Table 2: Regulatory status of the technology Country Organisation issuing approval Verbatim wording of the (expected) indication(s) (Expected) Date of approval (include expiry date for country of assessment) Launched (yes/no). If no include proposed date of launch Approval number (if available) Country of assessment Other countries
Suggested table 3: Relevant guidelines for diagnosis and management Name of society/organisation issuing guidelines Date of issue or last update Country/ies to which guideline applies Summary of recommendations (Level of evidence/grade of recommendation for the indication under assessment) Include a link to relevant guidelines if publicly available
Table 11: Methods of data collection and analysis of [state outcome] Study reference/ID Endpoint definition Method of data collection Method of analysis Table 12: Excluded data from the summary of study results Study reference/ID Excluded information (e.g. whole study/study arm/study outcome) Justification for exclusion Studies of technology under consideration Studies of comparator technologies (if applicable) Example table 13: 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 21: 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
Table 22: Risk of bias at study level: randomised studies Study reference/ ID Adequate generation of a randomisation sequence Adequate allocation concealment Blinding Incomplete outcome reporting Selective outcome reporting unlikely? Overall risk of bias Patient Medical personnel (carer, investigator, outcome assessor) Yes/no/unclear Yes/no/unclear Yes/no/unclear Yes/no/unclear Yes/no/unclear Yes/no/unclear Low/high Note: an answer ‘yes’ indicates a low risk of bias, and an answer ‘no’ indicates high risk of bias If the answer is ‘unclear’ or ‘no’, please give reasons for the classification
Table 24: Risk of bias at study level: non-randomised studies Study reference/ ID Outcome Bias due confounding Bias in selection of patients into the study Bias in measurement of interventions Bias due to departures from intended interventions Bias due to missing data Bias in measurement of outcomes Bias in selection of the reported result Overall bias [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] [Low/ moderate/ serious/ critical/ NI] NI=No information Insert reasons for the classification chosen