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## **NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE** 

## **Structural neuroimaging for first episode psychosis** 

## **Response to consultee, commentator and public comments on the ACD** 

**Consultee and Commentator response to the ACD** 

|**Consultee and**|**Commentator response to the ACD**||
|---|---|---|
|**Consultee or**<br>**commentator**|**Comments**|**Institute response**|
|Royal College<br>of Nursing|The Royal College of Nursing welcomes the opportunity to review the Appraisal<br>Consultation Document (ACD) of the technology appraisal of the use of Structural<br>neuroimaging in first episode psychosis.<br>The ACD is comprehensive and in our view, the relevant evidence has been taken into<br>account in coming to the recommendations.<br>We consider that the summaries of clinical and cost effectiveness are reasonable<br>interpretations of the evidence and that the preliminary views on the resource impact<br>and implications for the NHS seem appropriate.<br>The provisional recommendations of the Appraisal Committee seem sound.  However<br>we wondered whether the wording of item 1.1 should qualify that the first episode of<br>psychosis could occur with the absence of any other signs/symptoms suggestive of<br>other pathology where MRI/CT would be appropriate. It maybe that this point has been<br>addressed in other NICE guidance (for example CT scanning for Stroke), but it would<br>be helpful to clarify for this guidance.|Comments noted. No action required<br>The objective of carrying out this<br>appraisal was to determine the<br>clinical and economic value of<br>routine structural neuroimaging for all<br>patients with first episode psychosis<br>as against selective scanning only<br>when there are additional<br>neurological signs and symptoms<br>suggestive of a structural lesion. See<br>introductory text to section 4 of the<br>FAD.<br>Based on the evidence considered,<br>the guidance given in section 1 of the<br>FAD does not recommend routine<br>neuroimaging of people when there<br>are no signs, symptoms or clinical<br>findings suggestive of an underlying<br>structural lesion.|



National Institue for Health and Clinical Excellence CONFIDENTIAL 

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|**Consultee or**<br>**commentator**|**Comments**|**Institute response**|
|---|---|---|
|Department of<br>Health|The Department of Health has just two comments to make and they are as<br>follows:<br>1. para 2.1 Would you please consider defining the first episode psychosis a bit more<br>tightly?  It is generally suggested that symptoms be present for at least a month.<br>(certainly for the first episode teams to take people on), and<br>2. In para 2.3 we feel that the reference to finished episodes may not be clear to all<br>audiences.|<br>See amendments to FAD section<br>2.1. It has been suggested that a two<br>year duration limit should be used for<br>first-episode psychosis but this has<br>not been generally accepted. There<br>was no evidence presented<br>regarding a generally accepted<br>_minimum_duration of symptoms. See<br>also Technology Assessment Report<br>(page 2).<br>There is currently no clinical<br>consensus on the duration and time<br>limit for defining first-episode<br>psychosis, considering also the date<br>of presentation of first-episode<br>psychosis does not usually coincide<br>with onset of the condition and often<br>psychosis has a gradual onset.<br>See amendments to FAD section 2.3<br>to include a definition for finished<br>episodes.|



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|**Consultee or**<br>**commentator**|**Comments**|**Institute response**|
|---|---|---|
|NHS Quality<br>Improvement<br>Scotland|i)<br>Whether you consider that all the relevant evidence has been taken into account?<br>Yes. Although the document is not referenced and thus it difficult to ascertain<br>whether the sources of evidence were exhaustive, there are no glaring omissions.<br>ii)<br>Whether you consider that the summaries of clinical and cost effectiveness are<br>reasonable interpretations of the evidence?<br>Yes.<br>iii)<br>Whether you consider that the provisional recommendations of the Appraisal<br>Committee are sound and constitute a suitable basis for the preparation of<br>guidance to the NHS?<br>The key message is that structural neuroimaging for first episode psychosis offers<br>no persuasive overall benefit. The research data available to date supports this.<br>Importantly, routine imaging of this sort would not alter immediate treatment as<br>things stand currently.<br>iv) Whether you consider that there are any potential policy implications for SEHD?<br>The only issue that has a Scottish context is that of neuroimaging those at high<br>genetic risk of developing a psychotic illness. My reading of the data available to<br>date is that we are some way off recommending such a course of action as a<br>matter of routine.|Comments noted. No action<br>required. Note that references are<br>provided in the associated<br>Technology Assessment Report<br>Comments noted. No action<br>required.<br>Comments noted. No action<br>required.<br>Comments noted. No action<br>required.|



