Educational interventions aiming at improving adherence to treatment recommendations in type 2 diabetes

diabetes research and clinical practice 79 (2008) 377–388

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Review

Educational interventions aiming at improving adherence to treatment recommendations in type 2 diabetes A sub-analysis of a systematic review of randomised controlled trials Johan Wens a,*, Etienne Vermeire a,b, Hilary Hearnshaw c, Antje Lindenmeyer c, Yves Biot a, Paul Van Royen a a

Department of General Practice, Interdisciplinary Health Care and Geriatrics, University of Antwerp, Belgium Department of Nursing and Midwifery, University of Antwerp, Belgium c Centre for Primary Health Care Studies, University of Warwick, UK b

article info

abstract

Article history:

Objective: In the management of type 2 diabetes, a complex interaction takes place between

Received 13 February 2007

medical professionals’ treatment goals and patients’ health beliefs about the disease and its

Accepted 16 June 2007

treatment options.

Published on line 23 July 2007

The contribution of self-management education to adherence in general or even more specifically to medicine taking is not known. We assessed educational interventions aimed

Keywords:

at improving adherence to medical treatment recommendations, other than lifestyle advice.

Type 2 diabetes mellitus

Study design: Systematic literature review.

Patient education

Setting: This paper represents an analysis of eight articles describing an educational inter-

Adherence

vention as a subgroup of a Cochrane Review [E. Vermeire, J. Wens, P. Van Royen, Y. Biot, H.

Self-management

Hearnshaw, A. Lindenmeyer, Interventions for improving adherence to treatment recom-

Systematic review

mendations in people with type 2 diabetes mellitus, Cochrane Database of Systematic Reviews 2005, Issue 2, Art. No.: CD003638, doi:10.1002/14651858.CD003638.pub2] on interventions to improve adherence to treatment recommendations in people with type 2 diabetes. Results: Four studies reported interventions using face-to-face education, two reported on the effects of group education and two on distance education by telemedicine. Due to poor quality of study designs, a variety of heterogeneous outcome measures in different time intervals, unclear definitions of adherence, and difficulties in evaluating different aspects of education performed, general conclusions could not be drawn. Conclusion: Consistent conclusions about the effectiveness of educational interventions on adherence to treatment recommendations were hard to be drawn. There is an urgent need for well-designed intervention studies on the effect of different aspects of education on adherence to treatment recommendations. # 2007 Elsevier Ireland Ltd. All rights reserved.

* Corresponding author at: University of Antwerp, Faculty of Medicine, Department of General Practice, Interdisciplinary Health Care and Geriatrics, Universiteitsplein 1, 2610 Wilrijk, Antwerp, Belgium. Tel.: +32 3 820 25 29; fax: +32 3 820 25 26. E-mail address: [email protected] (J. Wens). 0168-8227/$ – see front matter # 2007 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.diabres.2007.06.006

378

diabetes research and clinical practice 79 (2008) 377–388

Contents 1. 2.

3.

4. 5.

1.

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Materials and methods . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1. Systematic literature search . . . . . . . . . . . . . . . . . 2.2. Study selection . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3. Data collection, quality assessment and analysis. Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1. Methodological quality . . . . . . . . . . . . . . . . . . . . . 3.2. Kind of interventions. . . . . . . . . . . . . . . . . . . . . . . 3.3. Quantitative synthesis. . . . . . . . . . . . . . . . . . . . . . Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conflicts of interests . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Introduction

The global burden of diabetes has been estimated at many occasions [2,3]. WHO estimated 135 million people to be affected in 1995, their number reaching 299 million by the year 2025 [4]. Over the last 30 years, type 2 diabetes has changed from being considered a relatively mild ailment associated with ageing, to one of the major contemporary causes of premature mortality and morbidity worldwide [5]. Diabetes is ranked among the leading causes of blindness, renal failure and lower limb amputation [6], and is one of the major causes of cardiovascular death. To date there is strong evidence that the vigorous treatment of type 2 diabetes can decrease morbidity and mortality [7–10]. However, treatment outcomes in many people with diabetes remain unsatisfactory. Since these outcomes may be improved by a number of – usually complex – interventions, full benefits of medication cannot be realized at currently achievable levels of adherence [11]. Non-adherence with therapeutic regimens therefore has been a continuing problem for health care providers and a major concern for public health [12,13]. Rather than the health care provider, the person living with the disease seems to be the key to successful management [14]. In addition, interventions focusing on modifying the behaviour of people living with diabetes seem to have better outcomes than those focusing on modifying clinician’s behaviour [15]. Earlier quantitative research on the use of formal diabetes education as a therapeutic tool, to promote self-management in adults with type 2 diabetes, did not produce consistent results in terms of improved metabolic control and of reduced risks for cardiovascular disease. Positive effects on patient knowledge, self-care behaviour, metabolic control, and psychological outcomes were reported in reviews on the effectiveness of education in type 2 diabetes [16–19]. However, in these reviews, a complete and adequate description of the interventions often is lacking. In general, comprehensive interventions combining cognitive, behavioural, and educational components are more effective than single-focus interventions [20]. Self-management education in patients

