Rationale and design of the multinational observational study assessing insulin use: the MOSAIc study

BMC Endocrine Disorders

William H Shrank²  Anthony Zagar¹  Niteesh K Choudhry²  John D Seeger²  Bradley H Curtis¹  Jennifer M Polinski² 

[1] Eli Lilly and Company, Indianapolis, IN, USA;Harvard Medical School, Boston, MA, USA

关键词: Epidemiology;    Health outcomes;    Treatment;    Insulin;    Type 2 diabetes;   

Others  :  1086296
DOI  :  10.1186/1472-6823-12-20

 received in 2012-05-04, accepted in 2012-09-17,  发布年份 2012

【 摘 要 】

Background

Although consensus guidelines recommend insulin progression among patients with type 2 diabetes (T2DM) who fail to meet glycemic targets over time, many fewer patients are progressed than may benefit. We describe the rationale and design of the MOSAIc (Multinational Observational Study Assessing Insulin use) study, a multinational observational cohort study to identify patient-, physician, and health care environment-based factors associated with insulin progression for patients with T2DM in real-world practice.

Methods/design

We will enroll 4,500 patients with T2DM taking initial insulin therapy for ≥3 months across 175 physician practice sites in 18 countries. Extensive demographic, clinical, and psychosocial data at the patient and physician level and practice site characteristics will be collected at baseline and regular intervals during a 24-month follow-up period. We will use a multivariable logistic regression model to identify predictors of insulin progression and highlight potential opportunities for health behavior intervention to improve insulin progression rates. Secondary outcomes include evaluating factors associated with glycemic control, hypoglycemia, and treatment adherence among patients who do and do not progress beyond their initial insulin therapy and exploring geographic heterogeneity in treatment.

Discussion

Practice site and patient recruitment began in 2011 and baseline data will be available in late 2012. The MOSAIC study’s longitudinal observational design as well as the breadth and depth of data will be used to explore and quantify predictors of insulin progression and to identify potential opportunities for health behavior intervention in order to improve T2DM treatment and clinical outcomes.

【 授权许可】

   
2012 Polinski et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]World Health Organization : Diabetes Programme. 2011. http://www.who.int/diabetes/facts/en/
• [2]Roglic G, Unwin N, Bennett PH, et al.: The burden of mortality attributable to diabetes: realistic estimates for the year 2000. Diab Care 2005, 28:2130-2135.
• [3]Wild S, Roglic G, Green A, Sicree R, King H: Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diab Care 2004, 27:1047-1053.
• [4]Centers for Disease Control and Prevention : National Diabetes Fact Sheet 2011. 2011. http://www.cdc.gov/diabetes/pubs/factsheet11.htm?utm_source=WWW&utm_medium=ContentPage&utm_content=CDCFactsheet&utm_campaign=CON
• [5]Nathan DM, Buse JB, Davidson MB, et al.: Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American diabetes association and the european association for the study of diabetes. Diab Care 2009, 32:193-203.
• [6]Type 2 diabetes. NICE Clinical Guideline 66, 87. 2008. http://www.nice.org.uk/guidance/index.jsp?action=byID&o=12165
• [7]American Association of Clinical Endocrinologists: Medical guidelines for clinical practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract 2011, 17:1-53.
• [8]Guler S, Vaz JA, Ligthelm R: Intensification lessons with modern premixes: from clinical trial to clinical practice. Diab Res Clin Pract 2008, 81:S23-S30.
• [9]Grant RW, Buse JB, Meigs JB: Quality of diabetes care in U.S. academic medical centers: low rates of medical regimen change. Diab Care 2005, 28:337-442.
• [10]NovoNordisk: The DAWN (Diabetes Attitudes, Wishes, and Needs) Study. 2011. http://www.dawnstudy.com/documents/article_page/document/dawn_study.asp
• [11]Peyrot M, Rubin RR, Lauritzen T, et al.: Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diab Care 2003, 28:2673-2679.
• [12]Korytkowski M: When oral agents fail: practical barriers to starting insulin. Int J Obes Relat Metab Disord 2002, 26:S18-S24.
• [13]Wallace TM, Matthews DR: Poor glycaemic control in type 2 diabetes: a conspiracy of disease, suboptimal therapy and attitude. Q J Med 2000, 93:369-374.
• [14]Phillips KA, Morrison KR, Andersen R, Aday LA: Understanding the context of healthcare utilization: assessing environmental and provider-related variables in the behavioral model of utilization. Health Serv Res 1998, 33:571-596.
• [15]Aday LA, Anderson R: A framework for the study of access to medical care. Health Serv Res 1974, 9:208-220.
• [16]Salti I, Benard E, Detournay B, et al.: A population-based study of diabetes and its characteristics during the fasting month of ramadan in 13 countries. Diab Care 2004, 27:2306-2311.
• [17]International Diabetes Federation: Diabetes Atlas. 2011. http://www.idf.org/diabetesatlas/
• [18]World Health Organization: World health statistics. 2011. http://www.who.int/whosis/whostat/EN_WHS2011_Full.pdf
• [19]Health Authority of Abu Dhabi Statistics. 2010. http://www.haad.ae/HAAD/LinkClick.aspx?fileticket=tz6kOZqeunM%3d&tabid=349
• [20]Cuddihy RM, Philis-Tsimikas A, Nazeri A: Type 2 diabetes care and insulin intensification: is a more multidisciplinary approach needed? Results from the MODIFY survey. Diabetes Educ 2011, 37:111-123.
• [21]Narayan KMV, Echouffo-Tcheugui JB, Mohan V, Ali MK: Global prevention and control of type 2 diabetes will require paradigm shifts in policies within and among countries. Health Aff 2012, 31:84-92.
• [22]Greenfield S, Sullivan L, Dukes KA, Silliman R, D'Agostino R, et al.: Development and testing of a new measure of case mix for use in office practice. Med Care 1995, 33:AS47-AS55.
• [23]Group EQL: EuroQol–a new facility for the measurement of health-related quality of life. Health Pol 1990, 16:199-208.
• [24]Fitzgerald JT, Funnell MM, Hess GE, Barr PA, Anderson RM, et al.: The reliability and validity of a brief diabetes knowledge test. Diab Care 1998, 21:706-710.
• [25]Bayliss EA, Ellis JL, Steiner JF: Barriers to self-management and quality-of-life outcomes in seniors with multimorbidities. Ann Fam Med 2007, 5:395-402.
• [26]Naegeli AN, Hayes RP: Expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction in insulin-naive patients with type 2 diabetes. Internat J Clin Pract 2010, 64:908-916.
• [27]Toobert DJ, Hampson SE, Glasgow RE: The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care 2000, 23:943-950.
• [28]Stewart AL, Napoles-Springer AM, Gregorich SE, Santoyo-Olsson J: Interpersonal processes of care survey: patient-reported measures for diverse groups. Health Serv Res 2007, 42:1235-1256.
• [29]Liang KY, Zeger SL: Longitudinal data analysis using generalized linear models. Biometrika 1986, 73:13-22.