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Biomedical subjects

M S Kramer

Publications and source records attributed to M S Kramer.

At least 55 records · Page 3Linked to original sources
PubMed2000

Urine culture from bag specimens in young children: are the risks too high?

OBJECTIVE: To compare the risks of contaminated culture results and consequent adverse clinical outcomes in urine specimens obtained by "clean-voided" bag method versus catheterization. STUDY DESIGN: Hospital-based cohort study of all children </=24 months with outpatient urine cultures (n = 7584) obtained from January 1993 to December 1995. Medical records were followed up for all children with contaminated culture results who had 1 or more additional cultures within 7 days of the original culture. Contamination rates of bag urine cultures from the emergency department and a pediatric test center were compared. RESULTS: Contamination rates were 62.8% and 9.1% (P <.001) in bag versus catheter specimens, respectively. Contamination rates of bag urine specimens collected in the emergency department and pediatric test center were 56.4% versus 69. 25%, respectively. Of the 3440 contaminated urines, 132 (1.7%) resulted in 1 or more adverse clinical outcomes. Adjusted odds ratios (and 95% CI) for these outcomes in bag versus catheter specimens were as follows: 4.9 (2.3 to 10.5) for unnecessary recall, infinite for delayed diagnosis and treatment, 4.8 (1.8 to 12.4) for unnecessary treatment, 15.6 (2.1 to 116.8) for unnecessary prolonged treatment, 4.1 (1.4 to 12.1) for unnecessary radiologic investigation, and 12.4 (1.6 to 95.5) for unnecessary hospital admission. CONCLUSIONS: The risks of the "noninvasive" bag urine culture appear to exceed its benefits.

Cell Culture Techniques↗
PubMed2000

High rates of infant macrosomia: a comparison of a Canadian native and a non-native population.

The Cree of James Bay have the highest ever reported mean birth weight and a high prevalence of infant macrosomia. This study was designed to examine independent risk factors for infant macrosomia among the Cree, to compare these to risk factors among non-Native Canadians and to determine if ethnic differences persist after adjusting for differences in the distribution of other risk factors. Macrosomia was defined as birth weight >90(th) percentile for gestational age of a reference population. Independent determinants of macrosomia were examined in 385 Cree and 5644 non-Native women. The potential effect of ethnicity (Cree vs. non-Native) was determined after statistically adjusting for age, parity, pregravid weight, height, net rate of weight gain, gestational diabetes mellitus (GDM) and smoking status. The prevalence of macrosomia among the Cree was 34.3% vs. 11.1% among non-Natives. Although GDM significantly increased the risk for macrosomia among the Cree (odds ratio: 4.46, 95% CI: 2.24-9.26), it was not a significant risk factor among non-Natives (odds ratio: 1.15, 95% CI: 0.79-1.65). The risk for infant macrosomia remained elevated among the Cree compared with non-Natives after adjusting for other risk factors (odds ratio: 3.64, 95% CI: 2.69-4.90). In conclusion, the Cree have a high prevalence of macrosomia despite controlling for important differences in pregravid weight and GDM. Some of this variation may be due to genetic differences in fetal growth. The differential impact of GDM on macrosomia in the two ethnic groups may be due to differences in treatment strategies for GDM.

Adult↗
PubMed2000

The Matthew effect: infant mortality in Canada and internationally.

OBJECTIVE: To examine whether the magnitude of improvement in the health status of a population over time is dependent on the previous health status of that population. DESIGN AND SETTING: A study of infant mortality rates in Canada's 12 provinces and territories between the periods 1961-1965 and 1991-1995, and of infant mortality rates in 133 countries between 1960 and 1995. MAIN OUTCOME MEASURES: Spearman's rank correlations, relative risks, and risk differences to measure the relationship between infant mortality in the 1960s and changes in infant mortality between the 1960s and 1990s. RESULTS: In Canada, regional rankings based on infant mortality rates in 1961-1965 were strongly correlated (inversely) with rankings based on the percent change in infant mortality between 1961-1965 and 1991-1995 (correlation coefficient = -.85). In contrast, internationally, rankings based on infant mortality rates in 133 countries in 1960 were positively correlated with percent change between 1960 and 1995 (correlation coefficient =.56). Regional differences in infant mortality rates, measured using relative risks, declined in Canada (highest relative risk: 4.2, compared with Ontario in the 1960s; highest relative risk: 2.2, compared with Ontario in the 1990s) but increased globally (highest relative risk: 5.0, compared with industrialized countries in 1960; highest relative risk: 15.1, compared with industrialized countries in 1995). CONCLUSIONS: Canadian regions with higher infant mortality rates in 1961-1965 achieved larger improvements compared with regions with initially lower infant mortality rates. The pattern observed within Canada is unlike the pattern observed internationally.

