{"id":115,"date":"2009-08-30T00:49:04","date_gmt":"2009-08-29T23:49:04","guid":{"rendered":"https:\/\/blogs.bmj.com\/bjsm\/?p=115"},"modified":"2009-08-30T00:49:04","modified_gmt":"2009-08-29T23:49:04","slug":"e-letter-no-discrepancy-between-protocol-and-trial-report","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bjsm\/2009\/08\/30\/e-letter-no-discrepancy-between-protocol-and-trial-report\/","title":{"rendered":"E-letter: No discrepancy between protocol and trial report"},"content":{"rendered":"<p><em><strong>Click <\/strong><\/em><a href=\"http:\/\/bjsm.bmj.com:80\/cgi\/content\/abstract\/bjsm.2009.062232v1\" target=\"_blank\"><em><strong>here<\/strong><\/em><\/a><em><strong> to read the original article.<\/strong><\/em><\/p>\n<hr \/>\n<p><!--StartFragment--><\/p>\n<p class=\"MsoNormal\"><span>We thank Professor Thornton for raising these issues and are grateful\u00a0for the opportunity to clarify details of the trial protocol and analysis.<\/span><\/p>\n<p class=\"MsoNormal\"><span> There is, in fact, no discrepancy between the description of outcomes\u00a0in the trial protocol published on the trial web site, the protocol that\u00a0was registered on the Australian New Zealand Clinical Trials Registry, and\u00a0the report published in the British Journal of Sports Medicine. All three\u00a0sources describe the same primary outcomes (risk of soreness and time to\u00a0injury) and the same secondary outcomes (severity of soreness, time to\u00a0(&#8220;preventable&#8221;) muscle\/ligament\/tendon injuries, time to injuries for\u00a0which professional care was sought, and perceptions of looseness during\u00a0and after exercise). In addition, all three sources describe the same\u00a0secondary analyses of the interactions between frequency of activity, age\u00a0and strength of belief in affects of stretching and each of the two\u00a0primary outcomes. Confusion may have arisen because in the trial report we\u00a0refer to the analysis of the interactions as &#8220;outcomes&#8221;, although the\u00a0analyses of interactions were conducted on the same primary and secondary\u00a0outcomes as listed above. And we may have added to the confusion by\u00a0inconsistently referring to the perceptions of looseness during and after\u00a0exercise as either one or two outcomes. We acknowledge that the wording\u00a0may not have been clear but we reiterate that there was no inconsistency\u00a0between the analyses described in the protocol, register and trial report.<\/span><\/p>\n<p class=\"MsoNormal\"><span> The protocol, register and trial report describe an analysis of the\u00a0subset of injuries which could plausibly be prevented by stretching. The\u00a0protocol (which is more detailed than the registry entry) indicated that\u00a0the classification of injuries into those that could and could not\u00a0plausibly be prevented by stretching would be classified by an independent\u00a0expert. We found that the data lacked sufficient detail to inform\u00a0decisions about whether individual injuries were preventable so we decided\u00a0simply to classify all muscle, ligament and tendon injuries as potentially\u00a0preventable. This decision was made before the allocation code was broken\u00a0without reference to the data. We did not know, at the time that decision\u00a0was made, that there would be a significant effect of stretching on the\u00a0subset of muscle, ligament and tendon injuries.<\/span><\/p>\n<p class=\"MsoNormal\"><span> As the protocol indicated, no adjustment was made for multiple\u00a0comparisons. We interpret frequentist analyses as Bayesian analyses with\u00a0vague priors[1] and, from this perspective, the decision not to make\u00a0adjustments for multiple comparisons is justified. At any rate, there were\u00a0only two primary outcomes so adjustment for multiple comparisons would not\u00a0have changed the conclusions from the primary analysis. We agree that the\u00a0finding of an effect on the secondary outcome of muscle, ligament and\u00a0tendon injuries is less robust than the finding of an effect on the\u00a0primary outcome risk of soreness because muscle, ligament and tendon\u00a0injuries were a secondary outcome. That is why we concluded that\u00a0stretching &#8220;probably reduces the risk of some injuries and does reduce the\u00a0risk of bothersome soreness&#8221;.<\/span><\/p>\n<p class=\"MsoNormal\">\n<p><!--EndFragment--><\/p>\n<p>Gro Jamtvedt<br \/>\nExecutive Director<br \/>\nNorwegian Knowledge Centre for the Health Services, Oslo, Norway<\/p>\n<p><strong>Reference:<br \/>\n<\/strong><br \/>\n1. Barnett V (1973). Comparative Statistical Inference. London:<br \/>\nWiley.<!--TrendMD v2.4.8--><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Click here to read the original article. We thank Professor Thornton for raising these issues and are grateful\u00a0for the opportunity to clarify details of the trial protocol and analysis. There is, in fact, no discrepancy between the description of outcomes\u00a0in the trial protocol published on the trial web site, the protocol that\u00a0was registered on the [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bjsm\/2009\/08\/30\/e-letter-no-discrepancy-between-protocol-and-trial-report\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1105],"tags":[1375,1106,424,1373,1372,1374],"class_list":["post-115","post","type-post","status-publish","format-standard","hentry","category-e-letters","tag-analysis","tag-eletter","tag-outcomes","tag-protocol","tag-stretching","tag-trial"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>E-letter: No discrepancy between protocol and trial report - BJSM blog - social media&#039;s leading SEM voice<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blogs.bmj.com\/bjsm\/2009\/08\/30\/e-letter-no-discrepancy-between-protocol-and-trial-report\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"E-letter: No discrepancy between protocol and trial report - BJSM blog - social media&#039;s leading SEM voice\" \/>\n<meta property=\"og:description\" content=\"Click here to read the original article. We thank Professor Thornton for raising these issues and are grateful\u00a0for the opportunity to clarify details of the trial protocol and analysis. 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We thank Professor Thornton for raising these issues and are grateful\u00a0for the opportunity to clarify details of the trial protocol and analysis. 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