53
http://www.futureofchildren.org
Individual-Level Injury
Prevention Strategies
in the Clinical Setting
Carolyn DiGuiseppi
Ian G. Roberts
Abstract
Health care providers have numerous opportunities to intervene with parents and
children to promote child safety practices that reduce rates of unintentional injuries.
These individual-level interventions may be delivered in a variety of settings such as
physician offices, clinics, emergency departments, or hospitals. This article systematically reviews 22 randomized controlled trials (RCTs) that examined the impact of
interventions delivered in the clinical setting on child safety practices and unintentional injuries. The results indicate that counseling and other interventions in the
clinical setting are effective at increasing the adoption of some safety practices, but
not others. Specifically, motor vehicle restraint use, smoke alarm ownership, and
maintenance of a safe hot tap water temperature were more likely to be adopted following interventions in the clinical setting. Clinical interventions were not proven
effective at increasing a variety of safety practices designed to protect young children
from injuries in the home, increasing bicycle helmet use, or reducing the occurrence of childhood injuries, though few studies examined the latter two outcomes.
Clinical interventions were most effective when they combined an array of health
education and behavior change strategies such as counseling, demonstrations, the
provision of subsidized safety devices, and reinforcement. The article concludes with
implications for research and practice.
U
nintentional injuries are the leading cause of death for children
and adolescents ages 1 to 19, accounting for more than 13,000
deaths each year in the United States. Effective prevention
strategies are needed to reduce this toll. This article will address injury
prevention strategies focused at the level of the individual. Individuallevel strategies can be offered in varied settings such as homes, residential institutions, work sites, clinics, emergency departments, or hospitals.
The role home visitors play in preventing childhood injuries has previously been reviewed.1 This article will focus on individual-level interventions delivered in clinical settings, including primary care (for example,
physician offices, clinics) and acute care (for example, emergency
departments, hospitals).
The Future of Children UNINTENTIONAL INJURIES IN CHILDHOOD Vol. 10 • No. 1 – Spring/Summer 2000
Carolyn DiGuiseppi,
M.D., M.P.H., is senior
research fellow at the
Child Health Monitoring
Unit in the Department
of Epidemiology and
Public Health, Institute
of Child Health, University College London
Medical School, in the
United Kingdom.
Ian G. Roberts, M.B.,
B.Ch., M.R.C.P., Ph.D.,
is senior lecturer in
epidemiology and director
of the Child Health
Monitoring Unit in the
Department of Epidemiology and Public Health,
Institute of Child Health,
University College
London Medical School,
in the United Kingdom.
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THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
To evaluate the effectiveness of such interventions, this article will examine the results of a systematic review of randomized controlled trials, or
RCTs (see Box 1). It will describe the evidence from this systematic review
in response to two primary questions: (1) What are the effects of individuallevel child and adolescent injury prevention interventions delivered in the
clinical setting on safety practices? (2) What are the effects of such interventions on injuries? The synthesis of evidence from all studies reviewed will
be presented first, followed by a more detailed discussion of specific safety
practices and injury outcomes. Finally, this article will examine implications
of these trials for practice and research.
Evaluating Individual-Level
Injury Prevention Strategies
Studies were included in the systematic
review if (1) the intervention was designed to
prevent unintentional injuries to children or
adolescents under 20 years of age; (2) the
intervention was delivered in a “clinical setting,” such as a physician’s office, a clinic, an
emergency department, or a hospital; (3)
participants were assigned randomly to intervention and control groups; and (4) the
study collected data on injuries, events that
can cause injuries (for example, falls), or
safety practices (for example, seat belt use).
This systematic review was restricted to RCTs
because effectiveness information from such
studies is less prone to bias than is information from other study designs, and because
clinical settings can be studied by using a randomized controlled design (see Box 2). The
review also considered how well each trial
met certain design principles that can influence study results even when random assignment is used (see Box 3). The strategies used
to find relevant trials and search results, the
assessment of study design issues, and analytic methods used are described in the
Appendix at the end of this article.
The systematic review identified 22 relevant RCTs that met the above conditions (see
Tables 1 to 5).2–23 Most trials assessed the
effect of the intervention on safety behaviors
rather than injuries. The outcomes assessed
included motor vehicle restraint use, bicycle
helmet use, safe hot tap water temperature,
smoke alarm ownership, and a variety of
safety practices designed to protect young
children from injuries in the home (identified collectively as “childproofing” the
home). The review found no relevant trials
evaluating clinical interventions designed to
prevent motorcycle, pedestrian, drowning,
alcohol-related, or firearm injuries, despite
their importance as causes of unintentional
injuries among children and adolescents (see
the article by Grossman in this journal issue).
The targeted population and the type
and duration of intervention varied among
the studies examined. Most trials enrolled
pregnant women or the parents of infants or
preschool-age children. Only three primarily
targeted school-age children,12–14 and none
specifically targeted adolescents. Most experimental interventions tested included written
educational materials and verbal counseling,
sometimes combined with strategies to reinforce the message delivered. About one-third
of the trials evaluated the effect of offering
subsidized safety devices, such as a free car
seat loan program or smoke alarm discount
coupons. These factors, in addition to the
design of the evaluation and the outcome
measures selected, were considered in the
evaluation of the scientific evidence of injury
prevention strategies in the clinical setting.
The Effectiveness of
Interventions in the
Clinical Setting
An Overview of the Impact
To assess the overall effectiveness of childhood injury prevention strategies delivered
in a clinical setting, evidence was synthesized
from studies that examined safety practices
and studies that examined injury outcomes.
Effects on Safety Practices
For most safety practices evaluated, counseling and other interventions in the clinical
setting resulted in a greater likelihood of
safety practice. For example, practices
including motor vehicle restraint use, smoke
alarm ownership, and maintenance of a safe
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Individual-Level Injury Prevention Strategies in the Clinical Setting
Box 1
Why Systematic Reviews?
Given ever-increasing amounts of scientific information, it is not surprising that
digesting and staying current with this information is difficult. Yet health professionals, policymakers, and consumers can only make informed health-related decisions if the decisions are based on the most accurate and up-to-date information
available. Too often, help is sought from incomplete or even inaccurate literature
reviews. Many reviews do not explain how decisions were made about what was
included in the review. Hence, the reader cannot judge whether such reviews accurately reflect the totality of evidence on a given topic. A review could be based, for
example, on the studies of which the author happened to have copies. Such “file
drawer” reviews may be more likely to include trials that support the authors’ preconceived opinions.1
In contrast, a systematic review uses a systematic approach to comprehensively
identify relevant literature, hence minimizing selection bias, and makes explicit
the methods used to conduct the review.1 Systematic reviews are more likely to
reflect the true state of available information on the topic of interest. Key aspects
of systematic reviews include (1) a well-formulated review question, (2) explicit
inclusion criteria, (3) an attempt to identify and include all relevant evidence,
(4) an adequate description of the methodology used to conduct the review, and
(5) an effort to link explicitly the conclusions to the evidence.
In response to the need for systematic, up-to-date reviews of all relevant trials
of health care, the Cochrane Collaboration was developed. This international
organization aims to help people make informed decisions about health care by
preparing, maintaining, and ensuring accessibility to systematic reviews of the
effects of health care interventions. Cochrane reviews, which are prepared and
maintained by international collaborative review groups, are published electronically in The Cochrane Database of Systematic Reviews. These reviews are readily available to inform and improve decision making about health care and research.
Endnote:
1 Chalmers, I., and Altman, D., eds. Systematic reviews. London: BMJ Publishing Group, 1995.
hot tap water temperature were more likely
to be adopted following interventions delivered in the clinical setting, and these differences were statistically significant. However,
clinical interventions were not effective at
increasing bicycle helmet use or increasing
the use of practices designed to protect
young children in the home.
Estimating the potential benefit from
each of these interventions depends on the
baseline rate of safety practice as well as on
the effectiveness of the intervention (as measured by the odds ratio). That is, all else
being equal, the absolute effect of interventions delivered in the clinical setting on the
rate of safety practice will be greater if the
baseline rate of use in the target population
is low. Based on estimates from the review,
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clinical counseling alone could increase
short-term infant motor vehicle restraint use
from the current 85%24 to about 88%, and
toddler restraint use from the current 60%24
to about 66%. Interventions that provided
subsidized car safety seats or extensive reinforcement could have a substantially greater
effect. Clinical interventions also could have
an important beneficial effect on unsafe hot
tap water temperatures. For example, if 90%
of households currently have a safe tap water
temperature, then counseling could
increase that proportion to about 95%. If
the baseline proportion were only 70%,
however, counseling could increase the
prevalence of safe hot tap water temperature
to as much as 84%. Similarly, given that an
estimated 93% of homes in the United
States are equipped with smoke alarms,25
55
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THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
Box 2
Randomized Controlled Trials
The randomized controlled trial (RCT) is regarded as the gold standard for evaluating interventions. This is because the challenge for any evaluator is to assemble
two or more comparable groups that have equal chances of experiencing the outcomes of interest. Observed differences in outcome between the intervention and
comparison groups can then be reasonably attributed to the intervention (or to
chance). Comparability can be achieved if chance alone, as occurs in random allocation, dictates whether a particular person or group of persons is assigned to a
particular group. If persons are allocated to a particular study group using other
methods (for example, by alternation or self-selection), there is a risk that the
groups might differ in ways that are not due to chance. In such a case, observed differences after intervention may be due to factors other than either the intervention
or chance. Because evaluators can have the most confidence in results from RCTs,
whenever possible, evaluations of injury prevention interventions should use this
design. Injury prevention interventions in the clinical setting are particularly suitable for evaluation in RCTs because the decision about which persons will receive
the intervention usually can be controlled by the investigator and therefore can be
randomly allocated. In contrast, engineering changes, product modification, legislation, and community programs are commonly evaluated using nonrandomized
trials or observational studies because the decisions about which product or area
receives the intervention are often determined by factors, such as politics or economics, that are beyond the investigator’s control.
clinical interventions would be likely to
increase this figure to 96%. All of these estimates are based on the assumption that
interventions are equally effective in populations with high and low baseline rates of
safety practice. As discussed later in this article, this may not necessarily be true.
