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PubMed1995

Developing an outcomes infrastructure for nursing. The Outcomes Taskforce.

An infrastructure to support the evaluation of patient care sensitive to the intervention of nursing personnel is being developed within a major health maintenance organization. In addition to traditional administrative measures of care, the database infrastructure will include measures of the patient's functional status, knowledge and engagement in care and psychosocial well-being. These measures are believed to be particularly sensitive to the independent intervention of the nurse. Reported here are the structures in place to monitor and support the reliability and validity of the administrative data elements; algorithm elements created to account for missing data; the model for the first generation of successful practice reports and the results of a study establishing the content validity of the clinical data elements.

Costs and Cost Analysis↗

PubMed1996

Application of random-effects regression models in relapse research.

This article describes and illustrates use of random-effects regression models (RRM) in relapse research. RRM are useful in longitudinal analysis of relapse data since they allow for the presence of missing data, time-varying or invariant covariates, and subjects measured at different timepoints. Thus, RRM can deal with "unbalanced" longitudinal relapse data, where a sample of subjects are not all measured at each and every timepoint. Also, recent work has extended RRM to handle dichotomous and ordinal outcomes, which are common in relapse research. Two examples are presented from a smoking cessation study to illustrate analysis using RRM. The first illustrates use of a random-effects ordinal logistic regression model, examining longitudinal changes in smoking status, treating status as an ordinal outcome. The second example focuses on changes in motivation scores prior to and following a first relapse to smoking. This latter example illustrates how RRM can be used to examine predictors and consequences of relapse, where relapse can occur at any study timepoint.

Alcoholism↗

PubMedDate not supplied

Non-ignorable missing covariates in generalized linear models.

We propose a likelihood method for estimating parameters in generalized linear models with missing covariates and a non-ignorable missing data mechanism. In this paper, we focus on one missing covariate. We use a logistic model for the probability that the covariate is missing, and allow this probability to depend on the incomplete covariate. We allow the covariates, including the incomplete covariate, to be either categorical or continuous. We propose an EM algorithm in this case. For a missing categorical covariate, we derive a closed form expression for the E- and M-steps of the EM algorithm for obtaining the maximum likelihood estimates (MLEs). For a missing continuous covariate, we use a Monte Carlo version of the EM algorithm to obtain the MLEs via the Gibbs sampler. The methodology is illustrated using an example from a breast cancer clinical trial in which time to disease progression is the outcome, and the incomplete covariate is a quality of life physical well-being score taken after the start of therapy. This score may be missing because the patients are sicker, so this covariate could be non-ignorably missing.

Algorithms↗

PubMed1993

Evaluating interventions with differential attrition: the importance of nonresponse mechanisms and use of follow-up data.

Evaluations of psychological interventions are often criticized because of differential attrition, which is cited as a severe threat to validity. The present study shows that differential attrition is not a problem unless the mechanism causing the attrition is inaccessible (unavailable for analysis). With a simulation study, we show that conclusions about program effects (a) are unbiased when there is no differential attrition, even with usual complete cases analysis; (b) may be severely biased when based on usual complete cases analyses and there is differential attrition; (c) are unbiased when based on the expectation-maximization (EM) algorithm, even when there is differential attrition, as long as the attrition mechanism is accessible; and (d) are biased, even with the EM algorithm, when the attrition mechanism is inaccessible. Following Little and Rubin (1987), we advocate the collection of new data from a random sample of subjects with initially missing data. On the basis of these data, we propose a simple correction to the EM algorithm estimates. In our study, the correction produced unbiased estimates of program effects parameters, even with an inaccessible attrition mechanism and substantial differential attrition.

Bias↗

PubMed1997

Free-living energy expenditure of adult men assessed by continuous heart-rate monitoring and doubly-labelled water.

Free-living energy expenditure was estimated by doubly-labelled water (DLW) and continuous heart-rate (HR) monitoring over nine consecutive days in nine healthy men with sedentary occupations but different levels of leisure-time physical activity. Individual calibrations of the HR-energy expenditure (EE) relationship were obtained for each subject using 30 min average values of HR and EE obtained during 24 h whole-body calorimetry with a defined exercise protocol, and additional data points for individual leisure activities measured with an Oxylog portable O2 consumption meter. The HR data were processed to remove spurious values and insert missing data before the calculation of EE from second-order polynomial equations relating EE to HR. After data processing, the HR-derived EE for this group of subjects was on average 0.8 (SEM 0.6) MJ/d, or 6.0 (SEM 4.2) % higher than that estimated by DLW. The diary-respirometer method, used over the same 9 d, gave values which were 1.9 (SEM 0.7) MJ/d, or -12.1 (SEM 4.0) % lower than the DLW method. The results suggest that HR monitoring can provide a better estimate of 24 h EE of groups than the diary-respirometer method, but show that both methods can introduce errors of 20% or more in individuals.

