Maternal health, antenatal and at 8 weeks after delivery, in home versus in-hospital fetal monitoring in high-risk pregnancies.

OBJECTIVE: To assess maternal health outcome, comparing high-risk pregnant women to either domiciliary monitoring or in-hospital monitoring, and a low risk pregnant group. DESIGN: Paper and pencil questionnaire, distributed antenatal and 8 weeks after the delivery. SETTING: A university hospital. SUBJECTS: Three groups: 130 high-risk pregnant women, who entered a randomized clinical trial and were allocated to either home (n=69) or in-hospital monitoring (n=61), and a reference cohort of low risk pregnant women (n=55). MAIN OUTCOME MEASURES: Antenatal physical and mental health (RAND36) and social experiences; mode of delivery; complications postpartum; physical health, mental health, and social experiences at 8 weeks postpartum. RESULTS: In all groups, antenatal physical health was considerably lower compared to the physical health of US women aged 18--44 years. Antenatal mental health was lower in high-risk women than in low-risk women (P<0.05). Antenatal maternal health, the mode of delivery, and maternal complications postpartum did not differ significantly between in-hospital and domiciliary monitored women. Eight weeks after delivery, physical health improved considerably in all groups; mental health was significantly lower in high-risks as compared to low-risk women (P<0.01). The allocated monitoring strategy showed a significant effect on mental health at 8 weeks after delivery; the mental health score being lower in the domiciliary monitored group (P<0.05). CONCLUSIONS: At 8 weeks after the delivery, physical health improves substantially in all groups. Mental health is higher in low-risks than in high-risks. Within the high-risk group domiciliary and in-hospital monitored women have the same physical maternal outcome at 8 weeks after delivery. However, mental maternal health in in-hospital monitored women at 8 weeks was probably biased by a medicalization effect.

Comparing treatment valuations between and within subjects in clinical trials: does it make a difference?

Valuations may be sensitive to biases, especially if elicited alongside randomized clinical trials. We investigated the construction of valuations assigned by women who entered a randomized clinical trial and were allocated to in-hospital or domiciliary monitoring. Women assigned valuations (0-10 visual analogue scale) to the strategy they had been allocated to and to the alternative strategy. Valuations were expressed as a between-subject difference (assigned by the women allocated to the respective strategies) and as within-subject differences (assigned by all women). Domiciliary monitoring was valued higher by the women allocated to that strategy (P = 0.10). In-hospital monitoring was valued higher by the women allocated to that strategy (P = 0.02). The average within-subject differences differed by allocated strategy (P<0.01). The within-subject valuation differences showed large variability between and within groups. An overrepresentation of women favoring domiciliary monitoring and asymmetric treatment experience inflated the average within-subject difference in the domiciliary group but deflated that difference in the in-hospital group. Neither the average between-subject difference nor the average within-subject differences are free of bias. Other study designs probably cannot prevent bias. Comparing within-subject and between-subject differences is instructive.

Interobserver variability of the neurological optimality score.

OBJECTIVE: To assess the interobserver reliability of the neurological optimality score. STUDY DESIGN: The neurological optimality score of 21 full term healthy, neurologically normal newborn infants was determined by two well trained observers. RESULTS: The interclass correlation coefficient was 0.31. Kappa for optimality (score of 58 or higher) was 0.19. A systematic difference of 1.3 points between the two observers was present. CONCLUSIONS: The interobserver variability of the neurological optimality score of the newborn infant is substantial. The subtle judgement of elicited responses as optimal or non-optimal proved to be especially critical in this concordance study. A difference of at least two points in the score is considered as a valid endpoint for comparative studies. If two or more observers are involved in the neurological examination of the newborn infant in a study to assess influences on perinatal morbidity, frequent re-instruction sessions are recommended.

Cost-minimization analysis of domiciliary antenatal fetal monitoring in high-risk pregnancies.

