In the report "Heart rate characteristics index monitoring for
bloodstream infection in an NICU: a 3-year experience", Coggins and
colleagues make several observations that are important for properly using
the HRC (HeRO) monitor in the NICU:
1) Continuous monitoring is more effective than intermittent. Coggins
analyzed scores recorded in the medical record every 12 hours, or 8% of
the hourly scores; high scores may have...
In the report "Heart rate characteristics index monitoring for
bloodstream infection in an NICU: a 3-year experience", Coggins and
colleagues make several observations that are important for properly using
the HRC (HeRO) monitor in the NICU:
1) Continuous monitoring is more effective than intermittent. Coggins
analyzed scores recorded in the medical record every 12 hours, or 8% of
the hourly scores; high scores may have been missed.
2) Many high HRC index scores are not associated with bloodstream
infection. We have found that an acute rise in the score can also be
associated with urinary tract infection, necrotizing enterocolitis,
clinical sepsis, acute respiratory deterioration, surgery[1], brain
injury[2][3], and administration of atropine. In some cases, a rise in the
score is not associated with any apparent illness or event.
3) Some infants with septicemia do not have an acute rise in the HRC index
prior to diagnosis. In the Coggins report, only 37% of the 46
intermittently-sampled cases of septicemia were associated with HRC index
>2. In our analysis from the continuously-sampled RCT, 79% of the 974
cases of septicemia in 700 VLBW infants, were associated with a score
>2 in the day before diagnosis[4].
4) The HRC index monitor should never replace clinical judgement. A
septic-appearing baby should get antibiotics regardless of the score, and
a baby with a high score but low clinical index of suspicion for infection
could be closely watched without antibiotics[5]. A scenario in which a
baby might benefit is the VLBW infant whose baseline HRC index is <1
for several days, followed by a rise to >2, prompting clinicians to
look more closely, send laboratory tests, and detect and treat infection
before the baby has obvious clinical deterioration.
Karen Fairchild MD,
David Kaufman MD,
John Kattwinkel MD
University of Virginia School of Medicine
1) Sullivan BA, Grice SM, Lake DE, et al. Infection and other
clinical correlates of abnormal heart rate characteristics in preterm
infants. J Pediatr 2014;164:775-80.
2) Vergales BD, Zanelli SA, Matsumoto JA, et al. Depressed heart
rate variability is associated with abnormal EEG, MRI, and death in
neonates with hypoxic ischemic encephalopathy. Am J Perinatol 2014;31:855-
62.
3) Fairchild KD, Sinkin R a, Davalian F, et al. Abnormal heart rate
characteristics are associated with abnormal neuroimaging and outcomes in
extremely low birth weight infants. J Perinatol 2014;34:375-9.
4) Fairchild KD, Schelonka RL, Kaufman D a, et al. Septicemia
mortality reduction in neonates in a heart rate characteristics monitoring
trial. Pediatr Res 2013;74:570-5.
5) Griffin MP, Lake DE, O'Shea TM, et al. Heart rate characteristics
and clinical signs in neonatal sepsis. Pediatr Res 2007;61:222-7.
Regarding Coggins' Heart rate characteristic index monitoring for
bloodstream infection in an NICU: a 3-year experience:
Wirschafter[1] has labeled the CDC definition a minimum estimate of
infection burden, while labeling antibiotic administration a maximum
estimate. The authors refuse to provide metrics such as Specificity and
NPV on the grounds that establishing health of the patients was not
possible. By...
Regarding Coggins' Heart rate characteristic index monitoring for
bloodstream infection in an NICU: a 3-year experience:
Wirschafter[1] has labeled the CDC definition a minimum estimate of
infection burden, while labeling antibiotic administration a maximum
estimate. The authors refuse to provide metrics such as Specificity and
NPV on the grounds that establishing health of the patients was not
possible. By their own logic, meeting the CDC definition may in fact
confer sickness, but the absence of meeting the definition does not confer
health.