Adult↗

PubMed1995

Issues in incorporation semantic integrity in molecular biological object-oriented databases.

Issues critical to ensuring semantic integrity in molecular biological data collections have been identified and include complexity, exceptions, missing data, changing models, holism and integration, delocalized data, interoperability and nomenclature. This combination is peculiar to biology and presents some interesting problems as a result. Little is known about semantic checking in object-oriented databases in general, but because such technology appears highly suitable for modeling biological data, it is appropriate to examine the ways in which object-oriented technology can support this functionality. It is concluded that object-oriented technology will support semantic checking even in a complex domain like biology. We propose 10 guidelines for future work including ways of treating exceptional cases and 'positioning' of constraints in a schema.

Biotechnology↗

PubMed1996

Admission base deficit predicts transfusion requirements and risk of complications.

BACKGROUND: Trauma center resource management could be facilitated by a readily available indicator of resource consumption. This marker should identify patients more likely to require transfusion and intensive care services and to develop complications. Base deficit (BD) has been shown to be a valuable indicator of shock, abdominal injury, fluid requirements, efficacy of resuscitation, and to be predictive of mortality after trauma. This study was performed to determine whether BD could be used to identify which patients were likely to require blood transfusion in the first 24 hours of hospitalization, and to develop shock-related complications and increased intensive care unit (ICU) and hospital stays. METHODS: A retrospective review of 2,954 patients admitted to the Valley Medical Center Level I trauma service from July 1990 through August 1995 was done using the trauma registry and blood bank data bases. Medical record review was done to supplement missing data. RESULTS: Transfusion requirements increased as the BD category became more severe (p < 0.001). Transfusions were required within 24 hours of admission in 72% of patients with a BD < or = -6 versus 18% of patients with a BD > -6 (p < 0.001, chi 2). Both ICU and hospital length of stay increased with worsening BD (p < 0.015 and p < 0.05, respectively). The frequency of adult respiratory distress syndrome (ARDS) (p < 0.01), renal failure (p = 0.015), coagulopathy (p < 0.001), and multiorgan system failure (MOF) (p = 0.002) all increased with increasingly severe BD. Discriminate analysis using Injury Severity Score (ISS) and BD category demonstrated predictive accuracy of 81%, 77%, and 77% for coagulopathy, ARDS, and MOF, respectively. Mortality also increased with worsening BD. When stratified by BD category, there was no difference between observed and predicted survival. CONCLUSIONS: Admission BD identifies patients likely to require early transfusion and increased ICU and hospital stays, and be at increased risk for shock-related complications. Patients with BD < or = -6 should undergo type and cross-match rather than type and screen. The use of ISS and BD category probability curves may identify candidates for early invasive monitoring.

Acid-Base Imbalance↗

PubMedDate not supplied

On summary measures analysis of the linear mixed effects model for repeated measures when data are not missing completely at random.

Subjects often drop out of longitudinal studies prematurely, yielding unbalanced data with unequal numbers of measures for each subject. A simple and convenient approach to analysis is to develop summary measures for each individual and then regress the summary measures on between-subject covariates. We examine properties of this approach in the context of the linear mixed effects model when the data are not missing completely at random, in the sense that drop-out depends on the values of the repeated measures after conditioning on fixed covariates. The approach is compared with likelihood-based approaches that model the vector of repeated measures for each individual. Methods are compared by simulation for the case where repeated measures over time are linear and can be summarized by a slope and intercept for each individual. Our simulations suggest that summary measures analysis based on the slopes alone is comparable to full maximum likelihood when the data are missing completely at random but is markedly inferior when the data are not missing completely at random. Analysis discarding the incomplete cases is even worse, with large biases and very poor confidence coverage.

Computer Simulation↗

PubMed1997

Individual subject random assignment is the preferred means of evaluating behavioral lifestyle modification.

Of the three most important approaches to evaluating lifestyle and health outcomes--observational studies, individual subject random assignment clinical trials, and community random assignment clinical trials--individual subject random assignment clinical trials provide the most useful information and the most certain inferences. Observational studies are limited by the collection of information on association of lifestyle instead of change in lifestyle with health outcomes, as well as by individual lifestyle selection that may be associated with particular outcomes. Community randomized trials may be the best way to decide such public health policy issues as whether or not to add fluoride to a water supply or to use a community-wide anti-smoking program. The limited amount of individual-specific data collected in community randomized trials, difficulties in accounting for missing data, and problems in data analysis because people move into or out of communities that are under study limit the value of community randomized trials for advising individuals whether or not to embark on a lifestyle modification program. Clinical trials of pharmacologic agents have successfully addressed challenges to individual subject random assignment clinical trials of lifestyle modification, such as long duration of study, access to study intervention(s) by individuals not assigned them, and cost.

