Designing a Minimum Dataset for the Cow's Milk Protein Allergy in Children: Identifying and Evaluating the Key Factors in Managing, Controlling and Monitoring the Cow's Milk Protein Allergy in Children: A Cross‐Sectional Study

Abstract

ABSTRACT

Background and Aims

Cow's milk protein allergy (CMPA) occurs when the body recognizes the protein in cow's milk as a foreign substance and attacks it. This study aims to design a minimum data set (MDS) for CMPA in children, as a prerequisite for implementing related registries and applications.

Methods

Initially for this descriptive cross‐sectional study, a literature review was performed. Then the required data elements were obtained from the studies and a questionnaire was designed. Subsequently, to approve the data set, the designed questionnaire was distributed to 20 relevant specialists throughout a two‐round Delphi technique. To analyze the data, descriptive statistics were used.

Results

Initially 137 data elements were obtained in five categories. After performing the primary round of Delphi, 108 data elements were accepted, and 29 data elements entered the second round of Delphi. Then, 12 data elements were accepted, and 17 data elements were removed. Totally, the final accepted data elements reached 120.

Conclusion

Determining a qualified MDS for CMPA in children is the most important step to implement health information systems such as registries. It can provide standardized data elements helping health managers identify the necessary information to create a successful system, also for epidemiologists, researchers and health policy makers obtaining the necessary statistics and information.

Introduction

Food allergy is an important health concern with a growing prevalence. It affects approximately 8% of children and is the most common reason of anaphylaxis and anaphylaxis-related emergency department visits in children. It accounts for 3 million doctor visits, 125,000 to emergency room, 2000 hospitalization and about150 deaths annually. The economic cost of food allergies is nearly $25 billion per year [1, 2]. Cow's milk protein allergy (CMPA) as one of the most prevalent food allergies in early childhood [3], occurs when the body perceives the protein in cow's milk as a foreign substance and attacks it. This disease is usually seen in children in the initial 2 years of life and particularly within the first year [4] and may cause long-term effects on growth and nutrition [3]. Symptoms of CMA can range from mild to severe, and can appear immediately after ingesting cow's milk or develop over time [4]. Gastrointestinal symptoms such as abdominal pain, vomiting, diarrhea, and blood in stool are common. Cutaneous symptoms like urticaria and angioedema, respiratory symptoms like wheezing, and even life-threatening anaphylactic reactions can occur in severe cases [5].

CMPA, like other food allergies, can be classified into two main categories: IgE-mediated and non-IgE mediated reactions [6]. IgE-mediated reactions are the most common type of CMPA, characterized by a rapid onset of symptoms due to an allergic antibody response. On the other hand, non-IgE mediated reactions occur through a different cellular pathway involving eosinophils or T-cells, and can cause delayed onset of symptoms [4]. Studies show that around 60% of CMA cases are IgE-mediated, although this percentage can vary depending on the population and age group being studied [3]. The remaining 40% of CMA cases are categorized as non-IgE-mediated or mixed forms. These types of CMA have varying mechanisms, presentations, and implications, making it difficult to accurately determine the overall prevalence of CMA [4].

Genetic predisposition and environmental factors, especially nutrition in the early years of each person's life and nutrition during pregnancy, are key factors that contribute to a person's food allergy [7].

CMPA can significantly impact both the individual and their family, not only due to the potential for life-threatening reactions but also because it can negatively affect health-related quality of life. Moreover, CMPA imposes substantial individual and societal costs that need to be considered in its management [8].

According to data, CMPA is a significant problem worldwide with lifelong health consequences and since it is the most prevalent and extensively researched food allergy in early childhood, it can serve as a model for understanding other food allergies [4].

Therefore, a comprehensive understanding of CMPA's epidemiology, symptoms, diagnostic criteria, and appropriate treatment is critical for a multidisciplinary team of healthcare professionals, including physicians, dietitians, and nurses. This knowledge can provide valuable insights to better understand other allergies and guide public health initiatives for improved prevention, diagnosis, and management of immediate hypersensitivity reactions. Ensuring proper diagnosis, prognosis, and identifying the likelihood of allergy resolution are therefore essential elements of CMPA management, as supported by multiple studies [3, 4, 9].

