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PubMed2000

Cauda equina syndrome secondary to lumbar disc herniation: a meta-analysis of surgical outcomes.

STUDY DESIGN: A meta-analysis of surgical outcomes of cauda equina syndrome secondary to lumbar disc herniation. OBJECTIVES: To determine the relationship between time to decompression after onset of cauda equina syndrome and clinical outcome, and to identify preoperative variables that were associated with outcomes. SUMMARY OF BACKGROUND DATA: The timing of surgical decompression for cauda equina syndrome is controversial. Although most surgeons recommend emergent decompression, results in certain studies show that delayed surgery may provide a satisfactory outcome. METHODS: A meta-analysis was performed to determine the correlation between timing of decompression and clinical outcome. One hundred four citations were reviewed, and 42 met the inclusion criteria. Preoperative and postoperative data were recorded. Length of time to surgery was broken down into five groups: less than 24 hours, 24-48 hours, 2-10 days, 11 days to 1 month, and more than 1 month. Logistic regression was used to determine the association between preoperative variables and postoperative outcomes. RESULTS: Outcomes were analyzed in 322 patients. Preoperative chronic back pain was associated with poorer outcomes in urinary and rectal function, and preoperative rectal dysfunction was associated with worsened outcome in urinary continence. In addition, increasing age was associated with poorer postoperative sexual function. No significant improvement in surgical outcome was identified with intervention less than 24 hours from the onset of cauda equina syndrome compared with patients treated within 24-48 hours. Similarly, no difference in outcome occurred in patients treated more than 48 hours after the onset of symptoms. Significant differences, however, were found in resolution of sensory and motor deficits as well as urinary and rectal function in patients treated within 48 hours compared with those treated more than 48 hours after onset of symptoms. CONCLUSIONS: There was a significant advantage to treating patients within 48 hours versus more than 48 hours after the onset of cauda equina syndrome. A significant improvement in sensory and motor deficits as well as urinary and rectal function occurred in patients who underwent decompression within 48 hours versus after 48 hours.

Adult↗

PubMed2002

Comparison of outcomes for unstable lower cervical flexion teardrop fractures managed with halo thoracic vest versus anterior corpectomy and plating.

STUDY DESIGN: A retrospective cohort study with cross-sectional outcome analysis was conducted. OBJECTIVES: To compare the outcome for two groups of patients with unstable cervical flexion teardrop fractures: those treated with halo thoracic vests and those treated with anterior corpectomy and plating. SUMMARY OF BACKGROUND DATA: With the evolution of safe and effective anterior cervical plates, the treatment of unstable cervical flexion teardrop fractures has shifted from halo immobilization to surgical stabilization. Although outcomes for these treatment alternatives have been reported, the literature reflects the inherent bias of retrospective studies without standardized health-related quality-of-life outcomes and without a control or comparative group. Furthermore, study populations have lacked homogeneity with respect to fracture patterns. METHODS: For this study, 45 patients with cervical flexion teardrop fractures and at least 2 years of follow-up evaluation were identified. Of these patients, 24 were treated with a halo thoracic vest and 21 with anterior corpectomy and plating. Unstable cervical flexion teardrop fractures were defined as those exhibiting failure of the anterior spine under compression and the posterior spine in tension. The primary outcome was radiographic kyphosis at follow-up assessment. Secondary outcomes included the MOS 36-Item Short-Form Health Survey and the Cervical Spine Research Society Long-Term Follow-Up questionnaire. RESULTS: The halo thoracic vest group and the anterior corpectomy and plating group were comparable for baseline demographic and clinical data, except for neurologic deficit (67% of the halo thoracic vest group and 96% of the anterior corpectomy and plating group had neurologic deficit). Most of the injuries occurred at C5. All 45 patients had radiographic follow-up evaluation, but only 17 of the 24 patients in the halo thoracic vest group and 13 of the 21 patients in the anterior corpectomy and plating group (30 of 45 in all) completed the health-related quality-of-life outcome instruments. The mean kyphosis was 11.4 degrees in the halo thoracic vest group and 3.5 degrees in the anterior corpectomy and plating group (P < 0.001). The difference remained significant, with control used for the baseline variables. The halo thoracic vest group had five failures, four of which were subsequently managed operatively. No major intra- or postoperative complications occurred in the anterior corpectomy and plating group. There were no significant differences in the MOS 36-Item Short-Form Health Survey mental component score and the Cervical Spine Research Society subscales even after adjustment for neurologic deficit. CONCLUSIONS: The results of this study indicate that anterior cervical plating is a safe and effective treatment for cervical teardrop fractures, and that it is superior to the halo thoracic vest for restoring and maintaining sagittal alignment and for minimizing treatment failures. There does not appear to be a relation between residual kyphosis and health-related quality-of-life outcomes. Although this raises questions about the relevance of restoring sagittal alignment in the treatment and outcome of cervical flexion teardrop fractures, the study was underpowered for secondary outcomes. Therefore, the secondary outcome results must be interpreted with caution.

