Broadening the Debate About Post-trial Access to Medical Interventions: A Qualitative Study of Participant Experiences at the End of a Trial Investigating a Medical Device to Support Type 1 Diabetes Self-Management.

Increasing ethical attention and debate is focusing on whether individuals who take part in clinical trials should be given access to post-trial care. However, the main focus of this debate has been upon drug trials undertaken in low-income settings. To broaden this debate, we report findings from interviews with individuals (n = 24) who participated in a clinical trial of a closed-loop system, which is a medical device under development for people with type 1 diabetes that automatically adjusts blood glucose to help keep it within clinically recommended ranges. Individuals were recruited from UK sites and interviewed following trial close-out, at which point the closed-loop had been withdrawn. While individuals were stoical and accepting of the requirement to return the closed-loop, they also conveyed varying degrees of distress. Many described having relaxed diabetes management practices while using the closed-loop and having become deskilled as a consequence, which made reverting back to pre-trial regimens challenging. Participants also described unanticipated consequences arising from using a closed-loop. As well as deskilling, these included experiencing psychological and emotional benefits that could not be sustained after the closed-loop had been withdrawn and participants reevaluating their pre- and post-trial life in light of having used a closed-loop and now perceiving this life much more negatively. Participants also voiced frustrations about experiencing better blood glucose control using a closed-loop and then having to revert to using what they now saw as antiquated and imprecise self-management tools. We use these findings to argue that ethical debates about post-trial provisioning need to be broadened to consider potential psychological and emotional harms, and not just clinical harms, that may result from withdrawal of investigated treatments. We also suggest that individuals may benefit from information about potential nonclinical harms to help make informed decisions about trial participation.

The declining marital-status earnings differential.

"Earnings differentials between married and unmarried [U.S.] men have been declining since the late 1960s. We consider two possible explanations for this decline: changes in the nature of selection into marriage; and changes in role specialization within marriage. Our analysis of changes in marriage differentials within cohorts supports only a small contribution of changes in selection. There is some evidence that differences in human-capital investment between married and unmarried men have fallen over time, but this effect has apparently been largely offset by increases in the return to that human capital." This is a revised version of a paper originally presented at the 1991 Annual Meeting of the Population Association of America.

Fertility timing, wages, and human capital.

PIP: This theoretical model posits that women who delay child bearing will be more likely to invest in human capital (training that enhances productivity but is costly). This investment is conditioned by a greater discount rate than an economy-wide growth rate of wages for non-human capital investor women. The aim of the model is to present a more unified view of relationships between wages and fertility timing identified in earlier research. The empirical analyses, using ordinary least squares techniques, was based on data from the National Longitudinal Survey of Young Women, 1968-82 annually, for a sample of 1817 White working women aged 28-38 in 1982. Data were available for wages, education, work experience, age, number of children, and the percentage in occupations (manager, professional, administrative, service, and blue collar). First wages of women not in school and without a first birth were obtained for 991 women in the sample. Descriptive statistics revealed that the average early wage of late child bearers was 37% higher than the average early wage of early child bearers and 43% higher for 1982 wages. Childless women, compared to early child bearers, experienced a growth in wages from 31-38%. The assumptions in the theoretical model were 1) that all women were equally productive in the labor market in the beginning; 2) that women bore only one child; 3) that women worked continuously for a period of time, except for time out for child bearing; 4) that all women had the option of investing in one type of human capital, which cost the same for all women; 5) that the only source of income was the woman's own earnings; and 6) that a woman's lifetime utility was a function of the present value of her lifetime income and the intervening time period for child birth. Differences in education, experience, tenure, and wages were strongly associated with differences in fertility timing. The results revealed that wages were higher for delayed child bearers, primarily because of larger accumulations of human capital, assuming joint human capital and fertility timing decisions. The interpretation of regressions to test family influence was that unobserved heterogeneity partly explained the empirical relationship. Wages were affected by education, experience, and tenure, as proxies for human capital. Results were consistent with the hypothesis but did not confirm the theory.^ieng

Heart rate and energy expenditure of pregnant and lactating women.

Data on heart rate and oxygen consumption of 21 mature pregnant women, and of 16 of them postpartum, were examined for evidence of the suitability of heart rate as an index of energy expenditure during pregnancy. Energy expenditure, measured by indirect calorimetry, and heart rate were recorded with subjects at rest (lying, sitting, and standing) and working (on a treadmill and cycle ergometer) at three different levels. Energy expenditure (EE) and heart rate (HR) were highly correlated during the second half of gestation and postpartum. Both EE and HR were affected by pregnancy state, but the relationship between HR and EE was not changed. Slopes of regression of two linear components of EE/HR relationship were 0.01-0.02 for resting, and 0.05-0.06 for working measures. The slopes under resting and working conditions are significantly different from zero, and from each other. Prediction of EE from HR is unreliable in the range 80-120 beats/min where resting and working HRs overlap.

Energy expenditure and consumption of mature, pregnant and lactating women.

Activity patterns, energy expenditure, and energy and protein consumption of mature women were determined during preganncy and lactation. Homemakers of average economic status from a mixed population were not significantly more active than teenage women, but the range of activities was greater. Average energy output for the latter half of gestation was 2,200 to 2,300 kcal per day; per unit of body weight, the mean was 32.5 +/- 4 kcal per kilogram for the twenty-week period. A small decline of 6 per cent in energy expenditure was noted near term. Allowing for deposition of fetal and material tissue, the average metabolizable energy need for this group was about 35 to 36 kcal per kilogram for the latter half of pregnancy. These data show that a pregnant woman of reference body weight (68 kg.) may vary in energy output by 800 to 900 kcal per day, depending on occupation. Homemakers with small children and especially those who work outside the home constitute a high energy work category. Thus, the need for considering work pace and work load, as well as body mass, in estimating the energy requirement during pregnancy was confirmed. Average daily energy intake reported was 1,955 kcal or 28.5 kcal per kilogram for the latter half of gestation. A mean protein intake of 1.17 gm. per kilogram per day represented 17 per cent of gross energy consumed. It is questionable whether the energy level consumed by these women was sufficient to maintain positive nitrogen balance on the days recorded. Lactating homemakers expended an average of 30 kcal per kilogram per day, exclusive of milk production. Energy intake was 30 kcal per kilogram, and was equal to 74 per cent of need when adjusted for milk production. Non-lactating women expended 34 kcal per kilogram per day, 13 per cent above the values for lactating women. Average energy intake of non-lactating women was 19 kcal per kilogram, with protein intake representing 19 per cent of energy consumed for both groups.

Basal metabolic rate and work energy expenditure of mature, pregnant women.

Resting and working metabolic rates and physical fitness of twenty-one mature women were studied at various intervals during the last half of pregnance and in sixteen of them again eight to twelve weeks postpartum. Basal rate (BMR) was increased more than body weight during pregnancy, and there was a small drop in BMR per unit body mass near term. Data on lean body mass (40K) suggest that the small terminal fall in BMR is not explained by a shift in body composition toward increased fat or water. The increase in energy cost of work paralleled the gain in body weight during preganacy. Net energetic efficiency thus appeared to be higher for work performed during pregnancy, if recovery rates are assumed to be uniform. However, according to their heart rate reponses to fixed hard work, the women were less fit during pregnancy than they were postpartum, with the level of fitness decreasing as pregnancy advanced. The prolonged rate of recovery suggests that oxygen uptake may be increased for a longer period after work in the pregnant woman. If this is true, energy expenditure will be seriously underestimated by the application of energy cost figures obtained in the conventional manner.