PubMed Health⌕ Search

PubMed · 383095

[Errors in clinical data collection (author's transl)].

Abstract

In the design of clinical trials the collection of the routine data is often not sufficiently defined. Numerous mistakes may occur in the registration of blood pressure, heart rate, body temperature, body weight, circumferences. The mistakes have to be prevented by standardization. In particular the intake of drugs especially during long-term medication has to be supervised.

Explore related subjects

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

U Gundert-Remy. 1978. [Errors in clinical data collection (author's transl)].. https://pubmed.ncbi.nlm.nih.gov/383095/

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

Impact of anatomic closure on somatic growth among small, asymptomatic children with secundum atrial septal defect.

We retrospectively identified 92 children aged </=9 years with isolated secundum atrial septal defect (ASD) with preoperative height or weight z score < or =1.0 (16th percentile), respectively. Children with additional cardiac malformations, chromosomal abnormalities, recognized syndromes, pulmonary hypertension, heart failure, prematurity (<34 weeks' gestation), or use of cardiac medications were excluded from further analysis. After exclusion, 24 low-weight and 25 low-height children were compared with 48 and 50 age-, gender-, and size-matched normal controls, respectively. Univariate and multivariate analyses were performed separately for height and weight groups for achieving an end point of improvement in height or weight z score by +0.5 after repair. There were no significant preoperative demographic differences. After repair, 50% of low-weight patients improved +0.5 SD in weight within 2.6 years versus 5.6 years for controls (p = 0.02). Similarly, 50% of low-height patients improved +0.5 SD in height within 1.7 years versus 11.6 years for controls (p <0.001). Multivariate analysis also indicated a benefit of repair with relative risks of 2.35 (95% confidence interval 1.20 to 4.62; p = 0.01) and 5.11 (95% confidence interval 2.45 to 10.65; p <0.0001), respectively, for improving height or weight by +0.5 SD in patients with ASD relative to controls. Furthermore, children heavier at repair were less likely to improve in weight (relative risk 0.56 [0.34, 0.92] per 1.0 z [p = 0.02]). Likewise, children older at repair were less likely to improve in height (relative risk 0.77 [0.64, 0.92] per year of age [p = 0.003]). We conclude that undersized children with ASD exhibit improved growth after repair. Poor growth should be considered a relative indication for early ASD repair.

Body Height↗

Risk factors for neonatal encephalopathy in Kathmandu, Nepal, a developing country: unmatched case-control study.

OBJECTIVE: To determine the risk factors for neonatal encephalopathy among term infants in a developing country. DESIGN: Unmatched case-control study. SETTING: Principal maternity hospital of Kathmandu, Nepal. SUBJECTS: All 131 infants with neonatal encephalopathy from a population of 21 609 infants born over an 18 month period, and 635 unmatched infants systematically recruited over 12 months. MAIN OUTCOME MEASURES: Adjusted odds ratio estimates for antepartum and intrapartum risk factors. RESULTS: The prevalence of neonatal encephalopathy was 6.1 per 1,000 live births of which 63% were infants with moderate or severe encephalopathy. The risk of death from neonatal encephalopathy was 31%. The risk of neonatal encephalopathy increased with increasing maternal age and decreasing maternal height. Antepartum risk factors included primiparity (odds ratio 2.0) and non-attendance for antenatal care (2.1). Multiple births were at greatly increased risk (22). Intrapartum risk factors included non-cephalic presentation (3.4), prolonged rupture of membranes (3.8), and various other complications. Particulate meconium was strongly associated with encephalopathy (18). Induction of labour with oxytocin was associated with encephalopathy in 12 of 41 deliveries (5.7). Overall, 78 affected infants (60%) compared with 36 controls (6%) either had evidence of intrapartum compromise or were born after an intrapartum difficulty likely to result in fetal compromise. A concentration of maternal haemoglobin of less than 8.0 g/dl in the puerperium was significantly associated with encephalopathy (2.5) as was a maternal thyroid stimulating hormone concentration greater than 5 mIU/l (2.1). CONCLUSIONS: Intrapartum risk factors remain important for neonatal encephalopathy in developing countries. There is some evidence of a protective effect from antenatal care. The use of oxytocin in low income countries where intrapartum monitoring is suboptimal presents a major risk to the fetus. More work is required to explore the association between maternal deficiency states and neonatal encephalopathy.

Body Height↗