Assessment of vaccination timeliness and associated factors among children in Toke Kutaye district, central Ethiopia: A Mixed study.

INTRODUCTION: Age inappropriate vaccination of children increases the rate of mortality and morbidity. All studies conducted in some areas of Ethiopia were only quantitative in nature and focused on the main cities ignoring rural communities.
OBJECTIVE: The objective of this study is to assess vaccination timeliness and associated factors among children in Toke Kutaye district, central Ethiopia.
METHODS: A community-based cross-sectional study with quantitative and qualitative data collection methods was used, for which simple random sampling was used to select 602 mothers/caregivers who have vaccinated children aged 12 to 23 months in the district. The collected data were entered into Epi-data version 3.1 and exported to SPSS version 23 for analysis. Bivariate analysis with a P-value of < 0.25 was used to select candidate variables for multivariate logistic regression. Adjusted odds ratio (AOR) with 95% CI and p-value < 0.05 were used to declare a significant association. Qualitative data responses were classified and then organized by content with thematic analysis.
RESULTS: A total of 590 respondents responded to the interviews, making a response rate of 98%. In this study, 23.9% (95% CI: 20.4-27.7) of children aged 12-23 months had received all vaccines in the recommended time intervals. Urban residence (AOR: 3.15, 95% CI: 1.56-6.4), participation of pregnant women in conferences (AOR: 2.35, 95% CI: 1.2-4.57), institutional delivery (AOR: 2.5: 95% CI: 1.32-4.20), and sufficient knowledge of mothers (AOR: 3, 95% CI: 1.82-5.10) were significantly associated with the timeliness of childhood vaccination. Qualitative findings revealed that lack of knowledge and lack of information from mothers or caregivers, and inadequate communication with health workers hindered timely vaccination.
CONCLUSION: The overall timeliness of the child's vaccination was low in this study. Residence, participation in a conference, place of delivery, and knowledge of the mothers were predictors of vaccination timeliness. Hence, promoting institutional delivery and increasing pregnant mothers awreness on vaccination timeliness through conference participation is compulsory.

Introduction

Immunization timeliness is the time at which child get a vaccine and by subtracting the infant’s date of birth from the day of vaccination. Vaccinations were delivered on time if they were received within the World Health Organization (WHO) approved time frames and within first year of life [1]. Vaccine timeliness is critical in sub-Saharan African nations because vaccine-preventable diseases are important contributors to high child mortality [2]. The importance of timely infant immunization is to ensure that children have a good response, minimize individual vulnerability, and prevent disease outbreaks within communities [3]. Frequently, to assess the efficacy of an immunization system and population-level vulnerability, overall vaccination coverage or levels of vaccination for particular antigen by age group are used. However, simply measuring coverage does not provide information on whether vaccinations were administered on time or in line with the prescribed schedule [4]. Timely immunization is critical in the first year of life, since transplacental immunity decreases fast [5, 6].

Immunization coverage and age-appropriateness remain considerably lower in low-income nations than in middle- and high-income countries [7]. Glogally, 9 million children were died as a result of vaccine-preventable illness of which sub-Saharan Africa accounted for 4.4 million death in 2009 [8]. Vaccine doses administered before the recommended age or without respecting the dose interval can lead to suboptimal immune response [9, 10]. According to one study, infant vaccination doses were usually delayed, with 63.8 percent of Diphtheria Pertussis Tetanus (DTP) dose 1, 63.1 percent of Polio dose 1, and 68.5 percent of measles delivered more than one month after the recommended date in Ethiopia [11]. According to the Ethiopia Demographic and Health Survey (EDHS), data on vaccination coverage among children aged 12–23 months who received specific vaccines at any time prior to the survey revealed that only four out of ten children (43%) had received all basic vaccinations. The findings of the timeliness of child vaccination in EDHS 2014 and 2016, ranged from 18–22% [12, 13]. However, study finding from in Menz Lalo district, Amhara region, Ethiopia found that only 6.2% of the kids had received vaccinations at the right age [14]. According to a research done in Addis Abeba, Ethiopia reported that 55.94 percent of the children were vaccinations on time [15].

Most of the research in Ethiopia focused on Expanded Programs on Immunization (EPI) coverage [16-19]. However, high vaccination coverage rates for particular vaccines may not always reflect timely vaccination or population immunity. According to the annual Report of Toke Kutaye woreda Health Office, more than 85% of children received full immunization services, although the timeliness of vaccination status is unknown and not usually emphasized. This resulted in a missed opportunity to determine the prevalence of age-appropriate immunizations among children. Moreover, the previous study carried out in certain regions of Ethiopia were only quantitative in nature and focused on major cities. Even the previous quantitative studies found low vaccine timeliness that recommend the investigation of underlying factors. To close these gaps, this study tried to assess Vaccine timeliness and associated factors among children by applying mixed approach study including rural and urban residents.

Methods and materials

Study design, period, and setting

A community-based cross-sectional quantitative study was supplemented qualitative method. The study was carried out in Toke Kutaye District of West Shewa Zone, Central Ethiopia, from 1 May to 30 June 2020. The Toke Kutaye District is one of the 22 districts of the West Shewa Zone and located at 126 kilometers at west of Addis Ababa, Ethiopia’s capital city. The district is separated administratively into four urban and twenty-three rural kebeles (the smallest administrative unit in Ethiopia). According to the woreda Health Office report, the Toke Kutaye district has a total population of 128,259, of whom 99,776 (78%) are rural residents, 28,483 (22%) are urban dwellers and a total of 26,721 households in 2019/2020. In these 2019/2020 fiscal years, the total population of children (12–23 months) was expected to be 3,724 (2.9 percent) [20].

Source and study populations

All mothers or caregivers who had immunized infants aged 12 to 23 months who lived or resided in the Toke Kutaye district throughout the data collection period were source populations. All mothers/caregivers who had vaccinated children aged 12 to 23 months, lived in the specified kebeles at the time of data collection and included in the study were study populations. The study included mothers/caregivers with vaccinated children aged 12 to 23 months, who had lived in the study area for at least 6 months and were willing to participate.

Sample size determinations

For a quantitative study

The required sample size was calculated using a single population proportion formula by assuming a 95% confidence level, 5% margin of error. Where; Z = 1.96 with 95% confidence level, P = 39.1% (proportion of age-appropriate vaccine (timely) vaccine for pentavalent one from the study conducted in Menz Lalo district Northeast Ethiopia [14]. Taking into account the 10% non-response rate and the design effect 1.5, the final sample size was 602.

For qualitative

Purposive sampling was used to select participants for the qualitative study.

Ten Focus Group Discussions (FGD) (one in each kebele) which comprise 8–12 individuals in each FGD were conducted with mothers who vaccinated their child from whom quantitative data were not collected. Participants of similar backgrounds in residents of the study area for more than six months were included. The modulators facilitated the FGD sessions, while the tape recorder recorded the responses of the FGDs respondents until the end of FGD discussion. The leaders of the kebele suggested the names of individuals who could participate in FGD. For the in-depth key informant interview (KII), three health extension workers (HEW) from three health posts and two nurses from two Health centers were selected purposely. Study interviews were conducted using a semi-structured interview guide with question-based questions related to the vaccine time lines aspect. We obtained the sample frame for this investigation by using a family folder.

