Systematic Errors in the Evaluation of Side Effects

Avery, Charles W.; Ibelle, Bertram P.; Allison, B.; Mandell, Nancy

doi:10.1176/ajp.123.7.875

Cited by 21 publications

(7 citation statements)

References 1 publication

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“…On the other hand, they might be suggestive with respect to symptoms (i.e. lead to more symptom reports) ( Ferrari, 2015 ; Ferrari and Russell, 2010 ), and certain symptoms that characterize the minority of individuals may not be included ( Avery et al., 1967 ; Barsky et al., 2002 ; Rosenzweig et al., 1993 ).…”

Section: Methodsmentioning

confidence: 99%

An idiographic approach to Idiopathic Environmental Intolerance attributed to Electromagnetic Fields (IEI-EMF) Part II. Ecological momentary assessment of three individuals with severe IEI-EMF

Dömötör

Ruzsa

Thuróczy

et al. 2022

Heliyon

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Section: Methodsmentioning

confidence: 99%

An idiographic approach to Idiopathic Environmental Intolerance attributed to Electromagnetic Fields (IEI-EMF) Part II. Ecological momentary assessment of three individuals with severe IEI-EMF

Dömötör

Ruzsa

Thuróczy

et al. 2022

Heliyon

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“…• 'Have you noticed any change in body function or had any physical complaints in the past week?' (Avery et al, 1967). This was used in a study in America in hospitalized depressed patients.…”

Section: Standard/open Questionmentioning

confidence: 99%

Clinical Trials—Collecting Safety Data and Establishing the Adverse Drug Reactions Profile

Talbot

Keisu

Ståhle

2011

Stephens' Detection and Evaluation of Adverse Drug Reactions

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“…There are differences, however, as to the interpretation of this finding. While some authors (Avery et al, 1967;Harlow, 1972) question the validity of these 'new' reactions obtained by the structured method, concluded that even in neurotic patients, rather than suggesting symp toms without a physiologic basis, the structured method calls attention to mild symptoms either overlooked or not related to drug. Rickels and Downing (1970) concluded that the structured method was more likely to lead to the conclusion that the incidence of side effects from a particular drug was higher than that from placebo.…”

Section: Problem Areasmentioning

confidence: 99%

The Assessment of Adverse Drug Reactions in Clinical Trials

Petrie¹,

Levine²

1978

Int Pharmacopsychiatry

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While postmarketing surveillance of adverse drug reactions (ADRs) has received wide attention in recent years, ADR and side effect assessment in clinical trials is an area which deserves further investigation. Despite the logic of a systematic approach to ADR detection from preclinical work through postmarketing monitoring, no such system exists. By increasing sensitivity, reliability and validity of ADR measurement, such a scheme would more effectively protect patients from dangerous drugs, assist the clinician by providing comparison data on adverse reactions of psychotropic agents, and improve comparability of experimental results across testing centers. We have focussed our inquiry on the assessment of ADRs in clinical trials. Expectations of such testing should be geared to the statistical realities of practical sample sizes. Within reason, such sample sizes could be altered in accord with anticipated frequencies of certain ADRs. In addition, laboratory standards for both low and high frequency reactions would assist consensus in defining particular ADRs. Agreement among investigators as to one or two useful ADR rating instruments would eliminate the large number of non-standard, often inadequate instruments now in use. Such an assessment instrument could be geared toward completeness, ease of execution and an effective data analysis. Objective measurement on a limited basis would be of further assistance. It is of critical importance for changes in adverse drug reaction methodology to truly assist the clinical researcher, without encumbering him with excessive guidelines and forms. Such a methodology should complement the clinical observation and rational approach which are basic elements of clinical observation.

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Systematic Errors in the Evaluation of Side Effects

Cited by 21 publications

References 1 publication

An idiographic approach to Idiopathic Environmental Intolerance attributed to Electromagnetic Fields (IEI-EMF) Part II. Ecological momentary assessment of three individuals with severe IEI-EMF

An idiographic approach to Idiopathic Environmental Intolerance attributed to Electromagnetic Fields (IEI-EMF) Part II. Ecological momentary assessment of three individuals with severe IEI-EMF

Clinical Trials—Collecting Safety Data and Establishing the Adverse Drug Reactions Profile

The Assessment of Adverse Drug Reactions in Clinical Trials

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