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with type 2 diabetes mellitus, especially interventions involving active participation, may have short-term effectiveness for improving diabetes knowledge, self-monitoring of blood glucose levels, self-reported dietary habits, and glycemic control [21]. However, the long-term outcomes of diabetes education, aiming at the promotion of self-management and adherence in adults with type 2 diabetes still have to be established. Diabetes self-management appears to be among the most difficult of all chronic illnesses’ self-management regimes [22,23]. Where quantitative studies failed to, the findings of qualitative studies contributed to a deeper understanding of the context in which diabetes education should be applied, in order to be successful in promoting self-management behaviours in adults with type 2 diabetes [24]. By setting self-care goals themselves, people may be more likely to adhere to treatment plans [14,25–27]. Therapeutic patient education may contribute to the adherence process by providing people with the information they need for priority setting and problem solving, assisting them in identifying realistic targets for behavioural changes, and providing ongoing emotional support and encouragement in their self-management plans. We performed a systematic review of published articles to identify the effectiveness of interventions aimed at improving adherence to medical treatment recommendations in people with type 2 diabetes mellitus, not lifestyle changes, diet nor exercise [1]. This paper reports a synthesis of studies of educational interventions that are a subgroup of studies included in the Cochrane Review.

2.

Materials and methods

2.1.

Systematic literature search

A systematic literature search [28] was conducted to identify interventions containing information on improving adherence to medical treatment recommendations, not oriented to other aspects such as exercise, attendance at clinic nor diet. Search terms consisted of the Cochrane Metabolic and Endocrine Disorders Group search strategy for type 2 diabetes

diabetes research and clinical practice 79 (2008) 377–388

mellitus and a combination of MESH terms: patient compliance, health behaviour, health education, self-care, patient education, patient satisfaction, educational status, patient dropouts, physician–patient relations and delivery of health care, all with subheadings and categories included. In addition, truncations of compliance, concordance and adherence were used besides word searches on self-care or selfmanagement. The full search strategy is described in the original Cochrane publication [1]. We searched electronically the Cochrane Library including the Cochrane Controlled Trials Register (CCTR) and the Database of reviews of effectiveness (DARE), the Metabolic and Endocrine Disorders Group Specialized Register, MEDLINE (1966 to November 2002), EMBASE (1980 to November 2002), Psych Info (1987 to November 2002), CINAHL (1982 to November 2002), Dissertation Abstracts (1961 to November 2002), ERIC (to November 2002), and furthermore Sociological Abstracts, Digital Dissertations Proquest, the National Library of Medicine Gateway and Current Controlled Trials. Besides these databases Internet search engines were used exhaustively. The reference lists of relevant articles were investigated too.

2.2.

Study selection (see Plate 1)

Studies in primary care, outpatient, community settings and hospital settings were included. Randomized and quasirandomized controlled trials, controlled before and after studies, observational studies and cohort studies were appropriate for inclusion. Two researchers (E.V. and J.W.) independently selected articles for review based on abstracts.

379

Full articles were retrieved for further assessment if the information given suggested that the study: 1. included patients with type 2 diabetes mellitus, 2. assessed adherence to medical treatment, not to exercise nor to diet, 3. measured an outcome of an intervention intended to enhance adherence, 4. aimed at patients as well as health care providers, 5. used a design as described in the inclusion criteria for study design. For the purpose of this study, adherence was defined in a broader way than WHO that considers adherence as the extent to which a person’s behaviour corresponds with agreed recommendations from a health care provider [29]. Also articles mentioning compliance, concordance or related aspects in title or abstract were included. For the purpose of this analysis the included papers were re-examined (Plate 1).

2.3.

