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Artikel Irfan
Artikel Irfan
Artikel Irfan
Thomas J. Sandora, MD, MPH*; Elsie M. Taveras, MD, MPH‡; Mei-Chiung Shih, PhD§;
Elissa A. Resnick, BS*; Grace M. Lee, MD, MPH*‡; Dennis Ross-Degnan, ScD‡; and
Donald A. Goldmann, MD*
ABSTRACT. Objective. Good hand hygiene may re- Conclusions. A multifactorial intervention emphasiz-
duce the spread of infections in families with children ing alcohol-based hand sanitizer use in the home re-
who are in out-of-home child care. Alcohol-based hand duced transmission of GI illnesses within families with
sanitizers rapidly kill viruses that are commonly associ- children in child care. Hand sanitizers and multifaceted
ated with respiratory and gastrointestinal (GI) infections. educational messages may have a role in improving
The objective of this study was to determine whether a hand-hygiene practices within the home setting. Pediat-
multifactorial campaign centered on increasing alcohol- rics 2005;116:587–594; hand hygiene, hand sanitizer, child
based hand sanitizer use and hand-hygiene education care, illness transmission, randomized controlled trial.
reduces illness transmission in the home.
Methods. A cluster randomized, controlled trial was
conducted of homes of 292 families with children who ABBREVIATIONS. GI, gastrointestinal; IRR, incidence rate ratio;
CI, confidence interval.
were enrolled in out-of-home child care in 26 child care
centers. Eligible families had >1 child who was 6 months
to 5 years of age and in child care for >10 hours/week.
M
ore than 7.5 million children who are
Intervention families received a supply of hand sanitizer
younger than 5 years are enrolled in out-of-
and biweekly hand-hygiene educational materials for 5
months; control families received only materials promot- home child care in the United States,1
ing good nutrition. Primary caregivers were phoned bi- where they are at high risk for acquiring contagious
weekly and reported respiratory and GI illnesses in fam- diseases, especially viral respiratory tract and gastro-
ily members. Respiratory and GI-illness–transmission intestinal (GI) infections.2–11 Transmission rates are
rates (measured as secondary illnesses per susceptible high because children readily exchange secretions,
person-month) were compared between groups, adjust- children with potentially communicable infections
ing for demographic variables, hand-hygiene practices, are not always excluded from child care, and staff
and previous experience using hand sanitizers. face daunting challenges in personal hand hygiene
Results. Baseline demographics were similar in the 2 and environmental sanitation.12,13 Infections that are
groups. A total of 1802 respiratory illnesses occurred
during the study; 443 (25%) were secondary illnesses. A
acquired in child care are readily transmitted to fam-
total of 252 GI illnesses occurred during the study; 28 ily members in the home,14–16 where organisms are
(11%) were secondary illnesses. The secondary GI-illness spread primarily via contaminated hands.17–25
rate was significantly lower in intervention families com- Handwashing with soap and water generally is ac-
pared with control families (incidence rate ratio [IRR]: cepted as a simple, effective measure to reduce the
0.41; 95% confidence interval [CI]: 0.19 – 0.90). The overall spread of infections in diverse settings. For example,
rate of secondary respiratory illness was not significantly handwashing interventions decreased illness rates in
different between groups (IRR: 0.97; 95% CI: 0.72-1.30). child care centers and absenteeism in schools.26,27 A
However, families with higher sanitizer usage had a mar- recent randomized, controlled trial showed that a
ginally lower secondary respiratory illness rate than home handwashing intervention in Pakistan reduced
those with less usage (IRR: 0.81; 95% CI: 0.65-1.09).
