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M H Biros

Publications and source records attributed to M H Biros.

At least 37 records · Page 2Linked to original sources
PubMed1999

Research fundamentals VI: misconduct in biomedical research.

The goal of medical research is the acquisition and application of new knowledge for the benefit of individual patients and society as a whole. Achieving this goal requires excellence in scientific methodology, honesty in data collection and interpretation, and realistic assessment of the implications of the findings. Underlying all steps in the acquisition of new knowledge is the absolute need for application of the highest ethical standards for research. Occasionally, ethical principles of research are breached because of lack of understanding or the carelessness of researchers. However, researchers have the obligation to know and apply basic principles of research ethics in order to avoid, prevent, or recognize deviations from ethical scientific behavior. When intentional violations of the principles of ethical research occur, the impact to the scientific and lay community can be profound. Misconduct can be prevented if the ethical principles of research are understood and consistently applied. This paper describes the sources and detection of misconduct in the production of science in order to provide emergency researchers with the knowledge needed to prevent misconduct from occurring at all.

Bias↗
PubMed1998

Supporting emergency medicine research: developing the infrastructure.

The long-term goals of developing research within the specialty of emergency medicine include the following: (1) to continue to improve the quality and quantity of emergency patient care; (2) to maximize the research potential of emergency health care professionals to develop new emergency research talent and enthusiasm; and (3) to establish the academic research credentials of the specialty of emergency medicine to become competitive for federal research funding, and further improve emergency patient care. This article addresses the process by which the infrastructure for emergency medicine research can be developed at academic medical centers and provides recommendations. The roles of the academic chair, research director, senior researcher, and departmental faculty are discussed.

Academic Medical Centers↗
PubMed1998

Supporting emergency medicine research: developing the infrastructure.

The long-term goals of developing research within the specialty of emergency medicine (EM) include the following: 1) to continue to improve the quality and quantity of EM research in order to ultimately improve emergency patient care; 2) to maximize the research potential of emergency health care professionals in order to develop new emergency research talent and enthusiasm; and 3) to establish the academic research credentials of the specialty of EM in order to become competitive for federal research funding, and further improve emergency patient care. This article addresses the process by which the infrastructure for EM research can be developed at academic medical centers and provides recommendations. The roles of the academic chair, research director, senior researcher, and departmental faculty are discussed.

Academic Medical Centers↗
PubMed1998

The power of words.

Explore the source record for details and available documents.

Emergency Medicine↗
PubMed1998

Emergency medicine and the development of the Food and Drug Administration's final rule on informed consent and waiver of informed consent in emergency research circumstances.

This article reviews the federal regulations for emergency and acute resuscitation research in effect prior to October 1996, the historical issues that contributed to the development of these regulations, the controversies that arose surrounding the application of these regulations to emergency research circumstances, and the methods by which the regulations were changed. The new regulations introduced by the U.S. Food and Drug Administration (FDA) also are reviewed.

Disclosure↗
PubMed1996

Effects of chemical pretreatment on posttraumatic cortical edema in the rat.

The purpose of this study was to evaluate the effects of mannitol (Man), dexamethasone (DM), dichloroacetic acid (DCA) and 1,3-butanediol (BD) in reduction of posttraumatic cortical edema following brain deformation injury to rats. Ten minutes prior to fluid percussion injury, each animal received one of four pretreatments or placebo: Man, 1 g/kg intravenously, DM 3.0 mg/kg intravenously, DCA 25 mg/kg intraperitoneally BD 0.5 mg/kg intraperitoneally (n = 12 per treatment group), or equivolume saline (n = 8 per corresponding trauma group). Six hours after trauma, cortical tissue was harvested. Using a benzene-kerosene gradient column calibrated with potassium sulfate standards, the specific gravity (SpG) of cortical tissue from each group was measured and compared (ANOVA, P < .05). The measured cortical SpG from traumatized animals receiving Man (mean 1.037 +/- SEM .001), DCA (1.038 +/- .001), and BD (1.039 +/- .001) were equal to SpG from untraumitized cortex (1.041 +/- .001), and were significantly greater than SpG from traumatized cortex for animals receiving DM (1.035 +/- .001) or placebo (1.033 +/- .002). Pretreatment with DCA, Man, and BD appears to protect against development of posttraumatic cortical edema when measured 6 hours after blunt head trauma in the rat. Each of these chemical treatments appears effective in preventing or reducing posttraumatic cortical edema.

