Many "simple" measurements in medicine have much less stringent
quality control measures than more complicated or sophisticated ones.
Perhaps it is assumed that they are less important or less likely to go
wrong, or the consequences any error are less significant. When were the
weighing scales or height measure in your clinic last calibrated? If you
measure visual acuity, are you sure the child...
Many "simple" measurements in medicine have much less stringent
quality control measures than more complicated or sophisticated ones.
Perhaps it is assumed that they are less important or less likely to go
wrong, or the consequences any error are less significant. When were the
weighing scales or height measure in your clinic last calibrated? If you
measure visual acuity, are you sure the child is standing 6m from the
Snellen chart? These "simple" measurements are essential for a paediatric
endocrinolgist and neurodevelopmental paediatrician, respectively.
Head circumference is a simple - and cheap - indicator of brain
growth. Bartram and colleagues highlight the importance when measuring
the head circumference of both technique and accurate equipment. The
third factor is actually measuring the head circumference in the first
place.
A colleague [AW Coe] and I reviewed the children on the waiting list
for MRI brain scans at a district general hospital [unpublished data]. Of
46 children, 23 [exactly 50%] had no record of having had their head
circumference measured at any recent out patient appointment. MRI brain
scans costing £400 - £500 had been requested, very few of which would
alter the management or outcome for the child. Yet a £1 tape measure had
not been used.
We read with interest the recent article by Del Buono et al.
evaluating the effect of sodium and magnesium alginate (Gaviscon) on
gastro-oesophageal reflux (GER) in infants [1]. It provides an objective
assessment of the effects of a drug widely used in the treatment of
paediatric GER by means of a double-blind drug vs placebo trial, in which
the effects of each treatment were evaluated by means of...
We read with interest the recent article by Del Buono et al.
evaluating the effect of sodium and magnesium alginate (Gaviscon) on
gastro-oesophageal reflux (GER) in infants [1]. It provides an objective
assessment of the effects of a drug widely used in the treatment of
paediatric GER by means of a double-blind drug vs placebo trial, in which
the effects of each treatment were evaluated by means of the simultaneous
application of multichannel intraluminal impedance and pH-metry (MII/pH).
The authors show that Gaviscon reduces this height, probably because it
increases the viscosity of the gastric content and hence acts in the same
way as thickened feeding [2]. They also found that fewer acid reflux
episodes occurred after Gaviscon, though the difference was not
significant. By contrast with the evidence produced in other studies [3],
therefore, these results seem to suggest that Gaviscon Infant has little
effect on GER when assessed in objective terms. It is, however, possible
that the significance of some of the differences they observed has been
weakened by the influence of sleep and wakefulness on GER episodes [4].
During 53 MII/pH 24h monitorings in infants with GER symptoms at our
Centre, we noted a significant difference between the number of episodes
during wakefulness (535 hr) and sleep (450 hr): 3.2 ± 4.1 episodes per hr
versus 1.8±3.3; p<0.001; CI 0.93±1.87). Del Buono et al. gave six milk
meals plus drug or placebo according to a 3+3 schedule.
If we suppose that a infant sleeps 12 hours a day, then the probability
that "sleep" and "wakefulness" periods were equally distributed between
Gaviscon and placebo in each of their 20 patients can be no more than 50%.
This probability drops even further if account is taken of the fact that
infants with GER sleep less than normal. The difference in GER frequency
between sleep and wakefulness, coupled with the asymmetrical distribution
of these phases, constitutes a "confounding factor" responsible for great
variability of all the frequency data (no. episodes per hour, no. of acid
episodes, no. of postprandial episodes per hour, etc.), whereas it may
have little influence on GER "quality" (duration; pH and height).
We thus believe that assessment of efficacy of the treatment of GER
by means of MII/pH requires longer observation periods (e.g. 24h-placebo
vs 24h-drug), or at all events consideration of the influence of sleep and
wakefulness on GER episodes.
