The impact of the SARS COV-2 pandemic on pediatric accesses in ED: A Healthcare Emergency Information System analysis.

BACKGROUND: The Emergency Department (ED) services play a fundamental role in managing the accesses of potential Sars-Cov-2 cases. The aim of this study is to evaluate the impact of the SARS COV-2 pandemic on pediatric accesses in Emergency Department of Lazio Region.
METHODS: The population includes all pediatric accesses (0-17 years) in the ED of Lazio Region during 2019 and 2020. Accesses were characterized by age, week and calendar period. Four periods were defined: pre-lockdown, lockdown, post-lockdown and the second wave. The trend of ED accesses (total or for specific cause) in 2020 (by period and week) were compared to them occurred in 2019. ED visits have been described by absolute frequency and percentage variation. Percentage variation of adult was also reported to compare the trend in adult and young population. The Chi-square test was used to compare characteristics of admissions in 2019 and 2020.
RESULTS: There is a large decrease of pediatric accesses in 2020 compared to 2019 (-47%), especially for younger age-classes (1-2 years: -52.5% and 3-5 years: -50.5%). Pediatric visits to ED in 2020 decreased following the same trend of adults, but more drastically (-47% vs -30%). ED accesses for suspected COVID-19 pneumonia trend show different characteristics between children and adults: in adults there is an increase in 2020, especially during the 2nd wave period (+321%), in children there is a decrease starting from the lockdown period to the achievement of the lowest level in December 2020 (-98%).
CONCLUSIONS: This descriptive study has identified a decrease of total pediatric accesses in ED in 2020 compared to 2019 and a different trend of accesses by adult and young population especially by cause. The monitoring of paediatric accesses could be a useful tool to analyse the trend of COVID-19 pandemic in Italy and to reprogramming of the healthcare offer according to criteria of clinical and organizational appropriateness.

Introduction

The year 2020 it will always be remembered as the beginning of the COVID-19 pandemic. In Italy, the first case of COVID-19 infection had been diagnosed on 20 February 2020 in Lombardy (North Italy). In the following days, part of North Italy was under lockdown and the rest of the country was on lockdown from 9 March 2020. Recommendations of Italy government required to ‘stay at home’ and to go to the Emergency Department (ED) only for medical emergencies or after contacting general practitioners or local health services.

The ED services play a fundamental role in managing the accesses of potential Sars-Cov-2 cases, ensuring the appropriate triage and isolation of potential cases [1]. The management of these accesses optimize the use of health resources that can be greatly reduced, especially when dealing with an epidemic caused by a new pathogen [2].

On 6 March 2020 in Lazio Region (central Italy) the Regional Health Service was re-organized to face with the pandemic pressure [3]. The reorganization of the health services limited the access the emergency room to emergency conditions and non-postponable health problems, in order to reduce potential contact with sources of Sars-Cov-2 infections and optimize ED workloads [3].

Several studies in these months have analysed the specific population of pediatric accesses to ED [4-9]. One of the first italian analysis involving data from two towns in northern Italy, Cremona (a city in the middle of Italian COVID-19 epidemics) and Novara (close to Lombardy), found a drastic decrease in ED admissions (-76% in Cremona and -64% in Novara) [4]. A following study conducted in North-Western Italy compared pediatric accesses in 23 Italian ED from March to May 2020 with the same period of 2019 [6]. They found a general decrease of pediatric accesses (-70.5%) in 2020 with a more evident reduction in hospitals without Pediatric Intensive Care Unit (PICU), for low priority triage admissions and a reduction of discharged patients. The reduction of pediatric accesses to ED was confirmed also by a study conducted in Singapore between January and August 2020 [7]. They found a huge reduction of ED admissions for respiratory (-87.9%) and gastrointestinal infections (-72.4%) and a lower reduction for trauma-related diagnoses (-40%). Kruizinga et al. quantify the effects of lockdown on pediatric care in 8 general hospitals in the Netherlands between January 2016 and June 2020 by diagnosis group and performed also a literature review regarding the effect of lockdowns on pediatric clinical care [8]. They found a reduction of 56% in pediatric hospital admissions and of 59% in ED visits with a largest reduction for communicable infections. The literature review confirmed this data with decreases of 30–89% for ED visits and 19–73% for admissions. The reduction of pediatric accesses to ED was also confirmed by Raucci et al. that analysed data from the two pediatric EDs of Lazio Region from February to April 2020 [9]. They found a decrease of 56 and 62%, respectively for Rome and Palidoro (Province of Roma) centers in particular for Diseases of Respiratory System, and for Diseases of the Nervous System and Sense Organs.

The impact of the lockdown and of the ‘stay at home’ indication on ED accesses for time-dependent pathologies was already evaluated in Lazio Region (central Italy) comparing the trend of total and cause-specific ED access from January 2020 to March 2020 with the same period of 2019 [10]. The objective of this study is to evaluate the impact of the SARS COV-2 pandemic on pediatric accesses in EDs of Lazio Region (central Italy) for all causes and in specific groups of patients with diagnosis of suspected COVID-19 pneumonia and symptoms of fever.

