FINE trial
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.[2] 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.[3] 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."[3]
Study[edit | edit source]
- 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 - FULL TEXT of study aims and design][2]
- 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 - ABSTRACT and Pubmed COMMENTS][4]
- 2010, Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial - RESULTS of FINE trial after 70-week follow-up[3]
- 2010, Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial - ABSTRACT of follow-up report and Pubmed COMMENTS[5]
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]
- 2017,
- 2015, Trial By Error, Continued: Why has the PACE Study’s “Sister Trial” been “Disappeared” and Forgotten?
- 2010, Not So Fine After All: the FINE Trial Crashes to Earth
- FINE Trials Experience
- Failure of FINE trial comes as no surprise’ – MEA responds to study results in British Medical Journal
- Add to FINE page https://forbetterscience.wordpress.com/2016/05/20/plos-correction-removes-previously-available-anonymised-patient-clinical-trial-data/
Consent Form[edit | edit source]
- Add FINE consent form http://retractionwatch.com/wp-content/uploads/2016/05/11.4.16-Mitchell-Response-consent-form-version3-MREC-2460904.pdf
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]
- ↑ 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
- ↑ 2.0 2.1 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
- ↑ 3.0 3.1 3.2 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
- ↑ https://www.ncbi.nlm.nih.gov/pubmed/16603058
- ↑ https://www.ncbi.nlm.nih.gov/pubmed/20418251
- ↑ http://www.investinme.org/Article-015%20FINE%20Trials.htm
- ↑ Exploring changes to PACE trial outcome measures using anonymised data from the FINE trial