Wyatt et al. (1) are to be commended for producing one of the largest
randomised controlled trial on the effectiveness of cranial osteopathy for
children with cerebral palsy, which was carried out on behalf of Cerebra.
Cranial osteopathy as an adjunctive treatment in cerebral palsy is not
new: Dr Beryl Arbuckle, an osteopathic physician, opened the Cerebral
Palsy Institute in the 1940s in the USA which offered osteopathic...
Wyatt et al. (1) are to be commended for producing one of the largest
randomised controlled trial on the effectiveness of cranial osteopathy for
children with cerebral palsy, which was carried out on behalf of Cerebra.
Cranial osteopathy as an adjunctive treatment in cerebral palsy is not
new: Dr Beryl Arbuckle, an osteopathic physician, opened the Cerebral
Palsy Institute in the 1940s in the USA which offered osteopathic
manipulative treatment to children with this condition(2).
There are however limitations to this study and the results should be
interpreted accordingly. The age range chosen for the trial was 5-12
years (mean7.8) whereas in reality, most children with cerebral palsy or
other neurological deficits who are treated with osteopathy are seen much
earlier to take advantage of the potentially greater plasticity of the
developing central nervous system. Earlier trials by Fryman (3) and
Duncan et al (4,5) studied a wider age range ranging from 11 months to 12
years which is more keeping with the age range encountered in clinical
practice. These earlier studies also suggested that children with mild
cerebral palsy (GMFCS6 category I) benefit the most from osteopathic
intervention. Therefore the results of this study may not be pertinent to
younger children nor to mild cerebral palsy.
Six osteopathic treatments over a period of six months were offered
to participants in the trial. However only 49 out of the 65 children
(75%) who were eventually included in the data analysis had all six
treatments, and the rest (n=11) had fewer than four treatments in all. Ten
out of the initial 71 children in the trial did not receive any treatment
and five of these were included in the eventual 65 children whose data
were analysed, which in view of the sample size may skew the results
unfavourably. It was stated that a clinically significant difference of
0.6 SDs in the primary outcome measures between the control and
intervention groups required a sample size of 60 children in each group,
but these results based on only 49 children who received all six
treatments must surely be flawed. The number and duration of the
treatments (each treatment averaging at 21 minutes) may suggest that
treatment was not as comprehensive as in previous studies that showed a
positive effect: Frymann (6-12 treatments ) and Duncan at al. (10 sessions
lasting 30-60 minutes).
A major limitation of this study was that the baseline measure used a
parent assessed GMFCS, whereas the outcome measure was an independently
assessed GMFM-667, an entirely different score in contrast to the smaller
study by Duncan et al (5) where both the baseline and outcome measures
were scored using GMFM-88. Ideally the outcome measure should also include
an assessment of the concepts specific to osteopathic management for
example, spinal and fascial restriction: both of which may be viewed as
correlates of muscle spasticity (8). Children with spasticity may vary in
terms of their function and tone from time to time; the clinical picture
is by no means static, and a longer term follow-up beyond the 6 month
period might yield interesting comparisons.
It was interesting to note that twice as many carers of children in
the intervention group as in the control group reported that the overall
health of the children under their care improved with osteopathic
treatment. This could be the starting point for more much needed
osteopathic research.
REFERENCES
1. Wyatt K, Edwards V, Franck L, Britten N, Creanor S, Maddick A,
Logan S. Cranial osteopathy for children with cerebral palsy: a randomised
controlled trial. Arch Dis Child 2011;96:505-512.
2. Arbuckle B. Cerebral palsy - special reference to importance of early
care of newborns. In: The Selected Writings of Beryl E. Arbuckle, DO,
FACOP. 2nd ed. Indianapolis, Ind: American Academy of Osteopathy;
1994:113.
3. Fryman VA, Carney RE, Springall P. Effect of osteopathic medical
management on neurological development in children, J Am Osteopathic Assoc
1992;92:729-744.
4. Duncan B, Barton L, Edmonds D et al. Parental perceptions of the
therapeutic effect from osteopathic manipulation or acupuncture in
children with spastic cerebral palsy. Clin Pediatr (Phila) 2004:43:349-53.
