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SAMJ: South African Medical Journal

On-line version ISSN 2078-5135
Print version ISSN 0256-9574

SAMJ, S. Afr. med. j. vol.109 n.4 Pretoria Apr. 2019


The Granada medium detected more positive GBS than the Xpert GBS (70 v. 66). The colonies on the medium were easily identified based on the orange colour. In addition, these colonies could be picked off without any difficulty. Twenty-four hours of incubation under anaerobic conditions was adequate and prolonged incubation was not necessary.

Initial Xpert GBS results were not available for 43 specimens (15.1%). In these cases, the instrument generated messages that included 'error' (24 specimens), 'invalid' (12 specimens) and 'no result' (6 specimens). These initial rates where results were unavailable were much higher than the 10.8% reported by El Helali et al.[8] or the 8.2% claimed by the manufacturer. However, they were found to be similar to rates reported in a Korean study by Park et al.[12] The major causes of invalid and error results were PCR inhibition and high syringe pressure exceeding the cut-off point, respectively. The presence of significant amounts of mucus or faeces in a sample is known to inhibit PCR and block the microfluidic channel in the cartridge. This effect was minimised in two ways. Firstly, excess mucus/secretions were wiped away at the point of collection, as recommended by the manufacturers. Secondly, a sterile gauze swab was used to wipe away excess mucus/faeces immediately prior to loading the swab into the Xpert GBS cartridge. The high error rate in this study could be a potential disadvantage to routine use of this assay as it would significantly escalate costs when repeat testing is warranted.

The cost of the Xpert GBS cartridge at the time of conducting this study was ZAR300.00 (USD30.45) per cartridge, whereas the cost of culture using Granada agar was ZAR19.00 - 154.00 (USD1.92 - 15.63) per test, depending on whether the CAMP test or latex agglutination was used to confirm the identity of the isolated colonies, respectively. Culture is therefore far cheaper, and this difference in cost will be more pronounced if repeat testing has to be done (15% of samples for Xpert GBS in this study).

The cost of the CDC-recommended culture method for screening for GBS is about the same as using Granada agar. The cost would amount to between ZAR19.75 and ZAR165.00 (USD2.00 - 16.75) per test depending on whether the CAMP test or latex agglutination is used to identify the colonies, respectively. It further has the disadvantage of a longer turnaround time of 48 - 72 hours compared with the Granada medium (24 - 48 hours).

The sensitivity of Xpert GBS compared with culture in this study (87%) was found to be lower than that detected in three other studies (95.8 - 98.5%),[8,13,14] but was comparable to the Korean study,[12] which showed a sensitivity of 86%. The specificity was consistent with other studies.[8,12-14]

Nine cases were Xpert GBS-negative and culture-positive. This could be due to the low bacterial load, which would be considered to be below the limit of detection of the assay. The limit of detection reported by Park et alS [12] was 300 colony-forming units per swab. In the 5 cases that were Xpert GBS-positive and culture-negative, it is possible that the Xpert GBS detected the cfb gene in non-viable GBS, or that other organisms such as enterococci hindered the isolation of GBS. Another possible explanation is that the Granada medium does not support the growth of non-haemolytic GBS colonies. Between 1% and 2% of GBS colonies are non-haemolytic.[15]

Although the Xpert GBS has been evaluated in other countries such as France and Korea, it is not used routinely in clinical practice.[8,12] In SA it is not even currently routine to screen for GBS in pregnancy in the public sector, let alone suggesting a method for screening. In our opinion, the current role of Xpert GBS is therefore for private obstetricians to use the test, either in their rooms or in the labour ward when a woman presents in labour. If GBS screening becomes routine practice in SA, the Xpert GBS could be considered as it can be used on the same machines/modules that are currently used to run the Xpert MTB/Rif test for tuberculosis. However, the cost of the cartridge will determine this.

The major advantage of the Xpert GBS assay is the rapid turnaround time of 37 - 55 minutes. It is also relatively easy to perform and therefore possible to use as a potential point-of-care assay. However, in resource-limited settings like SA, culture may be the only option available for the detection of GBS. This study clearly showed that the Granada medium has the advantage of easy and early detection of GBS with no significant escalation in the cost of culture.

