National Institute for Health and Care Excellence Draft Myalgic encephalomyelitis (or encephalopathy) / chronic fatigue syndrome: diagnosis and management [C] Evidence reviews for accessing health and social care services NICE guideline <number> Evidence reviews underpinning recommendations and research recommendations in the NICE guideline November 2020 Draft for Consultation These evidence reviews were developed by the National Guideline Centre DRAFT FOR CONSULTATION Disclaimer The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian. Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties. NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn. Copyright © NICE 2021. All rights reserved. Subject to Notice of rights. ISBN: DRAFT FOR CONSULTATION Contents Contents .............................................................................................................................. 4 Barriers and facilitators to accessing health and social care services ........................... 6 1 Barriers and facilitators to the process of diagnosing of ME/CFS............................ 7 1.1 Summary of the protocol ....................................................................................... 7 1.2 Methods and process ............................................................................................ 7 1.3 Qualitative evidence .............................................................................................. 7 1.1.1 Included studies ......................................................................................... 7 1.1.2 Excluded studies ........................................................................................ 8 1.1.3 Summary of qualitative studies included in the evidence review ................ 9 1.1.4 Summary of the qualitative evidence ........................................................ 16 1.1.5 Narrative summary of review findings ...................................................... 18 1.4 Barriers and facilitators to the diagnosis of ME/CFS in young people .................. 25 1.1.6 Narrative summary of review findings ...................................................... 25 1.1.7 Economic evidence .................................................................................. 29 2 Barriers and facilitators to the care of people with ME/CFS.................................... 30 2.1 Summary of the protocol ..................................................................................... 30 2.2 Methods and process .......................................................................................... 30 2.3 Qualitative evidence ............................................................................................ 30 2.3.1 Included studies ....................................................................................... 30 2.3.2 Excluded studies ...................................................................................... 30 2.4 Summary of studies included in the qualitative evidence ..................................... 31 2.5 Summary of the qualitative evidence ................................................................... 41 2.5.1 Narrative summary of review findings for adults (severity mixed or unclear) .................................................................................................... 43 2.6 Summary of the qualitative evidence ................................................................... 52 2.6.1 Narrative summary of review findings for Children and young people (severity: mixed/ unclear .......................................................................... 54 2.6.2 Economic evidence .................................................................................. 64 3 The committee’s discussion and interpretation of the evidence ............................ 66 3.1 The quality of the evidence .................................................................................. 66 3.2 Findings identified in the evidence synthesis ....................................................... 67 3.3 Cost effectiveness and resource use ................................................................... 78 3.4 Other factors the committee took into account ..................................................... 79 Appendices ........................................................................................................................ 80 Appendix A – Review protocols ................................................................................ 80 Appendix B – Literature search strategies ............................................................... 95 B.1 Clinical search literature search strategy ................................................................. 95 Appendix C – Qualitative evidence study selection ............................................... 100 4 DRAFT FOR CONSULTATION Appendix D – Qualitative evidence ......................................................................... 102 Appendix E GRADE-CERQual tables ...................................................................... 171 Appendix F Excluded studies ................................................................................. 218 References ....................................................................................................................... 226 5 DRAFT FOR CONSULTATION Access to care 1 Barriers and facilitators to accessing 2 health and social care services 3 Review questions 4 1. What are the barriers and facilitators to the diagnosis of ME/CFS? 5 2. What are the barriers and facilitators to the care of people with ME/CFS? 6 Introduction 7 People with ME/CFS are underserved by health and social care services and commonly 8 report difficulties in accessing care. This starts at the beginning of the person’s journey with 9 difficulties in obtaining a diagnosis. There is often a protracted process resulting in feelings of 10 disbelief, lack of understanding and frustration on the part of the patient. This has a 11 significant impact on quality of life and delays are likely to alter the trajectory of care and 12 treatment received. 13 Medical professionals have often been hesitant in giving a diagnosis of ME/CFS; this may 14 relate to lack of knowledge and various misconceptions about the condition within the health 15 and social care professions. Delays in diagnosis has a significant negative impact on people 16 with ME/CFS, with misdiagnoses also presenting as a problem. Some patients have 17 reported having an ME/CFS diagnosis withheld, whilst others claim that the diagnosis is used 18 as a “waste-basket diagnosis” for all patients with unexplained fatigue. Generally, there 19 seems to be a poor understanding of ME/CFS amongst health and social care professionals. 20 Challenges may also arise with referral to specialist services; due to the disparate nature of 21 ME/CFS services; (dependent on location), the same person could be referred to neurology, 22 psychiatry, immunology, endocrinology, rheumatology and pain services. This lack of unified 23 approach impacts on the person’s understanding and ability to manage their condition and 24 will inevitably lead to different approaches to treatment depending on speciality. These 25 difficulties accessing care can continue. 26 The committee used both reviews to inform their recommendations on accessing a diagnosis 27 and care for people with or suspected ME/CFS. The evidence found for the review questions 28 outlined above is in sections 1.3 and 2.3. The committee discussion of the evidence and 29 interpretation is in section 3. 30 © NICE 2021. All rights reserved. Subject to Notice of rights. 6 DRAFT FOR CONSULTATION Access to care 1 1 Barriers and facilitators to the process of 2 diagnosing of ME/CFS 3 1.1 Summary of the protocol 4 For full details see the review protocol in appendix A. 5 Table 1: Characteristics of review question Objective To identify the barriers and facilitators in the process of diagnosing people with ME/CFS Population and Adults, children and young people who are diagnosed with ME/CFS, or who are setting suspected of having ME/CFS by their primary clinician. Clinicians caring for people with ME/CFS, or people suspected to have ME/CFS Stratification: