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Biomedical subjects

N M Laird

Publications and source records attributed to N M Laird.

At least 19 recordsLinked to original sources
PubMed1992

Longitudinal studies with continuous responses.

The analysis of serial measurements obtained in longitudinal studies plays an increasingly prominent role in applied research. The last few years have seen the development of many new techniques for carrying out analyses, including computer software. These methods can be used in a variety of standard problems, including repeated measures and cross-over designs, as well as growth curve analyses. We review these new methods, their application, and available computer packages. Data from a longitudinal study of lung function is used to illustrate the methods.

Adolescent↗
PubMed1992

Physicians' perceptions of the risk of being sued.

We explore the deterrent effect of the tort system by assessing physician perceptions of the risk of being sued and the impact of those perceptions on their own practice. The data are from a mailed survey conducted in 1989 of a random sample of physicians who were practicing in New York State in 1984. The survey results were compared to the actual risk of suit using the between-group (Wald) test and logistic regression methods. We also surveyed physicians about practice changes undertaken in the last ten years, factors influencing practice standards, and the costs of being sued and included these in the analysis. On average, physicians estimate that 19.5 out of one hundred of their colleagues will be sued in a given year, approximately three times the actual rate, with significant differences by specialty, location, and suit history. Perceived risk is associated with self-reported changes in test-ordering frequency and reduction in practice scope. The median number of days lost from practice to defend a malpractice suit was three to five, and 6 percent of the physicians surveyed incurred some out-of-pocket expenses. These findings suggest that physicians respond to the messages sent by litigation in a manner consistent with the deterrent theory of tort litigation.

Age Factors↗
PubMed1991

Relation between malpractice claims and adverse events due to negligence. Results of the Harvard Medical Practice Study III.

BACKGROUND AND METHODS: By matching the medical records of a random sample of 31,429 patients hospitalized in New York State in 1984 with statewide data on medical-malpractice claims, we identified patients who had filed claims against physicians and hospitals. These results were then compared with our findings, based on a review of the same medical records, regarding the incidence of injuries to patients caused by medical management (adverse events). RESULTS: We identified 47 malpractice claims among 30,195 patients' records located on our initial visits to the hospitals, and 4 claims among 580 additional records located during follow-up visits. The overall rate of claims per discharge (weighted) was 0.13 percent (95 percent confidence interval, 0.076 to 0.18 percent). Of the 280 patients who had adverse events caused by medical negligence as defined by the study protocol, 8 filed malpractice claims (weighted rate, 1.53 percent; 95 percent confidence interval, 0 to 3.2 percent). By contrast, our estimate of the statewide ratio of adverse events caused by negligence (27,179) to malpractice claims (3570) is 7.6 to 1. This relative frequency overstates the chances that a negligent adverse event will produce a claim, however, because most of the events for which claims were made in the sample did not meet our definition of adverse events due to negligence. CONCLUSIONS: Medical-malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.

Clinical Competence↗
PubMed1991

Hospital characteristics associated with adverse events and substandard care.

To explore the epidemiology of adverse events (AEs), which were defined as injuries due to medical treatment, and that subset of AEs caused by negligence, we studied interhospital variation in these outcomes in a sample of 31,000 medical records drawn from a random selection of 51 hospitals in New York in 1984. We found a substantial variation in both AE rates (0.2% to 7.9%; mean, 3.2%) and the percentage of AEs due to negligence (1% to 60%; mean, 24.9%) among hospitals. Univariate analyses of AEs revealed that primary teaching institutions had significantly higher rates (4.1%) and rural hospitals had significantly lower ones (1.0%). The percentage of AEs due to negligence was lower in primary teaching (10.7%) and for-profit (9.5%) hospitals and was significantly higher in hospitals with predominantly (greater than 80%) minority patients who had been discharged (37%). These findings were corroborated by multivariate analysis. Our results suggest that AEs and negligence are not randomly distributed and that certain types of hospitals have significantly higher rates of injuries due to substandard care. These observations may represent an important improvement on existing measures of quality because they take into account the fact that some hospitals' populations may be at risk of suffering a poor outcome.

Hospital Records↗
PubMed1991

Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I.

BACKGROUND: As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care. METHODS: We reviewed 30,121 randomly selected records from 51 randomly selected acute care, nonpsychiatric hospitals in New York State in 1984. We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians. RESULTS: Adverse events occurred in 3.7 percent of the hospitalizations (95 percent confidence interval, 3.2 to 4.2), and 27.6 percent of the adverse events were due to negligence (95 percent confidence interval, 22.5 to 32.6). Although 70.5 percent of the adverse events gave rise to disability lasting less than six months, 2.6 percent caused permanently disabling injuries and 13.6 percent led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test chi 2 = 21.04, P less than 0.0001). Using weighted totals, we estimated that among the 2,671,863 patients discharged from New York hospitals in 1984 there were 98,609 adverse events and 27,179 adverse events involving negligence. Rates of adverse events rose with age (P less than 0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (P less than 0.01). There were significant differences in rates of adverse events among categories of clinical specialties (P less than 0.0001), but no differences in the percentage due to negligence. CONCLUSIONS: There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.