OBJECTIVE: To compare safety and cost-effectiveness of domiciliary antenatal fetal monitoring (cardiotocography and obstetric surveillance) with in-hospital monitoring in high-risk pregnancies. METHODS: From September 1992 to June 1994, 150 consecutive women with high-risk pregnancies, who would otherwise be monitored in the hospital, entered a randomized controlled trial of in-hospital (n = 74) or domiciliary (n = 76) monitoring. The main outcome measures were neonatal safety (Prechtl neurologic optimality score, the proportion of non-optimals) and cost-effectiveness. To test a two-point difference in mean Prechtl scores (two-tailed o = .05. 1-beta = .80), 150 women were needed. Safety and cost-effectiveness were analyzed according to intention to treat. Conditional on the safety outcomes, a cost-minimization analysis based on actual resource use was performed. Uncertainty of results was explored by sensitivity analyses. RESULTS: Neonatal outcomes were equal. No cost-shifting between the antenatal and postpartum period occurred. Substituting domiciliary for in-hospital monitoring reduced mean (standard deviation) antenatal costs from $3558 ($2841) to $1521 ($1459) per woman (P < .001). If costs were varied by the addition of 50%, costs were still reduced. The magnitude of the reduction was sensitive to the costs of hospital care and less sensitive to the costs of domiciliary monitoring. CONCLUSION: Domiciliary monitoring is safe and reduces costs by one-half. The technique seems transferable to other settings but local circumstances may sometimes hamper its dissemination.

High risk pregnancy monitored antenatally at home.

OBJECTIVE: Is domiciliary antenatal fetal surveillance for selected high risk pregnancies, a feasible alternative for hospital admission? DESIGN: A randomized controlled trial conducted at the Academical Medical Centre, Amsterdam, The Netherlands. SUBJECTS: Between September 1992 and June 1994, 76 women were at random allocated to domiciliary care and 74 women to hospital care. Criteria for inclusion were hypertension (26%), fetal growth retardation (24%), post term pregnancy (23%), diabetes (24%), preterm rupture of membranes (2%) and previous recurrent antenatal death (1%). MAIN OUTCOME MEASURES: Primary outcome measure was perinatal morbidity, measured by Prechtl's neonatal neurological optimality score. Secondary outcome variables were the occurrence of complications, obstetric interventions at labour, birthweight, gestational age at delivery and maternal and neonatal admission rates. RESULTS: In both groups there was one case of perinatal mortality. In both treatment groups the median of the neurological optimality score was found at 59. Also secondary outcome variables did not show significant differences. CONCLUSION: Domiciliary antenatal care for selected women with high risk pregnancy is feasible considering obstetric outcome.

Vasectomy and the risk of prostate cancer.

Even if there is a weak association between vasectomy and subsequent prostate cancer, we believe that large-scale studies on this question should be of low priority in developing countries where vasectomy is widely practised and where the incidence of prostate cancer is low. Arguments to justify this point of view are presented.

PIP: Studies in the US which have claimed that vasectomy increases the risk for prostate cancer have been evaluated and only weak associations (which may be due to methodological shortcomings) have been found. To resolve this issue, some investigators have called for confirmatory studies in developing countries and have, by this action, increased anxiety, especially in India. 2 examples will show that confirmatory studies are not needed in developing countries because of the low incidence of prostate cancer. The first example uses the total annual incidence of prostate cancer in Bombay (8.2/100,000) and assumes a vasectomy prevalence rate of 5% and a 60% higher risk of prostate cancer for vasectomized men. The implication of this would be that prostate cancer would occur in 8/100,000 nonvasectomized vs. 12.7/100,000 vasectomized men for a population attributable risk of 0.24/100,000/year, and the fraction of the disease attributable to exposure to vasectomy (population attributable fraction) would be 3% of all cases of prostate cancer in Bombay. The second example assumes a relative risk of 3 in a population where 10% of the men are vasectomized. The population attributable risk would be 1.67/100,000/year, and the population attributable fraction would be 0.17. Thus, the potential impact of vasectomy on public health in a country where prostate cancer is uncommon is small, even if a large percentage of the men had vasectomies. Also, the numbers of men to be followed to detect one case of cancer annually in each group would be too large for any realistic prospective study, and it is unlikely that a case-control study would add to our existing information. Thus, longterm studies into the longterm safety of vasectomies should occupy a low priority in developing countries where vasectomy is widely used and the incidence of prostate cancer is low.