Introduction
Globally, an estimated 10 million people developed TB disease in 2023, and there were an estimated 1.4 million deaths from TB (1.2 million among HIV-negative people and an additional 251,000 deaths among HIV-positive people) [
1]. Multidrug-resistant tuberculosis (MDR-TB) is now a serious threat to global health security, adding to the growing burden of antimicrobial resistance. In 2022, there were about one-half million new cases of rifampicin-resistant TB (RR-TB), but only one in three cases were reported by countries to have been treated [
2].
Globally, 3.4 percent of new TB cases and 18 percent of previously treated cases had MDR- or RR-TB [
2]. Ethiopia continues to be among the 30 high-burden TB, TB/HIV, and DR/MDR-TB countries in the world. According to the 2019 WHO Global TB Report, the incidence of TB is estimated to be 151 per 100,000 populations, and the mortality rate is 22 per 100,000 populations [
2]. These figures remain high despite commendable efforts by the NTLP, which have resulted in a steady decline in incidence over the years. TB treatment coverage, derived from new and relapse-notified TB cases divided by estimated incidence, was 69 percent in 2018, indicating that 31 percent of TB cases were missed. Among the 114,233 notified drug-sensitive (DS) TB cases in 2018, 69 percent were pulmonary TB, and of the nationally notified pulmonary TB cases, 62 percent were bacteriologically confirmed [
2,
3]. The National strategic plan for tuberculosis and leprosy control [
4], shows a remarkably steady decline in the estimated number of TB cases and a decline in case notifications since 2010 [
5].
Ethiopia is committed to accelerating the fight to end the TB epidemic by 2035, has endorsed the post-2015 Global End TB Strategy and the UNHLM targets, and has aligned its National TB Strategic Plan with the National Health Sector Transformation Plan. The National End TB Strategy aims to end the TB epidemic by reducing TB-related deaths by 95 percent and cutting incident TB cases by 90 percent between 2015 and 2035 [
4]. The strategy calls for the use of robust TB case finding and rapid diagnosis technologies to address the gap in finding missed cases and to decrease the threat of DR-TB. The NTLP has expanded TB services, through both public and private health facilities, to provide high-quality care [
6]. The strategic focus is on providing care at the community- and health facility-levels to improve case finding. As of June 2018, all public hospitals and health centers provided TB services, and community TB care had been rolled out to most health posts. The community TB strategy, which was incorporated into the Health Extension Program package, has proved feasible, acceptable, effective, and efficient [
7].
Health extension workers (HEWs) are tasked with identifying those with presumptive TB and referring them to health centers for diagnosis; providing treatment support; providing directly observed treatment, short course (DOTS) in some areas; tracing people lost to follow-up (LTFU); and carrying out contact investigation. This strategy has increased patient adherence and improved treatment outcomes [
8].
Comprehensive public-private mix directly observed treatment-short course (PPM-DOTS) services, supported by the USAID-funded Private Health Sector Support Program, started in 2006. With support from this program, a mix of TB services is currently provided at 546 private health facilities across the country: 247 provide diagnosis and treatment services; 32 provide TB diagnosis and referral services; and 267 provide presumptive TB referral services. The PPM-DOTS initiative contributed 15 percent of the TB cases notified nationally in 2018, although it engaged fewer than 3 percent of the private health facilities in the country [
3].
Although significant progress has been made towards ending tuberculosis (TB) as a public health burden, TB is still one of the leading causes of mortality in the world. Specifically, more than 1.8 million people die from TB every year, and approximately one-quarter of human immunodeficiency virus (HIV)-related deaths are due to TB [
7].
Despite intensified worldwide efforts to diagnose and successfully treat TB patients, the World Health Organization (WHO) estimates that almost 3 million cases are missed each year not diagnosed, treated or reported to National TB Programs (NTP). Additionally, the rapid emergence of multidrug resistant TB (MDR-TB) has the potential of reversing the two decades of progress that has been made mitigating the impact of TB [
9].
NTPs are increasing their efforts to improve the quality of TB diagnosis, care, and treatment services, in addition to improving access to TB care. Improving the basic standards of TB care can attract more clients by ensuring that they receive the care that they deserve. In addition, quality services help to improve adherence, diagnosis, and treatment and reduce the loss of follow-up, ultimately contributing to reducing the burden of TB disease, including drug-resistant TB (DR-TB). An improved understanding of what constitutes quality of care in TB programs would enhance the provision of integrated patient-centered TB care [
10].
