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We thank you for the opportunity to discuss our data with the two correspondents who raised some concerns regarding the selected population of our analysis on neonatal outcomes following new reimbursement criteria on palivizumab use. They also reported data collected during the same time period and apparently different from our main results.
In response to the first correspondent, our analysis is based on children < 2 years of age because the candidate for palivizumab treatments are included within this subpopulation. In fact, the therapeutic indication (1) of palivizumab includes not only the preterm infants up to 1 year of age but also children up to 2 years of age and treated for bronchopulmonary dysplasia or born with a serious heart disease. Furthermore, our selected population is consistent with previous analysis (2) that measured the association between updated guidelines-based palivizumab administration and hospitalization for Respiratory Syncytial Virus (RSV). Table 1 of our study reports children up to 6 months of age, both at risk of RSV and including hospitalization data. We agree that this is probably the subpopulation with the major impact of the palivizumab treatment and regulatory decision. However, also in this case no differences in hospitalization rate have been detected before-after the AIFA’ limitation for palivizumab: 1031/47.608 (21.7 ‰) and 436/22715 (19.2 ‰) hospitalizations, respectiv...
We thank you for the opportunity to discuss our data with the two correspondents who raised some concerns regarding the selected population of our analysis on neonatal outcomes following new reimbursement criteria on palivizumab use. They also reported data collected during the same time period and apparently different from our main results.
In response to the first correspondent, our analysis is based on children < 2 years of age because the candidate for palivizumab treatments are included within this subpopulation. In fact, the therapeutic indication (1) of palivizumab includes not only the preterm infants up to 1 year of age but also children up to 2 years of age and treated for bronchopulmonary dysplasia or born with a serious heart disease. Furthermore, our selected population is consistent with previous analysis (2) that measured the association between updated guidelines-based palivizumab administration and hospitalization for Respiratory Syncytial Virus (RSV). Table 1 of our study reports children up to 6 months of age, both at risk of RSV and including hospitalization data. We agree that this is probably the subpopulation with the major impact of the palivizumab treatment and regulatory decision. However, also in this case no differences in hospitalization rate have been detected before-after the AIFA’ limitation for palivizumab: 1031/47.608 (21.7 ‰) and 436/22715 (19.2 ‰) hospitalizations, respectively. As in our main analysis, we were not able to see an increase of hospitalization related to the new reimbursement decision but a significant reduction (p=0.033) that we assume could be related to a more accurate coding by hospital or with an increase for palivizumab compliance in babies with higher risk of RSV infections.
In the second letter the authors presented data from three different hospitals supporting hypothetical opposite trend in hospitalization compared with our results. However, data from two of the three hospitals are related to general cases of bronchiolitis not specifically associated with RSV. None of the three separate groups of patients have statistically significant differences between the considered periods. Furthermore, these data do not take into account the potential mobility of all patients from one hospital to another. The subjects included in our analysis come for 70% of cases by the same three hospitals located in Rome quoted by the correspondents; all others patients are from regional hospitals where patients may receive assistance under the regional health coverage. From our point of view this give a better and comprehensive prospective compared to single hospital analysis.
We recognise in the limitations of the study that our ecological analysis was not able to measure the impact on specific subpopulations and administrative data can lose some clinically relevant information.
However, we cannot understand how the data presented in these correspondences can be considered more real than those collected in our study and to disprove our conclusions.
Antonio Addis, Valeria Belleudi
Department of Epidemiology, Lazio Regional Health Service, Roma, Italy
1. European Medicine Agency - Synagis : EPAR - Product Information https://www.ema.europa.eu/documents/product-information/synagis-epar-product-information_en.pdf
2. Grindeland CJ, Mauriello CT, Leedahl DD, et al. Association Between Updated Guideline-Based Palivizumab Administration and Hospitalizations for Respiratory Syncytial Virus Infections. Pediatr Infect Dis J 2016;35:728–32.doi:10.1097/INF.0000000000001150Google Scholar
Dr Smith makes relevant and interesting points regarding the terminology used for fluids, which can be used for both “resuscitation” purposes and “maintenance” therapy, and we thank him for his interest and response.
The purpose of this clinical question was to review the current evidence for paediatric patients in relation to “ balanced fluids”, a term emerging in the medical literature. NICE recommends using any isotonic crystalloid, which covers a wide range of sodium concentration from 130 to 154mmol/L (reference 1 in the article).
The loss of electrolytes, either from the gut or as a result of renal impairment, needs regular clinical review. We observe that repeated bicarbonate measurements are not regularly undertaken after initial assessment or following admission and it is important to remind trainees to consider these losses, hence our recommendation of daily monitoring of electrolytes. By following this approach, appropriate individualised adjustments can be made to the fluid prescription of patients as necessary.
Our conclusion from this question highlighted that research needs to be undertaken in the paediatric population of bicarbonate/ lactate containing fluids to determine whether this may affect acute kidney injury and other specific clinical outcomes. We agree attention to detail is always necessary when caring for infants and children receiving intrav...
Dr Smith makes relevant and interesting points regarding the terminology used for fluids, which can be used for both “resuscitation” purposes and “maintenance” therapy, and we thank him for his interest and response.
The purpose of this clinical question was to review the current evidence for paediatric patients in relation to “ balanced fluids”, a term emerging in the medical literature. NICE recommends using any isotonic crystalloid, which covers a wide range of sodium concentration from 130 to 154mmol/L (reference 1 in the article).
The loss of electrolytes, either from the gut or as a result of renal impairment, needs regular clinical review. We observe that repeated bicarbonate measurements are not regularly undertaken after initial assessment or following admission and it is important to remind trainees to consider these losses, hence our recommendation of daily monitoring of electrolytes. By following this approach, appropriate individualised adjustments can be made to the fluid prescription of patients as necessary.
Our conclusion from this question highlighted that research needs to be undertaken in the paediatric population of bicarbonate/ lactate containing fluids to determine whether this may affect acute kidney injury and other specific clinical outcomes. We agree attention to detail is always necessary when caring for infants and children receiving intravenous fluids of any type.
