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Biomedical subjects

M E Charlson

Publications and source records attributed to M E Charlson.

At least 73 records · Page 4Linked to original sources

Medical patients at high risk for catastrophic deterioration.

The objective of this study was to develop criteria to demarcate patients at risk for catastrophic deterioration (arrest or major decompensation) and those likely to require intensive care. From an inception cohort of patients admitted to the medical service, 544 patients were evaluated prospectively for severity of illness and stability by the admitting residents; the course of patients was reviewed blindly by observers. Patients admitted with acute dyspnea, particularly those with chronic pulmonary disease, were at a significantly greater (p less than .01) risk of arrest. All but one of the other arrests occurred in patients who were rated unstable on admission and who had further deterioration of pre-existing problems in the hospital (p less than .0001). The deterioration rates were highest among patients rated as unstable, particularly in patients with comorbid disease. Patients who are unstable on admission or who begin to deteriorate due to comorbid disease or the condition leading to admission, should be considered at extremely high risk for subsequent arrest and should be admitted to critical care units for early observation.

Critical Care↗

Utilization of critical care units. A prospective study of physician triage and patient outcome.

To identify patients likely to be admitted to a critical care unit as well as those at high risk of deterioration, we studied all patients admitted to the medical service. Cardiac patients had a high likelihood of unit admission even if they were rated as not ill and stable, whereas ill and unstable noncardiac patients went to the floor. Stable cardiac or noncardiac patients who were not severely ill had very low deterioration and mortality, but unstable, severely ill patients with cardiac or noncardiac reasons for admission had high deterioration rates. If the goal is to admit patients at highest risk, the optimal strategy is to admit unstable, severely ill, and moribund patients in both the cardiac and noncardiac groups. By doing this, it is possible to decrease unit admission of patients likely to do well, increase the admission of patients likely to do poorly, while decreasing the number of patients admitted.

Cardiovascular Diseases↗

Why predictive indexes perform less well in validation studies. Is it magic or methods?

When prognostic indexes have been tested in a second population, they have often performed less well. Since this is believed to be inevitable, methodologic differences that may explain the discrepancies have been overlooked. Data from a prospective study of 232 patients undergoing noncardiac surgery were used to examine the effect of methodologic differences in assembly of population, postoperative surveillance, and the criteria for cardiac complications on the performance of Goldman's cardiac risk index. Our prospective population was used to simulate the methods used in Goldman's study and in three other studies using the risk index to demonstrate the potential impact of differences in population, surveillance, and outcome criteria for cardiac complications. If Goldman's detection and outcome criteria were employed and only the eligibility criteria used for assembly of the populations differed, the overall complication rates would be between 5.2% and 6.9%; and the complication rates for the different Goldman classes were similar. When both different detection strategies and different outcome criteria were used, however, important discrepancies in cardiac complication rates emerged. For example, complication rates in class 2 varied from 2% to 23%. In conclusion, important discrepancies in performance of prognostic indexes may arise from differences in surveillance strategies and definitions of outcome. With sufficient attention to methodologic consistency, the performance of predictive indexes may not inevitably deteriorate in subsequent studies.

Adult↗

Resuscitation: how do we decide? A prospective study of physicians' preferences and the clinical course of hospitalized patients.

Physicians have to address the question of the measures to be employed in the event that a patient's condition deteriorates after admission to the hospital. To identify the information that physicians use in making such decisions, all 604 patients admitted to the medical service during a one-month period were studied. The patient's age and residents' estimates of the patient's long-term prognosis and ability to function were the three primary factors that correlated with intervention preferences. When illness severity, the reason for admission, comorbidity, and poor function were taken into account, mortality and morbidity rates did not differ between patients for whom full vs not-full intervention was favored. Apart from differential rates of admission to critical care units, there were no important differences in the care, course, or mortality of patients for whom less than full intervention was initially favored. Suggestions that physicians should discuss resuscitation with all or most patients who may die are unrealistic. A more prudent strategy is to discuss the issue with patients whose hospital course is marked by a steady deterioration.

