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Biomedical subjects

Donald L Rosenstein

Publications and source records attributed to Donald L Rosenstein.

15 recordsLinked to original sources
PubMed2006

Psychotropic medication use in pediatric patients with cancer.

BACKGROUND: Use of psychotropic medication in medically ill adults, in particular, patients with cancer, is common. While increased use of psychotropic medications in children and adolescents in the general population has been reported, little is known about the prescribing practices for these medications in medically ill children. OBJECTIVE: To examine the frequency and types of psychotropic medications used in a population of children and adolescents with cancer. DESIGN: Retrospective review of the National Institutes of Health Medical Information System. SETTING: Pediatric Oncology Branch of the National Cancer Institute, National Institutes of Health. PARTICIPANTS: Three hundred forty-seven patients aged 1 to 21 years who were enrolled in clinical research trials at the Pediatric Oncology Branch between January 2000 and December 2003. MAIN OUTCOME MEASURES: Psychotropic medication use was analyzed according to cancer diagnosis and patient age. RESULTS: Fourteen percent of identified patients had been prescribed at least 1 psychotropic medication at the time of National Cancer Institute clinical trial enrollment. The most commonly used medications were anticonvulsant agents (8%) and antidepressant medications (7%), in particular, selective serotonin reuptake inhibitors. Anxiolytic medications could not be accurately assessed because of their frequent use as antiemetic agents in many chemotherapy regimens. Psychostimulant use was rare. CONCLUSIONS: This study suggests that psychotropic medications are commonly prescribed to children and adolescents with cancer. Clinical safety and efficacy trials are needed in medically ill children at high risk for mood and anxiety symptoms.

Adolescent↗
PubMed2006

The nature and power of the placebo effect.

Progress in understanding the placebo effect and its clinical significance depends on conceptual clarification of this elusive phenomenon and critical appraisal of research bearing on the influence of placebo interventions on clinical outcomes. Here we locate the placebo effect within a typology of modes of healing, distinguish between the observed placebo response in randomized controlled trials and the placebo effect, and examine critically a recent meta-analysis of clinical trials that challenges the reality of the placebo effect.

Analgesia↗
PubMed2005

Magnesium (mg) retention and mood effects after intravenous mg infusion in premenstrual dysphoric disorder.

BACKGROUND: Conflicting data exist regarding the presence of magnesium (Mg) deficiency and the therapeutic efficacy of Mg in premenstrual syndrome or premenstrual dysphoric disorder (PMDD). METHODS: The % Mg retention was determined using 24-hour urinary Mg excretion and the total dose of Mg given intravenously. In women with (n = 17) and without (n = 14) prospectively diagnosed PMDD, several blood measures of Mg and mood were obtained before, immediately after, and the day following an intravenous Mg (.1 mmol/kg) loading dose. A positive mood response was seen under open conditions; as open Mg infusion improved mood, subsequent PMDD patients (n = 10) were randomized in a double-blind, placebo-controlled, crossover fashion. RESULTS: Patients (31.5%) and control subjects (27.5%) retained comparable mean percentages of Mg. Neither group differed in measures of mean Mg before, immediately after, or the day following Mg infusion. Although there was a time effect for all mood measures in the patient group (p < .01 for all), there was neither a treatment nor time-by-treatment effect. CONCLUSIONS: Contrary to prior reports, we found no evidence of Mg deficiency in women with PMDD compared with control subjects. Furthermore, Mg was not superior to placebo in the mitigation of mood symptoms in women with PMDD.

Adult↗
PubMed2005

Research with stored biological samples: what do research participants want?

BACKGROUND: There is widespread disagreement about the type of consent needed for research with stored biological samples. Many believe consent for each future use is required to respect individuals. Others worry this approach may block important research. METHODS: We analyzed 1670 consent forms signed by research participants at the Warren G. Magnuson Clinical Center, National Institutes of Health, between January 1, 2000, and May 31, 2002, that offer options for future research with participants' biological samples. The research participants were healthy volunteers, family members of affected individuals, and individuals with a broad range of medical conditions enrolled in clinical research studies with and without the prospect of direct medical benefit. RESULTS: Overall, 87.1% of research participants given the option chose to authorize future research on any medical condition. More than 85% permitted unlimited future research with their stored biological samples regardless of sex, age, geographic location, or whether the individual was affected by the disease being studied or a healthy volunteer. Only 6.7% of those given the option to refuse all future research did so. Although African Americans were less likely to permit future research, 75.0% of African Americans still authorized unlimited future research with their samples. CONCLUSIONS: Most research participants authorize the unlimited future research use of their biological samples when given the opportunity to do so. These findings suggest that providing research participants with a simple binary choice to authorize or refuse all future research might allow individuals to control use of their samples, simplify consent forms, and allow important research to proceed.

Biological Specimen Banks↗
PubMed2004

Ethical issues concerning research in complementary and alternative medicine.

The use of complementary and alternative medicine (CAM) has grown dramatically in recent years, as has research on the safety and efficacy of CAM treatments. Minimal attention, however, has been devoted to the ethical issues relating to research on CAM. We argue that public health and safety demand rigorous research evaluating CAM therapies, research on CAM should adhere to the same ethical requirements for all clinical research, and randomized, placebo-controlled clinical trials should be used for assessing the efficacy of CAM treatments whenever feasible and ethically justifiable. In addition, we explore the legitimacy of providing CAM and conventional therapies that have been demonstrated to be effective only by virtue of the placebo effect.

Biomedical Research↗
PubMed2004

Decision-making capacity and disaster research.

