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Consent in the endoscopy department.

ABSTRACT: The demand for endoscopic procedures continues to increase and is likely to continue to do so for the foreseeable future. Alongside elective diagnostic procedures, the number of complex and therapeutic procedures is increasing. It is therefore vital that the consent process is comprehensive, and high standards in consenting patients are maintained. Consent is defined as a patient's agreement to treatment or an intervention proposed by a health professional. Careful patient selection is required when proposing endoscopic procedures with an appreciation of the risks and complications that are involved. This paper addresses the various components of gaining informed consent and the legal issues surrounding this process. Additionally, this article reviews legislation and focuses upon specific instances where further considerations have to be made; in a patient who lacks capacity, in children, in percutaneous endoscopic gastrostomy and in the patient who is a Jehovah's Witness.

SUBMITTER: Mohanaruban A

PROVIDER: S-EPMC5369752 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Consent in the endoscopy department.

Mohanaruban Aruchuna A Flanders Lucy L Dor Riaz R

Frontline gastroenterology 20140206 4

The demand for endoscopic procedures continues to increase and is likely to continue to do so for the foreseeable future. Alongside elective diagnostic procedures, the number of complex and therapeutic procedures is increasing. It is therefore vital that the consent process is comprehensive, and high standards in consenting patients are maintained. Consent is defined as a patient's agreement to treatment or an intervention proposed by a health professional. Careful patient selection is required ...[more]

PMID: 28839786

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Postal consent for upper gastrointestinal endoscopy.

Project description:BACKGROUND:Standards for good practice in clinical risk management issued by the Clinical Negligence Scheme for Trusts indicate that "appropriate information is provided to patients on the risks and benefits of proposed treatment, and of the alternatives available before a signature on a consent form is sought". AIMS:To investigate the practicability and patient acceptability of a postal information and consent booklet for patients undergoing outpatient gastroscopy. METHODS:Information about gastroscopy procedure, personalised appointment details, and a carbonised consent form were compiled into a single booklet. This was mailed to patients well in advance of their endoscopic procedure. Patient satisfaction for this new process was assessed by questionnaire. RESULTS:275 patients received a patient information booklet. Of these, 150 (54.5%) returned the consent form by post when they confirmed their attendance; 141 (94%) had signed the form, and the other nine requested further information. Of the remaining 125 booklets sent out, 115 (92%) forms were brought back on the day of the investigation having been previously signed. The remaining 10 (8%) required further information before signing the form. An audit of 168 patients was used to test reaction to the booklet and the idea of filling in the form before coming to hospital; 155 patients (92. 2%) reported the information given in the booklet to be "very useful", and all reported it to be "clear and understandable". CONCLUSION:A specifically designed patient information booklet with integral consent form is accepted by patients, and improves the level of understanding prior to the investigation being carried out.

| S-EPMC1727779 | biostudies-literature

Patient attitudes regarding consent for emergency department computed tomographies.

Project description:IntroductionLittle is known about patient attitudes towards informed consent for computed tomography (CT) in the emergency department (ED). We set out to determine ED patient attitudes about providing informed consent for CTs.MethodsIn this cross-sectional questionnaire-based survey study, we evaluated a convenience sample of patients' attitudes about providing informed consent for having a CT at 2 institutional sites. Historically, at our institutional network, patients received a CT at approximately 25% of their ED visits. The survey consisted of 17 "yes/no" or multiple-choice questions. The primary outcome question was "which type of informed consent do you feel is appropriate for a CT in the Emergency Department?"ResultsWe analyzed 300 survey responses, which represented a 90% return rate of surveys distributed. Seventy-seven percent thought they should give their consent prior to receiving a CT, and 95% were either comfortable or very comfortable with their physician making the decision regarding whether they needed a CT. Forty percent of the patients felt that a general consent was appropriate before receiving a CT in the ED, while 34% thought a verbal consent was appropriate and 15% percent thought a written consent was appropriate. Seventy-two percent of the ED patients didn't expect to receive a CT during their ED visit and 30% of the ED patients had previously provided consent prior to receiving a CT.ConclusionMost patients feel comfortable letting the doctor make the decision regarding the need for a CT. Most ED patients feel informed consent should occur before receiving a CT but only a minority feel the consent should be written and specific to the test.

| S-EPMC3935784 | biostudies-literature

Primary caregivers' experience with the informed consent process in the paediatric emergency department: An interview-based qualitative study.

