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Emergency medical services outcomes project I (EMSOP I): prioritizing conditions for outcomes research.

Over the past several years, out-of-hospital EMS have come under increased scrutiny regarding the value of the range of EMS as currently provided. We used frequency data and expert opinion to rank-order EMS conditions for children and adults based on their potential value for the study of effectiveness of EMS care. Relief of discomfort was the outcome parameter EMS professionals identified as having the most potential impact for the majority of children and adults in the top quartile conditions. Future work from this project will identify appropriate severity and outcome measures that can be used to study these priority conditions. The results from the first year of this project will assist those interested in EMS outcomes research to focus their efforts. Furthermore, the results suggest that nonmortality out-come measures, such as relief of discomfort, may be important parameters in determining EMS effectiveness.

Adolescent↗

Short-term alcohol and drug treatment outcomes predict long-term outcome.

INTRODUCTION: Although addiction is recognized as a chronic, relapsing condition, few treatment studies, and none in a commercially insured managed care population, have measured long-term outcomes. We examined the relationship of 6-month treatment outcomes to abstinence 5 years post-treatment, and whether the predictors of abstinence at 5 years were different for those who were, and were not, abstinent at 6 months. METHODS: The sample (N=784) is from an outpatient (day hospital and traditional outpatient) managed care chemical dependency program. Subjects were interviewed at baseline, 6 months, and 5 years. Logistic regression analysis was used to assess which individual, treatment and extra-treatment characteristics predicted alcohol and drug abstinence at 5 years. RESULTS: Abstinence at 6 months was an important predictor of abstinence at 5 years. Among those abstinent at 6 months, predictors of abstinence at 5 years were older age, being female, 12-step meeting attendance, and recovery-oriented social networks. Among those not abstinent at 6 months, being alcohol dependent rather than drug dependent, 12-step meeting attendance, treatment readmission, and recovery-oriented social networks predicted abstinence at 5 years. CONCLUSION: Our findings demonstrate a clear association between short-term and long-term treatment success. In addition, these results strongly support the importance of recovery-oriented social networks for those with good short-term outcomes, and the beneficial impact of readmission for those not initially successful in treatment.

Adolescent↗

Does intracoronary thrombus influence the outcome of high risk percutaneous transluminal coronary angioplasty? Clinical and angiographic outcomes in a large multicenter trial. EPIC Investigators. Evaluation of IIb/IIIa Platelet Receptor Antagonist 7E3 in Preventing Ischemic Complications.

OBJECTIVES: We sought to evaluate the impact of angiographically visible thrombus on short- and long-term clinical outcomes after percutaneous transluminal coronary angioplasty (PTCA). BACKGROUND: Intracoronary thrombus is frequently seen on angiography in patients with acute ischemic coronary syndromes or complex lesion morphology, or both, and is often considered to predict a higher rate of complications in patients undergoing PTCA. METHODS: Prospectively collected data from 2,099 patients undergoing high risk PTCA in the Evaluation of IIb/IIIa Platelet Receptor Antagonist 7E3 in Preventing Ischemic Complications (EPIC) trial were analyzed. In addition to aspirin and heparin, patients were randomized to receive either abciximab bolus and infusion, abciximab bolus alone or placebo. Based on an angiographic core laboratory interpretation, patients were classified into three groups: thrombus absent, thrombus possible or thrombus present. The primary end point at 30 days was the composite of death, myocardial infarction or urgent revascularization. The 6-month end point was the composite of death, myocardial infarction or any revascularization. RESULTS: Although abrupt closure was most common in patients with thrombus present compared with thrombus absent or possible (13%, 10.0% and 7.4%, respectively), neither the 30-day nor the 6-month clinical end points were different among the three groups (9%, 11% and 11.7%, respectively, and 30%, 34% and 31%, respectively). Most notably, the benefit of treatment with abciximab was present in all three thrombus groups, and the magnitude of benefit was not different among the thrombus groups. CONCLUSIONS: In high risk patients undergoing percutaneous coronary revascularization, features of thrombus on the preprocedure angiogram do not indicate an augmented risk of adverse clinical outcomes. Abciximab therapy reduces the rate of adverse outcomes regardless of the presence of thrombus and should therefore not necessarily be reserved for patients whose angiograms have features of intraluminal thrombus.