Materials and methods

This is a descriptive paper which includes all pediatric accesses (0–17 years) in the Emergency Departments of Lazio Region during 2019 and 2020. We collected data from the Healthcare Emergency Information System (HEIS). The HEIS database includes all visits occurring in Emergency Departments of the Lazio region and collects: patient demographics, admission information, visit and discharge dates and hours, ICD-9-CM diagnosis at discharge, reported symptoms on arrival, status at discharge (e.g., dead, hospitalized, or discharged at home) and triage score. The study used anonymous data from the health information system, so the approval of an ethics committee was not required.

Accesses in ED were characterized by age classes (0, 1–2, 3–5, 6–9, 10–14 and 15–17), week and calendar period (January-February, March-May, June-August and September-December). Age- classes reflect the organization of education in Italy, from the nursery school to the high school. Periods were defined to identify in 2020 the four phases of the pandemic: pre-lockdown, lockdown, post-lockdown and the second wave. We did not characterize and compare accesses to ED in 2019 and 2020 by triage because, during the last months of 2019, the Lazio region have changed the triage classification with the introduction of new guidelines for priority score definition [11].

A more specific analysis was conducted considering the cause of the access to ED. In particular suspected COVID-19 pneumonia and fever were considered. The suspected COVID-19 pneumonia was identify using the ICD-9-CM diagnosis at discharge (480–486, 487.0, 507, 021.2, 039.1, 052.1, 055.1, 073.0, 112.4, 114.0, 130.4, 136.3, 003.22, 115.05, 115.15, 115.95 and 078.89 associated to 484.8, 466.0, 490, 519.8 and 518.81–518.84) while the fever was defined on the basis of primary symptoms declared on arrival to ED.

To evaluate the different phases of the pandemic, the trend of ED accesses (total or for specific cause) in 2020 (by period and week) were compared to them occurred in 2019. ED visits have been described by absolute frequency and percentage variation. Percentage variation of adult was also reported to compare the trend in adult to young population. The Chi-square test was used to compare characteristics of admissions in 2019 and 2020. For some analysis, ED visits of population older than 17 years was also considered to evaluate the different impact of COVID-19 epidemic on young and adult population.

In a supplementary analysis the distribution of all symptoms declared at arrival was evaluated in the two years under study to better describe ED pediatric accesses in 2020.

Results

A total of 533,605 pediatric accesses in 46 EDs of Lazio Region occurred in 2019 and 2020. The 65.4% of them (348,742) occurred in 2019 and 184,863 in 2020.

The comparison between accesses in 2019 and 2020 by age-class and calendar period are described in Table 1.

Table 1

Pediatric accesses in EDs of Lazio Region, stratified by age-class and calendar period (2019, 2020).

Calendar period	Age class	2019	2020	%Var	p value
		n	n
Total	0	38,167	20,382	-46.6	< .0001
	1–2	64,338	30,545	-52.5
	3–5	63,559	31,471	-50.5
	6–9	60,709	32,757	-46.0
	10–14	77,567	43,411	-44.0
	15–17	44,402	26,297	-40.8
	Total	348,742	184,863	-47.0
January-Febrary (pre-lockdown)	0	7,854	6,897	-12.2	0.4270
	1–2	11,916	10,419	-12.6
	3–5	11,841	11,548	-2.5
	6–9	9,908	11,033	11.4
	10–14	12,991	14,022	7.9
	15–17	7,326	7,642	4.3
	Total	61,836	61,561	-0.4
March-May (lockdown)	0	9,587	3,029	-68.4	< .0001
	1–2	16,384	4,352	-73.4
	3–5	17,496	4,508	-74.2
	6–9	17,032	4,561	-73.2
	10–14	22,302	5,276	-76.3
	15–17	11,951	3,212	-73.1
	Total	94,752	24,938	-73.7
June-August (post-lockdown)	0	8,452	4,732	-44.0	< .0001
	1–2	15,456	6,871	-55.5
	3–5	15,586	7,194	-53.8
	6–9	16,595	8,481	-48.9
	10–14	17,531	11,160	-36.3
	15–17	10,489	7,684	-26.7
	Total	84,109	46,122	-45.2
September-December (2nd wave)	0	12,274	5,724	-53.4	< .0001
	1–2	20,582	8,903	-56.7
	3–5	18,636	8,221	-55.9
	6–9	17,174	8,682	-49.4
	10–14	24,743	12,953	-47.6
	15–17	14,636	7,759	-47.0
	Total	108,045	52,242	-51.6

There is a large decrease of pediatric accesses in 2020 in all age classes, but more evident between 1–2 years (-52.5%) and for 3–5 years (-50.5%) and lower for the age class 15–17 (-40.8%). Observing the results by calendar period, we noticed that there are none important differences between 2019 and 2020 during the “pre-lockdown” period (-0.4% for all ages), on the contrary, for the others periods analyses, we found a huge decrease of accesses of pediatric population in ED. In particular, the most important decrease was found, as expected, in the lockdown period (-73.7%) with no particular differences between age classes exception for neonatal one (-68.4%). During the post-lockdown period, that correspond with summer months, pediatric accesses to ED in 2020 were 46,122 compared to almost the double in 2019 (84, 109) with a percentage of variation of -45.2%. In this period the reduction is less evident for 10–14 and 15–17 age classes (-36.3% and -26.7% respectively). The most important decrease was observed for 1–2 age class. During the last period of the year (that correspond with the 2nd wave of the COVID-19 pandemic) accesses in 2020 are less than half of 2019 (-51.6%) with a most evident reduction for the younger age classes (0, 1–2, 3–5).

The trend of total pediatric access in 2019 and 2020 was showed in Fig 1.

