Browsing by Author "Bachmann, Max"

Now showing 1 - 16 of 16
  • Thumbnail Image
    Item
    Open Access
    Acceptability to general practitioners of national health insurance and capitation as a reimbursement mechanism
    (1999) Blecher, Mark Stephen; Bachmann, Max; McIntyre, Di
    Objective: The objectives of the study were to determine General Practitioners' attitudes to National Health Insurance (NHI) and to capitation as a mechanism of reimbursement. The study also aimed to explore determinants of these attitudes. Design: The methodology utilised a cross-sectional survey using telephone interviews and four focus group discussions. Setting: The study area was the Cape Peninsula area in the Western Cape Province of South Africa. Participants: 174 general practitioners (GPs) were randomly sampled from a total population of 874 GPs in the Cape Peninsula area. Main outcome measures: The main outcome measures were GPs' acceptance of NHI and of capitation as a method of reimbursement. Main results: Sixty three percent of GPs (63,3%) approved of NHI. More than 81 % approved of NHI if GPs were to maintain their independent status, for example their own premises and working hours. Eighty two percent (82,3%) said NHI would be a more equitable system of health care than the system that existed at that time, 88% approved of the fact that NHI would make care by GPs more accessible and 73% said they had the capacity to treat more patients. However, 61,3% of GPs disapproved of capitation as a form of reimbursement. The most common conditions cited by GPs for support of NHI were retention of professional autonomy, fee for service reimbursement and adequate levels of reimbursement. Conclusions: Most GPs in the Cape Peninsula were amenable to some form of NHI. However, approval of NHI is to some extent conditional to details of the NHI system, such as payment mechanisms, workload, income and effects on professional autonomy. The implications of GPs' preferences concerning the reimbursement mechanism for the feasibility of implementing a NHI in South Africa requires serious consideration by policy makers. While this research demonstrates broad ideological and conceptual support for some form of NHI or SHI, further research is required to provide more detailed quantitative information on the trade-offs that GPs would be prepared to make for them to support the introduction of a new socially based insurance system. A national survey of medical practitioners is recommended.
  • Thumbnail Image
    Item
    Open Access
    Addressing the quality and scope of paediatric primary care in South Africa: evaluating contextual impacts of the introduction of the Practical Approach to Care Kit for children (PACK Child)
    (2020-05-29) Murdoch, Jamie; Curran, Robyn; Cornick, Ruth; Picken, Sandy; Bachmann, Max; Bateman, Eric; Simelane, Makhosazana L; Fairall, Lara
    Background Despite significant reductions in mortality, preventable and treatable conditions remain leading causes of death and illness in children in South Africa. The PACK Child intervention, comprising clinical decision support tool (guide), training strategy and health systems strengthening components, was developed to expand on WHO’s Integrated Management of Childhood Illness programme, extending care of children under 5 years to those aged 0–13 years, those with chronic conditions needing regular follow-up, integration of curative and preventive measures and routine care of the well child. In 2017–2018, PACK Child was piloted in 10 primary healthcare facilities in the Western Cape Province. Here we report findings from an investigation into the contextual features of South African primary care that shaped how clinicians delivered the PACK Child intervention within clinical consultations. Methods Process evaluation using linguistic ethnographic methodology which provides analytical tools for investigating human behaviour, and the shifting meaning of talk and text within context. Methods included semi-structured interviews, focus groups, ethnographic observation, audio-recorded consultations and documentary analysis. Analysis focused on how mapped contextual features structured clinician-caregiver interactions. Results Primary healthcare facilities demonstrated an institutionalised orientation to minimising risk upheld by provincial documentation, providing curative episodic care to children presenting with acute symptoms, and preventive care including immunisations, feeding and growth monitoring, all in children 5 years or younger. Children with chronic illnesses such as asthma rarely receive routine care. These contextual features constrained the ability of clinicians to use the PACK Child guide to facilitate diagnosis of long-term conditions, elicit and manage psychosocial issues, and navigate use of the guide alongside provincial documentation. Conclusion Our findings provide evidence that PACK Child is catalysing a transition to an approach that strikes a balance between assessing and minimising risk on the day of acute presentation and a larger remit of care for children over time. However, optimising success of the intervention requires reviewing priorities for paediatric care which will facilitate enhanced skills, knowledge and deployment of clinical staff to better address acute illnesses and long-term health conditions of children of all ages, as well as complex psychosocial issues surrounding the child.
