Abstract
Objective:
To assess whether the use of visual aids to augment the consent process for pelvic floor surgeries affects patient understanding and satisfaction.
Methods:
We conducted a single-blind, randomized controlled trial. Adults planning robotic sacrocolpopexy or sub-urethral sling surgeries were eligible. All participants received standard pre-operative consent counseling. Participants randomized to the intervention also viewed slides with visual aids that paralleled standard counseling; participants randomized to the control group received only standard counseling. All participants completed surveys after their pre-operative visit, the day of surgery, and at their post-operative visit. Each survey contained 12 true-false questions about risks, benefits, and alternatives of surgery, and expectations during recovery. The primary outcome was the percentage of correct true-false questions. We conducted an intention-to-treat analysis.
Results:
We randomized 32 participants undergoing robotic sacrocolpopexy and 32 undergoing sub-urethral sling surgeries, yielding 16 in the intervention group and 16 in the control group for each procedure. The intervention and control groups for both surgeries were similar in age, body mass index, race, education, and previous surgery for similar symptoms.
Among participants undergoing robotic sacrocolpopexies, median knowledge scores at the pre-operative visit were similar between the intervention [92% (IQR: 86%, 100%)] and control [86 (IQR: 75%, 94%)] groups (P=0.21). Similar results were seen for participants undergoing sub-urethral sling procedures in the intervention [83.3% (IQR: 71%, 92%)] and control [83% (IQR: 75%, 88%)] groups (P=0.64).
Conclusions:
We found that using visual aids during the consent process for patients undergoing robotic sacrocolpopexy or sub-urethral sling surgeries did not improve knowledge.
Keywords: surgical consent, visual aids, patient knowledge, patient satisfaction
Introduction
The current standard of care for consenting patients undergoing pelvic floor surgeries involves one-on-one verbal counseling and obtaining written consent from the patient. The goal of the consent process is to ensure that the patient fully understands the procedure, along with its inherent risks and benefits. Alternative treatment options and expectations during the perioperative period are traditionally reviewed. The consent process is not standardized, resulting in variability both across providers and across patients even when consented by the same provider.1
There are deficiencies in patient knowledge and understanding of pelvic floor surgeries. A prospective study reported patient understanding of sacrocolpopexy without any intervention and found deficiencies, with a mean knowledge score of less than 70%.2 The literature cites many examples of quality improvement initiatives and studies to improve the surgical consent process, patient understanding and patient satisfaction. Several systematic reviews include prospective and randomized controlled trials using various patient counseling interventions, including videos, computer programs, electronic presentations, websites, slides, and written information; when data from multiple studies were combined, meta-analyses found that aids improved patient recall and knowledge but did not consistently affect satisfaction.3–6 Most trials reported outcomes including overall satisfaction, knowledge score, and perceived understanding.7–9 There is evidence from prospective studies showing improvements in knowledge about pelvic floor health after educational programs10 and that readiness for reconstructive pelvic surgery is associated with higher satisfaction, patient-perceived surgical outcome, and quality of life.11 However, there has not been a randomized controlled trial for improving the consent process using a visual aid for pelvic floor surgeries.
Our aim was to assess the effectiveness of added standardized visual aids during the traditional consent process for pelvic floor surgery. We hypothesized that visual aids would be an effective addition to the standard urogynecological consent process and would improve patient understanding and satisfaction.
Materials and Methods
We conducted a randomized controlled trial to investigate the effect of adding standardized visual aids during the consent process for robotic sacrocolpopexy and sub-urethral sling on patient understanding of and satisfaction with their procedure.
Patients who presented to our institution’s Section of Female Pelvic Medicine and Reconstructive Surgery were eligible to participate if they were ≥18 years of age, spoke English and were having a pre-operative visit for a planned robotic sacrocolpopexy or sub-urethral sling procedure. After providing informed consent, each participant was randomized to either: (1) the control arm and received standard verbal surgical consent counseling or (2) the intervention arm and received the standard verbal surgical consent counseling and then reviewed a standardized visual presentation for the procedure they planned to undergo. We used computer-generated block randomization stratified by surgical procedure to allocate participants in a 1:1 ratio.
