Patient Recall of Informed Consent at 4 Weeks After Total Hip Replacement With Standardized Versus Procedure-Specific Consent Forms

Abstract

Objectives: Informed consent plays a pivotal role in the operative process, and surgeons have an ethical and legal obligation to provide patients with information to allow for shared decision-making. Unfortunately, patient recall after the consent process is frequently poor. This study aims to evaluate the effect of procedure-specific consent forms on patient's recall four weeks after total hip replacement (THR).Methods: This is a prospective study using a posttest-only control group design. Sixty adult patients undergoing total hip replacement were allocated to be consented using either the generic or the surgery-specific consent form. Four weeks after surgery, a phone interview was conducted to assess patient's recall of risk of surgical complications.Results: Patient demographic characteristics and educational attainment were similar in both groups. There was a statistically significant increase in the mean number of risks recalled in the study group at 1.43 compared with 0.67 in the control group (P = 0.0131). Conclusions:Consent is a complex process, and obtaining informed consent is far from straightforward. A statistically significant improvement in patient's recall with the use of procedure-specific consent forms was identified, and based on this, we would advocate their use. However, overall patient recall in both groups was poor. We believe that improving the quality of informed consent may require the sum of small gains, and the use of procedure-specific consent forms may aid in this regard.

Influence of a Preadmission Procedure-Specific Consent Document on Patient Recall of Informed Consent at 4 Weeks After Total Hip Replacement: A Randomized Controlled Trial

“…18,20,31,32 The results of our study add to the evidence for a lack of effect for written information improving knowledge after consent given that there was no statistically significant difference between the groups for mean risk recall (16% versus 13%, P = 0.49). The results of the control group of this study (13% risk recall) are the same as those of the intervention group in Pomeroy et al, 5 a finding that adds to the validity of both studies given that these groups had an identical study protocol involving different patients and researchers. In contrast to our findings, Langdon et al 8 found a statistically significant improvement in knowledge recall after consent for THR when a written information sheet (48%) was used compared with verbal information (38%) only.…”

“…This finding is not unique to our study, with multiple other article reporting that between 30% and 50% of participants could not recall a single risk after consent at follow-up of 4 weeks or less. 5,15,24,34,35 This phenomenon is likely multifactorial in nature, with the passage of time, 16,21,23 a limited ability to understand the information provided at the time of consenting, and a preference for not wanting to know about the technical aspects of surgery including complications 36,37 all contributing. Some patients would prefer not to dwell on the complications associated with surgery, and this is reflected in the fact that risks are less likely to be recalled than other information provided at the time of consenting such as benefits of surgery or duration of inpatient stay.…”

“…The protocol for the control group in this study was identical to the protocol used in the intervention group of our previously published study. 5 All telephone follow-up was conducted by a single author (A.M.) who was blinded to group allocation. Any patient who could not be contacted within 3 days of the date of planned follow-up was deemed lost to follow-up.…”

Informed Written Consent for Orthopaedic Trauma in the Emergency Setting at a Tertiary Referral Centre: A Closed-Loop Audit

“…Furthermore, Sivanadarajah et al reported that the standardised consent forms endorsed by the British Orthopaedic Association are significantly more readable and understandable than heterogeneous institutional alternatives [ 9 ]. To address this, the authors note the findings of Pomeroy et al who advocate for procedure-specific consent forms for elective orthopaedic procedures in the elective setting, with significantly higher rates of patient recall of risk factors found at four weeks post-procedure [ 13 ]. However, this is often not applicable to orthopaedic trauma, as each case presenting to the ED is independent and unique to the last [ 14 ].…”

“…Therefore, online teaching sessions serve the purpose of attempting to reinforce the Hawthorne effect. Increasing literature reports that virtual patient education results in improved patient recall of the consent process and procedure in question [ 13 , 15 ]. However, no such data is available in relation to orthopaedic surgeons when obtaining informed consent in written form [ 12 , 16 ].…”