References
1.Del Buono R, Wenzl TG, Ball G, Keady S, Thomson M. Effect of
Gaviscon Infant on gastro-oesophageal reflux in infants assessed by
combined intraluminal impedance/pH. Arch Dis Child. 2005; 90: 460-463.
2.Wenzl TG, Schneider S, Scheele F, Silny J, Heimann G, Skopnik H.
Effects of thickened feeding on gastroesophageal reflux in infants: a
placebo-controlled crossover study using intraluminal impedance.
Pediatrics 2003; 111: 355-9.
3.Buts JP, Barudi C, Otte JB. Double-blind controlled study on the
efficacy of sodium alginate (Gaviscon) in reducing gastroesophageal reflux
assessed by 24 h continuous pH monitoring in infants and children. Eur J
Pediatr. 1987; 146: 156-8.
4.Schilter B. Gastro-oesophageal reflux in children: comparison of
different durations, positions and sleep-awake periods of pH monitoring in
the same patient. Eur J Pediatr. 1993; 152: 880-3.
We wish to comment on the methodology and findings of your recent
publication on South Asian Canadian immigrants with Cystic Fibrosis (CF).[1] The authors suggest that they are the first to describe the clinical
presentation of South Asians with CF are comparable to the rest of their
patients. We welcome the Asian CF prevalence calculations but note that we
have already demonstrated in a six fold large...
We wish to comment on the methodology and findings of your recent
publication on South Asian Canadian immigrants with Cystic Fibrosis (CF).[1] The authors suggest that they are the first to describe the clinical
presentation of South Asians with CF are comparable to the rest of their
patients. We welcome the Asian CF prevalence calculations but note that we
have already demonstrated in a six fold larger group[2], that there is no
delay in diagnosis and similar clinical presentations between Asians and
white CF patients using the UK CF Database (UKCFD).
This paper confirms
(but does not cite) the nationwide findings from the UK. With respect to
methodology, we are concerned that Mei-Zahav et al. failed to adjust for
important variables namely gender, genotype, CF-related diabetes[3] and the
ethnic origins of the control population (what were the proportion of
Hispanics, Jews etc?).
We recognise that there is controversy over
adjusting reference equations for anthropometric and pulmonary function
measurements for ethnicity.[4,5] Mei-Zahav et al. appear to have applied the
US reference charts on growth to Canadian patients and South Asian
immigrant CF populations alike, and have not adjusted for ethnicity in
their FEV1 % predicted calculations. Whilst the US growth charts are
derived from a more ethnically diverse population than the UK[6], we believe
the FEV1 % predicted calculations should be presented in adjusted and
unadjusted forms using the equivalent adjustment factors (for the UK,
ethnic adjustment factors have been published by the BTS/ARTP[7]).
We are
concerned about any attempt to draw inferences on differences in FEV1 %
predicted between a small study group of 15 Asian patients with different
rates of Pseudomonas aeruginosa infection to the control group (especially
when Pseudomonas status was determined by the snapshot of the latest
clinic visit which may fail to accurately record the true prevalence).
Mei-Zahav et al. note in their discussion that "with larger numbers, some of
the clinical differences we explored may have been significant". We have
performed such a study using a case-matched approach, and recently showed
that UK Asians with CF have significantly worse FVC % predicted, weight
and BMI Z scores and poorer FEV1% predicted in females compared with
matched white homozygous DeltaF508 patients.[8] Furthermore, we found
pancreatic sufficiency (PS) in 16% of the Asian patients which was not
significantly different to the controls (the Mei-Zahav paper reported PS
in 27% of Asian and 16% of controls).[8]
Finally, Mei-Zahav et al. amalgamated 30 alleles from South Asian
immigrant patients with reports for five other references from three
different continents to estimate a frequency of DeltaF508 of 66/162
alleles (41%) in this potentially heterogeneous population of Asians. The
registered UKCFD Asian patients in our study[2] (n=156 alleles) had a much
lower frequency of DeltaF508 of 29.5%.
