Browsing by Author "Zwarenstein, Merrick"
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- ItemRestrictedChest radiograph in acute respiratory infections(2005) Swingler, George H; Zwarenstein, MerrickBackground: Chest radiography is widely used during the management of acute lower respiratory infections, but the benefits are unknown. Objectives: To assess the effects of chest radiography on clinical outcome in acute lower respiratory infections. Search strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 1), MEDLINE (1950 to January 2007) and EMBASE (January 1976 to February 2007). Selection criteria: Randomised or quasi-randomised trials of chest radiography in acute respiratory infections. Data collection and analysis: Both review authors independently applied the inclusion criteria, extracted data and assessed trial quality. Main results: We identified two trials. One, of 522 outpatient children (and performed by the review authors), found that 46% of both radiography and control participants had recovered by seven days (relative risk (RR) 1.01, 95% confidence interval (CI) 0.79 to 1.31). Thirty-three per cent of radiography participants and 32% of control participants made a subsequent hospital visit within four weeks (RR 1.02, 95% CI 0.79 to 1.30) and 3% of both radiography and control participants were subsequently admitted to hospital within four weeks (RR 1.02, 95% CI 0.41 to 2.52). The other trial involving 1502 adults attending an emergency department found no significant difference in length of illness, the single outcome prespecified for this review (mean of 16.9 days in radiograph group versus 17.0 days in control group, P > 0.05). Authors’ conclusions: There is no evidence that chest radiography improves outcome in outpatients with acute lower respiratory infection. The findings do not exclude a potential effect of radiography, but the potential benefit needs to be balanced against the hazards and expense of chest radiography. The findings apply to outpatients only.
- ItemOpen AccessDiagnostic 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, SalahBACKGROUND: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.
- ItemOpen AccessEducational outreach to general practitioners reduces children's asthma symptoms: a cluster randomised controlled trial(BioMed Central Ltd, 2007) Zwarenstein, Merrick; Bheekie, Angeni; Lombard, Carl; Swingler, George; Ehrlich, Rodney; Eccles, Martin; Sladden, Michael; Pather, Sandra; Grimshaw, Jeremy; Oxman, AndrewBACKGROUND:Childhood asthma is common in Cape Town, a province of South Africa, but is underdiagnosed by general practitioners. Medications are often prescribed inappropriately, and care is episodic. The objective of this study is to assess the impact of educational outreach to general practitioners on asthma symptoms of children in their practice. METHODS: This is a cluster randomised trial with general practices as the unit of intervention, randomisation, and analysis. The setting is Mitchells Plain (population 300,000), a dormitory town near Cape Town. Solo general practitioners, without nurse support, operate from storefront practices. Caregiver-reported symptom data were collected for 318 eligible children (2 to 17 years) with moderate to severe asthma, who were attending general practitioners in Mitchells Plain. One year post-intervention follow-up data were collected for 271 (85%) of these children in all 43 practices.Practices randomised to intervention (21) received two 30-minute educational outreach visits by a trained pharmacist who left materials describing key interventions to improve asthma care. Intervention and control practices received the national childhood asthma guideline. Asthma severity was measured in a parent-completed survey administered through schools using a symptom frequency and severity scale. We compared intervention and control group children on the change in score from pre-to one-year post-intervention. RESULTS: Symptom scores declined an additional 0.84 points in the intervention vs. control group (on a nine-point scale. p = 0.03). For every 12 children with asthma exposed to a doctor allocated to the intervention, one extra child will have substantially reduced symptoms. CONCLUSION: Educational outreach was accepted by general practitioners and was effective. It could be applied to other health care quality problems in this setting.
- ItemOpen AccessEffectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial(BioMed Central Ltd, 2012) Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, StephenBACKGROUND: Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. METHODS: Trial design: Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room.Objective: To evaluate the effectiveness of the group diabetes education programmeOutcomes: Primary outcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. Secondary outcomes: self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570.DISCUSSION:The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely.TRIAL REGISTER:Pan African Clinical Trial Registry PACTR201205000380384
- ItemOpen AccessFrom PALSA PLUS to PALM PLUS: adapting and developing a South African guideline and training intervention to better integrate HIV/AIDS care with primary care in rural health centers in Malawi(BioMed Central Ltd, 2011) Schull, Michael; Cornick, Ruth; Thompson, Sandy; Faris, Gill; Fairall, Lara; Burciul, Barry; Sodhi, Sumeet; Draper, Beverley; Joshua, Martias; Mondiwa, Martha; Banda, Hastings; Kathyola, Damson; Bateman, Eric; Zwarenstein, MerrickBACKGROUND: Only about one-third of eligible HIV/AIDS patients receive anti-retroviral treatment (ART). Decentralizing treatment is crucial to wider and more equitable access, but key obstacles are a shortage of trained healthcare workers (HCW) and challenges integrating HIV/AIDS care with other primary care. This report describes the development of a guideline and training program (PALM PLUS) designed to integrate HIV/AIDS care with other primary care in Malawi. PALM PLUS was adapted from PALSA PLUS, developed in South Africa, and targets middle-cadre HCWs (clinical officers, nurses, and medical assistants). We adapted it to align with Malawi's national treatment protocols, more varied healthcare workforce, and weaker health system infrastructure.METHODS/DESIGN:The international research team included the developers of the PALSA PLUS program, key Malawi-based team members and personnel from national and district level Ministry of Health (MoH), professional associations, and an international non-governmental organization. The PALSA PLUS guideline was extensively revised based on Malawi national disease-specific guidelines. Advice and input was sought from local clinical experts, including middle-cadre personnel, as well as Malawi MoH personnel and representatives of Malawian professional associations. RESULTS: An integrated guideline adapted to Malawian protocols for adults with respiratory conditions, HIV/AIDS, tuberculosis, and other primary care conditions was developed. The training program was adapted to Malawi's health system and district-level supervision structure. PALM PLUS is currently being piloted in a cluster-randomized trial in health centers in Malawi (ISRCTN47805230).DISCUSSION:The PALM PLUS guideline and training intervention targets primary care middle-cadre HCWs with the objective of improving HCW satisfaction and retention, and the quality of patient care. Successful adaptations are feasible, even across health systems as different as those of South Africa and Malawi.
- ItemOpen AccessImplementing 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, EricBACKGROUND: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
- ItemOpen AccessStreamlining 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, EricBACKGROUND: 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
- ItemOpen AccessStrengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial(BioMed Central Ltd, 2010) Schull, Michael; Banda, Hastings; Kathyola, Damson; Fairall, Lara; Martiniuk, Alexandra; Burciul, Barry; Zwarenstein, Merrick; Sodhi, Sumeet; Thompson, Sandy; Joshua, Martias; Mondiwa, Martha; Bateman, EricBACKGROUND:In low-income countries, only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) patients eligible for anti-retroviral treatment currently receive it. Providing decentralized treatment close to where patients live is crucial to a faster scale up, however, a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services (e.g. tuberculosis, malaria, respiratory conditions). This study will test an adapted primary care health care worker training and guideline intervention, Practical Approach to Lung Health and HIV/AIDS Malawi (PALM PLUS), on staff retention and satisfaction, and quality of patient care.METHODS/DESIGN:A cluster-randomized trial design is being used to compare usual care with a standardized clinical guideline and training intervention, PALM PLUS. The intervention targets middle-cadre health care workers (nurses, clinical officers, medical assistants) in 30 rural primary care health centres in a single district in Malawi. PALM PLUS is an integrated, symptom-based and user-friendly guideline consistent with Malawian national treatment protocols. Training is standardized and based on an educational outreach approach. Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused (1-2 hours), intermittent, interactive sessions on-site in health centers. Primary outcomes are health care worker retention and satisfaction. Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS, tuberculosis, prevention-of-mother-to-child-transmission of HIV and other primary care conditions. Effect sizes and 95% confidence intervals for outcomes will be presented. Assessment of outcomes will occur at 1 year post- implementation.DISCUSSION:The PALM PLUS trial aims to address a key problem: strengthening middle-cadre health care workers to support the broader scale up of HIV/AIDS services and their integration into primary care. The trial will test whether the PALM PLUS intervention improves staff satisfaction and retention, as well as the quality of patient care, when compared to usual practice.TRIAL REGISTRATION:Current controlled Trials: ISRCTN47805230
