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Streptococcus agalactiaeAbstract
Objective:
to validate the content of the prevention protocol for early sepsis caused by
Streptococcus agalactiaein newborns.
Method:
a transversal, descriptive and methodological study, with a quantitative
approach. The sample was composed of 15 judges, 8 obstetricians and 7
pediatricians. The validation occurred through the assessment of the content of
the protocol by the judges that received the instrument for data collection -
checklist - which contained 7 items that represent the requisites to be met by the
protocol. The validation of the content was achieved by applying the Content
Validity Index.
Result:
in the judging process, all the items that represented requirements considered by
the protocol obtained concordance within the established level (Content Validity
Index > 0.75). Of 7 items, 6 have obtained full concordance (Content Validity
Index 1.0) and the feasibility item obtained a Content Validity Index of 0.93. The
global assessment of the instruments obtained a Content Validity Index of 0.99.
Conclusion:
the validation of content that was done was an efficient tool for the adjustment
of the protocol, according to the judgment of experienced professionals, which
demonstrates the importance of conducting a previous validation of the
instruments. It is expected that this study will serve as an incentive for the
adoption of universal tracking by other institutions through validated
protocols.
Introduction
The neonatal infection by the B group β-hemolytic Streptococcus (EGB),
or Streptococcus agalactiae, is considered an important problem of
public health, being the main cause of early neonatal sepsis, the generalized infection
that occurs on the first 48 hours of life, having a direct relationship with the
gestational or intra-partum period, according to the definition by the Brazilian
Ministry of Health. The sepsis represents one of the most important causes of neonatal
morbidity and mortality, and its incidence varies from one to eight cases for every
thousand born alive. In Brazil, the rate of mortality is around 25%. International
databases demonstrate that around 30 million of newborns are diagnosed with sepsis and
from one to two million of them die.
Among other complications due to the infection by the Streptococcus
agalactiaein newborns some of them need to be emphasized: meningitis,
pneumonia, septic abortion, chorioamnionitis, endometritis, increase in mortality and
morbidity, neurological deficit, long-term hospital confinement and neonatal decease.
Vertical transmission is the most common and its determining factor is the exposure of
the newborn to the EGB that are present in the vagina, which is colonized in the
intra-partum period. Among the newborns of mothers that possess the EGB, the
colonization occurs in 50% of the cases. Considering the prevalence of the national
maternal colonization in 20%, there will be incidence of two cases for every thousand
born, provided the absence of prophylactic interventions.
With the understanding of the relevance of this issue in the context of public health,
in the late 1990's, a process of implementation of prophylactic interventions started,
intending to control the EGB infection in newborns, which were improved through time. In
1996, the Center for Diseases Control and Prevention (CDC) published in the USA the
first national consensus directives about perinatal prevention of infections caused by
Streptococcus agalactiae. Two prophylactic strategies for the
intra-partum period were established. The first was based on the risk factors and the
second in the results of the tracking on the genitorectal secretion cultures, collected
between the 35 and the 37 week of pregnancy, for the EGB
research.
In August 2002, based on the new evidences of a retrospective study, these directives
were updated, being now recommended the universal tracking through genitorectal culture
between the 35 and the 37 week of gestation as the only
strategy for the orientation of the intra-partum chemoprophylaxis of the early infection
by the EGB. This approach consists in doing a microbiological examination, with the goal
of limiting, in terms of candidacy to the intra-partum prophylaxis, just the patients
colonized by the EGB, regardless of the risk factors. This study demonstrated that the
effectiveness of the late antenatal tracking, through the EGB culture, was 50% superior
to the alternate approach based on the risk factors.
In 2010, the 3 review of the directives based on the updated evidences of
perinatal prevention for the EGB was published. The CDC 2010 version highlights the
indications for universal "screening" on the 3 trimester of the gestation,
standardizing the laboratory methods about the collection and transportation of samples
for the detection of the GBS, taking into consideration the changes in the arrangement
and of the indication of the antimicrobials recommended for the intrapartum prophylaxis
and by supplying updates for the recommendations for newborns at risk to have an early
infection.
The change of conduct in the USA, through the implementation of the orientations
established by the CDC, suggests a decline in the incidence of the early disease caused
by the EGB in the country, provided that, among newborns with up to 6 days of life, the
incidence of the B group streptococcus disease was reduced from 0.47 of a thousand
successful births, between 1999 and 2001, to 0.34 of a thousand successful births,
between
2003 and 2005, which corresponds to a reduction of 27% after the implementation of the
CDC 2002 guide. Other data evinced that in the USA there was a reduction equivalent to
1.2% in the annual rate of hospitalization among the pre-term newborns, between 1988 and
2006, and that can be a consequence of the results of the implementation of the
preventive measures.
