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PubMed1991

Standardization of definitions and criteria for causality assessment of adverse drug reactions. Drug-induced blood cytopenias: report of an international consensus meeting.

International reporting of adverse drug reactions to pharmaceutical companies or drug regulatory authorities requires internationally accepted standard definitions of reactions and criteria for assessment of causality. Under CIOMS (Council for International Organizations of Medical Sciences) auspices, the Roussel Uclaf pharmaceutical company organized an international meeting concerning drug-induced blood cytopenias. The meeting resulted in proposed standard designations of blood cytopenias and criteria for causality assessment of neutropenia, thrombocytopenia and aplastic anemia.

Anemia, Aplastic↗

PubMed1990

Standardization of definitions and criteria of causality assessment of adverse drug reactions. Drug-induced liver disorders: report of an international consensus meeting.

International reporting of adverse drug reactions by pharmaceutical manufacturers to national drug regulatory authorities requires internationally accepted standard definitions of reactions and criteria for assessment of causality. The Council for International Organizations of Medical Sciences (CIOMS) undertook a pilot project to prepare such definitions and criteria, and proposed to use as its model a series of expert consensus meetings organized in France by the pharmaceutical company, Roussel Uclaf, with the participation of the official French network of pharmacovigilance. Under CIOMS auspices, an international meeting was organized to test the feasibility of adapting for international use the outcome of the French consensus meetings on drug-induced liver disorders. The meeting resulted in a series of proposed standard designations of drug-induced liver disorders and criteria of causality assessment.

Chemical and Drug Induced Liver Injury↗

PubMed1990

Causal prophylactic activity of a new 8-aminoquinoline derivative against Plasmodium cynomolgi B in rhesus monkeys.

A new 8-aminoquinoline derivative, N1-(3-acetyl-4-5-dihydro-2 furanyl)-N4-(6-methoxy-8-quinolinyl)1,4-pentanediamine, synthesized at CDRI, Lucknow, showed causal prophylactic activity at 3.16 mg/kg x 3 doses (on day -1, 0 and +1) against sporozoite induced P. cynomolgi B infection in rhesus monkeys. Single dose of 10 mg/kg of this compound on day 0 also prevented establishment of patient infection. Activity of the compound was comparable to that of primaquine (with causal prophylactic activity at 1.78 mg/kg in three day test and at 10.0 mg/kg in single dose test).

Animals↗

PubMed1989

Young children's causal inferences.

We report 2 experiments that show a striking development between the ages of 3 and 4 years in children's ability to make causal inferences about sequences of events. The task in the first experiment was to work out what had caused the change to an object that started out as odd (noncanonical) in 1 way and ended up as odd in 2 ways--starting, for example, as a broken cup and ending as a wet and broken cup. When asked to choose the instrument that had caused the change, 3-year-olds often selected the instrument that could have caused the initial state (a hammer, in our example) and not the instrument that would produce the change. 4-year-olds hardly ever made this mistake. In the second experiment, the 3-year-olds were able to make the correct choice when the change was from a canonical to a noncanonical state (cup-wet cup) but had much more difficulty when the change was from noncanonical to canonical (wet cup-dry cup). The difference was much smaller in the older group. The first of these tasks can be solved simply on the basis of knowledge that a particular instrument can cause a particular effect without reference to the initial state. The second task requires attention to the differences between initial and final state. We conclude that the ability to make genuine causal inferences develops between the ages of 3 and 4 years.

Child Development↗

PubMed1987

Causal role for an activated N-ras oncogene in the induction of tumorigenicity acquired by a human cell line.

ras oncogenes have been found in approximately 15% of the human tumors analyzed. However, a causal role for these genes in the tumorigenesis of human cells has yet to be shown. Tumorigenic late-passage PA-1 human teratocarcinoma cells (E-PA-1) contain an activated N-ras gene. In this report evidence is presented that nontumorigenic early passage revertant PA-1 cells (E-PA-1) contain only the germ-line protooncogene. Introduction by gene transfer of the activated L-PA-1 oncogene induces E-PA-1 cells to form tumors, suggesting that the activated N-ras oncogene has a causal role in the tumorigenesis of these cells.

Cell Adhesion↗

PubMed1988

[Assessment of causality in fatal incidents in relation to coronary angiography].

