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A systematic review on feasibility, safety and efficacy of hand hygiene in the community: effects on acute respiratory and gastrointestinal infections and absenteeism. Hübner Nils-Olaf 1*, Hübner Claudia1, Assadian Ojan2, Kramer Axel1
1Institute of Hygiene and Environmental Medicine, Ernst Moritz Arndt University
Greifswald, Walther Rathenau Str. 49a, 17489 Greifswald, Germany
2 Clinical Institute for Hygiene and Medical Microbiology of the Medical University of Vienna, Department of Hospital Hygiene, Vienna General Hospital, Waehringer Guertel 18-20, 1090 Vienna, Austria
*Corresponding author. Tel.:+49 3834 515542; fax: +49 3834 515541
E-mail address: [email protected]
KEYWORDS:
Hand hygiene, community, out-of-home child-care, schools, hand wash, hand rub,
rinse-free hand sanitizers, efficacy, safety, compliance, infection control, respiratory
diseases, diarrhoeal diseases, absenteeism, transmission, infectious diseases
Abstract Respiratory and diarrhoeal diseases cause massive economical damage because
they are a major reason for absenteeism from work in the industry, military and public
services and academic institutions and increase directly and indirectly healthcare
expenditures.
Hands are the primary vehicle of transmission of many infectious diseases. Therefore
hand hygiene is essential for preventing and controlling of infections in the health
care as well as in the community setting.
While hand washing with soap and water is the traditional way of hand hygiene,
overall compliance is essentially low and relies on several factors, as convenient
access to a sink, sufficient time to perform the procedure and problems with skin
tolerability. In the past years, several authors have investigated waterless hand
sanitizers as more effective and more compatible alternative to hand washing. Past
reviews on the topic focussed on the effectiveness of antimicrobial rinse free hand
1
sanitizer interventions in various settings, but other important aspects like safety,
handling issues, acceptance and compliance have not been reviewed so far.
Knowledge on these aspects is imperative before a broad, uncontrolled use in the
community, and especially in child-care and elementary schools, can be
recommended.
We conducted a literature review to answer whether rinse-free hand sanitizer
programmes in the community can be expected to be not only effective, but save and
feasible outside controlled trails.
It is concluded that rinse-free hand sanitizer programmes in the community can be
expected to be not only effective, but save and feasible outside controlled trails.
However, further, well designed studies in different settings are needed to strengthen
the evidence.
2
Introduction Respiratory and diarrhoeal diseases are the most common illnesses of mankind.
Diarrhoeal diseases are amongst the top three causes for child mortality in
developing countries [1]. The emergence of the severe acute respiratory syndrome
(SARS), the recent fear of a pandemic influenza and outbreaks of diarrhoea caused
by Norovirus have highlighted the importance of primary infection control measures
[2].
While mortality from respiratory and diarrhoeal diseases is essentially low in the
developed world, infectious diseases cause massive economical damage because
they are a major reason for absenteeism from work in the industry, military and public
services as well as academic institutions and increase healthcare expenditures
directly and indirectly. Even if symptoms are mild and the patient can continue to
attend school or work, concentration and productivity is altered and he becomes a
possible source for further spread of the infection.
The role of hand washing to control community based infections has been well
established [3], but applicability compliance and knowledge on its effectiveness is
essentially low [4].[5-8].
In the past years, several authors investigated antimicrobial waterless hand
formulations, which include antimicrobial rinse free hand sanitizer, alcohol based rubs
and gels, as alternative to hand washing. In 2004, Meadows and Le Saux [9] critically
reviewed the literature on the effectiveness of interventions using antimicrobial rinse
free hand sanitizer in elementary schools. By then, they identified 5 published studies
which indicated a difference in favour of the intervention, but as the evidence was of
low quality, most studies were not eligible for a meta-analysis.
In 2007, a review focussed on physical interventions to interrupt or reduce the spread
of respiratory viruses [10] and one review analyzed the effectiveness of hand hygiene
procedures [11], but the different endpoints of the encompassed studies were not
addressed so far.
Furthermore, other important aspects like safety, handling issues, acceptance and
compliance have not been reviewed so far. Knowledge on these issues is imperative
before a broad, uncontrolled use in the community and especially in child-care and
elementary schools can be recommended.
3
Because of the above, the aim of this review is to assess whether rinse-free hand
sanitizer programmes in the community can be expected to be not only effective, but
save and feasible outside controlled trails. Methods Search and Review strategy To identify eligible studies, a systematic literature research up to October 2007 was
performed in Medline, Web of Science, the Clinical trails register of the U.S. National
Library of Medicine (www.Clinicaltrails.gov) and Google Scholar, using the following
keywords: „hand sanitizer“, „hand hygiene“, „hand washing“, „absenteeism“, „school“,
and „day care“. When articles were identified, their reference list also was explored.