As part of the usual pre-operative visit, each participant first met with one of two fellowship-trained specialists in Female Pelvic Medicine and Reconstructive Surgery and received the standard of care verbal surgical consent counseling and provided written consent for the planned surgical procedure. The two specialists followed a similar standard consent process that addressed details of the procedure, along with the most common risks and benefits. Alternative treatment options and expectations during the perioperative period were reviewed. Then, participants randomized to the intervention arm viewed a booklet of slides with illustrations that explained all of the topics covered in the standard consent counseling. Specifically, the risks that were addressed included injury to nearby organs, risks of infection and bleeding, and risk of re-operation, while post-operative expectations included urinary catheter, constipation, pain management, and hospital stay. The content of the booklet was written at a seventh grade reading level. At the end of the pre-operative visit, all participants received the same survey to evaluate their understanding of the planned procedure, pre-operative and post-operative expectations, and satisfaction with the consent process. A similar survey was repeated immediately before their surgery and at the post-operative clinic visit one to two weeks following surgery.
The primary outcome was patients’ knowledge score at the end of the pre-operative clinic visit, with each participant’s knowledge score calculated as the percentage of 12 true or false questions that were answered correctly. Assuming 80% power and a two-sided alpha of 0.05, 12 patients per arm were needed to detect a 20-point absolute difference in the mean knowledge score with standard deviation of 17. After inflating the sample size for a non-normal data distribution and to allow for 10% loss to follow up, we aimed to enroll 16 participants per arm and thus 32 participants per surgical procedure. Secondary outcomes included patient satisfaction, self-assessed understanding of their procedure, immediate pre-operative knowledge, post-operative knowledge, and number of post-operative encounters before the scheduled post-operative clinic visit.
Data are presented as median with interquartile range or frequency and percent. We planned an intention-to-treat analysis. Data were compared using the Wilcoxon rank sum test, and p values less than 0.05 were considered statistically significant.
Results
We randomized 32 participants planning to undergo robotic sacrocolpopexy and 32 planning to undergo sub-urethral sling surgeries, yielding 16 in the intervention group and 16 in the control group for each procedure. The participant flow diagram is shown in Figure 1.
Figure 1.
Participant flow diagram
Among participants in the robotic sacrocolpopexy group, those in the intervention and control arms were similar with respect to age, body mass index, race/ethnicity, education, and history of surgery for similar symptoms. Participants in the sacrocolpopexy control arm had more vaginal deliveries and were less likely to have a history of cesarean delivery compared to those in the intervention arm. Among participants in the sub-urethral sling group, those in the intervention and control arms were similar with respect to age, body mass index, race/ethnicity, education, delivery history, and history of surgery for similar symptoms (Table 1).
Table 1.