Data collection, quality assessment and analysis

Two teams of reviewers (E.V. and J.W., P.V.R. and Y.B.) independently assessed all trials identified for inclusion. Three teams of two reviewers (H.H. and A.L. in addition to the two previous teams), assessed trial quality and extracted the data required. Researchers were not blinded about information on authors and journals. The quality of an individual trial was assessed by scoring a list of nine topics: randomisation, concealment of allocation, patient blinding,

Plate 1 – Progress of the study selection.

380

diabetes research and clinical practice 79 (2008) 377–388

blinding of administrator of treatment, blinding of outcome assessment, description of losses to follow-up/withdrawals, intention to treat analysis, similarity of groups at the start of the study and groups equally provided of care. Quality assessment was done individually by every individual researcher by scoring on these questions where answers were compared afterwards. Overall quality was graded as A (good), B (medium) or C (poor) by mutual agreement. Whenever reviewers disagreed, consensus was obtained through discussion or by a referee’s decision (PVR). The extracted data were entered in a structured Excel sheet adapted from the Cochrane Metabolic and Endocrine Disorder Group data extraction sheet. Studies with comparable interventions were grouped and the results were synthesised in a narrative way. HbA1c was considered a common outcome measure which allowed performing a meta-analysis to calculate pooled weighted mean differences (WMD). Because of clinical heterogeneity a random effects model was used. For this purpose the Cochrane review manager (RevMan) software package version 4.2 was used.

3.

Results

This paper summarizes the results of eight educational interventions aimed at improving adherence to medication. A total of 4387 references were identified of which only 74 studies met selection criteria and were assessed in full text of which 21 articles were include in the review. The selection process was done by two teams or reviewers assessing studies independently. The inter observer agreement of the first team (P.V.R. and Y.B.) expressed as a kappa was 0.526 (S.E. 0.085), that of the second team (E.V. and J.W.) was 0.827 (S.E. 0.032). The studies in this sub-analysis contain data of 772 patients. A summary of the study characteristics, methodological quality and outcome is shown in Table 1. Of the included studies six were randomized controlled trials (RCTs) (ordered alphabetically Jaber [30], Krier [31], Mease [32], Piette [33], Rachmani [34], White [35] and two studies were studies controlling before and after (CBAs) (Coast-Senior [36] and Jiang [37]).

3.1.

Methodological quality

The overall quality of the included studies was medium to low. The most frequent shortcomings were found in the concealment of allocation and the blinding procedures. Randomization was adequate in all six RCTs while concealment of allocation and blinding procedures were estimated as adequate in only one study [33]. In seven trials, groups were similar at the start of the study, in one study [34] data were missing. Intervention and control groups were equally provided of care in four studies [31,32,34,35], in one study [30] this was not the case and data were missing or unclear in three other studies [32,36,37]. Two studies did not describe losses to follow-up [34,37], six adequately described these losses. Only in four studies, it was clear that the authors performed an intention-to-treat analysis [32–35].

It is striking that not one author mentioned details about the calculation of the statistical power of the study. Moreover, not one of the studies included assessed any economical aspect of the interventions.

3.2.

Kind of interventions

The different educational intervention studies were grouped by the kind of intervention: (1) face-to-face education, (2) group education and (3) telemedicine education. (1) Face-to-face education Two studies [30,36] assessed the effect of pharmacistled interventions (pill count, Micro-Electro-Mechanical Systems (MEMS), comprehensive care, treatment adjustments or prescription refill reminders) on self-reported adherence, medication prescription refill, and metabolic parameters. The latter are indirect measurements of adherence. One paper [30] studied the impact of a pharmacist-delivered comprehensive care model on under-served urban African–Americans. Patients in the intervention group were offered diabetes education, medication counselling and evaluation, plus adjustment of their hypoglycaemic regimen. A significant improvement of HbA1c levels, from 11.5  2.9% to 9.2  2.1% ( p = 0.003), was obtained in the intervention group. Renal function parameters, fasting blood glucose, blood pressure and lipids were also outcome measures, but it remains unclear, based on the published data, whether differences were found between intervention and control groups. More hypoglycaemic episodes, reported as mild to moderate, occurred in the intervention group than the control group (17 versus 2, p = not mentioned). Health status and Quality of Life were not significantly improved in the intervention group. The second paper [36] reported the outcomes of a program of direct pharmacist involvement in initiating insulin treatment in the care of older veterans. A change from 11.1  1.6% to 8.9  1.4% ( p = 0.00004) in glycated haemoglobin was reported after 12 months in the intervention group of 23 veterans. The effect of quarterly visits of a diabetes educator was assessed versus usual care after 3, 6 and 9 months on HbA1c, different metabolic parameters, blood pressure and self-reported compliance with diet and medication [31]. A multivariate analysis using repeated measures technique showed no differences on HBA1c, on weight and adherence values using the initial value as a covariate. The comparisons over time and between groups showed no significant differences. Barriers were the small sample population (n = 39) and the poor adherence among both groups due to poor motivation and to lack of financial support to afford their medications. The effect of standard consultations was compared with a patient participating program in which patients shared therapeutic responsibilities with a follow-up of 48 months [34]. HbA1c, blood pressure, LDL and the number of cardiovascular events (total mortality, cerebrovascular mortality, non-fatal vascular events, non-fatal acute myocardial infarction, non-fatal stroke and coronary