The authors admit that only 8% of HeRO Scores were recorded, and this
offered an opportunity for bias. Importantly, the recorded and unrecorded
HeRO Scores were incorporated into clinical decisions during care of the
subjects. The presence of elevated HeRO Scores would have prompted action
on the part of caregivers that altered the presence, timing, and results
of blood cultures prior to antibiotic administration[2].
As discussed above, the authors assert that PPV, NPV Sensitivity, and
Specificity cannot be calculated. Yet, the authors go on to report that
"17/46 (37%) had at least one score >=2 recorded in the 48 h period
prior to [BSI]." THIS IS SENSITIVITY. Further, the authors report that
"BSI (at any time) was observed in just 5% of patients with HRC scores
>=2..." THIS IS PPV. Back-calculated from the numbers reported:
The authors characterize the 37% sensitivity versus 48hr BSI as
"limited," while completely ignoring the opportunity to improve the most
important outcome in a significant fraction of sick neonates. An optimist
might call actionable information for 37% of proven infections in the 48
hour window prior diagnosis something quite different: "extraordinary".
Beauty is in the eye of the beholder.
Sincerely,
Will King, CEO
1 - Antibiotic use for presumed neonatally acquired infections far
exceeds that for central line-associated blood stream infections: an
exploratory critique. Wirtschafter DD, Padilla G, Suh O, Wan K, Trupp D,
Fayard EE. J Perinatol. 2011 Aug;31(8):514-8. doi: 10.1038/jp.2011.39.
Epub 2011 May 5.
2 - Infection and Other Clinical Correlates of Abnormal Heart Rate
Characteristics in Preterm Infants. Sullivan BA, Grice SM, Lake DE,
Moorman JR, Fairchild KD. J Pediatr. (2014) Jan 9
3 - ROC calculated from a single threshold (HeRO = 2.0), and the
corresponding Sensitivity and Specificity (87% and 68%, respectively).
Sweeping across multiple thresholds would result in a more precise
calculation of ROC, which could be expected to exceed 0.80.
Conflict of Interest:
I am CEO of MPSC, manufacturer of the HeRO System.
We appreciate the comments from Fairchild et al., and acknowledge
that HRC monitoring has value in their NICU as an additional vital sign
that may lead to increased provider attention. Our finding of a
significantly lower correlation of HRC and proven sepsis likely stems from
the difference in the definition used and highlights both a significant
problem with diagnostic testing for neonatal sepsis in general (1) and the
p...
We appreciate the comments from Fairchild et al., and acknowledge
that HRC monitoring has value in their NICU as an additional vital sign
that may lead to increased provider attention. Our finding of a
significantly lower correlation of HRC and proven sepsis likely stems from
the difference in the definition used and highlights both a significant
problem with diagnostic testing for neonatal sepsis in general (1) and the
practical use of HRC outside of a clinical trial. We agree that modalities
that can identify infants at risk for or with disease prior to clinical
presentation can provide great clinical value. However, as with any
screening test for disease, it is important to know how often the test is
right and how often it is wrong.
In response to Mr. King, CEO of MPSC, manufacturer of the HeRO
System, our goal was to perform an unbiased analysis of EMR data as an
opportunity to share a "real-world" experience with HRC monitoring and its
association with sepsis in the NICU. As we stated in our paper, this work
stemmed from the fact that we were unable to identify a published report
of commonly reported indices for diagnostic testing using the HeRO System
including sensitivity, specificity, negative and positive predictive
value, as well as area under receiver operating curve [which were also not
reported in the large RCT (2)]. We would have liked to provide those
metrics for our study, but were not able to do so based on sound
statistical analysis. As we stated, since every baby with an elevated
score > 2 was not evaluated for sepsis at each instance that the score
was elevated, accurate predictive indices cannot be determined from the
data available in our report (3). We acknowledged that HRC scores are
monitored continuously in our NICU but not all scores were available for
analysis in the EMR. Our NICU policy is that bedside staff record HRC
scores at least once per shift in the EMR but also notify the provider if
scores are >2.5 and record the event. Hence, the available EMR data was
not entirely intermittent. In our paper, we reported not 8% of scores that
were recorded but rather that 8% (9,701) of all HRC scores recorded in the
EMR (127,673) over a 30-month period were > 2. The HRC score is
available to integrate into clinical care as suggested, however, our data
point out the limitations to accurate identification of sepsis ahead of
clinical signs, and hence prevention of death from this disease. Based on
our data, the actionable signal identifying sepsis by the definition we
used appears hidden in a large background of elevated scores not specific
to sepsis.