5. Duncan B, McDonough-Mears, Worden K et al. Effectiveness of osteopathy
in the cranial field and myofascial release versus acupuncture as
complementary treatment for children with spastic cerebral palsy: a pilot
study. J Am Osteopathic Assoc 2008;108:559-70.
6. Palisano R, Rosenbaum P, Walter S, et al. Development and reliability
of a system to classify gross motor function in children with cerebral
palsy. Dev Med Child Neurol 1997;39:214-23.
7. Russell DJ, Rosenbaum PL, Cadman DT, et al. The gross motor function
measure: a means to evaluate the effects of physical therapy. Dev Med
Child Neurol 1989;31:341-52.
We read with interest Dr Baines's article on assent for children's
participation in research [1] and were pleased that he has highlighted the
complexities surrounding assent. We agree that the current situation is
confused and legal guidance is inconsistent. This primarily hinges on the
poor definition of assent and its place in the consent process.
We do however challenge Dr Baines's suggestion that assent does...
We read with interest Dr Baines's article on assent for children's
participation in research [1] and were pleased that he has highlighted the
complexities surrounding assent. We agree that the current situation is
confused and legal guidance is inconsistent. This primarily hinges on the
poor definition of assent and its place in the consent process.
We do however challenge Dr Baines's suggestion that assent does not
have a place in research with children and can cause harm. The argument
that the current guidance on assent is inconsistent is a valid one, but it
does not necessarily follow that the concept of assent is irredeemably
invalid. The term "assent" gives recognition to the role for children that
lies between no involvement in discussions and full decisional authority
and demonstrates respect for the child.[2] It helps a child to achieve a
developmentally appropriate understanding of the nature of the condition
and allows children a chance to express their views and have these taken
into account to the extent that is appropriate. If the guidance to seek
assent was removed, it might be expected that children would still be
consulted about their research participation and presumably
incompatibility between parent and child could still arise. Therefore,
incompatibility is not a consequence of assent but a consequence of a
situation in which the views of both parent and child are important.
Even if assent is flawed and leads to box-ticking (similar arguments
can be put forward about the limitations of consent), the requirement to
seek assent at least creates a clear expectation that children be
consulted. It also creates an expectation that practitioners, not just
parents, take a role in this. Its removal could be symbolically
significant and lead to less openness with children. In the absence of
assent, practitioners may be less likely to consult with children about
research and the responsibility for consulting with them could be handed
entirely to parents. So the tensions between parent and child regarding
research participation would not disappear, although they might become
less visible. It has been shown that parental understanding of research
can be problematic, [3] and this would have implications for the quality
of their consultation with the child.
There are some important questions that we currently don't have
answers for. One of these is how frequent and serious are the tensions
that arise between the child and parent regarding research participation?
The RECRUIT study [4] was a qualitative study examining the consent
process and the views of parents, young people and practitioners during
this process. It cannot answer questions about how often disputes arise
but there was a clear and consistent message from children and parents
that they could usually resolve their differences, and that the tensions
that arose seemed to be a catalyst for helpful dialogue. At the onset of a
trial the practitioner should clearly think about the age and medical
condition of children that they are recruiting. A clear strategy should be
devised for how children may be best involved in the recruitment process
and the documentation that a child has been consulted in the decision
making.
Dr Baines is right that assent, and dissent, as concepts are less
well developed than consent. A definition taking into account all
stakeholders' views with an international consensus would seem a sensible
way forward from this point, with continued debate on the place of assent
in the recruitment process.
References
1 Baines P. Assent for children's participation in research is incoherent
and wrong. Arch. Dis. Child 2011; 0:adc.2011.211342v1-archdischild211342;
doi:10.1136/adc.2011.211342
2 Spriggs MP, Gillam LH. Consent in paediatric research: an evaluation of
the guidance provided in the 2007 NHMRC National statement on ethical
conduct in human research 2008; Med J Australia.188:360-2.