the incidence of diarrhea in households, an impres-
sive result considering the extremely challenging en-
vironment.28
From the *Division of Infectious Diseases, Children’s Hospital Boston,
Harvard Medical School, ‡Department of Ambulatory Care and Prevention,
Despite the acknowledged effectiveness of hand-
Harvard Pilgrim Health Care and Harvard Medical School, and §Clinical washing with soap and water, compliance requires
Research Program, Children’s Hospital Boston, Boston, Massachusetts. convenient access to a sink and sufficient time to
Accepted for publication May 2, 2005. perform the procedure. Alcohol-based hand sanitiz-
This work was presented in part at the 42nd Annual Meeting of the
ers, which do not require water, are a boon for har-
Infectious Diseases Society of America; September 30 to October 3, 2004;
Boston, MA. ried parents and busy caregivers in hospitals and
No conflict of interest declared. other institutions. They rapidly kill most bacteria and
doi:10.1542/peds.2005-0199 viruses, and products that contain emollients tend to
Reprint requests to (T.J.S.) Division of Infectious Diseases, Children’s Hos- be gentler on the hands than soap and water. An
pital Boston, 300 Longwood Ave, LO-650, Boston, MA 02115. E-mail:
thomas.sandora@childrens.harvard.edu
increasing body of literature suggests that regular
PEDIATRICS (ISSN 0031 4005). Copyright © 2005 by the American Acad- use of alcohol-based hand sanitizers can reduce
emy of Pediatrics. transmission of infections in hospitals and other
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within a child care center. We adjusted for demographic variables RESULTS
(including number of children age 0 –5 in household, household
income, race, and primary caregiver occupation and education
A total of 647 families received initial letters about
level) and previous experience using hand sanitizers (measured the study, and 218 of them opted out of further
by response to the survey item, “Have you ever used alcohol- contact (Fig 1). Of the remaining 429 families, 358
based hand sanitizers in your home?”). Our model also included (83%) were eligible for enrollment. Of the 71 ineligi-
a term to adjust for reported hand-hygiene practices in the home ble families, the most common reasons for ineligibil-
at baseline; this term was a score derived from responses to ity were current use of sanitizer in the home at least
respiratory- and GI-specific hand-hygiene items on the baseline
survey (Cronbach ␣,52 a measure of internal consistency, was .86 daily (n ⫽ 17), no children aged 6 months to 5 years
for the respiratory score and .86 for the GI score). The items that enrolled in child care for at least 10 hours/week (n ⫽
made up this score addressed issues such as length of time to 15), family member working with children under 6 (n
perform routine handwashing, changes in handwashing practices ⫽ 15), and family moving before end of study (n ⫽
during times of illness, and frequency of handwashing in relation 8). Of the eligible families, 292 (82%) agreed to enroll
to specific events associated with a high likelihood of illness
transmission. In a preplanned secondary analysis, we also com-
and provided written consent; 155 families (14 child
pared secondary illness rates stratified by amount of sanitizer use, care centers) were assigned randomly to the inter-
adjusting for the same set of covariates described above for the vention group, and 137 families (12 child care cen-
primary analysis. This analysis was performed to examine the ters) were assigned randomly to the control group. In
impact of amount of hand sanitizer use on rates of illness trans- the intervention group, 12 families withdrew before
mission in the intervention group. Statistical analyses were per- completion of the 5-month study period, and 3 were
formed using SAS version 9.0 (SAS Institute, Cary, NC). Two-
sided P ⬍ .05 indicated statistical significance.
lost to follow-up; in the control group, 11 families
Because we anticipated that the majority of observed illnesses withdrew, and 8 were lost to follow-up. The propor-
would be respiratory illnesses, sample size was calculated on the tion of families who completed the study did not
basis of the outcome of secondary respiratory illness rate. Under differ between intervention and control groups (P ⫽
the assumption of 2.14 secondary cases per family in the control .28, Fisher’s exact test).
group during the study period (based on data from our previous
Baseline demographic characteristics were similar
study), 348 families would be required to detect a 20% decrease in
secondary infections with 80% power. This calculation assumes in the control and intervention groups (Table 1).
that the correlation of illness burden among families in the same Overall, 79% of enrolled families were white; 91% of
child care center is 0.01.53 primary caregivers had at least a college degree, and
* Numbers may not sum to group totals for all variables because of missing responses.
