{"id":45145,"date":"2019-07-19T18:00:07","date_gmt":"2019-07-19T17:00:07","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=45145"},"modified":"2019-07-26T17:40:48","modified_gmt":"2019-07-26T16:40:48","slug":"jeffrey-aronson-when-i-use-a-word-core-outcome-sets-and-harms-in-clinical-trials","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2019\/07\/19\/jeffrey-aronson-when-i-use-a-word-core-outcome-sets-and-harms-in-clinical-trials\/","title":{"rendered":"Jeffrey Aronson: When I Use a Word . . . Core outcome sets and harms in clinical trials"},"content":{"rendered":"

\"\"<\/a>Last week<\/a> I discussed composite outcomes and the initiative known as COMET (Core Outcome Measures in Effectiveness Trials). In doing so I asked how many core outcome sets (lists of outcomes that are considered essential) have dealt with harms rather than benefits.<\/span><\/p>\n

I have now searched the <\/span>COMET database<\/span><\/a> for the term \u201cadverse\u201d and have found 97 items, of which 51 are listed as relating to core outcome sets.<\/span><\/p>\n

The core sets were developed by discussions of various kinds, usually with experts and in one case also with patients. In nine cases the Delphi method was specifically mentioned and in six cases consensus meetings; other methods were referred to as surveys, or discussions by panels or task forces; in a few cases the authors developed their core sets themselves.<\/span><\/p>\n

So, how many sets deal with harms? The results are summarized in the following diagram.<\/span>\"\"<\/a><\/p>\n

The numbers of items included in each set varied from 2 to 14 (median 7). Most of the items listed in core outcomes sets related to the nature of the condition being treated; pain (n=11) and impaired haemostasis (n=8) were the most frequent specific entries. Quality of life (n=9) and satisfaction with treatment (n=8) were also mentioned. <\/span><\/p>\n

Physical and mental functions (e.g. cardiac, renal, cognitive, emotional, physical function) were mentioned 12 times. <\/span><\/p>\n

Harms were specified in 25 cases, usually as \u201cadverse events\u201d (n=16), \u201cadverse effects\u201d (n=3), or \u201cadverse [drug] reactions” (n=3). \u201cAdverse outcomes\u201d featured only once, as did \u201charms\u201d. The vague term \u201cside effects\u201d appeared only once. In only two cases were more specific terms, such as \u201cmedication appropriateness\u201d and \u201cmedication regimen complexity\u201d, used, and prescribing was mentioned only once, in the context of prescribing errors.<\/span><\/p>\n

Death (or mortality) featured 11 times, but the cause of death (e.g. as a complication of the illness or of the intervention) was never specified as something to be recorded.<\/span><\/p>\n

Adherence to the intervention was referred to only once (as \u201ccompliance to treatment regimen\u201d).<\/span><\/p>\n

Costs and economic factors were mentioned six times.<\/span><\/p>\n

All this is rather disappointing, particularly from the point of view of the attention being paid to pharmacological interventions, or rather the lack of it. Merely to specify \u201cadverse events\u201d, or some suchlike term, is not enough. Here are my proposals for important items that should be included in all core outcome sets:<\/span><\/p>\n