Canada↗
PubMed2000

Temporal changes in sensitivity of rats to cerebral ischemic insult.

OBJECT: Experimental rat models are often used to study cerebral ischemia, yet rats are nocturnal animals that have activity cycles that are the opposite of those of humans. In the following study the authors examined the circadian rhythm of sensitivity to an ischemic insult in rats by using an intraluminal thread technique to produce reversible middle cerebral artery occlusion. METHODS: Ischemia (2 hours of blockage followed by 22 hours of reperfusion) was induced in rats according to the 24-hour clock at either 100, 400, 700, 1,000, 1,300, 1,600, 1,900, or 2,200 hours (11-14 rats per time period). The rat brains were removed, coronally sectioned, stained with 2,3,5-triphenyltetrazolium chloride and analyzed using commercially available software. Analysis of variance and cosinor-rhythmometry statistical tests were used for analysis of data. The time of day when the ischemic infarct was induced had a significant (p = 0.011) influence on the volume of the lesion. The volume of total brain infarct produced at 400 hours (7.65 +/- 1.31%) was more than three times greater than the volume produced at 1600 hours (2.1 +/- 0.34%). Cosinor-rhythm analysis indicated a peak occurrence of infarct volume at 6:02 (95% confidence interval 5:49-6:16). The size of the infarct correlated with core body temperature rhythms, which varied by 1.3 +/- 0.62 degrees C (mean +/- standard deviation). CONCLUSIONS: Circadian rhythms, as well as the reversed natural body rhythms of the rat compared with humans, should be considered when extrapolating data to human or other animal studies. Temporal rhythms may also provide information concerning the cascading disease processes associated with cerebral ischemia.

Animals↗
PubMed2000

Infant mortality by gestational age and birth weight in Canadian provinces and territories, 1990-1994 births.

We compared gestational age-specific and birth weight-specific infant mortality in the Canadian provinces (excluding Ontario) and territories using the linked birth and death records for 1990-1994 births. Compared with Quebec, early neonatal mortality rates were higher in Saskatchewan, Alberta and Newfoundland among extremely small and preterm infants and among infants with no information on gestational age and birth weight on their records. Post- neonatal mortality rates were higher in Prince Edward Island, Manitoba, Saskatchewan, Alberta, British Columbia and the Northwest Territories among preterm (and low birth weight) and term (and normal birth weight) infants. We suggest that differences in registration practices probably explain the substantial interprovincial variations in early neonatal mortality rates among extremely small and preterm infants, whereas differences in demographic profile and the quality of obstetric, neonatal and infant care probably explain interprovincial variations in infant mortality rates among less extremely small and preterm infants.

Adolescent↗
PubMed2000

Promotion of breastfeeding intervention trial (PROBIT): a cluster-randomized trial in the Republic of Belarus. Design, follow-up, and data validation.

