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PubMed2006

Proposal of a new staging and grading system of the liver for primary biliary cirrhosis.

AIMS: To define a new histological staging and grading system for primary biliary cirrhosis (PBC), to provide more information reflecting clinical laboratory data and the prognosis to hepatologists. METHODS AND RESULTS: First, 17 histological lesions of PBC were scored in 188 needle liver biopsy specimens. Factor analysis yielded three independent groups of factors: factor 1 (fibrosis, fibrous piecemeal necrosis, orcein-positive granules, bile plugs, Mallory bodies, feathery degeneration, bile duct loss and atypical ductular proliferation); factor 2 (portal inflammation, eosinophilic infiltration, lymphoid follicles, epithelioid granulomas, interface hepatitis and chronic cholangitis); and factor 3 (interface hepatitis, lobular hepatitis, acidophilic bodies and pigmented macrophages). The eight findings of factor 1, but not factors 2 and 3, were significantly correlated with clinical laboratory data and scores in the Mayo Clinic's prognostic model. Factor 1 lesions may reflect histological progression (staging), while factor 2 and 3 lesions may relate to necroinflammatory activity (grading). Then, we devised a staging and grading system using three lesions (bile duct loss, fibrosis and orcein-positive granules) from factor 1 and three from factors 2 and 3 (chronic cholangitis, interface hepatitis and lobular hepatitis). CONCLUSION: This new system might provide more pathological information on PBC patients for hepatologists.

Biopsy, Needle↗

PubMed2006

Significant upgrading affects a third of men diagnosed with prostate cancer: predictive nomogram and internal validation.

OBJECTIVE: To explore the rate of significant upgrading from biopsy to radical prostatectomy (RP) specimens in a contemporary cohort, and to develop a prognostic model capable of predicting the probability of significant upgrading, as previous reports indicate that up to 43% of men with low-grade prostate cancer at biopsy will be diagnosed with high-grade cancer at RP. PATIENTS AND METHODS: The study cohort comprised 4789 men (median age 63 years, range 39-82) treated with RP, with available clinical stage, prostate-specific antigen levels, biopsy and RP Gleason sum values. These variables were used as predictors in multivariate logistic regression models (LRMs) addressing the rate of significant Gleason sum upgrading, defined as a Gleason sum increase either from < or = 6 to > or = 7 or from 7 to > or = 8 between the biopsy and RP specimens. Regression coefficients were used to develop and validate (200 bootstrap re-samples) a nomogram predicting significant biopsy Gleason sum upgrading. RESULTS: Significant biopsy Gleason sum upgrading was recorded in 1349 (28.2%) patients. In multivariate LRMs, all predictors were highly significant (all P < 0.001). The bootstrap-corrected accuracy of the nomogram predicting the probability of significant Gleason sum upgrading between biopsy and RP specimens was 75.7%. CONCLUSION: Our nomogram might prove highly useful when the possibility of a more aggressive Gleason variant could change the treatment options.

Adult↗

PubMed2005

Healing diabetic neuropathic foot ulcers: are we getting better?

AIM: To benchmark by year the likelihood that an individual with a diabetic neuropathic foot ulcer will heal over more than a 10-year period. PATIENTS AND METHODS: A cohort study within a multicentre wound care network of individuals with a diabetic neuropathic foot ulcer who were treated by a standard wound care algorithm. The main outcome was a healed wound by the 20th week of care stratified by calendar year. RESULTS: We evaluated 27 193 individuals with a neuropathic foot ulcer. Between 1988 and 1990 approximately 66% of patients did not heal. By 1999 this percentage had decreased to 49%. The change in the rate of failure to heal is very closely associated with an increase over time in the proportion of patients seen with wounds identified as prognostically favourable using a previously published prognostic model (i.e. individuals with wounds < or = 2 cm2, wounds < or = 2 months old, and wounds of grade < or = 2). Nevertheless, even among those most likely to heal, the likelihood of failing to heal went from 62% prior to 1991 to 32% in 2000. CONCLUSIONS: We have shown that individuals with a diabetic neuropathic foot ulcer seeking care are more likely to heal today than 10 years ago. The primary reason for this improvement is that individuals are seeking care when their wounds are most easily treated and these are now more likely to heal.