Age Factors↗

Standards for the use of ordinal scales in clinical trials.

Ordinal scales are frequently used in clinical trials to quantify outcomes which are non-dimensional. They may be regarded as either single state or transition measures based on whether they assess the outcome at a single point in time or directly examine change which has occurred between two points in time. Each has unique structural and operating characteristics, so that different methodological standards for their construction and utilisation are required. All trials employing ordinal scales published in three leading journals between 1980 and 1984 were examined. For both types of scales the individual ranks must be clearly defined, mutually exclusive, and ordered in a hierarchical progression. Further, both types must be able to detect equally both improvement and deterioration. For this to be ensured with the single state scales the population under study must not be clustered at one extreme of the scale at entry into the trial. With the transition scales internal symmetry must be achieved. Strategies for determining the comparisons to be performed should include emphasis on within patient analysis for crossover trials. Concordance between scale scores and the other measures of outcome employed in the trial must be evaluated. Frequent violations were uncovered in the studies reviewed, and it is hoped that the simple rules outlined will prove useful in the planning and evaluation of future trials.

Classification↗

Closing the clinics: would it close the teaching hospital?

To improve their overall financial position, many teaching hospitals have considered decreasing the size of their clinics. To assess the effect this would have on the inpatient service, the medical ward service of The New York Hospital was studied during the 1981 to 1982 academic year. In 50 percent of hospitalizations, patients were enrolled in the clinic system before admission. In an additional 19 percent of hospitalizations, patients had either been previously seen in the emergency room or hospitalized at this institution, but never seen in a clinic. In the remaining 31 percent of hospitalizations, the patient's admission was the first contact with the institution. This group of "new" patients simply replaced the patients who died (14 percent) or were lost to the system through transfer to chronic-care facilities (11 percent) or referral to community physicians (7 percent). Twenty percent of patients discharged to a clinic were readmitted during the study year as opposed to only 3 percent of patients who were transferred to chronic-care facilities or referred to community physicians. The clinic system is the principal source of referral into the ward service and the most effective mechanism for insuring that a patient needing rehospitalization returns to the hospital. It is concluded that major reduction of clinic size will result in severe contraction of the inpatient service.

Health Facilities↗

Can the Sickness Impact Profile measure change? An example of scale assessment.

The Sickness Impact Profile is a well known measure of functional status which has been validated as a measure of differences in function between patients, but not as a measure of within-patient change. To evaluate its performance as a measure of change, the Sickness Impact Profile was compared to a transition index that directly assesses intra-patient differences in maximal physical and emotional function. With the index, patients rate themselves as much better, slightly better, the same, slightly worse or much worse as compared to a previous assessment. When compared to the corresponding index ratings, Sickness Impact Profile subscale score changes for a rating of worse were of greater magnitude than those for a rating of better. The inherent variability of the Sickness Impact Profile score was estimated using the standard deviation of the score change for the index rating "the same". For patients to be regarded as changed they had to lie outside the probability limits of this score change. Defined in this way, only patients who stated they were worse on the index were detected. Receiver operator characteristic curves were constructed and also demonstrated that deteriorations in function were more accurately detected. Using different score cutoffs, the best true positive rate (71%) was obtained using a one point change on the psychosocial subscale. This was accompanied by a 39% false positive rate. No score value appeared sufficiently accurate to be useful. Its apparent inability to detect improvements and deteriorations equally, and the wide standard deviations for a given change in function, may limit the use of the Sickness Impact Profile for following individuals over time.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Assessing illness severity: does clinical judgment work?