† Fisher’s exact test for categorical variables and Wilcoxon rank-sum test for continuous variables.
‡ Defined as physician, nurse, or dentist.
§ Comorbidities include asthma, allergies, heart disease, cancer, diabetes, kidney failure, immune system disorders, and chronic lung
disease.
储 The denominator for these variables is number of participants enrolled (control: n ⫽ 502; intervention: n ⫽ 551).
70% of families had an annual household income of secondary GI illnesses occurred during 3359 suscep-
at least $80 000. Participants were generally healthy; tible person-days at risk, producing a transmission
the most common underlying illness was asthma, rate of 0.25 secondary illnesses per susceptible per-
occurring in 7% of participants. son-month. The unadjusted incidence rate ratio (IRR)
A total of 1053 individuals in 292 families contrib- for secondary respiratory illness in intervention fam-
uted a total of 129 531 person-days of observation ilies compared with control families was 1.05 (95%
during the study; 382 of the individuals were 0 to 5 confidence interval [CI]: 0.78 –1.42; P ⫽ .75). The
years of age, 98 were 6 to 17 years of age, 559 were 18 unadjusted IRR for secondary GI illness in interven-
years or older, and 14 did not have age recorded. tion families compared with control families was 0.48
Table 2 shows the overall incidence rates for respi- (95% CI: 0.21–1.10; P ⫽ .08).
ratory and GI illness. A total of 1802 respiratory Predictors of GI and respiratory illness transmis-
illnesses occurred in 258 families; 1359 (75%) of these sion in the multivariable models are shown in Table
were primary illnesses. The overall respiratory ill- 3. After adjustment for race, household income, ed-
ness incidence rate was 0.42 illnesses per person- ucation level, and occupation of the primary care-
month. A total of 252 GI illnesses occurred in 138 giver; number of children aged 0 to 5 in the house-
families; 224 (89%) of these were primary illnesses. hold; previous experience using hand sanitizers; and
The overall GI-illness incidence rate was 0.06 ill- baseline hand-hygiene practices in the home, the rate
nesses per person-month. of secondary GI illness was significantly lower in
A total of 443 secondary respiratory illnesses oc- intervention families compared with control families
curred over 18 173 susceptible person-days at risk, (IRR: 0.41; 95% CI: 0.19 – 0.90; P ⫽ .03). The overall
producing a transmission rate of 0.74 secondary ill- rate of secondary respiratory illness was not signifi-
nesses per susceptible person-month. Twenty-eight cantly different between groups; the IRR in the in-
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TABLE 2. Illness Rates
GI Illnesses Respiratory Illnesses
Control Intervention Control Intervention
Total no. of illnesses 117 135 828 974
No. of families contributing 60 78 118 140
illnesses
Total no. of person-days of 60 413 69 118 60 413 69 118
observation
Total illness incidence rate* 0.06 0.06 0.42 0.43
No. of primary illnesses 99 125 626 733
No. of susceptible person-days 58 864 67 308 51 888 59 470
at risk for primary illness
Primary illness incidence rate† 0.05 0.06 0.37 0.37
No. of secondary illnesses 18 10 202 241
No. of susceptible person-days 1549 1810 8525 9648
at risk for secondary illness
Secondary illness incidence rate‡ 0.35 0.17 0.72 0.72
* Measured as number of illnesses per person-month.
† Measured as number of primary illnesses per susceptible person-month
‡ Measured as number of secondary illnesses per susceptible person-month
* Analyses adjusted for race/ethnicity (white non-Hispanic versus other), household income (⬍$80 000 vs ⱖ$80 000 per year), education
level of primary caregiver (ⱕcollege versus advanced degree), occupation of primary caregiver (medical 关physician, nurse, dentist兴 versus
not medical), number of children age 0 to 5 in household (1 vs ⱖ2), reported previous sanitizer use ever in home (yes versus no), and
baseline hand-hygiene–practice score (for GI or respiratory items).