Although numerous studies have investigated various aspects of CMPA, most of them have limitations in providing accurate data on the prevalence of the condition [4].

Based on our research, we could not find any study conducted to create a standardized minimum data set (MDS) for CMPA that could be used to generate trustworthy statistics and epidemiological information. This highlights the need for further research and standardized data collection to accurately understand the prevalence and impact of this disease.

Designing a minimum data set as a set of standard data elements is the initial step in managing data and information of disease [10]. MDS is a standard tool for data gathering and provides access to accurate and precise health data [11]. It has a great capacity to assist providing appropriate care and disease control measures and can provide a base for planning, management, and performance evaluation [12]. Furthermore managers, policymakers and programmers can use standard MDSs to know what necessary information should be included while designing a new system [13]. To access reliable and comparable information about the patients number, methods of treatment, and consequences of the provided health services, creating a registry based on a standard MDS is necessary [14]. As mentioned before, to our knowledge, this study is the first study which design an MDS for CMPA in children but some guidelines and studies [15, 16] have been performed to identify diagnosis criteria, risk factors, prevention, and treatments for this disease. Fiocchi et al. [15] introduced updated guidelines with the aim of providing comprehensive guidance in diagnosis and treatment of both types of CMPA (IgE and non-IgE-mediated) in children and adults. They also focused on recommendations for the 3 most relevant clinical aspects “(a) the diagnostic identification of the condition; (b) the choice of the replacement formula in case of CMPA in infancy when the mother is not able to breastfeed, and (c) the use of specific immunotherapy for CMPA.”

Allen et al. [16] performed a study to generate a guidance for milk allergy detection and management with the aim of safety reduction of milk allergy overdiagnosis and unnecessary use of specialized formula products, they gathered the consensus of 17 eligible experts about 4 key areas: “symptoms suggestive of milk allergy in an exclusively breastfed infant, maternal dietary elimination, infants presenting with blood in the stool and agreed terminology.” Their consensus guidance also contains the settings where healthcare experts should recommend breastfeeding women to restrict their diet. Therefore, according to the stated advantages in the background and since no MDS has been found for CMPA up to now, the intention of the present study is to design and present an MDS for CMPA in children.

Materials and Methods

Study Design and Setting

This descriptive cross-sectional study was directed in the following steps.

Step 1: Extracting the data elements required to design the minimum data set for CMPA in children.

Search Process

First, a literature review was directed on August 10, 2023, in three databases: PubMed, Web of Science and SCOPUS. To find correlated articles, we searched title and abstract of articles using following keywords and search strategy: (((milk hypersensitivity [Title/Abstract]) OR (cow's milk protein allergy [Title/Abstract])) OR (cow's milk allergy [Title/Abstract])) OR (CMPA[Title/Abstract]).

Inclusion and Exclusion Criteria

Inclusion criteria were articles in English or Persian languages, access to the full text of the articles, reference to data elements, and medical and administrative parameters correlated to the milk hypersensitivities, publication dates ranging from 2013 to 2023 and the studies that were done on the human species. Exclusion criteria were articles focused on other facets of CMPA (irrelevant to this study) and failure to afford distinct information, book and book chapters, letter to the editor and the conference abstracts.

Arrangement and Selection of the References

An over-all of 1624 articles were obtained from the 3 databases. The title and abstract of the articles were studied. Then as stated by the exclusion and inclusion criteria, 131 articles were included in the study. The full texts of the articles were studied, and conclusively the essential data were obtained. The obtained data were gathered using a data extraction form that its validity was confirm by two health information management experts. The form included fields such as data elements and references. It is noteworthy that, after the managerial and clinical data were obtained from the studies, two pediatric allergy subspecialists working in Afzalipour hospital associated with Kerman Medical Sciences University, examined them.

Step 2: Ultimate agreement of the data elements using a Delphi technique

Study Participation and Sampling

The study population included specialists and subspecialists from four fields of (1) Pediatric diseases, (2) pediatric allergy, (3) pediatric gastroenterology and (4) health information management working in educational and medical centers associated with Kerman University of Medical Sciences. As in utmost Delphi-based research, the number of experts has been frequently 15–20 [17], 15 specialists and subspecialists in the aforementioned fields were chosen to partake in the study. The following inclusion criteria applied to choose participants:

• Employment of participants in medical and educational centers associated with Kerman University of Medical Sciences.

