Development of a Common Outcome Data Set for Fall Injury
Prevention Trials: The Prevention of Falls Network Europe
Sarah E. Lamb, DPhil,?wEllen C. J?rstad-Stein, MSc,?Klaus Hauer, PhD,z§and
Clemens Becker, MD,zkon behalf of the Prevention of Falls Network Europe and Outcomes
The prevention of injury associated with falls in older peo-
ple is a public health target in many countries around the
world. Although there is good evidence that interventions
such as multifactorial fall prevention and individually pre-
scribed exercise are effective in reducing falls, the effect on
serious injury rates is unclear.1,2Historically, trials have not
been adequately powered to detect injury endpoints, and
variations in case definition across trials have hindered
meta-analysis.1It is possible that fall-prevention strategies
have limited effect on falls that result in injuries or are in-
effective in populations who are at a higher risk of injury.
Further research is required to determine whether fall-pre-
vention interventions can reduce serious injuries.
Prevention of Falls Network Europe (ProFaNE) is a
collaborative project to reduce the burden of fall injury in
older people through excellence in research and promotion
mission funds the network, which links clinicians, members
of the public, and researchers worldwide. The aims are to
identify major gaps in knowledge in fall injury prevention
and to facilitate the collaboration necessary for large-scale
clinical research activity, including clinical trials, compar-
undertaken in a 4-year program. As a first step, the devel-
opment of a common set of outcome definitions and meas-
ures for future trials or meta-analysis was considered. J Am
Geriatr Soc 53:1618–1622, 2005.
Key words: accidental falls, aged, fractures, consensus
development, outcome measures
1. An international meeting of 32 experts in which agree-
ment on the key domains for outcome assessment was
2. Within each domain, systematic literature reviews were
used to identify the quality and scope of measures used
in clinical trials to date.
3. A further 2-day international meeting in which expert
consensus recommendations for outcome measures in
each domain were developed.
ecommendations were generated by international ex-
Full methodological details and results of searches are
available.3Literature searches to identify measures used in
clinical trials were an exact replication of the Cochrane
Review of Interventions to Prevent Falls in the Elderly.1
Secondary searches identified additional reports of the
measures. All measures were assessed for quality in five
areasFcase definition, reliability, validity, responsiveness,
and acceptabilityFand the results were summarized in a
series of briefing papers. A group of 42 representatives of
the academic, policy, practice, and user communities at-
tended a consensus conference in November 2003. The
group was drawn from a range of disciplines and conti-
nents, including Australasia, Europe, and North America.
The consensus building used a modified nominal group
technique4that included integrating evidence from the
briefing papers alongside expert opinion and member
checking to approve the final consensus statements. Dis-
cussions, which included the rationale for decisions, were
taped, transcribed, and summarized.
Recommendation 1: Domains and Considerations
1. Domains should include falls, fall injury, physical activ-
ity, psychological consequences, and generic health-
related quality of life (HRQoL).
2. The selection of measures should focus on community-
The work for this report was funded by the European Commission
Address correspondence to Professor Sarah (Sallie) Lamb, Warwick Emer-
gency Care and Rehabilitation, Warwick Medical School, University of
Warwick, Coventry, CV4 7AL, United Kingdom.
From the?Warwick Emergency Care and Rehabilitation, University of
Warwick, Coventry, United Kingdom;wKadoorie Critical Care Research
Center, John Radcliffe Hospital, Oxford, United Kingdom;zDepartment
of Geriatric Rehabilitation, Robert Bosch Hospital, Stuttgart, Germany;
§Research Department, Bethanien-Krankenhaus an der Universita ¨t
Heidelberg, Heidelberg, Germany; andkGeriatric Center of the
University of Ulm, Ulm, Germany.
r 2005 by the American Geriatrics Society
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 meth-
ods of measurement.
5. The process should be founded on a review of measures
currently reported in clinical trials of fall and fall injury
Rationale: The inclusion of falls and injuries is not sur-
prising. The psychological domain was included because it
is an independent risk factor for poor outcome after fall-
prevention intervention5and is thus a legitimate and im-
portant target for interventions. Likewise, physical activity
is an important outcome, enabling autonomy and inde-
pendence. The group felt that the desirable profile of an
intervention is one that improves activity and confidence
while reducing falling. HRQoL is likely to capture unan-
ticipated effects of an intervention in terms of general,
emotional, and social health.6
The decision to focus on community-dwelling popula-
tions was a practical consideration because time and fund-
ing was limited. Future revisions of the consensus statement
will consider whether the recommendations are generaliz-
able to institutional settings.