Adult↗

PubMedDate not supplied

Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool.

OBJECTIVE: To provide clinicians with a brief screening tool to predict accurately which individuals may develop aberrant behaviors when prescribed opioids for chronic pain. DESIGN: One hundred and eighty-five consecutive new patients treated in one pain clinic took the self-administered Opioid Risk Tool (ORT). The ORT measured the following risk factors associated in scientific literature with substance abuse: personal and family history of substance abuse; age; history of preadolescent sexual abuse; and certain psychological diseases. Patients received scores of 0-3 (low risk), 4-7 (moderate risk), or >or= 8 (high risk), indicating the probability of their displaying opioid-related aberrant behaviors. All patients were monitored for aberrant behaviors for 12 months after their initial visits. RESULTS: For those patients with a risk category of low, 17 out of 18 (94.4%) did not display an aberrant behavior. For those patients with a risk category of high, 40 out of 44 (90.9%) did display an aberrant behavior. The authors used the c statistic to validate the ORT, because it simultaneously assesses sensitivity and specificity. The ORT displayed excellent discrimination for both the male (c = 0.82) and the female (c = 0.85) prognostic models. CONCLUSION: In a preliminary study, among patients prescribed opioids for chronic pain, the ORT exhibited a high degree of sensitivity and specificity for determining which individuals are at risk for opioid-related, aberrant behaviors. Further studies in a variety of pain and nonpain settings are needed to determine the ORT's universal applicability.

Adolescent↗

PubMed2000

Decision-making and outcomes of prolonged ICU stays in seriously ill patients.

BACKGROUND: Despite concern about the high costs and the uncertain benefit of prolonged treatment in the intensive care unit (ICU), there has been little research examining decision-making and outcomes for patients with prolonged ICU stays. OBJECTIVES: To evaluate decision-making and outcomes for seriously ill patients with an ICU stay of at least 14 days. DESIGN: A prospective cohort study. SETTING: Five teaching hospitals. PARTICIPANTS: Seriously ill patients enrolled in the Study To Understand Prognoses and Preferences for Risks and Outcomes of Treatments (SUPPORT). MEASUREMENT: Patients, their surrogate decision-makers, and their physicians were interviewed about prognosis, communication, and goals of medical care. Based on age, diagnoses, comorbid illnesses, and acute physiology data, the SUPPORT Prognostic Model provided estimates of 6-month survival on study days 1, 3, 7, and 14. Hospital costs were estimated from hospital billing data. RESULTS: Of the 9105 patients enrolled in SUPPORT, 1494 (16%) had ICU stays of 14 days or longer. The median length of stay in an ICU was 4 days for the entire SUPPORT cohort and 35 days for patients who were treated in an ICU for 14 days or longer. Median hospital costs were $76,501 for patients who had ICU stays 14 days or longer and $10,916 for patients who did not have long ICU stays. Fifty-five percent of patients with long ICU stays had died by 6 months, and an additional 19% had substantial functional impairment. Among patients with ICU stays of at least 14 days, only 20% had estimates of 6-month survival that fell below 10% at any time during their hospitalization. For patients with long ICU stays, the mean predicted probability of 6-month survival was 0.46 on study Day 3 and 0.47 on study Day 14. Fewer than 40% of patients (or their surrogates) reported that their physicians had talked with them about their prognoses or preferences for life-sustaining treatment. Among the patients who preferred a palliative approach to care, only 29% thought that their care was consistent with that aim. Those who discussed their preferences for care with a physician were 1.9 times more likely to believe that treatment was in accord with their preferences for palliation (95% CI, 1.4-2.5) CONCLUSIONS: Prolonged ICU stays were expensive and were often followed by death or disability. Patients reported low rates of discussions with their physicians about their prognoses and preferences for life-sustaining treatments. Many preferred that care focus on palliation and believed that care was inconsistent with their preferences. Patients were more likely to receive care consistent with their preferences if they had discussed their care preferences with their physicians.