Project description:ObjectiveThis study aims to understand primary caregivers' (PCG) experience with the informed consent (IC) process.MethodsWe conducted in-depth interviews with PCGs of paediatric patients who underwent a procedure requiring IC in the paediatric emergency department (PED) of a tertiary care paediatric centre in the USA, between January and March 2013 and between September 2013 and January 2014. We triangulated the qualitative findings from the PCG interviews with Likert-scale responses from the PCGs and with results from surveyed physicians.ResultsWe included 14 PCG-physician dyads. Our results show that PCGs understand the importance of the IC process. They appreciated the calm demeanor of providers, and the clarity of their wording. PCGs felt that IC can add to the stress, and that it could be made simpler and timelier. PCGs also had varying extents of retention of the information provided.ConclusionThis exploratory study suggests an overall positive IC experience of the PCGs while highlighting areas for improvement including a more thorough discussion of alternatives, a better assessment of knowledge transmission and retention by the PCG, and recognition of the PCG's discomfort during decision making in a stressful environment.

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Inclusion of older adults and reporting of consent processes in randomized controlled trials in the emergency department: A scoping review.

Project description:ObjectiveConducting research in the emergency department (ED) is often complicated by patients' acute and chronic illnesses, which can adversely affect cognition and subsequently capacity to consent for research, especially in older adults. Validated screening tools to assess capacity to consent for research exist, but neither the frequency of use nor which ones are used for ED research are known.MethodsWe conducted a scoping review using standard review techniques. Inclusion criteria included (1) randomized controlled trials (RCTs) from publication years 2014-2019 that (2) enrolled participants only in the ED, (3) included patients aged 65+ years, and (4) were fully published in English. Articles were sourced from Embase and screened using Covidence.ResultsFrom 3130 search results, 269 studies passed title/abstract and full text screening. Average of the mean or median ages was 55.7 years (SD 14.2). The mean number of study participants was 311.9 [range 8-10,807 participants]. A few (n = 13, 4.8%) waived or had exception from informed consent. Of the 256 studies requiring consent, a fourth (26.5%, n = 68) specifically excluded patients due to impaired capacity to consent. Only 11 (4.3%) documented a formal capacity screening tool and only 13 (5.1%) reported consent by legally authorized representative (LAR).ConclusionsMost RCTs enrolling older adults in EDs did not report assessment of capacity to consent or use of LARs. This snapshot of informed consent procedures is potentially concerning and suggests that either research consent processes for older patients and/or reporting of consent processes require improvement.

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Modified informed consent procedure: consent to postponed information.

Project description: Not available

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Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department: A Parallel-Group Randomized Controlled Trial.

Project description:Obtaining valid parental informed consent for pediatric procedures in the emergency department (ED) is challenging. We compared a video-assisted informed consent intervention with conventional discussion to inform parents about pediatric procedural sedation in the ED. We conducted a prospective randomized controlled trial using a convenience sample including the parents of children in the ED in whom procedural sedation for facial laceration was recommended. The video group watched an informational video. Conventional group participants received information from physicians during conventional discussion. The primary outcome was knowledge improvement of the video intervention compared with conventional discussion. The secondary outcome was parental satisfaction. Video and conventional groups comprised 32 and 30 participants, respectively. Mean knowledge scores of parents after intervention [±standard deviation] were higher in the video group (91.67 ± 12.70) than in the conventional group (73.33 ± 19.86). Knowledge score differences were significantly bigger in the video group (coefficient: 18.931, 95% confidence interval: 11.146-26.716). Video group participants reported greater satisfaction than conventional group participants. Parents' comprehension of and satisfaction with the informed consent process for pediatric procedural sedation may be improved with the use of an educational video. Standardized approaches should be developed by healthcare institutions to better educate parents, facilitate treatment decisions, and boost satisfaction in the ED.

| S-EPMC9778183 | biostudies-literature

Standardizing Endoscopy Training: A Workshop for Endoscopy Educators.

