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.     

The Application of Number Needed to Treat (NNT) to Clinical Problems in Radiotherapy

The goals of this report are: 1) to review the number needed to treat (NNT) concept, which, although well established in many sectors of medicine, is still relatively new to the radiotherapy community; 2) to discuss several clinical radiotherapy examples illustrating the inherent advantages of the NNT approach; and 3) to discuss potential future roles of the NNT concept within radiotherapy.     

Alveolar hydatid disease of the liver: Brief review and spectrum of adjacent organ invasion

The purpose of this study is to show the spectrum of adjacent organ invasion and to make a brief review of hepatic alveolar hydatid disease (AHD), using CT and MR imaging. We retrospectively reviewed CT and MR images of three patients with various adjacent organ invasions surgically and histologically proven to be AHD. Local invasion to right kidney and adrenal, right hemidiaphragm and lung were detected in one patient, right adrenal in another patient and gall bladder, duodenum, gastric wall and pancreas invasion in the other. AHD may rarely extend to the gall bladder, stomach, duodenum, pancreas, right adrenal and kidney, diaphragm, pleura and lung. The extension of the disease outside the liver is usually encountered in patients with large, peripherally located masses in the advanced stage of the disease.     

Automatic algorithm for correcting motion artifacts in time-resolved two-dimensional magnetic resonance angiography using convex projections.

Time-resolved contrast enhanced magnetic resonance angiography (MRA) may suffer from involuntary patient motion. It is noted that while MR signal change associated with motion is large in magnitude and has smooth phase variation in k-phase, signal change associated with vascular enhancement is small in magnitude and has rapid phase variation in k-space. Based upon this observation, a novel projection onto convex sets (POCS) algorithm is developed as an automatic iterative method to remove motion artifacts. The presented POCS algorithm consists of high-pass phase filtering and convex projections in both k-space and image space. Without input of detailed motion knowledge, motion effects are filtered out, while vasculature information is preserved. The proposed method can be effective for a large class of nonrigid motions, including through-plane motion. The algorithm is stable and converges quickly, usually within five iterations. A double-blind evaluation on a set of clinical MRA cases shows that a completely unsupervised version of the algorithm produces significantly better rank scores (P=0.038) when compared to angiograms produced manually by an experienced radiologist.     

ANALYSIS OF BURIED BUMPER SYNDROME AFTER PERCUTANEOUS ENDOSCOPIC GASTROSTOMY DUE TO USE OF A BUTTON‐TYPE KIT

Background: Buried bumper syndrome (BBS) is a rare complication of percutaneous endoscopic gastrostomy (PEG). Along with the widespread use of the button‐type kit, BBS is encountered frequently. Methods: In the present study, we examined causes and treatments for BBS among 1400 patients who had undergone PEG. Results: The causes of BBS after PEG were classified into two categories: early causes consisted of wound infection, inappropriate size of kit and severe lordosis, while late causes were inappropriate exchange of kit, rough management or weight gain. The treatments for BBS could be determined by the degree of wound infection, fistula and burial of the bumper. Conclusion: We prepared a flowchart for replacement, by which BBS can be managed safely and quickly without surgical or endoscopic intervention.