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PubMedDate not supplied

Low molecular weight heparinoid, ORG 10172 (danaparoid), and outcome after acute ischemic stroke: a randomized controlled trial. The Publications Committee for the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) Investigators.

CONTEXT: Anticoagulation with unfractionated heparin is used commonly for treatment of acute ischemic stroke, but its use remains controversial because it has not been shown to be effective or safe. Low molecular weight heparins and heparinoids have been shown to be effective in preventing deep vein thrombosis in persons with stroke, and they might be effective in reducing unfavorable outcomes following ischemic stroke. OBJECTIVE: To test whether an intravenously administered low molecular weight heparinoid, ORG 10172 (danaparoid sodium), increases the likelihood of a favorable outcome at 3 months after acute ischemic stroke. DESIGN: Randomized, double-blind, placebo-controlled, multicenter trial. SETTING AND PARTICIPANTS: Between December 22, 1990, and December 6, 1997, 1281 persons with acute stroke were enrolled at 36 centers across the United States. INTERVENTION: A 7-day course of ORG 10172 or placebo was given initially as a bolus within 24 hours of stroke, followed by continuous infusion in addition to the best medical care. Doses were adjusted in response to anti-factor Xa activity. MAIN OUTCOME MEASURES: Favorable outcome rated as the combination of a Glasgow Outcome Scale score of I or II and a modified Barthel Index of 12 or greater on a scale of 0 to 20 at 3 months or 7 days; very favorable outcome was recorded for the combination of a Glasgow Outcome Scale of I and a Barthel Index of 19 or 20 at 3 months or 7 days. RESULTS: At 3 months, 482 (75.2%) of 641 persons assigned to treatment with ORG 10172 and 467 (73.7%) of 634 patients treated with placebo had favorable outcomes (P=.49); 49.5% and 47%, respectively, of patients in each group had very favorable outcomes at 3 months. At 7 days, 376 (59.2%) of 635 persons given ORG 10172 and 344 (54.3%) of 633 receiving placebo had favorable outcomes (P=.07). For the same interval, 215 (33.9%) of 635 persons given ORG 10172 and 176 (27.8%) of 633 persons administered placebo had very favorable outcomes (P=.01; odds ratio, 1.36; 95% confidence interval, 1.06-1.73). Within 10 days of onset of treatment, serious intracranial bleeding events occurred in 14 patients given ORG 10172 (15 events) and in 4 placebo-treated patients (5 events) (P=.05). CONCLUSION: Despite an apparent positive response to treatment at 7 days, emergent administration of the antithrombotic agent, ORG 10172, is not associated with an improvement in favorable outcome at 3 months.

Aged↗

PubMed1998

A longitudinal analysis of nursing home outcomes.

OBJECTIVE: To investigate resident and facility attributes associated with long-term care health outcomes in nursing homes. DATA SOURCES: Quarterly Management Minutes Questionnaire (MMQ) survey data for Medicaid case-mix reimbursement of nursing homes in Massachusetts from 1991 to 1994, for specification of outcomes and resident attributes. Facility attributes are specified from cost report data. STUDY DESIGN: Multivariate logistic and "state-dependence" regression models are estimated for survival, ADL functional status, incontinence status, and mental status outcomes from longitudinal residence histories of Medicaid residents spanning 3 to 36 months in length. Outcomes are specified to be a function of resident demographic and diagnostic attributes and facility-level operating and nurse staffing attributes. PRINCIPAL FINDINGS: The estimated parameters for resident demographic and diagnostic attributes showed a great deal of construct validity with respect to clinical expectations regarding risk factors for adverse outcomes. Few facility attributes were associated with outcomes generally, and none was significantly associated with all four outcomes. CONCLUSIONS: The absence of uniform associations between facility attributes and the various long-term care health outcomes studied suggests that strong facility performance on one health outcome may coexist with much weaker performance on other outcomes. This has implications for the aggregation of individual facility performance measures on multiple outcomes and the development of overall outcome performance measures.

Activities of Daily Living↗

PubMed2006

Outcomes for surgical and endovascular management of intracranial aneurysms using a comprehensive grading system.