Adult↗

PubMed2005

The influence of subdiagnosis on radiographic and clinical outcomes after lumbar fusion for degenerative disc disorders: an analysis of the literature from two decades.

STUDY DESIGN: A critical review of published literature from 2 decades. OBJECTIVE: To critically analyze the literature from 1979 to 2000 in order to examine the influence of subdiagnosis on outcome after fusion for lumbar degenerative disc disorders. SUMMARY OF BACKGROUND DATA: Numerous diagnostic subgroups of degenerative disc disorders exist. Although it is commonly believed that surgical outcomes after lumbar fusion are influenced by these subdiagnoses, there is a paucity of literature demonstrating differences in clinical outcomes or fusion rates among them. As the indications for fusion have been under greater scrutiny recently, this information would be useful in prognosticating outcomes and optimizing patient selection. METHODS: A computer search of the English literature using the keywords "degenerative," "lumbar," and "fusion" was performed. Disorders were organized according to the following subdiagnostic groups: degenerative spondylolisthesis (DDDsp), herniated disc (DH), degenerative scoliosis (DDDsc), stable DDD (DDDs), dynamically unstable DDD (DDDu), and DDD that was not specified as either DDDu or DDDs (DDDn). For each group, the type of instrumentation, fusion location, fusion rate, clinical outcome, and complication rate were recorded in a computer database. Data were pooled by simple summation and statistically analyzed using a chi test or Fisher exact test. RESULTS: Of 244 articles identified, 78 satisfied inclusion criteria with data from 4454 patients recorded. The most common diagnosis was DDDn (50%), followed by DDDsp (25%), DH (14%), DDDu (6%), DDDs (3%), and DDDsc (2%). The DDDn group had a higher fusion rate than DDDsp (P = 0.025), but a lower clinical outcome (P = 0.051). Complication rates were highest in DDDsc, whereas this subdiagnosis also had the best reported clinical outcomes. In comparing individual subgroups, a trend towards higher fusion rate and better clinical outcome was noted in DDDsp cases with instrumentation compared to noninstrumented cases. This trend was reversed for patients in the DDDn group, in whom better clinical outcomes were noted after noninstrumented fusions regardless of a lower fusion rate. CONCLUSIONS: The present data indicate that clinical outcomes and fusion rates statistically differ among the various subgroups of degenerative disc disease. Concerning the use of instrumentation, it appears that it may have greater clinical benefit in patients with DDDsp than DDDn. These findings underscore the importance of delineating specific clinical diagnoses when documenting results of lumbar fusion. This information might also be useful for both selecting surgical candidates and discussing anticipated operative outcomes.

Humans↗

PubMed2004

A systematic review and critique of the literature relating hospital or surgeon volume to health outcomes for 3 urological cancer procedures.

PURPOSE: We performed a systematic review and critique of the literature of the relationship between hospital or surgeon volume and health outcomes in patients undergoing radical surgery for cancer of the bladder, kidney or prostate. MATERIALS AND METHODS: Four electronic databases were searched to identify studies that describe the relationship between hospital or surgeon volume and health outcomes. RESULTS: All included studies were performed in North America. A total of 12 studies were found that related hospital volume to outcomes. For radical prostatectomy and cystectomy all 8 included studies showed improvement in at least 1 outcome measure with increasing volume and never deterioration. For nephrectomy the 4 included studies produced conflicting results. Four studies were found that related surgeon volume to outcomes. All radical prostatectomy and cystectomy studies showed that some outcomes were better with higher surgeon volume and never deterioration. We did not find any studies of the effect of surgeon volume on outcomes after nephrectomy. The 3 studies of the combined effect of hospital and surgeon volume on outcomes after radical prostatectomy or cystectomy suggest that high volume hospitals have better outcomes, in part because of the effect of surgeon volume and vice versa. CONCLUSIONS: Outcomes after radical prostatectomy and cystectomy are on average likely to be better if these procedures are performed by and at high volume providers. For radical nephrectomy the evidence is unclear. The impact of volume based policies (increasing volume to improve outcomes) depends on the extent to which "practice makes perfect" explains the observed results. Further studies should explicitly address selective referral and confounding as alternative explanations. Longitudinal studies should be performed to evaluate the impact of volume based policies.

