Evidence generation plan
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5 Minimum evidence standards
The minimum evidence standards were informed by a combination of sources, including company submission, the external assessment group's report and committee discussions. These 3 different sources provided an overview of the clinical and economic evidence available to examine the use of the technology in the NHS. But, important limitations remain across different areas such as comparative effectiveness, long-term outcomes, better understanding of the reasons behind the reported attrition levels and cost effectiveness. The evidence base evaluated did not meet all the preferred standards for robust and generalisable data. So, NICE recommends further evidence generation through a suggested prospective comparative cohort study and qualitative research to address key uncertainties and support future decision-making on routine NHS use.
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