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Patient understanding of the consent process is often suboptimal and the reasons for this are poorly understood. In particular the role of cognitive function in assessing the level of understanding of consent has not been evaluated.
This study aims to assess the level of patient understanding of the informed consent process and the role of cognitiv...
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Context 1
... assessment of understanding the patient underwent the mini mental state examination (MMSE) to screen for cognitive dysfunction with the score being recorded. The MMSE is the most validated assessment of cognitive function 9 and was chosen for the study because of this and its ease of implementation (see fig 1). ...
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Citations
... Numerous earlier studies [37,38] have shown the reliability and validity of this Chinese MMSE. According to earlier research, an MMSE score of less than 24 was considered to be indicative of MCI (MCI is defined as MMSE = 0, otherwise MMSE = 1) [39][40][41]. ...
Background:
In view of the rapidly accelerating aging process in China, this study looked at the associations between vegetables and fruits intake pattens and cognitive function among the oldest old in China using the genetic sub study from the Chinese Longitudinal Healthy Longevity Survey (CLHLS).
Methods:
This study screened respondents who participated in all four surveys of longitudinal data from the CLHLS, and a total of 2454 participants were ultimately included. The relationships of cognitive function with vegetables and fruits intake patterns were examined using Generalized-estimating equations.
Results:
The prevalence range of mild cognitive impairment (MCI) was 14.3% to 16.9% at T1 to T3 and 32.7% at T4. There was a significant increase in the prevalence of MCI from T1 to T4 (β = 0.054; 95% CI, 0.037 to 0.070; p < 0.001; adjusted). The V+/F+ pattern significantly improved cognitive function in Chinese older adults compared with the V-/F- pattern (OR, 1.026; 95% CI, 1.001-1.053; p < 0.05).
Conclusion:
Older adults who frequently consume both fruits and vegetables experience a reduction in MCI risk relative to those consuming these food groups infrequently-emphasizing the critical importance of the regular intake of both fruits and vegetables in maintaining cognitive function.
... participants are approached is equally pertinent because inadequate time allotted for risk disclosure can limit patient understanding and recall of the risks disclosed [14,16]. Akin to the universal requirement of adequate time for comprehension and reflection when obtaining informed consent from a patient for participation in a research study, it behoves investigators to afford sufficient time when disclosing [17]. ...
... Moreover, the process of patient's actual understanding is of great importance, as this operation rarely occurs [30,31]. Yeoman et al. [32] evaluated the understanding rate of the informed consent after interviewing 100 patients, with the age ranging from 19 to 82 years. A mini state mental examination was performed after the informed consent process was realized showing that the understanding assessment might be suboptimal. ...
Therapeutic endoscopy represents a major step in evidence-based medicine with great potential in the evolution of non-invasive surgery. The evolutionary status of endoscopy has reached a level where some of the surgical intervention can be performed in a minimal invasive way, with great benefits for the patient. However, this rises up some ethical issues regarding the patient’s comfort zone, possible risks and complications and subjected the physician to possible litigation situations if not well trained. A rather good interaction and communication between patient and endoscopist is mandatory, as the health-care experience might be more satisfying. Unfortunate situations may also be avoided if intensive training and up to date knowledge and skills are acquired before jumping to therapeutic endoscopy. The continuous development and general focus on interventional endoscopy seems to have a key role on current medical standings. Therefore, in the following paper we have tried to underline the potential ethical problems that both the patient and the physician should take into consideration towards a better therapeutic endoscopic result.
... This study does not assess patients' recall of information disclosed by clinicians, but the patient's perception of the information disclosed, since it has been shown that many factors interfere with patients' ability to recall information provided by medical staff, including age, intellect, and cognition, 22 and some patients may already have information about surgery from other resources; if we had examined patients' recall of information, it would have been unknown whether this information had already existed or was provided by clinicians; therefore, in this study, we determined whether individual patients consider that informed consent has been obtained in an informed manner. According to guidelines, the information must be conveyed to the patient in such detail and in such manner using appropriate language to ensure that an informed decision can be made by a particular patient. ...
Introduction:
Informed consent constitutes one of the most important legal, professional, and ethical principles of a surgical operation. Consent obtained from a patient is only valid when the patient has received enough information regarding the proposed treatment option. This study aims to determine how much the patients are informed before undergoing surgery, as well as the factors influencing it in hospitals affiliated with Tehran University of Medical Sciences.
