Translating Best Evidence into Best CareEDITOR’S NOTE: Journals reviewed for this issue: Archives of Disease in Childhood, Archives of Pediatrics and Adolescent Med-icine, British Medical Journal, Journal of the American Medical Association, The Journal of Pediatrics, The Lancet, New EnglandJournal of Medicine, Pediatric Infectious Diseases Journal, and Pediatrics. Heidi Marleau, MLS, Ebling Library for the HealthSciences, University of Wisconsin, contributed to the review and selection of this month’s abstracts.

—John G. Frohna, MD, MPH

Installation of home safety devices reducesincidence of preventable injury in young childrenPhelan KJ, Khoury J, Xu Y, Liddy S, Hornung R, Lanphear BP.A randomized controlled trial of home injury hazard reduc-tion: the HOME injury study. Arch Pediatr Adolesc Med2011;165:339-45.

Question Does the installation of safety devices in the homesof young children reduce the rate of injuries, compared withprovision of handouts alone?

Design A nested, prospective, randomized controlled trial.

Setting Households in the Cincinnati, Ohio regional area.

Participants 355 mothers and their children from birth to 3years old (mean age 6.3 months) participating in the HomeObservation and Measures of the Environment study.

Intervention Installation of multiple passive measures (eg,stair gates, cabinet locks, and smoke detectors) to reduce ex-posure to injury hazards. Injury hazards were assessed athome visits by teams of trained research assistants using a val-idated survey. Both intervention and control groups receivedAmerican Academy of Pediatrics’ ‘‘The Injury PreventionProgram’’ information sheets on developmentally appropri-ate injury risks and control measures.

Outcomes Modifiable and medically attended injury (ie,telephone calls, office visits, and emergency visits for injury).

Main Results Injury hazardswere reduced in the interventionhomes but not in the control homes at 1 and 2 years (P< .004).There was no difference in the rate for all medically attendedinjuries in intervention children comparedwith controls: 14.3injuries (95% CI, 9.7-21.1 injuries) vs 20.8 injuries (95% CI,14.4-29.9 injuries) per 100 child-years (P = .17); but therewas a significant reduction in the rate of modifiable medicallyattended injuries in intervention children compared withcontrols: 2.3 injuries (95% CI, 1.0-5.5 injuries) vs 7.7 injuries(95% CI, 4.2-14.2 injuries) per 100 child-years (P = .03).

Conclusions An intervention to reduce exposure to hazardsin homes led to a 70% reduction in the rate of modifiablemedically attended injury.

Commentary Injuries in the home are a major public healthconcern, and a leading cause of death in children under theage of 5 years.1 Although it is logical to deduce that hazardsin the home environment contribute to a sequence of eventsculminating in an injury, our recent Cochrane Review foundinsufficient evidence to suggest that amelioration of such haz-ards reduced injuries.2 This study by Phelan et al demon-

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strates an intervention that reduces hazards in the home,and significantly reduces the rate of modifiable medicallyattended injuries in intervention children. It is also success-fully installed and maintained home safety devices in allintervention homes. One limitation of the study is its gener-alizability. Mothers were excluded from the trial if they were:younger than 18 years, could not speak fluent English, livingin public/shelter housing, or living in a property built after1978. These criteria excluded a high percentage of house-holds, which have been shown to be at increased risk of injuryand less likely to engage in safety practices.3-4 Additionally,the main outcome was based on a relatively small numberof modifiable medically attended injuries (interventiongroup, n = 5; control group, n = 16). Nevertheless, thiswell-conducted trial is a significant advance on previouswork, and provides encouraging results for the reduction ofhome injuries. It demonstrates the importance of actively in-stalling home safety devices to ameliorate hazards, ratherthan relying solely on safety advice as in other studies. Beforestrong policy recommendations can be made, the successfulhome safety intervention described in this trial should be rep-licated with larger sample sizes, and across different popula-tions and settings.

Samantha Turner, BScSwansea University

Swansea, United Kingdom

References

1. Peden M, Oyebite K, Ozanne-Smith J, Hyder AA, Branche C,

Rahman FAKM, Rivara F, Bartolomeos K, eds. World report on child in-

jury prevention. Geneva: World Health Organization Press; 2008.

2. Turner S, Arthur G, Lyons RA, Weightman AL, Mann MK, Jones SJ, et al.

Modification of the home environment for the reduction of injuries.

Cochrane Database Syst Rev 2011;2:CD003600.

3. Kendrick D, Mulvaney C, Burton P, Watson M. Relationships between

child, family and neighbourhood characteristics and childhood injury:

a cohort study. Soc Sci Med 2005;61:1905-15.

4. KendrickD.Children’s safety in the home: parents’ possession and percep-

tions of the importance of safety equipment. Public Health 1994;108:21-5.

Omalizumab reduces frequency of asthmaexacerbations in childrenBusseWW,MorganWJ, Gergen PJ,Mitchell HE, Gern JE, LiuAH, et al. Randomized trial of omalizumab (anti-IgE) forasthma in inner-city children.NEngl JMed2011;364:1005-15.

