scholarly journals 1424 Enhanced Consent in Endocrine Surgery in The Era Of COVID-19

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
K Greene ◽  
P Truran ◽  
R Bliss ◽  
J Ramsingh
Keyword(s):  
Informed Consent ◽  
Health Services ◽  
Informed Decision ◽  
Waiting List ◽  
Consent Process ◽  
Endocrine Surgery ◽  
Preoperative Risk ◽  
Clinic Appointment ◽  
The Impact ◽  
Second Peak

Abstract Aim Informed consent is the process by which surgeon and patient agree to undergo a procedure after the risk, benefits and alternative treatments have been discussed. The current COVID-19 pandemic provides unique challenges to the consent process such as the uncertain risk of acquiring the virus and the impact of a second peak on the health services. The aim of this audit was to use an enhanced consent tool to inform patients of specific risks associated with surgery during the pandemic. Method At the beginning of the pandemic, elective operating was postponed - these patients were added to a COVID-19 database. With the resumption of services, all patients had a telephone clinic appointment with a 2-fold aim: 1) to ensure they wanted to remain on the waiting list and 2) to discuss consent specifically with regard to COVID-19 using an enhanced consent tool. Results Over a 6-week period, 79 patients were contacted. All patients were awaiting thyroid, parathyroid and adrenal operations. Of the 79 patients contacted, 77 (97%) agreed to remain on the waiting list after discussing the risks using the enhanced consent tool. The remaining 2 patients asked for their operations to be delayed. To date, none of our patients have acquired COVID-19 upon the resumption of services. Conclusions Despite the uncertain risks of COVID-19, the majority of patients requiring endocrine surgery were happy to proceed. Ongoing review of available literature concerning preoperative risk and COVID-19 is essential for clinicians involved in the consent process. The use of an enhanced consent tool standardised the consent process and enabled patients to make an informed decision concerning their care.

The Impact of the Informed Consent Process on the Anxiety Levels of Patients Undergoing Rhinoplasty

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Abdulhalim Aysel ◽  
Uzdan Uz ◽  
Berrak Karatan ◽  
Enes Aydin ◽  
Esin Erdoğan ◽  
...  
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Process ◽  
Anxiety Levels ◽  
The Impact

scholarly journals BRINGING INFORMED CONSENT TO THE 21ST CENTURY – THE IMPACT OF AN ONLINE RESOURCE AND CONSENT PROCESS ON FERTILITY PATIENT PERCEPTIONS

2020 ◽  
Vol 114 (3) ◽  
pp. e48
Author(s):  
Abigail L. Bernard ◽  
Ashley K. Barbour ◽  
Jody L. Madeira ◽  
Steven R. Lindheim ◽  
Linnea R. Goodman
Keyword(s):  
Informed Consent ◽  
21St Century ◽  
Patient Perceptions ◽  
Consent Process ◽  
Online Resource ◽  
The Impact

scholarly journals Effects of Depression and Social Support on Comprehension and Recall of Informed Consent Information among Parkinson Disease Patients and Their Caregivers

2012 ◽  
Vol 43 (1) ◽  
pp. 67-83 ◽  
Author(s):  
Ellen J. Teng ◽  
Nancy J. Petersen ◽  
Christine Hartman ◽  
Ellen Matthiesen ◽  
Michael Kallen
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
Randomized Study ◽  
Depression Scale ◽  
Epidemiologic Studies ◽  
Consent Process ◽  
Support Person ◽  
The Impact

Objective: Relatively little attention has focused on the impact of psychiatric conditions on human subjects' comprehension of consent information. The purpose of this randomized study was to determine whether depression affects comprehension and recall of informed consent information among persons with Parkinson's disease and their caregivers and to evaluate the effects of support on comprehension and recall during the consent process. Method: Comprehension and recall of information were assessed using a modified version of the Modified Quality of Informed Consent Questionnaire, taken 1 week and 1 month later, and scored using a consensus-based algorithm. Participants also completed the Center for Epidemiologic Studies Depression Scale. Data analyses were conducted on 129 patients and caregivers ( t-tests, Fisher's exact tests, and ANCOVAs). Results: T-tests showed no significant differences in comprehension and recall between depressed and nondepressed participants at 1 week and 1 month. However, ANCOVA showed patients with a support person present had significantly higher comprehension and recall at 1 week but not at 1 month compared with controls. Caregivers present with a patient had lower comprehension/recall than those without a patient present ( p = 0.02). Conclusions: Having a support person present during the informed consent process helps depressed PD patients better retain information in the short term, but effects diminish over the long term. Implications for interventions will be discussed.

scholarly journals Back to the future: surgical rehearsal platform technology as a means to improve surgeon-patient alliance, patient satisfaction, and resident experience

2020 ◽  
pp. 1-8
Author(s):  
James M. Wright ◽  
Alankrita Raghavan ◽  
Christina H. Wright ◽  
Berje Shammassian ◽  
Yifei Duan ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Patient Satisfaction ◽  
Informed Consent ◽  
Academic Medical Center ◽  
Tumor Resection ◽  
Maslach Burnout Inventory ◽  
Consent Process ◽  
Patient Understanding ◽  
Physician Patient ◽  
The Impact