Community Health Services↗

PubMed1989

Nicardipine and propranolol in the treatment of essential hypertension.

Two hundred thirty-four patients with supine diastolic blood pressure of between 95 and 114 mm Hg were enrolled into a double-blind, randomized, parallel, multicenter trial. The patients were randomized to either nicardipine 30 mg tid, propranolol 40 mg tid, or nicardipine 30 mg tid and propranolol 40 mg tid for six weeks. Two hundred six patients yielded data for analyses. Of the 28 not included, seven had missing data, whereas the remaining 21 were excluded because they either failed to meet inclusion criteria or were noncompliant at endpoint. Both nicardipine and propranolol as monotherapies and in combination achieved statistically significant, (P less than .01), supine diastolic blood pressure reduction relative to baseline. The combination of nicardipine and propranolol showed a greater reduction in supine diastolic and systolic measurements than either of the monotherapies. Nicardipine produced greater blood pressure reductions one hour after dosing, whereas the propranolol treatment tended to produce slightly greater blood pressure decreases eight hours after dose. The combination always resulted in the greatest blood pressure reduction, independent of time after dose. Adverse experiences were reported by 26% of patients in the nicardipine-treated group, most often transient vasodilatory effects, by 17% of the propranolol-treated patients, and by 18% of the combination-treated group. This study demonstrated at the doses studied that nicardipine alone produced equivalent blood pressure reductions to those obtained by propranolol alone, but that the combination of these two drugs produced greater reductions in blood pressures than either of the monotherapies.

Adult↗

PubMed1998

Molecular phylogeny of the genus Hypochaeris using internal transcribed spacers of nuclear rDNA: inference for chromosomal evolution.

Sequences of the internal transcribed spacers (ITSs) of 18S-26S nuclear ribosomal DNA were used to resolve phylogenetic relationships and chromosomal evolution among 14 species of the genus Hypochaeris (Asteraceae). Parsimony analysis was performed for phylogenetic reconstruction, and sequence divergence between species was estimated. Pairwise sequence divergence within Hypochaeris genus ranged from 0% to 25.68% in ITS1 and from 0% to 17.08% in ITS2. A highly resolved strict-consensus tree was obtained that showed the phylogenetically useful information of ITS sequences within the genus Hypochaeris. Four clades could be well distinguished, one of them formed by the single species H. robertia, which appeared to be the most related to the ancestral species of the genus. The results agree with taxonomic classification based on morphological data, and the tree obtained, when indels are coded as missing data, aggregates the species having the same chromosome number, except in one clade. According to the ITS phylogenetic tree, the chromosomal evolution within the genus Hypochaeris conflicts with the previous hypothesis and suggests that karyotype evolution in Hypochaeris was accompanied with both decreasing and increasing dysploidy, probably with several chromosomal rearrangements, and from an ancestral basic chromosome number of 4 or 5.

Asteraceae↗

PubMed1995

The feasibility and cost of a large multicentre audit of process and outcome of prostatectomy.

Objective--To determine the feasibility of performing multicentre process and outcome audits of common interventions taking prostatic procedures as an example. Design--Prospective, cohort study. Setting--All National Health Service and independent hospitals in Northern, Wessex, Mersey, and South West Thames health regions. Patients--5361 men undergoing prostatectomy identified by 103 of the 107 urologists and general surgeons performing prostatectomy in the study regions. Main measures-- Rates of participation by surgeons and patients; completeness of clinical data provided by surgeons; patient response rate and completeness of patient derived data; and cost. Results--Most surgeons (103,96%) agreed to participate. Overall, the proportion of eligible patients invited to take part was high (89%), although this was only measured in South West Thames, where dedicated data collectors were employed. Few men (80, 1.5%) declined to participate. Of those surviving for three months after surgery, 82.4% (4226) completed and returned the postal questionnaire. The response rate was higher in South West Thames (86.7%) than in the other regions (80.6%-80.8%). The audit was well received: 91% of patients found the questionnaire easy to complete and only 2.3% of them disapproved. Completeness of data was high with both the hospital and patient questionnaires. Missing data occurred in less than 5% of responses to most questions. The attributable cost was 34.50 pounds per patient identified or 44 pounds for patients in whom either the treatment outcome or vital status was known three months after their prostatectomy. Conclusions--This multicentre audit of process and outcome of prostatectomy proved feasible in terms of surgeon participation, patient identification, and the quantity and quality of data collection. Whether the cost was warranted will depend on how surgeons use the audit data to modify their practice.

