A randomized controlled trial to determine whether a video presentation improves informed consent for hysterectomy

Pallett, Alicia C.; Nguyen, Bao; Klein, Natalie M.; Phippen, Neil T.; Miller, Caela; Barnett, Jason C.

doi:10.1016/j.ajog.2018.06.016

Cited by 37 publications

(50 citation statements)

References 10 publications

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“…Fifteen audiovisual interventions (56%) resulted in improved patient comprehension compared with standard informed consent (Figure 2), 34,39,40,42,48,50,61,64,65,68–70,84 and the remaining did not. Fifty-three percent (9/17) of audiovisual intervention trials with some bias risk resulted in improved patient comprehension 39,39,42,48,50,61,64,65 compared with 60% (6/10) of those with high bias risk. 34,40,68–70,84 Seventeen studies used audiovisual interventions in addition to standard informed consent, 34,36,37,39,40,48,50,59,60–62,64–66,68,70,84 of which 11 (65%) resulted in improved patient comprehension compared with control.…”

Section: Resultsmentioning

confidence: 99%

“…57,58 Five interventions reduced consultation time with the consenting provider by an average of 4 to 6.7 min. [59][60][61][62]85 One intervention with reduced consultation time resulted in improved patient comprehension. 61 Three verbal discussion with testfeedback or teach-back interventions required longer consultation times, by an average of 2.3, 2.6, and 21 min, and each resulted in improved patient comprehension compared with standard informed consent.…”

Section: Group Favored Cmentioning

confidence: 99%

“…[59][60][61][62]85 One intervention with reduced consultation time resulted in improved patient comprehension. 61 Three verbal discussion with testfeedback or teach-back interventions required longer consultation times, by an average of 2.3, 2.6, and 21 min, and each resulted in improved patient comprehension compared with standard informed consent. 34,82,83 Informed Consent and Vulnerable Populations Some studies conducted subanalyses on the basis of sociodemographic data, most commonly examining education (19 studies), age (16 studies), and gender (12 studies).…”

Section: Group Favored Cmentioning

confidence: 99%

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Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review

et al. 2020

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Background. Patient comprehension is fundamental to valid informed consent. Current practices often result in inadequate patient comprehension. Purpose. An updated review to evaluate the characteristics and outcomes of interventions to improve patient comprehension in clinical informed consent. Data Sources. Systematic searches of MEDLINE and EMBASE (2008–2018). Study Selection. We included randomized and nonrandomized controlled trials evaluating interventions to improve patient comprehension in clinical informed consent. Data Extraction. Reviewers independently abstracted data using a standardized form, comparing all results and resolving disagreements by consensus. Data Synthesis. Fifty-two studies of 60 interventions met inclusion criteria. Compared with standard informed consent, a statistically significant improvement in patient comprehension was seen with 43% (6/14) of written interventions, 56% (15/27) of audiovisual interventions, 67% (2/3) of multicomponent interventions, 85% (11/13) of interactive digital interventions, and 100% (3/3) of verbal discussion with test/feedback or teach-back interventions. Eighty-five percent of studies (44/52) evaluated patients’ understanding of risks, 69% (41/52) general knowledge about the procedure, 35% (18/52) understanding of benefits, and 31% (16/52) understanding of alternatives. Participants’ education level was reported heterogeneously, and only 8% (4/52) of studies examined effects according to health literacy. Most studies (79%, 41/52) did not specify participants’ race/ethnicity. Limitations. Variation in interventions and outcome measures precluded conduct of a meta-analysis or calculation of mean effect size. Control group processes were variable and inconsistently characterized. Nearly half of studies (44%, 23/52) had a high risk of bias for the patient comprehension outcome. Conclusions. Interventions to improve patient comprehension in informed consent are heterogeneous. Interactive interventions, particularly with test/feedback or teach-back components, appear superior. Future research should emphasize all key elements of informed consent and explore effects among vulnerable populations.

