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 6: Regulatory and reimbursement status of comparators Comparator name Regulatory authorisation status (yes/no/ongoing) Status of reimbursement recommendation (positive/negative/ongoing) Date of reimbursement decision If positive, level of reimbursement* Restrictions on reimbursement *Indicate if the comparator has complete or partial reimbursement. If partial reimbursement give a percentage of reimbursement
Table 17: Methods of data collection and analysis of [state outcome] Study reference/ID Endpoint definition Method of data collection Method of analysis Table 18: 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 19: Discontinuation and disruption of treatment by study Studies Reason for permanent discontinuation of treatment Reason for temporary discontinuation of treatment Number without post-discontinuation efficacy data Adverse events N (%) Lack of efficacy N (%) Other N (%) Adverse events N (%) Other N (%) N (%) Study Intervention Comparator Study Intervention Comparator
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
Table 25: Studies included in synthesis Study reference/ID Intervention Comparator 1 Comparator 2 Comparator 3 (add more columns as needed) Example: Smith 1990 x x Smith 1994 x x Table 26: Studies excluded from synthesis Study reference/ID Reasons for exclusion Describe the methods used to synthesise the evidence. Meta-analysis: state methods and models used and justify these. If Bayesian methods are used, justify the priors chosen. [add details here] Indirect or mixed treatment comparisons: state the statistical model, software and whether a fixed or random effects model has been used. Justify the choice of methods. If Bayesian methods are used, justify the priors chosen. The computer code and tables of study data entered into the indirect or mixed treatment comparison (including the outcomes data and numbers of patients in each of the trial arms for each outcome synthesised) should be included in an appendix. Narrative review: give details of the methods used. [add details here] Discuss the extent to which the studies may be considered (1) homogeneous as a group and (2) representative of the target population and treatments.