This project was funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number 05/52/01) and was published in full in Health Technology Assessment 2009; Vol.13: No.59

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.

Below is a list of questions to ask when considering the adaptation of information and/or data on safety (box 6). The first two questions consider relevance of this section of a report. There follows a list of reliability questions and lastly, a list of questions relating to transferability.

Question Box 6: Safety domain questions

a) To assess relevance

1. Were harms or safety assessed?

2. Is the scope of the safety assessment relevant to your question?

b) To assess reliability

The aspects that should be assessed concerning the sources of information are:

3. Was the search for studies reasonably comprehensive?

4. Were special sources consulted? : disease registers, routinely data collected (on utilisation, costs, adverse effects,..), consumer associations, etc..

The aspects that should be assessed concerning the sources of safety data are:

5. What are the sources of information/data? E.g. surveillance databases, declaration of incidents, safety report, RCT, case reports

Quality of the safety assessment (i.e. appraisal of evidence)

6. Were the criteria used for deciding which studies to include in the HTA report reported?

7. Was bias in the selection of studies avoided?

8. Did the selection of studies (in particular the choice of eligible study designs) minimise the possibility of including studies with a high propensity for bias?

9. Were the criteria used for assessing the validity of the included studies reported?

10. a) Were the inclusion criteria used for the primary studies appropriate to the study question posed by the HTA report?

b) Were the criteria used to assess the validity of the primary study appropriate?

11. Which risks have been reported and how were they measured?

12. a) Were the study outcomes valid?

b) Were the study outcomes pertinent?

13. Are the number of patients, their representativeness and the quality of the data high enough to exclude a modest but clinically relevant rate of serious complications? i.e. what is the potential for overlooking a possible serious adverse event?

14. Is there a possibility for a „class‟ effect adverse reaction or safety problem?

c) To assess transferability

15. Does the population described for eligibility match the population to which it is targeted in the target setting?

16. Are there any reasons to expect differences in complication rates (e.g. epidemiology, genetic issues, healthcare system (quality of care, surveillance))?

17. Are the requirements for its use (special measures needed for use/implementation, maintenance etc.) available in the target setting?

18. Is the necessary expertise (knowledge and skills) available in the target setting?

19. a) Is safety particularly dependent on training?

b) Are there types of teams to which the procedure should be limited for safety reasons?

c) Is there a need for special training or certification to deliver the intervention properly.

d) Would it be possible (affordable) to organise such training, if any?

Answers to these questions should help the user extract information and/or data from this section of the HTA report. This „adaptation material‟ on safety can be incorporated within an HTA report in your own setting. There may be a need to update these data and supplement it with local context data.