Effects on Childhood Injuries
Only two RCTs in this systematic review collected data on the effect of counseling in the
clinical setting on childhood injuries.4,19
These studies reported little or no effect on
minor injuries, and the reduction in hospitalizations, though clinically important, was
not statistically significant. As an estimate of
the potential benefit, there were 1% fewer
first-injury hospitalizations among intervention than control children (2.2% versus
3.1%) during the two-year trial of counseling
in general practices.19 Because hospitalizations are costly, clinical interventions that
produce even modest effects would be
worthwhile if the interventions could be
implemented cost effectively. Sufficiently
large trials that identify beneficial effects of
counseling on injuries, that also consider
costs in relation to effect and benefit, are
therefore needed.
Until such RCTs are conducted, conclusions regarding the effect of clinical counseling and other interventions on childhood
injuries rely on linking evidence from (1)
trials of the effectiveness of counseling on
safety practices with (2) observational studies
of the association between safety practices
and reductions in injury. This systematic
review provides evidence that clinical interventions are effective at increasing the use of
many safety practices, including motor vehicle restraint use, smoke alarm ownership, and
safe hot tap water temperatures. Previous
reviews of observational studies also report
beneficial effects of these and other safety
practices on childhood injuries.26–29 Thus,
there is indirect evidence that individual-level
interventions in the clinical setting are effective measures to reduce many childhood
unintentional injuries.
Impact on Targeted
Safety Practices
The previous section provided an overview of
the effectiveness of interventions delivered in
the clinical setting on child safety practices
and injury outcomes. This section examines in
greater detail the effect of such interventions
on specific safety practices, including motor
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Individual-Level Injury Prevention Strategies in the Clinical Setting
Box 3
Study Design Principles*
Even randomized controlled trials (RCTs) may be conducted without sufficient scientific rigor for evaluators to be confident of their results, and even strongly positive findings may be an artifact of design flaws rather than a reflection of a true
effect on outcomes. Well-conducted trials that adhere to certain design principles
tend to show smaller treatment benefits than do poorly conducted trials,1,2 because
design flaws will, on average, lead to overestimates of the benefits of intervention.
Examining these design characteristics is important when evaluating the estimated
impact of an intervention, since one is less confident of the validity of the results
of studies that use flawed designs.
Three important elements of study design were considered in this review:
Allocation Concealment: How well is the study group, to which the next recruited
subject will be allocated, concealed from the person enrolling subjects?
Blinded Outcomes Assessment: Are study outcomes assessed without knowledge of
group assignment?
Loss to Follow-Up: Is the withdrawal or exclusion of subjects after randomization
adequately described?
The adequacy of allocation concealment is particularly important; it has
been shown that intervention effects may be exaggerated by as much as 30% to
40% when allocation is not adequately concealed.1,2 Tables 1–5 provide a summary
of how the RCTs included in this systematic review handled each of these design
principles.
Endnote:
1
Schulz, K.F., Chalmers, I., Hayes, R.J., and Altman, D.G. Empirical evidence of bias: Dimensions of methodological quality
associated with estimates of treatment effects in controlled trials. Journal of the American Medical Association (1995)
273:408–12.
2
Moher, D., Pham B., Jones, A., et al. Does quality of reports of randomised trials affect estimates of intervention efficacy
reported in meta-analyses? Lancet (1998) 352:609–13.
vehicle restraint use, bicycle helmet use, safe
hot tap water temperature, smoke alarm ownership, and measures to childproof the home.
Strategies to childproof the home include
changes that are made to the home specifically to protect young children from common
household risks, and that would not typically
be implemented in homes where no children
reside (for example, outlet covers, stair gates).
Because only two trials evaluated injury outcomes,4,19 and both of these focused primarily
on home safety, these trials are discussed in
the section titled “Strategies to Childproof the
Home.” When appropriate, results were combined from multiple RCTs using meta-analysis
(see Box 4).
Motor Vehicle Restraint Use
Motor vehicle occupant injuries are the leading contributor to injury mortality and
morbidity among children and teenagers.
http://www.futureofchildren.org
Observational evidence indicates that, when
used, infant car seats reduce the chance of
serious injury or death by about 70%, toddler safety seats by 47%, and seat belts for
older children and adolescents by about
45% (see the article by Grossman in this
journal issue).26
Ten completed trials have evaluated interventions in the clinical setting to promote
motor vehicle restraint use (see Table 1).2–11
All of the interventions studied provided
information and encouragement to parents,
though the extent of this educational component varied substantially. One intervention, for example, provided multiple,
15-minute counseling sessions in conjunction with well-child care.4 Two other trials
involved limited education, instead focusing
on noneducational interventions. One of
these trials evaluated lending car seats to
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THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
58
Box 4
Pooling Results of Relevant Trials
The results from multiple randomized controlled trials (RCTs) can sometimes be
combined quantitatively, using a statistical method called meta-analysis.1 By combining the results of different trials, meta-analysis provides an overall estimate of
the effect of the intervention being studied, as well as an estimate of how precise
the effect estimate is. Quantitatively combining results from multiple trials may not
always be appropriate if there is significant variation in the results of the trials. In
such cases, the reasons for the variation should be explored.
In an attempt to limit the variability between studies, we restricted the trials
included in this systematic review by target population (children and adolescents
younger than 20 years old), interventions (those aimed at preventing unintentional injuries), setting (clinical), outcomes (safety practices and injuries), and
study design (RCTs). Because intervention effects may also vary with the intervention strategy (for example, educational counseling vs. offering free devices)
and/or the safety practice being promoted (for example, advice on the installation
of a smoke alarm vs. advice on bicycle helmet use), we only combined quantitatively studies that promoted the same safety practices and studies that used similar
intervention strategies. We tested each meta-analysis to see whether the results of
the included trials differed more than would be expected from chance alone. If
there was statistically significant variability (called “heterogeneity”) among the
individual trials, we explored differences in interventions, populations, settings, or
designs that might explain this variability.
Endnote:
1 Lau, J., Ioannidis, J.P.A., and Schmid, C.H. Quantitative synthesis in systematic reviews. Annals of Internal Medicine (1997)
127:820–26.
mothers of newborns at no charge.10 The
other trial evaluated a year-long reinforcement program involving parking lot monitors who rewarded families observed using
car seats and educated those who were not,
verbal reminders from staff, and other incentives for use.11 Six trials collected data on
either short-term use (less than six months
after the intervention) or long-term use
(more than six months after the intervention), while four trials evaluated use at more
than one follow-up. Data were available from
all but one trial.7 None of the trials provided
data on motor vehicle–related injuries.
Overall, the studies showed that families
who received the experimental intervention
were more likely to use a safety restraint for
their children than were families receiving
the control intervention, but this difference diminished at longer follow-up (see
Figure 1). Six of seven trials that reported
short-term motor vehicle restraint use
showed greater use in the experimental
group at follow-up, although the magnitude
of effect varied significantly between trials.
Compared with no intervention, short-term
motor vehicle restraint use was 30% more
likely after education alone, although this
result was not statistically significant. Much
larger, statistically significant effects were
seen in one trial that evaluated free car seat
loans10 and the trial with a year-long reinforcement program (described above).11
The beneficial effects of resource provision
(that is, free car seats) and of reinforcement
on behavior change are well documented.30
Interventions delivered in the clinical setting had only modest effects on long-term
car seat use in all six relevant trials, both individually and combined. Effects were similar
regardless of the type of intervention offered.