Study limitations

A limitation was that this was a single-centre study. As a result, there could be a potential source of bias in the selection of patients. Another potential source of bias may be that participants were only selected from the antenatal clinic and not from other sites at Kalafong Hospital such as the labour ward or the obstetrics and gynaecology wards. A further limitation was that the exact running time for each Xpert GBS test was not recorded. As a result, we could not determine factors such as the median duration and interquartile range for this test. In addition, participants with missing data could have been traced back to retrieve the data. A shortcoming of the study design was that it was purely a laboratory-based study comparing two assays.



Compared with the standard culture method, the Xpert GBS assay is a rapid and sensitive tool for prenatal detection of GBS. Ideally, it is a point-of-care test that should be used in the labour ward when a patient presents in labour. In view of the high primary error rate (17%) experienced in our study, the financial feasibility of potential uses will need to be evaluated further.

Declaration. The research described in this article was an MMed project of MS, the main author.

Acknowledgements. Prof. Anwar Hoosen, University of the Free State, critically revised the final draft of the manuscript.

Author contributions. MS: collection of specimens, laboratory processing of specimens, analysis of data, writing up of article; YD: laboratory processing of specimens, analysis of data; NM: writing up of article; AS: collection of specimens; MRL: writing up of article; FI: collection of specimens, laboratory processing of specimens, analysis of data, writing up of article.

Funding. The research was funded by a National Health Laboratory Services Research Grant (no. 94443) in fulfilment of MS's MMed project.

Conflicts of interest. None.



1. Winn HJ. Group B streptococcus infection in pregnancy. Clin Perinatol 2007;34(3):387-392.        [ Links ]

2. Koenig JM, Keenan WJ. Group B streptococcus and early onset sepsis in the era of maternal prophylaxis. Pediatr Clin North Am 2009;56(3):689-708.        [ Links ]

3. Chan SHS, Wan KH, Lee WH. Review on group B streptococcus infection. Hong Kong J Paediatr 2000;31(5):166-174.         [ Links ]

4. Madhi SA, Radebe K, Crewe-Brown H, et al. High burden of invasive Streptococcus agalactiae disease in South African infants. Ann Trop Paediatr 2003,23(1):15-23.        [ Links ]

5. Verani JR, McGee L, Schrag SJ. Prevention of perinatal group B streptococcal disease: Revised guidelines from CDC, 2010. MMWR 2010;59(RR-10):1-32. (accessed 19 October 2018).         [ Links ]

6. Rosa-Fraile M, Rodriguez-Granger J, Cueto-Lopez M, et al. Use of Granada medium to detect group B streptococcal colonization in pregnant women. J Clin Microbiol 1999;37(8):2674-2677.         [ Links ]

7. Morita T, Feng D, Kamio Y, et al. Evaluation of ChromID Strepto B as a screening media for Streptococcus agalactiae. BMC Infect Dis 2014;14:46.        [ Links ]

8. El Helali N, Nguyen JC, Ly A, et al. Diagnostic accuracy of a rapid real-time polymerase chain reaction assay for universal intrapartum group B streptococcus screening. Clin Infect Dis 2009;49(3):417-423.        [ Links ]

9. Picard FJ, Bergeron M. Laboratory detection of group B streptococcus for prevention of perinatal disease. Eur J Clin Microbiol Infect Dis 2004;23(9):665-671.        [ Links ]

10. Hallett AF, Govender P, Pillay SS, et al. Group B streptococci in blacks. S Afr Med J 1979;55(5):157-159.         [ Links ]

11. Kwatra G, Adrian PV, Shiri T, et al. Serotype-specific acquisition and loss of group B streptococcus recto-vaginal colonisation in late pregnancy. Plos One 2014;9(6):e98778.        [ Links ]

12. Park J, Cho D, Yang J, et al. Usefulness of a rapid real-time PCR assay in prenatal screening for group B streptococcus colonization. Ann Lab Med 2013;33(1):39-44.        [ Links ]

13. Church DL, Baxter H, Lloyd T, et al. Evaluation of the Xpert® group B streptococcus real-time polymerase chain reaction assay compared to StrepB Carrot Broth for the rapid intrapartum detection of group B streptococcus colonization. Diagn Microbiol Infect Dis 2011;69(4):460-462.        [ Links ]

