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Table 6 Risk of Bias Assessment for Modeling Studies

From: A systematic review of BCG vaccination policies among high-risk groups in low TB-burden countries: implications for vaccination strategy in Canadian indigenous communities

Criteria a

Criteria met (yes = 1, no/unclear = 0, NA = not applicable)

Study (Author, Year)

Manissero, 2008

Sutherland, 1989

Brewer, 2001

Gerberry, 2009

Model Structure:

 Inputs and outputs relevant to decision-making

1

1

1

1

 Structure consistent with the theory of the disease

1

1

1

1

 Structure is simple but includes essential elements for vaccine policy decision-making (and any simplifications are justified)

1

1

1

1

 Heterogeneity in the modelled population accounted for by stratifying by groups that have different outcome probabilities or costs

1

0

1

1

 Time horizon of the model sufficient to detect important (and clinically meaningful) differences in long-term health and cost outcomes

0

1

1

0

For Markov models / health state transition models:

 Health states appropriately defined, relevant subdivisions of health states included

NA

NA

1

1

 Where relevant, transition probabilities take into account clinical history

NA

NA

1

1

 Choice of cycle length justified

NA

NA

0

0

Data Identification:

 Systematic reviews of the literature conducted on key model inputs

0

0

1

0

 Ranges provided in base-case estimates of all input parameters for which sensitivity analyses were done

NA

NA

1

1

 Data based on expert opinion, if used, are derived via formal methods, e.g. Delphi

NA

NA

NA

NA

 Attempts to obtain new data prior to modeling have been considered

1

1

1

1

Data Incorporation and Modeling:

 Modeling methods follow accepted methods of biostatistics and epidemiology

1

1

1

1

 Included sensitivity analyses of key parameters

0

0

1

1

 Model validation:

 Model subjected to internal testing through input of extreme values (or equal values for replication testing)

1

0

0

1

 Calibration data, where available, should be from sources independent of those used to estimate inputs

1

0

0

1

 Source code available for peer-review

0

0

0

0

 Model based on the best evidence available at the time

1

1

1

1

  1. a Criteria based on the ISPOR Principles of Good Practice for Decision Analytic Modelling in Health-Care Evaluation [27]