Search PubMed⌕ Search

Biomedical subjects

M S Kramer

Publications and source records attributed to M S Kramer.

At least 163 records · Page 9Linked to original sources

Effects of obtaining a blood culture on subsequent management of young febrile children without an evident focus of infection.

To assess the effects of obtaining a blood culture on the subsequent diagnostic and therapeutic management of young febrile children without an evident focus of bacterial infection, we carried out a randomized controlled clinical trial of this procedure in 146 children 3 to 24 months of age who presented to our emergency department with an unexplained temperature of 39.0 degrees C or higher. Random assignment to either have (67 children) or not have (79) a blood sample taken for culture resulted in groups equivalent in age, sex, weight, socioeconomic status, temperature at enrolment and laboratory test results. No differences were detected in the rates of subsequent hospital admission, outpatient visits, determination of complete blood count or other blood tests, urinalysis or urine culture, chest or other roentgenography, or administration of antibiotics or other medications. Knowledge of the absence of such differences should be helpful in evaluating the relative benefits and costs of blood culture for young febrile children.

Ambulatory Care Facilities↗

Frequency, severity and risk factors for adverse drug reactions in adult out-patients: a prospective study.

To provide information on the frequency of adverse drug reactions in ambulatory patients we used intensive telephone surveillance to detect suspected reactions in 1026 patients seen at an internal medicine group practice over a 1-year period. Two hundred and ninety-two suspected reactions were detected. The majority of suspected reactions were mild, causing predominantly worry or discomfort. We used a published algorithm to assess the suspected reactions for drug causation with the following results: 40 (14%) unlikely; 193 (66%) possible; 56 (19%) probable; and 3 (1%) definite. The rate of probable or definite reactions was 49/1026 (5%) per patient and 58/3330 (2%) per drug course. Surprisingly, neither the age of the patient nor the number of other drugs he was taking modified the risk of a reaction to an individual newly-started drug. Our data suggest that fear of adverse reaction should not usually be a major factor in therapeutic decision making for an ambulatory patient even when the patient is old or already on multiple drugs.

Adolescent↗

Comparison of coaxial and side-by-side double lumen subclavian catheters with the single lumen catheter.

Subclavian catheters are increasingly being used for vascular access. Many double lumen catheters (DLCs) have been designed to alleviate the need for a single-needle machine. Clinical studies comparing the safety of various DLCs with single lumen catheters (SLCs) are scarce. This study compares our experience with Sh-SLCs (Single-Shiley), Vas-DLCs (Coaxial-Vascath), and Qu-DLCs (Side-by-Side, Quinton). Similar aseptic insertion and handling techniques were used. The catheters were filled with heparin at the end of dialysis (HD) and no interdialytic infusions were given. Fifty-two Sh-SLCs were inserted in 46 patients for 253 HDs, 71 Vas-DLCs in 47 patients for 185 HDs, and 51 Qu-DLCs in 38 patients for 215 HDs. HDs/catheter were 4.9, 2.6, and 4.2, the percent incidence of septicemia was 2%, 7%, and 0%, and the catheter failure was 11%, 48%, and 16% for Sh-SLCs, Vas-DLCs, and Qu-DLCs, respectively (P less than 0.05 Vas-DLC v Sh-SLC and Qu-DLC). The poor flow problems were more frequent on the left side with Vas-DLCs (16/31) and Qu-DLCs (7/17), but not with Sh-SLCs (2/25). Other major complications were not noted. These results suggest that infections and mechanical problems may be more frequent with Vas-DLCs than Sh-SLCs and Qu-DLCs. Use of Qu-DLCs is a safe and may be preferred since a single-needle machine is not required. Insertion of a DLC on the right side may be preferred due to higher mechanical problems on the left side.

Catheters, Indwelling↗

Adverse drug reactions in general pediatric outpatients.