The results of the British Paediatric Surveillance Unit survey show that aspirin in Kawasaki disease (KD) is used in the UK and Ireland at a medium dose of 30-50 mg/kg/day in the acute phase of the disease (1). The guidelines of the American Heart Association (AHA) of 2017 do not give a clear indication on what dose of aspirin should be used in the acute phase of KD, stating that "there are no data to suggest that one dose of aspirin is superior to the other" (3).
However, a recent review of the evidence of literature on the use of aspirin in KD (3), clearly shows that, in conjunction with intravenous immunoglobulin, low-dose ASA (3-5 mg/kg/day) in acute KD is not inferior to high-dose ASA (80-100 mg/kg/day) for reducing the risk of coronary artery (CA) abnormalities, duration of fever, responsiveness to IVIG and time of hospitalization (3). These results supports using low-dose (3-5 mg/kg/day) aspirin in the acute phase of KD (3,4). These studies did not consider the concomitant use of steroid therapy, of which the guidelines of AHA do not define a standardized use (2).
The question of which dose of ASA is used in the acute phase is relevant considering that aspirin treatment exposes a risk of gastrointestinal bleeding, hepatotoxicity and neurosensory hearing impairment and Reye syndrome, and that this effect is strictly dose dependent and related to duration of therapy (3).
We believe that the time has come to reconsider and update the guideli...
The results of the British Paediatric Surveillance Unit survey show that aspirin in Kawasaki disease (KD) is used in the UK and Ireland at a medium dose of 30-50 mg/kg/day in the acute phase of the disease (1). The guidelines of the American Heart Association (AHA) of 2017 do not give a clear indication on what dose of aspirin should be used in the acute phase of KD, stating that "there are no data to suggest that one dose of aspirin is superior to the other" (3).
However, a recent review of the evidence of literature on the use of aspirin in KD (3), clearly shows that, in conjunction with intravenous immunoglobulin, low-dose ASA (3-5 mg/kg/day) in acute KD is not inferior to high-dose ASA (80-100 mg/kg/day) for reducing the risk of coronary artery (CA) abnormalities, duration of fever, responsiveness to IVIG and time of hospitalization (3). These results supports using low-dose (3-5 mg/kg/day) aspirin in the acute phase of KD (3,4). These studies did not consider the concomitant use of steroid therapy, of which the guidelines of AHA do not define a standardized use (2).
The question of which dose of ASA is used in the acute phase is relevant considering that aspirin treatment exposes a risk of gastrointestinal bleeding, hepatotoxicity and neurosensory hearing impairment and Reye syndrome, and that this effect is strictly dose dependent and related to duration of therapy (3).
We believe that the time has come to reconsider and update the guidelines on the KD on two important therapeutic aspects: 1) the dose of aspirin to be used; 2) the early use of corticosteroid therapy, as suggested by the authors of this important surveillance study (1).
References
1. Tulloh RMR, Mayon-White R, Harnden A, et al. Kawasaki disease: a prospective population survey in the UK and Ireland from 2013 to 2015. Arch Dis Child. 2018 Aug 13. pii:archdischild-2018-315087. doi: 10.1136/archdischild-2018-315087. [Epub ahead of print]
2. McCrindle BW, Rowley AH, Newburger JW, et al. Diagnosis, Treatment, and Long-Term Management of Kawasaki Disease: A Scientific Statement for Health Professionals From the American Heart Association. Circulation. 2017;135(17):e927-e999.
3. Ho LGY, Curtis N. What dose of aspirin should be used in the initial treatment of Kawasaki disease? Arch Dis Child. 2017;102(12):1180-1182
4. Dallaire F, Fortier-Morissette Z, Blais S, et al. Aspirin Dose and Prevention of Coronary Abnormalities in Kawasaki Disease. Pediatrics 2017;139:e20170098.
Federico Marchetti, Lorenzo Mambelli
Department of Paediatrics,
Santa Maria delle Croci Hospital,
48121 Ravenna, Italy
e mail: federico.marchetti@auslromagna.it
We are kindly observing that the study on hospitalizations for infection due to respiratory syncytial virus should be conducted on infants aged <1 year old [1], and not on infants aged <2 years old. Such a choice is motivated by medical literature and since the prescription of palivizumab on the general population of preterm infants is up to 1 year of age. Moreover, the study does not tightly classify the hospitalization depending on the gestational age, a lack of information that exclude the possibility of a punctual statistical analysis on the infants whose gestational age is between 29-35 weeks, population matter of the analysis, impacted by the AIFA reimbursement limitations.
In the study infants aged <2 years old have been considered, the same subjects are statistically contributing to two consecutive seasons with different ages. The algebraic sum of the season 2014-2015 / 2015-2016 perpetuate the complexity of analysis of hospitalization for a specific season, if the infant is hospitalized in the season of his/her birth or next year.
As reported by Medici et al. [2], respiratory syncytial virus infection has a 2-years evolution, with a less critical year following a year with more abundant virus diffusion. By algebraically summing the data from two consecutive years the seasonality, so the stochasticity, is lost. Eventually the season 2016-2017 appear to be the less critical season. Environmental and patient conditions such...
We are kindly observing that the study on hospitalizations for infection due to respiratory syncytial virus should be conducted on infants aged <1 year old [1], and not on infants aged <2 years old. Such a choice is motivated by medical literature and since the prescription of palivizumab on the general population of preterm infants is up to 1 year of age. Moreover, the study does not tightly classify the hospitalization depending on the gestational age, a lack of information that exclude the possibility of a punctual statistical analysis on the infants whose gestational age is between 29-35 weeks, population matter of the analysis, impacted by the AIFA reimbursement limitations.
In the study infants aged <2 years old have been considered, the same subjects are statistically contributing to two consecutive seasons with different ages. The algebraic sum of the season 2014-2015 / 2015-2016 perpetuate the complexity of analysis of hospitalization for a specific season, if the infant is hospitalized in the season of his/her birth or next year.