We advocate that meticulous selection and control of variables is
essential to producing plausible findings in epidemiological work on
ethnic minorities in CF. For this reason, we have called for an
international approach to Registry data collection in CF disease
epidemiology.[9]
Acknowledgements
The authors are grateful for grants from the CF Trust and the National
Services Division of NHS (Scotland). We thank G. Mehta, M. Fraser and S.
Krawczyk for their expert data validation and all the data entry staff and
the Directors in CF Centres for their support. There are no conflicts of
interest.
References
1. Mei-Zahav M, Durie P, Zielenski J, Solomon M, Tullis E, Tsui LC
et al. The prevalence and clinical characteristics of cystic fibrosis in
South Asian Canadian immigrants. Arch Dis Child 2005;90:675-9.
2. McCormick J, Green MW, Mehta G, Culross F, Mehta A. Demographics
of the UK cystic fibrosis population: implications for neonatal screening.
Eur J Hum Genet 2002;10:583-90.
3. Sims EJ, Green MW, Mehta A. Decreased Lung Function in Female but
not Male Subjects With Established Cystic Fibrosis-Related Diabetes.
Diabetes Care 2005;28:1581-7.
4. White NW. 'Ethnic discounting' and spirometry. Respir Med
1995;89:312-3.
5. Kelly AM, Shaw NJ, Thomas AM, Pynsent PB, Baker DJ. Growth of
Pakistani children in relation to the 1990 growth standards. Arch Dis
Child 1997;77:401-5.
6. Kuczmarski RJ, Ogden CL, Guo SS et al. 2000 CDC Growth Charts for
the United States: Methods and Development. 246. 2002. National Center
for Health Statistics. Vital Health Stat. 11.
7. Guidelines for the measurement of respiratory function.
Recommendations of the British Thoracic Society and the Association of
Respiratory Technicians and Physiologists. Respir Med 1994;88:165-94.
8. McCormick J, Ogston SA, Sims EJ, Mehta A. Asians with cystic
fibrosis in the UK have worse disease outcomes than clinic matched white
homozygous DeltaF508 controls. J Cyst Fibros 2004;4:53-8.
9. McCormick J, Sims EJ, Green MW, Mehta G, Culross F, Mehta A.
Comparative analysis of Cystic Fibrosis Registry data from the UK with
USA, France and Australasia. J Cyst Fibros 2005;4:115-22.
We read with interest the recent article by Gibson et al. evaluating
surveillance of thyroid function in children and adolescents with Down’s
syndrome, as we have undertaken a retrospective cohort study of patients
with Down’s syndrome on the Wirral, born between 1977 and 2005.[1] The
thyroid function test results of 54 patients were analysed, and a high
prevalence of both hypothyroidism and isolated...
We read with interest the recent article by Gibson et al. evaluating
surveillance of thyroid function in children and adolescents with Down’s
syndrome, as we have undertaken a retrospective cohort study of patients
with Down’s syndrome on the Wirral, born between 1977 and 2005.[1] The
thyroid function test results of 54 patients were analysed, and a high
prevalence of both hypothyroidism and isolated raised thyroid stimulating
hormone (IR-TSH) were evident (table 1).
Of the 5 patients who became hypothyroid, all were identified after
the age of 10 years, and they had a median TSH of 12.7 mU/L with a range
of 6 – 84 mU/L, and a median thyroxine of 66 nmol/L with a range of 36 –
68 nmol/L, at diagnosis. The tests were all performed as part of routine
screening, and all of the patients were asymptomatic. Also, it is of
interest that 2 of these patients had an IR-TSH prior to their diagnosis
of hypothyroidism, and a repeat test 6 months after the IR-TSH found them
to be hypothyroid.
In summary, we feel that the reduction in frequency of screening
recommended by Gibson et al should be questioned due to the high
prevalence of hypothyroidism in this patient group (10% of our cohort).
Also, if one is to select a sub group of high risk patients, then our
results suggest that to repeat tests at 5 yearly intervals after an IR-TSH
may be too long, as 2 of our patients became hypothyroid within 6 months
of such a result.