Cystectomy↗

PubMed2004

Variability in trauma center outcomes for patients with moderate intracranial injury.

BACKGROUND: The variability of outcome between Trauma Centers has not been extensively studied as a possible avenue for performance improvement. Trauma Center variability in severity-adjusted survival for patients with moderate intracranial injury (MII) was studied in order to determine the association of MII-related process of care variables with outcomes. The analytic results were supplemented with peer review of MII patients with unexpected outcomes and identified potential process of care variables. METHODS: A retrospective cohort study was undertaken based on data submitted to a statewide trauma center database from July '95 through June '98. MII patients had one or more selected ICD-9-CM codes with an AIS-90 severity score of 3 or 4 but no higher. Severity adjustment was done using case matching and a logistic function based New Model that appropriately accounts for patients intubated on Emergency Department arrival. MII-related process of care variables derived from the database were identified and their relationship with outcome were evaluated individually and using multivariate methods. Trauma center personnel conducted standardized peer reviews. RESULTS: The study included data from 6765 patients treated at 26 trauma centers. Two centers (2PZW) had significantly more survivors than expected by both severity adjustment methods. Three had significantly fewer survivors than expected (3NZW). By several measures, patients treated in the 2PZW centers were more seriously injured and older than those in the 3NZW centers. CT of the head performed in the treating hospital was the only process of care variable associated with outcome in multivariate evaluations. Peer review also found little association between process of care variables and patient outcomes. However, peer review reported that 23.7% of unexpected deaths identified by case matching or the New Model were preventable or potentially preventable. Peer review also identified as medically unnecessary significant percentages of patients with unexpectedly long stays in hospital (26.4%) or in ICU (17.3%) identified by case matching. Nearly 45% of unexpected complications were judged preventable or potentially preventable. CONCLUSIONS: Two severity adjustment methods identified significant variability in trauma center outcomes for patients with MII. The difference in outcomes between the centers with better than expected (2PZW) and poorer than expected outcomes (3NZW) was substantial. Peer review identified significant opportunities for reducing unexpected deaths, stays in hospital and in ICU, and the occurrence of complications. Trauma registry data and peer reviews found little relationship between available process of care variables and patient outcomes. This study should stimulate discussions to understand reasons for outcome variability and ways to reduce it.

Adult↗

PubMed2006

Stakeholders' views on measuring outcomes for people with learning disabilities.

What works and how do we know? These are recurring questions for health and social care professionals, although mediated through differing philosophies and historical perspectives. The aims of the study reported here were to discover views of managers and commissioners of services for people with learning disabilities in Scotland regarding (a) current approaches to service evaluation (as an indication of what is to be measured) and (b) healthcare outcome measurement (as an indication of preferences regarding how this should be measured). A postal questionnaire was used to survey 94 stakeholders from the NHS, Local Authorities, and non-statutory organisations across Scotland. Respondents' views were sought on current approaches to service evaluation within learning disabilities; outcome measurement; appropriateness of specified methods of measuring health outcomes; desired future methods of outcome measurement within learning disabilities; and service user involvement in care. A 77% (73/94) response rate to the questionnaire was achieved. Different methods of service evaluation were used by different stakeholders. Staff appraisal was the most frequently identified method (used by 85% of respondents). Specific outcome measures were used by 32% of respondents although there were differences of opinion as to what constitutes specific outcome measures. Overall there was strong support for goal-setting and reviewing (83%) and individualised outcome measures (75%) as appropriate methods for use with people with learning disabilities. The hypothetical question asking what outcome measures should be introduced for this client group had by far the lowest response rate (51/73). The overwhelming majority of all respondents, 68 (92%), reported user involvement in their service. Staff ambivalence to outcome measurement was evident in the research and respondents highlighted the complexity and multidimensional nature of outcomes for this service user group. Managers recognised that outcome measurement was expected but were uncertain how to go about it.