Aged↗

PubMed1997

Now you see it, now you don't: a comparison of traditional versus random-effects regression models in the analysis of longitudinal follow-up data from a clinical trial.

To illustrate the limitations of commonly used methods of handling missing data when using traditional analysis of variance (ANOVA) models and highlight the relative advantages of random-effects regression models, multiple analytic strategies were applied to follow-up data from a clinical trial. Traditional ANOVA and random-effects models produced similar results when underlying assumptions were met and data were complete. However, analyses based on subsamples, to which investigators would have been limited with traditional models, would have led to different conclusions about treatment effects over time than analyses based on intention-to-treat samples using random-effects regression models. These findings underscore the advantages of models that use all data collected and the importance of complete data collection to minimize sample bias.

Adult↗

PubMed1998

Magnetic resonance imaging for the investigation of knee injuries: an investigation of preferences.

The conventional approach to the diagnosis and treatment of severe knee injuries is arthroscopy, a minimally invasive surgical procedure. Since arthroscopy is an invasive technique that carries risks, magnetic resonance imaging (MRI) is increasingly being used for diagnosis. MRI is potentially associated with diagnostic and therapeutic 'impacts', in that arthroscopy can be avoided. This paper reports a discrete choice conjoint analysis exercise that assessed the value placed on such 'impacts' by potential patients and investigated the degree to which respondents were willing to trade between process and outcome. The marginal rates of substitution between attributes were estimated. The results suggest that the diagnostic and therapeutic 'impacts' of MRI were valued by many respondents. The study has highlighted a number of important issues for the design and analysis of future health-related conjoint studies, including the use of treatment cost as an attribute, dealing with data from lexicographic respondents, and distinguishing between points of indifference and missing data.

Adult↗

PubMedDate not supplied

"Keyhole" method for accelerating imaging of contrast agent uptake.

Magnetic resonance (MR) imaging methods with good spatial and contrast resolution are often too slow to follow the uptake of contrast agents with the desired temporal resolution. Imaging can be accelerated by skipping the acquisition of data normally taken with strong phase-encoding gradients, restricting acquisition to weak-gradient data only. If the usual procedure of substituting zeroes for the missing data is followed, blurring results. Substituting instead reference data taken before or well after contrast agent injection reduces this problem. Volunteer and patient images obtained by using such reference data show that imaging can be usefully accelerated severalfold. Cortical and medullary regions of interest and whole kidney regions were studied, and both gradient- and spin-echo images are shown. The method is believed to be compatible with other acceleration methods such as half-Fourier reconstruction and reading of more than one line of k space per excitation.

Contrast Media↗

PubMed1994

Crossover designs for clinical trials.

I discuss three-period crossover designs for an efficient comparison of two test treatments with special application to clinical trials which often have many practical limitations. In this paper I specify a subset of three-period crossover designs so that the investigators are not left with the problematic two-period two-sequence design, should the trials be terminated after the second period. I show that there is a dramatic reduction in variability for estimating the direct and residual treatment effects in three-period designs compared to two-period designs. I also show that the universally optimal design with ABB and BAA sequences is unsuitable when a complex form of residual effects is suspected, such as the second-order residual effects or treatment by period interactions. The design with ABB, BAA, AAB, and BBA sequences is relatively robust to these uncertain model assumptions. I also discuss missing data problems and conclude that, even with a large proportion of missing values, the three-period design is far more efficient than the two-period design.

Analysis of Variance↗

PubMed1994

A PC program for classification into one of several groups on the basis of longitudinal data.

A stand-alone, menu-driven PC program, ZCLASS, written in GAUSS386i, for classifying subjects into one of several distinct, existing groups on the basis of longitudinal data is described, illustrated, and made available to interested readers. The program accepts data from studies where common times of measurement are planned, but missing data are accommodated in that one or more measurement sequences may be incomplete.

Anthropometry↗

PubMed1988

Microcomputer application of Bayesean probability testing for the identification of bacteria.

A computer program (BACTID) is described which facilitates the identification of bacteria based on a priori data and Bayesean probability testing. The program is not limited to a specific format, has a short execution time, can be easily applied to a variety of situations, and can be run on almost any microcomputer system operating under either 8-bit CP/M or 16-bit MS-DOS/PC-DOS. Additionally, BACTID (1) is not limited to one type of computer (hardware independent), (2) is not limited by size of the computer's random access (RAM independent), (3) can recognize various data bases matrices (format independent), (4) is able to compensate for missing data and (5) allows for various methods of data entry. The efficacy of the program was checked against a commercially available test system and a 99.34% agreement was obtained. Also, the execution time for a 46 x 21 element data matrix was as little as 3.5 s. These results show that microcomputer identification programs are not only viable alternatives to code book registers, but also offer flexibility which is not found in commercial systems.

Bacteria↗