Type I error rates from likelihood‐based repeated measures analyses of incomplete longitudinal data

The last observation carried forward (LOCF) approach is commonly utilized to handle missing values in the primary analysis of clinical trials. However, recent evidence suggests that likelihood‐based analyses developed under the missing at random (MAR) framework are sensible alternatives. The objective of this study was to assess the Type I error rates from a likelihood‐based MAR approach – mixed‐model repeated measures (MMRM) – compared with LOCF when estimating treatment contrasts for mean change from baseline to endpoint (Δ). Data emulating neuropsychiatric clinical trials were simulated in a 4 × 4 factorial arrangement of scenarios, using four patterns of mean changes over time and four strategies for deleting data to generate subject dropout via an MAR mechanism. In data with no dropout, estimates of Δ and SE_Δ from MMRM and LOCF were identical. In data with dropout, the Type I error rates (averaged across all scenarios) for MMRM and LOCF were 5.49% and 16.76%, respectively. In 11 of the 16 scenarios, the Type I error rate from MMRM was at least 1.00% closer to the expected rate of 5.00% than the corresponding rate from LOCF. In no scenario did LOCF yield a Type I error rate that was at least 1.00% closer to the expected rate than the corresponding rate from MMRM. The average estimate of SE_Δ from MMRM was greater in data with dropout than in complete data, whereas the average estimate of SE_Δ from LOCF was smaller in data with dropout than in complete data, suggesting that standard errors from MMRM better reflected the uncertainty in the data. The results from this investigation support those from previous studies, which found that MMRM provided reasonable control of Type I error even in the presence of MNAR missingness. No universally best approach to analysis of longitudinal data exists. However, likelihood‐based MAR approaches have been shown to perform well in a variety of situations and are a sensible alternative to the LOCF approach. MNAR methods can be used within a sensitivity analysis framework to test the potential presence and impact of MNAR data, thereby assessing robustness of results from an MAR method. Copyright © 2004 John Wiley & Sons, Ltd.     

Stjepan Metrović and Michel Maffesoli's 'implosive' defence of the Durkheimian tradition: theoretical convergences around Baudrillard's thesis on the 'end' of the social

This paper critically examines Metrovi? and Maffesoli's attempt to understand postmodernity through Émile Durkheim's nonrational link between society, religion and morality. Metrovi? (1991, 1997) and Maffesoli's (1996) work draws upon this emotional element when attempting to refute Baudrillard's (1983) cognitively focused, if implicit, critique of the Durkheimian tradition. Despite their best intentions, Metrovi? and Maffesoli still fail to exploit the partialities of Baudrillard's critique to the full. While both have some appreciation of the link between emotion and religion as found in Durkheim's The Elementary Forms of Religious Life (1912) they, nevertheless, fall short of grasping its full conceptual importance. This leads them to an implicit acceptance of Baudrillard's thesis on the ‘end’ of the social. This pitfall could have been avoided if Metrovi? and Maffesoli had built their respective analyses of the postmodern condition on a closer reading of The Elementary Forms. Reading this text alongside those other insights on emotion and social life as contained within Durkheim and Mauss's Primitive Classification (1903) and Talcott Parsons's subsequent writings on the sociological problem of religion, would have helped to distance the work of Metrovi? and Maffesoli from that of Baudrillard, and allowed them to offer a stronger and more comprehensive defence of the said tradition.     

The Effect of Repetition on Infants' Imitation From Picture Books Varying in Iconicity

Although picture‐book reading is commonplace during infancy, little is known about the impact of this activity on learning. A previous study showed that 18‐ and 24‐month‐olds imitated a novel action sequence presented in a book that was illustrated with realistic color photos, whereas they failed to imitate from books illustrated with less realistic drawings. In the research reported here, we hypothesized that increasing infants' exposure to a picture book would increase learning from books illustrated with both color photos and drawings. Independent groups of 18‐and 24‐month‐olds were exposed to a picture book either twice in succession or 4 times in succession. The results showed that, regardless of the iconicity of the illustrations, increasing the number of reading sessions significantly improved the infants' imitation scores, compared to age‐matched, no‐demonstration controls. The results are discussed in relation to representational insight and cognitive flexibility.     