House hold family folder

The Family Folder is a pouch that is distributed to each home in the kebele. It provides information on the household that will assist the HEW in identifying the family or household’s health (preventive, promotional, and environmental health) service requirements and providing the service or counseling accordingly. The Family Folder’s front and back sides are used to record information on: Household characteristics, latrine, hand-washing, waste disposal & drinking water facilities, and child health including vaccination status of children. The health cards and integrated maternal and child care cards are saved in the Family Folder for documenting illness information, preventative and promotional services to individual members of the household. Every family will get a Family Folder as part of government strategy to guarantee that every family receives family-centered health care. Health Extension Workers (HEWs) assigned to that health post (kebele) make house-to-house visits at least once a quarter to update household information while carrying a family folder. Vital registration data such as birth, migration, and death are updated daily based on reports from women’s development armies and health extension workers on outreaches, however overall family folder data will be updated every quarter in accordance with government policy. Both immigration and emigration are reported by the Women’s Development Army. Then, during outreach or home-to-home visits, health extension workers may confirm migration and record people who have moved into a new home in their field note book. Then they offer fresh family folders to immigrants and note on the family folder where they have moved for emigrants.

Sampling procedure

The kebeles and the households were chosen using a multistage sampling approach. The district was divided into rural and urban Kebeles, and then 9 rural and 1 urban kebeles were drawn at random from a total of 4 urban and 23 rural kebeles in the district. A total of 13,11 children were estimated to be eligible in the selected kebeles. First, the list of all eligible children (13,11) aged 12 to 23 months was taken from all health posts family folders and vaccination records of selected kebeles’ health posts. Furthermore, to ensure that no eligible kid was left out of the sampling frame, the list of eligible children obtained from the health posts family folder was cross-checked with the vaccination records in the health posts. In this manner, a comprehensive list of all eligible children in chosen 10 kebeles was created, comprising information such as a child’s name, his/her parent’s full name, the household’s unique identification number, and the subkebele/got. Then proportional to size allocation was made to determine the required sample size from each kebele. Finally, a simple random sampling technique was used to select the required number of children from each kebele using the children listed as a sampling frame which was obtained from family folders. If eligible children’s mother/care taker were not present at the time of data collection, a re-visit was arranged for a minimum of three times during the time of house hold survey. Purposive sampling was used to select participants (those whose children were vaccinated on time and those whose children were not vaccinated on time, urban dweller, and rural dwellers were included) for FGD conducted with mothers or caregivers and women development army group leaders and for key informant interviews (Fig 1).

Fig 1

Schematic presentation of a sampling technique for the timeliness of routine childhood vaccination and associated factors among children who vaccinated in the last year in Toke Kutaye District, West Shewa, Ethiopia, 2020.

Where B/D = Birbirsa Dogoma, MND = Melka nega denebe, N/F = Nega File, D/G = Deda Gelan, T/M = Toke Meti, C/C = Chancobi, and M = maruf.

Variables

Dependent variables

Childhood vaccination timeliness status.

Independent variables

Socio-Demographic Characteristics of the Children/Children’s Mothers: [Age, sex, marital status, number of children, residence, educational level, distance of Health Facility, mode of transport, occupation, telephone/mobile, and wealth index].

Utilization of Maternal Health Services by Mothers: [Participation in pregnant women conference (Pregnant women conference is a conference which is conducted at each kebele once per month by mid-wives and pregnant women to teach women about maternal and child health including vaccination), antenatal care utilization, place of delivery, post-natal care utilization, and receiving of tetanus toxoid vaccines, and season of birth of child].

Awareness/knowledge of mother/caretaker about Vaccines and Vaccination: [Knowledge of mother/caretaker on EPI information].

Operational definitions and definition of terms

Vaccine timeliness: is the time at which child get a vaccine and by subtracting the infant’s date of birth from the day of vaccination. Vaccinations were delivered on time if they were received within the World Health Organization (WHO) approved time frames [4] and checked by immunization card.

Age-appropriate vaccination (timely): is measured if a child was vaccinated within one month after the minimum age to administer the dose as recommended by WHO.

Age-inappropriate vaccination (untimely): is measured if a child was vaccinated earlier and/or delayed than the recommended age.

Delayed vaccination

A vaccination is considered delayed if it is administered more than two weeks beyond the required age for BCG, polio, pentavalent, and PCV doses, or more than a month for measles.

Early vaccination

Any vaccination administered more than four days before the required age for each vaccine/dose was defined. Furthermore, for measles vaccination, we looked at doses administered more than two weeks before the recommended age (Table 1).

Table 1

Operational definition in relation to WHO & national vaccination schedule for respondents in Toke Kutaye District, West Shewa Zone, Oromia Region, Ethiopia, 2020.

Vaccine	WHO recommendation		Operational definition
	Minimum age	Minimum interval	Delayed	Early
BCG	0	4 weeks	> 4 weeks
OPV 1	6 weeks	4 weeks	>10 week	<42 day
OPV 2	10 weeks	4 weeks	>14 week	< 70 day
OPV 3	14 weeks	4 weeks	>18 week	< 98 day
Pentavalent1	6 weeks	4 weeks	>10 week	<42 day
Pentavalent2	10 weeks	4 weeks	>14week	< 70 day
Pentavalent3	14 weeks	4 weeks	>18 week	< 98 day
PCV1	6 weeks	4 weeks	>10 week	<42 day
PCV 2	10 weeks	4 weeks	>14week	< 70 day
PCV 3	14 weeks	4 weeks	>18 weeks	< 98 day
Rota 1	6 weeks	4 weeks	>14 week	< 42 day
Rota 2	10 weeks	4 weeks	>18 week	< 70 day
Measles	9 months	4 weeks	> 10 months	< 270 days

Good knowledge

Thirteen knowledge assessment item questions each containing (1 = yes and 0 = no) alternatives were used. From thirteen questions, women who answered seven or more questions correctly were considered as knowledgable whereas those who answered below seven were considered as not knowledgable.

Data collection tool and techniques

Data were collected with face-to-face interviews using a structured questionnaire adapted from the Ethiopian Demographic Health Survey [13]. Age-appropriate vaccination schedule questions were developed from the WHO recommended schedule [4] and previously conducted similar research [14], which contain three parts. The first part was sociodemographic characteristics; the second part was the utilization of maternal health services by mothers, and the third part was awareness of mothers and barriers to vaccination service utilization related factors. The questionnaire was prepared in English and translated to Afan Oromo language by local language speakers who had BSc/Masters of Art in Afan Oromo language and the questionnaire was translated back to the English language by another individual who was blinded to the original English version and fluent in English and Afan Oromo, and comparison was made to check for its consistency. Finally, the Afan Oromo version was used to collect the data.

For qualitative data, open-ended guide questions for the FDGs and key informant interviews were developed in English and converted to Afan Oromo and then checked for validity. The tape recorder was used in the discussion and every discussion was recorded on the topics. Ten Bsc nurses and five BSC midwifery health professionals who were fluent Afan Oromo speakers were recruited for data collection and supervision, respectively. The reliability of the questionnaires was checked with Cronbach’s alpha with a value of 0.882 for vaccine timelines.

Data quality control and management

The questionnaire was pre-tested on 5% (31women) of eligible women in Kolba Anchab kebele, which was not included in the study, and necessary modifications were made based on the nature of the identified gaps. Three days of training was provided to data collectors and supervisors. The investigators checked the completeness, precision, and consistency of all collected data every day. Data double entry was used to make comparisons of two data cells and determine if there was a difference.

Data processing and analysis

The collected data were entered into the computer using Epi-data version 3.1 exported to SPSS version 23 for analysis. Logistic regression was used to identify important predictors of the timeliness of child vaccination. All covariates significant at p-value < 0.25 [21] in bivariate analysis were considered for further multivariate analysis. The fitness of the model was tested by the Hosmer-Lemeshow goodness-of-fit test. Finally, the adjusted odds ratio (AOR) with 95% CI and a p-value < 0.05 were used to declare a significant association.

Qualitative data

Qualitative data responses were categorized and then organized by content with thematic analysis. Data captured using tape records and notes was translated word by word into the English language and summarized manually in the main thematic area. Through this process, a verbatim was used to illustrate responses on relevant issues. The information obtained was triangulated with the quantitative information.