Accurate classification of clinical severity is important for interpreting casemix in clinical studies and for stratifying patients for clinical trials. To evaluate whether clinical judgment might be an effective method of estimating severity, all 604 patients admitted to the medical service in a one month period were rated at the time of admission by the responsible resident as to how sick they were. Within the 13 comorbid disease groups, and within the 15 basic categories of reason for admission, the physicians' severity ratings were the most significant predictor of in-hospital mortality. Death rates rose from 0% in those rated as not ill, to 2% in the mildly ill, to 6% in the moderately ill, to 23% in the severely ill, and to 58% in those rated as moribund (p less than 0.001). Sickness ratings also predicted time to death: mildly ill patients died after prolonged hospitalizations, while the moribund died shortly after admission. The patients' age, sex, race, the number of comorbid diseases or problems did not predict mortality. Patients with serious comorbidity (metastases, AIDS, or cirrhosis) had a higher mortality rate than other patients (p less than 0.001); however, the severity ratings predicted outcomes within this group (p less than 0.001) as well as among those without such serious comorbidity (p less than 0.001). Patients who were admitted with acute neurologic (p less than 0.05) or acute cardiovascular (p less than 0.01) events did have an independently worse prognosis. In conclusion, physicians' estimates or sickness provided an accurate estimate of illness severity, with mortality rates that essentially tripled from one stratum to the next. Clinical judgment may suffice to classify the clinical severity of patients at the time of enrollment in prospective trials and can provide a useful method of controlling for casemix.

Acute Disease↗

Cognitive impairment. Can it predict the course of hospitalized patients?

All patients admitted to three medical services at the New York Hospital during a one-month period were screened with Folstein's Mini-Mental State Examination. The prevalence of cognitive impairment was 19.8% (23 of 116). Cognitively "impaired" patients, ie, those with a Folstein score less than 24, were older, sicker, and less physiologically stable than the cognitively "intact." The in-hospital mortality (17 versus 5%) and morbidity (39 versus 18%) rates were higher for the cognitively "impaired" patients; these differences could be explained by the greater severity of illness, instability, and comorbidity found in these patients. Cognitively "impaired" patients were particularly susceptible to respiratory complications. Cognitively "impaired" patients had longer lengths of hospital stay, spent more time in hospital awaiting placement, and were more likely to be discharged to a nursing home or require home assistance than their cognitively "intact" counterparts. Three-month mortality rates were also higher for the cognitively "impaired" patients (30 versus 15%). These findings suggest that cognitive impairment on admission may be regarded as a marker for patients with poorer prognoses.

Aged↗

A patient-specific measure of change in maximal function.

We designed a short, patient-specific index that measures changes in maximal physical, mental, and emotional function. A baseline component, given at the initial interview, documents the patients' usual activities that require the most physical exertion and mental effort, as well as the patients' ability to cope with stress. A transition component assesses the subsequent change from these patient-specific norms. The index was evaluated in two separate studies involving medical and surgical patients. In the first study, the index was administered twice to 40 patients. Reliability was excellent for all three aspects of function. The transition index had a high degree of internal consistency. In a second study of 43 hospitalized patients, the validity of the index was assessed by comparing its performance with the Sickness Impact Profile; high correlations were found. In addition, the overall patterns of change differed in the expected directions in the medical and surgical groups. This index is unique in its ability to measure change directly, is interpretable in individual patients, and could be easily applied in clinical practice and research.

Activities of Daily Living↗

Reversibility of cognitive impairment in medical inpatients.

To determine outcomes of patients admitted to the hospital with global cognitive impairment and to identify factors that might predict improvement, we screened all medical ward admissions over a one-month period with Folstein's Mini-Mental State Examination. Of 115 patients, 23 (20%) scored less than 24, indicating that they were cognitively impaired. Nineteen patients survived to discharge and were followed up for three months; three additional patients died in this period. Nine (47%) of the 19 patients significantly improved their Mini-Mental State scores. Five (26%) of the 19 improved to normal. They scored better on the initial Mini-Mental State Examination and lower (less dementia) on Blessed's Dementia Rating Scale. Age, severity and stability of medical illness, presence of neurologic abnormalities, clinical course, extensiveness of medical evaluation, and psychiatric criteria for delirium did not predict improvement.

Adult↗

Rate of progression in breast cancer and the disease-free interval.

