Search PubMed⌕ Search

Biomedical subjects

M S Kramer

Publications and source records attributed to M S Kramer.

At least 199 records · Page 11Linked to original sources
PubMed1980

Operational criteria for adverse drug reactions in evaluating suspected toxicity of a popular scabicide.

A recently developed algorithm for the diagnosis of adverse drug reaction (ADR) was used to investigate the quality of evidence in reported cases of ADRs to 1% gamma benzene hexachloride (GBH), a popular scabicide and pediculicide currently under suspicion as a cause of central nervous system (CNS) toxicity, especially in children. Of the 53 reported cases of alleged toxicity, 37 were associated with lindane insecticide (greater than 1% GBH), which is not a pharmaceutical preparation. Of these 37 cases, 34 scored as definite or probable reactions on the algorithm. Of the 26 reports associated with the drug, 1% GBH, none scored as definite and only 6 as probable ADRs. Of these 6 probable cases, 5 represented inappropriate application or unintended ingestion. The use of rigorous operational criteria, such as those developed in this algorithm, permits a scientifically disciplined assessment of whether or not a drug has been fairly indicted, and also provides valuable clinical information about other aspects of suspected drug toxicity.

Bone Marrow↗
PubMed1980

The association of inflammatory bowel disease and X chromosomal abnormality.

Five patients with inflammatory bowel disease (IBD) had abnormalities of the X chromosome (the Turner syndrome). Based on the estimated prevalence rate of 1:10,000 live female births for the Turner syndrome and 1:50,000 for IBD, random association of these two conditions would be expected in 1:500 million live female births. Given these odds, the findings in these five patients would suggest a clinical association not based on pure chance and unlikely to be accounted for by Berkson's or other referral bias. It is speculated that abnormal immune mechanism could possibly increase the susceptibility of patients with Turner syndrome to develop IBD. Both conditions cause growth failure. Awareness of the association has clinical importance in identifying the cause of growth failure in a child with either X chromosomal abnormality or IBD.

Adolescent↗
PubMed1979

An algorithm for the operational assessment of adverse drug reactions. III. Results of tests among clinicians.

To determine how practicing clinicians use a recently developed algorithm for the diagnostic assessment of suspected adverse drug reactions (ADRs), eight clinicians--four board-certified, practicing physicians and four interns--rated the likelihood of 30 suspected ADRs. Each physician reviewed the case summaries, first using implicit clinical judgment and two months later by means of the ADR algorithm. The algorithm significantly improved the reproducibility of the senior clinicians' assessments as compared with their implicit assessments; however, the improvement in the interns' assessments with the algorithm was not significant. The validity of the physicians' assessments, which was measured by comparing their ratings with a consensus rating of the three algorithm developers, was also significantly improved by the use of the algorithm. When used by practicing clinicians, the algorithm improves the reproducibility and validity of their assessments of ADRs and should provide a more precise diagnostic approach to these complex clinical phenomena.

Child↗
PubMed1979

An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use.

Despite widespread clinical and epidemiologic attention to adverse drug reactions (ADRs), their clinical identification has been a nonreproducible act of unspecified subjective judgment; adequate operational criteria have not been available for diagnostic decisions about the cause of an observed untoward clinical manifestation. To improve scientific precision in the diagnosis of ADRs, we have developed an algorithm that provides detailed operational criteria for ranking the probability of causation when ADR is suspected between a drug and a clinical manifestation. The algorithm provides a scoring system for six axes of decision strategy: previous general experience with the drug, alternative etiologic candidates, timing of events, drug levels and evidence of overdose, dechallenge, and rechallenge. The sum of the scores is ordinally partitioned to rate the candidate ADR as definite, probable, possible, or unlikely.

Decision Making↗
PubMed1979

An algorithm for the operational assessment of adverse drug reactions. II. Demonstration of reproducibility and validity.