• Having a history of activity in the diagnosis and remedy of CMPA in children for more than 5 years. (except for health information managers).

• Having a history of activity in designing MDSs for diseases or chronic conditions. (only for health information managers).

Data Gathering Tool and Method

Here, by using the obtained data elements in the former step, a questionnaire was designed. The questionnaire had two separations: (1) the demographic information of experts and (2) the data elements which were needed to design the MDS of CMPA in children. The data elements were separated by the researcher into five categories of “administrative data,” “clinical records and risk factors,” “clinical presentation data,” “diagnosis data” and “treatment data.” To fix these categories, we had two sessions with two pediatric allergy subspecialists in Afzalipour hospital associated with Kerman University of Medical Sciences. In the first session, the obtained data were examined by them and in the second session, we asked them to express their views about categorizing the data elements and data elements were then categorized based on their opinion.

The questionnaire was designed in accordance with the Likert scale, including the terms completely agree, agree, have no opinion, disagree, and completely disagree. The validity of the questionnaire was validated by two health information managers and two pediatric allergy subspecialists and based on their opinions; some changes were made. Then the agreed questionnaire was designed.

To perform the Delphi technique, first, the designed questionnaire was distributed in person to the expert members on September 12, 2023. By September 20, all the questionnaires were completed and after gathering, we entered the data in SPSS software version 23, and the frequency of choices were calculated in percentage. The data which were approved by more than 75% of the experts were confirmed, and the data that were approved between 50% and 75% were re-surveyed, and those that were approved by less than 50% were removed [11].

For the second round of Delphi, 1 month later, based on the result of the analysis of the first round Delphi questionnaire, another questionnaire created and the data elements with the percentage 50%–75% were encompassed. Then the same members of the Delphi team were approached again, and the prepared questionnaires were distributed among them. After collecting the forms, the information obtained from the second round was analyzed. The criterion for selecting data elements in this method was the consensus of experts, however the consensus of experts did not mean finding the correct answer, but simply the agreement of the participants at a certain level on a desired topic, which in this study, more than 75% agreement on each element, was accepted as a consensus in that. So the data elements with a mean more than 75% were accepted as the ultimate elements for the MDS of CMPA in children and the other elements were omitted [11].

The reliability of the questionnaire was measured through Cronbach's alpha in SPSS 23 software with a value of 0.85.

Results

Twenty specialist and subspecialists in four fields of “Pediatric diseases,” “pediatric allergy,” “children's gastroenterology” and “health information management” participated in the study. The demographic information of them is displayed in Table 1. The frequency of women (n = 15.75%) was higher than the men and the frequency of specialists (n = 11.55%) was also informed higher than subspecialists. Furthermore, the average work experience of subspecialists was higher than specialists.

Table 1 Demographic information of experts.

Type of medical specialties	Frequency	sex	Education degree	Average work experience
Pediatrician	9	Male: 4	Specialist	16 years
Female: 5
Pediatric gastroenterologist	4	Male: 0	Subspecialist	14 years
Female: 4
Pediatric Allergist	5	Male: 1	Subspecialist	19 years
Female: 4
Health information manager	2	Male: 0	Specialist	13 years
Female: 2

The number of 137 data elements were divided into 5 categories including 2 parts of administrative data (37 items), 3 parts of clinical records and risk factors (49 items), 1 part of clinical presentation data (33 items), 2 parts of diagnostic data (13 items), and 1 part of treatment data (5 elements).

Results of the Primary Round of Delphi

As shown in Table 2, among the 37 elements of administrative data, which were divided into 2 subcategories of demographic data and birth data, elements of race or ethnicity and prolonged delivery, each with 75% agreement, elements of mother's blood group, father's blood group and father's age at birth of the patient, each with 70% agreement the elements of cesarean delivery with epidural anesthesia, mother's weight at birth and mother's height at birth, each with 60% agreement and the element of type of health insurance with 55% agreement, entered the next round of Delphi and the rest of the elements were each accepted by more than 75% of the experts as part of the ultimate set of minimum essential data for CMPA in children.

Table 2 The results of two Srounds of Delphi.

