Overview of selected studies
| Study ID number | Study (year), country | Research design and methods Period | Populations (number) | Study objectives | Level of care (diagnosis/treatment) | Dimensions of access | Summary of findings | Assessment of study quality (score) |
| Qualitative studies | ||||||||
| 1 | Bieh (2017) Nigeria | Qualitative FGDs, IDIs and KIIs 2014 | Patients (11) and health workers (4) | NA | Treatment | Structural and patient dimensions | Treatment delays due to stigma and discrimination, as well as a lack of required hospital tools. | B |
| 2 | Naidoo (2015) South Africa | Qualitative IDIs (part of a bigger study including a retrospective cohort 2010–2012 | Patients (26) | NA | Diagnosis and treatment | Structural and patient dimensions | Patients beliefs and knowledge of TB symptoms, wrong perceptions of healthcare and family commitments, compounded by health systems missed opportunities and delays, impact access. | A |
| Quantitative studies | ||||||||
| 3 | Cox (2015) South Africa | Retrospective trend analysis2009– 2013 | Patients (158) | Time to treatment initiation (TTI) before the decentralisation, during decentralisation and after decentralisation. | Diagnosis and treatment | Structural dimensions | Decentralisation and introducing Xpert were associated with significant reductions in TTI, after initial gains with the LPA. | B |
| 4 | Cox (2017) South Africa | Retrospective cohort study 2011–2013 | Patients (2508 in 2011) (2528 in 2013) | Treatment initiation were assessed among laboratory-diagnosed patients before and after Xpert implementation. | Diagnosis and treatment | Structural and patient dimensions | Patients age and HIV status, as well as diagnostic timeliness delay access. | A |
| 5 | Dlamini-Mvelase (2014) South Africa | Retrospective cohort study 2011–2012 | Patients (637) | Availability of confirmatory DST and TTI with Xpert compared with phenotypic and genotypic DST. | Diagnosis | Structural dimensions | Poor adherence to Xpert algorithmwas due to rollout of Xpert preceding training of clinicians | A |
| Quantitative studies | ||||||||
| 6 | Ebonwu (2013) South Africa | Cross-sectional study 2011 | Patients (942) | Evaluation of treatment uptake, loss to follow-up and retention of newly diagnosed patients. | Treatment | Structural and patient dimensions | Referrals from hospitals, some health districts, being HIV negative and township place of residence were associated with treatment non-initiation. | A |
| 7 | Evans et al (2018) South Africa | Retrospective cohort study: First cohort: 2011–2012 (35% Xpert implementation) Second cohort: 20132014 (>90% implementation) | Patients: First cohort (594) Second cohort 713 | Compared treatment initiation and TTI forlaboratory-confirmed patients with (first vs second cohort). | Diagnosis and treatment | Structural and patient dimensions | Xpert implementation increased diagnostic capacity and treatment rates. | A |
| 8 | Hanrahan et al (2012) South Afria | Observational cohort study: 2007– 2008 with MGIT phenotypic DST 2009– 2010 with LPA | Patients (n=1176 MGIT) and (n=1177 LPA) | Compared data on patients registration before and after an expanded DST algorithm. | Diagnosis and treatment | Structural and patient dimensions | Introducing the faster LPA DST testing cut down time to diagnosis and increased case detection without the expected impact on TTI due to other health system bottlenecks. | A |
| 9 | Hanrahan (2013) South Africa | Prospective cohort study Jul–Sep 2011 | Patients (641) | Evaluated diagnostic follow-up and outcomes for a cohort of presumptive patients screened using a single point-of-care Xpert. | Diagnosis and treatment | Structural and patient dimensions | Point-of-care Xpert provided quicker treatment initiation, mostly same day treatment. This was 2 weeks faster than for those started empirically or based on suggestive chest X-ray, and 20 weeks faster than for culture diagnosis. | A |
| 10 | Iruedo (2017) South Africa | Retrospective cohort study Jan 2009–Dec 2014 | Patients (342) | Analysed records of diagnosed patients, comparing diagnostic modalities to assess the Xpert effect on TTI. | Diagnosis and treatment | Structural and patient dimensions | Xpert significantly reduced the time to diagnosis and TTI. This was significantly shorter compared with LPA and culture/phenotypic DST. | A |