diabetes research and clinical practice 79 (2008) 377–388

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Table 1 – Overwiew of study results Author

Subheading

Coast-Senior [36]

Aims Methods

Descriptor To determine the impact of clinical pharmacists, involved in direct patient care, on the management of patients with type 2 diabetes who require insulin Patients were referred to clinical pharmacist for management of diabetes Controlled before and after study No blinding No concealment of allocation Adequate description of losses to follow-up Groups similar at the start of the study Single centre study in an urban area in the USA

Participants

Twenty-three type 2 diabetes patients Patients recruited in primary care services Sex: male 23 Mean age: 65 years, S.D. 9.4 HbA1c: 11.1%, S.D. 1.6 Fasting blood glucose: 219 mg/dl, S.D. 45 mg/dl Random blood glucose: 236 mg/dl, S.D. 72 mg/dl Duration since diagnosis: 8.8 years, S.D. 4.2 Treatment modality: diet + oral hypoglycaemic agents + insulin: 23

Interventions

Interview Initiating insulin Adjusting insulin Follow-up by appointment or phone call

Outcomes

HbA1c Fasting blood glucose (FBG), random blood glucose

Notes Quality Jaber [30]

Aims

Methods

Participants were veterans with multiple co-morbidities (mean 4, range 2–8) and on multiple medications (mean 5, range 2–10) Medium To determine the impact of a comprehensive pharmaceutical care model (pharmacist provided care) versus standard care on treatment outcomes of type 2 diabetes urban African-Americans Randomised controlled trial Adequate randomisation No blinding of patients and administrators, unclear blinding of outcome assessment Concealment of allocation: unclear Losses-to-follow-up adequately described No intention-to-treat analysis Groups were similar at the start of the study Groups were not equally provided of care Single centre study in a city in the USA

Participants

Outpatients Thirty-nine type 2 diabetes patients (intervention 17, control 22) Sex: intervention (female 12, male 5), control (female 15, male 7) Mean age: intervention (59 years, S.D. 12), control (65 years, S.D. 12) Ethnicity: intervention and control groups: 100% African-American Mean weight: intervention (93 kg, S.D. 22), control (88 kg, S.D. 19) BMI: intervention (34, S.D. 7), control (33, S.D. 7) BMI > 27: intervention (13), control (18) Systolic blood pressure: intervention (140 mmHg, S.D. 20), control (143, S.D. 23) Diastolic blood pressure: intervention (82, S.D. 10), control (88, S.D. 9) Hypertension: intervention (14), control (17) Lipid abnormalities: intervention (10), control (11) HbA1c: intervention (11.5%, S.D. 2.9), control (12.2%, S.D. 3.5) Fasting blood glucose: intervention (11.1 mmol/l, S.D. 4), control (12.7 mmol/l, S.D. 4.7)

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Table 1 (Continued ) Author Subheading

Descriptor Duration since diagnosis: intervention (6.8 years, S.D. 6.5), control (6.2 years, S.D. 4.8) Treatment modality: diet + oral hypoglycaemic agents: intervention (17), control (22) Exclusion criteria: type 1 diabetes, renal dysfunction, history of non-attendance

Interventions

Evaluation and adjustment of doses Education regarding diabetes and its complications Training on recognition of hypoglycaemia and hyperglycaemia Instructions on diet and exercise Training in self-monitoring of blood glucose Treatment was titrated to targets

Outcomes

Blood glucose control Self-recorded adherence Self-monitoring blood glucose logs

Jiang [37]