Patients with breast cancer have been classified as having slow, intermediate, or rapid rates of disease progression through the use of a clinical index, which depends on data from the patient's history. Patients without evidence of adverse progression of disease who waited 4 months or more between their first symptom and treatment were classified as slow; those waiting less than 4 months, intermediate. Patients with evidence of adverse progression were classified as rapid. We evaluated the 616 patients who had no evidence of distant disease at the time of treatment from an inception cohort of 685 patients to assess the correlation between the slow, intermediate, and rapid strata and the disease-free interval. Ten percent were in TNM stage I, 63% in TNM stage II, and 26% in TNM stage III. Among the 43% (266/616) of patients who developed recurrent disease, the median disease-free interval was longest in the slow stratum (33.6 months) and shortest in the rapid stratum (19.5 months). The difference in the 10-year disease-free survival rates in the three strata was significant (chi 2 = 26.4; p less than 0.001). The findings were similar when prognosis was assessed within the TNM stage or nodal groups. For example, in the rapid stratum, node-negative and node-positive patients had almost identical disease-free intervals. The independence of the contribution of the rate of disease progression strata to predicting disease-free survival was confirmed through the Cox analysis. If breast cancer did recur, the manifestation occurred sooner in patients who were demarcated as rapid by the clinical index. Thus the index estimates the aggressiveness of residual disease when it is present.

Breast Neoplasms↗

Delay in the treatment of carcinoma of the breast.

The prognostic impact of pretreatment delays was examined in an inception cohort of patients with carcinoma of the breast. Patients with delays of three months or more had a more advanced clinical stage than those with shorter delays; however, within each stage, prognosis was not affected by delay. Patients with delays of three months or more had a worse over-all prognosis than those with short delays because they had a less favorable distribution by anatomic stage and they had more adverse changes in clinical state. Nonetheless, progression of disease did not invariably occur among patients with longer delays. Patients with long delays, but without adverse changes had an excellent prognosis. The data suggests that carcinoma of the breast does not always progress as a function of time. Estimates were made of the number of patients who would benefit by reducing pretreatment delay. In this cohort, a maximum of 5 per cent of the patients were adversely affected by longer delays. Reducing delay may benefit only a small proportion of women with carcinoma of the breast.

Breast Neoplasms↗

Applying results of randomised trials to clinical practice: impact of losses before randomisation.

The problem of generalisability in randomised clinical trials was highlighted by studies that entered only 10-14% of screened patients. To determine the magnitude and source of prerandomisation losses in clinical trials a survey was conducted of 41 trials listed in the 1979 inventory of the National Institute of Health. Two thirds of the trials maintained screening logs, but only half maintained any records of the number of patients who met the eligibility criteria but were not entered into the trial. Among 21 trials (51%) that kept data on the number of patients who were eligible but not entered, losses of eligible subjects were attributable to refusals by patients in 25% and refusals by physicians in 29%. Other protocol requirements accounted for the remaining losses of eligible patients. Only a few trials documented the characteristics of patients who were eligible but not entered; in those trials the patients who were not entered were similar demographically but differed clinically from those enrolled. Thus minimising prerandomisation losses of eligible patients requires the use of less restrictive criteria for entering patients. Twenty four of the trials achieved 75% or more of their recruitment goals, eight between 25% and 74%, and six less than 25%. Among trials that screened less than twice their projected sample size, only three out of 13 (23%) achieved 75% or more of their recruitment goal. By contrast, 12 out of 16 trials (75%) that screened more than twice their projected sample size achieved 75% or more of their recruitment goal. Screening large numbers of patients appears to be a pragmatic requirement for success in achieving recruitment goals; therefore, trials should not be criticised as lacking generalisability on that basis alone. The number and characteristics of eligible patients who were not entered, however, were documented by only a few trials; these data are critical in the assessment of generalisability. Additionally, the number of patients with the index disease who did not meet the eligibility criteria should also be documented. Together, these two types of data characterise the population to whom the trial results may be applied.

Clinical Trials as Topic↗

Rate of disease progression in breast cancer: a clinical estimate of prognosis within nodal and anatomic stages.