Results

Sociodemographic characteristics of the respondents

Of 602 mothers/caregivers, 590 responded to the interviews, making a response rate of 98%. Of all respondents, 572(97%) were mothers and 18(3%) were caregivers. The age of the mothers or caregivers in this study ranged from 14 to 45 years with a mean of 29.4±5.91 years. The wealth index result showed that 24.9% of the respondents were in the first quintile (poorest) (Table 2). This finding is supported by FGD discussants, as one 35-year-old mother explained: “… health extension worker informs me about immunization to vaccinate my children because the health post is far from my house and I have no transportation cost, I was not vaccinated my child timely.”

Table 2

Sociodemographic characteristics of the respondents in Toke Kutaye Woreda, West Shewa Zone, Oromia Region, Ethiopia, 2020 (N = 590).

Variables	Frequency	Percent
Respondent
Mother	572	96.9
Caregiver	18	3.1
Age category of the mothers/caretakers
<20	42	7.1
20–30	326	56.9
31–40	213	36.1
≥40	18	3.1
Sex of child
Male	315	53.4
Female	275	46.6
Family size
< 5	507	85.9
≥ 5	83	14.1
Marital status of mother/care taker
Married	562	95.3
Unmarried	14	2.4
Divorced	5	0.8
Widowed	9	1.5
Residence
Urban	40	6.8
Rural	550	93.2
Mothers/caregivers educational status
Unable to read and wright	204	34.6
Able to read and write	175	29.7
Only primary education	152	25.8
Secondary education	49	80.3
Diploma and above	10	1.7
Mothers/caregivers occupation
Farmer	99	16.8
House wife	457	77.5
Daily laborer	12	2.0
Government employee	12	2.0
Othersa	11	1.9
Mode of transportation
On Foot	529	89.5
By Horse	59	10.0
By Car	2	0.3
Distance of vaccination site
Below 30 minutes	169	28.6
About30 minutes to one hour	316	53.6
Above one hour	105	17.8
Wealth index/quintile
Poorest	147	24.9
Poorer	127	21.5
Middle	117	19.8
Richer	105	17.8
Richest	94	15.9

a = student, private work, and non-government organization.

Utilization of health institution by mother/caregiver

Approximately 101 (17.1%) of the children were born from an unplanned pregnancy and 27 percent of the mothers did not attend the conference of pregnant women at all; However, 370(62.7%) of them had received at least three follow-ups of antenatal care. Concerning the place of delivery, 187(31.7%) had home delivery and 403 (67.3%) of the deliveries were in health facilities (Table 3).

Table 3

Maternal health care practices of respondents in Toke Kutaye Woreda, West Shewa Zone, Oromia Region, Ethiopia, 2020 (N = 590).

Variables	Frequency	Percent
Pregnancy status
Planned	489	82.9
Unplanned	101	17.1
Pregnant women’s conference participation
Not participated	162	27.5
≤ 2 Participation	346	58.6
≥ 3 Participation	82	13.9
ANC follow up
Yes	520	88.1
No	70	11.9
Number of ANC visit
≤ 2 Participation	150	25.4
≥ 3 Participation	370	62.7
Place of delivery
Home	187	31.7
Health facilities	403	68.3
PNC follow up
Yes	326	55.3
No	264	44.7
Number of PNC visit
one times	233	39.5
Two times	90	15.3
>2	3	0.5
TT status
No dose received	95	16.1
1 dose received	106	18.0
2 dose received	378	64.1
>2 doses received	11	1.9
Season of birth
Summer	222	37.6
Winter	123	20.8
Autumn	142	24.1
Spring	103	17.5

Awareness of vaccines and vaccine-preventable diseases

About one third of the mothers knew the time at which childhood vaccination started and 71.4% knew the age at which childhood vaccination ended correctly. Mothers or caregivers were asked to evaluate immunization services in their own opinion, given that in their residential area 62.2% of respondents mentioned that the delivery of immunization services is not too bad in their residential area, about (32.4%) thought it was good, and 3.6% stated that they do not have any idea about the services, however 11 mothers or caregivers (1.9%) complained about the service. This finding is supported by FGD discussants, as a 26 years old women who gave birth explained: “I go to the health post for the baby’s vaccination at six weeks because I do not know the time at which child start vaccine.” This finding is also supported by in-depth interview discussants: as one of the HEW discussant explained, “……I usually advise mothers on the correct time of immunization services, however, most mothers do not have better awareness about vaccination.“

More than three-forth, 77.5% and 64,6% knew about vaccine preventable diseases such as poliomilitis and tuberculosis respectively (Table 4).

Table 4

Awareness of mothers about vaccination utilization in Toke Kutaye District, West Shewa Zone Oromia, Ethiopia, 2020 (N = 590).

Variables	Frequency	Percent (%)
EPI information
Yes	589	99.8
No	1	0.2
Source of EPI information
Health profession	325	55.1
HEW	571	96.8
Radio	175	29.7
Friends	24	4.1
Neighbours	4	1.0
know the benefit of vaccines
Yes	579	98.1
No	11	1.9
Benefit of vaccine meshed (*)
To prevent the disease	470	79.7
For child health	303	51.4
For child groth	2	0.3
List of vaccines by respondents (*)
Tuberculosis	381	64.6
Poliomyelitis	457	77.5
Diphtheria	267	45.3
Pertussis	192	32.5
Diharrial	251	42.5
Measles	430	72.9
Tetanus	194	32.9
know age at which child start vaccine
Yes	444	75.3
No	146	24.7
know age at which child ended vaccine
Yes	421	71.4
No	169	28.6
Immunization services status at health facility
Good	191	32.4
Not too bad	367	62.2
Bad	11	1.9
No idea	21	3.6
Knowledge of mothers
Sufficient Knowledge	381	64.6
Insufficient Knowledge	209	35.4

*More than one answer; percentages calculated among the total (n = 590).

Timeliness (early, age appropriate, and delayed) of child vaccination

Only 35.3% (95% CI: 32.7 to 40.8), 72.4% (95% CI: 68.5 to 75.9), 70% (95% CI: 66.1 to 73.6), 68% (95% CI: 64.1 to 71.7), and 44% (95% CI: 3936 to 48.4) were vaccinated at appropriate age for BCG, Pentavalent 1–3 and measles vaccine doses respectively. The proportion of antigens received earlier than the recommended national schedule was 14.9% (95% CI: 12.0 to 18.0), 11.7% (95% CI: 8.8 to 13.9), 11% (95% CI: 7.6 to 12.4) and 29.9% (95% CI: 29.4 to 48.4) for Pentavalent 1–3 and measles vaccine doses respectively. The magnitudes of delayed BCG, Pentavalent 1–3, and measles vaccination were 64.7% (95% CI: 59.2 to 67.3), 12.7% (95% CI: 10.0 to 15.6), 18.3% (95% CI: 15.9 to 22.5), 21% (95% CI: 19.0 to 25.4) and 26% (95% CI: 18.9 to 26.1) respectively. Timely vaccination was highest for Pentavalent one (72.4%) and lowest for BCG (35.3%) whereas untimely vaccination was highest for BCG (64.7%) and Measles (55.9%) compared to other vaccines in the EPI schedule. Overall, 23.9% (95%CI: 20.4–27.7) of children aged 12–23 months were received their vaccinations at the recommended time interval (Table 5).

Table 5

Timeliness of vaccination among children aged 12–23 months in Toke Kutaye Woreda, West Shoa Zone, Oromia Region, Ethiopia, 2020.