Notes

Self-monitoring mentioned, but not specified and no data were presented

Quality

Medium

Aims

To assess diabetes self-care after a five-section diabetes education program including basic knowledge, dietary control, blood glucose monitoring, management of hypoglycaemia, medication compliance, foot care and exercise Controlled before and after study

Methods

Data are missing on patient, administrator of treatment, and outcome assessment blinding Concealment of allocation: not used Description of losses to follow-up: missing No intention to treat analysis Similarity of groups at the start of the study: not mentioned Groups equally provided of care: data missing Multicentre study in urban areas in Taiwan. Participants

Two hundred seventeen type 2 diabetes patients in an outpatient setting Inclusion criteria: aged between 35 and 70 years old, able to read, HbA1c level 8.0% and with stable metabolic control Sex: intervention (female 61, male 69), control (female 49, male 38) Age: intervention (52.3  6.7), control (52.9  7.4) Body mass index: intervention (25.2  3.5), control (25.6  3.2) Duration of disease since diagnosis: intervention (8.0 years  8.0), control 6.7 years  5.3) Treatment: diet and oral hypoglycaemic agents: intervention 121, control 87

Interventions Outcomes

A total of 121 attended four to five sections and were called the intervention group, the 87 who only received the basic section were called the control group Fasting plasma glucose HbA1c Total cholesterol Triglycerides Systolic and diastolic blood pressure Body weight Waist–hip ratio

Notes

Krier [31]

Quality

Poor

Aims Methods

To evaluate the effect of quarterly visits of a diabetes educator Randomised controlled trial Randomisation adequate Concealment of allocation: unclear Patients are blinded, but not the administrator of treatment, Blinding of outcome assessment: data missing Losses to follow-up described Intention-to-treat analysis: unclear Groups were similar at the start of the study

diabetes research and clinical practice 79 (2008) 377–388

Table 1 (Continued ) Author Subheading

383

Descriptor Groups were equally provided of care Single centre study in a city in the USA

Participants

Thirty-nine type 2 diabetes patients Twenty-one people were allocated to the intervention group and 18 to the control group Sex: intervention (female 9, male 5), control (female 10, male 4) Age: intervention (54.2  S.D. 5.6), control (56.2  S.D. 9) Ethnicity: intervention (six Afro-Americans), control (seven Afro-Americans) Smoking: intervention (3), control (3) Weight: intervention (97.4 kg  23.9), control (93.8  19.4) Locus of control: intervention (4.5  1), control (4.0  1.1) Knowledge test: intervention (11.3  3.8), control (14.2  3.6) HbA1c: intervention (9.6%  1.9), control (10.3%  2.3)

Interventions

Treatment modality: oral hypoglycaemic agents (intervention 8, control 7), insulin (intervention 5, control 5), combination (intervention 1, control 2) Quarterly visits of a diabetes educator versus usual care

Outcomes

HbA1c, four-point Lickert scale on compliance with diet and medication

Notes

Mease [32]

Quality

Medium

Aims Methods

To determine whether telemedicine can improve self-care for type 2 diabetes Randomised controlled trial Randomisation: adequate Blinding of patients, administrators or outcome assessors: unclear Concealment of allocation: unclear Adequate description of losses to follow-up Intention-to-treat analysis Groups were similar at the start of the study and were equally provided of care Single centre study in USA

Participants Interventions Outcomes

Twenty-eight type 2 diabetes patients with HbA1c > 8.0% recruited in primary care services Education classes and weekly telemedicine ‘visits’ versus education only HbA1c Weight

Notes Quality Piette [33]

Aims

Methods

Data on adherence are not available, although the intervention included ‘reinforcement of medication compliance’ Medium To evaluate automated telephone disease management with telephone nurse follow-up as a strategy for improving diabetes treatment processes and outcomes Randomised controlled trial Randomisation and concealment of allocation: adequate Blinding of patients and administrators: adequate Blinding of outcome assessment: adequate Description of losses to follow-up and intention-to-treat analysis Groups were similar at the start of the study No information on control group care

Participants

Type 2 diabetes patients recruited in an outpatient setting in a mixed rural and urban area Participants: intervention (132), control (140) Sex: intervention (male 126), control (male 138) Mean age: intervention (60 years, S.D. 10), control (61 years, S.D. 10) Ethnicity: intervention (black 32, hispanic 18, other 11), control (black 17, hispanic 16, other 15) BMI: intervention (31, S.D. 7), control (31, S.D. 6) HbA1c: intervention (8.2%, S.D. 1.7), control (8.1, S.D. 1.7) Serum glucose: intervention (188 mg/dl, S.D. 94), control (168 mg/dl, S.D. 68)

