2.1. Study Design, area and Period
A facility-based cross-sectional study was conducted in public health facilities of Kellem Wollega Zone, western Ethiopia from May 30 to June 30, 2016. Kellem Wollega zone is one of the eighteen zones of Oromia Regional State. Based on the 2007 Census conducted by the Central Statistical Agency of Ethiopia (CSA), this Zone has a total population of 797,666, of which 401,905 are men and 395,761 are women. By residence, 76,277 (9.56%) of the population are urban inhabitants. A total of 159,353 households were counted in this Zone, which results in an average of 5.01 persons per household (6). According to the 2015/2016 district based plan, there are about 34,470 of women expected to be pregnant in the year in the zone by conversion factors. Forty-five Health Centers and one zonal and one district hospital are currently providing ANC services in this zone.
2.2. Population and eligibility criteria
All pregnant women, who were attending ANC clinic, all health facilities, all facilities’ heads, and all ANC providers working at the public health facilities in the Kellem Wollega zone, were the source population. Selected health facilities, pregnant women attending ANC clinic at the selected health facilities, heads of the health facilities, and ANC providers who were providing the service at the selected public health facilities in Kellem Wollega Zone were the study population. Pregnant women who were seriously ill, with a mental health problem and hearing impairment were excluded from the study. In addition, ANC service providers with less than six months of working experience in selected facilities were excluded from the study.
2.3. Sample size determination
Sample size was determined using single population proportion formula, by considering the proportion of satisfied pregnant women from study done in Ambo town which was 89% (7), marginal of error of 5%, and confidence level of 95%.
After multiplying the calculated sample size by 2 for design effect and adding 5% for non-response rate, the final sample size becomes 316 pregnant mothers.
2.4. Sampling procedure
There are ten districts in the Kellem Wollega zone. Seven of them were selected by a simple random sampling technique using the lottery method. One health center was selected from each district and the lottery method was used when more than one facility exists in the district. DembiDollo Hospital was selected from the two public hospitals in the zone. The total calculated sample size was proportionally allocated to each health facility according to the number of attendants of the recent quarter ANC report. Finally, pregnant women who were registered and attending the antenatal care service during the data collection period were taken consecutively until the required sample size from the specific facility was fulfilled.
2.5. Data collection tools and procedures
A structured questionnaire was adapted from the Safe Motherhood Needs Assessment package to obtain information on services received by pregnant women during exit interviews (30). Satisfaction level was measured by 12 items of questions prepared to measure the level of satisfaction, adopted from similar studies conducted in the country. Satisfaction level with a Likert scale of 1 to 5 score and the mean satisfaction score was used as a cut-off point.
A checklist for client medical review was adopted as per the Ethiopian Federal Ministry of Health integrated cards of ANC, labor, delivery, newborn, and post-natal care.
Eight clinical nurses and two MPH holder supervisors were selected from facilities that were not included in the study. Two days of training were given for data collectors and supervisors on data collection techniques and all data collection tools. The data collectors conducted client exit interview and review of medical records.
Client exit interview: Clients were interviewed after they finished the whole process of antenatal care services at the exit area.
Data collectors reviewed all respondents’ medical records including the types of services clients received during their ANC visit on daily basis for all interviewed pregnant women. The attributes of output and some parts of process components of ANC quality were assessed from the client interview.
Facility audit: All selected facilities were audited to assess the health facilities’ capacity to deliver ANC services.
The components for structural aspects of ANC quality (Management system, Basic amenities, Infection prevention materials, ANC Diagnostic equipment, Laboratory equipment, and Essential drugs) were obtained from the audit.
Medical record review- A medical recording number was written on individual questionnaires to differentiate client medical records. Medical record review was done using a checklist adopted as per the Ethiopian Federal Ministry of Health integrated cards of ANC, labor, delivery, newborn and postnatal care service. The most components for process aspects of ANC quality (General, gynecological examination, and routine ANC tests done, drugs, and information given for pregnant women) were assessed.
2.6. Operational Definitions
Quality of ANC services: Based on Donabedian’s quality of care framework, this study assessed three aspects of the quality of care: structure, process, and outcome.