Results from the four trials that reported
both short- and long-term follow-up3,6,10,11
suggest that this apparent diminution of
effect over time occurred because control
subjects eventually increased their restraint
use to the same level as intervention subjects,
rather than because of a decline in use in the
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Individual-Level Injury Prevention Strategies in the Clinical Setting
59
Figure 1
The Effect of Clinical Interventions on Short-Terma Motor Vehicle
Restraint Use
ORb
95% CIc
Scherz (1976)
1.93
0.92, 4.02
Miller (1977)
1.12
0.78, 1.60
Moffit (1981)
1.69
0.46, 6.14
Greenberg (1982)
2.48
0.72, 8.57
Christophersen (1985)
0.79
0.20, 3.07
1.30
0.98, 1.74
Study
Graphic Representationd
Education Only
Total
Education and
Subsidized Devices
Christophersen (1982) 59.18
2.95, 1,187.78
➤
Education and
Reinforcement Program
Liberato (1989)
4.94
3.26, 7.50
0.01
0.1
Control Group
Better
1.0
10
100
Intervention Group
Better
a
Less than six months after the intervention. Note: There is no summary estimate for all trials because of statistically significant variation between the trials.
b
Odds Ratio (OR) measures the strength of the association between the intervention and the outcome. An OR=1.0 indicates no association. An OR>1.0 indicates a positive effect of the intervention on the outcome, and an OR<1.0 is a negative effect.
c
The 95% Confidence Interval (CI) estimates the expected range of the OR 95 out of 100 times. A “statistically significant”
result in this article is defined by a 95% CI that excludes 1.0.
d
The box corresponds to the OR. A box to the right of 1.0 favors the intervention group, while a box to the left of 1.0 favors
the control group. The length of the line corresponds to the 95% CI.
intervention group. Over time, the control
group may have received sufficient counseling, whether through usual well-child care,
community programs, or other sources, to
motivate them to obtain and use car
restraints. This does not imply that the experimental interventions were not beneficial,
however. Because clinical intervention accelerated restraint use, children in the intervention group were protected earlier, and thus
longer, than were those in the control group.
In summary, interventions in the clinical
setting that emphasized resources or reinforcement significantly increased short-term
motor vehicle restraint use, but they had a
limited effect on long-term restraint use,
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while education alone had only modest
effects on car seat use. These modest effects
were not surprising, given that the educational interventions generally lacked key
program elements that are recommended
to influence behavior (see Box 5). There was
no evidence about the effects on motor vehicle crash-related injuries, although a large
body of observational and laboratory
research has linked increased motor vehicle
restraint use with a substantially reduced risk
of injury.26,28
The majority of these studies were conducted before infant and child motor vehicle
restraint legislation was enacted in all states,
and similar interventions are unlikely to have
Table 1
Trial, Year,b
Country
Population
Enrolled
in Study
Intervention
Outcome
Assessment
Allocation
Concealment
Selected Outcomes
Intervention
Control
654 children 0 to I1: Pamphlet about car restraints
17 years old seen I2: I1+verbal instructions from
for WCC, private
pediatrician
practice
I3: I2+brief slide show on car restraints
C: No intervention
Self-reported usual
and most recent
use, two weeks
later
Not described
Short-term use:
182/296 (61%)
Short-term use:
130/221 (59%)
Scherz3
1976
United States
500 parents of
four-week-olds
seen for WCC,
military clinic
I1: Display about car seats
I2: I1+pamphlets about car seats
I3: I2+nurse encouragement to read
pamphlet and buy car seat
I4: I2+physician encouragement to
read pamphlet and buy car seat
C: No intervention
Self-reported usual
use, collected at
8-week and 9- to
12-month WCCs
Not described
Short-term use:
64/400 (16%)
Long-term use:
185/233 (79%)
Short-term use:
9/100 (9%)
Long-term use:
40/52 (77%)
171 parents of
six-month-olds
seen for WCC
I: 15-minute developmentally oriented
child safety education, hazard
assessment, and handout by research
physician at 6-, 9-, and 12-month
WCCs; usual WCC
C: Usual WCC
Self-reported usual
use 1 month
after 12-month
WCC
Not described
Long-term use:
18/55 (33%)
Long-term use:
16/53 (30%)
Four prenatal
classes
(225 expectant
parents)
I: Brief lecture on risk from auto crashes; Blinded observed
car seat demonstration; postpartum
use at hospital
car seat information
d/c
C: Postpartum car seat information
Not adequate
Short-term use:
24/57 (42%)
Short-term use:
4/18 (22%)
Moffit
1981
United States
50 pregnant
women seen for
prenatal care,
public health
clinic
I: Car seat education by health
educator (pamphlet, demonstration,
practice, film, lecture); low-cost car
seat loan
C: Instructions for car seat use, low-cost
car seat loan
Observed correct Not described
use at two-week
WCC; self-reported
use on last ride at
six months;
blinding not stated
Short-term use:
8/26 (31%)
Long-term use:
10/17 (59%)
Short-term use:
5/24 (21%)
Long-term use:
8/15 (53%)
Williams 7
1988c
United States
12 prenatal
classes
(165 pregnant
women)
I: One-hour safety lecture, including
motor vehicle safety and video;
usual safety education
C: One-hour lecture, handouts, and
video on infant stimulation and
feeding; usual safety education
Unblinded home
inspection two to
four weeks after
birth
Data not available
Data not available
4
5
Greenberg
c
1982
United States
6
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Adequate
THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
Miller 2
1977
United States
Kelly
1987
United States
60
Randomized Controlled Trials of Interventions in the Clinical Setting to Promote Motor Vehicle Restraint Usea
Randomized Controlled Trials of Interventions in the Clinical Setting to Promote Motor Vehicle Restraint Usea
Population
Enrolled
in Study
Trial, Year,b
Country
Barone 8
c
1988
United States
Intervention
Outcome
Assessment
Allocation
Concealment
Selected Outcomes
Intervention
Control
Long-term installed
seat: 36/36 (100%)
Long-term use:
9/9 (100%)
Five parenting
classes
(108 parents of
toddlers)
I: One-hour safety lecture, including
motor vehicle safety and video;
usual safety education
C: Usual safety education
Unblinded
inspection of
whether car seat
installed six months
after class;
observed use at
six-month WCCs
Not adequate
Long-term installed
seat: 39/41 (95%)
Long-term use:
6/6 (100%)
Unblinded
observation of
correct use at d/c,
1-, 6-, and 12month WCCs
Not adequate
Short-term use:
Short-term use:
59/64 (92%)
60/64 (94%)
Long-term use:
Long-term use:
data not available
data not available
Christophersen
c
1985
United States
9
129 women on
obstetric unit
after delivery
I: Discharge orders for loan program,
demonstration, and infant to ride
home in the car seat; handouts and
nurse demonstration at d/c; followup advice and handouts
C: Car seat loan program offered at
d/c, use encouraged
Christophersen
1982
United States
10
30 women on
obstetric unit
after delivery
I: Nurse offer to demonstrate correct
Blinded
Not adequate
car seat use, place infant in seat, and observation of
fasten seat into car; free car seat loan correct use at d/c,
C: No intervention
four- to six-week
WCCs
Short-term use:
10/15 (67%)
Long-term use:
4/14 (29%)
Short-term use:
0/15 (0%)
Long-term use:
3/13 (23%)
Six public health
clinics (families
of children under
five years old)
I: 10-month car seat promotion: staff
in-service; parking lot program to
reward families if children properly
restrained, warn and educate if not;
waiting room stickers, posters,
information, and mini-talks; verbal
reinforcement, incentives from staff;
usual advice about car seats
C: Usual advice about car seats
Short-term use:
170/450 (38%)
Long-term use:
159/450 (35%)
Short-term use:
49/450 (11%)
Long-term use:
135/450 (30%)
11
Liberato
c
1989
United States
Blinded
observation of
sample of cars
entering parking
lot 6 and 12
months after start
of program
a
I=intervention group; C=control group; WCC=well-child care visit; ED=emergency department; d/c=discharge.
b
See related endnotes at the end of this article.
c
Unpublished methodological details provided by author.
Not adequate
Individual-Level Injury Prevention Strategies in the Clinical Setting
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Table 1 (continued)
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THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
Box 5
Health Education Concepts
Extensive literature exists on the theoretical basis of health education, health
promotion, and behavior change.1 One useful framework, based on common
theoretical themes, identifies three types of factors that can be modified by health
education:2
Predisposing factors: Motivate the patient to change behavior. These include
knowledge, beliefs, values, attitudes, and confidence.
Enabling factors: Allow the motivation to be realized. These include skills
mastery (enhanced by modeling and practice),3 accessibility of resources, and
factors such as product design and legislation.
Reinforcing factors: Reinforce and reward implementation and maintenance of
the behavior. These may include, for example, follow-up visits or calls, incentives,
reminders, media messages, and legislative enforcement.
Endnotes:
1 Glanz, K., Lewis, F.M., and Rimer, B.K. Health behavior and health education: Theory, research, and practice. San
Francisco: Jossey-Bass, 1990.
2
Green, L.W., and Kreuter, M.W. Health promotion planning: An educational and environmental approach. 2d ed. Mountain View, CA: Mayfield Publishing, 1991.
