Biometrical journal. Biometrische Zeitschrift
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Mechanical ventilation is a common procedure of life support in intensive care. Patient-ventilator asynchronies (PVAs) occur when the timing of the ventilator cycle is not simultaneous with the timing of the patient respiratory cycle. The association between severity markers and the events death or alive discharge has been acknowledged before, however, little is known about the addition of PVAs data to the analyses. ⋯ The survival process is defined in terms of a cause-specific hazards model for the competing risks death or alive discharge. Our model indicates that the SOFA score is strongly related to vital status. PVAs are positively associated with alive discharge but there is not enough evidence that PVAs provide a more accurate indication of death prognosis than the SOFA score alone.
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There is conflicting evidence about the accuracy of bone scintigraphy (BS) for the diagnosis of complex regional pain syndrome 1 (CRPS 1). In a meta-analysis of diagnostic studies, the evaluation of test accuracy is impeded by the use of different imperfect reference tests. The aim of our study is to summarize sensitivity and specificity of BS for CRPS 1 and to identify factors to explain heterogeneity. ⋯ The sensitivity of BS was 0.87 (95% credible interval 0.73-0.97) and the overall specificity was 0.87 (0.73-0.95) in the model with the smallest DIC, in which missing values of the covariate are imputed within the Bayesian framework. The estimated effect of duration of symptoms on the threshold parameter was 0.17 (-0.25 to 0.57). We demonstrate that the Bayesian models presented in this paper are useful to address typical problems occurring in meta-analysis of diagnostic studies, including conditional dependence between index test and reference test, as well as missing values in the study-specific covariates.
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In recent months one of the most controversially discussed topics among regulatory agencies, the pharmaceutical industry, journal editors, and academia has been the sharing of patient-level clinical trial data. Several projects have been started such as the European Medicines Agency´s (EMA) "proactive publication of clinical trial data", the BMJ open data campaign, or the AllTrials initiative. The executive director of the EMA, Dr. ⋯ Besides these general aspects, data sharing also entails intricate biostatistical questions such as problems of multiplicity. An important issue in this respect is the interpretation of multiple statistical analyses, both prospective and retrospective. Expertise in biostatistics is needed to assess the interpretation of such multiple analyses, for example, in the context of regulatory decision-making by optimizing procedural guidance and sophisticated analysis methods.
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This paper investigates homogeneity test of rate ratios in stratified matched-pair studies on the basis of asymptotic and bootstrap-resampling methods. Based on the efficient score approach, we develop a simple and computationally tractable score test statistic. ⋯ Empirical results confirm that (i) the modified score statistic based on the bootstrap-resampling method performs better in the sense that its empirical type I error rate is much closer to the pre-specified nominal level than those of other tests and its power is greater than those of other tests, and is hence recommended, whilst the statistics based on the weighted least-squares estimate and logarithmic transformation are slightly conservative under some of the considered settings; (ii) the derived sample size formulae are rather accurate in the sense that their empirical powers obtained from the estimated sample sizes are very close to the pre-specified nominal powers. A real example is used to illustrate the proposed methodologies.
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Publication bias and related types of small-study effects threaten the validity of systematic reviews. The existence of small-study effects has been demonstrated in empirical studies. Small-study effects are graphically diagnosed by inspection of the funnel plot. ⋯ However, it requires a sensitivity analysis. Regression-based approaches are easier to implement and not based on a specific selection model. Both simulations and applications suggest that in the presence of strong selection both the trim-and-fill method and the Copas selection model may not fully eliminate bias, while regression-based approaches seem to be a promising alternative.