FINE trial

The FINE trial which stands for Fatigue Intervention by Nurses Evaluation was a study to examine two treatments, self-help treatment and pragmatic rehabilitation, for patients meeting the 1991 Oxford criteria for CFS. 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. 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."

Study

 * 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]
 * 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]
 * 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
 * 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

Funding
The FINE trial was funded by the UK's Medical Research Council.

Results
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.

Criticism

 * 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
 * 2010, FINE Trials Experience - Invest in ME Research
 * 2010, Failure of FINE trial comes as no surprise’ – MEA responds to study results in British Medical Journal
 * 2010, FINE Trial for CFS: Both significant and small?
 * 2012 - A valedictory dispatch from the Psychosocial School?
 * 2016 - Exploring changes to PACE trial outcome measures using anonymised data from the FINE trial


 * 2016, Plos correction removes previously available anonymised patient clinical trial data

Consent Form

 * Add FINE consent form http://retractionwatch.com/wp-content/uploads/2016/05/11.4.16-Mitchell-Response-consent-form-version3-MREC-2460904.pdf

Investigators

 * 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

 * FINE trial website