Consent for cataract surgery training: a national trainers' survey.
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ABSTRACT:
SUBMITTER: Steeples L
PROVIDER: S-EPMC3351061 | biostudies-other | 2012 May
REPOSITORIES: biostudies-other
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Project description:Purpose. To investigate whether adding video assistance to traditional verbal informed consent advisement improved satisfaction among cataract surgery patients. Methods. This trial enrolled 80 Chinese patients with age-related cataracts scheduled to undergo unilateral phacoemulsification surgery. Patients were randomized into two groups: the video group watched video explaining cataract-related consent information and rewatched specific segments of the video at their own discretion, before receiving traditional verbal consent advisement; the control group did not watch the video. Outcomes included patient satisfaction, refusal to consent, time to complete the consent process, and comprehension measured by a ten-item questionnaire. Results. All 80 enrolled patients signed informed consent forms. Compared with the control group, members of the video group exhibited greater satisfaction (65% versus 86%, p = 0.035) and required less time to complete the consent process (12.3 ± 6.7 min versus 5.6 ± 5.4 min, p < 0.001), while also evincing levels of comprehension commensurate with those reported for patients who did not watch the video (accuracy rate, 77.5% versus 80.2%, p = 0.386). Conclusion. The video-assisted informed consent process had a positive impact on patients' cataract surgery experiences. Additional research is needed to optimize patients' comprehension of the video.
| S-EPMC5278206 | biostudies-literature
Project description:PURPOSE:To determine the effect of the early introduction of cataract surgery training on the complication rates of resident-performed cataract surgery. SETTING:University of California San Diego, San Diego, California, USA. DESIGN:Retrospective case series. METHODS:Two classes of ophthalmology residents were examined, one class with a late introduction of cataract surgery and one with an early introduction of cataract surgery. All cataract cases in which residents acted as primary surgeon were included. Patient charts were reviewed to collect data on patient characteristics, surgical details, and intraoperative and postoperative complications. RESULTS:The late-introduction cohort comprised 3 residents who performed 540 cataract cases, all during their final year of residency. The early-introduction cohort comprised 4 residents who performed 780 cataract cases beginning in the first year of residency. The late-introduction cohort had higher rates of major intraoperative complications than the early-introduction cohort (8.5% versus 3.1%) and of anterior vitrectomy (7.6% versus 2.1%) (both P < .001). Examination of the anterior vitrectomy rate as a function of experience showed the early-introduction cohort had a stable anterior vitrectomy rate of 1% to 2% throughout training, while the late-introduction cohort had a peak anterior vitrectomy rate of 12% at approximately case 20. Multivariable regression analysis showed the early-introduction cohort was independently associated with a lower rate of anterior vitrectomy (hazard ratio, 0.49; 95% confidence interval, 0.36-0.66) after adjusting for differences in patient characteristics and surgical complexity. CONCLUSIONS:Early introduction of cataract surgery training significantly decreased the rate of major intraoperative complications, specifically anterior vitrectomy, in resident-performed cataract surgeries.
| S-EPMC6157597 | biostudies-literature
Project description:PurposeTo assess the effects of the American Academy of Ophthalmology's 2015 patient education video on patient information retention and anxiety preoperatively, on the day of surgery and postoperatively.MethodsThis is a prospective, surgeon-blinded randomized controlled trial at the University of Chicago Medical Center. Ninety-one patients with a diagnosis of first-eye cataract were randomized into either a video or control group. Subjects in both groups received face-to-face discussion with the surgeon and an informational brochure at the preoperative evaluation. Participants in the video group then viewed a four-minute educational video at the preoperative evaluation and on the day of surgery. Both groups completed an information retention quiz and a state anxiety assessment at the preoperative visit, on the day of surgery, and on the postoperative week one visit. Subject understanding of cataract surgery was measured using a twelve-question multiple choice quiz. State anxiety was measured by State Trait Anxiety Inventory-Y1 survey score.ResultsParticipants in the video group did not score significantly higher on the information retention quiz compared with the control group at the preoperative evaluation (8.7 ± 2.4 vs 7.7 ± 2.5, P = 0.07), but did so on the day of surgery (11.2 ± 0.8 vs 8.4 ± 1.7, P < 0.001) and postoperative week 1 visit (10.8 ± 1.5 vs 9.0 ± 2.0, P < 0.001). Subjects in the video group were significantly less anxious on the day of surgery (26.4 ± 5.1 vs 41.1 ± 10.3, P < 0.001).ConclusionsVideo supplementation to the traditional informed consent process demonstrated an improvement in patient understanding of cataract surgery at multiple timepoints and decreased anxiety on the day of surgery.
| S-EPMC7846231 | biostudies-literature
Project description:BACKGROUND:Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk. OBJECTIVE:To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs. DESIGN:National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios. SETTING:Web-based survey conducted in December 2014. PARTICIPANTS:2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%). MEASUREMENTS:Respondent's recommendation to an ethics review board and personal preference as a potential participant on how to obtain consent or notification in the 2 research scenarios. RESULTS:Most respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in accord with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. LIMITATION:Framing effects could have affected respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions. CONCLUSION:Most of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent. PRIMARY FUNDING SOURCE:Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.
