News & views News Stakeholder position statement on the NICE guideline for depression in adults Stakeholder position statement on the NICE guideline for depression in adults Download the pdf version of the position statement here. Andrew Balfour, CEO, Tavistock Relationships; Dr Stephen Buller, Chair, Psychotherapy Foundation; Gary Fereday, CEO, British Psychoanalytic Council (BPC); Professor Clare Gerada, General Practitioner and Senior Partner Hurley Group, Medical Director Practitioner Health Programme; Paul Jenkins, CEO, Tavistock & Portman NHS Trust; Dr Susan McPherson, Senior Lecturer and Research Impact Director, School of Health and Social Care, University of Essex; Dr Susan Mizen, Chair, Medical Psychotherapy Faculty, Royal College of Psychiatrists; Professor Sarah Niblock, CEO, UK Council for Psychotherapy (UKCP); Dr Felicitas Rost, President, Society for Psychotherapy Research (SPR) UK; Dr David Taylor, Hon. Consultant Psychiatrist Tavistock and Portman NHS Trust; Visiting Professor UCL Psychoanalysis Unit; Professor Sir Simon Wessely, Regius Chair of Psychiatry, King’s College London, President, Royal Society of Medicine, Past President, Royal College of Psychiatrists; Dr Hadyn Williams, CEO British Association for Counselling and Psychotherapy (BACP); Sarah Yiannoullou, Managing Director, National Survivor User Network (NSUN). Background According to the Mental Health Foundation, four in ten adults report experiencing depression at some time in their life. The sheer scale of depression in England and Wales should dictate that those charged with revising the 2009 guideline follow the most robust methodology in the most transparent way. In November 2017, the signatories to this position statement wrote to David Haslam, Chair of the National Institute for Health and Care Excellence (NICE), to formally request a second stakeholder consultation of the next revision of the guideline on the Recognition and Management of Depression in Adults, prior to its formal publication. We did this because, along with many other stakeholders, we were extremely concerned about significant flaws in methodology, lack of transparency and several inconsistencies we found in the draft document published in July 2017. We briefed a number of peers and MPs who took seriously our concerns that the document was not fit for purpose. In February 2018, an Early Day Motion was tabled and a number of MPs signed a cross-party letter to NICE asking that they respond to our letter. A meeting took place between the members of this stakeholder coalition and NICE in April, following which, the NICE executive opened a second four-week consultation on the revised draft. Summary of Serious Concerns The various methodological concerns we raised in our first response to the draft have not been addressed in the revised version. Thus, we maintain our position that this guideline is not fit for purpose and if published will seriously impede the care of millions of people in the UK suffering from depression, potentially even causing clinical harm. Under NICE’s own rules, a second consultation can occur exceptionally if “information or data that would significantly alter the guideline were omitted from the first draft, or evidence was misinterpreted in the first draft and the amended interpretation significantly alters the draft recommendations”[i]. Both conditions have been met in this case. Stakeholders identified wide ranging and fundamental methodological flaws in the draft and offered recommendations for addressing these. In spite of acknowledging the serious omissions and misinterpretations through issuing a second consultation, these key issues have not been addressed in the new draft. assurance process in the stakeholder response document and in the overall process appear to fall short of acceptable scientific standards and lack scientific integrity. Our position, therefore, is that a full and proper revision of the guideline must take place allowing sufficient time for the guideline group to properly address the concerns listed in this statement. These issues relate both to the omission of large amounts of data as well as the potentially significant material impact on the recommendations that would arise from their inclusion. If these issues are not adequately addressed, the treatment recommendations cannot be relied on. The draft guideline in its current form poses a serious threat to patient choice and will result in patients being offered a limited selection of treatments, which may not be the treatments that have the best chance of relieving their suffering (which in turn will contribute to poor cost effectiveness in the long term). The following amendments must be made before the guideline is published: NICE should conduct a proper analysis of 1 and 2-year follow-up data from trials and prioritise treatment recommendations made on the basis of these data over and above recommendations which are made on the basis of short term outcomes (less than 1 year). A full systematic review of primary studies of service user experience is required, employing formal methodology for qualitative synthesis; AND findings from such a review must be incorporated into the broader approach to quantitative review and treatment recommendations rather than being left as a stand-alone section. Trials where the majority of the population is clinically complex, chronic or treatment resistant need to be grouped together as ‘persistent depression’ for the purposes of review, following the European Psychiatric Association[ii]. The guideline review must look at the amount of clinical effect (e.g. partial recovery) from a severe baseline point and not ignore treatment effects because clients do not fully recover by the end of