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

The present study was conducted to assess the effect of an interactive computer-based multimedia tool on the patient’s attitude towards surgery, in particular, on the decisional conflict to undergo cataract surgery and decisional regret as well as on cataract-related knowledge.

As part of assessing the patient’s attitude towards the surgery, the patient’s wish to generally become involved in health-care decisions was evaluated by Degner CPS. The Degner CPS was primarily designed and used for patients with serious illnesses, but is widely used for assessing the preference for involvement in health care decision-making [19, 27]. At the beginning of the study, organizational issues occurred in the conduction of the Degner CPS. Therefore, an amendment was submitted to the ethics committee to increase sample size. The Degner CPS was only performed in 82 patients. The most preferred role was the collaborative role (31.7%). Combining the two active and two passive roles leads to a rather balanced result with a tendency towards the more passive roles, active 31.7%, collaborative 31.7% and passive 36.6%. In 64.6% the preferred order of roles corresponded to one of the 11 transitive permutations. In this study, for the ordinal score only those 11 transitive permutations were counted. Of those with a valid score, 22.6% scored 11, corresponding to the most passive patient role. A broader secondary peak can be seen at a score of 3–5, together representing 41.5% and corresponding to an active-collaborative role.

In this study, patients who used a computer-based tutorial additional to the standard informed consent procedure showed a slightly higher cataract-related knowledge in the MCQ questionnaire. This confirms the finding of a previous study using the CatInfo tool [10]. However, there was a higher difference between the groups in the previous study due to the difference in study design. In this study, the physician giving the informed consent received the printout of the CatInfo tool to guide him/her through the face-to-face discussion. In contrast, in the previous study the physician was masked and did not know, if the patient had received additional information through the use of the CatInfo tool [10].

Overall patients of both groups performed quite well on the MCQ. The mean score in both groups was higher than in the previous study, showing a mean score of 15 in the study group and 12 in the control group [10]. The study population in the previous study was slightly older than the one of this study (study group 73 versus 70 years; control group 75 versus 71 years). Another reason could be that, due to the fact that the other study was conducted several years earlier, the internet is now even more widely used among all age groups and, thereby, patients may have easier access to information material. Patients, especially younger ones, sometimes seem surprisingly well informed already on arrival for their pre-assessment visit, for example asking detailed questions on IOL types. However, one would expect that especially in the elderly, the use of the internet is not that widespread. In this study, only information on computer usage and not internet usage was collected. In our study population more than two thirds (69.4%) had a computer at home and more than half (52.3%) stated that they used a computer several times a day or a week; 4.5% several times a month, 14.2% rarely and 29.1% had never used a computer before. So, in the latter group use of Internet seems very unlikely.

A study assessing the quality content of educational cataract videos on “YouTube” has shown that the majority of videos were not adequately educational, also containing biased information with a commercial background [28]. Information material on websites has also been assessed regarding the readability. Studies have shown that online patient education material in ophthalmology was written above the recommended reading level for the average population, also by renowned ophthalmological societies [29,30,31]. So, there is concern that online contents are adequately presented and correctly understood by patients. The advantage of tools and videos that are shown before the face-to-face discussions is that questions can be answered and misunderstandings may be resolved straight away. With the CatInfo tool the patient gives feedback after each chapter using a traffic light system described above to ensure that the content has been understood. A printout that summarizes what the patient has selected after each chapter immediately tells the physician which topics have been poorly understood or were unclear.

As mentioned above, we need to bear in mind that, due to the higher age in the majority of cataract patients, the internet may not have gained such an importance compared to other generations. In our sample nearly one third of patients have never used a computer before.

Another possible explanation for the high knowledge in both groups in our study could be that at our department patients receive quite detailed information material via mail well ahead to their pre-assessment visit. Additional to the informed consent form they receive a detailed booklet on cataract surgery. In this study, knowledge was only assessed after the face-to-face discussion. To also assess the pre-existing knowledge, it would have been necessary to fill in a questionnaire before the start of the informed consent procedure and thereafter.