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|**Consultee or**<br>**commentator**|**Comments**|**Institute response**|
|---|---|---|
|NHS Quality<br>Improvement<br>Scotland|Reviewer 1<br>i)<br>Whether you consider that all the relevant evidence has been taken into account.<br>_A_limited_evidence base was noted.  What was found seems to have been used._<br>ii)<br>Whether you consider that the summaries of clinical and cost effectiveness are<br>reasonable interpretations of the evidence.<br>_Given the evidence provided, the summaries appeared fair._<br>iii) Whether you consider that the provisional recommendations of the Appraisal<br>Committee are sound and constitute a suitable basis for the preparation of<br>guidance to the NHS.<br>_Yes – given the uncertainty of the evidence, a ‘no change’ seems reasonable_<br>iv)  Whether you consider that there are any potential policy implications for SGHD?<br>_I have consulted colleagues with policy responsibility for aspects of mental health._<br>_The view is tha. From a mental health policy perspective,t not recommending_<br>_structural neuro-imaging for all patients with first episode presentation of_<br>_psychosis is acceptable for the time being given the evidence.  There are_<br>_therefore no policy implications at this time._|Comments noted. No action required<br>Comments noted. No action required<br>Comments noted. No action<br>required.<br>Comments noted. No action<br>required.|



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## **Comments received from website consultation** 

|**Commentator**|**Section of ACD**|**Comments**|**Institute response**|
|---|---|---|---|
|Professional<br>officer|3<br>6|3.2 Some MR neuroimaging may require contrast<br>enhancement, normally of a gadolinium chelate. Although<br>contrast reactions are rare they are not unknown and<br>additionally patients with impaired renal function may be<br>unsuitable for contrast enhancement.<br>6.0 We should support further research and systematic<br>studies to see if there are clinical benefits in imaging<br>atypical psychosis on presentation. This would then support<br>workforce development perhaps.|Comments noted. Although, contrast<br>enhancement may be needed, it is not<br>generally required for MRI scanning. See<br>amended FAD section 3.3.<br>Comments noted. No action required. The<br>research recommendations apply to<br>structural causes of first-episode psychosis;<br>not the various atypical psychotic disorders<br>with unusual features.|
|NHS<br>professional|1|We feel that the right decision has been made, however in<br>future we think a joint-director of the National Collaborating<br>Centre for Mental Health should be an observer on the<br>group and not just a consultee. We would also like to add<br>that there may be cases (suspected brain damage/atypical<br>presentation) where you might wish to use such imaging<br>techniques but clinicians may now be prevented from doing<br>so. There is potential for misinterpretation and some slight<br>adaptation of the words may help avoid this.|The objective of carrying out this appraisal<br>was to determine the clinical and economic<br>value of routine neuroimaging for all patients<br>with first episode psychosis as against<br>selective scanning with structural<br>neuroimaging only when there are<br>neurological signs and symptoms<br>suggestive of a structural lesion. See<br>introductory text to section 4 of the FAD.<br>The guidance given in section 1 of the FAD<br>does not recommend routine structural<br>neuroimaging of people when there are no<br>signs, symptoms or clinical findings<br>suggestive of an underlying structural lesion.<br>This doesn’t deter the use of structural<br>neuroimaging in the management of other<br>illnesses.|



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|**Commentator**|**Section of ACD**|**Comments**|**Institute response**|
|---|---|---|---|
|Other|1|Diagnosis: Recent development in MRI data analysis<br>methods, which take into account multiple defects<br>simultaneously from the whole brain, gives reason to<br>believe that MRI can be valuable method in diagnostic and<br>differential diagnostic for schizophrenia within functional<br>disorders. It is important for exclusion of psychotic<br>disorders caused by tumours, infections and other serious<br>organic agents. Treatment plan and outcome assessment:<br>Defects and their changes in CNS correlate with<br>neurocognitive performance and outcome in patients with<br>schizophrenia. Therefore, MRI scanning findings of first-<br>episode patients are important and valuable when need-<br>specific treatment and rehabilitation is planned for individual<br>patients. MRI scanning of first-episode patients is as<br>important as neurocognitive tests which are kept obligatory.<br>Repeated MRI is valuable in the cases when the effect of<br>drugs on certain CNS structures is assessed and/or when a<br>patient shows unexpectedly poor outcome possibly<br>correlating with pathological changes in CNS structures.<br>Same comments concerns also patients at risk for<br>psychosis. They often have MRI changes with same<br>significance as in first-episode patients.|Comments noted. No action required.|
|Other|2<br>3|Point 2.5 - patients with psychosis may be reluctant to<br>accept their condition because one of the features of<br>psychosis is lack of insight. 2.6 - we deleted "but these are<br>not routinely used in the UK" from the TAR because of peer<br>review comments. In some areas of the UK it is routinely<br>used but in others it isn"t.<br>There is also the cost of escorting patients to and from<br>psychatric care to the scanning centre|Comments noted. The appropriate<br>amendments have been made. See FAD<br>sections 2.5 and 2.6.<br>Comments noted. No action required.|



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|**Commentator**|**Section of ACD**|**Comments**|**Institute response**|
|---|---|---|---|
|Other|4|We changed the base case for tumours/cysts from 5% to<br>1% as feedback from a variety of sources suggested this<br>was more realistic. This changed our conclusions for the<br>base case of the threshold analysis. We then used 5% and<br>0.5% as variables in the sensitivity analysis. No other<br>comments.|Comments noted. No action required. The<br>Technology Assessment Report, in contrast,<br>states 1% and 0.5% as the prevalence rates<br>for tumours and cysts used in the sensitivity<br>analysis. The base case prevalence rate<br>was 5%.|



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