  • Thumbnail Image
    Item
    Open Access
    Addressing the quality of paediatric primary care: health worker and caregiver perspectives from a process evaluation of PACK child, a health systems intervention in South Africa
    (2021-01-28) Curran, Robyn; Murdoch, Jamie; Bachmann, Max; Bateman, Eric; Cornick, Ruth; Picken, Sandra; Simelane, Makhosazana L; Fairall, Lara
    Background The WHO’s Integrated Management of Childhood Illness (IMCI) has resulted in progress in addressing infant and child mortality. However, unmet needs of children continue to present a burden upon primary healthcare services. The capacity of services and quality of care offered require greater support to address these needs by extending and integrating curative and preventive care for the child with a long-term health condition and the child older than 5, not prioritised in IMCI. In response to these needs, the PACK Child intervention was developed and piloted in October 2017–February 2019 in the Western Cape Province of South Africa. We report health worker and caregiver perspectives of the existing paediatric primary care context as well as the extent to which PACK Child functions to address perceived problems within the current local healthcare system. Methods This process evaluation involved 52 individual interviews with caregivers, 10 focus group discussions with health workers, 3 individual interviews with trainers, and 31 training observations. Interviews and focus groups explored participants’ experiences of paediatric primary care, perspectives of the PACK Child intervention, and tensions with implementation in each context. Inductive thematic analysis was used to analyse verbatim interview and discussion transcripts. Results Perspectives of caregivers and health workers suggest an institutionalised focus of paediatric primary care to treating children’s symptoms as acute episodic conditions. Health workers’ reports imply that this focus is perpetuated by interactions between contextual features such as, IMCI policy, documentation-driven consultations, overcrowded clinics and verticalised care. Whilst these contextual conditions constrained health workers’ ability to translate skills developed within PACK Child training into practice, the intervention initiated expanded care of children 0–13 years and those with long-term health conditions, enhanced professional competence, improved teamwork and referrals, streamlined triaging, and facilitated probing for psychosocial risk. Conclusion PACK Child appears to be catalysing paediatric primary care to address the broader needs of children, including long-term health conditions and the identification of psychosocial problems. However, to maximise this requires primary care to re-orientate from risk minimisation on the day of attendance towards a view of the child beyond the day of presentation at clinics.
  • Thumbnail Image
    Item
    Open Access
    Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial
    (BioMed Central, 2018-03-22) Fairall, Lara; Petersen, Inge; Zani, Babalwa; Folb, Naomi; Georgeu-Pepper, Daniella; Selohilwe, One; Petrus, Ruwayda; Mntambo, Ntokozo; Bhana, Arvin; Lombard, Carl; Bachmann, Max; Lund, Crick; Hanass-Hancock, Jill; Chisholm, Daniel; McCrone, Paul; Carmona, Sergio; Gaziano, Thomas; Levitt, Naomi; Kathree, Tasneem; Thornicroft, Graham
    Background The scale-up of antiretroviral treatment (ART) programmes has seen HIV/AIDS transition to a chronic condition characterised by high rates of comorbidity with tuberculosis, non-communicable diseases (NCDs) and mental health disorders. Depression is one such disorder that is associated with higher rates of non-adherence, progression to AIDS and greater mortality. Detection and treatment of comorbid depression is critical to achieve viral load suppression in more than 90% of those on ART and is in line with the recent 90-90-90 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets. The CobALT trial aims to provide evidence on the effectiveness and cost-effectiveness of scalable interventions to reduce the treatment gap posed by the growing burden of depression among adults on lifelong ART. Methods The study design is a pragmatic, parallel group, stratified, cluster randomised trial in 40 clinics across two rural districts of the North West Province of South Africa. The unit of randomisation is the clinic, with outcomes measured among 2000 patients on ART who screen positive for depression using the Patient Health Questionnaire (PHQ-9). Control group clinics are implementing the South African Department of Health’s Integrated Clinical Services Management model, which aims to reduce fragmentation of care in the context of rising multimorbidity, and which includes training in the Primary Care 101 (PC101) guide covering communicable diseases, NCDs, women’s health and mental disorders. In intervention clinics, we supplemented this with training specifically in the mental health components of PC101 and clinical communications skills training to support nurse-led chronic care. We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual). The co-primary patient outcomes are a reduction in PHQ-9 scores of at least 50% from baseline and viral load suppression rates measured at 6 and 12 months, respectively. Discussion The trial will provide real-world effectiveness of case detection and collaborative care for depression including facility-based counselling on the mental and physical outcomes for people on lifelong ART in resource-constrained settings. Trial registration ClinicalTrials.gov ( NCT02407691 ) registered on 19 March 2015; Pan African Clinical Trials Registry ( 201504001078347 ) registered on 19/03/2015; South African National Clinical Trials Register (SANCTR) ( DOH-27-0515-5048 ) NHREC number 4048 issued on 21/04/2015.