3 Featherston K, Donovan JL. Random allocation or allocation at random?
Patients' perspectives of participation in a randomised controlled trial.
BMJ 1998 ;317:1177-80.
4 Shilling V, Williamson PR, Hickey H,et al. 2011Processes in recruitment
to randomised controlled trials (RCTs) of medicines for children
(RECRUIT): a qualitative study. Health Technology Assessment 15:15
Conflict of Interest:
We are all members of STAR Child Health standard development group for consent and recruitment
The Editorial by Drs.Southall and Samuels pointed out that fluid
challenges given in a recent study by Maitland et al. (1) to children in
the absence of hypovolemic shock may worsen severe anaemia.
It is important to note that 32% of all children enrolled had severe
anemia (Hb<5 g/dl) with no significant difference of this proportion
between groups.
Maitland et al. stated that their data showed that excess mortality w...
The Editorial by Drs.Southall and Samuels pointed out that fluid
challenges given in a recent study by Maitland et al. (1) to children in
the absence of hypovolemic shock may worsen severe anaemia.
It is important to note that 32% of all children enrolled had severe
anemia (Hb<5 g/dl) with no significant difference of this proportion
between groups.
Maitland et al. stated that their data showed that excess mortality with
fluid resuscitation was consistent across all subgroups. This is not the
case: Relating cause of death due to anemia as primary disease or
secondary condition that led to death ( appendix table 4b) to the
total number of children with severe anemia (haemoglobin <5 g/dl) in
each group shows that for the albumin bolus group (35/323) as well as for
the saline-bolus group (36/332) anemia related mortality was significantly
higher than in the group without bolus (18/332) (chi-square with Yates
correction 5.75, p=0.016). This difference was also significant for anemia
as primary disease that was judged to have lead to death. Anemia related
mortality hereby appeared to be the only disease related mortality
significantly increased in the groups with fluid resuscitation and appears
therefore to be the most likely explanation for the authors finding of
increased mortality in children receiving fluid resuscitation. A previous
study showed a higher mortality (18%) in children with severe malaria and
anemia who had fluid resuscitation with saline compared to controls (6%)
receiving maintenance fluids (2). Severe anemia is a common cause of
cardiac dysfunction in children in malaria endemic areas (3). It is
chronic iron deficiency anemia, common in the childhood population
investigated by the authors, as well as acute malaria, which lead to
cardiac dysfunction (4, 5). Correction of iron deficiency led to reversal
of myocardial and microcirculatory changes in a previous study(4). The
impact of fluid boluses on the mortality of children with cardiac
dysfunction related to severe chronic iron deficiency anemia and an
infectious disease, which may reduce cardiac function further (6) needs to
be re-investigated in this context.
References:
1. Maitland K, Kiguli S, Opoka RO, Engoru C, Olupot-Olupot P, Akech
SO, Nyeko R, Mtove G, Reyburn H, Lang T, Brent B, Evans JA, Tibenderana
JK, Crawley J, Russell EC, Levin M, Babiker AG, Gibb DM for the FEAST
Trial Group. Mortality after fluid bolus in African children with severe
infection. 10.1056/NEJMoa1101549.
2. Maitland K, Pamba A, English M, Peshu N, Marsh K, Newton C, Levin
M. Randomized Trial of Volume Expansion with Albumin or Saline in Children
with Severe Malaria: Preliminary Evidence of Albumin Benefit. Clin Infect
Dis. (2005) 40 (4): 538-545.
3. Yacoub S, Lang HJ, Shebbe M, Timbwa M, Ohuma E, Tulloh R, Maitland
K. Cardiac function and hemodynamics in Kenyan children with severe
malaria. Crit Care Med. 2010 Mar;38(3):940-5.
4. Georgieva Z, Georgieva M. Compensatory and adaptive changes in
microcirculation and left ventricular function of patients with chronic
iron-deficiency anaemia. Clin Hemorheol Microcirc 1997; 17: 21-30.