Abciximab↗

Therapeutic outcomes monitoring by community pharmacists for improving clinical outcomes in asthma.

OBJECTIVE: To determine the effect of enhanced therapeutic monitoring by community pharmacists on clinical outcomes of a convenience sample of asthma patients. METHODS: A one-year intervention study with scheduled visits and follow-ups at baseline, 4, 8, 12 and 24 months using a pre/post-test design, with a small convenience sample of 28 study patients, who performed their own controls. Outcomes measured were the severity of asthma symptoms, changes in the number of patients having peak expiratory flow (PEF) values below 85% or 70% of the optimal, changes in daily asthma medication and number of patients needing courses of oral steroids. RESULTS: A positive change was noticed in all the measures used, most clearly in the severity of asthma symptoms. During the intervention, mean scores of three out of five symptom measures improved significantly. Twenty-two (79%) patients had a net improvement in one or more asthma symptom indicators. The number of patients with PEF values below 85% of the optimal decreased from seven to four at 12 months. The number of patients having courses of oral steroids for asthma decreased. More than half (57%) of the patients had changes in their daily asthma medication. The effects lasted partly over one year after the intervention. CONCLUSIONS: The results of this study suggest that pharmacist intervention can have a positive effect on clinical outcomes of asthma patients. The results need to be confirmed with a study using a randomized controlled design.

Adult↗

Exploring the precursors of outcome evaluation in Australia: linking structure, process and outcome by peer review.

Reviews of the structure of the health system and the processes that contributed to them were the main forms of evaluation within nursing in Australia during the 1970s and 1980s. The documentation of the end result of care, or outcome evaluation, was rarely undertaken until more recent times. The development and implementation of formal assessment tools such as Qualpacs, the Phaneuf Nursing Audit, the Rush Medicus Nursing Process Methodology, Monitor, and Senior Monitor indicated the focus on structure and process evaluation. This paper examines how nursing care delivered to patients during the l970s and 1980s was evaluated, and explores why structure and process review were necessary precursors to outcome evaluation in the nineties. The necessity of linking structure and process analysis is discussed, in order to perform effective outcome evaluation to close the feedback loop between quality assessment and quality improvement. Peer review is one mechanism that can be used to achieve this. How this may also be a form of evidence-based practice which results in health gains for patients is also explored.

Australia↗

Maternal phenylketonuria in Western Australia: pregnancy outcomes and developmental outcomes in offspring.

OBJECTIVE: To examine the outcomes of phenylketonuric (PKU) pregnancies in Western Australia including birth characteristics and cognitive and behavioural outcomes in offspring. METHODS: A cross-sectional study of women and their offspring who were identified from the Western Australian Maternal PKU Program (WAMPKUP) from 1991 to 2000 was carried out. Cognitive assessments (K-BIT or Griffiths scales) were conducted on women and their children, and behavioural assessments (CBCL) were conducted on the children. RESULTS: Thirty pregnancies by nine women were registered on the WAMPKUP between 1991 and 2000. There were 16 live births, with one preterm delivery at 32 weeks. There were no congenital abnormalities. Five of the nine mothers and their nine children (aged 18 months-10 years) participated in developmental assessments. A linear relationship was shown between lower maternal IQ scores and later attainment of metabolic control in pregnancy (rs = -0.828; P = 0.01). There was significant correlation between lower offspring IQ scores and later attainment of metabolic control in pregnancy (rs = -0.734; P = 0.02). Correlation between maternal and offspring cognitive scores was not significant. Four of nine (44%) children rated in the clinical range for behavioural problems. Compared to children with no behavioural difficulties, these children had lower cognitive abilities (P = 0.05) and maternal metabolic control during pregnancy was poor (P = 0.05). CONCLUSIONS: Poor metabolic control in pregnancy is associated with poorer cognitive outcomes and increased behavioural difficulties in offspring of mothers with PKU. The results have implications for the implementation of appropriate dietary measures before conception in PKU pregnancies, and indicate a need for the establishment of multidisciplinary teams to follow up individuals with PKU to communicate the importance of pregnancy planning, to manage PKU pregnancies, and to follow up the offspring.