The consensus was that the size of the common out-
come data set should be carefully balanced to minimize the
burdenon respondents andmaximize follow-up.7Although
smaller trials and those conducted in more affluent coun-
tries might afford a greater number of and more-intensive
measurement protocols, the common data set proposed
should be achievable in most contexts. The common data
set is intended to promote consistency in collection and
reporting of essential elements. It is not the intention to
suggest that investigators should be limited in using addi-
tional outcomes if indicated.
Domains rejected from the outcome data set included
cognitive status and depression. Although these provide
descriptive information and might be important baseline
covariates, neither was considered a primary target of fall-
prevention interventions. It was considered that judicious
selection of HRQoL outcomes could detect general mental
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
3. Falls should be recorded using prospective daily record-
ing and a notification system with a minimum of month-
ly 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 summarized as number of falls,
number of fallers/nonfallers/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 ab-
solute risk difference between groups.
Rationale: The systematic review3revealed large varia-
tion in the definition of fall events and reinforced the need
for standardization. The group felt that this variation was
likely to be a majorfactor explaining differences in fallrates
in studies conducted in similar populations.8A simple def-
inition was deemed to be more appropriate for a common
data set than definitions that specified medical events or
situations (such as the Kellogg definition9). The recommen-
dation does not preclude investigators from reporting,
in addition, falls classified into subgroups based on etiology
The literature on difficulties of collecting fall data was
considered. Recall can be problematic.10,11Although older
people are able to recall falls in a general way over a 1-year
period, recall for events within the previous 3 to 6 months is
less accurate. Prospective registration systems, in which
a daily record of falls is made, are used widely. Monthly
telephone follow-up has proven to be effective,8,12–15the
purpose being to confirm that the event being reported fits
the definition of a fall and to document resultant injuries.
Figure 1. Flow chart of the consensus process.
PROFANE COMMON OUTCOME DATA SET
1619JAGSSEPTEMBER 2005–VOL. 53, NO. 9
Some researchers advocate weekly telephone follow-
up,10,11others monthly,13but the difference between these
is not known. Motion devices were not considered to be
The consensus panel recognized variations in the in-
terpretation and meaning of falls across cultures. For ex-
ample, there is no literal translation for the term ‘‘fall’’ in
German. Also, older people and health professionals differ
in their perspectives of falls.16The lay definition proposed
covers a range of possible interpretations of fall events.
Data summary and reporting problems apply equally to fall
and injury events. Data summaries should be simple. Meth-
ods of analysis should account for multiple events within
individuals and require a thorough understanding of the
distribution of events.
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
2. Injuries should be classified according to the Interna-
tional Classification of Diseases, 10th Revision, classi-
3. Data should be collected prospectively, alongside and
using the same methods as for fall reporting.
4. Injury data should be summarized as peripheral fracture
rate per person-year of follow-up, number of peripheral
fractures, number of people sustaining peripheral frac-
tures, and number of people sustaining multiple events.
5. Primary analysis should not be adjusted for physical ac-
tivity, and reporting should include the absolute risk
difference between groups.
Rationale: Despite pharmaceutical and medical advanc-
es, peripheral fractures remain a major threat to independ-
ence for olderpeople.Peripheralfracture rate,verified using
radiological evidence, was considered to be the only robust
and feasible measure of injury that could be recommended.
Peripheral fractures account for the majority of cost, mor-
bidity, andmortality generated by fall-related injury.17Soft-
tissue and organ injuries have been defined and classified in
a range of ways, none of which were considered satisfac-
tory. Injury severity scored according to resource use (such
as number of injuries requiring attendance at the emergency
department) was rejected because variability in treatment
protocols and service configurations within and between
countries render this liable to inaccuracy. Drawing a dis-
tinction between major and minor soft-tissue injuries has
historically been problematic, and there is no widely ac-
cepted approach. Accurate soft-tissue injury classification
would require rapid assessment of the injuryFin terms of
self-report or independent examination. Self-report was
considered to be susceptible to inaccuracy, and in many
situations it would not be feasible for an examination to
be scheduled within the short recovery period of soft-tissue
injuries. Vertebral fractures are not generally a conse-
quence of falling and were hence excluded from the
Recommendation 4: Psychological Consequences of
1. Psychological consequences of falls should be concep-
tualized 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
2. The measure should be scored per published guidance.18
Rationale: The group agreed that an increasing body of
evidence suggests that many older people experience psy-
chological difficulties related to falls.19The systematic re-
view highlighted a lack of consistency in defining the
psychological consequences of falling.19Constructs de-
scribed commonly in the literature included self-efficacy,
fear of falling, and activity limitation. The consensus was
that self-efficacy was the most appropriate construct, be-
cause it is developed from a strong theoretical base in social
The mFES was selected as the measure of self-efficacy
for the common outcome data set because it has good test–
retest reliability18and adequate levels of internal consist-
ency18and having been used in several trials, has proven
feasible, acceptable, and practical.19The measure has su-
perior responsiveness in frailer populations to the Activi-
ties-specific Balance and Confidence Scale and is unlikely to
suffer the ceiling effects apparent in the Falls Efficacy
Scale.21Alternative methods of measurement, such as the
Survey of Activities and Fear of Falling in the Elderly,22
offer the potential to link fear of falling and activity re-
striction more closely but are too long and burdensome to
consider as outcomes for clinical trials. The mFES18should
be adopted as the standard against which new measures are
developed and tested. It was recognized that the four items
of instrumental activities of daily living in the mFES may
require some modification. The ProFaNE group is under-
taking further development work.