In response to the interesting article by P B Juliusson et. al. on
Growth of Belgian & Norwegian Children compared to the WHO growth
standards published in Arch. Dis. of Childhood 2011, 96:916-921 and
appreciating the concerns raised by him, we raise few issues pertaining to
India. It is stated in the paper that there are significant deviations, we
put forth the point that developing countries must first start using WH...
In response to the interesting article by P B Juliusson et. al. on
Growth of Belgian & Norwegian Children compared to the WHO growth
standards published in Arch. Dis. of Childhood 2011, 96:916-921 and
appreciating the concerns raised by him, we raise few issues pertaining to
India. It is stated in the paper that there are significant deviations, we
put forth the point that developing countries must first start using WHO
charts, detect malnutrition which is one of the major roles of the charts
and then to find out deviations which may come as an offshoot. Using WHO
child growth charts, UNICEF has estimated that India has 43% prevalence of
undernutrition in under 5 children next only to Timor Leste of 49% which
is the highest in the world. Stunting is also seen in 48% of Indian
children, similar figures of Afghanistan being 59%, the highest in the
world1.
Use of integrated management of neonatal & childhood illness
(IMNCI) and WHO new growth charts has helped the country to detect Severe
Acute Malnutrition. As India was one of the six countries for data
collection of WHO new growth charts and that these charts give optimum
growth of children, it is scientific to use them. These charts give
percentiles and SAM is diagnosed when the wt. for ht. is below -3 Z score
on WHO growth charts or MUAC (Mid Upper Arm Circumference) of less than
115 cms. or pedal oedema of nutritional origin in children 6 months to 59
months. The country has to resolve through its medical community on the
first issue and switch to WHO charts from the ones that are in use through
the Indian Academy of Pediatrics (NCHS)2. The number of children
afflicted with SAM increases with the use of WHO new growth charts which
will mean attention to a larger population. 8 million children in India
are assumed to have SAM which will increase from 6.4% to around 15.6%.
It is therefore urged that pediatricians shift to the new methodology, as
one is aware that 61% of diarrhoea deaths and 53% of pneumonia deaths are
due to SAM. SAM increases the child mortality 9 times3. Second point in
diagnosis is community use of MUAC. Cutoff for diagnosis of SAM suggested
is 115 cm which will also be appropriate for India, as anthropometric
values around different populations of children upto 5 years remain
unchanged for weight and height; so will it be for mid arm circumference.
In addition to having diagnostic precision, one needs to have
standardized protocols for management of SAM. Efficacy and safety of
therapeutic nutrition products has been assessed world over and in
India4,5. Home based foods if standardized and supplemented with
micronutrients have given fair results when compared to RUTF which is
found better and superior.
If the country wishes to tackle SAM with priority, it will be
important to use weight for height as the specific criterion (weight for
age being a composite indicator, broad screening tool and it will detect
both acute and chronic malnutrition). It will be important to use MUAC in
detection and to facilitate use of standardized medicinal foods that would
get absorbed better through already atrophic intestines of these children
than the conventional home based rice and lentils some of which may not be
absorbed properly. The country thus needs an immediate roadmap, using WHO
new growth standards first, detect malnutrition and then find deviations.
We declare no conflict of interest.
Dr. M.A. Phadke - Senior Advisor, NRHM, Adjunct Professor,
Maharashtra University of Health Sciences and Visiting Scientist, Haffkine
Institute, Mumbai, India.
Dr. N.A. Kshirsagar- National Chair, ICMR, Director, Dean, PG
Institute of Medical Sciences, MGM, ESIC, Parel, Mumbai, India.
1. Tracking progress on child & maternal nutrition, UNICEF,
November 2009, 17-18.
2. Bhatnagar S, Lodha R, Choudhary P, Sachdev HPS, Shah N,
Narayan S, Wadhwa N, Makhija P, Kunnekel K and Ugra D, IAP guidelines
2006 on
Hospital based management of severely malnourished children (adapted from
the WHO guidelines). Ind. Ped. 2007; 44: 443-459.
3. WHO child growth standards and the identification of severe
acute malnutrition
in infants & children, 2009, Pg 4.
