Table 5.
Quality appraisal of records in this study.
| Quality Indicators | [78] | [53] | [84] | [80] | [83] | [70] | [69] | |
|---|---|---|---|---|---|---|---|---|
| Study Design | Power calculation reported | No | No | No | No | No | No | No |
| Inclusion/exclusion criteria reported | No | No | No | No | No | No | No | |
| Individual level allocation | No | Yes | NA | Yes | Yes | Yes | Yes | |
| Random allocation to groups/condition/order | Yes | Yes | NA | Yes | Yes | Yes | Yes | |
| Randomization procedure appropriate | Yes | Unclear | NA | Unclear | Unclear | Unclear | Unclear | |
| Confounders | Groups similar (sociodemographic) | Unclear | Unclear | Unclear | Yes | Yes | Unclear | Yes |
| Group balanced at baseline | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Yes | |
| Participants blind to research question | Yes | Yes | Unclear | Unclear | Unclear | Unclear | Yes | |
| Intervention Integrity | Clear description of intervention and control | Yes | Yes | NA | Yes | Yes | Yes | Yes |
| Consistency of intervention (within and between groups) | Yes | No | NA | Yes | Yes | Yes | No | |
| Data Collection Methods | Outcome assessors blind to group allocation | No | No | Unclear | Unclear | Unclear | Unclear | Yes |
| Baseline measures taken before the intervention | Yes | Unclear | NA | Yes | Yes | No | Yes | |
| Consistency of data collection | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Analyses | All outcomes reported (means and SD/SE) | No | Yes | No | No | No | Yes | No |
| All participants accounted for (i.e., losses/exclusions) | Yes | Yes | Yes | Yes | Yes | No | Yes | |
| ITT analysis conducted (all data included after allocation) | Unclear | Unclear | NA | Unclear | Unclear | No | Unclear | |
| Individual level analysis | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Statistical analysis methods appropriate for study design | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| External Validity | Sample representative of target population | No | No | No | No | No | No | No |
| Overall Quality Score | Total number of points (out of possible 38) | 20 | 18 | 8 | 20 | 20 | 16 | 22 |
| Quality rating as percent | 52.6 (M) | 47.4 (M) | 21.1 (L) | 52.6 (M) | 52.6 (M) | 42.1 (M) | 57.9 (M) | |
| Responded to query about “uncertain” ratings | Yes | Yes | NA | No | NA | Yes | ||
| Quality Indicators | [85] | [71] | [72] | [55] | [68] | [63] | [67] | |
| Study Design | Power calculation reported | No | No | No | No | No | No | No |
| Inclusion/exclusion criteria reported | No | No | Yes | No | No | Yes | No | |
| Individual level allocation | Yes | Yes | Yes | NA | Yes | Yes | No | |
| Random allocation to groups/condition/order | Yes | Yes | Unclear | NA | Yes | Yes | No | |
| Randomization procedure appropriate | Unclear | Unclear | Unclear | NA | Unclear | Unclear | NA | |
| Confounders | Groups similar (sociodemographic) | Yes | Unclear | Yes | Unclear | Unclear | Unclear | Yes |
| Group balanced at baseline | Unclear | Unclear | Yes | Unclear | Unclear | Unclear | Yes | |
| Participants blind to research question | Unclear | Yes | Unclear | Yes | Unclear | Yes | Unclear | |
| Intervention Integrity | Clear description of intervention and control | Yes | Yes | Yes | NA | Yes | Yes | Partial |
| Consistency of intervention (within and between groups) | No | No | No | NA | Yes | Yes | No | |
| Data Collection Methods | Outcome assessors blind to group allocation | Unclear | No | Unclear | NA | Unclear | Unclear | Unclear |
| Baseline measures taken before the intervention | Yes | Yes | No | NA | Yes | No | Yes | |
| Consistency of data collection | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Analyses | All outcomes reported (means and SD/SE) | No | Yes | Yes | No | Yes | No | No |
| All participants accounted for (i.e., losses/exclusions) | Yes | Yes | Yes | No | Yes | Yes | No | |
| ITT analysis conducted (all data included after allocation) | Unclear | Unclear | Unclear | NA | Unclear | Unclear | No | |
| Individual level analysis | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Statistical analysis methods appropriate for study design | Yes | Yes | No | Yes | Yes | Yes | No | |
| External Validity | Sample representative of target population | No | No | No | No | No | No | No |
| Overall Quality Score | Total number of points (out of possible 38) | 18 | 20 | 18 | 8 | 20 | 20 | 11 |
| Quality rating as percent | 47.4 (M) | 52.6 (M) | 47.4 (M) | 21.1 (L) | 52.6 (M) | 52.6 (M) | 28.9 (L) | |
| Responded to query about “uncertain” ratings | NA | Yes | No | No | ||||
| Quality Indicators | [86] | [65] | [64] | [87] | [66] | [73] | [74] | |