Humans↗

PubMed2000

Adverse outcomes and opioid analgesic administration in acute abdominal pain.

UNLABELLED: To the authors' knowledge, no outcome-based, randomized clinical trial of the safety of opioid analgesics in acute abdominal pain exists. OBJECTIVES: 1) To assess the feasibility of a randomized clinical trial of opioid safety by estimating the adverse outcome rate among patients with abdominal pain severe enough to necessitate opioid analgesics. 2) To explore the association of opioid administration with adverse outcomes in acute abdominal pain. METHODS: The authors conducted a prospective observational study of emergency department (ED) abdominal pain patients, and followed them by telephone at three weeks to determine whether an adverse outcome occurred (defined as obstruction, perforation, ischemia, hemorrhage, peritonitis, sepsis, or death). A logistic regression of factors predicting adverse outcome was performed. RESULTS: Adverse outcomes occurred in 67 of 860 abdominal pain patients (7.8%, 95% CI = 6.1% to 9.8%), and 252 of 860 (29%) received opioids. The adverse outcome rate was 12.7% (95% CI = 9.0% to 17.0%) among patients who received opioids. Variables predictive of adverse outcome in logistic regression included: ED diagnosis of adverse outcome (OR 12.4), age (OR 1.6 per decade), fever (OR 4.6), received opioids (OR 2.1), pain duration (OR 1.5 per day), and leukocytosis (OR 2.0). CONCLUSIONS: A clinical trial would need to randomize more than 1,500 patients to establish the equivalent adverse outcome rates of opioids and placebo: the sample size of all existing studies combined is insufficient to make such a conclusion. Although opioids were associated with a higher adverse outcome rate in this logistic regression, the authors believe this may be due to confounding by pain severity. They emphasize that the study's design precludes conclusion of a causal link. No change in clinical practice is warranted. A randomized clinical trial of sufficient size to definitively resolve this issue is needed.

Abdominal Pain↗

PubMed2002

Defining the outcome measures for out-of-hospital trials in acute pulmonary edema.

OBJECTIVE: Comparing studies of the effectiveness of out-of-hospital interventions in acute pulmonary edema (APE) is difficult due to the diversity of outcome measures used in the literature. The objective of this study was to define a set of clinically relevant outcome measures for future out-of-hospital trials in APE. METHODS: A Medline search and hand-search of bibliographies was undertaken to develop a list of APE outcome measures. A survey was mailed to a sample of 227 Canadian emergency physicians using the Dillman methodology, requesting that respondents select clinically relevant outcome measures from this list and rank them by importance. A selection frequency of >or=70% and a median ranking score were used to determine relevant outcome measures. RESULTS: The Medline and bibliography search identified 21 APE outcome measures. The survey response rate was 71%. Outcome measures selected most frequently were heart rate, respiratory rate, respiratory distress scale, subjective dyspnea scale, out-of-hospital intubation, emergency department (ED) intubation, survival to discharge, and out-of-hospital mortality. The median ranking score identified a similar set of measures: heart rate, respiratory rate, respiratory distress scale, subjective dyspnea scale, out-of-hospital intubation rate, and ED intubation rate. There was no significant difference in outcome selection between physicians who worked in communities with and without advanced out-of-hospital care. CONCLUSIONS: Clinically relevant out-of-hospital APE outcome measures were identified and endorsed by a representative survey of Canadian emergency physicians. Clinicians appear to favor short-term and non-mortality outcomes for out-of-hospital interventions. The use of this set of APE outcome measures may improve the design and comparability of future out-of-hospital trials.

Emergency Medical Services↗

PubMed1996

A prospective 1-5 year outcome study in first-admitted and readmitted schizophrenic patients; relationship to heredity, premorbid adjustment, duration of disease and education level at index admission and neuroleptic treatment.