We used a recently developed diagnostic adverse drug reaction (ADR) algorithm and an intensive telephone surveillance program to monitor all courses of prescription and nonprescription drug therapy in a general pediatric group practice for 1 year. A total of 3181 different children visited the practice during the year and received 4244 separate courses of drug therapy. Adverse symptoms were noted in 473 (11.1%) of these courses of therapy. Of 534 total adverse symptoms, however, only 24 scored as definite and 176 as probable ADRs. The main ADRs noted were antibiotic-associated gastrointestinal complaints and rashes, and various manifestations of CNS stimulation with bronchodilators. Sociodemographic variables significantly associated with the risk of a definite or probable ADR were socioeconomic status (P less than 0.0001), ethnic origin (P = 0.0015), and age (P less than 0.05). Treatment-related risk factors included treatment by a practitioner outside the study practice (usually during nonoffice hours) (P less than 0.001) and administration of a dosage above the range recommended by the manufacturer (P less than 0.001). Half the ADRs were judged as inconsequential by the children's parents, and most of the remainder resulted in only minor morbidity. Half were judged to be highly or probably preventable. Our results suggest that ADRs do not occur commonly in general pediatric outpatients and that most are mild and self-limited.

Adolescent↗

Determinants of weight and adiposity in the first year of life.

To overcome methodologic defects (failure to control for confounding factors, univariate statistical analyses) in previous studies of etiologic determinants of childhood adiposity, we carried out a prospective cohort study of 462 healthy, full-term infants observed from birth to 12 months. Postpartum, we obtained sociodemographic data and administered two recently validated scales of maternal attitudes toward feeding and infant body habitus. Parental heights and weights and infant feeding variables were determined by interview, and at 6 and 12 months we measured height and weight and triceps, subscapular, and suprailiac skinfolds. Multiple regression analysis was used to determine independently predictive factors for weight, body mass index (BMI = weight/height), and the sum of the three skinfold measurements. Birth weight, sex, age at introduction of solid, and duration of breast-feeding were all significant predictors of weight at 12 months (r2 = 0.296, P less than 0.0001). Significant determinants for BMI included birth weight, duration of breast-feeding, sex, and IBH (r2 = 0.125, P less than 0.0001); those for total skinfold were age at introduction of solid foods and birth weight (r2 = 0.038, P = 0.002). Similar results were obtained at 6 months, although slightly less of the variance was explained. We conclude that the ability to predict which babies will be heavy or obese during the first year is limited. Breast-feeding and delayed introduction of solid foods do offer some protective effect, however, and thus efforts to encourage these practices may be reaping some benefit.

Adult↗

Does participation in prenatal courses lead to heavier babies?

In a prospective epidemiologic survey of 1,676 primiparous women delivering in four Montreal hospitals during an eight-month period, we studied the impact of prenatal courses on birthweight, maternal weight gain, and cigarette smoking. Women who participated in prenatal courses were older and of higher socioeconomic status and were less likely to be smokers than non-participants. After adjustment for these differences, newborns of course participants had similar mean birthweights compared to those of non-participants (3286 grams vs 3271 grams), and the difference for maternal weight gain was substantially reduced. Most of the reduction in cigarette consumption occurred during the first three months of pregnancy, even among later participants, suggesting that something other than prenatal courses influenced cigarette smoking reduction in course participants. We conclude that as far as the birthweight objective is concerned, the format and content of prenatal courses (as currently constituted in the Montreal region) require re-examination, and new ideas and interventions need to be developed and tested.

Adult↗

Antibiotic-associated gastrointestinal symptoms in general pediatric outpatients.

As part of an intensive program of surveillance for adverse drug reactions in general pediatric outpatients, 2,714 courses of oral antibiotic therapy were monitored for the occurrence of gastrointestinal (GI) adverse drug reactions. Using a recently developed algorithm to establish a causal link between drugs and adverse symptoms, the risks of diarrheal or upper GI tract adverse drug reactions were found to vary considerably with different antimicrobial agents and, for several agents, according to the administered dosage. For diarrhea, the risk was lowest with sulfasoxazole and trimethoprim/sulfamethoxazole and was highest with cloxacillin. A significant dose-response effect was found with both amoxicillin and trimethoprim/sulfamethoxazole. For upper GI tract adverse drug reactions, the risk was again lowest with sulfasoxazole and trimethoprim/sulfamethoxazole and was highest with erythromycin. Knowledge of the risks of gastrointestinal adverse drug reactions with different agents and different doses should be clinically helpful in assessing risks and benefits when oral antibiotics are prescribed for children.

Ambulatory Care↗

Effect of formula supplementation in the hospital on the duration of breast-feeding: a controlled clinical trial.