No limits were used on date, geographical location or language. Additionally,
acquainted researchers were asked for relevant unpublished data or any articles on
known to them.
All reports of trails on the effect of hand disinfection, on acute respiratory and/or
gastrointestinal infections and absenteeism were included.
Studies were analysed for setting, design, duration, number and age of participants,
type of intervention, active agents used and primary endpoints
(respiratory/gastrointestinal infections or both). If data could be extracted from the
paper, odds ratios between the groups were calculated. If not, then raw data,
statistical tests and reported association were tabulated only. Furthermore, the effect
on compliance with hand hygiene measures, reported misuse, fire incidents, handling
issues and other problems were collected.
4
Results Eleven studies meeting the search and inclusion criteria were identified. Thereof 7
were case-control studies [8, 12-18], 3 were cross-over studies [19-21] and one used
a combined design [22].Most of the studies were conducted at primary schools or
homes of families with children who were enrolled in out-of-home child care
institutions. One study investigated the effect of a hand sanitizer in student halls and
military flight personnel, respectively. Ten studies were prospective, one
observational and only one was double-blinded, placebo controlled trial (Tab. 1).
Methodological quality As already performed and described by other reviews on the topic, the quality of
design and reporting in most of the included trails was low [9]. The only placebo-
controlled, double blinded study [8] included had other methodical problems (see
Table 3).
The used endpoints were not consistent between studies, making comparison
difficult. Most authors set the “days-ill-per subject” or the “number of days ill/total
days” as primary endpoint. Other authors report the number of single episodes as
well. Furthermore, definitions of episodes and symptoms and infections vary. Some
studies assessed the days ill as well as the days absent, but in most studies, only
days off work were reported.
With exception of WHITE [18] and VESSEY [21], sample size calculation was never
included. Some studies were not formally randomised or the randomisation method
remains unclear. Some authors did not assess the effect of the hand sanitizer alone,
but of a combined intervention of hand sanitizer together with education on hand
hygiene, making a differentiation of the single effects impossible. Hand washing
behaviour was not monitored in most trails. In one study, hand sanitizer use was
reported in the control group [18].
Among the eleven studies, five were funded by the manufacturer of the used product
and two of these were conducted by employees of the manufacturer and focussed
not on hand sanitizers in general but on the specific product. Only some authors
provided data on the antimicrobial efficacy of the used sanitizer. Reporting of
withdrawals and dropouts was insufficient in most studies. In one study, only an
abstract was available [16] Seven studies allowed for extraction of data for
calculation of odds ratios.
5
Efficacy of used products Different products were used in the identified studies. While most authors used
alcohol based hand sanitizers, a hand sanitizer containing benzalkonium chloride as
the active agent was used in two trails. While the antibacterial and antiviral spectrum
and fast action of ethanol is well known, current data on the activity of the
benzalkonium chloride based hand sanitizer against major viral pathogens typically
causing gastrointestinal or respiratory infections is insufficient. Other authors report
benzalkonium chloride to be effective against various viruses, but the contact time for
a significant reduction ranged from 2 minutes to 120 minutes [23].
Safety issues (fire incidents, misuse, intoxications) (Table 2) All studies were searched for data on fire incidents, misuse or intoxications. While
questionnaires on adverse effects and safety issues were not a central part in all
trails, no intoxications or fire incidents were reported. Misuse was only reported by
one author [21], but the incident which was reported - a child tried how many squirts
are needed to fill a cup - was seen as minor problem. This is particularly interesting,
because most studies were set in child care centres or elementary schools.
Compliance, adverse effects, handling issues and problems reported Five authors reported improved hand hygiene and preferred use of hand sanitizer in
the test group (Table 2). A reduced compliance with hand hygiene was never
reported. In two trails, hand sanitizers were used under supervision of the teacher.
One author reported the use of hand sanitizers even in the control group due to its
growing popularity. Handling problems as “too slippery”, “stinging”, “bad smell”,
“dislike” or “allergic reaction” reported derived chiefly from the texture and physical
properties of the used products.
Adverse reactions were mostly “dry skin” or “irritation” against the hand sanitizer or
the soap, that let to drop-outs in some trails [15, 21]. Other authors did not report any
problems. In one study two participants dropped out due to adverse reactions to the
soap [21]. No detailed data to quantify the adverse effects are reported.
