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. We undertook this investigation to understand whether surrogate decision makers would be receptive to permitting participation in a critical illness genetics study and whether their decision making was consistent with that of the patient represented. METHODS: We invited individuals identified as surrogates for critically ill adults, if required, as well as patients once recovered to participate in a survey designed to understand attitudes about genetic research. Associations between dependent (receptivity to participation, concordance of responses) and independent variables were tested using bivariate and multivariate logistic regression analyses. RESULTS: Most of the entire surrogate sample (n=439) reported familiarity with research, including genetic research; tended to view research as useful; and were receptive to allowing their family member participate (with 39.6% and 38.1% stating that this would be "very" and "somewhat likely," respectively) even absent direct benefit. Willingness to participate was similar comparing genetic and non-genetic studies (χ2 [1,n=439]=0.00127, p=0.972), though respondents expressed worry regarding lack of confidentiality of genetic data. Responses were concordant in 70.8% of the 192 surrogate-patient pairs analyzed. In multivariate analysis, African American race was associated with less receptivity to genetic data collection (p<0.05). No factors associated with concordance of surrogate-patient response were identified. CONCLUSIONS: Surrogates' receptivity to critical illness research was not influenced by whether the study entailed collection of genetic data. While more than two-thirds of surrogate-patient responses for participation in genetics research were concordant, concerns expressed regarding genetic data often related to breach of confidentiality. Emphasizing safeguards in place to minimize such breeches might prove an effective strategy for enhancing recruitment.

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. Path analysis was used to derive the final model (nonlatent, fully recursive, 1 indicator/variable). RESULTS: Surrogates with list-wise complete records (406) were analyzed. The following variables were not retained in the final model: education, income, religiosity, decision-making experience, discussion of patient's wishes, number of individuals assisting with decision making, trust in care providers, difficulty making decisions, and responsibility for decision making. Being white and having experience making treatment decisions for the patient during the current intensive care unit encounter affected the likelihood the surrogate would permit participation in research positively (parameter estimates, 0.281 and 0.06, respectively). No variable reflecting difficulty functioning in the surrogate role was associated with permitting research participation. CONCLUSIONS: We were unable to demonstrate a relationship between perceived difficulty in decision making in the surrogate role and receptivity to clinical trial participation.

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. METHODS: We analyzed survey data collected from 1,176 patients in nonurgent settings and 437 surrogates representing critically ill adults. Attitudes pertaining to genetic data (familiarity, perceptions, interest in participation, concerns) and demographic information were examined using univariate and multivariate techniques. RESULTS: We explored differences among respondents who were receptive (1,333) and nonreceptive (280) to genetic sample collection. Whereas factors positively associated with receptivity to research participation were "complete trust" in health-care providers (OR, 2.091; 95% CI, 1.544-2.833), upper income strata (OR, 2.319; 95% CI, 1.308-4.114), viewing genetic research "very positively" (OR, 3.524; 95% CI, 2.122-5.852), and expressing "no worry at all" regarding disclosure of results (OR, 2.505; 95% CI, 1.436-4.369), black race was negatively associated with research participation (OR, 0.410; 95% CI, 0.288-0.585). We could detect no difference in receptivity to genetic sample collection comparing ambulatory patients and surrogates (OR, 0.738; 95% CI, 0.511-1.066). CONCLUSIONS: Expressing trust in health-care providers and viewing genetic research favorably were associated with increased willingness for study enrollment, while concern regarding breach of confidentiality and black race had the opposite effect. Study setting had no bearing on willingness to participate.

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. Our data come from a survey conducted in three hospital ICUs. We interviewed 445 surrogates and 214 patients. The only thing that influences patients' confidence in their surrogate's decision is whether they had prior discussions with him or her; however, there are more influences operating on the surrogate's self-confidence. More confident surrogates are more likely to match their patients' wishes. Patients are more likely to agree to research participation than their surrogates would allow. The surrogates whose response did not match as closely were less trusting of the hospital staff, were less likely to allow patient participation if there were no direct benefits to the patient, had given less thought about the way genetic research is conducted, and were much less likely to have a person in their life who they would trust to make decisions for them if they were incapacitated.