Structural aspects of the quality: Management system, basic amenities, infection prevention facilities, diagnostic equipment, laboratory equipment, and essential drugs were components used to assess the structural aspects of the quality. The data for structural aspects of the quality were collected from facility audits.
Management system: Availability of trained ANC providers, mechanisms to obtain client opinion on service provided, and supervision visits from the external body within the past six months.
Basic amenities: Basic amenities assessed in this study for ANC service include a waiting area, private room for ANC, chair, electricity, and toilet, generator, and ambulance service. The availability and functionality of these basic amenities were checked at each facility during the facility audit.
Infection prevention materials: Availability of water sources, soap for hand washing, sterilizer, waste disposal bin, sharp container, latex glove, disinfectant, and antiseptic solutions at ANC room or in the facilities during facility audit.
Diagnostic Equipment: The diagnostic equipment for ANC services assessed in this study were, Gynecological examination light, examination couch, blood pressure measuring apparatus, stethoscope, fetoscope, adult weighing scale, Thermometer, vaginal speculum, and Tape meter. The Diagnostic equipment was assessed by checking their availability and functionality at the ANC clinic during a facility audit.
Laboratory equipment: The laboratory equipment assessed for ANC in this study include Microscopy, urine container, urine dipstick, test for Hgb or HCT, test for syphilis, and HIV test kits. All facilities were assessed for laboratory equipment during the facility audit.
Essential drugs: The drugs assessed as essential for ANC services include Tetanus toxoid, Iron, ARV, and Mebendazole. The facilities’ essential drugs were assessed by checking during a facility audit.
Process aspects of quality: Both the interpersonal and technical aspects of quality were assessed under the process of quality services.
Interpersonal aspects include client waiting time, client-providers’ interaction, privacy, and confidentiality of clients.
The technical aspects of quality were determined by assessing the completeness of the ANC consultation process for each pregnant woman included in the study. General and gynecological examinations are done, Laboratory tests are done, Drugs are given and Information provided for pregnant women during consultation time was parameters used to assess the completeness of the ANC consultation process.
These parameters were adopted from integrated cards of ANC, labor, delivery, newborn and post-natal care which were developed by the Ethiopian Federal Ministry of Health and WHO recommendation. Data for these parameters were obtained from medical record reviews and client exit interviews.
General and gynecological examination done: General and gynecological examinations done for clients were assessed by checking twelve elements of examination listed here. Gestational age, Weight, Blood pressure, Pallor, Jaundice, Chest abnormality, Heart abnormality, Vulvar ulcer, Vaginal discharge, Pelvic mass, Cervical lesion and Fetal Heart sound (gestational age greater than16 weeks) checked and recorded on client medical records.
Routine ANC laboratory tests are done: Routine ANC tests done for clients were assessed by checking if, Hemoglobin or hematocrit, Urine for Protein, Urine for infection, VDRL, HIV, Blood group &Rh factor done and recorded on client’s medical record.
Drugs are given: Drugs given for pregnant women were assessed by checking if Iron supplementation, TT vaccine, and Mebendazole were given during any of their visits. The data about Iron Supplementation was asked from the client interview and the rest were checked from clients’ medical records.
Information provided to pregnant women: Information provided for the pregnant women on recognizing danger signs during pregnancy and delivery, the importance of Birth Preparedness and Complication Readiness, places of delivery, type’s food to eat during pregnancy, exclusive breastfeeding, HIV testing during pregnancy, using Insecticide Treated Net and importance of postpartum family planning were assessed by clients exit interview.
Outcome aspects of quality: The Outcome aspects of quality were assessed by the level of client satisfaction with ANC service they received which was measured as follows.
The satisfaction of pregnant women: -was measured by health service-related statements prepared to measure satisfaction developed from a similar study.
Clients are categorized as not satisfied (if they score below or equals to the mean) or satisfied (if they score greater than the mean satisfaction score) by using client satisfaction rated by 12 items of questions. These questions were related to satisfaction of client on provider behavior, communication skill, waiting time, clinic amenities, waiting area, laboratory tests, drugs given, privacy during the consultation, procedure, information received about ANC services, continuity of care, the recommendation to other and general feeling of the client, each having five-point Likert scale from 1 indicating strongly disagree to 5 indicating strongly agree (3).
