Med forkus på ME-syke barn og unge: Esther Crawley og TEDxBristol 2017

Esther Crawley, som nylig publiserte resultater ifra SMILE (Specialist medical intervention lightning evaluation) studien, hvor ME-syke barn og ungdom under 18 år har deltatt i en behandlingsstudie hvor en av intervensjonene er et omstidt alternativt tre-dagers LP-kurs. Nå snart skal hun holde scenen i TEDxBristol med talen «Disrupting Your View Of ME».

Omtalen som følger:

Esther Crawley is a Professor of Child Health at the University of Bristol with a Senior Research Fellowship from the National Institute of Health Research.

She dedicates her waking hours to finding and delivering treatments for children whose lives have been devastated by Chronic Fatigue and ME, an illness that affects 1-2% of teenagers – that’s 10-20 children in a normal secondary school.

Esther is the clinical lead for the Bath specialist Chronic Fatigue Syndrome/ME service for children based at the Royal United Hospital in Bath, the largest service of its type in the world – providing assessment and treatment for over 450 children and young people with CFS/ME each year. Chronic Fatigue Syndrome is a debilitating illness that causes chaos to peoples lives.

Esther is passionate about trying to develop more effective treatments, and her research is world leading. But because of it, she has experienced harassment, threats and cyber stalking from a small group of activists who have dedicated their lives to try and stop her research. Esther and her colleagues who continue to practice in this area face an up-hill climb: research is slowed down as they deal with investigations and threats. Their patients suffer because clinicians and researchers wont work in this area.

Esther’s hard-hitting talk for TEDxBristol: Dare to Disrupt will explore why she has decided to continue with the research, despite the immense pressure she has been put under to stop. Her talks examines the difficult choices that many pioneers of medical research make – and the personal pressures, turmoil, threats and attacks that clinicians, scientists and researchers face when they choose to take a stand and do what is right, not what is easy.

I dare to disrupt because …
We need to disrupt views of this illness.Those who are ill with CFS/ME do not have a voice – they are too unwell. We need to provide their voice and we need to speak up about this illness. Because we, as a community, as a society, as friends, as neighbours and as parents should look after children who suffer.


Svik og urett

Hvor i verden er EMC domene?

Esther Crawley_turf. Esther M Crawley Centre for Child and Adolescent Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol. Dr Crawley is a medical advisor for the Association for Young People with ME (AYME), and for the
Sussex & Kent ME/CFS Society.

Tidslinje smiletrial (publikasjoner – dato innlevert manuskript)

Registrering av klinisk studie/RCT ISRCTN: 7 juni 2012
Studiestart 1 august 2012
Studien avsluttes 31 mars 2013
SMILE2013: 14 september 2012
Protokoll2013-RCT: 13 desember 2012
Parslow2015: 20 april 2015
SMILE2017-RCT: 17 mai 2017

Datainnsamling:
SMILE2013: 1 oktober 2010 – 16 juni 2012
SMILE2017-RCT: september 2010 – april 2013

REK vedtak (South West 2 Local Research Ethics Committee)
8 september2010, refnr: 10/H0206/32
31 mai 2011 refnr: ?, godkjent endring/tillegg i protokoll/studie.
6 september 2012 refnr: ?, godkjent endring/tillegg i protokoll/studie.

Publikasjoner som henviser til ISRCTN 81456207 .
Registrering ISRCTN: 7 juni 2012
Studiestart 1 august 2012
Studien avsluttes 31 mars 2013
SMILE2013, Protokoll2013-RCT, Parslow2015 og SMILE2017-RCT

SMILEtrial 2013:
Crawley, E., Mills, N., Beasant, L., Johnson, D., Collin, S. M., Deans, Z., … Montgomery, A. (2013). The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study). Trials, 14, 415. http://doi.org/10.1186/1745-6215-14-415

Protokoll2013:
Crawley E, Mills N, Hollingworth W, Deans Z, Sterne JA, Donovan JL, Beasant L, Montgomery A, Comparing specialist medical care with specialist medical care plus the Lightning Process for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial)., Trials, 2013, 14, 444, doi:10.1186/1745-6215-14-444.
https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-444

Parslow2015:
Parslow R, Patel A, Beasant L, Haywood K, Johnson D, Crawley E, What matters to children with CFS/ME? A conceptual model as the first stage in developing a PROM, Arch Dis Child, 2015 , 100, 12, 1141-1147, doi: 10.1136/archdischild2015-308831.
http://adc.bmj.com/content/100/12/1141

SMILEtrial2017:
Crawley EM, Gaunt DM, Garfield K, et al Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial Archives of Disease in Childhood Published Online First: 20 September 2017. doi: 10.1136/archdischild-2017-313375
http://adc.bmj.com/content/early/2017/09/21/archdischild-2017-313375

NorCAPITAL, norsk forskningsstudie på ME-syke barn og ungdom.

SMILEtrial CONSORT 2013 pasientene og tillegget for 2017
sammenligning CONSORT SMILEtrial vs NorCAPITAL
Antall deltakere NorCAPITAL og SMILEtrial
Diagnosekriter_NorCAPITAL_prosentvis fordeling av studiedeltakere
Diagnosekriter_NorCAPITAL_antall deltakere
Fatigue skår NorCAPITAL og SMILE baseline verdier
Fatigue skår NorCAPITAL og SMILE m oppfølging
NorCAPITAL_antall skritt pr dag

PS! NorCAPITAL brukte objektive mål som primære endemål og godt validerte spørreskjema for barn og unge, imotsetting til SMILE som brukte ingen objektive endemål og ingen aner hva som skjedde med deltakerene før seks mnd. SMILE studien har beklagligvis langt verre og mer kritikkverdig design og metode enn PACE2011. SMILE2017 mangler etiske betrakninger og vurdering i publikasjonen. De etiske retningslinjene og anbefalinger når en utfører forskning på barn og unge under 18 år er langt strengere enn forskning på voksne.

 

(…og der er en del kritikk jf NorCAPITAL, som bredere diagnosekriterier, rehabilitering under studieperiode og også noen av eksluderingsgrunnlag til studien er hyppig manifisterte symptomer, altså ofte en del av sykdomsbildet til ME-syke, se mer)

sånn…

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