As reported by Medici et al. [2], respiratory syncytial virus infection has a 2-years evolution, with a less critical year following a year with more abundant virus diffusion. By algebraically summing the data from two consecutive years the seasonality, so the stochasticity, is lost. Eventually the season 2016-2017 appear to be the less critical season. Environmental and patient conditions such as: birth order, birth weight, gestational age, age at onset of the RSV season, passive smoke [3-4]; these have not been taken into account in the study.
Administrative databases, e.g. CEDAP, Drug Claims Registry and Hospital Information System, may hide some more detail information offered instead by clinical studies.
1. Lanari, M., Giovannini, M., Giuffre, L., Marini, A., Rondini, G., Rossi, G. A., ... & Salvioli, G. P. (2002). Prevalence of respiratory syncytial virus infection in Italian infants hospitalized for acute lower respiratory tract infections, and association between respiratory syncytial virus infection risk factors and disease severity. Pediatric pulmonology, 33(6), 458-465.
2. Medici, M. C., Arcangeletti, M. C., Rossi, G. A., Lanari, M., Merolla, R., Di Luzio Paparatti, U., & Chezzi, C. (2006). Four year incidence of respiratory syncytial virus infection in infants and young children referred to emergency departments for lower respiratory tract diseases in Italy: the" Osservatorio VRS" study (2000-2004). MICROBIOLOGICA-BOLOGNA-, 29(1), 35.
3. Rossi, G. A., Medici, M. C., Arcangeletti, M. C., Lanari, M., Merolla, R., Paparatti, U. D. L., ... & Osservatorio RSV Study Group. (2007). Risk factors for severe RSV-induced lower respiratory tract infection over four consecutive epidemics. European journal of pediatrics, 166(12), 1267-1272.
4. Lanari, M., Giovannini, M., Giuffre, L., Marini, A., Rondini, G., Rossi, G. A., ... & Salvioli, G. P. (2002). Prevalence of respiratory syncytial virus infection in Italian infants hospitalized for acute lower respiratory tract infections, and association between respiratory syncytial virus infection risk factors and disease severity. Pediatric pulmonology, 33(6), 458-465.
We are writing to respond with our data, that, in the same region (Lazio), indicate a different pattern.
We have focused on the patients that were previously eligible for palivizumab treatment (only preterm infants, with gestational age>29 weeks), in three different hospitals located in Rome.
Please consider that the time frame is the year before and the year after of the AIFA reimbursement limitations, the same years where in Figure 1 of your manuscript you show higher hospitalizations before and lower hospitalizations after AIFA limitations.
At the NICU Casilino Hospital (ref.A) we have noticed an increase in the number of bronchiolitis from the year before (6 bronchiolitis/35 children with 30-32WGA; 17%) to the year after limitations (12/47; 26%).
At the Sapienza University of Rome we have registered an increase in hospitalizations for bronchiolitis in children with 30-36 WGA from 14 out of 165 hospitalizations (8.5%) during the 2015/16 season to 21/141 hospitalizations in the subsequent season (14.9%, p =0.05). Of them, respectively 8 (14%) and 13 (18.3%) were due to RSV, although the difference is not statistically significant. The total number of VRS+ increased significantly in the second year (ref.B).
At the OPBG we have analysed only the data from the 2016/17 season and we have noticed a higher incidence of bronchiolitis in the late preterm (13 VRS+/27 children 30-37WGA, not treated with palivizuma...
We are writing to respond with our data, that, in the same region (Lazio), indicate a different pattern.
We have focused on the patients that were previously eligible for palivizumab treatment (only preterm infants, with gestational age>29 weeks), in three different hospitals located in Rome.
Please consider that the time frame is the year before and the year after of the AIFA reimbursement limitations, the same years where in Figure 1 of your manuscript you show higher hospitalizations before and lower hospitalizations after AIFA limitations.
At the NICU Casilino Hospital (ref.A) we have noticed an increase in the number of bronchiolitis from the year before (6 bronchiolitis/35 children with 30-32WGA; 17%) to the year after limitations (12/47; 26%).
At the Sapienza University of Rome we have registered an increase in hospitalizations for bronchiolitis in children with 30-36 WGA from 14 out of 165 hospitalizations (8.5%) during the 2015/16 season to 21/141 hospitalizations in the subsequent season (14.9%, p =0.05). Of them, respectively 8 (14%) and 13 (18.3%) were due to RSV, although the difference is not statistically significant. The total number of VRS+ increased significantly in the second year (ref.B).
At the OPBG we have analysed only the data from the 2016/17 season and we have noticed a higher incidence of bronchiolitis in the late preterm (13 VRS+/27 children 30-37WGA, not treated with palivizumab; 48.2%), while in the 5 children ≤37WGA treated with prophylaxis, there was only 1 VRS+ (20%, ref.C).
Our data from the clinical point of view indicate an opposite trend with respect to your paper, with higher hospitalizations and higher RSV+ infections after AIFA limitations. Furthermore, we have analysed the population of interest, and not an administrative databases, where is possible to have the general hospitalitation data for bronchiolitis but not the correct number of at risk infants, therefore we believe they provide a more cautious picture of real world data.
References:
A. Picone, S., Fabiano, A., Roma, D., & Paolillo, P. (2018). Comparing of two different epidemic seasons of bronchiolitis. Italian journal of pediatrics, 44(1), 11.
B. Di Mattia G, Nenna R, Petrarca L, Frassanito A, Di Martino M, Cascio M and Midulla F. Ruolo della profilassi con Palivizumab nella prevenzione della bronchiolite nei bambini “late pre-term”. XXI congresso SIMRI, Napoli 12-14 Dicembre 2017
C. Vittucci AC, Di Camillo C, Rotondi Aufiero L, Marchili MR, and Villani A. VRS nei lattanti: un nemico ancora da combattere. XXIII Congresso Nazionale della Società Italiana di Neonatologia, Milano, 25-28 September 2017 (P188, page 99)
Having just read this article I am concerned about the terminology used as I am not sure it truly reflects the clinical problem posed. The article refers to "maintenance" fluids but the question asked relates more to “resuscitation” fluids.
