NICE has delayed the release of the new adult depression guidelines, after a group of experts argued they were ‘not fit for purpose’.
The group, which includes GPs and mental health leaders, have raised concerns regarding the ‘flawed’ methodology and out-of-date evidence used to create the recommendations.
They have warned that without a second consultation to address these issues, the guidelines will ‘seriously impede’ patient care and choice.
NICE has now agreed to ‘start a dialogue’ with the experts to try and ‘find a way forward’.
The draft guidelines include updates to advice on service delivery, lower and higher intensity psychological interventions and pharmacological interventions for moderate to severe depression.
The experts intially wrote to NICE chair David Haslam in November last year, to formally request a second consultation, ahead of the planned release in January.
They explained that not only does the guidance ignore the ‘severity’ of depression at the start of the treatment, but it focuses on short-term outcomes, despite depression often presenting as a long-term condition.
They also accused the guidelines of failing to meet the NHS parity of esteem mandate, which has stated that mental health should be equal to physical health.
The group said: ‘We are extremely concerned about significant flaws in methodology, lack of transparency and inconsistencies in the document’.
They added: ‘Without a second consultation being granted to allow these serious concerns to be addressed, the guideline will not be fit for purpose and will seriously impede good patient care and patient choice’.
Norfolk MP Norman Lamb, who focused on mental illness as a health minister in the Coalition Government, has since tabled a parliamentary motion which warned that the proposed changes could have a ‘profoundly detrimental impact’ on patients, and called on NICE to grant a second stakeholder consultation.
This was supported by over 20 MPs from across the UK.
He then wrote directly to NICE’s chief executive and reiterated that the guidelines will ‘not be fit for purpose unless these concerns are addressed’.
A NICE spokesperson said: ‘NICE recognises the importance of the guideline on depression, and aims to publish the updated version as soon as possible.
‘We want to ensure it is actively put into practice, and that any potential barriers to implementation are addressed both by commissioners and providers.’
Speaking to Pulse, Mr Lamb said: ‘The main concern is to ensure that the new guidelines are based on sound methodology in order to guarantee that people are not inappropriately excluded from effective treatment.
‘We would not tolerate anything less in cancer care, but the draft depression guideline seems to fall short in a number of respects. A second consultation would give the mental health sector confidence that these concerns have been taken on board and that the final guideline is in the best interests of patients.’
He then confirmed that NICE has ‘delayed publication of the new guidelines until September’ and have agreed to ‘start a dialogue with the group of experts to try to find a way forward’.
Earlier this year, a meta-analysis of over 500 trials and 116,000 patients with major depressive disorder, found that all 21 of the most common antidepressants were more effective than placebo for treating acute depression in the first eight weeks of treatment.
The team noted that some drugs were more effective than others, with agomelatine, amitriptyline, escitalopram, mirtazapine, paroxetine, venlafaxine and vortioxetine topping this list.
The experts’ concerns
- The current draft guideline has used inadequate methods for working out whether a treatment has shown itself to be effective within a research study – ignoring the severity of depression at the start of the treatment. Much better methods exist for this and are widely used in the research community.
- The draft guideline fails to meet the NHS agenda of ‘parity of esteem’, defined as valuing mental health equally with physical health. Despite depression often manifesting itself as a long-term condition, or becoming a long-term condition if immediate care is inadequate, the current draft recommendations are all made on the basis of very short-term outcomes (often 6-12 weeks). NICE guidelines for long term physical conditions would treat this evidence in question as inadequate, requiring at least 1 or 2 years follow-up data. Follow up data of 1-2 years has instead been completely ignored in the draft depression guideline.
- The current draft guideline has largely used out-of-date evidence of service user experiences mostly dating back to before 2004 and has failed even to incorporate this evidence into recommendations.
- The current draft guideline used statistical analyses that are associated with serious and unique risks. These were inadequately reported and addressed (leading to violations of statistical assumptions in the approach adopted) and this therefore puts the resulting treatment recommendations into serious question.
- The current draft guideline has an extremely narrow focus on symptom outcomes and fails to take into account other aspects of service user experience which have long been called for such as quality
- The current draft guideline is completely out of step with US and European guideline methodologies. The Guidance Development Group has created its own method for categorising depression by longevity and severity – leading to erroneous and unhelpful classification of research studies which do not match clinical, service user experiences or research outcomes.
- These serious methodological flaws undermine patient choice, with recommendations based on a poor methodology.
Source: National Survivor User Network