Outcome switching: removing reanalysis, as I see this is covered in a section below, so no need to duplicate
Okumaya devam et...
← Previous revision | Revision as of 00:52, 5 May 2024 |
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| There was also a change in how recovery (a secondary outcome) was defined. One of the original requirements was that patients would need to score over 85 on a [[SF-36|survey of physical functioning]], indicative of what healthy working-age people score. This was changed to a score of over 60.<ref name=":3">{{Cite journal |last=Geraghty |first=Keith J |date=2017 |title=Further commentary on the PACE trial: Biased methods and unreliable outcomes |url=http://journals.sagepub.com/doi/10.1177/1359105317714486 |journal=Journal of Health Psychology |language=en |volume=22 |issue=9 |pages=1209–1216 |doi=10.1177/1359105317714486 |pmid=28805517 |issn=1359-1053}}</ref> This meant that some were above 60 on this metric at the start of the trial, as the criterion for entry was a score of under 65. However, no patients were counted as recovered at trial entry, as they also needed to not meet the CFS criteria any more, and rate their overall health as much or very much better in order to be classed as recovered.<ref name=":8">{{Cite web |last=Racaniello |first=Vincent |date=2016-02-10 |title=An open letter to The Lancet, again {{!}} Virology Blog |url=https://virology.ws/2016/02/10/open-letter-lancet-again/ |access-date=2024-04-27 |language=en-US}}</ref><ref name=":3" /> | There was also a change in how recovery (a secondary outcome) was defined. One of the original requirements was that patients would need to score over 85 on a [[SF-36|survey of physical functioning]], indicative of what healthy working-age people score. This was changed to a score of over 60.<ref name=":3">{{Cite journal |last=Geraghty |first=Keith J |date=2017 |title=Further commentary on the PACE trial: Biased methods and unreliable outcomes |url=http://journals.sagepub.com/doi/10.1177/1359105317714486 |journal=Journal of Health Psychology |language=en |volume=22 |issue=9 |pages=1209–1216 |doi=10.1177/1359105317714486 |pmid=28805517 |issn=1359-1053}}</ref> This meant that some were above 60 on this metric at the start of the trial, as the criterion for entry was a score of under 65. However, no patients were counted as recovered at trial entry, as they also needed to not meet the CFS criteria any more, and rate their overall health as much or very much better in order to be classed as recovered.<ref name=":8">{{Cite web |last=Racaniello |first=Vincent |date=2016-02-10 |title=An open letter to The Lancet, again {{!}} Virology Blog |url=https://virology.ws/2016/02/10/open-letter-lancet-again/ |access-date=2024-04-27 |language=en-US}}</ref><ref name=":3" /> |
| A reanalysis of the PACE trial using the original primary outcome measures, found that while there was a significant effect of CBT and GET, this significance disappeared after correcting for the number of comparisons as specified in the original protocol. There was also no statistically significant difference between the GET, CBT, and control groups for recovery.<ref name=":42" /> | |
| === Subjective primary outcome measures and placebo === | === Subjective primary outcome measures and placebo === |
Okumaya devam et...