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Section: Resultsmentioning

confidence: 99%

Section: Group Favored Cmentioning

confidence: 99%

Section: Group Favored Cmentioning

confidence: 99%

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Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review

et al. 2020

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“…A recent randomized trial exposed women preparing for a hysterectomy to standard face-to-face preoperative counseling versus a video presentation, followed by standard preoperative face-to-face counseling. 13 The study found that women in the control arm were less likely to receive counseling about the risks of hysterectomy, such as thrombosis, and were less likely to receive counseling about postoperative expectations and the need for possible hormone replacement therapy. The study also found that the improvement in women's comprehension of the hysterectomy procedure was greater after exposure to a video presentation versus after standard counseling.…”

Section: Discussionmentioning

confidence: 95%

Patient Understanding of Uterine Fibroids and the Different Surgical Approaches to Hysterectomy

Belilovets

Gopal²,

Stockwell

et al. 2020

Women's Health Reports

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Objective: The purpose of this study was to assess understanding of the hysterectomy procedure and uterine fibroids among women in a general gynecology clinic. Materials and Methods: This was an anonymous cross-sectional survey. We adapted and pilot tested a survey instrument designed to assess understanding of the hysterectomy procedure and of uterine fibroids. The final version of the survey consisted of basic demographic questions, followed by 28 knowledge questions (Canadian Task Force Classification II-2). The survey was disseminated to women in the waiting room of one of our gynecology clinics. The patient population included women 18 years and older. Results: The mean age of respondents was 33.5 years old. In total, 69.5% of the respondents had at least some college education. In the group of questions related to different types of hysterectomies, the most poorly answered question was ''Which type of hysterectomy has the highest risk of damage to the bladder?'' Less than 40% of the respondents were able to identify a laparoscopic and robotic hysterectomy based on a written description. Of questions about uterine fibroids, the most poorly answered question was whether cancer that looks like fibroids is common, with >90% of the respondents incorrectly thinking that cancer that resembled fibroids is common. More than half of respondents did not know what a fibroid is. Conclusions: In this analysis of the understanding of the hysterectomy procedure and fibroids among an educated population, overall understanding was poor. Specific areas where knowledge was particularly poor were the different ways of doing a hysterectomy and uterine fibroids.

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“…[43] Physicians may communicate with parents about their perspectives and preferences, help them to discuss their values, and help them to make the best decisions for their children. A range of strategies have been used to improve patients' and parents' comprehension, including illustrative materials, lea ets and pamphlets, video descriptions, interactive computer programs, [3,[44][45][46][47][48][49][50][51][52] and "repeat back to me" or testing with feedback strategies. [53][54][55] We found that baseline knowledge score and the use of an educational video were signi cant predictors of parental knowledge and understanding.…”

Section: Discussionmentioning

confidence: 99%

A parental educational intervention to facilitate informed consent for pediatric procedural sedation in the emergency department: a parallel group randomized controlled trial

Lin

Yeh

Chen

et al. 2020

Preprint

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Background Obtaining valid parental informed consent for pediatric procedures in the emergency department (ED) is challenging. This study compared a video-assisted informed consent intervention with conventional consent discussion to inform parents about pediatric procedural sedation in the ED. Methods A video-assisted informed consent intervention was developed to explain the process, benefits, risks, and alternatives of pediatric procedural sedation. A prospective randomized controlled trial was conducted with a convenience sample of parents of children recommended for procedural sedation for facial laceration in the ED. Intervention group participants watched the video. Control group participants received information from physicians during conventional discussion. Participants completed pre- and post-education knowledge tests and rated their satisfaction with the informed consent process. The primary outcome was efficacy of the video intervention compared with conventional discussion. Secondary outcomes were parental satisfaction and consent refusal. A covariate-controlled multivariable regression model was used to analyze between-group differences in knowledge and satisfaction. Results There were 32 participants in the intervention group and 30 in the control group. Mean knowledge scores were higher in the intervention group (91.67 ± [standard deviation] 12.70) than in the control group (73.33 ± 19.86). The intervention group showed significantly greater knowledge score differences (coefficient: 18.931, 95% confidence interval: 11.146–26.716). Intervention group participants showed greater satisfaction than control group participants. Conclusions Video-assisted informed consent was superior to conventional discussion for informing parents during an ED informed consent process. Video-assisted informed consent may improve parents’ understanding of pediatric procedural sedation and satisfaction with the informed consent process in the ED. Institutions should develop structured methods and strategies to better inform parents, facilitate treatment decisions, and improve parent satisfaction in the ED. Trial registration: The ClinicalTrials.gov Identifier is NCT01850329. Registered 9 May, 2013 - Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/study/NCT01850329

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A randomized controlled trial to determine whether a video presentation improves informed consent for hysterectomy

Cited by 37 publications

References 10 publications

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review

Patient Understanding of Uterine Fibroids and the Different Surgical Approaches to Hysterectomy

A parental educational intervention to facilitate informed consent for pediatric procedural sedation in the emergency department: a parallel group randomized controlled trial

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