Statistical Distributions of Daily Breathing Rates for Narrow Age Groups of Infants and Children

Children may be more susceptible to toxicity from some environmental chemicals than adults. This susceptibility may occur during narrow age periods (windows), which can last from days to years depending on the toxicant. Breathing rates specific to narrow age periods are useful to assess inhalation dose during suspected windows of susceptibility. Because existing breathing rates used in risk assessment are typically for broad age ranges or are based on data not representative of the population, we derived daily breathing rates for narrow age ranges of children designed to be more representative of the current U.S. children's population. These rates were derived using the metabolic conversion method of Layton (1993) and energy intake data adjusted to represent the U.S. population from a relatively recent dietary survey (CSFII 1994–1996, 1998). We calculated conversion factors more specific to children than those previously used. Both nonnormalized (L/day) and normalized (L/kg-day) breathing rates were derived and found comparable to rates derived using energy estimates that are accurate for the individuals sampled but not representative of the population. Estimates of breathing rate variability within a population can be used with stochastic techniques to characterize the range of risk in the population from inhalation exposures. For each age and age-gender group, we present the mean, standard error of the mean, percentiles (50th, 90th, and 95th), geometric mean, standard deviation, 95th percentile, and best-fit parametric models of the breathing rate distributions. The standard errors characterize uncertainty in the parameter estimate, while the percentiles describe the combined interindividual and intra-individual variability of the sampled population. These breathing rates can be used for risk assessment of subchronic and chronic inhalation exposures of narrow age groups of children.     

Effects of Marriage and Children on Financial Risk Tolerance: A Synthesis of Family Development and Prospect Theory

Family development and prospect theory were used as a framework to predict variability in individuals' subjective financial risk tolerance within distinct family structures. Gender, age, and income were expected to interact with the main effects of family structure (marital status and children). Theory-generated hypotheses were examined in Study 1 (data from university housing respondents, n = 76) and Study 2 (the 1998 Survey of Consumer Finances, n = 4,305). One family structure main effect (child presence) was significant for investment risk tolerance in both studies. Family structure interactions (marital status × age and child × income) were significant for employment risk (Study 1), and child × age was significant for investment risk in Study 2.     

Efficient designs based on orthogonal arrays of type I and type II for experiments using units ordered over time or space

For a wide variety of applications, experiments are based on units ordered over time or space. Models for these experiments generally may include one or more of: correlations, systematic trends, carryover effects and interference effects. Since the standard optimal block designs may not be efficient in these situations, orthogonal arrays of type I and type II, which were introduced in 1961 by C.R. Rao [Combinatorial arrangements analogous to orthogonal arrays, Sankhya A 23 (1961) 283–286], have been recently used to construct optimal and efficient designs for many of these experiments. Results in this area are unified and the salient features are outlined.     

Consent and Informed Consent: Their Ongoing Evolutions in Clinical Care and Research on Humans

The dual concepts of 'consent' and 'informed consent' continue to have three evolutions. The primary evolution of consent in the patient–physician relationship began in Great Britain in 1767 in the British case, Slater v. Baker and Stapleton , in the judge-made law of consent. The term 'informed consent' within the patient–physician relationship entered the judicial lexicon in the 1957 California appellate case, Salgo v. Leland Stanford Junior University . In its second evolution within research on humans following the Nuremberg trials that included experimental atrocities on humans, there is a key focus on clarifying the purpose of research and specifying the reasons for the need for an even more extensive risk disclosure to individuals considering volunteering for study participation. This second evolution continues with the further refinement of the Declaration of Helsinki and, within the USA, a focus on the Belmont Report . In its third evolution in research in the social science, there has been a recognition of problems with informed consent to questionnaire research. When questionnaires involve patients with moderate or severe posttraumatic stress disorder or abused individuals, there needs to be intense consideration focused on how to best protect the participants with these conditions during the questionnaire study.