Search PubMed⌕ Search

Biomedical subjects

Steven Joffe

Publications and source records attributed to Steven Joffe.

At least 19 recordsLinked to original sources
PubMed2007

Advance care planning in patients undergoing hematopoietic cell transplantation.

Few data are available on the prevalence of advance care planning (ACP) in patients undergoing hematopoietic cell transplantation (HCT). We surveyed adult patients pre-HCT to ascertain completion of various elements of ACP. We also reviewed medical records for documentation of discussions regarding ACP and for the presence of written advance directives. Evaluable surveys were returned by 155 of 335 patients (46%) who underwent HCT during the study period; we obtained permission for medical record review from 137 of these 155 survey respondents (88%). We found that 69% of the respondents reported having designated a health care proxy, 44% had completed a living will, 61% had prepared an estate will, and 63% had discussed their wishes regarding life support with family and friends. In contrast, only 16% had discussed their wishes regarding life support with their clinicians. Documentation of discussions between clinicians and patients regarding most elements of ACP was rare. Written advance directives were present in the charts of 54 patients (39%). ACP was more common in older, college-educated, and allogeneic transplant patients. Even though ACP was more prevalent among this sample than in the general population, its use still could be enhanced, given the high risks of decisional incapacity and death that HCT patients face.

Adult↗
PubMed2006

Patients' views on financial conflicts of interest in cancer research trials.

BACKGROUND: Financial ties between researchers or medical centers and companies whose drugs are being tested have come under increasing scrutiny. METHODS: We conducted in-person interviews with 253 patients in cancer-research trials (a 93% response rate) at five U.S. medical centers to determine their attitudes regarding potential financial conflicts of interest among researchers and medical centers. RESULTS: More than 90% of patients expressed little or no worry about financial ties that researchers or institutions might have with drug companies. Most patients said they would have enrolled in the trial even if the drug company had paid the researcher for speaking (82% of those interviewed) or consulting (75%) or if the researcher had received royalty payments (70%) or owned stock in the company (76%). Similarly, most patients would have enrolled in the trial if their cancer center had owned stock in the drug company (77%) or received royalty payments from the company (79%). Most patients believed it was ethical for researchers to receive speaking fees (81%) or consulting fees (82%) from the company. However, a substantial minority of patients wanted disclosure of the oversight system for researchers (40%) and of researchers' financial interests (31%); 17% thought no disclosure to patients was necessary. CONCLUSIONS: Most patients in cancer-research trials were not worried about financial ties between researchers or medical centers and drug companies and would still have enrolled in the trial if they had known about such financial ties. A substantial minority wanted to be informed about the oversight system to protect against financial conflicts of interest and about researchers' financial interests.

Aged↗
PubMed2006

Ethical issues in cancer genetics: I 1) whose information is it?

This article presents and discusses four clinical cases that exemplify the complexity of ethical dilemmas concerning the provider's obligation to disclose or withhold genetic information from patients. Case 1: What is the responsibility of the cancer genetics provider to ensure that a positive test results is shared with distant relatives? Case 2: To ensure that results go to at-risk relatives, do we have the right to ignore the wishes of the designated next-of-kin? Case 3: Do we have the right to reveal a familial BRCA1 mutation to a patient's relative, who is at 50% risk? Case 4: Do we have an obligation to reveal that a patient is not a blood relative and therefore, not at risk to have inherited a familial mutation? These cases form the basis for discussing the provider's dual obligations to keeping patient confidentiality and informing patients and families about risk (i.e. duty to warn). We also provide a summary of consensus points and additional discussion questions for each case.

Adaptor Proteins, Signal Transducing↗
PubMed2006

Direct-to-consumer advertising in oncology.

Shortly before his death in 1995, Kenneth B. Schwartz, a cancer patient at Massachusetts General Hospital (MGH), founded The Kenneth B. Schwartz Center at MGH. The Schwartz Center is a nonprofit organization dedicated to supporting and advancing compassionate health care delivery, which provides hope to patients and support to caregivers while encouraging the healing process. The center sponsors the Schwartz Center Rounds, a monthly multidisciplinary forum in which caregivers reflect on important psychosocial issues faced by patients, their families, and their caregivers, and gain insight and support from fellow staff members. Increasingly, cancer patients are subjected to advertisements related to oncologic therapies and other cancer-related products in the popular media. Such direct-to-consumer advertising is controversial: while it may inform, educate, and perhaps even empower patients, it also has the ability to misinform patients, and strain their relationships with oncology providers. The U.S. Food and Drug Administration requires that direct-to-consumer advertising provide a balanced presentation of a product's benefits, risks, and side effects, but this can be difficult to achieve. Through a discussion of this topic by an oncology fellow, ethicist, cancer survivor, and senior oncologist, the role of direct-to-consumer advertising and its often subtle effects on clinical practice in oncology are explored. Although sparse, the medical literature on this increasingly prevalent type of medical communication is also reviewed.