Vaccination Schedule	Vaccine	Age appropriate time n (%)	Early n (%)	Delayed n (%)
Birth	BCG	208(35.3)	0 (0)	382 (64.7
6 weeks	OPV 1	425(72.0)	87(14.8)	78 (13.2)
10 weeks	OPV 2	409(69.3)	63(10.7)	118 (20.0)
14 weeks	OPV 3	397(67.3)	63(10.7)	130 (22.0)
6 weeks	PENTA 1	427(72.4)	88 (14.9)	75 (12.7)
10 weeks	PENTA 2	413(70.0)	69 (11.7)	108 (18.3)
14 weeks	PENTA 3	401(68.0)	65 (11.0)	124 (21.0)
6 weeks	PCV 1	426(72.2)	86 (14.6)	78 (13.2)
10 weeks	PCV 2	414(70.1)	68 (11.6)	108 (18.3)
14 weeks	PCV 3	399(67.6)	65 (11)	126 (21.4)
6 weeks	Rota 1	425(72.1)	87 (14.8)	77 (13.1)
10 weeks	Rota 2	407(69.0)	73 (12.4)	110 (18.6)
9 months	Measles	260(44.1)	176 (29.9)	153 (26.0)
Overall timeliness		141(23.9)	63 (10.7)	386 (65.4)

Reasons for age-inappropriate (not timely) immunizations

According to the survey findings, the majority (28.3%) of the respondents reported that the reasons for not following the appropriate time to receive vaccinations in a timely manner were lack of confirmed information. Among the respondents, one hundred forty-nine (25.3%) feared the adverse effect after immunization to follow the correct time to vaccinate their children (Fig 2).

Fig 2

Reason given by mothers or caregivers for not vaccinating their children on time in Toke Kutaye District, West Shewa Zone, 2020.

This finding is supported by evidence from FGD discussants. The most frequently mentioned reasons as a barrier to age-appropriate vaccinations by the discussants were lack of information, the belief that it is not important unless the child feels sick, and the idea of attending the baby’s immunization as important only for treatment. As one of the 29 years old discussants explained, “… …I gave birth at home… I did not know why I visit the hospital or the health center after delivery.” (This is supported by others two FGD participants). Another 21 years old mother explained:, “I do not consider returning back to the health facility is necessary after delivery and no one told me about Immunization service at the health facility, and when I have to return back to the health facility…” (This is supported by others two FGD participants). The study participants perceived that attending EPI services was not important unless their children were sick after delivery. A 36 years old woman FGD discussant explained, “… thanks to God, since I did not get sick and my child was fine, I did not go to the health facility for immunizations.”

Factors associated with childhood immunization timeliness

The age of mothers/caregivers, residence, educational status of the mother, participation in the pregnant women’s conference, history of prenatal care follow-up (ANC), history of postnatal care follow-up (PNC), status of the Tetanus Toxoid (TT) vaccine, place of delivery, knowledge of the start time of vaccination, know the age at which the child reaches the vaccine, knowledge of the start time of vaccination and the end time, and knowledge of the mothers were the variables that showed a significant association with the timeliness of child vaccination in bivariate analysis.

The result of multivariate logistic regression analysis showed that children who lived in urban areas had 3.15 times higher odds of receiving vaccines at the recommended age compared to rural children (AOR: 3.15, 95% CI: 1.56–6.4). Children whose mothers participated in a pregnant women’s conference had 2.35 times higher odds of receiving childhood vaccination in time compared to the odds of children whose mothers did not participate in the conference (AOR:2.35, 95% CI: 1.2–4.57). Mothers/caregivers who gave birth in Heath facilities had 2.5 times higher odds of vaccinating their children in time compared to those who gave birth at home (AOR: 2.5: 95% CI: 1.32–4.20). Mothers / caregivers who had sufficient knowledge of child vaccination had three times higher odds of taking their child’s vaccination within the recommended time interval compared to the odds of their counterparts (AOR: 3, 95% CI: 1.82–5.10) (Table 6). This was supported by FGD as a 28 years old mother said that “When mother took her child to the health facility, (for the health professionals) it is a good opportunity to give advice on the initiation time of the vaccine, when it should get sated age appropriate time and importance of timely completion of immunization for child so having follow-up for service utilization of the health institution is necessary for all mothers.” (This idea was supported by another 36 years woman).

Table 6

Factors associated with vaccination timeliness among children aged 12–23 months in Toke Kutaye District, West Shewa Zone, Oromia, Ethiopia, 2020 (N = 590).

Variables	Timeliness of vaccinations		COR 95% CI	AOR 95% CI
	Age appropriate	Age inappropriate
Residence
Urban	22(3.7%)	18(3.0%)	4.40(2.3–8.50)*	3.15(1.566.4)**
Rural	119(20.2%)	430(73.0)	1	1
Pregnant women’s conference participation
Yes	128(21.7%)	300(50.9%)	4.48(2.5–8.0)*	2.35(1.2–4.57)**
No	13(2.2%)	148(25.1%)	1	1
Place of delivery
Home	17(2.9%)	170(28.9%)	1	1
Health facilities	124(21.1%)	278(47.2%)	4.50(2.6–7.7)*	2.50(1.32–4.2)**
Knowledge of Mothers
Sufficient Knowledge	119(20.2%)	262(44.5%)	3.80(2.35–6.3)*	3.0(1.82–5.10)**
Insufficient Knowledge	22(3.7%)	186(31.6%)	1	1

COR = Crude Odds Ratio

* = P<0.25; AOR = Adjusted Odds Ratio

** = Significant level at p-value <0.05, 1 = reference

Discussion

According to the findings of this study, overall childhood vaccination timeliness was 23.9 percent among children aged 12 to 23 months. This means that the remaining 76.1 percent of children remained vulnerable to vaccine-preventable diseases, as failing to be vaccinated on time would lengthen children’s susceptibility period by reducing herd immunity. This figure is higher than the 6.2 percent discovered in the Menz Lalo region of northeast Ethiopia [14], and the 6.1 percent discovered in Kenya [11]. This mismatch might be related to differences in socioeconomic factors, study duration, design, site, and health-care access. This figure is comparable to the Ethiopia DHS 2016 finding of 22% [13]. This consistency might be attributed to similar study settings and the usage of EPI services throughout the country. This study result is low compared to Tanzania’s 41 percent [22], Nigeria’s 48 percent [23], Kampala, Uganda’s 45.6 percent [24], and China’s 44 percent [25]. This discrepancy might be explained by differences in study participant characteristics, sociodemographic factors, access to health care, and less or no attention to vaccination timeliness, as well as the lack of a timeliness indicator in Ethiopia’s immunization program and including only vaccinated children in the current study. This study discovered a gap in the timeliness of children’s immunization. Timely vaccinations of each antigen was low when compared to total: BCG (36.6 percent), OPV1 (72 percent), OPV2 (69.3 percent), OPV3 (67.3 percent), Pentavalent1 (72.4 percent), Pentavalent2 (70 percent), Pentavalent 3 (68 percent), PCV1 (72.1 percent), PCV2 (70 percent), PCV3 (67.6 percent), Rota1 (72 percent), Rota 2 (69.2 percent) and Measles (44 percent) were vaccinated at a suitable age. The finding of this study is higher compared to the findings in Menz Lalo district, Northeast Ethiopia for Penta1 (39.1%), Penta 2 (36.3%), Penta 3 (30.3%), and Measles (26.4%) (14). This study is also high compared to the study in Nigeria Penta 1 (61.5%), Penta2 (51.7%) and Penta 3 (46.7%) [23] and in China BCG (30%) penta1 (28%) and Measles (12%) [25]. This discrepancy might be due to differences in study participant characteristics, study period, design, and health service accessibility. The finding of this study is lower compared to studies conducted in Senegal, BCG (88.25%), Penta1 (74%), Penta 2 (75.64%) [26], Gambia, BCG (94.3%), Penta1 (78%), OPV1 (74.6%), and Measles (80%) [27]. This could be because the national vaccination policy, which has been aimed at achieving more than 95% vaccination coverage in 2030, had simply focused on up-to-date coverage, irrespective of the time of vaccination [3]. In general, a higher percentage of mothers vaccinated their children 96% to 100% for all antigens in the district, it is only 23.9% of mothers that met the required number of vaccinated their children as recommended by WHO. This clearly indicates that the recommended utilization of the EPI service in the district is still poor.

