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Methods in Medicines evaluation & Outcomes research (M2O)


The Methods in Medicines evaluation & Outcomes research (M2O) program generally deals with drug treatment and other medical interventions in practice. Advanced epidemiological and health-economic methods are used with the specific aim to support decision making and optimal use of such medical interventions.

Programme Leaders   Mission and Description of the Programme  

How can we increase quality of life for all citizens, especially the older people, and reduce costs of an ageing society? The ultimate mission of M2O is to contribute to the science of healthy ageing through development, validation and application of methodologies for assessments of (pharmacotherapeutic) medical interventions and their implementation. In particular, clinical ly relevant Big Data from patient cohorts are used to develop and apply advanced methods to further expand scientific knowledge on determinants and effects of (pharmacotherapeutic) interventions in practice, and to support decision making and their optimal use. Scientific research is conducted applying both randomized trial study designs and observational epidemiological study designs, health technology assessments (HTAs), and methods to support high-quality patient treatment and policy decisions concerning (pharmacotherapeutic) medical interventions.

Description of the Programme
M2O is steered by two units from the Department of Pharmacy and two units from the UMCG, i.e. PharmacoEpidemiology & PharmacoEconomics (PE2, Groningen Research Institute of Pharmacy [GRIP]), Pharmacotherapy & Pharmaceutical Care (PPC, GRIP), Clinical Pharmacology and Rational Drug Use of the Department of Clinical Pharmacy & Pharmacology ( UMCG) and the Health Technology Assessment (HTA) unit of the Department of Epidemiology (UMCG).

Main research fields are: Quality of Drug Utilization, Clinical & Genetic Pharmacoepidemiology, Pharmacotherapy & Pharmacovigilance and Health Economics & Health Outcomes Research. Within these fields, the following research themes and projects are currently distinguished and represent the focus of the program:

  1. Optimizing the quality and efficiency of (pharmacotherapeutical) interventions.
    a. Assessments of drug utilization and quality of pharmacotherapy with a focus on multi-morbidities and multifactorial diseases (in particular diabetes, cardiovascular, psychiatric and nephrological diseases), and on monitoring and management of medication safety and medication errors in vulnerable patient groups (e.g. in elderly, patients with multi-morbidity, children and newborns, pregnant women and patients with psychiatric disorders);
    b. Conduct of personalized and targeted (pharmaceutical) medical intervention studies, notably in abovementioned vulnerable patient groups;
    c. Conduct of trials and observational studies to evaluate new (educational) interventions and policies to further enhance the quality of treatment;
    d. Apply health economics, especially performing cost-effectiveness analyses of interventions.
  2. Development, validation and application of advanced methodologies to generate scientific knowledge on determinants and effects of interventions in routine medical practice as well as to support policy making.
    a. Research into causal methods using observational individual and aggregated population- and regional-level patient information by use of Big Data stored in large databases, such as IADB, Eurocat, GIANTT, LifeLines, Lareb, DIAMETRIC, PHAMOUS, VIPP, GPRD and RNG;
    b. Development of bias-adjustment techniques in meta-analyses and mixed-treatment comparisons;
    c. Development of health technology assessment (HTA) models combining data from various sources, as mentioned under point 2.a and 2.b.;
    d. Research into methods supporting patient-reported outcome measures (PROM).

As part of the M2O research program, large scale medical and pharmaceutical databases are maintained and research takes advantage of the presence of the unique stable population of the Northern provinces of the Netherlands. By joining forces, major advancements have been made in the organization and validation of existing ongoing data collections (for example, IADB, VIPP and GIANTT) as well as through combining ideas and methods from the different multidisciplinary units (PE2, PPC, Drug Utilization, and HTA). We aim to stabilize and further increase the funding for these “Big Data laboratories” and strengthen our grant positions by joint research projects. The ageing of the population and the vast and accruing possibilities for pharmacotherapy – both curative and preventive – pose challenges that cover a broad range of research sectors, even beyond pharmaceutical and medical sciences. This requires collaborations even beyond the M2O or SHARE internal structures, for example, with fields of sciences as demographics, economics, psychology and statistics which is reflected in several ongoing projects.

Relevance to Healthy Ageing  

The M2O program focuses on prevention and treatment of disease, considering effects on quality of life and costs, clinical management of drug therapy and drug safety, all explicitly as part of healthy ageing. Emphasis is on pharmacotherapy and (preventive) treatments through all stages of life from reproduction phase through phases of multi-factorial diseases and old age as well as primary prevention of diseases (screening and vaccines). One example of the focus on healthy ageing concerns the topic of vaccination throughout life course from childhood to adolescence and from maternity to old age.

Two examples of M2O’s research projects   

Pharmacogenetics and response to treatment of oral diabetes drugs
Researcher: Doti Martono

Type 2 diabetes mellitus is a major health burden with 350 million people suffering worldwide. Treatment with medication is usually required but response to diabetes treatment differs between individuals. Several factors may cause therapeutic failure, including clinical and genetic factors.
In this project, we focus on response to initial drug treatment in patients with type 2 diabetes. We will first explore which patient characteristics define the initial treatment choice and examine the clinical predictors of response to treatment in a large cohort of diabetes patients (GIANTT cohort). Next, the additional effect of gene variations between individuals on treatment response will be studied. Better understanding of the factors determining treatment outcomes may serve as a guide to make better drug choices at the start of diabetes treatment.


The willingness of elderly to be vaccinated
Researcher: Renske Eilers

In the coming years, the number of elderly will increase in the Netherlands.  As a result of natural deterioration of the immune system, this population is more susceptible than younger persons to infectious diseases. Vaccinating persons of fifty years or older is one possible strategy to promote healthy aging. Apart from possible benefits to these individuals, vaccination may yield social benefits, such as lower overall healthcare costs. Although acceptance is crucial, we don’t know much about the willingness of elderly to be vaccinated with vaccines currently available.
The aim of this project is to construct a model to estimate the willingness of elderly to accept vaccination against different infectious diseases. Qualitative research and a literature review will be used to design choice experiments. In such experiments, persons from the age of fifty will be presented with choices between vaccines with different characteristics. This way we can determine the relative importance of these characteristics.

Principal Investigators / nr of PhD students