Adolescent↗
PubMed1991

Modelling adolescent blood pressure patterns and their prediction of adult pressures.

Tracking of blood pressure in adolescent boys is investigated using a mathematical model that corresponds to progression along a constant percentile. A more general analysis, based on the method of principal components, is also proposed that determines various alternative tracks or patterns that are most prevalent in the longitudinal blood pressure data. The degree of tracking along a constant percentile curve for systolic pressure was moderately high, as evidenced by a tracking index of .78 explaining 81% of the variance, but less strong for diastolic (tracking index of .60) where tracking along a percentile explained 66% of the variance. The value of the more general analysis of blood pressure patterns may lie in the assessment of adolescent risk factors for elevated adult blood pressure. Using adolescent patterns determined by either statistical model, adult systolic at age 38 was predicted (R2 = .22) by the concept of a systolic fixed percentile curve in adolescence, and similarly for diastolic (R2 = .21). However, the more general analysis based on longitudinal principal components further suggests that boys who have a larger than usual systolic peak at age 14 years, which is near the time of the adolescent physical growth spurt in these boys, may be more likely to have higher systolic pressures at age 38. Because the adult data were incomplete and highly unbalanced, these findings were obtained using random-effects models for longitudinal data.

Adolescent↗
PubMed1990

Identification of adverse events occurring during hospitalization. A cross-sectional study of litigation, quality assurance, and medical records at two teaching hospitals.

STUDY OBJECTIVES: To estimate the efficacy of a medical record review for identifying adverse events and negligent case suffered by hospitalized patients. DESIGN: Cross-sectional study comparing an objective medical record review with information available from hospital quality assurance records as well as risk management and litigation records. SETTING: Two metropolitan teaching hospitals in the northeastern United States. MEASUREMENTS AND MAIN RESULTS: Using the litigation and risk management records as a criterion standard, we found that the medical record review had a sensitivity of 80% (93 of 116; 95% CI, 73% to 88%) for discovering adverse events and a sensitivity of 76% (51 of 67; 95% CI, 66% to 86%) for discovering negligent care. We estimated that record review of a random sample of hospitalizations across a geographic region would have even higher sensitivity (adverse-event sensitivity, 84%; negligence sensitivity, 80%). Moreover, we found that the adverse events we failed to discover led to less costly malpractice claims. A significant number of adverse events (20 of 172) among hospitalizations never gave rise to litigation or risk management investigation. Six of the twenty were due to negligent care. Quality assurance efforts at the level of the clinical departments in one hospital led to review of only 12 out of 82 risk management records. CONCLUSIONS: The overwhelming majority of adverse events and episodes of negligent care are discoverable with the methods we used to evaluate medical records. Quality assurance efforts using similar record review methods should be further evaluated.

Cross-Sectional Studies↗
PubMed1990

Maximum likelihood regression methods for paired binary data.

We discuss maximum likelihood methods for analysing binary responses measured at two times, such as in a cross-over design. We construct a 2 x 2 table for each individual with cell probabilities corresponding to the cross-classification of the responses at the two times; the underlying likelihood for each individual is multinomial with four cells. The three dimensional parameter space of the multinomial distribution is completely specified by the two marginal probabilities of success of the 2 x 2 table and an association parameter between the binary responses at the two times. We examine a logistic model for the marginal probabilities of the 2 x 2 table for individual i; the association parameters we consider are either the correlation coefficient, the odds ratio or the relative risk. Simulations show that the parameter estimates for the logistic regression model for the marginal probabilities are not very sensitive to the parameters used to describe the association between the binary responses at the two times. Thus, we suggest choosing the measure of association for ease of interpretation.

Humans↗
PubMed1990

Estimating rates of change in randomized clinical trials.

This article deals with the extension of the pretest-posttest clinical trial to the longitudinal data setting. We assume that a baseline (or pretest) measurement is taken on all individuals, who are then randomized, without regard to baseline values, to a treatment group. Repeated measurements are taken postrandomization at specified times. Our objective is to estimate the average rate of change (or slope) in the experimental groups and the differences in the slopes. Our focus is on the optimal use of the baseline measurements in the analysis. We contrast two different approaches:--a multivariate one that regards the entire vector of responses (including the baseline) as random outcomes and a univariate one that uses each individual's least squares slope as an outcome. Our multivariate approach is essentially a generalization of Stanek's Seemingly Unrelated Regression (SUR) estimator for the pretest-posttest design. The multivariate approach is natural to apply in this setting, and optimal if the assumed model is correct. However, the most efficient estimator requires assuming that the baseline mean parameters are the same for all experimental groups. Although this assumption is reasonable in the randomized setting, the resulting multivariate estimator uses postrandomization data as a covariate; if the assumed linear model is not correct, this can lead to distortions in the estimated treatment effect. We propose instead a reduced form multivariate estimator that may be somewhat less efficient, but protects against model misspecification.

Analysis of Variance↗
PubMed1990

Some statistical methods for combining experimental results.