OBJECTIVE: A systematic approach to the consideration of various factors on outcome demands a comprehensive grading system for patients with intracranial aneurysms. We have previously identified potential patient- and lesion-specific factors that correlate strongly with outcome after treatment for intracranial aneurysms, and we have developed a comprehensive grading system based on these factors. In this study, we evaluate this grading system in a large series of aneurysm patients treated by surgery and endovascular therapy. METHODS: Between January 1998 and January 2003, ruptured and unruptured aneurysm patients were prospectively entered into a database. Based on our previous study that showed which factors correlated strongly with outcome, data were collected on patient age, aneurysm size, Hunt and Hess grade, and Fisher scale (if presenting with subarachnoid hemorrhage), and a Massachusetts General Hospital grade was then applied. The modified Glasgow Outcome Scale was used for clinical assessment at follow-up, and a binary analysis classified patients into favorable versus unfavorable outcome. Univariate and multivariate analyses for the predictor variables were performed. RESULTS: One thousand forty-nine aneurysms in 914 patients were identified. Fifty-eight percent (n = 608) of the lesions were unruptured, and 25% (n = 261) were treated endovascularly. For patients treated either surgically or endovascularly, worsening outcome was demonstrated for higher Hunt and Hess grade (surgery, P < 0.001; endovascular, P < 0.001), Fisher scale (surgery, P < 0.001; endovascular, P < 0.001) and for older patients (surgery, P < 0.001; endovascular, P = 0.004). Size of aneurysm had a significant effect on outcome after surgery (P = 0.04), but not after endovascular therapy (P = 0.3). Overall, there was a greater proportion of favorable outcomes for anterior circulation compared with posterior circulation lesions (P < 0.0001). For both the surgical and endovascular subgroups, MGH grade correlated well with clinical outcomes. CONCLUSION: The MGH grade is a comprehensive grading system that is easily applied and that allows separation of patients with aneurysms into groups with markedly different outcomes. This information can potentially be helpful in making treatment decisions and when discussing projected outcome before surgical or endovascular intervention of both unruptured and ruptured aneurysms.

Adult↗

PubMed1995

Cerebral circulation assessed by transcephalic electrical impedance during the first day of life--a potential predictor of outcome?

Pulsatile changes in intracranial blood volume (transcephalic electrical impedance, delta Z), arterial blood pressure (aBP) and respiration were studied during the first day after birth in 42 neonates with a birth weight of 1040-3850 g and gestational age of 26-36 weeks. The neurological outcome was assessed at 1 year of age to study the predictive ability of delta Z. delta Z, ECG, respirogram and direct aBP were recorded at 8-h intervals. Outcome was adverse in seven infants of whom two died from severe peri-intraventricular haemorrhage. PCO2 was higher (6.2 kPa) in the infants with adverse outcome than in those infants with favourable outcome (5.0 kPa) (P = 0.004). Blood glucose (4.5 vs. 3.3 mmol/l, P = 0.030) and first day administration of fluid (80 vs. 63 ml/kg/day, P = 0.003) behaved, respectively. Of the infants receiving dopamine therapy, 60% had adverse outcome while only 11% of those not receiving dopamine had adverse outcome (P = 0.016). Of the infants with high diastolic blood pressure levels, 32% had adverse outcome, while none with low diastolic blood pressure levels had adverse outcome (P = 0.031). Spectral analysis was used to examine signal variabilities in the frequency domain. During the first 24 h of life, the variabilities of aBP and respiration were equal in all the infants. The high-frequency delta Z signal variability (1.50-4.00 Hz, heart rate level) was found to be lower in the infants with adverse outcome (330 units) than in the infants with favourable outcome (1280 units, P = 0.017). The low delta Z variability allowed us to assume that there is a decrease of pulsatile cerebral blood flow (CBF) in the infants with adverse outcome. We speculate that this may result from the 'no reflow phenomenon', increased tissue pressure due to ischaemia and/or PIVH, the 'brain sparing effect' or constriction of main cerebral arteries due to increased pressure support or metabolic factors (PCO2, glucose). We believe that transcephalic impedance provides a potential cot-side method for monitoring cerebral circulation in the neonatal period with an ability to predict outcome.

Blood Glucose↗

PubMed2004

Outcome value and early warning indications as determinants of willingness to learn from experience.

In this study of willingness to learn from experience, it was hypothesized that managers would show a negative outcomes bias, that is, a stronger tendency to initiate "learning-from-experience" processes after negative outcomes than after positive outcomes. Another aim of the study was to explore the impact of the existence of early warning signals about decision outcomes on the magnitude of the negative outcome bias. Eighty-three managers were asked to read vignettes describing a managerial decision and its outcomes. The outcomes were either positive or negative, and in half of the cases early warning signals existed that made it possible to predict potential negative outcomes while in the other half there were no such signals. The managers were asked to evaluate the need for a learning-from-experience process in general and to rate the degree to which several specific learning processes should be instituted in each of the scenarios. As hypothesized, a negative-outcome bias was found. The more negative the outcomes described, the stronger the managers' inclination to recommend a more intensive learning process. Similarly, a need to ensure control and follow-up procedures was reported mostly after negative outcomes. The existence of early warning signals before the decision was taken did not influence the motivation to learn. Theoretical implications regarding the impact of negative outcomes in general and implications for understanding learning from experience processes in particular are discussed.

