Paediatric Neurology Patients: Parental Awareness of Adverse Effects of Long-term Corticosteroid Therapy

Background: Corticosteroids are potent medications used to treat in many inammatory conditions in paediatric neurology practice. Although corticosteroids are benecial, their adverse effects may be numerous and vary. As parents are the primary caregivers of paediatric patients, assessing their awareness is timely important. Methods: To determine the parental awareness on adverse effects of corticosteroid therapy in Paediatric Neurology Patients in the Neurology Unit at the Lady Ridgeway Hospital, Colombo, Sri Lanka. In this descriptive cross-sectional study, 300 parents of paediatric neurology patients on long-term corticosteroid therapy in the paediatric neurology unit were included. Parents were volunteered for the study and signed informed consent. Ethical approval was obtained from the Ethics Review Committee of the same hospital. Data were collected using content validated, pre-tested self-administered questionnaire during January to March 2020. Results: Of the total parents, the majority were mothers (87%, n=262) and more than 70% (n=211) of them completed their secondary education. Findings demonstrated that parents had average awareness about adverse effects of long-term steroid therapy including child’s susceptibility to infections (69.0%, n=207), increase blood glucose levels (69.7%, n=209), moon face (60.3%. n=181), central obesity (60.3%, n=181), increase blood pressure levels (58.0%, n=174) and (irritability 50.3%, n=151) while poor awareness on adverse effects include buffalo humps (26.7%, n=80) increase fracture tendency (24.3%, n=73), tarry colour stools (24.3%, n=73), vision impairment (24.0%, n=72), glaucoma (17.3%, n=52), cataract (16.0%, n=48 ) and delayed wound healing (23.0%, n=69). According to the ndings, overall mean (SD) knowledge percentage on parental awareness of adverse effects was found to be low (38.24 ±

Most of the neurological conditions among children are more common in clinical practice and are chronic and frustrating to parents. Recent evidence shows that corticosteroids which are synthetic drugs that closely resemble cortisol, a hormone that our body produce naturally, (Prednisolone, Methylprednisolone and Adrenocorticotrophin) have been used extensively to treat many of these neurological conditions (auto immune diseases, epilepsy) due to their antiin ammatory and structural effects. Furthermore, Global literature reveal that, a major concern related corticosteroid, especially in children and adolescents, is the possible development of adverse effects. The most frequent ones are excessive weight gain, hyperphagia, water retention with oedema, cushingoid appearance, hypertension, behavioural disturbances, increased infection susceptibility, electrolyte disturbances, hyperglycaemia, glycosuria, impaired glucose tolerance, frank diabetes, and sleep disorders. Furthermore, long term adverse effects such as hypothalamus-pituitary axis suppression, psychosis, osteoporosis, nephrocalcinosis, brain atrophy, cataracts and, in children growth retardation, have also been reported [6][7][8][9].
Although corticosteroids are bene cial medication in paediatric neurology practice. Prolong use (more than six month) of high doses of corticosteroids are associated with number of adverse effects; affecting various systems of the body such as immune, musculoskeletal. Ocular, dermatological, central nervous, endocrine, cardiovascular and gastrointestinal system. According to the study done in Italy on topical steroids (TCS) it reveals that topical corticosteroids (TCS) phobia is widespread among Italian families of children with Atopic dermatitis. Fear of TCS is associated with fear of applying too much cream, thus increasing the risk of poor compliance and treatment failure. That study highlighted that therapeutic education of the parents should need to be implemented.
Children are more vulnerable to those adverse effects than adult and therefore especial attention and care is needed to prevent adverse effects among paediatric neurology patients. Because majority of paediatric neurology patients receive corticosteroids on long term basis. Lack of parental awareness of adverse effects and their preventive measures may signi cantly attribute to limiting the success of preventing adverse effects of long-term corticosteroid therapy among paediatric neurology population and also lead to discontinuation of therapy. Corticosteroids usage prevalence in paediatric neurology population in neurology unit Lady Ridgeway Hospital (LRH) has increase signi cantly due to their therapeutic effect on some neurological conditions. This situation emphasizes the growing need of prevention of adverse effects of this potent medications while sparing the bene t of the treatment. Parental awareness plays a major role in identifying and prevention of such adverse events. Therefore, this study is attempted explore parental awareness of adverse effects and prevention of long-term corticosteroid therapy among paediatric neurology patients in neurology unit at LRH.