To avoid methodologic pitfalls in previous observational studies linking formula supplementation in the hospital to early discontinuation of breast-feeding, a controlled clinical trial of restricted supplementation was conducted. In a pretrial sample of 621 newborns, a comparison of two "well-baby" nurseries found no differences in either hospital supplementation practices or the proportion of infants still being breast-fed at 4 or 9 weeks postpartum. Restriction of supplementation in one of the nurseries for the trial period (n = 781) did not result in higher breast-feeding rates at 4 or 9 weeks. There was, however, a slightly greater mean percent of birth weight lost in the restricted group (6.0% v 5.1%; P less than .001). In examining the control group for evidence of an "observational" association, it was found that infants still breast-feeding at 4 or 9 weeks were far more likely to have been unsupplemented than those no longer being breast-fed. It thus appears that formula supplementation in the hospital is a marker, rather than a cause, of breast-feeding difficulty.

Adult↗

Parental fever phobia and its correlates.

Parents of 202 young febrile children were surveyed about their knowledge, attitudes, and fears concerning fever and its treatment. Forty-eight percent of the parents considered temperatures less than 38.0 degrees C to be "fevers", 43% felt that temperatures less than 40.0 degrees C could be dangerous to a child, 21% favored treatment for fevers less than 38.0 degrees C, and 15% believed that, left untreated, temperature could rise to 42.0 degrees C or higher. Fifty-three percent advocated waking a febrile child at night to administer antipyretic therapy. Young age of the child was associated with a preference for use of acetaminophen over aspirin and, unexpectedly, with a higher parental threshold for consideration of fever. The higher their child's temperature at the time they were questioned, the higher the minimum temperature that parents considered a cause for concern. Surprisingly, higher socioeconomic status was not associated with a lesser degree of fever phobia. In fact, parents of higher socioeconomic status were more concerned about the risks of brain damage or seizures as sequelae of fever than were parents of lower socioeconomic status. It is concluded that undue fear and overly aggressive treatment of fever are epidemic among parents of infants and young children, even among the highly educated and well-to-do. Considerable effort will be required on the part of pediatricians and other child health workers to reeducate these parents about the definition, consequences, and appropriate treatment of fever.

Attitude to Health↗

Care in a birth room versus a conventional setting: a controlled trial.

A controlled clinical trial was carried out to assess whether a birth room setting would influence the care of mothers and newborns. Of the 163 low-risk women enrolled, 49 (30%) manifested some prenatal risk and were excluded. The remaining 114 were allocated by strict alternation to a birth room or a conventional setting. Of the 56 women allocated to the birth room, 63% of the primiparas and 19% of the multiparas were later transferred. The numbers in the two settings who had oxytocin stimulation, epidural anesthesia, forceps delivery or cesarean section did not show statistically significant differences. The episiotomy rates were slightly lower in the birth room than in the conventional setting, and the rates of an intact perineum were higher in the birth room. Neither the Apgar scores nor the morbidity rates of the infants showed statistically significant differences related to the setting to which the mother had been allocated, although more infants from the conventional setting were admitted to a special care unit. Both "experimental" groups of women less often received routine perineal shaving, enemas or intravenous infusions than did an obstetrically similar nonexperimental comparison group. Despite the apparent inability in this setting for the birth room to influence the rate of major obstetric procedures (except for episiotomy) and outcomes, the authors believe that a birth room is desirable in tertiary care centres as well as in community hospitals.

Adult↗

Scientific challenges in the application of randomized trials.

In recent years, scientific challenges in the application of randomized trials have become more apparent, especially with the extension of such trials to the assessment of nondrug treatments, such as health education, psychotherapy, and health care provision. Six issues (individual v group randomization, blinding and unblinding, the effect of trial participation on outcome, selective subject participation, treatment compliance, and standardized v individualized treatment) are discussed in terms of their impact on internal validity, generalizability (external validity), and clinical relevance. Specific design strategies may be necessary to enhance these methodological and clinical desiderata. Attention to these challenges should lead to improvements in future randomized trials.

Attitude↗

The use of preventable adverse outcomes to study the quality of child health care. A new application of case-control research.

