Managing cardiovascular disease risk in patients with severe mental illness

Severe mental illnesses are among the leading causes of global burden, with high morbidity rates and an estimated excess mortality of 1·5–3 times higher than the general population, with a shorter life-expectancy.1Murray CJL Atkinson C Bhalla K et al.The state of US health, 1990-2010: burden of diseases, injuries, and risk factors.JAMA. 2013; 310: 591-608Crossref PubMed Scopus (1807) Google Scholar Cardiovascular diseases and diabetes represent the highest proportion of all natural causes of death in populations with severe mental illnesses.2Hoang U Goldacre MJ Stewart R Avoidable mortality in people with schizophrenia or bipolar disorder in England.Acta Psychiatr Scand. 2013; 127: 195-201Crossref PubMed Scopus (72) Google Scholar Consequently, the need for new strategies to address this problem is increasing. Evidence to support treatment with statins for dyslipidaemia, metformin for weight loss, and bupropion for smoking cessation is good;3McGinty EE Baller J Azrin ST Juliano-Bult D Daumit GL Interventions to address medical conditions and health-risk behaviors among persons with serious mental illness: a comprehensive review.Schizophr Bull. 2016; 42: 96-124PubMed Google Scholar however, evidence is scarce regarding multi-risk factor approaches for cardiovascular disease management in populations with severe mental illnesses that resemble real-life clinical practice. In The Lancet Psychiatry, David Osborn and colleagues4Osborn D Burton A Hunter R et al.Clinical and cost-effectiveness of an intervention for reducing cholesterol and cardiovascular risk for people with severe mental illness in English primary care: cluster randomised controlled trial.Lancet Psychiatry. 2018; (published online Jan 22.)http://dx.doi.org/10.1016/S2215-0366(18)30007-5Summary Full Text Full Text PDF PubMed Scopus (47) Google Scholar report on the Primrose intervention, a new patient-centred care model for cardiovascular disease management in a population with severe mental illnesses, which involved a multi-risk factor, individualised intervention based on Behaviour Change Wheel theory.5Michie S van Stralen MM West R The behaviour change wheel: a new method for characterising and designing behaviour change interventions.Implement Sci. 2011; 6: 42Crossref PubMed Scopus (4702) Google Scholar Patients discussed, and with practice nurses or health-care assistants agreed, goals to lower cardiovascular disease risk, such as adhering to statins, improving diet or physical activity levels, reducing alcohol, or quitting smoking.4Osborn D Burton A Hunter R et al.Clinical and cost-effectiveness of an intervention for reducing cholesterol and cardiovascular risk for people with severe mental illness in English primary care: cluster randomised controlled trial.Lancet Psychiatry. 2018; (published online Jan 22.)http://dx.doi.org/10.1016/S2215-0366(18)30007-5Summary Full Text Full Text PDF PubMed Scopus (47) Google Scholar In Osborn and colleagues' cluster randomised trial,4Osborn D Burton A Hunter R et al.Clinical and cost-effectiveness of an intervention for reducing cholesterol and cardiovascular risk for people with severe mental illness in English primary care: cluster randomised controlled trial.Lancet Psychiatry. 2018; (published online Jan 22.)http://dx.doi.org/10.1016/S2215-0366(18)30007-5Summary Full Text Full Text PDF PubMed Scopus (47) Google Scholar done in 76 rural and urban general practices in England with 327 patients, the primary outcome, total cholesterol concentration, decreased in both treatment groups at 12 months (−0·22 mmol/L [SD 1·1] for Primrose vs −0·36 mmol/L [1·1] for treatment as usual). However, mean total cholesterol did not differ between the groups (5·4 mmol/L [SD 1·1] for Primrose vs 5·5 mmol/L [1·1] for treatment as usual; mean difference estimate 0·03, 95% CI −0·22 to 0·29; p=0·788). In the context that this study was not a non-inferiority trial, it is not possible to state that the Primrose intervention is equally effective to treatment as usual for cholesterol management, although, the sample size was large enough to rule out type II error. Nonetheless, the authors were able to provide an informative and fair discussion of the absence of a difference between treatment groups, which contributes to knowledge in this specialty. The outstanding contribution of this study, which was not fully explored, is the evidence of a superiority of the Primrose intervention over treatment as usual in terms of cost-effectiveness. The mean 12-month health-care cost per patient for the Primrose intervention was £2580 (SE 249; 95% CI 1899 to 3261) compared with £3404 (401; 2467 to 4340) for treatment as usual, with a cost difference of −£824 (95% CI −568 to 1079) in favour of Primrose. With an 89% probability, Primrose is cost-effective at a £20 000 willingness to pay for a quality-adjusted life-year (QALY) gained and 98% at a £0 willingness to pay for a QALY gained. It is not surprising that the Primrose intervention was not superior to treatment as usual. The authors suggested a positive effect derived from an increase in cardiovascular disease awareness in staff members of the general practices involved in the study, alongside a positive effect of the individualised cardiovascular disease risk factor feedback delivered to participants of both treatment groups at baseline. Hence, it is possible that Primrose could have been proven superior to treatment as usual in terms of clinical effectiveness in a different setting. A future step for Osborn and colleagues could be to test Primrose in a low-income or middle-income country, with poorer quality of health care. Finally, the authors should deepen the analysis of the true differences between Primrose and treatment as usual. It could be informative to assess the fidelity of treatment as usual, in terms of health-care access and effectively delivered interventions to improve physical health. Participants of both treatment groups had usual access to mental health services, which also take into consideration cardiovascular disease risk management. Moreover, patients in the National Health Service have an average of 5·5 consultations each year,6NHS DigitalTrends in consultation rates in general practice—1995–2009.http://digital.nhs.uk/catalogue/PUB01077Google Scholar which is similar to the intervention group in which less than half of participants attended more than six Primrose appointments. However, no information was provided regarding extra study consultation in other health-care services in either group. Thus, it is not possible to rule out health-care service access as a possible residual confounder. Is the fact that the study failed to show a difference in outcome between groups of clinical interest? Yes. This well planned study is one of the first bricks to build new knowledge on an urgent matter for a large proportion of the general population. Future studies should focus on fidelity, alternative settings, assessment of the role of health-care access, and analysis of the main effective components of the Primrose intervention. Much more research is needed to improve the standard of care for people with severe mental illnesses. CC graduated from University College London, where DO, LM, MK, and RB are members of the teaching staff, with an MSc in Mental Health Sciences Research in 2015. MK and LM were CC's research project supervisors. CC was granted a UCL Division of Psychiatry Scholarship during the MSc. Clinical and cost-effectiveness of an intervention for reducing cholesterol and cardiovascular risk for people with severe mental illness in English primary care: a cluster randomised controlled trialTotal cholesterol concentration at 12 months did not differ between the Primrose and treatment-as-usual groups, possibly because of the cluster design, good care in the treatment-as-usual group, short duration of the intervention, or suboptimal focus on statin prescribing. The association between the Primrose intervention and fewer psychiatric admissions, with potential cost-effectiveness, might be important. Full-Text PDF Open Access