Academic Medical Centers↗
PubMed2005

Informed consent for medical treatment and research: a review.

The practice of informed consent has historical roots in various disciplines, including medicine, moral philosophy, and the law. It is closely tied to philosophical notions of respect for persons and respect for individual autonomy. Consent to treatment is rooted in case law. Consent to research, in contrast, has its basis in ethical codes, statutes, and administrative regulations, with the courts playing a lesser role. In this article, we define the elements of informed consent in the treatment setting, outline its ethical and legal foundations, and explore some of its limitations. We contend that informed consent plays a critical role in clinical medicine but that other models of decision making deserve consideration under particular circumstances. We also delineate the current federal regulatory schemes guiding human subject research in the U.S., highlight how consent to research differs from consent to treatment, and explore the difficulties that arise in research involving cancer patients and certain vulnerable populations.

Humans↗
PubMed2004

Physicians' attitudes about quality-of-life issues in hematopoietic stem cell transplantation.

Studies investigating quality of life (QOL) after hematopoietic stem cell transplantation demonstrate the spectrum of QOL outcomes awaiting survivors. Nevertheless, how transplantation physicians interpret and apply QOL information to clinical practice is poorly understood. We conducted a cross-sectional survey of transplantation physicians to address these issues and received 180 (24%) responses from physicians in 29 countries. Seventy-two percent reported that their patients are willing to accept poor QOL for a small chance of cure. Only 28% said that QOL considerations "often" or "almost all the time" enter into patients' decisions about transplantation. This contrasted with physicians' reported attention to QOL in their discussions with patients. Although 53% of physicians reported using QOL results to modify practice, 55% would be more likely to use these data if they were more understandable. To ensure generalizability of the results, a validation sample was randomly selected, and these 85 physicians (response rate, 76%) confirmed the findings of the original survey. Given the extensive data regarding posttransplantation QOL, resources should be devoted to exploring how patients and physicians use these data in clinical care and in devising methods to ensure that QOL results are interpretable and relevant to patients and physicians.

Adaptation, Psychological↗
PubMed2004

Satisfaction of the uncertainty principle in cancer clinical trials: retrospective cohort analysis.

OBJECTIVE: To assess whether publicly funded adult cancer trials satisfy the uncertainty principle, which states that physicians should enroll a patient in a trial only if they are substantially uncertain which of the treatments in the trial is most appropriate for the patient. This principle is violated if trials systematically favour either the experimental or the standard treatment. DESIGN: Retrospective cohort study of completed cancer trials, with randomisation as the unit of analysis. SETTING: Two cooperative research groups in the United States. STUDIES INCLUDED: 93 phase III randomised trials (103 randomisations) that completed recruitment of patients between 1981 and 1995. MAIN OUTCOME MEASURES: Whether the randomisation favoured the experimental treatment, the standard treatment, or neither treatment; effect size (outcome of the experimental treatment compared with outcome of the standard treatment) for each randomisation. RESULTS: Three randomisations (3%) favoured the standard treatment, 70 (68%) found no significant difference between treatments, and 30 (29%) favoured the experimental treatment. The average effect size was 1.20 (95% confidence interval 1.13 to 1.28), reflecting a slight advantage for the experimental treatment. CONCLUSIONS: In cooperative group trials in adults with cancer, there is a measurable average improvement in disease control associated with assignment to the experimental rather than the standard arm. However, the heterogeneity of outcomes and the small magnitude of the advantage suggest that, as a group, these trials satisfy the uncertainty principle.

Clinical Trials, Phase III as Topic↗
PubMed2004

Oncology physician and nurse practices and attitudes regarding offering clinical trial results to study participants.

Despite recent interest on the part of advocates and researchers of oncology clinical trials in sharing study results, participants in these trials are not routinely informed about the results. We identified oncology physicians and nurses through the Cancer and Leukemia Group B database and surveyed them about sharing clinical trial results with participants. Of 1977 eligible members, 796 (40.3%) responded to the mailed survey, 497 (62.4%) of whom reported that they offer trial results to participants less than one-fifth of the time. A total of 576 (72.4%) of responders believed that most patients want to know the results of studies, and 634 (79.7%) of responders expressed willingness to offer results to most study participants in the future, believing that most patients want to know trial results and that routinely offering results would not have a negative effect on patients. Concerns of some responders about routinely offering trial results included negative emotional effect on patients, patient difficulty understanding the information, and resources required to offer the results. Of concern, 16.2% (129/796) of responders believed an obligation to offer results to study participants would make them less likely to enroll patients on studies. Future studies should consider sharing trial results with patients and evaluating the process and its effect on both patients and clinicians.

