Consent Discussions Research Articles

Implementation of a Bundled Consent Process in the ICU: A Single-Center Experience*

A bundled consent process, where patients or surrogates provide consent for all commonly performed procedures on a single form at the time of ICU admission, has been advocated as a method for improving both rates of documented consent and patient/family satisfaction, but there has been little published literature about the use of bundled consent. We sought to determine how residents in an academic medical center with a required bundled consent process actually obtain consent and how they perceive the overall value, efficacy, and effects on families of this approach. Single-center survey study. Medical ICUs in an urban academic medical center. Internal medicine residents. We administered an online survey about bundled consent use to all residents. Quantitative and qualitative data were analyzed. One-hundred two of 164 internal medicine residents (62%) completed the survey. A majority of residents (55%) reported grouping procedures and discussing general risks and benefits; 11% reported conducting a complete informed consent discussion for each procedure. Respondents were divided in their perception of the value of bundled consent, but most (78%) felt it scared or stressed families. A minority (26%) felt confident that they obtained valid informed consent for critical care procedures with the use of bundled consent. An additional theme that emerged from qualitative data was concern regarding the validity of anticipatory consent. Resident physicians experienced with the use of bundled consent in the ICU held variable perceptions of its value but raised concerns about the effect on families and the validity of consent obtained with this strategy. Further studies are necessary to further explore what constitutes best practice for informed consent in critical care.

Is the Informant Adequately Informed? Attitudes Regarding the Informed Consent Discussion

Is the Informant Adequately Informed? Attitudes Regarding the Informed Consent Discussion

Parents’ and clinicians’ views on conducting paediatric diagnostic test accuracy studies without prior informed consent: qualitative insight from the Petechiae in Children study (PiC)

ObjectiveThe Petechiae in Children (PiC) study assesses the utility of presenting features and rapid diagnostic tests in the diagnosis of serious bacterial infection in feverish children with non-blanching rashes. An...

"When a Girl Says No, You Should Be Persistent Until She Says Yes": College Students and Their Beliefs About Consent.

One in five college women report being sexually assaulted with 23% to 45% of men reporting attempting or completing a sexual assault while attending a university. One important concept in preventing sexual assault is consent. It is important to ensure that when students are being asked to wait for consent, they understand what consent is and the potential ways it could manifest in a sexual situation. In total, 25 female and 20 male college students participated in semistructured focus groups or interviews to gain a better understanding of their perspectives of consent and how they ensure that it has been given. Results demonstrate that college students do not have a consistent, coherent, or precise definition of consent. Participants often described consent using vague language and were only able to clearly identify verbal indicators of consent. Much of the discussion of consent centered around an individual's ability or inability to clearly and directly communicate his or her needs. Data also show that how students communicate about consent is influenced by gender expectations. There are multiple complicating factors when determining consent, including alcohol consumption. Participants discussed not understanding how to navigate sexual encounters when one or both parties had been consuming alcohol. Results also showed that there are multiple factors that may lead women to say yes to sex they don't want, and men to not ask for consent. For college students, consent is a complex concept-a concept they may not have a practical and useful definition of. Sexual assault prevention must take steps to provide college students with a definition of consent informed by their experiences and the reality of their sexual encounters.

A Subpoena: The Other Exception to Confidentiality

A good deal of attention is paid in counselor education programs to the significance of confidentiality and the rare categories of exception that would compel the counselor to break that sacred vow. The exceptions identified are danger to self, danger to others, and child abuse. In some states, additional mention is made of situations involving elder abuse. Rarely, however, do counselor educators discuss the impact of litigation on the sanctity of the counselor–client relationship and the ability of a subpoena to pierce the cloak of confidentiality that otherwise protects a client’s innermost thoughts and raw vulnerability. This article is an examination of the long arm of the court system and, by extension, the role of a subpoena as the often overlooked, other, exception to confidentiality. The effect of court involvement initiated either by the counselor’s client or by an opposing party on the counselor–client relationship should be clearly addressed in informed consent discussions and written documents to avoid unforeseen complications when a counselor receives and responds to a subpoena.

Decision-Making Regarding Ventilator Support in Children with SMA Type 1-A Cross-Sectional Survey among Physicians.

