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The research colleagues Hoffmann and Schink have highlighted potential limitations in outpatient healthcare research. This, in principle, is to be welcomed. Unfortunately, there are limitations to the healthcare research-based approach to patients and treatment outcomes in routine care. Nobody thought about establishing a platform prior to the introduction of a disease-specific healthcare program that would allow to generate high-quality scientific evidence for the evaluation of costs and health benefits. One of the reasons for this is that under everyday conditions it is rather difficult to get a primary care physician or a specialist interested in collecting relevant patient and treatment data for evaluation and research purposes. And it is even more difficult to collect matching data of a control group for comparison. Therefore, we used propensity score matching for our study to be able to make use of routine data of the statutory health insurer involved (1).

Due to the limited amount of data available, the approach chosen for our study has qualitative limitations with regard to the theoretical scientific requirements for data quality in healthcare research. As the insurer was not in the position to provide additional data on comorbidities or sociodemographic data for our study, only the variables “age, sex and severity of the condition (NYHA stage)“ were used for the matching. The authors are fundamentally aware of the limitations of this approach with regard to group heterogeneity (selection bias) and have discussed these in their paper. The question, however, arises to what extent we have to be prepared in the current discussion about health technology assessment (HTA)-based data and their limitations to use the available routine data as a base for early forward-looking statements. This approach may help us to further improve the quality of patient care, especially in the light of limited resources.

From their perspective, the readers may be concerned about a potential immeasurable time bias – however, such considerations would not meet the authors’ requirements. According to the available data from the statutory health insurer, no patients enrolled in the healthcare program died during the first six months. Furthermore, there is the concern regarding the “reported physician contacts“; here an evaluation method has to define a standard which can be used to integrate, for example, physician contacts as a study criterion. In this study, the criterion “diagnosis-related physician contacts“ was defined.

Any study incorporating an analysis of statutory health insurance routine data, which were primarily collected for billing purposes, has certain limitations (24). Especially with regard to the limitations in the use of HTA as well as prospective randomized controlled trails (RCTs) for the evaluation of data derived from routine care of multimorbid patients, there is a pressing need to evaluate and publish healthcare research data (5). It would be a mistake to not make use of the data collected so far and the insights derived from these on how to optimize the current healthcare situation because of methodological limitations, which can unfortunately be found in most health economic evaluations of the treatment programs for multimorbid patients established to date. Rather, the results from healthcare routine studies should stimulate healthcare decision makers to generate valid and reliable data that can be used to create highest quality scientific evidence and to take the HTA perspective into account prior to the implementation of healthcare programs.

DOI: 10.3238/arztebl.2014.0681

On behalf of the authors

Prof. Dr. med. Dipl.-Kfm. (FH) Rainer Riedel

Verena Hendricks, M.Sc.

Institut für Medizin-Ökonomie & Medizin

Versorgungsforschung Rheinische Fachhochschule Köln gGmbH

University of Applied Sciences, Köln

riedel@rfh-koeln.de

Conflict of interest statement

The data collection and analysis expenses of the Institute for Health Economics and Health-Care Research (Institut für Medizin-Ökonomie & Medizinische Versorgungsforschung) at the University of Applied Sciences, Cologne, which was entrusted with the scientific support of the CorBene Program, were reimbursed by the participating company health insurers.

The authors declare that no conflict of interest exists.

1.
Hendricks V, Schmidt S, Vogt A, et al.: Case management program for patients with chronic heart failure—effectiveness in terms of mortality, hospital admissions and costs. Dtsch Arztebl Int 2014; 111: 264–70. VOLLTEXT
2.
Stock S, Drabik A, Büscher G, et al.: German diabetes management programs improve quality of care and curb costs. Health Aff (Millwood) 2010; 29: 2197–205. CrossRef MEDLINE
3.
Miksch A, Laux G, Ose D, et al.: Is there a survival benefit within a German
primary care-based disease management program? Am J Manag Care 2010; 16: 49–54. MEDLINE
4.
Lindner R, Ahrens S, Köppel D, Heilmann T, Verheyen F: The benefit and efficiency of the disease management program for type 2 diabetes. Dtsch Arztebl Int 2011; 108: 155–62. VOLLTEXT
5.
Gartlehner G, West SL, Mansfield AJ, et al.: Clinical heterogeneity in systematic reviews and health technology assessments: synthesis of guidance documents and the literature. Int J Technol Assess Health Care 2012; 28: 36–43. CrossRef MEDLINE
1.Hendricks V, Schmidt S, Vogt A, et al.: Case management program for patients with chronic heart failure—effectiveness in terms of mortality, hospital admissions and costs. Dtsch Arztebl Int 2014; 111: 264–70. VOLLTEXT
2.Stock S, Drabik A, Büscher G, et al.: German diabetes management programs improve quality of care and curb costs. Health Aff (Millwood) 2010; 29: 2197–205. CrossRef MEDLINE
3.Miksch A, Laux G, Ose D, et al.: Is there a survival benefit within a German
primary care-based disease management program? Am J Manag Care 2010; 16: 49–54. MEDLINE
4.Lindner R, Ahrens S, Köppel D, Heilmann T, Verheyen F: The benefit and efficiency of the disease management program for type 2 diabetes. Dtsch Arztebl Int 2011; 108: 155–62. VOLLTEXT
5.Gartlehner G, West SL, Mansfield AJ, et al.: Clinical heterogeneity in systematic reviews and health technology assessments: synthesis of guidance documents and the literature. Int J Technol Assess Health Care 2012; 28: 36–43. CrossRef MEDLINE

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