The Editor’s choice March 2021

written by Jess G. Fiedorowicz, Editor-in-Chief, Journal of Psychosomatic Research, Professor and Senior Research Chair in Adult Psychiatry, University of Ottawa, Head and Chief of Mental Health, The Ottawa Hospital Scientist, Ottawa Hospital Research Institute, March 2021

Jess Fiedorowicz, JPR’s Editor-in-Chief

The Editor’s Choice –

Our first Journal of Psychosomatic Research Editor’s Choice of 2021 delves into the murky waters of symptom attribution, or, for that matter, misattribution.  Of course, not all symptoms patients experience are due to the direct physiological effects of a given medication that they are taking.  Patients may misattribute symptoms as side-effects of a medication when that is not the case.  Early in my career, while working as a study physician on a clinical trial of a pharmacologic agent for Huntington disease, I was called urgently to see a very angry couple.  The participant experienced a significant worsening in motor symptoms with a decline in function.  His wife was irate that he may have incurred permanent harm as a result of participation in the study.  Both the participant and his wife were entirely convinced that his clinical worsening was due to drug.  They formally complained and he withdrew from the study.  We completed a serious adverse event report and after discussion of this event with the principal investigator and sponsor, the decision was made to break the blind for this participant to inform their subsequent clinical treatment.  The blind was broken and, as you might guess from the context of this story, the participant was on placebo.  Much to their surprise, we ultimately communicated this to him and his wife in an empathic manner and explained the treatment assignment, and how it is common to misattribute symptoms to a particular treatment and how this is one reason placebo-controlled studies remain necessary.  When patients have negative expectations of a treatment, it can reduce the likelihood of benefit and increase the likelihood of side effects and other bad outcomes.  This is the nocebo effect (1).

Our selection for this quarter’s Editor’s Choice, “When symptoms become side effects:  Development of the side effect attribution scale (SEAS)” presents the validation of an instrument designed to assess the degree to which people believe their symptoms are side-effect of a treatment (2).  Such misattribution is key to the nocebo effect.  First author Kate MacKrill summarizes their paper with the following:

The SEAS was used to examine side effect attribution beliefs in three samples: university students receiving a flu vaccine, patients with rheumatoid arthritis and gout, and patients who had recently switched to a generic version of an anti-epilepsy medicine. Across these studies, participants had a greater tendency to attribute symptoms as side effects if they had a higher perceived sensitivity to medicines, greater anxiety, greater non-adherence, greater medicine information seeking, lower belief in the efficacy of a medicine, and lower trust in pharmaceutical agencies. The SEAS was more strongly associated with these variables than the total number of side effects.

This article was selected as an Editor’s Choice largely due to the potential utility of the scale.  It seems many newly developed scales are either trying to do something that’s been done before a little better or are carving out a niche so narrow as to render widespread use unlikely.  The SEAS, should it be able to garner some attention, has potential for broad use and impact.

            Although clinical trials typically have the joint goal of assessing both efficacy and safety, safety data tends to be given short shrift in terms of both systematic collection and rigorous reporting of symptoms that may represent side-effects (3).  Many symptoms are only passively captured with open-ended questioning (4).  Physician attribution of the likely relation to study drug is often crudely collected and seldom reported.  Participant assessment is generally wholly ignored.  The SEAS provides a unique opportunity for those designing a wide range of studies to systematically and rigorously assess side-effect attribution.  If utilized in this fashion, the SEAS could have tremendous reach.  It also extends beyond existing measures, such as the General Assessment of Side Effects, which simply indicate yes or know as to whether a person believes the side-effect is a treatment (5).  The SEAS was developed to more fully and dimensionally capture the range of attribution beliefs concerning side-effects.

            The scale yields a side effect Attribution Total Score, which measures the extent to which an individual believes their symptoms are due to or not due to a medication.  The Attribution Total Score demonstrated good internal consistency (0.87-0.97 across samples).  It also correlated better than an Attribution Binary Score with measures related to trust in funders and expectations, worries, or behaviors related to side-effects, supporting its validity.  The authors suggest future research could identify a brief score, that might be useful for the study of nocebo effects, although a broad survey of various side-effects as the reported measure includes may be useful for more general systematic collection in clinical trials to simultaneously collect both the presence and attribution of symptoms experienced. 


See this link fyi: https://www.journals.elsevier.com/journal-of-psychosomatic-research/editors-choice/when-symptoms-become-side-effects


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