treatment. Moreover, categorisations of depression severity must be based on validated tools, not un-validated non-transparent functions of them. Findings from indirect or mixed comparisons using Network Meta-Analysis (NMA) should only be used to supplement evidence derived from direct comparisons. NICE must reanalyse the data using standard meta-analyses and should NMA be used to supplement the findings a validated and reliable model for doing so should be employed. NICE must run a reanalysis of studies using quality of life and/or functioning outcomes where these are available and prioritise recommendations based on these measures, given that these are the measures of greatest priority to service users. This position statement outlines in detail below the basis for each of these required amendments. Methodological focus of concerns This coalition of stakeholders is driven by and comes from a position of psychotherapeutic neutrality and scientific integrity, just as the development of the guideline should be. In other words, whilst some of the organisations involved may have a particular leaning towards one therapeutic approach or another, our concerns are directed towards the methodology adopted by the guideline development group and specifically their (a) selection, (b) grouping, and (c) analysis of the supporting evidence. The evidence-based medicine paradigm has been shaped by medical science. This requires some adjustment when comparing and contrasting medical treatments with psychological treatments. The overall methodological approach in the guideline inherently favours (a) medical trials over psychological trials; and (b) particular psychological treatments over others. This is not an acceptable scientific stance and creates biases that are based on subjective choices rather than good scientific evidence of treatment effectiveness. Moreover, we note that the guideline displays an over-reliance on one type of scientific method and fails to take account of the wide variety of good quality evidence available that uses a variety of methodologies and designs. Relying entirely on Randomized Controlled Trials (RCTs) represents a seriously restricted model of science. The various limitations of RCTs specifically in the field of mental health have been pointed out repeatedly by experts from many scientific disciplines and positions irrespective of therapeutic modality. Most psychotherapy trials are not sufficiently powered to detect true differences[iii], and guidelines that ignore important evidence as they occur in clinical practice are concerning. Thus, there is a need to take account of large standardised routine outcome datasets, such as the Improving Access to Psychological Therapies (IAPT) dataset. As the Health Foundation and Cochrane Collaboration have stressed[iv],[v], creating sound policy requires that we draw on a diverse range of evidence and that cohort studies as well as qualitative and case study research evidence maximizes the value of reviews to policy and practice decision-making. We recognise that some of these broader methodological matters should and will be addressed in our stakeholder responses to the NICE manual consultation currently ongoing. Nevertheless, serious methodological flaws in the current draft guideline for depression outlined below relate to the Guideline Committee’s application of methodological practices set out in the current NICE manual. The guideline must enable NHS services to deliver ‘parity of esteem’ ‘Parity of esteem’ refers to the legal requirement, set out in the Health and Social Care Act (2012), for NHS bodies to give equal priority to mental and physical health. Treatment recommendations set out in the draft guideline for depression will have a direct impact on the future commissioning of mental health care services and workforce planning (including IAPT and secondary care) and thus have an impact on the care of millions of people with depression and their families. Depression often manifests as a long-term condition, or becomes a long-term condition if immediate care is inadequate. Depression can also be highly episodic and there is a high relapse rate. For example 38% of IAPT clients are repeat attenders[vi]. It is imperative for research to demonstrate that treatment effects are long-lasting, or indeed to note where effects might appear over the long-term follow-up (sleeper effects). NICE states that “the aim of [an] intervention is to restore health through the relief of symptoms and restoration of function, and in the longer term, to prevent relapse”. NICE guidelines for long-term physical conditions such as epilepsy and asthma examine treatment outcome data over 1-10 years. The evaluation of treatments for depression must meet the same standards as guidelines for long term physical conditions. This requires the guideline to base recommendations on evidence concerning the long-term effectiveness of treatments. The current draft recommendations are all made on the basis of very short-term outcomes (often 6-12 weeks) and always less than 1 year. This is inadequate as a basis for recommendations for long-term conditions (whether physical or mental). NICE guidelines for long-term physical conditions would treat this evidence as inadequate, requiring at least 1 or 2 years follow-up data. Follow up data of 1-2 years have been omitted in the draft depression guideline. The Guideline Committee state that there are insufficient studies with long term follow up data to conduct such analyses. If this is the case then it is inappropriate for the guideline to make any firm recommendations for specific treatments based on (albeit large amounts of) short-term outcome data. Large amounts of poor evidence must not be used in