Residential medication management reviews of antithrombotic therapy in aged care residents with atrial fibrillation: assessment of stroke and bleeding risk.

WHAT IS KNOWN AND OBJECTIVE: Antithrombotics reduce the risk of stroke in individuals with atrial fibrillation (AF). However, optimal prescribing of antithrombotics in older people remains a challenge. The objective of this study was to assess the risk of stroke for aged care home residents with AF and to examine the pharmacist-led medication reviews on the utilization of antithrombotic therapy. METHODS: This retrospective study included a random sample of de-identified residential medication management reviews (RMMRs) conducted by accredited pharmacists in aged care homes in Sydney, Australia, between August 2011 and December 2012. The study participants were 146 residents aged 65 years and older with AF living in low- and high-care residential aged care facilities. Antithrombotic therapy was examined among the residents, before and after medication review. CHADS2 , CHA2 DS2 -VASc, and HEMORR2 HAGES scoring tools were used to assess the risk of stroke and bleeding and indicate the appropriateness of antithrombotic therapy. RESULTS AND DISCUSSION: The mean age (±SD) of individuals was 88·4 (7·5) years, and 63·7% (n = 93) were female. The majority of residents (n = 99, 67·8%) were aged between 85 and 99 years. The mean (±SD) CHADS2 score was 3·1 (1·1), CHA2 DS2 -VASc was 4·6 (1·5), and HEMORR2 HAGES was 2·3 (1·0). All residents were classified as being at high risk of developing stroke. A total of 115 of 146 (78·8%) residents with AF were prescribed antithrombotics. There was a relatively low usage of anticoagulation (28·1%), and few recommendations from the medication review pharmacists to alter the thromboprophylactic therapy in AF. Application of the CHA2 DS2 -VASc risk tool indicated that 146 residents were eligible for antithrombotic treatments; of these, 74 (50·7%) were prescribed antiplatelets and 41 (28·1%) were prescribed anticoagulants. Of the 31 (21·2%) residents with AF were not prescribed antithrombotics, 21 (67·7%) had relative contraindications for anticoagulant treatments. WHAT IS NEW AND CONCLUSION: Although there was a high overall use of antithrombotic agents, the study found a reluctance to prescribe or recommend anticoagulants in eligible older people with AF, potentially due to associated contraindications and multimorbidity. The use of guideline-recommended stroke risk tools could assist medication review pharmacists in optimizing antithrombotic therapy in older adults with AF.

Relationships between the family environment and school-based obesity prevention efforts: can school programs help adolescents who are most in need?

Identifying factors that contribute to students' behavior and weight improvements during school-based obesity prevention interventions is critical for the development of effective programs. The current study aims to determine whether the support and resources that adolescent girls received from their families were associated with improvements in physical activity (PA), television use, dietary intake, body mass index (BMI) and body composition during participation in New Moves, a school-based intervention to prevent obesity and other weight-related problems. Adolescent girls in the intervention condition of New Moves (n = 135), and one parent of each girl, were included in the current analysis. At baseline, parents completed surveys assessing the family environment. At baseline and follow-up, 9-12 months later, girls' behaviors were self-reported, height and weight were measured by study staff and body fat was assessed using dual-energy X-ray absorptiometry. Results showed few associations between family environment factors and girls' likelihood of improving behavior, BMI or body composition. These findings suggest that in general, school-based interventions offer similar opportunities for adolescent girls to improve their PA, dietary intake, and weight, regardless of family support.

The comparative and cumulative effects of a dietary restriction and exercise on weight loss.

OBJECTIVE: To assess the independence of changes made in diet and physical activity for weight loss; and, to examine the comparative and cumulative effects of these behavioral changes on weight loss outcomes. DESIGN: The observational study is based on longitudinal data collected from 674 women and 288 men enrolled in a 2-year weight loss program introduced into a managed care setting. MEASUREMENTS: The outcome variable was body mass index (BMI) change from baseline to 2-year follow-up. Primary independent variables were changes in physical activity and dietary fat intake, assessed as continuous measures using the Paffenbarger Physical Activity Questionnaire and Block Fat Screener Questionnaire, respectively. Two-way ANCOVA was used to assess the relative effect on BMI of behavioral changes. RESULTS: Study results showed no preference for diet or physical activity change as a weight loss strategy. For both genders, the relationship between the two behaviors was synergistic rather than compensatory. Examination of the comparative benefits of behavioral changes indicated that, for women and men, restricting fat intake was more effective than increasing exercise for weight loss. While fat restrictions alone contributed to weight loss in both genders, exercise alone provided weight loss benefits to men, only. The cumulative effect of weight loss behaviors varied by gender. In women, an interaction was observed. The response of weight to fat restriction was greater among those who increased their exercise moderately or substantially. In men, there was no interaction; exercise increases helped to offset weight gain or provided small weight loss benefits at all levels of dietary fat change. CONCLUSION: Dietary changes appeared to be more effective than increased physical activity for weight loss. For women, the cumulative effect of concomitant changes in diet and exercise on weight loss was more than additive.