Spinal muscular atrophy (SMA) is a neuromuscular disorder characterized by muscle atrophy and severe proximal muscle weakness. In the absence of curative treatment, it has been controversial whether critically ill infants with SMA type 1 should receive ventilator support. The aim of this study was to investigate the process of decision-making regarding ventilator support in children with SMA type 1 from the perspectives of physicians. A web-based survey with 17 questions and 2 case vignettes was conducted in 671 physicians in Germany and Switzerland from 12/2016 to 03/2017. The survey focused on factors influencing the decision about ventilator support and the content in informed consent discussions. Additionally, physicians were asked about their general attitude towards mechanical ventilation in children with SMA type 1 and their hypothetical clinical management in emergency settings using case vignettes. Hundred and sixty-five physicians participated in the survey (50.3% child neurologists, 18.8% specialists for ventilator support, 6.1% pediatric palliative care physicians, and 6.1% with more than one of these specializations). Of all physicians, 44.2% confirmed to have experience with SMA type 1 patients using ventilator support. In summary, our results show that physicians' attitudes and experiences about mechanical ventilation in children with SMA type 1 vary considerably and are likely to influence the outcome in informed consent discussions and the hypothetical management in emergency settings.

Training surgeons and the informed consent discussion in paediatric patients: a qualitative study examining trainee participation disclosure

BackgroundThe process of obtaining informed consent is an important and complex pursuit, especially within a paediatric setting. Medical governing bodies have stated that the role of the trainee surgeon must...

A Contemporary Medicolegal Analysis of Outpatient Interventional Pain Procedures: 2009-2016.

Closed malpractice claim studies allow a review of rare but often severe complications, yielding useful insight into improving patient safety and decreasing practitioner liability. This retrospective observational study of pain medicine malpractice claims utilizes the Controlled Risk Insurance Company Comparative Benchmarking System database, which contains nearly 400,000 malpractice claims drawn from >400 academic and community medical centers. The Controlled Risk Insurance Company Comparative Benchmarking System database was queried for January 1, 2009 through December 31, 2016, for cases with pain medicine as the primary service. Cases involving outpatient interventional pain management were identified. Controlled Risk Insurance Company-coded data fields and the narrative summaries were reviewed by the study authors. A total of 126 closed claims were identified. Forty-one claims resulted in payments to the plaintiffs, with a median payment of $175,000 (range, $2600-$2,950,000). Lumbar interlaminar epidural steroid injections were the most common procedures associated with claims (n = 34), followed by cervical interlaminar epidural steroid injections (n = 31) and trigger point injections (n = 13). The most common alleged injuring events were an improper performance of a procedure (n = 38); alleged nonsterile technique (n = 17); unintentional dural puncture (n = 13); needle misdirected to the spinal cord (n = 11); and needle misdirected to the lung (n = 10). The most common alleged outcomes were worsening pain (n = 26); spinal cord infarct (n = 16); epidural hematoma (n = 9); soft-tissue infection (n = 9); postdural puncture headache (n = 9); and pneumothorax (n = 9). According to the Controlled Risk Insurance Company proprietary contributing factor system, perceived deficits in technical skill were present in 83% of claims. Epidural steroid injections are among the most commonly performed interventional pain procedures and, while a familiar procedure to pain management practitioners, may result in significant neurological injury. Trigger point injections, while generally considered safe, may result in pneumothorax or injury to other deep structures. Ultimately, the efforts to minimize practitioner liability and patient harm, like the claims themselves, will be multifactorial. Best outcomes will likely come from continued robust training in procedural skills, attention paid to published best practice recommendations, documentation that includes an inclusive consent discussion, and thoughtful patient selection. Limitations for this study are that closed claim data do not cover all complications that occur and skew toward more severe complications. In addition, the data from Controlled Risk Insurance Company Comparative Benchmarking System cannot be independently verified.