Child Behavior↗

Similarities in outcomes for men and women after drug misuse treatment: results from the National Treatment Outcome Research Study (NTORS).

The National Treatment Outcome Research Study (NTORS) is a prospective, multi-site treatment outcome study of drug misusers in the UK. This paper reports the characteristics and problems of male and female clients at intake to treatment, and changes in substance use, health problems, and criminal behaviour at follow-up. The sample comprised 753 subjects (552 men and 201 women) followed-up 1 year after starting treatment in 54 programmes chosen to be representative of the main national treatment modalities. Men and women presented to treatment with different problems and characteristics. Women reported more frequent cocaine use, greater health problems, and were more likely to have a drug-using partner and be responsible for children. Despite different profiles of problems, men and women both made significant reductions in their problem behaviours following treatment. At 1-year follow-up, men and women reported reductions in drug use, health problems and criminal behaviour. However, women did not reduce their alcohol consumption significantly, and improvements in crime were less pronounced than for men. After controlling for pretreatment differences, gender was not predictive of any of the outcome measures reported.

Adult↗

Treatment outcome and outcome associations in children with pervasive developmental disorders treated with selective serotonin reuptake inhibitors: a chart review.

PURPOSE: The aim of this study was to determine the outcome and predictors of outcome with selective serotonin reuptake inhibitors (SSRIs) in outpatient children and adolescents with pervasive developmental disorders (PDDs). METHOD: Clinic charts were reviewed for 89 outpatient youths with a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of a PDD who were treated with SSRIs. Response was determined using the Clinical Global Impressions (CGI) scale. Side-effect and demographic data, including family history, were recorded. RESULTS: Forty-four point nine percent (44.9%) were determined to be much improved and considered responders. Fifty-four percent (54%) of the subjects demonstrated activation side effects. In 35.4% of these subjects, the activation side effects led to drug discontinuation. Pearson chi-squared and regression analysis demonstrated an association between SSRI response and a family history of PDD. There were no significant associations between clinical variables and activation side effects. CONCLUSIONS: SSRI treatment led to modest response rate in this group of youths with PDDs. Activation side effects were frequent, often leading to treatment dropouts. Potential outcome associations include a family history of PDDs.

Adolescent↗

Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use.

The Glasgow Outcome Scale (GOS) is the most widely used outcome measure after traumatic brain injury, but it is increasingly recognized to have important limitations. It is proposed that shortcomings of the GOS can be addressed by adopting a standard format for the interview used to assign outcome. A set of guidelines are outlined that are directed at the main problems encountered in applying the GOS. The guidelines cover the general principles underlying the use of the GOS and common practical problems of applying the scale. Structured interview schedules are described for both the five-point GOS and an extended eight-point GOS (GOSE). An interrater reliability study of the structured interviews for the GOS and GOSE yielded weighted kappa values of 0.89 and 0.85, respectively. It is concluded that assessment of the GOS using a standard format with a written protocol is practical and reliable.

Adolescent↗

Influence of heart rate, blood pressure, and beta-blocker dose on outcome and the differences in outcome between carvedilol and metoprolol tartrate in patients with chronic heart failure: results from the COMET trial.

AIMS: We studied the influence of heart rate (HR), systolic blood pressure (SBP), and beta-blocker dose on outcome in the 2599 out of 3029 patients in Carvedilol Or Metoprolol European Trial (COMET) who were alive and on study drug at 4 months after randomization (time of first visit on maintenance therapy). METHODS AND RESULTS: By multivariable analysis, baseline HR, baseline SBP, and their change after 4 months were not independently related to subsequent outcome. In a multivariable analysis including clinical variables, HR above and SBP below the median value achieved at 4 months predicted subsequent increased mortality [relative risk (RR) for HR>68 b.p.m. 1.333; 95% confidence intervals (CI) 1.152-1.542; P<0.0001 and RR for SBP>120 mmHg 0.78; 95% CI 0.671-0.907; P<0.0013]. Achieving target beta-blocker dose was associated with a better outcome (RR 0.779; 95% CI 0.662-0.916; P<0.0025). The superiority of carvedilol as compared to metoprolol tartrate was maintained in a multivariable model (RR 0.767; 95% CI 0.663-0.887; P=0.0004) and there was no interaction with HR, SBP, or beta-blocker dose. CONCLUSION: Beta-blocker dose, HR, and SBP achieved during beta-blocker therapy have independent prognostic value in heart failure. None of these factors influenced the beneficial effects of carvedilol when compared with metoprolol tartrate at the pre-defined target doses used in COMET.

