Dataset Information

How important is 'accuracy' of surrogate decision-making for research participation?

ABSTRACT:

Background

There is a longstanding concern about the accuracy of surrogate consent in representing the health care and research preferences of those who lose their ability to decide for themselves. We sought informed, deliberative views of the older general public (?50 years old) regarding their willingness to participate in dementia research and to grant leeway to future surrogates to choose an option contrary to their stated wishes.

Methodology/principal findings

503 persons aged 50+ recruited by random digit dialing were randomly assigned to one of three groups: deliberation, education, or control. The deliberation group attended an all-day education/peer deliberation session; the education group received written information only. Participants were surveyed at baseline, after the deliberation session (or equivalent time), and one month after the session, regarding their willingness to participate in dementia research and to give leeway to surrogates, regarding studies of varying risk-benefit profiles (a lumbar puncture study, a drug randomized controlled trial, a vaccine randomized controlled trial, and an early phase gene transfer trial). At baseline, 48% (gene transfer scenario) to 92% (drug RCT) were willing to participate in future dementia research. A majority of respondents (57-71% depending on scenario) were willing to give leeway to future surrogate decision-makers. Democratic deliberation increased willingness to participate in all scenarios, to grant leeway in 3 of 4 scenarios (lumbar puncture, vaccine, and gene transfer), and to enroll loved ones in research in all scenarios. On average, respondents were more willing to volunteer themselves for research than to enroll their loved ones.

Conclusions/significance

Most people were willing to grant leeway to their surrogates, and this willingness was either sustained or increased after democratic deliberation, suggesting that the attitude toward leeway is a reliable opinion. Eliciting a person's current preferences about future research participation should also involve eliciting his or her leeway preferences.

SUBMITTER: Kim SY

PROVIDER: S-EPMC3561414 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

How important is 'accuracy' of surrogate decision-making for research participation?

Kim Scott Y H SY Kim H Myra HM Ryan Kerry A KA Appelbaum Paul S PS Knopman David S DS Damschroder Laura L De Vries Raymond R

PloS one 20130131 1

<h4>Background</h4>There is a longstanding concern about the accuracy of surrogate consent in representing the health care and research preferences of those who lose their ability to decide for themselves. We sought informed, deliberative views of the older general public (≥50 years old) regarding their willingness to participate in dementia research and to grant leeway to future surrogates to choose an option contrary to their stated wishes.<h4>Methodology/principal findings</h4>503 persons age ...[more]

PMID: 23382969

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Project description:Background/objectiveSurrogate decision makers for patients with intracerebral hemorrhage (ICH) are frequently asked to make difficult decisions on use of life-sustaining treatments. We explored ICH surrogate satisfaction with decision making and experience of decision regret using validated measures in a prospective multicenter study.MethodsCases of non-traumatic ICH were enrolled from three hospitals (September 2015-December 2016), and surrogate decision makers were invited to complete a self-administered survey. The primary outcome was the 10-item decision-making subscale of the Family Satisfaction in the Intensive Care Unit scale (FSICU-DM, range 0-100, higher is greater satisfaction), and the secondary outcome was the decision regret scale (range 0-100, higher is greater regret). Linear regression models were used to assess the association between satisfaction with decision making and pre-specified covariates using manual backward selection.ResultsA total of 73 surrogates were approached for participation (in person or mail), with 48 surrogates returning a completed survey (median surrogate age 60.5 years, 63% female, 77% white). Patients had a median age of 72.5, 54% were female, with a median admission Glasgow coma scale of 10, in-hospital mortality of 31%, and 56% with an in-hospital DNR order. Physicians commonly made treatment recommendation (> 50%) regarding brain surgery or transitions to comfort measures, but rarely made recommendations (< 20%) regarding DNR orders. Surrogate satisfaction with decision making was generally high (median FSICU-DM 85, IQR 57.5-95). Factors associated with higher satisfaction on multivariable analysis included greater use of shared decision making (P < 0.0001), younger patient age (p = 0.02), ICH score of 3 or higher (p = 0.03), and surrogate relationship (spouse vs. other, p = 0.02). Timing of DNR orders was not associated with satisfaction (P > 0.25). Decision regret scores were generally low (median 12.5, IQR 0-31.3).ConclusionsConsidering the severity and abruptness of ICH, it is reassuring that surrogate satisfaction with decision making was generally high and regret was generally low. However, more work is needed to define the appropriate outcome measures and optimal methods of recruitment for studies of surrogate decision makers of ICH patients.

Project description:Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research.A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008.None.Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults.Institutional Review Boards reported that, in the previous year, they sometimes (49%), frequently (33%), or very frequently (2%) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6%) do not accept surrogate consent for research from any persons, and 22% of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15% disallow any research regardless of risk in studies without direct benefit, whereas 39% allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11%; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13%-21%). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives.Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.