Weight-teasing among adolescents: correlations with weight status and disordered eating behaviors.

OBJECTIVES: This study aimed to assess the prevalence of perceived weight-teasing and associations with unhealthy weight-control behaviors and binge eating in a population-based sample of youth. Particular focus was placed on overweight youth, who may be most vulnerable to weight-teasing. METHODS: The study population included 4746 adolescents from St Paul/Minneapolis public schools who completed surveys and anthropometric measurements as part of Project EAT, a population-based study of eating patterns and weight concerns among teens. RESULTS: There were statistically significant associations between perceived weight-teasing and weight status; both overweight and underweight youth reported higher levels of teasing than average weight youth. Very overweight youth (body mass index (BMI) > or = 95th percentile) were most likely to be teased about their weight; 63% of very overweight girls, and 58% of very overweight boys reported being teased by their peers, while weight-teasing by family members was reported by 47% of these girls and 34% of these boys. Youth who were teased about their weight, particularly overweight girls, reported that it bothered them. Perceived weight-teasing was significantly associated with disordered eating behaviors among overweight and non-overweight girls and boys. For example, among overweight youth, 29% of girls and 18% of boys who experienced frequent weight-teasing reported binge-eating as compared to 16% of girls and 7% of boys who were not teased. CONCLUSIONS: Many adolescents, in particular those who are overweight, report being teased about their weight and being bothered by the teasing. Weight-teasing is associated with disordered eating behaviors that may place overweight youth at increased risk for weight gain. Educational interventions and policies are needed to curtail weight-related mistreatment among youth.

Binge and purge behavior among adolescents: associations with sexual and physical abuse in a nationally representative sample: the Commonwealth Fund survey.

OBJECTIVES: (1) To examine associations between binge and purge behavior and sexual and physical abuse among adolescents; (2) to determine if these associations remain significant after controlling for sociodemographic and anthropometric characteristics; and (3) to identify aspects of abuse associated with binge and purge behavior. METHOD: A nationally representative sample of 6728 adolescents in 5th-12th grades completed the Commonwealth Fund Survey of the Health of Adolescent Girls and Boys. RESULTS: Binge and purge behavior was nearly twice as prevalent among girls (13%) as boys (7%), and was significantly associated with all abuse types (physical, sexual, or both). Associations were strongest among individuals who had experienced both physical and sexual abuse [odds ratios 4.28 (girls) and 8.25 (boys)]. Differences in binge and purge behavior by gender and type of abuse across abuse characteristics were limited. A higher percentage of abused youth that did not discuss their abuse reported binge-purge behavior than those who did discuss their abuse. Abused girls and boys who did talk to someone about the abuse most often discussed the abuse with their best friend (42.5% and 18.0%, respectively), their mother (38.8% and 32.2%, respectively), and their friends (27.2% and 19.5%, respectively). DISCUSSION: Being physically and/or sexually abused was associated with greater likelihood for engaging in binge and purge behaviors. Discussing the abuse experience with another person may help to reduce binge-purge behavior, as abused adolescents who did not discuss the abuse were more likely to report binge-purge behavior than those who did discuss their abuse.

Optimal continuous sequential boundaries for monitoring toxicity in clinical trials: a restricted search algorithm.

