Effect of depression on mortality and cardiovascular morbidity in type 2 diabetes mellitus after 3 years follow up. The DIADEMA study protocol

BMC Psychiatry

Miguel A Salinero-Fort⁴  Francisco López-López⁶  María I Granados-Menéndez³  Carmen Y Fuentes-Rodríguez²  Juan Cárdenas-Valladolid¹  Paloma Gómez-Campelo⁴  Carmen de Burgos-Lunar⁵ 

[1] Unidad de Apoyo Técnico, Gerencia Adjunta de Planificación y Calidad del Servicio Madrileño de Salud, (C/ O’Donell, 55), Madrid, (28007), Spain;Gerencia, Hospital Carlos III, (C/ Sinesio Delgado, 10), Madrid, (28029), Spain;Centro de Salud Monóvar, Dirección Asistencial Este, Servicio Madrileño de Salud, Madrid, Spain;Fundación de Investigación Biomédica, Hospital Carlos III, (C/ Sinesio Delgado, 10), Madrid, (28029), Spain;Unidad de Epidemiología Clínica e Investigación, Hospital Carlos III, (C/ Sinesio Delgado, 10), Madrid, (28029), Spain;Centro de Salud Vicente Muzas, Dirección Asistencial Este, Servicio Madrileño de Salud, Madrid, Spain

关键词: Primary health care;    Type 2;    Diabetes mellitus;    Depression;   

Others  :  1124336
DOI  :  10.1186/1471-244X-12-95

 received in 2012-05-09, accepted in 2012-06-26,  发布年份 2012

【 摘 要 】

Background

Type 2 diabetes mellitus and depression are highly prevalent diseases that are associated with an increased risk of cardiovascular disease and mortality. There is evidence about a bidirectional association between depressive symptoms and type 2 diabetes mellitus. However, prognostic implications of the joint effects of these two diseases on cardiovascular morbidity and mortality are not well-known.

Method/design

A three-year, observational, prospective, cohort study, carried out in Primary Health Care Centres in Madrid (Spain). The project aims to analyze the effect of depression on cardiovascular events, all-cause and cardiovascular mortality in patients with type 2 diabetes mellitus, and to estimate a clinical predictive model of depression in these patients.

The number of patients required is 3255, all them with type 2 diabetes mellitus, older than 18 years, who regularly visit their Primary Health Care Centres and agree to participate. They are chosen by simple random sampling from the list of patients with type 2 diabetes mellitus of each general practitioner.

The main outcome measures are all-cause and cardiovascular mortality and cardiovascular morbidity; and exposure variable is the major depressive disorder.

There will be a comparison between depressed and not depressed patients in all-cause mortality, cardiovascular mortality, coronary artery disease and stroke using the Chi-squared test. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors that might alter the effect recorded will be taken into account in this analysis. To assess the effect of depression on the mortality, a survival analysis will be used comparing the two groups using the log-rank test. The control of potential confounding variables will be performed by the construction of a Cox regression model.

Discussion

Our study’s main contribution is to evaluate the increase in the risk of cardiovascular morbidity and mortality, in depressed Spanish adults with type 2 diabetes mellitus attended in Primary Health Care Setting. It would also be useful to identify subgroups of patients for which the interventions could be more beneficial.

【 授权许可】

   
2012 de Burgos-Lunar et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1 .