Fig 1

Weekly trend of pediatric access to ED for all causes (2019, 2020).

The blue line refers to pediatric ED accesses in 2019, the yellow line to pediatric ED accesses in 2020. The grey bars indicate the percent variation of pediatric ED accesses in 2020 and 2019 and purple bars indicate the percent variation of adult ED accesses in 2020 and 2019. Different colours of the time represent the four phases of the pandemic in 2020: Grey = pre-lockdown, orange = lockdown, light blue = post lockdown and yellow = the second wave.The trend of pediatric accesses by week showed a higher number of visits in ED during the end of January and the first part of February 2020 compared to 2019 and then a huge decreased starting from the end of February 2020 and across the beginning of the lockdown period. From the end of March 2020 to September, pediatric visits to ED start to increase but, in spite of that, are lower compared to 2019. This trend decreases again during the 2nd wave period. The percentage variation of pediatric access in 2020, compared to 2019, had the same trend of what was observed in adult population (%Var adult) in the same period, but the reduction is higher.

The same analysis was made for suspected COVID-19 pneumonia (Fig 2).

Fig 2

Weekly trend of pediatric access to ED for suspected COVID-19 pneumonia (2019, 2020).

The blue line refers to pediatric ED accesses in 2019 for pneumonia, the yellow line refers to pediatric ED accesses in 2020 for pneumonia. The grey bars indicate the percent variation of pediatric ED accesses for pneumonia in 2020 and 2019 and purple bars indicate the percent variation of ED accesses for pneumonia in 2020 and 2019 for the adult population. Different colours of the time represent the four phases of the pandemic in 2020: Grey = pre-lockdown, orange = lockdown, light blue = post lockdown and yellow = the second wave.The trend of pneumonia ED visits in 2020 shows an important decreas starting from the first week of February to mid-April and then became stable with a number of accesses lower than 20 by week. This trend in the adult population is different. For adults there was an increment during the lockdown period, a decrease during the second part of the lockdown period and the summer and then a clear increase during the 2nd wave reaching a growth of access of 321% in November 2020 compared to the same week in 2019 (1,794 vs 426).

In Fig 3 the number of accesses in ED for suspected COVID-19 pneumonia and the percentage variation by year and age class were reported.

Fig 3

ED access for suspected COVID-19 pneumonia, by age class and year (2019, 2020).

The blue bars refer to ED accesses for suspected COVID-19 pneumonia in 2019, the yellow bars refer to for suspected COVID-19 pneumonia in 2020 and the grey bars indicate the percent variation of ED accesses for pneumonia in 2020 and 2019.

The different impact of the COVID-19 pandemic in adult and young population is clearer comparing the number of accesses in ED for suspected COVID-19 pneumonia in 2019 and 2020 by age class. In 2020, in fact, the number of accesses for suspected COVID-19 pneumonia are lower for young population and higher for adult population, compared to 2019. In particular the highest increment was observed for the age class 51–60.

Trend of pediatric ED accesses in 2019 and 2020 with symptoms of fever in regional ED was shown in Fig 4.

Fig 4

Weekly trend of pediatric access to ED for symptom of fever (2019, 2020).

The blue line refers to pediatric ED accesses in 2019 for fever, the yellow line refers to pediatric ED accesses in 2020 for fever. The grey bars indicate the percent variation of pediatric ED accesses for fever in 2020 and 2019 and purple bars indicate the percent variation of ED accesses for fever in 2020 and 2019 for the adult population. Different colours of the time represent the four phases of the pandemic in 2020: Grey = pre-lockdown, orange = lockdown, light blue = post lockdown and yellow = the second wave. In the pre-lockdown period, we found a greater number of accesses in ED with symptoms of fever in 2020 compared to 2019 (+10%). A trend inversion was observed at the beginning of the lockdown period (-76.6%) and continues until the end of the post-lockdown period (-65.6%). At the beginning of the 2nd wave period, 2019 and 2020 trend are quite similar, but the difference increases in the last weeks of the year.

The distribution of symptoms declared at ED arrival in 2019 and 2020 (see S1 Table) showed that there is no difference in the percentage distribution of symptoms between the two years, the majority of ED visits are for symptoms of fever (14% in 2019 and 14.6% in 2020), trauma or burn (29.2% in 2019 and 31.5% in 2020) and other symptoms or complaints (40% in 2019 and 38.6% in 2020).

The percentage of ED accesses for fever resulted higher in 2020, compared to 2019, from the beginning of the year to the end of March of 2020 and again at the beginning of September until the end of November (S1 Fig). The percentage of ED accesses for trauma or burns is higher in 2020 since the beginning of March to the end of September (see S1 Fig).

Discussion

This descriptive study analysed pediatric (0–17 years) accesses to all EDs in Lazio Region in 2019 and 2020. We observed a huge reduction of visits in young population, ED pediatric accesses in 2020 decreased of 47% compared to 2019, as reported also by other studies [4-10,12-17]. This study, similarly to others, reported some characteristics of pediatric accesses to ED in 2020 compared to 2019, but, focused, in particular, on the trend analysis, useful to understand the evolution of the behaviour in relation to the pandemic. The trend analysis was made by week, but percentage variation in accesses were reported also by period (pre-lockdown, lockdown, post-lockdown and 2nd wave), as already done by some previous studies [7,9,16].

