Single technology appraisal and highly specialised technologies evaluation: User guide for company evidence submission template

D1.1 Identification and selection of relevant studies

This section provides guidance on identifying and selecting relevant studies that provide evidence for:

This information should be submitted as appendix D to the main submission.

To identify and select relevant studies, it is expected that a systematic literature search will be carried out in line with NICE's health technology evaluation guidance development manual sections 3.4.2, 3.4.4 and 3.4.5.

In exceptional circumstances a systematic literature search may not be necessary. If a systematic literature search is not included in the submission, the company must confirm that no other additional relevant studies have been done outside its organisation.

Advise whether a search strategy was developed to identify relevant studies. If a search strategy was developed and a literature search carried out, provide details under the subheadings listed in this section. Key aspects of study selection can be found in Systematic reviews: CRD's guidance for undertaking reviews in health care (University of York Centre for Reviews and Dissemination).

Search strategy

Describe the search strategies used to retrieve relevant clinical data. The methods used should be justified with reference to the decision problem. Sufficient detail should be provided so that the results may be reproduced. This includes a full list of all information sources and the full electronic search strategies for all databases, including any limits applied.

Study selection

Provide details of the treatments to be compared. This should include all treatments identified in the final NICE scope. If additional treatments have been included, the rationale should be provided. For example, additional treatments may be added to make a connected network for a mixed treatment comparison.

Describe the inclusion and exclusion selection criteria, language restrictions and the study selection process in a table. Justification should be provided to ensure that the rationale for study selection is transparent. A suggested table format is provided below.

A flow diagram of the numbers of studies included and excluded at each stage should be provided using a validated statement for reporting systematic reviews and meta-analyses, such as the PRISMA flow diagram. The total number of studies in the statement should equal the total number of studies listed in section 2.1.

When data from a single study have been drawn from more than 1 source (for example, a poster and a published report) or when trials are linked (for example, an open-label extension to a randomised controlled trial [RCT]), this should be clearly stated.

For indirect and mixed treatment comparisons

Summary of trials included in indirect or mixed treatment comparisons

In a table provide a summary of the trials used to carry out the indirect comparison or mixed treatment comparison. A suggested table format is presented below. When there are more than 2 treatments in the comparator sets for synthesis, include a network diagram.

If the table or network diagram provided does not include all the trials that were identified in the search strategy, the rationale for exclusion should be provided.

Methods and outcomes of studies included in indirect or mixed treatment comparisons

Provide the rationale for the choice of outcome measure chosen, along with the rationale for the choice of outcome scale selected.

Discuss the populations in the included trials, especially if they are not the same as the populations specified in the NICE scope. If they are not the same:

Describe whether there are apparent or potential differences in patient populations between the trials. If this is the case, explain how this has been taken into account.

Provide the following for each trial included:

Methods of analysis of studies included in indirect or mixed treatment comparisons

Provide a clear description of the indirect or mixed treatment comparison methodology. If the company considers that an indirect treatment comparison or mixed treatment comparison is inappropriate, the rationale should be provided and alternative analyses explored (for example, naive indirect comparison or a narrative overview).

Refer to NICE's health technology evaluation guidance development manual, sections 3.4.11 to 3.4.21.

For studies which will be detailed in section 2.4 of the main submission (that is, studies assessing the intervention technology), cross reference the submission rather than repeating the information in appendix D.

Supply any programming language used (for example the WinBUGS code).

Risk of bias of studies included in indirect or mixed treatment comparisons

D1.2 Participant flow in the relevant randomised control trials

Provide details of the numbers of participants who were eligible to enter the trials. Include the number of participants randomised and allocated to each treatment. Provide details of and the rationale for participants who crossed over treatment groups, were lost to follow up or withdrew from the RCT. Provide a CONSORT diagram showing the flow of participants through each stage of each of the trials

D1.3 Quality assessment for each trial

For studies that will be detailed in section 2.5 of the main submission (that is, studies assessing the intervention technology), cross reference the submission rather than repeating the information in appendix D.