{"id":45089,"date":"2019-07-12T16:43:30","date_gmt":"2019-07-12T15:43:30","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=45089"},"modified":"2019-07-22T09:19:47","modified_gmt":"2019-07-22T08:19:47","slug":"jeffrey-aronson-when-i-use-a-word-composite-outcomes-and-core-outcome-sets","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2019\/07\/12\/jeffrey-aronson-when-i-use-a-word-composite-outcomes-and-core-outcome-sets\/","title":{"rendered":"Jeffrey Aronson: When I Use a Word . . . Composite outcomes and core outcome sets"},"content":{"rendered":"<p><span style=\"font-weight: 400\"><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.jpg\" alt=\"\" width=\"118\" height=\"151\" \/><\/a>Last week I discussed the composite origins of the word \u201ccomposite\u201d. It comes from the Latin words cum, with or together, and ponere to put. Ponere comes from aposinere, a verb that H W Fowler would have called a <\/span><a href=\"http:\/\/blogs.bmj.com\/bmj\/2018\/04\/27\/jeffrey-aronson-when-i-use-a-word-how-to-create-neologisms\"><span style=\"font-weight: 400\">barbarism<\/span><\/a><span style=\"font-weight: 400\">, a word derived by joining together two words from different languages, in this case the Greek adverb \u1f00\u03c0\u1f79, which primarily meant away from or far from a place, and the Latin verb sinere, to leave alone or allow.<\/span><\/p>\n<p><span style=\"font-weight: 400\">To compose is to put things together, and putting things together makes them composite. The word entered English as \u201ccomposita\u201d, short for \u201ccomposita columna\u201d, an architectural term. It first appeared in <\/span><i><span style=\"font-weight: 400\">The First and Chief Grounds of Architecture . . . <\/span><\/i><span style=\"font-weight: 400\">(1563), the earliest English text on classical architecture, by the English architect John Shute. It was not, I think, coincidental that this was just one year after the publication of a book by the Italian architect Giacomo Barozzi da Vignola (pronounced <\/span><i><span style=\"font-weight: 400\">veen<\/span><\/i><span style=\"font-weight: 400\">-yolah), <\/span><i><span style=\"font-weight: 400\">Regola delli cinque ordini d&#8217;architettura<\/span><\/i><span style=\"font-weight: 400\"> (1562). Vignola described the five orders of classical architecture\u2014Tuscan, Doric, Ionic, Corinthian, and composite, distinguishable by the shapes of the tops of the columns (the capitals). The Composite order is a combination of the Ionic and Corinthian.<\/span><\/p>\n<p><a href=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/07\/Fig-1-231-Aronson.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-45090 aligncenter\" src=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/07\/Fig-1-231-Aronson.jpg\" alt=\"\" width=\"469\" height=\"485\" srcset=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/07\/Fig-1-231-Aronson.jpg 517w, https:\/\/blogs.bmj.com\/bmj\/files\/2019\/07\/Fig-1-231-Aronson-290x300.jpg 290w\" sizes=\"auto, (max-width: 469px) 100vw, 469px\" \/><\/a><\/p>\n<p><span style=\"font-weight: 400\">In the 17<\/span><span style=\"font-weight: 400\">th<\/span><span style=\"font-weight: 400\"> century the meaning of composite became more general: compound or made up of various parts or elements; or, more simply, not simple in structure. The idea that things may be compounded then spread to a wide range of fields: a composite number is one that is not prime; a composite sailing vessel has an iron framework covered with wood; a composite candle is one made of a mixture of substances, originally stearic acid and the stearin of coconut oil; a composite portrait is a single photographic portrait, produced by combining separate portraits of two or more people, nowadays easily done by photoshopping.<\/span><\/p>\n<p><span style=\"font-weight: 400\">A composite flower is one that looks like a single flower but is in fact composed of many smaller individual flowers (florets); such flowers belong to the family of Compositae, now called Asteraceae, of which there are about 600 genera, including various types of asters (daisies), arnica, chamomile, goldeneye, marigold, snakeroot, tansy, thistle, and wormwood.