Ethiopia is grouped as one of the 30 countries with the highest TB, HIV/TB, and MDR-TB burdens in the world. Although both TB prevalence and incidence rates have been showing a steady decline, TB remains a major public health problem, claiming thousands of lives each year [
11]. According to the first population-based national prevalence survey conducted in 2011/12, the prevalence rate of all forms of TB for all groups in Ethiopia was found to be 240 per 100,000 [
8]. The incidence of all forms of TB was 247 per 100,000 in 2012 but had fallen to 164 per 100,000 populations, according to a 2018 WHO report [
9]. During the year 2010/11, 159,017 TB cases were notified to the national program in Ethiopia; among these, 151,866 (95.5%) were new cases [
10]. The current National TB and Leprosy Strategic Plan envisions an end to the TB epidemic in Ethiopia and aims to reduce the TB prevalence rate by 35%, the TB incidence rate by 30%, and the TB mortality rate by 45% between 2013 and 2020. The Strategic Plan targets have placed a strong emphasis on improving quality of care [
12]. However, comprehensive evidence on the structural domain of quality TB service among health facilities is lacking in the Sidama region. Therefore, this study aimed to assess the quality of the structural domain of TB service at health facilities in the Sidama region of southern Ethiopia.
Methods and Materials
Study Area
This study was conducted in the Sidama National Regional State of southern Ethiopia. The Sidama National Regional State is located in the southern part of Ethiopia, bordering: in the north, the south, and the east with Oromia; and in the west with the Southern Nations and Nationalities Peoples Region (SNNPR). Sidama region has three agro-ecological zones comprising 29.3% lowland (“kola”), 55% midland (“woina-dega”), and 15.7% highland (“Dega”). In Sidama, the highest area is the tip of Garamba Mountain, which is 3300 m above sea level, and the lowest is located in Loka Abaya woreda, near Abaya Lake, which is 1200 m above sea level [
13].
The region has an estimated population size of 4,569,336 (a projected estimate based on CSA 2012). The inhabitants are fairly distributed in all parts of Sidama except the western part of the region, where the inhabitants are sparsely distributed compared to the other parts. The average population density is 612 persons per km2. About 79% of the inhabitants are rural, and 21% are urban residents. The female population is 50.1% and the male is 49.9%, of which the working age groups (15–49 years) make up 23.3% [
14].
Sidama National Regional State has a total of 31 districts and 636
kebeles. It has a total of 709 health facilities, which are comprised of 1 comprehensive specialized hospital, 4 general hospitals, 17 primary hospitals, 134 health center, and 553 health posts [
4]. According to the 10-year prospective plan document of Sidama National Regional State (September 2021), the economic growth of the region was 9.9% in the 2009 Ethiopian fiscal year (EFY), 10.0% in the 2010 EFY, 9.0% in the 2011 EFY, and 8.3% in the 2012 EFY, and the past five-year average was 9.3%. And according to the national poverty headcount index in 2016, 20.7% of the Sidama population lives below the national poverty line. From this figure, 21.9% is rural and 14.4% is urban [
6].
Study Design and Period
An institutional-based cross-sectional study was conducted between June-July, 2022.
Study Population
The study was carried out at tuberculosis (TB) case notification, diagnostic, and treatment health facilities located in Sidama regional state. All health facilities that provide TB care were included in this study. Based on the national protocol for tuberculosis service quality assessment guidelines, the structural indicators of TB quality service were studied. This was the facility auditing tool, and the data collection tools were prepared in English and then translated into Sidaamu affo and customized to the local terms and context as needed.
Sampling Techniques
The Sidama region has a total of 31 districts and seven town administrations. As the population distribution and climatic conditions are heterogeneous, the first 31 districts were clustered into 7 clusters, considering the minimum 20% sample from the total population. From each cluster, one district was selected by simple random sampling. Again, considering the minimum 20% sample from the total 167 health facilities that provide TB services in the region, 34 health facilities were considered. The 34 health facilities were selected from the 7 districts based on proportional allocation by simple random sampling techniques.