Study design
This was a quantitative descriptive cross-sectional conducted at the Lady Ridgeway Hospital for Children (LRH), Colombo, Sri Lanka. The tertiary care hospital is considered as the largest children's hospital in the world with a bed-strength of over 900. The study was conducted among parents attending to the neurology unit with their children for long-term steroid therapy. During 5 th January and 31 st March 2019.
Purposive heterogeneous sampling technique had been used in this study, which allow to obtain a representative sample by using a judgment, which will result in saving time and money. The study design was quantitative descriptive study design.
Sample size determination and sampling procedures Three hundred parents (father or mother) of children with neurological diagnosis and receiving corticosteroids in long term basis in neurology unit at LRH were purposively recruited for this crosssectional study. Parents with children age less than 14 years who had diagnosed for with neurological disorder and on corticosteroids for long-term basis at the neurology unit were recruited for this study.

Study instrument and Data collection
Data was collected using structured questionnaire which was developed after reviewing literature and by obtaining inputs from clinical medical experts. It was consisted with three sections and only the second section (secondary data from clinic books) lled by investigators and the rest was led by parents. The rst section was lled with socio-demographic information of the parents. The second section comprised eight parts with 23 questions which were focused on assessment of parental awareness of corticosteroid adverse effects. Third section was included 18 items to assess parental awareness of preventive measures of cortico-steroid adverse effects. Questionnaire were initially developed in English and then translated in English and Tamil and it was administered considering parents preference medium. Content validity of the questionnaire was ensured by clinic and research experts. Questionnaire was pre-tested among 10 parents who did not involve in the study and nalized with incorporating comments received during the pre-test. Data were collected during 5 th January and 31 st March 2019. In general, 15-20 questionnaires were lled during a day without disturbing parents their clinic routines (Please refer the additional le -questionnaire in the supplementary section). Clari cations were Continuous follow up and supervision by the supervisors and principal investigators occurred throughout the data collection period.

Limitation of data collection
There were some limitations of data collection such as children were not given speci c diagnosis for their disease, parents with most aggressive children could not ll the questionnaire, some children accompanied by their relations and guardians, faraway parent refuse to ll questionnaire because concern about time and more children with short term corticosteroid therapy. In addition to that researchers expect participation of equal number of both parents. Unfortunately, this did not occur during data collection period. Fathers participation is very less when compared with mother's participation.

Ethical consideration
Ethical clearance was obtained from Ethics Review Committee of the Lady Ridgeway Children Hospital, Sri Lanka, with the permission to conduct the research at neurology unit. When the inclusion criteria were met, participant given the information letter which was in Sinhala, Tamil or English. Written consent was taken prior to the study from the participants who was willing to accept. Privacy and con dentiality preserved throughout the study. Personal details were not been mentioned. A code given for each record. Data collection done without hindrance for the participants day to day activities. There were no any risks for the individual subject.

Data analysis
After collecting data from the subject, the investigators prepare the data for analysis. In this study the data were prepared according to above data preparation by using software such as Microsoft excel and Statistical Package for the Social Science (SPSS) version 18 [10].

Results
In this study questionnaire had 65 questions with some data views and variable views. According to the answers of questionnaire, researchers given marks as bellow, Yes-1 mark, No-0 mark, Don't know-0 mark. After that answer no and don't know considered together. Then the marks converted into the percentage. Study consisted of three hundred parents of paediatric neurology patients with long term corticosteroid therapy. The results were reported in terms of describing characteristics of the study sample. When nding socio-demographics characteristics in the study sample; mothers were accompanied their children most (87.3%). Most of them were in between 31-40 years (55.0%) of age and most of them have another child also 46.0%. According to the ethnic distribution of the sample, 89.0% were Sinhalese. Participating percentage of working parents were 28.7% ( Table 1).
Association between socio-demographic characteristics and parental awareness of adverse effects of corticosteroid therapy Association between social-demographics characteristics and parental awareness of adverse effects of corticosteroids are shown in Table 2. Accordingly, there were statistically signi cant association between number of children in a family (p = 0.049) and ethnicity (p = 0.000) with the parental awareness of the adverse effects of corticosteroids. However, there is no signi cance association between parental awareness of the adverse effects of corticosteroids and category of parent, parent's age, educational level, employment status and monthly income.

