Simpler language improved patients’ recall of mesh-related risks

SCOTTSDALE, ARIZ. – Patients giving consent to undergo midurethral sling surgery are more likely to remember being advised of the risks of surgical mesh if their surgeon speaks at a lower grade level.

This was among the key findings of a longitudinal cohort study of 71 women reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

Analysis of the consent discussions, which lasted an average of 15 minutes, showed that surgeons were significantly more likely to mention the immediate risks of mesh than the long-term risks, reported first author Dr. Brook L. McFadden, a urogynecologist at the Ohio State University Wexner Medical Center in Columbus. But patients were equally likely to remember both groups of risks.

Neither the specific term surgeons used to refer to the midurethral sling implant – mesh, tape, or graft – nor the number of times they used the term during the discussion affected patients’ recall of mesh risks 6 weeks after surgery. The length of the discussion also had no significant impact.

However, the lower the grade level at which the surgeon spoke, the greater patients’ recall of risks, even though the cohort was fairly well educated. On average, the surgeons spoke at about the 6th- to 7th-grade level.

"This was a homogeneous, young, educated population, which may not be generalizable," Dr. McFadden noted. "And we cannot account for counseling that occurred prior to or after the surgical consent session that may have impacted recall."

Invited discussant Dr. Bela Kudish, a urogynecologist at the Winnie Palmer Hospital Center for Advanced Gynecologic Surgery and Pelvic Medicine in Orlando, noted, "As providers, many of us are trying to balance the principles of nonmaleficence, beneficence, and autonomy of the patient in an attempt to improve the counseling process, to emphasize the shared responsibility in decision making in patients who undergo this procedure."

"How are you planning to improve the study design to identify factors specific to the consent process that may influence the recall, since this was a study that was done in four centers with a nonstandardized consent process?" she asked the investigators.

"I think at this point, the surgical consent process is not limited to that moment that you sign papers. It starts in the first moment when you meet the patient. So I think we need to start broadening our understanding and our evaluation of the consent process to include the very beginning counseling that’s occurring from day 1. And I also think we need to spend more time trying to reconcile what patients want to know and what they think is important with what we want them to remember, maybe what the lawyers want them to remember, and try to make that more patient centered," Dr. McFadden replied at the meeting, which was jointly sponsored by the American College of Surgeons.

"In your opinion, what is the ideal way of counseling patients to increase the recall of risk?" Dr. Kudish further queried.

"I do try to spend time asking the patient, ‘How do you best learn? Is it written, is it verbal? Do you like pictures?’ And try to incorporate what works best for them. And I think that the utility of decisional aids, while we have presented work that did not show great use recently, that is where this is going to go: using decisional aids starting from the very beginning, day 1, up until surgery, and even beyond this," Dr. McFadden maintained.

Session cochair Dr. Andrew Cassidenti of St. Joseph Hospital, Orange, Calif., commented, "Your point is excellent. I think the informed consent is really your relationship with the patient. It’s not a document, it’s a relationship and it’s an understanding of your confidence, your capabilities, your experience, what you can do for them, your results, and an honest discussion. I think that really is the key to keeping lawyers at bay."

The study enrolled patients who could read and write English and were undergoing only midurethral sling surgery. "At these four centers, we did not specify specifically how the surgeons were to [address] consent. They did this all in their normal way, so that had variation," Dr. McFadden noted.

Consent discussions were audio recorded and transcribed, and the transcripts were analyzed for their content and grade level of the surgeon’s speech according to the Flesch-Kincaid scale.

Patients completed a 21-item recall checklist. Their recall score was calculated as the number of items recalled divided by the number the surgeon actually mentioned, multiplied by 100.

The patients’ mean age was 53 years; 83% were white and 66% had some college education or more, reported Dr. McFadden. On average, they had almost 15 years of education.

The percentage of physicians who mentioned various immediate risks of mesh ranged from 94% for bleeding to 97% for organ damage (mean, 95%). Patient recall scores at 6 weeks after surgery ranged from 71% for bleeding to 90% for the need for a catheter (mean, 80%).

The percentage of physicians who mentioned the long-term risks of mesh ranged from 30% for continued leakage and groin pain to 92% for mesh erosion, a notable high outlier (mean, 58%). Patient recall scores ranged from 33% for chronic urinary tract infection to 95% for continued leakage (mean, 68%).

Surgeons were significantly more likely to mention the immediate risks than the long-term risks (95% vs. 58%; P less than .01), but patients were similarly likely to recall these two groups of risks.

When referring to the midurethral sling implant, surgeons most commonly used the terms mesh (87%) and tape (81%), and less commonly used the term graft (14%). On average, there were 5.9 uses of mesh per consent session, 7.4 uses of tape, and 0.5 uses of graft.

A variety of sociodemographic factors (patient age, education, race/ethnicity, and health literacy score) and consent-related factors (duration of the discussion, mesh term used, and number of uses) were not significantly associated with patients’ recall of risks.

But the lower the grade level at which the surgeon spoke, the greater patients’ recall was (r = –0.26, P less than .05).