4. Beesabathuni K N and Natchu UCM Production and Distribution
of Therapeutic Nutritional Product for Severe Acute Malnutrition in India,
Opportunities and challenges, Ind. Ped 2010; Aug 47 : 702-706.
5. Singh A S, Kang G, Ramachandran A, Sarkar R, Peter P and Bose A.
Locally made ready to use therapeutic food for treatment of Malnutrition.
lnd. Ped. 2010; Aug 47 : 679-685.
Dear Sir,
Case reports have their importance in the medical literature as you
pointed in your editorial [1]. Many journals opt not to publish them as
they are not considered "research", but they tend to forget that in many
situations, when clinicians are faced with a rare presentation of a common
disease or just a rare disease, they recur to case reports in order to
form an opinion and counsel patients. Moreover, textbook...
Dear Sir,
Case reports have their importance in the medical literature as you
pointed in your editorial [1]. Many journals opt not to publish them as
they are not considered "research", but they tend to forget that in many
situations, when clinicians are faced with a rare presentation of a common
disease or just a rare disease, they recur to case reports in order to
form an opinion and counsel patients. Moreover, textbooks are champions in
quoting: "this entity was reported X times in the medical literature."
Thus "BMJ case report" entered this field in order to answer the need of
case reports publications.
Informed consent for case report publication has raised new barriers for
publication. For a discussion on the right for privacy and confidentiality
versus the importance of publishing important issues and teaching see
Levine and Stagno [2].
In your editorial the different pros and cons are discussed, with the
eventual decision of withholding the publication... but... eventually,
though the case itself was not published, it was practically disclosed in
the text...
[1] Wacogne I. Publish and be damned? Arch Dis Child. 2011 Sep;96(9):789-
90.
[2] Levine SB and Stagno SJ.Informed Consent for Case Reports. The Ethical
Dilemma of Right to Privacy Versus
Pedagogical Freedom. Psychother Pract Research, 2001, 10: 193-201.
The excellent review by Sharkey and Shahidullah of oral propranolol
treatment for infantile haemangioma did not consider the formulation of
propranolol that might be used.[1] In UK a solution of propranolol
hydrochloride has a Marketing Authorisation (Syprol(TM); Rosemont
Pharmaceuticals Ltd) but is used off-label for this indication. It is
available in four different strengths of 1, 2, 8 and 10 mg/ml so there is
potent...
The excellent review by Sharkey and Shahidullah of oral propranolol
treatment for infantile haemangioma did not consider the formulation of
propranolol that might be used.[1] In UK a solution of propranolol
hydrochloride has a Marketing Authorisation (Syprol(TM); Rosemont
Pharmaceuticals Ltd) but is used off-label for this indication. It is
available in four different strengths of 1, 2, 8 and 10 mg/ml so there is
potential for confusion and medication error especially when patients move
between different care settings. Syprol also contains excipients such as
propyl parahydroxybenzoate (E216) for which questions of safety have been
raised and the higher strengths (which would reduce dose volume) also
contain Sunset Yellow (E110) which has not been specifically evaluated in
infants. Sharkey and Shahidullah also report diarrhoea as a potential
propranolol adverse reaction but note that it may be attributable to the
excipient maltitol. Maltitol is a constituent of all strengths of Syprol
and may be given in large doses if the lower strengths of Syprol are used
for larger doses of propranolol.
The UK is at least fortunate in having the option to use a
commercially manufactured solution of propranolol which has been quality
assured through the medicines licensing process. We were concerned to note
that in Australia preparation by the carer of a solution from tablets is
promoted because there is no authorised preparation and liquid
preparations compounded by the pharmacist are considered to be too
expensive.[2]
Sharkey and Shahidullah report widespread use of propranolol for
infant haemangioma and note several studies that may provide evidence of
safety and efficacy. Relevant clinicians need to link with an appropriate
pharmaceutical manufacturer to ensure that the indication and a suitable
age-appropriate formulation receive a Marketing Authorisation.
Consultation with the regulatory authorities should reveal which of the
options for authorisation best suit the circumstances.