Pediatric visits to ED in 2020 decreased following the same trend of adults [10] but more drastically, especially regarding ED accesses for suspected COVID-19 pneumonia, pediatric trend show different characteristics highlighting a different impact of the pandemic in adults and children. In the adult population, in fact this trend describes the COVID-19 infections evolution with a first increment of accesses during the lockdown period and a more significant increment after the summer. Pediatric accesses in ED with diagnosis of pneumonia decreased since February 2020 until the first part of the lockdown period and then remain stable at a low level. The decrease of total pediatric accesses and the different trend in suspected pneumonia accesses in children and adult could depend by different aspects:

The infection of COVID-19 is more serious and dangerous in the adult population than in children that generally, in case of infection, present light symptoms and have lower necessity to go to the ED;

Most of previous pediatric accesses to ED would be inappropriate;

The fear of a contagious of COVID-19 have reduced the visits.

For the first reason we decided to analysed the trend of pediatric ED visits with symptoms of fever that represents one of the most common symptoms of the COVID-19 infections in children. In this case we found an increment of visits in ED exactly at the beginning of the 2nd wave period also corresponding to the reopening of schools.

Most of the pediatric accesses to ED depends on parent’s perception of child’s health status, so in 2020 the fear of a contagious actually could have reduced the accesses, but it is possible that this fear could have caused an inappropriate choice of not bring the child in ED, and to underestimate his needs of medical care, with a possible long-term negative impact on health generating more problems than the virus itself [12,13].

We also characterized ED visits by declared symptoms at arrival and we found no difference in the percentage distribution of symptoms in 2019 and 2020. On the contrary, Iozzi et al. found an increase in absolute terms of accesses in ED for trauma in 2020 compared to 2019 [15]. They analyzed specifically the period that goes from 10 March to 3 May. We found an increment of the percentage distribution of accesses for trauma in 2020 compared to 2019 during summer and spring months.

Our study is based on a large population, because include all ED accesses in Lazio Region (more than 5,755,000 inhabitants in 2020). This allowed us to compare data by year, period and week also considering specific causes and age-classes. A previous study analysed the trend of pediatric ED accesses in Lazio Region from February 2020 to April 2020 [9]. In our study we considered data for the entire 2020 year (from January to December) performing a trend analysis that help to better understand the evolution of the pandemic in terms of ED accesses in the pediatric population.

During the Sars-Cov-2 epidemic, we observed a massive reduction of pediatric accesses to EDs with different trend by specific cause and also compared to the adult population. The reduction in accesses to the ED services was especially due to potentially deferrable conditions, which demonstrates a great potential of the system to reduce the use of ED for high-risk conditions of inappropriateness. The correct application of the restrictive rules and the reorganization of access methods to the ED seems to have had the virtuous effect of a potential optimization of the available health resources.

On the other hand, the reduction of pediatric accesses in ED services could cause some consequences in terms of health outcomes and appropriateness of treatments; it will be necessary to continue following up and monitoring over time trend of ED accesses and pediatric health indicators to evaluate possible long-term consequences due directly or indirectly by the pandemic [18,19].

The epidemic emergency caused by Sars-Cov-2 requires tools aimed at decision support, with short, medium and long-term time horizons. The comparison of accesses to first aid services during the SARS-Cov-2 epidemic with previous periods can provide useful elements both for the promotion and improvement of planning and management of critical situations such as that caused by a new infectious agent [20]; furthermore, the monitoring of pediatric accesses is a tool suitable for the reprogramming of the healthcare offer according to criteria of clinical and organizational appropriateness. This assessment will need to be further investigated by defining a set of indicators to monitor the use of health services at both regional and national levels. In addition, it will be essential to assess the indirect impact of the "diversion" of resources on the national emergency on the management of other care pathways, including through the analysis of total and cause mortality.

Conclusion

This study has identified a decrease of total paediatric accesses in Emergency Department in 2020 compared to 2019 and a different trend of accesses by adult and young population especially by cause. The monitoring of paediatric accesses could be a useful tool to analyse the trend of COVID-19 pandemic in Italy and to reprogramming of the healthcare offer according to criteria of clinical and organizational appropriateness.

In particular, the systematic monitoring of paediatric accesses to the emergency room could be a solid base for further evaluation of the potential missed treatments for non-deferrable conditions and the emerging paediatric pathologies during the pandemic phases. A better understanding of how the epidemic affects children health may guide future public health interventions.

Distribution of declared symptoms at ED arrival (2019, 2020).

(XLSX)

Click here for additional data file.

Weekly pediatric access with symptoms of fever and trauma or burns on total (2019, 2020).

Yellow and blue lines with dots indicate the percentage of pediatric ED accesses for trauma and burn in 2020 and 2019 respectively; yellow and blue lines without dots indicate the percentage of pediatric ED accesses for fever in 2020 and 2019 respectively.

(TIF)

Click here for additional data file.

21 Dec 2021

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Reviewer #2: Reviewer’s comments on manuscript :

The impact of the SARS COV-2 pandemic on pediatric accesses in ED: a Healthcare Emergency Information System analysis. Pediatric ED accesses during SARS COV-2 pandemic.

Francesca Mataloni, Paola Colais, Luigi Pinnarelli, Danilo Fusco and Marina Davoli

Department of Epidemiology, Lazio Regional Health Service, Rome, Italy

As a pediatrician who trained in the European Union, and repeated pediatric residency training in the United States, I am deeply sympathetic with the authors’ implicit hypothesis that medical care for children reveals underlying structures and stresses in the health care system of a society, particularly in pandemic times.