| Study Design | Power calculation reported | No | No | No | No | No | No | No |
| Inclusion/exclusion criteria reported | No | Yes | Yes | No | No | Yes | Yes | |
| Individual level allocation | No | No | Yes | Yes | Yes | Yes | Yes | |
| Random allocation to groups/condition/order | No | No | Yes | Yes | Yes | Yes | Yes | |
| Randomization procedure appropriate | NA | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | |
| Confounders | Groups similar (sociodemographic) | Partial | Partial | Unclear | Unclear | Yes | Yes | Yes |
| Group balanced at baseline | Unclear | Unclear | Unclear | Partial | Unclear | Yes | Yes | |
| Participants blind to research question | Unclear | Yes | Yes | Yes | Yes | Unclear | Unclear | |
| Intervention Integrity | Clear description of intervention and control | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Consistency of intervention (within and between groups) | Yes | Yes | Yes | Yes | No | No | No | |
| Data Collection Methods | Outcome assessors blind to group allocation | Unclear | No | Unclear | Unclear | No | Unclear | Unclear |
| Baseline measures taken before the intervention | No | Yes | No | Yes | Yes | Yes | Yes | |
| Consistency of data collection | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Analyses | All outcomes reported (means and SD/SE) | Yes | No | No | No | No | Yes | Yes |
| All participants accounted for (i.e., losses/exclusions) | No | Yes | Yes | Yes | Yes | Yes | Yes | |
| ITT analysis conducted (all data included after allocation) | No | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | |
| Individual level analysis | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Statistical analysis methods appropriate for study design | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| External Validity | Sample representative of target population | No | No | No | No | No | No | No |
| Overall Quality Score | Total number of points (out of possible 38) | 13 | 19 | 20 | 21 | 20 | 24 | 24 |
| Quality rating as percent | 34.2 (M) | 50.0 (M) | 52.6 (M) | 55.3 (M) | 52.6 (M) | 63.2 (M) | 63.2 (M) | |
| Responded to query about “uncertain” ratings | No | No | No | |||||
| Quality Indicators | [88] | [89] | [79] | [58] | [81] | [82] | [54] | |
| Study Design | Power calculation reported | No | No | No | Study 3: No | Yes | No | No |
| Inclusion/exclusion criteria reported | Yes | Yes | Yes | Study 3: No | Yes | Yes | Yes | |
| Individual level allocation | Yes | Yes | Yes | Study 3: No | No | Yes | NA | |
| Random allocation to groups/condition/order | Yes | Yes | Yes | Study 3: Yes | Unclear | Yes | NA | |
| Randomization procedure appropriate | Unclear | Unclear | Unclear | Study 3: Unclear | Unclear | Unclear | NA | |
| Confounders | Groups similar (sociodemographic) | Yes | Yes | Yes | Study 3: Unclear | Yes | Yes | Unclear |
| Group balanced at baseline | Yes | Yes | Yes | Study 3: Unclear | Yes | Yes | Unclear | |
| Participants blind to research question | No | Unclear | Unclear | Study 3: Yes | Unclear | No | Unclear | |
| Intervention Integrity | Clear description of intervention and control | Yes | Yes | Yes | Study 3: Yes | Yes | Yes | NA |
| Consistency of intervention (within and between groups) | No | No | No | Study 3: No | No | Yes | NA | |
| Data Collection Methods | Outcome assessors blind to group allocation | No | Unclear | Unclear | Study 3: No | Unclear | Unclear | Unclear |
| Baseline measures taken before the intervention | No | No | No | Study 3: No | No | Yes | NA | |
| Consistency of data collection | Yes | Yes | Yes | Study 3: Yes | Yes | Yes | Yes | |
| Analyses | All outcomes reported (means and SD/SE) | No | No | Yes | Study 3: No | No | No | No |
| All participants accounted for (i.e., losses/exclusions) | Yes | Yes | Yes | Study 3: Yes | Yes | Yes | No | |
| ITT analysis conducted (all data included after allocation) | Unclear | Unclear | Unclear | Study 3: Unclear | Unclear | Unclear | NA | |
| Individual level analysis | Yes | Yes | Yes | Study 3: Yes | Yes | Yes | Yes | |
| Statistical analysis methods appropriate for study design | Yes | Yes | No | Study 3: Yes | No | Yes | Yes | |
| External Validity | Sample representative of target population | No | No | No | Study 3: No | No | No | No |
| Overall Quality Score | Total number of points (out of possible 38) | 20 | 20 | 20 | Study 3: 14 | 16 | 24 | 8 |
| Quality rating as percent | 52.6 (M) | 52.6 (M) | 52.6 (M) | Study 3: 36.8 (M) |
42.1 (M) | 63.2 (M) | 21.1 (L) | |
| Responded to query about “uncertain” ratings | Yes | No | No | Yes | ||||
| Quality Indicators | [61] | [90] | [91] | [77] | [75] | [57] | [60] | |