OBJECTIVEInformed consent, when performed appropriately, serves many roles beyond simply obtaining the prerequisite medicolegal paperwork to perform a surgery. Prior studies have suggested that patient understanding is poor when verbal communication is the sole means of education. Virtual reality platforms have proven effective in enhancing medical education. No studies exist that have demonstrated the utility of virtual reality–facilitated informed consent (VR-IC) in improving the physician-patient alliance. The aim of this study was to determine the utility of VR-IC among patients providing consent for surgery and the impact of this educational and information technology–based strategy on enhancing the physician-patient alliance, patient satisfaction, and resident-physician perception of the consent process.METHODSProspective, single-site, pre- and postconsent surveys were administered to assess patient and resident perception of informed consent performed with the aid of VR-IC at a large tertiary academic medical center in the US. Participants were adult patients (n = 50) undergoing elective surgery for tumor resection and neurosurgical residents (n = 19) who obtained patient informed consent for these surgical procedures. Outcome measures included scores on the Patient-Doctor Relationship Questionnaire (PDRQ-9), the modified Satisfaction with Simulation Experience Scale, and the Maslach Burnout Inventory. Patient pre- and postconsent data were recorded in real time using a secure online research data platform (REDCap).RESULTSA total of 48 patients and 2 family members provided consent using VR-IC and completed the surveys pre- and postconsent; 47.9% of patients were women. The mean patient age was 57.5 years. There was a statistically significant improvement from pre- to post–VR-IC consent in patient satisfaction scores. Measures of patient-physician alliance, trust, and understanding of their illness all increased. Among the 19 trainees, perceived comfort and preparedness with the informed consent process significantly improved.CONCLUSIONSVR-IC led to improved patient satisfaction, patient-physician alliance, and patient understanding of their illness as measured by the PDRQ-9. Using VR-IC contributed to residents’ increased comfort in the consent-gathering process and handling patient questions. In an era in which satisfaction scores are directly linked with hospital and service-line outcomes and reimbursement, positive results from VR-IC may augment physician and hospital satisfaction scores in addition to increasing measures of trust between physicians and patients.

scholarly journals An evaluation of the process of informed consent: views from research participants and staff

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lydia O’ Sullivan ◽  
Laura Feeney ◽  
Rachel K. Crowley ◽  
Prasanth Sukumar ◽  
Eilish McAuliffe ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Study ◽  
Contextual Factors ◽  
Informed Consent Process ◽  
Small Sample ◽  
Consent Process ◽  
Online Research ◽  
Research Staff ◽  
Research Participants ◽  
The Impact

Abstract Background The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant’s autonomy and information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process. Methods Research staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically. Results Research participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources. Conclusions Research participants in this study were overwhelmingly positive about their experience of the informed consent process. However, research staff expressed concern about how much participants have understood and studies of patient comprehension of research study information would seem to confirm these fears. This study highlights the importance of allocating adequate time to informed consent discussions, and research staff could consider using Teach Back techniques. Trial Registration Not applicable

Obtaining Patient Informed Consent (IC) for Hematopoietic Cell Transplantation. How Much Information Is Enough?.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2189-2189
Author(s):  
Ariadni Hotidou ◽  
Charalambos Kartsios ◽  
Ioanna Sakellari ◽  
Panagiotis Kaloyiannidis ◽  
Athanasios Fassas ◽  
...  
Keyword(s):  
Informed Consent ◽  
Side Effects ◽  
Cell Transplantation ◽  
Hematopoietic Cell Transplantation ◽  
Hematopoietic Cell ◽  
Consent Process ◽  
Individual Autonomy ◽  
Risks And Benefits ◽  
Numeric Data ◽  
The Impact

