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Table 1 Summary of recommendations from the Prevention of Falls Network Europe (ProFaNE) consensus

From: Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention

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