Continuous monitoring of severe adverse experiences can ensure the timely termination of a clinical trial if the therapy is shown to be harmful. In this paper we present methods for choosing a stopping rule for continuous monitoring of toxicity in small trials. They are especially useful for small phase II trials of about 30 patients for monitoring a binary toxicity event that is observed relatively quickly compared to the efficacy outcome. In 1987 Goldman described an algorithm for computing the exact type I error rate (alpha) and power (1-beta) of a specified discrete stopping boundary for sequential monitoring of a study with a fixed maximum number of patients (N) to be enrolled on the experimental therapy. Only an upper boundary was used since trials are only terminated for an excess frequency of toxicity and not for a low rate. By repeated use of this algorithm a stopping rule can be identified which has nearly the chosen level of (alpha) and a reasonable power depending on the design parameters of the study. The work reported here embeds this earlier algorithm as a subroutine in a larger FORTRAN program which searches all boundaries that fulfil constraints on size and power, as specified by the user. The search is restricted so that only those boundaries with size in a small neighbourhood of the chosen alpha are examined and displayed if the power is above a set minimum. These restrictions reduce the number of boundaries examined to only 0.4 per cent of all possible boundaries, thus reducing running time to a practical few seconds. Many such boundaries exist, the one with the largest power can then be chosen for monitoring the trial. The average sample number (ASN) and the expected relative loss (ERL) are also computed. The criterion for choosing may also be based on small ASN or low ERL in addition to power and appropriate alpha.

The relationship between restraint and weight and weight-related behaviors among individuals in a community weight gain prevention trial.

PURPOSE: The present study evaluated the cross-section and prospective associations between the Eating Inventory's (EI) total, flexible and rigid dietary restraint scales and changes in weight and behaviors in a community sample of adults enrolled in a 3 y weight gain prevention study. METHODS: Subjects were participants in the Pound of Prevention (POP) study, a community-based weight gain prevention trial. RESULTS: Higher levels of baseline total, flexible and rigid dietary restraint were related to lower weight and more weight-controlling behaviors at the baseline assessment. Baseline restraint measures positively predicted increases in weighing frequency over the 3 y follow-up. Increases in restraint over the follow-up period were related to decreases in weight, energy intake and television watching, and increases in self-weighing and physical activity. CONCLUSION: The EI's total, flexible and rigid restraint scales were not differently associated with weight and behaviors in this heterogeneous sample of adults who were attempting to lose weight. Developing methods to increase behavioral and cognitive strategies to control weight may help to prevent weight gain in clinical and community samples.

Low heart rate variability in a 2-minute rhythm strip predicts risk of coronary heart disease and mortality from several causes: the ARIC Study. Atherosclerosis Risk In Communities.

BACKGROUND: Low heart rate variability (HRV) is associated with a higher risk of death in patients with heart disease and in elderly subjects and with a higher incidence of coronary heart disease (CHD) in the general population. METHODS AND RESULTS: We studied the predictive value of HRV for CHD and death from several causes in a population study of 14 672 men and women without CHD, aged 45 to 65, by using the case-cohort design. At baseline, in 1987 to 1989, 2-minute rhythm strips were recorded. Time-domain measures of HRV were determined in a random sample of 900 subjects, for all subjects with incident CHD (395 subjects), and for all deaths (443 subjects) that occurred through 1993. Relative rates of incident CHD and cause-specific death in tertiles of HRV were computed with Poisson regression for the case-cohort design. Subjects with low HRV had an adverse cardiovascular risk profile and an elevated risk of incident CHD and death. The increased risk of death could not be attributed to a specific cause and could not be explained by other risk factors. CONCLUSIONS: Low HRV was associated with increased risk of CHD and death from several causes. It is hypothesized that low HRV is a marker of less favorable health.

Comparison of computer-assigned Minnesota Codes with the visual standard method for new coronary heart disease events.

The Minnesota Code is the most widely used electrocardiogram (ECG) classification system for epidemiologic studies and has been incorporated into several Computer algorithms. The authors compared the Modular ECG Analysis System (MC-MEANS) and NOVACODE computer ECG findings with the Visual coding standard for agreement and prognostic associations with coronary heart disease (CHD) events occurring during follow-up from 1987 to 1995 in 2,116 individuals participating in the Atherosclerosis Risk in Communities (ARIC) Study. The exact agreement between Visual and computer findings was greater than 90% for all Minnesota Code categories except Q-code, which was 77% for MC-MEANS and 81% for NOVACODE. Approximately 60% of all Q-codes were assigned by computer methods only. Among the 2,116 participants, there were 246 (11.6%) new coronary events. Unadjusted relative risks for codes assigned by the three methods were similar. When computer methods disagreed on code severity, the CHD occurrence rates for MC-MEANS-detected severer code versus NOVACODE-detected severer code were 21% and 7%, respectively. This study provides clear evidence that computers assign more and severer Minnesota Codes with similar prognostic importance as does the Visual method; it also alerts researchers to potential problems in pooling Minnesota Code data read by different methods.

Disordered eating among adolescents: associations with sexual/physical abuse and other familial/psychosocial factors.

