OBJECTIVES: Reliable and valid judgments are necessary for regulatory authorities to merit confidence from care institutions and society and preserve authority. Moreover, limited reliability and validity of regulatory judgments increase the risk of limited improvement of the quality of health care. The goal of the study is to obtain insight in (dis) advantages of different regulatory instruments for regulation of health care. METHOD: In this study, the reliability and validity of judgments generated by a lightly structured and highly structured regulatory instrument used by the Dutch Health Care Inspectorate are compared. RESULTS: Results indicate that the lightly structured instrument causes a large variety in discussed topics in regulatory visits: indicators pointing out potential risks in care are not always part of these discussions, by which incentives to improve care remain unjustly undone. Both types of instruments show variations in the meaning of judgments, indicating validity problems. CONCLUSION: The results of our study suggest that regulation of health care requires thorough appraisal of instruments. Several requirements are identified: first, an instrument that justifies the complexity of care with an accompanying explicit set of standards is necessary. Second, commitment of inspectors to the instrument is essential. And third, training of inspectors is indispensable.
OBJECTIVES: Reliable and valid judgments are necessary for regulatory authorities to merit confidence from care institutions and society and preserve authority. Moreover, limited reliability and validity of regulatory judgments increase the risk of limited improvement of the quality of health care. The goal of the study is to obtain insight in (dis) advantages of different regulatory instruments for regulation of health care. METHOD: In this study, the reliability and validity of judgments generated by a lightly structured and highly structured regulatory instrument used by the Dutch Health Care Inspectorate are compared. RESULTS: Results indicate that the lightly structured instrument causes a large variety in discussed topics in regulatory visits: indicators pointing out potential risks in care are not always part of these discussions, by which incentives to improve care remain unjustly undone. Both types of instruments show variations in the meaning of judgments, indicating validity problems. CONCLUSION: The results of our study suggest that regulation of health care requires thorough appraisal of instruments. Several requirements are identified: first, an instrument that justifies the complexity of care with an accompanying explicit set of standards is necessary. Second, commitment of inspectors to the instrument is essential. And third, training of inspectors is indispensable.