2.1 Study design

This study is a cross-sectional study with an analytical component.

2.2 Setting and population

Cochlear implant surgery is performed at 19 centers/hospitals in Egypt under the umbrella of health insurance. The study used multistage cluster sampling. Using the random number function (RAND in Microsoft Excel), five centers were selected, namely Mansoura University Hospital, Sporting Hospital of Students in Alexandria, Bahtim Hospital, Wadi El-Nile Hospital, and Ain Shams Hospital.

Inclusion criteria: Parents of children aged ≤ 5 years with an IQ score ≥ 80, who received unilateral cochlear implant for bilateral moderate to deep sensorineural hearing loss, with at least one year of follow up after the surgery.

2.3 Sample size

A previous study that used the Glasgow Children’s Benefit Inventory (GCBI) score for assessment of the outcome of cochlear implantation in children and found that the standard deviation (SD) was 24. Based on this SD, with a precision of ± 5 and confidence level of 95%, the calculated sample size was found to be 89 participants using the online sample size calculator (https://epitools.ausvet.com.au/onemean). Given the study's sampling strategy (multistage cluster sampling), a design effect of 2 was applied to adjust the sample size, resulting in a final sample size of 178. Two hundred children who met the inclusion requirements and attended the chosen locations between February and August 2021 were included in the study.

2.4 Measurements/instruments

A pre-designed structured questionnaire was used to collect data from parents/guardians of the children who attended for follow-up. Data related to the child’s hearing history was obtained from the medical files of the patients. The questionnaire included the following sections:

2.4.1 Sociodemographic data

Sociodemographic data were collected using a validated Arabic questionnaire [12] for socioeconomic status. For the assessment of health literacy among the parents, we used the Single Item Health Literacy Screener (SILS). The SILS has one question: “How often do you ask someone for help to read the instructions and leaflets from a doctor or pharmacy?” The answers were recorded on a 5-point Likert scale: 5-never, 4-rarely, 3-sometimes, 2-often, or 1-always [13]. Adequate health literacy included parents who answered “never or rarely”, while inadequate health literacy included those answered “sometimes, often, or always” [14].

2.4.2 Child hearing history

This section included information on the timing and cause of deafness, use of auditory aids before implantation, duration of auditory deprivation, degree of hearing loss, presence of additional disabilities, and communication modality.

2.4.3 Clinical assessment data

This data was retrieved from the patients’ medical records. Data included assessment of the child’s hearing before surgery (e.g., IQ, degree of hearing loss), auditory performance score at the time of the interview, age at implantation, and any complications related to the surgery if applicable. The degrees of HL included in the study were dee HL (hearing threshold ≥ 91 dB), severe (hearing threshold: 71–90 dB), and moderate to severe (hearing threshold: 41–70) [15]. The auditory performance score [16] at the time of the interview was categorized as follows: no awareness of environmental sounds (0), awareness of environmental sounds (1), response to speech (2), identification of the environmental sounds (3), discrimination of common sounds without lip reading (4), understanding common phrases without lip reading (5, understanding conversation (6), and use telephone with known speaker (7).

2.4.4 Arabic validated Glasgow score

The Glasgow Children’s Benefit Inventory (GCBI) is a tool used to assess the health-related quality of life (QOL) after intervention in children who have undergone cochlear implant. The Arabic version of this tool was validated for assessment of the benefits of cochlear implant in children as reported by parents. The GCBI includes 24 items divided into 4 constructs; physical health (e.g., visits to the doctors, colds, need for medications), learning (e.g., absence from schools, leaning, concentration, distractibility, fun with friends), emotions (e.g., self-esteem, happiness, confidence, self-care), and vitality (e.g., overall life, things they do, progress, liveliness). The internal consistency of the tool was high (Cronbach’s α = 0.9). The GCBI uses a 5-point Likert scale ranging from 1 (much worse than before surgery to 5 much better than before surgery). The average of scores of these questions was deducted by 3, and then multiplied by 50 to obtain a benefit scale: -100 (i.e. maximal negative benefit) / 0 (i.e. no benefit) / + 100 (i.e. maximal positive benefit) [11].

2.4.5 Parental expectations

Parental Expectations regarding communication capabilities, social skills, academic achievement, and changes in future life of their Children, and knowledge of rehabilitation needs among parents. This questionnaire was adopted from Kumar et al. (2017) [7]. Answers were rated on a Likert scale from one (strongly disagree) to five (strongly agree). The questionnaire was translated into Arabic and back-translated into English to ensure linguistic validity and was reviewed for content validity by two independent public health experts. The score content validity index average of the items of this questionnaire (S-CVI) was 1. For statistical analysis, the answers were categorized into two groups: (1) (disagree/uncertain) (2) agree.

2.4.6 Decision making of parents

This section aims to explore how easy was the decision to have cochlear implant for their child. This section asked the participants about their involvement in decision making and the source of their first information about the surgery. This section used Likert scale questions ranging from 1 (strongly disagree) to 5 (strongly agree) to ask about the availability of information related to surgery, its complications, the need for follow up and if the decision to undergo surgery was a difficult one. For statistical analysis, the answers were categorized into 2 groups (1) agree and (2) (uncertain/disagree). Yes/no questions were then used to explore the reasons behind difficult decisions, and who supported the parents during decision-making [17].

2.4.7 Barriers to Care Questionnaire (BCQ)

Barriers to Care Questionnaire (BCQ): is a reliable tool used to assess sociobehavioral processes that negatively affect the patient's experience in the healthcare and reduce access to high quality care for children with special health needs. The BCQ is a multidimensional tool that includes five dimensions: expectations, marginalization, skills, knowledge, and pragmatics, with internal consistency reliability (alpha) of 0.95. Six questions from the original 39-item BCQ, were not included as they were not suitable for the Arabic culture. Each question has 5 possible answers (0 no problem, 1 a minor problem, 2 a problem, 3 big problems, 4 very big problem). It was translated into Arabic and back translated into English to ensure linguistic validity. Content and construct validity were checked by two independent public health experts [10]. The score content validity index average of the items of this section (S-CVI) was 1. For statistical analysis for each dimension of quality, categories of the answers were grouped into two categories (1) (no/minor problem) and (2) (a problem to very big problem).

2.5 Data collection

Participants who met the inclusion criteria were interviewed at the selected centers using the study questionnaire. Data from the medical files of patients were accessed after approval from the healthcare centers and patients’ guardians. A pilot study was conducted with twenty parents at the Sporting Hospital of Students in Alexandria to ensure easy understanding and clarity of the tools.

2.6 Ethical considerations

Nurses were informed about the objectives, purpose of the survey, expected benefits, types of information required, and publication of the findings before their participation. Only eligible parents who agreed to participate were included in the study. Informed written consent was obtained from all participants.

2.7 Data analysis

Data was analyzed and tabulated using SPSS version 26. No missing data was found in the questionnaires completed by the researcher. Categorical data was presented as frequency and proportions. Nonparametric continuous data in Table 2 (e.g., age of the child, auditory performance score) were presented as categorical data based on their median. Patients with QOL score > median (41.7) were considered to have a good outcome compared to a poor outcome. Bivariate analysis was conducted to assess the different predictors of good outcome. Chi-square and Fisher’s Exact Tests were used wherever suitable. Variable found to be significant (p < 0.05) were entered into multiple binary logistic regressions to find the significant independent predictors of a good outcome.