Meta-analysis
Because of the notable heterogeneity of the studies, a formal meta-analysis was not
possible. Instead, we extracted data (days absent or ill/total days and episodes/
susceptible days, respectively), if possible, and calculated odds ratios as measure of
6
association (Table 4). For studies were this approach was not possible, the number
of participants, raw data, statistical tests and reported association are given (Tabel5) Data extracted studies (Table 4)
Sufficient data from seven studies could be extracted. From six studies, data on the
number of episodes were available, from three trails both episodes and days of
absence are reported, and for two studies data on days of absence and days ill are
reported separately.
Odds ratios for the episodes/susceptible days range between 0.47 and 1.06,
respectively, indicating no effect or a protective effect associated with the
intervention. Some authors differentiated even further between absenteeism due to
respiratory and gastrointestinal symptoms, other authors reported the incidence of
illness, not of absence.
Odds ratios for the days ill or absent/susceptible days range from 0.37 to 1.28,
respectively. The largest effect was reported by Van Camp and Ortega [22] in a
military setting, followed by White et al. [17, 18]0.56 (student hall) while the effects in
school settings as reported by Dyer et al. [19] and White et al [8] seem to be
somewhat smaller. From these two studies, not only the days absent but the days ill
were reported. The odds ratios of the days ill and absent significantly differed.
Studies were data extraction was not possible
From four studies, data could not be extracted. For these studies, raw data, statistical
tests and reported association are summarized in table 5. All authors reported an
effect in favour of the intervention, but endpoints and statistical methods differed
decisively.
7
Discussion The role of the hand as a vehicle for contagious micro-organisms has been
established over 150 years ago by Ignaz Semmelweis [24]. Particularly when people
live and work in close proximity to one each other, as in families, kinder gardens,
elementary schools, college dormitories and military barracks, hands can become the
primary mode of transmission for many infectious diseases. In these close
environments, infection is not only spread by direct hand-to-hand contact, but by
indirect contact, were inanimate objects as doorknobs and other frequently touched
surfaces serve as resting grounds for cross-contamination [11, 25-30]. Today, hand hygiene is known as the single most important measure to prevent
health care associated infections [31]. Due to their higher efficacy, tolerability and
applicability compared to hand washing, alcohol based products are now
recommended as standard for hand disinfection in hospitals in Middle Europe as well
as the USA and other countries worldwide [32-35]. Likewise, routine hand washing
has been cited as being "the most important hygiene measure in preventing the
spread of infection" by the World Health Organization (WHO) [2], but compliance in
hand washing in healthcare facilities and the community is often lacking[7, 8].
Several authors reported factors associated with poor compliance in hand washing
such as insufficient time during the day, to few, hardly accessible or substandard
washing facilities and dermal intolerance [8, 18, 20]. Therefore, waterless hand
sanitizers could be an alternative to hand washing, because they are not bound to
fixed washing places, more effective and faster to use. While alcoholic hand rubs and
hand sanitizing gels have been proven to be superior to antiseptic soaps and water in
terms of efficacy, tolerability and compliance [32, 33, 35], hand hygiene outside of
health care facilities is still mainly based on hand washing.
We identified eleven studies that investigated the effect of hand sanitizers on the
transmission of contagious diseases outside of health care facilities. These studies
varied decisively in setting, size, quality and endpoints.
Most studies set the days absent per subject or the number of day’s absent/total days
as primary endpoint. This is reasonable, since most authors see the reduction of
days of work or school as the primary target for their intervention.
The number of days absent is, on the other hand, not an ideal indicator for the
number of days ill, because not every subject who becomes ill will become absent,
and different patients need different time to recover. Odds ratios for the days ill and
8
absent/total days as reported by Dyer et al. [19] and White et al. [8], for instance,
differ substantially (Table 4).
Even if symptoms are mild and allow continuing attending school or work,
concentration and productivity can be altered and the infected becomes a possible
source for further spread of the infection. These factors were not assessed in any
study.
Reporting of the days absent or ill alone is therefore insufficient to describe the effect
of hand sanitizer used on controlling of infectious diseases in the community, but
independent episodes have to be reported, as done by some authors, too. Obviously,
hand hygiene can break the chain of infection and can therefore lead to fewer
episodes (illness/absenteeism) per subject over the duration of the investigation, but
this may not necessarily lead to fewer days ill or absent. While hand hygiene can
stop the spread of infection, it is doubtful if it can attenuate an infection by lowering
the number of incorporated infective particles. While single episodes were reported
by some authors, definitions of “an episode” differed markedly.