It is important to be clear as to the aim of treatment in the individual patient when prescribing fluids rather than just following a guideline. The paper debates the relative merits of 0.9% sodium chloride and balanced fluids as “maintenance” fluids. To my mind “maintenance” fluids are administered to patients who have a replete extracellular fluid (ECF) volume. If ECF volume is low then “resuscitation” fluids are required. “Maintenance” and “resuscitation” fluids have different roles and therefore might be expected to have different characteristics.
As the article refers to “maintenance” fluids I will deal with these first. This fluid is needed to replicate the fluid that the patient would normally be drinking but for a variety of reasons may not be able to ingest. It should be differentiated in turn from "replacement" fluid which is the fluid given on top of the "maintenance" fluid when patients have fluid losses in excess of those normally anticipated. This includes diarrhoea, vomiting and fluid from surgical drains. The fluid used for "replacement" needs to match the composition and volume of the fluid being lost. Once "resuscitation" and "replacement" fluid...
Having just read this article I am concerned about the terminology used as I am not sure it truly reflects the clinical problem posed. The article refers to "maintenance" fluids but the question asked relates more to “resuscitation” fluids.
It is important to be clear as to the aim of treatment in the individual patient when prescribing fluids rather than just following a guideline. The paper debates the relative merits of 0.9% sodium chloride and balanced fluids as “maintenance” fluids. To my mind “maintenance” fluids are administered to patients who have a replete extracellular fluid (ECF) volume. If ECF volume is low then “resuscitation” fluids are required. “Maintenance” and “resuscitation” fluids have different roles and therefore might be expected to have different characteristics.
As the article refers to “maintenance” fluids I will deal with these first. This fluid is needed to replicate the fluid that the patient would normally be drinking but for a variety of reasons may not be able to ingest. It should be differentiated in turn from "replacement" fluid which is the fluid given on top of the "maintenance" fluid when patients have fluid losses in excess of those normally anticipated. This includes diarrhoea, vomiting and fluid from surgical drains. The fluid used for "replacement" needs to match the composition and volume of the fluid being lost. Once "resuscitation" and "replacement" fluids have been taken care of and the ECF compartment is full, "maintenance" fluid needs to be prescribed. This equates to insensible water losses and urine output and will be the same as the fluid and electrolytes we take in orally each day. Current guidelines propose the use of a fluid containing 154 mmol/l of sodium. This article questions whether this should be accompanied by chloride or a mix of chloride and potential bicarbonate. However none of us would dream of drinking such a fluid and the recommended sodium intake for infants is around 3 mmol/kg/day which for a 10 kg child given the standard 1 litre of maintenance fluid equates to a solution containing 30 mmol/l or 0.18% sodium chloride. This is the sodium concentration you will find in total parenteral nutrition (TPN). Using 0.9% sodium chloride gives 154 mmol of sodium or 15.4 mmol/kg! The concern about using hypotonic solutions as “maintenance” fluid centres around the notion that the syndrome of inappropriate anti-diuretic hormone secretion (SIADH) is a common phenomenon and administration of hypotonic solutions will cause hyponatraemia. However SIADH is overdiagnosed and when ADH levels are raised it is almost always appropriate i.e. ADH is being produced in response to ECF volume contraction. In that situation an isotonic solution is required. Once ECF volume has been restored ADH production will almost always be switched off and continuing use of isotonic solutions will risk causing hypernatraemia.
The question that should have been asked was which fluid was more appropriate for “resuscitation” purposes? In the scenario described it is the administration of a 20ml/kg bolus of 0.9% sodium chloride that has led to a hyperchloraemic metabolic acidosis. We have recently had this discussion in our department and as in this article, have had to look primarily at evidence from adult studies. At this meeting the use of isotonic crystalloid as "maintenance" fluid was questioned and subsequently we have seen three cases of hypernatraemia as a result of 0.9% sodium chloride “maintenance” therapy.
"Resuscitation" fluid is given to restore ECF volume. To achieve this it would make sense to use a fluid that matches the composition of ECF and unfortunately 0.9% saline only goes part of the way to achieving this. ECF contains 140 mmol/l of sodium, 4 mmol/l of potassium, 113 mmol/l of chloride and 26 mmol/l of bicarbonate and as a result, when using 0.9% sodium chloride to correct a deficit there is an excess of chloride and a lack of bicarbonate. This creates a metabolic acidosis. It therefore makes sense to use balanced fluids containing potential bicarbonate. The studies quoted in this article are primarily related to severely ill patients many with sepsis in whom ongoing problems with ECF volume will be an issue and cannot be extrapolated to children on a general paediatric ward.
In summary, prescription of intravenous fluids should only be made after a careful assessment of the patient, in particular their ECF volume status. If that is reduced an isotonic solution should be administered. A balanced solution makes more sense physiologically but the evidence supporting its use over 0.9% saline is limited, particularly in the paediatric population. If there are ongoing losses they should be replaced by a solution best matching the fluid being lost. If it is not possible to establish the electrolyte content of the fluid losses an isotonic solution is advised. Once ECF volume is replete then a hypotonic solution should be given and on our ward we would use 0.45% saline + 2.5% dextrose. This is still providing more sodium than is normally recommended if giving fluids orally or in TPN. Unfortunately ECF volume status is notoriously difficult to assess and if there is doubt isotonic solutions will be safer. However if 0.9% sodium chloride continues to be administered as "maintenance" fluid we will see more cases of hypernatraemia. Whatever strategy is adopted it is essential to monitor serum electrolytes at least daily in children receiving a significant (>50%) proportion of their fluids intravenously.
I have not mentioned the ongoing debate about the volume of "maintenance" fluid we should be giving children. Currently this is based on recommendations made by Holliday and Segar in the 1950’s, matching fluid requirement to energy expenditure. It is now recognised that these do not reflect the fluid requirements of unwell children lying in bed and as a result “maintenance” fluid volume prescriptions may be twice what they should be. The prescription of more water than is needed is potentially a contributing factor to hypotonic solutions producing hyponatraemia - the prescribing of too much water rather than too little sodium. It is also likely that the cases of hyponatraemia reported in the literature were the result of the prescribing of hypotonic solutions to patients who were deplete of ECF in which case isotonic solutions should have been given.