OBJECTIVE: To examine associations between disordered eating behaviors and a range of familial/psychosocial factors, including sexual and physical abuse experiences, among adolescent girls and boys. METHOD: A statewide representative sample of 9,943 students in Grades 7, 9, and 11 in Connecticut completed a comprehensive survey on adolescent health within their schools. The present analysis focused on measures of disordered eating, sexual and physical abuse, familial factors, peer support, and depressive symptoms. RESULTS: Youth at increased risk for disordered eating included those who perceived family communication, parental caring, and parental expectations as low and those who reported sexual or physical abuse experiences. After adjusting for differences in familial/psychosocial factors, associations between abuse experiences and disordered eating were weakened. However, youth who reported sexual abuse were still at increased risk for disordered eating, even after adjusting for physical abuse, sociodemographics, and familial/psychosocial factors (girls: odds ratio [OR] = 1.99, 95% confidence interval [CI] = 1.51, 2.64; boys: OR = 4.88, 95% CI = 2.94, 8.10). Youth reporting physical abuse were also at increased risk for disordered eating after adjusting for sexual abuse, sociodemographics, and familial/psychosocial factors (girls: OR = 2. 00, 95% CI = 1.52, 2.62; boys: OR = 1.95, 95% CI = 1.26, 3.04). DISCUSSION: The findings suggest that strong familial relationships may decrease the risk for disordered eating among youth reporting abuse experiences, but both sexual and physical abuse are strong independent risk factors for disordered eating among both adolescent girls and boys.

Weight-related behaviors among adolescent girls and boys: results from a national survey.

OBJECTIVE: The study objectives were to assess (1) the prevalence of dieting and disordered eating among adolescents; (2) the sociodemographic, anthropometric, psychosocial, and behavioral correlates of dieting and disordered eating; and (3) whether adolescents report having discussed weight-related issues with their health care providers. DESIGN: Cross-sectional school-based survey. STUDY POPULATION: A nationally representative sample of 6728 adolescents in grades 5 to 12 who completed the Commonwealth Fund surveys of the health of adolescent girls and boys. MAIN OUTCOME MEASURES: Dieting and disordered eating (binge-purge cycling). RESULTS: Approximately 24% of the population was overweight. Almost half of the girls (45%) reported that they had at some point been on a diet, compared with 20% of the boys. Disordered eating was reported by 13% of the girls and 7% of the boys. Strong correlates of these behaviors included overweight status, low self-esteem, depression, suicidal ideation, and substance use. Almost half of the adolescents (38%-53%) reported that a health care provider had at some point discussed nutrition or weight with them. Discussions on eating disorders were reported by lower percentages of girls (24%) and boys (15%). CONCLUSIONS: The high prevalence of weight-related concerns suggests that all youth should be reached with appropriate interventions. Special attention needs to be directed toward youth at greatest risk for disordered eating behaviors, such as overweight youth, youth engaging in substance use behaviors, and youth with psychological concerns such as low self-esteem and depressive symptoms.

Predictors of weight gain in the Pound of Prevention study.

OBJECTIVES: This study examined cross-sectional and prospective relationships between macronutrient intake, behaviors intended to limit fat intake, physical activity and body weight. DESIGN: The overall goal was to identify diet and exercise behaviors that predict and/or accompany weight gain or loss over time. Specific questions addressed included: (a) are habitual levels of diet or exercise predictive of weight change; (b) are habitual diet and exercise levels associated cross-sectionally with body weight; and (c) are changes in diet and exercise associated with changes in body weight over time? PARTICIPANTS: Subjects were a sample of community volunteers (n=826 women, n=218 men) taking part in a weight gain prevention project over a 3-year period. MEASURES: Body weight was measured at baseline and annually over the study period. Self-report measures of diet and exercise behavior were also measured annually. RESULTS: Among both men and women, the most consistent results were the positive association between dietary fat intake and weight gain and an inverse association between frequency of physical activity and weight gain. Individuals who weighed more both ate more and exercised less than those who weighed less. Individuals who increased their physical activity level and decreased their food intake over time were protected from weight gain compared to those who did not. Frequency of high-intensity physical activity was particularly important for both men and women. Additionally, women who consistently engaged in higher levels of moderate physical activity gained weight at a slower rate compared to women who were less active. CONCLUSIONS: Overall results indicated that both cross-sectionally and prospectively, the determinants of weight and weight change are multifactorial. Attention to exercise, fat intake and total energy intake all appear important for successful long term control of body weight.

