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National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis.

ABSTRACT: BACKGROUND AND PURPOSE:No standard approach to obtaining informed consent for stroke thrombolysis with tPA (tissue-type plasminogen activator) currently exists. We aimed to assess current nationwide practice patterns of obtaining informed consent for tPA. METHODS:An online survey was developed and distributed by e-mail to clinicians involved in acute stroke care. Multivariable logistic regression analyses were performed to determine independent factors contributing to always obtaining informed consent for tPA. RESULTS:Among 268 respondents, 36.7% reported always obtaining informed consent and 51.8% reported the informed consent process caused treatment delays. Being an emergency medicine physician (odds ratio, 5.8; 95% confidence interval, 2.9-11.5) and practicing at a nonacademic medical center (odds ratio, 2.1; 95% confidence interval, 1.0-4.3) were independently associated with always requiring informed consent. The most commonly cited cause of delay was waiting for a patient's family to reach consensus about treatment. CONCLUSIONS:Most clinicians always or often require informed consent for stroke thrombolysis. Future research should focus on standardizing content and delivery of tPA information to reduce delays.

SUBMITTER: Mendelson SJ

PROVIDER: S-EPMC5829003 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis.

Mendelson Scott J SJ Courtney D Mark DM Gordon Elisa J EJ Thomas Leena F LF Holl Jane L JL Prabhakaran Shyam S

Stroke 20180212 3

<h4>Background and purpose</h4>No standard approach to obtaining informed consent for stroke thrombolysis with tPA (tissue-type plasminogen activator) currently exists. We aimed to assess current nationwide practice patterns of obtaining informed consent for tPA.<h4>Methods</h4>An online survey was developed and distributed by e-mail to clinicians involved in acute stroke care. Multivariable logistic regression analyses were performed to determine independent factors contributing to always obtai ...[more]

PMID: 29440586

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Project description:BackgroundObtaining informed consent for intravenous thrombolysis in acute ischemic stroke can be challenging, and little is known about if and how the informed consent procedure is performed by neurologists in clinical practice. This study examines the procedure of informed consent for intravenous thrombolysis in acute ischemic stroke in high-volume stroke centers in the Netherlands.MethodsIn four high volume stroke centers, neurology residents and attending neurologists received an online questionnaire concerning informed consent for thrombolysis with tissue-type plasminogen activator (tPA). The respondents were asked to report their usual informed consent practice for tPA treatment and their considerations on whether informed consent should be obtained.ResultsFrom the 203 invited clinicians, 50% (n = 101) completed the questionnaire. One-third of the neurology residents (n = 21) and 21% of the neurologists (n = 8) reported that they always obtain informed consent for tPA treatment. If a patient is not capable of providing informed consent, 30% of the residents (n = 19) reported that they start tPA treatment without informed consent. In these circumstances, 53% of the neurologists (n = 20) reported that the resident under their supervision would start tPA treatment without informed consent. Most neurologists (n = 21; 55%) and neurology residents (n = 45; 72%) obtained informed consent within one minute. None of the respondents used more than five minutes for informed consent. Important themes regarding obtaining informed consent for treatment were patients' capacity, and medical, ethical and legal considerations.ConclusionThe current practice of informed consent for thrombolysis in acute ischemic stroke varies among neurologists and neurology residents. If informed consent is obtained, most clinicians stated to obtain informed consent within one minute. In the future, a shortened information provision process may be applied, making a shift from informed consent to informed refusal, while still considering the patient's capacity, stroke severity, and possible treatment delays.

Project description: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.

Project description:We examined the process of obtaining informed consent (IC) for clinical research purposes in long-term care facilities (LTCFs) in Rhode Island (RI), USA. We assessed factors that were associated with resident ability to consent, such as Brief Interview for Mental Status scores. We used a self-administered questionnaire to further understand the effect of LTCF staff evaluation of ability to consent on residents' autonomy and control over their medical decision making.Observational clinical studyLong-term care setting.LTCF personnel provided us with residents' names, as well as their professional assessment of resident ability to consent. We used Brief Interview for Mental Status (BIMS) scores to assess the cognitive capacity of all residents to assess, and compare it to the assessment provided by LTCF personnel. A logistic regression analysis was performed to determine the relationship between LTCF assessment of resident ability to consent and BIMS score or confirmed diagnosis of dementia as seen from residents' medical charts. A self-administered questionnaire was filled out by the personnel of 10 LTCFs across RI, USA.LTCF personnel in 9 out of 10 recruited facilities reported that their assessment of resident ability to consent was based on subjective assessment of the resident as alert and oriented. There was a statistically significant relationship between the LTCF assessment of resident ability to consent and previously diagnosed dementia (OR: 0.211, 95% CI 0.107-0.415). Therefore, as BIMS scores increased, the likelihood that the resident would be deemed able to consent by LTCF personnel also increased. Furthermore, there was a statistically significant relationship between LTCF assessment of resident ability to consent and BIMS scores (OR: 1.430, 95% CI 1.274-1.605).There is no standard on obtaining IC for research studies conducted in LTCFs. We recommend that standardizing the process of obtaining IC in LTCFs can enhance the ability to perform research with LTCF residents.

Project description:BackgroundProper informed consent is essential for patients to have sound knowledge about the indication, risks, and benefits of a proposed surgical procedure. The study aim was to assess the perceptions of postoperative patients about the informed consent process and identify various influential factors in a tertiary care hospital.MethodsA cross-sectional study was conducted from February to August 2018 at a tertiary care hospital in Lahore, Pakistan. A validated questionnaire was used to conduct interviews of 101 patients planning to undergo elective surgery after fulfilling all ethical considerations. A purposive sampling technique was employed to enroll and the data analysis was performed by using SPSS version 23.ResultsOut of total 101 patients, 50 (49.5%) of them were males and the mean age of total sample was 36.98 ± 14.23 years. The majority 92 (91.1%) considered informed consent to be important and that it did not influence their surgical decision 85 (84.2%). Consent was obtained by the consulting surgeon from 41 (40.6%) patients and by the residents/house officer from 60 (59.4%) patients. Fifteen (14.8%) patients signed the consent form themselves, and 86 (85.1%) relatives of patients signed. Ninety-eight (97.0) patients were told about indications of the surgery, and 54 (53.5%) were told about possible complications. Seventy-five (74.3%) patients were informed about alternatives to surgery. Significant reasons for not signing were language (p = 0.03), educational status (p = 0.002), and not being informed by relatives before signing (p = 0.02).ConclusionThe patients had adequate knowledge about the process of informed consent and considered it important. Factors identified as barriers to signing the consent form by the patients themselves included language, better educational status, and not being asked by relatives. It is imperative to involve the patients in the process of consent, especially in signing by them or in their presence by their surrogate.

Project description:The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.

Dataset Information

National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis.

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National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis.

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