Adrenergic beta-Antagonists↗

EUROMAC. A European concerted action: maternal alcohol consumption and its relation to the outcome of pregnancy and child development at 18 months. Results--strategy of analysis and analysis of pregnancy outcome.

Analyses were made of the relation between maternal alcohol consumption before and in early pregnancy and five infant outcome variables: birthweight, crown-heel length, occipitofrontal circumference and the Apgar scores at 1 and 5 minutes. The data were analysed for all centres combined and separately. From tabulation of the mean values of the outcome variables by alcohol consumption, it appeared that a poorer outcome was related to consumption of 120 g/week absolute alcohol or more. Multiple regression analysis was used to allow for possible confounding by the child's gestational age at birth and sex, the mother's age, parity and smoking habit, and survey centre. Two threshold models were applied to the combined data, taking the confounders into account. The offset threshold model (assuming no effect of alcohol up to a threshold value, and then a constant multiplicative effect at higher levels) suggested a negative effect on birthweight at about 60 g/week absolute alcohol, but with a wide 85% confidence interval of 5-130 g/week. A step function threshold model, which assumes a constant effect above the threshold value, behaved erratically. Similar analyses for crown-heel length and occipitofrontal circumference provided only a very poor fit to the data. Data on reported congenital anomalies are presented by survey centre and maternal alcohol consumption, but due to the unstandardized method of collection they were not analysed further.

Alcohol Drinking↗

Health outcomes after prostatectomy or radiotherapy for prostate cancer: results from the Prostate Cancer Outcomes Study.

BACKGROUND: Radical prostatectomy and external beam radiotherapy are the two major therapeutic options for treating clinically localized prostate cancer. Because survival is often favorable regardless of therapy, treatment decisions may depend on other therapy-specific health outcomes. In this study, we compared the effects of two treatments on urinary, bowel, and sexual functions and on general health-related quality-of-life outcomes over a 2-year period following initial treatment. METHODS: A diverse cohort of patients aged 55-74 years who were newly diagnosed with clinically localized prostate cancer and received either radical prostatectomy (n = 1156) or external beam radiotherapy (n = 435) were included in this study. A propensity score was used to balance the two treatment groups because they differed in some baseline characteristics. This score was used in multivariable cross-sectional and longitudinal regression analyses comparing the treatment groups. All statistical tests were two-sided. RESULTS: Almost 2 years after treatment, men receiving radical prostatectomy were more likely than men receiving radiotherapy to be incontinent (9.6% versus 3.5%; P:<.001) and to have higher rates of impotence (79.6% versus 61.5%; P:<.001), although large, statistically significant declines in sexual function were observed in both treatment groups. In contrast, men receiving radiotherapy reported greater declines in bowel function than did men receiving radical prostatectomy. All of these differences remained after adjustments for propensity score. The treatment groups were similar in terms of general health-related quality of life. CONCLUSIONS: There are important differences in urinary, bowel, and sexual functions over 2 years after different treatments for clinically localized prostate cancer. In contrast to previous reports, these outcome differences reflect treatment delivered to a heterogeneous group of patients in diverse health care settings. These results provide comprehensive and representative information about long-term treatment complications to help guide and inform patients and clinicians about prostate cancer treatment decisions.

Aged↗

Outcomes measurement in pain management: issues of disease complexity and uncertain outcomes.

Pain is a complex disease process. Pain management requires an interdisciplinary rather than a multidisciplinary clinical intervention, interdisciplinary because the factors that may affect pain intensity and duration occur simultaneously. A particular problem exits when measuring outcomes from chronic diseases, disorders, and impairments because neither a cure nor death is a likely outcome. The clinical and psychosocial determinates of pain complicate the assessment of level of pain and the measurement of pain management outcomes. The major obstacle to assessing change from a pain intervention is the lack of a gold standard. Because we have no gold standard for better functional health, our evaluation of the responsiveness of health status measures regarding pain management will continue to be plagued with the question "responsive to what"?

