Perspectives of Decisional Surrogates and Patients Regarding Critical Illness Genetic Research.

Background: Critical illness research is challenging due to disease severity and because patients are frequently incapacitated. Surrogates called upon to provide consent might not accurately represent patient preferences. Though commonplace, genetic data collection adds complexity in this context.

Does difficulty functioning in the surrogate role equate to vulnerability in critical illness research? Use of path analysis to examine the relationship between difficulty providing substituted judgment and receptivity to critical illness research participation.

Purpose: Individuals who struggle to provide substitute judgment for the critically ill often find it challenging to engage in decision making for therapeutic interventions. Although essential to the conduct of research, how these individuals respond to requests for clinical trial participation is poorly understood.

Methods: Survey data collected to examine surrogate attitudes toward research provided the conceptual framework to explore influences on decision making.

Exploring determinants of surrogate decision-maker confidence: an example from the ICU.

This article is an exploratory data analysis of the determinants of confidence in a surrogate decision maker who has been asked to permit an intensive care unit (ICU) patient's participation in genetic research. We pursue the difference between surrogates' and patients' confidence that the surrogate can accurately represent the patient's wishes. The article also explores whether greater confidence leads to greater agreement between patients and surrogates.

Surrogate receptivity to participation in critical illness genetic research: aligning research oversight and stakeholder concerns.

Background: Collection of genetic biospecimens as part of critical illness investigations is increasingly commonplace. Oversight bodies vary in restrictions imposed on genetic research, introducing inconsistencies in study design, potential for sampling bias, and the possibility of being overly prohibitive of this type of research altogether. We undertook this study to better understand whether restrictions on genetic data collection beyond those governing research on cognitively intact subjects reflect the concerns of surrogates for critically ill patients.

Real-time perspectives of surrogate decision-makers regarding critical illness research: findings of focus group participants.

Objective: We undertook the current investigation to explore how the pressures of serving as a surrogate decision-maker (SDM) for an acutely ill family member influence attitudes regarding clinical investigation.

Methods: We conducted a prospective study involving SDMs for critically ill patients cared for in the ICUs of two urban hospitals. Measurements included participation in focus groups designed to explore perceptions of ICU care and clinical research.

Considerations in the construction of an instrument to assess attitudes regarding critical illness gene variation research.

Clinical studies conducted in intensive care units are associated with logistical and ethical challenges. Diseases investigated are precipitous and life-threatening, care is highly technological, and patients are often incapacitated and decision-making is provided by surrogates. These investigations increasingly involve collection of genetic data.

Tightening conflict-of-interest policies: the impact of 2005 ethics rules at the NIH.

Purpose: To determine both the intended and unintended effects of the National Institutes of Health (NIH) 2005 ethics rules by examining changes in publishing rates and the frequency of external relationships among NIH scientists.

Method: After identifying eligible intramural scientists and administrators from institutes' Web pages and central directories, a mailed survey was administered to 900 NIH research faculty between October 2008 and January 2009 (response rate 70.1%).

Factors that influence practitioners' interpretations of evidence from alternative medicine trials: a factorial vignette experiment embedded in a national survey.

Background: Clinical trial evidence in controversial areas such as complementary and alternative medicine (CAM) must be approached with an open mind.

Objective: To determine what factors may influence practitioners' interpretation of evidence from CAM trials.

Research Design: In a mailed survey of 2400 US CAM and conventional medicine practitioners we included 2 hypothetical factorial vignettes of positive and negative research results for CAM clinical trials.

Participation of academic scientists in relationships with industry.

Relationships between academic researchers and industry have received considerable attention in the past twenty years. However, current data on the prevalence, magnitude, and trends in such relationships are rare. In a mailed survey of 3,080 academic life science researchers conducted in 2007, we found that 52.

Alternative medicine research in clinical practice: a US national survey.

Background: Little is known about whether federally funded complementary and alternative medicine (CAM) research is translating into clinical practice. We sought to describe the awareness of CAM clinical trials, the ability to interpret research results, the acceptance of research evidence, and the predictors of trial awareness among US clinicians.

Methods: We conducted a cross-sectional mailed survey of 2400 practicing US acupuncturists, naturopaths, internists, and rheumatologists.

Patients' views on identifiability of samples and informed consent for genetic research.

It is unclear whether the regulatory distinction between non-identifiable and identifiable information--information used to determine informed consent practices for the use of clinically derived samples for genetic research--is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers.

Adverse events during hospitalization: results of a patient survey.

Background: A two-stage probability sample of patients recently discharged from 16 general acute care hospitals in Massachusetts were interviewed to determine the rates at which patients experience what they considered to be adverse events, to describe the kinds of events they reported, and to identify the correlates of those reports.

Methods: Eligible respondents were adults, 18 years of age or older, who were medical or surgical patients overnight or longer between April 1 and October 1, 2003, and who were discharged to their homes in Massachusetts. Questions covered perceptions of adverse events during hospitalizations and possible correlates of those events.

Integration of the biopsychosocial model: perspectives of medical students and residents.

Purpose: To examine residents' and medical students' attitudes toward the incorporation of psychosocial factors in diagnosis and treatment and to identify barriers to the integration of evidence-based, mind-body methods.