Different waterless hand sanitizers were used in the studies. Most authors used
alcohol based formulations and two used benzalkonium chloride. Benzalkonium
chloride and ethanol have different scopes of activity. While alcohols, especially
ethanol, are effective against bacteria as well as enveloped and in higher
concentration also not enveloped viruses, the efficacy of benzalkonium chloride, and
of the used product in particular, against viruses depends on the virus [33] [36].
Furthermore, benzalkonium chloride is known to have a weak activity against gram-
negative bacteria, and is prone to contamination by these organisms [37-39].Keeping
in mind that most gastrointestinal and respiratory infections are caused by viruses
and gram negative organisms, alcohol - based sanitizers seem to be the better
alternative [35].
Arguments often raised against the use of waterless hand rubs in the community and
in hospitals are the potential risks as fire and intoxication hazards, and dermal
tolerance. Particularly in kindergartens and elementary schools, the risk of
intoxication seems to be a serious issue. In the last years, several postings in the
internet, chain e-mails and media raised public concerns on the safety of hand
sanitizers in the United States and other countries [40]. Even in Central Europe, were
alcohol based rubs are the standard for hand disinfection in hospitals, paediatricians
are aware on possible risks from ingestion, but cases of actual intoxication with hand
9
rubs in Germany are not known to the authors. In the studies reviewed, one author
reported children played occasionally with the new, and therefore interesting gooey
hand sanitizer used, but accidental or intentional ingestion was not reported by any
study.
Accidental poisoning in childhood is a common reason for admission to emergency
departments and a motive to contact poison control centres. Aside of medical drugs,
plants and household chemicals, intoxications with soaps, shampoos and other liquid
and solid detergents, that are provided and used without restrictions or supervision in
child care facilities, schools and in the home, are frequently reported [41-43]. In most
cases, intoxication was mild and outcome was good, but much severer cases are
reported too. Ingestion of soaps can lead to the foaming and cause pulmonary
damage. Furthermore, a large proportion of consumer soaps contain antimicrobial
agents with toxic potential [44]. Parents, teachers and caregivers should well advice
children in the possible risks of toxic substances, and hazardous chemicals should
always be stored safe, but the risk of intoxication with hand sanitizer is low and
comparable to liquid soap that is used by millions of children every single day.
As alcohol based hand sanitizer contain at least 50% alcohol, they are flammable.
When alcoholic hand rubs were first recommended by the Centers of Disease Control
and Prevention (CDC) in October 2002, fire safety concerns arose in many health
care settings.
Alcohol-based hand-rubs have a long history as disinfectants in health care settings
and have been used safely for more than 120 years in European countries to
disinfect hands. Since then, fire hazards associated with alcohol based hand
sanitizing products (gels and rubs) have been scientifically assessed by different
authors, concluding the apparently low potential fire hazard that may occur with their
use is far outweighed by the potential benefits [45]. In none of the studies reviewed,
fire incidents have been reported.
The dermal tolerance of hand hygiene products has been extensively discussed in
recent years. In the studies assessed, most authors report an improved compliance
with hand hygiene and a preference to hand sanitizers over soap in the test group,
but some authors reported adverse effects of hand sanitizers, too [15]. Undoubtedly,
compliance with hand hygiene is strongly influenced by the tolerability of hand
hygiene procedures [33]. It has been shown that frequent hand washing invariably
10
leads to chronic dermatitis as repeatedly described for health care workers. The
often cited drying effect of alcohols on the skin can be prevented by adding
emollients, humectants, or other skin-conditioning agents that are part of most
commercially available hand sanitizers [46]. Alcohol based formulas containing such
skin conditioners have been proven in many prospective trials to cause caused
substantially less skin irritation and dryness than soaps or antimicrobial detergents
[47] [48] [49]. A transient stinging sensation, as reported in one of the studies
assessed, can be caused even by well-tolerated alcohol hand rubs, particularly at the
site of any broken skin, but is no need to worry. Proper skin care is most important to
avoid skin lesions, especially in the cold season [50]. As the peak incidence of
respiratory and gastrointestinal diseases is in winter, some of the studies were set in
this season. The association between skin condition, weather and adverse effects
reported should therefore be noted.
While most identified trails suffer from methodical problems, calculated odds ratios
and reported associations imply a preventive effect of hand sanitizers on contagious
diseases in the community. Hand hygiene interventions introducing hand sanitizers
as convenient and barrier-free alternative to soap and water have been shown not
only to reduce the incidence of illness, but can reduce the number of days ill and
absent, as well. As hand sanitizers are safe to use and to handle, no limits to the
uncontrolled use in the community exist. Therefore, hand hygiene and sanitizer use
should be encouraged as infection control measure in the community and further
studies investigating the effect of hand sanitizer used in other settings than the ones
studies should be conducted to improve evidence on the topic.