Among 2,353 coronary angiographies (from 1.10.1984 until 30.9.1987) four lethal cases were seen. In two cases there was evidence for a causal relationship between coronary angiography and the lethal outcome (0.9%). Possible mechanisms of death are discussed. The clinical course and the time sequence between coronary angiography and the death are considered to be important criteria of a causal relationship.

Aged↗

PubMed1988

[The causality principle of psychotherapy and supportive methods in group psychotherapy--reflections on the principles of method combinations].

A causality principle of psychotherapy is offered, starting from a technologically orientated concept of psychotherapy as a process. Working from target, commencement, principles, and means, psychotherapeutic methods may be characterised. From these, rules governing the therapist's mode of conduct are arrived at. The causality principle provides a theoretic and practical basis for the integration of ancillary methods into various therapeutic concepts, and for therapeutic teamwork.

Combined Modality Therapy↗

PubMed1988

[The status of life events in causal analytic considerations in child and adolescent psychiatry: model development trials with LISREL (linear structural relationship analysis)].

An epidemiological longitudinal child psychiatric study with 334 eight- and thirteen-year-olds tried to put life events in an optimal order within a model of causal interrelations. The causal connections were tested by a Linear Structural Relationship Analysis (LISREL), which in addition to life events included child psychiatric disorders, adverse family factors and learning disabilities. By testing different models it could be demonstrated, that adverse family factors do not directly influence the number of life events of 8 to 13-year-old children. Adverse family factors influence life events as well as psychiatric disorders at age 13 predominantly by way of early psychiatric disorders. Psychiatric disorders at age 13 are best predicted by psychiatric disorders at age 8 and to a smaller degree by life events and learning disabilities.

Adolescent↗

PubMed1980

Causal attributions: bias in the nurse-patient relationship.

The study relates the social psychological concept of attribution to professional nursing practice. Namely, dispositional vs. situational causal attribution as affected by position (nurse/patient) and role (actor/observer) and its impact on the therapeutic relationship. Contrary to most studies in this field this one moves out of the laboratory and tests actual psychiatric patients and correspondent nursing staff. Twenty nurses and twenty patients responded to statements representing situational and dispositional causal attributions about 22 behaviors of nurses and 22 behaviors of patients. Both patients and nurses tended to attribute the behavior of patients to causes inherent in their personality more often than to external factors. Nurses also tended to give more internal causation to their own behavior while patients gave equal numbers of external and internal causes to nurses' behavior. The findings which support an information processing approach to understanding perceptions are discussed as to their implications for the nurse-patient relationship.

Adult↗

PubMed1984

Causal thinking in practice: strengths and weaknesses of the clinical vantage point.

The place of causal inference in clinical practice is considered. One function relates to the validation of existing knowledge, as in the evaluation of the medical literature, and is exemplified by the process of editorial selection. A second function relates to the validation of potential knowledge, as in the testing of hypotheses, and is exemplified by the pursuit of a nutritional cause of retarded mental development. Features of clinical practice that contribute strengths or weaknesses to causal inference are then examined. These include the diagnostic process, the effect of cumulative clinical experience, continuity of observation and follow-up, and the focus on disease.

Child↗

PubMed1983

A causal analysis of birth weight in the offspring of monozygotic twins.

Data were collected on the birth weights of 1,694 offspring of 385 sets of twins including 108 male and 131 female monozygotic pairs. To resolve the influence of birth order from the genetic, environmental, and maternal effects on birth weight, we analyzed the full-sib and maternal and paternal half-sib correlation matrices for birth orders one to five using a causal model that assumed each live-born child had an influence on the weight of the subsequent birth. Prenatal maternal influences explained 40% of the variation in birth weight of the first-born child and 52% for the fifth child; genetic or environmental factors common to monozygotic twins accounted for 72% of this effect, while environmental variables unique to individual mothers were responsible for the remaining 28%. The inclusion of a birth-order parameter resulted in a highly significant improvement in the goodness of fit of the causal model such that by the fifth child, 46% of the maternal variation could be attributed to the cumulative effects of previous live births.

Adult↗

PubMed1981

[Acute, recent and sometimes persistent Mycoplasma pneumoniae infections associated with neurologic manifestations. Discussion of causal relations].

