Outcome switching
Outcome switching or outcome swapping is when authors of a clinical trial "move the goal posts" during a trial, which may be done to achieve the desired results or may accidentally affect the trial's findings.[citation needed]
The PACE trial authors, in a clinical trial of ME/CFS patients undergoing GET/CBT, employed this tactic.
Contents
Pre-specified outcomes[edit | edit source]
When a clinical trial has a protocol published in advance, it will typically include pre-specified primary outcomes, these are the main measures used to determine if an intervention or drug is effective. Secondary outcomes are considered to be less important. For example, change in average pain level measured with a questionnaire, biological test results or physical measurements of ability.[citation needed]
Outcome swapping is the process of changing these primary outcomes during the trial or prior to publication.[citation needed] For example, a secondary outcome may be changed with a primary outcome, which may give then change the results reported in the trial publication.
In the PACE trial, outcome swapping led to results showing that both CBT and GET were moderately effective, but when a secondary analysis used the original pre-specified outcomes this showed the interventions were less effective than the previously published results.[citation needed]
Articles on Outcome switching in clinical trials[edit | edit source]
- How Outcome Switching is Corrupting Medical Research[1]
- For my next trick... [2]
- Is Outcome Switching Still A Problem In Clinical Trials?[3]
- How researchers dupe the public with a sneaky practice called "outcome switching"[4]
Tracking outcome switching
PACE trial[edit | edit source]
- In 2016, Julie Rehmeyer gave the talk Bad Statistics, Bad Reporting, Bad Impact on Patients: The Story of the PACE Trial Slideshow given at the 2016 Joint Statistics Meetings[6] (Notes may be be viewed by clicking the “Notes” icon just above the comments section in the slideshow link.)
- David Tuller spoke about and answered questions on the PACE trial and its flaws.
- Feb 28, 2016, David Tuller gave a speech with Q&As.[7]
- Feb 27, 2016, An Interview with David Tuller, held at The Forgotten Plague Conference, discussing the flaws of the Pace trial.[8]
Learn more[edit | edit source]
See also[edit | edit source]
- Alem Matthees won a Freedom of Information Act tribunal for the release of the PACE trial data.
References[edit | edit source]
- ↑ Lane, Christopher (Apr 30, 2016). "How Outcome Switching is Corrupting Medical Research". Psychology Today. Retrieved Aug 11, 2018.
- ↑ "For my next trick..." The Economist. Mar 26, 2016. Retrieved Aug 11, 2018.
- ↑ Miseta, Ed (Mar 7, 2016). "Is Outcome Switching Still A Problem In Clinical Trials". www.clinicalleader.com. Retrieved Aug 11, 2018.
- ↑ Belluz, Julia (Dec 29, 2015). "How researchers dupe the public with a sneaky practice called "outcome switching"". Vox. Retrieved Aug 11, 2018.
- ↑ "Tracking switched outcomes in clinical trials". COMPare. Retrieved Aug 11, 2018.
- ↑ Rehmeyer, Julie (Aug 1, 2016). "Bad Statistics, Bad Reporting, Bad Impact on Patients: The Story of the PACE trial". www.slideshare.net. Retrieved Aug 11, 2018 – via SlideShare.
- ↑ Tuller, David (Mar 28, 2016). "Lezing dr David Tuller met Nederlandse ondertiteling". YouTube. ME/cvs Vereniging.
- ↑ Tuller, David (Mar 4, 2016). "Interview with David Tuller (Amsterdam, 27th February 2016)". YouTube. Frank Twisk.
- ↑ "PACE trial - MEpedia". me-pedia.org. Retrieved Aug 11, 2018.
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