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. Wanting to know about research being done was important to 72% of patients when samples would be anonymous and to 81% of patients when samples would be identifiable. Only 17% wanted to know about the identifiable scenario but not the anonymous scenario (i.e., following the regulatory distinction). Curiosity-based reasons were the most common (37%) among patients who wanted to know about anonymous samples. Of patients wanting to know about either scenario, approximately 57% would require researchers to seek permission, whereas 43% would be satisfied with notification only. Patients were more likely to support permission (versus notification) in the anonymous scenario if they had more education, were Black, less religious, in better health, more private, and less trusting of researchers. The sample, although not representative of the general population, does represent patients at academic medical centers whose clinical samples may be used for genetic research. Few patients expressed preferences consistent with the regulatory distinction between non-identifiable and identifiable information. Data from this study should cause policy-makers to question whether this distinction is useful in relation to research with previously collected clinically derived samples.

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. Respondents were asked to provide authorization for review of their medical records. Those respondents who agreed over the phone to be mailed authorization forms were sent a copy of their hospital's form and were asked to sign and return it. Measured characteristics of the forms included number of pages, number of fields, distinctness of institution's name, whether a witness was required, and requirement of Social Security Number (SSN). RESULTS: We received 1021 signed forms (50.3% of all sent forms). The likelihood of return was affected by the requirement of the SSN, the clarity of the hospital name, and providing an extra copy for respondents' records. In logistic regression analysis, besides age and gender, only the SSN and clarity of the hospital name identification were significant. CONCLUSION: Forms should be clear about the institution from which they come, easy to understand, and should not ask for SSN or other highly sensitive information unrelated to health care.

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, 67.2%). The questionnaire focused on the financial relationships that the members had with industry (e.g., employment, membership on boards, consulting, receipt of royalties, and paid speaking). RESULTS: We found that 36% of IRB members had had at least one relationship with industry in the past year. Of the respondents, 85.5% said they never thought that the relationships that another IRB member had with industry affected his or her IRB-related decisions in an inappropriate way, 11.9% said they thought this occurred rarely, 2.4% thought it occurred sometimes, and 0.2% thought it occurred often. Seventy-eight respondents (15.1%) reported that at least one protocol came before their IRB during the previous year that was sponsored either by a company with which they had a relationship or by a competitor of that company, both of which could be considered conflicts of interest. Of these 78 members (62 voting members and 16 nonvoting members), 57.7% reported that they always disclosed the relationship to an IRB official, 7.7% said they sometimes did, 11.5% said they rarely did, and 23.1% said they never did. Of the 62 voting members who reported conflicts, 64.5% reported that they never voted on the protocol, 4.8% said they rarely did, 11.3% said they sometimes did, and 19.4% said they always did. Most respondents reported that the views of IRB members who had experience working with industry were beneficial in reviewing industry-sponsored protocols. CONCLUSIONS: Relationships between IRB members and industry are common, and members sometimes participate in decisions about protocols sponsored by companies with which they have a financial relationship. Current regulations and policies should be examined to be sure that there is an appropriate way to handle conflicts of interest stemming from relationships with industry.

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. RESULTS: The response rate was 27%. Although a majority of physicians seem to recognize the importance of addressing psychosocial issues, approximately one third believe that addressing such factors would lead to minimal or no improvements in outcomes. A minority reports their training regarding the role of psychosocial factors was effective, and relatively few indicate interest in receiving further training in these areas. Males were less likely to believe in the importance of addressing psychosocial factors. Additional factors included perceptions that training was poor in these areas; feelings of low self-efficacy to address psychosocial issues and the perception that such factors are difficult to control; lack of knowledge of the evidence-base supporting the role of psychosocial factors; and lack of time and inadequate reimbursement to address the psychosocial domain. CONCLUSIONS: These results suggest the need for more comprehensive training in the role of psychosocial factors in health. In addition, the finding that physicians identify lack of time and inadequate reimbursement as significant barriers suggests that the current health care delivery system may, in many respects, be antithetical to the biopsychosocial model.

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. Reports from participating teams and an evaluation survey were then used to identify successful techniques for reconciling medications. RESULTS: For the 50 participating hospitals, implementation strategies most strongly correlated with success included active physician and nursing engagement, having an effective improvement team, using small tests of change, having an actively engaged senior administrator, and sending a team to multiple collaborative sessions. DISCUSSION: Adoption of the reconciling safe practices proved challenging. The process of writing medication orders at patient transfer points is complex. The hospitals' experiences demonstrated that implementing the proposed safe practices requires a team effort with leadership support and vigilant measurement.

