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A R Feinstein

Publications and source records attributed to A R Feinstein.

At least 235 records · Page 13Linked to original sources

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↗

Alternative data sources and discrepant results in case-control studies of estrogens and endometrial cancer.

In most case-control studies, little attention has been given to two features that can affect the odds ratio: 1) self-selection of the people who are available for interviews, and 2) disagreements between the data obtained by medical records and by direct conversation. The authors investigated these problems during two separate case-control studies of estrogens and endometrial cancer. When interviews were attempted with all patients, fewer controls than cases were available. In samples of patients from a tumor registry, more controls than cases had died before the interview could be solicited, and fewer control patients could be located. In patients sampled from a diagnostic test registry, more controls than cases refused participation. The interview data about estrogen usage disagreed with previously recorded medical information in 16% (52/324) of patients). Among persons marked as "non-users" in medical record data, more cases than controls were available for interview and thus for redesignation as estrogen users. The bias produces a possible artificial increase in the odds ratio when interview and medical record data are combined. Since patients available for interview were systematically biased in favor of having both estrogen use and endometrial cancer, the odds ratio for this association should be calculated separately for record and for interview data.

Connecticut↗

The effectiveness of panendoscopy on diagnostic and therapeutic decisions about chronic abdominal pain.

To evaluate the impact of panendoscopy on diagnosis and management, we asked several gastroenterologists to state their diagnoses, management plans, and confidence in these plans before performing endoscopy in patients with chronic abdominal or thoracic pain; and to repeat the same decisions after endoscopy. To evaluate acceptance of the procedure, patients were later interviewed about their discomfort during its performance. To check the way that changes in diagnosis may have affected patient management, we formed six diagnostic groups that roughly correspond to differing treatments. The postendoscopic diagnostic groupings revealed two unsuspected cancers and disagreed with the original classification in 38 (45%) of 84 patients. Dramatic or substantial changes in management occurred in 37 (44%) patients, but often did not correspond to changes in diagnosis. Conversely, management was often unchanged despite alterations in diagnosis. Patients expressed about equal preferences for barium meal as for panendoscopy, and 75% would have agreed to a repeat endoscopy without hesitation. Although the ultimate benefits of postendoscopy management changes were not ascertained, we believe that these results support the use of panendoscopy in patients with persistent and unexplained symptoms.

Abdomen↗

Ordering patterns and clinical impact of cardiovascular nuclear medicine procedures.

We analyzed the ordering and impact of the first 171 fee-for-service cardiovascular nuclear medicine procedures at one hospital. The ordering physicians said 72% of the study results were useful and 28% contributed to changes in patient management. Experienced cardiology reviewers, however, felt that only 65% of studies were appropriately ordered, that 97% of appropriately ordered studies provided potentially useful information, and that 12% of all studies made important contributions to appropriate changes in patient management. The revieweres were most likely to rate exercise thallium procedures and procedures ordered by physicians from distant hospitals as being appropriately ordered and having important clinical impact. We conclude that (1) ordering physicians and revieweres may disagree substantially in their estimates of the impact of a diagnostic test; and (2) although a test may yield important information in appropriate patients, its total clinical impact will depend on how often it is suitably ordered and used.

Cardiovascular Diseases↗

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↗

Post-menopausal oestrogens protect against fractures of hip and distal radius. A case-control study.

To assess the efficacy of oestrogens in preventing the common major limb fractures of postmenopausal women, retrospective case-control research was used for a new purpose--to explore beneficial rather than adverse effect of treatment. Postmenopausal women admitted with fractures of the hip or distal radius and matched women admitted to the orthopaedic service for other reasons were surveyed. The "risk" of the non-oestrogen users, was estimated by inverting the customary odds ratio to calculate protection in terms of numbers of (exposed controls x non-exposed cases) divided by (exposed cases x non-exposed controls). Medical-record data for oestrogen usage in 157 matched case-control pairs gave an odds ratio for "protection" of 1.5 (10 x 150 divided by 7 x 147). If "exposure" was defined as starting oestrogens within 5 years of the menopause, this ratio rose to 2.6 (10x153 divided by 4x147). With oestrogen usage ascertained from standardised interviews of 80 case-control pairs, the ratio was 3.0 (20x72 divided by 8x60) (p=0.01), and rose to 3.8 (16x75 divided by 5x64) (p=0.01) for oestrogen "exposure" that began within five years of menopause. When lateral chest X-rays were blindly reviewed, the prevalence of oesteoporosis was 32% in the fracture cases and 15% in controls (p less than 0.01). The results add epidemiological evidence for the belief that exogenous oestrogens protect against postmenopausal osteoporosis.

Aged↗

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↗

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↗