Debjani Mueller1,2, Robert C Pattinson3,4,5, Tsakane M Hlongwane3,4,5, Reinhard Busse6, Dimitra Panteli7. 1. Department of Health Care Management, Berlin Institute of Technology, Berlin, Germany. dbmueller7@yahoo.de. 2. Charlotte Maxeke Research Cluster, Johannesburg, South Africa. dbmueller7@yahoo.de. 3. Department of Obstetrics and Gynaecology, School of Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa. 4. Research Centre for Maternal, Fetal, Newborn and Child Health Care Strategies, University of Pretoria, Pretoria, South Africa. 5. Maternal and Infant Health Care Strategies Research Unit, South African Medical Research Council, Pretoria, South Africa. 6. Department of Health Care Management, Berlin Institute of Technology, Berlin, Germany. rbusse@tu-berlin.de. 7. Department of Health Care Management, Berlin Institute of Technology, Berlin, Germany. dimitra.panteli@tu-berlin.de.
Abstract
BACKGROUND: This study had a threefold aim: to test the value of stakeholder involvement in HTA to reduce evidence gaps and interpret findings; and to assess a medical device by applying the EUnetHTA Core Model (CM) in South Africa and thus ultimately provide a first overview of evidence for potential widespread adoption of the technology in a primary health care (PHC) setting. Used in primary healthcare setting for obstetric use, the technology under assessment is a low-cost continuous wave Doppler ultrasound (DUS). METHODS: The scoping of the assessment was defined by involving policy makers in selecting the domains and corresponding questions relevant to the ultrasound and its use. Additionally, hospital managers were invited to respond to dichotomous questions on the criteria for procurement. To substantiate evidence obtained from an initial literature review, different stakeholders were identified and consulted. The evidence generated fromall steps was used to populate the high-ranked assessment elements of the CM. RESULTS: The HTA on continuous-wave DUS incorporated the evidence on organizational, ethical, and social value of its use together with effectiveness, safety, and cost-effectiveness of the technology. The domains on "health problem" and "safety" had a higher rank than the rest of the nine domains. Unexplained fetal mortality is the largest single contributor to perinatal deaths in South Africa. Pregnant women in PHC setting were examined using a continuous-wave DUS, after their routine antenatal visit. The healthcare professionals interviewed, indicated the benefit in the use of continuous-wave DUS in the PHC setting and the need for training. CONCLUSIONS: Collection and generation of evidence based on the HTA CM and the chosen decision criteria provided a generalized but structured guidance on the methodology. Several questions were not applicable for the technology and the context of its use and elimination of those that are inappropriate for the African context, resulted in a pragmatic solution. Engaging and consulting local stakeholders was imperative to understand the context, reduce evidence gaps, and address the uncertainties in the evidence, ultimately paving the way for technology adoption. Given the ongoing studies and the evolving evidence base, the potential of this technology should be reassessed.
BACKGROUND: This study had a threefold aim: to test the value of stakeholder involvement in HTA to reduce evidence gaps and interpret findings; and to assess a medical device by applying the EUnetHTA Core Model (CM) in South Africa and thus ultimately provide a first overview of evidence for potential widespread adoption of the technology in a primary health care (PHC) setting. Used in primary healthcare setting for obstetric use, the technology under assessment is a low-cost continuous wave Doppler ultrasound (DUS). METHODS: The scoping of the assessment was defined by involving policy makers in selecting the domains and corresponding questions relevant to the ultrasound and its use. Additionally, hospital managers were invited to respond to dichotomous questions on the criteria for procurement. To substantiate evidence obtained from an initial literature review, different stakeholders were identified and consulted. The evidence generated fromall steps was used to populate the high-ranked assessment elements of the CM. RESULTS: The HTA on continuous-wave DUS incorporated the evidence on organizational, ethical, and social value of its use together with effectiveness, safety, and cost-effectiveness of the technology. The domains on "health problem" and "safety" had a higher rank than the rest of the nine domains. Unexplained fetal mortality is the largest single contributor to perinatal deaths in South Africa. Pregnant women in PHC setting were examined using a continuous-wave DUS, after their routine antenatal visit. The healthcare professionals interviewed, indicated the benefit in the use of continuous-wave DUS in the PHC setting and the need for training. CONCLUSIONS: Collection and generation of evidence based on the HTA CM and the chosen decision criteria provided a generalized but structured guidance on the methodology. Several questions were not applicable for the technology and the context of its use and elimination of those that are inappropriate for the African context, resulted in a pragmatic solution. Engaging and consulting local stakeholders was imperative to understand the context, reduce evidence gaps, and address the uncertainties in the evidence, ultimately paving the way for technology adoption. Given the ongoing studies and the evolving evidence base, the potential of this technology should be reassessed.
Entities:
Keywords:
Doppler ultrasound; Health technology assessment; South africa
Authors: S Kate Alldred; Boliang Guo; Yemisi Takwoingi; Mary Pennant; Susanna Wisniewski; Jonathan J Deeks; James P Neilson; Zarko Alfirevic Journal: Cochrane Database Syst Rev Date: 2015-12-10
Authors: Joshua P Vogel; Alfred O Osoti; Anthony J Kelly; Stefania Livio; Jane E Norman; Zarko Alfirevic Journal: Cochrane Database Syst Rev Date: 2017-09-13