1. Starkey E, Shahidullah H. Propranolol for infantile haemangiomas:
a review. Arch Dis Child 2011;96:890-893.
2. Greenhill NB, Deacon GB, Phillips RJ. J Paediatr Child Health
2011;47:484. Giving propranolol tablets to infants with hemangiomas -
solubility in water.
Marlow and colleagues suggest the use of the formula "Weight = 2(age)
+10" for children between 1 and 10 years.
An individual age group analysis has clearly not been performed here.
Had Marlow and colleagues done this they would have found that the formula
above suffers with similar problems as the APLS formula. After all, their
formula describes a straight line with the same gradient as the APLS
formula.
Marlow and colleagues suggest the use of the formula "Weight = 2(age)
+10" for children between 1 and 10 years.
An individual age group analysis has clearly not been performed here.
Had Marlow and colleagues done this they would have found that the formula
above suffers with similar problems as the APLS formula. After all, their
formula describes a straight line with the same gradient as the APLS
formula.
At age 9, "Weight = 2(age) +10" will underestimate (on average) by
some 22% and at age 10 by nearly 28%. It will also overestimate weights of
1 year olds by 7%.
A simple literature search would have revealed that this formula was
rejected in a 2007 paper published in this journal(1); for the reasons
above.
To state that this formula is applicable from 1-10years is wrong - it
barely works for 2-8 years and to have a formula with such a limited range
is pointless.
By publishing this Marlow et al are adding to the existing confusion
concerning weight estimation formulae. The formula they propose is similar
to the APLS and should be treated as such - ie not used due to very poor
accuracy at certain ages.
(1)Luscombe MD, Owens BD Weight estimation in resuscitation: is the
current formula still valid? Arch Dis Child 2007;92:412-415
Conflict of Interest:
The authors have published previous papers on this subject.
In her article, Mary Rudolph makes an interesting and perhaps even
feasible proposal. However, the fact that a reasonably accurate obesity
risk tool could be developed and applied does not necessarily mean that
screening is a good idea. We would raise the following objections:
1. With the estimated sensitivity (73%) and specificity (53%), the
positive predictive value would be only 28%, if the prevalence of obesity
was 2...
In her article, Mary Rudolph makes an interesting and perhaps even
feasible proposal. However, the fact that a reasonably accurate obesity
risk tool could be developed and applied does not necessarily mean that
screening is a good idea. We would raise the following objections:
1. With the estimated sensitivity (73%) and specificity (53%), the
positive predictive value would be only 28%, if the prevalence of obesity
was 20%, i.e. only less than 1 out of 3 infants identified as positive by
the test would really develop obesity. And 20% is a pretty high prevalence
at 6-8 years of age, much higher than current values in many EU countries.
If, on the other hand, 20% was the sum of overweight and obesity, a common
figure nowadays in many EU countries, the objection would be: is it worth
screening for overweight?
2. As noted by Mary Rudolph, the number and proportion of false positives
would be very high. In addition to the anxiety for children, parents and
families, there would be the risk of useless interventions by health and
other (e.g. pre-school and school, social) professionals. These
interventions, being mostly of a promotional nature, may not be dangerous,
but would certainly be unnecessary and expensive.
3. In addition, and even for true positive infants, we have very little
evidence of effectiveness, unlike interventions for growth faltering. We
have recently published a systematic review that shows the paucity of
evidence.(1)
4. Should effective interventions be available, screening, as a risk
approach, may not be the best solution for obesity in children. Following
Geoffrey Rose's population approach, i.e. implementing effective
interventions to the whole population as opposed to a group at risk, may
reduce the burden of disease by a larger extent.
5. Finally, screening programmes tend to medicalise problems, to deviate
the attention to medical as opposed to other strategies. Obesity in
children is a medical problem, but is also a social economic,
environmental, psychological, emotional etc problem. An approach that
limits, or give the proper weight to, the medical component of obesity
would be in our opinion preferable.