| 11 | Jacobson (2012) South Africa | Retrospective cohort study 2007–2011 | Patients (197) | Compared records of patients tested using the MTBDRplus and with culture-based DST to determine if TTI from specimen collection was shortened. | Diagnosis and treatment | Structural and patient dimensions | The use of LPA for diagnosis dramatically improved TTI but laboratory and clinical operational delays remained a problem. | A |
| Quantitative studies | ||||||||
| 12 | Jacobson et al (2017) South Africa | Retrospective cohort in Western Cape: two samples at baseline— for Xpert; and for LPA plus DST 2011– 2013. Prospective cohort in three other provinces: one sample collected at baseline for Xpert; a subsequent one for LPA plus culture-based DST only with detection of RR-TB. 2012– 2013 | Patients (1332) *Western Cape Province: (835) *Eastern Cape, Free State and Gauteng Province: (497) | Quantified the time to DST results and proportion of patients potentially placed on suboptimal therapy. | Diagnosis and treatment | Structural and patient dimensions | Incomplete and decreasing adherence to National requirements for DSTimpedes diagnosis rates. Long turnaround time for DST results following RR-TB diagnosis. | A |
| 13 | Jokwiro et al (2018) Zimbabwe | Cross-sectional study. 2016– 2017 with two phases: Xpert only for presumptive DR-TB and HIV coinfection: 2016; Xpert recommended for all presumptive patients: 2017. | . Thirteen Xpert assays (13 137 total assays): *2016: (4556) *2017: (8581) | Compared the use of deploying Xpert only for presumptive DR-TB and HIV coinfection vs Xpert for all presumptive TB patients. | Diagnosis | Structural dimensions | Increased access to Xpert utilisation beyond high-risk groups slightly increased detection of drug susceptible TB, but not DR-TB strains. Persistent HS challenges impeded Xpert utilisation. | A |
| 14 | Kweza (2018) South Africa | Cross-sectional survey 2015 | Patients (1255) | Estimated the proportion of patients missed by PHCs using surveys and testing. | Diagnosis | Structural and patient dimensions | HS missed most patients with TB attending PHCs for TB-related symptoms and for other reasons. | A |
| 15 | McLaren (2017) South Africa | Healthcare evaluation 2004–2011 | 26 million tests in 429 hospitals | Assessed quality of care in public health facilities by analysing National Health Laboratory Service database for TB tests . | Diagnosis | Structural and patient dimensions | Facilities not adhering to national standards for TB testing. However, DST rates improved steadily over time. Testing rates were transiently affected by policy and guideline changes. | B |
| Quantitative studies | ||||||||
| 16 | Metcalfe et al (2016) Zimbabwe | Prospective study: 2011– 2014 | Patients (352) | Diagnostic accuracy and TTI for Xpert were compared with culture and DST. | Diagnosis and treatment | Structural and patient dimensions | Rapid diagnosis with Xpert was not, in itself, enough to remove health system delays to treatment initiation. | A |
| 17 | Mohr (2017) South Africa | Retrospective cohort study 2012– 2014 | Patients (543) | Analysed records of diagnosed patients to assess proportion that could have been diagnosed earlier. | Diagnosis | Structural dimensions | Lack of guideline adherence led to patients not being diagnosed. | A |
| 18 | Moyo et al (2015) South Africa | Retrospective analysis study: 2008–2013 | Adolescent patients (71) | Analysed data for adolescents patients to describe frequency of treatment success or failure, loss to follow-up and deaths. | Treatment | Structural and patient dimensions | Treatment refusal and loss to follow-up were the predominant reasons for non-initiation of treatment. | A |
| 19 | Naidoo (2014) South Africa | Observational analysis of 10 facilities 2008– 2012 | Patients (541) | Study compared TTI in MDRTBPlus Line Probe Assay vs Xpert-based algorithms. | Diagnosis and treatment | Structural and patient dimensions | Xpert reduced TTI by reducing LTAT. However, patients were being delayed by other steps needed before treatment initiation. | A |
| 20 | Nkosi (2013) South Africa | Cross-sectional survey 2008 | Patients (148) | Determined reasons for non-referral of DR-TB patients. | Treatment | Structural and patient dimensions | Poor HCW knowledge of the national DR-TB guidelines, and patients loss to follow-up contributed to non-referrals. | A |