The reproducibility and validity of an algorithm for diagnosis of adverse drug reactions (ADRs) were tested in a clinical spectrum of 30 suspect cases. Using a questionnaire derived from the algorithm the three algorithm developers (nonexperts) agreed on the probability of ADR in 67% of cases, with pair-wise agreement varying from 73% to 87%. The pair-wise agreement of two clinical pharmacologic experts rose from 47% without the algorithm to 63% with the algorithm, with Kw, a chance-corrected index of weighted agreement, increasing from 0.26 to 0.57. The algorithmic assessments of the three nonexperts agreed with expert consensus in 80% to 83% of cases. The ADR algorithm appears to provide a reproducible and valid method of evaluating the likelihood of ADRs in individual patients. Its use can help improve the diagnostic and epidemiologic approach to these important, complex clinical phenomena.

Adult↗
PubMed1979

Accuracy of cord blood screening for sickle hemoglobinopathies. Three- to five-year follow-up.

The strategic advantages of neonatal diagnosis of sickle hemoglobinopathies depend on an accurate cord blood screening procedure. One hundred thirty-eight black children in whom a range of normal and abnormal hemoglobin genotypes was identified by agar gel and cellulose acetate hemoglobin electrophoresis at birth were retested by cellulose acetate three to five years later. The original cord blood diagnoses were verified in all 138, including all 26 with major sickle syndromes (SS, S-beta thalassemia, and SC). Cord blood hemoglobin electrophoresis using these techniques permits accurate neonatal diagnosis of major and minor sickle hemoglobinopathies.

Anemia, Sickle Cell↗
PubMed1979

Adolescent secondary amenorrhea: association with hypothalamic hypothyroidism.

In adolescent girls, secondary amenorrhea can result from a variety of physiologic and psychologic disturbances. Previous reports associating amenorrhea and primary hypothyroidism have not distinguished between the alternative etiologic roles of thyroxine deficiency and hyperprolactinemia. We have evaluated two girls with secondary amenorrhea who had clinical and chemical evidence of hypothyroidism. Both had low basal T4 values (0.8 and 3.2 microgram/dl), calculated free T4 (0.1 and 0.7 ng/dl), and T3 (51 and 81 ng/dl). Both had undetectable basal TSH with normal TSH response to TRH. Basal FSH and LH values were normal, as was the response to LHRH. Basal prolactin levels were 6 and 14 ng/ml, respectively, and both girls had growth hormone responses of greater than or equal to 15 ng/ml in response to insulin-induced hypoglycemia. Pituitary-adrenal function and reserve were also normal. In neither patient was there any historical, physical, or laboratory features compatible with anorexia nervosa. After treatment with 1-thyroxine, both girls had a resumption in menses. These two adolescent girls thus appear to have isolated hypothalamic hypothyroidism. The associated secondary amenorrhea demonstrates that thyroid deficiency alone, without hyperprolactinemia, can interfere with normal hypothalamic-pituitary-ovarian function.

Adolescent↗
PubMed1979

Amberlite hemoperfusion in the treatment of acute drug intoxication.

Hemoperfusion is more effective than hemodialysis in clearing drugs from the blood of patients with acute overdose. In addition, the clinical improvement in the depth of coma is dramatic during hemoperfusion. There is normalization of the respiratory and circulatory systems usually within one hour, and response to verbal command within a few hours of initiating treatment. Amberlite XAD-4 is an unchanged polystyrene resin with a particular adsorptive attraction for lipid-soluble drugs. It is a more effective adsorbent than some of the coated or uncoated carbons in clearing blood of most of the drugs commonly involved in life-threatening acute overdose.

Animals↗
PubMed1978

Growth and development in children with sickle-cell trait. A prospective study of matched pairs.

To ascertain if sickle-cell trait (Hb AS) impairs physical growth and cognitive development, we prospectively investigated 50 matched pairs of black children. For each child with Hb AS, an Hb AA child was matched at birth for sex, birth date, birth weight, gestational age, five-minute Apgar score and socioeconomic status. Between the ages of three and five years, the members of each matched pair were evaluated, with one month of one another, by persons "blind" to the hemoglobin genotype. Twelve outcome measurements were obtained at evaluation: height, weight, head circumference, skin-fold thickness, cross-sectional area of arm muscle, bone age, five scores of the McCarthy Scales of Children's Abilities, and the Peabody Picture Vocabulary Test. There were no statistically significant differences in these measurements favoring the AA group. The results show that children with sickle-cell trait in this age group have no deficits in standard measurements of growth and development and emphasize the importance of rigorous methods when clinical groups are assembled and compared.

Anemia, Sickle Cell↗