The extent to which victims of a disaster are able to make capacitated and voluntary decisions to enroll in research is an important and virtually unexplored question. Although there are no compelling data to suggest that experiencing a severe trauma, in and of itself, renders all or even most individuals incapable of making autonomous decisions, the assessment of decision-making capacity (DMC) for research participation warrants serious consideration. This paper provides a framework for and procedural approach to the assessment of DMC in research with individuals exposed to disaster. Particular attention is paid to the implementation of additional safeguards to protect subjects who are vulnerable by virtue of impaired DMC. Recommendations are offered to clinical investigators, ethical review boards, and policymakers with regard to the design, review, and conduct of research in the aftermath of disaster.

Decision Making↗
PubMed2003

Ethical considerations in psychopharmacological research involving decisionally impaired subjects.

RATIONALE: Research subjects who are unable to provide informed consent must be protected from exploitation. The federal regulations governing human subjects research mandate additional protections for "mentally disabled" subjects but include neither a definition of this "vulnerable" population nor any guidance on what safeguards should be employed or how they should be implemented. OBJECTIVES: This article begins with a definition of vulnerability due to a mental disorder in the context of the clinical research setting. It is organized along the following sequential phases of psychopharmacological research: study design and methodology; protocol review; subject recruitment and enrollment; conduct and monitoring of the study; and manuscript preparation and publication. Practical recommendations are then offered to clinical researchers and Institutional Review Boards (IRBs) for implementing additional protections for decisionally impaired subjects at each phase of the psychopharmacological research process. METHODS: A computer-assisted literature review was performed to identify descriptions of safeguards for decisionally impaired subjects. Recommendations for additional protections were also drawn from the authors' experiences with the IRB review process and the conduct and monitoring of clinical research with decisionally impaired subjects. RESULTS: The use of informed consent monitoring and the independent assessment of decision-making capacity are two feasible safeguards that IRBs can mandate for research with decisionally impaired subjects. There has been little systematic implementation of other safeguards such as research advance directives or prospective authorization for research participation. CONCLUSIONS: Clinical investigators and IRBs are under considerable scrutiny with respect to the protection of decisionally impaired research subjects. There is a pressing need for data-driven strategies for the optimal protection of decisionally impaired research subjects.

Biomedical Research↗
PubMed2003

Clinical research and the physician-patient relationship.

All practicing physicians should be prepared to respond to requests from patients for advice about participating in clinical trials research. Even physicians who choose not to conduct clinical trials but rather devote their practice to clinical care may have patients who consider volunteering for research. In advising patients about clinical research, physicians enhance the physician-patient relationship and contribute to the overall goals of evidence-based medicine. We discuss several ethical and practical challenges facing physicians who wish to help their patients make decisions about volunteering for clinical trials. In addition, we suggest how preparation for advising patients about clinical research participation can be incorporated into the medical education process.

Clinical Trials as Topic↗
PubMed2003

Ethical aspects of research into the etiology of autism.

Advances in understanding autism and other developmental neuropsychiatric disorders will come from an integration of various research strategies including phenomenologic, functional neuroimaging, and pharmacologic methods, as well as epidemiologic approaches aimed at identifying genetic and environmental risk factors. The highly heritable nature of autism makes it scientifically valuable to involve parents and siblings as research participants. However, many studies on autism pose ethical challenges because they do not offer the prospect of direct benefit to subjects. In this article, we present an in-depth ethical analysis of current nontherapeutic research strategies that are common in autism research. The ethical analysis applies a proposed ethical framework for evaluating clinical research focusing on seven ethical requirements: (1) social or scientific value, (2) scientific validity, (3) fair subject selection, (4) favorable risk-benefit ratio, (5) independent review, (6) informed consent, and (7) respect for potential and enrolled research participants.

Autistic Disorder↗
PubMed2002

Reporting of ethical issues in publications of medical research.

Clinical investigators rarely describe the rationale for ethically controversial features of study design or procedures instituted to enhance the protection of patients taking part in research, or how they ensured informed consent. We recommend a policy of extensive reporting of pertinent ethical issues to promote public accountability for clinical research. Guidelines are presented, and possible objections to this recommended policy are addressed.

Ethics, Research↗
PubMed2002

National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders.

A consensus conference on the use of placebo in mood disorder studies consisted of expert presentations on bioethics, biostatistics, unipolar depression, and bipolar disorder. Work groups considered evidence and presented statements to the group. Although it was not possible to write a document for which there was complete agreement on all issues, the final document incorporated input from all authors. There was consensus that placebo has a definite role in mood disorder studies. Findings of equivalence between a new drug and standard treatment in active control studies is not evidence of efficacy unless the new drug is also significantly more effective than placebo. Add-on studies in which patients are randomized to standard therapy plus the investigational drug or standard therapy plus placebo are especially indicated for high-risk patients. Mood disorders in elderly and pediatric patients are understudied, and properly designed trials are urgently needed. Research is needed on the ethical conduct of studies to limit risks of medication-free intervals and facilitate poststudy treatment. Patients must fully understand the risks and lack of individualized treatment involved in research.

Bipolar Disorder↗
PubMed2002

Enrolling decisionally impaired adults in clinical research.

Progress in diagnosing, treating, and preventing medical conditions that impair decision-making abilities depends on clinical research involving individuals who may be either unable to or have diminished ability to give informed consent. Such research, however, raises ethical concern and controversy about the potential exploitation of these vulnerable individuals. This article addresses a range of ethical and practical issues concerning the enrollment of adults who are decisionally impaired, and those at risk of becoming so, in clinical research. These include (1) the relationship of decision-making capacity to competence, and the framework for determining competence in adults receiving clinical care and making treatment decisions for those who lack competence; (2) the differences between clinical practice and clinical research that influence the criteria for permissible research involving incompetent adults and the applicability of the framework guiding treatment decisions to clinical research decisions; and (3) the regulatory framework developed to guide the ethical participation of children in research and its applicability to determining the scope and limits of research with incompetent adults.

Adult↗