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Table 1 (Continued ) Author Subheading

Descriptor All complications: intervention (1), control (0.7) Vascular symptoms: intervention (0.7, S.D. 0.8), control (0.6, S.D. 0.8) Treatment modality: insulin: intervention (39), control (31)

Interventions

Telephone nurse follow-up versus usual care

Outcomes

All diabetes related symptoms Hypo- and hyperglycaemic symptoms Vascular symptoms HbA1c Serum glucose Self-monitoring frequency Foot inspection Weight monitoring Podiatry visits Ophthalmology visits Diabetic clinic visits Cholesterol tests

Notes

Quality Rachmani [34]

Aims Methods

Patients were veterans aged younger than 75, with a life expectancy of more than 12 months having a touch tone telephone a home. Newly diagnosed type 2 diabetes were not included Medium To examine whether sharing therapeutic responsibility with patients will improve outcome Randomised controlled trial Randomisation adequate Concealment of allocation: unclear Blinding of patients or administrators of treatment: data missing Blinding of outcome assessors: unclear Losses to follow-up: data missing Intention-to-treat analysis Groups were similar at the start of the study and were equally provided of care Single centre study in Israel It is not clear whether patients were recruited in rural or urban areas

Participants

One hundred forty-two type 2 diabetes patients: intervention (71), control (70) Sex: intervention (female 35, male 36), control (female 37, male: 33) Mean age: intervention (57.4 years), control (56.8 years) BMI: intervention (28.4), control (28.7) Systolic blood pressure: intervention (162 mmHg, S.D. 7.3), control (160 mmHg, S.D. 6.9) Diastolic blood pressure: intervention (96 mmHg, S.D. 2.4), control (95 mmHg, S.D. 2.0) High density lipoproteins: (intervention 38 mg/dL, S.D. 3), control (39 mg/dL, S.D. 4) Trigycerides: intervention (236 mg/100 ml, S.D. 42), control (243 mg/100 ml, S.D. 36) Low density lipoproteins: intervention (146 mg/dL, SD 10), control (146 mg/dL, SD 9) HbA1c: intervention (9.5%, S.D. 1.6), control (9.6%, S.D. 1.9) Retinopathy: intervention (11), control (10)

Interventions Outcomes

Treatment modality: diet alone (intervention 18, control 16), diet + oral hypoglycaemic agent (intervention 43, control 46), diet + insulin (intervention 10, control 8) Involving patients in the process of their management by providing them with tools to monitor and supervise the effects of therapy in comparison to a standard consultation Total mortality Non-fatal vascular events Cerebrovascular death Non-fatal acute myocardial infarction Non-fatal stroke Coronary artery bypass surgery HbA1c, BMI Albumin/creatinine ratio

diabetes research and clinical practice 79 (2008) 377–388

Table 1 (Continued ) Author Subheading

385

Descriptor Blood pressure Retinopathy Glomerular filtration rate

Notes

White [35]

Quality

Medium

Aims Methods

To compare the effect of group management versus an advice-educational technique Randomised controlled trial Randomisation: adequate Concealment of allocation: inadequate Blinding of patient, administrator of treatment, and of outcome assessment: data missing Losses to follow-up clearly described Intention-to-treat analysis Groups were similar at the start of the study Groups were equally provided of care

Participants

Thirty-two type 2 diabetes outpatients Inclusion criteria: less than satisfactory control (FBG > 140 mg/dl), infrequent hypoglycaemic reactions (<1/mol), no history of ketoacidosis, body weight >15% above the mean value for height, no history of alcohol abuses or severe personality disorder, and no current use of glucocorticoids Sex: men only Age: intervention (62.4 years  5.5), control (60.7 years  6.4) Percentage of weight excess: intervention (36.3%  21.0), control (44.3%  21.0) Duration since diagnosis: intervention (10.2 years  12.9), control (13.6 years  9.6)