The satisfaction with the tool was high. Interestingly, VAS scores were even higher regarding the question, whether they would want to use such a tool before another surgery. This could mean that the concept of this multi-media approach seems to be very well accepted and patients would appreciate an implementation of such tools beyond ophthalmology.

Our focus was to assess the patient’s attitude before and after surgery, and to explore whether multi-media assisted informed consent influences decisional conflict and decisional regret. Overall patients were shown to have a very low decisional conflict regarding their decision to undergo cataract surgery. We reported the score as decisional confidence, as explained by Buchholz et al. [24], with 100 meaning the highest decisional confidence and thereby the lowest decisional conflict. The overall score and also in the assessed subscales mean scores were slightly higher in the study group, but no statistically significant difference was found. The high decisional confidence in both groups could result from the physician being very informative and supportive when giving informed consent. The value of the CatInfo tool could be much higher when this is not the case.

The DCS has already been used for the assessment of the decisional conflict related to cataract surgery. Newman-Casey et al. assessed how non-physician pre-surgical counselors teaching patients in India influenced knowledge and the decisional conflict [32]. They did not use the current 16-items questionnaire for research purposes but used the original 9 questions and added 3 of the 7 new items. The score was also calculated differently. Comparing before and after the teaching, the decisional conflict score was shown to improve by 14%, meaning the decisional conflict decreased. In our study the decisional conflict was not assessed at the start of the pre-assessment visit, only after. Therefore, we cannot give any information on how much the informed consent process strengthened the decisional confidence.

The high decisional confidence scores in our study could have also resulted from a generally rather low decisional conflict, as patients are normally aware of the planned surgery several months in advance.

The DRS assessed the “remorse or distress” of the decision to undergo cataract surgery [25]. Overall, decisional regret was small. Mean scores were even lower in the study group, but not statistically significant. To assess the effect of the CatInfo tool on decisional regret, cataract surgery and the following postoperative period had to be without major complications. One patient suffered from a retinal detachment soon after the cataract surgery, before the 1-month telephone interview. Therefore, the score of that patient was excluded. Reasons for regret with the decision in patients with higher scores seem to have been dysphotopsia, glare and more intense perception of floaters after surgery. One patient with a DRS score of 55 had an epiretinal membrane already present at the pre-assessment visit, which was treated with pars plana vitrectomy and membrane peeling 6 months after cataract surgery. As postoperative VA and visual function influence the satisfaction with the decision and thereby regret, patients should ideally not have any additional ophthalmological conditions affecting vision or, if a more real-life study setting is preferred, randomization should be stratified for additional conditions. In this study, patients with other ocular diseases were included. All patients seen at the pre-assessment visit were referred for cataract surgery with a referral letter of their community ophthalmologist. Inclusion and randomization took place before the ophthalmological examination. Ocular comorbidities, that were recorded at the pre-assessment visit, were relatively evenly distributed without any statistically significant differences between the groups. Also, after exclusion of patients with comorbidities and exclusion of patients with comorbidities potentially affecting VA, no statistically significant difference was found in the DRS score between the study group and the control group. As expected, regret was higher in patients with comorbidities potentially affecting VA than in those without.

Measurement of VA as an outcome related to regret would have been an interesting measure, but the only postoperative follow-up visit in this study was performed via telephone interview. Another limitation is that patients were not systematically evaluated regarding issues after surgery such as dysphotopsia, that could influence regret after surgery. Only patients, who seemed to have greater regret, were asked about reasons for their regret and a note was made in the comment field.

More than two thirds of study group patients answered in the telephone interview that they would be willing to trade face-to-face informed consent discussion time in order to use such a tool in a future informed consent process. For some patients this question was rather difficult to understand, despite detailed explanations. This resulted in a relatively high number of missing responses, which poses a limitation.

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