  • Thumbnail Image
    Item
    Open Access
    Collaborative care for the detection and management of depression among adults with hypertension in South Africa: study protocol for the PRIME-SA randomised controlled trial
    (BioMed Central, 2018-03-22) Petersen, Inge; Bhana, Arvin; Folb, Naomi; Thornicroft, Graham; Zani, Babalwa; Selohilwe, One; Petrus, Ruwayda; Mntambo, Ntokozo; Georgeu-Pepper, Daniella; Kathree, Tasneem; Lund, Crick; Lombard, Carl; Bachmann, Max; Gaziano, Thomas; Levitt, Naomi; Fairall, Lara
    Background The high co-morbidity of mental disorders, particularly depression, with non-communicable diseases (NCDs) such as cardiovascular disease (CVD), is concerning given the rising burden of NCDs globally, and the role depression plays in confounding prevention and treatment of NCDs. The objective of this randomised control trial (RCT) is to determine the real-world effectiveness of strengthened depression identification and management on depression outcomes in hypertensive patients attending primary health care (PHC) facilities in South Africa (SA). Methods/design The study design is a pragmatic, two-arm, parallel-cluster RCT, the unit of randomisation being the clinics, with outcomes being measured for individual participants. The 20 largest eligible clinics from one district in the North West Province are enrolled in the trial. Equal numbers of hypertensive patients (n = 50) identified as having depression using the Patient Health Questionnaire (PHQ-9) are enrolled from each clinic, making up a total of 1000 participants with 500 in each arm. The nurse clinicians in the control facilities receive the standard training in Primary Care 101 (PC101), a clinical decision support tool for integrated chronic care that includes guidelines for hypertension and depression care. Referral pathways available include referrals to PHC physicians, clinical or counselling psychologists and outpatient psychiatric and psychological services. In the intervention clinics, this training is supplemented with strengthened training in the depression components of PC101 as well as training in clinical communication skills for nurse-led chronic care. Referral pathways are strengthened through the introduction of a facility-based behavioural health counsellor, trained to provide structured manualised counselling for depression and adherence counselling for all chronic conditions. The primary outcome is defined as at least 50% reduction in PHQ-9 score measured at 6 months. Discussion This trial should provide evidence of the real world effectiveness of strengtheneddepression identification and collaborative management on health outcomes of hypertensive patients withcomorbid depression attending PHC facilities in South Africa. Trial registration South African National Clinical Trial Register: SANCTR ( http://www.sanctr.gov.za/SAClinicalTrials ) (DOH-27-0916-5051). Registered on 9 April 2015. ClinicalTrials.gov : ID: NCT02425124 . Registered on 22 April 2015.
  • Thumbnail Image
    Item
    Open Access
    Comorbidities between tuberculosis and common mental disorders: a scoping review of epidemiological patterns and person-centred care interventions from low-to-middle income and BRICS countries
    (2020-01-15) Janse Van Rensburg, André; Dube, Audry; Curran, Robyn; Ambaw, Fentie; Murdoch, Jamie; Bachmann, Max; Petersen, Inge; Fairall, Lara
    Abstract Background There is increasing evidence that the substantial global burden of disease for tuberculosis unfolds in concert with dimensions of common mental disorders. Person-centred care holds much promise to ameliorate these comorbidities in low-to-middle income countries (LMICs) and emerging economies. Towards this end, this paper aims to review 1) the nature and extent of tuberculosis and common mental disorder comorbidity and 2) person-centred tuberculosis care in low-to-middle income countries and emerging economies. Main text A scoping review of 100 articles was conducted of English-language studies published from 2000 to 2019 in peer-reviewed and grey literature, using established guidelines, for each of the study objectives. Four broad tuberculosis/mental disorder comorbidities were described in the literature, namely alcohol use and tuberculosis, depression and tuberculosis, anxiety and tuberculosis, and general mental health and tuberculosis. Rates of comorbidity varied widely across countries for depression, anxiety, alcohol use and general mental health. Alcohol use and tuberculosis were significantly related, especially in the context of poverty. The initial tuberculosis diagnostic episode had substantial socio-psychological effects on service users. While men tended to report higher rates of alcohol use and treatment default, women in general had worse mental health outcomes. Older age and a history of mental illness were also associated with pronounced tuberculosis and mental disorder comorbidity. Person-centred tuberculosis care interventions were almost absent, with only one study from Nepal identified. Conclusions There is an emerging body of evidence describing the nature and extent of tuberculosis and mental disorders comorbidity in low-to-middle income countries. Despite the potential of person-centred interventions, evidence is limited. This review highlights a pronounced need to address psychosocial comorbidities with tuberculosis in LMICs, where models of person-centred tuberculosis care in routine care platforms may yield promising outcomes.