Giving Birth at the health institution was positively associated with vaccine timelines in this study. This result was supported by studies done in the Menz Lalo area of northeast Ethiopia [14], Dessie town [17], and Gambia [27], that indicated that giving birth in a health facility had a direct and substantial connection with vaccine timeliness. This is because mothers who gave birth at a health facility had a better chance of being informed and receiving health education about the benefits of EPI services. This enhances child health care in general, including the behavior of moms seeking childhood vaccinations. In the current study, being an urban resident was an independent predictor of the child’s vaccination timeliness. This finding is consistent with one of Ethiopian findings [14]. This might be because urban resident moms have better information and realize the significance of vaccination, as well as variations in the availability, accessibility, and functionality of health services in urban areas than rural areas. In the current study, children of mothers / caregivers who attended pregnant women’s conferences were more likely to vaccinate their children at the proper age than those who did not attend the conferences. This result is consistent with findings from earlier research in the Menz Lalo area of Northeast Ethiopia [14]. This is due to the moms who attended pregnant women conferences may have received more information, understanding about timely immunization of their children, greater awareness about vaccine-preventable illnesses, and recognized the value of vaccines. Children of mothers/caregivers who had sufficient knowledge about childhood vaccination were more likely to be immunized at the recommended time interval than children of mothers/caregivers who had insufficient knowledge of vaccines and VPDs. This finding is consistent with research done in the Menz Lalo region of North East Ethiopia [14] and in Dessie Town [17]. The possible reason is because moms or caregivers who understand the childhood vaccination schedule, vaccine-preventable illnesses, and reasons for vaccination are more likely to bring their kids to the immunization location at the appropriate time. This finding is supported by the evidence from FGD participant. The most commonly stated barriers to age-appropriate vaccination were a lack of knowledge, the belief that it is not necessary unless the mother is unwell, and viewing attendance to EPI services as vital primarily for the care of the infant. As one participant put it, "I didn’t know when, how many times, or why I go to the health center for immunization.”

Strength of the study

Being a community-based study and utilizing qualitative research to examine areas that the quantitative survey did not address.

Limitation of the study

The study’s participants were chosen based on the presence of vaccination cards, which may have resulted in selection bias because infants whose parents did not keep their immunization cards were excluded. Using family folder to get study population which may has poor quality sice it is not electronic based. Since this study included only vaccinated children, the proportion of untimely vaccination was slightly larger and unable to evaluate vaccine coverage. Another limitation of this study is unable to include children more than 23 months old who could receive vaccination in the future time.

Conclusion

This study conclude that the overall vaccination timeliness of children was poor. Residence, attending the conference of pregnant women, site of delivery, and knowledge of mothers were factors associated with the timeliness of vaccination. As a result, health leaders and policymakers should pay attention to and incorporate vaccination timeliness into the EPI program. Furthermore, promoting institutional delivery and increasing pregnant mothers awreness on vaccination timeliness through conference participation is compulsory to improve childhood vaccination timeliness.

(RAR)

Click here for additional data file.

9 Sep 2021

PLOS ONE

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Additional Editor Comments (if provided):

This is very important work on immunization and can be good contribution if the authors can address the comments provided by both the reviewers. In addition to the reviewers' suggestions, please elaborate the qualitative research piece with more clarity: how many FGDs were conducted? How it was done? How the coding was done? What software was used for analysis? Please also re-work on the measure section to clearly define all variables included in the analysis irrespective of whether they are outcomes or predictors. Finally, I suggest you take the service of an English language editor as there are several misspelling, and grammatically errors in the sentences. I also advise authors to examine the PLOS One author guidelines and structure your paper accordingly.

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- https://www.researchsquare.com/article/rs-56134/v1

- https://panafrican-med-journal.com/content/series/27/3/8/full/

- https://www.tandfonline.com/doi/full/10.1080/21645515.2018.1480242

- http://tropmedhealth.biomedcentral.com/articles/10.1186/s41182-016-0013-x

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Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: This paper has to do with a very important subject topic in public health related to timeliness of routine vaccination and associated factors. Though the WHO fixes the minimum age required to be eligible for various vaccines in the Expanded Program on Immunization (EPI), it is important to note that the minimum age is based on the evidence or believe that vaccinating the child before the said age might to induce the desired immune response but does not in away mean that the children are not at risk of the various vaccine preventable diseases. It is therefore a well justified topic to merit consideration viewed it potential public health significance. The authors applied a mixed methods of study i.e. community based cross sectional study design coupled with FGD and informants’ interview. The methodologic approach is quite sound given that it is a complex topic and requires critical examination from various dimensions.

However, well will like to make some comments that if addressed might improve the quality of the paper.

Abstract

1. Methods part of the abstract fails to describe briefing the sampling technique for the quantitative component of the study. We suggest this should be included.

2. The results section should give a brief description of the sample composition. For instance, how many children were included in total, what proportion of children receive their scheduled vaccine etc. In as far as the timeliness is important, herd immunity is created in the community by high vaccination coverage. Late vaccination poses an individual risk while low coverage poses but individual and community risk.

3. The first sentence says “In this study, 23.9% (95%CI: 20.4 -27.7) of children aged 12-23 months had received all vaccines at the recommended time intervals”. It is importance to clearly define “recommended time interval” in this context. The EPI objective is that a child completes all his/her vaccines before 12 months (0-11months) but it is not clear if this is what the sentence means or something else. Please clarify.

Introduction

1. Statement like “Out of 9 million deaths of children globally as a result of vaccine-preventabledisease, a bigger proportion occurred in sub-Saharan Africa which was 4.4 million” requires the author to specify the year. It is important for the reader to know when the situation was reported.

2. The sentence “Vaccine doses administered too close together or too early can lead to suboptimal immune response” needs to be rephrase. In fact, for the vaccines in the EPI, we do not have counter indication of administering them together. It only poses a problem of doses of the same vaccine are administered without respective the recommended 4 weeks interval. On the other hand, what is meant by “too early”? I suggest the sentence should be “vaccine doses administered before the recommended age or without respecting the dose-interval can lead to suboptimal immune response”

Methods

1. In general, this study relied on the records of households at the level of the health facility. This is a bit risky as we do not have a clou on how the households’ folders are updated and managed. Are the household folders electronic or paper register? How is the update done? When updating the folders, how is population movement managed? Has any study been done to assess the quality of data in these folders? It will be good to open a subheading under materials and methods to write about the households’ folders and provide the answers to all up mentioned question. The population is very dynamic, and therefore some children in the family folders might have left to a different woreda where they can still complete their immunization and on time while others not born in the woreda, who had started or even completed their vaccination schedule in a different woreda may arrive at various ages. These “new arrival” may or may not have their vaccination card. How were such cases treated in the family folders at health facility? The understanding of these question is paramount to a better understanding of the designs and its potential limitations in this study.

2. One issue with external validity of this study is that the investigators seem to have included only children vaccinated. In fact, children who did not receive any vaccine at all forms part of those who did not receive their vaccines on time. That is why it was important for the team not to assess timeliness without assessing coverage. Please kindly clarify the study population.

3. For the qualitative section of this study, the investigators said that only family who had resided in the kebeles for at least 6 months were included in the study. Please justify this decision.

4. Furthermore, you said the kebeles header suggested informant that could give reliable information. What do you mean by “reliable information”? I would have preferred a FGD and interview of various families purposely selecting those whose children where vaccinated on time and those whose children were not vaccinated on time urban dweller and rural dwellers. In purposive sampling, there is still some logical selection of people. It will be good to describe the people included finally in the results section so that it will guide the interpretation of the results.

