Developing countries in sub-Saharan Africa and Asia account for close to 80% of the global TB burden [1
]. It is therefore unsurprising that South Africa, a high-burden TB country, struggles with this pandemic which remains the main driver of morbidity and mortality [2
]. Within this context, local and international research highlighting gaps and weaknesses in TB protocol implementation [3
] and a global call for shifts towards quality improvement [9
] motivated us to consider the quality of TB screening in South Africa.
There is growing consensus that increasing healthcare coverage is unlikely to improve health outcomes if the quality of care is lagging [12
]. There are few studies on the quality of TB diagnosis and treatment [11
]. Some of these use novel approaches yet still find that there are significant gaps in the quality of TB care in high-burden countries [7
]. Our study adds to the literature in the quality of care space.
Measuring quality of care comes with challenges [16
]. The available measurement tools have strengths and weaknesses. At a facility level, few reliable measures exist that can be easily implemented and used to flag problems with quality of care. Patient acceptability and satisfaction indicators can capture some aspects of quality. However, while easy to compile and reasonably affordable, they are subjective in nature [18
], suffer from recall constraints [19
] and are limited by the difficulty with clinical assessments [16
]. Clinical vignettes are useful for measuring provider knowledge, but this is not a good indicator of provider effort since evidence suggests that knowledge and practice diverge [18
]. Direct provider observation—while simple to execute—is subject to the Hawthorne effect [16
]. Clinical audits of patient files have their own shortcomings and are often reliant on small samples [22
]. Routinely captured health outputs—such as TB success and cure rates—are influenced by both demand and supply factors which make it difficult to interpret facility-level changes in such indicators.
The Standardised Patient (SP) method is an attempt to seek more accurate and reliable measurement of the clinical aspect of a healthcare interaction [15
]. Although this method is regarded as a gold standard for measuring quality of care [30
] it also suffers from weaknesses such as only being feasible for easily simulated conditions; the possibility of exposing SPs to hazardous environments; its limitation to contexts where ‘walk-ins’ are acceptable; and, the general dislike of the method by healthcare providers [16
]. However, used alongside existing indicators, data derived from the SP method can offer a more comprehensive understanding of quality of care compared to alternative methods.
The purpose of this study is to objectively measure the quality of TB screening at metro-district primary healthcare (PHC) facilities in South Africa using the SP method. This is the first multi-district SP study in South Africa. The method allows researchers to observe how PHC providers identify, test and advise presumptive TB patients, and whether this aligns with clinical protocols and best practice.
Summary statistics for the variables of interest were generated (Table S4
). Results are reported as a percentage, followed by the absolute value and 95% confidence interval in brackets. Variables of interest were stratified by SP, facility (Table S5
), gender and age (Table S6
). No consistent pattern of significant variation in means emerged, except across SPs—and to a lesser degree—across facilities.
3.1. Case Description and Management
The case description for each SP was presumed TB with more than two weeks of coughing, fever and weight loss. Having the SPs present in this manner allowed us to observe how PHC providers identify, test and advise presumptive TB patients.
The failed visit rate captures the proportion of unsuccessful facility visits where the SP left the facility without consulting a provider. This rate makes provision for excluding cases where the SP could not visit a facility because it was their local or ‘home facility’. Overall, the failed visit rate was 6% or nine out of a potential 152 patient-provider interactions (Table S3
For the 143 analysable interactions SPs presented with the following opening statement: ‘I have been coughing a lot recently’. Programme managers and clinicians advised against adding ‘for two weeks’ because this could appear contrived or rehearsed and not aligned with how patients who are concerned about their cough would normally present at facilities. If they were not triaged or identified for TB screening, SPs were trained to add: ‘I think I may have TB’. We required SPs to track whether they mentioned TB explicitly in their opening statement. More than 90% (91%; 124; 0.85–0.95) of SPs were triaged for TB screening without the need to mention TB.
3.2. Adequate Case Management
Based on a review of guidelines and protocols, and consultations with clinical experts and programme managers, we defined a minimum level of case management for TB screening as a sputum test and an offer of a HIV test. Applying this definition, we find that 43% (61; 0.35–0.51) of SPs were correctly managed. This result is driven mainly by a low rate of HIV tests offered, since sputum tests were conducted at 84% (120; 0.77–0.89) of visits while HIV tests were offered at only 47% (67; 0.39–0.55). SPs were asked about household TB contacts in 54% (77; 0.46–0.62) of cases.
Using the SANTMG benchmark of checking for four essential TB symptoms: coughing for more than two weeks, weight loss, night sweats, and fever for more than two weeks, the overall finding shows that just over half (55%) of the essential history checklist questions were asked. The prevalence of the questions asked was: cough duration (80%; 114; 0.73–0.86), night sweats (59%; 84; 0.50–0.67) weight loss (55%; 78; 0.46–0.63) and duration of fever (25%; 36; 0.19–0.33).
3.3. Medical Examinations
Blood pressure and weight measurements were performed most frequently (43% (61; 0.35–0.52) and 38% (54; 0.31–0.47), respectively) at SP TB screenings. Pulses were checked the least frequently at 13% (18; 0.08–0.20) of interactions. Temperatures were taken at 16% (22; 0.10–0.27) of interactions overall and in 22% (8; 0.11–0.39) of cases where the SPs were asked whether they had a fever (the standardised response was yes).
3.4. Dispensing of Antibiotics
For interactions where no temperatures were taken, antibiotics were prescribed 8% (10; 0.05–0.15) of the time (10 out of 119 cases). Amoxycillin was prescribed for most of these cases (eight), while penicillin was prescribed for one case and a trimethoprim and sulfamethoxazole combination antibiotic for another.
3.5. Access to Surgical Masks
SPs had access to surgical masks in 48% (69; 0.40–0.57) of cases.
