{"id":44548,"date":"2019-05-03T11:52:30","date_gmt":"2019-05-03T10:52:30","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=44548"},"modified":"2019-05-10T14:05:13","modified_gmt":"2019-05-10T13:05:13","slug":"jeffrey-aronson-when-i-use-a-word-desirable-benefits-and-acceptable-harms","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2019\/05\/03\/jeffrey-aronson-when-i-use-a-word-desirable-benefits-and-acceptable-harms\/","title":{"rendered":"Jeffrey Aronson: When I use a word . . .  Desirable benefits and acceptable harms"},"content":{"rendered":"<p><a href=\"https:\/\/blogs.bmj.com\/bmj\/files\/2014\/12\/jeffrey_aronson.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft wp-image-32935\" src=\"https:\/\/blogs.bmj.com\/bmj\/files\/2014\/12\/jeffrey_aronson-223x300.jpg\" alt=\"jeffrey_aronson\" width=\"106\" height=\"131\" \/><\/a><span style=\"font-weight: 400\"><span style=\"font-weight: 400\">Reading about the idea of a minimal clinically important difference (<\/span><a href=\"https:\/\/blogs.bmj.com\/bmj\/2019\/04\/05\/jeffrey-aronson-when-i-use-a-word-minimal-clinically-important-difference\"><span style=\"font-weight: 400\">MCID<\/span><\/a><span style=\"font-weight: 400\">), I came across another term, less widely used: the patient acceptable symptom state or PASS.<\/span><\/span><\/p>\n<p><span style=\"font-weight: 400\">The earliest reference to this term that I have found, in PubMed and other databases, is from 2005, although the underlying concept antedates this. For example, at the OMERACT conference in 2003, dealing with outcome measures in rheumatology, there was <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/12672221\"><span style=\"font-weight: 400\">discussion<\/span><\/a><span style=\"font-weight: 400\"> of whether improvement in pain is more important than improvement in function or vice versa, and how patients balance improved outcomes from a treatment against its adverse effects when deciding whether a therapeutic intervention is acceptable. <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/16874795\"><span style=\"font-weight: 400\">Unsurprisingly<\/span><\/a><span style=\"font-weight: 400\">, patients with joint diseases want both relief of pain and improved function.<\/span><\/p>\n<p><span style=\"font-weight: 400\">As Figure 1 shows, the term \u201cpatient acceptable symptom state\u201d has not been widely used, with a current total of only 137 hits in PubMed at a median of nine per year, although there has recently been a small upturn, with 31 hits in 2018 and already 27 in 2019. Most of the publications deal with either rheumatology or joint surgery.<\/span><\/p>\n<figure id=\"attachment_44551\" aria-describedby=\"caption-attachment-44551\" style=\"width: 688px\" class=\"wp-caption alignnone\"><a href=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/05\/aronson_desirable.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-44551 size-full\" src=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/05\/aronson_desirable.jpg\" alt=\"\" width=\"688\" height=\"569\" srcset=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/05\/aronson_desirable.jpg 688w, https:\/\/blogs.bmj.com\/bmj\/files\/2019\/05\/aronson_desirable-300x248.jpg 300w, https:\/\/blogs.bmj.com\/bmj\/files\/2019\/05\/aronson_desirable-640x529.jpg 640w\" sizes=\"auto, (max-width: 688px) 100vw, 688px\" \/><\/a><figcaption id=\"caption-attachment-44551\" class=\"wp-caption-text\">Figure 1. The numbers of papers containing the term \u201cpatient acceptable symptom\/atic state\u201d since 2005 (source PubMed); blue symbols text words, orange symbols titles<\/figcaption><\/figure>\n<p><span style=\"font-weight: 400\">The \u201cpatient acceptable symptom state\u201d has been <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/15130902\"><span style=\"font-weight: 400\">defined<\/span><\/a><span style=\"font-weight: 400\"> as \u201cthe value beyond which patients consider themselves well\u201d and, <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/17934093\"><span style=\"font-weight: 400\">more precisely<\/span><\/a><span style=\"font-weight: 400\">, \u201cthe highest level of symptom beyond which patients consider themselves well\u201d. However, there is a difference between being well and being better. The former implies complete recovery while the latter admits the possibility of residual disability. And what is merely acceptable need not be what is desirable.