3
U.S. Preventive Services Task Force. Patient education and counseling for prevention. In Guide to clinical preventive
services. 2d. ed. C. DiGuiseppi, D. Atkins, S. Woolf, and D. Kamerow, eds. Washington, DC: U.S. Government Printing
Office, 1996, pp. 1xxv–1xxxiii.
the same impact now. The trial that showed
the strongest effect on car seat use, for example, was conducted before infant restraints
were required by law (see the article by
Schieber, Gilchrist, and Sleet in this journal
issue); very few subjects in the control group
used restraints, and none used them correctly. In such a population, many families
may fail to use car seats simply because they
are unaware of the potential benefits. Now
that use is 60% to 85% across the United
States,24 these interventions are likely to have
quite a different impact, so these results
cannot be generalized to the current situation. Parents who do not use child car seats
after a decade of legislation are likely to be
harder to influence than were the subjects of
these trials. There is a clear need for additional studies under present circumstances.
Many children in car seats are not correctly restrained, reducing the effectiveness
of the restraints (see the article by Grossman
in this journal issue). Clinical counseling has
the potential to influence correct car seat
use, particularly if the intervention includes
demonstrations, practice, and reinforcement. New trials are needed to evaluate the
effect of such interventions on correct and
consistent car seat use. The optimal solutions for correct and consistent motor vehicle restraint use, however, are likely to come
from engineering and regulatory changes
that would turn child restraints into built-in
safety features that are as easy to use as seat
belts.31 To this end, the National Highway
Traffic Safety Administration (NHTSA) has
established a new federal motor vehicle
safety standard that requires motor vehicle
manufacturers to equip vehicles with uniform child restraint anchorage systems,
effective September 1, 1999.32
Bicycle Helmet Use
Bicycle crashes are a major cause of injury
and death among school-age children and
adolescents. Most bicycle crash-related
hospitalizations and deaths are attributable
to head injuries.33 Observational studies
estimate that bicycle helmets reduce the
risk of head injuries after crashes by at least
two-thirds.28
Two trials tested the effect of counseling
school-age children and their parents about
bicycle helmet use (see Table 2).12,13 The brief
interventions in these two trials were identical
and included information, persuasion, and a
http://www.futureofchildren.org
Individual-Level Injury Prevention Strategies in the Clinical Setting
PHOTO OMITTED
list of stores that sold helmets. In one trial, the
intervention was delivered by the emergency
physician who treated the child for a bicycle
injury,12 and in the other by the child’s own
pediatrician during well-child care.13
These trials, individually and combined,
showed no effect on subsequent helmet purchases two to three weeks after counseling. In
the first study, 9% in the intervention group
and 8% in the control group purchased helmets; in the second study, an additional 7%
of families in both groups purchased helmets. Overall, the likelihood of purchasing a
helmet after intervention only increased by
10%, a difference that was not statistically significant. The study’s author states that
helmet use also did not differ significantly
after intervention, although numerical data
were not available.34 No studies evaluated
effects of interventions on bicycle injuries.
In a third trial, children in both groups
were offered identical counseling and materials promoting bicycle helmet use.14 This trial
did not evaluate counseling; instead, the trial
compared two ways to subsidize helmet ownership in low-income families: free bicycle helmets versus a $5 copayment for a helmet
(although the copayment was reduced or
waived for families who could not pay). The
authors speculated that families who made a
copayment would perceive the helmets as
more valuable, and that their helmet use
might be greater. Consistent bicycle helmet
http://www.futureofchildren.org
use was 1.4 times more likely among children
whose families were required to make a copayment than among children given a free
helmet. Although not statistically significant,
the results suggest that requesting copayment
may increase helmet use and is unlikely to
adversely affect it. It is not clear from the
report, however, whether requiring a copayment led to fewer families getting a helmet.
The clinics requesting copayment distributed
fewer helmets than did those providing free
helmets (218 versus 288), but the authors did
not report how many families refused helmets.
In summary, available trials do not show
that individual counseling increases bicycle
helmet ownership or use, nor is there any evidence about the effects of counseling on
injury occurrence. However, there were only
two relevant trials, involving very limited interventions. Counseling in the clinical setting
may have failed because only isolated, onetime counseling sessions were offered, and
they did not address key issues such as negative peer attitudes toward helmet use.35 Other
studies have shown positive effects on childhood bicycle helmet ownership and use from
community-based educational interventions
that included clinical counseling as one component of a broader effort (see the article by
Klassen and colleagues in this journal issue).36
Safe Hot Tap Water Temperature
The leading cause of hospitalizations for
burns among children under five years of age
63
64
Table 2
Randomized Controlled Trials of Interventions in the Clinical Setting to Promote Bicycle Helmet Usea
Trial, Year,b
Country
Population
Enrolled
in Study
Outcome
Assessment
Intervention
Allocation
Concealment
Selected Outcomes
Intervention
Control
373 children
ages 1 to 17
in ED with
bicycle injury
I: Brief physician counseling and
pamphlets about bicycle helmets;
helmet survey
C: Helmet survey
Self-report by
unblinded
interview two to
three weeks later
Not adequate
Helmet purchase:
15/161 (9%)
Helmet purchase:
14/173 (8%)
Cushman13
c,d
1991
Canada
339 families with
1 or more
bicyclists ages
5 to 18 seen for
WCC
I: Brief physician counseling and
pamphlets about bicycle helmets;
helmet survey
C: Helmet survey
Self-report by
unblinded
interview two to
three weeks later
Not adequate
Helmet purchase:
12/167 (7%)
Helmet purchase:
12/172 (7%)
Six public health
clinics
(506 families of
children 6 to 12
years of age)
I: Small copayment for helmet;
education and materials promoting
helmet use
C: Free bicycle helmet; education and
materials promoting helmet use
Unblinded selfreport by
questionnaire two
to three weeks
later
Not adequate
Consistent helmet
use: 147/180 (82%)
Consistent helmet
use: 186/243 (76%)
14
http://www.futureofchildren.org
Kim
c
1997
United States
a
I=intervention group; C=control group; WCC=well-child care visit; ED=emergency department.
b
See related endnotes at the end of this article.
c
Unpublished methodological details provided by author.
d
Unpublished outcomes data provided by author.
THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
Cushman12
1991c,d
Canada
Individual-Level Injury Prevention Strategies in the Clinical Setting
65
Figure 2
The Effect of Clinical Interventions on Safe Hot Tap Water Temperature
Study
Thomas (1984)
ORa
95% CIb
10.48
3.01, 36.47
Kelly (1987)
1.72
0.76, 3.91
Williams (1988)
2.82
1.09, 7.33
Barone (1988)
1.16
0.46, 2.91
2.32
1.46, 3.68
Total
Graphic Representationc
0.01
0.1
Control Group
Better
1.0
10
100
Intervention Group
Better
a
Odds Ratio (OR) measures the strength of the association between the intervention and the outcome. An OR=1.0
indicates no association. An OR>1.0 indicates a positive effect of the intervention on the outcome, and an OR<1.0 is a
negative effect.
b
The 95% Confidence Interval (CI) estimates the expected range of the OR 95 out of 100 times. A “statistically significant”
result in this article is defined by a 95% CI that excludes 1.0.
c
The box corresponds to the OR. A box to the right of 1.0 favors the intervention group, while a box to the left of 1.0 favors
the control group. The length of the line corresponds to the 95% CI.
is scalds.37 Hot tap water scald burns can be
prevented by setting household water heaters
at or below 120°F to 130°F.29 The incidence of
such burns has declined, possibly due to
legislation mandating maximum preset
temperature settings of 120°F on new hotwater heaters (see the article by Grossman in
this journal issue). Because thermostats in
hot-water heaters may be inaccurate, parents
are advised to measure the hot-water temperature using a thermometer and, if required,
lower the temperature to the safe range.
Six trials were found that evaluated the
effect of interventions delivered in the clinical
setting on lowering, testing, and/or maintaining a safe hot tap water temperature (see
Table 3).4,7,8,15–17 One of these trials also evaluated the effects of the intervention on injuries
from all causes combined (see “Strategies to
Childproof the Home”), but it did not provide data specifically on scald burns.4 Five
trials tested educational interventions;4,7,8,15,16
one of these trials also provided free hot-water
thermometers.8 The sixth trial tested the
effect of providing a free thermometer compared with no thermometer when all subjects
received advice and information.17
All five trials of education reported positive effects, with a more than twofold greater
http://www.futureofchildren.org
likelihood of lowering hot tap water temperature (or of testing it, if “lowering” was not
reported) and of using a safe hot tap water
temperature, after education (see Figure 2).
There was statistically significant variation
among them, however, largely due to one
trial16 that reported a more than 10-fold
greater likelihood in use after the intervention. Unlike the other trials, this trial had
weaknesses in all measured aspects of study
design (see Table 3), and such flaws may
exaggerate estimates of benefit.38,39 This also
was the earliest of the trials, and its subjects
had the lowest baseline likelihood of using a
safe temperature.