14. Gavino M, Wang E. A comparison of a new rapid real-time polymerase chain reaction system to traditional culture in determining group B streptococcus colonization. Am J Obstet Gynecol 2007;197(4):388.e1-4.        [ Links ]

15. Edwards MS, Baker CJ. Streptococcus agalactiae (group B streptococcus). In: Bennett JE, Dolin R, Blaser MJ, eds. Mandell, Douglas and Bennett's Principles and Practice of Infectious Diseases. 8th ed. Philadelphia: Elsevier Saunders, 2015:2340-2347.         [ Links ]



M Said

Accepted 18 May 2018

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A contextualisation approach to health promotion guideline development in South Africa



N SiegfriedI; B DraperII; G DraperIII; M PorterIV; C BonaconsaV; J HunterVI; L Moeng-MahlanguVII; S AsmallVIII

IMB ChB, MPH Hons, FCPHM (SA), DPhil; Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Cape Town, South Africa
IIMB ChB, MMed (PH), PGDip Psych; Private consultant, Cape Town, South Africa
IIIMB ChB, MSc (Mother and Child Health), FCOG (SA), MPhil (Higher Education), PGDip Educational Technology; Private consultant, Cape Town, South Africa
IVMB ChB, MPH; Independent researcher and public health consultant, Elliotdale, South Africa
VBCur, MSc (Nursing); Department of Paediatrics and Child Health, Faculty of Health Sciences, University of Cape Town, South Africa
VIBA (Cur), PGDip Health Services Management, MBA; Primary Health Care, National Department of Health, Pretoria, South Africa
VIIMSc (Dietetics); Health Promotion and Nutrition, National Department of Health, Pretoria, South Africa
VIIIMB ChB; Health System Strengthening: Primary Health Care, National Department of Health, Pretoria, South Africa





BACKGROUND. Risk factors for chronic illness contribute significantly to the disease burden in South Africa. The National Department of Health (NDoH) commissioned the development of a toolkit of health promotion guidelines for use by healthcare professionals working in the primary care setting to address this burden.
OBJECTIVES. To (i) demonstrate the contextualisation approach to evidence-based health promotion recommendations; and (ii) present the development process of a contextually sensitive and illustrated fit-for-purpose product.
METHODS. A contextualised approach was used whereby evidence from rigorous guidelines produced elsewhere was tailored to local conditions. The scope of the toolkit included five risk factors and 22 conditions identified by the NDoH and was underpinned by the Theory of Planned Behaviour. Potential health promotion messages relevant to risks, conditions or both were formulated as population, intervention, comparison and outcome (PICO) questions. The team searched for and selected evidence for each PICO question in a stepwise hierarchical manner and categorised sources as: (i) World Health Organization (WHO) guidelines; (ii) Cochrane systematic reviews; and (iii) non-Cochrane systematic reviews. Those messages supported by source-based evidence were included in the toolkit with culturally appropriate illustrations. Regular engagement with stakeholders included an initial health department stakeholder consultation, a focus group with national programme managers on the appearance and content of a draft toolkit, and a presentation of the final draft at a forum of provincial managers. Final approval of the toolkit rested with programme representatives.
RESULTS. A total of 152 PICO questions were formulated. Supporting evidence was identified from 42 current WHO guidelines and 45 Cochrane systematic reviews to answer 147 PICO questions with several guidelines relevant to more than one risk or condition. Evidence for a further five PICO questions was obtained from non-Cochrane systematic reviews. Six additional service delivery messages and four 'no harm' messages were included to align the toolkit with current national guidelines. The illustrated toolkit was well received by stakeholders nationally and provincially, with programme managers expressing a high degree of willingness to adopt a preventive approach in the primary care clinic setting.
CONCLUSIONS. Use of a tailored contextualised approach to health promotion guidelines resulted in a culturally appropriate tool based on evidence gathered from rigorous sources and probably reduced development time and costs. Adherence to a robust framework to identify evidence ensured that the toolkit conforms to international guideline development standards.