Table 1. Outcomes of thyroid function testing
TFT Outcome
Number of patients in Wirral
Euthyroid
25
IR-TSH
23
Acquired hypothyroidism
5
Congenital hypothyroidism
1
T Briggs, K Poole, J Robertson, D Manning
Reference
1. Gibson PA, Newton RW, Selby K et al. Longitudinal Study of thyroid
function in Down’s Syndrome in the first two decades. Arch Dis Child
2005;90:574-578.
Correspondence to Dr D.Manning: donal.manning@whnt.nhs.uk
We dispute the claim that Schoen represents the North American view.1 We think that he represents only his personal view and that of a few disciples.
Schoen’s claims have been rejected wherever he goes. When he published in the New England Journal of Medicine in 1990,2 his views were opposed by Poland.3 When he published in Acta Paediatrica Scandinavia in 1991,4 his views were rebutted by Bollgren & Winberg.5 When Schoen published in this journal in 19976 his views were countered by Hitchcock7 and also by Nicoll.8 In the present instance, his views are offset by Malone.9
When the Canadian Paediatric Society published their position statement on neonatal circumcision in 1996,10 they followed the views of Poland,3 not those of Schoen.2 Although Schoen was chairman of the American Academy of Pediatrics (AAP) task force on circumcision that published in 1989,11 he did not serve on the AAP task force on circumcision that published in 1999.12 That second task force distanced the AAP from the views published by Schoen’s task force11 a decade earlier.
Schoen’s present views on circumcision are strikingly similar to Wolbarst’s,13 which were published nearly a century ago. This suggests that Schoen’s views are founded in a desire to preserve his culture of origin, not in medical science. Goldman writes:
One reason that flawed studies are published is that science is affected by cultural values. A principal method of preserving cultural values is to disguise them as truths that are based on scientific research. This 'research' can then be used to support questionable and harmful cultural values such as circumcision. This explains the claimed medical 'benefits' of circumcision.14
The present North American view is that neonatal circumcision is not of medical value and that any benefits are more than offset by the risks, complications, and disadvantages of non-therapeutic infant circumcision. The Canadian Paediatric Society says, “Circumcision of the newborn should not be routinely performed.”10 The American Academy of Family Physicians described neonatal circumcision as “cosmetic” in nature.15 More recently, the College of Physicians and Surgeons of British Columbia reported:
Infant male circumcision was once considered a preventive health measure and was therefore adopted extensively in Western countries. Current understanding of the benefits, risks and potential harm of this procedure, however, no longer supports this practice for prophylactic health benefit. Routine infant male circumcision performed on a healthy infant is now considered a non-therapeutic and medically unnecessary intervention.16
A recent North American cost-utility study concluded:
Neonatal circumcision is not good health policy, and support for it as a medical procedure cannot be justified financially or medically.17
The statistics provided by Schoen on the incidence of circumcision in North America are out of date. The popularity of non-therapeutic infant circumcision is declining. The Association for Genital Integrity reports that only 13.9 percent of male infants in Canada were circumcised in 2003.18 Data provided by the National Hospital Discharge Survey indicates that the percentage of male infants circumcised in the United States declined to 55.1 percent in 2003.19 One expects to see further declines in the popularity of circumcision as newer data are reported. Many health maintenance organizations in the USA and most Canadian health insurance plans no longer pay for non-therapeutic circumcision of infant boys.
With regard to prevention of urinary tract infection (UTI), the only North American recommendation we can find is that of the Section on Breastfeeding of the AAP, which recommends breastfeeding to reduce the incidence of UTI in all infants.20 It says that procedures that “may traumatize the infant” or otherwise interfere with breastfeeding initiation should be avoided.20 Circumcision, a highly traumatic procedure, which apparently produces an “infant analogue of post-traumatic stress disorder,”21 works against breastfeeding initiation and ultimately against optimum child health and development as well as establishment of UTI protection by breastfeeding.22 The most recent AAP task force on circumcision does not recommend circumcision to prevent UTI or for any other reason.12
Both parents and health care providers have a general duty to consider the “best interests” of the whole child.23 This must include sexual and psychological well-being24 and the child’s interest in preserving his legal right to bodily integrity.25 Most discussions of the alleged value of circumcision in preventing UTI usually take an excessively narrow view.