Project description:IntroductionEndoscopy education in the US traditionally follows the apprenticeship model, in which educators often have little formal training in education, and the acquisition of procedural skills by trainees relies heavily on procedure volume and learning by doing. A growing appreciation of the need to formally educate endoscopy trainers has led to the development of mandatory training curricula in other countries, but the implementation of such courses in the US has been limited. This 1-hour workshop aimed to provide educators the rationale and skills to offer a more standardized approach to procedural training.MethodsWe implemented a 1-hour interactive workshop designed for both gastroenterology faculty and trainees. The four sections of the workshop focused on: (1) rationale for standardized approach, (2) verbal and physical preparation for training, (3) training using standardized language and avoidance of cognitive overload, and (4) providing feedback. Four interactive video cases followed by large-group discussion were included.ResultsA total of 13 gastroenterology faculty and trainees attended the workshop. Eight additional members of the gastroenterology faculty watched an online video of the workshop. Survey data revealed that the workshop was effective in helping faculty set goals with trainees (M pre = 2.4, M post = 3.6), identify standardized language to use during endoscopy (M pre = 3.1, M post = 3.8), and give feedback after sessions (M pre = 3.4, M post = 4.1).DiscussionA 1-hour lecture-based interactive workshop with video cases was an engaging and effective introduction to formal endoscopy education techniques. The format was easy to incorporate into faculty conferences and can help bridge the current gap in formal endoscopy faculty training.

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'Relative Consent' or 'Presumed Consent'? Organ donation attitudes and behaviour.

Project description:Legislation, in the form of presumed consent, has been argued to boost organ donation but most evidence disregards the practice of seeking relative's consent, which can either 'veto' donation decisions, or 'legitimize them', by removing any possible conflict with the donor's family. We study the effect of presumed consent alongside family consent on individuals' willingness to donate (WTD) one's own and relatives' organs, and on actual organ donation behaviours. Using data from 28 European countries for the period 2002-2010, we found that presumed consent (PC) policies are associated with increased willingness to donate organs, but this effect was attenuated once internal family discussions on organ donation were controlled for. Our findings indicate that relative's consent acts as a veto of donation intentions and attenuates the effect of regulation on actual donations. More specifically, PC increases WTD one's own and relatives' organs in countries where no family consent is required. Consistently, we find that family consent attenuates the influence of regulatory environment on actual donations. The effect is driven by the influence of family discussions which increased WTD, and in combination with presumed consent translated into higher organ donation rates.

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Written Informed Consent for Computed Tomography of the Abdomen/Pelvis is Associated with Decreased CT Utilization in Low-Risk Emergency Department Patients.

Project description:IntroductionThe increasing rate of patient exposure to radiation from computerized tomography (CT) raises questions about appropriateness of utilization. There is no current standard to employ informed consent for CT (ICCT). Our study assessed the relationship between informed consent and CT utilization in emergency department (ED) patients.MethodsAn observational multiphase before-after cohort study was completed from 4/2010-5/2011. We assessed CT utilization before and after (Time I/Time II) the implementation of an informed consent protocol. Adult patients were included if they presented with symptoms of abdominal/pelvic pathology or completed ED CT. We excluded patients with pregnancy, trauma, or altered mental status. Data on history, exam, diagnostics, and disposition were collected via standard abstraction tool. We generated a multivariate logistic model via stepwise regression, to assess CT utilization across risk groups. Logistic models, stratified by risk, were generated to include study phase and a propensity score that controlled for potential confounders of CT utilization.Results7,684 patients met inclusion criteria. In PHASE 2, there was a 24% (95% CI [10-36%]) reduction in CT utilization in the low-risk patient group (p<0.002). ICCT did not affect CT utilization in the high-risk group (p=0.16). In low-risk patients, the propensity score was significant (p<0.001). There were no adverse events reported during the study period.ConclusionThe implementation of ICCT was associated with reduced CT utilization in low-risk ED patients. ICCT has the potential to increase informed, shared decision making with patients, as well as to reduce the risks and cost associated with CT.

| S-EPMC4703183 | biostudies-literature

Consent Codes: Maintaining Consent in an Ever-expanding Open Science Ecosystem.

Project description:We previously proposed a structure for recording consent-based data use 'categories' and 'requirements' - Consent Codes - with a view to supporting maximum use and integration of genomic research datasets, and reducing uncertainty about permissible re-use of shared data. Here we discuss clarifications and subsequent updates to the Consent Codes (v4) based on new areas of application (e.g., the neurosciences, biobanking, H3Africa), policy developments (e.g., return of research results), and further practical considerations, including developments in automated approaches to consent management.

| S-EPMC9931855 | biostudies-literature

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