Fifteen per cent (15; 0.09–0.23) of SPs did not receive any verbal or written communication about returning to collect their TB test results. Only 28% (33; 0.20–0.37) reported that nurses explained the importance of returning for their TB test results.
To be considered of acceptable quality, TB care needs to comply with (international) standards [7
]. For South Africa, TB screening protocols used at a PHC level comply with the SANTMG which is derived from the World Health Organization’s TB guidelines. The discussion highlights some of the missed opportunities in the current implementation of TB screening protocols which were identified using the SP method.
While an overall failed visit rate of 6% may seem low at first glance, this translated into nine of the SPs not having the opportunity to be screened for TB (Table S3
). This represents a loss of presumptive TB patients from the TB care cascade at the earliest point. In this study, SPs were not given a waiting time in terms of how long they should wait before leaving, i.e. SPs could only leave the facility when instructed to do so by staff at the facility. Often no reason was provided when SPs were told to leave the facility, other times they were informed it was due to staff constraints, e.g., a nurse being on sick leave. Patients who have experienced failed visits at a PHC facility may also become discouraged and could be reluctant to return. Systems need to be developed to ensure that presumptive TB patients are prioritised, even when facilities are short-staffed.
Given the prioritisation of HIV and TB care in South Africa over the past two decades through additional funding and training, it is disappointing to see that in only 43% of cases did the public healthcare system meet the minimum threshold for adequate case management. This was driven mainly by a lower than expected rate of offering HIV tests (47% of cases) which is concerning given the high TB/HIV co-infection rate in South Africa (57% in 2015 [31
]) and the resources that have been invested in training, awareness and fighting stigma. It is also worrisome because the level of sensitivity of TB test results using Xpert®
, the recommended TB diagnostic tool in South Africa, is influenced by HIV status [39
]. False-negative TB test results carry costs for the individual and perpetuate the spread of infectious TB. Even though sputum tests were conducted often (84% of visits), there is room for improvement.
Besides people who are HIV positive, the SANTMG recommends that a high index of suspicion is required for patients who have been in contact with a person with confirmed TB. From this perspective, enquiring whether anyone in the household had confirmed TB was viewed as important by TB control programme managers. Despite this, SPs were asked about household TB contacts in only 54% of cases.
There are many potential reasons for deviations from protocols including inadequate training, lack of knowledge, deficiencies in monitoring and evaluation [40
] and, more broadly, a lack of clinical governance [42
]. Unfortunately, due to our limited sample, we cannot test the plausibility of rival explanations for poor protocol compliance.
Checking for the four main symptoms of pulmonary TB is essential in a clinical interaction since every patient with a positive TB symptom should be tested for TB, according to the SANTMG. The overall finding shows that just over half of the essential history checklist questions were asked. Similarly, physical examinations linked to TB screening were conducted at less than 50% of SP interactions. Cough duration emerged as the most frequently asked essential history checklist question, which implies that healthcare providers relied almost exclusively on this symptom when determining whether the patient requires a sputum test or not.
In less than 10% of the interactions SPs had to provide the additional statement of ‘I think I may have TB’ before being triaged or identified for TB screening. This reinforces a hypothesis that persistent coughing, the opening statement of the SP, is top of mind as a TB symptom and elicits the appropriate referral within the facility.
A worrisome finding emerged: 8% of SP interactions where no temperatures were taken resulted in the prescription of antibiotics. Considering the local antibiotic algorithm and TB screening protocol, there was no indication for antibiotics to be administered. Practices such as this may lead to an increase in drug-resistant bacteria in South Africa. Further research is needed to understand why this practice occurs. It may be a form of empirical antibiotic treatment that is practiced in certain countries [15
], though the South African TB protocol does not allow for empirical antibiotic treatment unless the patient has a temperature greater than, or equal to, 38 degrees Celsius [36
]. Irrespective of the rationale, the risks associated with this practice are high and, at this preliminary stage, should be considered unsafe.
Providing surgical masks has been deemed a best practice by clinical experts and programme managers and is considered an infection-control measure. SPs had access to a surgical mask at less than half of interactions (48%). Making surgical masks more readily available to all patients entering facilities is a simple and pragmatic way of reducing the risk of droplet infection [46
Lack of information-sharing, particularly in terms of continuity of care, emerged during the interactions: approximately two out of ten SPs were not informed about returning to the facility for their TB test results. Even when cases were managed correctly, very little effort was made to explain the importance of returning for TB test results. This was explained at less than a third of interactions (28%). The overall trend suggests low effort exerted in communicating valuable information to the patient regarding the dangers of untreated TB and the need to start treatment as soon as possible.
This suggests that a diagnostic gap exists with some presumptive TB patients leaving facilities without being tested for TB; others leaving the facility without knowing that they need to return for results and why; and, some TB test results may come back as a false-negatives. These findings about deficiencies in diagnostic protocol compliance add to the literature analysing the weaknesses in the health system and can provide useful feedback to national and provincial governments.
We argue, based on this study and the relevant studies cited, that the care provided for TB screening in South Africa is not as effective as it could be given its resources. The multiple gaps in protocol adherence are a concern that needs to be acknowledged and addressed because they contribute to TB deaths and disappointing TB outcomes. Protocols and best practices may need to be interrogated to ensure that their most important elements are prioritised, allowing for more pragmatic implementation in high-burden settings. Ensuring that basic and important steps in the TB screening protocol are adhered to may prevent the loss of presumptive TB patients in the healthcare system.
The increasing popularity of the SP method in measuring the quality of healthcare is supported by the findings of this study which was able to identify deficiencies in the health system, specifically provider behaviour that compromised the diagnostic evaluation of TB patients. The method has been used as a complementary but ad hoc monitoring tool in other countries [28