Neurological disorders associated with recent and sometimes persistent Mycoplasma pneumoniae infections were present in 9 patients, examined within the course of a year, during the 1980 epidemic in Saint-Etienne, France. Cases included 5 with acute polyneuritis, 2 with lymphocytic meningitis, 1 with a bilateral optic neuritis, and 1 with mild encephalitis presenting as an amnesic disorder. Causal relationships are examined with respect to semiological, biological, therapeutic and epidemiological data. Clinically an initial infection compatible with the mycoplasmic etiology and its time relationship with the nervous system lesion appear to be more significant than the inflammatory neurological symptoms and signs. It is often impossible to ascertain the efficiency of the antibiotic therapy, which thus cannot help to the aetiological diagnosis. From the biological point of view, though seroconversion by complement fixation test remains the basis of the diagnosis, it has been completed by the isolation of Mycoplasma pneumoniae in the blood of 3 of the patients, and by a longitudinal study of specific blood IgM levels in the 6 others. Presence in the CSF of these locally synthesised specific IgM during the early stages of the neurological disorders in 2 patients, constitutes a new significant fact for the physiopathological discussions and a basic fact to clarify the aetiological diagnosis. The concept of persistent infection is discussed with respect to the isolation of Mycoplasma pneumoniae in the blood at a late stage, and the abnormally long presence of high levels of specific serum IgM levels. This biological persistence does not always correspond to a chronic course of the clinical disease which was observed in only 3 of the patients. The mixed viral infection, present in 3 cases, is linked with immunity disorders due to Mycoplasma pneumoniae, which are mainly a cell immunity depression: this markedly complicates the analysis of causal relationships. Finally, the chronological order of the clinical and biological events remains of prime importance when studying each case individually, whereas epidemiological data are essential for establishing a posteriori that the neurological manifestations were true complications of the microorganism.

Acute Disease↗

PubMed1981

Suppressive and causal prophylactic activity of floxacrine in various avian malaria models.

Floxacrine, a 7-chloro-10-hydroxy-3(4-trifluoromethylphenyl)-3, 4-dihydroacridine-1,9-(2H, 10H)-dione and various standard malarials were found to be distinctly less active against avian malaria parasites than against rodent or nonhuman primate malaria parasites. Especially the suppressive action against asexual stages of P. gallinaceum, P. praecox and P. cathemerium was markedly reduced in comparison with that ascertained in mice infected with P. berghei. Similar results were observed in sporozoite-induced infections of P. gallinaceum and P. cathemerium respectively. Expressed as quotient of calculated causal prophylactic activity (CPD50) floxacrine was 42 and pyrimethamine 54 times more active against P. berghei yoelii than P. gallinaceum. The blood schizontocidal effect of floxacrine proved superior to that of mefloquine, chloroquine and mepacrine, whereas the causal prophylactic activity was slightly inferior to that of pyrimethamine but superior to that of primaquine. In vitro floxacrine revealed no effect against sporozoites of P. gallinaceum even at concentrations of 100 mcg/ml.

Acridines↗

PubMed1994

Causal nonresponse models for repeated categorical measurements.

This paper uses causal models for nonresponse (Fay, 1986, Journal of the American Statistical Association 81, 354-365) to extend the conditional likelihood procedure for repeated categorical outcome variables to allow for nonrandomly missing data. The extension based on causal models is similar to the log-linear approach presented by Conaway (1992, Journal of the American Statistical Association, 87, 817-824), but has the advantage that the parameters are directly interpretable in terms of the distribution of the outcome variables. As with log-linear model approach, all of the computations can be done with standard statistical software. The methods are first described in terms of a simple example with three binary responses with no covariates and then are applied to a more complicated example. A simulation study evaluates the properties of the estimates based on the proposed method.

Adolescent↗

PubMed1993

Reoxygenation injury of rat hepatocytes: evaluation of nucleotide depletion and oxidative stress as causal components.