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. Two thirds of respondents reported they had "ever used" some form of CAM therapy; however, only 7.6% of these patients had discussed their use of CAM therapies with clinicians. Among patients who had used CAM therapies during the week before their most recent visits, clinician-patient discussions about CAM therapy use were associated with better overall patient ratings of quality of care. CONCLUSION: Use of CAM therapies was common among Chinese and Vietnamese Americans who had limited proficiency with the English language. Although discussions about CAM therapy use with clinicians were uncommon, these discussions were associated with better ratings of quality of care.

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. RESULTS: Of 122 institutions approached, 107 participated. There was a high degree of consensus among administrators about the acceptability of several contractual provisions relating to publications. For example, more than 85 percent reported that their office would not approve provisions giving industry sponsors the authority to revise manuscripts or decide whether results should be published. There was considerable disagreement about the acceptability of provisions allowing the sponsor to insert its own statistical analyses in manuscripts (24 percent allowed them, 47 percent disallowed them, and 29 percent were not sure whether they should allow them), draft the manuscript (50 percent allowed it, 40 percent disallowed it, and 11 percent were not sure whether they should allow it), and prohibit investigators from sharing data with third parties after the trial is over (41 percent allowed it, 34 percent disallowed it, and 24 percent were not sure whether they should allow it). Disputes were common after the agreements had been signed and most frequently centered on payment (75 percent of administrators reported at least one such dispute in the previous year), intellectual property (30 percent), and control of or access to data (17 percent). CONCLUSIONS: Standards for certain restrictive provisions in clinical-trial agreements with industry sponsors vary considerably among academic medical centers. Greater sharing of information about legal relationships with industry sponsors is desirable in order to build consensus about appropriate standards.

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. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.

Surveying minorities with limited-English proficiency: does data collection method affect data quality among Asian Americans?

BACKGROUND: Little is known about how modes of survey administration affect response rates and data quality among populations with limited-English proficiency (LEP). Asian Americans are a rapidly growing minority group with large numbers of LEP immigrants. OBJECTIVE: We sought to compare the response rates and data quality of interviewer-administered telephone and self-administered mail surveys among LEP Asian Americans. DESIGN: This was a randomized, cross-sectional study using a 78-item survey about quality of medical care that was given to Vietnamese, Mandarin, or Cantonese Chinese patients in their native language. MEASURES: We examined response rates and missing data by mode of survey and language groups. To examine nonresponse bias, we compared the sociodemographic characteristics of respondents and nonrespondents. To assess response patterns, we compared the internal-consistency reliability coefficients across modes and language groups. RESULTS: We achieved an overall response rate of 67% (322 responses of 479 patients surveyed). A higher response rate was achieved by phone interviews (75%) as compared with mail surveys with telephone reminder calls (59%). There were no significant differences in response rates by language group. The mean number of missing item for the mail mode was 4.14 versus 1.67 for the phone mode (P< or =0.000). There were no significant differences in missing data among the language groups and no significant differences in scale reliability coefficients by modes or language groups. CONCLUSIONS: Telephone interviews and mail surveys with phone reminder calls are feasible options to survey LEP Chinese and Vietnamese Americans. These methods may be less costly and labor-intensive ways to include LEP minorities in research.

Family perspectives on end-of-life care at the last place of care.

CONTEXT: Over the past century, nursing homes and hospitals increasingly have become the site of death, yet no national studies have examined the adequacy or quality of end-of-life care in institutional settings compared with deaths at home. OBJECTIVE: To evaluate the US dying experience at home and in institutional settings. DESIGN, SETTING, AND PARTICIPANTS: Mortality follow-back survey of family members or other knowledgeable informants representing 1578 decedents, with a 2-stage probability sample used to estimate end-of-life care outcomes for 1.97 million deaths from chronic illness in the United States in 2000. Informants were asked via telephone about the patient's experience at the last place of care at which the patient spent more than 48 hours. MAIN OUTCOME MEASURES: Patient- and family-centered end-of-life care outcomes, including whether health care workers (1) provided the desired physical comfort and emotional support to the dying person, (2) supported shared decision making, (3) treated the dying person with respect, (4) attended to the emotional needs of the family, and (5) provided coordinated care. RESULTS: For 1059 of 1578 decedents (67.1%), the last place of care was an institution. Of 519 (32.9%) patients dying at home represented by this sample, 198 (38.2%) did not receive nursing services; 65 (12.5%) had home nursing services, and 256 (49.3%) had home hospice services. About one quarter of all patients with pain or dyspnea did not receive adequate treatment, and one quarter reported concerns with physician communication. More than one third of respondents cared for by a home health agency, nursing home, or hospital reported insufficient emotional support for the patient and/or 1 or more concerns with family emotional support, compared with about one fifth of those receiving home hospice services. Nursing home residents were less likely than those cared for in a hospital or by home hospice services to always have been treated with respect at the end of life (68.2% vs 79.6% and 96.2%, respectively). Family members of patients receiving hospice services were more satisfied with overall quality of care: 70.7% rated care as "excellent" compared with less than 50% of those dying in an institutional setting or with home health services (P<.001). CONCLUSIONS: Many people dying in institutions have unmet needs for symptom amelioration, physician communication, emotional support, and being treated with respect. Family members of decedents who received care at home with hospice services were more likely to report a favorable dying experience.