Activities of Daily Living↗

PubMed2000

Living and dying with chronic obstructive pulmonary disease.

OBJECTIVE: To characterize chronic obstructive pulmonary disease (COPD) over patients' last 6 months of life. STUDY DESIGN: A retrospective analysis of a prospective cohort from the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT). SETTING: Hospitalization for exacerbation of COPD at five US teaching hospitals. PARTICIPANTS: COPD patients who died within 1 year (n = 416) among 1016 enrolled. METHODS: Interview and medical record data were organized into time windows beginning with death and ending 6 months earlier. OUTCOME MEASURES: Days in hospital, prognosis, illness severity, function, symptoms, patients' preferences, and impacts on families. RESULTS: One-year survival was 59%, 39% had > or = 3 comorbidities, and 15 to 25% of the patients' last 6 months were in hospitals. Exacerbation etiologies included respiratory infection (47%) and cardiac problems (30%). Better quality of life predicted longer survival (ARR: 0.36; 95% CI, 0.19-0.87) as did heart failure etiology of exacerbation (ARR: 0.57; CI, 0.40, 0.82). Estimates of survival by physicians and by prognostic model were well calibrated, although patients with the worst prognoses survived longer than predicted. Patients' estimates of prognosis were poorly calibrated. One-quarter of patients had serious pain throughout, and two-thirds had serious dyspnea. Patients' illnesses had a major impact on more than 25% of families. Patients' preferences for Do-Not-Resuscitate orders increased from 40% at 3 to 6 months before death to 77% within 1 month of death; their decisions not to use mechanical ventilation increased from 12 to 31%, and their preferences for resuscitation decreased from 52 to 23%. CONCLUSIONS: Patients with advanced COPD often die within 1 year and have substantial comorbidities and symptoms. Adequate description anchors improved care.

Aged↗

PubMed2005

Disease progression: identification of high-risk groups and individuals for periodontitis.

AIMS: While the role of bacteria in the initiation of periodontitis is primary, a range of host-related factors influence the onset, clinical presentation and rate of progression of disease. The objectives of this review are (1) to present evidence for individual predictive factors associated with a patient's susceptibility to progression of periodontitis and (2) to describe the use of prognostic models aimed at identifying high-risk groups and individuals in a clinical setting. METHODS: Relevant publications in the English language were identified after Medline and PubMed database searches. Because of a paucity of longitudinal studies investigating factors including clinical, demographic, environmental, behavioural, psychosocial, genetic, systemic and microbiologic parameters to identify individuals at risk for disease progression, some association studies were also included in this review. FINDINGS AND CONCLUSIONS: Cigarette smoking is a strong predictor of progressive periodontitis, the effect of which is dose related. High levels of specific bacteria have been predictive of progressive periodontitis in some studies but not all. Diabetics with poor glycaemic control have an increased risk for progression of periodontitis. The evidence for the effect of a number of putative factors including interleukin-1 genotype, osteoporosis and psychosocial factors is inconclusive and requires further investigation in prospective longitudinal studies. Specific and sensitive diagnostic tests for the identification of individuals susceptible to disease progression are not yet a reality. While factors assessed independently may not be valuable in predicting risk of future attachment loss, the combination of factors in a multifactorial model may be useful in identifying individuals at risk for disease progression. A number of multifactorial models for risk assessment, at a subject level have been developed but require validation in prospective longitudinal studies.

Alcohol Drinking↗

PubMed2003

A systematic review of physicians' survival predictions in terminally ill cancer patients.