5. What is the meaning of “If the eligible children were not present during the visit, a revisit was arranged at a minimum of three times during the time of the survey”? where was the data sources, health facility vaccination register or the households? This need to be clarified in the paper. It is unclear where the researchers had the household folders and health facility vaccination register but choose to collect data with interview at households on children immunization. Did they think that the registers may not be up to date?

Results

1. The results section should bring out the vaccination coverage before checking the timeliness

Reviewer #2: The authors provide a manuscript that explores factors associated with vaccination timeliness among children in Ethiopia. Given the (relatively) recent push to improve vaccination timeliness alongside vaccination coverage, the topic of this manuscript is timely. To improve the impact of the paper, I would encourage the authors to seek out a manuscript editing service, as many portions of the paper were difficult to understand (in terms of grammar, punctuation, and word choice). More specific comments are below:

ABSTRACT

-There is a typo in the results section. You have written that "insufficient knowledge of mothers" was associated with vaccination timeliness, but in the body of the paper you say that more vaccination knowledge is associated with timeliness.

INTRODUCTION

-The authors should more specifically define what vaccination timeliness is in the introduction. Please also provide a more detailed explanation of the importance of vaccination timeliness (versus simple vaccination coverage) and why it is important to understand the factors associated with vaccination timeliness.

-It would be helpful for the audience (who may not be well versed in vaccination schedules) for you to briefly list out which vaccines are included in the Ethiopian EPI vs what the ‘basic’ vaccinations are before citing statistics about vaccination coverage.

-Please fully write out a what an acronym stands for before using the acronym for the first time. For example, in the introduction you use acronyms for each of the vaccine doses and for EPI but you do not define what the acronyms stand for. The list of acronyms at the end of the paper is helpful but is not a substitute for defining the acronyms in the paper.

METHODS

-2.1: Write out what FGD stands for before using the acronym.

-2.4: Include the total number of urban and rural kebeles in the district (i.e. 4 urban and 23 rural).

-2.4: What is the difference between the 3,742 eligible children and the 1,311 eligible children? Please clarify.

-2.5: For maternal knowledge - Why were women who scored greater than the mean number of questions considered to have good knowledge? A more robust measure of maternal knowledge would be to determine a set number of questions a woman must answer correctly to be considered knowledgeable, rather than simply correctly answering more questions than the average woman in the sample.

-2.7: Provide the number of women (not just the percentage) who completed the pre-test.

-2.8: Please include a list of all predictors included in bivariate analyses as well as their categories. Also, please describe (briefly) what a pregnant woman’s conference is for those who are not familiar with the Ethiopian context.

RESULTS

-3.3: Include results of awareness of vaccine-preventable disease.

-3.4: Include proportions of children with early and delayed vaccination. Also, report overall coverage of vaccines, to contrast differences in general coverage of a vaccine and timely uptake of a vaccine.

-3.5: You provide direct quotes and state that it is quoted material from multiple women – please report the quote from the woman who directly stated it and then mention the number of women who agreed with her comment.

-3.6: Define what TT is before using the abbreviation.

-3.6: The second paragraph starts with “After checking of confounding variables…” If you are examining predictors of timely vaccination (rather than examining a specific relationship between a particular exposure and timely vaccination) you would not have confounders, as there is no relationship to confound. If there were covariates you included in the model (whose relationship to timely vaccination is not being tested) then you should list out those covariates in the methods section.

DISCUSSION

-The authors should more fully discuss the implications of the results and potential reasons for the relationships between timely vaccination and associated factors beyond stating the findings are consistent with previous literature.

-Please expand upon both the strengths and the limitations of the analysis. Consider how aspects of the study design, sampling method, topic area, locale, methods, etc. are strengths/limitations of the study. Please expand upon your comment about how only including children with vaccination cards would influence your results. Additionally, you mentioned in the methods (2.2) that children had to be vaccinated to be eligible for the study. If unvaccinated children were not included in your study, the proportion of untimely vaccination is likely larger than you report (unvaccinated children can be thought of as children with long delays in their vaccination, as they have not yet received a vaccine by 12-23 months but could still receive it in the future). Please discuss this limitation.

REFERENCES

-Review references and ensure they have all relevant fields and are formatted correctly. For example, references 3 and 8 refer to the World Health Organization as “Organization WH.” Additionally some references (ex. #5) do not have journal titles included. Finally, reference 3 and 26 are duplicates.

TABLES AND FIGURES

-Overall, review the tables for consistency (i.e., use the same number of decimals for all percentages) and spelling/grammar.

-Figure 1: What are the numbers in parentheses under each of the kebeles and why do some of them have letters (ex. MND (117) and Maru f(105))? Clarify in a footnote.

-Figure 1: What are the numbers under “proportional allocation?” Clarify in a footnote.

-Figure 2: I would recommend converting Figure 2 into a table that also includes general coverage of each vaccine dose among children 12-23 months. This would allow you to explicitly compare vaccination coverage vs timeliness. Plus, the figure is difficult to read in black and white (the age appropriate and early colors look like the same color) and the numbers on the figure overlap, making them difficult to read.

-Figure 3: Label the x-axis (percent) rather than titling the figure “%”

**********

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Reviewer #1: No

Reviewer #2: No

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8 Nov 2021

PONE-D-20-40561

Title: Assessment of vaccination timeliness and associated factors among Children in Toke Kutaye District, Central Ethiopia: A mixed study

To: Editorial Office of PLO ONE

Dear Sir or Madam.

As it is to be recalled, I have sent a paper entitled “Assessment of vaccination timeliness and associated factors among Children in Toke Kutaye District, Central Ethiopia: A mixed study” to be published on your journal. First of all, we would like to thank the reviewers and editorials for their valuable and constructive comments for our manuscript. Thus, as per the reviewers and editorials comments we have revised and modified the document and also we tried to address each comment one by one. We hope the revised manuscript addressed the reviewer’s concerns and has resulted in a paper that is clearer, and more persuasive. We also want to confirm you that this manuscript is not submitted elsewhere and had only been submitted to the current Journal.

With regards

Berhanu Senbeta Deriba (Lecturer, Researcher, MPH)

Corresponding author

Dear reviewers

We thank you for reviewing and providing us with important and valid comments that helped us to enrich our manuscript. Really we would like to appreciate and thank you for your valuable, constructive comments too. Based on your suggestions, we have incorporated the comments into the manuscript, and we have also provided a response to each comment as follows.

Additional Editor Comments (if provided):

This is very important work on immunization and can be good contribution if the authors can address the comments provided by both the reviewers. In addition to the reviewers' suggestions, please elaborate the qualitative research piece with more clarity: how many FGDs were conducted?

Author Response: Ten FGDs were conducted.

How it was done?

Author Response: Participants of similar backgrounds in residents of the study area for more than six months were included. The modulators facilitated, the FGDs sessions while the tape recorder recorded the responses of the FGDs respondents until the end of FGD discussion. The kebele leaders suggested the names of individuals who could participate in FGD. The study interviews were held using a semi structured interview guide with probing questions linked to the vaccine time lines aspect.

How the coding was done?

Author Response: The transcripts were examined by the research team prior to coding to identify significant themes and build a code book. All members of the study team coded the transcripts. To increase inter-coder reliability, the coders utilized the code book separately, and coding discrepancies were resolved through conversation. Following that, a final edition of the code book was created, as well as categories and topics. For each topic and category, the coded transcripts were further examined and summarized in narratives.

What software was used for analysis?

Author Response: It was analyzed manually and no software was used for analysis of qualitative data.

