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. 2008 Apr 11;24(2):237–252. doi: 10.1093/her/cyn015

Table II.

List of criteria for the quality assessment of RCTs on the effectiveness of stage-based dietary interventions in primary care: modification of critical appraisal tool developed by the Effective Public Health Practice Project [28]

Component section Items and response choices Example of component ratings: rated as weak ifa
Selection bias 1. Were the providers/patients likely to be representative of the target population? (very likely/somewhat likely/not likely)
2. What percentage agreed to participate? (80–100%/60–79%/<60%/not reported/not applicable)
1. Not likely or
2. Less than 60% or
1. Somewhat likely and
2. Not reported
Allocation bias 1. Was the method of random allocation stated? (Yes/No)
2. If yes, was it appropriate? (Yes/No)
3. Was the method of random allocation reported as concealed? (Yes/No)
1. No and
1. No and
1. No
Confounders 1. Were there group differences for important confounders? (Yes/No/Cannot tell/Not applicable)
    ’Providers’: age, gender, attitudes toward counseling, counseling practices, postgraduate education in counseling
    ’Patients’: age, gender, BMI/weight/waist circumference, dietary behavior, readiness to change dietary habits
2. If yes, were they adequately managed in the analysis? (Yes/No/Not applicable)
3. Were there important confounders not reported? (Yes/No)
1. Cannot tell or
1. Yes and 2. No and
3. Yes or
1. Yes and
2. No and
3. No or
1. No and
2. Not applicable and
3. Yes
Blinding Were the outcome assessors blinded? (Yes/No/Not reported/Not applicable) No or Not reported
Data collection methods 1. Were data collection tools shown or were they known to be valid? (Yes/No)
2. Were data collection tools shown or were they known to be reliable? (Yes/No)
1. No and 2. Yes or
1. No and 2. No
Withdrawals and dropouts What was the percentage of participants completing the study? (80–100%/60–79%/<60%/Not reported/Not applicable) Less than 60% or
Not reported
Analysis 1. Was there a sample size calculation or power calculation? (Yes/Partially/No)
2. Was there a statistically significant difference between the groups? (Yes/No/Not reported)
3. Were the statistical methods appropriate? (Yes/No/Not reported)
4. What was the allocation unit? (Community/Organization or institution/Group/Provider/Client)
5. What was the analytical unit? (same than previous)
6. If the above two were different, was cluster analysis performed? (Yes/No/Not applicable)
7. Was the analysis performed with an intention to treat? (Yes/No/Cannot tell)
1. No and
2. Yes and
3. No and
4. + 5. Different unit and
6. No and
7. No
Intervention integrity 1. What percentage of the providers/participants received the intervention? (80–100%/60–79%/<60%/Not reported/Not applicable)
2. Was the consistency of the intervention measured? (Yes/No/Not reported/Not applicable)
3. Was contamination likely? (Yes/No/Cannot tell)
1. Less than 60% or Not reported and
2. No or Not reported and
3. Yes or Cannot tell
Total scorea Weak, moderate, strong
a

Based on the dictionary for this particular tool [29].