OBJECTIVE: To systematically review the accuracy of physicians' clinical predictions of survival in terminally ill cancer patients. DATA SOURCES: Cochrane Library, Medline (1996-2000), Embase, Current Contents, and Cancerlit databases as well as hand searching. STUDY SELECTION: Studies were included if a physician's temporal clinical prediction of survival (CPS) and the actual survival (AS) for terminally ill cancer patients were available for statistical analysis. Study quality was assessed by using a critical appraisal tool produced by the local health authority. DATA SYNTHESIS: Raw data were pooled and analysed with regression and other multivariate techniques. RESULTS: 17 published studies were identified; 12 met the inclusion criteria, and 8 were evaluable, providing 1563 individual prediction-survival dyads. CPS was generally overoptimistic (median CPS 42 days, median AS 29 days); it was correct to within one week in 25% of cases and overestimated survival by at least four weeks in 27%. The longer the CPS the greater the variability in AS. Although agreement between CPS and AS was poor (weighted kappa 0.36), the two were highly significantly associated after log transformation (Spearman rank correlation 0.60, P < 0.001). Consideration of performance status, symptoms, and use of steroids improved the accuracy of the CPS, although the additional value was small. Heterogeneity of the studies' results precluded a comprehensive meta-analysis. CONCLUSIONS: Although clinicians consistently overestimate survival, their predictions are highly correlated with actual survival; the predictions have discriminatory ability even if they are miscalibrated. Clinicians caring for patients with terminal cancer need to be aware of their tendency to overestimate survival, as it may affect patients' prospects for achieving a good death. Accurate prognostication models incorporating clinical prediction of survival are needed.

Analysis of Variance↗

PubMed1993

DNA densitometry of colorectal cancer.

DNA analysis was assessed by densitometry for 281 cases of colorectal adenocarcinoma. Detection of aneuploidy in a single case rose from 65% if one, to 92.5% when three or more sections, were analysed. Although aneuploid tumours had significantly larger nuclear areas than near diploid tumours (p = 0.009), densitometric measurements showed no association with clinicopathological variables. DNA content determined by densitometry was compared with that from flow cytometry on 465 tissue sections from 241 cases. Aneuploidy assessed by flow cytometry was significantly associated with that determined by densitometry (p < 0.01 for all comparisons), ploidy state being similar in 381 sections (82%, kappa = 0.63, p < 0.001), and 187 cases (77.6%, kappa = 0.57, p < 0.001). Univariate survival analysis showed that DNA densitometric variables had no significant association with survival in (a) all cases, (b) cases without lymph node metastases, or (c) cases without distant metastases. Multivariate regression analysis of densitometric and clinicopathological variables identified Dukes's stage, patient age, and tumour differentiation as the combination of variables most closely related to survival. Densitometric measurement of DNA content could not significantly improve on the prognostic model containing these three variables. It is concluded that, although the assessment of DNA content by densitometry is comparable with that of flow cytometry, conventional histological variables remain the best predictors of prognosis in colorectal cancer.

Adenocarcinoma↗

PubMed1986

Lymphocytic infiltration and survival in rectal cancer.

Lymphocytic infiltration was assessed semiquantitatively in 447 specimens of rectal cancer. Corrected five year survivals for pronounced, moderate, and little lymphocytic infiltration were 92%, 65% and 36%, respectively. Grading was shown to be reproducible in an intraobserver study (observed agreement 81%, expected agreement 34%, kappa coefficient 0.72). In the multivariate survival analysis of grade and stage related variables lymphocytic infiltration was the only grade related variable to be accepted within the prognostic model. This model also included the number of lymph node metastases and the extent of tumour spread. It is suggested that the conservation of the normal interactive traffic between epithelium and mucosa associated lymphoid tissue (MALT) signals a low grade growth. This is supported by the association between lymphocytic infiltration and the expression of secretory component by malignant epithelium.

Humans↗

PubMed1998

Application of the MRC brain tumour prognostic index to patients with malignant glioma not managed in randomised control trial.