Adult↗

Use of the scoliosis research society outcomes instrument to evaluate patient outcome in untreated idiopathic scoliosis patients in Japan: part I: comparison with nonscoliosis group: preliminary/limited review in a Japanese population.

STUDY DESIGN: This preliminary study evaluates untreated Japanese patients with idiopathic scoliosis using the Scoliosis Research Society Outcomes Instrument (SRS-24). OBJECTIVES: To determine the baseline patient outcome score using the SRS-24 for untreated Japanese scoliosis patients compared with a nonscoliosis group. SUMMARY OF BACKGROUND DATA: The SRS instrument with 24 questions was developed to help evaluate patient-perceived outcomes of idiopathic scoliosis treatment. Evaluation of untreated Japanese idiopathic scoliosis patients using the SRS instrument has not been reported. METHODS: Japanese idiopathic scoliosis patients (n = 141) (mean age, 13.6 years; range, 10-17 years) with a Cobb angle of more than 20 degrees who were not treated with a brace or surgery, were evaluated in comparison with a nonscoliosis group (healthy junior high school students; n = 72) using the SRS-24. The scoliosis group was categorized as mild deformity group with a major curve Cobb angle of less than 30 degrees, moderate deformity group with 30 degrees to 49 degrees, and severe deformity group with more than 50 degrees. The patients were evaluated using section 1 (15 questions) of the SRS-24, which was divided into four domains: total pain, general self-image, general function, and activity. Reliability, as determined by internal consistency, was validated using Cronbach's alpha for these domain scales. RESULTS: The severe deformity group had the lowest scores compared with the other deformity groups and the nonscoliosis group in pain (P < 0.0001) and self-image (P < 0.05) domains. The scores for questions 3 (P < 0.0001) and 5 (P < 0.0001), evaluation of self-image of back appearance, were significantly lower in the scoliosis group than those in the nonscoliosis group. This tendency was more significant in the patients with greater curve magnitude. Scores for questions 14 and 15, evaluation of general self-image, in the scoliosis group were, however, higher than those in the nonscoliosis group. Internal consistency using Cronbach's alpha was 0.57 (pain), 0.27 (general self-image), -0.08 (general function), and 0.15 (overall level of activity). CONCLUSION: Untreated scoliosis patients with severe deformity were inclined to complain of being self-conscious or distressed regarding their back appearance compared with age- and sex-matched control adolescents. The control group was inclined to have, however, a negative general self-image compared with the patients group. Internal consistency using Cronbach's alpha for all domains was considerably low. The baseline of the SRS-24 scores in the Japanese population might differ from that of the Western population because of differences in national culture. Therefore, further study is necessary to clarify the validity of the SRS-24 domains for Japanese patients.

Adolescent↗

Ethnicity and birth outcome: New Zealand trends 1980-2001: Part 2. Pregnancy outcomes for Maori women.

BACKGROUND: While traditionally Maori perinatal mortality has been similar to that of other ethnic groups, rates of preterm birth, small for gestational age (SGA) and teenage pregnancy have remained high. AIMS: To review current trends in preterm birth, SGA and teenage pregnancy for Maori during 1980-2001 and to highlight the major factors that have influenced Maori reproductive outcomes during this period. METHODS: De-identified birth registration data from 1 189 120 singleton live births and 5775 stillbirths were analysed for 1980-2001. Outcomes of interest included preterm birth, SGA and late fetal death while explanatory variables included maternal ethnicity, age and NZ Deprivation Index decile. Trend analysis was undertaken for 1980-1994 and multivariate logistic regression was used to explore risk factors for 1996-2001. RESULTS: During 1980-1994, Maori women had the highest preterm birth rates of any ethnic group in New Zealand, but in relative terms, inequalities declined as a consequence of a non-significant 7% fall in rates being offset by a statistically significant 30% increase for the European/other ethnic group. Rates of SGA were also higher amongst Maori women but declined by 25% during the 1980-1994 period. In addition, Maori women experienced significant socioeconomic gradients in SGA, with risk for Maori women in the most deprived NZDep areas being double that of Maori living affluent areas. Paradoxically, while Maori women had high rates of teenage pregnancy, this did not confer additional risk for preterm birth or SGA during the 1996-2001 period. CONCLUSIONS: While high rates of teenage pregnancy amongst Maori women appear not to confer additional risk for preterm birth or SGA, the social consequences of early childbearing may well be significant. The persistence of elevated rates of preterm birth and large socioeconomic gradients in SGA amongst Maori suggest that broader social and policy interventions are necessary if Maori are to achieve optimal birth outcomes in the coming decades.