<\/span><\/p>\n<p><span style=\"font-weight: 400\">The difference between the minimal clinically important difference and the patient acceptable symptom state has been <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/19128938\"><span style=\"font-weight: 400\">said<\/span><\/a><span style=\"font-weight: 400\"> to be that the former deals with whether and to what extent the condition is improved, while the latter deals with whether the change is acceptable to the patient. However, the <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/2691207\"><span style=\"font-weight: 400\">definition<\/span><\/a><span style=\"font-weight: 400\"> of the minimal clinically important difference is \u201cthe smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate, in the absence of troublesome side effects and excessive cost, a change in the patient&#8217;s management\u201d. It is hard to see how that differs substantially from the patient acceptable symptom state, assuming that what patients perceive as beneficial is also what they consider to be acceptable, even if only minimally. It seems unlikely that anyone who perceives a benefit would not consider it acceptable or that anyone with a change that they consider to be minimally acceptable would not also consider it to be beneficial. In fact, the <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/16874795\"><span style=\"font-weight: 400\">assertion<\/span><\/a><span style=\"font-weight: 400\"> that the minimal clinically important improvement is the change required to achieve the patient acceptable symptom state unites the two terms.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Two disadvantages of the term \u201cpatient acceptable symptom state\u201d are the difference between \u201cacceptable\u201d and \u201cdesirable\u201d and that it is restricted to symptoms, ignoring signs. A patient with scalp psoriasis or a facial haemangioma, for example, might consider the lesions cosmetically undesirable, even if they caused no symptoms by themselves. Sacrificing the acronym, we might change \u201cacceptable symptom\u201d to \u201cdesirable outcome\u201d.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Two disadvantages of the term \u201cminimal clinically important difference\u201d are that it does not focus sufficiently on the patient, which, as I have previously <\/span><a href=\"https:\/\/blogs.bmj.com\/bmj\/2019\/04\/26\/jeffrey-aronson-when-i-use-a-word-important-differences\"><span style=\"font-weight: 400\">discussed<\/span><\/a><span style=\"font-weight: 400\">, can be at least partly mitigated by omitting the word \u201cclinically\u201d, and that it does not distinguish between beneficial and harmful differences, despite the inclusion of the word \u201cbeneficial\u201d in the definition. Awareness of this has led <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/17934093\"><span style=\"font-weight: 400\">some<\/span><\/a><span style=\"font-weight: 400\"> to use the term \u201cminimal clinically important <\/span><i><span style=\"font-weight: 400\">improvement<\/span><\/i><span style=\"font-weight: 400\">\u201d. However, it might be better to separate the two concepts more explicitly, and to refer to minimal benefit and maximal harm.<\/span><\/p>\n<p><span style=\"font-weight: 400\">This in turn suggests two new terms, which encapsulate all of these ideas and eliminate the disadvantages of the current terms: the minimal desirable benefit of a treatment and the maximal acceptable harm, where the latter is a composite of the harm of intervening and the harm of not doing so.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Then the benefit to harm balance of an intervention could be regarded as the extent to which the former outweighs the latter (a favourable balance) or the latter outweighs the former (an unfavourable balance).<\/span><\/p>\n<p><em><strong>Jeffrey Aronson<\/strong>\u00a0is a clinical pharmacologist, working in the Centre for Evidence Based Medicine in Oxford&#8217;s Nuffield Department of Primary Care Health Sciences. He is also president emeritus of the British Pharmacological Society.<\/em><\/p>\n<p><strong>Competing interests:<\/strong>\u00a0None declared.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Reading about the idea of a minimal clinically important difference (MCID), I came across another term, less widely used: the patient acceptable symptom state or PASS. The earliest reference to [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2019\/05\/03\/jeffrey-aronson-when-i-use-a-word-desirable-benefits-and-acceptable-harms\/\">More&#8230;<\/a><\/p>\n","protected":false},"author":1,"featured_media":38359,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5762],"tags":[],"class_list":["post-44548","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-jeff-aronsons-words"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Jeffrey Aronson: When I use a word . . . 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