Isolated rat hepatocytes were used for the evaluation of nucleotide depletion and oxidative stress as two causal components of postischemic injury following oxygen deficiency. The ATP and GTP loss during anoxia was accompanied by temporary increases of nucleotide degradation products. The critical duration of anoxia for a complete ATP restoration during reoxygenation was between 30 and 60 min. The oxidative stress during reoxygenation was demonstrated by decrease of GSH concentration and increase of TBA-RS level. The tremendous GSH loss could not be balanced by the slight GSSG increase during reoxygenation. Prevention of GSH decrease and TBA-RS increase in parallel to prevention of viability loss in presence of oxipurinol in contrast to lacking improvement of ATP and GTP restoration by this drug speak in favor for the oxidative stress as major causal component for postischemic injury of hepatocytes in comparison with depletion of energy-rich purine nucleotides. The inhibition of formation of reactive oxygen species via xanthine oxidase reactions was found to be the dominant protective effect of oxipurinol against postischemic injury of hepatocytes in comparison with lacking influence on nucleotide salvage and ATP/GTP regeneration and with radical scavenging.

Adenosine Triphosphate↗

PubMed1993

Epidemiologic evidence for a causal relation between vaccination and fibrosarcoma tumorigenesis in cats.

Within the past 2 years, a putative causal relationship has been reported between vaccination against rabies and the development of fibrosarcomas at injection sites in cats. A retrospective study was undertaken, involving 345 cats with fibrosarcomas diagnosed between January 1991 and May 1992, to assess the causal hypothesis. Cats with fibrosarcomas developing at body locations where vaccines are typically administered (n = 185) were compared with controls (n = 160) having fibrosarcomas at locations not typically used for vaccination. In cats receiving FeLV vaccination within 2 years of tumorigenesis, the time between vaccination and tumor development was significantly (P = 0.005) shorter for tumors developing at sites where vaccines are typically administered than for tumors at other sites. Univariate analysis, adjusted for age, revealed associations between FeLV vaccination (odds ratio [OR] = 2.82; 95% confidence interval [CI] = 1.54 to 5.15), rabies vaccination at the cervical/interscapular region (OR = 2.09; 95% CI = 1.01 to 4.31), and rabies vaccination at the femoral region (OR = 1.83; 95% CI = 0.65 to 5.10) with fibrosarcoma development at the vaccination site within 1 year of vaccination. Multivariate analysis, adjusted for age and other vaccines, also revealed increased risks after FeLV (OR = 5.49; 95% CI = 1.98 to 15.24) and rabies (OR = 1.99; 95% CI = 0.72 to 5.54) vaccination.(ABSTRACT TRUNCATED AT 250 WORDS)

Adjuvants, Immunologic↗

PubMed1995

[Causal attributions and coping with illness by breast cancer patients: results of a longitudinal study].

The present 3-year longitudinal study investigated the relationship between causal attribution and coping mechanism. Data were collected in a group of 66 breast cancer patients by self-report questionnaires. Three issues were addressed: 1. How do the patients explain the cause of their illness? 2. Do the subjective causes change over the course of three years? 3. What kind of relationship can be found between the causal attributions and the coping mechanism of the patients? Results showed a predominance of psychological attribution. Only little statistical prove could be found for changes between the four ratings. Analysing the individual data of the patients however revealed changing perceptions for about half the patients. A relationship between psychological attribution and depressive coping and problem solving as well were found.

Adaptation, Psychological↗

PubMed1996

A graph-grammar approach to represent causal, temporal and other contexts in an oncological patient record.

The data of a patient undergoing complex diagnostic and therapeutic procedures do not only form a simple chronology of events, but are closely related in many ways. Such data contexts include causal or temporal relationships, they express inconsistencies and revision processes, or describe patient-specific heuristics. The knowledge of data contexts supports the retrospective understanding of the medical decision-making process and is a valuable base for further treatment. Conventional data models usually neglect the problem of context knowledge, or simply use free text which is not processed by the program. In connection with the development of the knowledge-based system THEMPO (Therapy Management in Pediatric Oncology), which supports therapy and monitoring in pediatric oncology, a graph-grammar approach has been used to design and implement a graph-oriented patient model which allows the representation of non-trivial (causal, temporal, etc.) clinical contexts. For context acquisition a mouse-based tool has been developed allowing the physician to specify contexts in a comfortable graphical manner. Furthermore, the retrieval of contexts is realized with graphical tools as well.

Adverse Drug Reaction Reporting Systems↗