Please also re-work on the measure section to clearly define all variables included in the analysis irrespective of whether they are outcomes or predictors. Finally, I suggest you take the service of an English language editor as there are several misspelling, and grammatically errors in the sentences. I also advise authors to examine the PLOS One author guidelines and structure your paper accordingly.

Author Response: Thank you; we have corrected it.

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Author Response: Thank you we have corrected it.

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Author Response: Thank you for your constructive comment; we have accepted the comments and corrected it accordingly.

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We will update your Data Availability statement on your behalf to reflect the information you provide.

Author Response: Thank you for your constructive comment; we have accepted the comments and corrected it accordingly.

7. Please amend your list of authors on the manuscript to ensure that each author is linked to an affiliation. Authors’ affiliations should reflect the institution where the work was done (if authors moved subsequently, you can also list the new affiliation stating “current affiliation:.” as necessary).

Author Response: No author was moved from his former organization. Therefore, keep the affiliation of authors as it was stated in the manuscript before.

8. We noticed you have some minor occurrence of overlapping text with the following previous publication(s), which needs to be addressed:

- https://www.researchsquare.com/article/rs-56134/v1

- https://panafrican-med-journal.com/content/series/27/3/8/full/

- https://www.tandfonline.com/doi/full/10.1080/21645515.2018.1480242

- http://tropmedhealth.biomedcentral.com/articles/10.1186/s41182-016-0013-x

The text that needs to be addressed involves the Introduction and parts of the Discussion section.

In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the methods section. Further consideration is dependent on these concerns being addressed.

[Note: HTML markup is below. Please do not edit.]

Author Response: Thank you for your constructive comment; we have accepted the comments and corrected it accordingly.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: Yes

Author Response: Thank you for your constructive comment; we have accepted the comments and corrected it accordingly.

4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: No

Author Response: We would like to appreciate your valuable comments. As a result, we have accepted the comments and corrected it accordingly.

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This paper has to do with a very important subject topic in public health related to timeliness of routine vaccination and associated factors. Though the WHO fixes the minimum age required to be eligible for various vaccines in the Expanded Program on Immunization (EPI), it is important to note that the minimum age is based on the evidence or believe that vaccinating the child before the said age might to induce the desired immune response but does not in away mean that the children are not at risk of the various vaccine preventable diseases. It is therefore a well justified topic to merit consideration viewed it potential public health significance. The authors applied a mixed methods of study i.e. community based cross sectional study design coupled with FGD and informants’ interview. The methodologic approach is quite sound given that it is a complex topic and requires critical examination from various dimensions.

However, well will like to make some comments that if addressed might improve the quality of the paper.

Abstract

1. Methods part of the abstract fails to describe briefing the sampling technique for the quantitative component of the study. We suggest this should be included.

Authors Response: Thank you for your nice and constructive comments; we have accepted the comment and corrected it accordingly.

2. The results section should give a brief description of the sample composition. For instance, how many children were included in total, what proportion of children receive their scheduled vaccine etc. In as far as the timeliness is important, herd immunity is created in the community by high vaccination coverage. Late vaccination poses an individual risk while low coverage poses but individual and community risk.

Authors Response: We thank you for your valuable comment. We have accepted the comment and corrected it.

3. The first sentence says “In this study, 23.9% (95%CI: 20.4 -27.7) of children aged 12-23 months had received all vaccines at the recommended time intervals”. It is importance to clearly define “recommended time interval” in this context. The EPI objective is that a child completes all his/her vaccines before 12 months (0-11months) but it is not clear if this is what the sentence means or something else. Please clarify.

Authors Response: It means age appropriate vaccination. Age-appropriate vaccination (timely): is measured if a child was vaccinated within one month after the minimum age to administer the dose as recommended by WHO.

Introduction

1. Statement like “Out of 9 million deaths of children globally as a result of vaccine-preventable disease, a bigger proportion occurred in sub-Saharan Africa which was 4.4 million” requires the author to specify the year. It is important for the reader to know when the situation was reported.

Authors Response: Thank you we have corrected it accordingly.

2. The sentence “Vaccine doses administered too close together or too early can lead to suboptimal immune response” needs to be rephrase. In fact, for the vaccines in the EPI, we do not have counter indication of administering them together. It only poses a problem of doses of the same vaccine are administered without respective the recommended 4 weeks’ interval. On the other hand, what is meant by “too early”?

Authors Response: Early vaccination: Any vaccination administered more than four days before the required age for each vaccine/dose was defined. Furthermore, for the measles vaccination, we looked at doses administered more than two weeks before the recommended age.

I suggest the sentence should be “vaccine doses administered before the recommended age or without respecting the dose-interval can lead to suboptimal immune response”

Authors Response: It is a nice observation so that we have accepted the comments and corrected it accordingly.

Methods

1. In general, this study relied on the records of households at the level of the health facility. This is a bit risky as we do not have a clue on how the households’ folders are updated and managed. Are the household folders electronic or paper register?

Authors Response: Paper register, but updated regularly.

How is the update done?

Authors Response: Vital registration like birth, migration and death are updated every day by the report of women development army and health extension workers out reach works, but overall family folder data will be updated every quarter as the government policy.

When updating the folders, how is population movement managed?

Authors Response: As mentioned above, one way women development army report both immigration and emigration. Another way during out rich or home to home visit health extension workers can see migration or those who changed house register on their field note book. Then they give new family folder for immigrants and mention on family folder where they have moved for emigrants on their family folder.

Has any study been done to assess the quality of data in these folders?

Authors Response: Yes

It will be good to open a subheading under materials and methods to write about the households’ folders and provide the answers to all up mentioned question. The population is very dynamic, and therefore some children in the family folders might have left to a different woreda where they can still complete their immunization and on time while others not born in the woreda, who had started or even completed their vaccination schedule in a different woreda may arrive at various ages. These “new arrival” may or may not have their vaccination card. How were such cases treated in the family folders at health facility?

Authors Response: We have corrected it accordingly.

The understanding of these question is paramount to a better understanding of the designs and its potential limitations in this study.

Authors Response: We have include this issue in the limitation of the study.

2. One issue with external validity of this study is that the investigators seem to have included only children vaccinated. In fact, children who did not receive any vaccine at all forms part of those who did not receive their vaccines on time. That is why it was important for the team not to assess timeliness without assessing coverage. Please kindly clarify the study population.

Authors Response: All mothers and caregivers who had immunized infants aged 12 to 23 months who lived or resided in the Toke Kutaye district throughout the data collection period were considered source populations. Mothers and caregivers who had no vaccinated children were not source population for this study.

3. For the qualitative section of this study, the investigators said that only family who had resided in the kebeles for at least 6 months were included in the study. Please justify this decision.

Authors Response: This is to consider permanent residents of the district and not to include those who came from another area because they cannot represent the district in which the study was carried out. Moreover, those who did not live in the district for less than six months do not have family folder from which the evidence of the family was obtained.

4. Furthermore, you said the kebeles header suggested informant that could give reliable information. What do you mean by “reliable information”?

Authors Response: We have corrected it because it created certain sort of confusion. What we mean by reliable information was that those who explain themselves and about EPI well for qualitative study.

I would have preferred a FGD and interview of various families purposely selecting those whose children were vaccinated on time and those whose children were not vaccinated on time urban dweller and rural dwellers. In purposive sampling, there is still some logical selection of people. It will be good to describe the people included finally in the results section so that it will guide the interpretation of the results.

Authors Response: Thank for your valuable comments’ we have accepted the comments and corrected it accordingly.

5. What is the meaning of “If the eligible children were not present during the visit, a revisit was arranged at a minimum of three times during the time of the survey”? where was the data sources, health facility vaccination register or the households? This need to be clarified in the paper.

Authors Response: We used family folders available at health posts for obtaining lists of vaccinated children (sampling frame). The data were collected at community level at the households. Any time the child start vaccine the mother or care taker will be given immunization card which will be filled immunization status at every immunization visit.

