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The '''FINE trial''' which stands for Fatigue Intervention by Nurses Evaluation<ref name="FINE, 2006" /> was a study to examine two treatments, self-help treatment and pragmatic rehabilitation, for patients meeting the 1991 [[Oxford criteria]] for [[Chronic fatigue syndrome|CFS]].<ref name="FINE, 2006" /> About 10% of the trial participants were non-ambulatory and about 30% met the 1994 [[London criteria]] for [[myalgic encephalomyelitis|ME]], but separate results for these groups were not published.<ref name="FINE, 2010" /> 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."<ref name="FINE, 2010" /> ==Study== *2006, [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1456982/ 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]<ref name="FINE, 2006" /> *2006, [https://www.ncbi.nlm.nih.gov/pubmed/16603058 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]<ref>{{Cite journal | last = Wearden | first = A. J. | author-link = Alison Wearden | last2 = Riste | first2 = L. | authorlink2 = Lisa Riste | last3 = Dowrick | first3 = C. | authorlink3 = Christopher Dowrick | last4 = Chew-Graham | first4 = C. | authorlink4 = Carolyn Chew-Graham | last5 = Bentall | first5 = R. P. | authorlink5 = Richard Bentall | last6 = Morriss | first6 = R. K. | authorlink6 = Richard Morriss | last7 = Peters | first7 = S. | author-link8 = Sarah Peters | last8 = Dunn | first8 = G. | author-link8 = Graham Dunn | last9 = Richardson | first9 = G. | author-link9 = Gerry Richardson | date = 2006-04-07 | title = 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]| url = https://www.ncbi.nlm.nih.gov/pubmed/16603058|journal=BMC medicine|volume=4|issue= | pages = 9|doi=10.1186/1741-7015-4-9|issn=1741-7015|pmc=1456982|pmid=16603058|quote=|via=}}</ref> *2010, [http://www.bmj.com/content/340/bmj.c1777.long 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<ref>{{Cite journal | last = Wearden | first = Alison J. | last2 = Dowrick | first2 = Christopher | last3 = Chew-Graham | first3 = Carolyn | last4 = Bentall | first4 = Richard P. | last5 = Morriss | first5 = Richard K. | last6 = Peters | first6 = Sarah | last7 = Riste | first7 = Lisa | last8 = Richardson | first8 = Gerry | last9 = Lovell | first9 = Karina | date = 2010-04-23 | title = Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial| url = https://www.bmj.com/content/340/bmj.c1777|journal=BMJ|language=en|volume=340 | pages = c1777|doi=10.1136/bmj.c1777|issn=0959-8138|pmid=20418251|issue=|quote= | author-link = Alison Wearden | authorlink2 = Christopher Dowrick | authorlink3 = Carolyn Chew-Graham | authorlink4 = Richard Bentall | authorlink5 = Richard Morriss|via= | authorlink6 = Sarah Peters | author-link8 = Lisa Riste | author-link8 = Gerry Richardson | author-link9 = Karina Lovell}}</ref> *2010, [https://www.ncbi.nlm.nih.gov/pubmed/20418251 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<ref>{{Cite journal | last = Wearden | first = Alison J. | last2 = Dowrick | first2 = Christopher | last3 = Chew-Graham | first3 = Carolyn | last4 = Bentall | first4 = Richard P. | last5 = Morriss | first5 = Richard K. | last6 = Peters | first6 = Sarah | last7 = Riste | first7 = Lisa | last8 = Richardson | first8 = Gerry | last9 = Lovell | first9 = Karina | date = 2010-04-23 | title = COMMENTS {{!}} Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial| url = https://www.ncbi.nlm.nih.gov/pubmed/20418251|journal=BMJ (Clinical research ed.)|volume=340 | pages = c1777|issn=1756-1833|pmc=2859122|pmid=20418251|issue=|via=|quote= | author-link = Alison Wearden | authorlink2 = Christopher Dowrick | authorlink3 = Carolyn Chew-Graham | authorlink4 = Richard Bentall | authorlink5 = Richard Morriss}}</ref> ==Funding== The FINE trial was funded by the UK's [[Medical Research Council]].<ref>{{Cite web | url=http://www.investinme.org/Article-015%20FINE%20Trials.htm | title = FINE Trials | last = Invest in ME Research | first = | authorlink = Invest in ME Research | date = |website=[[Invest in ME Research]]|archive-url=|archive-date=|url-status=|access-date=2019-01-28}}</ref> ==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.<ref name="CarterSam20130719pubmed">{{cite journal| title = Letter to the Editor: ‘Recovery from chronic fatigue syndrome after treatments given in the PACE trial’: recovery or remission?| journal = Psychological Medicine |volume =43 | issue =8 | pages = 1787-1788| date = Jul 19, 2013| url = https://www.cambridge.org/core/journals/psychological-medicine/article/letter-to-the-editor-recovery-from-chronic-fatigue-syndrome-after-treatments-given-in-the-pace-trial-recovery-or-remission/2D0B3E2A3D4E3DDE43B4DF7056669341 | archive-url = |quote= | author-link = Samuel Carter|via=|url-status=dead | last = Carter | first = Samuel|archive-date= |doi=10.1017/S0033291713001268 |pmc=|pmid= 23866112}}</ref> ==Criticism== *2010, [http://phoenixrising.me/archives/11854 Not So Fine After All: the FINE Trial Crashes to Earth] *2010, [http://www.investinme.org/Article-015%20FINE%20Trials.htm FINE Trials Experience] - [[Invest in ME Research]] *2010, [http://www.meassociation.org.uk/2010/05/failure-of-fine-trial-comes-as-no-surprise-mea-responds/ Failure of FINE trial comes as no surprise’ – MEA responds to study results in British Medical Journal] * 2010, [https://www.bmj.com/content/340/bmj.c2988 FINE Trial for CFS: Both significant and small?] <ref>{{Cite journal | last = Carter | first =Samuel | author-link = Sam Carter | date = Jun 9, 2010 | title = FINE Trial for CFS: Both significant and small?