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Biomedical subjects

Bernard Lo

Publications and source records attributed to Bernard Lo.

At least 19 recordsLinked to original sources
PubMed2007

Establishing procedures for institutional oversight of stem cell research.

Academic health centers (AHCs), which are at the forefront of stem cell research, need to establish institutional stem cell research oversight committees (SCROs) to comply with 2005 National Academy of Sciences (NAS) recommendations and to establish public trust in this sensitive research. Institutional review boards (IRBs) typically lack the expertise and time to adequately review the specific ethical issues raised by stem cell research. To assure careful, timely, and coordinated review of the science and ethics of stem cell protocols, AHCs need to address many practical procedural issues, such as SCRO membership, quorum, conflicts of interest, and procedures for protocol review. The SCRO committee at the University of California San Francisco (UCSF), established in 2003, has developed detailed policies and procedures on these issues. The UCSF SCRO has broad scientific expertise and uses ad hoc reviewers to strengthen the review process. Studies receiving full SCRO review have three lead reviewers: a scientist, a reviewer with ethics expertise, and a public representative. Studies introducing human stem cells into nonhuman blastocysts receive full review, even if the stem cells are anonymized. Some protocols are eligible for expedited review. The SCRO neither replaces nor duplicates review by the IRB and institutional animal care and use committees. Other AHCs can draw on the UCSF experience when developing their own policies and procedures for stem cell research oversight.

Academic Medical Centers↗
PubMed2007

Prognostication during physician-family discussions about limiting life support in intensive care units.

OBJECTIVE: Prognostic information is important to the family members of incapacitated, critically ill patients, yet little is known about what prognostic information physicians provide. Our objectives were to determine the types of prognostic information provided to families of critically ill patients when making major end-of-life treatment decisions and to identify factors associated with more physician prognostication. DESIGN: Multiple-center, cross-sectional study. SETTING: ICUs of four hospitals. SUBJECTS: Thirty-five physicians, 51 patients, and 169 family members. INTERVENTIONS: We audiotaped 51 physician-family conferences in which there were deliberations about major end-of-life treatment decisions at four hospitals in 2000-2002. Conferences were coded to identify the types of prognostic information provided by physicians. We used a mixed-effects regression model to identify factors associated with more prognostication by physicians. MEASUREMENTS AND MAIN RESULTS: The mean number of prognostic statements per conference was 9.4+/-6.4 (range 0-29). Eighty-six percent of conferences contained discussion of the patient's anticipated functional status or quality of life, compared with 63% in which the chances for survival were discussed (p=.01). There were significantly more statements about prognosis for functional outcomes per conference compared with statements about prognosis for survival (median 4 [interquartile range 2-8] vs. 1 [interquartile range 0-3]; p<.001). Increasing educational level of the family was independently associated with more prognostic statements by physicians (p<.001) as was the degree of physician-family conflict about withdrawing life support (p<.001) and the physician's race being white (p=.009). CONCLUSIONS: Prognostication occurred frequently during physician-family deliberations about whether to forego life support, but physicians did not discuss the patient's prognosis for survival in more than one third of conferences. Less educated families received less information about prognosis. Future studies should address whether these observations partially explain the high prevalence of family misunderstandings about prognosis in intensive care units.

Adult↗
PubMed2007

Relatively increased von Willebrand factor activity after off-pump coronary artery bypass graft surgery.

High shear forces can induce structural changes in the shape of the von Willebrand factor (VWF) molecule, making it more sensitive for ADAMTS-13, a specific VWF protease. This leads to proteolysis of the highest-molecular-weight multimers, which are the most effective in platelet-mediated hemostasis under conditions of high shear stress. The use of cardiopulmonary bypass (CPB) is accompanied with high shear forces and could therefore lead to diminished VWF activity. Therefore, we studied VWF activity in patients undergoing myocardial revascularization. We enrolled 60 patients undergoing coronary artery bypass graft (CABG) surgery with and without CPB (30 in each group). ADAMTS-13 activity, VWF antigen (VWF:Ag) and propeptide levels were measured directly before and after the procedure. VWF activity was determined using both the ristocetin cofactor activity (VWF:Rcof) and collagen binding (VWF:CB) assays. VWF:Rcof and VWF:CB, both corrected for VWF:Ag, were significantly increased after the procedure in the off-pump group (p < 0.001 and p = 0.05, respectively), but not in the CPB group. Postoperative VWF:Ag and VWF-propeptide levels significantly increased in both groups. ADAMTS-13 activity increased after both types of surgery after correction for hemodilution. Postoperative VWF:Rcof levels correlated with postoperative D-dimer levels (p = 0.025) and were associated with early cognitive decline in the off-pump group (p = 0.025). Our data indicate that VWF activity is increased after off-pump CABG, but not after CABG with CPB. Since release of VWF is comparable in both groups, shear stress-induced proteolysis due to the use of CPB may be responsible for the decreased VWF activity.