Parental awareness in preventive measures of corticosteroids' adverse effects
Questionnaire consisted questions under eight categories with 18 questions to measure parental awareness of preventive measures of corticosteroids adverse effects (n=300) and ndings are showed in Table 4 and Figure 3. According to the ndings, the most of parents have knowledge to keep child away from crowded places (70.0%, n=217), and to take immediate medical advices if the child contact to chickenpox virus needed 67.0% (n=201). Higher proportion of parents knew the need of immediate medical if the child is suffering from fever,, cough vomiting and diarrhoea (>86%) However, parental awareness prevent measures for fractures is vey low (29.3%, n=88).  (Figure 4).
Association between socio-demographic characteristics and parental awareness of preventive measures of adverse effects of corticosteroids As shown in Table 5 , there were signi cant associations between parental awareness of prevention of adverse effects of corticosteroids and their monthly income (p = 0.001) and adequacy of the income (p = 0.027) .

Discussion
Corticosteroids have been the mainstay of management for more than a half-century [11]. Findings of this study show that parental awareness of corticosteroid adverse effects and preventive measure in uence the continuation of their treatment of their children. Many studies have illustrated how patient attitude and knowledge effects the continuation of their children steroid therapy and this may reduce implication of hospital stay thus leading to economic bene t [12].
In this study it was shown that the majority of participants have poor awareness on adverse effects of long term corticosteroid therapy. Sample of 217 participants out of sample population of 300 demonstrated poor awareness of adverse effects of corticosteroids. Since the male and female participants sample were not comparable awareness mothers' verses fathers. These results were contrast with another study was done in Netherland, nding of that study have shown that parents' awareness of adverse effect was good [13]. A similar situation, in Arab Emirates, Al Lela et al., (2014) pointed out parents' awareness about it associated risks was poor. Most probable reason for Netherland study in contrast with our study [14], Netherland is developed country and they use new technology and educational method than Sri Lanka.
In during long term corticosteroid treatment was poor. The better awareness the adverse effects like increased hunger, moon like face attributed to the parents personal experience with their own children who were on long term corticosteroid therapy. Finding of present study revealed that parent was more awareness regarding side effect of increase hunger 73.3% (n = 220) than the others. There was a similar situation found in Netherland. According to them most frequent was change in taste (61%), facial ushing (61%), feeling sick or having stomach pain and disturbance(44%) (Jongen at al., 2010). Hungry and tasty is most common personal experience in among participant's child. So that ndings were similar in both the countries.
According to the ndings of study, socio demographic data, monthly income (p = 0.001) and adequacy of the income (p = 0.027) were statistically signi cant associated with preventive measures of adverse effects of corticosteroids. The preventive measure for adverse effects of corticosteroid also related to family income of the people, who have more income (> Rs30000)had taken many preventive methods than the family's low incomes. In the present study, researcher identify they have less awareness about vitamin D Supplement that should be given to prevent fracture (29.3%). These results were contrasts with another study done in England. Chalitsios et al., (2020) pointed out that meta-analysis demonstrate a clinically statistically signi cant prevention of bone loss at lumbar spine and fore arm with vitamin D and calcium in corticosteroid treatment [15]. In UK, this study done about oral corticosteroid treatment for the prevention of osteoporosis. The study highlighted that large number of people in population who are taking continuous oral steroids and shows the preventive measures for osteoporosis, are being implemented in frequently.
Findings of the present study highlighted preventive measure knowledge percentage of parental awareness of adverse effects was higher and can be accepted as adequate they have good preventive awareness. Result of parental preventive awareness was good 65.7% (n = 197).These results were contrasts with another study done in Morocco. This study done with long term glucocorticoids steroid hormone therapy. According to their result weight gain (27%) an out of (18%) patient reported episodes of treatment discontinuation [16]. It may be reason for poor knowledge about preventive measure of adverse effects of steroid therapy in Morocco.

Conclusions
In most neurological condition among children requiring treatment with corticosteroids in long term basis. This therapy cannot be replaced by any other. Usually, long term treatment with corticosteroids bene ts outweigh the adverse effects, with time. However, complication of therapy may become burden for the children. In most cases, unable to give up treatment with long term corticosteroids and for that reason it is not possible to avoid the adverse effects. However, with increasing parental awareness of corticosteroid adverse effects and proper prevention methods they can be minimize or prevent. According to the ndings of study conducted in LRH Neurology Unit overall parental awareness of adverse effects are poor and preventive awareness of adverse effects of long-term corticosteroid therapy are good. Therefore, special attention needed to increase parental awareness of adverse effects of long-term corticosteroid therapy.