The Hospital das Clínicas of the Federal University of Pernambuco (HC/UFPE) did not have
the protocol for the prevention of the neonatal infection by the EGB. This way, the
genitorectal culture is not done frequently, which makes it impossible to know the state
of the maternal colonization. Given that, the prevention of the perinatal infection by
EGB is done through the administration of the intra-partum antibiotic in pregnant women
that present risk factors on neonatal transmission, such as the long period necessary
for the rupture of the amniotic membrane and the premature labor. However, this approach
presents a limited efficiency and such indiscriminate use of antibiotics, in all
pregnant women with risk factors, may contribute for the emergence of new and more
resistant strains.
Given the available evidences about the relevance of the infection within public health
policies, the consequences for the concept and the precision of the intra-partum
prophylaxis based on the universal tracking, it was developed a protocol for the
prevention of the neonatal sepsis by the EGB, based on the recommendations of the CDC
2010 guide, to be implemented in the pre-natal, obstetrics and neonatal units of the
HC/UFPE.
Taken into consideration the importance of the adequacy of the protocol regarding the
semantic and content aspects, the validation of the content by judges emerge as a tool
to meet this requirement, because it allows professionals that are experienced in this
area to provide significant collaborations to the protocol.
Provided what was mentioned previously, this study had the goal of validating the
content of the prevention protocol of the early sepsis caused by
theStreptococcus agalactiaein newborns.
Method
This is a transversal, descriptive and methodological study with a quantitative
approach, conducted at the HC/UFPE, an institution specialized in the care of highrisk
pregnancies, between May and August 2013.
The population was made of obstetricians and pediatricians from the Obstetrics Center at
the HC/UFPE, with a minimum experience of four years in pediatrics or obstetrics. The
sample, by willfulness, included 10 obstetricians and 10 pediatricians. These were
included due to a 4 year minimum experience in neonatology at the HC/ UFPE. The adopted
criteria for exclusion were the following: failure to deliver the questionnaire within
the established deadline or the inadequate filling of the questionnaires.
The validation by the judges occurred through the evaluation of the content of the
protocol for the prevention of neonatal sepsis caused by EGB, based on the CDC 2010
guide. Through this, the contact was established in order to invite pediatricians and
obstetricians to participate in the research. For all those that accepted participating,
the protocol that was made to meet the requirements of the study was delivered, as well
as a letter containing the objectives of the study, the justification of the process of
the assessment protocol and the instrument for the data collection, a checklist
containing seven items that represent the requisites to be met by the protocol.
The evaluation of the instrument occurred from the classification of every item in terms
of being adequate, partially adequate or inadequate. The ones considered adequate were
those that completely met the established requirement; partially adequate were those
that required some changes; and inadequate were those that expressed a complete
non-compliance in relation to the established criteria.
The judges were instructed to give the material back after the analysis and to give
their final opinion personally to the researchers, within the 30 day deadline. For the
cases in which were considered to have inadequacies, the reasons were explained, the
suggestions described and the contents rewritten, improved and submitted to a new
assessment. To the judges were also granted explanations, when they were requested,
related to the practices established in the protocol.
The variables that were analyzed were: vocabulary, relevance, clinical-scientific
aspects, clarity, feasibility, organization and scope. After the assessment of the
protocol, the validation of the content was done, with the application of the Content
Validity Index (CVI) that measures the proportion or percentage of the judges that
express agreement in relation to the instrument's items.
The specialized literature presents different possibilities for the calculation of the
CVI, as well as for the establishment of its minimum level of concordance. It is
possible to calculate the score of this Index by adding up the items that were deemed
relevant. In the case of this study, it was considered an adequate judgment by all
judges. The CVI calculation for the instrument, as a whole, was done through the
addition of all the CVIs, calculated separately, divided by the number of items of the
instruments. It was considered the minimum concordance index for the CVI the number
0.75, by consensus, both for the assessment of every item and the instrument general
assessment.
The data collected were electronically processed, with the aid of the Excel 20 program.
For the analysis the manual calculation of the CVI was applied, as it was previously
described and percentages for the characterization of the sample were utilized.
All the judges were informed about the goals of the research, being included only the
participants that signed the Informed Consent Form. The ethical aspects were observed,
with respect to the Resolution 466/2012 of the Brazilian National Health Council (CNS).
The data collection started after the approval of the project by the Research Ethics
Committee of the Center of Health Sciences at the Federal University of Pernambuco
(ruling 487.861).