ADAM Proteins↗
PubMed2006

Clinical decision-making: Patients' preferences and experiences.

OBJECTIVE: To determine the congruence between patients' preferred style of clinical decision-making and the style they usually experienced and whether this congruence was associated with socio-economic status and/or the perceived quality of care provided by the respondent's regular doctor. METHODS: Cross-sectional survey of the American public using computer-assisted telephone interviewing. RESULTS: Three thousand two hundred and nine interviews were completed (completion rate 72%). Sixty-two percent of respondents preferred shared decision-making, 28% preferred consumerism and 9% preferred paternalism. Seventy percent experienced their preferred style of clinical decision-making. Experiencing the preferred style was associated with high income (OR, 1.59; 95% CI, 1.16-2.16) and having a regular doctor who was perceived as providing excellent or very good care (OR, 2.39; 95% CI, 1.83-3.11). CONCLUSION: Both socio-economic status and having a regular doctor whom the respondent rated highly are independently associated with patients experiencing their preferred style of clinical decision-making. PRACTICE IMPLICATIONS: Systems which promote continuity of care and the development of an on-going doctor-patient relationship may promote equity in health care, by helping patients experience their preferred style of clinical decision-making.

Adult↗
PubMed2006

Clinical trial design issues raised during recombinant DNA advisory committee review of gene transfer protocols.

Gene transfer clinical trial protocols are reviewed by the Recombinant DNA Advisory Committee (RAC). Identifying the design concerns and suggestions commonly raised during RAC review may help investigators and sponsors shorten the process of protocol development and improve the quality of gene transfer trials. We therefore examined 53 full public reviews of gene transfer clinical trial protocols performed by the RAC between December 2000 and June 2004 to determine what trial design concerns or suggestions RAC members raised during written review or public discussion or in the formal letter to investigators after the review was completed. We also determined how frequently these concerns were raised. We found that RAC members raised issues regarding selection of subjects in 89% of reviews, dose escalation in 77%, selection of safety end points in 76%, biological activity measures in 66%, and overall design in 60% of reviews. The most common issue raised by RAC reviewers was the need to exclude subjects at increased risk for adverse events. Furthermore, in 89% of reviews, at least one design issue pertaining to safety of participants was raised. In 91% of reviews, at least one design concern was presented as a written RAC recommendation or concern to the investigator after the public review. When submitting protocols for RAC review, investigators and sponsors might devote more attention to issues that RAC reviewers commonly raise. Such attention might help strengthen clinical trial protocols, shorten the protocol development process, and enhance the protection of research participants.

Clinical Protocols↗
PubMed2006

Decisions to limit life-sustaining treatment for critically ill patients who lack both decision-making capacity and surrogate decision-makers.

OBJECTIVE: Many intensive care unit (ICU) physicians have withdrawn life-support from a patient who lacked decision-making capacity and a surrogate decision-maker, yet little is known about the decision-making practices for these patients. We sought to determine how often such patients are admitted to the ICU of a metropolitan hospital and how end-of-life decisions are made for them. DESIGN: Prospective, observational cohort study. PATIENTS AND SETTING: Consecutive adult patients admitted to the medical ICU of a metropolitan West Coast hospital during a 7-month period in 2003 to 2004. MEASUREMENTS: Attending physicians completed a questionnaire about the decision-making process for each patient for whom they considered limiting life-support who lacked decisional capacity and a legally recognized surrogate decision-maker. MAIN RESULTS: Of the 303 patients admitted during the study period, 49 (16%; 95% confidence interval [CI], 12-21%) lacked decision-making capacity and a surrogate during the entire ICU stay. Compared with all other ICU patients, these patients were more likely to be male (88% vs. 69%; p = .002), white (42% vs. 23%; p = .028), and > or =65 yrs old (29% vs. 13%; p = .007). Physicians considered withholding or withdrawing treatment from 37% (18) of the 49 patients who lacked both decision-making capacity and a surrogate decision-maker. For 56% (10) of these 18 patients, the opinion of another attending physician was obtained; for 33% (6 of 18), the ICU team made the decision independently, and for 11% (2 of 18), the input of the courts or the hospital ethics committee was obtained. Overall, 27% of deaths (13 of 49) during the study period were in incapacitated patients who lacked a surrogate (95% CI, 15-41%). CONCLUSIONS: Sixteen percent of patients admitted to the medical ICU of this hospital lacked both decision-making capacity and a surrogate decision-maker. Decisions to limit life support were generally made by physicians without judicial or institutional review. Further research and debate are needed to develop optimal decision-making strategies for these difficult cases.