One should not characterize Schoen’s personal view as representing the North American view. North America has moved on.
Reflecting to the letter of Mark P Tighe, et al.[1] we would like to
report our case with rhesus-haemolytic disease treated with D-penicillamine (DPA) and phototherapy without exchange transfusion:
We recently cared for a term infant boy (blood group B, Rh-positive, weighed 3100 gm) who was born at 37. gestation to a 33-year old, blood group B, Rh-negativ mother. During pregnancy the indirect Coom...
Reflecting to the letter of Mark P Tighe, et al.[1] we would like to
report our case with rhesus-haemolytic disease treated with D-penicillamine (DPA) and phototherapy without exchange transfusion:
We recently cared for a term infant boy (blood group B, Rh-positive, weighed 3100 gm) who was born at 37. gestation to a 33-year old, blood group B, Rh-negativ mother. During pregnancy the indirect Coombs tests showed: 1 : 16 and 1:32 titres, respectively. The baby was born as an 11.offspring of his mother and appeared jaundice at 10 hours of life and had moderate anaemia. The direct Coombs test was strongly positive (++++) in the cord blood. At 12 hours of age, the bilirubin level was 207 micromol/liter; the haemoglobin value was 119 g/liter. Phototherapy and orally administered D-penicillamine (300 mg/kg per day divided in four doses for 5 days) were started. The clinical characteristics of the infant with Rh-haemolytic disease are shown in Table 1.
His physical growth and developmental processes at 18 months of age revealed no abnormalities of neurodevelopmental maturation, as based on an evaluation of motor developmental milestones, and date obtained by the classic neurologic
examination, and cerebral neuromotor maturational markers. Although this combined therapy of hyperbilirubinaemia has been performed successfully in our case concerning the avoidance of an exchange transfusion in the infant with haemolytic disease, care must be taken not to overlook developing anaemia which may require transfusion. Table 1 showes that the baby's lowest haemoglobin level was 67 g/liter on day 9 and 130 g/liter on day 12, clarifiying the existence of a serious haemolytic process and the efficacy of a single red blood cell transfusion.
According to our calculation the cost of DPA treatment would be about 15 - USD (5 days treatment for a newborn with 3 kg of body weight needs 5x900 mg DPA, i.e. 300 mg/kg daily, in divided doses. That is 4500 mg DPA total). 18 capsules of 250 mg orally administered D-penicillamine costs about 15.3 - USD in the USA. The performance of an exchange transfusion with 600 ml donor blood, however, costs approximately 150 - USD, not to speak about the risk of the exchange itself: 3 death per 1000 procedures and the risk of AIDS and hepatitis from transfusion. Furthermore, without proper treatment about 25% of infants suffering from serious hyperbilirubinaemia are expected to be at risk of neurodevelopmental disorders at 1 year of age in developing countries [2].
Finally, we would like to emphasize that the combined alternative treatment of rhesus haemolytic disease described herein is a safe, inexpensive and effectice therapy even for the extremely jaundiced African infants.
(1) Mark P Tighe, Alyson O'Donnell, Mary Morgan Bloodless treatment
of infants with rhesus-haemolytic disease Electronic letter (29 November
2004)
(2) Wolf MJ, Wolf B, Bijleveld C et al. The predictive value of
developmental testing of extremely jaundiced African infants.
Developmental Medicine& Child Neurology 1998; 40:405-410.
I read with great interest and satisfaction the following two
articles in your journal: Lowes and Gregory – “Management of newly diagnosed diabetes: home or
hospital?” [1] and McEvilly and Kirk – “Twenty years of a multidisciplinary paediatric diabetes home care unit”.[2] Indeed, the need to admit newly diagnosed children and adolescents to a hospital can be markedly reduced and even avoided.