place of small amounts of good evidence. NICE should conduct a proper analysis of 1 and 2-year follow-up data where available and prioritise treatment recommendations made on the basis of this data over and above current recommendations made on the basis of short term outcomes (less than 1 year). This is likely to alter the recommendations significantly, since, for example, where follow-up data is available these tend to be favourable to longer-term therapies over short-term therapies. The guideline must review evidence on service user experience Ensuring that the views and experiences of those who use the services are properly taken account of, should be the sine qua non of a publicly funded body tasked with devising clinical guidelines, particularly as these services are fundamentally shaped by the guidance NICE produces. While the guideline committee has consulted service users as part of the guideline development process, it has largely ignored the voices of service users, using out-of-date evidence of service user and carer experiences mostly dating back to before 2004 and has failed even to incorporate this evidence into treatment recommendations. The decision not to update this section is not justified given that evidence relating to service user experience has at least equal value to quantitative evidence of clinical outcomes. In omitting such a significant body of evidence, NICE has failed to follow its own stated approach to Patient and Public Involvement (PPI), which “reflects policy initiatives to involve patients, service users, carers and the public across the NHS and social care.” In setting out its approach to PPI, NICE refers to policy contained in the Health and Social Care Act 2012; the NHS Constitution; Putting People at the Heart of Care 2009; and Essential Standards of Quality and Safety. These policies collectively enshrine the right of service users to be fully involved in decisions affecting their care. The specific role of NICE within the planning of healthcare is to commission or conduct methodologically robust systematic reviews of evidence and to use findings from such reviews to inform a set of guidelines for the delivery and implementation of care. PPI must reflect this specific role and hence guidelines must include methodologically rigorous reviews concerning service user experience. By not updating this section, the guideline fails to reflect the dynamic context in which people experience depression which is intertwined with the social and economic context in which people live. There is growing evidence of the impact of austerity on depression and many clients have been significantly affected by reductions in their benefits, loss of work or changes to employment conditions resulting from the economic downturn and political choices. There have been changes which may impact on the extent to which clients encounter stigma. Moreover, recent policy changes, such as the Care Act 2014 and benefits changes, mean that carers’ experiences are unlikely to be the same as in 2004 or 2009. These changes in context are further justification for ensuring up to date evidence is reviewed and included in this guideline now. The service user section copied over from the 2009 guideline was itself inadequate. The overall approach was methodologically weak, unsystematic and lacking the level of transparency and rigour expected in qualitative synthesis approaches as referred to in the NICE manual. A scoping search was carried out in March 2018 by Dr Susan McPherson to identify qualitative peer reviewed research published between 2009 and 2018. This scoping found 93 studies that included over 2500 participant voices that were not considered. In addition, a further qualitative systematic review examines the experiences of relatives and carers of people with depression using formal qualitative synthesis methods[vii]. This recent literature extends client experience data to many under-represented groups (such as those listed in the scoping document as requiring ‘special consideration’); and takes account of changes in socio-economic and cultural circumstances. Given the purpose of a NICE review is to conduct methodologically sound reviews of evidence, a full systematic review of primary studies is required, employing formal methodology for synthesis such as meta-ethnographic synthesis, meta-synthesis or formal grounded theory as recommended in the NICE manual[viii]. This would enhance understanding. [i] NICE (2014). Developing NICE guidelines: the manual [ii] Jobst, A., Brakemeier, E.L., Buchheim, A., Caspar, F., Cuijpers, P., Ebmeier, K.P… Padberg, F. (2016). European Psychiatric Association Guidance on psychotherapy in chronic depression across Europe. European Psychiatry, 33, 18–36. [iii] Leichsenring, F., Abbass, A., Hilsenroth, M.J., Leweke, F., Luyten, P., Keefe, J.R.… Steinert, C. (2017). Biases in research: risk factors for non-replicability in psychotherapy and pharmacotherapy research. Psychological Medicine, 47(6), 1000-1011. [iv] Health Foundation (2017). Healthy lives for healthy people. [v] Cochrane Collaboration (2011). [vi] Hepgul, N., King, S., Amarasinghe, M., Breen, G., Grant, N., Grey, N… Cleare, A.J. (2016). Clinical characteristics of patients assessed within an Improving Access to Psychological Therapies (IAPT) service: results from a naturalistic cohort study (Predicting Outcome Following Psychological Therapy; PROMPT). BMC Psychiatry, 16(1), 52. [vii] McPherson & Priestley (2016). Couples Disease: the experience of living with a partner with chronic depression. Journal of Couple and Relationship Therapy, 17(2), 128-145. [viii] NICE (2014). Developing NICE guidelines: the manual, p107. Download the pdf version of the position statement here.