Advances in science and technology are generally the product of multiple investigations. This article discusses statistical methods for combining empirical results from a series of different experiments or clinical investigations. We delineate the steps an assessor might take in combining data from different studies and provide references for topics not discussed in detail. The article reviews some of the most commonly used statistical techniques for combining results in the medical and social sciences.

Analysis of Variance↗
PubMed1989

A comparison of statistical methods for combining event rates from clinical trials.

We compare two statistical methods for combining event rates from several studies. Both methods treat each study as a separate stratum. The Peto-modified Mantel-Haenszel (Peto) method estimates a combined odds ratio assuming homogeneity across strata and provides a test for heterogeneity. The DerSimonian and Laird modified Cochran method (D&L) produces a weighted average of rate differences, where the weights allow for among-study variability. We analyse 22 meta-analyses from ten reports by both methods. The pooled estimates are divided by their standard errors to produce a Z-statistic. A t-test comparing Z-statistics from all 22 studies suggests that the D&L method tends to be more conservative [d(Peto - D&L) = 0.29, t = 2.53, p = 0.02]. For a subset of 14 non-heterogeneous studies, the difference is smaller and non-significant (d = 0.09, t = 0.72, p = 0.49). The results from the methods correlate well (r = 0.66 for all 22 studies, r = 0.95 for 14 non-heterogeneous studies). Thus, the presence of heterogeneity influences our conclusion. We discuss the statistical and scientific implications of these findings.

Clinical Trials as Topic↗
PubMed1987

Inter-laboratory variability in Ames assay results.

The Ames test is widely used in the screening of chemicals and compounds for potential carcinogenic effect. There is, however, considerable inter-laboratory variability in results from this assay. Using data from the RTI Collaborative Study of the EPA Ames Test Protocol, we show that their reported standard errors of estimates of mutagenicity fall far short of capturing day-to-day or laboratory-to-laboratory variation. We estimate the factors by which the standard errors must be inflated to account for these sources of variation. The laboratory protocol and previous studies suggest that much of this variation may be caused by factors that are relatively constant within days (e.g. technician, incubation temperature, S9 liver homogenate preparation) but vary over days and across laboratories. Therefore, such variation might be reduced through use of a reference compound tested on the same day and under the same conditions as the test chemical. This conjecture was, however, not supported by analyses that considered the positive control compound and a pure chemical as possible reference assays.

Laboratories↗
PubMed1986

Kartagener's syndrome. A blinded, controlled study of cilia ultrastructure.

We investigated respiratory mucosa cilia ultrastructure in patients homozygous for the gene for Kartagener's syndrome (KS) and patients apparently phenotypic for KS who had bronchiectasis and sinusitis but without situs inversus. Parents, as obligate carriers of the recessive KS gene, were also evaluated among other control groups. The four patients with KS had significantly fewer cilia outer dynein arms than normal subjects or parents of patients with KS. Two of five patients apparently phenotypic for KS demonstrated distinctive ultrastructural changes. No other subjects demonstrated explicit ultrastructural abnormalities. Internal control specimens showed that the number of outer dynein arms was consistent within a subject compared with variation between subjects. The outer dynein arm serves as a dependable ultrastructural marker. Carriers of KS do not demonstrate distinctive morphologic cilia abnormalities. Not every patient with chronic bronchiectasis and sinusitis demonstrates abnormal cilia ultrastructure.

Adolescent↗
PubMed1979

Sample-size estimation: a sensitivity analysis in the context of a clinical trial for treatment of mild hypertension.

The effectiveness of treatment for mild hypertension (diastolic pressures of 85 to 105 mm Hg) has not been conclusively demonstrated. Both the costs of a carefully designed clinical trial and the likelihood that it will produce definitive answers will depend importantly on the sample size. This paper presents sample-size estimates under a variety of assumptions regarding the characteristics of the population to be studied, the degree of blood pressure control to be achieved, and the health benefits to be expected. Under a central set of assumptions, the estimated sample size per group is 22,700 with death as an endpoint and 14,000 with morbid events (CHD and stroke) as endpoints. As individual assumptions are varied one at a time, required sample sizes range from 10,900 to 101,100 and from 6,800 to 63,100 for the respective endpoints. Results are most sensitive to the degree of blood pressure control actually achieved to the expected health benefits from blood pressure control. They are also highly sensitive to the sex composition of the population and to expected dropout rates. The choice of sample size will depend on the decision maker's assessment of the likelihood that each assumption will be fulfilled and on the degree of willingness to risk an inconclusive study result. By making explicit the effect of variation in each assumption, decision making is rendered more susceptible to critical examination by outside reviewers.

Adult↗
PubMedDate not supplied

An analysis of two-period crossover designs with carry-over effects.

The crossover design is a type of longitudinal study with subjects receiving different treatments in different time periods. When carry-over effects are absent, the usual crossover design is structured so that all the information about treatment effects is contained in the within-subject contrasts; standard analyses are based on these within-subject contrasts and ignore any between-subject information. With carry-over effects present these standard analyses can be very inefficient, especially for suboptimal designs. We describe alternative approaches based on methods for the analysis of longitudinal data.

Longitudinal Studies↗