This paper summarizes the objectives, design, follow-up, and data validation of a cluster-randomized trial of a breastfeeding promotion intervention modeled on the WHO/UNICEF Baby-Friendly Hospital Initiative (BFHI). Thirty-four hospitals and their affiliated polyclinics in the Republic of Belarus were randomized to receive BFHI training of medical, midwifery, and nursing staffs (experimental group) or to continue their routine practices (control group). All breastfeeding mother-infant dyads were considered eligible for inclusion in the study if the infant was singleton, born at > or = 37 weeks gestation, weighed > or = 2500 grams at birth, and had a 5-minute Apgar score > or = 5, and neither mother nor infant had a medical condition for which breastfeeding was contraindicated. One experimental and one control site refused to accept their randomized allocation and dropped out of the trial. A total of 17,795 mothers were recruited at the 32 remaining sites, and their infants were followed up at 1, 2, 3, 6, 9, and 12 months of age. To our knowledge, this is the largest randomized trial ever undertaken in area of human milk and lactation. Monitoring visits of all experimental and control maternity hospitals and polyclinics were undertaken prior to recruitment and twice more during recruitment and follow-up to ensure compliance with the randomized allocation. Major study outcomes include the occurrence of > or = 1 episode of gastrointestinal infection, > or = 2 respiratory infections, and the duration of breastfeeding, and are analyzed according to randomized allocation ("intention to treat"). One of the 32 remaining study sites was dropped from the trial because of apparently falsified follow-up data, as suggested by an unrealistically low incidence of infection and unrealistically long duration of breastfeeding, and as confirmed by subsequent data audit of polyclinic charts and interviews with mothers of 64 randomly-selected study infants at the site. Smaller random audits at each of the remaining sites showed extremely high concordance between the PROBIT data forms and both the polyclinic charts and maternal interviews, with no evident difference in under- or over-reporting in experimental vs control sites. Of the 17,046 infants recruited from the 31 participating study sites, 16,491 (96.7%) completed the study and only 555 (3.3%) were lost to follow-up. PROBIT's results should help inform decision-making for clinicians, hospitals, industry, and governments concerning the support, protection, and promotion of breastfeeding.

Adult↗
PubMed1999

Continued breastfeeding and child growth in the second year of life: a prospective cohort study in western Kenya.

BACKGROUND: The value of postinfancy breastfeeding for growth and nutritional status is debated. We have investigated this issue in a longitudinal study. METHODS: We prospectively followed up a cohort of 264 children in western Kenya for 6 months (mean age 14 months [range 9-18] at baseline) to investigate the nature of the association between breastfeeding and growth. Only 14 (5.3%) children had been weaned at baseline, and 173 (65.5%) were still breastfed at follow-up. For analysis, children were classified into three groups of breastfeeding duration as a proportion of the total follow-up period (0-49%, n=42; 50-99%, n=49; and 100%, n=173). FINDINGS: In general linear models multivariate analysis, children in the longest-duration breastfeeding group gained 3.4 cm (p=0.0001) and 370 g (p=0.005) more than those in the shortest duration group, and 0.6 cm (p=0.0015) and 230 g (p=0.038) more than children in the intermediate group. The strongest association between breastfeeding and linear growth was observed in households that had no latrine and daily water use of less than 10 L per person. INTERPRETATION: Our findings support WHO's recommendation to continue breastfeeding for at least 2 years, especially in settings with poor sanitation and inadequate water supply.

Body Height↗
PubMed1999

Discovery of the antidepressant and anti-emetic efficacy of substance P receptor (NK1) antagonists.

The development of small-molecule antagonists of the substance P (SP)-preferring tachykinin NK1 receptor during the past decade represents an important opportunity to exploit these molecules as novel therapeutic agents. On the basis of its anatomical localization and function, SP has been implicated in diverse pathophysiologies; of these, diseases of the CNS have been examined in the greatest detail. Although SP is best known as a pain neurotransmitter, it also controls vomiting and various behavioural, neurochemical and cardiovascular responses to stress. Recent clinical trials have confirmed the efficacy of NK1 receptor antagonists to alleviate depression and emesis but, surprisingly, not pain. Thus, multiple clinical trials, targeted to appropriate patient populations, are necessary to define the therapeutic potential of novel neurotransmitter ligands.

Antidepressive Agents↗
PubMed1999

Uses of ecologic studies in the assessment of intended treatment effects.

Because of the potential for confounding by indication (disease severity) in individual-level observational studies of intended treatment effects, a treatment designed to prevent an adverse event may appear to cause it. We use a hypothetical example to show that despite substantial variation in the frequency of treatment among patients residing in different geographic areas, a constant area-specific mortality rate can be observed, indicating the absence of confounding by indication at the ecologic level. The advantage of ecologic over individual-level observational studies in the assessment of intended treatment effects holds even if variations in disease severity, socioeconomic status, and other unmeasured factors are taken into account, as long as treatment utilization is influenced by practice style in the local medical community independently of disease severity. Ecologic studies can suggest the need for changes in practice, help resolve ethical issues, and indicate priorities for randomized trials.

Bias↗
PubMed1999

Determining exposure underreporting in pharmacoepidemiologic case-control studies: methods and example.

