Table 3.
Results from the Delphi survey.
| Item | Round 1 Median score | Round 1 Item IN/OUT or NO CONSENSUS | Round 2 Median score | Round 2 Number (%) rated 7 to 9 | Round 2 Number (%) rated 1 to 3 | Round 2 Item IN/OUT or NO CONSENSUS | Item status after final voting |
|---|---|---|---|---|---|---|---|
| Title | 8 | IN | 8 | 39 (81.3) | 3 (6.3) | IN | IN |
| Trial registration number | 8 | IN | 8 | 42 (87.5) | 1 (2.1) | IN | IN |
| Source of funding | 8 | IN | 8 | 40 (83.3) | 2 (4.2) | IN | IN |
| Purpose of health economics analysis plan (HEAP) | 8 | IN | 8 | 37 (77.1) | 2 (4.2) | IN | IN |
| Sponsor approval | 6.5 | NO CON | 6 | 14 (29.2) | 5 (10.4) | NO CON | OUT |
| Trial protocol version | 7 | IN | 7 | 37 (77.1) | 1 (2.1) | IN | IN |
| Trial statistical analysis plan (SAP) version | 7 | IN | 7 | 34 (70.8) | 1 (2.1) | IN | IN |
| Trial HEAP version | 8 | IN | 8 | 42 (87.5) | 1 (2.1) | IN | IN |
| HEAP revisions | 7 | IN | 7 | 35 (72.9) | 2 (4.2) | IN | IN |
| Table of contents | 6 | NO CON | 5 | 11 (22.9) | 9 (18.8) | NO CON | OPTIONAL LIST |
| Abbreviations/glossary of terms/definitions | 6.5 | NO CON | 6 | 18 (37.5) | 5 (10.4) | NO CON | OPTIONAL LIST |
| Roles and responsibilities | 7 | IN | 7 | 33 (68.8) | 0 (0) | NO CON | IN |
| Signature(s) of person(s) writing HEAP (and date) | 6 | NO CON | 6 | 16 (33.3) | 9 (18.8) | NO CON | IN |
| Signature of senior health economist (HE) who is guarantor of the economic evaluation (and date) | 6 | NO CON | 6 | 18 (37.5) | 6 (12.5) | NO CON | IN |
| Signature of the chief investigator for the trial | 6 | NO CON | 6 | 15 (31.3) | 9 (18.8) | NO CON | IN |
| Trial background and rationale | 7 | IN | 7 | 35 (72.9) | 2 (4.2) | IN | IN |
| Aim(s) of the trial | 8 | IN | 8 | 38 (79.2) | 1 (2.1) | IN | IN |
| Objectives and/or research hypotheses of the trial | 7 | IN | 8 | 37 (77.1) | 2 (4.2) | IN | IN |
| Trial population | 7 | IN | 7 | 41 (85.4) | 2 (4.2) | IN | IN |
| Intervention and comparator(s) | 9 | IN | 9 | 47 (97.9) | 1 (2.1) | IN | IN |
| Trial design | 8 | IN | 8 | 45 (93.8) | 1 (2.1) | IN | IN |
| Trial start and end dates | 7 | IN | 7 | 33 (68.8) | 3 (6.3) | NO CON | IN |
| Aim(s) of economic evaluation | 9 | IN | 9 | 48 (100) | 0 (0) | IN | IN |
| Objectives(s)/hypotheses of economic evaluation | 9 | IN | 9 | 47 (97.9) | 0 (0) | IN | IN |
| Overview of economic analysis | 9 | IN | 9 | 48 (100) | 0 (0) | IN | IN |
| Jurisdiction | 7 | IN | 7 | 38 (79.2) | 2 (4.2) | IN | IN |
| Perspective(s) | 9 | IN | 9 | 47 (97.9) | 0 (0) | IN | IN |
| Time horizon | 9 | IN | 9 | 48 (100) | 0 (0) | IN | IN |
| Monitoring collection of health economic data | 7 | NO CON | 7 | 34 (70.8) | 4 (8.3) | IN | OPTIONAL LIST |
| Database management | 7 | NO CON | 7 | 25 (52.1) | 5 (10.4) | NO CON | OPTIONAL LIST |
| Data entry | 7 | NO CON | 6 | 23 (47.9) | 4 (8.3) | NO CON | OPTIONAL LIST |
| Data cleaning for analysis | 7 | IN | 7 | 33 (68.8) | 5 (10.4) | NO CON | IN |
| Data archiving | 6.5 | NO CON | 6 | 17 (35.4) | 4 (8.3) | NO CON | OPTIONAL LIST |