Vol. 159, No. 3 � September 2011

Question Among children and adolescents with asthma,does omalizumab decrease asthma exacerbations and symp-toms, compared with placebo?

Design Randomized, double-blind, placebo-controlled, par-allel-group trial.

Setting Multiple centers in the United States.

Participants 419 children, adolescents, and young adults (6-20years old) with persistent asthma. At randomization, 73% hadmoderate or severe disease.

Intervention Participants were randomized to subcutaneousinjections of omalizumab (75 to 375 mg based on weight) orplacebo every 2 or 4 weeks for a total of 60 weeks (15 or 30injections).

Outcomes The primary outcome was severity of asthmasymptoms. Secondary outcomes included asthma exacerba-tions and other validated measures of asthma control.

Main ResultsOmalizumab significantly reduced the numberof days with asthma symptoms, from 1.96 to 1.48 days per2-week interval, a 24.5% decrease (P < .001). Similarly, oma-lizumab significantly reduced the proportion of participantswho had one or more exacerbations from 48.8 to 30.3%(P < .001, number needed to treat = 6). Improvementsoccurred with omalizumab despite reductions in the use ofinhaled glucocorticoids and long-acting beta-agonists.

Conclusions When added to a regimen of guidelines-basedtherapy for inner-city children, adolescents, and youngadults, omalizumab further improved asthma control, nearlyeliminated seasonal peaks in exacerbations, and reduced theneed for other medications to control asthma.

Commentary Omalizumab, a humanized monoclonal anti-IgE antibody, is clinically effective, although cost-effectivenesshas not been conclusively demonstrated. Some of the difficul-ties with establishing the cost-effectiveness of omalizumab arerelated to the fact that improvements in quality of life andreductions in exacerbations are not accompanied by changesin lung function on which many costs-effectiveness modelsare based.1 Responses to omalizumab are variable and,although cost-effectiveness appears to be greater in those withsevere disease, to date there is no reliable way of identifyingthose people prior to starting treatment. This study showsthat omalizumab has a significant impact on asthma controland exacerbations in an inner-city population of children andyoung adults with severe asthma. It also suggests that it ismore effective in those who are both sensitized and exposedto cockroach allergen. Compared with those who were neithersensitized nor exposed to cockroach allergen, people receivingomalizumab had bigger reductions in inhaled corticosteroiddose (P = .03), asthma exacerbations (P = .06), and increasedodds of not having an asthma exacerbation (P = .06). Thismay represent the beginning of a different approach to selectingpatients for treatment with omalizumab, which allows prioridentification of likely responders. Importantly, however, it isclear from neither the paper nor the supplementary appendiceshow many people in this study were both sensitized and

exposed to cockroach allergen. Further validation of thisapproach is required before it can be used to reliably to identifyresponders to omalizumab.

Samantha Walker, PhDSenior Lecturer (Hon)

Centre for Population Health SciencesUniversity of Edinburgh, Scotland

Director of Research and Policy, AsthmaLondon, United Kingdom

Reference

1. Sullivan SD, Turk F. An evaluation of the cost-effectiveness of oma-

lizumab for the treatment of severe allergic asthma. Allergy 2008;63:

670-84.

Inhaled corticosteroids are beneficial in treatingasthma exacerbations in children with mildpersistent asthmaMartinez FD, Chinchilli VM, Morgan WJ, Boehmer SJ,Lemanske RF, Jr, Mauger DT, et al. Use of beclomethasonedipropionate as rescue treatment for children with mildpersistent asthma (TREXA): a randomised, double-blind,placebo-controlled trial. Lancet 2011; 377: 650-7.

Question Among children with mild persistent asthma, howeffective are inhaled corticosteroids as rescue treatment?

Design Randomized, double-blind, placebo-controlled trial.

Setting Five clinical centers in the United States.

Participants 843 children and adolescents (ages 5-18 years)with mild persistent asthma were enrolled.

Intervention 288 participants were assigned to one of fourtreatment groups (with the remainder excluded during therun-in period based on pre-defined criteria): (1) twice dailybeclomethasone with beclomethasone plus albuterol as res-cue (combined group); (2) twice daily beclomethasone withplacebo plus albuterol as rescue (daily beclomethasonegroup); (3) twice daily placebo with beclomethasone plusalbuterol as rescue (rescue beclomethasone group); and(4) twice daily placebo with placebo plus albuterol as rescue(placebo group).

Outcomes The primary outcome was time to first exacerba-tion that required oral corticosteroids. The secondary out-come measured linear growth.

Main Results Compared with the placebo group (49%, 95%CI 37-61), the frequency of exacerbations was lower in thedaily (28%, 18-40, P = .03, number needed to treat [NNT]= 5), combined (31%, 21-43, P = .07, NNT = 6), and rescue(35%, 24-47, P = .07, NNT = 8) groups. Frequency of treat-ment failure was 23% (95% CI 14-43) in the placebo group,compared with 5.6% (1.6-14) in the combined (P = .012),2.8% (0-10) in the daily (P = .009), and 8.5% (2-15) in therescue (P = .024) groups. Compared with the placebo group,

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