Many pharmacoepidemiologic case-control studies have to rely on what their subjects relate about the drugs to which they have been exposed and the durations of exposure. There is often good reason to suppose that not all exposures are actually reported and to suspect reporting rates may differ between cases and controls. We introduce two procedures designed to determine the extent of underreporting of exposures. These procedures make use of data from the case-control study itself, as well as sales, demographic and market research data for a reference population to which study subjects belong. We apply these procedures to data from the International Primary Pulmonary Hypertension Study (IPPHS) linking anorexigens with PPH. We show that exposures to the anorectic agent dexfenfluramine beginning in or before 1989 were highly significantly underrepresented in the data for IPPHS controls, relative to exposures beginning after 1989 (P<0.01); there is no corresponding evidence for relative underrepresentation of early exposure for IPPHS cases. However, data on control exposures from 1990 to 1992 are consistent with the hypothesis that these exposures were not underreported to the IPPHS. Subject to certain key modeling assumptions and the availability of some supplemental data, it is possible to investigate the extent of underreporting of exposure in a pharmacoepidemiologic case-control study and in particular to determine if study results are likely to have been affected by recall bias.

Adolescent↗
PubMed1999

Novel strategies for pharmacotherapy of depression.

Modulating monoamine activity as a therapeutic strategy continues to dominate antidepressant research, with a recent emphasis on agents with multiple targets, including combined serotonin/noradrenaline re-uptake inhibitors and numerous serotonin receptor ligands. An important new development has been the emergence of potential novel mechanisms of action, notably modulation of the activity of neuropeptides substance P and corticotrophin-releasing factor, and the intracellular messenger cyclic adenosine monophosphate. Efforts in this area have recently been rewarded by the demonstration of antidepressant efficacy of the substance P receptor antagonist MK-0869.

Animals↗
PubMed1999

Changes in the registration of stillbirths < 500 g in Canada, 1985-95. Fetal-Infant Mortality Study Group of the Canadian Perinatal Surveillance System.

We assessed recent temporal trends in the registration of stillbirths in Canada, with particular regard to stillbirths < 500 g. Data from the Statistics Canada live birth and stillbirth databases for the period 1985-95 were used for the study. The primary analysis was restricted to data from 10 of the 12 provinces and territories of Canada. Data from Newfoundland were excluded because birthweight distributions were not available prior to 1990, and data from Ontario were excluded because of concerns about data quality. The proportion of stillbirths < 500 g increased by 47% [95% confidence interval (CI) 32, 63%], from 12.7% of stillbirths with known birthweight in 1985-7 to 18.7% in 1993-5. Similarly, the rate of stillbirths < 500 g increased by 36% [95% CI 21, 53%], from 7.2 to 9.8 per 10,000 total births from 1985-7 to 1993-5. Similar increases in stillbirth rates were not observed in other low birthweight categories. Live births < 500 g increased 53% [95% CI 33, 77%], from 4.6 to 7.0 per 10,000 live births. Some provinces and territories had low rates of stillbirths < 500 g and no increasing trend, whereas other provinces showed higher rates and increases over time. These regional differences were consistent with differences in stillbirth definitions across the provinces and territories of Canada. Spatio-temporal comparisons of crude stillbirth rates are likely to be compromised unless differences and changes in birth registration practices are addressed.

Canada↗
PubMed1999

Pharmacokinetics of rizatriptan tablets during and between migraine attacks.

Gastric stasis during migraine attacks results in delayed absorption of several orally administered antimigraine agents. This study, as part of a larger trial, was conducted to examine the pharmacokinetics of rizatriptan tablets during and between migraine attacks. Participating patients met IHS criteria for migraine with or without aura, and suffered between one and eight migraines per month for the previous 6 months. In part 1 of the study, 21 patients were randomized to receive a single 5-mg tablet of rizatriptan or placebo in the migraine-free state. In part 2, the same patients were treated during migraine with rizatriptan 5-mg tablets (n=18) or placebo (n=3). Blood samples were obtained before dosing and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after dosing. The plasma concentration profile (ie, AUC((0-infinity)), C(max), T(max)) of rizatriptan 5-mg tablets administered during and between migraine attacks were comparable. The median T(max) for rizatriptan between and during attacks was 1 hour, indicating rapid absorption even during a migraine attack. Rizatriptan 5 mg was well tolerated and 67% of the patients experienced headache relief 2 hours postdose.

Adolescent↗