Most patients experiencing 30-day postoperative stroke after carotid endarterectomy will initially experience disability

ObjectiveAlthough modern rates of stroke after carotid endarterectomy (CEA) have been low, the functional outcomes of stroke after CEA are unclear. Our goal was to assess the degree of initial disability in patients without baseline stroke-related impairment who had undergone CEA and experienced an early postoperative stroke. MethodsThe National Surgical Quality Improvement Program CEA-targeted database was queried for CEA cases from 2011 to 2014. Patients who had experienced a postoperative stroke were included, and the modified Rankin scale (mRS) was used to assess the degree of initial disability from stroke (0, none; 1, no significant; 2, slight; 3, moderate; 4, moderately severe; 5, severe disability; 6, dead). The mRS score was categorized as not applicable (NA) in the absence of any stroke. Patients were excluded if they had had a preoperative mRS score >1. The 30-day outcomes among the cohorts with a postoperative mRS score of NA/0 to 1, 2 to 3, and 4 to 5 were compared. Multivariable analysis was used to determine the predictors of higher initial postoperative mRS scores. ResultsA total of 8797 patients with CEA and preoperative mRS scores of NA/0 to 1 were identified. Their mean age was 71 ± 8.8 years, and 61% were men. Most were asymptomatic (88%) and had been taking antiplatelet agents (90%) and statins (82%) preoperatively. At 30 days, the postoperative stroke rate was 1.1% and mortality was 0.6%. Of the patients with a postoperative stroke after CEA, 35.4% had had stable initial postoperative mRS scores of NA/0 to 1, and most had had increased initial postoperative disability with mRS scores of 2 to 3 (32.3%) or 4 to 5 (32.3%). The cohorts with greater initial postoperative mRS scores exhibited a longer length of stay (2.2 ± 3.3 vs 5.8 ± 3.9 vs 11.9 ± 18.8 days; P < .001) and greater rates of major adverse cardiac events (2.7% vs 100% vs 100%; P < .001). Multivariable analysis showed that the initial postoperative disability, determined by a greater mRS score, was independently associated with preoperative bleeding disorder/chronic anticoagulation (odds ratio, 1.79; 95% confidence interval, 1.04-3.11; P = .037) and operative time by hour (odds ratio, 1.38; 95% confidence interval, 1.11-1.7; P = .003). ConclusionsAlthough the rate of stroke after CEA has been low, almost two thirds of patients who experienced a stroke within 30 days postoperatively developed some degree of initial postoperative disability and one third developed initial moderately severe to severe disability. These findings provide an evidence base for improved informed consent and risk-benefit discussions with patients.

Impact of US Public Health Service increased risk deceased donor designation on organ utilization.

Under US Public Health Service guidelines, organ donors with risk factors for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) are categorized as increased risk donors (IRD). Previous studies have suggested that IRD organs are utilized at lower rates than organs from standard risk donors (SRD), but these studies were conducted prior to universal donor nucleic acid test screening. We conducted risk-adjusted analyses to determine the effect of IRD designation on organ utilization using 2010-2017 data (21626 heart, 101160 kidney, 52714 liver, and 16219 lung recipients in the United States) from the Organ Procurement and Transplantation Network. There was no significant difference (P<.05) between risk-adjusted utilization rates for IRD vs SRD organs for adult hearts and livers and pediatric kidneys, livers, and lungs. Significantly lower utilization was found among IRD adult kidneys, lungs, and pediatric hearts. Analysis of the proportion of transplanted organs recovered from IRD by facility suggests that a subset of facilities contribute to the underutilization of adult IRD kidneys. Along with revised criteria and nomenclature to identify donors with HIV, HBV, or HCV risk factors, educational efforts to standardize informed consent discussions might improve organ utilization.

Attitudes of postnatal women and maternity staff towards audio recording of consent discussions.

Audio recording consent discussions, and giving a copy of the recording to the patient to keep, might improve the consent process and reduce the risk of misunderstandings, complaints or medicolegal claims. However, there may be concerns over confidentiality and how being recorded could affect the consent discussion. We ascertained the views of 50 postnatal women and 100 maternity staff (25 anaesthetists, 25 obstetricians and 50 midwives) on making audio recordings of consent discussions. There was a wide range of opinions, with women and staff similarly supportive of audio recording overall, but the women were more supportive of recording than the staff when asked if they were against it, or whether they would support recording the discussion if the patient requested it; and less concerned than the staff regarding the potential disadvantages of audio recording. There were no significant differences in the views between anaesthetists, obstetricians and midwives.

ACOG Committee Opinion No. 774 Summary: Opportunistic Salpingectomy as a Strategy for Epithelial Ovarian Cancer Prevention.