Category	Subcategory	Number of data elements	Initial round of Delphi	Next round of Delph	The final number of confirmed data elements
< 50%	50%–75%	> 75%	< 50%	50%–75%	> 75%
Administrative data	Demographic data	24	0	7	17	1	3	3	20
Birth data	13	0	6	7	0	4	2	9
Records and risk factors	Patient clinical records	17	0	3	14	0	2	1	15
Clinical records of the patient's family	24	0	11	13	2	4	5	18
Maternal nutrition during pregnancy	8	0	2	6	0	1	1	7
Clinical data	Patient clinical data	33	0	0	33	0	0	0	33
Diagnosis	Type of disease	4	0	0	4	0	0	0	4
Diagnosis method	9	0	0	9	0	0	0	9
Treatment	Suggested treatments	5	0	0	5	0	0	0	6
	Total	137	0	29	108	3	14	12	120

Among the 49 data elements related to clinical records and risk factors, which were divided into 3 subcategories of clinical records of the patient, clinical records of the patient's family, and mother's nutrition during pregnancy, the elements of congenital anomalies, long-term jaundice of the child in early birth, Maternal bleeding during pregnancy, gestational diabetes in the mother, blood pressure in the mother's pregnancy and placental insufficiency during the mother's pregnancy, with 75% agreement, elements of fetal distress, history of infertility in parents, maternal eclampsia during pregnancy, with 70% agreement and elements of frequency of mother's pregnancy, autism disease in parents, autism disease in siblings or first degree relatives, psychiatric diseases in mother during pregnancy and the use of supplementary vitamins during pregnancy (type of vitamin), with 65% agreement, the element of history of abortion in the mother with 55% agreement, and the element of whether the mother took psychiatric drugs during pregnancy with 50% agreement, entered the next round of Delphi and the rest of the elements were each accepted by more than 75% of experts as part of the ultimate set of minimum essential data for CMPA in children.

The set of elements related to clinical presentation data, diagnosis, and treatment were all accepted by more than 75% of experts as part of the ultimate minimal essential data set for CMPA in children.

Results of the Next Round of Delphi

The responses of the next round of Delphi questionnaires were analyzed and among the administrative data, 8 elements, including the type of health insurance, mother's occupation, father's occupation, mother's income, cesarean delivery with epidural anesthesia, weight of the mother at birth of the patient, height of the mother at birth of the patient and prolonged delivery with a score of less than 75% were omitted from the minimum necessary data set of CMPA in children and the remaining 5 elements related to the administrative data that entered the next round of the survey by Delphi method, with the agreement of more than 75% of the experts, remained in the minimum needed data set of CMPA in children.

Among the data related to the records and risk factors, 9 elements, including congenital anomalies, long-term jaundice of the child at the beginning of birth, history of infertility in the parents, number of times of pregnancy of the mother, history of abortion in the mother, bleeding of the mother during pregnancy, eclampsia of the mother During pregnancy, psychiatric illnesses in the mother during pregnancy and whether the mother took psychiatric medications during pregnancy were omitted from the minimum necessary data set for CMPA in children with a score of less than 75%.

And the remaining 7 elements related to records and risk factors that were entered in the next round of the Delphi survey, with the conformity of more than 75% of the experts, remained in the minimum necessary data set of CMPA in children.

Meanwhile, all the elements related to the clinical presentation data, diagnosis, and treatment in the initial round of Delphi, with the conformity of more than 75% of the experts, remained in the minimum necessary data collection of cow's milk protein allergy in children and none of them entered the next round of the Delphi survey. Table 2 shows the number of data elements in different rounds of the research, and Supporting Information S1: Appendix S1 lists all accepted and rejected elements along with the points they have earned in each round of Delphi.

Discussion

In this study, an MDS for the children involved in CMPA was designed. Out of 137 identified data elements, 120 data elements were finalized by experts for designing an MDS of CMPA. Among all the identified subcategories, the data elements of “Clinical data of the patient,” “Type of disease,” “Diagnosis methods” and “Suggested treatments” subcategories were the most important and all of them were approved by all the experts with an average score of over 80% in the first round of Delphi.

Studies have shown that demographic data, are required to acquire information on health consequences and vital occurrence such as fertility, mortality, morbidity, and immigration [18], Lucyk et al., [19] performed a study about obstacles to data quality induced from the process of coding health information and mentioned that to monitor population health, health care planning, research and surveillance, administrative data are needed. In the present study we gathered 37 important administrative data items into 2 “Demographic” and “birth data” subcategories in designing an MDS for CMPA and with the agreement of experts, 29 items as the minimum administrative data related to CMPA were finalized in this category.