Affect↗

PubMed1996

Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators.

BACKGROUND: Acute changes in cerebral function after elective coronary bypass surgery is a difficult clinical problem. We carried out a multicenter study to determine the incidence and predictors of -- and the use of resources associated with -- perioperative adverse neurologic events, including cerebral injury. METHODS: In a prospective study, we evaluated 2108 patients from 24 U.S. institutions for two general categories of neurologic outcome: type I (focal injury, or stupor or coma at discharge) and type II (deterioration in intellectual function, memory deficit, or seizures). RESULTS: Adverse cerebral outcomes occurred in 129 patients (6.1 percent). A total of 3.1 percent had type I neurologic outcomes (8 died of cerebral injury, 55 had nonfatal strokes, 2 had transient ischemic attacks, and 1 had stupor), and 3.0 percent had type II outcomes (55 had deterioration of intellectual function and 8 had seizures). Patients with adverse cerebral outcomes had higher in-hospital mortality (21 percent of patients with type I outcomes died, vs. 10 percent of those with type II and 2 percent of those with no adverse cerebral outcome; P<0.001 for all comparisons), longer hospitalization (25 days with type I outcomes, 21 days with type II, and 10 days with no adverse outcome; P<0.001), and a higher rate of discharge to facilities for intermediate- or long-term care (69 percent, 39 percent, and 10 percent ; P<0.001). Predictors of type I outcomes were proximal aortic atherosclerosis, a history of neurologic disease, and older age; predictors of type II outcomes were older age, systolic hypertension on admission, pulmonary disease, and excessive consumption of alcohol. CONCLUSIONS: Adverse cerebral outcomes after coronary bypass surgery are relatively common and serious; they are associated with substantial increases in mortality, length of hospitalization, and use of intermediate- or long-term care facilities. New diagnostic and therapeutic strategies must be developed to lessen such injury.

Age Factors↗

PubMed2001

Review of the use of somatosensory evoked potentials in the prediction of outcome after severe brain injury.

OBJECTIVE: Review the predictive powers of somatosensory evoked potentials (SEPs) in severe brain injury. DATA SOURCES: Publications in the scientific literature, manual review of article bibliographies, and questioning workers in the field. STUDY SELECTION: Studies addressing the prediction of outcome after severe brain injury using SEPs. DATA EXTRACTION: To determine the outcome of patients with either normal or bilaterally absent SEPs as categorized using the Glasgow Outcome Scale into favorable outcomes (good or moderate disability) or unfavorable outcomes (severe disability, vegetative, or dead). Studies were included if they were in English and allowed the determination of outcomes for all patients with normal or bilaterally absent SEPs. Papers were not considered if subjects were neonates, consisted of abstracts where all necessary details were unavailable, were case reports or duplications of other published studies, or dealt only with brain dead subjects. DATA SYNTHESIS: For all studies (n = 44), positive likelihood ratio, positive predictive value, and sensitivity were 4.04, 71.2%, and 59.0%, respectively, for normal SEPs (predicting favorable outcome) and 11.41, 98.5%, and 46.2%, respectively, for bilaterally absent SEPs (predicting unfavorable outcome). Summary receiver operating characteristic curve analysis detected a cut-off criterion effect for only blinded studies of bilaterally absent SEPs. Twelve patients (12/777) were identified with bilaterally absent SEPs who had favorable outcomes. These false positives are typically pediatric patients or have suffered traumatic brain injuries. We suggest criteria for the use of bilaterally absent SEPs in the prediction of poor outcome, which include absence of focal lesions, subdural or extradural fluid collections, and no decompressive craniotomy in previous 48 hrs. Using these criteria the data suggest that the false-positive rate is <0.5% for bilaterally absent SEPs. CONCLUSIONS: SEPs are powerful predictors of outcome, particularly poor outcome, if patients with focal lesions, subdural effusions, and those who have had recent decompressive craniotomies are excluded.

Adult↗

PubMed2004

Judging trauma center quality: does it depend on the choice of outcomes?