The authors are led by Dr. Marina Davoli, the renowned epidemiologist, Director of the Department of Epidemiology of the region of Lazio centering on Italy’s capital Rome and coordinator of the Cochrane Reviews on Drugs and Alcohol.

Nevertheless, their manuscript is deeply flawed and requires foundational reshaping, even at that most basic level of research diligence and scriptural veracity that peer reviewers usually presume and take for granted.

1.

The authors’ statement on data availability is remarkable for its sentence-by-sentence progressing restrictiveness, giving no access to the cited regulations of the European Union (EU) and the State of Italy, and culminating in placing the regional regulations of Lazio as the finally deciding ones (which in bureaucratic reality means Dr. Davoli et al. themselves, a most Kafkaesk turn). The authors’ statement so remarkable that I insert it here :

56 Availability of data and materials: Data related to the findings reported in our manuscript are not

57 available because of stringent legal restrictions regarding privacy policy on personal information in

58 Europe (European legislative decree on privacy policy 2016/679, Italian legislative decree on privacy

59 policy D.lgs. 101/18). For these reasons, our dataset cannot be made available on a public

60 repository. Although data are appropriately anonymized we are not authorize to share any dataset,

61 because data are restricted by the Institutional Review Board of the Health 61 Information System Unit

62 of Lazio Region. Data are however available from Lazio Region with its permission and upon

63 reasonable request.

I consider this statement to be most extraordinary.

I note that this statement inverses the actual legal structure: Any regional regulation pertaining to the privacy protection of medical data in Italy is overruled by the national regulation, and any Italian national regulations are overruled by those of the European Union if conflicting with them.

The EU and Italian regulations cited by the authors in actual fact do not block the scientific use of and access to fully anonymized patient data (see https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679 and https://www.cliclavoro.gov.it/Normative/Decreto-Legislativo-10-agosto-2018-n.101.pdf).

The Lazio Region regulations cited by the authors are nowhere to be found on the www, are not identified by them as present on the www, and collide with the national regulations of Italy on anonymized data use / sharing for research purposes, see Garante per la protezione dei dati personali, Resolution n. 85, March 1st, 2012. The English-speaking world was immediately introduced to this remarkable Italian regulation (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3477977/pdf/AJPH.2012.300991.pdf), which was reviewed in further detail by Calzolari et al. soon after (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3696949/pdf/bio.2012.0058.pdf) and today is explicitly referenced as the very basis for current epidemiological research in Italy (e.g. https://ijponline.biomedcentral.com/articles/10.1186/s13052-021-01168-4).

Before inserting the above paragraph into this review, I submitted it for review to the Ethics Division of the Istituto Superiore di Sanità (ISS), the Italian NIH, without naming any of the authors or the title / content of their submission.

ISS explained that “the European and national rules for personal data protection do not apply to anonymized data and do not block the scientific use of and access to fully anonymized patient data. Personal data protection is the subject of European and national, not regional, regulations: I am not aware of Lazio Region regulations on this matter.”

To assure veracity of this verbatim quote and to assure anonymity of its high-ranking Italian author, I will separately submit a copy of the email string to the PLOS ONE Office for their review and disposition.

The finding that the authors elect to shield their database with a willfully presented construction of unreferenced privacy rules that fail peer examination as well as expert review, make this manuscript in its present form unfit to be published anywhere.

I am willing to review the authors’ modified re-submission only if that properly corrected version contains in its Supporting Information the entire dataset on which they build their key arguments, the data being anonymized in accordance with Garante per la protezione dei dati personali, Resolution n. 85, March 1st, 2012.

2.

The authors quote several publications by Italian colleagues on related topics of ‘COVID pandemic impact on pediatric care’. Among those I see a recent paper in the Italian Journal of Pediatrics, indicating that the authors are following pertinent papers in this periodical.

The authors do not quote, however, a publication in that same journal covering the same Italian region during the same period on the same topic with the – in essence - same graphics and the same conclusions : That pertinent paper was published in January 2021 by Umberto Raucci et al. and has already been accessed over 3000 times: https://doi.org/10.1186/s13052-021-00976-y . It offers a more detailed clinical spectrum of the pediatric ER visits 2019-2020 than the authors’ manuscript, contains a more robust data analysis, and provides a more readable Discussion.

I do not consider the authors’ effort a ‘me-too project of minor originality’.

The authors’ current version holds the seed for crucial growth by adding aspects that similar studies left out, but that are accessible to the authors by reason of their powerful placement at the Department of Epidemiology of the Lazio Regional Health Service.

In particular, I envision a re-analysis of the regional pediatric ER visits in conjunction with other parameters that affected the well-being of Italian children, such as i) the relation to pediatric prescriptions, in particular of antibiotic (topical/systemic anti-bacterial and anti-fungal), anti-asthma (incl. steroids), anti-seizure, and ADHD medications; and ii) the relation to school closures, a destructive event in the lives of Italian children, see https://ftp.iza.org/dp14785.pdf .

Did the reduction in pediatric ER visits, which the authors and others noted, coincide with reductions in the major categories of pediatric prescriptions, and are these categories similarly impacted ? Is there any relation between pediatric ER visits and school closures ? These are key questions of more than regional or national significance. I encourage the authors to apply their considerable reputation and resources in a dedicated effort to acquire the answers.