Primary prevention of disordered eating among preadolescent girls: feasibility and short-term effect of a community-based intervention.

OBJECTIVE: To evaluate a community-based intervention aimed at the primary prevention of disordered eating among preadolescent girls. DESIGN: Girl Scout troop members were randomized into control and intervention groups. Program feasibility and effect at postintervention and 3-month follow-up were evaluated. SUBJECTS/SETTING: 226 girls (mean age = 10.6 years, standard deviation = 0.7) from 24 Girl Scout troops. INTERVENTION: Six 90-minute sessions focusing on media literacy and advocacy skills. MAIN OUTCOME MEASURES: Evaluation focused on program satisfaction and short-term effect on dieting behaviors, body image attitudes, and media knowledge, attitudes, and habits. STATISTICAL ANALYSES: Performed t tests, chi 2 tests, and analyses of covariance including troop as a random source of variation. RESULTS: At baseline, 29% of the girls were trying to lose weight. The program had a notable positive influence on media-related attitudes and behaviors including internalization of sociocultural ideals, self-efficacy to impact weight-related social norms, and print media habits. A modest program effect on body-related knowledge and attitudes was apparent at post-intervention (i.e., on body size acceptance, puberty knowledge, and perceived weight status) but not at follow-up. Significant changes were not noted for dieting behaviors, but they were in the hypothesized direction. Satisfaction with the program was high among girls, parents, and leaders. APPLICATIONS/CONCLUSIONS: It is feasible to use community youth settings, such as the Girl Scouts, to implement interventions to prevent disordered eating behaviors. The program led to positive trends in outcome variables; however, longer and more intensive interventions are needed for lasting changes in body image and dieting behaviors.

Interpreting age, period and cohort effects in plasma lipids and serum insulin using repeated measures regression analysis: the CARDIA Study.

Observed changes in health-related behaviours and disease risk factors may arise from physiological or environmental changes, or from biases due to sampling or measurement errors. We illustrate problems in the interpretation of such changes with longitudinal data from the Coronary Artery Risk Development in Young Adults (CARDIA) study. Mean plasma cholesterol was 14 mg/dl higher in 27- than in 20-year-old black men cross-sectionally, but longitudinally it declined by 4 mg/dl during the 7 years. To sort out these contradictory assessments of the effect of age/passage of time, we estimated age and period effects under the assumptions that age effects are a smooth function of age independent of period, and that period effects are changes common to persons across all ages. Simple estimates the age effect, such as the cross-sectional age slopes, may be confounded by cohort effects, by interactions of time and age after baseline, or by the occurrence of non-linearities in response after baseline. We note examples of each potential type of bias. The data and background literature support the assumption that cohort effects do not seriously compromise interpretation for these variables in the CARDIA study. Strong secular decreases in plasma cholesterol, apparently due to population-wide dietary change, mask increases with ageing. Age increases in triglycerides are largely explained by increases in body fatness. For these data, we cautiously accept the cross-sectional age slope as an estimate of ageing and the age-matched time trend as an estimate of secular trend.

Analysis of failure times for multiple infections following bone marrow transplantation: an application of the multiple failure time proportional hazards model.

We report an application of the proportional hazards model for multiple failure times in a study arising from the Bone Marrow Transplant Database at the University of Minnesota. The study compared the risk of infections after transplantation for patients who received allogeneic bone marrow transplants from unrelated donors (URD) versus related donors (RD). In 249 patients there was a total of 365 infections in 2.5 years of follow-up. The multiple failure time model uses all the data and provides empirical estimates of standard errors that incorporate the within-person dependencies in the data. The estimate of relative risk associated with URD was 1.4 (naive 95 per cent confidence interval 1.14 to 1.73, empirical 1.08 to 1.79), compared to the estimate 1.6 (naive or empirical, 1.1 to 2.1) from the proportional hazards model on 165 first infections only. The multivariate model gives great flexibility in modelling, for example, in accommodating a separate base hazard function for each type of failure and in allowing analysis of intervals between infections as an alternative to analysis of time from a marker event, here transplantation.

Analysis of data from group-randomized trials with repeat observations on the same groups.