Compared to advice alone, providing a
free thermometer with advice increased the
likelihood of lowering hot tap water temperature by 70%, although the result was based
on only one trial and was not statistically
significant.17
In summary, families are more likely to test
and lower their hot tap water to a safe temperature when counseled to do so. While regulatory changes requiring safe settings at the
factory may have substantially reduced the risk
of hot tap water burns since these studies were
performed, some families remain at risk from
older heaters or malfunctioning thermostats
66
Table 3
Randomized Controlled Trials of Interventions in the Clinical Setting to Promote Safe Hot Tap Water Temperaturea
Trial, Year,b
Country
Population
Enrolled
in Study
Kelly4
1987
United States
171 parents of
six-month-olds
seen for WCC
I: 15-minute developmentally oriented
child safety education, hazard
assessment, and handout by
research physician at 6-, 9-, and
12-month WCCs; usual WCC
C: Usual WCC
Blinded home
inspection,
questionnaire, and
medical chart
review 1 month
after 12-month
WCC
Not described
Safe temperature:
41/55 (74%)
Safe temperature:
34/54 (63%)
Williams7
c
1988
United States
12 prenatal
classes
(165 pregnant
women)
I: One-hour safety lecture, including
handouts on burn prevention; usual
safety education
C: One-hour lecture, handouts, and
video on infant stimulation and
feeding; usual safety education
Unblinded home
inspection two to
four weeks after
birth
Adequate
Safe temperature:
22/39 (56%)
Safe temperature:
11/35 (31%)
8
Five parenting
classes
(108 parents of
toddlers)
I: One-hour safety lecture, including
slides and handouts on burn
prevention; hot-water gauge; tap
water thermometer; usual safety
education
C: Usual safety education
Unblinded home
inspection six
months after class
Not adequate
Safe temperature:
17/41 (41%)
Lowered
temperature:
18/41 (44%)
Safe temperature:
15/38 (39%)
Lowered
temperature:
11/38 (29%)
15
696 pregnant
women
admitted for
delivery
I: Pamphlet about scalds; free tap
water thermometer; one-minute
education about pamphlet and
thermometer
C: Pamphlet about scalds, free tap
water thermometer
Self-report two to
nine months later;
blinding not stated
Not described
Tested temperature:
155/302 (51%)
Tested temperature:
88/302 (29%)
http://www.futureofchildren.org
Shapiro
1987
United States
Outcome
Assessment
Allocation
Concealment
Selected Outcomes
Intervention
Control
THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
Barone
c
1988
United States
Intervention
Randomized Controlled Trials of Interventions in the Clinical Setting to Promote Safe Hot Tap Water Temperaturea
Trial, Year,b
Country
Thomas16
1984
United States
17
Katcher
c
1989
United States
Population
Enrolled
in Study
Outcome
Assessment
Intervention
Allocation
Concealment
Selected Outcomes
Intervention
Control
16 well-baby
classes
(55 parents
enrolled)
I: Burn prevention lecture, pamphlets,
and handouts; usual safety
guidance
C: Usual safety guidance
Home inspection
four to six weeks
after class;
blinding not stated
Not adequate
Safe temperature:
22/29 (76%)
Lowered
temperature:
19/29 (66%)
Safe temperature:
6/26 (23%)
Lowered
temperature:
0/26 (0%)
686 children
ages 0 to 18
seen at
outpatient clinic
I: Free tap water thermometer; brief
advice and pamphlet about hot
tap water and scalds
C: Brief advice and pamphlet about
hot tap water and scalds
Self-report at one
month; blinding
not stated
Not adequate
Tested temperature:
122/263 (46%)
Lowered
temperature:
29/205 (14%)
Tested temperature:
55/240 (23%)
Lowered
temperature:
17/193 (9%)
a
I=intervention group; C=control group; WCC=well-child care visit; ED=emergency department.
b
See related endnotes at the end of this article.
c
Unpublished methodological details provided by author.
Individual-Level Injury Prevention Strategies in the Clinical Setting
http://www.futureofchildren.org
Table 3 (continued)
67
68
THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
or because their thermostat has been reset to
an unsafe temperature setting.
Smoke Alarm Ownership
Residential fires are the second leading
cause of injury deaths among young children (see the article by Grossman in this
journal issue). Owning a smoke detector has
been estimated to reduce the risk of death in
a residential fire by more than two-thirds.40
Seven trials evaluated the effect of counseling interventions in the clinical setting
on smoke alarm ownership (see Table
4).4,7,8,16,18–20 Two of these trials also collected
data on all injuries combined (see “Strategies to Childproof the Home”),4,19 but neither reported data specifically about
fire-related injuries. Six trials evaluated
Residential fires are the second leading cause
of injury deaths among young children.
Owning a smoke detector has been estimated
to reduce the risk of death in a residential
fire by more than two-thirds.
counseling for prospective parents or families of young children in primary care
settings,4,7,8,16,18,19 and one advised families of
children hospitalized for burns.20 All interventions included an educational component, though the intensity of the education
varied. Three interventions also provided
discounts for smoke alarms.16,18,19
Four trials reported increased smoke
alarm ownership after clinical counseling,4,8,16,18 while two reported no significant
effects on smoke alarm ownership.7,20 One of
the latter trials also did not provide numerical data on smoke alarm outcomes.7 The seventh trial reported no effect of intervention
on all safety practices combined, but data
specifically on smoke alarms were not available.19 When the results of the five trials with
data available were combined, smoke alarm
ownership was 1.7 times more likely in counseled families compared with families that
received usual care (see Figure 3). This estimate may be biased upward, however, by the
inability to include data from two trials that
found no significant intervention effects.
The results of the trials did not vary significantly, but there were differences worth
noting. The trials with the largest effects
offered subsidies—discount coupons16 or discounted smoke alarms18—in addition to
counseling. Smoke alarm ownership was
nine times more likely in families who
received both counseling and discounted
alarms than in the control families who
received neither. The one trial that found no
effect on ownership (and also reported outcome data) evaluated the impact of a teaching
booklet added to routine hospital discharge
teaching for children with burn injuries.20 The
absence of an effect may have resulted from its
emphasis on burn management, the limited
nature of the intervention, or the focus on an
injured population. However, this hospitalbased trial also had the strongest study design
among the trials. Inadequate allocation concealment and unblinded outcome assessment
in the other trials may have exaggerated their
interventions’ effects.
In summary, counseling families about
smoke alarms increased smoke alarm ownership nearly twofold, although the effect
might have been smaller if data from all
seven trials had been available. Observational studies have linked smoke alarm ownership to a substantially reduced risk of
death in the event of a residential fire (see
the article by Grossman in this journal
issue). Therefore, even a modest effect of
counseling on ownership may lead to important decreases in fire-related injuries.
The effect on ownership is much stronger
when discounted smoke alarms are provided,
possibly because low-income families, who are
least likely to own smoke alarms,41 require
assistance to overcome cost barriers. Trials of
community programs involving home visits to
distribute free smoke alarms have reported
large increases in smoke alarm ownership42
and decreases in fire-related injuries.43 Such
community approaches may be more useful
for targeting the highest-risk families, who are
less likely to have access to injury prevention
counseling and may require assistance to purchase and install alarms.
Strategies to Childproof the Home
Among children under age five, falls, poisoning, cuts, burns, smoke inhalation,
drowning, suffocation, and choking cause at
least two-thirds of all unintentional injuries.
http://www.futureofchildren.org
Individual-Level Injury Prevention Strategies in the Clinical Setting
69
Figure 3
The Effect of Clinical Interventions on Smoke Alarm Ownership
ORa
95% CIb
Thomas (1984)
5.09
0.53,48.85
Kelly (1987)
1.36
0.44, 4.23
Barone (1988)
2.38
0.41,13.82
Jenkins (1996)
0.86
0.39, 1.93
Clamp (1998)
12.70
Study
Total
1.74
Graphic Representationc
1.60,100.85
1.03, 2.96
0.01
0.1
Control Group
Better
1.0
10
100
Intervention Group
Better
a
Odds Ratio (OR) measures the strength of the association between the intervention and the outcome. An OR=1.0
indicates no association. An OR>1.0 indicates a positive effect of the intervention on the outcome, and an OR<1.0 is a
negative effect.
b
The 95% Confidence Interval (CI) estimates the expected range of the OR 95 out of 100 times. A “statistically significant”
result in this article is defined by a 95% CI that excludes 1.0.
c
The box corresponds to the OR. A box to the right of 1.0 favors the intervention group, while a box to the left of 1.0 favors
the control group. The length of the line corresponds to the 95% CI.
Many of these injuries occur in the home,
where young children spend most of their
time. Household risk factors for injuries
to young children include unprotected
stairs, windows, and fireplaces; and
improperly stored household cleaning
agents, medications, matches, and sharp
objects (see the article by Grossman in
this journal issue). Strategies to childproof the home include changes that are
made specifically to protect young children from these risks, and that would not
typically be implemented in homes without children.
