Consideration of Potential Risks / Side Effects

This criterion is assessed in two steps:

1. Are potentially false incentives captured by the indicator? if so:
   
2. Will such false incentives be balanced out through appropriate measures, such as for example the use of parallel indicators (antagonists)?

Examples of quality indicators with false incentives make the understanding of this criterion easier: Quality indicator “avoidance of perforations in acute appendicitis”. The use of this quality indicator could create an incentive to make the indication for an appendectomy too broad to avoid perforations at all costs.

The risk of such a false incentive can be controlled by using a parallel indicator “confirmation of the suspected diagnosis, acute appendicitis, by histological findings”. If a parallel indicator is necessary, both indicators should be used together or not at all.

This criterion does not evaluate whether in principle the use of inappropriate (e.g. not sufficiently risk-adjusted) indicators in the context of public reporting can give false incentives (e.g. for risk selection).

Potential false incentives can possibly also be controlled by referring to the risks in the description of the indicator (rationale) or in an interpretation aid or by using upper and lower reference ranges for the quality indicator of concern.

Definition
Known (or suspected) risks or side effects from the application of the quality indicator to health care processes or outcomes are described, and if necessary considered.

Core Statement
The following statement is assessed: “There are no risks known or the known or suspected risks are considered, if necessary, through the use of the indicator.”

Information Base for the Assessment
For the assessment of the core statement, as much relevant information as possible should be compiled. Sources of information can for example be data from the quality assurance activities (e.g. performance measurement by BQS), in particular from the Structured Dialogue* and feedbacks from the hospitals. Also, an essential source of information is the clinical judgment, which undesired consequences can occur with the pursuit of the quality goal.

Furthermore, the evaluators can contribute also from their areas of expertise (e.g. quality circles, self-help organizations, scientific societies, pay-for-performance).

Assessment Process
After all evaluators have acknowledged and understood the information base, they assess the core statement.

A detailed process description can be found in Appendix 1.

Assessment Stages
1 = does not apply
2 = rather does not apply
3 = rather applies
4 = applies
Abstention

Comment
The core statement was formulated in the negative (“there are no risks known …”); because: the statement applies should as in the other criteria be regarded as a positive assessment.