Study Variable
Structure refers to the foundational elements and the environmental factors that facilitate (or hinder) health facilities and service providers from providing high-quality TB services and care. This includes the physical infrastructure of the health facility; the availability and organization of specific TB services, as determined by the type and level of the health facility; the availability of and adherence to national TB standards and guidelines; appropriate human resources to provide services offered; staff training and competencies; the availability of drugs, medical equipment, and other supplies; adequate management and supervision structures and systems; and resources and funding for social support, such as payment schemes and incentives and transportation reimbursement, to facilitate the delivery and receipt of TB services. (QTSA: Global Implementation Guide, p. 15).
To conduct assessments on service qualities of TB in health facilities by using facility audit, tool was endorsed from Ethiopia QTSA which was adapted from WHO. This tool was developed by MEASURE: Evaluation (funded by the United States Agency for International Development (USAID). all countries of the world including Ethiopia used these tools to assess status of Quality of Tuberculosis Services [
15].
Facility audit measures include the physical infrastructure of the health facility; the availability and organization of specific TB services; the availability of and adherence to national TB standards and guidelines; appropriate human resources to provide services offered; staff training and competencies; the availability of drugs, medical equipment, and other supplies; and adequate management and supervision structures and systems. The structural quality of TB services was measured according to the Donabedian quality measurement model [
16].
The structural dimension was measured depending on the level of implementation of the Ethiopian NTLP guidelines, which were adopted from WHO-recommended structural inputs by health facilities [
17]. The 54 major indicators were used to assess structural dimensions. These indicators were grouped under the following major TB service categories: TB screening and diagnosis services, TB treatments, infection control, laboratory networks, medical equipment’s and supplies, TB drug supplies, linkage with other services and the community, management of TB-HIV patients, implementation of TPT, management of MD-TB patients, trained TB care providers, patient counseling about TB, adherence, TB policies and guidelines, privacy, waiting time, and supportive supervision [
16].
Facility audit indicators that measure the structural domain of quality services for TB were summarized using the principles of the TB Quality of Care Framework. The percentage of each service indicator in the health facilities score was calculated, and structural quality was classified as: very good (90–100), good (80–89), marginal (70–79), poor (60–69), and very poor (50–59) [
18].
Data Collection Techniques
Twenty data collectors were recruited for the actual data collection. All the data collectors were health professionals who have a bachelor's degree. The data collectors were selected based on their experience in data collection from similar previous studies. Two days of training were given by experts on how to use the Kobo data collection smart mobile phone application. Both the English and Sidamu afoo-translated questionnaires were fed into the Kobo collect server and the assigned data collector gathered the required information from each study facility.
Facility Audit
The facility audit was performed by using the structured questionaries’ for the availability and functionality of TB services in each study health facility. On top of this, the data collectors performed on-site examinations using an observation check list.
Quality Control (Assurance)
To assure the quality of the data, properly designed data collection instruments were developed in English after thoroughly revising related literature, and they were contextualized to suit the research objective, local situations, and language. The English version of the questionnaire was translated into the local language (Sidamu afoo) and translated back to English to check consistency by medical professionals. Before the actual data collection, the questionnaire was pre-tested on two public and one private clinic in rural areas of Boricha district, and necessary modifications were made specifically to the understanding ability of specific items. Every day, the completeness and consistency of the collected data were reviewed and checked by supervisors and the principal investigator. Discussions were made with the interviewers at the end of the day and in the morning, and corrective actions were taken timely to minimize errors committed during the interview. The principal investigator and supervisors select a few health posts and individuals who work in public and private health care centers to check the validity of the data. All study tools were pre-tested, training provided for the data collectors and supervisors, daily field supervision, and data completeness were conducted to assure data quality assurance.
Data Analysis Techniques
The data analysis was linked to the structural domains of quality of care described in the four pillars of TB quality service. The data were exported to SPSS version 25 for data preparation and analysis. Missing data (less than 5%) was ignored since it was small compared to the total data set count. Univariate analysis established proportions, frequencies, and percentages regarding the performance of the health units on the different parameters of TB service delivery. For confidentiality reasons, the health facility names were replaced with letters when reporting tests were done. For each problem, the number of times it was mentioned by the different health care workers was tallied and the total recorded. A descriptive statistic was used to obtain the descriptive measures of important and outcome variables.
