Introducing an Ethics Framework for health priority-setting in South Africa on the path to universal health coverage.

BACKGROUND: South Africa (SA) has embarked on a process to implement universal health coverage (UHC) funded by National Health Insurance (NHI). The 2019 NHI Bill proposes creation of a health technology assessment (HTA) body to inform decisions about which interventions NHI funds will cover under UHC. In practice, HTA often relies mainly on economic evaluations of cost-effectiveness and budget impact, with less attention to the systematic, specific consideration of important social, organisational and ethical impacts of the health technology in question. In this context, the South African Values and Ethics for Universal Health Coverage (SAVE-UHC) research project recognised an opportunity to help shape the health priority-setting process by providing a way to take account of multiple, ethically relevant considerations that reflect SA values. The SAVE-UHC Research Team developed and tested an SA-specific Ethics Framework for HTA assessment and analysis. OBJECTIVES: To develop and test an Ethics Framework for use in the SA context for health priority-setting. METHODS: The Framework was developed iteratively by the authors and a multidisciplinary panel (18 participants) over a period of 18 months, using the principles outlined in the 2015 NHI White Paper as a starting point. The provisional Ethics Framework was then tested with multi-stakeholder simulated appraisal committees (SACs) in three provinces. The membership of each SAC roughly reflected the composition of a potential SA HTA committee. The deliberations and dedicated focus group discussions after each SAC meeting were recorded, analysed and used to refine the Framework, which was presented to the Working Group for review, comment and final approval. RESULTS: This article describes the 12 domains of the Framework. The first four (Burden of the Health Condition, Expected Health Benefits and Harms, Cost-Effectiveness Analysis, and Budget Impact) are commonly used in HTA assessments, and a further eight cover the other ethical domains. These are Equity, Respect and Dignity, Impacts on Personal Financial Situation, Forming and Maintaining Important Personal Relationships, Ease of Suffering, Impact on Safety and Security, Solidarity and Social Cohesion, and Systems Factors and Constraints. In each domain are questions and prompts to enable use of the Framework by both analysts and assessors. Issues that arose, such as weighting of the domains and the availability of SA evidence, were discussed by the SACs. CONCLUSIONS: The Ethics Framework is intended for use in priority-setting within an HTA process. The Framework was well accepted by a diverse group of stakeholders. The final version will be a useful tool not only for HTA and other priority-setting processes in SA, but also for future efforts to create HTA methods in SA and elsewhere.

Simultaneous extrusion and intrusion of a scleral buckle in a patient with Marfan's syndrome.

An Asian male in his late 50s with known Marfan's syndrome (MFS) presented with sudden deterioration in vision and loss of globe structure 13 years after the placement of a silicone scleral encircling band for the management of retinal detachment. Surgical exploration revealed simultaneous intrusion and extrusion of the encircling band resulting in globe perforation and collapse. This was managed by removal of the encircling band and a scleral patch graft over the defect. This case highlights that in patients with thin sclera, such as in MFS, scleral perforation is a potential complication that should be considered in patients undergoing scleral buckling. Management of this complication is also technically difficult because of impaired healing of the sclera in these patients.

Use of hydroxypropylmethylcellulose 2% for removing adherent silicone oil from silicone intraocular lenses.

BACKGROUND/AIMS: To investigate the effect of hydroxypropylmethylcellulose (HPMC) on the physical interaction (contact angle) between silicone oil and a silicone intraocular lens (IOL). METHODS: In vitro experiments were performed, to determine the effect of HPMC (0.5%, 1% or 2%), with or without an additional simple mechanical manoeuvre, on the contact angle of silicone oil at the surface of both silicone and acrylic (control) IOLs. A balanced salt solution chamber was used. The study group comprised 21 silicone and nine acrylic IOLs. RESULTS: The median contact angle of silicone oil on silicone IOL was 99 degrees. The addition of HPMC 2% alone did not significantly alter the contact angle. HPMC 2% combined with an additional single mechanical manoeuvre increased the contact angle to 180 degrees (greater non-wetting), with complete separation of silicone oil from silicone IOL within 1 min. The manoeuvre alone, or in conjunction with a lower concentration of HPMC (0.5 or 1%), was ineffective in increasing the contact angle. CONCLUSION: We present a novel, non-toxic technique of using hydroxypropylmethylcellulose 2% combined with a simple mechanical manoeuvre, for the removal of adherent silicone oil droplets from silicone intraocular lenses.

Early steps in mammalian sex determination.

Since the cloning of the Y-located testis-determining factor, sex determining region Y (SRY), several other genes have been implicated in the process of mammalian sex determination. Mutations of an SRY-related gene, SRY-related high-mobility group box 9 (SOX9), result in autosomal sex reversal and campomelic dysplasia. The genes Steroidogenic factor 1 (SF1) and Wilms' tumour 1 (WT1) are required for early gonadal development as well as for the formation of adrenals and kidneys respectively. The gene responsible for adrenal hypoplasia congenita, DAX1, is a candidate for the X-linked dosage sensitive sex reversal gene (DSS).

Integrins and their extracellular-matrix ligands in gastric-cancer.

Extracellular matrix (ECM) proteins and their specific cellular receptors, play an important role in the regulation of epithelial morphogenesis and differentiation. Alterations in their expression and function have been found in a number of malignant tumours and these changes may help to explain their dedifferentiation and altered behaviour. In this study we have investigated expression and distribution of the epithelial beta 1 integrins (alpha 2 beta 1, alpha 3 beta 1 and alpha 6 beta 1) and their ECM ligands (fibronectin, tenascin and laminin) in normal and neoplastic tissue. An up-regulation of two isoforms of fibronectin, and tenascin was seen in tumour associated matrix compared to normal stroma. Loss or down regulation of alpha integrin chains was seen more frequently in poorly differentiated carcinomas (alpha 2 p=0.002; alpha 3 p=0.013; alpha 6 p=0.0012) irrespective of tumour type (diffuse or intestinal) than in well/moderately differentiated tumours. Cell adhesion assays revealed that the ability of gastric carcinoma cell lines to bind matrix glycoproteins correlated to their degree of differentiation. Furthermore, poorly differentiated cell lines showed a down-regulation of alpha 2 and alpha 6 integrin expression. These data indicate that architectural and cytological differentiation in gastric carcinoma relates to altered patterns of expression of matrix glycoproteins and their receptors. The traditional Lauren classification seems to reflect these differences in cell-matrix interactions. Differing patterns of expression of those molecules involved in cell-matrix interactions may prove to be a more objective and biologically more relevant means of classifying gastric cancer.