Thank you to the authors for bringing the concept of ACPs and their importance to the forefront for consideration in practice. Thankfully, I have never had to utilise one in my professional practice, but having recently been encouraged to use an antenatal ACP for our daughter, I would offer personal support to the intentions that they should be used in practice, when appropriate. Our daughter was given a terminal diagnosis antenatally, and the decisions that followed to prepare for her birth and her death would have been overwhelming and emotionally charged in the immediate aftermath and I can only assume that our journey would have looked very different without one. Instead, the decisions and plans were considered, they were controlled and they were based on our true wishes for our daughter and our family. As the authors relate too in their article, without the ACP there would have been significant likelihood that the decisions we made for our daughter would have been made ad-hoc, under emotional pressure, and the outcome of her peaceful and comfortable death, surrounded by her family and in our arms, would likely have not been as achievable. Furthermore, the authors comment that it guides healthcare providers and parents, in a structured manner to ensure needs and wishes are met and I could not agree more. I think much of the conversations that took place, would have taken place without the ACP document, but the concept as a whole encouraged timely discussions, e...
Thank you to the authors for bringing the concept of ACPs and their importance to the forefront for consideration in practice. Thankfully, I have never had to utilise one in my professional practice, but having recently been encouraged to use an antenatal ACP for our daughter, I would offer personal support to the intentions that they should be used in practice, when appropriate. Our daughter was given a terminal diagnosis antenatally, and the decisions that followed to prepare for her birth and her death would have been overwhelming and emotionally charged in the immediate aftermath and I can only assume that our journey would have looked very different without one. Instead, the decisions and plans were considered, they were controlled and they were based on our true wishes for our daughter and our family. As the authors relate too in their article, without the ACP there would have been significant likelihood that the decisions we made for our daughter would have been made ad-hoc, under emotional pressure, and the outcome of her peaceful and comfortable death, surrounded by her family and in our arms, would likely have not been as achievable. Furthermore, the authors comment that it guides healthcare providers and parents, in a structured manner to ensure needs and wishes are met and I could not agree more. I think much of the conversations that took place, would have taken place without the ACP document, but the concept as a whole encouraged timely discussions, ensured all parties were included, and offered a prompt that the conversations we would be having would be difficult, but that they were incredibly important. I, obviously can not be sure of how our team of professionals found the logistical use of our ACP at the time, but I can only assume it was of benefit, as they provided our daughters care, as requested, without any additional need for questions or decisions at an incredibly difficult time. From a parents viewpoint, the conversations that occurred whilst completing the ACP with our team, ensured that we had considered all aspects of her care, that we understood options and that everyone in the team, including us as parents, were all in agreement around ceiling of care. Our healthcare team knew her name from before she was born and therefore referred to her as such from the minute she arrived; they knew we wished for her sibling to join us as soon as possible to meet her, and they arranged this to prevent us wasting our fleeting moments together with texts and phone-calls or battling to allow relatives access to the busy the ward; they knew we wished to have photos taken and as such they did not fear snapping every moment for us (as a result we have the most beautiful and natural photos that we will cherish forever); they knew we wanted time alone so did not feel awkward at leaving us to just be together, and they knew that we wanted her not to leave our side, and that was never questioned. The ACP (and all the staff who made it happen!) brought us a beautiful short life for our daughter and a calm and peaceful death, which is really all you can hope for in such tragic circumstances.
I welcome Himmelmann’s editorial concerning the prevention of respiratory problems for individuals with cerebral palsy1. As a speech and language therapist working within a multi-disciplinary nutrition team, I recognise the need to increase our understanding of the complex interactions between risk factors through collaboration across stakeholders. It is of particular concern that solids or liquids in the lungs or windpipe have been identified as the cause of death for almost a quarter of people with cerebral palsy2.
With this in mind, we developed the Eating and Drinking Ability Classification System (EDACS) for people with cerebral palsy from age 3 years. EDACS classifies limitations to eating and drinking ability in 1 of 5 levels, replacing frequently used terms “mild”, “moderate” and “severe” which lack shared definition. Key features of “safety” and “efficiency” are used to determine 5 distinct levels of ability: from Level I Eats and drinks safely and efficiently through to Level V Unable to eat or drink safely – tube feeding may be considered to provide nutrition. EDACS demonstrated strong content validity and excellent inter-observer reliability when used by speech and language therapists3. EDACS is free to download from www.edacs.org along with sixteen completed translations. Ten other language translations are currently in process.
Himmelmann1 points out associations between limitations to gross motor function and...
I welcome Himmelmann’s editorial concerning the prevention of respiratory problems for individuals with cerebral palsy1. As a speech and language therapist working within a multi-disciplinary nutrition team, I recognise the need to increase our understanding of the complex interactions between risk factors through collaboration across stakeholders. It is of particular concern that solids or liquids in the lungs or windpipe have been identified as the cause of death for almost a quarter of people with cerebral palsy2.
With this in mind, we developed the Eating and Drinking Ability Classification System (EDACS) for people with cerebral palsy from age 3 years. EDACS classifies limitations to eating and drinking ability in 1 of 5 levels, replacing frequently used terms “mild”, “moderate” and “severe” which lack shared definition. Key features of “safety” and “efficiency” are used to determine 5 distinct levels of ability: from Level I Eats and drinks safely and efficiently through to Level V Unable to eat or drink safely – tube feeding may be considered to provide nutrition. EDACS demonstrated strong content validity and excellent inter-observer reliability when used by speech and language therapists3. EDACS is free to download from www.edacs.org along with sixteen completed translations. Ten other language translations are currently in process.
Himmelmann1 points out associations between limitations to gross motor function and someone’s eating and drinking abilities. We found that there was a statistically significant but only moderate positive correlation between EDACS and the widely used GMFCS4 for a group of children with CP (n=128 Kendall’s tau 0.5)3. The clinical relevance of this is that some children with limited gross motor function will show greater ability when eating and drinking; conversely, other children who walk with or without assistance may eat and drink with increased risk of choking or aspiration.