Discussion
This study assessed the quality of TB care in the Sidama region and helped program implementers and coordinators, service providers, and all those concerned improve the quality of care delivered to TB patients so as to reduce the burden of the disease in the region and country at large. The study also serves as a base line for other studies and is used as a benchmark for continuous quality improvement processes in the regions in particular and in the country in general. The study identified major constraints in delivering quality TB care in the study area. Multiple quality problems were identified in all structural components of tuberculosis services.
A facility audit assessed the quality of TB services based on the national guidelines for TB services in public health facilities. Structural factors in health facilities were used to assess the quality of TB services. The key TB control structural indicators were evaluated for their systemic and direct effects on the quality of TB care. The study revealed that the required structural factors were not optimally implemented during the study period, as mentioned in
Table 1. The poor implementation of these structural factors affects the accessibility and effectiveness of the quality of TB services and adherence to treatment. The study shows that the poor quality of TB service delivery and suboptimal implementation in public health facilities were key determinants of poor outcomes for TB treatment. The provision of TB care by poorly trained and inadequately supervised TB focal persons was related to high treatment interruptions. Patients were more likely to miss their daily treatment when their follow-up was made in structurally poor health facilities and they had limited access to daily TB care consultations. Moreover, health facilities face high patient defaults and poor capacity to treat minor illnesses.
In this cross-sectional study conducted to assess the quality of TB health services in health facilities, we found that TB quality services are the cornerstone of any National Tuberculosis Program (NTP) [
17]. Assessing the quality of TB treatment services is important because it tells us how the health system is performing and leads to improved care. In this study, efforts have been made to identify constraints in all structural components of TB care using Donabedian’s quality assessment model in healthcare facilities in Sidama regional states. In this study, the overall quality score of structural components was 50.25%, which indicates that the majority of the studied facilities were structurally poor. The structural quality score found in our study is lower than a study conducted in the Jimma Zone with an overall structural quality score of 56% [
19]. Moreover, it is lower than a study conducted in Sidama Zone previously, which reported an overall structural quality score of 85% [
20].
This might be due to a discrepancy in the program managers’ attention for the program evaluation, poor leadership quality and withdrawal of support for NGO, constraints on resource allocation and infrastructure variations, and the COVID-19 pandemic.
Regarding the availability of TB services, the main deficiencies observed were screening services, diagnosis services (either clinical or laboratory), availability of first-line drug susceptibility testing, availability of second-line drug susceptibility testing, providing care and treatments, providing care and treatments for TB-HIV co-infection, providing care and treatments for drug-resistant TB, and providing pediatric TB care and treatments, in which the score ranged from 0% to 97.5% among the health facilities. This was not in line with the national guideline for TB screening, diagnosis, and treatment [
17].
The drug and diagnostic components of the structural quality of TB care were a shortage of laboratory reagents, slides for sputum smear microscopy, flip charts, and TB posters in the local language, in which the score ranged from 10% to 67.5% among the health facilities. A study conducted in Ethiopia showed a higher score in this respect (75% and 81%) due to the availability of a copy of the NTP guidelines, essential TB drugs, and diagnostic tests in the facility [
18].
The current study found weak supervision patterns. Only 16 (40%) and 9 (22.5%) health facilities were supervised in the last 6 months, from the woreda and regional health bureaus, respectively, and the supervision pattern was also unplanned and lacked the clean, time-bound written form of feedback. Our facility audit findings are lower than the findings of a study conducted previously in Sidama Zone, South Ethiopia [
20]. Planned supervision patterns from upper-level program leaders will help to identify and fill the health facility gaps needed to deliver quality TB services.
From the drug and diagnostic supplies of structural quality of TB care, only 26 (65%) facilities had all approved drugs and medicines available on the day of the assessment. This indicated that all health facilities had no sufficient first-line anti-TB drugs and other supplies for one month. This is not consistent with the national minimum recommendation that every facility should have at least a one-month stock level for existing patients [
17].
The health education program and other community-related TB services that were conducted by HEWS and community volunteers for TB control activities were found to be poor in all health facilities. It was found that only 52.5% of health facilities had community linkage, and 16 (40) facilities had up-to-date TB posters on walls, leaflets, brochures, and/or pamphlets in local languages for distribution, i.e., educational materials about TB that were not recommended by NTLP. This is also comparable to a study conducted in the Sidama zone previously in Addis Ababa, Ethiopia [
20,
21]. This might be due to the poor attention given by health care providers. Even if health facilities had the responsibility to make linkages and support community level TB services, small health facilities had community linkages and program coordinators for health education activities, even if they played a great role in the prevention of TB transmission.