James L. Wynn, J?rn Hendrik Weitkamp, Jeff Reese, Ann Stark
1. Wynn JL, Wong HR, Shanley TP, Bizzarro MJ, Saiman L, Polin RA.
Time for a neonatal-specific consensus definition for sepsis. Pediatric
critical care medicine : a journal of the Society of Critical Care
Medicine and the World Federation of Pediatric Intensive and Critical Care
Societies. 2014;15(6):523-8.
2. Moorman JR, Carlo WA, Kattwinkel J, Schelonka RL, Porcelli PJ,
Navarrete CT, et al. Mortality reduction by heart rate characteristic
monitoring in very low birth weight neonates: a randomized trial. The
Journal of pediatrics. 2011;159(6):900-6 e1.
3. Coggins SA, Weitkamp JH, Grunwald L, Stark AR, Reese J, Walsh W,
et al. Heart rate characteristic index monitoring for bloodstream
infection in an NICU: a 3-year experience. Arch Dis Child Fetal Neonatal
Ed. 2015.
May I suggest an alternative term for the egregious "upper extremity"
used in the title of Labore and Befell's article. I believe that the body
part to which they are referring is also known as an "arm"?
The overall tone of this systematic review is to reassure the reader
that waterbirths are safe; this is not justified by the results which rely
almost exclusively on extremely poor quality retrospective cohort studies.
Different study designs have significant differences in their
susceptibility to bias and the authors have largely ignored this issue.
Larger, non-randomised studies, more prone to bias, carry more weight ; n...
The overall tone of this systematic review is to reassure the reader
that waterbirths are safe; this is not justified by the results which rely
almost exclusively on extremely poor quality retrospective cohort studies.
Different study designs have significant differences in their
susceptibility to bias and the authors have largely ignored this issue.
Larger, non-randomised studies, more prone to bias, carry more weight ; no
meta-analysis should have been done with these data.
In contrast to the use of immersion in the first stage of labour,
waterbirth confers no benefit to the mother or baby and puts the baby at
unacceptable risk; current trials are too small to rule this out. Adverse
events for the baby are rare but devastating. A hypoxic-ischaemic fetus
will aspirate water when gasping while immersed.
The authors have deemed that a large, prospective, cohort study is an
acceptable approach to determining the benefit/harm ratio for waterbirth.
Such non-randomised studies are prone to significant bias. The control
group would be fundamentally different to the waterbirth group, and such
differences would undermine the major principle that both groups should be
as similar as possible with respect all other factors that may be related
to treatment and outcomes except for the intervention. With non-random
assignment in a cohort study, equally eligible women with different risks
for adverse outcomes will be assigned the intervention group (consciously
or unconsciously) based on how the women themselves or their caregivers
perceive the risk of adverse outcome -large numbers of women enrolled in
this way will seriously imbalance the treatment groups with regard to
factors affecting outcomes.
An appropriately sized, good quality RCT with longterm follow-up
remains the only reliable way to assess both the efficacy and the safety
of waterbirths.
We are grateful for the interest in our paper and the opportunity to
refute the suggestion that it is falsely reassuring. Our paper provides a
fair and accurate representation of the best available data; it concludes
that "this systematic review and meta-analysis did not identify definitive
evidence that waterbirth causes harm to neonates ... However, there is
currently insufficient evidence to conclude that there are no...
We are grateful for the interest in our paper and the opportunity to
refute the suggestion that it is falsely reassuring. Our paper provides a
fair and accurate representation of the best available data; it concludes
that "this systematic review and meta-analysis did not identify definitive
evidence that waterbirth causes harm to neonates ... However, there is
currently insufficient evidence to conclude that there are no additional
risks or benefits for neonates".
