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

Abstract

Objective: To investigate parents’ understanding of the risks of primary cleft palate surgery after counseling with and without the use of a written informational aid. Design: Prospective, randomized, single-blind trial. Setting: Academic tertiary care center. Participants: Parents of children undergoing primary cleft palate surgery. Interventions: 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. Main Outcomes Measure: Parents’ recall of 9 specific surgical risks 3 weeks after informed consent discussion. Results: 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. Conclusion: 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.

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

“…17,18,20,[30][31][32] Kinnersley et al 3 in their 2013 Cochrane Collaboration systematic review and meta-analysis found that written interventions improved both short-term and long-term knowledge after consent when compared with controls; however, a number of studies published subsequent to that meta-analysis failed to show a benefit. 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.…”

“…5 There is conflicting evidence, however, regarding the efficacy of written interventions such as pamphlets or information sheets, with some studies finding it beneficial, 7,8,19,[25][26][27][28][29] whereas others did not show a significant effect. 17,18,20,[30][31][32] Kinnersley et al 3 in their 2013 Cochrane Collaboration systematic review and meta-analysis found that written interventions improved both short-term and long-term knowledge after consent when compared with controls; however, a number of studies published subsequent to that meta-analysis failed to show a benefit. 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).…”

“…Procedure-specific consent forms have been shown to significantly improve patient recall of risks in total knee arthroplasty, 6 knee arthroscopy, 6 and THR 5 . There is conflicting evidence, however, regarding the efficacy of written interventions such as pamphlets or information sheets, with some studies finding it beneficial, 7,8,19,25–29 whereas others did not show a significant effect 17,18,20,30–32 . Kinnersley et al 3 in their 2013 Cochrane Collaboration systematic review and meta-analysis found that written interventions improved both short-term and long-term knowledge after consent when compared with controls; however, a number of studies published subsequent to that meta-analysis failed to show a benefit 18,20,31,32 .…”

The effectiveness of interventions to increase patient involvement in decision-making in orthodontics: A systematic review

“…Most studies (n=8) were undertaken in orthodontic departments in dental hospitals or district general hospitals within the United Kingdom (UK). Of the remaining studies, four were undertaken in hospital settings in the United States of America (Al-Taha et al, 2019; Kang et al, 2009; Pawlak et al, 2015; Phillips et al, 2001) and one in UK primary schools (Anderson and Freer, 2005).…”

“…Of the included studies, all but two recruited participants undergoing orthodontic treatment alone, with the majority of participants being young people (aged 9 and 18 years). Participants in one study were parents of children undergoing primary cleft palate surgery (Al-Taha et al, 2019), and in another were adults undergoing combined orthodontic and orthognathic treatment (Phillips et al, 2001). Thomson et al (2001), Kang et al (2009) and Pawlak et al (2015) also included adult participants through recruitment of patient-parent pairs.…”