Someone’s eating and drinking ability is not readily observed in most clinical contexts. Whilst video-fluoroscopic swallowing examinations will support identification of “silent aspiration”, it provides a useful but partial view of the overall clinical picture. Some health professionals may rely on parent or carer report. Parents were involved in the development of EDACS and found it easy to use to describe their children’s eating and drinking abilities. However, questions remain about parents’ use of EDACS to describe their children’s eating and drinking abilities. Direct comparisons of parents' and speech and language therapists’ classifications using EDACS revealed more disagreements than between pairs of speech and language therapists, although these were consistent: parents either agreed with speech and language therapists or parents systematically rated their children as more able than speech and language therapists, by one level3.
EDACS provides a framework which makes explicit the extent of the disagreement between parents and professionals including implications for safety and efficiency of children's eating/drinking. There is uncertainty whether children experience adverse health outcomes because of these disagreements. Disagreements between parents and healthcare teams regularly occur in this emotionally charged area of function. It can be challenging for the multi-disciplinary team to provide children with cerebral palsy and their parents with person-centred healthcare with consequent negative impacts on the well-being and quality of life of their child and family5.
EDACS provides a framework with potential to support person-centred healthcare. Further work needs to be carried out to implement use of EDACS across community and acute healthcare settings to fully realise its preventative potential.
References:
1. Himmelmann K. Putting prevention into practice for the benefit of children and young people with cerebral palsy Archives of Disease in Childhood Published Online First: 18 July 2018. doi: 10.1136/archdischild-2018-315134
2. Glover G and Ayub M (2010). How people with learning disabilities die. Published by Improving Health and Lives: Learning Disabilities Observatory. http://www.improvinghealthandlives.org.uk/uploads/doc/vid_9033_IHAL2010-... accessed 21 September 2013.
3. Sellers D, Mandy A, Pennington L, Hankins M and Morris C (2014). Development and reliability of a system to classify the eating and drinking ability of people with cerebral palsy. Developmental Medicine & Child Neurology 56(3):245-251
4. Palisano R, Rosenbaum P, Walter S, Russell D, Wood E and Galuppi B (1997). Development and Reliability of a System to Classify Gross Motor Function of Children with Cerebral Palsy. Developmental Medicine &Child Neurology 39:214 -223.
5. Cowpe E, Hanson B and Smith C (2014). What do parents of children with dysphagia think about their MDT? A qualitative study. BMJ Open 4 e005934.
Thank you for the opportunity to reply, here is our response.
We would like to thank the authors for their valuable comments, we believe that these comments add to and complement our article. Our article aimed to cover a wide breadth of common gynaecological conditions that can affect children and unfortunately we were therefore not able to go in to great detail for each condition covered. We would certainly agree on the importance of an early diagnosis for lichen sclerosus and collaboration with a dermatologist for treatment if available. The British Association of Dermatologists guidelines for the management of lichen sclerosus was not published when we wrote our article, we can see that this is a very valuable resource.
We read with interest the review on ‘The paediatrician and the management of common gynaecological conditions’ (1). This is an important topic but we have concerns about incorrect information in this paper with respect to vulval disorders. Most vulval conditions are dermatological rather than gynaecological and the involvement of a dermatologist in the management of these children is vital. The breadth of paediatric vulval disease is not reflected in this paper including the concept of vulval presentation of various skin conditions (eg. psoriasis, chronic bullous dermatosis of childhood, erythema multiforme) and the need to examine the rest of the skin including the hair, nails and mucosa.
There appears to be some confusion within the article, for example, a vaginal discharge is not a vulval disorder. While a discharge can lead to a vulvitis, the two problems of vaginitis and vulvitis should be distinguished as the investigation and management of each is very different.
The commonest condition seen in children presenting with vulval symptoms is an irritant dermatitis which is not specifically mentioned in the section on vulval irritation. This is often seen in those with a background of atopy and requires emollients and a mild topical steroid application intermittently with good hygiene measures. Other important disorders such as Lipschutz ulcers and genital warts have been omitted.
However, our major concerns relate to the section o...
We read with interest the review on ‘The paediatrician and the management of common gynaecological conditions’ (1). This is an important topic but we have concerns about incorrect information in this paper with respect to vulval disorders. Most vulval conditions are dermatological rather than gynaecological and the involvement of a dermatologist in the management of these children is vital. The breadth of paediatric vulval disease is not reflected in this paper including the concept of vulval presentation of various skin conditions (eg. psoriasis, chronic bullous dermatosis of childhood, erythema multiforme) and the need to examine the rest of the skin including the hair, nails and mucosa.
There appears to be some confusion within the article, for example, a vaginal discharge is not a vulval disorder. While a discharge can lead to a vulvitis, the two problems of vaginitis and vulvitis should be distinguished as the investigation and management of each is very different.
The commonest condition seen in children presenting with vulval symptoms is an irritant dermatitis which is not specifically mentioned in the section on vulval irritation. This is often seen in those with a background of atopy and requires emollients and a mild topical steroid application intermittently with good hygiene measures. Other important disorders such as Lipschutz ulcers and genital warts have been omitted.
However, our major concerns relate to the section on lichen sclerosus (LS). This is an important condition which is often under-recognized or with significant delay in diagnosis. The references used are old and not original. The major symptom is itch which is not always synonymous with irritation. One of the frequent presenting symptoms of LS in children is constipation which again is not mentioned. LS should always be treated, even if asymptomatic as it is a disease that can lead to permanent anatomical change with functional sequelae. Detailed guidelines for the management of LS have been published recently (2) and were agreed by the Royal College of Paediatrics and Child Health in the consultation process. All the evidence shows that a 3 month induction regimen of an ultra-potent topical steroid is the first line treatment (3). Thereafter, the management is individualized to maintain control of symptoms and signs (4). The management outlined in this review is incorrect and gives the wrong message. It should be corrected as otherwise it will lead to undertreatment and its potential consequences. As with all vulval disorders, these children should be under the care of those experienced in the management of this condition and should receive dermatological input as part of the multi-disciplinary team.