【 参考文献 】

• [1]Centers for Disease Control and Prevention: National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States. Department of Health and Human Services, Centers for Disease Control and Prevention, Atlanta, GA: U.S; 2011. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf webcite
• [2]Soriguer F, Goday A, Bosch-Comas A, Bordiú E, Calle-Pascual A, Carmena R, Casamitjana R, Castaño L, Castell C, Catalá M, Delgado E, Franch J, Gaztambide S, Girbés J, Gomis R, Gutiérrez G, López-Alba A, Martínez-Larrad MT, Menéndez E, Mora-Peces I, Ortega E, Pascual-Manich G, Rojo-Martínez G, Serrano-Rios M, Valdés S, Vázquez JA, Vendrell J: Prevalence of diabetes mellitus and impaired glucose regulation in Spain: the [e-mail] Study. Diabetologia 2012, 55(1):88-93.
• [3]Moore H, Summerbell C, Hooper L, Cruickshank K, Vyas A, Johnstone P, Ashton V, Kopelman P: Dietary advice for treatment of type 2 diabetes mellitus in adults. Cochrane Database of Syst Rev 2004, 3:CD004097.
• [4]Fox CS, Coady S, Sorlie PD, Levy D, Meigs JB, D’Agostino RB, Wilson PW, Savage PJ: Trends in cardiovascular complications of diabetes. JAMA 2004, 292:2495-2999.
• [5]Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M: Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med 1998, 339(4):229-234.
• [6]Booth GL, Kapral MK, Fung K, Tu JV: Recent trends in cardiovascular complications among men and women with and without diabetes. Diabetes Care 2006, 29:32-37.
• [7]Engelgau MM, Geiss LS, Saaddine JB, Boyle JP, Benjamin SM, Gregg EW, Tierney EF, Rios-Burrows N, Mokdad AH, Ford ES, Imperatore G, Narayan KM: The evolving diabetes burden in the United States. Ann Intern Med 2004, 140:945-950.
• [8]World Health Organization: The World Health Report 2001—Mental Health: New Understanding. New Hope, Geneve, Switzerland; http://www.who.int/whr/2001/en/whr01_en.pdf webcite
• [9]Musselman DL, Evans DL, Nemeroff CB: The relationship of depression to cardiovascular disease: epidemiology, biology, and treatment. Arch Gen Psychiatry 1998, 55(7):580-592.
• [10]Cuijpers P, Smit F: Excess mortality in depression: a meta-analysis of community studies. J Affect Disord 2002, 72(3):227-236.
• [11]Knol MJ, Twisk JWR, Beekman ATF, Heine RJ, Snoek FJ, Pouwer F: Depression as a risk factor for the onset of type 2 diabetes mellitus. A meta-analysis. Diabetologia 2006, 49:837-845.
• [12]Anderson RJ, Freedland KE, Clouse RE, Lustman PJ: The prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care 2001, 24:1069-1078.
• [13]Ali S, Stone MA, Peters JL, Davies MJ, Khunti K: The prevalence of co-morbid depression in adults type 2 diabetes: systematic review and meta-analysis. Diabet Med 2006, 23:1165-1173.
• [14]Von Korff M, Katon W, Lin E, Simon G, Ciechanoswski P, Ludman E, Oliver M, Rutter C, Young B: Work disability among individuals with diabetes. Diabetes Care 2005, 28:1326-1332.
• [15]Golden SH, Lazo M, Carnethon M, Bertoni AG, Schreiner PJ, Roux AV, Lee HB, Lyketsos C: Examinig a bidirectional association between depressive symptoms and diabetes. JAMA 2008, 299(23):2751-2759.
• [16]Knol MJ, Heerdink ER, Egberts AC, Geerlings MI, Gorter KJ, Numans ME: Depressive symptoms in subjects diagnosed and undiagnosed type2 diabetes. Psychosom Med 2007, 69:300-305.
• [17]Engum A: The role of depression and anxiety in onset of diabetes in a large population-based study. J Psychosom Res 2007, 62(1):31-38.
• [18]Nouwen A, Winkley K, Twisk J, Lloyd CE, Peyrot M, Ismail K, Pouwer F: European Depression in Diabetes (EDID) Research Consortium: Type 2 diabetes mellitus as a risk factor for the onset of depression: a systematic review and metaanalysis. Diabetologia 2010, 53(12):2480-2486.
• [19]Mezuk B, Eaton WW, Albrecht S, Golden SH: Depression and type 2 diabetes over the lifespan: a meta-analysis. Diabetes Care 2008, 31(12):2383-2390.
• [20]De Jonge P, Roy JF, Saz P, Marcos G, Lobo A: Prevalent and incident depression in communitydwelling elderly persons withdiabetes mellitus: ZARADEMP Project. Diabetologia 2006, 49:2627-2633.
• [21]Lustman PJ, Clouse RE: Depression in diabetic patients: the relationship between mood and glycemic control. J Diabetes Complications 2005, 19(2):113-122.
• [22]Gonzalez JS, Peyrot M, McCarl LA, Collins EM, Serpa L, Mimiaga MJ, Safren SA: Depression and diabetes treatment nonadherence: a meta-analysis. Diabetes Care 2008, 31(12):2398-2403.
• [23]Schram MT, Baan CA, Pouwer F: Depression and quality of life in patients with diabetes: a systematic review from the European depression in diabetes (EDID) research consortium. Curr Diabetes Rev 2009, 5(2):112-119.
• [24]Koopmans B, Pouwer F, de Bie RA, van Rooij ES, Leusink GL, Pop VJ: Depressive symptoms are associated with physical inactivity in patients with type 2 diabetes. The DIAZOB Primary Care Diabetes study. Fam Pract 2009, 26(3):171-173.
• [25]De Groot M, Anderson R, Freedland KE, Clouse RE, Lustman PJ: Association of depression and diabetes complications: a meta-analysis. Psychosomatic Medicine 2001, 63:619-630.