Adult↗
PubMed2004

Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review.

BACKGROUND: Many oncologists believe that patients with cancer who enroll in clinical trials have better outcomes than those who do not enroll. We aimed to assess the empirical evidence that such a trial effect exists. METHODS: We developed a conceptual framework for comparison of trial and non-trial patients. We then did a comprehensive literature search to identify studies that compared outcomes between these groups. We critically evaluated these studies to assess whether they provide valid and generalizable support for a trial effect. FINDINGS: We identified 26 comparisons, from 24 published articles, of outcomes among cancer patients enrolled and not enrolled in clinical trials. 21 comparisons used retrospective cohort designs. 14 comparisons provided some evidence that patients enrolled in trials have improved outcomes. However, strategies to control for potential confounding factors were inconsistent and frequently inadequate. Only eight comparisons restricted non-trial patients to those meeting trial eligibility criteria. Of these, three noted better outcomes in trial patients than in non-trial patients. Children with cancer, patients with haematological malignant disease, and patients treated before 1986 were disproportionately represented in positive studies. INTERPRETATION: Despite widespread belief that enrollment in clinical trials leads to improved outcomes in patients with cancer, there are insufficient data to conclude that such a trial effect exists. Until such data are available, patients with cancer should be encouraged to enroll in clinical trials on the basis of trials' unquestioned role in improving treatment for future patients.

Clinical Trials as Topic↗
PubMed2002

Views of American oncologists about the purposes of clinical trials.

BACKGROUND: Many research subjects believe incorrectly that the primary purpose of clinical trials is to benefit the participants rather than to improve therapy for future patients. However, few data are available about how physicians view trials. METHODS: We mailed surveys to a stratified random sample (n = 1120) of U.S. medical, pediatric, and other oncology specialists who were selected from the American Society of Clinical Oncology Membership Directory. Respondents were asked to select, from a list of options, their reasons for enrolling individual patients in trials and what they thought the main societal purposes of clinical trials are. We used logistic regression models to evaluate which demographic and clinical practice characteristics were associated with responses to these questions. All statistical tests were two-sided. RESULTS: Of the 547 physicians (48.8%) who responded, 40.5% of the medical oncologists, 32.3% of the pediatric oncologists, and 62.6% of the other oncology subspecialists reported enrolling individual patients in clinical trials to improve future therapy. Most of the other respondents reported enrolling patients to ensure that they received state-of-the-art treatment. When asked about the main societal purpose of clinical trials, 72.7% of the medical oncologists, 59.4% of the pediatric oncologists, and 81.9% of the other oncology subspecialists cited improving future therapy; most of the other respondents cited ensuring state-of-the-art treatment for participants. In multivariable analysis, medical oncologists (odds ratio [OR] = 0.6, 95% confidence interval [CI] = 0.3 to 0.9) and pediatric oncologists (OR = 0.3, 95% CI = 0.2 to 0.5) were less likely than other oncologists to identify improving future therapy as the main societal purpose of clinical trials, whereas industry physicians (OR = 4.6, 95% CI = 1.1 to 20.5) chose this option more often than physicians who did not work for industry. CONCLUSIONS: Many respondents viewed the main societal purpose of clinical trials as benefiting the participants rather than as creating generalizable knowledge to advance future therapy. This view, which was more prevalent among specialists such as pediatric oncologists that enrolled greater proportions of patients in trials, conflicts with established principles of research ethics.

Adult↗
PubMed2002

Chronic disseminated intravascular coagulation and childhood-onset skin necrosis resulting from homozygosity for a protein C Gla domain mutation, Arg15Trp.

A toddler of Haitian descent presented with an 18-month history of chronic consumption coagulopathy, followed by catastrophic skin necrosis. Protein C deficiency (1% to 3% of control) was noted by functional assay; chromogenic assay and antigen levels were 30% of control. Plasma infusion abrogated the disseminated intravascular coagulation-like state. The authors identified a homozygous mutation, C1432T, resulting in a missense, Arg15Trp, in the gamma-carboxyglutamate domain of the protein. Chronic consumption coagulopathy without purpura fulminans or venous thrombosis is a rare presentation of defective protein C pathway. The result of this mutation is a mixed type I (low antigen) and type II (low function) phenotype.

Amino Acid Sequence↗