OBJECTIVES: The MRC brain tumour prognostic index, which uses clinical variables to place patients in different outcome categories, has not been evaluated on a cohort outside a randomised controlled trial. The aims of this study were to (a) determine in a large cohort of patients, derived solely from one centre and not in a clinical trial, whether the MRC prognostic index stratified patients for outcome; (b) compare actual outcomes with those obtained in the original studies; and (c) examine whether neuropathological diagnosis was an independent prognostic variable. METHODS: The MRC prognostic index was calculated for 236 patients with either glioblastoma or anaplastic astrocytoma managed at a dedicated neuro-oncology clinic in Edinburgh between 1989 and 1995. RESULTS: For this mixed population of malignant glioma the median survival was 8.6 months. Two year survival was 72.2% for patients with an MRC index score of 1-10; 36.3% for those with an index score of 11-15; 25.1% for those scoring 16-20; 20.4% with those scoring 21-25; 4.8% with those scoring 26-33; and 0% for those scoring 34-38. Exclusion of 79 patients who would not have been eligible for the MRC studies from which the index was derived, because they were either too old or did not receive radiotherapy, still resulted in a similar pattern of stratification but with significantly improved median survival times for the lowest two categories. Multivariate analysis of prognostic variables in the Edinburgh cohort showed that patients with anaplastic astrocytoma did significantly better than those with glioblastoma (p<0.001). CONCLUSIONS: Although there were some differences in median survival times between the patients in the original MRC studies and the Edinburgh cohort in similar prognostic categories and a tendency to improved two year survivorship in the Edinburgh cohort these differences have arisen because (a) the Edinburgh cohort was accrued about 10 years later than the study has shown that even outside the setting of a prospective controlled trial and with relaxed inclusion criteria the Medical Research Council (MRC) prognostic index is a robust predictor of outcome in patients with malignant glioma. Survival clearly declines as the prognostic index increases. Moreover, the prognostic model can be substantially improved by the addition of histology data, although there is some evidence that this will require complex modelling procedures.

Adult↗

PubMed1999

Adding insult to injury: the prognostic value of early secondary insults for survival after traumatic brain injury.

OBJECTIVES: To assess the prognostic value of summary measures of secondary physiological insult in addition to baseline clinical variables for patients with traumatic brain injury. METHODS: A series of 110 patients with traumatic brain injury had data on intracranial pressure (ICP), arterial blood pressure (ABP), cerebral perfusion pressure (CPP), arterial O2 saturation (SaO2), temperature in degrees C (Temp), and heart rate in beats/min (HRT) monitored and recorded every minute. Secondary insults were defined according to the Edinburgh University secondary insult grading system. The prognostic value of summary measures of these secondary insults was assessed by adding them to a prognostic model for survival at 1 year after controlling for baseline clinical variables using a previously validated model. RESULTS: Of the eight secondary insults measured, only ICP added significantly to the prediction of survival in the first 72 hours after injury. The particular type of summary measure did not seem to influence the results. After the addition of ICP to the model, none of the other secondary insult measures could improve the predictive power of the model significantly. CONCLUSIONS: Early intracranial hypertension is confirmed as a sign of poor prognosis in patients with traumatic brain injury, even after controlling for baseline clinical variables. The value or otherwise of treating such secondary insults, however, can only be definitively established in the context of prospective randomised controlled trials. The specific pathophysiological evolution of secondary insults is still the subject of much research, and a clear understanding will be necessary before the development of specific treatments is feasible.

Adult↗

PubMed2004

Sources of variability in uncertain medical decisions in the ICU: a process tracing study.

BACKGROUND: Consistency of medical decision making (equity) is an important component of quality of care. When patients with chronic obstructive pulmonary disease (COPD) present with an exacerbation needing respiratory support they may die if it is not provided. However, if the disease has reached its terminal stage, ventilation will prolong the process of dying. The ventilation outcome is uncertain and there is evidence of variability when this decision is made, the sources of which are not well understood. OBJECTIVES: To identify sources of variability and propose ways of tackling them in order to promote equity in this type of medical decision. METHODS: Six case histories were selected from hospital records of COPD patients. Fourteen senior doctors from seven hospitals in the West Midlands participated. A process tracing approach was used which consisted of (1) withholding case information until specifically requested by the doctors, (2) estimating survival during the decision making process, and (3) concurrent questioning regarding information interpretation and its impact on survival estimates and decisions. RESULTS: The observed decision variability was attributed to doctors attaching importance to different information, gathering different information, and interpreting information differently. There were significant differences between doctors in the amount of information requested. CONCLUSIONS: Differences in information gathering and interpretation by clinicians can result in different decisions being made about the same patient. This variation may exist for other uncertain medical decisions and may be tackled by providing clinicians with prognostic models in the form of usable decision aids.

