The Management of Schizophrenia in Clinical Practice (MOSAIC) Registry: A focus on patients, caregivers, illness severity, functional status, disease burden and healthcare utilization
Introduction
Schizophrenia, a chronic and debilitating multifaceted syndrome that afflicts over 60 million individuals worldwide (Perälä et al., 2007), has a considerable adverse impact not only on the patient's health and well-being, but also on their families and wider society (Knapp et al., 2004). The economic impact of schizophrenia on healthcare budgets is substantial, typically between 1.5 and 3% of national healthcare expenditure (Knapp et al., 2004). In the United States (US), schizophrenia is associated with annual direct and indirect costs of over $60 billion covering hospitalizations, the need for long-term medical management, housing, emergency room visits, legal expenses, psychosocial support and disability payments as well as life-time lost vocational productivity (Wu et al., 2005). Notably, the economic burden extends well beyond the healthcare system to other care organizations and public sector bodies, such as social service (welfare) agencies, housing departments and the criminal justice system (Knapp et al., 2004). As a result of the shift of burden of care from hospitals, most people with schizophrenia are now being cared for in the community where caregivers often experience significant stress, depression and/or anxiety and have high levels of emotional and financial burden (Martens and Addington, 2001, Saunders, 2003).
Overall, there is paucity of large scale studies in the US to assess the potential unmet need for treatment in schizophrenia. While a number of studies have utilized data from the US Schizophrenia Care and Assessment Program (US-SCAP), a 3-year, prospective, observational, non-interventional study (n = 2327) of schizophrenia treatment in usual-care settings in the US conducted between July 1997 and September 2003 (Ascher-Svanum et al., 2006, Ascher-Svanum et al., 2010, Cuyún Carter et al., 2011), many worldwide studies have not included populations from the US. For example, The Schizophrenia Outpatient Health Outcomes (SOHO) study, a 3-year, prospective, observational study designed to assess the comparative costs and outcomes of antipsychotic drug treatment in over 10,000 patients, was conducted in 10 Western European Countries (Haro et al., 2003, Haro et al., 2006). Likewise, the Worldwide-Schizophrenia Outpatient Health Outcomes (W-SOHO) study, which was undertaken to provide longitudinal data about the course of illness, treatment patterns and clinical and functional outcomes for more than 17,000 patients, was conducted in 37 countries in the following six regions: Southern Europe (n = 5788), North Europe (n = 4291), Central and Eastern Europe (n = 2175), Latin America (n = 2566), Northern Africa and the Middle East (n = 1341) and East Asia (n = 1223) (Karagianis et al., 2009, Haro et al., 2011). As such, there continues to be a dearth of “real-world” data to fill in the many information gaps in the US. Notably, a better understanding of clinical stages and disease progression along a continuum of illness for patients in usual care is needed to advance scientific understanding of the disease and its treatment (Tandon et al., 2009). Furthermore, there is limited quantification of the totality of the burden of schizophrenia on the patient, the family, the healthcare system and society.
Disease registries have been increasingly used for medical disorders such as diabetes, asthma, congestive heart failure and depression (Casalino et al., 2003), where they have provided substantial insights about the natural history and management of these conditions (Metzger, 2004, Schmittdiel et al., 2005). While some schizophrenia registries have been established to examine certain aspects of the disease (e.g., antipsychotic use, long-term treatment and clinical and functional outcomes) (Olivares et al., 2009, Peuskens et al., 2010), few have attempted to examine the entirety of the disease in a global approach.
In 2012, the Management of Schizophrenia in Clinical Practice (MOSAIC) disease-based registry (NCT01746134) was initiated to address some of the information gaps in our understanding of the impact and burden of schizophrenia and also to provide insight into the current status of schizophrenia care in the US. Through the collection of real-world data relating to a diverse representation of patients with a diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder, the objectives of this prospective, non-interventional, MOSAIC registry were to: (i) describe the longitudinal course of schizophrenia; (ii) document the patterns of treatment in usual mental healthcare settings at all stages in the illness trajectory; and (iii) estimate the burden of disease from the perspective of patients, caregivers and providers (clinical and societal). Recruitment to the registry began in December 2012 with ongoing assessment continuing through May 2014. At the time of study discontinuation, 550 participants and 229 caregivers had been enrolled in the registry. Here, we present various data sets for these 550 participants enrolled in the schizophrenia MOSAIC registry. Data collected include information on symptoms, cognition, functioning and treatments received. In addition, data on medical co-morbidities and the characteristics of patients across the life-span were examined.
Section snippets
Patient Assessment Centers
A network of 15 centralized Patient Assessment Centers (PACs) was formed to act as foci of clinical oversight and evaluation, each with up to 10 peripheral clinical treatment centers (TCs) at a variety of practice settings (Fig. 1). The majority of study sites were located at Community Mental Health Centers (CHMC) (69%), with the remainder located in academic departments of psychiatry (38%). PACs had a mean of 2.8 TCs.
Clinicians at TCs recruited and referred patients along with medical record
Participant disposition
Between December 2012 and February 2014, 550 participants were screened and enrolled across 42 study sites represented by 15 PACS. In addition, 229 caregivers or key informants for these patients were enrolled, the results of which will be reported in a subsequent manuscript. The great majority of participants (511/550 [92.9%]) enrolled in the registry remained until the study was stopped in May 2014, approximately 13 months after study initiation. Of the 39 participants who did not remain in
Discussion
The MOSAIC schizophrenia registry represents a unique research infrastructure and methodological model to observe patients receiving usual care in a variety of treatment settings. Moreover, it demonstrates the feasibility of such a registry and establishes a foundation for further much needed attempts. This US-based registry compliments the ongoing European-based multinational registry (PATTERN) which has similar objectives (Haro et al., 2014). No large-scale US registry has yet done enough to
Role of funding source
This study was not a Phase III registrational study with the intent to assess efficacy of an investigational agent for schizophrenia and Genentech does not currently have a medication approved for the indication of schizophrenia.
Contributors
Henry Nasrallah participated in the writing and multiple edits of the manuscript drafts and in presenting the data at national meetings. Philip Harvey contributed to the design of the study and participated in the writing and review of the manuscript drafts. Daniel Casey and Tracey Skale reviewed the manuscript drafts. Csilla Csoboth was involved in the proposed analyses. James Hudson was involved in the design of the study and the collection of data. Laura Julian was involved in the design of
Conflict of interest
Henry Nasrallah has received research grants from Forest, Forum, Genentech and Otsuka and has been a consultant and on the speaker's bureau for Boehringer-Ingelheim, Genentech, Forum, Janssen, Lundbeck, Merck, Novartis, Otsuka, Sunovion and Teva. Philip Harvey has received consulting fees from Abbvie, Boehringer-Ingelheim, Forum Pharma, Forest labs, Genentech, Otsuka-America, Roche Pharma, Sunovion Pharma and Takeda Pharma. Daniel Casey is a consultant to Genentech. James Hudson has received
Acknowledgments
The authors received medical editing support from inVentiv Medical Communications, which was funded by F. Hoffmann-La Roche Ltd. The authors would also like to thank all the investigators, their site staff, and research participants and their caregivers in collection of these data.
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