  • Thumbnail Image
    Item
    Open Access
    The costs and effects of the practical approach to lung health in South Africa
    (2006) Fairall, Lara Rosemary; Bachmann, Max; Bateman, Eric
    Includes bibliographical references (p. 285-323).
  • Thumbnail Image
    Item
    Open Access
    The development and validation of a respiratory guideline for nurses in primary care in South Africa
    (2006) English, René Glynnis; Bateman, Eric D; Bachmann, Max
    The Practical Aproach to Lung Health in South Africa (P ALSA) initiative aims to improve the diagnosis and management of patients with respiratory diseases in primary care. An algorithm-based syndromic guideline integrating common respiratory diseases for nurses was developed after review of a generic respiratory guideline, medical literature, local policies, and qualitative research.
  • Thumbnail Image
    Item
    Open Access
    Diagnostic accuracy of an integrated respiratory guideline in identifying patients with respiratory symptoms requiring screening for pulmonary tuberculosis: a cross-sectional study
    (BioMed Central Ltd, 2006) English, Rene; Bachmann, Max; Bateman, Eric; Zwarenstein, Merrick; Fairall, Lara; Bheekie, Angeni; Majara, Bosielo; Lombard, Carl; Scherpbier, Robert; Ottomani, Salah
    BACKGROUND:To evaluate the diagnostic accuracy of the integrated Practical Approach to Lung Health in South Africa (PALSA) guideline in identifying patients requiring bacteriological screening for tuberculosis (TB), and to determine which clinical features best predict suspected and bacteriologically-confirmed tuberculosis among patients with respiratory symptoms. METHODS: A prospective, cross-sectional study in which 1392 adult patients with cough and/or difficult breathing, attending a primary care facility in Cape Town, South Africa, were evaluated by a nurse using the guideline. The accuracy of a nurse using the guideline to identify TB suspects was compared to that of primary care physicians' diagnoses of (1) suspected TB, and (2) proven TB supported by clinical information and chest radiographs. RESULTS: The nurse using the guideline identified 516 patients as TB suspects compared with 365 by the primary care physicians, representing a sensitivity of 76% (95% confidence interval (CI) 71%-79%), specificity of 77% (95% CI 74%-79%), positive predictive value of 53% (95% CI 49%-58%), negative predictive value of 90% (95% CI 88%-92%), and area under the receiver operating characteristic curve (ARUC) of 0.76 (95% CI 0.74-0.79). Sputum results were obtained in 320 of the 365 primary care physicians TB suspects (88%); 40 (13%) of these were positive for TB. Only 4 cases were not identified by the nurse using the guideline. The primary care physicians diagnostic accuracy in diagnosing bacteriologically-confirmed TB (n = 320) was as follows: sensitivity 90% (95% CI 76%-97%), specificity 65% (95% CI 63%-68%), negative predictive value 7% (95% CI 5%-10%), positive predictive value 99.5% (95% CI 98.8%-99.8%), and ARUC 0.78 (95% CI 0.73-0.82). Weight loss, pleuritic pain, and night sweats were independently associated with the diagnosis of bacteriologically-confirmed tuberculosis (positive likelihood ratio if all three present = 16.7, 95% CI 5.9-29.4). CONCLUSION: The PALSA guideline is an effective screening tool for identifying patients requiring bacteriological screening for pulmonary tuberculosis in this primary care setting. This supports the randomized trial finding that use of the guideline increased TB case detection.