Opportunistic salpingectomy may offer obstetrician-gynecologists and other health care providers the opportunity to decrease the risk of ovarian cancer in their patients who are already undergoing pelvic surgery for benign disease. By performing salpingectomy when patients undergo an operation during which the fallopian tubes could be removed in addition to the primary surgical procedure (eg, hysterectomy), the risk of ovarian cancer is reduced. Although opportunistic salpingectomy offers the opportunity to significantly decrease the risk of ovarian cancer, it does not eliminate the risk of ovarian cancer entirely. Counseling women who are undergoing routine pelvic surgery about the risks and benefits of salpingectomy should include an informed consent discussion about the role of oophorectomy and bilateral salpingo-oophorectomy. Bilateral salpingo-oophorectomy that causes surgical menopause reduces the risk of ovarian cancer but may increase the risk of cardiovascular disease, cancer other than ovarian cancer, osteoporosis, cognitive impairment, and all-cause mortality. Salpingectomy at the time of hysterectomy or as a means of tubal sterilization appears to be safe and does not increase the risk of complications such as blood transfusions, readmissions, postoperative complications, infections, or fever compared with hysterectomy alone or tubal ligation. The risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization. Additionally, ovarian function does not appear to be affected by salpingectomy at the time of hysterectomy based on surrogate serum markers or response to in vitro fertilization. Plans to perform an opportunistic salpingectomy should not alter the intended route of hysterectomy. Obstetrician-gynecologists should continue to observe and practice minimally invasive techniques. This Committee Opinion has been updated to include new information on the benefit of salpingectomy for cancer reduction, the feasibility of salpingectomy during vaginal hysterectomy, and long-term follow-up of women after salpingectomy.

ACOG Committee Opinion No. 774: Opportunistic Salpingectomy as a Strategy for Epithelial Ovarian Cancer Prevention.

Opportunistic salpingectomy may offer obstetrician-gynecologists and other health care providers the opportunity to decrease the risk of ovarian cancer in their patients who are already undergoing pelvic surgery for benign disease. By performing salpingectomy when patients undergo an operation during which the fallopian tubes could be removed in addition to the primary surgical procedure (eg, hysterectomy), the risk of ovarian cancer is reduced. Although opportunistic salpingectomy offers the opportunity to significantly decrease the risk of ovarian cancer, it does not eliminate the risk of ovarian cancer entirely. Counseling women who are undergoing routine pelvic surgery about the risks and benefits of salpingectomy should include an informed consent discussion about the role of oophorectomy and bilateral salpingo-oophorectomy. Bilateral salpingo-oophorectomy that causes surgical menopause reduces the risk of ovarian cancer but may increase the risk of cardiovascular disease, cancer other than ovarian cancer, osteoporosis, cognitive impairment, and all-cause mortality. Salpingectomy at the time of hysterectomy or as a means of tubal sterilization appears to be safe and does not increase the risk of complications such as blood transfusions, readmissions, postoperative complications, infections, or fever compared with hysterectomy alone or tubal ligation. The risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization. Additionally, ovarian function does not appear to be affected by salpingectomy at the time of hysterectomy based on surrogate serum markers or response to in vitro fertilization. Plans to perform an opportunistic salpingectomy should not alter the intended route of hysterectomy. Obstetrician-gynecologists should continue to observe and practice minimally invasive techniques. This Committee Opinion has been updated to include new information on the benefit of salpingectomy for cancer reduction, the feasibility of salpingectomy during vaginal hysterectomy, and long-term follow-up of women after salpingectomy.

Modern era surgical outcomes of elective and emergency giant paraesophageal hernia repair at a high-volume referral center.

Repair of giant paraesophageal hernia (PEH) has historically been associated with significant morbidity and mortality such that elective repair is only offered to symptomatic patients. Recent reports suggest modern era outcomes have improved such that elective repair may now be safer than historically thought. Furthermore, the morbidity of emergency surgery may still be significant. These changes may have important implications for patient selection for elective repair. The objectives of this study were to determine and compare modern era surgical outcomes after elective and emergency repair of giant PEHs at a high-volume tertiary care center. A retrospective review was conducted for all Type II-IV giant PEH repairs performed between 1 January 2012 and 31 December 2017. Type 1 hiatal hernias, fundoplication for reflux, and any co-surgery other than cholecystectomy were excluded from the final analysis. Baseline patient demographics, operative details, postoperative complications within 30 days and in-hospital or 30-day mortality were tabulated from the electronic medical record. Data were reported as median (interquartile range) unless otherwise specified. A total of 352 cases were reviewed, of which 204 met inclusion criteria (18 emergency, 186 elective). Eight had Type II PEH, 146 had Type III, and 50 had Type IV. Median length of stay was shorter in the elective group [1 (1) day elective vs. 5 (7) days emergency, p < 0.0001], and emergency patients were less likely to return directly to their original residence at discharge (13, 72% emergency vs 185, 99.4% elective, p < 0.0001). There were significantly more major complications (Clavien-Dindo score ≥ 3) in the emergency group (5, 28% emergency vs. 10, 5% elective, p = 0.005). There were no perioperative deaths in either group. Morbidity and mortality in both groups were less than historically reported. Informed consent discussions and patient selection for repair of giant PEHs should reflect modern era and institution-specific outcomes.