| url = https://www.bmj.com/content/340/bmj.c2988|journal=[[The BMJ]]|language=en|volume=340|issue= | pages = c2988|doi=10.1136/bmj.c2988|issn=0959-8138|pmid=20534659|quote=|via=}}</ref> * 2012, [https://www.bmj.com/rapid-response/2011/11/02/valedictory-dispatch-psychosocial-school A valedictory dispatch from the Psychosocial School?]<ref>{{Cite web | last = Carter | first = Sam | authorlink = Sam Carter | date = Jun 9, 2012 | title = A valedictory dispatch from the Psychosocial School? {{!}} Rapid Responses to articles |url =https://www.bmj.com/rapid-response/2011/11/02/valedictory-dispatch-psychosocial-school|publisher =[[The BMJ]]|language=en|access-date=2019-01-29|quote=|via=}}</ref> *2013, [https://www.cambridge.org/core/journals/psychological-medicine/article/letter-to-the-editor-recovery-from-chronic-fatigue-syndrome-after-treatments-given-in-the-pace-trial-recovery-or-remission/2D0B3E2A3D4E3DDE43B4DF7056669341 Letter to the Editor: ‘Recovery from chronic fatigue syndrome after treatments given in the PACE trial’: recovery or remission?]<ref name="CarterSam20130719pubmed" /> *2015, [http://www.virology.ws/2015/11/09/trial-by-error-continued-why-has-the-pace-studys-sister-trial-been-disappeared-and-forgotten/ Trial By Error, Continued: Why has the PACE Study’s “Sister Trial” been “Disappeared” and Forgotten?] * 2016, [http://wames.org.uk/cms-english/2016/02/exploring-changes-to-pace-trial-outcome-measures/ Exploring changes to PACE trial outcome measures using anonymised data from the FINE trial]<ref name="CarterSam20160215pubmed" >{{cite web|journal = Psychological Medicine | volume = | issue = | pages = | title = Exploring changes to PACE trial outcome measures using anonymised data from the FINE trial | date = Feb 15, 2016| archive-url = https://wames.org.uk/cms-english/exploring-changes-to-pace-trial-outcome-measures/|archive-date = Feb 18, 2018 |url= https://www.ncbi.nlm.nih.gov/pubmed/23363640#cm23363640_14248|quote= | author-link = Sam Carter|via=|url-status=live | last = Carter | first = Sam}}</ref> * 2016, [https://forbetterscience.wordpress.com/2016/05/20/plos-correction-removes-previously-available-anonymised-patient-clinical-trial-data/ 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 Wearden|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 Bentall|Richard P. Bentall]], Professor of clinical psychology, School of Psychology, University of Bangor, Adeilad Brigantia, Bangor, Gwynedd, UK *[[Richard Morriss|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== *[https://web.archive.org/web/20080509080043/http://www.fine-trial.net/ FINE trial website (as archived by Wayback Machine in 2008)] ==See also== *[[PACE trial]] ==References== <references> <ref name="FINE, 2006">{{Cite journal | last =Wearden | first1 = A. | author-link1 = Alison Wearden | last2 = Riste | first2 = L. | authorlink2 = Lisa Riste | last3 = Dowrick | first3 = C. | authorlink3 = Christopher Dowrick | last4 = Chew-Graham | first4 = C. | authorlink4 = Carolyn Chew-Graham | last5 = Bentall | first5 = R. | authorlink5 = Richard Bentall | last6 = Morriss | first6 = R. | authorlink6 = Richard Morriss | last7 =Peters | first7 = S. | author-link8 = Sarah Peters | last8 = Dunn | first8 = G. | author-link8 = Grahan Dunn | last9 = Richardson | first9 = G. | author-link9 = Gerry Richardson | last10 = Lovell | first10 = K. | author-link10 = Karina Lovell | last11 = Powell | first11 = P. | author-link11 = Pauline Powell | title = 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] | journal = BMC Medicine | volume = 4 | issue = 9 | page = | date = 2006 | pmid = 16603058 | doi = 10.1186/1741-7015-4-9 | url = https://www.ncbi.nlm.nih.gov/pubmed/16603058 }}</ref> <ref name="FINE, 2010">{{Cite journal | last =Wearden | first1 = A. | author-link1 = Alison Wearden | last2 = Dowrick | first2 = C. | authorlink2 = Christopher Dowrick | last3 = Chew-Graham | first3 = C. | authorlink3 = Carolyn Chew-Graham | last4 = Bentall | first4 = R. | authorlink4 = Richard Bentall | last5 = Morriss | first5 = R. | authorlink5 = Richard Morriss | last6 = Peters | first6 = S. | authorlink6 = Sarah Peters | last7 =Riste | first7 = L. | author-link8 = Lisa Riste | last8 = Richardson | first8 = G. | author-link8 = Gerry Richardson | last9 = Lovell | first9 = K. | author-link9 = Karina Lowell | last10 = Dunn | first10 = G. | author-link10 = Graham Dunn | title = Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial | journal = The BMJ | volume = 2010 | issue = 340 | page = | date = 2010 | pmid = | doi = 10.1136/bmj.c1777 }}</ref> </references> [[Category:Notable studies]] [[Category:Psychological paradigm]]
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