Linguistic and cultural barriers to care.

CONTEXT: Primarily because of immigration, Asian Americans are one of the fastest growing and most ethnically diverse minority groups in the United States. However, little is known about their perspectives on health care quality. OBJECTIVE: To examine factors contributing to quality of care from the perspective of Chinese- and Vietnamese-American patients with limited English language skills. DESIGN: Qualitative study using focus groups and content analysis to determine domains of quality of care. SETTING: Four community health centers in Massachusetts. PARTICIPANTS: A total of 122 Chinese- and Vietnamese-American patients were interviewed in focus groups by bilingual interviewers using a standardized, translated moderator guide. MAIN OUTCOME MEASURES: Domains of quality of care mentioned by patients in verbatim transcripts. RESULTS: In addition to dimensions of health care quality commonly expressed by Caucasian, English-speaking patients in the United States, Chinese- and Vietnamese-American patients with limited English proficiency wanted to discuss the use of non-Western medical practices with their providers, but encountered significant barriers. They viewed providers' knowledge, inquiry, and nonjudgmental acceptance of traditional Asian medical beliefs and practices as part of quality care. Patients also considered the quality of interpreter services to be very important. They preferred using professional interpreters rather than family members, and preferred gender-concordant translators. Furthermore, they expressed the need for help in navigating health care systems and obtaining support services. CONCLUSIONS: Cultural and linguistically appropriate health care services may lead to improved health care quality for Asian-American patients who have limited English language skills. Important aspects of quality include providers' respect for traditional health beliefs and practices, access to professional interpreters, and assistance in obtaining social services.

Data withholding in academic genetics: evidence from a national survey.

CONTEXT: The free and open sharing of information, data, and materials regarding published research is vital to the replication of published results, the efficient advancement of science, and the education of students. Yet in daily practice, the ideal of free sharing is often breached. OBJECTIVE: To understand the nature, extent, and consequences of data withholding in academic genetics. DESIGN, SETTING, AND PARTICIPANTS: Mailed survey (March-July 2000) of geneticists and other life scientists in the 100 US universities that received the most funding from the National Institutes of Health in 1998. Of a potential 3000 respondents, 2893 were eligible and 1849 responded, yielding an overall response rate of 64%. We analyzed a subsample of 1240 self-identified geneticists and made a limited number of comparisons with 600 self-identified nongeneticists. MAIN OUTCOME MEASURES: Percentage of faculty who made requests for data that were denied; percentage of respondents who denied requests; influences on and consequences of withholding data; and changes over time in perceived willingness to share data. RESULTS: Forty-seven percent of geneticists who asked other faculty for additional information, data, or materials regarding published research reported that at least 1 of their requests had been denied in the preceding 3 years. Ten percent of all postpublication requests for additional information were denied. Because they were denied access to data, 28% of geneticists reported that they had been unable to confirm published research. Twelve percent said that in the previous 3 years, they had denied another academician's request for data concerning published results. Among geneticists who said they had intentionally withheld data regarding their published work, 80% reported that it required too much effort to produce the materials or information; 64%, that they were protecting the ability of a graduate student, postdoctoral fellow, or junior faculty member to publish; and 53%, that they were protecting their own ability to publish. Thirty-five percent of geneticists said that sharing had decreased during the last decade; 14%, that sharing had increased. Geneticists were as likely as other life scientists to deny others' requests (odds ratio [OR], 1.39; 95% confidence interval [CI], 0.81-2.40) and to have their own requests denied (OR, 0.97; 95% CI, 0.69-1.40). However, other life scientists were less likely to report that withholding had a negative impact on their own research as well as their field of research. CONCLUSIONS: Data withholding occurs in academic genetics and it affects essential scientific activities such as the ability to confirm published results. Lack of resources and issues of scientific priority may play an important role in scientists' decisions to withhold data, materials, and information from other academic geneticists.