Recommendation 5: HRQoL
1. For the ProFaNE common outcome data set, the recom-
mended measures of HRQoL are the Short Form 12
(SF12) version 2 and European Quality of Life Instru-
ment (EuroQoL EQ-5D).
Rationale: Fivemeasureswere identifiedas havingbeen
used in fall-prevention trials previously. These were the
Quality of Life Questionnaire of the European Foundation
for Osteoporosis, the Short Form 36 (SF36), the Notting-
ham Health Profile, the Sickness Impact Profile, and the
SF12 (reviewed in23). Although not used in fall-prevention
trials previously, the group considered that the EuroQoL
EQ-5D24should also be taken into account. The Quality of
Life Questionnaire of the European Foundation for Os-
teoporosis was rejected because it is a disease-specific in-
Nottingham Health Profile, and the Sickness Impact Pro-
file were rejected because, despite good psychometric prop-
erties, they place a substantial burden on respondents. The
EuroQoL EQ-5D is simple and responsive to large changes
in health and has been translated into several European
The SF36, the
LAMB ET AL.
SEPTEMBER 2005–VOL. 53, NO. 9 JAGS
languages. It has been used widely in older populations.23
Health utility indices have been developed allowing easy
linkage to economic analysis.25There is some evidence of
ceiling effects at item level, and the instrument may be in-
sensitive to subtle changes in healthy populations,23but in
frail populations, the EuroQoL EQ-5D demonstrates better
sensitivity than the SF36.26The SF12 version 2 is a short-
ened version of the SF36. It has been translated widely and
is practical. A health utility index is available for use along-
side the SF12 in health economic analysis,27but it has a
shorter track record than the EuroQoL EQ-5D utility. The
SF12 has the potential to yield a broader assessment of
mental and physical health than the EuroQoL EQ-5D in a
response format that may be more appropriate in older
people.28A head-to-head comparison is needed to substan-
tiate these claims. An advantage of the EuroQoL EQ-5D is
that, unlike the SF12, there is no license fee.
Recommendation 6: Physical Activity Measures
1. Further research is required before a measure of physical
activity can be recommended for inclusion in the com-
mon data set.
Rationale: Systematic reviewing revealed seven meas-
ures that had previously been used in clinical trials.3The
group considered that all these measures were too long and
complex for routine administration. The experts did not
identify any other measures as being potentially relevant.
The Seven-Day Recall Questionnaire was considered the
best basis for future development but will require modifi-
cation for frailer populations.
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 ef-
fect, taking time and compliance to evidence an effect.
Recommendation 8: Methodological Questions that
Need to Be Addressed
1. Comparison of the performance of various HRQoL
measures in clinical and cost-effectiveness analyses.
2. Developmentandvalidationof a simple physicalactivity
3. Identification of cognitive ability required to ensure ad-
equate completion of the various instruments.
4. Assessment of the practicality, reliability, and validity of
proxy and postal response.
5. Consensus on the minimally clinically important differ-
ProFaNE is an extensive, international network of re-
searchers who have collaborated to develop a common
outcome data set for use in future trials and to identify
important methodological questions. Further research is
required to determine whether fall-prevention interventions
can reduce serious injuries and to identify factors important
to the successful implementation of programs. High-quality
evidence could be gained from large-scale trials. A trial with
serious injury as an end-point would likely require multiple
sites (possibly multinational). Prospective pooling of indi-
vidual patient data or trial results in meta-analysis would
assist in yielding important evidence. All approaches would
benefit from common outcomes.