Project description:IntroductionThe participation of general practitioners (GPs) in primary care research is variable and often poor. We aimed to develop a substantive and empirical theoretical framework to explain GPs' decision-making process to participate in research.MethodsWe used the grounded theory approach to construct a substantive theory to explain the decision-making process of GPs to participate in research activities. Five in-depth interviews and four focus group discussions were conducted among 21 GPs. Purposeful sampling followed by theoretical sampling were used to attempt saturation of the core category. Data were collected using semi-structured open-ended questions. Interviews were recorded, transcribed verbatim and checked prior to analysis. Open line-by-line coding followed by focus coding were used to arrive at a substantive theory. Memoing was used to help bring concepts to higher abstract levels.ResultsThe GPs' decision to participate in research was attributed to their inner drive and appreciation for primary care research and their confidence in managing their social and research environments. The drive and appreciation for research motivated the GPs to undergo research training to enhance their research knowledge, skills and confidence. However, the critical step in the GPs' decision to participate in research was their ability to align their research agenda with priorities in their social environment, which included personal life goals, clinical practice and organisational culture. Perceived support for research, such as funding and technical expertise, facilitated the GPs' participation in research. In addition, prior experiences participating in research also influenced the GPs' confidence in taking part in future research.ConclusionsThe key to GPs deciding to participate in research is whether the research agenda aligns with the priorities in their social environment. Therefore, research training is important, but should be included in further measures and should comply with GPs' social environments and research support.

Project description:BackgroundShared decision-making is the gold standard for good clinical practice, and thus, psychometric instruments have been established to assess patients' generic preference for participation (e.g., the Autonomy Preference Index, API). However, patients' preferences may vary depending on the specific disease and with respect to the specific decision context. With a modified preference index (API-Uro), we assessed patients' specific participation preference in preference-sensitive decisions pertaining to urological cancer treatments and compared this with their generic participation preference.MethodsIn Study 1, we recruited (N = 469) urological outpatients (43.1% urooncological) at a large university hospital. Participation preference was assessed with generic measures (API and API case vignettes) and with the disease-specific API-Uro (urooncological case vignettes describing medical decisions of variable difficulty). A polychoric exploratory factor analysis was used to establish factorial validity and reduce items. In Study 2, we collected data from N = 204 bladder cancer patients in a multicenter study to validate the factorial structure with confirmatory factor analysis. Differences between the participation preference for different decision contexts were analyzed.ResultsStudy 1: Scores on the specific urooncological case vignettes (API-Uro) correlated with the generic measure (r = .44) but also provided incremental information. Among the disease-specific vignettes of the API-Uro, there were two factors with good internal consistency (α ≥ .8): treatment versus diagnostic decisions. Patients desired more participation for treatment decisions (77.8%) than for diagnostic decisions (22%), χ2(1) = 245.1, p ≤ .001. Study 2: Replicated the correlation of the API-Uro with the API (r = .39) and its factorial structure (SRMR = .08; CFI = .974). Bladder cancer patients also desired more participation for treatment decisions (57.4%) than for diagnostic decisions (13.3%), χ²(1) =84, p ≤ .001.ConclusionsThe desire to participate varies between treatment versus diagnostic decisions among urological patients. This underscores the importance of assessing participation preference for specific contexts. Overall, the new API-Uro has good psychometric properties and is well suited to assess patients' preferences. In routine care, measures of participation preference for specific decision contexts may provide incremental, allowing clinicians to better address their patients' individual needs.

Project description:BackgroundRecent discussions about health care reform have raised questions regarding the value of advance directives.MethodsWe used data from survey proxies in the Health and Retirement Study involving adults 60 years of age or older who had died between 2000 and 2006 to determine the prevalence of the need for decision making and lost decision-making capacity and to test the association between preferences documented in advance directives and outcomes of surrogate decision making.ResultsOf 3746 subjects, 42.5% required decision making, of whom 70.3% lacked decision-making capacity and 67.6% of those subjects, in turn, had advance directives. Subjects who had living wills were more likely to want limited care (92.7%) or comfort care (96.2%) than all care possible (1.9%); 83.2% of subjects who requested limited care and 97.1% of subjects who requested comfort care received care consistent with their preferences. Among the 10 subjects who requested all care possible, only 5 received it; however, subjects who requested all care possible were far more likely to receive aggressive care as compared with those who did not request it (adjusted odds ratio, 22.62; 95% confidence interval [CI], 4.45 to 115.00). Subjects with living wills were less likely to receive all care possible (adjusted odds ratio, 0.33; 95% CI, 0.19 to 0.56) than were subjects without living wills. Subjects who had assigned a durable power of attorney for health care were less likely to die in a hospital (adjusted odds ratio, 0.72; 95% CI, 0.55 to 0.93) or receive all care possible (adjusted odds ratio, 0.54; 95% CI, 0.34 to 0.86) than were subjects who had not assigned a durable power of attorney for health care.ConclusionsBetween 2000 and 2006, many elderly Americans needed decision making near the end of life at a time when most lacked the capacity to make decisions. Patients who had prepared advance directives received care that was strongly associated with their preferences. These findings support the continued use of advance directives.

