The written submissions provide a professional view of the place of the technology in current clinical practice and in the care pathway. This includes evidence that relates to some or all of the following:
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Variations between groups of patients, in particular different baseline risks of the condition and the potential for different subgroups of patients to benefit.
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Identifying appropriate outcome and surrogate outcome measures.
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Significance of side effects or adverse reactions.
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The clinical benefits.
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Circumstances in which the technology or treatment is used, including:
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the need for concomitant treatments
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the settings in which technology is used (for example, primary or secondary care, or in specialist clinics)
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the need for additional professional input (for example, community care, specialist nursing or other healthcare professionals).
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Relevant potential comparators.
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Information on unpublished evidence. Such information should be accompanied by sufficient details to enable a judgement as to whether it meets the same standards as published evidence and to determine potential sources of bias.
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Evidence from registries and clinical audit.
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Published clinical guidelines produced by specialist societies.
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The effect of potential guidance on how care is delivered.
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Education and training requirements of NHS staff.
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Patients who would use the technology.
If the technology was previously recommended with managed access, then the written submissions could include:
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experience of the technology during the managed access period
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how many patients had the technology and whether anyone declined treatment, and the reasons for this
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the variation between groups of patients who had the technology and the potential for different subgroups of patients to benefit
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expected use of the technology in clinical practice
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any points of learning arising from the managed access period.