South Africa (SA) faces a quadruple burden of disease comprising communicable, non-communicable, perinatal and maternal, and injury-related disorders.[1] In 2010, the highest proportion of disability-adjusted life-years lost in SA was attributable to preventive factors including alcohol use, high body mass index, high blood pressure, dietary risks and smoking (when unsafe sex is excluded as a separate risk factor).[2]

SA has adopted the principles of universal health coverage, and the introduction of national health insurance in the country is anticipated.[3] Within this policy arena, there is a shift from a curative, facility-centred service delivery model of healthcare to preventive health promotion through patient empowerment.[4] Several condition-based national guidelines incorporate health promotion messages, but no national guidelines for health promotion in primary care exist. In 2015, to address this gap, the National Department of Health (NDoH) commissioned the development of a toolkit of health promotion guidelines specifically for use in primary care.

Guideline development methodology has gained increasing prominence in the knowledge translation field over the past decade. Guidelines are ideally created through a process of expert public consultation following evidence collation and interpretation in the context of other factors including priority, affordability, feasibility and acceptability.[5] While such processes may lead to rigorous and fit-for-purpose guidelines, the process is often lengthy and expensive. Several alternative approaches to guideline formulation have been defined, including: (i) adoption of guidelines already in existence with limited changes to the key messages prior to implementation; (ii) contextualisation, where guidelines produced elsewhere can be adopted but additional information is required to fit local conditions; and (iii) adaptation, where guidelines produced elsewhere are amended to include local research evidence and expert group consensus.[6-8] Alternative approaches are likely to provide more efficient use of resources and have particular applicability in resource-constrained settings. A further approach which combines adoption, adaptation and de novo guidelines development has recently been described and labelled adolopement.[9]



In this article we demonstrate how we tailored the methodology of a guidelines contextualisation approach to ensure that the health promotion recommendations contained in the primary care Health for All toolkit were evidence based, of high quality and up to date, and relevant to SA. We further present the parallel process undertaken to develop a contextually sensitive and illustrated fit-for-purpose product for primary care providers and their clients.




Inclusion criteria

Before development commenced, the NDoH specified that the toolkit conform to the following: (i) be a clinical tool for use by health professionals at primary care facilities; (ii) be used in one-on-one consultation with presenting clients; (iii) focus on five key risks of chronic illness, namely diet and nutrition, lack of physical activity, tobacco use, harmful alcohol and drug use, and unsafe sexual behaviours; and (iv) align with specific current programme policies and existing national clinical guidelines.

At the time of development of the toolkit, a guideline for the management of clinical conditions, Primary Care 101 (PC101), was already well established in SA primary care facilities.[10] The intention of the toolkit was to supplement the clinical guidelines by identifying and mitigating risk in both healthy clients and those with existing conditions. The toolkit would equip healthcare workers with tools to guide clients to live well and prevent further complications within their own locus of control.

During the development process, the NDoH expanded the scope beyond a risk-based approach to include a conditions-based health promotion approach to 22 common communicable and chronic non-communicable diseases, mental health, sexual reproductive health, cancer and oral health (Table 1).

Exclusion criteria

Activities that form part of regular provision of healthcare services, either by the healthcare professional directly or by the broader health system, were excluded from the development process. For example, a recommendation that a patient with tuberculosis should seek HIV counselling and testing was considered an action that the treating healthcare professional should encourage and arrange for referral, rather than an action that the patient would be encouraged to pursue on their own. Upstream determinants of health were also not considered, e.g. regulations to restrict salt in foodstuffs or environmental risks.

Establishing underlying principles

An initial literature review was conducted to identify appropriate and effective health promotion strategies and principles to underpin the toolkit. These were shared and agreed with the NDoH prior to commencement of the project and included: (i) recognition of the importance of self-management; (ii) visual representation of risk; (iii) cultural appropriateness; and (iv) the promotion of health literacy. As there are several theories of behavioural change, we identified the Theory of Planned Behaviour to inform and guide development of the toolkit.[11] According to the model, behavioural intention is primarily influenced by a person's attitude and subjective norms, but recognises that perceived behavioural control also modifies intention. Based on systematic review evidence, motivational interviewing techniques incorporating those used in brief interventions were selected as the communication method to deliver the toolkit recommendations.[12]

The principles of evidence-based healthcare to promote rigorous research methods to identify and appraise all available evidence formed the theoretical foundation for the inclusion of recommendations.[13] Specifically, we recognised that guidelines based on well-conducted systematic reviews should form the basis of all included recommendations.