Adult↗
PubMed2005

Palliative sedation in dying patients: "we turn to it when everything else hasn't worked".

Despite skilled palliative care, some dying patients experience distressing symptoms that cannot be adequately relieved. A patient with metastatic breast cancer, receiving high doses of opioids administered to relieve pain, developed myoclonus. After other approaches proved ineffective, palliative sedation was an option of last resort. The doctrine of double effect, the traditional justification for palliative sedation, permits physicians to provide high doses of opioids and sedatives to relieve suffering, provided that the intention is not to cause the patient's death and that certain other conditions are met. Such high doses are permissible even if the risk of hastening death is foreseen. Because intention plays a key role in this doctrine, clinicians must understand and document which actions are consistent with an intention to relieve symptoms rather than to hasten death. The patient or family should agree with plans for palliative sedation. The attending physician needs to explain to them, as well as to the medical and nursing staff, the details of care and the justification for palliative sedation. Because cases involving palliative sedation are emotionally stressful, the patient, family, and health care workers can all benefit from talking about the complex medical, ethical, and emotional issues they raise.

Procedural Sedation↗
PubMed2005

Clinical decision making during public health emergencies: ethical considerations.

Recent public health emergencies involving anthrax, the severe acute respiratory syndrome (SARS), and shortages of influenza vaccine have dramatized the need for restrictive public health measures such as quarantine, isolation, and rationing. Front-line physicians will face ethical dilemmas during public health emergencies when patients disagree with these measures. Patients might request interventions that are not recommended or for which they are not eligible, or they might object to intrusive or restrictive measures. The physician's primary responsibility in such emergencies is to the public rather than to the individual patient. In public health emergencies, physicians need to address the patient's needs and concerns, recognize their changed roles, and work closely with public health officials. Physicians can still work on behalf of patients by advocating for changes in policies and exceptions when warranted and by mitigating the adverse consequences of public health measures. Before an emergency occurs, physicians should think through how they will respond to foreseeable dilemmas arising when patients disagree with public health recommendations.

Decision Making↗
PubMed2005

'She gave it her best shot right away': patient experiences of biomedical and patient-centered communication.

OBJECTIVE: Medical educators and researchers recommend a patient-centered interviewing style, but little empirical data exists regarding what aspects of physician communication patients like and why. We investigated patient responses to videotaped doctor-patient vignettes to ascertain what they liked about patient-centered and biomedical communication. METHODS: We conducted semi-structured interviews with 230 adult medicine patients who viewed videotapes depicting both patient-centered and biomedical physician communication styles. We used a mixed methods approach to derive a "ground-up" framework of patient communication preferences. RESULTS: Respondents who preferred different communication styles articulated different sets of values, important physician behaviors, and physician-patient role expectations. Participants who preferred the patient-centered physician (69%) liked that she worked with and respected patients and explored what the patient wanted. Participants who preferred the biomedical physician (31%) liked that she prevented harm, demonstrated medical authority, and delivered information clearly. CONCLUSIONS: Patients like (and dislike) patient-centered communication for thoughtful, considered reasons that appear grounded in their values and expectations about physicians, patients, and the clinical encounter. PRACTICE IMPLICATIONS: Better understanding the diversity of patient communication preferences may lead to more effective and individualized care.

Adult↗
PubMed2005

HIPAA and patient care: the role for professional judgment.

Federal health privacy regulations, commonly known as the Health Insurance Portability and Accountability Act (HIPAA) regulations, came into effect in April 2003. Many clinicians and institutions have relied on consultants and risk managers to tell them how to implement these regulations. Much of the controversy and confusion over the HIPAA regulations concern so-called incidental disclosures. Some interpretations of the privacy regulations would limit essential communication and compromise good patient care. This article analyzes misconceptions regarding what the regulations say about incidental disclosures and discusses the reasons for such misunderstandings. Many misconceptions arise from gaps in the regulations. These gaps are appropriately filled by professional judgment informed by ethical guidelines. The communication should be necessary and effective for good patient care, and the risks of a breach of confidentiality should be proportional to the likely benefit for the patient's care. The alternative for communication should be impractical. We offer specific recommendations to help physicians think through what incidental disclosures in patient care are ethically permissible and what safeguards ought to be taken. Physicians should work with risk managers and practice administrators to develop policies that promote good communication in patient care, while taking appropriate steps to protect patient privacy.