Only 67 percent of health facilities reviewed the progress of each TB patient registered for TB treatments at least once a month during treatment; this showed poor adherence. This is also not in line with the study conducted in Jimma and Addis Ababa [
19,
21]. This might be due to a lack of adequate access to training regarding the management of TB, weak follow-up from health facility managers, and weak system integration.
This study also revealed that all health facilities sampled had no essential requirements for TB diagnosis and treatment. This could be attributed to a lack of consistent monthly and quarterly supervision by the district team, regions, and a few times by the ministry of health officials as recommended by the ministry of health and the presence of development and implementing partners who worked on TB-related activities. This study was not in line with a study carried out on the quality of tuberculosis care in Ethiopia, which revealed that the delivery of materials, drugs, and supplies for tuberculosis control activities was fairly good [
22].
This study also found that health facilities had trained manpower with d/t topics that are new or refresher training was audited during data collection, which ranges from 15% to 60% of health facilities. This is lower than the study conducted in Gana at rural districts in which all health center service providers were trained on all necessary training on TB [
23].
Only 24 (60%) of the health facilities had a waiting area for patients, 25 (62.5%) health facilities had a private area for counseling, and no health facility had a separate area for sputum specimen collection. This is lower than the study conducted in South Africa, which reported a far better score in this category in public health facilities (67% and 82%), and higher than the study conducted in the Jimma Zone, which had a score 50% [
19,
24]. Moreover, only 24 (60%) of health facilities had internal and external quality assurances for smear microscopy. This leads to low quality control for sputum smears, and this is a major quality problem given the burden of the disease in the community as a whole since smear-positive patients are the source of Mycobacterium tuberculosis infection [
17]. This may occur due to a lack of trained manpower, less control over laboratory activities from upper-level health authorities, and resource scarcity. However, each parameter used to measure structural dimensions may not have an equal contribution to the quality of care.
Conclusions
The basic structural and essential requirements for TB diagnosis and treatment were poor in the Sidama region of southern Ethiopia. Comprehensive strengthening of the health system, focusing on the structural quality of health facilities, is crucial. The regional TB department should maintain all structural indicators mentioned under the categories of availability of TB services, infrastructure, capacity building for all service providers, and management of TB services for all accessible health facilities in Sidama regions, according to the NTLP guidebook and WHO.
The regional and woreda health authority offices should expand the TB M&E system to monitor all TB activities by including routine performance indicators for TB screening and diagnosis practices, including all supplies, through regular supportive supervision. All health facilities should fulfill all necessary supplies, like first- and second-line drugs, laboratory equipment, and diagnostic supplies. All health facilities should start first- and second-line drug-sensitivity testing. All health facilities should control infection protocols. Regional health authorities should integrate with NGO to fill resource and capacity problems.
Declarations
Funding
The president's office of the Sidama region provided support for this work. the conception, design, analysis of data, manuscript preparation, and publication were all done independently of the funding agencies.
Ethics Approval and Consent to Participate
Ethical clearance and approval were obtained from the institutional review board (IRB) of Hawassa University, college of medicine and health science, and a letter of permission was sent to the district health officer. Informed consent was sought from the respondents to fully participate in the study. The privacy of the respondents was maintained, and the confidentiality of the information was respected (personal identification and ideas were not used in a way that might threaten the respondent). The research team acknowledges the respondent for their valuable time.
Authors’ Contributions
AA: conceptualized, ensured data curation, did the formal analysis, and wrote the manuscript. aa: wrote the manuscript. TMS: wrote the manuscript. MTT: wrote the manuscript. ttd: wrote the manuscript. BAB: wrote the manuscript. DDG: wrote the manuscript. AY: conceptualized, ensured data curation, did the formal analysis, and wrote the manuscript. All authors read and approved the final manuscript.
Competing Interests
The authors declare that they have no competing interests.
Consent for Publication
Not applicable.
Availability of Data and Materials
The datasets supporting the conclusions of this article are included within the article.
Acknowledgments
We would like to acknowledge Hawassa University and Sidama region public health institute for their technical support.