  • Thumbnail Image
    Item
    Open Access
    Differences in access and patient outcomes across antiretroviral treatment clinics in the Free State province: A prospective cohorot study
    (2010) Ingle, Suzanne M; May, Margaret; Uebel, Kerry; Timmerman, Venessa; Kotze, Eduan; Bachmann, Max; Sterne, Jonathan A C; Egger, Matthias; Fairall, Lara
    Objective. To assess differences in access to antiretroviral treatment (ART) and patient outcomes across public sector treatment facilities in the Free State province, South Africa. Design. Prospective cohort study with retrospective database linkage. We analysed data on patients enrolled in the treatment programme across 36 facilities between May 2004 and December 2007, and assessed percentage initiating ART and percentage dead at 1 year after enrolment. Multivariable logistic regression was used to estimate associations of facility-level and patient-level characteristics with both mortality and treatment status. Results. Of 44 866 patients enrolled, 15 219 initiated treatment within 1 year; 8 778 died within 1 year, 7 286 before accessing ART. Outcomes at 1 year varied greatly across facilities and more variability was explained by facility-level factors than by patient-level factors. The odds of starting treatment within 1 year improved over calendar time. Patients enrolled in facilities with treatment initiation available on site had higher odds of starting treatment and lower odds of death at 1 year compared with those enrolled in facilities that did not offer treatment initiation. Patients were less likely to start treatment if they were male, severely immunosuppressed (CD4 count ≤50 cells/μl), or underweight (<50 kg). Men were also more likely to die in the first year after enrolment. Conclusions. Although increasing numbers of patients started ART between 2004 and 2007, many patients died before accessing ART. Patient outcomes could be improved by decentralisation of treatment services, fast-tracking the most immunodeficient patients and improving access, especially for men.
  • Thumbnail Image
    Item
    Open Access
    Highly active antiretroviral treatment and health related quality of life in South African adults with human immunodeficiency virus infection: A cross-sectional analytical study
    (BioMed Central Ltd, 2007) Louwagie, Goedele; Bachmann, Max; Meyer, Kobus; Booysen, Frikkie; Fairall, Lara; Heunis, Christo
    BACKGROUND:Health Related Quality of Life (HRQoL) is an important outcome in times of Highly Active Antiretroviral Treatment (HAART). We compared the HRQoL of HIV positive patients receiving HAART with those awaiting treatment in public sector facilities in the Free State province in South Africa. METHODS: A stratified random sample of 371 patients receiving or awaiting HAART were interviewed and the EuroQol-profile, EuroQol-index and Visual Analogue Scale (VAS) were compared. Independent associations between these outcomes and HAART, socio-demographic, clinical and health service variables were estimated using linear and ordinal logistic regression, adjusted for intra-clinic clustering of outcomes. RESULTS: Patients receiving HAART reported better HRQoL for 3 of the 5 EuroQol-dimensions, for the VAS score and for the EuroQol index in bivariable analysis. They had a higher mean EuroQol index (0.11 difference, 95% confidence interval [CI] 0.04; 0.23), and were more likely to have a higher index (odds ratio 1.9, 95% CI 1.1; 1.3), compared to those awaiting HAART, in multivariate analysis. Higher mean VAS scores were reported for patients who were receiving HAART (6.5 difference, 95% CI 1.3; 11.7), were employed (9.1, 95% CI 4.3; 13.7) or were female (4.7, 95% CI 0.79; 8.5). CONCLUSION: HAART was associated with improved HRQoL in patients enrolled in a public sector treatment program in South Africa. Our finding that the EuroQol instrument was sensitive to HAART supports its use in future evaluation of HIV/AIDS care in South Africa. Longitudinal studies are needed to evaluate changes in individuals' HRQoL.
  • Thumbnail Image
    Item
    Open Access
    Hypertension in Cape Town clothing industry clinics: Does treatment match risk?
