Outcomes3 The health outcomes upon which the comparative clinical performance of molecular testing for LQTS (in addition, or as a triage for the current diagnostic approaches for LQTS), versus the comparator of current LQTS diagnostic approaches alone, will be measured are: Effectiven ess Primary (patient relevant) mortality/survival • incidence of life-threatening events, ie. cardiac arrest • quality of life • Secondary incidence of symptoms, including arrhythmia (eg tachycardia), length of the patient’s • QTc in milliseconds, torsade de pointes (TdP), T-wave alternans, notched T wave in 3 leads, low heart rate for age, ventricular fibrillation and syncope patient anxiety • age at diagnosis • Safety psychological and physical harms from testing • Summary of PICO to be used for assessment of evidence (systematic review) 7 provides a summary of the PICO used to: (1) define the question for public funding, (2) select the evidence to assess the safety and effectiveness of molecular testing for LQTS, and (3) provide the evidence-based inputs for any decision-analytic modelling to determine the cost-effectiveness of molecular testing for LQTS. The methodology for undertaking this assessment of molecular testing in the diagnosis of LQTS is outlined in detail in the "Assessment methodology" section of the protocol. These will be assessed in the event that there is direct evidence of the effect of molecular testing on health outcomes (eg 3 randomised controlled trials or intervention studies). In the absence of this evidence, a linked evidence approach will be used – the PICO criteria that are relevant to this type of evidence are given in Appendix A.
Outcomes3 The health outcomes upon which the comparative clinical performance of molecular testing for LQTS (in addition, or as a triage for the current diagnostic approaches for LQTS), versus the comparator of current LQTS diagnostic approaches alone, will be measured are: Effectiven ess Primary (patient relevant) • mortality/survival • incidence of life-threatening events, ie. cardiac arrest • quality of life Secondary • incidence of symptoms, including arrhythmia (eg tachycardia), length of the patient’s QTc in milliseconds, torsade de pointes (TdP), T-wave alternans, notched T wave in 3 leads, low heart rate for age, ventricular fibrillation and syncope • patient anxiety • age at diagnosis Safety • psychological and physical harms from testing Summary of PICO to be used for assessment of evidence (systematic review) 7 provides a summary of the PICO used to: (1) define the question for public funding, (2) select the evidence to assess the safety and effectiveness of molecular testing for LQTS, and (3) provide the evidence-based inputs for any decision-analytic modelling to determine the cost-effectiveness of molecular testing for LQTS. The methodology for undertaking this assessment of molecular testing in the diagnosis of LQTS is outlined in detail in the "Assessment methodology" section of the protocol. 3 These will be assessed in the event that there is direct evidence of the effect of molecular testing on health outcomes (eg randomised controlled trials or intervention studies). In the absence of this evidence, a linked evidence approach will be used – the PICO criteria that are relevant to this type of evidence are given in Appendix A.
1151_FinalDAP.docx