Five trials were found that evaluated
counseling families to childproof their
homes, all of which targeted children
under five years of age (see Table
5).4,18,19,21,22 Four trials involved intensive
interventions,4,18,19,21 and two of these also
evaluated the effect of offering free or discounted safety devices.18,19 The fifth trial
offered a brief intervention in the emergency department.22 The trials assessed various safety practices, most commonly safe
storage of household medications, cleaning
agents, matches, and sharp objects; and use
of electric outlet covers.
http://www.futureofchildren.org
Overall, intervention appeared to have
little effect on safety practices. Two trials
reported modest effects that were not statistically significant.4,21 Two others reported no statistically significant differences between
intervention and control households, but they
provided no data.19,22 In contrast, one trial
reported strongly positive and statistically significant beneficial effects for most outcomes.18
Combined results from the three trials
that provided numerical outcome data4,18,21
show that, compared with control families,
intervention families were 1.8 times more
likely to store cleaning agents safely. There
was also a modest effect on safe storage of
matches (which was not statistically significant) among the two trials that reported
this outcome.4,21 These estimates may have
been biased upward, however, by the failure
to include data from the two trials that
found no significant differences between
intervention and control households.19,22
Because of marked variation in the results
for use of electric outlet covers and for safe
storage of medications and knives, data
from the three trials that studied these outcomes could not be combined. Most of the
trials used similarly intensive interventions,
70
Table 4
Randomized Controlled Trials of Interventions in the Clinical Setting to Promote Smoke Alarmsa
Trial, Year,b
Country
Population
Enrolled
in Study
Kelly4
1987
United States
171 parents of
6-month-olds
seen for WCC
I: 15-minute developmentally oriented
child safety education, hazard
assessment, and handout by
research physician at 6-, 9-, and
12-month WCCs; usual WCC
C: Usual WCC
Blinded home
inspection,
questionnaire, and
medical chart
review 1 month
after 12-month
WCC
Not described
Own alarm:
8/55 (15%)
Own alarm:
6/54 (11%)
Williams7
c
1988
United States
12 prenatal
classes
(165 pregnant
women)
I: One-hour lecture and handouts
on burn prevention; usual safety
education
C: One-hour lecture, handouts, and
video on infant stimulation and
feeding; usual safety education
Unblinded home
inspection two to
four weeks after
birth
Adequate
Data not available
Data not available
Five parenting
classes
(108 parents of
toddlers)
I: Slides and handouts on burn
prevention; usual safety education
C: Usual safety education
Unblinded home
inspection six
months after class
Not adequate
Own alarm:
39/41 (95%)
Own alarm:
34/38 (89%)
16 well-baby
classes
(55 parents
enrolled)
I: Burn prevention lecture, pamphlets,
and handouts; coupon for smoke
alarm; usual safety guidance
C: Usual safety guidance
Home inspection
four to six weeks
after class;
blinding not
stated
Not adequate
Own alarm:
28/29 (97%)
Own alarm:
22/26 (85%)
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16
Thomas
1984
United States
Outcome
Assessment
Allocation
Concealment
Selected Outcomes
Intervention
Control
THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
8
Barone
c
1988
United States
Intervention
Randomized Controlled Trials of Interventions in the Clinical Setting to Promote Smoke Alarmsa
Selected Outcomesc
Trial, Year,b
Country
Population
Enrolled
in Study
Clamp18
c
1998
United Kingdom
165 families of
children under
age 5 in
general practice
I: Injury prevention advice from
physician; leaflets; discounted
smoke alarms
C: Usual care
Unblinded selfreport survey six
weeks after visit
Adequate
Own alarm:
82/83 (99%)
Own alarm:
71/82 (87%)
36 general
practices (2,052
children ages
3 to 13 months)
I: Safety advice by health visitors and
nurses; discounted smoke alarms;
home safety checks; first aid training
C: Usual care
Unblinded record
review for injuries;
self-reported
safety practices
Adequate
Data not available
Data not available
141 families of
children under
17 years of age
in burn unit
I: Discharge teaching book on burn
follow-up management and burn
prevention; routine d/c teaching
C: Routine d/c teaching
Self-report at
first follow-up clinic
visit by blinded
interviewer
Adequate
Own alarm:
45/62 (73%)
Own alarm:
46/61 (75%)
19
Kendrick
c,d
1999
United Kingdom
20
Jenkins
c,d
1996
Canada
Intervention
Outcome
Assessment
a
I=intervention group; C=control group; WCC=well-child care visit; ED=emergency department; d/c=discharge.
b
See related endnotes at the end of this article.
c
Unpublished methodological details provided by author.
d
Unpublished outcomes data provided by author.
Allocation
Concealment
Intervention
Control
Individual-Level Injury Prevention Strategies in the Clinical Setting
http://www.futureofchildren.org
Table 4 (continued)
71
72
Table 5
Randomized Controlled Trials of Interventions in the Clinical Setting to Promote Childproofing the Homea
Trial, Year,b
Country
Population
Enrolled
in Study
Kelly 4
1987
United States
171 parents of
6-month-olds
seen for WCC
c
Intervention
I: 15-minute developmentally oriented
child safety education, hazard
assessment, and handout by
research physician at 6-, 9-, and
12-month WCCs; usual WCC
C: Usual WCC
Outcome
Assessment
Blinded home
inspection,
questionnaire, and
medical chart
review 1 month
after 12-month
WCC
Allocation
Concealment
Not described
Selected Outcomes
Intervention
Outlet covers:
23/54 (43%)
Safe storage of
Medicines:
54/54 (100%)
Cleaners:
43/54 (80%)
Sharp objects:
41/54 (76%)
Matches:
49/54 (91%)
Parent-reported “accidents”:
OR=0.78 (0.35, 1.74)
Parent-reported ED visits:
OR=1.60 (0.53, 4.84)
Medically attended injuries:
OR=1.47 (0.60, 3.60)
Hospitalizations:
OR=0.98 (0.06, 16.11)
http://www.futureofchildren.org
Clamp18
d
1998
United Kingdom
165 families of
children under
age five in
general practice
I: Injury prevention advice from
physician; leaflets; discounted
safety devices
C: Usual care
Unblinded selfreport six weeks
after visit
Adequate
Outlet covers:
68/83 (82%)
Safe storage of
Medicines:
79/83 (95%)
Cleaners:
59/83 (71%)
Sharp objects:
52/83 (63%)
Outlet covers:
38/82 (46%)
Safe storage of
Medicines:
68/82 (83%)
Cleaners:
49/82 (60%)
Sharp objects:
26/82 (32%)
THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
Outlet covers:
28/55 (51%)
Safe storage of
Medicines:
55/55 (100%)
Cleaners:
49/55 (89%)
Sharp objects:
43/55 (78%)
Matches:
51/55 (93%)
Control
Randomized Controlled Trials of Interventions in the Clinical Setting to Promote Childproofing the Homea
Trial, Year,b
Country
19
Kendrick
d,e
1999
United Kingdom
c
Population
Enrolled
in Study
36 general
practices
(2,052 registered
children ages
3 to 13 months)
Outcome
Assessment
Intervention
I: Safety advice by health visitors and
nurses; discounted safety devices;
home safety checks; first aid training
C: Usual care
Unblinded record
review for injuries;
self-reported
safety practices
Allocation
Concealment
Adequate
Selected Outcomes
Intervention
Control
Medically attended injury:
OR=0.97 (0.72, 1.30)
ED visit for injury:
OR=1.02 (0.76, 1.37)
GP attendance for injury:
OR=0.75 (0.48, 1.17)
Hospitalization for injury:
OR=0.69 (0.42, 1.12)
Data on safety practices not available
21
Dershewitz
1977
United States
22
Woolf
1987
United States
330 families with
children ages
0 to 4 seen for
WCC or minor
illness, prepaid
health plan
I: Booklet and 20-minute discussion on
home safety by research assistant;
telephone reinforcement 4 weeks
later; free safety devices
C: Free safety devices
Blinded inspection,
questionnaire at
home visit one
month later
Not described
Outlet covers:
89/101 (88%)
Safe storage of
Medicines:
22/101 (22%)
Cleaners:
1/101 (1%)
Sharp objects:
32/101 (32%)
Matches:
47/101 (47%)
Outlet covers:
88/104 (85%)
Safe storage of
Medicines:
20/104 (19%)
Cleaners:
0/104 (0%)
Sharp objects:
38/104 (36%)
Matches:
43/104 (41%)
343 families of
children 5 years
of age or
younger seen in
ED for nonurgent
care
I: Brief counseling and handout on
poisoning prevention; telephone
sticker; free ipecac; questionnaire
about poisoning
C: Questionnaire about poisoning
Self-report by
blinded interview
four to six months
later
Not described
Data not available
Data not available
a
I=intervention group; C=control group; WCC=well-child care visit; ED=emergency department.
b
See related endnotes at the end of this article.
c
Odds Ratio (OR) measures the strength of the association between the intervention and the outcome. An OR=1.0 indicates no association. An OR>1.0 indicates a positive effect of the intervention
on the outcome, and an OR<1.0 indicates a negative effect. The 95% confidence interval (in parentheses) estimates the expected range of the OR 95 out of 100 times. A “statistically significant”
result in this article is defined by a 95% confidence interval that excludes 1.0.
Unpublished methodological details provided by author.
e
Unpublished outcomes data provided by author.
73
d
Individual-Level Injury Prevention Strategies in the Clinical Setting
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Table 5 (continued)
THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
74
PHOTO OMITTED
so it is not clear whether these marked variations were due to differences in the quality
of the interventions or the study designs, or
to other unknown factors.