3.

The manuscript is rich in non-idomatic English and carries the signs of rapid translation, with Italian remnants in sentence structure and even left-over words, e.g. line 131 on page 7 : “… age classes (0, 1-2, 3-5, 6-9, 10-14 e 15-17)…”, ‘e’ being the Italian ‘and’. Conclusions are dramatic and over-reaching, e.g. lines 43-44 on page 3 / line 299 on page 17: “The monitoring of pediatric accesses is a fundamental tool to monitor the trend of COVID-19 pandemic ” – that clearly is not so at all, not in even one of the many nations around the globe affected by the current pandemic.

Sadly, I feel compelled to add as a pediatrician, since it would attract so much more attention and funding to the care of children …

In summary: Requiring major revision

Hartmut M. Hanauske-Abel, MD PhD

**********

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Reviewer #1: No

Reviewer #2: Yes: Hartmut M. Hanauske-Abel, MD PhD

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4 Feb 2022

POINT BY POINT RESPONSE TO THE COMMENTS

Comments to the Author

Reviewer #1:

I read your piece with interest. Please find below some comments/suggestions:

1. Please make sure that your formatting follows PLOS's guidelines for article formatting, and grammatical clarity.

Answer: We checked PLOS ONE’s style requirements and we can confirm that our manuscript meets them.

2. Can the authors provide a specific clause by an ethical committee/IRB that states/allows waiver of of ethical approval in such circumstances? I believe such clause would further strengthen the point.

Answer: The use of anonymized data from Health Information Systems does not require the approval of an ethical committee. We are authorized to use anonymized data for scientific purposes in accordance with Garante per la protezione dei dati personali, Resolution n. 85, March 1st, 2012.

3. Can the authors provide clarification as to why age 17 was used as a cutoff for the pediatric age group. The definition of the pediatric demographic varies across countries (some 0-15, some 0-18…). Was 17 taken as the cutoff because that’s the definition of the demographic in Italy/Lazio?

Answer: According to Italian regulations, the definition of Italian pediatric population is strictly less than 18 years. (https://www.senato.it/service/PDF/PDFServer/DF/339076.pdf)

4. Suggest to have ||152-153: "ED pediatric accesses in 2020 decreased 47% compared to 2019." at the beginning of the discussion section.

Answer: According to your suggestion, the beginning of the conclusion section was modified as follow: “This study analysed pediatric (0-17 years) accesses to all EDs in Lazio Region in 2019 and 2020. We observed a huge reduction of visits in young population, ED pediatric accesses in 2020 decreased of 47% compared to 2019, as reported also by other studies [5-11, 13-18].”

5. Suggest to put argument presented in ||248 last, as the other two points take precedence in terms of relevance in this article.

Answer: Thank you for the suggestion. We changed the text as follow: “The decrease of total pediatric accesses and the different trend in suspected pneumonia accesses in children and adult could depend by different aspects:

• The infection of COVID-19 is more serious and dangerous in the adult population than in children that generally, in case of infection, present light symptoms and have lower necessity to go to the ED;

• Most of previous pediatric accesses to ED would be inappropriate;

• The fear of a contagious of COVID-19 have reduced the visits.”

6. Suggest to have idea of excluding triage comparison mentioned in ||272-273 up in the methods section, to better define the inclusion/exclusion criteria.

Answer: Following your comment we decided to move this part in the methods section: “Accesses in ED were characterized by age classes (0, 1-2, 3-5, 6-9, 10-14 and 15-17), week and calendar period (January-February, March-May, June-August and September-December). Periods were defined to identify in 2020 the four phases of the pandemic: pre-lockdown, lockdown, post-lockdown and the second wave. We do not characterized and compared accesses to ED in 2019 and 2020 by triage because, during the last months of 2019, the Lazio region have changed the triage classification with the introduction of new guidelines for priority score definition [12].”

7. The conclusion can use some strengthening in terms of health systems and general public health implications of the study.

Answer: Thanks for your comment we had modify the conclusion (line 299-307).

Reviewer #2:

Reviewer’s comments on manuscript :

The impact of the SARS COV-2 pandemic on pediatric accesses in ED: a Healthcare Emergency Information System analysis. Pediatric ED accesses during SARS COV-2 pandemic.

Francesca Mataloni, Paola Colais, Luigi Pinnarelli, Danilo Fusco and Marina Davoli

Department of Epidemiology, Lazio Regional Health Service, Rome, Italy

As a pediatrician who trained in the European Union, and repeated pediatric residency training in the United States, I am deeply sympathetic with the authors’ implicit hypothesis that medical care for children reveals underlying structures and stresses in the health care system of a society, particularly in pandemic times.

The authors are led by Dr. Marina Davoli, the renowned epidemiologist, Director of the Department of Epidemiology of the region of Lazio centering on Italy’s capital Rome and coordinator of the Cochrane Reviews on Drugs and Alcohol.

Nevertheless, their manuscript is deeply flawed and requires foundational reshaping, even at that most basic level of research diligence and scriptural veracity that peer reviewers usually presume and take for granted.

