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Table 5 Summary of reportable findings and normal ranges used in Insight 46

From: Study protocol: Insight 46 – a neuroscience sub-study of the MRC National Survey of Health and Development

Measurements with Reportable Results Normal range/Non-reportable Findings Reportable Findings and Associated Duty-of-care Actions
Blood pressure Systolic 91–139 mmHg
Diastolic 61–84 mmHg
Severely low AND symptomatic: Systolic ≤90 or diastolic ≤60 mmHg — recommended to visit GP within five days
Mildly raised: Systolic 140–159 or diastolic 85–99 mmHg — recommended to visit GP within three months
Moderately raised: Systolic 160–179 or diastolic 100-114 mmHg — recommended to visit GP within 2–3 weeks
Severely raised: systolic ≥180 or diastolic ≥115 mmHg — recommended to visit GP within five days
Blood results • Glucose 3.5–10 mmol/l
• Haemoglobin
Female 11.5–15.5 g/dl
Male 13.0–17.0 g/dl
• Platelets 150–400 109/l
• Urea 1.7–8.3 mmol/l
• Creatinine
Female 49–92 μmol/l
Male 66–112 μmol/l
• Vitamin B12 191–900 pg/ml
• TSH 0.27–5.5 mIU/l
Out of normal range: The study member is advised to see their GP within an appropriate time frame dependent on the result and the GP is informed.
Action level: Results are discussed with the study member during a post-visit telephone call and are advised to see their GP urgently. The study member’s GP is contacted and receives results within 48 h of clinic visit. The action level for blood results are as follows:
• Glucose >20 mmol/l
• Haemoglobin <10 or >20 g/dl
• Platelets <100 or >1000 109/l
• Urea >20 mmol/l
• Creatinine >200 μmol/l
• Vitamin B12 < 100 pg/ml
• TSH <0.1 or >10 mIU/l
Pure Tone Audiometry Thresholds <35 dB in the range of 0.5–4 kHz Results are available on the day of the visit and reported to the GP. If any of the thresholds in either ear are ≥35 dB or if there is a difference between the ears of ≥20 dB at two or more frequencies in the range 0.5–4 kHz, the participant is advised to consult their GP.
Mini-Mental State Examination (MMSE) 25–30 A score ≤ 24 results in a letter asking the GP to consider the findings in the context of the study member’s known background (education, medication history, anxiety, depression, etc). The study member receives a letter suggesting they make an appointment to see their GP.
Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Queen Square Brain Bank criteria for parkinsonism not met Only clear and previously undiagnosed Parkinson’s disease will be reported to study members and their GPs. This will be based on the video and clinical assessment (including UPDRS score) performed by a clinical research associate. Where the individual is found to fulfil Queen Square Brain Bank criteria for parkinsonism, a letter will be sent to the GP explaining the findings and recommendations for clinical action. A letter will also be sent to the study member stating that an abnormality has been found and advising them to contact their GP.
Note: Queen Square Brain Bank criteria for parkinsonism:
• Bradykinesia and
• At least one of the following:
o Muscular rigidity;
o Rest tremor;
o Postural instability.
MRI The following incidental findings will not be routinely fed-back to individuals or their GPs:
• White matter hyperintensities;
• Suspected demyelination;
• Non-acute brain infarction;
• Chronic hydrocephalus;
• Asymmetric ventricles;
• Lipoma of corpus callosum;
• Developmental abnormalities (including venous anomalies);
• Enlarged cisterna magna;
• Enlarged perivascular spaces;
• Chiari malformation; and
• Hippocampal or other focal brain atrophy.
Urgent events during/around scanning:
Any emergency occurring around the time of the scan will be dealt with by the clinical research associate, and the participant will be sent to A&E.
Non-urgent incidental findings:
The following incidental findings will be flagged as reportable by a consultant neuroradiologist and will be reported to participants and their GPs:
• Acute brain infarction;
• Acute brain haemorrhage (note: not old bleeds);
• Intracranial mass lesions (note: not meningiomas in locations considered highly unlikely to cause problems);
• Suspected intracranial aneurysm or vascular malformation (including cavernomata) (note: not aneurysms less than 7 mm in diameter);
• Colloid cyst of the 3rd ventricle;
• Acute hydrocephalus;
• Significant sinus disease with suspicion of underlying pathology (e.g., unilateral sinus opacification); and
• Other unexpected, serious, or life-threatening findings. 
Where a reportable incidental finding is identified, the GP will be advised of the nature of the abnormality, what clinical action is recommended. A letter will also be sent to the participant stating that an abnormality has been found and advising the participant to contact his or her GP.