Dr. McFadden disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Patients giving consent to undergo midurethral sling surgery are more likely to remember being advised of the risks of surgical mesh if their surgeon speaks at a lower grade level.

This was among the key findings of a longitudinal cohort study of 71 women reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

Analysis of the consent discussions, which lasted an average of 15 minutes, showed that surgeons were significantly more likely to mention the immediate risks of mesh than the long-term risks, reported first author Dr. Brook L. McFadden, a urogynecologist at the Ohio State University Wexner Medical Center in Columbus. But patients were equally likely to remember both groups of risks.

Neither the specific term surgeons used to refer to the midurethral sling implant – mesh, tape, or graft – nor the number of times they used the term during the discussion affected patients’ recall of mesh risks 6 weeks after surgery. The length of the discussion also had no significant impact.

However, the lower the grade level at which the surgeon spoke, the greater patients’ recall of risks, even though the cohort was fairly well educated. On average, the surgeons spoke at about the 6th- to 7th-grade level.

"This was a homogeneous, young, educated population, which may not be generalizable," Dr. McFadden noted. "And we cannot account for counseling that occurred prior to or after the surgical consent session that may have impacted recall."

Invited discussant Dr. Bela Kudish, a urogynecologist at the Winnie Palmer Hospital Center for Advanced Gynecologic Surgery and Pelvic Medicine in Orlando, noted, "As providers, many of us are trying to balance the principles of nonmaleficence, beneficence, and autonomy of the patient in an attempt to improve the counseling process, to emphasize the shared responsibility in decision making in patients who undergo this procedure."

"How are you planning to improve the study design to identify factors specific to the consent process that may influence the recall, since this was a study that was done in four centers with a nonstandardized consent process?" she asked the investigators.

"I think at this point, the surgical consent process is not limited to that moment that you sign papers. It starts in the first moment when you meet the patient. So I think we need to start broadening our understanding and our evaluation of the consent process to include the very beginning counseling that’s occurring from day 1. And I also think we need to spend more time trying to reconcile what patients want to know and what they think is important with what we want them to remember, maybe what the lawyers want them to remember, and try to make that more patient centered," Dr. McFadden replied at the meeting, which was jointly sponsored by the American College of Surgeons.

"In your opinion, what is the ideal way of counseling patients to increase the recall of risk?" Dr. Kudish further queried.

"I do try to spend time asking the patient, ‘How do you best learn? Is it written, is it verbal? Do you like pictures?’ And try to incorporate what works best for them. And I think that the utility of decisional aids, while we have presented work that did not show great use recently, that is where this is going to go: using decisional aids starting from the very beginning, day 1, up until surgery, and even beyond this," Dr. McFadden maintained.

Session cochair Dr. Andrew Cassidenti of St. Joseph Hospital, Orange, Calif., commented, "Your point is excellent. I think the informed consent is really your relationship with the patient. It’s not a document, it’s a relationship and it’s an understanding of your confidence, your capabilities, your experience, what you can do for them, your results, and an honest discussion. I think that really is the key to keeping lawyers at bay."

The study enrolled patients who could read and write English and were undergoing only midurethral sling surgery. "At these four centers, we did not specify specifically how the surgeons were to [address] consent. They did this all in their normal way, so that had variation," Dr. McFadden noted.

Consent discussions were audio recorded and transcribed, and the transcripts were analyzed for their content and grade level of the surgeon’s speech according to the Flesch-Kincaid scale.

Patients completed a 21-item recall checklist. Their recall score was calculated as the number of items recalled divided by the number the surgeon actually mentioned, multiplied by 100.

The patients’ mean age was 53 years; 83% were white and 66% had some college education or more, reported Dr. McFadden. On average, they had almost 15 years of education.

The percentage of physicians who mentioned various immediate risks of mesh ranged from 94% for bleeding to 97% for organ damage (mean, 95%). Patient recall scores at 6 weeks after surgery ranged from 71% for bleeding to 90% for the need for a catheter (mean, 80%).

The percentage of physicians who mentioned the long-term risks of mesh ranged from 30% for continued leakage and groin pain to 92% for mesh erosion, a notable high outlier (mean, 58%). Patient recall scores ranged from 33% for chronic urinary tract infection to 95% for continued leakage (mean, 68%).

Surgeons were significantly more likely to mention the immediate risks than the long-term risks (95% vs. 58%; P less than .01), but patients were similarly likely to recall these two groups of risks.

When referring to the midurethral sling implant, surgeons most commonly used the terms mesh (87%) and tape (81%), and less commonly used the term graft (14%). On average, there were 5.9 uses of mesh per consent session, 7.4 uses of tape, and 0.5 uses of graft.

A variety of sociodemographic factors (patient age, education, race/ethnicity, and health literacy score) and consent-related factors (duration of the discussion, mesh term used, and number of uses) were not significantly associated with patients’ recall of risks.

But the lower the grade level at which the surgeon spoke, the greater patients’ recall was (r = –0.26, P less than .05).

