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 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 14: 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 15: Results summary [insert study reference] (non-comparative studies) Outcome Intervention Baseline N= Follow-up (insert time point) N= Absolute difference* (95% confidence interval) Relative difference* (95% confidence interval) *Specify the type of difference presented in the submission The table may need to be adapted to include multiple time points Include in the table numbers of outcome events (n/N) or summary measures (mean/median and SD)
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
Risk of bias at outcome level: randomised studies Include all outcomes included in the evidence synthesis. For each study outcome included in the evidence synthesis, state whether: the outcome assessor was blinded intention-to-treat (ITT) was appropriately implemented selective outcome reporting is unlikely the study is free from other (outcome-specific) aspects that affect the risk of bias. The information can be included in a table (see table 23). Table 23: Risk of bias outcome level for [outcome x] Study Blinding of outcome assessors ITT appropriately implemented Selective outcome reporting unlikely Is the study free of other outcome specific aspects that can affect the risk of bias Overall risk of bias Yes/ no/ unclear Yes/ no/ unclear Yes/ no/ unclear Yes/ no/ unclear Low / High Repeat the table for each outcome included in the evidence synthesis. Risk of bias: non-randomised studies Include all studies that were used in the evidence synthesis, including (if applicable) studies of comparator technologies. Include ongoing and unpublished studies if these data are available. Risk of bias assessment results can be displayed separately for each outcome. Therefore separate assessment of risk of bias at the outcome level is not required for non-randomised studies. For each non-randomised study identified, state whether there is: