Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis

TY - JOUR

T1 - Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis

AU - White, Peter D

AU - Abbey, Susan

AU - Angus, Brian

AU - Ball, Harriet A

AU - Buchwald, Dedra

AU - Burness, Christine

AU - Carson, Alan

AU - Chalder, Trudie

AU - al., et

PY - 2023/5/3

Y1 - 2023/5/3

N2 - Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) is a disabling long-term condition of unknown cause. The National Institute of Health and Clinical Excellence (NICE) published a guideline in 2021 that highlighted the seriousness of the condition, but also recommended that graded exercise therapy (GET) should not be used and cognitive behaviour therapy (CBT) should only be used to manage symptoms and reduce distress, not to aid recovery. This U-turn in recommendations from the previous 2007 guideline is controversial. We suggest that the controversy stems from anomalies in both processing and interpretation of the evidence by the NICE committee. The committee: 1) Created a new definition of CFS/ME, which “down-graded” the certainty of trial evidence; 2) Omitted data from standard trial end points used to assess efficacy; 3) Discounted trial data when assessing treatment harm in favour of lower quality surveys and qualitative studies; 4) Minimized the importance of fatigue as an outcome; 5) Did not use accepted practices to synthesise and GRADE trial evidence; 6) Interpreted GET as mandating fixed increments of change when trials defined it as collaborative, negotiated, and symptom dependent; 7) Deviated from NICE recommendations of rehabilitation for related conditions, such as chronic primary pain; 8) Recommended an energy management approach in the absence of supportive research evidence. We conclude that the dissonance between this and the previous guideline was the result of deviating from usual scientific standards of the NICE process. The consequences of this are that patients may be denied helpful treatments and therefore risk persistent ill health and disability.

AB - Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) is a disabling long-term condition of unknown cause. The National Institute of Health and Clinical Excellence (NICE) published a guideline in 2021 that highlighted the seriousness of the condition, but also recommended that graded exercise therapy (GET) should not be used and cognitive behaviour therapy (CBT) should only be used to manage symptoms and reduce distress, not to aid recovery. This U-turn in recommendations from the previous 2007 guideline is controversial. We suggest that the controversy stems from anomalies in both processing and interpretation of the evidence by the NICE committee. The committee: 1) Created a new definition of CFS/ME, which “down-graded” the certainty of trial evidence; 2) Omitted data from standard trial end points used to assess efficacy; 3) Discounted trial data when assessing treatment harm in favour of lower quality surveys and qualitative studies; 4) Minimized the importance of fatigue as an outcome; 5) Did not use accepted practices to synthesise and GRADE trial evidence; 6) Interpreted GET as mandating fixed increments of change when trials defined it as collaborative, negotiated, and symptom dependent; 7) Deviated from NICE recommendations of rehabilitation for related conditions, such as chronic primary pain; 8) Recommended an energy management approach in the absence of supportive research evidence. We conclude that the dissonance between this and the previous guideline was the result of deviating from usual scientific standards of the NICE process. The consequences of this are that patients may be denied helpful treatments and therefore risk persistent ill health and disability.

KW - chronic fatigue syndrome

KW - myalgic encephalomyelitis

KW - National Institute of Health and Clinical Excellence

KW - management

KW - treatment

KW - cognitive behaviour therapy

KW - graded exercise therapy

U2 - 10.1136/jnnp-2022-330463

DO - 10.1136/jnnp-2022-330463

M3 - Article

SN - 0022-3050

JO - Journal of Neurology, Neurosurgery and Psychiatry

JF - Journal of Neurology, Neurosurgery and Psychiatry

ER -