Table 6.

Triangulation with key recommendations on the economic evaluation alongside clinical or pragmatic trials

#	Key recommendations	Overview findings
1	Study design: Based on well-designed pragmatic/naturalistic trials with fewer strict protocols
2	Selection of subjects and sites: Seek for proximity to real-world target population and less restrictive patient inclusion criteria
3	Sample size: Based on important clinical outcome correlated with economic outcome, previous pilot or wider CI for ICER/CEAC
4	Estimates beyond trial: Appropriate length of follow-up, estimates beyond trial require survival analysis, link to final outcomes or regression
5	Comparator: Current practice or standard of care should be the comparator, although there may be different standards of care
6	Measures of outcomes: Direct, single measures are preferred. Utilities collected directly from study subjects at regular intervals
7	Data collection (resource use and costs): Relevant resource use and cost measures collected with clinical data (case report forms, patient records, patient diaries, interviews, computerized record linkage)
8	Valuation of costs: May include: microcosting; unit costing; and gross costing
9	Methods for cost and outcome analysis: Arithmetic mean cost differences, bootstrapping, OLS or GLM for between group comparison; multivariable methods for outcomes; confidence intervals, p values, ICERs on various time horizons; summary measures
10	Reporting: General description of trial and major findings; economic data collected alongside trial; missing and censored data; methods to construct, compare and project costs and outcomes; statistical methods; results on resource use, costs and outcomes; results within and beyond time horizon of trial.

CI confidence intervals, ICER incremental cost-effectiveness ratio, CEAC cost-effectiveness acceptability curve