| Statistical software used for HE analysis | 7 | IN | 7 | 35 (72.9) | 3 (6.3) | IN | IN |
| Identification of resources | 9 | IN | 9 | 47 (97.9) | 0 (0) | IN | IN |
| Measurement of resource use data | 9 | IN | 9 | 48 (100) | 0 (0) | IN | IN |
| Valuation of resource use data | 9 | IN | 9 | 45 (93.8) | 0 (0) | IN | IN |
| Identification of outcome(s) | 9 | IN | 9 | 48 (100) | 0 (0) | IN | IN |
| Measurement of outcome(s) | 9 | IN | 9 | 48 (100) | 0 (0) | IN | IN |
| Valuation of outcome(s) | 9 | IN | 9 | 47 (97.9) | 0 (0) | IN | IN |
| Analysis population | 9 | IN | 9 | 45 (93.8) | 0 (0) | IN | IN |
| Timing of analyses | 8 | IN | 8 | 40 (83.3) | 1 (2.1) | IN | IN |
| Discount rates for costs and benefits | 9 | IN | 9 | 43 (89.6) | 1 (2.1) | IN | IN |
| Cost-effectiveness threshold(s) | 8.5 | IN | 8 | 39 (81.3) | 4 (8.3) | IN | IN |
| Statistical decision rule(s) | 8 | IN | 8 | 39 (81.3) | 3 (6.3) | IN | IN |
| Analysis of resource use | 9 | IN | 9 | 43 (89.6) | 0 (0) | IN | IN |
| Analysis of costs | 9 | IN | 9 | 46 (95.8) | 0 (0) | IN | IN |
| Analysis of outcomes | 9 | IN | 9 | 47 (97.9) | 0 (0) | IN | IN |
| Missing data | 9 | IN | 9 | 48 (100) | 0 (0) | IN | IN |
| Analysis of cost-effectiveness | 9 | IN | 9 | 47 (97.9) | 0 (0) | IN | IN |
| Sampling uncertainty | 9 | IN | 9 | 47 (97.9) | 0 (0) | IN | IN |
| Subgroup analysis/Analysis of heterogeneity | 9 | IN | 9 | 45 (93.8) | 0 (0) | IN | IN |
| Sensitivity analyses | 9 | IN | 9 | 47 (97.9) | 0 (0) | IN | IN |
| Post hoc analyses | 8 | IN | 8 | 38 (79.2) | 2 (4.2) | IN | OUT |
| Extrapolation or decision analytic modeling | 9 | IN | 9 | 46 (95.8) | 0 (0) | IN | IN |
| Model type | 9 | IN | 9 | 44 (91.7) | 1 (2.1) | IN | IN |
| Model structure | 8.5 | IN | 8 | 44 (91.7) | 1 (2.1) | IN | IN |
| Treatment effect beyond the end of the trial | 8.5 | IN | 8 | 42 (87.5) | 2 (4.2) | IN | IN |
| Other key assumptions | 8 | IN | 8 | 41 (85.4) | 1 (2.1) | IN | IN |
| Methods for identifying and estimating parameters | 8 | IN | 8 | 43 (89.6) | 1 (2.1) | IN | IN |
| Model uncertainty | 9 | IN | 9 | 45 (93.8) | 1 (2.1) | IN | IN |
| Model validation | 8 | IN | 8 | 42 (87.5) | 1 (2.1) | IN | IN |
| Subgroup analyses/Heterogeneity | 8 | IN | 8 | 41 (85.4) | 2 (4.2) | IN | IN |
| Value of information analysis | 6.5 | NO CON | 6 | 20 (41.7) | 6 (12.5) | NO CON | OPTIONAL LIST |
| Responsibility for health economic results and reporting | 7 | NO CON | 6.5 | 24 (50) | 4 (8.3) | NO CON | OUT |
| Reporting standards | 7 | IN | 7 | 35 (72.9) | 2 (4.2) | IN | IN |
| Reporting deviations from the HEAP | 8 | IN | 8 | 40 (83.3) | 2 (4.2) | IN | IN |
| References to trial and statistical master file | 6 | NO CON | 6 | 13 (27.1) | 9 (18.8) | NO CON | OUT |
| References to other trial documents | 6.5 | NO CON | 6 | 19 (39.6) | 5 (10.4) | NO CON | OPTIONAL LIST |
| Appendices: Resource use data collected | 7 | IN | 7 | 33 (68.8) | 4 (8.3) | NO CON | IN |
| Appendices: Reporting checklists | 6 | NO CON | 6 | 13 (27.1) | 12 (25) | NO CON | OUT |
| Appendices: Illustrations | 5 | NO CON | 5 | 3 (6.3) | 13 (27.1) | NO CON | OPTIONAL LIST |