11
Conclusion Since hands are the primary vehicle of transmission of many infectious diseases,
hand hygiene is essential for infection control in hospitals as well as in the
community. While hand washing with soap and water is the traditional way of hand
hygiene, overall compliance is low and relies on several factors, as convenient
access to a sink and sufficient time to perform the procedure.
Waterless hand rubs or sanitizers do not require a fixed infrastructure and are less
irritating than frequent hand washing. Alcohol-based formulas are effective against a
broad antimicrobial spectrum, including bacteria, yeast and enveloped viruses. They
are fast acting, can be used “on the go” and are less irritating than frequent hand
washing. Provision of hand sanitizers can therefore improve compliance with hand
hygiene in hospitals and in the community.
While all identified studies had some methodical problems, taken all evidence
together, an increasing body of literature suggests that regular use of alcohol-based
hand sanitizers in the community may reduce transmission of infections and lead to
lower absenteeism.
In all studies reviewed, no safety, fire hazard or handling issues that would limit the
uncontrolled use in the community were reported. This is particularly remarkable,
because most studies were set in child-care and elementary schools were possible
misuse or intoxication would be more likely and hand rubs are seen as potential
hazard even in countries were alcoholic hand disinfection is traditionally used in
hospitals.
We conclude that rinse-free hand sanitizer programmes in the community can be
expected to be not only effective, but save and feasible outside controlled trails.
However, further, well designed studies in different settings are needed to strengthen
the evidence.
12
Tables
Table 1: Setting, Design, Duration, Size, Intervention, Active Agents used and Endpoints ( Respiratory , Gastrointestinal (GI)- Infections or both)
Author Setting Design Duration Size Interventions Active agent Endpoints
Sandorra et al.,
2005, [15]
homes of families with children who were enrolled
in out-of-home child care, USA
prospective, randomized, case-control
5 months
292 families with 1053
individuals
hand sanitizer and hand-hygiene education vs. hand-hygiene education only
alcohol incidences of
acute respiratory and GI infections
Tompson, 2004 [16]
primary school, USA
prospective, randomized, case-control
Winter 2003 138
hand sanitizer and hand-hygiene
education vs. no intervention
alcohol illness absenteeism
Lee et al., 2005, [14]
homes of families with children who were enrolled
in out-of-home child care, USA
prospective, observational, case-control
7 months
261 families enrolled, 208 families with
837 individuals analysed
Survey, symptom ,biweekly telephone
calls, documentation of
hand hygiene practice including
use of hand sanitizer
alcohol acute respiratory and GI infections
Dyer et al., 2000,
[19]
primary school, USA
prospektive, open-label cross-over
8 + 2 weeks 420
hand sanitizer, hand washing and
hand-hygiene education vs.
hand washing and hand-hygiene
education only
benzalkonium chloride
acute respiratory and GI infections
Hammond et al.,
2000, [13]
primary school, USA
prospektive case-control
one school-
year 6080
hand sanitizer and hand-hygiene
education vs. no intervention
alcohol 62%
illness absenteeism
Vessey et al., 2007,
[21]
primary school, USA
prospective, randomised cross-over
2 x 2 months
18 classes with 383 students
hand sanitizer and hand-hygiene education vs. hand-hygiene education only
alcohol illness absenteeism
White et al., 2001,
[8]
primary school, USA
prospective, double-blind,
placebo-controlled
5 weeks 769 hand sanitizer vs. placebo
benzalkonium chloride
illness absenteeism
Morton und
Schultz, 2004, [20]
primary school, USA
prospective, randomised cross-over
100 days
17 classes with 285
students from which 253 completed
course
hand sanitizer and hand-hygiene education vs. hand-hygiene education only
alcohol 60%
illness absentism
White et al., 2003 et 2005, [17, 18]
student hall, USA
prospektive, case-control
one semester 430
hand sanitizer and hand-hygiene education vs.
Standard hand hygiene
alcohol 62%
Symptoms associated with
acute respiratory infections and hand hygiene
behaviour
Guinan et al., 2002
[12]
primary school, USA
prospective, case-control 3 month 290
hand sanitizer and hand-hygiene education vs.