The two trials that measured injury outcomes (all types of injuries combined)
showed that, with intervention, the likelihood of injury hospitalization was reduced
by 27%.4,19 One trial19 also reported that the
likelihood of injury resulting in attendance
by a general practitioner was reduced by
25%, and the other4 found that the risk of
parent-reported “accidents” was reduced by
22% in the intervention group. However,
none of these differences were statistically
significant. Moreover, no intervention
effects were associated with the risk of emergency visits for injury,4,19 medically attended
injuries,4,19 injury severity scores,19 or length
of hospital stay.19
In summary, evidence from this systematic review suggests that clinical counseling
has little effect on most home safety practices designed to childproof the home. It is
possible that the scope and intensity of the
interventions were not adequate to reduce
household hazards, or that study families
were overwhelmed or confused by the
number and variety of safety practices
recommended. High cost, difficulty obtaining recommended safety devices,44 the
need for technical skills and tools to install
some devices, and residence in rental
accommodation should be recognized as
important barriers to implementing advice
about home safety, particularly for lowincome households.27
Trials in this review also do not establish
that clinical interventions aimed at making
homes safer for children will reduce
injuries. Such interventions may fail to
reduce injuries if they do not change safety
practices, or if changes in these practices do
not affect injuries. This review provides
some support for the first explanation.
However, there also is a lack of wellconducted observational studies demonstrating that the general home safety measures
advocated in these trials are associated with
a reduction in childhood injuries. For
example, although the widespread use of
child-resistant containers for medications
and household chemicals has reduced
childhood poisonings,29 any added effect of
locking away such containers has not been
evaluated. Lack of evidence about the
impact of these strategies on injury outcomes makes it difficult to ascertain the
extent children would benefit from clinical
interventions that encourage their parents
to adopt measures to childproof the home.
Implications for Practice
and Research
This systematic review provides evidence
that interventions delivered in the clinical
setting are likely to be successful at increasing the adoption of some safety practices
aimed at reducing childhood injuries, but
not others. Elements of these trials that may
have influenced their effectiveness have
important practice and policy implications.
This section examines characteristics of
these studies in relation to designing and
implementing clinical strategies and setting
future research agendas for childhood
injury prevention.
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Individual-Level Injury Prevention Strategies in the Clinical Setting
Implications for Practice
In general, the trials reviewed support evidence from research that describes three
types of factors that health education can
modify: predisposing, enabling, and reinforcing (see Box 5).30 Trials that had the
greatest effect on safety practices used a
combination of these strategies, combining
education with reinforcement or with free
or subsidized safety devices, for example. As
future clinical interventions to improve
child safety are developed, practitioners
should be aware that counseling alone may
not be sufficient to alter behavior.
The clinical interventions that appeared
most effective—those involving advice,
demonstrations, subsidized safety equipment, and reinforcement through repeated
messages and visits, incentives, and
rewards—are time consuming. Yet, the
average clinician has only limited time to
devote to injury prevention. The busy clinician should consider focusing injury prevention counseling on practices where a
beneficial effect is most likely to result. It
would be reasonable to emphasize correct
and consistent motor vehicle restraint use,
installation and maintenance of smoke
alarms, and testing and maintaining a safe
hot tap water temperature.
Careful consideration of the target population also is important to maximize the
impact of interventions in the clinical setting
on child safety practices. For example, this
review did not find evidence to support
injury prevention counseling that targeted
bicycle helmet ownership. However, these
were the only trials reviewed that targeted
school-age children.12,13 The lack of impact
may reflect differences in the responsiveness
to safety counseling of families of school-age
children compared with pregnant women
or parents of newborns.
Similarly, study populations also varied in
terms of the health of the children targeted.
Most trials enrolled parents or parents-to-be
in well-care settings, including prenatal and
parenting classes. However, two trials—one
promoting bicycle helmet purchase12 and
the other smoke alarm ownership20—
targeted injured children. Neither of these
trials found differences in safety practices
comparing intervention and control groups.
Parents of injured children may be less
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amenable to safety messages, or perhaps
such parents receive safety messages from
other sources that outweigh any potential
impact from the experimental intervention.
Study populations also differed according to the baseline level of safety practice.
For most safety practices, there were greater
effects in trials where baseline use was low.
These trials were usually implemented
before legislation mandating safety practice
was enacted. It is reasonable to assume that
when only a small proportion of the population has adopted a safety practice, others can
be influenced simply by providing information, advice, and persuasion. When 90% of
the population has already adopted a practice, however, it is likely that the remaining
The busy clinician should consider
focusing injury prevention counseling on
practices where a beneficial effect is most
likely to result.
families are prevented from doing so not by
lack of awareness, but by more substantial
barriers such as cost, access, language, or culture. In these instances, low-cost availability
of safety devices, and education sensitive to
the local culture and available in the local
language, may be critical to increase use.
The clinical setting may not be suitable
for implementing the entire range of information, modeling, resources, and reinforcement required to change safety practices,
particularly for some populations, including
parents of school-age or injured children.
Clinical interventions may be more effective
if delivered in the context of broader community, legislative, engineering, and regulatory changes. In many communities,
physicians and other health professionals
have provided leadership for effective injury
prevention programs and legislation.26,27
Clinicians may wish to consider playing an
advocacy role as a means of preventing
injuries, while continuing to support behavior change with clinical interventions.
Implications for Research
Many of the trials identified in this review
were conducted more than a decade ago,
75
76
THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
PHOTO OMITTED
before legislation and regulations regarding infant safety seats, bicycle helmets,
smoke alarm installation, and preset hotwater heater temperatures were implemented (see the article by Schieber,
Gilchrist, and Sleet in this journal issue). It
is doubtful that the brief, simple interventions evaluated in the past would have the
same impact today. The identification of
efficient and cost-effective clinical interventions that improve safety practices in
the current regulatory and legislative environment is needed. In developing such
trials, careful attention to evaluation
design is essential to reduce the possibility
of biased results.
This review supports previous research
showing that studies with weaker evaluation
methods, on average, report larger effect
estimates than do studies with stronger
methods.38,39 For example, for safe hot tap
water temperature, smaller effects were
observed among the trials that used adequate study methods. Hence, while the best
available evidence supports counseling to
promote certain safety practices, the benefit
may be less than that reported here because
many of the trials reviewed did not use
adequate study methods. Additional RCTs
that adhere to rigorous design principles
would be useful to supplement the results
reported in this systematic review. Also, studies are needed to examine the effects of
interventions in the clinical setting on safety
practices aimed at reducing other causes of
childhood injuries, including pedestrian,
firearm, drowning, recreational, and alcoholrelated injuries.
The evidence about the impact of counseling in the clinical setting on childhood
injuries is limited. Although injuries—and
resulting hospitalization, disability, and
death—are of primary interest in evaluations of injury prevention interventions,
these outcomes are relatively rare in the general population. Consequently, most studies
examine effects on intermediate outcomes
such as safety practices, which are more
easily measured. Counseling interventions
that target safety behaviors can be considered effective if evidence shows that changing the safety behavior can reduce injury risk
and that clinicians can influence this behavior through counseling.
Evidence that changing a safety behavior will reduce injury risk usually comes
from studies that observe people who have
and have not chosen to implement a safety
practice, to see whether the two groups’
injury rates differ.28,29 Such observational
studies are more subject to systematic bias
than are RCTs because other differences
may exist between people who have and
have not chosen to initiate that practice,
and those differences may also affect injury
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Individual-Level Injury Prevention Strategies in the Clinical Setting
risk. For example, fire fatalities occur less
commonly among households that have
smoke alarms,40 but these households may
differ from households without alarms
in other ways that also affect fire fatalities,
such as the occupants’ ages, disabilities, or
use of alcohol, or the condition of the
property. Therefore, it is important to
identify such differences and correct for
them in the analysis.40 A number of wellconducted observational studies examining the association of safety behaviors and
injury outcomes have made substantial
efforts to identify and control for such
“confounding variables.”26–29 For other
areas, such as linking measures to childproof the home with reduced childhood
injuries, well-conducted observational
studies are still needed. Nevertheless, it
is important to recognize that even the
best observational studies can only correct for identified, measured differences
and that other differences (unidentified
or unmeasured) might also influence
outcomes. The evidence that is least subject to bias comes from RCTs that report
injury outcomes. Large trials of good
methodological quality would be valuable
for quantifying the benefit of counseling in the clinical setting on injuries
among children.
Conclusions
The clinical setting offers numerous opportunities for interventions to promote childhood safety practices because most young
children are seen regularly for well-child
care, immunizations, and minor illnesses.
Pregnant women, through participation in
regular prenatal visits and classes, also form
a ready target for strategies designed to protect their infants. Emergency departments
and hospitals are potential settings for injury
prevention strategies for those for whom an
emergency visit may provide the only opportunity to receive preventive services, such as
older adolescents or families with limited
access to care.
Physicians caring for children have long
recognized the importance of injury prevention counseling.45,46 Offering guidance
to prevent injuries to infants, children, and
adolescents has been recommended by
professional societies,47–49 government
agencies,50 and national task forces.26,27,51
Although many regard injury prevention
http://www.futureofchildren.org
guidance as beneficial, this benefit had not
been adequately quantified prior to this systematic review. The costs of injury prevention may compare favorably with those of
injury treatment and rehabilitation (see the
article by Miller, Romano, and Spicer in this
journal issue), yet funding for injury prevention interventions in the clinical setting
is not always provided by third-party payers.
