Outcome switching

From MEpedia, a crowd-sourced encyclopedia of ME and CFS science and history
Jump to: navigation, search

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.

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]

Tracking outcome switching

PACE trial[edit | edit source]

  • David Tuller spoke about and answered questions on the PACE trial and its flaws.

SMILE trial[edit | edit source]

In the SMILE trial, school attendance was swapped from a primary outcome to a secondary outcome during the trial, with all primary outcomes then based only on questionnaire results, despite the unblinded treatment which encouraged children to believe they would recover and no longer see themselves as ill.[10] The Archives of Disease in Childhood held an investigation but failed to retract the study, instead publishing an extensive editor's note.[10]

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]

  1. Lane, Christopher (Apr 30, 2016). "How Outcome Switching is Corrupting Medical Research". Psychology Today. Retrieved Aug 11, 2018. 
  2. "For my next trick..." The Economist. Mar 26, 2016. Retrieved Aug 11, 2018. 
  3. Miseta, Ed (Mar 7, 2016). "Is Outcome Switching Still A Problem In Clinical Trials". www.clinicalleader.com. Retrieved Aug 11, 2018. 
  4. Belluz, Julia (Dec 29, 2015). "How researchers dupe the public with a sneaky practice called "outcome switching"". Vox. Retrieved Aug 11, 2018. 
  5. "Tracking switched outcomes in clinical trials". COMPare. Retrieved Aug 11, 2018. 
  6. 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. 
  7. Tuller, David (Mar 28, 2016). "Lezing dr David Tuller met Nederlandse ondertiteling". YouTube. ME/cvs Vereniging. 
  8. Tuller, David (Mar 4, 2016). "Interview with David Tuller (Amsterdam, 27th February 2016)". YouTube. Frank Twisk. 
  9. "PACE trial - MEpedia". me-pedia.org. Retrieved Aug 11, 2018. 
  10. 10.010.1 Brown, Nick (Jul 2019). "Editor's Note on Correction to Crawley et al 2018". Archives of Disease in Childhood. 

PACE trial - A controversial study which claimed that CBT and GET were effective in treating "CFS/ME", despite the fact that its own data did not support this conclusion. Its results and methodology were widely disputed by patients, scientists, and the peer-reviewed scientific literature.

The information provided at this site is not intended to diagnose or treat any illness.
From MEpedia, a crowd-sourced encyclopedia of ME and CFS science and history.