Systematic Review of Adherence, Compliance and Quality of Life in Type 2 Diabetes Patients.

Kumar J1 B. Pharm. D.M.M, Nair R2 PhD

1,2 College of Pharmacy, University of Toledo, Toledo, OH, USA.

To systematically review the studies that evaluate the quality of life as an outcome of adherence or compliance in type 2 diabetes patients.

Diabetes mellitus is one of the most common chronic diseases. In 2007, 246 million people worldwide have diabetes. By 2025, the figure is expected to rise to 380 million. Type 2 diabetes constitute about 85% to 95% of all diabetic cases1.

In type 2 diabetes, either the body does not produce enough insulin or the cells ignore insulin. Type 2 diabetes leads to serious vascular, nephrologic, neurologic and ophthalmological complications2.

Non adherence with therapeutic regimens among diabetic patients is a continuing problem3. Enhancing adherence to treatment may lead to improved clinical outcomes and reduced number of complications4.

The patients perception of treatment effectiveness is becoming increasingly important to choose the treatment regimen for chronic diseases such as diabetes. The tools used to measure patients perceptions are quality of life and other patients reported outcomes. When Interventions improve patient perception about their mental and physical health, this improvement enhances patients commitment to self management and their adherence with treatment regimen, which leads to patients’ improved quality of life5.

Various types of interventions have been studied either to improve treatment adherence or quality of life in diabetes patients. It is important to evaluate change in quality of life due to interventions aimed at improving patients’ adherence.

Studies were excluded if they:

1) Measure adherence or quality of life due to use of a different drug treatment

2) Retrospective database studies mentioning adherence were not included

Authors Type Country of study population

N Mean (SD) age of sample

Mean (SD) duration of diabetes

Follow up Intervention Main Outcomes measured

Kim et al7 RCT Korea 20-I

16-C

59.7-I

60.9-C

14.0-I

13.4-C

12 weeks Nurse telephone calls HbA1C, self reported adherence to diabetes

Kim et al8 Quasi experimental pretest-posttest

Korea 33 43.5 (12.6) N/A 12 weeks Nurse led short message service by cellular phone or internet

HbA1C, adherence to diabetic medications, physical exercise, diet, foot care

Krass et al9 Parallel group, repeated measure

Australia 82-C

106-I

64 (9)-I

65 (10)-C

8 (1-38)-I

6 (1-50)-C

9 months Pharmacist disease management vs. usual care

Risk of non-adherence, medication regimen changes

Whitlock et al10 RCT USA 28 N/A N/A 3 months Home telemedicine care vs.

Standard care

HbA1c, weight

Piette et al11 RCT US veteran affairs

132-I

140-C

60 (10)-I

61 (10)-C

N/A Weekly and periodic calls

Telephone nurse follow up vs. usual care All diabetes related symptoms

Rachmani et al12

RCT Israel 71-I

72-C

57.4 (4.2)-I

56.8 (4.0)-C

8 (5.6)

6.1 (4.5)

Follow up for 4 years

Standard consultation vs.

Patient participation

HbA1C, BMI, GFR, blood pressure, albumin/creatinin ratio, non fatal stroke, cardiovascular death

.

Abbreviations: RCT, Randomized control trials; HbA1C, Glycosylated hemoglobin; I, Intervention group; C, Control group, BMI, Body mass index; GFR, Glomerular filtration rate

The main aim of this literature review was to evaluate studies that measure quality of life as an outcome due to intervention used to improve adherence. However, no studies has look quality of life as outcome associated with interventions used to improve adherence/compliance.

Table 2: Characteristics of interventions studies that measures quality of life

Authors Type Population N Mean (SD) age

Mean (SD) duration of diabetes

Follow up Intervention Outcomes measured

Wattana et al13 RCT Thailand 75-I

72-C

59.7-I

60.9-C

58.4 (10.05)-I

55.1 (10.22)-C

6 month Diabetes education program HbA1C, CHD risk, quality of life

Pibernik okanovic et al14

Quasi experimental with repeated measure and control group

Croatia 73-I

72-C

53.3 (5.1)-I

52.8 (4.2)-C

8 (5.6)

6.1 (4.5)

3 and 6 months 6 weekly sessions on empowered based education

HbA1C, quality of life

Table 1: Characteristics of Interventions studies that measures adherence

The literature search was done by searching the Cochrane library, Ohiolink and Pubmed for articles published between Jan, 2000 and Mar, 2008 to identify interventions containing information on improving adherence and quality of life in type 2 diabetes patients.