This study used Monte Carlo simulations to evaluate the performance of alternative models for the analysis of group-randomized trials having more than two time intervals for data collection. The major distinction among the models tested was the sampling variance of the intervention effect. In the mixed-model ANOVA, the sampling variance of the intervention effect is based on the variance among group x time-interval means. In the random coefficients model, the sampling variance of the intervention effect is based on the variance among the group-specific slopes. These models are equivalent when the design includes only two time intervals, but not when there are more than two time intervals. The results indicate that the mixed-model ANOVA yields unbiased estimates of sampling variation and nominal type I error rates when the group-specific time trends are homogenous. However, when the group-specific time trends are heterogeneous, the mixed-model ANOVA yields downwardly biased estimates of sampling variance and inflated type I error rates. In contrast, the random coefficients model yields unbiased estimates of sampling variance and the nominal type I error rate regardless of the pattern among the groups. We discuss implications for the analysis of group-randomized trials with more than two time intervals.

Validation of death certificate diagnosis of out-of-hospital sudden cardiac death.

The validity of death certificate diagnosis of out-of-hospital sudden cardiac death (OOH-SCD) was studied among 108,676 30- to 74-year-old residents in 5 Minnesota communities using 6-year mortality data (1985 to 1990). Among 4,244 total deaths, location of death was listed on the certificate as out of hospital in 2,035 cases. Of those, 911 were judged not to have OOH-SCD because they had actually been admitted to the hospital or were noncardiovascular deaths. Among the remaining 1,124, 254 were diagnosed as OOH-SCD using a thorough, physician-based procedure that used clinical records, autopsy reports, and an informant (next-of-kin) interview. We used only death certificate information to define OOH-SCD simply and inexpensively as ICD-9 code 427.5 (cardiac arrest) plus location of death listed as out-of-hospital. Compared with the physician diagnosis, sensitivity was only 24%, whereas specificity was 85%. When the definition of OOH-SCD was expanded to include ICD codes 410-414 (acute myocardial infarction and chronic coronary artery disease), sensitivity improved to 87%, whereas specificity became 66%. However, even with this higher sensitivity and specificity, only 27% of the cases labeled OOH-SCD by death certificate agreed with the physician diagnosis. Death certificate diagnosis of OOH-SCD included many erroneous cases, and may not have been suitable for study of etiologic factors, such as cardiac dysrhythmias. Death certificate diagnosis may be useful to assess population time trends in OOH-SCD, provided that misclassification (false-positive rate) remains constant over time.

Prognostic associations of Minnesota Code serial electrocardiographic change classification with coronary heart disease mortality in the Multiple Risk Factor Intervention Trial.

A central requirement for epidemiologic studies and clinical trials is a bias-free, objective determination of cardiac incidence rates between comparison groups. Epidemiologic studies and clinical trials frequently use changes in the Minnesota Code to document incident ischemic events. An electrocardiographic (ECG) classification system was developed to document significant ECG pattern change using objective comparison rules for side-by-side annual ECG comparison. Previously, we showed that major evolving Q waves were strongly and independently associated with total and coronary disease mortality. Using baseline-to-annual ECG comparisons in the Multiple Risk Factor Intervention Trial, we evaluated major evolving Q waves, minor evolving Q waves combined with major evolving ST-T waves and major evolving ST-T waves alone for their prognostic associations with coronary, cardiovascular, and total mortality during 16 years of follow-up. The 16-year coronary mortality rate in men with evolving minor Q waves plus evolving ST-T waves had an average adjusted relative risk of 4, equivalent to that of a major evolving Q wave. These risk ratios held whether a clinical infarction had occurred. Silent evolving ST-T waves without Q-wave change had an average adjusted relative coronary mortality risk of 1.6. Serial comparison methodology documents additional incident ischemic ECG events beyond the traditional major Minnesota Q-code change used in older epidemiologic studies. The procedure is standardized, quantitative, and repeatable. It is applicable for any study, present or past, that used Minnesota coding. The method is also well suited for incorporation in computer analysis programs.

Recruitment, retention and characteristics of women in a prospective study of preconceptional risks to reproductive outcomes: experience of the Diana Project.

Preterm delivery, low birthweight, and intrauterine growth retardation are common and recalcitrant problems in many countries. Although much remains to be learned, we know particularly little about the relationships between preconceptional and early pregnancy exposures and these and other reproductive outcomes. The study presented here was primarily designed to investigate the relationships between nutritional exposures measured before and during pregnancy and reproductive outcomes. This paper describes methods used to recruit the required 1000 preconceptional women from the collaborating health maintenance organisation (HMO) and the retention of participants in this time-intensive study. The results presented demonstrate that an adequate completion rate (66.3%), and a remarkably representative sample of women that poses few threats to the study's validity, can be obtained by population-based recruitment of women from an HMO.