<\/span><\/p>\n<p><span style=\"font-weight: 400\">In clinical efficacy trials outcomes are typically classified as either <\/span><a href=\"https:\/\/blogs.bmj.com\/bmj\/2019\/05\/24\/jeffrey-aronson-when-i-use-a-word-outcomes-primary-and-secondary\"><span style=\"font-weight: 400\">primary or secondary<\/span><\/a><span style=\"font-weight: 400\">. The primary outcome is regarded as being the most <\/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\">important<\/span><\/a><span style=\"font-weight: 400\"> or clinically relevant. It determines the trial size, according to the expectation that a given effect size will be detectable. Effect sizes are not guaranteed to be detectable for secondary outcomes. Thus, certain potentially important outcomes may not be properly studied\u2014harms, for example, both the nature and frequency of which are often unpredictable, and which may be of less interest to those who are keen to demonstrate benefits. However, in effectiveness trials (also called pragmatic trials), if one is unwilling to regard important outcomes as secondary, one may want to include more than one outcome in the primary category\u2014a composite outcome.<\/span><\/p>\n<p><span style=\"font-weight: 400\">The idea of a composite core outcome set, combining earlier ideas of individual core outcome measures and sets of measures, first emerged, as far as I can discover, as \u201c\u2018core sets\u2019 of outcomes\u201d in a 2008 <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2346505\/\"><span style=\"font-weight: 400\">systematic review<\/span><\/a><span style=\"font-weight: 400\">; the inverted commas suggested a relatively recent usage. The figure below shows the evolution of interest in this, from publications in the field.<\/span><\/p>\n<p><a href=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/07\/Fig-2-231-Aronson.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-45091 size-full\" src=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/07\/Fig-2-231-Aronson.jpg\" alt=\"\" width=\"555\" height=\"455\" srcset=\"https:\/\/blogs.bmj.com\/bmj\/files\/2019\/07\/Fig-2-231-Aronson.jpg 555w, https:\/\/blogs.bmj.com\/bmj\/files\/2019\/07\/Fig-2-231-Aronson-300x246.jpg 300w\" sizes=\"auto, (max-width: 555px) 100vw, 555px\" \/><\/a><\/p>\n<p><span style=\"font-weight: 400\">This soon led to the initiative known as COMET (Core Outcome Measures in Effectiveness Trials), the originators of which first met in <\/span><a href=\"https:\/\/blogs.bmj.com\/bmj\/2010\/03\/08\/the-comet-initiative\/\"><span style=\"font-weight: 400\">2010<\/span><\/a><span style=\"font-weight: 400\">. The <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/28681707\"><span style=\"font-weight: 400\">COMET Handbook<\/span><\/a><span style=\"font-weight: 400\"> outlines the objectives of the initiative and describes current knowledge of how core sets are developed, implemented, reviewed, and adopted, and makes recommendations for practice and research. The use of core outcome sets should reduce heterogeneity between trials and improve reporting. It should therefore lead to higher quality trials and make it easier for the results of trials to be compared, contrasted, and combined, reducing waste in research.<\/span><\/p>\n<p><span style=\"font-weight: 400\">How many core outcome sets deal with harms rather than benefits? I have searched databases of bioscience publications for terms containing the phrase \u201ccore set\u201d coupled with an extensive list of terms related to adverse drug reactions; I have found nothing. Searching the <\/span><a href=\"http:\/\/www.comet-initiative.org\"><span style=\"font-weight: 400\">COMET database<\/span><\/a><span style=\"font-weight: 400\"> for terms related to adverse reactions yields 97 items, of which 51 are listed as containing core outcome sets. How many of these specify sets of adverse drug reactions, and how many of them involve sets studied prospectively, I have yet to discover.<\/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>Last week I discussed the composite origins of the word \u201ccomposite\u201d. It comes from the Latin words cum, with or together, and ponere to put. Ponere comes from aposinere, a [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2019\/07\/12\/jeffrey-aronson-when-i-use-a-word-composite-outcomes-and-core-outcome-sets\/\">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-45089","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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