It does indeed state that "existing evidence is not strong enough to
examine the relative risk of rare and potentially devastating adverse
events" as well as citing the risk of aspiration in a compromised baby who
was born gasping (paragraph 8).
It is incorrect to suggest that the susceptibility to bias of
different study designs was ignored and that results are reliant on poor
quality retrospective studies. The entire meta-analysis was repeated, for
every outcome, using data only from randomised controlled trials. These
results were entirely consistent with the primary analysis and are
available to view in supplementary file D.
There are a number of ways to examine safety and capture rare,
serious adverse events. The merits and drawbacks of each approach must be
carefully considered before any future study. We recognise the limitations
of prospective cohort studies and agree that a large, adequately powered
RCT would be ideal to determine the safety of waterbirth. However, there
are significant ethical and practical issues with randomising enough
women. In one UK pilot, of 40 women randomised to water birth, only 10
delivered in water.[1] The National Institute for Health Research recently
called for an observational study to address this question and stated the
design 'should not involve randomisation given the rarity of adverse
events'.[2]
[1] Woodward J, Kelly SM. A pilot study for a randomised controlled
trial of waterbirth versus land birth. BJOG: an international journal of
obstetrics & gynaecology. 2004 Jun 1;111(6):537-45.
[2] National Institute for Health Research (NIHR). HTA commissioned
funding opportunities, call 15_157 'Delivering babies in or out of water'.
http://www.nets.nihr.ac.uk/funding/hta-commissioned
I read the article by Watson et al and the accompanying Editorial.
While it is an interesting concept to link nurse patient ratios with
mortality this does not take into account the individual nurses and their
experiences. I would challenge the authors to demonstrate how
retrospective data measures acuity and nursing experience. The authors
presented the 1:1 ratio as measured by the percentage of ICU days where
there wa...
I read the article by Watson et al and the accompanying Editorial.
While it is an interesting concept to link nurse patient ratios with
mortality this does not take into account the individual nurses and their
experiences. I would challenge the authors to demonstrate how
retrospective data measures acuity and nursing experience. The authors
presented the 1:1 ratio as measured by the percentage of ICU days where
there was one nurse per patient. Realistically each patient has a
different level of acuity and this will determine the nurse to patient
ratio. However even with a one to one ratio each nurse also has a
different level of experience. With the critical shortage of nurses in
acute care areas in both the UK and Australia the practice is to recruit
less experienced nurses and many NICUs take first year nurse graduates.
How these nurses are supported and supervised to provide a level of safe
practice would be a more meaningful measure to link with mortality or
indeed morbidity in this vulnerable patient population.. If there is
inadequate supervision from senior nurses or clinical nurse educators then
the novice nurses learn from each other, indeed an unsafe practice.
Perhaps a more useful measure would be for researchers to assist
clinicians in auditing practices so we know what is actually being
practiced and then look at morbidity and mortality as an outcome. As an
experienced neonatal nurse I would challenge researchers that mortality is
not a reliable measure of nursing work - we need to develop a set of
outcome measures that are meaningful measures of nursing work in the NICU.
By clinicians and researchers working together we can then strive to
ensure the NICU is a safe environment and we would have measures to
improve practice and outcomes for the infants and their families.
Hellman, Knigthon et Al and Carter in the accompanying editorial
raise many issues dealing with the end of life care of sick newborn
babies. Although consensus within multidisciplinary teams in each centre
is recorded as being achieved relatively easily, the wide variation
between centres in how each deals with the issue of withholding life
saving treatments, particularly where there are 'quality of life issues'
und...
Hellman, Knigthon et Al and Carter in the accompanying editorial
raise many issues dealing with the end of life care of sick newborn
babies. Although consensus within multidisciplinary teams in each centre
is recorded as being achieved relatively easily, the wide variation
between centres in how each deals with the issue of withholding life
saving treatments, particularly where there are 'quality of life issues'
underscores a wider lack of consensus amongst practicing neonatologists.
This raises a number of issues. The most challenging of which is why,
when there is such variation between units is there such agreement within
them? This could be because like-minded people work together, or more
likely people who work together become like minded. More disturbingly, it
raises the possibility that the consensus may not be as great as perceived
with particularly junior members of the decision making team- perhaps even
the parents- feeling unable to voice dissent.
