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 Oxford criteria for CFS. It is considered to be the 'sister' 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

 * 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]
 * 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]
 * 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
 * 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
 * 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

 * 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