Standard hand hygiene
alcohol 62%
illness absentism
Van Camp and
Ortega, 2007, [22]
military flight personnel,
USA
prospective, case-control
and longitudinal cross-over
2 winter 117
alcoholic hand sanitizer vs.
standard hand hygiene
alcohol acute illness rate
13
Table 2: Age of participants ( I= infant, 0-5 years old); E = elementary school child, 5-12 years old; H = high school student ,12 – 17 years old; A = Adult, > 17years old) effect on compliance with hand hygiene measures, misuse, fire incidents and handling issues and other problems reported
Author Age of participants Compliance Misuse Fire
incidents Handling issues
Other problems
Sandorra et al.,
2005, [15] I, E ,H , A none
reported none
reported none
reported
“stinging” (10%) bad smell (6%) dislike (2%),
“allergic reaction” (2%) and “too slippery” (1%)
reported
45 families reported 112 adverse events related
to hand sanitizer use; 21 of these families reported an
adverse event only once, and 24 of
them reported an adverse event on 2 or more
occasions. 63% of the reactions were
“dry skin,” 18% were “irritation.”
Tompson, 2004 [16]
E none reported
none reported
none reported
none reported
none reported
Lee et al., 2005, [14]
Families, with at least
one I
none reported
none reported
none reported
none reported
none reported
Dyer et al., 2000,
[19] E
agent was used under teacher supervision
none reported
agent used not flammable
none reported
none reported
Hammond et al.,
2000, [13] E, A
improved compliance
compared to hand washing;
approximately 1.5- 5 uses of sanitizer per
student and day
none reported
none reported
none reported
“no adverse events were found among the participants in
the study.”
Vessey et al., 2007,
[21] E
hand sanitizer preferred to soap
and water; improved
adherence and better hand cleansing by
students during the study period
“was less of an issue but still possible”, no ingestion or intoxication
reported, but occasionally
students “played” with gel
none reported
maintaining adequate
supplies of soap, paper towels,
and sanitizer was observed as an
issue.
1 of 383 participants dropped out due to irritating
effects of the sanitizer, 2 others due to irritating
effects of the soap
White et al., 2001,
[8] E
agent was used under teacher supervision, compliance
problems with teachers led to
drop-outs
none reported
agent used not flammable
none reported
none reported
Morton und
Schultz, 2004, [20]
E none reported
none reported
none reported
none reported
10 of 285 participants dropped out due to skin
problems r
White et al., 2003 et 2005, [17, 18]
A
significant better hand hygiene in
test group; knowledge about
hand hygiene increased in the
test group but not in the control
group; attitude toward gel sanitizers
increased over time in test group.
none reported
none reported
none reported
“[..] there was some hand sanitizer use
among students in the control group. This is
attributed to the growing popularity of instant hand
sanitizers.
Guinan et al., 2002
[12] E
agent was used under teacher supervision
none reported
none reported
none r eported
none reported
14
Van Camp und
Ortega, 2007, [22]
A
“The requirement for regular
dispenser refills throughout the
winter demonstrated
significant hand sanitizer use.”
none reported
none reported
none reported
none reported
Table 3: Primary outcome (IRR= incidence rate ratio) and quality assessment
Author Primary outcome Quality Assessment Reason for exclusion from meta analysis Comments
Sandorra et al.,
2005, [15]
secondary GI-illness rate significantly lower in intervention families compared with control families IRR: 0.41; 95% confidence interval [CI]: 0.19–0.90); overall secondary respiratory illness rate was not significantly different between groups IRR: 0.97; 95% CI: 0.72-1.30); higher sanitizer usage let to had a marginally lower secondary respiratory illness rate (IRR: 0.81; 95% CI: 0.65-1.09).
illness assessment was based on symptom reporting by caregivers; neither participants nor investigators were blinded; hand sanitizer use was not directly observed; study design allowed not to separate the impact of hand sanitizer use from the effect of the educational intervention
Tompson, 2004, [16]
28% overall reduction in absenteeism due to illness compared to control
participants and coordinators not blinded; only absences registered; no data on dropouts,
total days not reported only abstract available
Lee et al., 2005, [14]
Use of alcohol-based hand gels was associated with lower respiratory illnesses rate, IRR (Adjusted for Site) 0.6 (0.4–0.9) (95% CI)
not formally randomized; outcome measure based on reports by family caregiver; frequency of hand hygiene not validated; awareness of hand hygiene in the interruption of illness transmission unclear
total days not reported purely observational
Dyer et al., 2000,
[19]
41.9% fewer illness-related absence days compared to control, (28.9% decrease in respiratory and 49.7% in gastrointestinal illnesses) and 31.7% decrease in absence incidence (44.2% in respiratory and 50.2% gastrointestinal illnesses) compared to control
not formally randomized; neither participants or study-coordinators blinded;
author is employed by manufacturer of the product the trail is
focussed on; no data on the antimicrobial
efficacy of the product provided
Hammond et al.,
2000, [13]
overall reduction in absenteeism due to infection 19.8% compared
with control (p < .05). in the school system with the largest teacher population (n = 246)
teacher absenteeism decreased 10.1% (trend) in the schools
where sanitizer was used
schools were paired based on similarities in student
population and geographic location but not formally randomized; 25 of
3080 students did not participate/complete the study and were removed from the
database;. neither participants or study-coordinators blinded;
author is employed by manufacturer of the
product used
Vessey et al., 2007,
[21]
“no significant differences in absenteeism rates were
demonstrated. A follow-up focus group comprised of teachers and school nurses indicated that hand
sanitizers were preferred over soap and water.”