1.The authors’ statement on data availability is remarkable for its sentence-by-sentence progressing restrictiveness, giving no access to the cited regulations of the European Union (EU) and the State of Italy, and culminating in placing the regional regulations of Lazio as the finally deciding ones (which in bureaucratic reality means Dr. Davoli et al. themselves, a most Kafkaesk turn). The authors’ statement so remarkable that I insert it here :

56 Availability of data and materials: Data related to the findings reported in our manuscript are not

57 available because of stringent legal restrictions regarding privacy policy on personal information in

58 Europe (European legislative decree on privacy policy 2016/679, Italian legislative decree on privacy

59 policy D.lgs. 101/18). For these reasons, our dataset cannot be made available on a public

60 repository. Although data are appropriately anonymized we are not authorize to share any dataset,

61 because data are restricted by the Institutional Review Board of the Health 61 Information System Unit

62 of Lazio Region. Data are however available from Lazio Region with its permission and upon

63 reasonable request.

I consider this statement to be most extraordinary.

I note that this statement inverses the actual legal structure: Any regional regulation pertaining to the privacy protection of medical data in Italy is overruled by the national regulation, and any Italian national regulations are overruled by those of the European Union if conflicting with them.

The EU and Italian regulations cited by the authors in actual fact do not block the scientific use of and access to fully anonymized patient data (see https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679 and https://www.cliclavoro.gov.it/Normative/Decreto-Legislativo-10-agosto-2018-n.101.pdf).

The Lazio Region regulations cited by the authors are nowhere to be found on the www, are not identified by them as present on the www, and collide with the national regulations of Italy on anonymized data use / sharing for research purposes, see Garante per la protezione dei dati personali, Resolution n. 85, March 1st, 2012. The English-speaking world was immediately introduced to this remarkable Italian regulation (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3477977/pdf/AJPH.2012.300991.pdf), which was reviewed in further detail by Calzolari et al. soon after (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3696949/pdf/bio.2012.0058.pdf) and today is explicitly referenced as the very basis for current epidemiological research in Italy (e.g. https://ijponline.biomedcentral.com/articles/10.1186/s13052-021-01168-4).

Before inserting the above paragraph into this review, I submitted it for review to the Ethics Division of the Istituto Superiore di Sanità (ISS), the Italian NIH, without naming any of the authors or the title / content of their submission.

ISS explained that “the European and national rules for personal data protection do not apply to anonymized data and do not block the scientific use of and access to fully anonymized patient data. Personal data protection is the subject of European and national, not regional, regulations: I am not aware of Lazio Region regulations on this matter.”

To assure veracity of this verbatim quote and to assure anonymity of its high-ranking Italian author, I will separately submit a copy of the email string to the PLOS ONE Office for their review and disposition.

The finding that the authors elect to shield their database with a willfully presented construction of unreferenced privacy rules that fail peer examination as well as expert review, make this manuscript in its present form unfit to be published anywhere.

I am willing to review the authors’ modified re-submission only if that properly corrected version contains in its Supporting Information the entire dataset on which they build their key arguments, the data being anonymized in accordance with Garante per la protezione dei dati personali, Resolution n. 85, March 1st, 2012.

Answer: There are restrictions on publicly sharing data of our study, because they are from a third party (Lazio region). However, as we stated in “Availability of data and materials” section, the data are available from Lazio Region with its permission and upon reasonable request, by contacting direttore.direzionesalute@regione.lazio.it. The Lazio Region provide anonymized data for scientific purposes, according to regulations from Garante per la protezione dei dati personali and from European legislative decree on privacy policy 2016/679 and Italian legislative decree on privacy policy D.lgs. 101/18. On the other hands, considering these regulations and stating the same usage restrictions, studies based on data from health information systems have already been published.

2.The authors quote several publications by Italian colleagues on related topics of ‘COVID pandemic impact on pediatric care’. Among those I see a recent paper in the Italian Journal of Pediatrics, indicating that the authors are following pertinent papers in this periodical.

The authors do not quote, however, a publication in that same journal covering the same Italian region during the same period on the same topic with the – in essence - same graphics and the same conclusions : That pertinent paper was published in January 2021 by Umberto Raucci et al. and has already been accessed over 3000 times: https://doi.org/10.1186/s13052-021-00976-y . It offers a more detailed clinical spectrum of the pediatric ER visits 2019-2020 than the authors’ manuscript, contains a more robust data analysis, and provides a more readable Discussion.

Answer: We would like to thank the reviewer for the useful comment, we apologize for the oversight. The study of Raucci et al. is very interesting and important to focus the Italian, and in particular, the Lazio context. We added this reference to our paper. We would like to underline that the analysis of Raucci et al. is referred to first part of 2020 (from February to April). Our analysis goes more ahead considering all accesses from January to December 2020.

I do not consider the authors’ effort a ‘me-too project of minor originality’.

The authors’ current version holds the seed for crucial growth by adding aspects that similar studies left out, but that are accessible to the authors by reason of their powerful placement at the Department of Epidemiology of the Lazio Regional Health Service.

In particular, I envision a re-analysis of the regional pediatric ER visits in conjunction with other parameters that affected the well-being of Italian children, such as i) the relation to pediatric prescriptions, in particular of antibiotic (topical/systemic anti-bacterial and anti-fungal), anti-asthma (incl. steroids), anti-seizure, and ADHD medications; and ii) the relation to school closures, a destructive event in the lives of Italian children, see https://ftp.iza.org/dp14785.pdf .