FM Lewis MD FRCP, St John’s Institute of Dermatology, Guy’s & St Thomas’ Hospital, London
SS Velangi FRCP Queen Elizabeth University Hospital, Birmingham
SM Taibjee MB BCh BMedSci MRCPCH CCT Derm DipRCPath (Dermatopathology) Dorset County Hospital, Dorchester
References
1. Ritchie JK et al. The paediatrician and the management of common gynaecological conditions. Arch Dis Child 2018;108:703-6
2. Lewis FM Tatnall FM, Velangi SS et al. British Association of Dermatologists guidelines for the management of lichen sclerosus, 2018. Br J Dermatol 2018;178:839-53.
3. Mashayeki S, Flohr C, Lewis FM. The treatment of vulval lichen sclerosus in prepubertal girls: a critically appraised topic. Br J Dermatol 2017;176:307-16.
4. Ellis E, Fischer G. Prepubertal-onset vulvar lichen sclerosus: the importance of maintenance therapy in long-term outcomes. Ped Dermatol 2015:32:461-7.
Dear Editor,
We thank you for the opportunity to discuss our data with the two correspondents who raised some concerns regarding the selected population of our analysis on neonatal outcomes following new reimbursement criteria on palivizumab use. They also reported data collected during the same time period and apparently different from our main results.
In response to the first correspondent, our analysis is based on children < 2 years of age because the candidate for palivizumab treatments are included within this subpopulation. In fact, the therapeutic indication (1) of palivizumab includes not only the preterm infants up to 1 year of age but also children up to 2 years of age and treated for bronchopulmonary dysplasia or born with a serious heart disease. Furthermore, our selected population is consistent with previous analysis (2) that measured the association between updated guidelines-based palivizumab administration and hospitalization for Respiratory Syncytial Virus (RSV). Table 1 of our study reports children up to 6 months of age, both at risk of RSV and including hospitalization data. We agree that this is probably the subpopulation with the major impact of the palivizumab treatment and regulatory decision. However, also in this case no differences in hospitalization rate have been detected before-after the AIFA’ limitation for palivizumab: 1031/47.608 (21.7 ‰) and 436/22715 (19.2 ‰) hospitalizations, respectiv...
Show MoreDear Sir/ Editor,
Dr Smith makes relevant and interesting points regarding the terminology used for fluids, which can be used for both “resuscitation” purposes and “maintenance” therapy, and we thank him for his interest and response.
The purpose of this clinical question was to review the current evidence for paediatric patients in relation to “ balanced fluids”, a term emerging in the medical literature. NICE recommends using any isotonic crystalloid, which covers a wide range of sodium concentration from 130 to 154mmol/L (reference 1 in the article).
The loss of electrolytes, either from the gut or as a result of renal impairment, needs regular clinical review. We observe that repeated bicarbonate measurements are not regularly undertaken after initial assessment or following admission and it is important to remind trainees to consider these losses, hence our recommendation of daily monitoring of electrolytes. By following this approach, appropriate individualised adjustments can be made to the fluid prescription of patients as necessary.
Our conclusion from this question highlighted that research needs to be undertaken in the paediatric population of bicarbonate/ lactate containing fluids to determine whether this may affect acute kidney injury and other specific clinical outcomes. We agree attention to detail is always necessary when caring for infants and children receiving intrav...
Show MoreThe results of the British Paediatric Surveillance Unit survey show that aspirin in Kawasaki disease (KD) is used in the UK and Ireland at a medium dose of 30-50 mg/kg/day in the acute phase of the disease (1). The guidelines of the American Heart Association (AHA) of 2017 do not give a clear indication on what dose of aspirin should be used in the acute phase of KD, stating that "there are no data to suggest that one dose of aspirin is superior to the other" (3).
Show MoreHowever, a recent review of the evidence of literature on the use of aspirin in KD (3), clearly shows that, in conjunction with intravenous immunoglobulin, low-dose ASA (3-5 mg/kg/day) in acute KD is not inferior to high-dose ASA (80-100 mg/kg/day) for reducing the risk of coronary artery (CA) abnormalities, duration of fever, responsiveness to IVIG and time of hospitalization (3). These results supports using low-dose (3-5 mg/kg/day) aspirin in the acute phase of KD (3,4). These studies did not consider the concomitant use of steroid therapy, of which the guidelines of AHA do not define a standardized use (2).
The question of which dose of ASA is used in the acute phase is relevant considering that aspirin treatment exposes a risk of gastrointestinal bleeding, hepatotoxicity and neurosensory hearing impairment and Reye syndrome, and that this effect is strictly dose dependent and related to duration of therapy (3).
We believe that the time has come to reconsider and update the guideli...
Dear authors,
We are kindly observing that the study on hospitalizations for infection due to respiratory syncytial virus should be conducted on infants aged <1 year old [1], and not on infants aged <2 years old. Such a choice is motivated by medical literature and since the prescription of palivizumab on the general population of preterm infants is up to 1 year of age. Moreover, the study does not tightly classify the hospitalization depending on the gestational age, a lack of information that exclude the possibility of a punctual statistical analysis on the infants whose gestational age is between 29-35 weeks, population matter of the analysis, impacted by the AIFA reimbursement limitations.
Show MoreIn the study infants aged <2 years old have been considered, the same subjects are statistically contributing to two consecutive seasons with different ages. The algebraic sum of the season 2014-2015 / 2015-2016 perpetuate the complexity of analysis of hospitalization for a specific season, if the infant is hospitalized in the season of his/her birth or next year.
As reported by Medici et al. [2], respiratory syncytial virus infection has a 2-years evolution, with a less critical year following a year with more abundant virus diffusion. By algebraically summing the data from two consecutive years the seasonality, so the stochasticity, is lost. Eventually the season 2016-2017 appear to be the less critical season. Environmental and patient conditions such...
Dear authors, dear editors,
We are writing to respond with our data, that, in the same region (Lazio), indicate a different pattern.
Show MoreWe have focused on the patients that were previously eligible for palivizumab treatment (only preterm infants, with gestational age>29 weeks), in three different hospitals located in Rome.
