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OBJECTIVES: To identify clinical characteristics of elderly inpatients that predict their chance of falling (phase 1) and to use these characteristics to derive a risk assessment tool and to evaluate its power in predicting falls (phases 2 and 3). DESIGN: Phase 1: a prospective case-control study. Phases 2 and 3: prospective evaluations of the derived risk assessment tool in predicting falls in two cohorts. SETTING: Elderly care units of St Thomas's Hospital (phase 1 and 2) and Kent and Canterbury Hospital (phase 3). SUBJECTS: Elderly hospital inpatients (aged > or = 65 years): 116 cases and 116 controls in phase 1,217 patients in phase 2, and 331 in phase 3. MAIN OUTCOME MEASURES: 21 separate clinical characteristics were assessed in phase 1, including the abbreviated mental test score, modified Barthel index, a transfer and mobility score obtained by combining the transfer and mobility sections of the Barthel index, and several nursing judgements. RESULTS: In phase 1 five factors were independently associated with a higher risk of falls: fall as a presenting complaint (odds ratio 4.64 (95% confidence interval 2.59 to 8.33); a transfer and mobility score of 3 or 4 (2.10 (1.22 to 3.61)); and primary nurses' judgment that a patient was agitated (20.9 (9.62 to 45.62)), needed frequent toileting (2.48 (1.08 to 5.70)), and was visually impaired (3.56 (1.26 to 10.05)). A risk assessment score (range 0-5) was derived by scoring one point for each of these five factors. In phases 2 and 3 a risk assessment score > 2 was used to define high risk: the sensitivity and specificity of the score to predict falls during the following week was 93% and 88% respectively in phase 2 and 92% and 68% respectively in phase 3. CONCLUSION: This simple risk assessment tool predicted with clinically useful sensitivity and specificity a high percentage of falls among elderly hospital inpatients.