Regulatory demands on data quality for the environmental risk assessment of pharmaceuticals.

The evaluation of the quality of data and their use within the review of environmental risk assessment of human as well as veterinary pharmaceuticals is described from a regulatory point of view. A definition and differentiation in three categories for the reliability of data are given. Existing criteria relating to international testing standards for categorising reliability are adopted for their use within the environmental risk assessment of pharmaceuticals. A systematic documentation of evaluating reliability for literature data as well as for experimental studies (effect and environmental fate studies) is proposed. The data quality criteria are defined in order to increase the transparency of the evaluation process in Germany and thus the quality of the environmental risk assessment of pharmaceuticals.

A prospective analysis of the relationship between walking and mood in sedentary ethnic minority women.

Walking for exercise is becoming widely recognized for bestowing health benefits. This study examined the association of walking for exercise and mood in sedentary, ethnic minority women over a five-month period. Ethnic minority women (N = 102) participated in a randomized, controlled trial of a 7-week behaviorally based telephone and mail intervention that promoted the adoption of walking for exercise compared to a non-behavioral minimal intervention. At 2-month post-test and 5-month follow-up, participants reported significant decreases in depressive mood and increases in vigor. Increase in walking over the course of the study was associated with change in vigor. Limited evidence was found to support a relationship between walking for exercise and mood improvement in ethnic-minority women.

A home-based behavioral intervention to promote walking in sedentary ethnic minority women: project WALK.

A home-based telephone and mail intervention was evaluated for its effectiveness in promoting walking in a sample of sedentary, ethnic minority women. One hundred twenty-five women (ages 23-54) were randomly assigned to behavioral or brief educational interventions. Women in the 8-week behavioral condition received behavior change materials through the mail and 6 structured telephone counseling sessions. Educational condition participants received a single 5-min telephone call and educational information. Both groups reported significantly increased walking at a 2-month posttest (M change = 86 and 81 min per week for behavioral and educational groups, respectively) and 5-month follow-up (M change = 40 and 52 min per week). A 30-month follow-up of 50 participants indicated both groups continued to report more walking than at baseline. The behavioral intervention was not superior to the educational condition at any assessment point. The findings may be explained as (a) both interventions were equally effective, so extensive telephone counseling is unnecessary; (b) changes over time reflected secular trends; or (c) increases in self-reported walking may be due to socially desirable reporting. Other strategies need to be evaluated for promoting walking that are tailored to the needs of ethnic minority women.

Active vs. passive methods of recruiting ethnic minority women to a health promotion program.

Ethnic minority women have been underrepresented in health promotion research. There is a need to develop effective methods of recruiting ethnic minority women to health promotion programs and research studies. This article evaluates several methods for recruiting ethnic minority women to a study of a telephone and mail intervention encouraging participation in a home-based walking program. One hundred twenty-six sedentary ethnic minority women between the ages of 25 and 55 were recruited using two types of approaches. Number of participants screened, number enrolled, and recruitment efficiency (ratio of number recruited/number screened) were assessed. "Active" recruitment, contacting targeted individuals in person, by phone, or by mail, yielded 236 screened and 29 recruited with a recruitment efficiency of 11%. "Passive" recruitment, informing the community through public notices and waiting for volunteers to call, yielded 151 screened and 97 recruited with a recruitment efficiency of 64%. Those recruited by active or passive methods did not differ by demographic characteristics, baseline psychosocial variables, or dropout rates. Passive recruits walked significantly more at five-month follow-up than active recruits. Passive recruitment may be more economical at the cost of potentially biased samples.