Appendix 1: Data abstraction form
Citation/Country Meets Inclusion/Exclusion Criteria?
__Yes(Women within one year after pregnancy, At least 1 month (4 weeks), behavioral interventions, English, RCT ’s)
__No (Stop!) (After one year post-pregnancy, Fewer than 4 weeks, Pharmacotherapy and surgical studies, other languages, non- RCT /Meta-analysis
Study Question(s)
Research Design (Describe Intervention and setting)
Study Design Setting Sample Size Source Population (Location)
Study Population(descriptive: demographics, eligibility criteria) and how chosen (volunteers, recruitment, tertiary care clinics, population-based, etc) Subgroups available (AA, Multi vs Primiparous)
Initial comparability of groups (ie, method of randomization or group composition; concealment of allocation)
Randomization?
Groups Similar at Baseline?
Arms of Research (Comparators and T ype of Intervention) Drop outs (no endpoint data), adherence, cross-overs (other terms: attrition; loss to follow-up) Potential for selection bias (grade + to +++, and explain)
_* _** _***
Measurement (of
exposure/intervention; outcomes; potential confounders): reliability and validity of measurement instruments; how measurements were performed; include blinding if needed
Which Outcomes?
Potential for measurement bias (grade + to +++, explain)
_* _** _***
Potential confounders (name what they are and how each was controlled: ie, by randomization, restriction, statistical adjustment, stratification, etc)
56 Potential for confounding (grade +
to +++, explain)
Analysis (intention to treat if applicable, other adjustment, etc) Results: magnitude and direction (point estimate); random error/precision (confidence interval); statistical significance Comments on Costs and Harms Clinical/public health importance of the result (explain) for the source population and wider populations
Q uality: Overall judgment of internal validity (good, fair, poor – explain)
Use USPST F
_Good: meet all criteria, the least bias (+ selection bias, +measurement bias) results are valid. Comparable groups are assembled initially and maintained throughout the study (follow-up at least 80 percent); reliable and valid measurement instruments are used and applied equally to the groups; interventions are spelled out clearly; all important outcomes are considered; and appropriate attention to confounders in analysis. In addition, for RCTs, intention to treat analysis is used.
_Fair: presumably fulfill all quality criteria but do not report their methods sufficiently to answer all of our questions. Some bias. Studies will be graded "fair" if any or all of the following problems occur, without the fatal flaws noted in the "poor" category below: Generally comparable groups are assembled initially but some question remains whether some (although not major) differences occurred with follow-up; measurement instruments are acceptable (although not the best) and generally applied equally; some but not all important outcomes are considered; and some but not all potential confounders are accounted for. Intention to treat analysis is done for RCT s.
_Poor: fatal flaw (defined as a methodological shortcoming that leads to a very high risk of bias) in one or more categories and will exclude them from our analyses. Studies will be graded "poor" if any of the following fatal flaws exists: Groups assembled initially are not close to being comparable or maintained throughout the study; unreliable or invalid measurement instruments are used or not applied at all equally among groups (including not masking outcome assessment); and key confounders are given little or no attention. For RCTs, intention to treat analysis is lacking.
O ve rall Strength of Body of Evide nce
Includes the 4 elements below
__High: High confidence that the evidence reflects the true effect. Further research is very unlikely to change our confidence in the estimate of effect.
__Moderate: Moderate confidence that the evidence reflects the true effect. Further research may change our confidence in the estimate of the effect and may change the estimate.
__Low: Low confidence that the evidence reflects the true effect. Further research is likely to change our confidence in the estimate of the effect and is likely to change the estimate.
__Insufficient: Evidence either is unavailable or does not permit estimation of an effect.
Risk of Bias (Study design and aggregate quality)
Consistency
Directness/Strength of Association Precision
External validity: applicability of findings to other populations beyond the source population
_Good:T he study differs minimally from the US primary care population/situation/providers and only in ways that are unlikely to affect the outcome; it is highly probable (>90%) that the clinical
_Fair: T he study differs from the US primary care
population/situation/providers in a few ways that have the potential to affect the outcome in a clinically important way; it is only moderately
_Poor:The study differs from the US primary care population/ situation/ providers in many way that have a high likelihood of affecting the clinical
57 experience with the intervention observed in the study will be attained in the US primary care setting.
probable (50%-89%) that the clinical experience with the intervention in the study will be attained in the US primary care setting.
outcomes; the probability is low (<50%) that the clinical experience with the intervention observed in the study will be attained in the US primary care setting.
Comments and your interpretation of the information from the study (include consistency with other studies if you can) (include conflicts of interest; selective endpoint reporting)
58