Comparators in the assessment On the basis of the alternatives presented, identify the technologies to be used as comparator(s) for the assessment. Comparators can differ from the technology in their mechanism of action (whether physical, chemical or mechanical). If the comparators are different from the technologies identified as alternatives to the intervention or the technologies to which the intervention will be added, provide a justification for the differences. [add details here] Current use of the technology Summary of issues relating to current use of the technology In no more than 6 bullet points describe key statements about the current use of the technology. For example, include statements about the availability and reimbursement status of the technology in other countries, the populations in which the technology is currently used (if available). key statement key statement key statement key statement key statement key statement Current use of the technology Complete only if the technology is available in one or more European countries. Describe the experience of using the technology, for example the health conditions and populations, and the purposes for which the technology is currently used. Include whether the current use of the technology differs from that described in the (expected) authorisation. [add details here]
Table 10: Methods of data collection and analysis of [state outcome] Study reference/ID Endpoint definition Method of analysis Example table 11: Results summary for [state outcome] (dichotomous) Study reference/ID Outcome intervention n/N (%) Outcome Comparator n/N (%) Absolute difference* (95% confidence interval) (p value) Relative difference* (95% confidence interval) (p value) *Specify the type of difference presented in the submission Order studies by their comparison, e.g. all studies comparing the intervention with comparator x are listed first, followed by all studies comparing the intervention with comparator y. A study may appear in the table more than once if it has more than two treatment arms. Example table 12: Results summary for [state outcome] (continuous) Study reference/ID Outcome intervention N= Mean/Median (SD) Outcome Comparator N= Mean/Median (SD) Absolute difference* (95% confidence interval) (p value) Relative difference* (95% confidence interval) (p value) *Specify the type of difference presented in the submission Order studies by their comparison, e.g. all studies comparing the intervention with comparator x are listed first, followed by all studies comparing the intervention with comparator y. A study may appear in the table more than once if it has more than two treatment arms.
Example table 16: Frequency and severity of adverse events Study [insert study reference or identifier] System organ/ class/adverse events All grades Serious adverse events Death Intervention (n = x) n (%) Comparator (n = x) n (%) Relative risk (95% CI) Risk difference (95% CI) Intervention (n = x) n (%) Comparator (n = x) n (%) Relative risk (95% CI) Risk difference (95% CI) Intervention (n = x) n (%) Comparator (n = x) n (%) Relative risk (95% CI) Risk difference (95% CI) Class 1 (for example, nervous system disorders) Adverse event 1 Adverse event 2 Class 2 (for example, vascular disorders) Adverse event 3 Adverse event 4 CI, confidence interval Adapted from European Public Assessment Reports published by the European Medicines Agency From tables 3a and 5 of the EUnetHTA safety guideline