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In light of the increasing numbers of detentions of mentally unwell patients in the UK and the recent review of the Mental Health Act, this editorial seeks to analyse the process of Section 12 approval of doctors from a medical educational perspective. We compare the approval mechanisms with assessments in other specialities and suggest evidence-based improvements. We believe that a rethinking of the Royal College of Psychiatrists' learning objectives for Section 12 approval and the introduction of a summative assessment would improve the knowledge and skills of clinicians performing an important and scrutinised role within our society.
The use of pharmacogenomics (PGx) testing has the potential to accelerate response to psychopharmacologic therapy (Rx) and improve outcomes; accordingly PGx use to select appropriate Rx is increasing. One such commercially available test is the Genecept Assay (the Assay [Genomind]) which measures variants of 18 genes (12 pharmacodynamic and 6 CYP450) for which response, tolerability or exposure to various Rx has been reported. Recent interest in genetics has led patients (pts) to be stewards of their own genetic data. In 2017 we launched a Patient Gateway to allow pts to retrieve their genetic results, have access to mental health information, and record outcomes following use of the Assay.
To assess the effectiveness of Rx recommendations following use of the Assay, as reported on a purpose-built patient portal.
Pts receiving the Assay were invited to visit an online, interactive portal. Pts providing informed consent (IC) were asked to record their baseline overall health using a 4- point modified patient global index (m-PGI) of severity. Pts also recorded their conditions, medications, and supplements, and various symptoms. Pts were invited to visit the portal ad libitum and re-rate their overall health using the m-PGI. These data were then combined with the pts’ genetic results using custom scripts in Python (v 3.6.4) and R (v 3.5.1). All identifying data were removed. Pts included in this analysis responded (at least) twice to the health questionnaire. New medications were subsequently scored as concordant, discordant, or indeterminate with the Assay’s recommendations, using predetermined criteria. We report the initial results for this subgroup herein.
Since launch 9,401 unique patient profiles were created on the Gateway; 5,207 (55%) of these provided IC. Of these, 410 provided at least 2 m-PGI scores. Seventy-three (73) of these pts reported scores at least 4weeks apart and started 222 medications in the interim. 69.4% of pts identified as female; 70.8% had a diagnosis of generalized anxiety disorder, while 50.0% and 31.9% had diagnoses of major depressive disorder and post-traumatic stress disorder, respectively. 60.2% of pts reported improvement on the m-PGI of ≥1 unit; 20% had a ≥2-unit improvement. Pts reporting improvement were more likely (77% vs 66%); to have been placed on medication that were concordant with the assay than those who were not improved, although this difference did not reach statistical significance.
In this naturalistic, virtual trial of a PGx assay to guide pharmacotherapy in individuals with mental health illness, most users reported improvement in overall health. More pts whose medication was reported as concordant with the Assay reported improvement than those with discordant medications. Data collection is ongoing and updated data will be provided.