Table 6 Summary of PPICO to define research questions to investigate the effectiveness and cost-effectiveness of OCT as a means of identifying patients eligible for treatment with ocriplasmin on the PBS Population Prior tests Intervention Direct evidence Reference Outcomes to be comparator standard/ assessed evidentiary standard Patients who Biomicroscopy OCT Standard ophthalmic The reference Efficacy outcomes: have undergone assessment without standard for Clinical Clinical utility clinical and determining the OCT examination Clinical validity baseline “accuracy” of OCT Surgery Analytical validity ophthalmic is the ocriplasmin Or watchful waiting assessment and clinical trial Safety/Adverse events in whom the evidence base. Not assessed treating Current practice ophthalmologists without OCT would suspects will need to be as Modelled endpoints: have a condition accurate and Likelihood the test will consistent with effective as this lead to an improved the PBS Authority method for health outcome i.e., Required listing identifying patients linked evidence for ocriplasmin to ensure OCT approach of the ability adds no value. of OCT to change Natural history to treatment decisions provide support for the case of OCT in the absence of any other standard.including the rationale behind current clinical guidelines or criteria
Table 6 Summary of PPICO to define research questions to investigate the effectiveness and cost-effectiveness of OCT as a means of identifying patients eligible for treatment with ocriplasmin on the PBS Population Prior tests Intervention Direct evidence comparator Reference standard/ evidentiary standard Outcomes to be assessed Patients who have undergone clinical and baseline ophthalmic assessment and in whom the treating ophthalmologists suspects will have a condition consistent with the PBS Authority Required listing for ocriplasmin Biomicroscopy Clinical examination OCT Standard ophthalmic assessment without OCT Surgery Or watchful waiting The reference standard for determining the “accuracy” of OCT is the ocriplasmin clinical trial evidence base. Current practice without OCT would need to be as accurate and effective as this method for identifying patients to ensure OCT adds no value. Natural history to provide support for the case of OCT in the absence of any other standard.including the rationale behind current clinical guidelines or criteria Efficacy outcomes: Clinical utility Clinical validity Analytical validity Safety/Adverse events Not assessed Modelled endpoints: Likelihood the test will lead to an improved health outcome i.e., linked evidence approach of the ability of OCT to change treatment decisions
1370-OCT%20for%20sVMA%20-Final%20Protocol%20accessible(D14-1103373).docx