Clinical injury prevention interventions
have important resource implications,
including time and effort devoted to the
intervention and the costs of pamphlets,
equipment, and other materials. Estimates
of the likely effects of clinical interventions
The costs of injury prevention may
compare favorably with those of injury
treatment and rehabilitation, yet funding
for injury prevention interventions in the
clinical setting is not always provided by
third-party payers.
on safety practices and injuries provide
important input for cost-effectiveness analyses and for policy decisions about implementation and funding.
This systematic review found that
individual-level interventions delivered in a
clinical setting are a promising way to promote improvements in certain safety practices, including motor vehicle restraint use,
smoke alarm ownership, and safe hot tap
water temperature, and, consequently, to
reduce injuries. Further research may
expose additional opportunities for clinical interventions that are as yet unproven
or untested; for example, counseling adolescents about safety practices. For some
types of injuries, strategies aimed at the
school, community, state, or nation, or
clinical interventions delivered in the context of such strategies, may be more effective at reducing childhood injuries.
The assistance of Catherine Godward (data
collection, screening citations) and Drs. David
Dunn and Julian Higgins (statistical advice) is
gratefully acknowledged. The authors are solely
responsible for the results reported.
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THE FUTURE OF CHILDREN – SPRING/SUMMER 2000
Appendix
Methodology and Search Results of the Systematic Review
This review was developed using the methods of the Cochrane Collaboration (see Box 1) and will be
published and periodically updated in the Cochrane Database of Systematic Reviews.
Methods
Data Sources
We searched the Cochrane Controlled Trials Register (CCTR)(The Cochrane Library 1998, issue #3),
Cochrane Injuries Review Group database (searched August 1998), MEDLINE EXPRESS (1966–August
1998), EMBASE (1980–August 1998), Cumulative Index to Nursing and Allied Health (1982–August 1998),
and Dissertation Abstracts (1861–August 1998). The CCTR was searched using injury- and age-related
content terms (available from author on request). MEDLINE was searched by combining these content
terms with a search strategy for identifying controlled trials.1 Similar search strategies were developed
for the other databases. There were no language restrictions.
We searched the bibliographies of published reviews2–7 and a review on the World Wide Web
(http://depts.washington.edu/hiprc/childinjury). We reviewed presentation abstracts from four World
Conferences on Injury Prevention and Control.8–11 We contacted authors of relevant trials, the membership of the International Society for Child and Adolescent Injury Prevention, and more than 50 organizations and institutions in Europe, North America, Australia, and New Zealand.
Inclusion Criteria
We included studies if: (1) the intervention was designed to prevent unintentional injuries to persons ages
0 to 19; (2) the intervention was delivered in a clinical setting, such as physician offices, clinics, or hospitals; (3) participants were assigned randomly to intervention and control groups; and (4) the study collected data on injuries, events that can cause injuries (for example, falls), or safety practices.
Study Selection
Two researchers independently screened citations to exclude studies that clearly failed to meet our first
three inclusion criteria; differences were resolved by discussion. The full texts of remaining citations
were reviewed and additional studies were excluded using the same criteria. We contacted the corresponding authors or other coauthors of all remaining studies to determine eligibility, request study
details, and identify additional trials.
Data extraction
Two researchers independently extracted data on study design, participants, and interventions. To assess
study design, we extracted information on methods of allocation concealment, blinding of outcomes
assessment, and the withdrawal or exclusion of subjects after randomization.12,13 We rated allocation
concealment as adequate if the methods contained elements indicative of concealment (for example,
allocation by independent statistician) and inadequate if the method was not convincing of concealment (for example, coin toss at enrollment) or was not described.
One researcher extracted outcome data. For two trials,14,15 data as reported was not usable in our
analyses. Christophersen and colleagues15 reported outcomes for each group as percentages, but
reported only total numbers of subjects randomized (n=129) and lost to follow-up at 12 months (n=53).
To calculate denominators, we assumed that equal numbers were randomized to each group and that
there was no loss to follow-up at first observation (which occurred immediately after intervention);
numerators were calculated from published percentages. We excluded later assessments. Miller and
Pless14 reported a mean car seat use score by combining self-reported usual use and use when traveling
to the doctor’s office that day. We estimated the proportion of subjects who reported both “always used
car seat” and “used car seat that day” from the mean postintervention scores for each group and the published postintervention distributions of responses to “always used” and “use on that day” for the total
sample. We calculated numerators from these proportions using published group denominators. The
sum of participants in each group did not equal the total number of participants reported. As the authors
were unable to provide correct data, we made conservative assumptions in our calculations.
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Individual-Level Injury Prevention Strategies in the Clinical Setting
Appendix (continued)
Analysis
Primary outcome measures included injuries and safety practices. We compared the number and rate of
injuries during follow-up. For safety practices, we compared postintervention prevalences between intervention and control groups. For car restraint use, we assessed short- and long-term follow-up results,
defining the earliest measurement in a given trial as “short term” and the last measurement as “long
term.” Where only one measurement was reported, we arbitrarily assigned follow-up periods up to six
months as short term and six months or more as long term.
We explored whether variations in study results were related to the study population, intervention
characteristics (duration, use of reinforcement techniques, subsidization of safety devices), or study
design (allocation concealment, blinding of outcomes assessment).
Using Review Manager 3.1, meta-analyses were performed to combine odds ratios between intervention and control groups, using fixed-effects models. We used a significance level of 10% to test for
heterogeneity. When the results from more than one intervention group were reported,14,16 we combined data from all intervention groups, except when exploring heterogeneity according to intervention
characteristics. Kim and colleagues17 reported odds ratios and confidence intervals that were adjusted
for nonindependence of data; from these, we calculated adjusted numerators and denominators for use
in our meta-analyses using standard techniques.
To combine the data on injury outcomes, which in one trial was reported only as adjusted odds ratios
and confidence intervals,18 a pooled odds ratio for each injury outcome was calculated as an inverse variance weighted average of the study-specific odds ratios.
For cluster randomized trials, we reduced subject numbers to an “effective sample size” to take into
account the cluster randomization,19 using an estimate of the intraclass correlation coefficient (0.0027)
from a published trial involving randomized clinical practices.20 All meta-analyses include effective
sample sizes. The unadjusted numerators and denominators are shown in the tables.
Search Results
We identified 10,330 unduplicated citations, of which 103 were potentially eligible. We reviewed the full
texts of 101 studies; two were available only in abstract. Twenty-one trials (reported in 20 papers and two
abstracts) met all inclusion criteria, 79 studies were excluded after full text review, and 2 trials were
excluded based on information provided by investigators. We received responses from the investigators
of 18 (86%) of 21 eligible trials, from which we identified one additional trial.18
Endnotes:
1 Dickersin, K., Scherer, R., and Lefebvre, C. Identifying relevant studies for systematic reviews. British Medical Journal (1994) 309:1286-91.
2
See note no. 26 at the end of this article.
3
See note no. 27 at the end of this article.
4
Bass, J.L., Christoffel, K.K., Widome, M., et al. Childhood injury prevention counseling in primary care settings: A critical review of the literature. Pediatrics
(1993) 92:544-50.
5
Ciliska, D., Hayward, S., Thomas, H., et al. A systematic overview of the effectiveness of home visiting as a delivery strategy for public health nursing interventions. Canadian Journal of Public Health (1996) 87:193–38.
6
Munro, J., Coleman, P., Nicholl, J., et al. Can we prevent accidental injury to adolescents? A systematic review of the evidence. Injury Prevention (1995) 1:249–55.
7
Towner, E., Simpson, G., Jarvis, S., and Dowswell, T. Health promotion in childhood and young adolescence for the prevention of unintentional injuries.
London: Health Education Authority, 1996.
8
First World Conference on Accident and Injury Prevention. Final program. Stockholm, Sweden, September 17–20, 1989.
9
Second World Conference on Injury Control. Abstracts: Workshops, oral presentations, poster sessions. Atlanta, Georgia, May 20–23, 1993.
10
Third International Conference on Injury Prevention and Control. Presentation abstracts. Melbourne, Australia, February 18–22, 1996.
11
Fourth World Conference on Injury Prevention and Control. Book of abstracts, Vol. I and II. Amsterdam, Netherlands, May 17–20, 1998.
12
See note no. 38 at the end of this article.
13
See note no. 39 at the end of this article.
14
See note no. 2 at the end of this article.
15
See note no. 9 at the end of this article.
16
See note no. 3 at the end of this article.
17
See note no. 14 at the end of this article.
18
See note no. 19 at the end of this article.
19
Hauck, W.W., Gilliss, C.L., Donner, A., and Gortner, S. Randomization by cluster. Nursing Research (1991) 40:356–58.
20
Donner, A., and Klar, N. Confidence interval construction for effect measures arising from cluster randomization trials. Journal of Clinical Epidemiology
(1993) 46:123-31.
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