Interventions

Group management versus an advice-educational technique

Outcomes

HbA1c

Notes Quality

Poor

artery bypass surgery) were evaluated in both groups. HbA1c improved by from 9.5  1.6% before to 8.2  1.5% after the patient participation program ( p < 0.05 versus standard care group). (2) Group education Group education was compared with a usually used management technique, based on advice and education over 6 months in 32 veterans [35]. The advice-education control group format was designed to minimize subject interaction by having a nurse and a dietician give lectures on the disease and is management. The experimental management group was divided in three smaller groups of less than eight members which met separately with a clinical psychologist experienced in small group management. An endocrinologist served as a consultant on call for the psychologist during and between experimental group sessions. Subjects in the experimental group were encouraged to interact and assessed their own and their peers’ progress towards managing their diabetes by sharing ideas, advice, and support. There was a 10% decline in HbA1c levels ( p < 0.05) during the first 3 months of the study in both groups, The effect, however, did not persist until the end of the study. The effect of a five-section education program intervention over 4 months was compared with a basic course (control) by measuring of fasting blood glucose, HbA1c,

serum cholesterol, triglycerides, blood pressure and body weight [37]. The educational program covered the definition of diabetes mellitus, dietary control and meal plan, urine and blood glucose testing, action of insulin and oral hypoglycaemic agents, symptoms and treatment of hypoglycaemia and uncontrolled hyperglycaemia, foot care and exercise. Those who attended only Section 1, the basics of diabetes mellitus, were considered the control group. Those who attended four to five were designed as the experimental group. In both the experimental and the control groups, the decline in HbA1c levels was statistically significant (from 9.4  1.2% to 8.7  1.4% p < 0.001, versus from 9.3  1.4% to 9.0  1.5%, p = 0.008). In the experimental group, the decline in fasting plasma glucose, total cholesterol, systolic blood pressure, body weight and waist–hip ratio was also statistically significant. The effect on drug adherence, though assessed by a questionnaire, was not reported separately. (3) Telemedicine education The comparison of the effectiveness of education classes plus a weekly nurse telemedicine ‘home visit’ versus usual care showed a statistically significant reduction in mean HbA1c level of 14% (from 9.5 (8.1–12.6)% to 8.2 (5.7–10.2)%, p < 0.05) over a period of 3 months [32]. The mean weight reduction was limited and there were no significant changes on a Diabetes Quality of Life scale or on

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the Medical Outcome Health Survey SF-36 scale. Some metabolic parameters such as micro-albuminuria, serum creatinin and serum lipids did not improve during the study period. Physicians and case managers considered telemedicine to have a high benefit, but technological problems were a major obstacle. A nurse-led automated telephone management intervention, with weekly follow-up nurse calls about self-care, medication adherence and symptoms, showed a small but statistically significant ( p = 0.04) lowering of glycated haemoglobin for patients with an initial level of 8%(33). Patients in the intervention group also reported more frequent glucose self-monitoring and foot inspections and a 10% reduction in diabetes related symptoms. However, there was no significant lowering of glycated haemoglobin levels for the entire intervention group. Finally there were no differences between groups in the proportion of patients reporting one or more medication adherence problems.

3.3.

Quantitative synthesis

Studies assessing educational interventions ranging from offering education individually [30,31,33,36] over group education [35,37] to education on distance [32,33] were pooled statistically. Since comparable assessments on medication taking were not available in the different studies, the HbA1c was used as a common outcome measure. The weighted mean difference (WMD) of the studies evaluating the effect of education offered individually on the short (3–6 months) and medium term (9–12 months) was calculated. It was not surprising that the I2 test exceeded 70%, indicating considerable levels of heterogeneity [38] thus making statistical pooling almost unacceptable.

4.

Discussion

This subgroup analysis of a Cochrane Systematic Review could not draw clear and consistent conclusions on the effect of educational interventions aimed at improving adherence in medication taking in people living with type 2 diabetes. A slightly positive overall effect is shown, but this leaves us with the question whether a small statistical significant effect entails clinical relevant effects. Moreover, even when an effect has been shown it remains unclear which intervention or which part of a complex educational intervention contributed the most to the perceived effect. A second conclusion of this review is that there is an urgent need for high quality interventional and observational studies on the relation between education in people living with type 2 diabetes and adherence to medicine taking or even self management as a whole, assessing effectiveness and efficiency of the performed interventions. Finally, authors should clearly define adherence and should search for valid methods to measure the adherence as they define it. Though the review process was performed according to the Cochrane Metabolic and Endocrine Diseases Collaborative Review Group recommendations, there are some limitations.

