Demographic characteristics

Cohort A group of individuals that share a particular statistical or demographic characteristic, e.g., exposure. 

Our current study of drug use and crime in arrestees in Manhattan overcame some of these measurement problems and enabled us to address some of these basic questions regarding POP use and crime. The recent use of PCP (as well as other drugs) in male arrestees was measured by a urinalysis of a specimen obtained within hours after arrest. We therefore did not have to rely on each person s accurate report that he had taken PCP. We shall use the urinalysis test results, with information from interviews with the arrestees, and from their criminal records, to describe the prevalence of PCP use in arrestees, the demographic characteristics of users and the types of offenses for which they are arrested. The next section describes our study of drug use and crime in arrestees in Manhattan. 

Tsuang MT, Simpson JC, Kronfol Z. (1982). Subtypes of drug abuse with psychosis. Demographic characteristics, clinical features, and family history. Arch Gen Psychiatry. 39(2) 141-47. 

This book is organized in seven major chapters. The first chapter addresses the historical presence of African Americans in the chemistry community. The second chapter discusses the demographic characteristics of the responding chemists. The third focuses on the interviewees educational experiences. The fourth chapter discusses workforce-related issues. The fifth chapter discusses professional activities, while the sixth chapter focuses on racial attitudes. The final chapter discusses the implications of the findings for policy and research. 

Storey, M. L., Forshee, R. A., and Anderson, P. A. (2004). Associations of adequate intake of calcium with diet, beverage consumption, and demographic characteristics among children and adolescents. J. Am. Coll. Nutr. 23,18-33. 

Gotlib, I.H., Whiffen, V.E., Mount, J.H., Milne, K., and Cordy, N.I. (1989) Prevalence rates and demographic characteristics associated with depression in pregnancy and the postpartum. / Consult Clin Psychol. 57 269-274. 

The report of results should include data, analysis, and presentation. Specifically, the data report should include the description of the flow of the patients through the study, as well as the number of patients included in each stage of the analysis and/or subgroup examined. The data report should provide distributions (including missing values) of basic demographic characteristics (e.g., sex and age), standard (disease-specific) prognostic... 

Chung, H.S. et al., Demographic characteristics of zipeprol-associated deaths in Korea, A reft. Pharm. Res., 21, 286, 1998. 

A similar table may be presented for demographic characteristics. Specific characteristics that are important can vary from study to study, but typical ones include gender, age, race, and baseline data of relevance, e.g., weight, blood pressure, and heart rate. Information concerning the use of concomitant or concurrent medications and evaluations of subject adherence or compliance with the trial s treatment schedule is also typically presented. 

In general, multiple (up to 30-40) blood samples can be obtained per subject to measure dmg and metabolite concentrations as well as biomarkers in these phase I clinical trials. Furthermore, pharmacodynamic measurements can be included to get a first impression on the drug effect in humans, however, limited by the fact that healthy volunteers were studied and not patients. As strict inclusion and exclusion criteria are used, the demographic characteristics of the healthy volunteers do not provide sufficient spread to investigate the effect of intrinsic factors. Therefore, phase I trials provide very rich data to develop pharmacokinetic and pharmacodynamic models on biomarker, but cannot be used to develop models for efficacy, safety, influence of patient factors on PK and/or PD and disease progression. 

When we create two groups by dividing subjects on the basis of one demographic characteristic, but find the resulting groups also tend to differ in other ways, there is confounding. 

Thus, a multiple dose study was performed in which all healthy and hepatic impaired individuals, received the same dose. It was the aim to include 12 patients with various and well distributed degrees of hepatic impairment (according to the Child-Pugh score) and 12 pair-matched (based on demographic characteristics) healthy subjects, in order to have 10 patients and 10 subjects evaluable. The pharmacokinetics of XYZ123 in plasma (total and unbound) and in urine was assessed after the first dose and at steady state after the seventh dose. The pharmacokinetics in plasma of its main metabolite XYZ456 was also assessed. 

The demographic characteristics were similar in both groups (Table 18). The median Child-Pugh score of patients with hepatic impairment was 7 with a range of 5-11 (Table 19). 

Clinical Laboratory Evaluation in Clinical Trials. In this section, data from individual studies should be combined and analyzed. Relationships between laboratory tests and clinically relevant subsets of patients as well as particular adverse events and laboratory abnormalities should be assessed. The relationship of drug-related abnormalities to dose, duration of treatment, and patient demographic characteristics should be explored where applicable. 

In addition, the protocol should call for examination of the demographic characteristics of these patients, medical history, physical examination, and other patient characteristics known by the consultant clinicians and cited in the literature as possibly significant. Some of these may simply be recorded and later duly noted with relation to the test product s effects, and others may serve at the outset as part of the inclusion/exclusion criteria. As always, numerical definitions are more useful but may not be appropriate to all demographic criteria. 

Comparability of treatment groups, as remarked above, is basic to every clinical trial. Thus, a first step in analysis is to confirm comparability for each baseline variable or relevant combination of variables. If it is discovered that comparability is lacking with regard to disease status, risk factors, or demographic characteristics, the statistician should document the potential effect on subsequent analyses. 

The overall incidence of adverse experience rates should be statistically compared across treatment groups. Analyses also should be undertaken to examine the data for relationships to dosage, duration of treatment, total dose, and demographic characteristics, as well as any other potentially relevant characteristics. 

Clinical and demographic characteristics fully described Representative... 

This brief review has shown that there are some differences in the way dietary risk assessment is practiced between the US and the EU. Many of the differences have to do in the types of input data that are available, or in some of the methods used to collect the data. Regarding the food consun tion data, the US surveys use a dietary recall method, whereas the UK approach is a diary method that weighs and measures the amount of food consumed. In the US, data are collected for two non-consecutive days, whereas in the UK surveys, data are collected for either 4 or 7 consecutive days. The US survey is conducted as an integrated whole and includes all segments of the population. In contrast, the UK surveys are conducted for specific population groups. Finally, the US survey collects data at the household level, whereas the UK survey targets demographic characteristics, based upon census information. 

It is obvious that societal concerns play a major role in how the consumer perceives risks and benefits (Tables 1 and 2). Furthermore, consumers do not distinguish between food safety risks and diet-related risks. Their risk perception depends on different traditions and perceived benefits. It also depends on demographic characteristics such as age, sex, or education, as well as psychological characteristics such as knowledge, experiences, or... 

Hanssens Y, Deleu D, Taqi A. Etiologic and demographic characteristics of poisoning a prospective hospital-based study in Oman. J Toxicol Clin Toxicol 2001 39(4) 371-80. 

The presentation of an ongoing or future clinical study in an advertisement, based on one or more medicinal products, and especially presentation of the objectives, the protocol, demographic characteristics of patients or interim results, is not acceptable because this does not provide complete information to prescribers and could, in certain cases, constitute anticipation of the results that are incomplete and not yet validated. 

Clinical and demographic characteristics of the study population (e.g. age, sex, spectrum of presenting symptoms, comorbidity, current treatments, recruitment centers). ... 

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