| 21 | Oga-Omenka et al (2019) Nigeria | Retrospective cohort study. 2015– 2017 | Patients (996) | Examined treatment rates and TTI using 2015 the TB programme records. | Treatment | Structural and patient dimensions | Geographic location and level of healthcare influenced patient treatment initiation within the time recommended by the National guidelines. | A |
| Quantitative studies | ||||||||
| 22 | Oliwa et al (2018) Kenya | Cross-sectional study: 2015 | Patients (82 313) | Analysed National TB programme data for case notification rates, and capacity to perform diagnostic tests. | Diagnosis | Structural and patient dimensions | Despite guideline specifications, Xpert use was suboptimal, negatively affecting diagnosis, especially in children and low risk groups. | A |
| 23 | Timire et al (2019) Zimbabwe | Cohort study 2017– 2018 | Patients (133) | Determined the impact of the Hain technology (timeliness and proportion of DST tests). | Diagnosis and treatment | Structural and patient dimensions | While decentralisation and treatment access positively impacted TTI, distance from the NRL hindered timely collection and return of DST. | A |
| 24 | Van Den Handel (2015) South Africa | Prospective evaluation of different diagnostic approaches 2011– 2013 | Patients (1449) | Determined the impact of Xpert and decentralisation on patient care in areas with poor access to laboratory services. | Diagnosis | Structural dimensions | Xpert introduction and decentralisation impacted treatment rates and timelines, but did not significantly increase rates of detection. | A |
| Mixed-methods studies | ||||||||
| 25 | Doulla et al (2019) Tanzania | Qualitative FGDs, IDIs: 2012 Quantitative cross-sectional sample analysis: 2011– 2013 | Qualitative 45 HCW Quantitative 2759 samples | Evaluated the effectiveness and stakeholder perception of routine surveillance system for previously treated TB cases. | Diagnosis | Structural dimensions | Delayedspecimen transportation, lack of resources and other laboratory challenges (eg, miscommunication, inconsistent training, etc) delayed diagnosis. | A |
| 26 | Mpagama et al (2019) Tanzania | Retrospective cohort study and cross-sectional study: 2015 | 28 TB districts 399 patients | Identified healthcare barriers to implementation of molecular diagnostics and TB collaborative practices in HIV clinics. | Diagnosis and treatment | Structural and patient dimensions | Overall, underdiagnosesoccurred where drug resistance is expected to be prevalent. HCWs lacked the tools, expertise and knowledge to appropriately manage patients with TB. | B |
| Mixed-methods studies | ||||||||
| 27 | Mnyambwa et al (2018) Tanzania | Retrospective cohort study: 2013– 2016 Qualitative: IDIs | Chart review: patients (782) Qualitative interviews: TB coordinators (27) | Assessed the effectiveness of the Xpert GxAlert platformon linkage of patients to care. | Diagnosis and treatment | Structural and patient dimensions | Although the GxAlert platform improved diagnosis, healthcare inconsistencies impaired correct management of patients. | B |
| 28 | Westhuizen et al (2017) South Africa | Cross-sectional study: 2015 | Medical students (12) | Determined the frequency and impact of occupational TB disease in current medical students and recently graduated doctors. | Diagnosis and treatment | Structural and patient dimensions | Overall, medical students did not have adequate access to the support and services needed for all TB care, including DR-TB. | B |
| 29 | Zimri (2012) South Africa | Qualitative FGDs and quantitative case control 2011 | 10 FGD with parentsand providers; Case control: 50 patients each arm | Caregivers of children referred to a specialist paediatric MDR-TB clinic to determine why many child contacts were not brought for assessment. | Diagnosis | Structural and patient dimensions | HCW attitude, coloured ethnicity, the mother being the source case, having a smoker in the house, transport time, cost and number of transitions, and fear of infection were identified as barriers. | A |
DR-TB, drug-resistant TB; DST, drug-sensitivity testing; FGDs, focus group discussions; HCW, healthcare worker; HS, health system; IDI, in-depth interviews; KIIs, key informant interviews; LPA, line probe assay; LTAT, Laboratory turn-around time; MDR, multidrug-resistant TB; MGIT, mycobacteria growth indicator tube; NA, not applicable; NRL, National or Central Reference Laboratory; PHC, Primary Health Clinics; RR-TB, rifampicin-resistant TB; TB, tuberculosis; TTI, time to treatment initiation; Xpert, GeneXpert MTB/RIF Assay.