Background
Methods/design
Protocol and registration
Literature search
Eligible studies
Data collection
Study selection
Inclusion criteria | Exclusion criteria | |
---|---|---|
Population | Eczema (synonyms: atopic eczema, atopic dermatitis) ICD-10 code: L20 | Populations with other skin diseases other than eczema |
Dyshidrotic eczema, seborrheic eczema, chronic actinic dermatitis, asteatotic eczema, allergic contact eczema, irritant contact eczema, varicose eczema, stasis eczema ICD-10 codes: L21 to L30 | ||
Study designs | Studies presenting primary data in the form of a Cost of illness, cost effectiveness, cost utility, cost benefit, cost consequences, cost analysis, utility analysis, contingent valuation | Studies without an explicit economic objective |
Review articles, although the reference list for these will be checked for primary studies that should be included | ||
Outcomes | Utility, QALYs, willingness to pay/accept | |
Publication type | Articles available in full text in English | Abstracts, letters, reviews |
Data abstraction and management
General information | |
Review ID | |
Author, year | |
Title | |
Reviewer | |
Date of review | |
Publication type | |
Population and setting | |
Type of study | |
Stated type of economic analysis | |
Actual type of economic analysis (if different) | |
Country of study | |
Study setting | |
Population | |
Study size | |
Method of recruitment | |
Recruitment time period | |
Inclusion criteria | |
Exclusion criteria | |
Study design | |
Primary intervention | |
Secondary intervention(s) | |
Comparators | |
Time horizon (for follow-up) | |
Outcomes | |
Outcomes measure (1) | |
Method of measurement (1) | |
Outcome measure (2) | |
Method of measurement (2) | |
Outcome measure (3) | |
Method of measurement (3) | |
Secondary outcome measure(s) | |
Method of measurement(s) | |
For utility studies: what value set or direct method of measurement has been used? | |
Timing of measurements | |
Discount rate, outcomes | |
Method of dealing with missing data—outcomes | |
Resource and cost information | |
Cost perspective | |
Intervention costs | |
Direct cost items | |
Method of capturing direct cost items | |
Direct cost data sources | |
Indirect cost items | |
Method of capturing indirect cost items | |
Indirect cost data sources | |
Resource items collected | |
Resource use, recall period | |
Method of dealing with missing data—cost | |
Price year | |
Currency | |
Inflation rate, cost | |
Discount rate, cost | |
Results | |
Resource use and costs | |
Outcomes | |
Reported cost effectiveness | |
Appropriateness of ICER | |
Sensitivity analysis | |
Major result(s) | |
Conclusions | |
Funding source | |
Model specific information | |
Type of decision analytic model | |
Model perspective | |
Model population | |
Cohort or individual? | |
Model assumptions | |
Model exclusions | |
Method for dividing disease severity | |
Distinction between body/face eczema? | |
Interventions included | |
Time horizon | |
Cycle length | |
Value of any parameters used | |
Source of parameters | |
Software used for model | |
Type of sensitivity analysis performed | |
Method of model validation | |
Author specified limitations |
Quality assessment and data presentation
Item no. | Recommendation | Reported on page/paragraph no. | Yes/no/partial/unclear/not applicable | |
---|---|---|---|---|
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. | ||
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. | ||
Introduction | ||||
Background and objectives | 3 | Provide an explicit statement of the broader context for the study. 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. | ||
Setting and location | 5 | State relevant aspects of the system(s) in which the decision(s) need(s) to be made. | ||
Study perspective | 6 | Describe the perspective of the study and relate this to the costs being evaluated. | ||
Comparators | 7 | Describe the interventions or strategies being compared and state why they were chosen | ||
Time horizon | 8 | State the time horizon(s) over which costs and consequences are being evaluated and say why appropriate. | ||
Discount rate | 9 | Report the choice of discount rate(s) used for costs and outcomes and say why appropriate. | ||
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. | ||
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. | ||
11b | Synthesis-based estimates: Describe fully the methods used for identification of included studies and synthesis of clinical effectiveness data | |||
Measurement and valuation of preference based outcomes | 12 | If applicable, describe the population and methods used to elicit preferences for outcomes. | ||
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. | ||
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. | |||
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. | ||
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. | ||
Assumptions | 16 | Describe all structural or other assumptions underpinning the decision-analytical model. | ||
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. | ||
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. | ||
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 incremental cost effectiveness ratios. | ||
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). | ||
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. | |||
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. | ||
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. | ||
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. | ||
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 International Committee of Medical Journal Editors recommendations |
Dimensions of quality | Questions for critical appraisal | Response (Yes/no/partial/unclear/NA) | Comments |
---|---|---|---|