Confidentiality↗
PubMed2005

C-reactive protein is a risk indicator for atrial fibrillation after myocardial revascularization.

BACKGROUND: Activation of the complement system after coronary artery bypass graft surgery involves C-reactive protein (CRP). This inflammatory response is related to baseline CRP levels and associated with postoperative arrhythmia, in particular atrial fibrillation (AF). We investigated whether baseline CRP levels are a risk indicator for the occurrence of AF and whether this phenomenon is cardiopulmonary bypass dependent. METHODS: C-reactive protein was measured in perioperative blood samples of patients of the Octopus Study (coronary artery bypass graft surgery with [n = 73] or without cardiopulmonary bypass [n = 79]). Baseline CRP was dichotomized into a low and a high baseline group, using a cutoff value of 3.0 mg/L. RESULTS: After coronary artery bypass graft surgery with cardiopulmonary bypass 11 of 53 patients (21%) with low preoperative CRP levels had AF versus 11 of 20 patients (55%) with high baseline CRP levels (p = 0.01). In the off-pump group AF occurred in 4 of 52 patients (8%) who had low baseline CRP levels, versus 8 of 27 patients (30%) with high preoperative CRP levels (p = 0.002). After adjusting for age, the odds ratio (95% confidence interval) was 4.6 (1.4 to 15.3) with cardiopulmonary bypass, 3.7 (0.93 to 14.7) in the off-pump group, and 3.3 (1.4 to 7.6) for both groups together. Continuous baseline CRP was an independent predictor for AF in a multivariate logistic regression model (p = 0.02). CONCLUSIONS: Patients with high baseline CRP levels are at higher risk of having postoperative AF in both on-pump and off-pump surgery.

Aged↗
PubMed2005

Institutional review board guidance on pediatric research: missed opportunities.

OBJECTIVE: To examine whether and how institutional review boards (IRBs) are using their web-sites to provide guidance to investigators conducting pediatric research. STUDY DESIGN: We studied guidance on pediatric research from IRB web-sites at the 25 US medical schools, plus affiliated hospitals, research centers, and public health schools, and the top National Institutes of Health-funded (>5 million dollars) children's hospitals with separate IRBs. We also included 1 IRB that was not otherwise eligible because other IRBs use its web-based research ethics training program. Our final study population was 39 IRB web-sites. RESULTS: IRB web-sites generally provide basic information about pediatric research. However, few IRBs discuss important ethical issues on which the regulations are silent. Moreover, some IRBs provide incorrect advice about the regulations. More detailed IRB guidance may help pediatric investigators think through ethical issues and protect children in clinical research. Helpful approaches we identified include checklists and "points to consider," concrete examples to illustrate regulatory requirements, and discussion of areas of controversy. CONCLUSION: Few IRBs present the kind of detailed guidance that investigators might need to ensure ethically designed protocols. IRBs should revise their web-sites to ensure that they provide accurate, comprehensive, and sufficiently detailed guidance.

Child↗
PubMed2004

Resuscitating advance directives.

Advance directives have not fulfilled their promise of facilitating decisions about end-of-life care for incompetent patients. Many legal requirements and restrictions concerning advance directives are counterproductive. Requirements for witnessing or notarizing advance directives make it difficult for patients to complete a written directive during a physician visit. State laws that establish a hierarchy of family surrogates for incompetent patients who have not appointed a proxy are inflexible and may not apply to common clinical situations. Advance directives would be more useful if they emphasized discussing end-of-life care with physicians rather than completing a legal document. State laws should be revised to encourage patients to discuss advance directives with physicians and to complete them during an office visit. Such patient-physician discussions about end-of-life care can lead to more informed patient decisions. Procedures for written advance directives should be simplified. Patients should be able to designate health care proxies through oral statements to physicians. These reforms will encourage discussions between patients and physicians about advance directives and may lead to more informed decisions near the end of life.

Advance Directives↗
PubMed2004

How pediatricians counsel parents when no "best-choice" management exists: lessons to be learned from hypoplastic left heart syndrome.