Method: A random sample of third- and fourth-year medical students and residents was drawn from the Masterfiles of the American Medical Association. A total of 661 medical students and 550 residents completed a survey, assessing attitudes toward the role of psychosocial factors and the clinical application of behavioral/mind-body methods.

Providing high-quality care for limited English proficient patients: the importance of language concordance and interpreter use.

Background: Provider-patient language discordance is related to worse quality care for limited English proficient (LEP) patients who speak Spanish. However, little is known about language barriers among LEP Asian-American patients.

Objective: We examined the effects of language discordance on the degree of health education and the quality of interpersonal care that patients received, and examined its effect on patient satisfaction.

Do characteristics of HIPAA consent forms affect the response rate?

Objective: Under the The Health Insurance Portability and Accountability Act Privacy Rule, researchers are required to obtain written authorization from patients to gain access to protected health information. The purpose of this research was to examine how the characteristics of authorization forms used by hospitals affect the likelihood of consent.

Method: This work reports on a recent telephone survey (administered January to August 2004) of previously hospitalized patients from 16 Massachusetts hospitals.

Financial relationships between institutional review board members and industry.

Background: Little is known about the nature, extent, and consequences of financial relationships between industry and institutional review board (IRB) members in academic institutions. We surveyed IRB members about such relationships.

Methods: We surveyed a random sample of 893 IRB members at 100 academic institutions (response rate, 67.

Barriers to the integration of psychosocial factors in medicine: results of a national survey of physicians.

Purpose: Examine physicians' attitudes toward the incorporation of psychosocial factors in diagnosis and treatment and identify barriers to the integration of evidence-based mind-body methods.

Method: Random sample of primary care physicians and physicians from selected non-primary specialties was drawn. A total of 1058 physicians completed a 12-page survey.

Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.

We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials.

Reconciling medications at admission: safe practice recommendations and implementation strategies.

Background: Fifty hospitals collaborated in a patient safety initiative developed and implemented by the Massachusetts Coalition for the Prevention of Medical Errors and the Massachusetts Hospital Association.

Methods: A consensus group identified safe practices and suggested implementation strategies. Four collaborative learning sessions were offered, and teams monitored their progress and shared successful strategies and lessons learned.

Data withholding in genetics and the other life sciences: prevalences and predictors.

Purpose: To better understand the variety and prevalence of data withholding in genetics and the other life sciences and to explore factors associated with these behaviors.

Method: In 2000, a sample of 2,893 geneticists and other life scientists (OLS) at the 100 most research-intensive universities in the United States were surveyed concerning data withholding and sharing. The instrument was developed and pretested in 1999.

Complementary and alternative medical therapy use among Chinese and Vietnamese Americans: prevalence, associated factors, and effects of patient-clinician communication.

Objective: We examined the use of complementary and alternative medical (CAM) therapies among Chinese and Vietnamese Americans who had limited proficiency with the English language and explore the association between patient-clinician discussions about CAM therapy use and patient assessments of quality of care.

Methods: We surveyed Chinese and Vietnamese Americans who visited 11 community health centers in 8 major cities throughout the United States.

Results: Of the 4410 patients surveyed, 3258 (74%) returned completed questionnaires.

Bereaved family member perceptions of quality of end-of-life care in U.S. regions with high and low usage of intensive care unit care.

Objectives: To compare the quality of end-of-life care of persons dying in regions of differing practice intensity.

Design: Mortality follow-back survey.

Setting: Geographic regions in the highest and lowest deciles of intensive care unit (ICU) use.

Resident physicians' preparedness to provide cross-cultural care.

Context: Two recent reports from the Institute of Medicine cited cross-cultural training as a mechanism to address racial and ethnic disparities in health care, but little is known about residents' educational experience in this area.

Objective: To assess residents' attitudes about cross-cultural care, perceptions of their preparedness to deliver quality care to diverse patient populations, and educational experiences and educational climate regarding cross-cultural training.

Design, Setting, And Participants: A survey was mailed in the winter of 2003 to a stratified random sample of 3435 resident physicians in their final year of training in emergency medicine, family practice, internal medicine, obstetrics/gynecology, pediatrics, psychiatry, or general surgery at US academic health centers.

Academic medical centers' standards for clinical-trial agreements with industry.

Background: Although industry sponsors provide approximately 70 percent of the funding for clinical drug trials in the United States, little is known about the legal agreements that exist between industry sponsors and academic investigators. We studied institutional standards regarding contractual provisions that restrict investigators' control over trials.

Methods: We used a structured, cross-sectional mail survey of medical-school research administrators responsible for negotiating clinical-trial agreements with industry sponsors.

Error reporting and disclosure systems: views from hospital leaders.

Context: The Institute of Medicine has recommended establishing mandatory error reporting systems for hospitals and other health settings.

Objective: To examine the opinions and experiences of hospital leaders with state reporting systems.

Design And Setting: Survey of chief executive and chief operating officers (CEOs/COOs) from randomly selected hospitals in 2 states with mandatory reporting and public disclosure, 2 states with mandatory reporting without public disclosure, and 2 states without mandatory systems in 2002-2003.