Unlabelled: Aim. To evaluate the governmental regulation system introduced in October 2002 by investigating the prevalence of pressure ulcers (PUs) and to investigate the relationship between the change in prevalence and the structure and system within hospitals.

Methods: This retrospective cohort study used 2582 randomly sampled hospitals in Japan. Questionnaires were mailed to each type of hospital, including university hospitals, acute hospitals, acute and long-term (mixed care) hospitals, long-term care hospitals, and psychiatric hospitals. Prevalence and severity of pressure ulcers over 4 consecutive periods (1 month before the introduction of regulation, immediately after the introduction, 6 months later, and 1 year later) and related factors for the improved prevalence were assessed.

Results: The overall prevalence before the regulation was 4.26%, which decreased to 4.18% immediately after regulation, and to 3.95% and 3.64% 6 months and 1 year later, respectively. The overall proportion of Stage III and IV pressure ulcers acquired after admission was 23.9% and 10.9%, respectively, before introduction of regulation, and gradually decreased to 18.8% and 8.1%, respectively, after 1 year. The related factor for improved PU prevalence was sufficient distribution of alternating air mattresses (odds ratio = 2.259, 95% CI; 1.091-4.679, P = 0.028).

Conclusion: The governmental regulation had a clinically important effect on the decrease in PU prevalence. The regulation focused on the structure of hospitals was confirmed to influence the outcome of hospital care quality.

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