Please consider that the time frame is the year before and the year after of the AIFA reimbursement limitations, the same years where in Figure 1 of your manuscript you show higher hospitalizations before and lower hospitalizations after AIFA limitations.
At the NICU Casilino Hospital (ref.A) we have noticed an increase in the number of bronchiolitis from the year before (6 bronchiolitis/35 children with 30-32WGA; 17%) to the year after limitations (12/47; 26%).
At the Sapienza University of Rome we have registered an increase in hospitalizations for bronchiolitis in children with 30-36 WGA from 14 out of 165 hospitalizations (8.5%) during the 2015/16 season to 21/141 hospitalizations in the subsequent season (14.9%, p =0.05). Of them, respectively 8 (14%) and 13 (18.3%) were due to RSV, although the difference is not statistically significant. The total number of VRS+ increased significantly in the second year (ref.B).
At the OPBG we have analysed only the data from the 2016/17 season and we have noticed a higher incidence of bronchiolitis in the late preterm (13 VRS+/27 children 30-37WGA, not treated with palivizuma...
Having just read this article I am concerned about the terminology used as I am not sure it truly reflects the clinical problem posed. The article refers to "maintenance" fluids but the question asked relates more to “resuscitation” fluids.
It is important to be clear as to the aim of treatment in the individual patient when prescribing fluids rather than just following a guideline. The paper debates the relative merits of 0.9% sodium chloride and balanced fluids as “maintenance” fluids. To my mind “maintenance” fluids are administered to patients who have a replete extracellular fluid (ECF) volume. If ECF volume is low then “resuscitation” fluids are required. “Maintenance” and “resuscitation” fluids have different roles and therefore might be expected to have different characteristics.
As the article refers to “maintenance” fluids I will deal with these first. This fluid is needed to replicate the fluid that the patient would normally be drinking but for a variety of reasons may not be able to ingest. It should be differentiated in turn from "replacement" fluid which is the fluid given on top of the "maintenance" fluid when patients have fluid losses in excess of those normally anticipated. This includes diarrhoea, vomiting and fluid from surgical drains. The fluid used for "replacement" needs to match the composition and volume of the fluid being lost. Once "resuscitation" and "replacement" fluid...
Show MoreThank you to the authors for bringing the concept of ACPs and their importance to the forefront for consideration in practice. Thankfully, I have never had to utilise one in my professional practice, but having recently been encouraged to use an antenatal ACP for our daughter, I would offer personal support to the intentions that they should be used in practice, when appropriate. Our daughter was given a terminal diagnosis antenatally, and the decisions that followed to prepare for her birth and her death would have been overwhelming and emotionally charged in the immediate aftermath and I can only assume that our journey would have looked very different without one. Instead, the decisions and plans were considered, they were controlled and they were based on our true wishes for our daughter and our family. As the authors relate too in their article, without the ACP there would have been significant likelihood that the decisions we made for our daughter would have been made ad-hoc, under emotional pressure, and the outcome of her peaceful and comfortable death, surrounded by her family and in our arms, would likely have not been as achievable. Furthermore, the authors comment that it guides healthcare providers and parents, in a structured manner to ensure needs and wishes are met and I could not agree more. I think much of the conversations that took place, would have taken place without the ACP document, but the concept as a whole encouraged timely discussions, e...
Show MoreI welcome Himmelmann’s editorial concerning the prevention of respiratory problems for individuals with cerebral palsy1. As a speech and language therapist working within a multi-disciplinary nutrition team, I recognise the need to increase our understanding of the complex interactions between risk factors through collaboration across stakeholders. It is of particular concern that solids or liquids in the lungs or windpipe have been identified as the cause of death for almost a quarter of people with cerebral palsy2.
With this in mind, we developed the Eating and Drinking Ability Classification System (EDACS) for people with cerebral palsy from age 3 years. EDACS classifies limitations to eating and drinking ability in 1 of 5 levels, replacing frequently used terms “mild”, “moderate” and “severe” which lack shared definition. Key features of “safety” and “efficiency” are used to determine 5 distinct levels of ability: from Level I Eats and drinks safely and efficiently through to Level V Unable to eat or drink safely – tube feeding may be considered to provide nutrition. EDACS demonstrated strong content validity and excellent inter-observer reliability when used by speech and language therapists3. EDACS is free to download from www.edacs.org along with sixteen completed translations. Ten other language translations are currently in process.
Himmelmann1 points out associations between limitations to gross motor function and...
Show MoreThank you for the opportunity to reply, here is our response.
We would like to thank the authors for their valuable comments, we believe that these comments add to and complement our article. Our article aimed to cover a wide breadth of common gynaecological conditions that can affect children and unfortunately we were therefore not able to go in to great detail for each condition covered. We would certainly agree on the importance of an early diagnosis for lichen sclerosus and collaboration with a dermatologist for treatment if available. The British Association of Dermatologists guidelines for the management of lichen sclerosus was not published when we wrote our article, we can see that this is a very valuable resource.
Kind Regards
Jo Ritchie
Dear Sir,
We read with interest the review on ‘The paediatrician and the management of common gynaecological conditions’ (1). This is an important topic but we have concerns about incorrect information in this paper with respect to vulval disorders. Most vulval conditions are dermatological rather than gynaecological and the involvement of a dermatologist in the management of these children is vital. The breadth of paediatric vulval disease is not reflected in this paper including the concept of vulval presentation of various skin conditions (eg. psoriasis, chronic bullous dermatosis of childhood, erythema multiforme) and the need to examine the rest of the skin including the hair, nails and mucosa.
There appears to be some confusion within the article, for example, a vaginal discharge is not a vulval disorder. While a discharge can lead to a vulvitis, the two problems of vaginitis and vulvitis should be distinguished as the investigation and management of each is very different.
The commonest condition seen in children presenting with vulval symptoms is an irritant dermatitis which is not specifically mentioned in the section on vulval irritation. This is often seen in those with a background of atopy and requires emollients and a mild topical steroid application intermittently with good hygiene measures. Other important disorders such as Lipschutz ulcers and genital warts have been omitted.
However, our major concerns relate to the section o...
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