Enhancing practitioners\u2019 confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training \u2013 a Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) study

BackgroundEcLiPSE (Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children) is a randomised controlled trial (RCT) in the United Kingdom. Challenges to success include the need to immediately administer an intervention without informed consent and changes in staffing during trial conduct, mainly due to physician rotations. Using literature on parents’ perspectives and research without prior consent (RWPC) guidance, we developed an interactive training package (including videos, simulation and question and answer sessions) and evaluated its dissemination and impact upon on practitioners’ confidence in recruitment and consent.MethodsQuestionnaires were administered before and immediately after training followed by telephone interviews (mean 11 months later), focus groups (mean 14 months later) and an online questionnaire (8 months before trial closure).ResultsOne hundred and twenty-five practitioners from 26/30 (87%) participating hospitals completed a questionnaire before and after training. We conducted 10 interviews and six focus groups (comprising 36 practitioners); 199 practitioners working in all recruiting hospitals completed the online questionnaire. Before training, practitioners were concerned about recruitment and consent. Confidence increased after training for explaining (all scale 0–5, 95% CIs above 0 and p values < 0.05): the study (66% improved mean score before 3.28 and after 4.52), randomisation (47% improvement, 3.86 to 4.63), RWPC (72% improvement, 2.98 to 4.39), and addressing parents’ objections to randomisation (51% improvement, 3.37 to 4.25). Practitioners rated highly the content and clarity of the training, which was successfully disseminated. Some concerns about staff availability for training and consent discussions remained.ConclusionsTraining improved practitioners’ confidence in recruitment and RWPC. Our findings highlight the value of using parents’ perspectives to inform training and to engage practitioners in trials that are at high risk of being too challenging to conduct.

Developing a conceptual, reproducible, rubric-based approach to consent and result disclosure for genetic testing by clinicians with minimal genetics background

PurposeIn response to genetic testing being widely ordered by nongenetics clinicians, the Consent and Disclosure Recommendations (CADRe) Workgroup of the Clinical Genome Resource (ClinGen; clinicalgenome.org) developed guidance to facilitate communication about genetic testing and efficiently improve the patient experience. Considering ethical, legal, and social implications, and medical factors, CADRe developed and pilot tested two rubrics addressing consent for genetic testing and results disclosure. The CADRe rubrics allow for adjusting the communication approach based on circumstances specific to patients and ordering clinicians. MethodsWe present results of a formative survey of 66 genetics clinicians to assess the consent rubric for nine genes (MLH1, CDH1, TP53, GJB2, OTC; DMD, HTT, and CYP2C9/VKORC1). We also conducted interviews and focus groups with family and patient stakeholders (N = 18), nongenetics specialists (N = 27), and genetics clinicians (N = 32) on both rubrics. ResultsFormative evaluation of the CADRe rubrics suggests key factors on which to make decisions about consent and disclosure discussions for a “typical” patient. ConclusionWe propose that the CADRe rubrics include the primary issues necessary to guide communication recommendations, and are ready for pilot testing by nongenetics clinicians. Consultation with genetics clinicians can be targeted toward more complex or intensive consent and disclosure counseling.