International consensuscan begainedusinga varietyof
means.4The modified nominal group technique allows
face-to-face discussion and resolution of concerns. Useful
techniques to protect against inappropriate influence by in-
dividuals with strong opinions include group facilitation by
an outside individual and a requirement to use evidence
briefings in the consensus process. Frailty and Injuries: Co-
operative Studies of Intervention Techniques undertook the
first attempt to standardize definitions and measurement of
outcomes for fall prevention trials.29The ProFaNE recom-
mendation builds on this work by engaging international
collaboration in identifying measures and integrating de-
velopments over the last 10 years.
Nearly all community-dwelling older people should be
able to complete the outcome measurements. Apart from a
measure of physical activity, the data set is sufficient to
capture the important outcomes of fall injury trials. The
common outcome data set is much shorter than the Frailty
and Injuries: Cooperative Studies of Intervention Tech-
niques data set and is of a length and format that may
facilitate good response rates in postal follow-up.7It is an-
ticipated that researchers will supplement the data set with
other measures, reflecting local priorities and needs. It is
also recognized that considerably more work needs to be
undertaken to translate the measures into a range of lan-
guages and to ensure cultural compatibility.
These recommendations are intended for use in trials in
which the target of intervention is a reduction in fall-related
injury. Trials that target bone health or investigate the
combined effects of fall and bone health interventions as a
method of preventing nonvertebral fractures should use the
recommendation. There is little congruity for the measures
traditionally used in the two fields, and the broader effects
of bone health interventions on falls, self-efficacy, and
physical activity are, in the most part, not known.30
The authors are confident that the search strategy cap-
tured all measures that should have been considered. No
information relating to thresholds for minimal clinically
important differences for any of the psychological,
HRQoL, or physical activity measures, from the individu-
al or societal perspective, was found. This matter will be
addressed in future revisions of the recommendations.
International collaboration has the potential to yield
important information on the effectiveness of interventions
and the cultural and psychosocial factors that influence
their implementation. It is the authors’ intention to refine
the recommendations in 2007 as new evidence for the psy-
chometric and practical properties of measures emerges.
Outcome Consensus Group
Claire Ballinger, United Kingdom; Clemens Becker, Ger-
many; Francesco Benvenuti, Italy; Nina Beyer, Denmark;
Marc Bonnefoy, France; Cindy Bramhall, United Kingdom;
Ian Cameron, Australia; John Campbell, New Zealand;
Jaqueline Close, United Kingdom; Colin Cryer, United
Kingdom; Malgorzata Fedyk-Lukasik, Poland; Bill Gilles-
pie, United Kingdom; Lesley Gillespie, United Kingdom;
PROFANE COMMON OUTCOME DATA SET
1621 JAGS SEPTEMBER 2005–VOL. 53, NO. 9
Peter Gore, United Kingdom; Klaus Hauer, Germany; Kirs-
tie Haywood, United Kingdom; Ellen J?rstad-Stein, United
Kingdom; Sirkka-Liisa Kivela ¨, Finland; Martina Kron, Ger-
many; Susan Kurrle, Australia; Sallie Lamb, United King-
Germany; Rolf Moe-Nilssen, Norway; Klaus Pfeiffer, Ger-
many; Steve Richardson, United Kingdom; Antoni Salva,
Spain; Anna Skalska, Poland; Dawn Skelton, United King-
dom; Mark Speechley, Canada; Chris Spray, United King-
dom; Chris Todd, United Kingdom; John Wark, Australia;
and Wiebren Ziljstra, Netherlands.
Additional comments were provided by Stephen Lord,
Australia; Dave Buchner, United States; Clare Robertson,
New Zealand; and Fiona Shaw, United Kingdom.
The authors wish to thank Lesley Gillespie for allowing us
to replicate her search strategy and providing copies of pa-
pers. All workshop attendees are thanked for their valuable
and energetic input, and a special thanks to the workgroup
facilitatorsFClaire Ballinger, Chris Spray, and Kirstie Hay-
Financial Disclosure: The authors are participants in
the Prevention of Falls Network Europe (ProFaNE) The-
matic Network, which is a project within Key Action 6 (The
Aging Population and Their Disabilities), part of the Euro-
pean Union’s Quality of Life and Management of Living
Resources Programme, funded by the European Commis-
sion (QLRT-2001–02705). The content of the manuscript
and the Community is not responsible for any use that
might be made of the information presented in the text.
Author Contributions: Sarah E. LambFconcept for
original study, study design and analysis, wrote original
draft of paper, guarantor. Ellen C. J?rstad-SteinFstudy de-
sign and analysis, drafting of manuscript, edited original
manuscript. Klaus HauerFcontributed to design, analysis,
drafting of manuscript. Clemens BeckerFconcept for orig-
inal study, study design and analysis, drafting of manu-
script, guarantor. All authors have read and approved the
final version of the manuscript.
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