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. 2009 Mar 13;24(4):699–720. doi: 10.1093/her/cyp006

Table I.

Study internal and external validity coding criteria

Criteria description Scoring for criteria
Internal validity criteria
Study design and methods
1 Was the method of randomisation appropriate? Y = 1; N = 0
2 Were baseline groups equivalent on important demographic measures? Y = 1; N = 0; unknown = 0
If No, was analysis conducted to estimate/adjust for effect of demographic measure on outcomes? Y = 1; N = 0; unknown = 0
3 Did the design of the study isolate the technology or the tailoring effect by comparing to a group with either no technology or no tailoring? Y = 1; N = 0
4 Was retention rate ≥80% at post-test/post-intervention follow-up? Y = 1; N = 0
5 Were outcome measurement instruments valid? Was there a description of instrument reliability/validity (reference or coefficients) or did they use a well-established known valid measure? Y = 1; N = 0
Study analysis
6 Was power analysis reported to determine sample size? Y = 1; N = 0
7 Were analyses conducted with consideration for missing data that maintain fidelity of the randomization (e.g. intention to treat, imputation)? Note: if 100% retention then N/A Y = 1; N = 0
Intervention design
8 Was the intervention based on theory? Y = 1; N = 0
External validity criteria
Program reach and sample representativeness
1 Were recruitment methods and/or inclusion and exclusion criteria sufficiently described? Both = 1; either = 0.5; none = 0
2 Were participation/recruitment rates provided OR Are analyses reported on the similarity and differences between participants versus either those who decline or the intended target audience (individuals or settings)? Y = 1; N = 0
3 Was a large heterogenous sample used? Was the representativeness of participants described? Was a homogenous/heterogeneous sample sought for target population? Do the exclusion criteria used reduce the generalisability of findings? Generalizable population = 1
4 Was the representativeness of the setting described? Was the study conducted in an uncontrolled/controlled setting? Can their findings only be generalized to the limited conditions within which the research was carried out? Generalizable setting (real-life) = 1; controlled = 0
5 Were all participants who entered trial accounted for at its conclusion i.e. Are data on attrition by condition reported OR was dropout rate described? Y = 0.5; N = 0
Are dropouts compared with completers OR are the dropout's characteristics and reasons for dropout described? Y = 0.5; N = 0
Important outcomes for decision making
6 Was the use of comparison conditions relevant to real-world decisions? (the computer-tailored treatment group was compared with either non-computerized or non-tailored programs rather than no treatment) Y = 1; N = 0
7 Are data on the costs presented? Y = 1; N = 0
8 Was there sufficient description of the intervention, including: method of tailoring, duration and intensity (amount of contact time required)? Y = 1; N = 0
Maintenance of effects
9 Are data reported on maintenance or longer term effects? Short term = 0; medium term = 0.5; long term = 1