1. Monasta L, Batty GD, Macaluso A, Ronfani L, Lutje V, Bavcar A, van
Lenthe FJ, Brug J, Cattaneo A. Interventions for the prevention of
overweight and obesity in preschool children: a systematic review of
randomized controlled trials. Obesity Reviews 2011;12:e107-e118
We all recognise the importance of adverse event reporting but we
must also be aware that this can provide a mechanism whereby chance
associations can have a profound impact on clinical practice. The recent
case report by Shenoy and colleagues highlights this issue (1). As a
result of their report, which is meant to show that infacol has an adverse
effect on thyroid function tests in a baby with congenital hypothyroidism...
We all recognise the importance of adverse event reporting but we
must also be aware that this can provide a mechanism whereby chance
associations can have a profound impact on clinical practice. The recent
case report by Shenoy and colleagues highlights this issue (1). As a
result of their report, which is meant to show that infacol has an adverse
effect on thyroid function tests in a baby with congenital hypothyroidism
(CHT), parents in this situation will probably be advised to avoid
infacol. Whilst this may be no bad thing, some may argue, there are wider
issues at stake here. Managing congenital hypothyroidism is not easy and
the dose will frequently need to be adjusted in the first weeks depending
upon clinical and biochemical parameters. There are numerous shifting
variables to consider in CHT including the variation in the time taken for
TSH levels to suppress (which is not necessarily closely related to
disease severity (2)), issues regarding assay performance and interference
from levels of circulating antibodies, differences in the quality of the
thyroxine tablet preparation used,(3) differences in absorption depending
upon time of drug administration (4) as well as concordance and potential
problems with drug administration in an uncooperative baby. It is very
difficult to predict what will happen to thyroid function tests in a baby
with CHT which is why recent literature has highlighted the need for
frequent thyroid function measurement (5). The case report by Shenoy
highlights these issues quite well because, long after stopping the
infacol drops, there was an increase in FT4 concentrations from 18 to 22
weeks in a growing child despite the thyroxine dose remaining unchanged.
When there are a host of variables to consider 'n=1' must be treated with
extreme caution.
1. Balapatabendi M, Harris D, Shenoy SD. Drug interaction of
levothyroxine with infant colic drops. Arch Dis Child. 2011 Jul 23. [Epub
ahead of print]
2. Bakker B, Kempers MJ, DeVijlder JJ, et al. Dynamics of the plasma
concentrations of TSH, FT4 and T3 following thyroxine supplementation in
congenital hypothyroidism. Clin Endocrinol 2002;57:529-537
3. Toft A. Bioequivalence of generic preparations of levothyroxine.
Clin Endocrinol 2009 Oct;71(4):603
4. Nienke Bolk N, Visser TJ, Kalsbeek A, Van Domburg RT, Berghout A.
Effects of evening vs morning thyroxine ingestion on serum thyroid hormone
profiles in hypothyroid patients. Clinical Endocrinol 2007;66:43-48
5. Balhara B, Misra M, Levitsky LL. Clinical monitoring guidelines
for congenital hypothyroidism: laboratory outcome data in the first year
of life. J Pediatr 2011 ;158(4):532-7
What is missing from this welcome paper on systemic approaches in the
early months of life is attachment, the most thoroughly researched
paradigm in developmental psychology (Music 2011). Attachment is a
biological system that we share with all mammals (and many other species)
for protecting the infant, but the mother's capacity to do so - to love
her child - is powerfully influenced by her own relationships,
particularl...
What is missing from this welcome paper on systemic approaches in the
early months of life is attachment, the most thoroughly researched
paradigm in developmental psychology (Music 2011). Attachment is a
biological system that we share with all mammals (and many other species)
for protecting the infant, but the mother's capacity to do so - to love
her child - is powerfully influenced by her own relationships,
particularly with her mother (Fonagy et al 1991).
Thus while it is important to identify depression and anxiety in new
parents (Glover 2011) it is also essential to ask at first contact how
well mother feels supported by her parents, and by her partner. We are
indeed programmed to be attuned to infants (Tronick 2007, Strathearn et al
2008) but there are many anxieties and disappointments from the past that
can interfere with this delicate and fundamental process. "The ghost in
the nursery" is the imprint of care experienced in the previous
generation (Freiberg et al 1975).
