[The Economic Evaluation of the GLICEMIA 2.0 Study as an Example of a Complex Intervention]. / Die gesundheitsökonomische Evaluation der GLICEMIA 2.0-Studie als Beispiel für eine komplexe Intervention.

BACKGROUND: A piggyback approach was used to evaluate the cost-effectiveness of the prevention program delivered at the point of care pharmacy in the GLICEMIA 2.0 study that sought to guide participants in the intervention group to improved glycemic control in type 2 diabetes with sustained incentivization of lifestyle changes, therapeutic compliance, and adherence. The control group received passive medication management and monitoring. METHODS: Primary endpoint of the GLICEMIA 2.0 study was the stabilization of HbA1c values. For health economic evaluation, incremental differences in output changes were examined, defined as the difference in the distribution of the HbA1c values between both groups over time. Direct program costs and anticipated indirect costs of service utilization were used as cost parameters. A net monetary benefit approach was used to validate cost-effectiveness thresholds via the formation of ICER values. RESULTS: The intervention group had significantly higher reductions in HbA1c-values. Risk stratification of initial HbA1c showed (short-term) cost effectiveness for initially higher HbA1c values. Due to the limited study period, no long-term differences in medical resource utilization could be assessed. CONCLUSION: The GLICEMIA program indicates considerable effectiveness potentials, especially for high-risk patients. The study design seems to have assisted the intervention group's adherence in contrast to the control group. Detailed impacts within the complex intervention could not be validated due to restrictions of the study design as a complex intervention. Overall, statements about effect sustainability and further utilization rates progressions are limited due to a lack of follow-up.

[Quality of Life and Satisfaction During the Diabetes Prevention Program GLICEMIA: a Cluster-Randomized, Controlled Trial]. / Lebensqualität und Zufriedenheit während der Teilnahme am Diabetes-Präventionsprogramm GLICEMIA: eine cluster-randomisierte, kontrollierte Studie.

OBJECTIVES: We aimed to assess the health-related quality of life as well as participant satisfaction during the pharmacy-based diabetes prevention program GLICEMIA. METHODS: GLICEMIA comprises 3 individual counseling sessions and 5 group-based lectures addressing a lifestyle modification. In a cluster-randomized controlled trial, GLICEMIA was compared with reduced standard information in the control group. After 12 months, the groups were compared regarding the diabetes risk score FINDRISC, health-related quality of life with the 12-item Short Form health survey (SF-12) and participant satisfaction. RESULTS: In total, the data of 1,087 participants were analyzed. During GLICEMIA, 38.9% reduced their FINDRISC whereas 20.9% reached this goal in the control group. Moreover, the physical quality of life improved significantly in the intervention group compared with the control group (adjusted effect size: 2.39 points, 95% CI 1.43-3.34). Participants of GLICEMIA who reduced their diabetes risk had enhanced mental and physical quality of life after one year. This was not observed in the control group. The overall benefit and satisfaction were rated very high in the intervention group. CONCLUSION: Participation in GLICEMIA results in a significant reduction of the diabetes risk according to the FINDRISC, as well as an improved physical and mental quality of life. The high satisfaction of the participants reflects the overall benefit. Nationwide implementation of the program is recommended.

Effects of the lifestyle intervention program GLICEMIA in people at risk for type 2 diabetes: a cluster-randomized controlled trial.

OBJECTIVE: The aim of this study was to assess the efficacy of a 12-month prevention program conducted in 42 community pharmacies in reducing the risk for diabetes. RESEARCH DESIGN AND METHODS: In a cluster-randomized controlled trial in 1,092 participants, mean change in the risk for diabetes (indicated by the Finnish Diabetes Risk Score [FINDRISC]) between intervention and control groups was calculated. In the intervention program GLICEMIA, three appointments with individual counseling and five educational group sessions were combined, whereas in the control group, only information about the participants' health was obtained in three assessments. RESULTS: After adjusting for cluster structure and differences in baseline characteristics, improvement in FINDRISC in the intervention group was 0.74 points (95% CI 0.42-1.04) above the control group. CONCLUSIONS: The GLICEMIA program shows the feasibility of a pharmacy-based intervention and leads to a significant modest reduction in diabetes risk score but does not reduce the rate of diabetes progression over 1 year.

Preventive counselling for public health in pharmacies in South Germany.

BACKGROUND: No overview of preventive health activities conducted by pharmacists in South Germany has been available until now. Moreover, little about the needs of the public is known with regard to pharmacy-based preventive services. OBJECTIVES: To gain an overview of the preventive health services and campaigns carried out by pharmacists in the federal state of Bavaria, and to assess the interest of the public for pharmacy-based preventive care counselling. SETTING: Pharmacies in the seven Bavarian administrative districts, South Germany. METHODS: In September 2010, all 3,470 pharmacies in Bavaria were mailed a questionnaire concerning their preventive health activities. The pharmacists were given the opportunity to complete the questionnaire either online or to mail them in. To assess the needs of pharmacy-based preventive health services in the Bavarian population, customers of 50 pharmacies were invited to fill in an anonymous self-completion questionnaire in March 2011. MAIN OUTCOME MEASURE: Relevant preventive health services which can be provided by pharmacists in order to meet the customers' needs. RESULTS: 519 of 3,470 pharmacies (15.0 %) took part in the survey. 60.5 % (n = 314) conducted at least one preventive health activity in the past and 51.6 % (n = 268) offering a disease prevention education event at least once a year. As a result of the pharmacists' survey, a ranking list of the most frequent preventive care activities was established. The projects conducted often lacked structured project schedules and evaluations. The survey assessing customer needs was completed by 1,808 customers in 49 of 50 community pharmacies. Pharmacists were identified as the preferred provider in 29 of the 31 preventive care services listed in the questionnaire. A ranking list with the top ten preventive subjects of highest interest was compiled. CONCLUSIONS: Pharmacists are active in many different prevention subjects and there is a great interest in pharmacy-based preventive care counselling in the Bavarian population. Very few structured, well planned and evaluated preventive projects have been conducted in Bavarian community pharmacies. Further surveys are needed to analyse the benefit of pharmacy-based preventive care counselling for the Bavarian population.