Results
Initially, the sample included 20 judges. However, there were 5 exclusions: 2 for
refusal in participating in all phases, 1 for inadequate filling of the form, 1 for not
returning the material and 1 that abandoned. This way, the sample was made up by 15
judges, 8 obstetricians and 7 pediatricians. Table
1shows the characterization of the judges.
Data related to the identification of the judges, according to gender,
experience and titration. Recife, PE, Brazil, 2013.
It can be observed in Table 1that among the
participants there was the prevalence of the feminine gender (9 = 60%). The experience
years varied from 10 to 38 years, and 14 (93.5%) of the judges had an experience time
greater than 10 years. Regarding the titration, 5 (33.3%) had a Master's degree and 2
(13.3%) had a PhD.
As it was demonstrated in Table 2, in the process
of judging the requisites related to the protocol of prevention of the neonatal sepsis
caused by EGB, after the first assessment which was done by the judges no item was
deemed as inadequate. However, only the item relevance had total approval (CVI 1.0) and
the others required changes. It was observed that the items vocabulary, clarity and
feasibility had a CVI below the established level (CVI < 0.75).
First step of judgment made by the judges about the items of the protocol
of prevention of the early infection by theStreptococcus
agalactiaein a newborn. Recife, PE, Brazil, 2013.
- Second step of the judgment of the items of the protocol of prevention of
the early infection by Streptococcus agalactiaein newborns.
Recife, PE, Brazil, 2013.
When the protocol was submitted for a new analysis after its correction, considering the
suggestions of the judges, all the items obtained concordance within the established
level (CVI > 0.75). Of the 7 items, 6 obtained full concordance (CVI = 1.0) and the
item Feasibility obtained a CVI of 0.93. The global assessment of the instruments had a
CVI of 0.99, demonstrating concordance within the established level ( Table 3).
The most important questionings highlighted by the judges considered to be necessary for
adjustments were related to the structure of the flowcharts, the adequacy of the
vocabulary, the lack of description of the evidence levels, repeated information, the
need for the elaboration of sentences more clearly and the inclusion of the diagram in
the description of the prenatal conduct. For other questionings, clarifications were
provided by personal contact established with the judge.
Discussion
Considering the titration of the judges and the minimum experience time of 10 years in
almost all cases, adding that the HC/UFPE is a hospital-school in which the activities
are together with the learning, research and extension inseparably, it is possible to
state that it is an experienced group and it is inserted in a context that provides the
opportunity for constant updating, suggesting that the judges possess the desirable
qualification for the judgment of the protocol.
The obstetrics nurses are qualified to provide care for low-risk pregnancies during the
prenatal period, for normal childbirth without dystocia and in the puerperium, in health
facilities or at home. In case there is any complication during pregnancy that may
characterize a high-risk pregnancy, these professionals should refer the pregnant woman
to the doctor, so that he or she can continue to provide assistance. Keeping in mind
that HC/UFPE is an institution specialized in the care of high-risk pregnancies, in
which the care to these patients in the Prenatal and at the Obstetrics Center is given
by the doctor - the sample did not include nurses.
The low-risk prenatal is done by the professionals that belong to the Program for the
Family's Health (PSF), which is present in 92% of Brazilian cities. Given that, the
doctors and nurses that act within the PSF need to pay attention to the importance of
doing the microbiological exam for the detection of the B
groupβ-hemolitic Streptococcus. The challenge consists in, up to the
present moment, the limited availability in the labs entailed to the Brazilian Sistema
Único de Saúde (Unified Health System) for the prenatal routine, which suggests the need
for stimulating the professionals to the introduction of the classification of the
Streptococcus agalactiaebetween the 35 and the
37 weeks in the assessment of the pregnant women, in their respective
local health facility.
Regarding the judgment process, it can be observed that the item Relevance obtained
consensual total approval, which highlights the importance of doing
theswabin the pregnant women for the research of the B
groupβ-hemolitic Streptococcus, as a way to orientate the
prophylaxis and the treatment directed to the reduction of the prevalence of the
neonatal infection by the group B Streptococcusare limited, provided
that the recommendation for the universal tracking for the EGB research in all pregnant
women between the 35 and the 37 weeks is not present in the
manuals written by the Ministry of Health, which is restricted to special situations,
such as: premature rupture of the membrane, premature labor and pregnant women that are
HIV-positive.
The justification is based on a systematic review, that assessed the use of the
intra-partum prophylactic antibiotic and the maternal and neonatal outcomes, making
clear that, although there is a decrease in the occurrence of the infection caused by
the EGB (RR 0.17, CI 95%, 0.04 to 0.74), there is a possibility that the results were
influenced by the authors, due to a methodological flaw of the studies. The authors add
that currently there are no satisfactory evidences to state that the intra-partum
antibiotic prophylaxis is related to the reduction of the neonatal mortality due to this
disease.