BACKGROUND: Hypoplastic left heart syndrome (HLHS) is a life-threatening congenital cardiac defect. Three mutually exclusive management options exist: the Norwood palliative procedure, cardiac transplantation, and comfort care without surgical intervention. OBJECTIVES: To assess which management options are presented to parents of infants with HLHS, and to determine what factors influence physicians' recommendations. DESIGN: Cross-sectional survey. SETTING: Fourteen of the largest pediatric cardiac surgery centers in the United States. PARTICIPANTS: Attending physicians in neonatology, cardiology, critical care practice, and cardiac surgery. INTERVENTION: A survey was distributed asking physicians what options they present to parents of infants with HLHS and what their recommendations are in general, as well as physician perceptions of HLHS outcomes and demographic information. MAIN OUTCOME MEASURES: Which options physicians discuss and which they recommend. RESULTS: Of 454 eligible physicians 257 (57%) responded to the survey, of which 110 make treatment recommendations to parents. Neonatologists were least likely to recommend surgery. Physicians who recommend surgery recommend procedures performed at their own institution over those performed elsewhere (odds ratio, 2.80; 95% confidence interval, 2.24-3.51). Twenty-six percent of physicians do not discuss nonsurgical management, and 25% of those at centers that do not perform cardiac transplantation do not discuss this option. The recommendations physicians make to parents are poorly associated with their predictions of postoperative outcomes. CONCLUSIONS: Physician recommendations to parents are poorly associated with their estimates of outcomes, and some physicians recommend the treatment preferred at their own institution over other options even when they predict better outcomes from another approach. Further, many physicians do not disclose all reasonable management options to parents of infants with HLHS. These findings raise doubts as to whether parents are given adequate information to make truly informed decisions.

Adult↗
PubMed2004

Informed consent in human oocyte, embryo, and embryonic stem cell research.

Research with human oocytes, embryos, and additional embryonic stem cell lines is needed to address important scientific questions and to fulfill the promise of stem cell transplantation for degenerative diseases. Proponents need to develop guidelines for the appropriate conduct of embryonic stem cell research. Such guidelines will help build public trust and acceptance for this research. In this article, we offer recommendations for informed consent, discussing who should give consent, what the consent process should cover, when consent should be obtained, and who should obtain consent. Consent to use embryos for research should be obtained from oocyte and sperm donors as well as from the woman or couple undergoing infertility treatment. The consent discussion must cover information that donors need to know to make an informed decision about various types of research. Donations for research should be discussed at the initiation of advanced infertility treatment and reconfirmed if possible at the time of actual donation for research. Treating assisted reproduction technology physicians can help with the consent process, provided that they are not involved in the research.

Embryo, Mammalian↗
PubMed2004

Patient-centered communication: do patients really prefer it?

OBJECTIVE: To investigate patient preferences for a patient-centered or a biomedical communication style. DESIGN: Randomized study. SETTING: Urgent care and ambulatory medicine clinics in an academic medical center. PARTICIPANTS: We recruited 250 English-speaking adult patients, excluding patients whose medical illnesses prevented evaluation of the study intervention. INTERVENTION: Participants watched one of three videotaped scenarios of simulated patient-physician discussions of complementary and alternative medicine (CAM). Each participant watched two versions of the scenario (biomedical vs. patient-centered communication style) and completed written and oral questionnaires to assess outcome measurements. MEASUREMENTS AND MAIN RESULTS: Main outcome measures were 1) preferences for a patient-centered versus a biomedical communication style; and 2) predictors of communication style preference. Participants who preferred the patient-centered style (69%; 95% confidence interval [CI], 63 to 75) tended to be younger (82% [51/62] for age < 30; 68% [100/148] for ages 30-59; 55% [21/38] for age > 59; P < .03), more educated (76% [54/71] for postcollege education; 73% [94/128] for some college; 49% [23/47] for high school only; P= .003), use CAM (75% [140/188] vs. 55% [33/60] for nonusers; P= .006), and have a patient-centered physician (88% [74/84] vs. 30% [16/54] for those with a biomedical physician; P < .0001). On multivariate analysis, factors independently associated with preferring the patient-centered style included younger age, use of herbal CAM, having a patient-centered physician, and rating a "doctor's interest in you as a person" as "very important." CONCLUSIONS: Given that a significant proportion of patients prefer a biomedical communication style, practicing physicians and medical educators should strive for flexible approaches to physician-patient communication.

Adult↗