BACKGROUND: Trauma centers routinely benchmark their survival outcomes against a national norm using the TRISS methodology. However, the use of survival as a measure of the effectiveness of trauma care may be too limited in scope because it fails to capture information regarding functional outcomes. METHODS: The objective of this study was to develop a prediction model that allows hospitals to benchmark their functional outcomes in blunt trauma patients, and to determine whether the assessment of hospital "quality" depends on the choice of outcome measure: survival or survival combined with functional outcome. This retrospective cohort study was based on patients, aged 18 years or older, in the National Trauma Database who sustained blunt trauma in 1999 without associated head or spinal cord injury. We developed a sequential logistic model to predict the probability of a good functional outcome. The TRISS methodology was customized to this data set to obtain a survival model. Using each of these prediction models, we then obtained two standardized measures of hospital performance: one based on the number of survivors and the other based on the number of survivors with good functional outcomes. These standardized outcome measures were then used to identify low-performance and high-performance hospitals. The ranking based on these two different measures were compared. RESULTS: Fifteen of the 27 hospitals in the study cohort were categorized differently when their performance was benchmarked using survival versus functional outcome. Kappa analysis revealed minimal agreement between these two quality measures on the identity of hospital quality outliers (kappa = 0.04; p = 0.35). CONCLUSION: The evaluation of hospital quality depends on whether hospital performance is judged by looking at survival or at survival combined with functional outcome. Because functional status is an important outcome of major concern to survivors, it is important to include it in hospital performance assessment. Consideration should be given to including functional outcome in the evaluation of trauma center performance.

Benchmarking↗

PubMed2004

Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals.

BACKGROUND: Randomized controlled trials almost always have some individuals with missing outcomes. Inadequate handling of these missing data in the analysis can cause substantial bias in the treatment effect estimates. We examine how missing outcome data are handled in randomized controlled trials in order to assess whether adequate steps have been taken to reduce nonresponse bias and to identify ways to improve procedures for missing data. METHODS: We reviewed all randomized trials published between July and December 2001 in BMJ, JAMA, Lancet and New England Journal of Medicine, excluding trials in which the primary outcome was described as a time-to-event. We focused on trial designs, how missing outcome data were described and the statistical methods used to deal with the missing outcome data, including sensitivity analyses. RESULTS: We identified 71 trials of which 63 (89%) reported having partly missing outcome data: 13 trials had more than 20% of patients with missing outcomes. In 26 trials that measured the outcome at a single time point, 92% performed a complete case analysis and 8% imputed the missing outcomes using baseline values or the worst case value. In 37 trials with repeated measures of the outcome, 46% performed complete case analyses, potentially excluding individuals with some follow-up data, while 14% performed a repeated measures analysis, 19% used the last observation carried forward, 11% imputed with the worst case value and 2% imputed using regression predictions. Thirteen (21%) of trials with missing data reported a sensitivity analysis. CONCLUSIONS: Our review shows that missing outcome data are a common problem in randomized controlled trials, and are often inadequately handled in the statistical analysis in the top tier medical journals. Authors should explicitly state the assumptions underlying the handling of the missing outcomes and justify them through data descriptions and sensitivity analyses.

Bias↗

PubMed2005

Long-term outcome of cognitive behaviour therapy clinical trials in central Scotland.