Appearance of the toolkit

The NDoH requested that the appearance of the toolkit reflect other guidelines already in use in primary care. Additionally, the toolkit would stand on the desk with a page of detailed informative text facing the provider and a page of illustrated messages facing the patient for each risk and condition. Premised on individuals' limited capacity to recall information and comply with only a limited number of resolutions,[14] five actionable ('to do') messages would be linked to each risk and condition. Healthcare providers would be encouraged to present a maximum of two 'to do' messages to a patient for their consideration. Illustrations would be used to depict all the included health promotion messages and would be culturally sensitive to improve comprehension and recall of messages.[15] The development team contracted a graphic designer familiar with the healthcare setting to conceptualise and produce the appearance and illustrations within a typical SA local community thematic.

Evidence application Question formulation

At the outset, the development team generated a list of health promotion messages sourced from current national primary care guidelines, the Essential Drugs List and condition-specific guidelines developed by local clinical associations (list available from authors). In addition, health promotion messages in the SA managed healthcare sector were sourced and a search for country-level health promotion guidelines was conducted. Those considered relevant to the SA context were included, and were primarily Canadian and Australian health promotion guidelines with a focus on indigenous populations.[16-18]

The team supplemented the above with messages drawn from their extensive clinical experience (including primary healthcare, certain medical specialties, nursing, dietetics and public health), and engagement with peer networks to develop a matrix of health promotion messages linked to each of the identified risks and conditions (Fig. 1). Together the members of the development team then systematically evaluated each of the messages for the following: (i) did the message include an 'actionable' intervention; and (ii) was it theoretically possible for the client to adopt the intervention activity into their lives.



If the above criteria were met, the message was reformulated as a research question using the PICO format (P = population, I = intervention, C = comparison, O = outcome). For many messages, it was necessary first to articulate whether the intervention itself was effective and then secondly to identify whether promoting the intervention was effective. For example, a message to promote exercise in people with osteoarthritis required identification of both whether physical activity is effective for osteoarthritis and if so, whether promotion of the physical activity is effective. Within the PICO question, the specific primary outcome also required articulation. The final PICO question was therefore reformulated as: 'Does physical activity (I) and promotion thereof compared with no activity (C) reduce the pain (O) experienced by people with osteoarthritis (P)?'

Evidence algorithm

For each PICO, we searched for evidence using a predetermined algorithm in a stepwise hierarchical approach to determine inclusion or exclusion of each health message.

Step 1 involved a search of World Health Organization (WHO) content webpages mapped to each of the five risks or 22 conditions to identify guidelines (2010 onwards) that used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to formulate recommendations.[5] WHO guidelines are aimed at low- and middle-income countries and are therefore likely to be relevant to the SA setting. The GRADE approach is a widely used method to appraise overall quality of evidence that includes evaluation of risk of bias, imprecision, indirectness and inconsistency in evidence syntheses.[19] It is a useful indicator of the rigour of guideline development. Where a recommendation relevant to the PICO was identified in a WHO guideline, it was marked for possible inclusion in the toolkit and no further search was undertaken; if no recommendation was identified, step 2 was activated.

Step 2 involved a search of the Cochrane Library for relevant Cochrane systematic reviews (2010 onwards) using search terms for the risks and conditions. Cochrane reviews are widely recognised as the gold standard of systematic reviews of effectiveness,[20] and conducting a GRADE assessment[19] of the quality of the evidence is mandatory. If evidence was available from a Cochrane review to inform the PICO, it was marked for possible inclusion; if no relevant review was identified, step 3 was undertaken.

Step 3 comprised a comprehensive search of the PubMed and Embase databases using a syntax strategy of terms related to the intervention and/or population in the PICO and filtered by study design (systematic review and randomised controlled trial). Where relevant non-Cochrane systematic reviews of effectiveness were identified, we selected the review based on the most recent date of publication combined with the presence of randomised controlled trials in the review study selection criteria and use of a quality appraisal approach to rate the evidence, such as GRADE or a comparable approach. If more than one review met the criteria or if reviews included different studies, we applied the AMSTAR tool to each review to appraise its quality, and selected the review of higher quality for inclusion.[21] Had no reviews been identified, we had planned to conduct a de novo systematic review, but in the event this was not necessary.

