Study design, period and setting
An institution-based observation prospective follow up study was conducted among children who aged 1 months to 18 years and admitted to pediatric intensive care unit of the University of Gondar comprehensive specialized hospital from February 1, 2018, to July 30, 2019.
The hospital is located in Gondar city, in Amhara Region, 741 km Northwest of Addis Ababa, It is a comprehensive specialized teaching and referral hospital, with a total of 641 beds and 96 beds in the pediatrics side, where a multidisciplinary team of diverse professionals provide a range of health care services for approximately 2806 inpatient and 11986 outpatient children beyond the neonatal age coming from the northwest part of the country including the neighboring administrative regions. The major causes of pediatric admission to the hospital are pneumonia, malaria, neonatal infections, tuberculosis, heart failure, meningitis and other various types of metabolic and organ system-based emergencies according to hospital statistics. On average there are about 25 pediatric critical care admissions per month. The PICU was established in 2013 it has six beds with electronic monitors and one mechanical ventilators. The organizational detail of the PICU in this hospital is lacking. Team composition is often limited to a general pediatrician, resident, interns and a handful of senior-level nurses. Pediatric intensivists, respiratory therapists, pharmacists, and dieticians are not available.
Population and sample
The patients aged 1 month to 18 years admitted to pediatric intensive care unit and stayed more than two hours in the hospital were included in the study. Cases having incomplete data and surgical patients admitted only for recovery purposes was excluded from the study.
The sample size for this study was determined using a single population proportion of P = 21%, from previous Bangladesh study  5% margin of error the sample size becomes 254 and after adding 10% contingency, the sample size will be 279. A total of 395 patients were admitted to the PICU from February 1 2018 to July 30 2019. Data was collected from 327 patients who fulfilled the inclusion criteria, whereas fourteen patients were excluded from the study due to incomplete baseline data.
Data collection procedure
Data was collected by treating physicians using standardized questionnaire after taking consent from caretakers. Clinical characterstics like, SBP, pupillary light reflex, SaO2 need of mechanical ventilator was assessed and documented within the first hour and entered into an electronic App to calculate pediatrics index mortality 2 (PIM2) score. The PIM2 was used in our research because it doesn’t need extensive laboratory investigation and it is not affected by subsequent interventions since it is scored within one hour of admission. Sociodemographic data and medical history were taken by interview. Diagnosis, laboratory indices, and courses in the hospital were filled by chart review at discharge. We used the WHO International Classification of Diseases 10th version for disease category and only the primary diagnosis was used for ICD-10 assignment in patients having multiple diagnoses. The collected data were double-checked by the data collector and the principal investigator. There were orientations and training about data collection and the objective of the study every three months and demonstration every Monday for treatining phsysicians and data collectors. The principal investigators surevised the overall process and check completeness of questionaires everyday.
Variable of the study and operational definitions
The main dependent variable was time to death (event), whereas sociodemographic characteristics (age, sex, relation with the caregiver, care giver’s educational status, occupation Hospital arrival and admission related factors (duration of illness before admission, time- day and month of admission, source of admission, staff level at admission) clinical characteristics and management-related factors (diagnosis, admission vital signs, comorbidity, nutritional status, vaccination status, interventions given in the ICU and before admission, PIM2 score, MODS, Complications) were the independent variables.
Event (death): is defined as a patient who died in the hospital during the course of treatment
Censored: discharged alive from the ICU
LOS: refers to the duration of stay in a number of days from the date of admission to the date of discharge
Short term outcome: the outcome of the patient until s/he leaves the hospital
Data processing and analysis
After the data were checked for its consistency and completeness, it was entered into EpiData version 3.1 exported to STATA version 14 for cleaning and analysis. Descriptive statistics like mean, median, proportions were carried out to to summarize baseline characteristics and pattern of admission. In addition, summary statistics like life table, log-rank test and Kaplan-meir curves computed was used to detremimne the incidence rate (IR) of death and to compare survival curves between the different categories of the explanatory variables.
Both bivariate and multivariate Cox proportional hazard models were used to identify the predictors. Variables with p-value < 0.2 in the bivariate analysis were entered into the multivariate proportional hazard model. Ninety-five percent confidence interval (95% CI) of hazard ratio was computed and variable having p-value < 0.05 in the multivariate Cox proportional hazards model was considered as significantly and independently associated with the dependent variable. Cox proportional hazard model fitness was checked using the Schoenfeld residuals test.
Ethical approval and consent to participate
Ethical clearance was obtained from the Institutional Ethical Review Board of College of Medicine and Health Sciences, University of Gondar (ref.no 20/12/2018). Informed verbal consent was obtained from the caretakers. The name or any other identifying information was not recorded on the questionnaire and all information is taken from the chart was kept strictly for confidential and in a safe place. The information retrieved was used only for the study purpose.