Effect of early intensive multifactorial therapy compared with routine care on self-reported health status, general well-being, diabetes-specific quality of life and treatment satisfaction in screen-detected type 2 diabetes mellitus patients (ADDITION-Europe): A cluster-randomised trial

Diabetologia

Volumn 56, Issue 11, 2013, Pages 2367-2377

  Van Den Donk, Maureen ^a   Griffin, Simon J ^b   Stellato, Rebecca K ^a   Simmons, Rebecca K ^b   Sandbæk, Annelli ^c   Lauritzen, Torsten ^c   Khunti, Kamlesh ^d   Davies, Melanie J ^d   Borch Johnsen, Knut ^e   Wareham, Nicholas J ^b   Rutten, Guy E H M ^a  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^c AARHUS UNIVERSITY   (Denmark)

^d UNIVERSITY OF LEICESTER   (United Kingdom)

^e HOLBÆK HOSPITAL   (Denmark)

Author keywords

Diabetes screening; Health status; Intensive treatment; Patient reported outcome measures; Primary care; Quality of life; Treatment satisfaction; Type 2 diabetes mellitus

Indexed keywords

ACETYLSALICYLIC ACID; ANGIOTENSIN RECEPTOR ANTAGONIST; ANTIDIABETIC AGENT; ANTIHYPERTENSIVE AGENT; ANTILIPEMIC AGENT; CHOLESTEROL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; HEMOGLOBIN A1C; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

ADULT; AGED; ANTHROPOMETRY; ARTICLE; AUDIT OF DIABETES DEPENDENT QUALITY OF LIFE; CARDIOVASCULAR DISEASE; CONSERVATIVE TREATMENT; CONTROLLED STUDY; DENMARK; DIABETES TREATMENT SATISFACTION QUESTIONNAIRE; EARLY INTENSIVE MULTIFACTORIAL THERAPY; EUROQOL 5 DIMENSIONS; EUROQUOL VISUAL ANALOGUE SCALE; FEMALE; FOLLOW UP; GENERAL PRACTICE; HEALTH STATUS; HUMAN; MAJOR CLINICAL STUDY; MALE; NETHERLANDS; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PARALLEL DESIGN; PATIENT CARE; PATIENT SATISFACTION; PRESCRIPTION; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; ROUTINE CARE; SELF REPORT; SHORT FORM 36; SHORT FORM OF THE WELL BEING QUESTIONNAIRE; UNITED KINGDOM; WELLBEING; WORLD HEALTH ORGANIZATION;

EID: 84885872497     PISSN: 0012186X     EISSN: 14320428     Source Type: Journal    
DOI: 10.1007/s00125-013-3011-0     Document Type: Article

References (32)

1. Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O (2003) Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med 348:383-393
2. Gaede P, Lund-Andersen H, Parving HH, Pedersen O (2008) Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med 358:580-591
3. Griffin SJ, Borch-Johnsen K, Davies MJ et al (2011) Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial. Lancet 378:156-167
4. Peyrot M, Rubin RR, Lauritzen T, Snoek FJ, Matthews DR, Skovlund SE (2005) Psychosocial problems and barriers to improved diabetes management: results of the Cross-National Diabetes Attitudes, Wishes and Needs (DAWN) Study. Diabet Med 22:1379-1385
5. Black N (2013) Patient reported outcome measures could help transform healthcare. BMJ 346:f167
6. Darzi A (2008) Quality and the NHS next stage review. Lancet 371:1563-1564
7. UK Prospective Diabetes Study Group (1999) Quality of life in type 2 diabetic patients is affected by complications but not by intensive policies to improve blood glucose or blood pressure control (UKPDS 37). Diabetes Care 22:1125-1136
8. Anderson RT, Narayan KM, Feeney P et al (2011) Effect of intensive glycemic lowering on health-related quality of life in type 2 diabetes: ACCORD trial. Diabetes Care 34:807-812
9. Echouffo-Tcheugui JB, Simmons RK, Williams KM et al (2009) The ADDITION-Cambridge trial protocol: a cluster-randomised controlled trial of screening for type 2 diabetes and intensive treatment for screen-detected patients. BMC Public Health 9:136
10. Janssen PG, Gorter KJ, Stolk RP, Rutten GE (2009) Randomised controlled trial of intensive multifactorial treatment for cardiovascular risk in patients with screen-detected type 2 diabetes: 1-year data from the ADDITION Netherlands study. Br J Gen Pract 59:43-48
11. Lauritzen T, Griffin S, Borch-Johnsen K, Wareham NJ, Wolffenbuttel BH, Rutten G (2000) The ADDITION study: proposed trial of the cost-effectiveness of an intensive multifactorial intervention on morbidity and mortality among people with type 2 diabetes detected by screening. Int J Obes Relat Metab Disord 24(Suppl 3):S6-S11
12. Webb DR, Khunti K, Srinivasan B et al (2010) Rationale and design of the ADDITION-Leicester study, a systematic screening programme and randomised controlled trial of multi-factorial cardiovascular risk intervention in people with type 2 diabetes mellitus detected by screening. Trials 11:16
13. Sandbaek A, Griffin SJ, Rutten G et al (2008) Stepwise screening for diabetes identifies people with high but modifiable coronary heart disease risk. The ADDITION study. Diabetologia 51:1127-1134
14. Van den Donk M, Sandbaek A, Borch-Johnsen K et al (2011) Screening for type 2 diabetes. Lessons from the ADDITION-Europe study. Diabet Med 28:1416-1424
15. Alberti KGMM, Zimmet PZ (1999) Definition, diagnosis and classification of diabetes mellitus and its complications. World Health Organization, Geneva
16. Collins R, Armitage J, Parish S, Sleigh P, Peto R (2003) MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet 361:2005-2016
17. McIntosh A, Hutchinson A, Home PD et al (2001) Royal College of General Practitioners. Clinical guidelines and evidence review for type 2 diabetes: management of blood glucose. University of Sheffield, Sheffield, UK
18. Royal College of General Practitioners in Denmark (1999) Type 2-diabetes in general practice - diagnosis and treatment. Royal College of General Practitioners, Copenhagen, Denmark
19. Rutten GEHM, Verhoeven S, Heine RJ et al (1999) Dutch College of General Practitioners. Practice guidelines: diabetes mellitus type 2. Huisarts Wetenschap 42:67-84
20. Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30:473-483
21. Dolan P (1997) Modeling valuations for EuroQol health states. Med Care 35:1095-1108
22. Brooks R (1996) EuroQol: the current state of play. Health Policy 37:53-72
23. Pouwer F, van der Ploeg HM, Ader HJ, Heine RJ, Snoek FJ (1999) The 12-item well-being questionnaire. An evaluation of its validity and reliability in Dutch people with diabetes. Diabetes Care 22:2004-2010
24. Pouwer F, Snoek FJ, van der Ploeg HM, Ader HJ, Heine RJ (2000) The well-being questionnaire: evidence for a three-factor structure with 12 items (W-BQ12). Psychol Med 30:455-462
25. Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R (1999) The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL. Qual Life Res 8:79-91
26. Bradley C (1994) Diabetes treatment satisfaction questionnaire. In: Bradley C (ed) Handbook of psychology and diabetes: a guide to psychological measurement in diabetes research and practice. Harwood Academic, Chur, pp 111-132
27. Donders AR, van der Heijden GJ, Stijnen T, Moons KG (2006) Review: a gentle introduction to imputation of missing values. J Clin Epidemiol 59:1087-1091
28. Webb DR, Khunti K, Gray LJ et al (2012) Intensive multifactorial intervention improves modelled coronary heart disease risk in screen-detected type 2 diabetes mellitus: a cluster randomized controlled trial. Diabet Med 29:531-540
29. Van den Donk M, Gorter KJ, Rutten GE (2010) No negative effects of a multi-factorial, intensified treatment on self-reported health status, treatment satisfaction, and diabetes-related distress in screen-detected type 2 diabetes patients. The ADDITION-Netherlands study. Qual Life Res 19:509-513
30. Davies MJ, Heller S, Skinner TC et al (2008) Effectiveness of the Diabetes Education and Self Management for Ongoing and Newly Diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial. BMJ 336:491-495
31. Redekop WK, Koopmanschap MA, Stolk RP, Rutten GE, Wolffenbuttel BH, Niessen LW (2002) Health-related quality of life and treatment satisfaction in Dutch patients with type 2 diabetes. Diabetes Care 25:458-463
32. Cleveringa FG, Minkman MH, Gorter KJ, van den Donk M, Rutten GE (2010) Diabetes Care Protocol: effects on patient-important outcomes. A cluster randomized, non-inferiority trial in primary care. Diabet Med 27:442-450