    (2001) Sephton_E_A; Bachmann, Max
    Background: The management of hypertension according to the patient' s absolute risk of cardiovascular disease. rather than their blood pressure in isolation from other risk factors, is now widely advocated because it targets treatment at those with most to gain. In South Africa blood pressure is traditionally managed according to the patient's level of blood pressure. Main Objective: To identify the proportion of traditionally treated hypertensive patients who may benefit from cessation or intensification of treatment as judged by a risk-based approach to their management. Design: A cross sectional descriptive survey of patients and their medical records with assessment of absolute risk of cardiovascular disease using Framingham risk equations. Setting: Eight Clothing Industry Health Benefit Fund clinics in Cape Town, South Africa. Participants: 382 women and men, predominantly coloured, attending for the treatment of hypertension Main outcome measure: The proportions of patients in whom the predicted risk of a cardiovascular event within 5 years is less than 10% and those in whom the risk within five years is greater than 20%. Results: 65% of participants (CI 60 - 70%) were at less than 10% risk of a cardiovascular event in the next 5 years and 19% (Cl 15-23%) were at more than 20% risk of a cardiovascular event despite current treatment. 5% (CI 3.2-7.9%) were at greater than 20% risk of a cardiovascular event in the next 5 years having no previous history of a cardiovascular event. 14% (CI 10-17%) were at greater than 20% risk of a cardiovascular event in the next 5 years because of a previous history of a cardiovascular event. 1.3% (CI 0.4-3%) were at less than 10% risk of a cardiovascular event within the next 5 years, despite having a systolic blood pressure over 170mmHg. Conclusion: Assessment of the cardiovascular risk of patients treated for hypertension identifies those patients at most and least risk. Resources could therefore be targeted at those with the most to gain from treatment and the unwanted side effects of antihypertensive medication avoided in those at low risk. Almost two thirds of patients currently being treated for hypertension were at less than 10% risk of developing a cardiovascular event within the next 5 years. A trial of medication reduction or cessation in this group is justified and the resources could be redirected at those 5% whose risk remains very high despite current levels of treatment.
  • Thumbnail Image
    Item
    Open Access
    Implementing nurse-initiated and managed antiretroviral treatment (NIMART) in South Africa: a qualitative process evaluation of the STRETCH trial
    (BioMed Central Ltd, 2012) Georgeu, Daniella; Colvin, Christopher; Lewin, Simon; Fairall, Lara; Bachmann, Max; Uebel, Kerry; Zwarenstein, Merrick; Draper, Beverly; Bateman, Eric
    BACKGROUND:Task-shifting is promoted widely as a mechanism for expanding antiretroviral treatment (ART) access. However, the evidence for nurse-initiated and managed ART (NIMART) in Africa is limited, and little is known about the key barriers and enablers to implementing NIMART programmes on a large scale. The STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV) programme was a complex educational and organisational intervention implemented in the Free State Province of South Africa to enable nurses providing primary HIV/AIDS care to expand their roles and include aspects of care and treatment usually provided by physicians. STRETCH used a phased implementation approach and ART treatment guidelines tailored specifically to nurses. The effects of STRETCH on pre-ART mortality, ART provision, and the quality of HIV/ART care were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of factors affecting the implementation of the programme. METHODS: This study was a qualitative process evaluation using in-depth interviews and focus group discussions with patients, health workers, health managers, and other key informants as well as observation in clinics. Research questions focused on perceptions of STRETCH, changes in health provider roles, attitudes and patient relationships, and impact of the implementation context on trial outcomes. Data were analysed collaboratively by the research team using thematic analysis. RESULTS: NIMART appears to be highly acceptable among nurses, patients, and physicians. Managers and nurses expressed confidence in their ability to deliver ART successfully. This confidence developed slowly and unevenly, through a phased and well-supported approach that guided nurses through training, re-prescription, and initiation. The research also shows that NIMART changes the working and referral relationships between health staff, demands significant training and support, and faces workload and capacity constraints, and logistical and infrastructural challenges. CONCLUSIONS: Large-scale NIMART appears to be feasible and acceptable in the primary level public sector health services in South Africa. Successful implementation requires a comprehensive approach with: an incremental and well supported approach to implementation; clinical guidelines tailored to nurses; and significant health services reorganisation to accommodate the knock-on effects of shifts in practice.TRIAL REGISTRATION:ISRCTN46836853
  • Thumbnail Image
    Item
    Open Access
    Methods for analyzing cost effectiveness data from cluster randomized trials
    (BioMed Central Ltd, 2007) Bachmann, Max; Fairall, Lara; Clark, Allan; Mugford, Miranda
    BACKGROUND:Measurement of individuals' costs and outcomes in randomized trials allows uncertainty about cost effectiveness to be quantified. Uncertainty is expressed as probabilities that an intervention is cost effective, and confidence intervals of incremental cost effectiveness ratios. Randomizing clusters instead of individuals tends to increase uncertainty but such data are often analysed incorrectly in published studies. METHODS: We used data from a cluster randomized trial to demonstrate five appropriate analytic methods: 1) joint modeling of costs and effects with two-stage non-parametric bootstrap sampling of clusters then individuals, 2) joint modeling of costs and effects with Bayesian hierarchical models and 3) linear regression of net benefits at different willingness to pay levels using a) least squares regression with Huber-White robust adjustment of errors, b) a least squares hierarchical model and c) a Bayesian hierarchical model. RESULTS: All five methods produced similar results, with greater uncertainty than if cluster randomization was not accounted for. CONCLUSION: Cost effectiveness analyses alongside cluster randomized trials need to account for study design. Several theoretically coherent methods can be implemented with common statistical software.
