NICE has announced that it will explore how it uses real world data in forming its guidance. As part of this, it has put out a statement of intent for consultation.
NICE (the National Institute of Health and Care Excellence) is now proposing to extend its use of real world data to include data from sources such as:
- hospital records of operations
- registries which collect data on how particular treatments are used
- surveys of people using services
- data collected on national trends, such as how many people have a condition
The statement of intent, published by NICE, describes what kind of evidence NICE currently uses to develop guidance, what broader types of data are available, when and why broader types of data should be considered, and also practical considerations associated with data analytics.
In highlighting when broader types of data should be considered, NICE says:
“For some types of NICE guidance, the committee developing the guidance may make research recommendations if a systematic review has identified gaps in the evidence. These research recommendations offer structured questions that, if addressed, may produce evidence that can be used in updates of the guidance.
“The observed discrepancy between the effects of a health intervention in routine clinical practice (effectiveness) and the effects demonstrated in RCTs (efficacy) is known as the ‘efficacy effectiveness gap’”
The statement of intent then outlines contextual factors that contribute towards this ‘evidence gap’.
- “the actual use of the intervention (for example, adherence, co-medication, dose/intensity, duration of use)
- patient and disease (for example, age, gender, behavioural factors, baseline risk, genetics, severity of disease, comorbidities)
- healthcare system (for example, implementation, medical practices, screening policies)”
The statement of intent also goes into detail regarding how NICE could potentially evolve its data collection in line with these contextual factors.
The consultation is open for responses from 13th June – 13th September.
The consultation can be found here.