Table 1. Overview of evaluation criteria used in.
Bottrell 2000 (15) | Briguglio 1995 (16) | Brown 2004 (24) | Cattapan 2016 (23) | Durfy 1998 (17) | Eisenstaedt 1993 (18) | Ezeome 2011 (28) | Gargoum 2014 (26) | Glick 2010 (19) | Hopper 1993 (20) | Krahn 2016 (22) | Montgomery 1995 (25) | Shaz 2009 (21) | Vucemilo 2015 (27) | |
Meta-information | ||||||||||||||
Creators/authors of the consent form | – | – | – | – | – | – | – | – | – | – | – | – | – | – |
Date of issue | – | – | – | – | – | – | – | – | – | – | – | – | – | – |
Information sources listed | – | – | – | – | – | – | – | – | – | – | – | – | – | – |
Objectives of the consent form | + | – | – | – | – | – | – | – | + | – | – | – | + | – |
Signatures (Who signs/confirms? What is being confirmed?) and legal information (e.g., cancellation rights) | + | + | – | + | + | + | + | + | + | + | + | – | + | + |
Further information sources mentioned | + | + | – | + | – | – | – | – | + | – | + | – | + | – |
Formal data (e.g., names and addresses) | – | + | + | – | – | – | + | – | – | – | – | – | + | + |
Content | ||||||||||||||
Information about the intervention (e.g., type, extent, preparation, and follow-up) | + | + | + | + | + | – | + | + | + | + | + | + | + | + |
Alternatives/treatment options | + | + | + | – | + | + | + | + | + | + | – | + | – | + |
Option of doing nothing/watchful waiting | + | – | + | – | + | – | + | – | + | – | – | – | – | + |
Diagnostics only: Information on test effectiveness (e.g., sensitivity, specificity, predictive values) | \ | \ | \ | \ | + | \ | \ | \ | \ | \ | \ | \ | \ | \ |
Benefit of the intervention | + | – | + | + | + | – | + | – | + | – | + | – | + | + |
Harm of the intervention | + | + | + | + | + | + | + | + | + | + | + | + | + | + |
Information on anesthesia | – | + | – | – | – | – | + | – | – | – | – | + | – | – |
Costs | – | – | + | + | + | – | – | – | – | – | – | – | – | – |
Presentation | ||||||||||||||
Numerical presentation of frequencies/rates | – | + | – | – | – | – | – | + | – | – | – | – | – | – |
Comprehensible language (e.g., when explaining technical terms)* | – | – | + | – | – | – | – | – | – | – | – | – | – | – |
Images/figures/illustrations | – | – | + | – | – | – | – | – | – | – | – | + | – | – |
Ensuring that patients understand the information | + | – | – | – | – | – | – | – | + | – | – | – | – | – |
+, Criterion was used; –, criterion was not used; \, criterion does not apply
defined assessment/evaluation/rating criteria, relevant for supporting informed decision-making
additional evaluation criteria that were used in the included studies
* Evaluations on the basis of readability indices were not considered.