• [26]Lin EH, Rutter CM, Katon W, Heckbert SR, Ciechanowski P, Oliver MM, Ludman EJ, Young BA, Williams LH, McCulloch DK, Von Korff M: Depression and advanced complications of diabetes: a prospective cohort study. Diabetes Care 2010, 33:264-269.
• [27]Black SA, Markides KS, Ray LA: Depression predicts increased incidence of adverse health outcomes in older Mexican Americans with type 2 diabetes. Diabetes Care 2003, 26(10):2822-2828.
• [28]Bruce DG, Davis WA, Starkstein SE, Davis TM: A prospective study of depression and mortality in patients with type 2 diabetes: The Fremantle Diabetes Study. Diabetologia 2005, 48:2532-2539.
• [29]Egede LE, Nietert PJ, Zheng D: Depression and all-cause and coronary heart disease mortality among adults with and without diabetes. Diabetes Care 2005, 28(6):1339-1345.
• [30]Lin EH, Heckbert SR, Rutter CM, Katon WJ, Ciechanowski P, Ludman EJ, Oliver M, Young BA, McCulloch DK, Von Korff M: Depression and increased mortality in diabetes: unexpected causes of death. Ann Fam Med 2009, 7:414-421.
• [31]Katon W, Russo J, Lin EH, Heckbert SR, Ciechanowski P, Ludman EJ, Von Korff M: Depression and diabetes: factors associated with major depression at five-year follow-up. Psychosomatics 2009, 50:570-579.
• [32]Stanković Z, Jašović-Gašić M, Zamaklar M: Psycho-social and clinical variables associated with depression in patients with type 2 diabetes. Psychiatr Danub 2011, 23(1):34-44.
• [33]King M, Walker C, Levy G, Bottomley C, Royston P, Weich S, Bellón-Saameño JA, Moreno B, Svab I, Rotar D, Rifel J, Maaroos HI, Aluoja A, Kalda R, Neeleman J, Geerlings MI, Xavier M, Carraça I, Gonçalves-Pereira M, Vicente B, Saldivia S, Melipillan R, Torres-Gonzalez F, Nazareth I: Development and validation of an international risk prediction algorithm for episodes of major depression in general practice attendees: the PredictD study. Arch Gen Psychiatry 2008, 65(12):1368-1376.
• [34]de Burgos-Lunar C, Salinero-Fort MA, Cárdenas-Valladolid J, Soto-Díaz S, Fuentes-Rodríguez CY, Abánades-Herranz JC, del Cura-González I: Validation of diabetes mellitus and hypertension diagnosis in computerized medical records in primary health care. BMC Med Res Methodol 2011, 11(1):146. BioMed Central Full Text
• [35]Schramm TK, Gislason GH, Køber L, Rasmussen S, Rasmussen JN, Abildstrøm SZ, Hansen ML, Folke F, Buch P, Madsen M, Vaag A, Torp-Pedersen C: Diabetes patients requiring glucose-lowering therapy and nondiabetics with a prior myocardial infarction carry the same cardiovascular risk: a population study of 3.3 million people. Circulation 2008, 117(15):1945-1954.
• [36]Domingo-Salvany A, Regidor E, Alonso J, Alvarez-Dardet C: Proposal for a social class measure. Working Group of the Spanish Society of Epidemiology and the Spanish Society of Family and Community Medicine. Aten Primaria 2000, 25(5):350-363.
• [37]López-Ibor JJ, Valdés M: DMS-IV-TR-AP. Manual diagnóstico y estadístico de los trastornos mentales. Texto revisado, Barcelona: Masson; 2004.
• [38]Ferrando L, Franco L, Soto M, Bobes J, Soto O, Franco L, Gilbert J: MINI International Neuropsychiatric Interview. Instituto IAP, Madrid; 1998.
• [39]Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC: The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998, 59(Suppl 20):22-33.
• [40]Kokoszka A, Pouwer F, Jodko A, Radzio R, Mućko P, Bieńkowska J, Kuligowska E, Smoczyńska O, Skłodowska Z: Serious diabetes-specific emotional problems in patients with type 2 diabetes who have different levels of comorbid depression: a Polish study from the European Depression in Diabetes (EDID) Research Consortium. Eur Psychiatry 2009, 24(7):425-430.
• [41]Christensen H, Batterham PJ, Grant JB, Griffiths KM, Mackinnon AJ: A population study comparing screening performance of prototypes for depression and anxiety with standard scales. BMC Med Res Methodol 2011, 11:154. BioMed Central Full Text
• [42]Esposito E, Wang JL, Williams JV, Patten SB: Mood and anxiety disorders, the association with presenteeism in employed members of a general population sample. Epidemiol Psichiatr 2007, 16(3):231-237.
• [43]Conejo-Galindo J, Medina O, Fraguas D, Terán S, Sainz-Cortón E, Arango C: Psychopathological sequelae of the 11 March terrorist attacks in Madrid: an epidemiological study of victims treated in a hospital. Eur Arch Psychiatry Clin Neurosci 2008, 258(1):28-34.
• [44]Sherbourne CD, Stewart AL: The MOS social support survey. Soc Sci Med 1991, 32(6):705-714.
• [45]Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M: Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J ClinEpidemiol 1998, 51(11):1171-1178.
• [46]Soldatos CR, Dikeos DG, Paparrigopoulos TJ: Athens Insomnia Scale: validation of an instrument based on ICD-10 criteria. J Psychosom Res 2000, 48(6):555-560.
• [47]Fernández Cuenca R: Análisis de los servicios sanitarios. Sociedad Española de Salud Pública y Administración Sanitaria. In Informe SESPAS 1998: La salud pública y el futuro del estado de bienestar. Escuela Andaluza de SaludPública, Granada; 1998:249-298.