We contacted technical leads at the WHO directly when uncertainties existed as to the inclusion of GRADE in a WHO guidelines process. We also contacted authors of Cochrane reviews and Cochrane editors to access review results if the review was identified at the protocol stage.

Following on from the stepwise selection process, a separate evidence source document was compiled in tabular form, colour-coded by source type and including the recommendation or message as presented in the evidence source, the reference(s), the level of evidence, and alignment with national guidelines where relevant.

Selection of health promotion message

A maximum of five key health promotion ('to do') messages were selected for each risk and condition. Messages were prioritised according to quality of the evidence (high-quality effectiveness data were preferable), relevance to the local setting, and feasibility including affordability to the client. Where more than five messages existed per risk or condition, additional messages were included only when considered vital in addressing the burden of disease. Final selection was achieved through consensus within the development team.

Engagement with stakeholders

The development-feedback timeline included: (i) an internal national departmental key stakeholder engagement meeting and focus group held in May 2015 to finalise the scope and proposed toolkit format; (ii) a consultation with national departmental programme managers in August 2015, where a draft version of the toolkit, including a sample graphic of a condition and risk section, was presented and written feedback was invited; and (iii) a national forum comprising national and provincial departmental representatives in November 2015, where the final draft of the toolkit was showcased and commentaries were invited.

Ethical considerations

This article reports a development process commissioned by the NDoH, and ethics approval was not required.



Evidence application

A total of 152 PICO questions were formulated. We identified evidence from 42 current WHO guidelines and 45 Cochrane systematic reviews to answer 147 PICO questions (several guidelines were relevant to more than one risk or condition). As no evidence was forthcoming from WHO guidelines or Cochrane reviews for five PICO questions, we conducted comprehensive searches of PubMed and Embase to identify evidence from non-Cochrane systematic reviews of effectiveness in support of each PICO question (Table 2).[22-26]

In addition to the PICO-based health messages, there were six messages that were classified as service delivery messages (for example, 'Know your HIV status') and four that were included as 'no harm' messages upon request by the national department to ensure alignment with national guidelines.

Several health promotion messages were linked to more than one risk or condition. For example, a message to increase physical activity was pertinent to the risk factor of lack of physical activity, overweight and obesity, and for multiple conditions including hypertension, cardiovascular disease and diabetes. Therefore, in the final format, the toolkit includes 34 discrete 'to do' health promotion messages for the risk factors and 98 discrete 'to do' messages for the included conditions.

Engagement with stakeholders

At the first focus group held within the NDoH, stakeholders requested that consideration be given to the socioeconomic and cultural context of users of the health services during the development of the toolkit. They also requested that the toolkit be illustrated, colourful and user friendly. These concerns were addressed prior to the presentation of the draft toolkit at the consultation with programme managers within the NDoH, many of whom provided written feedback on sections relevant to their programmes.

At the national forum where the final draft was showcased, over 90% of 95 participants felt that the toolkit was contextually appropriate (Fig. 1) and supported the shift in approach from a disease model to a risk-based approach to achieving a healthy lifestyle. Participants raised two challenges to the implementation of the toolkit: (i) language was limited to English, which is not the first language of most presenting clients; and (ii) overburdening staff with the introduction of a new guideline into a resource-strapped system. Despite these concerns, there was widespread support from directors and programme managers from all nine provinces for embedding health promotion and health risk mitigation within the overall responsibility of healthcare providers.



Main findings

The Health for All health promotion toolkit is the first national comprehensive suite of health promotion guidelines aimed at addressing both health risk behaviours and health conditions of clients presenting to primary care facilities. As such it allows healthcare providers to identify and mitigate risk, even in healthy patients, and serves as a guide to clients to live well with existing conditions and prevent further complications. Development of the toolkit employed a guidelines contextualisation approach to ensure that all health promotion messages were based on evidence retrieved through rigorous methods. The approach was tailored so that messages selected for inclusion were based on feasibility and relevance to the local context in SA.

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