scholarly journals Adequacy of measures of informed consent in medical practice: A systematic review

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0251485
Author(s):  
Kerry A. Sherman ◽  
Christopher Jon Kilby ◽  
Melissa Pehlivan ◽  
Brittany Smith
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Medical Practice ◽  
Information Provision ◽  
Self Report ◽  
Consent Process ◽  
Medical Practitioners ◽  
Voluntary Consent ◽  
User Acceptability ◽  
Information Comprehension

As a critical component of medical practice, it is alarming that patient informed consent does not always reflect (1) adequate information provision, (2) comprehension of provided information, and (3) a voluntary decision. Consequences of poor informed consent include low patient satisfaction, compromised treatment adherence, and litigation against medical practitioners. To ensure a well-informed, well-comprehended, and voluntary consent process, the objective and replicable measurement of these domains via psychometrically sound self-report measures is critical. This systematic review aimed to evaluate the adequacy of existing measures in terms of the extent to which they assess the three domains of informed consent, are psychometrically sound and acceptable for use by patients. Extensive searching of multiple databases (PsychINFO, PubMed, Sociological Abstracts, CINAHL, AMED) yielded 10,000 potential studies, with 16 relevant scales identified. No existing scale was found to measure all three consent domains, with most only narrowly assessing aspects of any one domain. Information provision was the most frequently assessed domain, followed by comprehension, and then voluntariness. None of the identified scales were found to have adequate evidence for either high quality psychometric properties or patient user acceptability. No existing scale is fit for purpose in comprehensively assessing all domains of informed consent. In the absence of any existing measure meeting the necessary criteria relating to information, comprehension and voluntariness, there is an urgent need for a new measure of medical consent to be developed that is psychometrically sound, spans all three domains and is acceptable to patients and clinicians alike. These findings provide the impetus and justification for the redesign of the informed consent process, with the aim to provide a robust, reliable and replicable process that will in turn improve the quality of the patient experience and care provided.

Excessive Risk Disclosure: The Effects of the Law on Medical Practice

2005 ◽  
Vol 7 (2) ◽  
pp. 93-112
Author(s):  
Rob Heywood
Keyword(s):  
Informed Consent ◽  
Medical Practice ◽  
Detrimental Effect ◽  
Self Determination ◽  
Consent Process ◽  
Risk Disclosure ◽  
Medical Practitioners ◽  
The Law ◽  
Excessive Risk ◽  
The Way

This article examines the debate surrounding the challenging concept of informed consent. It argues whilst the English courts have effectively excluded the use of the tort of battery as an appropriate mechanism for protecting a patient's right to self-determination, they have left the law in a state of flux due to the uncertainties associated with categorising similar claims within negligence where the onus is on risk disclosure. This confusion may stem firstly from the fact that medical practitioners are unsure exactly which risks to disclose, and secondly, from the way in which both doctors and patients perceive the consent process. The paper suggests this disorder may be having a detrimental effect on medical practice as medical practitioners are taking it upon themselves to disclose excessive information, which patient's may not want or need. A suggestion is also made that in these situations, in order that the law truly respects self-determination, consideration must be given to the patient's desire to waive their right to informed consent. ‘while all are agreed that “doctor knows best” is no longer acceptable, for some “doctor knows better” is just as outdated and paternalistic. The assumption that the doctor's knowledge is deployed to ends that are of benefit to patients is treated with suspicion.’ 1

scholarly journals Changing of Chinese psychiatrists’ attitudes toward consent process to treatment and its association with the China’s National Mental Health Law

2018 ◽  
Vol 54 (1) ◽  
pp. 11-21
Author(s):  
Jingjing Huang ◽  
Yang Shao ◽  
Huajian Ma ◽  
Weimin Yang ◽  
Huafang Li
Keyword(s):  
Mental Health ◽  
Informed Consent ◽  
Treatment Plan ◽  
Physical Restraint ◽  
Informed Consent Process ◽  
Self Report ◽  
Consent Process ◽  
Health Law ◽  
Mental Health Law ◽  
National Mental Health

Objective Few studies have addressed informed consent in Chinese psychiatric practice. We wished to explore psychiatrists’ attitudes toward informed consent in Shanghai after promulgation of the first national law for mental health care in China: the National Mental Health Law. Method A total of 398 psychiatrists were recruited from seven psychiatric hospitals in Shanghai. Their anthropometric data were collected. A confidential, self-report questionnaire addressing attitudes toward the informed consent process was completed by all participants. Results Most respondents would like to inform patients/guardians of the diagnosis (95.2%), treatment plan (93.5%), treatment goals and potential adverse effects of prescribed medications (94.7%), and alternative treatment plans (71.9%). In addition, 58.4% of psychiatrists thought that the informed consent process for physical restraint was difficult to follow. According to logistic regression, psychiatrists not trained to use the National Mental Health Law were more likely to have a negative attitude toward the informed consent process compared with those trained (adjusted odds ratio = 0.21; 95% confidence interval: 0.07–0.59; p = 0.003). Conclusions Psychiatrists trained to use the National Mental Health Law had more positive attitudes toward the informed consent process. Lack of such training could affect the attitudes of psychiatrists toward the informed consent process in China.