Because cohort methods are insensitive in detecting rare outcomes, the authors used the more sensitive case-control technique to investigate whether pediatricians or nonpediatric generalists are better able to recognize severe acute illness or to avoid preventable complications. We selected "indicator" outcomes for four types of common acute illness and enrolled patients who had contacted a physician more than 24 hours prior to an index emergency room visit for the same illness. Case (N = 103) were patients with adverse outcomes, i.e. potentially preventable complications or delayed diagnosis, treatment, or referral. Controls (N = 103) were those with acceptable outcomes (uncomplicated illness or prompt diagnosis, treatment, or referral) and were matched according to age, SES, and illness type. The overall results indicate no evidence of better care by pediatricians: prior contract with a pediatrician was associated with an estimated relative risk (omega) of adverse outcome of 1.32 (95% confidence interval, 0.76-2.29). Within the two largest illness categories (gastroenteritis and pneumonia-respiratory), the results were similar: omega = 1.16 (0.68-1.99) and 2.23 (0.82-6.04), respectively. Potential confounders were controlled for by multiple logistic regression analysis, but omega remained virtually unchanged. Nor were the findings altered by elimination of outliers or restriction of "contact" to office visits only. The authors conclude that study pediatricians and generalists provide equivalent acute illness care to children and that the case-control method provides a feasible and highly suitable approach to the study of the quality of medical care.

Acute Disease↗

Lidocaine removal during resin hemoperfusion for phenobarbital intoxication.

A deeply comatose patient with severe phenobarbital intoxication was hemoperfused with an Amerlite XAD-4 column. She was receiving lidocaine for ventricular ectopy. The rate of lidocaine infusion had to be increased to control ventricular arrhythmias during hemoperfusion. Plasma clearance for lidocaine by the column was 122 ml/min at initiation and 75 ml/min at 2 h. These findings suggest that an increment in lidocaine infusion may be needed during resin hemoperfusion in patients receiving this drug because of its removal by the column.

Female↗

The Yale algorithm. Special workshop--clinical.

The assessment of causality in drug-event associations depends on the setting and purpose of such an assessment. Epidemiologists are primarily interested in population-based inferences about whether a given drug can cause a certain adverse drug reaction (ADR), and if so, how often it does so. Pharmaceutical industries and regulatory agencies are also concerned with population-based risks, but in addition must worry about individual cases. Clinicians are primarily interested in the individual, ie, whether a given drug did cause a certain adverse event in a particular patient. The authors describe an algorithm that provides specific, detailed criteria for ranking the probability that an observed untoward clinical manifestation was caused by a given drug. The criteria are subdivided into six axes of decision strategy with a built-in scoring system that ordinally ranks the probability of an adverse drug reaction as definite, probable, possible, or unlikely. To illustrate the use of the algorithm, the authors assess a reference case of pancreatitis occurring after administration of methyldopa.

Drug-Related Side Effects and Adverse Reactions↗

Methodologic standards for controlled clinical trials of early contact and maternal-infant behavior.

To provide an objective evaluation of published studies on the effect of early contact on subsequent maternal-infant behavior, a set of 11 methodologic standards generally applicable to controlled clinical trials of perinatal care was developed. Sixteen reports of early contact trials were assessed and seven of the 11 standards were found to be satisfactorily fulfilled. The four "problem" standards were: adequate definition of subjects, randomization, subject bias, and treatment contamination (care giver) bias. Of the five best trials fulfilling eight or more of the standards, three reported a beneficial effect of early contact, while two demonstrated no effect. The evidence that early contact improves subsequent maternal-infant behavior thus remains inconclusive. It is urged that for future research in this domain more attention be given to adequate subject definition, strict randomization procedures, and safeguards against bias by the subjects or their care givers.

Child Behavior↗

Promotion of breast-feeding in a Chinese community in Montreal.

Following a prospective survey that showed a very low rate of breast-feeding (10%) in 1977-79 among Chinese women in Montreal, a culturally targeted program, which included individual prenatal counselling and a community-wide promotion and education campaign, was developed to improve the rates. The study group consisted of all Chinese women delivering in 1980 and 1981 who had taken their infants to one pediatrician for continuing care. The rates of breast-feeding in the 88 women who had received prenatal counselling and the 93 women who had not were compared. Although the rates were substantially increased for both groups over the 1977-79 rate (54% and 34% in 1980 and 65% and 55% in 1981 respectively), the 2-year rate was significantly higher for the counselled group compared with the uncounselled group in the later study (59% v. 43%). The greatest effect of counselling was seen in young, primiparous women of higher socioeconomic status who spoke French or English in addition to Chinese. However, 33% of the counselled women who had started breast-feeding had stopped by 1 month, compared with only 15% of the uncounselled women. Thus, although the rates of breast-feeding in ethnic groups can be increased with the use of a language- and culture-specific approach, more support and encouragement must be given to women who start breast-feeding so that they will continue longer.

Adult↗