Informed consent: do information pamphlets improve post-operative risk-recall in patients undergoing total thyroidectomy: Prospective randomized control study

Abstract

BackgroundInformed consent consists of basic five elements: voluntarism, capacity, disclosure, understanding, and ultimate decision-making. Physician disclosure, patient understanding, and information retention are all essential in the doctor-patient relationship. This is inclusive of helping patients make and manage their decisions and expectations better and also to deal with any consequences and/or complications that arise. This study investigates whether giving patients procedure-specific handouts pre-operatively as part of the established informed consent process significantly improves overall risk-recall following surgery. These handouts outline the anticipated peri-operative risks and complications associated with total thyroidectomy, as well as the corrective measures to address complications. In addition, the influence of potential confounders affecting risk-recall, such as anxiety and pre-existing memory disturbance, are also examined.MethodsConsecutive adult (≥18 years old) patients undergoing total thyroidectomy at a single academic tertiary care referral centre are included. Participants are randomly assigned into either the experimental group (with pamphlets) or the control group by a computerized randomization system (Clinstat). All participants filled out a Hospital Anxiety and Depression Scale (HADS) and they are tested by the physician for short-term memory loss using the Memory Impairment Screen (MIS) exam. All patients are evaluated at one week post-operatively. The written recall questionnaire test is also administered during this clinical encounter.ResultsForty-nine patients are included - 25 of them receive verbal consent only, while another 24 patients received both verbal consent and patient education information pamphlets. The overall average of correct answers for each group was 83 % and 80 % in the control and intervention groups, respectively, with no statistically significant differences. There are also no statistically significant differences between the two groups, in both interview duration, in time between interviews, and in recall tests. No correlation is also apparent between the pre-op HADS score and the recall questionnaire overall score.ConclusionsA pre-operative thyroid surgical information pamphlet alone might not be sufficient to enhance patient test scores and optimally educate the patient on their expected care pathway in thyroid surgery. Supplementation with alternative means of patient education perhaps using emerging technologies needs to be further investigated.Electronic supplementary materialThe online version of this article (doi:10.1186/s40463-016-0127-5) contains supplementary material, which is available to authorized users.

A systematic review of information format and timing before scheduled adult surgery for peri‐operative anxiety

“…We selected 34 trials with 3742 participants, of which 29 were randomised, controlled , 4 were quasi‐randomised and 1 was cluster‐randomised (Figs. and ; Table ).…”

“…Patients with an inadequate understanding of the language used to transmit information were not studied in these trials. The effects of different information formats were tested by 30 trials and different timings by 5 trials .…”

A qualitative study of patients’ views of techniques to reduce dental anxiety

“…Providing preparatory information before invasive medical procedures could be effective in reducing patients' anxiety and complaints and enhancing the success of treatment in many medical specialties [27,28]. It has also been shown that providing information to patients can help dentally anxious people prepare for treatment and in turn this reduces anxiety levels.…”

A prospective, randomized, single‐blinded trial for improving health outcomes in rhinology by the use of personalized video recordings

“…Many different methods for improving patient education have been tried using written information (such as brochures or pamphlets written at a grade‐level equivalent) and standardized audio or video recording and interactive web pages with mixed results. While some studies found that providing visual or written information can increase percentage of retained information from 20% to 50%, a recent randomized controlled trial by Alsaffar et al . failed to show any significant improvement in written recall questionnaire among patients that received surgical information pamphlet prior to their thyroidectomies compared to controls.…”

“…Specifically, the surveys used during the study to test patient's recall were custom designed and are not validated, peer‐reviewed surveys to test recall and satisfaction. However, our questionnaires were based on similar studies published in the literature . Second, we were not able to achieve significance when assessing overall recall and subgroup analyses focusing on the number of video views to recall risk were not possible due to a higher dropout rate than anticipated.…”