Publication Cohort (a) With control group (b) Pre/post intervention (c) Random assignment (d) Random selection for assessment (e) Sample size >100 (f) Follow-up ≥80% (g) Comparable socio-demographics between study groups (h) Comparable outcome measures at baseline (i) Total
Kelly et al. [32] 1 1 1 1 1 1 0 1 1 8
Kalichman et al.[37] 1 1 1 1 1 1 0 1 1 8
Margolin et al. [23] 1 1 1 1 1 0 0 1 1 7
Sorensen et al. [38] 1 1 1 1 1 1 0 1 1 8
Purcell et al. [39] 1 1 1 1 1 1 1 1 1 9
Gilbert et al. [24] 1 1 1 1 1 1 1 1 1 9
Williams et al. [40] 1 1 1 1 1 1 1 1 1 9
Coleman et al. [41] 1 1 1 1 1 0 1 1 1 8
Rose et al. [8] 1 1 1 1 1 1 1 1 1 9
Teti et al. [22] 1 1 1 1 1 1 0 1 1 8
Wolitski et al. [9] 1 1 1 1 1 1 1 1 1 9
Kalichman et al. [20] 1 1 1 1 1 1 1 1 1 9
* One point score for meeting each of the following items: (a) was a prospective cohort, (b) used a comparison arm, (c) collected pre and post intervention data, (d) used random assignment of participants to study arms , (e) did random sampling for assessments, (f) sample size > 100,(g) follow-up rate ≥ 80%, (h) had a comparison group with comparable socio-demographics such as age, education, race, employment, income, marital status and others [score “1” if > 50% variables were comparable between study arms, and ‘0’ if not], and (i) had a comparison arm with comparable outcome measures at baseline between study arms.
Table 2: Quality assessment of study design for 12 randomized clinical trials (rigor scores*).
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