First, on the one hand a comprehensive search in different electronic databases and by hand searching was performed, but on the other hand one may assume that in this area of research many studies may be unpublished. Unfortunately, funnel plots could not be calculated to assess publication bias because of the high clinical heterogeneity. Second, only eight studies could be included in this analysis. The most important reason for exclusion was the low quality of retrieved studies which main shortcomings were the unclear or missing concealment of allocation and the blinding procedures. Moreover, the lack of appropriate operational definitions of adherence contributed to a high exclusion rate. In a majority of articles, although compliance or adherence was mentioned to be the topic of research, it merely was diabetes care in general or self-care in particular that was assessed. Many authors even did not feel the need to define adherence nor did they make no clear distinction between compliance, adherence or concordance [12]. The authors’ lack of definition of adherence was the most disturbing factor in this reviewing process. At least authors could lay upon Glasgow and Anderson [25] who state that the constructs of ‘compliance’ and ‘adherence’ might be replaced by ‘collaborative goal-setting’ and ‘on-going self-management support’. Third, as a result of the lack of definition, valid measurement instruments and valid outcome measures are missing. Since HbA1c was shown in most of the included studies this outcome measure was used as a proxy for adherence. Fourth, this review was not able to explore which educational interventions or which part of complex interventions contributed most to the overall effect size. Fifth is the sample size that may limit the synthesis and its conclusions. Most of the studies included rather small numbers of participants limiting statistical procedures and hence preventing from doing comparisons between groups and subgroups. Sixth, no economic aspects were studied. This is quite surprising because, although better diabetes outcomes are aimed at by governments, managed care organizations, caregivers and by patients themselves, no economic consequences of interventions were considered. Seventh, the literature review was completed in November 2002 and trials published since then may differ in their results, although they would be unlikely to substantially change the conclusions drawn from the eight trials included in this review. An update of the review will be performed in 2008. Besides the mentioned limitations and weaknesses, a number of strengths are to be stressed. The review’s conclusions are consistent with a UK Health Technology Assessment systematic review [39] which concludes that education, as part of an intensification of treatment, produces improvement in diabetic control in type 1 diabetes, which has not consistently been shown in type 2 though. For people with type 2 diabetes, a meta-analysis assessing the role of education shows overall modest improvements in glycaemic control too [40]. The problems that were faced in the reviewing process seem to be common to reviewing adherence issues in medical care in general. Authors of different systematic reviews of adherence to treatment for blood pressure lowering medication [41], lipid lowering drugs [42] or even medication adherence as a whole for chronic health problems [11] described exactly the same problems and pitfalls. In general clear conclusions were hard to be drawn.

diabetes research and clinical practice 79 (2008) 377–388

The importance of education on improving adherence to medication has been stressed earlier [43]. The relation between adherence to medications (based on pharmacy claims) and clinical outcomes has been shown for type 2 diabetes, since a 10% decrease in adherence to metformin and statins was associated with an increase of 0.14% of HbA1c [44]. It has to be stressed that clinical outcomes are not always consistently related to the magnitude of adherence results [45]. The complexity of adherence has prevented the development of a gold standard method of measurement [46]. Direct and indirect measurements are being used, but serious obstacles remain in generating valid and reliable estimates of the extent of adherence [12]. Aiming at understanding better and improving more adherences, a focus on reliability and validity of adherence measurement is urgently needed [47]. Moreover, it is challenging to decide which outcomes of educational interventions should be considered. Adherence to treatment recommendations is to be found in physical activity, eating, medication taking, monitoring of blood glucose, problem solving as for sick days, reducing risks for diabetes complications and psychosocial adaptation [48]. Further research into this area is desperately needed. It is striking that in such an ‘epidemic disease’ with a high human and financial burden so little high quality research on improving adherence has been executed. Though everybody claims that education is an essential part of the management of diabetes, the effectiveness of educational interventions on adherence and the relation between adherence and clinical outcomes still need clarification. Also, the efficiency of different educational interventions such as group sessions, education on distance and the use of new information technology need to be studied more profoundly, not omitting economic assessments [21,49,50].

5.

Conclusions

The question whether educational interventions aiming at improving adherence to medication in people living with type 2 diabetes are effective remains unanswered. In spite of a high number of abstracts fitting the search strategy only eight studies could be included in this subgroup analysis of a systematic review. Though the term ‘adherence’ is often mentioned in titles or abstracts, adherence itself is not the subject of the research presented. It is important though to state that this review did not show evidence that educational interventions may be ineffective or even harmful. Finally, this review process point at how trustworthy research in the future should be conducted.

Conflicts of interests None.

Acknowledgement The research project was made possible by an unconditional grant of Primary Care Diabetes Europe ivzw/inpo.

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