| S-EPMC5573142 | biostudies-literature
Project description:BackgroundResearch in novel therapies for Alzheimer disease (AD) relies on persons with AD as research subjects. Because AD impairs decisional capacity, informed consent often must come from surrogates, usually close family members. But policies for surrogate consent for research remain unsettled after decades of debate.MethodsWe designed a survey module for a random subsample (n = 1,515) of the 2006 wave of the Health and Retirement Study, a biennial survey of a nationally representative sample of Americans aged 51 and older. The participants answered questions regarding one of four randomly assigned surrogate-based research (SBR) scenarios: lumbar puncture study, drug randomized control study, vaccine study, and gene transfer study. Each participant answered three questions: whether our society should allow family surrogate consent, whether one would want to participate in the research, and whether one would allow one's surrogate some or complete leeway to override stated personal preferences.ResultsMost respondents stated that our society should allow family surrogate consent for SBR (67.5% to 82.5%, depending on the scenario) and would themselves want to participate in SBR (57.4% to 79.7%). Most would also grant some or complete leeway to their surrogates (54.8% to 66.8%), but this was true mainly of those willing to participate. There was a trend toward lower willingness to participate in SBR among those from ethnic or racial minority groups.ConclusionsFamily surrogate consent-based dementia research is broadly supported by older Americans. Willingness to allow leeway to future surrogates needs to be studied further for its ethical significance for surrogate-based research policy.
| S-EPMC2663398 | biostudies-literature
Project description:BackgroundUnlike new drugs and medical devices, most surgical procedures are developed outside clinical trials and without regulatory oversight. Surgical professional organizations have discussed how new procedures should be introduced into practice without agreement on what topics informed consent discussions must include. To provide surgeons with more specific guidance, we wanted to determine what information patients and surgeons consider essential to disclose before an innovative surgical procedure.MethodsOf those approached, 85 of 113 attending surgeons and 383 of 541 adult postoperative patients completed surveys; responses to the surveys were 75% and 71%, respectively. Using a 6-point Likert scale, participants rated the importance of discussing 16 types of information preoperatively for 3 techniques (standard open, laparoscopic, robotic) offered for a hypothetic partial hepatectomy.ResultsCompared with surgeons, patients placed more importance on nearly all types of information, particularly volumes and outcomes. For all 3 techniques, approximately 80% of patients indicated that they could not decide on surgery without being told whether it would be the surgeon's first time doing the procedure. When considering an innovative robotic surgery, a clear majority of both patients and surgeons agreed that it was essential to disclose the novel nature of the procedure, potentially unknown risks and benefits, and whether it would be the surgeon's first time performing the procedure.ConclusionTo promote informed decision-making and autonomy among patients considering innovative surgery, surgeons should disclose the novel nature of the procedure, potentially unknown risks and benefits, and whether the surgeon would be performing the procedure for the first time. When accurate volumes and outcomes data are available, surgeons should also discuss these with patients.
| S-EPMC3602241 | biostudies-literature
Project description:PurposeTo describe current cataract surgery practice patterns and trends among Korean ophthalmologists.MethodsA survey was conducted among members of the Korean Society of Cataract and Refractive Surgery in October 2020. Of the 998 questionnaires, 262 (26.3%) were received for analysis. Data were analyzed using descriptive statistics and compared with those of previous surveys.ResultsThe largest percentage of respondents (39%) had <5 years of practical experience, and 40% had >11 years of practical experience. The average, median, and mode monthly volumes of cataract surgeries performed by the Korean Society of Cataract and Refractive Surgery members were 31, 20, and 10 cases, respectively. Topical anesthesia was administered by 85% of the respondents. For intraocular lens (IOL) calculations, 96% of the respondents used optical biometry. The proportion of surgeons providing femtosecond laser-assisted cataract surgery increased significantly from 5% in 2018 to 29% in 2020. This increase was accompanied by an increase in the multifocal IOLs. Those who implant multifocal IOL for >10% of their cases increased from 16% (2018) to 29% (2020). Topical nonsteroidal anti-inflammatory drugs were prescribed postoperatively by 76% of the respondents. Most respondents (70%) prescribed these anti-inflammatory drugs for 4 weeks.ConclusionsThis survey provided a comprehensive update on current cataract surgery practice in the Republic of Korea. The results highlighted the increasing use of premium IOLs, femtosecond laser-assisted cataract surgery, optical biometry, and topical anesthesia to better meet the patients' needs.
