Bias in the selection of qualified evidence for what is considered SDM in mental health

Our main concern is with bias in the presentation of what is considered representative evidence for effective SDM mental health research and practice, and, specifically, in SMI (e.g. schizophrenia, bipolar disorder, major depressive disorder), and its implications for the evolving research on SDM in mental health. The search criteria adopted by NICE exclude studies conducted with people in ‘situations in which people lack mental capacity to make their own decisions about healthcare at that time’.¹ This is a problematic decision that excludes those considered to be ‘without capacity’ from engaging in the SDM process. It dismisses a priori evidence for rich SDM research with individuals with SMI,^{Reference Zisman-Ilani, Barnett, Harik, Pavlo and O'Connell3,Reference Duncan, Best and Hagen6–Reference Stovell, Morrison, Panayiotou and Hutton8} and enhances stigmatic beliefs about the ability of individuals with SMI and other concerns regarding capacity to engage in an SDM process, an assumption that is not yet evidence-based.^{Reference Zisman-Ilani, Hurford, Bowen, Salzer and Thomas9,Reference Zisman-Ilani, Roth and Mistler10} As a result, the NICE recommendations for effectiveness approaches and activities to increase engagement in SDM (Evidence Document A) are based on only eight quantitative studies of SDM in mental health and ten qualitative studies. Of the included quantitative studies, only six^{Reference Harris, Lovell, Day and Roberts11–Reference Yamaguchi, Taneda, Matsunaga, Sasaki, Mizuno and Sawada16} are relevant to SMI and addressed SDM in community mental health settings (the others focused on primary care or patients with behavioural health issues^{Reference Alegria, Nakash, Johnson, Ault-Brutus, Carson and Fillbrunn17} or patients with dementia^{Reference Goossens, Sevenants, Declercq and Van Audenhove18}). Only one quantitative study measuring recovery,^{Reference Yamaguchi, Taneda, Matsunaga, Sasaki, Mizuno and Sawada16} a primary goal and outcome in mental health that is associated with SDM,^{Reference Zisman-Ilani, Lysaker and Hasson-Ohayon19–Reference Davidson21} was included. Of the included qualitative studies,^{Reference Bradley and Green22–Reference Shepherd, Shorthouse and Gask31} only four^{Reference Giacco, Mavromara, Gamblen, Conneely and Priebe24–Reference Lin, Renwick and Lovell26,Reference Mahone, Farrell, Hinton, Johnson, Moody and Rifkin28} involved the perspectives and attitudes of patients or individuals with mental health conditions on SDM (the rest addressed providers’ perspectives^{Reference Bradley and Green22–Reference Hamann, Kohl, McCabe, Bühner, Mendel and Albus25, Reference Mahone, Farrell, Hinton, Johnson, Moody and Rifkin27–Reference Shepherd, Shorthouse and Gask31}), and most of these qualitative studies were valued by the NICE as having a high^{Reference Bradley and Green22,Reference Mahone, Farrell, Hinton, Johnson, Moody and Rifkin27,Reference Mahone, Farrell, Hinton, Johnson, Moody and Rifkin28} to moderate^{Reference Chong, Aslani and Chen23,Reference Giacco, Mavromara, Gamblen, Conneely and Priebe24,Reference Lin, Renwick and Lovell26} risk of bias.

SDM research in mental health has evolved rapidly in the past two decades,^{Reference Zisman-Ilani, Barnett, Harik, Pavlo and O'Connell3} presenting one of the fastest growth curves in SDM research and practice. The first call for clinicians, patients and the scientific community to adopt SDM into mental health was in 2003, with a first overview of SDM in mental health introducing the concept and providing legitimacy of, and justification for, doing SDM in psychiatry.^{Reference Hamann, Leucht and Kissling32} In 2010, a second review was published,^{Reference Duncan, Best and Hagen6} identifying two German randomised controlled studies of SDM, one conducted in an acute in-patient psychiatric setting^{Reference Hamann, Langer, Winkler, Busch, Cohen and Leucht33,Reference Hamann, Cohen, Leucht, Busch and Kissling34} and the other in a community primary care setting.^{Reference Loh, Simon, Wills, Kriston, Niebling and Härter35} In 2017, a third review was published, including 31 unique studies, of which 20 were research articles evaluating SDM interventions.^{Reference Zisman-Ilani, Barnett, Harik, Pavlo and O'Connell3} The latter demonstrated, for the first time, the heterogeneity of SDM tools and interventions for individuals with mental health conditions, including those with an SMI, and described a wide array of settings, research designs and various SDM in mental health outcomes, calling for an expansion of the narrow view of what can be considered SDM in mental health intervention and outcomes.^{Reference Zisman-Ilani, Barnett, Harik, Pavlo and O'Connell3} Thus, the limited number of included SDM in mental health studies in the NICE guidelines is not representative of the richness of SDM research in mental health, its focus or its quality. Recommendations drawn on such a small poll of studies lag behind the emerging and developing field of research and practice, create a narrow representation of SDM in mental health, and lead to bias in future research and practice of SDM in mental health when designing and testing interventions, tools and measures.

