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Table 5 Questions

From: Ethics reporting practices in randomized controlled trials of physical therapy interventions after stroke

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?   
  1. aitem counted in the number of ethics-related issues reported