| Study Design | Power calculation reported | No | No | No | No | No | No | No |
| Inclusion/exclusion criteria reported | Yes | Yes | No | No | Yes | No | Yes | |
| Individual level allocation | Yes | Yes | Unclear | Yes | Yes | No | Yes | |
| Random allocation to groups/condition/order | Yes | Yes | Unclear | Unclear | Yes | No | Yes | |
| Randomization procedure appropriate | Unclear | Yes | Unclear | Unclear | Unclear | NA | Unclear | |
| Confounders | Groups similar (sociodemographic) | Unclear | Unclear | Yes | Unclear | Yes | Unclear | Unclear |
| Group balanced at baseline | Unclear | Unclear | Yes | Unclear | Yes | Unclear | Unclear | |
| Participants blind to research question | Unclear | No | Unclear | Unclear | Unclear | Unclear | Unclear | |
| Intervention Integrity | Clear description of intervention and control | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Consistency of intervention (within and between groups) | Yes | No | No | No | Yes | No | Yes | |
| Data Collection Methods | Outcome assessors blind to group allocation | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear |
| Baseline measures taken before the intervention | No | No | No | Yes | Yes | Yes | Partial | |
| Consistency of data collection | Yes | Yes | Yes | Yes | Yes | No | Yes | |
| Analyses | All outcomes reported (means and SD/SE) | No | No | No | No | No | No | No |
| All participants accounted for (i.e., losses/exclusions) | Yes | Yes | Yes | Yes | No | No | Yes | |
| ITT analysis conducted (all data included after allocation) | Unclear | Unclear | Unclear | Unclear | No | Unclear | Unclear | |
| Individual level analysis | Yes | Yes | Unclear | Yes | Yes | Yes | Yes | |
| Statistical analysis methods appropriate for study design | No | No | Unclear | Yes | Yes | No | Yes | |
| External Validity | Sample representative of target population | No | No | No | No | No | No | No |
| Overall Quality Score | Total number of points (out of possible 38) | 16 | 16 | 10 | 14 | 22 | 6 | 19 |
| Quality rating as percent | 42.1 (M) | 42.1 (M) | 26.3 (L) | 36.8 (M) | 58.9 (M) | 15.8 (L) | 50.0 (M) | |
| Responded to query about “uncertain” ratings | ||||||||
| Quality Indicators | [76] | [59] | [56] | [92] | [62] | [93] | [94] | |
| Study Design | Power calculation reported | No | No | No | No | No | No | Yes |
| Inclusion/exclusion criteria reported | Yes | No | Yes | Yes | No | Yes | No | |
| Individual level allocation | NA | No | Yes | No | Unclear | Unclear | Yes | |
| Random allocation to groups/condition/order | NA | No | No | Yes | Unclear | Unclear | Yes | |
| Randomization procedure appropriate | NA | NA | NA | Unclear | Unclear | Unclear | Unclear | |
| Confounders | Groups similar (sociodemographic) | Unclear | Yes | Yes | Unclear | Yes | Unclear | Unclear |
| Group balanced at baseline | Unclear | Yes | Yes | Unclear | Yes | Unclear | Unclear | |
| Participants blind to research question | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Yes | |
| Intervention Integrity | Clear description of intervention and control | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Consistency of intervention (within and between groups) | Yes | No | No | Yes | No | No | No | |
| Data Collection Methods | Outcome assessors blind to group allocation | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear | Unclear |
| Baseline measures taken before the intervention | No | Yes | Yes | Yes | Yes | Yes | No | |
| Consistency of data collection | Yes | No | Yes | Yes | Yes | Yes | Yes | |
| Analyses | All outcomes reported (means and SD/SE) | Yes | No | No | Yes | Yes | Yes | Yes |
| All participants accounted for (i.e., losses/exclusions) | Yes | Yes | Yes | No | Yes | No | Yes | |
| ITT analysis conducted (all data included after allocation) | NA | Unclear | Unclear | No | Unclear | No | Unclear | |
| Individual level analysis | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Statistical analysis methods appropriate for study design | Yes | No | Yes | Yes | Yes | Yes | Yes | |
| External Validity | Sample representative of target population | No | No | No | No | No | No | No |
| Overall Quality Score | Total number of points (out of possible 38) | 16 | 12 | 20 | 18 | 18 | 14 | 20 |
| Quality rating as percent | 42.1 (M) | 31.6 (L) | 52.6 (M) | 47.4 (M) | 47.4 (M) | 36.8 (M) | 52.6 (M) | |
| Responded to query about “uncertain” ratings | ||||||||
ITT: intention to treatment; Yes = 2; Partial (Pa.) = 1; No = 0; Unclear (Un) = 0; NA = criterion inapplicable to this study design; any changes made after consultation with study authors are highlighted in boldface. Appraisal quality: High (H): 67–100%, Moderate (M): 34–66%, Low (L): 0–33% [19].