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Headline
Keeping instruments moist is estimated to reduce the risk of surgically transmitted Creutzfeldt–Jakob disease cases and associated costs; other strategies evaluated did not appear cost-effective.
Abstract
Background:
Creutzfeldt–Jakob disease is a fatal neurological disease caused by abnormal infectious proteins called prions. Prions that are present on surgical instruments cannot be completely deactivated; therefore, patients who are subsequently operated on using these instruments may become infected. This can result in surgically transmitted Creutzfeldt–Jakob disease.
Objective:
To update literature reviews, consultation with experts and economic modelling published in 2006, and to provide the cost-effectiveness of strategies to reduce the risk of surgically transmitted Creutzfeldt–Jakob disease.
Methods:
Eight systematic reviews were undertaken for clinical parameters. One review of cost-effectiveness was undertaken. Electronic databases including MEDLINE and EMBASE were searched from 2005 to 2017. Expert elicitation sessions were undertaken. An advisory committee, convened by the National Institute for Health and Care Excellence to produce guidance, provided an additional source of information. A mathematical model was updated focusing on brain and posterior eye surgery and neuroendoscopy. The model simulated both patients and instrument sets. Assuming that there were potentially 15 cases of surgically transmitted Creutzfeldt–Jakob disease between 2005 and 2018, approximate Bayesian computation was used to obtain samples from the posterior distribution of the model parameters to generate results. Heuristics were used to improve computational efficiency. The modelling conformed to the National Institute for Health and Care Excellence reference case. The strategies evaluated included neither keeping instruments moist nor prohibiting set migration; ensuring that instruments were kept moist; prohibiting instrument migration between sets; and employing single-use instruments. Threshold analyses were undertaken to establish prices at which single-use sets or completely effective decontamination solutions would be cost-effective.
Results:
A total of 169 papers were identified for the clinical review. The evidence from published literature was not deemed sufficiently strong to take precedence over the distributions obtained from expert elicitation. Forty-eight papers were identified in the review of cost-effectiveness. The previous modelling structure was revised to add the possibility of misclassifying surgically transmitted Creutzfeldt–Jakob disease as another neurodegenerative disease, and assuming that all patients were susceptible to infection. Keeping instruments moist was estimated to reduce the risk of surgically transmitted Creutzfeldt–Jakob disease cases and associated costs. Based on probabilistic sensitivity analyses, keeping instruments moist was estimated to on average result in 2.36 (range 0–47) surgically transmitted Creutzfeldt–Jakob disease cases (across England) caused by infection occurring between 2019 and 2023. Prohibiting set migration or employing single-use instruments reduced the estimated risk of surgically transmitted Creutzfeldt–Jakob disease cases further, but at considerable cost. The estimated costs per quality-adjusted life-year gained of these strategies in addition to keeping instruments moist were in excess of £1M. It was estimated that single-use instrument sets (currently £350–500) or completely effective cleaning solutions would need to cost approximately £12 per patient to be cost-effective using a £30,000 per quality-adjusted life-year gained value.
Limitations:
As no direct published evidence to implicate surgery as a cause of Creutzfeldt–Jakob disease has been found since 2005, the estimations of potential cases from elicitation are still speculative. A particular source of uncertainty was in the number of potential surgically transmitted Creutzfeldt–Jakob disease cases that may have occurred between 2005 and 2018.
Conclusions:
Keeping instruments moist is estimated to reduce the risk of surgically transmitted Creutzfeldt–Jakob disease cases and associated costs. Further surgical management strategies can reduce the risks of surgically transmitted Creutzfeldt–Jakob disease but have considerable associated costs.
Study registration:
This study is registered as PROSPERO CRD42017071807.
Funding:
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 11. See the NIHR Journals Library website for further project information.
Contents
- Plain English summary
- Scientific summary
- Chapter 1. Introduction
- Chapter 2. Clinical evidence
- Methods for systematic reviews
- The incidence of Creutzfeldt–Jakob disease and the prevalence of Creutzfeldt–Jakob disease-related prions in humans in the UK
- The risk of Creutzfeldt–Jakob disease transmission via surgery
- Incubation periods of acquired transmissible spongiform encephalopathys
- The infectivity of Creutzfeldt–Jakob disease
- The evidence on the efficacy of prion decontamination procedures for surgical instruments
- The evidence that instruments used for high-risk procedures remain in their original sets after decontamination
- The evidence for complication rates of single-use compared with reusable instruments for high-risk procedures
- The evidence for the likelihood of future surgery for a patient undergoing high-risk procedures
- Chapter 3. Cost-effectiveness
- Background
- The conceptual model
- Key model parameters
- Calibration targets
- Categorisation of surgical units, establishing probabilistic sensitivity analysis configurations that are plausible and generating likelihood functions for plausible probabilistic sensitivity analysis configurations
- Strategies modelled
- Epidemiological results
- Cost-effectiveness results
- Chapter 4. Discussion and conclusions
- Acknowledgements
- References
- Appendix 1. Clinical effectiveness search strategies
- Appendix 2. Cost-effectiveness search strategies
- Appendix 3. Excluded studies from the clinical reviews with reasons for exclusion
- Appendix 4. Elicitation exercise relating to epidemiological parameters (conducted 18 January 2018)
- Appendix 5. The assumed age profile of patients receiving each operation
- Appendix 6. The operations considered to be at high risk
- Appendix 7. The calibration methodology
- Glossary
- List of abbreviations
About the Series
Article history
The research reported in this issue of the journal was funded by the HTA programme as project number 17/48/01. The contractual start date was in August 2017. The draft report began editorial review in October 2018 and was accepted for publication in June 2019. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Declared competing interests of authors
none
Last reviewed: October 2018; Accepted: June 2019.
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