Type of mother's delivery (natural or cesarean section) was one of the important data elements that we considered in the design of the MDS related to CMPA under the category of birth data. This data element was approved by 90% of experts and, there are studies that have addressed the effect of the type of mother's delivery on food allergies [20, 21] Lack, G. [22]. reviewed nonspecific factors that might be associated in immune modulation and food allergy and cesarean section was mentioned as one of the factors that appear to raise the risk of developing food allergy. The presence of this data element in the registries derived from this MDS and the review of relevant statistics in this field by managers and health professionals and researchers as well as mothers who decide to perform an elective cesarean (without medical reasons) can be useful.

A study by Vassallo et al., [23] about the correlation between the season of birth and food allergy in children under 5 years of age in Boston, showed that the number of food allergies in children born in autumn and winter was higher than those born in spring and summer. On the other hand, the comparison by Samady et al., [24] about the symptoms of food-induced anaphylaxis shock in infants aged less than 12 months and older children, showed that the age of the child can play a focal role in the occurrence of different symptoms of food allergy. In the present study, we presented the elements of age and date of birth as two separate items in the subcategory of demographic data to help researchers who use the registries derived from this MDS to collect statistics related to age and date of birth. Anyway, these two items were approved by more than 90% of experts in Delphi surveys. The review of studies on designing MDSs related to other diseases showed that, unlike the present study, some did not mention the age and date of birth separately [13, 25]. So certainly, calculating the age of patients at the time of disease onset based on their date of birth will be a time-consuming task for researchers however, same as the present study, In the design of MDSs for bipolar disorder [26], diabetic foot [11] and upper limb disability [27], these two elements have been considered separately.

In many studies that deal with the design of the minimum needed data set for various diseases, the element of race or ethnicity is not considered for demographic information [28, 29] or just one of them (race or ethnicity) are considered [30]. Sasaki et al., [31] believed that Asian background correlated with an enhanced risk of food allergy, also Mahdavinia et al., [32] in a study described disease phenotypes and discrepancies in health care utilization among African American, Hispanic, and white children with food allergy and they concluded that food allergy phenotypes vary among children of diverse racial and/or ethnic backgrounds in the United States and African American and Hispanic children are at higher risks of unfavorable outcome than white children. Because in some countries like Iran, there is no racial diversity and ethnic diversity is important and based on studies that mention some factors such as hygiene and diet can be effective in food allergies [22], and these factors may differ among different ethnic groups, in this study, we considered the two items of race and ethnicity as one item in the subcategory of demographic data.

Meystre et al., [33] studied about clinical data reuse and believed that clinical data is essential for high value healthcare, upgraded healthcare management, decreased healthcare costs, population health management, and efficient clinical research. In the present study we identified “Patient clinical records,” “Clinical records of the patient's family” and “patient presentation data” in separated subcategories to completely cover the collection of all necessary clinical data of the patients to achieve the stated goals.

Hou et al., [34] conducted a study to examine the independent relevance of genetic predisposition to CMA in Chinese children and concluded that genetic risk for CMA was exacerbated among those with parental history of allergy. Johansson et al., [35] also believed that both genetic variants and environmental factors are the risk factors for food allergies also, many other studies have been done on the effect of genetics on food allergies [36–38]. Furthermore, Toro-Monjaraz et al., [39] believed that the mixture of genetic predisposition, perinatal factors, and intestinal imbalance may play fundamental role in CMPA pathogenesis. In the present study, the items related to the history of various types of allergic diseases in the patient's parents, sibling, and first-degree relatives as well as various factors in the perinatal period such as maternal eclampsia during pregnancy, pregnancy blood pressure, placental insufficiency during mother's pregnancy have been considered and approved by most experts participating in the study.

Meraji et al., [40] conducted a study to compile a minimum national data set in the field of management of congenital anomalies in Iran. Like the present study, due to the significance of knowing about the mother's condition, they have also discussed the mother's clinical records. In addition, they also considered a subcategory called the maternal socioeconomic status, which was not considered as a separate subcategory in the present study, but some items related to the socioeconomic status of the patient and his family are included in different subcategories.

