{"id":44594,"date":"2019-05-10T14:05:11","date_gmt":"2019-05-10T13:05:11","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=44594"},"modified":"2019-05-24T14:32:18","modified_gmt":"2019-05-24T13:32:18","slug":"jeffrey-aronson-when-i-use-a-word-reported-outcomes","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2019\/05\/10\/jeffrey-aronson-when-i-use-a-word-reported-outcomes\/","title":{"rendered":"Jeffrey Aronson: When I use a word . . .  Reported outcomes"},"content":{"rendered":"<p><span style=\"font-weight: 400\">In the last few weeks I have been discussing criteria that prescribers may consider in deciding whether to introduce a therapeutic intervention. They include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">the 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\">), a measure of how large a change in the patient\u2019s condition needs to be to justify using an intervention, assuming a good benefit to harm balance and cost-effectiveness;<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">the minimal important difference (<\/span><a href=\"https:\/\/blogs.bmj.com\/bmj\/2019\/04\/12\/jeffrey-aronson-when-i-use-a-word-clinical\"><span style=\"font-weight: 400\">MID<\/span><\/a><span style=\"font-weight: 400\">), a similar measure, omission of the word \u201cclinically\u201d being intended to focus attention on the patient rather than the clinician;<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">the <\/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\">importance<\/span><\/a><span style=\"font-weight: 400\"> of the size of the difference, which, if achieved, is not always important to the patient, but may be important to others, such as family or carers, or even the clinician;<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">the patient acceptable symptom state (<\/span><a href=\"https:\/\/blogs.bmj.com\/bmj\/2019\/05\/03\/jeffrey-aronson-when-i-use-a-word-desirable-benefits-and-acceptable-harms\"><span style=\"font-weight: 400\">PASS<\/span><\/a><span style=\"font-weight: 400\">), a much less widely used term, intended to focus on \u201cthe highest level of symptom beyond which patients consider themselves well\u201d.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">At the end of these explorations I came to the conclusion that it would be helpful to introduce two new concepts to clarify the ideas that the various terms imply: minimum desirable benefits and maximum acceptable harms. These terms imply that what is acceptable to the patient (or family or carers) in terms of beneficial outcomes may not be what the patient actually wants, and that whatever the patient wants in the way of benefit must be tempered by the realization that harms can occur and that what matters is not either the desire to achieve benefit nor the hope of avoiding harms, but a combination of the two, commonly expressed as the benefit to harm balance, which has <\/span><a href=\"https:\/\/www.bmj.com\/content\/352\/bmj.i537\"><span style=\"font-weight: 400\">three components<\/span><\/a><span style=\"font-weight: 400\">:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">the probability of benefit from using the treatment;<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">the probability of harm from using the treatment;<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">the probability of harm from not using the treatment.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">The harm side of the balance is a composite that reflects the difference in risks from the two possible sources of harm.<\/span><\/p>\n<p><span style=\"font-weight: 400\">In considering whether individual benefit is to be gained, judgment in the first place relies on the results of population studies, combined with information about characteristics of the patient that may predict whether and to what extent benefit is likely (e.g. age, sex, renal and hepatic function, concurrent medications that might interact with the proposed intervention, previous experience of other interventions, and in a few cases genetic factors).<\/span><\/p>\n<p><span style=\"font-weight: 400\">If an intervention is introduced, one then has the opportunity to determine whether the desired outcome has been achieved, by monitoring. Here two forms of information are available. First, objective measures of outcomes: Has the blood pressure fallen satisfactorily? Has the haemoglobin concentration risen? Is the cellulitis regressing?<\/span><\/p>\n<p><span style=\"font-weight: 400\">Secondly, and particularly when objective observations are not possible, one relies on the patient\u2019s report of the extent to which unwanted symptoms have been reduced or eliminated: Is there less anxiety? Is the pain less severe? Has the anorexia abated, the appetite improved?<\/span><\/p>\n<p><span style=\"font-weight: 400\">In assessing improvement in symptoms the term \u201cpatient reported outcomes\u201d is often used. The earliest instance of this term listed in PubMed dates from <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/4680\"><span style=\"font-weight: 400\">1976<\/span><\/a><span style=\"font-weight: 400\">, but there is nothing after that until <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/1615871\"><span style=\"font-weight: 400\">1992<\/span><\/a><span style=\"font-weight: 400\"> (Figure 1). The related term \u201cpatient reported outcome measures\u201d first appeared in PubMed in <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/14643998\"><span style=\"font-weight: 400\">2003<\/span><\/a><span style=\"font-weight: 400\">, although earlier instances can be found elsewhere, going back to at least 1994. Of about 15 000 items listed in PubMed, about 250 are specified in their titles as being systematic reviews of patient reported outcomes; the first, on the effect of growth hormone on cognitive functions, was published in <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/15701572\"><span style=\"font-weight: 400\">2005<\/span><\/a><span style=\"font-weight: 400\">.<\/span><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-44595 alignnone\" src=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/05\/aronson_10may2019.jpg\" alt=\"\" width=\"678\" height=\"493\" srcset=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/05\/aronson_10may2019.jpg 678w, https:\/\/blogs.bmj.com\/bmj\/files\/2019\/05\/aronson_10may2019-300x218.jpg 300w, https:\/\/blogs.bmj.com\/bmj\/files\/2019\/05\/aronson_10may2019-640x465.jpg 640w\" sizes=\"auto, (max-width: 678px) 100vw, 678px\" \/><\/p>\n<p><b>Figure 1.<\/b><span style=\"font-weight: 400\"> The numbers of papers containing the term \u201cpatient reported outcomes\/outcome measures\u201d since 1992 (source PubMed); one paper in 1976 has been omitted; blue symbols text words, orange symbols titles; the term has become increasingly popular since about 2010<\/span><\/p>\n<p><span style=\"font-weight: 400\">Other terms that have been affixed to \u201cpatient reported\u201d include: outcome instrument, physician-patient discussion, purpose of visit, problem status, experience, discussion, satisfaction, change, [severity of] symptoms, outcomes difference, and questionnaires. <\/span><\/p>\n<p><span style=\"font-weight: 400\">In contrast \u201cclinician reported outcomes\u201d yields only 57 hits, \u201ccarer\/caregiver reported outcomes\u201d 25, and \u201cfamily reported outcomes\u201d a mere nine; one paper referred to \u201cfamily caregiver-reported outcomes\u201d. While it appears that there is little about healthcare that a patient cannot report, what others might report seems to be of little interest.<\/span><\/p>\n<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=\"96\" height=\"109\" \/><\/a><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>In the last few weeks I have been discussing criteria that prescribers may consider in deciding whether to introduce a therapeutic intervention. They include: the minimal clinically important difference (MCID), [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2019\/05\/10\/jeffrey-aronson-when-i-use-a-word-reported-outcomes\/\">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-44594","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 v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Jeffrey Aronson: When I use a word . . . 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