OBJECTIVES: To establish the long-term outcome of participants in clinical trials of cognitive behaviour therapy (CBT) for anxiety disorders and psychosis, examining the effectiveness and cost-effectiveness associated with receiving CBT in comparison with alternative treatments. DESIGN: An attempt was made to contact and interview all of the participants in eight randomised, controlled, clinical trials of CBT for anxiety disorders and two randomised, controlled, clinical trials of CBT for schizophrenia conducted between 1985 and 2001. Case note reviews of healthcare resources used in the 2 years prior to entering the trials and the 2 years prior to follow-up interview were undertaken. SETTING: Mixed rural and urban settings in five localities in central Scotland. Anxiety disorder trials were conducted mainly in primary care and included three with generalised anxiety disorder, four with panic disorder and one with post-traumatic stress disorder (PTSD). The psychosis studies (one on relapse prevention and one with chronic disorder) were conducted in secondary care. PARTICIPANTS: Of the 1071 entrants to the 10 studies, 489 agreed to participate (46% of original entrants, 52% of those available to contact). INTERVENTIONS: Follow-up interviews took place between 1999 and 2003, 2-14 years after the original treatment. Interviews for Trials 1-8 were conducted by a research psychologist blind to original treatment condition. Interviews for Trials 9 and 10 were conducted by community psychiatric nurses also blind to treatment condition. Case note reviews were completed following the interview. MAIN OUTCOME MEASURES: For Trials 1-8 the main interview-based outcome measures were: Anxiety Disorders Interview Schedule-DSM-IV for diagnosis and co-morbidity, Clinical Global Severity (0-8) and the Hamilton Anxiety Rating Scale. The main patient-rated measures were: Brief Symptom Inventory, SF-36 II, Clinical Global Improvement (1-7), and the Positive and Negative Affect Scale. For Trials 9 and 10 the primary outcome measure was the interview-based Positive and Negative Syndrome Scale (PANSS). RESULTS: For the anxiety disorder studies (Trials 1-8), over half of the participants (52%) had at least one diagnosis at long-term follow-up, with significant levels of co-morbidity and health status scores comparable to the lowest 10% of the general population. Only 36% reported receiving no interim treatment for anxiety over the follow-up period with 19% receiving almost constant treatment. Patients with PTSD did particularly poorly. There was a 40% real increase in healthcare costs over the two time periods, mainly due to an increase in prescribing. A close relationship was found between poor mental and physical health for those with a chronic anxiety disorder. Treatment with CBT was associated with a better long-term outcome than non-CBT in terms of overall symptom severity but not with regard to diagnostic status. The positive effects of CBT found in the original trials were eroded over longer time periods. No evidence was found for an association between more intensive therapy and more enduring effects of CBT. Long-term outcome was found to be most strongly predicted by the complexity and severity of presenting problems at the time of referral, by completion of treatment irrespective of modality and by the amount of interim treatment during the follow-up period. The quality of the therapeutic alliance, measured in two of the studies, was not related to long-term outcome but was related to short-term outcome. The cost-effectiveness analysis showed no advantages of CBT over non-CBT. The cost of providing CBT in the original trials was only a very small proportion (6.4%) of the overall costs of healthcare for this population, which are high for both physical and mental health problems. In the psychosis studies (Trials 9 and 10), outcome was generally poor with only 10% achieving a 25% reduction in total PANSS scores from pretreatment to long-term follow-up, also cost-effectiveness analysis showed no advantages of CBT over non-CBT, although healthcare costs fell over the two time periods mainly owing to a reduction in inpatient costs. CONCLUSIONS: Psychological therapy services need to recognise that anxiety disorders tend to follow a chronic course and that good outcomes with CBT over the short term are no guarantee of good outcomes over the longer term. Clinicians who go beyond standard treatment protocols of about 10 sessions over a 6-month period are unlikely to bring about greater improvement. Poor outcomes over the long term are related to greater complexity and severity of presenting problems at the time of referral, failure to complete treatment irrespective of modality and the amount of interim treatment during the follow-up period. The relative gains of CBT are greater in anxiety disorders than in psychosis. Longitudinal research designs over extended periods of time (2-5 years), with large numbers of participants (500+), are required to investigate the relative importance of patient characteristics, therapeutic alliance and therapist expertise in determining the cost-effectiveness of CBT in the longer term.

Anti-Anxiety Agents↗

PubMed2005

Assistive technology outcomes in work settings.

Successfully documenting the outcomes of assistive technology (AT) interventions in the workplace benefits people with disabilities, service providers and agencies. However, no work related system currently exists that comprehensively collects the data needed to analyze such outcomes. Part of the reason for this absence of an outcome system is that, while the concept is simple, the process is complex and depends on the acquisition of data that represent many outcomes related variables. This article describes the exploratory work of the NIDRR (National Institute on Disability and Rehabilitation Research) funded ATOMS Project (Assistive Technology Outcomes Measurement System) and its efforts to identify existing data that might be used as the basis for an outcomes measurement system. Sample records from four assistive technology service programs were acquired and evaluated for the data they housed. This study discovered that AT service programs fail to collect consistent or sufficient data for outcomes analysis. However, discussions with AT programs that provided services to State vocational rehabilitation agencies revealed an interesting potential. Assistive technology service data in combination with data collected by State vocational rehabilitation departments might coalesce the needed data. The Federal Rehabilitation Services Administration (RSA) 911 Report aggregates many variables of outcomes related information including employment status and the success of the vocational rehabilitation investment. This combined database could answer a range of assistive technology outcomes related questions of interest to service providers, people with disabilities, and vocational rehabilitation State agencies. This paper describes the data needed in an outcomes system, reviews the data that appear to be available today related to AT outcomes, and projects how data from two diverse programs might be used together to create a significant outcomes database.

Biomedical Enhancement↗

PubMed1979

[Fate of subsequent pregnancies in relation to the outcome of previous pregnancies].