I read with great interest and satisfaction the following two
articles in your journal: Lowes and Gregory – “Management of newly diagnosed diabetes: home or
hospital?” [1] and McEvilly and Kirk – “Twenty years of a multidisciplinary paediatric diabetes home care unit”.[2] Indeed, the need to admit newly diagnosed children and adolescents to a hospital can be markedly reduced and even avoided.
The clinical diagnosis of Type 1 diabetes mellitus in a child has a
profound impact on the family. The diagnosis of a lifelong disease with
threatening acute and chronic complications is received by the parents and
older children as a “shock” followed by the bleak reality of having to
accept being different, accepting daily responsibilities and worries of
the future.
We came to the conclusion that without active treatment of the early
and late psychological impacts, metabolic adjustment of children with
diabetes is impossible. Thus we considered the diagnosis of Type 1
diabetes causing a “psychological crisis” which necessitates a “crisis
intervention program”.[3] It is for these reasons that in 1969 we
initiated at the Institute of Pediatric Endocrinology and Diabetes a
“multidisciplinary comprehensive treatment scheme composed of pediatric
endocrinologist, education nurse, dietician, psychologist and social
worker”.[4] With the exception of the rare and short admissions because
of DKA or social reasons the diabetes education is performed in an
“ambulatory setting”. Accepting that psychological stability in the family
[4] is a basic factor in the control of diabetes, which is better taken
care of including psychologists and social workers in the team, we found
this system very rewarding during its 36 years of practice both in the
adjustment to the disease and its metabolic control. Thus the combination
of the multidisciplinary and ambulatory treatment approach seem to be
optimal for the young patient and its family. This approach has been
recommended by ISPAD (International Society for Pediatric and Adolescent
Diabetes) in its Consensus of 1995 and 2000.
References
1.Lowes L, Gregory JW. Management of newly diagnosed diabetes: home
or hospital? Arch Dis Child 2004;89:934-7.
2.McEvilly A, Kirk J. Twenty years of a multidisciplinary paediatric
diabetes home care unit. Arch Dis Child 2005;90:342-5.
3.Galatzer A, Amir S, Gil R, et al. Crisis intervention program in
newly diagnosed diabetic children. Diabetes Care 1982;5:414-9.
4.Laron Z, Galatzer A, Amir S, et al. A multidisciplinary
comprehensive, ambulatory treatment scheme for diabetes mellitus in
children. Diabetes Care 1979;2:342-8.
Oesophageal pH monitoring has been used to monitor gastro-oesophageal reflux (GOR).
However, Buono et al. point out that this method will not record instances of 'neutral-reflux' after a feed (1). They say that multiple intraluminal impedance measurement is a more appropriate way to assess GOR. Using the technique they have found that Gaviscon does not reduce reflux. The number and height of reflux with Gav...
Oesophageal pH monitoring has been used to monitor gastro-oesophageal reflux (GOR).
However, Buono et al. point out that this method will not record instances of 'neutral-reflux' after a feed (1). They say that multiple intraluminal impedance measurement is a more appropriate way to assess GOR. Using the technique they have found that Gaviscon does not reduce reflux. The number and height of reflux with Gaviscon infant was not different from periods with placebo.
Alongside impedance measurement, Buono et al. also performed conventional pH monitoring. They found that Gaviscon did not reduce acid reflux in their study. This contradicts the findings of previous studies which found Gaviscon reduces acid reflux.[2, 3] Differences in the study design are responsible for this difference. Buts et al. used random allocation to Gaviscon or placebo treatment.[2] Washington on the other hand used a cross-over design but the cross-over was performed one week apart.[3] In contrast to this, in the present study, 6 random administrations of Gaviscon infant and placebo were employed in a 24 hour period (3+3). There was no wash-out period between drug and placebo. In effect all patients in this study were given Gaviscon three times in 24 hours. It is not surprising that there was no difference between patients. We cannot therefore accept the findings of this study without serious reservations.