Baseline characteristics among intervention and controls arms, stratified by type of procedure
| Robotic Sacrocolpopexy | Sub-Urethral Sling | |||
|---|---|---|---|---|
| Intervention n=16 |
Control n=16 |
Intervention n=16 |
Control n=16 |
|
| Age (years) | 61.5 (51, 66) |
65 (57.5, 70) |
48 (42, 56.5) |
49.5 (46, 58) |
| Body mass index (kg/m2) | 26 (24, 28.5) |
27 (24, 31) |
28.2 (23, 34) |
27 (24, 36) |
| Race | ||||
| White | 13 (81) | 12 (75) | 8 (50) | 14 (88) |
| Black | 2 (13) | 1 (6) | 5 (31) | 1 (6) |
| Other/unknown | 1 (6) | 3 (18) | 3 (19) | 1 (6) |
| Hispanic | 2 (13) | 2 (13) | 3 (19) | 2 (13) |
| Education | ||||
| Less than high school | 0 (0) | 3 (19) | 0 (0) | 0 (0) |
| High school/GED | 3 (19) | 2 (13) | 4 (25) | 4 (25) |
| Some college | 1 (6) | 2 (13) | 2 (13) | 1 (6) |
| College degree | 9 (56) | 6 (38) | 6 (38) | 8 (50) |
| Graduate degree | 3 (19) | 3 (19) | 4 (25) | 3 (19) |
| Vaginal deliveries | ||||
| 0 | 0 (0) | 0 (0) | 2 (13) | 1 (6) |
| 1–3 | 15 (94) | 11 (69) | 11 (69) | 13 (81) |
| ≥4 | 1 (6) | 5 (31) | 3 (19) | 2 (13) |
| Cesarean deliveries | ||||
| 0 | 16 (100) | 13 (81) | 14 (88) | 13 (81) |
| ≥1 | 0 (0) | 3 (19) | 2 (13) | 3 (19) |
| Previous surgery for similar symptoms | 1 (6) | 0 (0.0) | 2 (13) | 3 (19) |
| Surgeon | ||||
| Surgeon A | 11 (69) | 11 (69) | 10 (63) | 13 (81) |
| Surgeon B | 5 (31) | 5 (31) | 6 (38) | 3 (19) |
Data are presented as median (interquartile range) or n (%)
Among participants planning to undergo robotic sacrocolpopexies, median knowledge scores at the pre-operative visit were similar between the intervention [92% (IQR: 86%, 100%)] and control [86% (IQR: 75%, 94%)] arms (P=0.21). Scores on the day of surgery and at the post-operative visit also were similar between the intervention and control arms (both P ≥0.77). There was no notable change in the knowledge scores from the pre-operative visit to either the day of surgery or the post-operative visit; this minimal change was similar between the intervention and control arms (both P ≥0.55). Knowledge scores and change in knowledge scores are shown in Table 2. In both arms, the median number of post-operative encounters was 1 [(IQR: 1 −1); P=0.77].
Table 2:
Median knowledge scores and changes in knowledge scores for pre-operative visit, day of surgery, and post-operative visit
| Robotic Sacrocolpopexy | Sub-Urethral Sling | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intervention | Control | Intervention | Control | |||||||
| n | Median (IQR) | n | Median (IQR) | P | n | Median (IQR) | n | Median (IQR) | P | |
| Pre-operative visit | 14 | 92 (86, 100) |
16 | 86 (75, 94) |
0.21 | 15 | 83 (71, 92) |
15 | 83 (75, 88) |
0.64 |
| Day of surgery | 11 | 92 (79, 92) |
13 | 83 (75, 92) |
0.77 | 11 | 83 (71, 96) |
12 | 79 (67, 92) |
0.60 |
| Post-operative visit | 10 | 83 (83, 92) |
13 | 83 (83, 92) |
0.97 | 10 | 92 (69, 98) |
10 | 92 (77, 100) |
0.88 |
| Difference between pre-operative visit and day of surgery | 10 | 4 (−6, 8) |
13 | 0 (−8, 8) |
0.55 | 11 | 0 (−4, 0) |
11 | 0 (−8, 0) |
0.76 |
| Difference between pre-operative visit and post-operative visit | 8 | 4 (−2, 8) |
13 | 0 (−8, 8) |
0.97 | 9 | 0 (−8, 0) |
10 | −8 (−8, 0) |
0.71 |
IQR: interquartile range
Among participants planning to undergo sub-urethral sling procedures, median knowledge scores at the pre-operative visit were similar for the intervention [83% (IQR: 71%, 92%)] and control [83% (IQR: 75%, 88%)] arms (P=0.64). Scores on the day of surgery and at the post-operative visit also were similar between the intervention and control arms (both P ≥0.60). There was no notable difference in the knowledge scores from the pre-operative visit to either the day of surgery or the pre-operative visit; this minimal change was similar between the intervention and control arms (both P ≥0.71). Both arms had a median of 1 post-operative encounter (intervention arm IQR: 1–1; control arm IQR: 1–1.5; P=0.38).
