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 |