  • Thumbnail Image
    Item
    Open Access
    Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol
    (BioMed Central Ltd, 2008) Fairall, Lara; Bachmann, Max; Zwarenstein, Merrick; Lombard, Carl; Uebel, Kerry; van Vuuren, Cloete; Steyn, Dewald; Boulle, Andrew; Bateman, Eric
    BACKGROUND: A major barrier to accessing free government-provided antiretroviral treatment (ART) in South Africa is the shortage of suitably skilled health professionals. Current South African guidelines recommend that only doctors should prescribe ART, even though most primary care is provided by nurses. We have developed an effective method of educational outreach to primary care nurses in South Africa. Evidence is needed as to whether primary care nurses, with suitable training and managerial support, can initiate and continue to prescribe and monitor ART in the majority of ART-eligible adults.METHODS/DESIGN:This is a protocol for a pragmatic cluster randomised trial to evaluate the effectiveness of a complex intervention based on and supporting nurse-led antiretroviral treatment (ART) for South African patients with HIV/AIDS, compared to current practice in which doctors are responsible for initiating ART and continuing prescribing. We will randomly allocate 31 primary care clinics in the Free State province to nurse-led or doctor-led ART. Two groups of patients aged 16 years and over will be included: a) 7400 registering with the programme with CD4 counts of [less than or equal to] 350 cells/mL (mainly to evaluate treatment initiation) and b) 4900 already receiving ART (to evaluate ongoing treatment and monitoring). The primary outcomes will be time to death (in the first group) and viral suppression (in the second group). Patients' survival, viral load and health status indicators will be measured at least 6-monthly for at least one year and up to 2 years, using an existing province-wide clinical database linked to the national death register.TRIAL REGISTRATION:Controlled Clinical Trials ISRCTN46836853
  • Thumbnail Image
    Item
    Open Access
    Task shifting and integration of HIV care into primary care in South Africa: The development and content of the streamlining tasks and roles to expand treatment and care for HIV (STRETCH) intervention
    (BioMed Central Ltd, 2011) Uebel, Kerry; Fairall, Lara; van Rensburg, Dingie; Mollentze, Willie; Bachmann, Max; Lewin, Simon; Zwarenstein, Merrick; Colvin, Christopher; Georgeu, Daniella; Mayers, Pat; Faris, Gill; Lombard, Carl; Bateman, Eric
    BACKGROUND:Task shifting and the integration of human immunodeficiency virus (HIV) care into primary care services have been identified as possible strategies for improving access to antiretroviral treatment (ART). This paper describes the development and content of an intervention involving these two strategies, as part of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) pragmatic randomised controlled trial. METHODS: DEVELOPING THE INTERVENTION:The intervention was developed following discussions with senior management, clinicians, and clinic staff. These discussions revealed that the establishment of separate antiretroviral treatment services for HIV had resulted in problems in accessing care due to the large number of patients at ART clinics. The intervention developed therefore combined the shifting from doctors to nurses of prescriptions of antiretrovirals (ARVs) for uncomplicated patients and the stepwise integration of HIV care into primary care services. RESULTS: COMPONENTS OF THE INTERVENTION:The intervention consisted of regulatory changes, training, and guidelines to support nurse ART prescription, local management teams, an implementation toolkit, and a flexible, phased introduction. Nurse supervisors were equipped to train intervention clinic nurses in ART prescription using outreach education and an integrated primary care guideline. Management teams were set up and a STRETCH coordinator was appointed to oversee the implementation process.DISCUSSION:Three important processes were used in developing and implementing this intervention: active participation of clinic staff and local and provincial management, educational outreach to train nurses in intervention sites, and an external facilitator to support all stages of the intervention rollout.The STRETCH trial is registered with Current Control Trials ISRCTN46836853.