As the recognition of these controversies, related to the viability and the impact of
the orientations published by the CDC, has a result in the lack of standardization of
the preventive strategies in many countries and the uncertainty about the efficiency of
these practices, recently a systematic review with meta-analysis, through an electronic
query at the Cochrane Library, that had the goal of determining the best tracking
strategy for the EGB in pregnant women. The results of this study demonstrated that the
adoption of the universal tracking and of the antibiotic prophylaxis resulted in an
important reduction in the incidence of the neonatal sepsis, making clear that the
adoption of the universal tracking for pregnant women, added to the antibiotic
prophylaxis, are efficient measures.
As the importance of this theme is considered in the context of Public Health, the City
Department of Health of São Paulo published a technical note based on the CDC 2002
guide, for the tracking and prophylaxis of the EGB among the pregnant women registered
in the Mãe Paulistana Program. Statistical data referring to the acquired infections in
the perinatal period in the city of São Paulo demonstrate that there was a reduction
from 57.8%, in 2000, to 55.1% in 2008, and that can be related to the impact of the
actions of the public policies regarding the care to the neonatal infection caused by
the EGB.
It is of great importance that the tracking for the research of the EGB in all pregnant
women between the 35 and the 37 weeks is included in the
Ministry of Health's manuals, given that the indiscriminate use of antibiotics may
entail an increase in the resistant strains. Furthermore, it is known that policies
based on prevention result in a cost-effectiveness relation that is superior to the
healing model.
At the HC/UFPE, the prophylaxis is based in the administration of crystalline penicillin
in pregnant women that present risk factors. However, the impossibility of identifying
the state of the maternal colonization can be interpreted as a risk for the transmission
of the infection. This fact was demonstrated in the study conducted in pregnant women
that have undergone intra-partum prophylaxis for the prevention of the maternal
transmission of the EGB infection, based on risk factors in a maternity hospital in
Minas Gerais, Brazil. The results revealed that 71.2% of the patients that received
intra-partum prophylaxis according to their risk factors were not colonized by the EGB.
On the other hand, 33.3% of the patients that did not receive the intra-partum
prophylaxis were colonized. While the first piece of information may indicate that the
clinical judgment led to the unnecessary use of antibiotics in around 7 out of 10
pregnant women, the second one indicates that the clinical judgment has flaws, provided
that the colonized patients, that do not present risk factors, will not benefit from the
prophylaxis.
The penicillin remains as the antibiotic of choice for the intra-partum prophylaxis,
given that the EGB presents a considerable sensibility. On the other hand, a study done
in a maternity hospital in Ceará, Brazil, demonstrated a high resistance in 4 out of 9
cases of pregnant women colonized by the Streptococcus agalactiae. This
finding may be justified by the identification of molecular forms of these bacteria that
present mutations in the gene of the protein of penicillin bonding, resulting in the
reduction of the susceptibility to this medicine. Given that, the promotion of the
rational use of the antibiotics becomes important, which was made possible through the
development of the protocols. In the present study the protocol that was developed
limited the chemo-prophylaxis, provided that in the pregnant women with a positive
result for the culture this should only be indicated for the women colonized by the EGB
or in the presence of asymptomatic bacteriuria, intra-partum fever, or a history of
newborns stricken by the infection by the Streptococcus agalactiaein
previous births.
It is worth highlighting that this study presented a limitation, provided that the
validity of the content is a subjective process, being necessary a future validation
through additional clinical application. This fact remits to the need for the conduction
of future researches, with the intent of verifying the results of the application of the
protocol in the neonatology and obstetrics sectors of the HC/UFPE.
Conclusion
The validation of the content done in this study was an effective tool to assess the
adequacy of the protocol, in agreement with the judgment emitted by professionals with a
wide experience in their area. According to the results that were obtained, after
pondering the suggestions proposed by the judges, the content of the protocol for the
prevention of the early neonatal sepsis by the Streptococcus
agalactiaecan be considered satisfactory and adequate, demonstrating the
importance of doing a previous validation of the instruments. This first step represents
an important phase in the validation process; however, the need for the production of
studies should be highlighted, with the intention of submitting them to clinical
applications.
Bearing in mind the serious consequences of the early perinatal streptococcal disease,
in opposition to the methods of tracking of the B-group Streptococcus in the prenatal
period, it is expected that this study works as an incentive to the adoption of the
universal tracking by other institutions, both in the public and private healthcare
systems, through validated protocols, based on the scientific knowledge that comes from
researches based on the prevalence, prophylaxis and therapeutics of this relevant
perinatal pathology.
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