References
1. Del Buono R, Wenzl TG, Ball G, Keady S, Thomson M. Effect of Gaviscon Infant on gastro-oesophageal reflux in infants assessed by combined intraluminal impedance/pH. Arch Dis Child. 2005; 90: 460-463.
2. Buts JP, Barudi C, Otte JB. Double-blind controlled study on the efficacy of sodium alginate (Gaviscon) in reducing gastroesophageal reflux assessed by 24 h continuous pH monitoring in infants and children. Eur J Pediatr. 1987; 146: 156-158.
3. Washington N, Greaves JL, Iftikhar SY. A comparison of gastro-oesophageal reflux in volunteers assessed by ambulatory pH and gamma monitoring after treatment with either Liquid Gaviscon or Algicon Suspension. Aliment Pharmacol Ther. 1992; 6: 579-588
We were interested to read this letter. The authors feel that
children with community needlestick injuries’ should be treated the same
as healthcare workers. This seems to miss the point of our paper.
Hospital needlestick injuries are very different to out-of-hospital
needlestick injuries: the blood is generally dry so therefore less likely
to be infectious1, the injuries are often superficial: again...
We were interested to read this letter. The authors feel that
children with community needlestick injuries’ should be treated the same
as healthcare workers. This seems to miss the point of our paper.
Hospital needlestick injuries are very different to out-of-hospital
needlestick injuries: the blood is generally dry so therefore less likely
to be infectious1, the injuries are often superficial: again less likely
to be infectious1 and, although the HIV status of the needlestick user is
often unknown, the incidence outside of London is very low.
The risk of HIV transmission is estimated to be less than 1:100 0002.
Our study was not designed to show the risk of transmission (which
incidentally would need a study of more than 100 000 patients) but showed
that only half those offered follow up returned for their appointment.
Studies examining needle stick exposure and HIV seroconversion have shown
that no children seroconverted despite not receiving HIV PEP3-5. Within
this population of children were included those who sustained injuries
from areas with a high prevalence of injecting drug use. Zamora and
colleagues6 evaluated HIV-1 proviral DNA from 28 discarded syringes of
intravenous drug users and found no traces of the virus, concluding that
the risk of HIV transmission in that setting was zero.
These children are therefore in a low risk group for transmission of
infectious viruses and, together with the low rate of attendance for
follow-up it is still reasonable, we feel, to offer follow up to those
children who have high risk injuries or in whom parents have a high level
of anxiety.
References
(1) Havens P.L. Committee on Pediatric AIDS. Postexposure prophylaxis
in children and adolescents for nonoccupational exposure to human
immunodeficiency virus. Pediatrics. 2003; 111: 1475-1489
(2) Post exposure prophylaxis (PEP) guidelines for children exposed
to blood borne viruses. www.bhiva.org/chiva. Accessed 29 June 2004
(3) Wyatt J.P. Robertson C.E. Scobie W.G. Out of hospital needle
stick injuries. Arch. Dis. Child. 1994; 70: 245-246
(4) Nourse C.B. Charles C.A. McKay M. Keenan P. Butler K.M. Childhood
needle stick injuries in the Dublin metropolitan area. Irish Medical
Journal. 1997; 90(2): 66-69
(5) Aragon-Pena A.J. Arrazola-Martinez M.P. Garcia de codes A. et
al. Prevencion de hepatitis B y reisgo de infeccion por VIH en ninos
accidentados con agujas y /o jeringuillas abandonadas. Atencion
Primaria. 1996; 17: 18-140
(6) Zamora A.B. Rivera M.O. Garcia-Algar O. Cayla-Buqueras J. Vall-
Combelles O. Garcia- Saiz A. Detection of infectious human
immunodeficiency type 1 virus in discarded syringes of intravenous drug
users. Pediatr. Infect. Dis. J. 1998; 17: 655-657
In his letter from February 15th 2005 Dr Paradise criticises our review
and raises 4 major points [1]: (1) he claims we overlooked previously
published critiques of the controlled non-randomised trials conducted
between 1920 and 1960; (2) we considered only pooled risk differences
across studies and we thereby did not relate the outcomes to the
stringency...
