Browsing by Author "Lutge, Elizabeth"

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    Economic support to improve tuberculosis treatment outcomes in South Africa : a pragmatic cluster-randomized controlled trial
    (BioMed Central, 2013-05) Lutge, Elizabeth; Lewin, Simon; Volmink, Jimmy; Friedman, Irwin; Lombard, Carl
    Abstract Poverty undermines adherence to tuberculosis treatment. Economic support may both encourage and enable patients to complete treatment. In South Africa, which carries a high burden of tuberculosis, such support may improve the currently poor outcomes of patients on tuberculosis treatment. The aim of this study was to test the feasibility and effectiveness of delivering economic support to patients with pulmonary tuberculosis in a high-burden province of South Africa. Methods This was a pragmatic, unblinded, two-arm cluster-randomized controlled trial, where 20 public sector clinics acted as clusters. Patients with pulmonary tuberculosis in intervention clinics (n = 2,107) were offered a monthly voucher of ZAR120.00 (approximately US$15) until the completion of their treatment. Vouchers were redeemed at local shops for foodstuffs. Patients in control clinics (n = 1,984) received usual tuberculosis care. Results Intention to treat analysis showed a small but non-significant improvement in treatment success rates in intervention clinics (intervention 76.2%; control 70.7%; risk difference 5.6% (95% confidence interval: -1.2%, 12.3%), P = 0.107). Low fidelity to the intervention meant that 36.2% of eligible patients did not receive a voucher at all, 32.3% received a voucher for between one and three months and 31.5% received a voucher for four to eight months of treatment. There was a strong dose–response relationship between frequency of receipt of the voucher and treatment success (P <0.001). Conclusions Our pragmatic trial has shown that, in the real world setting of public sector clinics in South Africa, economic support to patients with tuberculosis does not significantly improve outcomes on treatment. However, the low fidelity to the delivery of our voucher meant that a third of eligible patients did not receive it. Among patients in intervention clinics who received the voucher at least once, treatment success rates were significantly improved. Further operational research is needed to explore how best to ensure the consistent and appropriate delivery of such support to those eligible to receive it. Trial registration Current Controlled Trials ISRCTN50689131
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    Economic support to improve tuberculosis treatment outcomes in South Africa : a qualitative process evaluation of a cluster randomized controlled trial
    (BioMed Central, 2014-06) Lutge, Elizabeth; Lewin, Simon; Volmink, Jimmy
    Background Poverty undermines the adherence of patients to tuberculosis treatment. A pragmatic cluster randomized controlled trial was conducted to investigate the extent to which economic support in the form of a voucher would improve patients’ adherence to treatment, and their treatment outcomes. Although the trial showed a modest improvement in the treatment success rates of the intervention group, this was not statistically significant, due in part to the low fidelity to the trial intervention. A qualitative process evaluation, conducted in the final few months of the trial, explained some of the factors that contributed to this low fidelity. Methods In-depth interviews were conducted with patients who received vouchers, nurses in intervention clinics, personnel in shops who administered the vouchers, and managers of the TB Control Programme. These interviews were analyzed thematically. Results The low fidelity to the trial intervention can be explained by two main factors. The first was nurses’ tendency to ‘ration’ the vouchers, only giving them to the most needy of eligible patients and leaving out those eligible patients whom they felt were financially more comfortable. The second was logistical issues related to the administration of the voucher as vouchers were not always available for patients on their appointed clinic dates, necessitating further visits to the clinics which they were not always able to make. Conclusions This process evaluation identifies some of the most important factors that contributed to the results of this pragmatic trial. It highlights the value of process evaluations as tools to explain the results of randomized trials and emphasizes the importance of implementers as ‘street level bureaucrats’ who may profoundly affect the way an intervention is administered. Trial registration Current Controlled Trials ISRCTN50689131, registered 21 April 2009.The trial protocol is available at the following web address: http://www.hst.org.za/publications/study-protocol-economic-incentives-improving-clinical-outcomes-patients-tb-south-africa.
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    Researching complex interventions in health : the state of the art
    (BMC Health Services Research, 2016) Craig, Peter; Rahm-Hallberg, Ingalill; Britten, Nicky; Borglin, Gunilla; Meyer, Gabriele; Kopke, Sascha; Noyes, Jane; Chandler, Jackie; Levati, Sara; Sales, Anne; Thabane, Lehana; Giangregorio, Lora; Feeley, Nancy; Cossette, Sylvie; Taylor, Rod; Hill, Jacqueline; Richards, David A.; Kuyken, Willem; von Essen, Louise; Williams, Andrew; Hemming, Karla; Lilford, Richard; Girling, Alan; Taljaard, Monica; Dimairo, Munyaradzi; Petticrew, Mark; Baird, Janis; Moore, Graham; Odendaal, Willem; Atkins, Salla; Lutge, Elizabeth; Leon, Natalie; Lewin, Simon; Payne, Katherine; Van Achterberg, Theo; Sermeus, Walter; Pitt, Martin; Monks, Thomas
    ENGLISH SUMMARY : Keynote presentations