Search terms included key words, “Diabetes mellitus type 2”, “patient compliance, health education, patient education, physician patient relations” and “Quality of life”. The reviewer Identified the relevant literature using the following inclusion and exclusion criteria.

1. International Diabetes Federation. Diabetes e-atlas, 3rd edition. http://www.eatlas.idf.org. Accessed 04/20/08.2. American Diabetes Association. Type 2 diabetes. http://www.diabetes.org/type-2-diabetes.jsp. Accessed 04/20/083. Vermeire E, Hearnshaw H, Royen PV et al. Patient adherence to treatment: three decades of research. A comprehensive review. Journal of Clinical Pharmacy and Therapeutics; 2001, 26:331-3424. Vermeire E, Wens J, Van Royen P, Hearnshaw H, Lindemeyer A. Interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus. Cochrane Database of Systematic Reviews 2005, Issue 2, Art No.; CD003638. DOI: 10.1002/14651858. CD003638.pub2.5. Zhang x, Norris EL, Chowdhury FM et al. The effect of interventions on health related quality of life among persons with diabetes. A Systematic Review. Medical Care; 2007, volume 45,No. 9:820-346. Vermeire E, Hearnshaw H, Royen PV et al. A systematic review of adherence with medications for diabetes. Response to Cramer. Diabetes Care. 2004; 27(9); 22847. Kim HS, Oh JA. Adherence to diabetes control recommendations: Impact of nurse telephone calls. J Adv Nurs. 2003;44:256-618. Kim HS, Kim NC, An Sh. Impact of a nurse short message service intervention for patients with diabetes. J Nurs Care Qual. 2006,Vol. 21,No. 3,266-719. Krass I, Taylor SJ, Smith C. Impact on medication use and adherence of Australian pharmacist’s diabetes care services. J Am Pharm Assoc. 2005;43:33-4010. Whitlock WL, Mease A. Brown K et al. Telemedicine improve diabetic management. Mil. Medicine. 2000;165 (8): 579-8411. Piette JD, Weinberger M, Kraemer FB et al. Impact of automated calls with nurse follow up on diabetes treatment outcomes in a department of veterans affairs health care system. Diab. Care; 2001,24(2),202-0812. Rachmani RZ, Levi Z, Slavachevski I et al. Teaching patients to monitor their risk factors retard the progression of vascular complications in high risk patients with Type 2 diabetes mellitus. A randomized prospective study. Diab Med; 2002,19,385-9213. Wattana c, Srisuphan W, Pothiban L. et al. Effects of a diabetes self management plan on glycemic control, coronary heart disease, and quality of life among Thai patients with type 2 diabetes. Nursing and Health Sciences.. 2007,9,135-14114. Pibernik-Okanovic M, Prasek M, Polijicanin-Filipovic T et al. Effects of an empowered based psychosocial intervention on quality of life and metabolic control in Type 2 diabetic patients. Patient Education and Counselling. 2004;52;193-99

1) No data on quality of life as an outcome measured due to intervention aimed at improving adherence was found.

2) The interventions that measures adherence were mainly of types: diabetes education, nurse, pharmacist and physician led intervention.

3) Nurse led interventions increased adherence to medication, diet and glucose monitoring.

4) Pharmacist led interventions also increased adherence to medications.

5) Patient education is found to be an intervention that enhances the quality of life.

Background:

Objective:

Methods

Inclusion criteria

Results

Initial search resulted in 2229 abstracts. Many of these abstract were overlapping as one key search term diabetes mellitus, type 2 was common. After applying the inclusion/exclusion criteria, 8 studies were identified from USA, Korea, Australia, Croatia, Israel and Thailand. The major finding were:

References

Studies were included if they:

1) Were published in English

2) Identify intervention to improve treatment recommendation not exercise or diet

3) Aimed at patients only

Conclusion

Discussion

The authors searched only three databases to identify the relevant articles. The systematic review done on a similar topic by Lindemeyer et al reported that Embase contributed 63.6%, Medline 36.4%, and the Cochrane database 51.5% of relevant articles in their review6. The author did not have access to other databases such as Embase at his academic institution. The articles mentioned in this review might not represent the all relevant articles available on the topic.

Exclusion criteria

Enhanced adherence to treatment recommendation can lead to better clinical outcome and reduced number of complications in type 2 diabetes. The enhanced adherence and improved clinical outcomes can lead to improve quality of life for patients. It is important to measure change in quality of life due to intervention aimed at improving adherence.

Limitations