Effectiveness of consenting in Otorhinolaryngology

Open Medicine ◽  
2012 ◽  
Vol 7 (2) ◽  
pp. 198-202
Author(s):  
Nnaemeka Okpala ◽  
Amala Okpala ◽  
Gareth John ◽  
Hugh Cox
Keyword(s):  
Informed Consent ◽  
Therapeutic Alliance ◽  
Medical Practice ◽  
Consent Form ◽  
Consent Process ◽  
Pharyngeal Pouch ◽  
Consent Forms ◽  
Ethical Component ◽  
At Home

AbstractInformed consent in today’s medical practice has become a cornerstone and a routine ethical component playing a major role in forming a therapeutic alliance with the patient. The present study sought to analyse the effectiveness of the consent forms and the consenting process in Otorhinolaryngology. This three month questionnaire-based study covered varying operations which ranged from tonsillectomies, grommet insertions to pharyngeal pouch stapling. Twenty-nine percent of consent forms were signed on the day of the operation. Of the patients who received leaflets (51%) during the process of informed consent, a majority (88%) found it useful. The respondents were satisfied with the explanation of the procedure, benefits and complications (70–74%). Majority kept their consent forms at home (60%) and did not bother engaging in further search with regards to the information in the consent form (81%). Majority of the patients agreed that they had enough time to make an informed consent. Patients were satisfied with the consent process but more can be done to improve the consenting process.

scholarly journals Digital tools in the Informed Consent process: a systematic review

2019 ◽  
Author(s):  
Gesualdo Francesco ◽  
Laura Palazzani ◽  
Dimitris Dimitriou ◽  
Javier Diez Domingo ◽  
Jaime Fons-Martinez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Surgical Procedures ◽  
Interactive Multimedia ◽  
Digital Technologies ◽  
Informed Consent Process ◽  
Digital Tools ◽  
Consent Process ◽  
Multimedia Tools ◽  
Positive Effect

Abstract Background: Providing understandable information to patients is necessary to achieve the two main aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital, technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical care and clinical trials. Understanding, comprehension, satisfaction and participation were compared for digital tools versus the traditional Informed Consent process. Methods: We searched for studies on available electronic databases, including Pubmed, ISI web of science (WoS), and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to April 2018, that focused on the use of digital Informed Consent tools for surgery, diagnostic procedures, therapeutic interventions, and clinical research. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia. Results: Our search yielded 1046 publications. After title and abstract screening 182 studies were retained for full-text analysis, of which 38 publications were included. Studies examined interactive multimedia (17/38), non-interactive multimedia (11/38), and videos (10/38), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and RCTs (12/38). For RCTs, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions: Digital technologies for informed consent were not found to affect negatively any of the outcomes, and overall, interactive multimedia tools seem desirable. Interactive multimedia tools indicated a higher impact than passive videos. Presence of a researcher may potentially enhance efficacy of different outcomes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardisation is needed to conclusively assess impact.

Information Prescription and Information Therapy

2013 ◽  
Vol 3 (2) ◽  
pp. 85-87
Author(s):  
Riddhi Doshi
Keyword(s):  
Systematic Review ◽  
Medical Practice ◽  
Observational Studies ◽  
Randomized Trials ◽  
Developed Countries ◽  
Current Medical ◽  
Medical Practitioners ◽  
Current Medical Practice

Gavgani et al., through their systematic review, explore the existing evidence in the area of information prescription and information therapy. The application of Information prescription and information therapy has been explored in a number of developed countries through randomized trials and observational studies. The low awareness about these concepts among medical practitioners has been highlighted. This commentary highlights the routes for IP/Ix dissemination and its application in current medical practice.

scholarly journals Digital tools in the Informed Consent process: a systematic review

2019 ◽  
Author(s):  
Gesualdo Francesco ◽  
Laura Palazzani ◽  
Dimitris Dimitriou ◽  
Javier Diez Domingo ◽  
Jaime Fons-Martinez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Surgical Procedures ◽  
Interactive Multimedia ◽  
Digital Technologies ◽  
Informed Consent Process ◽  
Digital Tools ◽  
Consent Process ◽  
Multimedia Tools ◽  
Positive Effect

Abstract Background: Providing understandable information to patients is necessary to achieve the two main aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital, technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical care and clinical trials. Understanding, comprehension, satisfaction and participation were compared for digital tools versus the traditional Informed Consent process. Methods: We searched for studies on available electronic databases, including Pubmed, ISI web of science (WoS), and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to April 2018, that focused on the use of digital Informed Consent tools for surgery, diagnostic procedures, therapeutic interventions, and clinical research. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia. Results: Our search yielded 1046 publications. After title and abstract screening 182 studies were retained for full-text analysis, of which 38 publications were included. Studies examined interactive multimedia (17/38), non-interactive multimedia (11/38), and videos (10/38), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and RCTs (12/38). For RCTs, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions: Digital technologies for informed consent were not found to affect negatively any of the outcomes, and overall, interactive multimedia tools seem desirable. Interactive multimedia tools indicated a higher impact than passive videos. Presence of a researcher may potentially enhance efficacy of different outcomes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardisation is needed to conclusively assess impact.

scholarly journals Digital tools in the Informed Consent process: a systematic review

2021 ◽  
Author(s):  
Gesualdo Francesco ◽  
Margherita Daverio ◽  
Laura Palazzani ◽  
Dimitris Dimitriou ◽  
Javier Diez Domingo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Clinical Research ◽  
Surgical Procedures ◽  
Interactive Multimedia ◽  
Digital Technologies ◽  
Informed Consent Process ◽  
Digital Tools ◽  
Consent Process ◽  
Positive Effect

Abstract Background: Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital, technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice.. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process.Methods: We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia.Results: Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions: Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact. Trial registration: NA

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