Primary stabbing headache (PSH) is a short-lasting but troublesome headache disorder which has been known for several decades. We surveyed and registered consecutive patients with PSH in a headache clinic in Taiwan. A total of 80 patients (24 M/56 F, 53.2 +/- 16.2 years) were enrolled in our study. Migraine was reported in 20 (25%) patients and was less common in those with PSH onset at >50 years than those with onset at <50 years (14% vs. 38%, P = 0.02). The headache was unilateral in 59% of the patients and always in a fixed area in 36%. The head pain frequently involved extratrigeminal regions (70%) and in 30 patients (38%) was accompanied by jolts, i.e. head or body movements. Indomethacin was effective (74%) in patients who received it. Our study showed primary stabbing headache was a common and easily treated headache disorder in headache clinic. However, 70% of our patients could not fulfil criterion A 'exclusively or predominantly in the distribution of the first division of the trigeminal nerve' and 15% could not fulfil criterion C 'no accompanying symptoms' of the International Classification of Headache Disorders-II criteria proposed for PSH.
The risk score based on age, waist circumference and family history of diabetes is efficient as a layperson-oriented diabetes screening tool for health promotion and for population-based screening programmes.
SynopsisA community survey of dementia was conducted on a Chinese islet. A total of 221 men and 234 women in the age range of 50–92 were assessed. The Cognitive Abilities Screening Instrument (CASI), a 100-point cognitive test designed for cross-cultural studies and adapted in Chinese for individuals with little or no formal education, was administered twice by trained field workers with a retest interval of 3 to 4 weeks. In addition, all participants were assessed by physicians who did not know the CASI scores. The physicians' assessment included a complete neurological examination, plus semi-structured tests and interviews covering cognitive abilities, daily activities, depression, cerebrovascular disease, and Parkinson's disease. Dementia was diagnosed by consensus among the physicians according to the DSM-III-R criteria. Among the 455 participants, 16 cases of dementia were identified, including 13 with probable Alzheimer's disease and 1 each with vascular dementia, Parkinson's disease, and alcoholism. The rates of dementia were 0, 3·9 and 11·5% for the age groups of 50–69, 70–79 and 80–92; and 4·4, 2·0 and 0% for the education groups of 0–1, 2–6 and 7–15 years of schooling. No sex difference was found after controlling for education. The Chinese version of the CASI had an intraclass retest reliability of 0·90. Using a cut-off score of ≤ 50 for dementia, the sensitivity was 0·88 and the specificity was 0·94. The preliminary study suggests that the CASI can be used in Chinese populations with generally low education levels and that Alzheimer's disease was the most common type of dementia in this population.
Pharmacogenomics is the science of determining how the benefits and adverse effects of a drug vary among a target population of patients based on genomic features of the patient's germ line and diseased tissue. By identifying those patients who are most likely to respond while eliminating serious adverse effects, the therapeutic index of a drug can be substantially increased. This may facilitate demonstrating the effectiveness of the drug and may avoid subsequent problems due to serious adverse events. Our objective here is to provide clinical trial designs and analysis strategies for the utilization of genomic signatures as classifiers for patient stratification or patient selection in therapeutics development. We review methods for the development of genomic signature classifiers of treatment outcome in high-dimensional settings, where the number of variables available for prediction far exceeds the number of cases. The split-sample and crossvalidation methods for obtaining estimates of prediction accuracy in developmental studies are described. We present clinical trial designs for utilizing genomic signature classifiers in therapeutics development. The purpose of the classifier is to facilitate the identification of groups of patients with a high probability of benefiting from it and avoiding serious adverse events. We distinguish exploratory analysis during the development of the genomic classifier from prospective planning and rigorous testing of therapeutic hypotheses in studies that utilize the genomic classifier in therapeutics development. We discuss a variety of clinical trial designs including those utilizing specimen collection and assay prospectively for newly accrued patients and those involving a prospectively planned analysis of archived specimens from a previously conducted clinical trial. Our discussion of the development and use of classifiers of efficacy is mostly focused on applications in oncology using classifiers based on biomarkers measured in tumors. Some of the same considerations apply, however, to development of efficacy and safety classifiers in nononcologic diseases based on single-nucleotide germline polymorphisms.
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