Dr. McFadden disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Patients giving consent to undergo midurethral sling surgery are more likely to remember being advised of the risks of surgical mesh if their surgeon speaks at a lower grade level.

This was among the key findings of a longitudinal cohort study of 71 women reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

Analysis of the consent discussions, which lasted an average of 15 minutes, showed that surgeons were significantly more likely to mention the immediate risks of mesh than the long-term risks, reported first author Dr. Brook L. McFadden, a urogynecologist at the Ohio State University Wexner Medical Center in Columbus. But patients were equally likely to remember both groups of risks.

Neither the specific term surgeons used to refer to the midurethral sling implant – mesh, tape, or graft – nor the number of times they used the term during the discussion affected patients’ recall of mesh risks 6 weeks after surgery. The length of the discussion also had no significant impact.

However, the lower the grade level at which the surgeon spoke, the greater patients’ recall of risks, even though the cohort was fairly well educated. On average, the surgeons spoke at about the 6th- to 7th-grade level.

"This was a homogeneous, young, educated population, which may not be generalizable," Dr. McFadden noted. "And we cannot account for counseling that occurred prior to or after the surgical consent session that may have impacted recall."

Invited discussant Dr. Bela Kudish, a urogynecologist at the Winnie Palmer Hospital Center for Advanced Gynecologic Surgery and Pelvic Medicine in Orlando, noted, "As providers, many of us are trying to balance the principles of nonmaleficence, beneficence, and autonomy of the patient in an attempt to improve the counseling process, to emphasize the shared responsibility in decision making in patients who undergo this procedure."

"How are you planning to improve the study design to identify factors specific to the consent process that may influence the recall, since this was a study that was done in four centers with a nonstandardized consent process?" she asked the investigators.

"I think at this point, the surgical consent process is not limited to that moment that you sign papers. It starts in the first moment when you meet the patient. So I think we need to start broadening our understanding and our evaluation of the consent process to include the very beginning counseling that’s occurring from day 1. And I also think we need to spend more time trying to reconcile what patients want to know and what they think is important with what we want them to remember, maybe what the lawyers want them to remember, and try to make that more patient centered," Dr. McFadden replied at the meeting, which was jointly sponsored by the American College of Surgeons.

"In your opinion, what is the ideal way of counseling patients to increase the recall of risk?" Dr. Kudish further queried.

"I do try to spend time asking the patient, ‘How do you best learn? Is it written, is it verbal? Do you like pictures?’ And try to incorporate what works best for them. And I think that the utility of decisional aids, while we have presented work that did not show great use recently, that is where this is going to go: using decisional aids starting from the very beginning, day 1, up until surgery, and even beyond this," Dr. McFadden maintained.

Session cochair Dr. Andrew Cassidenti of St. Joseph Hospital, Orange, Calif., commented, "Your point is excellent. I think the informed consent is really your relationship with the patient. It’s not a document, it’s a relationship and it’s an understanding of your confidence, your capabilities, your experience, what you can do for them, your results, and an honest discussion. I think that really is the key to keeping lawyers at bay."

The study enrolled patients who could read and write English and were undergoing only midurethral sling surgery. "At these four centers, we did not specify specifically how the surgeons were to [address] consent. They did this all in their normal way, so that had variation," Dr. McFadden noted.

Consent discussions were audio recorded and transcribed, and the transcripts were analyzed for their content and grade level of the surgeon’s speech according to the Flesch-Kincaid scale.

Patients completed a 21-item recall checklist. Their recall score was calculated as the number of items recalled divided by the number the surgeon actually mentioned, multiplied by 100.

The patients’ mean age was 53 years; 83% were white and 66% had some college education or more, reported Dr. McFadden. On average, they had almost 15 years of education.

The percentage of physicians who mentioned various immediate risks of mesh ranged from 94% for bleeding to 97% for organ damage (mean, 95%). Patient recall scores at 6 weeks after surgery ranged from 71% for bleeding to 90% for the need for a catheter (mean, 80%).

The percentage of physicians who mentioned the long-term risks of mesh ranged from 30% for continued leakage and groin pain to 92% for mesh erosion, a notable high outlier (mean, 58%). Patient recall scores ranged from 33% for chronic urinary tract infection to 95% for continued leakage (mean, 68%).

Surgeons were significantly more likely to mention the immediate risks than the long-term risks (95% vs. 58%; P less than .01), but patients were similarly likely to recall these two groups of risks.

When referring to the midurethral sling implant, surgeons most commonly used the terms mesh (87%) and tape (81%), and less commonly used the term graft (14%). On average, there were 5.9 uses of mesh per consent session, 7.4 uses of tape, and 0.5 uses of graft.

A variety of sociodemographic factors (patient age, education, race/ethnicity, and health literacy score) and consent-related factors (duration of the discussion, mesh term used, and number of uses) were not significantly associated with patients’ recall of risks.

But the lower the grade level at which the surgeon spoke, the greater patients’ recall was (r = –0.26, P less than .05).

Dr. McFadden disclosed no relevant conflicts of interest.