| Title and abstract |
|---|
| Title | 1 | Identify the study as an economic evaluation or use more specific terms, such as ‘cost-effectiveness analysis’, and describe the interventions compared | Not applicable. Economic evaluation was conducted as part of a clinical trial |
| Abstract | 2 | Provide a structured summary of objectives, perspective, setting, methods (including study design and inputs), results (including base case and uncertainty analyses) and conclusions |
Page vii/lines 4–11
Page viii/lines 23–26 and 29–32
|
| Introduction |
|---|
| Background and objectives | 3 | Provide an explicit statement of the broader context for the study | Page 5/lines 6–22 |
| Present the study question and its relevance for health policy or practice decisions | |
| Methods |
|---|
| Target population and subgroups | 4 | Describe characteristics of the base-case population and subgroups analysed, including why they were chosen | Page 7/lines 33–39 and page 9/lines 1–14 |
| Setting and location | 5 | State relevant aspects of the system(s) in which the decision(s) need(s) to be made | Page 7/lines 15–26 |
| Study perspective | 6 | Describe the perspective of the study and relate this to the costs being evaluated | Page 57/lines 13–15 |
| Comparators | 7 | Describe the interventions or strategies being compared and state why they were chosen | From page 2/line 11 to page 4/line 41 |
| Time horizon | 8 | State the time horizon(s) over which costs and consequences are being evaluated and say why appropriate | Page 57/lines 3–10 |
| Discount rate | 9 | Report the choice of discount rate(s) used for costs and outcomes and say why appropriate | Page 57/lines 13–15 |
| Choice of health outcomes | 10 | Describe what outcomes were used as the measure(s) of benefit in the evaluation and their relevance for the type of analysis performed | From page 60/line 13 to page 61/line 28 |
| Measurement of effectiveness | 11a | Single study-based estimates: describe fully the design features of the single effectiveness study and why the single study was a sufficient source of clinical effectiveness data | From page 7/line 5 to page 22/line 7 |
| 11b | Synthesis-based estimates: describe fully the methods used for identification of included studies and synthesis of clinical effectiveness data | Not applicable |
| Measurement and valuation of preference based outcomes | 12 | If applicable, describe the population and methods used to elicit preferences for outcomes |
Page 71/line 9
Page 71/lines 32–37
|
| Estimating resources and costs | 13a | Single study-based economic evaluation: describe approaches used to estimate resource use associated with the alternative interventions. Describe primary or secondary research methods for valuing each resource item in terms of its unit cost. Describe any adjustments made to approximate to opportunity costs | Page 57/line 20 to page 60/line 12 |
| 13b | Model-based economic evaluation: describe approaches and data sources used to estimate resource use associated with model health states. Describe primary or secondary research methods for valuing each resource item in terms of its unit cost. Describe any adjustments made to approximate to opportunity costs |
Page 65/line 10 to page 66/line 5
Page 68/lines 1–5/see Table 33
|
| Currency, price date and conversion | 14 | Report the dates of the estimated resource quantities and unit costs. Describe methods for adjusting estimated unit costs to the year of reported costs if necessary. Describe methods for converting costs into a common currency base and the exchange rate | Page 57/lines 24 and 25 and page 23/line 4 |
| Choice of model | 15 | Describe and give reasons for the specific type of decision-analytical model used. Providing a figure to show model structure is strongly recommended |
Page 65/lines 3–10
Page 66/see
|
| Assumptions | 16 | Describe all structural or other assumptions underpinning the decision-analytical model |
Page 65/lines 3–13
Page 68/lines 1–18 and page 69/lines 1–4
|
| Analytical methods | 17 | Describe all analytical methods supporting the evaluation. This could include methods for dealing with skewed, missing, or censored data; extrapolation methods; methods for pooling data; approaches to validate or make adjustments (such as half-cycle corrections) to a model; and methods for handling population heterogeneity and uncertainty |
Page 67/lines 1 and 2
Page 57/lines 8 and 9
Page 60/lines 13–23 and page 61/lines 1–25
|
| Results |
|---|
| Study parameters | 18 | Report the values, ranges, references, and, if used, probability distributions for all parameters. Report reasons or sources for distributions used to represent uncertainty where appropriate. Providing a table to show the input values is strongly recommended | Pages 67/see Table 33 |
| Incremental costs and outcomes | 19 | For each intervention, report mean values for the main categories of estimated costs and outcomes of interest, as well as mean differences between the comparator groups. If applicable, report ICERs |
Page 62/lines 3–17/see Table 32
Page 68/lines 23–43/see Table 34
|
| Characterising uncertainty | 20a | Single study-based economic evaluation: describe the effects of sampling uncertainty for the estimated incremental cost and incremental effectiveness parameters, together with the impact of methodological assumptions (such as discount rate, study perspective) | Page 62/lines 8–17 |
| 20b | Model-based economic evaluation: describe the effects on the results of uncertainty for all input parameters, and uncertainty related to the structure of the model and assumptions | Page 68/lines 26–43 |
| Characterising heterogeneity | 21 | If applicable, report differences in costs, outcomes, or cost-effectiveness that can be explained by variations between subgroups of patients with different baseline characteristics or other observed variability in effects that are not reducible by more information | Not applicable |
| Discussion |
|---|
| Study findings, limitations, generalisability and current knowledge | 22 | Summarise key study findings and describe how they support the conclusions reached. Discuss limitations and the generalisability of the findings and how the findings fit with current knowledge |
Page 75/lines 41–44
Page 76/lines 35–41
Page 77/lines 33–41
|
| Other |
|---|
| Source of funding | 23 | Describe how the study was funded and the role of the funder in the identification, design, conduct and reporting of the analysis. Describe other non-monetary sources of support | Page xxv |
| Conflicts of interest | 24 | Describe any potential for conflict of interest of study contributors in accordance with journal policy. In the absence of a journal policy, we recommend authors comply with the International Committee of Medical Journal Editors’ recommendations | Pages iii |