S1: Statement of decision problem/objective | Is there a clear statement of the decision problem? | ||
Is the objective of the evaluation and model specified and consistent with the stated decision problem? | |||
Is the primary decision maker specified? | |||
S2: Statement of scope/perspective | Is the perspective of the model stated clearly? | ||
Are the model inputs consistent with the stated perspective? | |||
Has the scope of the model been stated and justified? | |||
Are the outcomes of the model consistent with the perspective, scope and overall objective of the model? | |||
S3: Rationale for structure | Has the evidence regarding the model structure been described? | ||
Is the structure of the model consistent with a coherent theory of the health condition under evaluation? | |||
Have any competing theories regarding model structure been considered? | |||
Are the sources of data used to develop the structure of the model specified? | |||
Are the causal relationships described by the model structure justified appropriately? | |||
S4: Structural assumptions | Are the structural assumptions transparent and justified? | ||
Are the structural assumptions reasonable given the overall objective, perspective and scope of the model? | |||
S5: Strategies/comparators | Is there a clear definition of the options under evaluation? | ||
Have all feasible and practical options been evaluated? | |||
Is there justification for the exclusion of feasible options? | |||
S6: Model type | Is the chosen model type appropriate given the decision problem and specified causal relationships within the model? | ||
S7: Time horizon | Is the time horizon of the model sufficient to reflect all important differences between options? | ||
Is the time horizon of the model, and the duration of treatment and treatment effect described and justified? | |||
Has a lifetime horizon been used? If not, has a shorter time horizon been justified? | |||
S8: Disease states/pathways | Do the disease states (state transition model) or the pathways (decision tree model) reflect the underlying biological process of the disease in question and the impact of interventions? | ||
S9: Cycle length | Is the cycle length defined and justified in terms of the natural history of disease? | ||
D1: Data identification | Are the data identification methods transparent and appropriate given the objectives of the model? | ||
Where choices have been made between data sources, are these justified appropriately? | |||
Has particular attention been paid to identifying data for the important parameters in the model? | |||
Has the process of selecting key parameters been justified and systematic methods used to identify the most appropriate data? | |||
Has the quality of the data been assessed appropriately? | |||
Where expert opinion has been used, are the methods described and justified? | |||
D2: Pre-model data | Are the pre-model data analysis methodology based on justifiable statistical and epidemiological techniques? | ||
D2a: Baseline data | Is the choice of baseline data described and justified? | ||
Are transition probabilities calculated appropriately? | |||
Has a half cycle correction been applied to both cost and outcome? | |||
D2b: Treatment effects | If relative treatment effects have been derived from trial data, have they been synthesised using appropriate techniques? | ||
Have the methods and assumptions used to extrapolate short-term results to final outcomes been documented and justified? Have alternative assumptions been explored through sensitivity analysis? | |||
Have assumptions regarding the continuing effect of treatment once treatment is complete been documented and justified? Have alternative assumptions been explored through sensitivity analysis? | |||
D2c: Quality-of-life weights (utilities) | Are the utilities incorporated into the model appropriate? | ||
Is the source for the utility weights referenced? | |||
Are the methods of derivation for the utility weights justified? | |||
D3: Data incorporation | Have all data incorporated into the model been described and referenced in sufficient detail? | ||
Has the use of mutually inconsistent data been justified (i.e. are assumptions and choices appropriate)? | |||
Is the process of data incorporation transparent? | |||
If data have been incorporated as distributions, has the choice of distribution for each parameter been described and justified? | |||
D4: Assessment of uncertainty | Have the four principal types of uncertainty been addressed? | ||
If not, has the omission of particular forms of uncertainty been justified? | |||
D4a: Methodological | Have methodological uncertainties been addressed by running alternative versions of the model with different methodological assumptions? | ||
D4b: Structural | Is there evidence that structural uncertainties have been addressed via sensitivity analysis? | ||
D4c: Heterogeneity | Has heterogeneity been dealt with by running the model separately for different sub-groups? | ||
D4d: Parameter | Are the methods of assessment of parameter uncertainty appropriate? | ||
Has probabilistic sensitivity analysis been done, if not has this been justified? | |||
If data are incorporated as point estimates, are the ranges used for sensitivity analysis stated and justified? | |||
C1: Internal consistency | Is there evidence that the mathematical logic of the model has been tested thoroughly before use? | ||
C2: External consistency | Are the conclusions valid given the data presented? | ||
Are any counterintuitive results from the model explained and justified? | |||
If the model has been calibrated against independent data, have any differences been explained and justified? | |||
Have the results of the model been compared with those of previous models and any differences in results explained? |