Project description:IMPORTANCE:Hospitalized older adults often lack decisional capacity, but outside of the intensive care unit and end-of-life care settings, little is known about the frequency of decision making by family members or other surrogates or its implications for hospital care. OBJECTIVE:To describe the scope of surrogate decision making, the hospital course, and outcomes for older adults. DESIGN, SETTING, AND PARTICIPANTS:Prospective, observational study conducted in medicine and medical intensive care unit services of 2 hospitals in 1 Midwestern city in 1083 hospitalized older adults identified by their physicians as requiring major medical decisions. MAIN OUTCOMES AND MEASURES:Clinical characteristics, hospital outcomes, nature of major medical decisions, and surrogate involvement. RESULTS:According to physician reports, at 48 hours of hospitalization, 47.4% (95% CI, 44.4%-50.4%) of older adults required at least some surrogate involvement, including 23.0% (20.6%-25.6%) with all decisions made by a surrogate. Among patients who required a surrogate for at least 1 decision within 48 hours, 57.2% required decisions about life-sustaining care (mostly addressing code status), 48.6% about procedures and operations, and 46.9% about discharge planning. Patients who needed a surrogate experienced a more complex hospital course with greater use of ventilators (2.5% of patients who made decisions and 13.2% of patients who required any surrogate decisions; P <?.001), artificial nutrition (1.7% of patients and 14.4% of surrogates; P <?.001), and length of stay (median, 6 days for patients and 7 days for surrogates; P <?.001). They were more likely to be discharged to an extended-care facility (21.2% with patient decisions and 40.9% with surrogate decisions; P <?.001) and had higher hospital mortality (0.0% patients and 5.9% surrogates; P <?.001). Most surrogates were daughters (58.9%), sons (25.0%), or spouses (20.6%). Overall, only 7.4% had a living will and 25.0% had a health care representative document in the medical record. CONCLUSIONS AND RELEVANCE:Surrogate decision making occurs for nearly half of hospitalized older adults and includes both complete decision making by the surrogate and joint decision making by the patient and surrogate. Surrogates commonly face a broad range of decisions in the intensive care unit and the hospital ward setting. Hospital functions should be redesigned to account for the large and growing role of surrogates, supporting them as they make health care decisions.

Project description:BackgroundInstances of surrogate decision-making are expected to increase with the rise in hospitalised older adults in Japan. Few large-scale studies have comprehensively examined the entire surrogate decision-making process. This study aimed to gather information to assess the current state of surrogate decision-making in Japan.MethodsA cross-sectional survey was conducted using online questionnaires. A total of 1000 surrogate decision-makers responded to the questionnaire. We examined the characteristics of surrogate decision-makers and patients, content of surrogate decision-making meeting regarding life-sustaining treatment between the doctors and surrogate decision-makers, extent of involvement of the various parties in the surrogate decision-making process, judgement grounds for surrogate decision-making, and frequency of involvement in the surrogate decision-making process.ResultsOf the participants, 70.5% were male and 48.3% were eldest sons. Only 7.6% of the patients had left a written record of their preferences and 48.8% of the surrogates reported no knowledge of the patient having expressed their prior intentions regarding medical care in any form. Respondents indicated that their family meetings with healthcare professionals mostly included the information recommended by guidelines in a surrogate decision-making meeting in Japan. Most participants reported a good understanding of the meeting content. Although many participants based their decisions on multiple grounds, surrogates' considerations may not adequately reflect respect for patient autonomy in Japan. Specifically, the eldest son considered his own preference more frequently than that of the other surrogate decision-makers. In 26.1% of the cases, either zero or one family meeting with healthcare professionals was held. In these cases, significantly fewer decisions involved the participation of healthcare professionals other than the doctor compared to cases with multiple meetings.ConclusionsSurrogate decisions in Japan are most commonly made by eldest sons and may not frequently consider the perspectives of other surrogates. The finding that patient preferences were rarely known suggests a role for increased advance care planning.

Dataset Information

How important is 'accuracy' of surrogate decision-making for research participation?

Background

Methodology/principal findings

Conclusions/significance

Publications

How important is 'accuracy' of surrogate decision-making for research participation?

Similar Datasets

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