Literature DB >> 27807258

'PACE-Gate': When clinical trial evidence meets open data access.

Keith J Geraghty1.   

Abstract

Science is not always plain sailing and sometimes the voyage is across an angry sea. A recent clinical trial of treatments for chronic fatigue syndrome (the PACE trial) has whipped up a storm of controversy. Patients claim the lead authors overstated the effectiveness of cognitive behavioural therapy and graded exercise therapy by lowering the thresholds they used to determine improvement. In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request.

Entities:  

Keywords:  chronic fatigue syndrome; clinical trials; cognitive behavioural therapy; psychotherapy; treatment

Mesh:

Year:  2016        PMID: 27807258     DOI: 10.1177/1359105316675213

Source DB:  PubMed          Journal:  J Health Psychol        ISSN: 1359-1053


  10 in total

1.  Approaching recovery from myalgic encephalomyelitis and chronic fatigue syndrome: Challenges to consider in research and practice.

Authors:  Andrew R Devendorf; Carly T Jackson; Madison Sunnquist; Leonard A Jason
Journal:  J Health Psychol       Date:  2017-11-28

2.  Are ME/CFS Patient Organizations "Militant"? : Patient Protest in a Medical Controversy.

Authors:  Charlotte Blease; Keith J Geraghty
Journal:  J Bioeth Inq       Date:  2018-07-03       Impact factor: 1.352

Review 3.  The Updated NICE Guidance Exposed the Serious Flaws in CBT and Graded Exercise Therapy Trials for ME/CFS.

Authors:  Mark Vink; Alexandra Vink-Niese
Journal:  Healthcare (Basel)       Date:  2022-05-12

4.  Evidence-Based Care for People with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis.

Authors:  Michael Sharpe; Trudie Chalder; Peter D White
Journal:  J Gen Intern Med       Date:  2021-11-17       Impact factor: 6.473

5.  Using a participatory approach to develop and implement the UK ME/CFS Biobank.

Authors:  Eliana M Lacerda; Caroline C Kingdon; Erinna W Bowman; Luis Nacul
Journal:  Fatigue       Date:  2017-10-30

Review 6.  How have selection bias and disease misclassification undermined the validity of myalgic encephalomyelitis/chronic fatigue syndrome studies?

Authors:  Luis Nacul; Eliana M Lacerda; Caroline C Kingdon; Hayley Curran; Erinna W Bowman
Journal:  J Health Psychol       Date:  2017-03-01

Review 7.  Multidisciplinary rehabilitation treatment is not effective for myalgic encephalomyelitis/chronic fatigue syndrome: A review of the FatiGo trial.

Authors:  Mark Vink; Alexandra Vink-Niese
Journal:  Health Psychol Open       Date:  2018-08-06

8.  The Importance of Accurate Diagnosis of ME/CFS in Children and Adolescents: A Commentary.

Authors:  Keith James Geraghty; Charles Adeniji
Journal:  Front Pediatr       Date:  2019-01-21       Impact factor: 3.418

9.  Better governance, better access: practising responsible data sharing in the METADAC governance infrastructure.

Authors:  Madeleine J Murtagh; Mwenza T Blell; Olly W Butters; Lorraine Cowley; Edward S Dove; Alissa Goodman; Rebecca L Griggs; Alison Hall; Nina Hallowell; Meena Kumari; Massimo Mangino; Barbara Maughan; Melinda C Mills; Joel T Minion; Tom Murphy; Gillian Prior; Matthew Suderman; Susan M Ring; Nina T Rogers; Stephanie J Roberts; Catherine Van der Straeten; Will Viney; Deborah Wiltshire; Andrew Wong; Neil Walker; Paul R Burton
Journal:  Hum Genomics       Date:  2018-04-26       Impact factor: 4.639

10.  Improving Access to Psychological Therapies (IAPT) - The Need for Radical Reform.

Authors:  Michael J Scott
Journal:  J Health Psychol       Date:  2018-02-02
  10 in total

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