Adverse outcome of the previous pregnancy as a risk factor for the next one has lately been given increased attention. Particular concern has been expressed as to the possible adverse effects of induced abortion on subsequent pregnancy outcome (1, 2, 3, 4, 5, 6). The purpose of the present report was to establish on the basis of population studies whether and to what extent, abnormal outcome of pregnancy increases the risk of abnormal outcome of the next or further pregnancies. Particular attempt was made to evaluate the increased risk of abnormal outcome of pregnancy following spontaneous and induced abortion. A sample of the studied population was originally collected in several Departments of Obstetrics for a study on epidemiology of low birth weight, and its selection was conditioned by that study. The sample included women whose present pregnancy resulted in the delivery of a live born child. This pregnancy was not taken into consideration in the present study except as a basis for selection of 2 study groups of women who previously had at at least 2 pregnancies (except the present one): Group A consisted of 1180 women who gave birth in the recent pregnancy to a full term child weighing over 3000 g and Group B of 1170 women who delivered a low birth weight infant in their previous pregnancy. Mothers of infants weighing between 2500 and 3000 g were also included in this group because the foetal growth tables for Polish newborn infants showed that weight limits at the 5th percentile for full term male infant ranged between 2500-2800 g and below 10th percentile between 2600 and 3000 g. The following outcomes of previous pregnancies were considered: Full term newborn infant (FT) Low birth weight infant (less than or equal to 2500 g) (Pr) Spontaneous abortion (SA) Induced abortion (IA) Other outcomes (O) Contingency tables containing information on the frequency of different outcomes of earlier and later pregnancies were prepared and the effects of the mode of termination of the earlier pregnancy on the later ones were demonstrated. Interrupted pregnancies were not included in the whole number of cases for the calculation of the percent value, as the decision to interrupt is usually arbitrary and very seldom related to the outcome of the previous pregnancy. The differences between the distribution of pregnancy outcomes in various categories of termination of earlier pregnancy were tested by standard Chi square test which was useful also for testing the dependence of the mode of outcome of the preceding and the following pregnancy. The relative risk coefficient was also calculated for two different combinations of outcomes.(ABSTRACT TRUNCATED AT 400 WORDS)

Abortion, Induced↗

PubMed2001

Predictors of outcomes of carpal tunnel release.

OBJECTIVE: To identify factors that are predictive of the outcomes of greatest importance to patients-i.e., symptom relief, functional improvement, and satisfaction with the outcomes of surgery-following carpal tunnel release. METHODS: We analyzed data from the Maine Carpal Tunnel Study, a community-based study of the outcomes of treatment for carpal tunnel syndrome. In a cohort of patients who underwent carpal tunnel release, a preoperative physical examination was performed and questionnaires were completed preoperatively and at 6, 18, and 30 months postoperatively. The questionnaires assessed symptom severity, upper extremity functional limitations, mental health, general physical health status, the relative severity of individual symptoms, satisfaction with the results of surgery, sociodemographic factors, and for those subjects who were in the workforce, aspects of the work environment. The associations between preoperative factors and the 3 principal outcomes (symptom severity, upper extremity functional limitations, and satisfaction with the results of surgery, all evaluated at 18 months postoperatively) were assessed with bivariate and multivariate linear regression and logistic regression analyses. RESULTS: Two hundred forty-one subjects were enrolled and 188 (78%) completed followup surveys 18 months postoperatively. Two-thirds of the patients reported being completely or very satisfied with the outcomes of surgery at 6, 18, and 30 months postoperatively. A range of clinical and work-related variables were associated with outcomes. In multivariate analyses, greater preoperative upper extremity functional limitation was predictive of greater functional limitations postoperatively. Worse mental health status was significantly associated with more severe symptoms and lower satisfaction. Alcohol use was also associated with more severe symptoms and lower satisfaction. Among workers, involvement of an attorney was significantly associated with greater functional limitation, more severe symptoms, and lower satisfaction. Recipients of worker's compensation who did not hire an attorney had generally good outcomes. Of note, physical examination parameters were not predictive of the outcomes of surgery. CONCLUSION: The outcomes of carpal tunnel release in community-based practices are excellent. Predictors of the outcomes of surgery are disease-specific and generic clinical factors as well as work-related factors. The strongest predictors of less favorable outcomes are worse scores on patient-reported measures of upper extremity functional limitation and mental health status, alcohol use, and the involvement of an attorney. Clinicians should carefully evaluate patients' functional status, mental health status, health habits, and attorney involvement prior to performing carpal tunnel release, and discuss with patients the prognostic implications of these parameters.