| S-EPMC8357609 | biostudies-literature
Project description:ImportanceCataract surgery is the most commonly performed intraocular surgery. Academic centers have mandates to train the next surgeon generation, but resident roles are often hidden in the consent process.ObjectiveTo investigate associations of full preoperative disclosure of the resident role with patient consent rates and subjective experience of the consent process.Design, setting, and participantsFull scripted disclosure of residents' roles in cataract surgery was delivered by the attending surgeon. Qualitative analysis was conducted from recorded interviews of patients postoperatively regarding consent process experience and choice of whether to allow resident participation. Associations were sought regarding demographic characteristics and consent rates. Patients were recruited though a private community office. Surgery was performed at a single hospital where resident training was routinely conducted. The study included systemically well patients older than 18 years with surgical cataract. They had no previous eye surgery, English fluency, and ability to engage in informed consent decision-making and postsurgery interview. Patients were ineligible if they had monocular cataracts, required additional simultaneous procedures, had history of ocular trauma, or had cataracts that were surgically technically challenging beyond the usual resident skill level.InterventionsEligible patients received an informed consent conversation by the attending physician in accordance with a script describing projected resident involvement in their cataract surgery. Postoperatively, patients were interviewed and responses were analyzed with a quantitative and thematic qualitative approach.Main outcomes and measuresConsent rates to resident participation and qualitative experience of full disclosure process.ResultsNinety-six patients participated. Participants were between ages 50 and 88 years, 53 were men (55.2%), and 75 were white (85.2%). A total of 54 of 96 participants (56.3%; 95% CI, 45.7%-66.4%) agreed to resident involvement. There were no associations between baseline characteristics and consent to resident involvement identified with any confidence, including race/ethnicity (60% [45 of 75] in white patients vs 30.8% [4 of 13] in nonwhite patients; difference, 29.2%; 95% CI, -0.7% to 57.3%; Fisher exact P = .07). Thematically, those who agreed to resident involvement listed trust in the attending surgeon, contributing to education, and supervision as contributing factors. Patients who declined stated fear and perceived risk as reasons.Conclusions and relevanceOur results suggest 45.7% to 66.4% of community private practice patients would consent to resident surgery. Consent rates were not associated with demographic factors. Because residents are less often offered the opportunity to do surgery on private practice patients vs academic center patients, this may represent a resource for resident education.
| S-EPMC6659148 | biostudies-literature
Project description:PurposeThe coronavirus disease 2019 (COVID-19) pandemic has had an immense impact on the healthcare industry. Oral and maxillofacial surgery (OMS) clinical practice uniquely exposes providers to COVID-19. The purpose of the present study was to understand the effect of the COVID-19 pandemic on OMS residency training programs (OMSRTPs): 1) training and education; 2) availability and use of personal protective equipment (PPE); 3) experience with, and use of, screening and viral testing; 4) resident experience; and 5) program director (PD) experience and observations of the immediate and future effects on OMSRTPs.Materials and methodsOMS residents and PDs in OMSRTPs in the United States were invited to participate in the present cross-sectional study from April 1, 2020 to May 1, 2020. A 51-question survey was used to evaluate the effects of COVID-19 on OMSRTPs and to assess the 5 specific aims of the present study.ResultsA total of 160 residents and 13 PDs participated in the survey, representing 83% of US states or territories with OMSRTPs. Almost all residents (96.5%) reported modifications to their training program, and 14% had been reassigned to off-service clinical rotations (eg, medicine, intensive care unit). The use of an N95 respirator mask plus standard PPE precautions during aerosol-generating procedures varied by procedure location, with 36.8% reporting limited access to these respirators. Widespread screening practices were in use, with 83.6% using laboratory-based viral testing. Residents scheduled to graduate in 2022 were most concerned with the completion of the graduation requirements and with decreased operative experience. Most residents (94.2%) had moved to web-based didactics, and a plurality (47%) had found increased value in the didactics.ConclusionsSweeping alterations to OMS clinical practice have occurred for those in OMSRTPs during the COVID-19 pandemic. Although the overall OMSRTP response has been favorable, residents' concerns regarding the ubiquitous availability of appropriate PPE, operative experience, and completion of graduation requirements requires further deliberation.
| S-EPMC7831533 | biostudies-literature
Project description:Objective:The purpose of this paper was to conduct a systematic review of existing literature on simulation-based training of cataract surgery. Available literature was evaluated and projections on how current findings could be applied to cataract surgery training were summarised. The quality of included literature was also assessed. Methods and analysis:The PubMed, Embase and Cochrane Library databases were searched for articles pertaining to simulation training in cataract surgery on 18 November 2019. Selected articles were qualitatively analysed. Results:A total of 165 articles were identified out of which 10 met inclusion criteria. Four studies reported construct validity of the EyeSi simulator. Six studies demonstrated improved surgical outcomes corresponding to training on the simulator. Quality assessment of included studies was satisfactory. Conclusion:Current studies on simulation training in cataract surgery all point towards it being an effective training tool with low risk of study biases confounding this conclusion. As technology improves, surgical training must embrace and incorporate simulation technology in training.
| S-EPMC7481074 | biostudies-literature