In a prospective outcome study, 120 DSM-III-R schizophrenic patients were followed for up to 5 years after index admission, when a comprehensive clinical and demographical examination was undertaken with the aim to find early prognostic factors for outcome. They were 86 males (72%) and 34 females (28%), and 66 (55%) were first-admitted and never before treated at index admission from a geographically defined area. Outcome was evaluated 1, 3 and 5 years after index admission by use of a Strauss-Carpenter outcome scale. At year five, 101 patients could be evaluated. Seven (7%) patients had committed suicide during the 5 years' follow-up period. 30% of the patients was considered to have a good, 14% a poor and 56% an intermediate outcome. It was found that 58% had not been in hospital during the last year, 27% were employed on the open market, 25% met friends regularly and 38% had no or only mild symptoms at the five years' follow-up evaluation. Females had a significantly better outcome than males. High education level and absence of premorbid deviant behaviour at index admission predicted a good outcome whereas problems in school (with friends and/or teachers) reported by relatives predicted poor outcome. No relationship was found between outcome and age at onset of the disorder and no gender difference in age at onset of the disorder. Patients with a family history of schizophrenia improved more between year one and five as compared with those without a family history, but heredity in itself was not an important factor for outcome. At 5 years after index admission, 40% of patients were on classical neuroleptics and 33% on clozapine whereas 19% were without medication. Of the total sample of 101 patients, 10% were drug-free and had a very good outcome at the 5 years' evaluation. The data indicate that there is a substantial subgroup of schizophrenic patients with a good prognosis and they can be characterized by female sex (even in a group without gender difference in age at onset), absence of premorbid deviant behaviour and a high education level at index admission.

Adolescent↗

PubMed2004

Diagnostic characteristics of pulpal blood flow levels associated with adverse outcomes of luxated permanent maxillary incisors.

Laser Doppler flowmetry (LDF) is a non-invasive method to assess pulpal blood flow (PBF). Dental injury has been associated with significant PBF reduction. The purpose of this study was (i) to describe PBF characteristics of teeth with specific clinical outcomes, and (ii) to demonstrate diagnostic characteristics for different threshold PBF values for detection of specific multiple adverse outcomes. In 80 trauma patients, a single maxillary incisor treated by repositioning and splinting, and the respective contralateral homologous control tooth were investigated by LDF to assess local PBF values. Perfusion units (PU) were taken in two sessions, on the day of splint removal (session I), and 12 weeks after splint removal (session II). The ability of session II-related PBF measurements at 2.9, 6.4 and 9.9 PU levels to identify adverse outcomes occurring 36 weeks after splint removal was investigated. Adverse outcomes were classified as type I (loss of sensitivity), type II (periapical radiolucency), type III (grey discolouration), type IV (loss of sensitivity and periapical radiolucency), and type V (loss of sensitivity, periapical radiolucency and grey discolouration of crown). Receiver-operator characteristic (ROC) curves were used to evaluate the sensitivity and specificity of PBF assessments. There was a significant increase in PBF values from session I to session II (P=0.0001) for teeth without an adverse outcome, while teeth affected by a type II-V outcome showed a significant decrease in PBF values (P <0.05). PBF measurements did not change over time for the contralateral incisors (P >0.05). A type IV and V outcome occurred in 21 and 24% of the instances, respectively. The PBF of 2.9 PU demonstrated a sensitivity of 70% and a specificity of 93% for type V outcomes. The best likelihood ratio was found for the PBF 2.9 PU level and incisors associated with a type V outcome. The data suggest that the LDF test to be a valuable diagnostic adjunct for luxated teeth showing signs of adverse outcomes including grey discolouration or a combination of other signs. However, it may also become necessary to apply clinical decision-making methods in order to correctly evaluate the value of information gathered. The clinical implication is that LDF may become useful in the prediction of adverse outcomes at a much earlier time period than may be accomplished by standard sensitivity tests.

Adolescent↗

PubMed1998

What do health authorities think of population based health outcome indicators?

OBJECTIVES: To determine the role of population based indicators of health outcome in local health outcome assessments; the constraints of using such indicators; how they could be made more useful; and whether health authorities had developed their own indicators of health outcome. DESIGN: A structured telephone interview with representatives of 91 of the 100 English health authorities. RESULTS: Interviewees, asked to give details on two clinical areas in which population health outcome assessments had been of most value, nominated 147 examples in over 30 clinical areas. They chose 50 (34%) of the examples because of an outlying national indicator, and 20 (14%) because of local variations in a national indicator. The main perceived constraints in the use of population based indicators of health outcome were: data validity and timeliness; the attributability of these health outcomes to the quality of health care; the difficulties of changing clinical behavior; and organisational change within health authorities. To make these indicators more useful interviewees wanted an increased use of process indicators as proxies for health outcome, indicator trend data, and indicator comparisons of districts with similar population structures. Some recent publications have started to consider some of these issues. 27 (30%) health authorities had developed their own indicators, mostly provider based process indicators. 10 of these used their own indicators to manage the performance of local provider units. CONCLUSIONS: Population based indicators of health outcome had an important role in prompting districts to undertake population health outcome assessments. Health authorities also used these indicators to examine local variations in health outcome. They helped to highlight areas for further investigation, initiated data validation, and enabled the monitoring of changes to services. Comparative population based indicators of health outcome may have an increasing part to play in assessing the performance of health authorities.