2.7. Data quality assurance
The questionnaire was prepared in English. Then it was translated to Afaan Oromo and translated back to English by language professionals for its consistency. Two days of training was given for data collectors and supervisors. The Questionnaire was pretested on 15 pregnant women out of the study area. Medical records were standard tool as it was developed nationally and providers have training on health information management system. During data collection time, the data collectors were closely supervised. The questionnaire and checklist were checked for completeness and consistency.
2.8. Data processing and analysis
Following the data collection, data were coded and, entered into EPI Data version 3.1 and exported to SPSS version 20.0 for analysis.
Structural aspects of quality: To assess structural aspects of the quality, six different components (Management system, Basic amenities, Diagnostic equipment, Infection prevention materials, Laboratory equipment, and Essential drugs) were used and indices for each of them were generated. To generate an index, each variable was used to assess the six different components of structural aspects that were scored, and then the sum of the scores was obtained. For example, the management system index had three variables in which each was given a score of ‘1’ if present and ‘0’ if absent. The management system index, therefore, had values ranging from (0–3). A similar approach was used for the generation of indices for Basic amenities, Diagnostic equipment, Infection prevention materials, Laboratory equipment, and Essential drugs. The Basic amenities index had values ranging from (0–7), Diagnostic equipment index had values ranging from (0–8), Infection prevention materials index had values ranging from (0–8), Laboratory equipment index had values ranging from (0–6), and Essential drugs index had values ranging from (0–4), depending on the number of variables assessed in each of them as described under the operational definition above.
To compute comparison between the health facilities’ structural aspects of the quality, the indices of basic amenities, diagnostic equipment, infection prevention materials, and laboratory equipment were categorized into two,” Poor or good”.
The structural aspects of the quality were graded as poor if its categorized index value was between zero and four and as good if the value was above five (8). While for the Management system and Essential drugs, the indices generated were not categorized and the results presented in narrative and table.
Process aspects of quality: - To assess process aspects of the quality, four different components (General and Gynecological examination are done, Routine ANC tests are done, Drugs are given and Information provided for pregnant women) were used and indices for each of them were also generated. The variables described under each of these categories or components were first scored, such that a variable was given a score of one if undertaken and zero if not undertaken, and then the scores were summed under each of the components described above to generate an index. General and Gynecological examination done index had values ranging from (0–12), Routine ANC tests are done index had values ranging from (0–6), Drugs given index had values ranging from (0–3), and Information provided for pregnant women index had values ranging from (0–8).To compute comparison between the health facilities process aspects of the quality, the indices of General and Gynecological examination were categorized, and Information provided for pregnant women was categorized into two categories,” Poor or good”. The process aspects of the quality were graded as ‘poor’ if its index value was between zero and six, and ‘good’ if the value was seven and above (8). While for Routine ANC tests done and Drugs are given, the indices generated were not categorized and the results presented by the bar graph and narrated.
Outcome aspects of quality
Pregnant women’s satisfaction was used to assess the outcome aspects of the quality of ANC services. Pregnant women's satisfaction was measured by statements related to health services prepared to measure the satisfaction of clients. Clients were categorized as satisfied (if they score above the mean satisfaction score) or not satisfied (if they score equals or below the mean) by using Client satisfaction that was rated by 12 items of health service statements.
These statements were related to satisfaction of client on provider behavior, communication skill, waiting time, Clinic amenities, waiting area, laboratory tests, and drugs are given, privacy during the consultation, procedure, information received about ANC services, continuity of care, the recommendation to other services and a general feeling of the client. Each question has one to five-point of Likert scales.
Descriptive statistics and logistic regression analysis were performed for client satisfaction. In the logistic regression, both bivariate and multivariate analyses were carried out to identify factors associated with client satisfaction. Assumptions of logistic regression like model fitness, multicolinearity and normality were checked. All the variables were entered into bivariate logistic regression analysis and those explanatory variables with a p value < 0.25 in the crude analysis were considered as a candidate for multivariate logistic regression analysis and those variables with a p-value < 0.05 in the multivariate logistic regression analysis were considered as a significant predictors of satisfaction. Finally, the results of the analysis were reported in texts, tables, and graphs as appropriate.