Invitation to Tender
Contract Award Notice
Questions and Answers
What is the definition of “TB outbreak among children”?
E.g. is outbreak defined by a specific number of affected children? Do you only consider TB cases among children, or also children latently infected with Mycobacterium tuberculosis?
In this context an outbreak among children is defined as any situation where several (more than one) children are infected in an outbreak setting, this may include, but not limited to, transmission within a school, nursing home, and hospital setting etc. As the project concerns to comprehensively assess how the management of children affected in such outbreaks should be dealt with, also the management of latent TB infection is of interest. For the purpose of the measurement of impact of TB outbreaks among children in relation to the overall epidemiological situation of childhood TB, only TB disease cases are of interest.
What is the definition of a child? Less than 15 years?
Paediatric TB is defined as TB among children less than 15 years of age and childhood normally extends to 18 years of age. For the purpose of the assessment on how to manage outbreaks, children up to 18 years of age may be of interest. However, for the purpose of the measurement of impact of TB outbreaks among children in relation to the overall epidemiological situation of childhood TB, to be consistent with the age classifications of surveillance reporting of TB cases, we are interested in the children less than 15 years of age.
Task 1 entails to draft a survey, while ECDC will administer it through its competent bodies. Who is collecting and analyzing the data?
The collection and analysis of data is the responsibility of the tenderer under tasks 1 and 5 and the results shall be presented in deliverable 5. ECDC is only responsible to administer the survey, due to our policy on surveys to Member States.
Will ECDC assist in translation of the policy documents collected under task 1 and written in EU languages not widely spoken?
All components of the tender should be covered by the tenderer, thus also the translations of policy documents are the main responsibility of the tenderer. However, in the part of the tender describing the proposed methodology, it is free to specify which languages that can be covered by the tenderer in the work under this contract. The tenderer can also propose that English summaries of relevant policies are to be inquired and provided by the specific countries in the step of the survey or the in depth interviews. In the event of any complications with translations during the course of the contract, these can be dealt in agreement with ECDC experts.
To what extent do you expect grey literature to be reviewed?
E.g. Does it include published experiences and practices in newspaper articles or only in medical grey literature?
The grey literature review may also cover material on national websites, in newspapers and other non-medical grey literature.
What (objective) criteria does ECDC propose to select outbreaks for in depth interviews under task 4?
Should in-depth interviews be conducted for all identified TB outbreaks among children? The number of outbreaks among children may be very high depending on the definition.
Answer for question 6 and 7
It is free for the tenderer to propose a suitable methodology for the criteria of selecting outbreaks for the in depth interviews. The quality and quantity of the methodology should allow for a comprehensive assessment of current practices and the description of best practices as mentioned under tasks 4 and 8. As described in the tender specifications (Section 4, 1.18 Technical evaluation) the quality of the proposed methodology will be assessed in the evaluation of the tenders.
Do you request using formal qualitative methods for analysis of in-depth interviews (e.g. with transcription) or do you accept a more journalistic approach?
Formal qualitative methods for the in depth interviews are not requested in the tender specifications, it will be up to the tenderer to propose a suitable methodology so that the objective of the tender is satisfactory fulfilled.
We suspect that the in-depth interviews may need ethical clearance from an ethical review committee. Do you agree? If yes, does ECDC have an ethical review committee that could assess the protocol quickly? What is the average time from submission to clearance? We want to check as this might be a hurdle in the timely completion of the work.
We have not foreseen that ethical clearance should be necessary for this assessment. The focus should be on the overall management of TB outbreaks among children to identify good (public health) practices/policies of for example contact tracing, detection of latent TB infection, crisis support and information etc. Thus, the in depth interviews are not aimed to collect information about individual cases and/or the identity/details of individual cases, therefore we have no reasons to believe that ethical clearance should be necessary. In any case, ECDC does not have an independent ethical review committee where such clearance could be given for studies on national level. If some countries would require ethical clearance, it will have to be through ethical clearance of the specific country.
As several estimates are possible to measure epidemiological impact, which measurements/estimates do you propose? You mention collection of the total number of children involved in outbreaks. These can be related to the total number of notified TB cases among children, to the total number of notified TB cases, to the estimated total number of childhood TB cases, to the estimated total number of all TB cases, etc.
As mentioned under task 1, A. We are interested in the estimated impact of TB outbreaks among children on overall epidemiological situation of TB among children in the EU/EEA Member States. It is free for the tenderer to propose a suitable methodology so that the objective of the estimation is satisfactory fulfilled. Also, it remains to be determined if the results of the literature reviews will allow an accurate measurement of epidemiological impact, so the estimations will be done in agreement with ECDC experts.