4 Research recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future. The Guideline Development Group's full set of research recommendations is detailed in the full guideline.

The aetiology of CFS/ME was outside the scope of the guideline and therefore a systematic search of the area was not carried out.  For that reason, the GDG has not made a research recommendation about the causes of CFS/ME, but it recognises that research in this area would be very helpful.

4.1 Extrapolating use of intervention strategies

Are intervention strategies that have been shown to be effective in mildly to moderately affected adults also effective in children and in people (adults and children) with severe CFS/ME?

Why this is important

There is limited evidence for the use or effectiveness of strategies recommended in this guideline in these two patient groups. Population data suggest that these groups constitute a significant percentage of the population with CFS/ME. Some patient experience suggests that some of these interventions may be harmful and/or not effective.

4.2 Delivery of standard methods of care

Are there more efficient ways of delivering standard methods of care? For example, what is the most efficient way of delivering domiciliary care for people with CFS/ME?

Why this is important

Randomised controlled trials, with adequate power, are needed to compare different methods of delivering standard methods of care, and whether outcomes differ depending on whether they are delivered in primary or secondary care. Subgroup analysis may clarify which approach is most efficient (that is, cost effective without decreasing efficacy) in different groups of people with CFS/ME (for example, people who are severely affected).

4.3 Prevalence and course of the illness

What is the prevalence and incidence of CFS/ME in different populations? What is the natural course of the illness?

Why this is important

Reliable information on the prevalence and incidence of this condition is needed to plan services. This will require well-constructed epidemiological studies across different populations to collect longitudinal data to predict outcome, and to calculate the economic impact of loss of work or education.

We recommend that these questions are answered using a mixture of:

  • cross-sectional population studies, including people with different levels of disease severity from all ethnic groups and social classes

  • longitudinal cohorts of people with CFS/ME, and population cohorts to assess the incidence and prognosis of CFS/ME in a previously normal cohort.

4.4 Measuring outcome

What is the best way of measuring outcome in research studies?

Why this is important

There is a lack of studies in this area. Knowing what is important to people with CFS/ME is crucial for designing future studies. It is not known how best to measure improvement scientifically for people with CFS/ME, and how much of an improvement is significant. More information is needed on functional outcomes such as return to work or education, return to normal family life or social activities, or increased self-esteem, to inform future estimates of the cost effectiveness of treatment.

  • National Institute for Health and Care Excellence (NICE)