Community Health Planning↗

PubMed2001

Can we predict poor outcome at presentation in patients with lobar hemorrhage?

OBJECTIVE: Supratentorial lobar hemorrhage can be devastating. Outcome prediction at presentation is important in triage and management decisions as well as appropriate resource utilization. We performed a decision tree analysis combining clinical and CT scan features to predict poor and hopeless outcome at initial presentation in patients with lobar hemorrhage. METHODS: We analyzed 81 patients with spontaneous lobar hemorrhage presenting within 48 hours of initial neurologic symptoms. In the first analysis, poor outcome was defined as Glasgow outcome score (GOS) of 1 (death), 2 (vegetative state) or 3 (dependence) at discharge. A second analysis was based on worst possible outcome (GOS 1-2). Binary recursive partitioning was fitted in a model, and odds ratios with 95% confidence intervals (CI) were calculated. RESULTS: Lobes involved were temporal (36%), parietal (33%), frontal (25%) and occipital (6%). Seventy-three percent of patients presented less than 17 h after initial ictus. The probability of poor outcome was 97% (CI 85-100%) in patients with hemorrhage greater than 40 cm(3). In the subset of patients with a volume less than 40 cm(3), time interval from ictus to presentation (< 17 h) together with a Glasgow coma score (GCS) less than or equal to 13 predicted poor outcome. Eighty-five percent (CI 42-99%) of those presenting early with GCS less than or equal to 13 had a poor outcome. In the second analysis, all patients with GCS less than or equal to 12 and septum pellucidum shift > 6 mm had GOS of 1 or 2 (CI 72-100%). CONCLUSION: Poor outcome in patients with lobar hemorrhage is associated with a hemorrhage size of more than 40 cm(3), GCS less than or equal to 13, but also dependent on time interval between ictus and presentation. This is consistent with prior studies demonstrating deterioration from enlargement may occur when patients present early on. Stupor and septum pellucidum shift greater than 6 mm on CT scan at presentation predict a hopeless outcome in conservatively treated patients. Ninety-one percent of patients were treated medically, thus these outcomes are largely a reflection of the natural history of spontaneous lobar hemorrhage. These signs may influence triage and management decisions.

Adolescent↗

PubMed1996

Angioscopic predictors of early adverse outcome after coronary angioplasty in patients with unstable angina and non-Q-wave myocardial infarction.

BACKGROUND: Clinical and angiographic criteria have a limited ability to predict adverse outcome in patients with unstable angina who are undergoing percutaneous transluminal coronary angioplasty (PTCA). We investigated whether the use of angioscopy can improve prediction of early adverse outcome after PTCA. METHODS AND RESULTS: Angioscopic characterization of the culprit lesion was performed before PTCA in 32 patients with unstable angina and 10 with non-Q-wave infarction. Seven patients (17%) had an adverse outcome (myocardial infarction, repeat PTCA, or need for coronary artery bypass graft surgery) within 24 hours after PTCA. Six of 18 patients with a yellow culprit lesion had an adverse outcome compared with 1 of 24 in whom the culprit lesion was white (P = .03). Six of 20 patients with plaque disruption suffered an adverse outcome compared with 1 of 22 with nondisrupted plaques (P = .04). Six of 17 patients with intraluminal thrombus had an adverse outcome, whereas only 1 of 25 patients without thrombus suffered an adverse outcome (P = .01). Yellow color, disruption, and thrombus at the culprit lesion site were associated with an eightfold increase in risk of adverse outcome after PTCA. The prediction of PTCA outcome based on characteristics of the plaque that were identifiable by angioscopy was superior to that estimated by the use of angiographic variables. CONCLUSIONS: In patients with unstable angina and non-Q-wave infarction, angioscopic features of disruption, yellow color, or thrombus at the culprit lesion site can identify patients at high risk of early adverse outcome after PTCA. Angioscopy was superior to angiography for prediction of PTCA outcome.

Adult↗

PubMed1996

Use of a global test for multiple outcomes in stroke trials with application to the National Institute of Neurological Disorders and Stroke t-PA Stroke Trial.

BACKGROUND: The National Institute of Neurological Disorders and Stroke (NINDS) held a workshop on statistical approaches to analysis of acute stroke trials that have multiple pre-specified outcomes. An objective was to plan for statistical analysis of the NINDS t-PA Stroke Trial, a randomized, double-blind, placebo-controlled trial of recombinant tissue plasminogen activator (rt-PA) for patients with acute ischemic stroke. Treatment success was defined as a "consistent and persuasive difference" in the proportion of patients achieving favorable outcomes on the Barthel Index, Modified Rankin Scale, Glasgow Outcome Scale, and National Institutes of Health Stroke Scale. The Data and Safety Monitoring Committee for the trial recommended this outcome because the committee did not believe that a positive result for a single outcome would provide sufficient evidence of efficacy. SUMMARY OF COMMENT: Workshop participants accepted the global test as a viable approach to testing the primary trial hypothesis. Clinician participants advocated categorizing outcomes as favorable/unfavorable, outcomes more clinically meaningful than continuous outcomes for evaluating a drug with potentially serious side effects. They agreed that a global test was appropriate for ischemic stroke when no single outcome is accepted. Hypothetical, special-case examples illustrate that highly correlated outcomes diminish the power of the global test. NINDS t-PA Stroke Trial data demonstrate the clinical interpretability of the global test. CONCLUSIONS: Workshop participants concluded that a global statistic should be used to test the trial's primary hypothesis accompanied by secondary tests of individual outcomes. Workshop participants recommended familiarizing the clinical/scientific community with the global approach.

Acute Disease↗

PubMed2001

Therapist reporting of suspected child abuse and maltreatment: factors associated with outcome.

Several studies have found that making a report of suspected child abuse or maltreatment concerning a client in psychotherapy is more likely to have a positive outcome for the relationship or to effect no change, than to be damaging. The current study examined factors that were associated with outcome. Three variables, all of which concerned the client-therapist relationship, were found to be important for outcome. The quality of the relationship before the report made the greatest contribution to predicting outcome, with stronger alliances associated with positive outcome. Also important is the length of time in treatment, with longer periods of time related to positive outcome. In addition, more effective handling of making the report is related to positive outcome in that it differentiated improved from no-change groups. Lastly, statistical trends were found both for a relationship between therapist comfort in reporting and positive outcome, and for families tending to have more negative outcomes than adults in individual treatment or children. This is the first time that the examination of factors related to outcome was based upon information received from mental health professionals who were confirmed by CPS as reporters of suspected child abuse and maltreatment. Findings from this and related studies should be incorporated into training programs to ease concerns about the effects of reporting on the psychotherapy relationship and to offer guidance about factors that could increase positive outcomes. Such training could provide needed information to practitioners in reporting situations and enable more complete reporting.

Adult↗

PubMed1999

Predicting outcome of inpatient detoxification of substance abusers.

OBJECTIVE: Variables that have been identified as predictors of outcome of substance abuse treatment--coping style, addiction severity and addiction-related problems, psychopathology, and treatment motivation--were examined as predictors of outcome of inpatient detoxification. METHODS: A cohort of 175 drug abuse patients consecutively admitted to an inpatient detoxification clinic in the Netherlands were assessed. Baseline data were obtained on psychopathology using the Symptom Checklist-90, on severity and addiction-related problems using the Addiction Severity Index (ASI), on personal coping style using the Utrecht Coping List, on motivation using the CMRS scales, and on sociodemographic background. Positive detoxification outcome was defined as transfer to inpatient rehabilitation treatment. RESULTS: Of the 175 admissions, 81 (46 percent) had a positive outcome, and 94 (54 percent) had a negative outcome. Severe drug use and severe medical problems, as measured by the ASI, were the best predictors of a negative outcome of detoxification. Self-rated suitability of postdetoxification treatment was also a predictor of positive outcome, although to a lesser degree than the ASI variables. Established predictors of residential drug abuse treatment outcome, such as psychopathology, coping style, and sociodemographic variables, did not predict outcome of detoxification. CONCLUSIONS: Caution is necessary when applying results of inpatient treatment outcome studies to inpatient detoxification programs. Different factors may play a role in the outcome of detoxification. To improve the rate at which patients in detoxification programs are transferred to longer-term rehabilitation, more attention should be paid to medical conditions and to the direct consequences of drug use, such as withdrawal symptoms and craving during detoxification.

