have been identified, but there is no access to the level of data required, this should be stated. Summary of methodology of the relevant randomised controlled trials It is expected that all key aspects of methodology will be in the public domain; if a company wishes to submit aspects of the methodology in confidence, prior agreement must be obtained from NICE. Provide the information specified in sections 4.3.1 and 4.3.2. 3 to 6b of the CONSORT should be provided for all RCTs listed: Trial design – brief description of trial design, including details of randomisation if applicable. Eligibility criteria – a comprehensive description of the eligibility criteria used to select the trial participants, including any definitions and any assessments used in recruitment. Settings and locations where the data were collected – describe the locations where the trial was carried out, including the country and, if applicable, the care setting (for example, primary care [GP or practice nurse], secondary care [inpatient, outpatient, day case]). Trial drugs and concomitant medications – provide details of trial drugs and comparator(s), with dosing information and titration schedules if appropriate. Provide an overview of concomitant medications permitted and disallowed during the trial. Primary, secondary and tertiary outcomes – all outcome measures listed in the trial protocol, whether primary, secondary or tertiary, should be identified and completely defined. The rationale for excluding data on any of the outcomes listed in the study protocol should be provided. When outcomes are assessed at several time points after randomisation, indicate the
Did the analysis include an intentiontotreat analysis? If so, was this appropriate and were appropriate methods used to account for missing data? Consider how closely the RCT(s) reflects routine clinical practice in England. In addition to parallel group RCTs, there are other randomised designs (for example, randomised crossover trials and randomised cluster trials) in which further quality criteria may need to be considered when assessing bias. Key aspects of quality to be considered can be found in (University of York Centre for Reviews and Dissemination). If there is more than 1 RCT, tabulate a summary of the responses applied to each of the quality assessment criteria. A suggested table format for the quality assessment results is presented below. Table X Quality assessment results for parallel group RCTs Trial number (acronym) Trial 1 Trial 2 [Add more columns as needed] Was randomisation carried out appropriately? (yes/no/not clear/N/A) (yes/no/not Was the concealment of treatment allocation adequate? (yes/no/not clear/N/A) (yes/no/not clear/N/A) Were the groups similar at the outset of the study in terms of prognostic factors? (yes/no/not clear/N/A) (yes/no/not clear/N/A) Were the care providers, participants and outcome assessors blind to treatment allocation? (yes/no/not clear/N/A) (yes/no/not clear/N/A) Were there any unexpected imbalances in (yes/no/not clear/N/A) (yes/no/not clear/N/A)
Table X Base-case results Technologies Total costs (£) Total LYG QALYs costs (£) Incremental LYG Incremental QALYs ICER (£) versus baseline (QALYs) ICER (£) incremental (QALYs) ICER, incremental cost-effectiveness ratio; LYG, life years gained; QALYs, quality-adjusted life years