Method:
This is a cross-sectional, descriptive-analytic study of 300 patients undergoing surgery in 7 teaching hospitals affiliated with Tehran University of Medical Sciences. The patients were recruited through clustered sampling. Data were collected using a questionnaire completed by interview. Data were analyzed on SPSS software using descriptive and inferential statistics.
Result:
The mean score of data provision for patients was 27.09 out of 60, indicating the level of information provided as unacceptable. Among 12 questions dealing with data provision, patients had received an intermediate level of information about nature of the disease, type of surgery, benefits and importance of the surgery, and complications of rejecting the recommended therapy. On the contrary, they had not received enough information about the surgical procedure, type of anesthesia, potential complications of surgery, potential risks of surgery, other therapy options instead of surgery, length of hospital stay for surgery, postsurgical follow-up, and expenses of the surgery. In the majority (85%) of cases, the surgeon was reported to be the information provider. Among the variables studied, level of information received was directly related to the patient's education level.
Discussion:
The findings of this study indicate that during the process of obtaining an informed consent for surgery, patients do not receive sufficient information, and it is necessary to provide the essential information in an understandable manner adjusted for the patient's level of education.
... The overall distribution of educational level differed among these studies, and the proportion of patients with basic education (13.3%) in our study population was relatively small, which may account for the difference. One report has indicated that adequate cognitive function does not predict a high level of understanding of the informed consent process, whereas cognitive impairment precludes it [21]. One-third of our patients thought the consent document needed some adjustments. ...
Only a few reports have examined informed consent for gastrointestinal endoscopy in Korea. The aim of this study was to evaluate the appropriateness of the informed consent procedure in Korea.
A total of 209 patients who underwent endoscopy were asked to answer a self-administered structured questionnaire on the informed consent procedure for gastrointestinal endoscopy.
One hundred thirteen patients completed questionnaires and were enrolled. In the survey, 91.2% answered that they understood the procedure, and the degree of understanding decreased with age; 85.8% were informed of the risks of the procedure, and the proportion was higher for inpatients and for those receiving therapeutic endoscopy or endoscopic retrograde cholangiopancreatography; 60.2% were informed of alternative methods, and the proportion was higher in older patients; 76.1% had the opportunity to ask questions during the informed consent procedure, and the proportion was higher in inpatients. The understanding of the risks of the endoscopic procedure was better in the younger and more highly educated groups. About 80% had sedation before endoscopy, and only 56% were informed of the risks of sedation during endoscopy.
The current informed consent process may be reasonably acceptable and understandable to the patients. However, the understanding of the risks of endoscopy was insufficient especially in the cases of older, poorly educated patients and outpatients. The information about alternatives, the opportunity to ask for additional information, and the information about the risks of sedation during endoscopy were also insufficient in the current consent process.
... 34 However, adequate cognitive function does not predict a high level of understanding of the informed consent process, whereas cognitive impairment precludes it. 35 A patient's incompetence or lack of decision-making capacity by virtue of age, alcohol, or drugs, or by intellectual impairment is not an exception to the informed consent process. Special care must be taken in obtaining informed consent from patients who are incompetent. ...
This is one of a series of statements discussing the utilization of GI endoscopy in common clinical situations. The American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee the prepared this text In preparing this guideline, MEDLINE and PubMed databases were used to search publications through February 2006 that related to the topic of "informed consent for gastrointestinal endoscopy" by using the keyword(s) "informed consent," "Patient information," "risk," "gastrointestinal endoscopy," "endoscopy," "endoscopic procedures," and "Procedures." The search was supplemented by accessing the "related articles "feature of PubMed with articles identified on MEDLINE and PubMed as the references. Pertinent studies published in English were reviewed. Studies or reports that described fewer than 10 patients were excluded from the analysis if multiple series with more than 10 patients that addressed the same issue were available. The strength of reported evidence and the recommendations based on reviewed studies were graded on the strength of the supporting evidence (Table 1).(1) Guidelines for appropriate utilization of endoscopy are based on a critical review of the available data and expert consensus. Further controlled clinical studies may be needed to clarify aspects of this statement, and revision may be necessary as new data appear. Clinical consideration may justify a course of action at variance to these recommendations.