In his letter from February 15th 2005 Dr Paradise criticises our review
and raises 4 major points [1]: (1) he claims we overlooked previously
published critiques of the controlled non-randomised trials conducted
between 1920 and 1960; (2) we considered only pooled risk differences
across studies and we thereby did not relate the outcomes to the
stringency of the inclusion criteria of the individual trials;(3) we
failed to consider the nature and severity of the episodes that occurred
among trial participants, and (4) we generalised our results obtained in
children of which most were not severely affected to children who are. Dr
Paradise brings up some relevant items, but we disagree with some.
First, controlled non-randomised studies are indeed less valid than
randomised controlled trials. We therefore presented the results of the
controlled non-randomised studies as circumstantial evidence in a separate
table (table 3 of the article). Despite their shortcomings, the results of
the more recent and methodologically sounder controlled non-randomised
studies [2,3] appeared to be surprisingly similar to those of the
randomised trials.
Second, pooling of the results of the randomised trials was certainly
justified in view of the lack of relevant heterogeneity among the studies.
To take heterogeneity due to differences in design into account, we used a
random effect model. Unfortunately, it was not possible to identify
subgroups of children that might benefit (more) from the operation since
the randomised trials published so far did not provide detailed results
according to clinically relevant subgroups. We do, however, agree with Dr
Paradise that there are subgroups of children that do benefit from
(adeno)tonsillectomy. An efficient approach to detect these subgroups is
to perform an individual patient data (IPD) meta-analysis including the
original data from all (adeno)tonsillectomy trials performed in children
so far, including the trials by Dr Paradise and his group.
Third, we indeed did not assess the influence of adenotonsillectomy
on the severity of throat infections among trial participants. The main
reason for this is the notion that any effect on the severity (and not the
number) of the infections is likely to be attributable to information
bias, caused by definition by the non-blinded nature of the studies.
Parents of children in the watchful waiting group may be more likely to
report a sore throat or upper respiratory infection as "severe" than
parents of children in the surgical group, which would result in an
overestimation of the effect of (adeno)tonsillectomy.
Finally, we agree that very frequent throat infections (7 or more in
past year) is an adequate indication for tonsillectomy in children. That
is why we excluded such children from our trial, which was published in
2004.[4] Consistent with the results of the most recent trial by the group
of Dr Paradise in "less severely affected children",[5] we found that in
children with mild to moderate symptoms of throat infections the
likelihood of substantial benefit from tonsillectomy is indeed small. We
therefore concluded that in these children the operation had no relevant
clinical benefits to offer over a watchful waiting policy.
References
1. Paradise JL. Effectiveness of tonsillectomy depends on stringency of indications [electronic response to van Staaij BK et al. Adenotonsillectomy for upper respiratory infections: evidence based?] archdischild.com 2005http://adc.bmjjournals.com/cgi/eletters/90/1/19#1370
2. Roydhouse N. A controlled study of adenotonsillectomy. Arch
Otolaryngol 1970;92:611-6.
3. Paradise JL, Bluestone CD, Bachman RZ, Colborn DK, Bernard BS,
Taylor FH et al. Efficacy of tonsillectomy for recurrent throat infection
in severely affected children. Results of parallel randomized and
nonrandomized clinical trials. N Engl J Med 1984; 310:674-83.
4. van Staaij BK, van den Akker EH, Rovers MM, Hordijk GJ, Hoes AW,
Schilder AG. Effectiveness of adenotonsillectomy in children with mild
symptoms of throat infections or adenotonsillar hypertrophy: open,
randomised controlled trial. BMJ 2004;329:651.
5. Paradise JL, Bluestone CD, Colborn DK, Bernard BS, Rockette HE,
Kurs-Lasky M. Tonsillectomy and adenotonsillectomy for recurrent throat
infection in moderately affected children. Pediatrics 2002; 110:7-15.
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