From data obtained in the patient's history, the clinical rate of progression of disease in breast cancer patients can be estimated as slow, intermediate, or rapid. The strata defined by these rates had previously been shown to create prognostic gradients within groups of patients similar in anatomic stage or nodal status. In a second, validating cohort of 465 women with primary breast cancer, the strata delineating rate of disease progression were shown to have a cogent prognostic impact when the proportional hazards model was used to control simultaneously for nodal and anatomic status. In addition, the distinctions persisted when different types of treatment were taken into account. These findings from a multivariate analysis employing the Cox method confirmed the importance of clinical rate of disease progression in estimating prognosis of breast cancer.

Adenocarcinoma↗

The effectiveness of a consultation. Compliance with initial recommendations.

To identify the attributes of an effective consultation, 202 general medicine consultations were analyzed to assess the extent of compliance with the consultant's initial recommendations. The overall compliance rate was 77 percent. Compliance decreased as the number of recommendations increased. The consultant made more recommendations among patients who had more complex and more severe illnesses. Although compliance did increase significantly in severely ill patients (p less than 0.01), with each severity level, compliance was higher when five or fewer recommendations were made. In fact, compliance decreased from 96 percent in severely ill patients with small consultation lists to 79 percent in those with large lists. Compliance was greatest with recommendations involving medications and least with those requiring direct physician and nursing action. Multivariate analysis confirmed that clinical severity of the patients' illnesses and the type and number of recommendations were all predictors of compliance. To promote overall compliance, consultants should limit the total number of recommendations in their initial consultation to five or fewer, focusing on issues central to current patient care. This is especially true in severely ill patients. Since recommendations that must be implemented by physicians or nurses have a lower compliance rate, consultants must carefully follow up those requests.

Age Factors↗

General medicine consultation. Lessons from a clinical service.

The 564 consultations performed by a general medicine consultation service during its first year were analyzed in order to provide a concrete definition of this new academic domain. Of the consultations, 52 percent were for patients on the surgical service. Among these patients, the most common reason for consultation was the preoperative management of chronic illness, specifically, hypertension, diabetes, and angina; 47 percent of such patients had two or more chronic illnesses. The service recommended cancellation of planned surgery in 2 percent and postponement in 9 percent of the 210 patients seen preoperatively. Patients on the psychiatric service accounted for 47 percent of the consultations. In this group, diagnostic issues were the most common reasons for consultation, that is, abdominal pain, dementia, and the suspicion of thyroid disease. Only 12 percent of the patients were seen for prognostic reasons, usually related to the planned use of electroconvulsive therapy or tricyclic antidepressants. The service was evaluated by the referring physicians who rated the service favorably on its "mechanics," as well as on its qualitative performance. However, complaints of triviality were voiced when the average length of the list of recommendations seemed disproportionate to the complexity of the problems. The service was also evaluated by the residents who had provided consultations. From their perspective, the service was more successful in teaching the "art" of consultation than the "science." This experience provides an operational definition of the work facing a general medicine consultation service as well as data useful in focusing future educational programs and research efforts.

Family Practice↗

Rapid growth rate: a method of identifying node-negative breast cancer patients with a high risk of recurrence.

Among node-negative patients with localized breast cancer (TNM stages T1-3 N0-1 M0), the rate of disease progression, classified with a clinical method of assessment, was rapid in 12%. Prognosis was substantially worse in the rapid groups than in patients classified as slow or intermediate. For instance, the 10 yr disease free survival rate was 55 and 50% in the rapid groups compared with 71% in the intermediate and 82% in the slow groups. Additionally, among those who did develop recurrent disease, the disease-free interval was shortest in the most rapid group (10 months) and longest in the slow group (50 months). The distinctive prognostic gradients formed by the growth-rate strata persisted when differences in symptomatic state, histologic type, tumor size, menstrual status, age, and treatment were taken into account through the Cox proportional hazards model. The node-negative patients who were identified as rapid have had a high risk of recurrence, while those with slow growth rates had an excellent prognosis. The index could improve therapeutic efficacy in this subset of patients by identifying high risk patients in whom adjuvant therapies may do more good than harm.

Breast Neoplasms↗