Abstract Introduction: Importance of the IC process emerges from the respect of individual autonomy and the right to self-determination. Beyond being informed, consent involves evaluating, making and signifying a decision. Hematopoietic cell transplantation (HCT) is a complex therapeutic option of “last resort” requiring patients’ full understanding and approval. Candidates shall sign detailed documents describing potentially lethal complications and percentages of survival and cure, before HCT. Objectives-Methods: One hundred twenty post-HCT patients were studied after giving IC. They answered a questionnaire and participated in semi-structured interviews focusing on their experience of consent process. Our aim was to evaluate: a) patients’ comprehension, perception and impact of the IC process, b) the degree to which they assimilated purposes, risks and benefits of transplantation, c) factors influencing patients’ decision to proceed with HCT, d) patient’s psychological status at the time of giving IC. Results: IC was considered as an important medico-legal aspect of HCT by 82% of the population. The transition from informal verbal agreement to a formal written contract implied an important psychological impact for the patient. Significant distress occurred by detailed descriptions of potential side effects and mortality. The awareness of only hope of cure centered patient’s attention negatively on numeric data regarding death risks and survival. Discordance was showed between pre-HCT expectations and actual outcomes. Consent process failed to prepare patients for the post-HCT difficulties of recovery. Patients indicated insufficient provision of information regarding the impact of HCT in their quality of life. Patients made the decision to undergo HCT prior to possessing any substantial knowledge of risks and benefits of the procedure. Decision was largely based on positive outcome expectation. HCT was valued as a cure and therefore this belief determined their decision. Degree of comprehension depended on age, emotional resources, educational level, familial relationships and physician’s personality. Conclusions: Despite patients’ claim to understand important information regarding HCT (treatment risks, side effects, outcome probabilities) IC resulted in confusion and anxiety. Considerable distress occurred by detailed descriptions of potential side effects and mortality. Numeric data was proven useless and seriously altered the physician-patient interaction. Providing details of risks and benefits during the IC process may have little impact on the patients’ decision-making. Patient’s life-threatening illness and limitations on treatment options alter the voluntary nature of their decision. IC has little significance to the patient in terms of his autonomous decision to proceed with treatment. Patient’s continuing education is critical and can help HCT candidates to accept what to expect at different stages of treatment. Comprehensiveness of HCT information is a cognitive, emotional and relational procedure demanding appropriate approach to be successful. Providing information is required at every stage of the HCT procedure and has great importance for the development of a trusting relationship with doctors. Accurate counseling empowers patients to make informed decisions. The findings of the present study give implications for clinical practice and for further research.

The impact of disease severity on the informed consent process in clinical research

1996 ◽  
Vol 100 (3) ◽  
pp. 261-268 ◽  
Author(s):  
Monica H. Schaeffer ◽  
David S. Krantz ◽  
Alison Wichman ◽  
Henry Masur ◽  
Eddie Reed ◽  
...  
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Disease Severity ◽  
Informed Consent Process ◽  
Consent Process ◽  
The Impact

Informed Consent in Clinical and Research Settings: What Do Patients and Families Need to Make Informed Decisions?

2015 ◽  
Vol 24 (4) ◽  
pp. 130-139 ◽  
Author(s):  
Helen M. Sharp
Keyword(s):  
Informed Consent ◽  
Family Members ◽  
Cognitive Disorders ◽  
Informed Consent Process ◽  
Consent Process ◽  
Clinical Settings ◽  
Risks And Benefits ◽  
Suboptimal Outcome ◽  
Research Environments ◽  
The Impact

Informed consent requires that patients in clinical settings and participants in research voluntarily agree to a proposed plan based on their understanding of a clear and thorough explanation of purpose, risks, benefits, and alternatives. Although the need to obtain informed consent is well understood in clinical and research environments, the evidence suggests that patients, family members, and participants in research are often unclear about options, risks, and benefits even after providing “informed” consent. Individuals with communication or cognitive disorders are at particular risk for a suboptimal outcome of the informed consent process. There are many barriers to achieving true informed consent, but the use of appropriate strategies can minimize the impact of these barriers and allow clinicians and researchers to improve the process of achieving true informed consent.

scholarly journals PO 8194 OPTIMISED INFORMED CONSENT FOR PARTICIPANTS IN A RANDOMISED CONTROLLED TRIAL IN RURAL UGANDA: A COMPARATIVE PROSPECTIVE COHORT STUDY

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A22.1-A22
Author(s):  
James Ditai ◽  
Jesca Kanyago ◽  
Rachael Nambozo ◽  
Nathan Kanyago ◽  
Julian Abeso ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Informed Consent ◽  
Controlled Trial ◽  
Informed Consent Process ◽  
African Women ◽  
Consent Process ◽  
Research Information ◽  
Slide Show ◽  
Randomised Controlled ◽  
The Impact

BackgroundPoor participant understanding of research information can be a problem in community interventional studies in rural African women where levels of illiteracy, dependency and compliance are high. We assessed the impact of alternative consent models on participants’ understanding of the clinical trial information and its contribution to the informed consent process in rural Uganda.MethodsThis was a prospective comparative cohort, nested within a pilot study of community distribution of alcohol-based hand rub to prevent neonatal sepsis (BabyGel). As part of the informed consent process, information about the trial was presented using one of three consent methods: standard researcher-read information; a ‘slide show’ using illustrated text on a flip chart; and a video showing the patient information sheet (PIS) being read as if by a newsreader in either English or the local language. In addition, all women received a written PIS in their preferred language. Each information method was used for 1 week of recruitment. Two days after recruitment, women’s understanding of the clinical trial was evaluated.ResultsA total of 30 pregnant women from 13 villages in Mbale participated in this study. Majority 90% (27/30) were assessed for recall of trial information within planned 48 hours. The slide-show was the most popular, with a mean score not less than 4.2 highest [mean (sd) range: 4.8 (0.6) [4–5]] by women who had been recruited using any of the three models. The slide show was preferred by 63% of the women (19/30), compared with 17% (5/30) and 20% (6/30) who preferred the standard and video show message, respectively. Reasons given included the benefits of having pictures to aid understanding, and the logical progression of the information.ConclusionOur results suggest that a slide-show message is an effective and popular alternative way of presenting trial information to women in rural Uganda, many of whom had little or no literacy.

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