Table 3 shows the proportion of participants who correctly answered select knowledge questions. At the pre-operative visit, for participants in the robotic sacrocolpopexy group, questions with the lowest proportion of correct answers were “surgery is the only option for treating my symptoms” and “I may need more surgeries after this surgery”. This trend continued on the day of surgery and at the post-operative visit. At the pre-operative visit, for participants in the sub-urethral sling group, questions with the lowest proportion of correct answers were “if I am admitted to the hospital after surgery, the length of stay would usually be 1 day” and “I may need more surgeries after this surgery”.
Table 3.
Proportion of participants who correctly answered select knowledge questions in the intervention and control arms, stratified by type of procedure
| Robotic Sacrocolpopexy | Sub-Urethral Sling | ||||||
|---|---|---|---|---|---|---|---|
| Intervention | Control | P | Intervention | Control | P | ||
| Pre-operative visit, n | 15 | 16 | 15 | 16 | |||
| Surgery is the only option for treating my symptoms | 9 (60) | 10 (63) | 1.0 | 10 (67) | 12 (75) | 0.70 | |
| If I am admitted to the hospital after surgery, the length of stay would usually be 1 (one) day | 13 (87) | 15 (94) | 0.6 | 7 (47) | 7 (44) | 1.0 | |
| I may experience significant pain after surgery that can be managed with pain medications | 14 (93) | 14 (88) | 1.0 | 13 (87) | 11 (69) | 0.39 | |
| There is no chance that my symptoms will come back after this surgery | 12 (80) | 14 (88) | 0.65 | 8 (53) | 15 (94) | 0.02 | |
| I may need more surgeries after this surgery | 10 (67) | 8 (50) | 0.47 | 11 (73) | 6 (38) | 0.07 | |
| Day of surgery, n | 12 | 15 | 12 | 12 | |||
| Surgery is the only option for treating my symptoms | 7 (64) | 9 (60) | 1.0 | 7 (58) | 6 (50) | 1.0 | |
| If I am admitted to the hospital after surgery, the length of stay would usually be 1 (one) day | 11 (92) | 14 (93) | 1.0 | 8 (67) | 7 (58) | 1.0 | |
| I may experience significant pain after surgery that can be managed with pain medications | 12 (100) | 15 (100.0) | - | 12 (100) | 11 (92) | 1.0 | |
| There is no chance that my symptoms will come back after this surgery | 7 (58) | 9 (60) | 1.0 | 7 (58) | 8 (67) | 1.0 | |
| I may need more surgeries after this surgery | 6 (50) | 7 (45) | 1.0 | 8 (67) | 6 (50) | 0.68 | |
| Post-operative visit, n | 8 | 13 | 11 | 10 | |||
| Surgery is the only option for treating my symptoms | 4 (50) | 7 (54) | 1.0 | 7 (64) | 6 (60) | 1.0 | |
| If I am admitted to the hospital after surgery, the length of stay would usually be 1 (one) day | 7 (88) | 11 (85) | 1.0 | 8 (73) | 8 (80) | 1.0 | |
| I may experience significant pain after surgery that can be managed with pain medications | 8 (100) | 13 (100) | - | 11 (100) | 9 (90) | 0.48 | |
| There is no chance that my symptoms will come back after this surgery | 6 (75) | 11 (85) | 0.62 | 7 (64) | 7 (70) | 1.0 | |
| I may need more surgeries after this surgery | 4 (50) | 7 (54) | 1.0 | 5 (46) | 5 (50) | 1.0 | |
Data are presented as n (%)
For participants in the robotic sacrocolpopexy group, all participants in both arms reported that they were satisfied with their counseling at each of the three visits. For those in the sub-urethral sling group, all participants reported they were satisfied with their counseling at the pre-operative visit and on the days or surgery. At the post-operative visit 100% of participants in the intervention arm and 90% of participants in the control arm reported that they were satisfied.