Did the reduction in pediatric ER visits, which the authors and others noted, coincide with reductions in the major categories of pediatric prescriptions, and are these categories similarly impacted ? Is there any relation between pediatric ER visits and school closures ? These are key questions of more than regional or national significance. I encourage the authors to apply their considerable reputation and resources in a dedicated effort to acquire the answers.

Answer: Thanks for your comments. The reduction of pediatric ER visits in Lazio Region coincide also with a reduction of pediatric prescription (antibiotic, amoxicillin and clavulanic acid and cortisone aerosol). We reported this trend in our Regional Health Evaluation Program (PReValE) in the territorial assistance section (http://10.8.7.16/prevale2021/). We added this reference to the paper. For what concern the school closures, in Lazio Region schools were closed from march 2020 to June 2020, whereas the decrement of ED accesses is evident during the entire year.

3.The manuscript is rich in non-idomatic English and carries the signs of rapid translation, with Italian remnants in sentence structure and even left-over words, e.g. line 131 on page 7 : “… age classes (0, 1-2, 3-5, 6-9, 10-14 e 15-17)…”, ‘e’ being the Italian ‘and’. Conclusions are dramatic and over-reaching, e.g. lines 43-44 on page 3 / line 299 on page 17: “The monitoring of pediatric accesses is a fundamental tool to monitor the trend of COVID-19 pandemic.” – that clearly is not so at all, not in even one of the many nations around the globe affected by the current pandemic.

Sadly, I feel compelled to add as a pediatrician, since it would attract so much more attention and funding to the care of children …

Answer: Thanks for your comments, we have corrected the error at line 131 and revised the conclusions as follow: “The monitoring of paediatric accesses could be a useful tool to analyse the trend of COVID-19 pandemic in Italy and to reprogramming of the healthcare offer according to criteria of clinical and organizational appropriateness.”

Submitted filename: Response to Reviewers.docx

Click here for additional data file.

16 Jun 2022

8 Jul 2022

Comments to the Author

Reviewer #1: All comments and feedback have been rightly addressed. I thank the authors for taking these suggestions to heart and assimilating them to ensure that sound data is out out there for the scientific community and beyond.

Reviewer #3: This is a limited descriptive study which clearly shows that there was an impact on ED attendances in children in the Lazio region of Italy during 2020. This is shown as a comparison to 2019, and does not take into account any possible trends.

Numerous studies have now shown that the pandemic affected ED attendances. This is another study which adds to this evidence, and has the advantage of showing that the impact continued into 2020 beyond the first lockdown.

I do not feel able to comment on the extensive comments by Reviewer 2 on data access. I am surprised that ethical approval is not required for use of deidentified data – I have to obtain approval in the UK, although the process is relatively quick.

Answer: In Italy is not necessary the approval by an ethical committee when the analysis are based on anonymized data from Health Information Systems.

I do think that there needs to be tightening up of language the paper, which is clearly comprehensible, but some of the tenses and word choice is surprising.

Answer: the language has been revised.

I would like to see more information in the legend/title of the figures and less in the text.

For example, the different colours over time in Figures 1,2 and 4 should be explained in the Figure legend. I am not sure what they correspond to.

Answer: The different colours of the time represent the four phases of the pandemic in 2020: grey= pre-lockdown, orange=lockdown, light blue=post lockdown and yellow= the second wave. Thanks for your suggestion we have integrated this information in the figure legends.

Figure 3 is an unusual presentation of data and I do not think it adds.

Answer: Figure 3 is a modified age pyramid that compared ED accesses in 2019 and 2020 by age classes, instead of male and female population. In our opinion is useful to understand the different impact of the pandemic on ED accesses by age classes.

The methods should emphasise that this is a descriptive paper.

Answer: We modified the text reporting that this is a descriptive study both in the “Material and Methods” paragraph and in the “Discussion” one.

I would like to see a justification of the age groups which I am sure are reflective of Italian systems, but seem irregular to a non-Italian reader.

Answer: Age groups reflect the Italian education from the nursery school to the high school. Thanks to your suggestion, we added this information in the methods paragraph.

Results in Table 1 include a p-value but it is not clear in the methods which statistical test was used to assess this change.

Related to this on line 168 you say: we noticed that there are none important differences between 2019 166 and 2020 during the “pre-lockdown” period (-0.4% for all ages)’ despite a p-value of <0.001. I am not surprised by the significant p-value, but it is odd to class something as unimportant when you have identified it as significant statistically.

Answer: Thanks for your note, actually the difference between ED accesses of 2019 and 2020 for the “pre-lockdown” period is not significant, it was an oversight. We have modified the table reporting the exact p-value.

Line 196 – increament – this is not a word – increment does not really work in this sentence – increase would work well here.

Answer: The sentence has been revised.

The Figure legends should include %Var children if this is what the grey bars are.

Answer: The figure legends have been modified as requested.

The discussion is fine, but does not add very much to add to our understanding of the challenges and impact on children’s health during lockdown.

I enjoyed the final paragraph of the conclusion.

Submitted filename: Response to Reviewers.docx

Click here for additional data file.

22 Jul 2022

The impact of the SARS COV-2 pandemic on pediatric accesses in ED: a Healthcare Emergency Information System analysis

PONE-D-21-31990R2

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Reviewers' comments:

27 Jul 2022

PONE-D-21-31990R2

The impact of the SARS COV-2 pandemic on pediatric accesses in ED: a Healthcare Emergency Information System analysis

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