neither participants or study- coordinators blinded; content
analysis on participants' experiences with soap and
water/hand sanitizer performed but not reported
study was supported by an unrestricted
grant from manufacturer
White et al., 2001,
[8]
Illness absidence and absence-incidence significantly lower in
test group (p<0,01)
hand washing not monitored; from 1700 possible participants only 769 were used for data collection; no detailed drop-out statistics provided; no cross-over confirmation
3 of 4 Authors are employed by
manufacturer of the product the trail is
focussed on; data on the antimicrobial
efficacy of the product provided are very
limited
15
Morton und
Schultz, 2004, [20]
significantly fewer children in the alcohol gel group contracted an
illness compared to control
not blinded; randomisation criteria unclear; assignment of classes to groups not reported,
hand washing not monitored
days absent per group not reported,
reporting of primary endpoints and
Statistical methods questionable,; status of skin of participants
who dropped out assessed but not
reported
White et al., 2003 et 2005, [17, 18]
statistically significant overall increase in hand hygiene behavior and reduction in
symptoms, illness rates, and absenteeism between the product and control group. Reductions in upper respiratory symptoms from
14.8 % to 39.9% total improvement in illness rate
20.0%. product group had 43% less missed school/work days.
some hand sanitizer use in the control group; halls grouped
for academic emphasis but not formally randomised; hand
hygiene behaviour was questioned but not controlled
study was partially funded by
manufacturer of product
Guinan et al., 2002,
[12]
number of absences was 50.6% lower in the
test group (p < .001)
study was not formally randomized; no data on
withdrawals and dropouts provided
Van Camp und
Ortega, 2007, [22]
acute illness rates 2.4% in 2004/5 (no hand sanitizer),0.9% in 2005/6 when hand sanitizer provided. no year-to-year difference for the control group: illness rates 2.4% in 2004/5 and2.3% in 2005/6. “Making hand sanitizer readily available […] may reduce the occurrence of acute illness and number of duty days lost”
preliminary investigation, no formal randomisation, not prospective, not blinded, not controlled; personnel usually stationed for only 1 yr, so the different years compared different people. heterogeneous groups (pilots vs. pilots and other personnel, differences in education and rank) “causal relationships between HS and illness rates cannot be proven”
“the study was not designed to prove the effectiveness of hand sanitizers. It was an observation of the results of providing ready access to hand sanitizers in the fighter squadron operations buildings as a way of encouraging the other squadrons to also provide hand sanitizers access.”