A further issue is the weight given to medical opinion in making
ethical and moral judgements. In common with most doctors, I received
little or no formal training in ethics. I can use technical language to
make my forthright opinions sound ethical, but in an era increasingly
asking for evidence I have little to back these up. Historically the
medical profession has not always cloaked itself in glory when trying to
play society's moral arbiter. We can often lapse into a language of
certainty and authority which makes it difficult for others to challenge
our positions.
I have another difficult personal issue, which being late to the
table I have only just realised. In common with most doctors of my
generation I was not encouraged to think about why I do what I do. I see
that there are many different types of doctors, many of us in hospital
seem to be 'fixing' doctors in that we see ourselves as people that make
problems better. If we could cope with uncertainty and some degree of
failure we may be in different specialties. Patients that will not or
cannot be fixed can challenge me as a doctor and make me feel in some way
'undermined.' In these situations I worry that decisions that I make or
recommend may be as much for my benefit as they are for my patients or
their family. As a 'fixer' it is easier to discard rather than live with
broken things. These are incredibly complex feelings to acknowledge but
they certainly do exist.
The obvious solution, as is available in much of North America and
other countries in the world would be to establish Ethics panels who could
judge these matters. These could be hospital based, regional or supra
regional and would include members with proper training in Ethics and
legal knowledge. Undoubtedly their deliberations would be heavily informed
by medical evidence and input, in much the same way that medical input
informs but does not make, safeguarding decisions which are ultimately in
the gifts of the courts and their agents. This would provide safeguards
for patients, families and the medical teams who look after them.
We read with interest the paper by Cuttini et al (1). Although policy
regarding parental visiting is a relatively easier issue to evaluate,
parental participation in decision making, particularly in decisions with
strong ethical overtones, is a much more complex issue. It is difficult to
evaluate with accuracy with accuracy and by its nature much more
controversial. The paper does not stress that data col...
We read with interest the paper by Cuttini et al (1). Although policy
regarding parental visiting is a relatively easier issue to evaluate,
parental participation in decision making, particularly in decisions with
strong ethical overtones, is a much more complex issue. It is difficult to
evaluate with accuracy with accuracy and by its nature much more
controversial. The paper does not stress that data collected from each
participating unit through a structured questionnaire completed by the
unit co- ordinator, represent policies, that is the intention and stance
of each unit towards the particular issue for evaluation. Data collected
through questionnaires and interviews involving both unit staff and
parents would have provided a better understanding of the actual practice
of each participating unit.
No unit from Greece took part in the study by Cuttini et al (1) but
Greece is briefly mentioned in the discussion, using results from a
previous study (2) where in a sample of 38 units from 11 European
countries it was shown that the 9 units imposing visiting restrictions
were in France, Greece, Italy and Portugal.
We would like to provide further information regarding visiting
policies in Greek NICUs. There are 15, two of which are private; twelve
attached to maternity hospitals and the remaining three are in children's
hospitals and accept distant referrals. In all but one (Aglaia Kyriakou
Children's Hospital) visiting restrictions are imposed. These allow
parents only and the usual practice is ½ -1 hour visiting time in the
morning and afternoon (excepting lactating mothers). The most common
reasons given for imposing restrictions are an increased danger of
infection and a disruptive effect on the unit.
We conducted a survey through a questionnaire and an interview of
parents whose baby has been cared for in another NICU imposing visiting
restrictions before transfer to our NICU and / or parents who had a
previous baby in another NICU imposing restrictions. The overwhelming
majority (98.6%) said they preferred the liberal policy we have adopted
with respect to visiting. One mother of preterm baby with bronchopulmonary
dysplasia said that 'if I had delivered at term I would be with my baby,
if I had not delivered prematurely I would also be with my baby (in my
womb), now that I have delivered prematurely why can't I be with my baby?
We conclude that in Greece there is a demand for unrestricted
parental visiting but most Greek NICUs do not meet this demand for reasons
which are not based on medical or sociological evidence.
