Table 1.
Summary of recommendations from the Prevention of Falls Network Europe (ProFaNE) consensus
Recommendation 1: Domains and considerations |
1. Domains should include falls, fall injury, physical activity, psychological consequences, and generic health-related quality of life (HRQoL) |
2. The selection of measures should focus on community-dwelling populations |
3. The common data set should consider cost and ease of application in a wide range of countries |
4. The recommendations should include details on methods of measurement |
5. The process (of developing a common data set) should be founded on a review of measures currently reported in clinical trials of fall and fall injury prevention interventions |
Recommendation 2: Falls |
1. A fall should be defined as ‘an unexpected event in which the participants come to rest on the ground, floor, or lower level’ |
2. Ascertainment must consider the lay perspective of falls. Participants should be asked, ‘In the past month, have you had any fall including a slip or trip in which you lost your balance and landed on the floor or ground or lower level?’ |
3. Falls should be recorded using prospective daily recording and a notification system with a minimum of monthly reporting. Telephone or face-to-face interview should be used to rectify missing data and to ascertain further details of falls and injuries |
4. Fall data should be summarised as number of falls, number of fallers/non-fallers/frequent fallers, fall rate per person year, and time to first fall (as a safety measure) |
5. Primary analysis of fall data should not be adjusted for physical activity, and reporting should include the absolute risk difference between groups |
Recommendation 3: Injuries |
1. The recommended common data set measure is the number of radiologically confirmed peripheral fracture events per person year. This should include the limbs and limb girdles |
2. Injuries should be classified according to the International Classification of Diseases, 10th revision, classification system |
3. Data should be collected prospectively, alongside and using the same methods as for fall reporting |
4. Injury data should be summarised as peripheral fracture rate per person-year of follow-up, number of peripheral fractures, number of people sustaining peripheral fractures, and number of people sustaining multiple events |
5. Primary analysis should not be adjusted for physical activity, and reporting should include the absolute risk difference between groups |
Recommendation 4: Psychological consequences of falling |
1. Psychological consequences of falls should be conceptualised in terms of fall-related self-efficacy, defined as ‘the degree of confidence a person has in performing common activities of daily living without falling’ and measured using the modified Falls Efficacy Scale (mFES) |
2. The measure should be scored per published guidance |
Recommendation 5: HRQoL |
1. For the ProFaNE common outcome data set, the recommended measures of HRQoL are the Short Form 12 (SF-12) version 2 and European Quality of Life Instrument (EuroQoL EQ-5D) |
Recommendation 6: Physical activity measures |
1. Further research is required before a measure of physical activity can be recommended for inclusion in the common data set. |
Recommendation 7: Time points for follow-up for the ProFaNE common data set |
1. Many fall-prevention interventions require longer-term follow-up (12 months) because they have a delayed effect, taking time and compliance to evidence an effect |