Aged↗

PubMed2005

Obesity, weight gain, and risk of biochemical failure among prostate cancer patients following prostatectomy.

PURPOSE: Several lines of evidence suggest that diet and weight gain may be important environmental factors implicated in prostate carcinogenesis, especially in tumor progression. The purpose of this study was to evaluate obesity at different ages in a well-characterized cohort of prostate cancer patients treated with prostatectomy and to develop a prognostic model that incorporates body mass index (BMI) as a measure of obesity. EXPERIMENTAL DESIGN: We carried out a prospective study of 526 patients registered at the M.D. Anderson Cancer Center from 1992 to 2001. Kaplan-Meier and Cox proportional hazard analyses were done. RESULTS: During an average follow-up of 54 months, 97 (18%) post-prostatectomy patients experienced biochemical failure. Patients who were obese (BMI > or = 30 kg/m2) at diagnosis had a higher rate of biochemical failure than nonobese men (P = 0.07). Those obese at 40 years had an even greater rate of biochemical failure (P = 0.001). Higher BMI at diagnosis [hazard ratio (HR), 1.07; P = 0.01] and Gleason score = 7(4 + 3) and > or =8 (HR, 3.9; P = 0.03 and HR, 10.0; P < or = 0.001, respectively) remained significant independent predictors of biochemical failure in multivariate analysis. Men who gained weight at the greatest rate (>1.5 kg/y) between 25 years and diagnosis progressed significantly sooner (mean time, 17 months) than those who exhibited a slower weight gain (mean time, 39 months; P(trend) = 0.005). The inclusion of obesity to the clinical nomogram improved performance. CONCLUSIONS: Our findings validate the importance for a role of obesity in prostate cancer progression and suggest a link to the biological basis of prostate cancer progression that can be therapeutically exploited.

Adult↗

PubMed2006

Reduced expression of CAMTA1 correlates with adverse outcome in neuroblastoma patients.

PURPOSE: A distal portion of 1p is frequently deleted in human neuroblastomas, and it is generally assumed that this region harbors at least one gene relevant for neuroblastoma development. A 1p36.3 commonly deleted region, bordered by D1S2731 and D1S214 has been defined. The present study surveys whether expression of genes mapping to this region is associated with tumor behavior. EXPERIMENTAL DESIGN: Candidate genes localized within the deleted region were identified by sequence data analysis. Their expression was assessed in a cohort of 49 primary neuroblastomas using cDNA microarray analysis. Gene expression patterns associated with known prognostic markers and patient outcome were further evaluated by quantitative real-time reverse transcription-PCR in a cohort of 102 neuroblastomas. RESULTS: The commonly deleted region spans 261 kb and encompasses two genes, FLJ10737 and CAMTA1. We found no evidence for an association of FLJ10737 expression with established prognostic variables or outcome. In contrast, low CAMTA1 expression characterized tumors with 1p deletion, MYCN amplification, and advanced tumor stages 3 and 4. Moreover, low CAMTA1 expression was significantly associated with poor outcome (P < 0.001). In multivariate analysis of event-free survival, the prognostic information of low CAMTA1 expression was independent of 1p status, MYCN status, tumor stage, and age of the patient at diagnosis (hazard ratio, 3.52; 95% confidence interval, 1.21-10.28; P = 0.02). CONCLUSIONS: Our data suggest that assessment of CAMTA1 expression may improve the prognostic models for neuroblastoma and that it will be important to define the biological function of CAMTA1 in this disease.

Age Factors↗

PubMed2003

Motor evoked potentials in predicting recovery from upper extremity paralysis after acute stroke.