It is worth noting that, in Greece, infants beyond the neonatal
period have been admitted to children's wards with their mothers for many
years.
Dr H D Dellagrammaticas MD, FRCPCH
Dr Nicoletta Iacovidou MD
NICU, 2nd Department of Paediatrics
University of Athens
Aglaia Kyriakou Children's Hospital
115 27 Athens, Greece
References
1. Cuttini M, Rebagliato M, Bortoli P, et al. Parental visiting, communication and participation
in ethical decisions: a comparison of neonatal unit policies in Europe.
Arch Dis Child Fetal Neonatal Ed 1999;81:F84 - F91
2. Reid M, Andersen E, EC Study Group of Parental Involvement in Neonatal
Care (Adam H, Cuttini M et al). Variations in family visiting policies in
neonatal intensive care units in eleven EC countries. Pediatr Perinat
Epidemiol 1994;8:41 - 52
In the report "Heart rate characteristics index monitoring for bloodstream infection in an NICU: a 3-year experience", Coggins and colleagues make several observations that are important for properly using the HRC (HeRO) monitor in the NICU: 1) Continuous monitoring is more effective than intermittent. Coggins analyzed scores recorded in the medical record every 12 hours, or 8% of the hourly scores; high scores may have...
Regarding Coggins' Heart rate characteristic index monitoring for bloodstream infection in an NICU: a 3-year experience:
Wirschafter[1] has labeled the CDC definition a minimum estimate of infection burden, while labeling antibiotic administration a maximum estimate. The authors refuse to provide metrics such as Specificity and NPV on the grounds that establishing health of the patients was not possible. By...
We appreciate the comments from Fairchild et al., and acknowledge that HRC monitoring has value in their NICU as an additional vital sign that may lead to increased provider attention. Our finding of a significantly lower correlation of HRC and proven sepsis likely stems from the difference in the definition used and highlights both a significant problem with diagnostic testing for neonatal sepsis in general (1) and the p...
May I suggest an alternative term for the egregious "upper extremity" used in the title of Labore and Befell's article. I believe that the body part to which they are referring is also known as an "arm"?
Conflict of Interest:
None declared
The overall tone of this systematic review is to reassure the reader that waterbirths are safe; this is not justified by the results which rely almost exclusively on extremely poor quality retrospective cohort studies. Different study designs have significant differences in their susceptibility to bias and the authors have largely ignored this issue. Larger, non-randomised studies, more prone to bias, carry more weight ; n...
We are grateful for the interest in our paper and the opportunity to refute the suggestion that it is falsely reassuring. Our paper provides a fair and accurate representation of the best available data; it concludes that "this systematic review and meta-analysis did not identify definitive evidence that waterbirth causes harm to neonates ... However, there is currently insufficient evidence to conclude that there are no...
I read the article by Watson et al and the accompanying Editorial. While it is an interesting concept to link nurse patient ratios with mortality this does not take into account the individual nurses and their experiences. I would challenge the authors to demonstrate how retrospective data measures acuity and nursing experience. The authors presented the 1:1 ratio as measured by the percentage of ICU days where there wa...
The 'Dr Isaac 'Harry' Gosset Collection' a repository of UK General Paediatric and Premature Baby Care 1947-1965 is now on line.
http://www.northamptongeneral.nhs.uk/AboutUs/Ourhistory/Dr-Gosset/The -Dr-Isaac-Harry-Gosset-Collection.aspx
Conflict of Interest:
I am the author of the paper I am replying to
Hellman, Knigthon et Al and Carter in the accompanying editorial raise many issues dealing with the end of life care of sick newborn babies. Although consensus within multidisciplinary teams in each centre is recorded as being achieved relatively easily, the wide variation between centres in how each deals with the issue of withholding life saving treatments, particularly where there are 'quality of life issues' und...
Editor,
We read with interest the paper by Cuttini et al (1). Although policy regarding parental visiting is a relatively easier issue to evaluate, parental participation in decision making, particularly in decisions with strong ethical overtones, is a much more complex issue. It is difficult to evaluate with accuracy with accuracy and by its nature much more controversial. The paper does not stress that data col...
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