Adult↗

PubMed2000

Outcomes after abdominal aortic aneurysm repair: comparison of mortality defined by centralized VA Patient Treatment File data versus hospital-based chart review.

BACKGROUND: Outcomes after abdominal aortic aneurysm (AAA) repair have been reported by individual Veterans Affairs medical centers (VAMCs) and for the entire VA patient population. PURPOSE: This study was done to determine whether outcomes defined using VA Patient Treatment File (PTF) data were comparable to those defined by direct chart review in those undergoing repair of intact AAA. METHODS: Focused chart review was performed in all veterans undergoing such AAA repair in a sample of VAMCs (n = 5) for separate 1-year periods during fiscal years (FY) 1991-1993. A previous report of outcomes after AAA repair for all veterans in DRGs 110 and 111 during FY 1991-1993 was based on PTF data that were further analyzed by Patient Management Category (PMC) software. Outcomes after AAA repair were defined in a similar fashion using PTF data and PMC analysis in the same sample VAMCs for which direct chart review data were available. Outcomes defined by chart review were then compared to those based on PTF data. RESULTS: Three of the 69 patients undergoing repair of intact AAA for which chart review data were available were assigned to DRGs other than 110 and 111 and, by definition, were not included in the PTF-derived database. Nine of 10 additional patients undergoing chart review were not identified as having undergone AAA repair by PMC software: 7 had procedure codes 39.25 instead of more standard AAA repair codes 38.34 or 38.44. Two additional patients with codes 38.64 or 38.66 were not identified as having undergone AAA repair by PMC software. The 10th patient not included in the PTF-derived database underwent additional operative procedures. Of the 13 patients missed by the combined PTF and PMC outcome analyses but identified by chart review, none died or had cardiac complications. One of these 13 patients had pulmonary complications based on chart review and PTF but was excluded by PMC analysis. There remained a total of 56 patients at the five sample VAMCs common to the PTF-derived and chart-derived databases identified as having undergone repair of intact AAA. There were two in-hospital deaths in these patients, and both were identified by each approach to outcome assessment. Four of these 56 patients had postoperative cardiac complications (ICD-9-CM code 997. 10) which were identified by both PTF and chart review. Postoperative pulmonary complications (ICD-9-CM code 997.30) were present in 4 of the 56 cases and were also identified by both PTF-based and chart-based outcome analyses. CONCLUSIONS: All deaths as well as cardiac or respiratory complications identified by chart review at the study hospitals were also affirmed by the PTF. Due to study methodologies (which restricted analysis to those in DRGs 110 and 111 and which included secondary analyses of PTF data by PMC software), 19% of patients who underwent repair of intact AAA identified by hospital-based chart review were excluded from the PTF-based outcome analysis. Outcomes defined using large databases such as the VA PTF may be comparable to those defined by chart review if study methodologies permit. Discrepancies in outcome assessment between direct chart review and large database analysis in the present study were due to methodologies used, not to deficiencies, per se, in PTF data.

Aged↗

PubMed1978

Quality assurance in primary care: a strategy based on outcome assessment.

We describe an outcome-based approach to quality assurance in primary care and present data from an initial study made to explore its usefulness. A questionnaire, which asked patients to report on the status of their problem in terms of the amount of symptoms, activity limitation, and anxiety it caused, was mailed to adults who had been seen a month previously for upper respiratory tract infection, sore throat, or urinary tract infection. Outcome standards developed for these conditions indicated that patients should report no symptoms, activity limitation, or anxiety. Of the 127 patients who responded, 17% failed to meet these standards. A review of their medical records was conducted to test the value of using substandard problem-status outcome as an indicator of important deficiencies in care. Definite deficiencies in care were found for 57% of those with substandard outcomes and for 2% of those with acceptable outcomes. Corrective action was judged likely to benefit 95% of the cases with substandard outcome and 7% of those with acceptable outcomes. Data from the medical records were insufficient to explain the reasons for substandard outcome in all cases, thus emphasizing the need to examine also patient- and system-related variables not evident in the medical record. An approach to quality assurance that is based on measuring outcome and then determining the reasons for poor outcome in useful for uncovering correctable errors in the delivery of primary care. In order for the approach to be effective in improving care, the outcome measures used must be sensitive to the role of primary care in assisting partients to resolve health problems.

Ambulatory Care↗

PubMed1996

A comparison of outcome criteria in the diagnosis of renovascular hypertension.