Adaptation, Psychological↗

PubMed2006

MR diffusion-weighted imaging and outcome prediction after ischemic stroke.

BACKGROUND: MR diffusion-weighted imaging (DWI) shows acute ischemic lesions early after stroke so it might improve outcome prediction and reduce sample sizes in stroke treatment trials. Previous studies of DWI and outcome produced conflicting results. OBJECTIVE: To determine whether DWI lesion characteristics independently predict outcome in a broad range of patients with acute stroke. METHODS: The authors recruited hospital-admitted patients with all severities of suspected stroke, assessed stroke severity on the NIH Stroke Scale (NIHSS), performed early brain DWI, and assessed outcome at 3 months (modified Rankin Scale). Clinical data and DWI lesion parameters were evaluated in a logistic regression model to identify independent predictors of outcome at 3 months and a previously described "Three-Item Scale" (including DWI) was tested for outcome prediction. RESULTS: Among 82 patients (mean NIHSS 7.1 [+/-6.3 SD]), the only independent outcome predictors were age and stroke severity. Neither DWI lesion volume nor apparent diffusion coefficient nor the previously described Three-Item Scale predicted outcome independently. Comparison with previous studies suggested that DWI may predict outcome only in patients with more severe cortical ischemic strokes. CONCLUSIONS: Across a broad range of stroke severities, diffusion-weighted imaging (DWI) did not predict outcome beyond that of key clinical variables. Thus, DWI is unlikely to reduce sample sizes in acute stroke trials assessing functional outcome, especially where estimated treatment effects are modest.

Acute Disease↗

PubMed2005

Factors associated with neurological outcome and lesion progression in traumatic subarachnoid hemorrhage patients.

OBJECTIVE: Traumatic subarachnoid hemorrhage (tSAH) is a frequent finding after closed-head injuries, and its presence is a powerful factor associated with poor outcome. The exact mechanism linking tSAH and an adverse outcome is poorly understood. The aim of this study was to identify the factors that may predict outcomes and changes in the computed tomographic (CT) scans of lesions in a selected population of tSAH patients. METHODS: We evaluated 141 patients admitted consecutively from January 1, 1997, to January 31, 1999, with a CT diagnosis of tSAH. The admission and "worst" CT scans were recorded. CT scan changes were reported as "significant CT progression" (changes in the Marshall classification) or "any CT progression." The amount of subarachnoid blood was recorded using a modified Fisher classification. Outcome was assessed at 6 months after injury with the Glasgow Outcome Scale. RESULTS: Twenty-eight patients (19.9%) had an unfavorable Glasgow Outcome Scale outcome. In the univariate analysis, prognosis was significantly related to age, admission Glasgow Coma Scale score, Marshall CT classification score at admission and on the worst CT scan, amount of tSAH, and volume of the associated brain contusions. From multivariate analysis, the only factors independently related to outcome were the Glasgow Coma Scale score (P < 0.01) and size of the tSAH at admission (P < 0.001). Thirty-four patients (24.1%) had significant CT lesion progression, and 66 patients (46.8%) had some lesion progression. Patients having significant progression of the lesion had a higher risk of an unfavorable outcome (32 versus 10%; P = 0.004). Unadjusted factors predicting CT progression were the Glasgow Coma Scale score at admission, the Marshall classification at admission, the amount of subarachnoid blood, and the presence or volume of associated brain contusions at admission. Independent factors associated with significant CT progression were the amount of tSAH (P < 0.001) and the presence or volume of brain contusions at admission (P < 0.001). CONCLUSION: The outcome of patients with tSAH at admission is related in a logistic regression analysis to the admission Glasgow Coma Scale score and to the amount of subarachnoid blood. These patients also have a significant risk of CT progression. The amount of subarachnoid blood and the presence of associated parenchymal damage are powerful independent factors associated with CT progression, thus linking poor outcomes and CT changes.

Aged↗