Bias in the selection of qualified outcomes and study designs for SDM in mental health studies

Compared with the limited number of included SDM in mental health studies, several important studies were excluded owing to a lack of high-quality evidence because of either a failure to present an objective primary outcome of SDM as defined by the NICE,^{Reference Perestelo-Perez, Rivero-Santana, Sanchez-Afonso, Perez-Ramos, Castellano-Fuentes and Sepucha36–Reference Zisman-Ilani, Roe, Elwyn, Kupermintz, Patya and Peleg38} the study design^{Reference Zisman-Ilani, Roe, Elwyn, Kupermintz, Patya and Peleg38,Reference Lord, Livingston and Cooper39} or the involvement of non-certified clinicians (e.g. peer workers) as the SDM providers.^{Reference Simmons, Batchelor, Dimopoulos-Bick and Howe40}

Bias in addressing cultural differences in SDM practice

The articles in Evidence Document B focused on SDM interventions. The search criteria adopted by the NICE exclude ‘non-English language papers’ studies conducted in ‘Non-OECD countries.’ As a result, only nine studies of SDM in mental health conducted in five Western countries, were included: USA,^{Reference Raue, Schulberg, Bruce, Banerjee, Artis and Espejo14,Reference Alegria, Nakash, Johnson, Ault-Brutus, Carson and Fillbrunn17} Germany,^{Reference Hamann, Mendel, Meier, Asani, Pausch and Leucht49,Reference Hamann, Holzhüter, Blakaj, Becher, Haller and Landgrebe50} The Netherlands,^{Reference Metz, Veerbeek, Twisk, van der Feltz-Cornelis, de Beurs and Beekman12,Reference Joosten, de Weert, Sensky, van der Staak and de Jong51} Saudi Arabia^{Reference Aljumah and Hassali52} and Japan.^{Reference Yamaguchi, Taneda, Matsunaga, Sasaki, Mizuno and Sawada16,Reference Ishii, Okumura, Sugiyama, Hasegawa, Noda and Hirayasu53} The majority of study populations included people of White or Northern European descent, or those belonging to a majority group in a given country. Thus, and based on the limited included SDM studies in mental health, there are no practical recommendations on the inclusion of culturally appropriate SDM recommendations for mental health practice. Facing a medical and ethical urgency to include Black, Asian and minority ethnic groups in clinical studies of SDM, randomised controlled trials have been recently cited as a potential source of structural racism and discrimination in healthcare research.^{Reference Courtright54–Reference Scharff, Mathews, Jackson, Hoffsuemmer, Martin and Edwards57} Black, Asian and minority ethnic people are often more suspicious of participation in clinical controlled trials because of historic events (e.g. the Tuskegee syphilis study) and more current actions, including socioeconomic and healthcare system inequities.^{Reference Scharff, Mathews, Jackson, Hoffsuemmer, Martin and Edwards57} Expanding the definition of SDM in mental health to additional outcomes, decisions, populations and more naturalistic quasi-research design could have expanded the scope of the included articles, allowing better representation of cultural and ethnic diversity when conducting SDM research.^{Reference Zisman-Ilani, Barnett, Harik, Pavlo and O'Connell3}

To summarise, the upcoming NICE SDM guidelines represent a positive and important effort for patients, healthcare providers and families, policy makers and SDM researchers. We understand that in an effort to draw conclusions, there is a need to define clear boundaries between what is considered the gold standard in SDM evidence, tools and practice. Yet, we feel that with regard to SDM in mental health, the upcoming NICE recommendations are simplified, lag behind the emerging and developing field of research and practice, and create a narrow representation of SDM in mental health. The recommendations are also strongly biased toward Western countries and culture, as well as being White or belonging to a majority group.^{Reference Burkhard, Cicek, Barzilay, Radhakrishnan and Guloksuz58–Reference Matthews, Savoy, Paranjape, Washington, Hackney and Galis61} Considering the international impact of NICE guidelines on SDM practice, and since many studies of SDM in mental health fall outside of the NICE inclusion criteria, we worry that this narrow representation of SDM will become the gold standard, overlooking other effective research and interventions of SDM in mental health. For example, the NICE guidelines ignore the concept of shared advance decision making in mental health, SDM around decisions about advance care planning^{Reference Swanson, Swartz, Elbogen, Van Dorn, Ferron and Wagner62,Reference de Jong, Kamperman, Oorschot, Priebe, Bramer and van de Sande63} and the significant body of literature in mental health around the Joint Crisis Plan.^{Reference Thornicroft, Farrelly, Szmukler, Birchwood, Waheed and Flach64,Reference Molyneaux, Turner, Candy, Landau, Johnson and Lloyd-Evans65}

We call on the NICE to revise their SDM recommendations for SDM studies, or at least to acknowledge that there exist other forms, designs and outcomes important for successful SDM in mental health. We hope that our call will foster an open and diverse discussion about the concept of SDM in mental health, the goals of SDM in mental health, define desired outcomes, support development of appropriate measures, acknowledge the needed diversity in research designs and address issues related to cultural relevancy.