The outcome criteria used for the diagnosis of renovascular hypertension (RVHT) following renal revascularization have not been validated. Differing criteria of indeterminate accuracy have yielded conflicting conclusions concerning the prevalence and efficacy of treatment of RVHT. We compared the accuracy of conventional outcome criteria used in the diagnosis of RVHT to that of novel, ordered outcome analysis to determine whether such an analysis might provide a more consistent means of diagnosing RVHT. Twenty-seven patients underwent intervention for treatment of presumed RVHT (group I), and 40 patients with presumed essential hypertension were treated with antihypertensive medication alone (group II). A standard dichotomized (improved or unimproved) outcome scheme and a five-level, ordered outcome scheme (ranging from definitely unimproved to definitely improved) were used to generate nominal outcomes of therapy for each patient. The resultant outcome groups were examined to determine the effect of such partitioning on blood pressure and medication requirements. To determine their diagnostic accuracy, the conventional and ordered outcome schemes were compared with a consensus outcome scheme derived from the use of numerous criteria. Significant correlations were observed between the ordered outcome score and posttreatment reductions in systolic blood pressure (r = 0.53, p = 0.007), diastolic blood pressure (r = 0.74, p = 0.0001), and medication score (r = 0.71, p = 0.0001). Overall diagnostic accuracy was estimated to be 91% for ordered criteria and 85% for dichotomized criteria. Correlation of the ordered and conventional schemes' assignments with the consensus scheme's assignments was 0.79 (p = 0.0001) and 0.63 (p = 0.0001), respectively. A simple, ordered outcome scheme compares favorably with the standard dichotomized scheme in assigning a diagnosis of RVHT to patients following renal revascularization or nephrectomy. The ordered scheme offers the advantages of simplicity and accuracy over current schemes.

Aged↗

PubMed1984

Identifying and measuring unintended outcomes.

Unintended outcomes of governmental actions have received little attention from evaluators. The argument made here is that outcome evaluations should routinely include efforts to identify and measure unintended outcomes. A systems perspective is presented which treats governmental actions as disequilibrating intrusions into reacting systems that produce an array of outcomes, only some of which are intended. Intended and unintended outcomes can be valued monetarily, in terms of human rights, or both; specifically, outcomes having monetary value alter both the level and distribution of income while outcomes with rights value alter the level and distribution of rights. More needs to be done on unintended outcomes. The systems approach offered here requires further elaboration. Design modification that increase the chances of identifying and measuring unanticipated outcomes are needed, especially for designs based on non-equivalent groups and time-series data. Instrumentation is needed for designs based on non-equivalent groups and time-series data. Instrumentation is needed that will more accurately and sensitively register unanticipated outcomes. In the meantime, evaluators should pay more attention to theoretical predictions, the experiences of those involved with programs similar to the ones being evaluated, intercultural differences, and to unintended outcomes that originate within government itself.

Evaluation Studies as Topic↗

PubMed2007

Predictors of functional outcomes after surgical treatment of distal radius fractures.

PURPOSE: Identifying predictors of outcomes is important in anticipating and treating patients with underlying factors that may affect recovery. The predictors of functional outcomes after distal radius fracture (DRF) treatment have not been well defined in the past. METHODS: This was a prospective cohort study designed to identify predictors of hand outcomes after DRF treatment. The study included consecutive patients with inadequately reduced DRFs who had open reduction and internal fixation with volar plating. Demographic and socioeconomic data were collected at the time of the initial treatment. Outcome data were collected 3, 6, and 12 months after surgery. Outcome evaluation consisted of radiographic measurements and the Michigan Hand Outcomes Questionnaire (MHQ). We hypothesized that the following factors are important predictors of functional outcomes: (1) age, (2) socioeconomic status, (3) severity of fracture pattern, and (4) postsurgical radiographic measurements. Regression models were developed using the overall MHQ score as the outcome variable at 3 months and 1 year after surgery. RESULTS: Sixty-six patients had data available at 3 months and 49 patients had data available at 1 year. At 3 months after surgery, radiographic incongruity (step + gap) was a significant predictor after controlling for age, fracture type, dorsal-volar tilt angulation, and income. Patients with increased incongruity reported lower MHQ scores (worse functional outcomes). At 1 year after surgery, however, only age and income were significant predictors after controlling for fracture type. Increased age and decreased income were associated with lower MHQ scores. CONCLUSIONS: After successful surgery and hand therapy, only age and income were significantly associated with long-term outcomes 1 year after surgery. Precise anatomic reduction enhances short-term functional outcomes in DRF treatment. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic, Level I.

Age Factors↗