- ItemOpen AccessSupporting middle-cadre health care workers in Malawi: lessons learned during implementation of the PALM PLUS package(BioMed Central, 2014-05-12) Sodhi, Sumeet; Banda, Hastings; Kathyola, Damson; Joshua, Martias; Richardson, Faye; Mah, Emmay; MacGregor, Hayley; Kanike, Emmanuel; Thompson, Sandy; Fairall, Lara; Bateman, Eric; Zwarenstein, Merrick; Schull, Michael JBackground: The government of Malawi is committed to the broad rollout of antiretroviral treatment in Malawi in the public health sector; however one of the primary challenges has been the shortage of trained health care workers. The Practical Approach to Lung Health Plus HIV/AIDS in Malawi (PALM PLUS) package is an innovative guideline and training intervention that supports primary care middle-cadre health care workers to provide front-line integrated primary care. The purpose of this paper is to describe the lessons learned in implementing the PALM PLUS package. Methods: A clinical tool, based on algorithm- and symptom-based guidelines was adapted to the Malawian context. An accompanying training program based on educational outreach principles was developed and a cascade training approach was used for implementation of the PALM PLUS package in 30 health centres, targeting clinical officers, medical assistants, and nurses. Lessons learned were identified during program implementation through engagement with collaborating partners and program participants and review of program evaluation findings. Results: Key lessons learned for successful program implementation of the PALM PLUS package include the importance of building networks for peer-based support, ensuring adequate training capacity, making linkages with continuing professional development accreditation and providing modest in-service training budgets. The main limiting factors to implementation were turnover of staff and desire for financial training allowances. Conclusions: The PALM PLUS approach is a potential model for supporting mid-level health care workers to provide front-line integrated primary care in low and middle income countries, and may be useful for future task-shifting initiatives.
- ItemOpen AccessTask 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, EricBACKGROUND: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.
- ItemOpen AccessThe impact of chest radiography on the diagnosis, clinical management and outcome of acute lower respiratory infections in children(1999) Swingler, George Henry; Hussey, Gregory; Zwarenstein, MerrickBackground. When available, chest radiography is widely used in acute lower respiratory infections in children. Its impact on clinical outcome is unknown. Methods. A randomised controlled trial was performed of 522 children aged 2 to 59 months who met the World Health Organisation case definition for pneumonia. The main outcome was time to recovery, measured in a subset of 398 participants who offered a telephone number. Subsidiary outcomes included diagnosis, elements of clinical management and subsequent use of health facilities. Findings. There was a marginal improvement in time to recovery, which was not clinically significant. The median time to recovery was seven days in both groups, 95% CI 6-8 days and 6-9 days in the radiograph and control groups respectively (p=0.50, log rank test). The hazard ratio for recovery was 1.08 (95% CI 0.85 to 1.34). This lack of effect was not modified by clinicians' experience and no sub-groups of children were identified in whom the radiograph had an effect. Pneumonia was diagnosed more often in the radiograph group (14.4% vs. 8.8%, p=0.03) and bronchiolitis less often ( 44% vs. 56%, p=0.005). Antibiotic usage was higher in the radiograph group (60.8% vs. 52.2%, p=0,05). There were no differences in subsequent health facility usage. Interpretation. Despite a net change in diagnosis and an increase in antibiotic usage, chest radiography did not affect clinical outcome in outpatient children with acute lower respiratory infection. This lack of effect was independent of clinicians' experience. There were no clinically identifiable sub-groups of children within the World Health Organisation case definition of pneumonia who benefited from radiography. It is concluded that routine use of chest radiography is not beneficial in ambulatory children over two months of age with acute lower respiratory infection.