Discussion
In this randomized controlled trial, we found that augmenting the standard surgical consent process with paper-based slides including illustrations for patients undergoing robotic sacrocolpopexy or sub-urethral sling surgeries did not improve knowledge or satisfaction. Overall, participants in both the intervention and control groups had high knowledge scores and were satisfied with the consent process. Questions regarding other treatment options and needing further surgeries had the lowest proportion of correct answers for participants in both arms of the robotic sacrocolpopexy group. Questions regarding other treatment options and length of expected admission had the lowest proportion of correct answers for participants in both arms of the sub-urethral sling group.
A Cochrane meta-analysis showed statistically significant improvements in knowledge when measured immediately after interventions to improve information delivery during the surgical informed consent process. However, the interventions did not affect satisfaction.6 Results from individual studies are mixed. A randomized trial evaluating multiple education modalities for patients undergoing total knee arthroplasty found that patients who were satisfied with the consent process may have better recall of risks, benefits and expectations of surgery. However, similar to our study, this trial also found that neither retention nor satisfaction was influenced by reinforcement methods such as video or nurse education.12 Another randomized controlled trial found that video-based informed consent improved knee arthroscopy patient comprehension compared with traditional verbal informed consent.13 A similar study of patients considering knee arthroscopy surgery found that a computer-based multimedia presentation was associated with improved knowledge and better knowledge retention at the time of surgery and 6 weeks later compared with the standard verbal consent and pamphlets.14 In the ophthalmology literature, a randomized study found that informed consent information sheets at lower reading grade levels and videotape presentations improved patient understanding of the risks, benefits, and alternatives to cataract surgery.15 In the field of pelvic surgery, Hallock et al. conducted an observational study of women seeking surgical treatments for pelvic floor disorders and found that patients with a better understanding of the planned surgery were more likely to be satisfied with their treatment decision.16
Even though our study did not show that using visual aids during the consent process for patients undergoing robotic sacrocolpopexy or sub-urethral sling surgeries improved knowledge or satisfaction, we did identify potential areas of improvements. Specifically, patients undergoing both robotic sacrocolpopexy and sub-urethral sling surgeries seem to have the least knowledge regarding possible need for future surgeries. Those undergoing robotic sacrocolpopexy surgeries also were uncertain about treatment options other than surgery, while those undergoing sub-urethral sling surgeries were uncertain about the lengths of potential hospital admissions. Evaluating areas where patients had the least amount of knowledge regarding the surgical consent process may help us target areas of patient education.
Our study has several strengths, including a prospective randomized controlled study design, which was powered based on data from published literature. The visual aids and the questionnaires were standardized, and the questionnaires were repeated at three time points to capture patients’ peri-operative experience. During the study, clinicians were blinded to the participants’ study arm.
This study is limited by our inability to blind participants to their treatment group. The generalizability of our findings is limited by the fact that we excluded patients whose first language was not English and also may be limited by the relatively high education level of the participants.
In conclusion, patients generally were satisfied with the current surgical consent process and had relatively high levels of understanding; however, there are gaps in knowledge and thus areas for improvement. While we found that augmenting the standard consent process with paper-based slides with illustrations did not improve knowledge or satisfaction for patients undergoing robotic sacrocolpopexy or sub-urethral sling surgeries, further research should investigate other methods to improve the patient experience during the surgical consent counseling process. Surgical consent and counseling is an important aspect of surgical practice that we should continue to improve, particularly given the diversity of our ever-growing patient population.
Acknowledgments
This work was conducted with support from Harvard Catalyst | The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic health care centers. The funding sources had no involvement in the study design, collection, analysis, or interpretation of data, the writing of the report, or the decision to submit the article for publication.