Adolescent↗

Orthodontic process and outcome: efficacy studies--strategies for developing process and outcome measures: a new era in orthodontics.

The development of process and outcome measures in orthodontics lends itself to retrospective clinical studies. Once valid and reliable measures have been tested, prospective studies may utilize these measures to assess the quality of orthodontic treatment outcome and the duration and process of treatment. The findings from two retrospective studies comparing the quality of outcome using the peer assessment rating (PAR) occlusal index and duration of treatment are reported. Class I and Class II treatment comparisons indicate the duration of treatment time is increased on average 5 months in Class II, division 1 patients. In the second study, the effect of extraction/non-extraction treatment in a sample that included all types of malocclusion indicates that, on average, treatment time is increased by approximately 5 months when extractions are included as part of the orthodontic treatment plan.

Analysis of Variance↗

Development and validation of a core outcome measure for palliative care: the palliative care outcome scale. Palliative Care Core Audit Project Advisory Group.

OBJECTIVES: To develop an outcome measure for patients with advanced cancer and their families which would cover more than either physical symptoms or quality of life related questions. To validate the measure in various specialist and non-specialist palliative care settings throughout the UK. DESIGN: A systematic literature review of measures appropriate for use in palliative care settings was conducted. In conjunction with a multidisciplinary project advisory group, questions were chosen for inclusion into the scale based on whether they measured aspects of physical, psychological, or spiritual domains pertinent to palliative care, and whether similar items had shown to be valid as part of another measure. A staff completed version was developed to facilitate data collection on all patients throughout their care, and a patient completed version was designed to enable the patient to contribute to the assessment of their outcomes when possible. A full validation study was conducted to evaluate construct validity, internal consistency, responsiveness to change over time, and test-retest reliability. Assessments were timed. SETTING: Eight centres in England and Scotland providing palliative care, including inpatient care, outpatient care, day care, home care, and primary care. PATIENTS: A total of 450 patients entered care during the study period. Staff collected data routinely on patients in care long enough to be assessed (n = 337). Of these, 262 were eligible for patient participation; 148 (33%) went on to complete a questionnaire. MAIN MEASURES: The Palliative Care Outcome Scale (POS), the European Organisation for Research on Cancer Treatment, and the Support Team Assessment Schedule. RESULTS: The POS consists of two almost identical measures, one of which is completed by staff, the other by patients. Agreement between staff and patient ratings was found to be acceptable for eight out of 10 items at the first assessment. The measure demonstrated construct validity (Spearman rho = 0.43 to 0.80). Test/re-test reliability was acceptable for seven items. Internal consistency was good (Cronbach's alpha = 0.65 (patients), 0.70 (staff)). Change over time was shown, but did not reach statistical significance. The questionnaire did not take more than 10 minutes to complete by staff or patients. CONCLUSION: The POS has acceptable validity and reliability. It can be used to assess prospectively palliative care for patients with advanced cancer.

England↗

Pregnancy outcome in women with labor-onset hypertension. Similar outcome between labor-onset hypertension and preeclampsia.

Labor-onset hypertension is a poorly documented category, and there is scanty information concerning the outcome of pregnancy in this condition. A retrospective study was performed to compare the pregnancy outcome of 36 patients with labor-onset hypertension (group A) with 36 patients with classical preeclampsia diagnosed before labor (group B) who were matched for parity and age. There was no difference in age, past history of hypertensive pregnancies or family history of hypertension between the two groups. The need for intrapartum hypertensive and anticonvulsant treatment as well as the outcome of pregnancy were similar in both groups. The only significant difference was that group A patients had lower maximum and booking systolic and diastolic pressures. The results indicate that labor-onset hypertension represents a late manifestation of the preeclampsia process, because these patients had lower blood pressure in pregnancy and would not be identified until intrapartum elevation of blood pressure satisfied the diagnostic criteria of preeclampsia.

Apgar Score↗