Table 4: Number of participants, endpoints and odds ratios for studies were data could be extracted (R = respiratory; GI = gastrointestinal)
Author N or days absent (a) or ill (a) / total days (d) episodes/susceptible days
Test Control Test Control Odds ratio Test Control Odds ratio
Sandorra et al.,
2005, [15]
155 families
137 families
none reported
none reported non analysed GI: 0,0055
R: 0,0249
GI: 0,0116 R: 0,0236 (illness)
GI: 0,47 R: 1,06 (illness)
Dyer et al., 2000,
[19] 210 210
0,0517ad
0,0118id
(Total) 0,0572ad(R) 0,0064id(R) 0,0446ad(GI)
0,0054id(GI)
0,0455ad
0,020id
(Total) 0,0455ad(R) 0,0127id(R) 0,0455ad(GI)
0,0076id(GI)
1,14ad
0,57id
(Total) 1,28ad(R) 0,50id(R) 0,97ad(GI)
0,71id(GI)
0,0071 (total
absenteeism) 0,0037
(R absenteeism) 0,0034
(GI absenteeism)
0,0135
(total absenteeism) 0,0075
(R absenteeism) 0,0061
(GI absenteeism)
0,52
(total absenteeism) 0,50
(R absenteeism) 0,56
(GI absenteeism)
Vessey et al., 2007,
[21] 380 cross-over none
reported none
reported none analysed 0,0008
(absenteeism) 0,0008
(absenteeism) 1,00
(absenteeism)
White et al., 2001,
[8] 388 381
0,083 ad
0,016 id
(Total) 0,0888ad(R) 0,0112id(R) 0,0028ad(GI)
0,0047id(GI)
0,101ad
0,024 id
(Total) 0,0967ad(R) 0,0164id(R) 0,0047ad(GI)
0,0071id(GI)
0,81ad
0,67id
(Total) 0,91ad(R) 0,68id(R) 0,60ad(GI)
0,66id(GI)
0,0099 (absenteeism)
0,072 (R absenteeism)
0,0028 (GI absenteeism)
0,0153
(absenteeism) 0,011
(R absenteeism) 0,0047
(GI absenteeism)
0,65
(absenteeism) 0,67
(R absenteeism) 0,60
(GI absenteeism)
White et al., 2003 et 2005, [17, 18]
215 215 0,0063ad 0,0113ad 0,56ad 0,0417
(illness) 0,0547
(illness) 0,75
(illness)
16
Guinan et al., [12] 145 145 none
reported none
reported n/a 0,0105
(absenteeism) 0,0208
(absenteeism) 0,50
(absenteeism)
Van Camp und
Ortega, 2007, [22]
56 61
T1/T2: 0,0089**ad
T/C: 0,0089***ad
T1/T2: 0,024**ad
T/C: 0,023***ad
T1/T2: 0,37**ad
T/C: 0,39***adnone
reported none
reported none analysed
• one episode = one week; ** Test group, Winter 2004/5 (no intervention) vs. Winter 2005/6 (hand sanitizer);*** Test
group (sanitizer) vs. Control group (no intervention) Winter 2005/6
Table 5: Number of participants, raw data, statistical tests and reported association for studies were data could not be extracted
Author N Raw data reported
Test Control Test Control
Statistical tests and measures of association reported
Tompson, 2004, [16]
138 children; 3 classrooms as control
group and three as test group.
days absent per participant: 2,3
days absent per participant: 3,2
overall reduction in absenteeism due to illness 28% in test group compared to control.
Lee et al., 2005, [14]
837 people (287 children up to 5 years old, 152 children 6–17 years old, 395 adults, 3 of unknown age) in 208
families; 105 352 person-days of
observation; families observed for an
average of 128 days (range: 29–174 days). 185 (89%) of families returned completed
surveys.
446 secondary respiratory illnesses in 21452 susceptible person-days of observation, or 0.63 (95% CI: 0.58–0.69) illnesses per susceptible person-month. 63 gastrointestinal illnesses in
5500 susceptible person-days of observation, or 0.35 GI (95% CI: 0.27– 0.45) illnesses per
susceptible person-month.
use of alcohol-based hand gels was associated with reduced respiratory illness transmission; use of hand sanitizer seemed to reduce GI illness transmission (trend) ( bivariate analyses using Poisson regression at the family level (illnesses per family as outcome; number of susceptible person-days within the family as; site of enrolment as fixed factor); frequent use of hand sanitizer was associated with lower rates of respiratory 8but not gastrointestinal) illness transmission (multivariate analyses with site of enrolment as fixed factor using forward and backward stepwise Poisson regression models with set at 0,15 to enter and remove terms from the model)
Hammond et al.,
2000, [13]
Students: 3075
Teachers: 135
Students:3005
Teachers: 111
days absent per participant: Students:
2,4
Teachers: 3,54
days absent per participant: Students:
3,2 Teachers: 3,91
Students: statistically significant overall reduction in absenteeism due to illness was 19.8% for test group
compared to control (P < 0,05, 2-sample t test) Teachers: statistically significant reduction in teacher
absenteeism of 10.1% (p< 0,05, pooled 2 sample t test)
Morton und
Schultz, 2004, [20]
253 in 17 classrooms: group 1: 8 classrooms group 2: 9 classrooms
overall absent due to illness n = 211 never absent due to illness n = 42 ill regardless of test/control group n = 103 ill while in control group n = 69 ill while in test group n = 39 in phase 1 no differences in days absent between groups, in phase 2 3,5% vs. 2,9% days absent per group
odds of being absent reduced by 43% by hand sanitizer use; significantly fewer children became ill while in test group (chi-square = 7.787; p = .0053 McNemar's test for dichotomous variables with paired subjects)
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