† Reference groups for calculating IRRs are indicated by an IRR of 1.0.
‡ Occupation was not included in the GI-illness model because of nonconvergence (as a result of small number of transmissions).
tervention group was 0.97 compared with the control ⱕ2 oz per 2-week period. Adjusting for the same
group (95% CI: 0.72–1.30; P ⫽ .83). covariates as in the primary model, the IRR of sec-
We also performed a preplanned stratified analy- ondary respiratory illness for those who used the
sis to assess whether the rate of respiratory illness larger amount of hand sanitizer was 0.81 compared
transmission in intervention families was associated with those who used the smaller amount (95% CI:
with amount of sanitizer use. Primary caregivers 0.65–1.09; P ⫽ .06). In addition, comparing each stra-
reported using the hand sanitizer with a median tum within the intervention group with control fam-
frequency of 5.2 times per day. Fifty-five (38%) of the ilies, those who used the larger amount of hand
intervention families used ⬎2 oz of hand sanitizer sanitizer had an IRR of 0.83 (95% CI: 0.60 –1.17) for
per 2-week period (which corresponds to ⬃60 secondary respiratory illness, whereas those who
pushes [1 mL each] from a pump bottle, or 4 –5 uses used the smaller amount had an IRR of 1.02 (95% CI:
per day). We compared secondary respiratory illness 0.74 –1.41). This dose-response relationship was not
rates in these families with rates in families who used observed for GI illness; the adjusted IRR for second-
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forms for data collectors). We did not directly ob- 3. Sullivan P, Woodward WE, Pickering LK, DuPont HL. Longitudinal
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ACKNOWLEDGMENTS 26. Niffenegger JP. Proper handwashing promotes wellness in child care.
Dr Sandora was funded by the Glaser Pediatric Research Net- J Pediatr Health Care. 1997;11:26 –31
work. Study funds and hand sanitizer were provided by GOJO 27. Master D, Hess Longe SH, Dickson H. Scheduled hand washing in an
Industries, Inc (Akron, OH). The sponsor did not participate in elementary school population. Fam Med. 1997;29:336 –339
data analysis or manuscript preparation and did not have ap- 28. Luby SP, Agboatwalla M, Painter J, Altaf A, Billhimer WL, Hoekstra
proval rights over the publication. RM. Effect of intensive handwashing promotion on childhood diarrhea
We gratefully acknowledge the families who participated in the in high-risk communities in Pakistan: a randomized controlled trial.
study, as well as our research assistants: Odelya Pagovich, Ipek JAMA. 2004;291:2547–2554
Kutlu, and Sugi Narayanasamy. We also thank the following 29. Ehrenkranz NJ, Alfonso BC. Failure of bland soap handwash to prevent
members of the Clinical Research Program at Children’s Hospital hand transfer of patient bacteria to urethral catheters. Infect Control Hosp
Boston: David Wypij, PhD, for assistance with study design; Mag- Epidemiol. 1991;12:654 – 662
gie McCarthy for help with randomization procedures and design 30. Marples RR, Towers AG. A laboratory model for the investigation of
of study forms; and Joe Rezuke for creation of our database. contact transfer of micro-organisms. J Hyg (Lond). 1979;82:237–248
31. Mackintosh CA, Hoffman PN. An extended model for transfer of micro-
organisms via the hands: differences between organisms and the effect
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A Randomized, Controlled Trial of a Multifaceted Intervention Including
Alcohol-Based Hand Sanitizer and Hand-Hygiene Education to Reduce Illness
Transmission in the Home
Thomas J. Sandora, Elsie M. Taveras, Mei-Chiung Shih, Elissa A. Resnick, Grace M.
Lee, Dennis Ross-Degnan and Donald A. Goldmann
Pediatrics 2005;116;587
DOI: 10.1542/peds.2005-0199
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