OBJECTIVE: The use of motor evoked potentials (MEPs) in predicting recovery after stroke still appears to be somehow equivocal. We assessed the prognostic value of MEPs with respect to arm and hand motor recovery in acute stroke patients. METHODS: This cohort study included 43 consecutive acute stroke patients with complete paralysis of the upper extremity. MEPs of the abductor digiti minimi muscle (ADM) and the biceps brachii muscle (BB) were obtained within 10 days after stroke onset. The upper limb subset of the Fugl-Meyer Motor Assessment was used to evaluate the motor performance at regular intervals until 6 months after stroke. RESULTS: The follow-up was complete in 40 patients (2 patients died and 1 patient had a recurrent stroke); 14 patients showed motor recovery of the arm and their mean 26-week arm motor score was 17.93 (range 3-30, SD 11.68); hand motor recovery occurred in 11 patients and their mean 26-week hand motor score was 11.09 (range 4-14, SD 4.10). Stepwise logistic regression revealed prognostic models for both arm and hand motor recovery based on BB MEPs (odds ratio 7.69, confidence interval, CI, 1.16-50.95) and ADM MEPs (odds ratio 16.20, CI 2.51-104.40), respectively. CONCLUSIONS: The predictive significance of MEPs with respect to motor recovery of the upper extremity was obvious in our homogeneous sample of patients. This agrees with the paradigm that motor recovery after infarction is strongly dependent on a critical residual sparing of the corticospinal function. In this context, the test properties of MEPs in predicting motor recovery are discussed. The added value of MEPs with respect to motor recovery of the upper extremity should be regarded as established for patients with initial paralysis, especially since clinical examination alone lacks the possibility to detect the potential for motor recovery in these cases.

Adolescent↗

PubMed2006

Improving patient selection for clinical acute stroke trials.

OBJECTIVE: To optimize patient inclusion criteria for clinical acute stroke trials. METHODS: We stratified probabilities of death and complete recovery based on two validated prognostic models using age and the National Institutes of Health Stroke Scale (NIH-SS) at admission. In an independent data set of 1,725 consecutively admitted patients with acute ischemic stroke, computer simulation with various inclusion thresholds was used to calculate the number and percentage of potential treatment responders, i.e. who had not died or spontaneously recovered. RESULTS: Using defined thresholds for recovery and mortality, inclusion and exclusion criteria could be designed to considerably decrease both trial time and study size compared to a fixed inclusion criterion based on the NIH-SS alone. Other thresholds may allow optimization of either trial time or study size. CONCLUSIONS: The resulting models provide a validated approach for an efficient study inclusion of potential treatment responders based on the Barthel Index 100 days after ischemic stroke. These techniques provide the opportunity for improved stroke trials in terms of enrollment speed, treatment effect size or both.

Adolescent↗

PubMed2002

Health status predicts long-term outcome in outpatients with coronary disease.

BACKGROUND: Although patient-reported health status measures have been used as end points in clinical trials, they are rarely used in other settings. Demonstrating that they independently predict mortality and hospitalizations among outpatients with coronary disease could emphasize their clinical value. METHODS AND RESULTS: This study evaluated the prognostic utility of the Seattle Angina Questionnaire (SAQ), a disease-specific health status measure for patients with coronary artery disease. Patients were enrolled in a prospective cohort study from 6 Veterans Affairs General Internal Medicine Clinics. All patients reporting coronary artery disease who completed a SAQ and had 1 year of follow-up were analyzed (n=5558). SAQ predictor variables were the physical limitation, angina stability, angina frequency, and quality-of-life scores. The primary outcome was 1-year all-cause mortality, and a secondary outcome was hospitalization for acute coronary syndrome (ACS). Lower SAQ scores were associated with increased risks of mortality and ACS admissions. Prognostic models controlling for demographic and clinical characteristics demonstrated significant independent mortality risk with lower SAQ physical limitation scores; odds ratios for mild, moderate, and severe limitation were 1.5, 2.0, and 4.0 versus minimal limitation (P<0.001). Odds ratios for mild, moderate, and severe angina frequency were 0.8, 1.2, and 1.6 (P=0.078). The odds ratios for ACS admission among those with mild, moderate, and severe angina frequency were 1.4, 2.0, and 2.2, respectively (P=0.016). CONCLUSIONS: SAQ scores are independently associated with 1-year mortality and ACS among outpatients with coronary disease and may serve a valuable role in the risk stratification of such patients.

Aged↗