Footnotes
The authors report no conflict of interest. Registered with ClinicalTrials.gov NCT02313701
References
- 1.Falagas ME, Korbila IP, Giannopoulou KP, et al. Informed consent: how much and what do patients understand? Am J Surg. 2009;198(3):420–435. doi: 10.1016/j.amjsurg.2009.02.010. [DOI] [PubMed] [Google Scholar]
- 2.Adams SR, Hacker MR, Merport Modest A,et al. Informed consent for sacrocolpopexy: is counseling effective in achieving patient comprehension? Female Pelvic Med Reconstr Surg. 2012;18(6):352–356. doi: 10.1097/SPV.0b013e31827816c5. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Farrell E, Whistance R, Phillips K, et al. Systematic review and meta-analysis of audio-visual information aids for informed consent for invasive healthcare procedures in clinical practice. Patient Educ Couns. 2014;94(1):20–32. [DOI] [PubMed] [Google Scholar]
- 4.Nehme J, El-Khani U, Chow A,et al. The use of multimedia consent programs for surgical procedures: a systematic review. Surg Innov. 2013;20(1):13–23. [DOI] [PubMed] [Google Scholar]
- 5.Schenker Y, Fernandez A, Sudore R, et al. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review. Med Decis Making. 2011;31(1):151–173. doi: 10.1177/0272989X10364247. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Kinnersley P, Phillips K, Savage K, et al. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database Syst Rev. 2013;(7):CD009445. doi: 10.1002/14651858.CD009445.pub2. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Hoppe DJ, Denkers M, Hoppe FM, et al. The use of video before arthroscopic shoulder surgery to enhance patient recall and satisfaction: a randomized-controlled study. J shoulder Elb Surg. 2014;23(6):e134–9. doi: 10.1016/j.jse.2013.09.008. [DOI] [PubMed] [Google Scholar]
- 8.Huber J, Ihrig A, Yass M, et al. Multimedia support for improving preoperative patient education: a randomized controlled trial using the example of radical prostatectomy. Ann Surg Oncol. 2013;20(1):15–23. doi: 10.1245/s10434-012-2536-7. [DOI] [PubMed] [Google Scholar]
- 9.Bollschweiler E, Apitzsch J, Apitsch J, et al. Improving informed consent of surgical patients using a multimedia-based program? Results of a prospective randomized multicenter study of patients before cholecystectomy. Ann Surg. 2008;248(2):205–211. doi: 10.1097/SLA.0b013e318180a3a7. [DOI] [PubMed] [Google Scholar]
- 10.Geoffrion R, Robert M, Ross S, et al. Evaluating patient learning after an educational program for women with incontinence and pelvic organ prolapse. Int Urogynecol J. 2009;20(10):1243–1252. doi: 10.1007/s00192-009-0919-5. [DOI] [PubMed] [Google Scholar]
- 11.Kenton K, Pham T, Mueller E,et al. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007;197(6):654.e1–6. doi: 10.1016/j.ajog.2007.08.059. [DOI] [PubMed] [Google Scholar]
- 12.Johnson MR, Singh JA, Stewart T, et al. Patient understanding and satisfaction in informed consent for total knee arthroplasty: A randomized study. Arthritis Care Res (Hoboken). 2011;63(7):1048–1054. doi: 10.1002/acr.20475. [DOI] [PubMed] [Google Scholar]
- 13.Rossi MJ, Guttmann D, MacLennan MJ, Lubowitz JH. Video Informed Consent Improves Knee Arthroscopy Patient Comprehension. Arthrosc J Arthrosc Relat Surg. 2005;21(6):739–743. doi: 10.1016/j.arthro.2005.02.015. [DOI] [PubMed] [Google Scholar]
- 14.Cornoiu A, Beischer AD, Donnan L, et al. Multimedia patient education to assist the informed consent process for knee arthroscopy. ANZ J Surg. 2011;81(3):176–180. doi: 10.1111/j.1445-2197.2010.05487.x. [DOI] [PubMed] [Google Scholar]
- 15.Shukla AN, Daly MK, Legutko P. Informed consent for cataract surgery: Patient understanding of verbal, written, and videotaped information. J Cataract Refract Surg. 2012;38(1):80–84. doi: 10.1016/j.jcrs.2011.07.030. [DOI] [PubMed] [Google Scholar]
- 16.Hallock JL, Rios R, Handa VL. Patient satisfaction and informed consent for surgery. Am J Obstet Gynecol. 2017;217(2):181.e1–181.e7. doi: 10.1016/j.ajog.2017.03.020. [DOI] [PubMed] [Google Scholar]