Baird et al., [41] conducted a study to develop multicenter coordinated registry network (CRN). To develop the CRN, a group of uterine fibroids specialists, and the patient community, participated to identify the essential data elements needed to assess uterine fibroid therapy technologies. In this study, like the present study, the two-round Delphi method was used to reach an agreement on the minimum essential data set but against the present study, their study population included patients as well as specialists.

Guidelines and consensus were other studies that focused on diagnosis, management, and treatment of cow's milk protein allergy in the world.

Matthai et al. [42] formulated a consensus statement to proper diagnosis and management of CMPA. A group of experts contributed in the study and reached an agreement on various issues related to subject including prevention, diagnosis, management, and treatment to overcome low awareness among pediatricians also Toca et al., [43] developed guidelines on diagnosis and treatment of CMPA of the Latin American Society. They formulated pertinent questions, surrounding the themes of (1) clinical manifestations and diagnosis, (2) diagnostic tools, and (3) treatment, then specified the average of the consensus opinions among experts and when 75% agreement was attained, the recommendations on diagnosis and treatment were framed. As in the present study, experts participated in these studies to confirm the items and reach a consensus but unlike the present study, the volume of information in these consensus and guidelines is very large and although they provide useful information about various aspects of the disease to the people who need this information, but they are not originally prepared for the intention of designing and presenting a minimum essential data set of the CMPA and they cannot be applied directly for designing computer systems, applications and the relevant registries also, the large amount of information presented in them may be boring for the readers and reduce their willingness to use them however, by using these guidelines and consensus, relevant MDSs can be prepared and can be useful for health managers, researchers, epidemiologists, system designers, and registry creators.

Limitation and Recommendation

One of the limitations of this study was that, based on the author's research, there was no MDS specifically designed for CMPA and so we had to use the MDS of other chronic diseases and conditions to gain initial insight into creating an optimal minimum data set [25, 44–46]. Therefore, it is suggested to conduct similar studies according to the conditions and clinical facilities of each country to collect and classify effective indicators in prevention, management, research, and policy making. Also, to use this data set, it is suggested to the creators of registries and application designers and health managers to use this MDS as a basis for creating related systems and applications. Furthermore, the participants in the current study were 20 specialists associated with Kerman University of Medical Sciences, for future studies, it is recommended to use the opinions of more specialists as well as the experiences of the families of children involved in this disease.

Conclusion

In this study, we designed an MDS for CMPA in children. This MDS can be used as a basis for creating registries related to this disease, and since in many countries, including Iran, there are no accurate statistics on the number of cases of CMPA and the effect of independent and dependent variables on decrease or increase of this disease, the use of related registries by researchers, managers and policy makers can have a substantial impression on improving the management, diagnosis, control and reduction of the complications of this disease and improve the grade of life of involved children and their families and be effective in increasing the parent's information, before the birth of the child to prevent it and after the birth of the child to early diagnosis and better control its symptoms and complications.

Author Contributions

Farzaneh Asadilari: conceptualization, investigation, writing – original draft, writing – review and editing, software, resources, project administration. Sadrieh Hajesmaeel-Gohari: conceptualization, methodology, validation, visualization, formal analysis, project administration, supervision, writing – review and editing. Roghayeh Ershad Sarabi: conceptualization, methodology, validation, visualization, supervision, formal analysis, project administration, writing – review and editing. Nasrin Bazargan: data curation, supervision, project administration, validation, formal analysis, resources, visualization. Sarehsadat Ebrahimi: validation, visualization, formal analysis, project administration, data curation, supervision, resources.

Acknowledgments

The authors are extremely grateful to all the experts who cooperated with us in the two rounds of the Delphi survey.

Ethics Statement

The protocol of this study was accepted by the research ethical committee of Kerman University of Medical Sciences (IR.KMU.REC.1402.483). The expert's partaking in both round of Delphi was totally voluntarily, and they had possibility to quit the study whenever they wish.

Conflicts of Interest

The authors declare no conflicts of interest.

Data Availability Statement

The authors confirm that the data supporting the findings of this study are available within the article and its supporting materials.

Transparency Statement

The lead author Roghayeh Ershad Sarabi affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

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