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Quality of case reports of adverse drug reactions with psychotropic drugs: a 25-year review

Quality of case reports of adverse drug reactions with psychotropic drugs: a 25-year review
Quality of case reports of adverse drug reactions with psychotropic drugs: a 25-year review
Case reports of adverse reactions with psychotropic drugs can be useful in raising hypotheses, to be tested with more rigorous study designs. However such reports have significant methodological drawbacks, making it hard to determine causality. We undertook a systematic assessment of the quality of case reports and small case series published within Human Psychopharmacology over 25 years. For reports of adverse drug reactions, modified Bradford Hill criteria for causality (for consistency, strength, specificity, temporal relationship and plausibility) were used to ascertain the quality of the account. Reports which had been cited at least 10 times by December 2010 were examined in detail, to assess their overall contribution in extending understanding and influencing clinical practice. Of 40 reports of adverse drug reactions, only seven were sufficiently robust for confidence in probable or possible causality. Nine reports had been cited more than 10 times: the five most frequently cited reports of adverse drug reactions described movement disorders, suicidal thoughts and discontinuation symptoms with SSRIs: clinical relevance was high, but their quality was not markedly greater than less frequently cited reports. Nearly all reports of adverse drug reactions, published in a single journal over 25 years, were insufficiently robust to demonstrate probable causality. Reports that are cited frequently become influential because of their potential clinical relevance, rather than due to their methodological quality.

0885-6222
413-420
Talat, B.
d21cd045-f7f7-4062-99dd-d11cc5d55823
Mayers, A.
9aa4ef80-4a78-463b-8442-6975a66c72a9
Baldwin, D.S.
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Talat, B.
d21cd045-f7f7-4062-99dd-d11cc5d55823
Mayers, A.
9aa4ef80-4a78-463b-8442-6975a66c72a9
Baldwin, D.S.
1beaa192-0ef1-4914-897a-3a49fc2ed15e

Talat, B., Mayers, A. and Baldwin, D.S. (2013) Quality of case reports of adverse drug reactions with psychotropic drugs: a 25-year review. Human Psychopharmacology: Clinical and Experimental, 28 (5), 413-420. (doi:10.1002/hup.2329).

Record type: Article

Abstract

Case reports of adverse reactions with psychotropic drugs can be useful in raising hypotheses, to be tested with more rigorous study designs. However such reports have significant methodological drawbacks, making it hard to determine causality. We undertook a systematic assessment of the quality of case reports and small case series published within Human Psychopharmacology over 25 years. For reports of adverse drug reactions, modified Bradford Hill criteria for causality (for consistency, strength, specificity, temporal relationship and plausibility) were used to ascertain the quality of the account. Reports which had been cited at least 10 times by December 2010 were examined in detail, to assess their overall contribution in extending understanding and influencing clinical practice. Of 40 reports of adverse drug reactions, only seven were sufficiently robust for confidence in probable or possible causality. Nine reports had been cited more than 10 times: the five most frequently cited reports of adverse drug reactions described movement disorders, suicidal thoughts and discontinuation symptoms with SSRIs: clinical relevance was high, but their quality was not markedly greater than less frequently cited reports. Nearly all reports of adverse drug reactions, published in a single journal over 25 years, were insufficiently robust to demonstrate probable causality. Reports that are cited frequently become influential because of their potential clinical relevance, rather than due to their methodological quality.

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Published date: 2013
Organisations: Faculty of Medicine

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Local EPrints ID: 367924
URI: http://eprints.soton.ac.uk/id/eprint/367924
ISSN: 0885-6222
PURE UUID: 24d35531-39a3-4aa8-a0b0-cb09065fdcd3
ORCID for D.S. Baldwin: ORCID iD orcid.org/0000-0003-3343-0907

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Date deposited: 21 Aug 2014 09:36
Last modified: 18 Feb 2021 16:44

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Contributors

Author: B. Talat
Author: A. Mayers
Author: D.S. Baldwin ORCID iD

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