FINE trial

From MEpedia, a crowd-sourced encyclopedia of ME and CFS science and history

The FINE trial which stands for Fatigue Intervention by Nurses Evaluation[1] was a study to examine two treatments, self-help treatment and pragmatic rehabilitation, for patients meeting the 1991 Oxford criteria for CFS.[1] About 10% of the trial participants were non-ambulatory and about 30% met the 1994 London criteria for ME, but separate results for these groups were not published.[2] It is considered to be the 'sister' trial to the PACE trial.

The FINE trial authors concluded after a 70-week follow-up that the 18-week program was not an effective treatment for CFS/ME because the small improvement in fatigue, sleep and depression that were initially observed were not maintained in a long-term follow-up: "Pragmatic rehabilitation delivered at home by trained general nurses over a period of 18 weeks improved fatigue, sleep, and depression among patients with CFS/ME, but these effects were not maintained in the long term once treatment was completed. Supportive listening delivered by trained general nurses was not an effective treatment for CFS/ME in primary care. More studies are needed to determine the optimal conditions under which pragmatic rehabilitation can be delivered to patients in the community with CFS/ME and whether the limited benefits seen in this trial can be sustained."[2]

Study[edit | edit source]

Funding[edit | edit source]

The FINE trial was funded by the UK's Medical Research Council.[6]

Results[edit | edit source]

Sam Carter applied the criteria from a PACE trial study to the data from the FINE trial and questioned whether the recovery rates in the PACE study had been inflated by as much as six-fold as a result.[7]

Criticism[edit | edit source]

Consent Form[edit | edit source]

Investigators[edit | edit source]

  • Alison J. Wearden - FINE Trial Principal Investigator, Reader (University Lecturer) in psychology, School of Psychological Sciences, University of Manchester, Manchester, UK
  • Lisa Riste - FINE Trial Manager, School of Psychological Sciences, University of Manchester, Manchester, UK
  • Christopher Dowrick, Professor of primary medical care, School of Population, Community and Behavioural Sciences, University of Liverpool, Liverpool, UK
  • Carolyn Chew-Graham, Professor of primary care, School of Community Based Medicine, University of Manchester, Manchester, UK
  • Richard P. Bentall, Professor of clinical psychology, School of Psychology, University of Bangor, Adeilad Brigantia, Bangor, Gwynedd, UK
  • Richard K. Morriss, Professor of psychiatry and community mental health, School of Community Health Sciences, Institute of Mental Health, University of Nottingham, Nottingham, UK
  • Sarah Peters, Senior lecturer in psychology, School of Psychological Sciences, University of Manchester, Manchester, UK
  • Graham Dunn - FINE trial statistician, Professor of biomedical statistics, School of Community Based Medicine, University of Manchester, Manchester, UK
  • Gerry Richardson, Senior research fellow in health economics, Centre for Health Economics, University of York, York and Hull York Medical School, University of York, Heslington, York, UK
  • Karina Lovell, Professor of mental health, School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK
  • Pauline Powell, Infectious Diseases Unit, Royal Liverpool University Hospital, UK

Learn more[edit | edit source]

See also[edit | edit source]

References[edit | edit source]

  1. 1.0 1.1 1.2 Wearden, A.; Riste, L.; Dowrick, C.; Chew-Graham, C.; Bentall, R.; Morriss, R.; Peters, S.; Dunn, G.; Richardson, G.; Lovell, K.; Powell, P. (2006). "Fatigue Intervention by Nurses Evaluation – The FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. [ISRCTN74156610]". BMC Medicine. 4 (9). doi:10.1186/1741-7015-4-9. PMID 16603058.
  2. 2.0 2.1 Wearden, A.; Dowrick, C.; Chew-Graham, C.; Bentall, R.; Morriss, R.; Peters, S.; Riste, L.; Richardson, G.; Lovell, K.; Dunn, G. (2010). "Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial". The BMJ. 2010 (340). doi:10.1136/bmj.c1777.
  3. Wearden, A. J.; Riste, L.; Dowrick, C.; Chew-Graham, C.; Bentall, R. P.; Morriss, R. K.; Peters, S.; Dunn, G.; Richardson, G. (April 7, 2006). "Fatigue Intervention by Nurses Evaluation--the FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. [ISRCTN74156610]". BMC medicine. 4: 9. doi:10.1186/1741-7015-4-9. ISSN 1741-7015. PMC 1456982. PMID 16603058.
  4. Wearden, Alison J.; Dowrick, Christopher; Chew-Graham, Carolyn; Bentall, Richard P.; Morriss, Richard K.; Peters, Sarah; Riste, Lisa; Richardson, Gerry; Lovell, Karina (April 23, 2010). "Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial". BMJ. 340: c1777. doi:10.1136/bmj.c1777. ISSN 0959-8138. PMID 20418251.
  5. Wearden, Alison J.; Dowrick, Christopher; Chew-Graham, Carolyn; Bentall, Richard P.; Morriss, Richard K.; Peters, Sarah; Riste, Lisa; Richardson, Gerry; Lovell, Karina (April 23, 2010). "COMMENTS | Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial". BMJ (Clinical research ed.). 340: c1777. ISSN 1756-1833. PMC 2859122. PMID 20418251.
  6. Invest in ME Research. "FINE Trials". Invest in ME Research. Retrieved January 28, 2019.
  7. 7.0 7.1 Carter, Samuel (July 19, 2013). "Letter to the Editor: 'Recovery from chronic fatigue syndrome after treatments given in the PACE trial': recovery or remission?". Psychological Medicine. 43 (8): 1787–1788. doi:10.1017/S0033291713001268. PMID 23866112.
  8. Carter, Samuel (June 9, 2010). "FINE Trial for CFS: Both significant and small?". The BMJ. 340: c2988. doi:10.1136/bmj.c2988. ISSN 0959-8138. PMID 20534659.
  9. Carter, Sam (June 9, 2012). "A valedictory dispatch from the Psychosocial School? | Rapid Responses to articles". The BMJ. Retrieved January 29, 2019.
  10. Carter, Sam (February 15, 2016). "Exploring changes to PACE trial outcome measures using anonymised data from the FINE trial". Psychological Medicine. Archived from the original on February 18, 2018.