivity of prediction of 92% and a specificity of 94%. Initial C-tau levels were also a significant predictor of subsequent ICP with higher initial C-tau levels associated with elevated ICP (P=0.014). Initial GCS score were correlated with clinical outcome (P=0.026) and demonstrated a sensitivity of 50% and a specificity of 100% for predicting dichotomized clinical outcome. Statistical analysis indicated that initial C-tau levels and initial GCS scores were independent predictors of clinical outcome. The present preliminary study demonstrates that initial CSF C-tau levels are a significant predictor of ICP and clinical outcome with particular sensitivity for identifying severe TBI patients with good clinical outcome. Future studies employing a larger sample size and clinical outcome assessment at longer periods after hospitalization will be needed to determine the utility of initial C-tau levels as a clinical biomarker in TBI.

Adolescent↗

PubMed2001

Defining early seizure outcomes in pediatric epilepsy: the good, the bad and the in-between.

PURPOSE: To examine different approaches to classifying seizure outcomes. METHODS: In a prospective cohort study of children (N=613) with newly diagnosed epilepsy, seizure outcomes at 2 years were classified as 'good' (> or =1 year remission), 'bad' or 'intractable' (> or = AED failures, > or =1 seizure/month over > or =18 months), and 'indeterminate' (neither 'good' nor 'bad'). Outcomes at 2 years were compared to outcomes in those followed 4 or more years. The associations of three commonly studied prognostic factors, etiology, age at onset, and syndromic grouping with the three-level outcome were assessed. RESULTS: 595 (97.1%) children were followed > or =2 years. A 'good', indeterminate, and 'bad' outcome was present in 314 (52.8%), 235 (38.3%), and 46 (7.7%) children. Problems with treatment were recorded in 64.7% of the indeterminate group. In 390 children followed > or =4 years, early 'good' and 'bad' outcomes persisted in approximately 80%. About half of those with indeterminate 2-year outcomes later achieved remission, 8% met criteria for intractability, and 37% remained indeterminate. Most of the associations with etiology, age, and syndrome were due to variation in the proportion that met criteria for intractability and not remission. CONCLUSIONS: Many children have indeterminate outcomes, often in association with treatment issues. Clearly 'good' and 'bad' early outcomes can be identified and persist > or =2 years later. In the absence of pharmaco-resistance, lack of early remission (indeterminate outcome) is usually not associated with a bad outcome, at least over the next few years.

Adolescent↗