Introduction
Methods
Results and discussion
Existence of guidelines for modelling studies
Identification of key reporting items
Dimension of Quality | Reporting item | Philips | Unal | ISPOR | Nuijten | Stout | Drummond | Kopec |
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STRUCTURE
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Decision problem/objective | Is there a clear statement of the decision problem? | x | x | x | ||||
Is the objective of the evaluation specified and consistent with the stated decision problem? | x | x | ||||||
Is the primary decision-maker specified? | x | x | ||||||
Scope/perspective | Is the perspective of the model clearly stated? | x | x | x | ||||
Are the model inputs consistent with the stated perspective? | x | x | ||||||
Are definitions of the variables in the model justified? | x | |||||||
Has the scope of the model been stated and justified? | x | x | ||||||
Are the outcomes of the model consistent with the perspective, scope and overall objective of the model? | x | |||||||
Rationale for structure | Is the structure of the model consistent with a coherent theory of the health condition under evaluation? | x | x | x | ||||
Are the sources of data used to develop the structure of the model specified? | x | |||||||
Are the causal relationships described by the model structure justified appropriately? | x | |||||||
Structural assumptions | Are the structural assumptions clearly stated and justified? | x | x | x | x | |||
Are the structural assumptions reasonable given the overall objective, perspective and scope of the model? | x | |||||||
Strategies/comparators | Is there a clear definition of the options under evaluation? | x | x | x | ||||
Have all feasible and practical options been evaluated? | x | |||||||
Is there justification for the exclusion of feasible options? | x | |||||||
Model type | Is the chosen model type appropriate given the decision problem and specified causal relationships within the model? | x | x | x | ||||
Time horizon | Is the time horizon of the model sufficient to reflect all important differences between options? | x | x | x | ||||
Are the time horizon of the model, the duration of treatment and the duration of treatment effect described and justified? | x | |||||||
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 the interventions? | x | x | x | ||||
Cycle length | Is the cycle length justified? | x | x | x | ||||
Parsimony | Is there indication that the structure of the model is as simple as possible and that any simplifications are justified? | x | ||||||
DATA
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Data identification | Are the data identification methods transparent and appropriate given the objectives of the model? | x | x | x | ||||
Are results reported in a way that allows the assessment of the appropriateness of each parameter input and each assumption in the target settings? | x | |||||||
Where choices have been made between data sources, are these justified appropriately? | x | x | x | |||||
Where data from different sources are pooled, is this done in a way that the uncertainty relating to their precision and possible heterogeneity is adequately reflected? | x | |||||||
Are the data used to populate the model relevant to the target audiences (i.e., decision-makers) and settings? | x | |||||||
Has particular attention been paid to identifying data for the important parameters in the model? | x | |||||||
Has the quality of the data been assessed appropriately? | x | x | x | |||||
Where expert opinion has been used, are the methods described and justified? | x | x | x | x | ||||
Data modelling | Is the data modelling methodology based on justifiable statistical and epidemiological techniques? | x | x | |||||
Baseline data | Is the choice of baseline data described and justified? | x | ||||||
Are transition probabilities calculated appropriately? | x | x | x | |||||
Treatment effects | If relative treatment effects have been derived from trial data, have they been synthesized using appropriate techniques? | x | x | |||||
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? | x | x | x | |||||
Have assumptions regarding the continuing effect of treatment once treatment is complete been documented and justified? Have alternative assumptions been explored through sensitivity analysis? | x | |||||||
Risk factors | Has evidence supporting the modeling of risk factors as having an additive or multiplicative effect on baseline probabilities or rates of disease incidence or mortality been presented? | x | ||||||
Data incorporation | Have all data incorporated into the model been described and referenced in sufficient detail? | x | x | x | ||||
Has the use of mutually inconsistent data been justified (i.e., are assumptions and choices appropriate)? | x | |||||||
Is the process of data incorporation transparent? | x | x | ||||||
If data have been incorporated as distributions, has the choice of distribution for each parameter been described and justified? | x | x | ||||||
If data have been incorporated as distributions, is it clear that second order uncertainty is reflected? | x | x | ||||||
Assessment of uncertainty | Have the four principal types of uncertainty been addressed? | x | ||||||
If not, has the omission of particular forms of uncertainty been justified? | x | |||||||
Methodological | Have methodological uncertainties been addressed by running alternative versions of the model with different methodological assumptions? | x | ||||||
Structural | Is there evidence that structural uncertainties have been addressed via sensitivity analysis? | x | x | |||||
Heterogeneity | Has heterogeneity been dealt with by running the model separately for different subgroups? | x | x | |||||
Parameter | Are the methods of assessment of parameter uncertainty appropriate? | x | x | x | x | x | ||
If data are incorporated as point estimates, are the ranges used for sensitivity analysis stated clearly and justified? | x | x | ||||||
Which sensitivity analyses were carried out? | x | |||||||
CONSISTENCY
| ||||||||
Internal consistency | Is there evidence that the mathematical logic of the model has been tested thoroughly before use? | x | x | x | ||||
External consistency | Are any counterintuitive results from the model explained and justified? | x | x | x | ||||
If the model has been calibrated against independent data, have any differences been explained and justified? | x | x | ||||||
How was the model calibrated? | x | |||||||
Calibration - description of source data | x | x | ||||||
Calibration - description of search algorithm | x | x | ||||||
Calibration - description of goodness-of-fit metric | x | x | ||||||
Calibration - description of acceptance criteria | x | x | ||||||
Calibration - description of stopping rule | x | x | ||||||
Have the results of the model been compared with those of previous models and any differences in results explained? | x | x | x | x | ||||
VALIDITY
| ||||||||
Output plausibility | Has evidence of face validity - evaluation by experts in the subject matter area for a wide range of input conditions and output variables, over varying time horizons – been presented? | x | ||||||
Predictive validity | Was the validity of the model tested? | x | x | x | x | |||
Is there a description of how the validity of the model was checked? | x | x | ||||||
How was the validity quantified? (e.g., % explained) | x | |||||||
COMPUTER IMPLEMENTATION
| Is the software used in the study listed and its choice justified? | x | x | x | ||||
TRANSPARENCY
| Is the model available to the reader? | x | ||||||
Is a detailed document describing the calibration methods available? | x | |||||||
Do the authors provide relevant appendices? | x | |||||||
SPONSORSHIP
| Is disclosure of relationship between study sponsor and performer of the study provided? | x |