The effects of modifying elements of written informed consent forms for elective surgical or invasive procedures: A systematic review
Stefanie Bühn, Elen Huppertz, Alina Weise, Julia Lühnen, Anke Steckelberg, Roland Brian Büchter, Simone Hess, Kyung-Eun (Anna) Choi, Tim Mathes
Patient Education and Counseling, February 2023; 107
Abstract
Objective
To study the effect of modifying content and design elements within written informed-consent-forms (ICF) for patients undergoing elective surgical or invasive procedures.
Methods
We included (quasi-)randomized trials in which a modified written ICF (e.g. visual aids) was compared to a standard written ICF. We searched PubMed, Web-of-Science and PsycINFO until 08/2021. Risk of Bias was assessed. The complexity of intervention was assessed using the Intervention Complexity Assessment Tool for Systematic Reviews.
Results
Eleven trials with 1091 participants were eligible. Effect sizes and levels of evidence varied from trivial to moderate and there were contradictory findings for some outcomes. Providing patients with more information in general or specific information on risks and complications mostly increased anxiety. The use of verbal risk presentation decreased anxiety and increased satisfaction. A lower readability level decreased anxiety and improved comprehension and knowledge.
Conclusion
Our results suggest that providing more information and addressing certain types of risks have differential effects. While more information improved knowledge, it also increased anxiety. We did not find any or only insufficient evidence for many other possible ICF modifications.
Practice implications
When developing ICFs the differential impact of different elements on patient important outcomes should be carefully considered.

An evaluation of the efficacy of a supplemental computer-based tutorial to enhance the informed consent process for cataract surgery: an exploratory randomized clinical study
Research
Marlies Ullrich, Oliver Findl, Katharina Kefer, Birgit Döller, Ralph Varsits, Julius Hienert, Nino Hirnschall
BMC Ophthalmology, 11 November 2022; 22(430)
Open Access
Abstract
Background
To assess whether informing patients with a computer-based tutorial in addition to standard informed consent influences the patient’s attitude towards surgery and increases patient’s knowledge.
Methods
In this prospective, exploratory, randomized clinical study, patients scheduled for their first eye cataract surgery were randomly allocated to two groups, receiving standard face-to-face informed consent (control group) or additionally using an interactive computer-based tool (CatInfo) containing an audiovisual presentation about cataract and its treatment (study group). Cataract-related knowledge and decisional confidence (decisional conflict scale (DCS)) were assessed as well as one-month postoperatively decisional regret (decision regret scale (DRS)) and willingness to exchange face-to-face discussion time for the use of such a tool.
Results
The study comprised 134 patients, 64 patients in the study group and 70 in the control group. Patients in the study group answered more questions correctly, 16.3 ± 2.0 (median 16.5, 11.0–19.0) versus 15.5 ± 1.9 (median 16.0, 8.0–19.0; p = 0.01). Patients showed a high decisional confidence with a study group mean DCS score of 92.4 ± 9.8 (median 96.9, 65.6–100) and control group score of 91.6 ± 10.9 (median 95.3, 43.3–100; p = 0.52). Mean DRS score in the study group was 2.5 ± 8.0 (median 0, 0–40) and 4.3 ± 12.5 (median 0, 0–75) in the control group (p = 0.14). Of study group patients 23 (67.6%) were willing to trade time, on average 158 ± 180 s (median 120 s, 45–900). Satisfaction with the tool was high with a mean of 9.1 ± 1.3 out of 10 (median 9.7, 5.0–10).
Conclusions
Cataract-related knowledge was generally good, with slightly higher scores in the study group. In both groups, decisional confidence was high and regret after surgery was low. A tendency towards slightly higher decisional confidence and lower regret was found in the study group, although these differences were not statistically significant. Additional use of an interactive computer-based tool may prove useful in the informed consent process in a high-volume cataract outpatient setting.

The role of knowledge and medical involvement in the context of informed consent: a course or a blessing?
Caterina Milo
Medicine, Health Care and Philosophy, 1 November 2022
Open Access
Abstract
Informed consent (IC) is a key patients’ right. It gives patients the opportunity to access relevant information/knowledge and to support their decision-making role in partnership with clinicians. Despite this promising account of IC, the relationship between ‘knowledge’, as derived from IC, and the role of clinicians is often misunderstood. I offer two examples of this: (1) the prenatal testing and screening for disabilities; (2) the consent process in the abortion context. In the first example, IC is often over-medicalized, that is to say the disclosure of information appears to be strongly in the clinicians’ hands. In this context, knowledge has often been a curse on prospective parents. Framing information in a doctor-centred and often negative way has hindered upon prospective parents’ decision-making role and also portrayed wrong assumptions upon disabled people more widely. In the second context, information is more often than not dismissed and, in a de-medicalized scenario, medical contribution often underplayed. The latter leads to an understanding of the dialogue with clinicians as a mere hinderance to the timely access to an abortion. Ultimately, I claim that it is important that knowledge, as derived from IC, is neither altogether dismissed via a process of de-medicalization, nor used as a curse on patients via a process of over-medicalization. None of the two gives justice to IC. Only when a better balance between medical and patients’ contribution is sought, knowledge can aspire to be a blessing (i.e. an opportunity for them), not a curse on patients in the IC context.

The “teach-back” method improves surgical informed consent and shared decision-making: a proof of concept study
Research
Kevin D. Seely, Jordan A. Higgs, Lindsey Butts, Jason M. Roe, Colton B. Merrill, Isain Zapata, Andrew Nigh
Patient Safety in Surgery, 28 October 2022; 16(33)
Open Access
Abstract
Introduction
The teach-back method is a communication tool that can improve patient safety and shared decision-making. Its utility in patient care has been studied extensively in many areas of clinical medicine. However, the literature on teach-back in surgical patient education and informed consent is limited, and few studies have been conducted to test its impact on perioperative patient interactions. The objective of this study was to evaluate if the teach-back method can improve informed consent and surgeon trust. An assessment of the time required to be implemented was also evaluated.
Methods
A standardized interaction role-playing a pre-operative informed consent discussion was designed. Laparoscopic cholecystectomy was selected as the proposed procedure. Standardized patients were split into two groups: teach-back and a control group. The control group was delivered a script that discloses the risks and benefits of laparoscopic cholecystectomy followed by a concluding prompt for any questions. The teach-back group was presented the same script followed by the teach-back method. Interactions were timed and patients completed a quiz assessing their knowledge of the risks and benefits and a survey assessing subjective perceptions about the interaction. Statistical analysis through Generalized Linear Models (GLMs) was used to compare visit length, performance on the comprehension quiz, and subjective surgeon trust perceptions.
Results
34 participants completed the scenario, the comprehension quiz, and the survey (n = 34). Analysis of the subjective evaluation of the physician and encounter was significant for increased physician trust (p = 0.0457). The intervention group performed higher on the knowledge check by an average of one point when compared to the control group (p = 0.0479). The visits with intervention took an average of 2.45 min longer than the control group visits (p = 0.0014). People who had the actual procedure in the past (evaluated as a confounder) were not significantly more likely to display the same effect as the teach-back method, suggesting that the knowledge and trust gained were not based on previous experiences with the procedure.
Conclusion
When employed correctly by surgeons in the perioperative setting, the teach-back method enhances shared decision-making, comprehension, and surgeon trust. Incorporating the teach-back method into risk and benefit disclosures effectively informs and more fully engages patients in the informed consent process. Notably, the added benefits from using teach-back can be obtained without a burdensome increase in the length of visit.