It is unclear where the researchers had the household folders and health facility vaccination register but choose to collect data with interview at households on children immunization. Did they think that the registers may not be up to date?

Authors Response: The registration and family folder only has the evidence of time when child took vaccine, but they do not have full information about factors associated with vaccine timelines and others relevant data for the study.

Results

1. The results section should bring out the vaccination coverage before checking the timeliness

Authors Response: We did not collected data from unvaccinated children and it is not in lined with our study objectives.

Reviewer #2: The authors provide a manuscript that explores factors associated with vaccination timeliness among children in Ethiopia. Given the (relatively) recent push to improve vaccination timeliness alongside vaccination coverage, the topic of this manuscript is timely. To improve the impact of the paper, I would encourage the authors to seek out a manuscript editing service, as many portions of the paper were difficult to understand (in terms of grammar, punctuation, and word choice). More specific comments are below:

Authors Response: Thank you for your nice observation; we have corrected it accordingly.

ABSTRACT

-There is a typo in the results section. You have written that "insufficient knowledge of mothers" was associated with vaccination timeliness, but in the body of the paper you say that more vaccination knowledge is associated with timeliness.

Authors Response: Thank you for your nice observation; we have corrected it accordingly.

INTRODUCTION

-The authors should more specifically define what vaccination timeliness is in the introduction. Please also provide a more detailed explanation of the importance of vaccination timeliness (versus simple vaccination coverage) and why it is important to understand the factors associated with vaccination timeliness.

Authors Response: We thank you for your nice observation. We have accepted the comments and corrected it in the revised manuscript

-It would be helpful for the audience (who may not be well versed in vaccination schedules) for you to briefly list out which vaccines are included in the Ethiopian EPI vs what the ‘basic’ vaccinations are before citing statistics about vaccination coverage.

Authors Response: Thank you for your constructive comment. We have mentioned this issue under operational definition of vaccination timeliness. Would you see table 1 please?

-Please fully write out a what an acronym stands for before using the acronym for the first time. For example, in the introduction you use acronyms for each of the vaccine doses and for EPI but you do not define what the acronyms stand for. The list of acronyms at the end of the paper is helpful but is not a substitute for defining the acronyms in the paper.

Authors Response: Thank you for your nice observation; we have corrected it accordingly.

METHODS

-2.1: Write out what FGD stands for before using the acronym.

Authors Response: Thank you for your nice observation; we have corrected it accordingly.

-2.4: Include the total number of urban and rural kebeles in the district (i.e. 4 urban and 23 rural).

Authors Response: Thank you, we have corrected it accordingly.

-2.4: What is the difference between the 3,742 eligible children and the 1,311 eligible children? Please clarify.

Authors Response: Thank you, we have corrected it accordingly.

It was edition error: actually 3,742 was the total number of 12-23 months old children in the district ( 27 kebeles) and 1,311 was 12-23 months old children in the selected kebeles (10 kebeles).

-2.5: For maternal knowledge - Why were women who scored greater than the mean number of questions considered to have good knowledge? A more robust measure of maternal knowledge would be to determine a set number of questions a woman must answer correctly to be considered knowledgeable, rather than simply correctly answering more questions than the average woman in the sample.

Authors Response: Thank you for your valuable comment, we have corrected it accordingly.

-2.7: Provide the number of women (not just the percentage) who completed the pre-test.

Authors Response: Thank you; We have corrected it accordingly.

-2.8: Please include a list of all predictors included in bivariate analyses as well as their categories.

Authors Response: Thank you; We have corrected it accordingly.

Also, please describe (briefly) what a pregnant woman’s conference is for those who are not familiar with the Ethiopian context.

Authors Response: Pregnant women conference is a conference which is conducted at each kebele once per month by mid-wives and pregnant women to teach women about maternal and child health including vaccination.

RESULTS

-3.3: Include results of awareness of vaccine-preventable disease.

Authors Response: Thank you; we have corrected it accordingly.

-3.4: Include proportions of children with early and delayed vaccination. Also, report overall coverage of vaccines, to contrast differences in general coverage of a vaccine and timely uptake of a vaccine.

Authors Response: Thank you for your valuable comment, we have corrected it accordingly.

-3.5: You provide direct quotes and state that it is quoted material from multiple women – please report the quote from the woman who directly stated it and then mention the number of women who agreed with her comment.

Authors Response: Thank you for your valuable comment, we have corrected it accordingly.

-3.6: Define what TT is before using the abbreviation.

Authors Response: We have corrected it accordingly.

-3.6: The second paragraph starts with “After checking of confounding variables…” If you are examining predictors of timely vaccination (rather than examining a specific relationship between a particular exposure and timely vaccination) you would not have confounders, as there is no relationship to confound. If there were covariates you included in the model (whose relationship to timely vaccination is not being tested) then you should list out those covariates in the methods section.

Authors Response: Thank you for your valuable comment, we have corrected it accordingly.

DISCUSSION

-The authors should more fully discuss the implications of the results and potential reasons for the relationships between timely vaccination and associated factors beyond stating the findings are consistent with previous literature.

Authors Response: Thank you; we have corrected it accordingly.

-Please expand upon both the strengths and the limitations of the analysis. Consider how aspects of the study design, sampling method, topic area, locale, methods, etc. are strengths/limitations of the study. Please expand upon your comment about how only including children with vaccination cards would influence your results.

Authors Response: Thank you for your valuable comment, we have corrected it accordingly.

Additionally, you mentioned in the methods (2.2) that children had to be vaccinated to be eligible for the study. If unvaccinated children were not included in your study, the proportion of untimely vaccination is likely larger than you report (unvaccinated children can be thought of as children with long delays in their vaccination, as they have not yet received a vaccine by 12-23 months but could still receive it in the future). Please discuss this limitation.

Authors Response: Thank you; it is a nice observation and we have corrected it accordingly.

REFERENCES

-Review references and ensure they have all relevant fields and are formatted correctly. For example, references 3 and 8 refer to the World Health Organization as “Organization WH.”

Authors Response: Thank you; We have corrected it accordingly.

Additionally, some references (ex. #5) do not have journal titles included. Finally, reference 3 and 26 are duplicates.

Authors Response: It is unpublished on Journal but released on line.

TABLES AND FIGURES

-Overall, review the tables for consistency (i.e., use the same number of decimals for all percentages) and spelling/grammar.

Authors Response:

-Figure 1: What are the numbers in parentheses under each of the kebeles and why do some of them have letters (ex. MND (117) and Maruf(105))? Clarify in a footnote.

Figure 1: What are the numbers under “proportional allocation?” Clarify in a footnote.

Authors Response: We have corrected accordingly.

-Figure 2: I would recommend converting Figure 2 into a table that also includes general coverage of each vaccine dose among children 12-23 months. This would allow you to explicitly compare vaccination coverage vs timeliness. Plus, the figure is difficult to read in black and white (the age appropriate and early colors look like the same color) and the numbers on the figure overlap, making them difficult to read.

Authors Response: We have made the correction.

-Figure 3: Label the x-axis (percent) rather than titling the figure “%”

Authors Response: We have agreed with your comment, but majority of the texts in the graph are long, we are unable to correct it as per your comment.

Submitted filename: Response to Reviewers.docx

Click here for additional data file.

23 Dec 2021

Assessment of vaccination timeliness and associated factors among children in  Toke Kutaye district, central Ethiopia: A Mixed study.

PONE-D-20-40561R1

Dear Dr. Deriba,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #2: All comments have been addressed

**********

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The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #2: Yes

**********

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The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #2: Yes

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19 Jan 2022

PONE-D-20-40561R1

Assessment of vaccination timeliness and associated factors among children in  Toke Kutaye district, central Ethiopia: A Mixed study.

Dear Dr. Deriba:

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