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Interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus

[Protocol for a Cochrane Systematic Review]

Investigators:
Wens J
Van Royen P
Hearnshaw H

Background
Type 2 diabetes mellitus is one of the most common chronic diseases. The number of people living with it is continuously increasing worldwide.

Once diabetes has been diagnosed, patients are confronted with the need for life-style adaptation. A treatment with oral hypoglycaemic agents or insulin is often unavoidable.

Patient compliance or adherence to treatment has been acknowledged, irrespective the type of pathology, to be a major problem in health care, involving consumers and health care providers equally. Not one in two patients adheres to treatment to health care recommendations as proposed. Medical non-compliance imposes a considerable financial burden upon modern health care systems.

There are no satisfactory data in the literature on the effects of adherence-enhancing interventions on diabetes-related morbidity and mortality, and on the obstacles and constraints patients experience. It has not been assessed either what the most effective strategies have in common. Therefore a systematic review is designed to determine the effects of interventions targeted at type 2 diabetes patients to improve their adherence to advice on medical treatment (aimed at metabolic, blood pressure and blood lipids control) and appointment keeping.

Methods
Using electronic search strategies in all relevant databases from 1966 to 2002, to identify relevant trials. Inclusion criteria were people living with type 2 diabetes, the assessment of adherence to medical treatment (nor to exercise, nor to diet) and the measurement of an outcome of an intervention enhancing adherence. RCTs fulfilling these criteria are eligible for this review. Quasi-randomised and controlled clinical trials will be included but will be analysed separately. Patient-oriented outcome measures such as general or diabetes-related mortality and morbidity, indicators of adherence, indicators of quality of life and wellbeing, adverse effects of interventions, obstacles to adherence as well as costs will be considered.

After inclusion the methodological quality of all included studies will be assessed independently by two reviewers by means of a score list. Using structured forms again two reviewers will independently extract data (the quality criteria, participant details, intervention details, outcome measures, baseline and post-intervention results, and main conclusions). Inter-observer variations are to be calculated and expressed as a kappa. The authors will undertake a descriptive review of all included studies. Data will be summarised statistically if they are available, of sufficient quality and sufficiently homogenous. Only the effect size of comparable interventions will be pooled. If not, qualitative synthesis will be performed. If there is a significant effect for one of the main outcome measures, subgroup analyses will be performed. At last, sensitivity analyses in order to explore the influence of different factors on the effect size, such as: excluding combined interventions and excluding studies of the lowest quality.

Progress report
The protocol was published in the Cochrane Library in March 2002. Searches and additional searches resulted in about 5000 abstracts in September 2002. Inclusion and exclusion were piloted resulting in a final inclusion form. The inclusion of articles will be finished at July 1st.
Quality assessment and data-extraction are planned afterwards. Data-entry, data-control and analyses with the RevMan software are planned in October. In January 2004 additional analyses will be performed resulting in the preparation of the conclusions.