Implantable cardioverter defibrillator (ICD) management complexities challenge the ethos of fully informed consent, particularly for the typically multi-morbid elderly patient considering the device for primary prevention. The Heart Rhythm Society recommends providers include discussion on the potential need for later device deactivation or non-replacement at the time of first implant, and to revisit this at appropriate intervals. The initial consent procedure could meet this standard by incorporating the future need to discuss further such issues when the recipient's clinical condition changes to such an extent that defibrillation would no longer be beneficial. At the time of obtaining consent, some patients may lack the will or capacity to make medically complex decisions when it would be necessary for healthcare surrogate decision-makers to contribute to this process. Ensuring an appropriate level of understanding and response may be enhanced by the use of information and decision aids. With improved communication regarding the nuances of ICD therapy, device eligible patients and those close to them, will be empowered with a better understanding of the nature, benefits and risks of ICD implantation, allowing them to make treatment decisions consistent with their values. This article is protected by copyright. All rights reserved
We conducted a review of informed consent studies involving surgical and invasive procedures and report the degree to which current research targets a broader scope of patient outcomes beyond comprehension.
Using PubMed, Cumulative Index to Nursing and Allied Health Literature, and Excerpta Medical Database, we identified 97 articles for review. Six members coded articles and generated scores of study design quality.
The mean quality score (10.7 out of a total score of 20) was low. Most studies were single institution-based, relying on one-time data collections. Randomly assigning subjects to study conditions, using power analysis to determine subject numbers, and reporting psychometric evidence, such as reliability and validity, were not widely reported. Most frequently targeted patient outcomes were knowledge, understanding and satisfaction. Core informed consent outcomes (e.g. capacity, voluntariness, decision making) and emotional factors (e.g. anxiety) were not extensively addressed.
Informed consent research may benefit from applying qualitative methods to more directly tap into patients' beliefs and decisions by eliciting in patients' own words their emotions and reasoning around processing informed consent content.
Research that addresses patient perspectives toward surgical interventions should tap into underexplored ethical and emotional factors that shape decision making.
Kao S.-H., Hsu L.-L., Hsieh S.-I. & Huang T.-H. (2013) The effects of two educational interventions on knowledge and competence of nurses with regard to conveying gastroscopy-related information to patients. Journal of Advanced Nursing 69(4), 793–804. doi: 10.1111/j.1365-2648.2012.06062.x
Aim. The study was to compare the effects of two different educational interventions on knowledge and competence of nurses regarding conveying gastroscopy-related information to patients.
Background. Nurses play an important role in helping patients undergo gastroscopy and must be familiar with the procedure to provide related patient education.
Design. A quasi-experimental study.
Methods. This study in 2010 involved a pre-test and two post-tests. The experimental group (n = 25) received a multimedia CD-ROM, and the comparator group (n = 40) received a pocket booklet. The effects of the two educational interventions were measured using the Knowledge Test Gastroscopy Nursing Instruction Scale, the Self-Evaluation Gastroscopy Nursing Instruction Scale, and the Gastroscopy Nursing Instruction Learning Satisfaction Scale.
Results. No overall significant difference in knowledge scores between the two groups was found, but subsequent post hoc analysis showed significantly higher scores in the experimental group than in the comparator group at week 6. A significant within-subjects effect of the self-evaluation gastroscopy nursing instruction scores from baseline–week 6 was dependent on the experimental group or the comparator group. There were significant between-subjects effects overall, at week 3 and at week 6.
Conclusion. Both educational interventions improved nurses’ knowledge and competence in gastroscopy-related information. However, the CD-ROM-based intervention had long-term effects on knowledge and had short-term and long-term effects on competence.
Decisions to insert percutaneous endoscopic gastrostomy (PEG) tubes may be difficult because patients have serious underlying disease, and the procedure has associated risks. Patients may also lack mental capacity to consent to PEG insertion. This study aimed to prospectively determine the prevalence of mental incapacity in hospitalised patients undergoing PEG insertion.
Mental capacity was assessed using the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) in 72 consecutive inpatients referred for PEG insertion. Cognitive function was measured using the Mini-Mental State Examination (MMSE). Sixty eight inpatients and 69 outpatients having diagnostic upper gastrointestinal (UGI) endoscopy were similarly studied.
Thirty nine of the PEG patients had suffered stroke, and none had a primary diagnosis of dementia. Seventy four % (53/72) of inpatients referred for PEG, 22% (15/68) of inpatients having UGI endoscopy, and 3% (2/69) of outpatients having UGI endoscopy, lacked mental capacity, p < 0.001. MMSE scores were normal in just 18% of inpatients having PEG, in 72% of inpatients having UGI endoscopy, and in 91% of outpatients having UGI endoscopy, p < 0.001.
Amongst inpatients undergoing PEG insertion there is a high prevalence (three-quarters patients) of mental incapacity to consent to this important intervention. Decisions have to be made on behalf of most inpatients referred for PEG insertion.
