Parental Communication Not to Smoke and Adolescent Cigarette Smokers' Readiness to Quit: Differences by Age

There is limited information on the relationship between parental practices that specifically discourage current cigarette smoking and adolescent cessation, and how this relationship varies by age. Among 1629 adolescent smokers, self-reported receipt of parental communication not to smoke was significantly and positively associated with readiness to quit. The strength and significance of this association decreased from early to middle adolescence and was not significant in late adolescence.     

Fisher information matrix for nonlinear mixed effects multiple response models: Evaluation of the appropriateness of the first order linearization using a pharmacokinetic/pharmacodynamic model

We focus on the Fisher information matrix used for design evaluation and optimization in nonlinear mixed effects multiple response models. We evaluate the appropriateness of its expression computed by linearization as proposed for a single response model. Using a pharmacokinetic–pharmacodynamic (PKPD) example, we first compare the computation of the Fisher information matrix with approximation to one derived from the observed matrix on a large simulation using the stochastic approximation expectation–maximization algorithm (SAEM). The expression of the Fisher information matrix for multiple responses is also evaluated by comparison with the empirical information obtained through a replicated simulation study using the first‐order linearization estimation methods implemented in the NONMEM software (first‐order (FO), first‐order conditional estimate (FOCE)) and the SAEM algorithm in the MONOLIX software. The predicted errors given by the approximated information matrix are close to those given by the information matrix obtained without linearization using SAEM and to the empirical ones obtained with FOCE and SAEM. The simulation study also illustrates the accuracy of both FOCE and SAEM estimation algorithms when jointly modelling multiple responses and the major limitations of the FO method. This study highlights the appropriateness of the approximated Fisher information matrix for multiple responses, which is implemented in PFIM 3.0, an extension of the R function PFIM dedicated to design evaluation and optimization. It also emphasizes the use of this computing tool for designing population multiple response studies, as for instance in PKPD studies or in PK studies including the modelling of the PK of a drug and its active metabolite. Copyright © 2009 John Wiley & Sons, Ltd.     

One‐ and two‐stage design proposals for a phase II trial comparing three active treatments with control using an ordered categorical endpoint

Phase II clinical trials are performed to investigate whether a novel treatment shows sufficient promise of efficacy to justify its evaluation in a subsequent definitive phase III trial, and they are often also used to select the dose to take forward. In this paper we discuss different design proposals for a phase II trial in which three active treatment doses and a placebo control are to be compared in terms of a single‐ordered categorical endpoint. The sample size requirements for one‐stage and two‐stage designs are derived, based on an approach similar to that of Dunnett. Detailed computations are prepared for an illustrative example concerning a study in stroke. Allowance for early stopping for futility is made. Simulations are used to verify that the specified type I error and power requirements are valid, despite certain approximations used in the derivation of sample size. The advantages and disadvantages of the different designs are discussed, and the scope for extending the approach to different forms of endpoint is considered. Copyright © 2008 John Wiley & Sons, Ltd.     

Measurement in clinical trials: A neglected issue for statisticians?

Biostatisticians have frequently uncritically accepted the measurements provided by their medical colleagues engaged in clinical research. Such measures often involve considerable loss of information. Particularly, unfortunate is the widespread use of the so‐called ‘responder analysis’, which may involve not only a loss of information through dichotomization, but also extravagant and unjustified causal inference regarding individual treatment effects at the patient level, and, increasingly, the use of the so‐called number needed to treat scale of measurement. Other problems involve inefficient use of baseline measurements, the use of covariates measured after the start of treatment, the interpretation of titrations and composite response measures. Many of these bad practices are becoming enshrined in the regulatory guidance to the pharmaceutical industry. We consider the losses involved in inappropriate measures and suggest that statisticians should pay more attention to this aspect of their work. Copyright © 2009 John Wiley & Sons, Ltd.     

Zolpidem induced nocturnal sleep‐related eating disorder (NSRED) in a male patient

Nocturnal Sleep‐Related Eating Disorder (NSRED) is a well‐documented sleeping disorder where the person is reported to experience bizarre eating behavior during sleep. Although various causes are implicated in this disorder, role of drugs cannot be ruled out. Here we narrate an interesting rare case report of a drug‐induced new onset NSRED, where a 45‐year‐old man on zolipdem performed an unexpected and bizarre eating behavior during somnambulistic state, type of which has not been reported earlier in the literature. The case falls under even rarer category as such behavior in sleep is reported mainly in woman. © 2008 by Wiley Periodicals, Inc. Int J Eat Disord 2009     

Soul City: a sustainable edutainment vehicle facilitating social change

This paper outlines the programming model employed by the Soul City Institute for Health and Development Communication, a South African NGO, in using ‘edutainment’ to facilitate social change. The paper refers to the intersection of this model and current thought on health promotion and various social change theories. It also discusses key challenges and factors contributing to sustainability over 12 years.     

Pituitary adenomas: Trans‐sphenoidal experience of 300 cases

Objective: The main aim of the present study was to examine the effectiveness and complication rate of the 1 cm right‐sided unilateral sublabial trans‐sphenoidal surgery for patients with pituitary adenoma equal to or greater than 5 mm in diameter. Method: A total of 350 patients were surgically treated for pituitary adenomas between December 1999 and December 2003 in an academic neurosurgical unit in China. Three hundred patients (86%) were treated with the 1‐cm right‐sided unilateral sublabial trans‐sphenoidal approach. The mean age of patients was 43 years (range 10–78 years) and female patients accounted for 59% of the total. One hundred and ninety‐six (64%) patients had functioning endocrine tumours and 104 (36%) patients had non‐functioning tumours or macroadenomas. Tumours which were outside this simple and basic classification were excluded from the study. Results: There were no operative mortalities. One patient developed hypopituitarism and 16 (5%) developed transient diabetes insipidus that required pituitrin treatment. The remission rate for macroadenoma was 85% and that for microadenoma was 98.5% during a medium term follow‐up of 1–5 years. One hundred and fifteen patients had prolactin secreting tumours and 90.4% achieved endocrine remission. Fifty‐six patients had growth hormone secreting tumours and 75.4% achieved endocrine remission. Preoperatively, one hundred and fifty‐one patients presented with visual impairment and 148 (98%) achieved a documented improvement in visual acuity. The mean duration of hospital stay was 4 days (range 3–7 days). Conclusion: This minimally invasive trans‐sphenoidal surgery for pituitary adenomas could be used as the primary treatment for small pituitary tumours. The effectiveness of the tumour removal and low morbidity rate compare favourably with the conventional sublabial approach as well as the more recently developed endoscopic endonasal approaches.     

Occupational injury and illness in the semiconductor manufacturing industry

Two thousand nine hundred and ninety-four reports of OSHA-reportable occupational injury or illness cases in 1984 from member companies of a national trade association of semiconductor manufacturing firms were analyzed. The 37 participating manufacturing facilities represented 16 companies employing over 95,000 persons, or approximately one-third of the U.S. work force for this industry in 1984. The annual incidence rate for all reportable injuries and illnesses was 2.7 per 100 full-time employees (FTE) for men and 3.7 per 100 FTE for women. Strains, sprains, or dislocations were the most frequently reported incidents (N = 956 [31.9%]), followed by cuts, lacerations, punctures, scratches, and abrasions (N = 445 [14.9%]), and chemical burns (N = 401 [13.4%]). Increased work-loss days per case were associated with manufacturing sites that did not have an employee health clinic on the premises, with custodial occupations, and with female gender.