Table 5 Questions
a1.0 | Was ethics review committee or institutional review board study approval reported? | a6.0 | Were information about sample size estimates reported? |
1.1 | Was the name of the committee reported? | a6.1 | Were power calculations performed? |
1.2 | Was the location of the committee reported? | a7.0 | Were comparator interventions appropriate? |
a1.4 | Were details about the ethics committee reported? | a7.1 | Was the dosage of the intervention provided to groups comparable? |
a2.0 | Was it reported if informed consent was obtained? | 8.0 | Was the eventual use of placebo justified? |
2.1 | Was the consent for participation written? | a9.0 | Was potential harm for participants mentioned? |
2.2 | Was the consent for participation oral? | a9.1 | Were plans for collecting adverse events and other unintended effects mentioned? |
2.3 | How was consent (and possibly assent) acquired for members of vulnerable populations? | a9.2 | Were plans for assessing adverse events and other unintended effects mentioned? |
a2.4 | Were details about the consent process reported? | a9.3 | Were plans for reporting adverse events and other unintended effects mentioned? |
a3.0 | Were incentives or compensation for participants reported? | a9.4 | Were plans for managing adverse events and other unintended effects mentioned? |
3.1 | What did they receive, money, a gift, free medical care or treatment, free transportation or other services? | a9.5 | Were presence/absence of harm or adverse events reported? |
3.2 | Were details about incentives or compensation given to participants reported? | a10.0 | Was mentioned if appropriate follow up care was assured? |
a4.0 | Were funders reported? | a11.0 | Were steps taken to assess if participants had reduced competence (eg. use of validated screening tools for cognitive ability) reported? |
4.1 | How many organizations were involved? | 11.1 | Which measures were taken to protect participants with reduced competence best interests? |
4.2 | What were the funding sources? Governmental agencies, private foundations, or some other type? | a12.0 | Were steps taken to prevent unauthorized access to personal and clinical data (confidentiality) mentioned? |
4.3 | Were details about funders reported? | ||
a5.0 | Were there statements about potential conflicts of interest? | a12.1 | Was confidentiality preserved? |
5.1 | Was any conflict declared? | a13.0 | Was reported if the study was conducted in accordance with the Helsinki Declaration? |
5.2 | Were details about conflicts of interest reported? |