Imaging-Based 3-Dimensional Printing for Improved Maxillofacial Presurgical Planning: A Single Center Case Series

Purpose3-D printing is an increasingly widespread technology that allows physical models to be constructed based on cross-sectional medical imaging data. We sought to develop a pipeline for production of 3-dimensional (3-D) models for presurgical planning and assess the value of these models for surgeons and patients. MethodsIn this institutional review board–approved, single-center case series, participating surgeons identified cases for 3-D model printing, and after obtaining patient consent, a 3-D model was produced for each of the 7 participating patients based on preoperative cross-sectional imaging. Each model was given to the surgeon to use during the surgical consent discussion and preoperative planning. Patients and surgeons completed questionnaires evaluating the quality and usefulness of the models. ResultsThe 3-D models improved surgeon confidence in their operative approach, influencing the choice of operative approach in the majority of cases. Patients and surgeons reported that the model improved patient comprehension of the surgery during the consent discussion, including risks and benefits of the surgery. Model production time was as little as 4 days, and the average per-model cost was $350. Conclusions3-D printed models are useful presurgical tools from both surgeon and patient perspectives. Development of local hospital-based 3-D printing capabilities enables model production with rapid turnaround and modest cost, representing a value-added service for radiologists to offer their surgical colleagues.

Chemotherapy-Induced Cognitive Decline: Moving from the Mechanistic Debate towards Prevention and Treatment—A Clinical Review

Patients receiving chemotherapy have reported cognitive challenges including short-term memory loss and reduced executive functioning. While cognitive decline can be multifactorial and related to aging, depression, surgery, and other medications, there has been a steadily increasing body of knowledge showing a significant association between cognitive decline and chemotherapy administration. This clinical review summarizes patient-reported cognitive changes, support from neuroimaging and neuropsychological testing. The mechanism of action of and patient susceptibilities to cognitive decline are reviewed. Current behavioral and pharmacologic interventions are discussed. There is a need to identify patients at risk for developing chemotherapy induced cognitive decline and to screen for early signs of cognitive deterioration. The risk of cognitive dysfunction and possible interventions should be included in the informed consent discussion with patients who are undergoing cytotoxic treatments.

Affirmative sexual consent? Direct and unambiguous consent is rarely included in discussions of recent sexual interactions

Sexual activity typically follows an implicit sexual script or a normative sequence of behaviours that are involved in a sexual interaction. It is unclear whether or how affirmative sexual consent is incorporated in individual sexual scripts and interactions. The current research explores how sexual consent may be expressed and verified as part of individuals’ sexual interactions. Undergraduate participants from an Ontario university ( N = 92; 58 males, 34 females) completed a series of open-ended questions that asked them to describe their sexual experiences with a new and long-term partner from beginning to end. Analysis of presence of consent-related behaviours in participants’ accounts were assessed on the basis of a priori themes and extensions of these themes. Thematic analyses identified the following themes: 1) Sex proceeding with escalating intensity of nonverbal sexual behaviour, 2) Passive behaviours that do not indicate unwillingness to have sex, 3) Indirect verbal communication of interest in sex, 4) Indications that sex “just happened,” 5) Descriptions of the context in which sex occurred, and 6) Direct discussions relevant to sexual consent. Results indicated that direct discussion of sexual consent was exceedingly rare and that most sexual interactions included indirect, veiled, and coded behaviours that require inference of sexual consent or non-consent. Consent-related themes varied as a function of both participant gender (male versus female) and nature of relationship (new versus long-term). The findings of this study have implications for sexual health education, sexual assault prevention interventions, and public policy development.

The Effect of Written Information on Recall of Surgical Risks of Primary Cleft Palate Repair: A Randomized Controlled Study.

To investigate parents' understanding of the risks of primary cleft palate surgery after counseling with and without the use of a written informational aid. Prospective, randomized, single-blind trial. Academic tertiary care center. Parents of children undergoing primary cleft palate surgery. Parents were randomized to receive a standard informed consent discussion with or without provision of a written informational aid in the form of a pamphlet. Parents' recall of 9 specific surgical risks 3 weeks after informed consent discussion. Forty parents enrolled in and completed the study (20 participants each in the control and intervention groups). There were no statistically significant differences between groups in terms of baseline demographics. The mean number of risks recalled were 3.7 (1.6) for the control group and 4.2 (1.9) for the intervention group (P = .37). The most commonly recalled risks were fistula formation and bleeding, while the least frequent were facial growth restriction and need for further surgery. No differences in risk recall were observed based on participant's gender, level of education, or income. Parents of children undergoing primary cleft palate surgery recall less than 50% of counseled risks. The use of a written aid in the form of a pamphlet did not significantly improve recall in this sample. These results demonstrate that surgeons should implement additional measures to improve comprehension of surgical risks.