eTable. Evaluation sheet for the content analysis of consent forms used in Germany.

Topic:				Code:
Meta-information	Yes	Partly	No	Comments
Author of the information – Institution or company is named. – Authors are named. If no authors are named: – Scientific or medical advisers are named.		– – –
Topicality – Date of issue is given.		–
Information sources – Information sources are listed. If yes: – Allocation of the information sources is possible. – Explanations of the information sources are provided (e.g., selection, evidence base, quality).		– – –
Objectives – Any objective of the consent form is listed. The objective listed is: – Preparation for the pre-operation discussion. – Support for a decision in favor of or against consenting to the procedure. – Enabling the patient to make an informed decision. – Documentation of the pre-operation discussion.		– – – – –
Signature It is possible to document, that the patient – consents to having the procedure, – refuses to have the procedure, – has received information, – has read the consent form, – has understood the information, – waives their right to receiving the information, – had enough time to consider their decision, – pays attention to behavioral rules/is able to pay attention.		– – – – – – – –
Contents Explanations are given on:	Yes	Partly	No	Comments
Type, extent, and undertaking of the intervention		–
Preparation and follow-up, including possible impairments/restrictions (e.g., nil by mouth, fitness to drive, ability to work)		–
Further therapeutic/diagnostic measures, that (may) result from the present intervention (e.g., reoperation)		–
Alternatives – Option of doing nothing/watchful waiting. – Additional treatment options.		– –
Only for diagnostic procedures: Test effectiveness – Is described verbally. – Numerical data (sensitivity, specificity, predictive values).		– –
Benefit of the intervention regarding patient relevant endpoints (mortality, morbidity, quality of life) – Endpoints are named. – Benefits are described in comparison with a different option. – The probability of a benefit is quantified (verbally or numerically).		– –
Harms/risks of the intervention regarding patient relevant endpoints (mortality, morbidity, quality of life) – Endpoints are named. – Harms are described in comparison with a different option. – The probability of harm is quantified (verbally or numerically).		– –
How the information is presented	Yes	Partly	No	Comments
Presentation of frequencies/rates of benefits and harms – Frequencies/rates are presented by using verbal descriptors. – Frequencies/rates are presented by using numerical descriptors. (percentages or natural frequencies) If numerical descriptors are used: – The same reference values are used. If benefits and/or harms are quantified in comparison with a control intervention (numerical): – Measures of relative risk are used. – Measures of absolute risk are used.		–
Language – Technical terms are used. – Explanations are given for technical terms used. – Directive language is used.		–
Supplementary materials (films, 3D models, or multimedia modules)	Yes	Partly	No	Comments
Films – Are available. – It is noted on the consent form whether the patient has received such material. If supplementary materials are used, they include the following topics: – Disease pattern. – Processes. – Risk communication.		– – – – –