Rather than adding complexity this view simplifies the clinical task
because there is always a need to find out how the mother sees her baby.
As the authors say the carer's experience is the 'core driver', but that
applies as much to her recollection of being looked after in her own
childhood as to what she now thinks is the matter with her child.
The transdisciplinary approach advocated here encourages the routine
inclusion of mental health assessment and provision in perinatal and
infant paediatric services (Barlow et al 2010).
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during pregnancy predict the organization of infant-mother attachment at
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Wyatt et al. (1) are to be commended for producing one of the largest randomised controlled trial on the effectiveness of cranial osteopathy for children with cerebral palsy, which was carried out on behalf of Cerebra. Cranial osteopathy as an adjunctive treatment in cerebral palsy is not new: Dr Beryl Arbuckle, an osteopathic physician, opened the Cerebral Palsy Institute in the 1940s in the USA which offered osteopathic...
We read with interest Dr Baines's article on assent for children's participation in research [1] and were pleased that he has highlighted the complexities surrounding assent. We agree that the current situation is confused and legal guidance is inconsistent. This primarily hinges on the poor definition of assent and its place in the consent process.
We do however challenge Dr Baines's suggestion that assent does...
The Editorial by Drs.Southall and Samuels pointed out that fluid challenges given in a recent study by Maitland et al. (1) to children in the absence of hypovolemic shock may worsen severe anaemia. It is important to note that 32% of all children enrolled had severe anemia (Hb<5 g/dl) with no significant difference of this proportion between groups. Maitland et al. stated that their data showed that excess mortality w...
In response to the interesting article by P B Juliusson et. al. on Growth of Belgian & Norwegian Children compared to the WHO growth standards published in Arch. Dis. of Childhood 2011, 96:916-921 and appreciating the concerns raised by him, we raise few issues pertaining to India. It is stated in the paper that there are significant deviations, we put forth the point that developing countries must first start using WH...
Dear Sir, Case reports have their importance in the medical literature as you pointed in your editorial [1]. Many journals opt not to publish them as they are not considered "research", but they tend to forget that in many situations, when clinicians are faced with a rare presentation of a common disease or just a rare disease, they recur to case reports in order to form an opinion and counsel patients. Moreover, textbook...
The excellent review by Sharkey and Shahidullah of oral propranolol treatment for infantile haemangioma did not consider the formulation of propranolol that might be used.[1] In UK a solution of propranolol hydrochloride has a Marketing Authorisation (Syprol(TM); Rosemont Pharmaceuticals Ltd) but is used off-label for this indication. It is available in four different strengths of 1, 2, 8 and 10 mg/ml so there is potent...
Marlow and colleagues suggest the use of the formula "Weight = 2(age) +10" for children between 1 and 10 years.
An individual age group analysis has clearly not been performed here. Had Marlow and colleagues done this they would have found that the formula above suffers with similar problems as the APLS formula. After all, their formula describes a straight line with the same gradient as the APLS formula.
...
In her article, Mary Rudolph makes an interesting and perhaps even feasible proposal. However, the fact that a reasonably accurate obesity risk tool could be developed and applied does not necessarily mean that screening is a good idea. We would raise the following objections: 1. With the estimated sensitivity (73%) and specificity (53%), the positive predictive value would be only 28%, if the prevalence of obesity was 2...
We all recognise the importance of adverse event reporting but we must also be aware that this can provide a mechanism whereby chance associations can have a profound impact on clinical practice. The recent case report by Shenoy and colleagues highlights this issue (1). As a result of their report, which is meant to show that infacol has an adverse effect on thyroid function tests in a baby with congenital hypothyroidism...
What is missing from this welcome paper on systemic approaches in the early months of life is attachment, the most thoroughly researched paradigm in developmental psychology (Music 2011). Attachment is a biological system that we share with all mammals (and many other species) for protecting the infant, but the mother's capacity to do so - to love her child - is powerfully influenced by her own relationships, particularl...
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