Animals↗
PubMed1996

Research directions in emergency medicine.

The goal of emergency medicine is to improve health while preventing and treating disease and illness in patients seeking emergency medical care. Improvements in emergency medical care and the delivery of this care can be achieved through credible and meaningful research efforts. Improved delivery of emergency medical care through research requires careful planning and the wise use of limited resources. To achieve this goal, emergency medicine must provide appropriate training of young investigators and attract support for their work. Promotion of multidisciplinary research teams will help the specialty fulfill its goals. The result will be the improvement of emergency medical care which will benefit not only the patients emergency physicians serve but also, ultimately, the nation's health.

Emergency Medicine↗
PubMed1996

Delayed diagnosis of thoracolumbar fractures in multiple-trauma patients.

OBJECTIVES: To determine the frequency of delayed diagnosis of major thoracolumbar vertebral fractures (T-L Fxs) in ED multiple-trauma patients, and to determine the differences between cases of delayed and nondelayed diagnoses of T-L Fx. METHODS: A retrospective chart review was conducted of 181 trauma patients with 310 major T-L Fxs (compression, burst, or chance Fxs or dislocations). Data collected included the time of the diagnosis of T-L Fx, the patient's clinical presentation in the ED, the mechanism of injury, and the outcome. RESULTS: Of the 181 patients with major T-L Fxs, 138 were diagnosed in the ED (nondelayed group), and 43 were diagnosed after the patient left the ED (delayed group). Of these, 33 cases occurred in unstable patients requiring emergent medical imaging and/or operation, 7 occurred when emergency physicians failed to detect subtle compression Fxs on ED radiographs, and 3 occurred in stable patients who were not radiographed in the ED. The delayed group were more often critical, and hypotensive, and had lower Glasgow Coma Scale (GCS) scores than did the nondelayed group. The delayed group patients also had more cervical spine injuries, multiple noncontiguous spinal Fxs, high-energy mechanisms of injury, and direct blunt assaults to the back than did the nondelayed group patients. There were 13 patients with T-L Fxs, GCS scores = 15, and normal back examinations. There were 43 patients who had neurologic deficits associated with their injuries; 11 patients with incomplete cord lesions progressed, including 3 in the delayed group. CONCLUSIONS: A delay in the diagnosis of T-L Fx in hospitalized trauma patients is frequently associated with an unstable patient condition that necessitates higher-priority procedures than ED T-L spine radiographs. Such patients should receive spinal precautions until more complete evaluation can be performed. The decision to selectively radiograph T-L spines in multiple-trauma patients should consider the mechanism of injury, the presence of possible confounders to physical examination, and clinical signs and symptoms of back injury.

Adolescent↗
PubMed1996

The frequency of unsuspected minor illness or injury in intoxicated patients.

OBJECTIVE: To determine the frequency of unsuspected minor illness or injury in a group of patients frequently seen in the ED for acute intoxication. METHODS: The medical records of the 20 patients seen most frequently in the ED for acute intoxication in 1993 were reviewed for the number of ED visits for intoxication, the number of associated documented episodes of minor trauma or illness, the extent of ED workup of discovered illness or injury, and patient disposition from the ED. RESULTS: The 20 study patients were evaluated in the ED 1,858 times in 1993 for acute intoxication, a mean of 92.5 visits/patient (+/- 26.6). The most frequent injury was minor trauma above the neck, occurring a mean of 9 times (+/- 3.6) in each of the study patients during 1993. Evaluation included repeated neurologic examinations and frequent radiography of the cervical spine (n = 80), skull (n = 5), facial bones (n = 6), and mandible (n = 5). A limited number of head CT scans also were done (n = 8). The most frequent minor illnesses were gastritis (n = 7), managed with hydration, and mild hypothermia (n = 6), managed with passive rewarming. CONCLUSIONS: The incidence of unsuspected minor illness or injury in this patient group was substantial. While most unsuspected medical problems had little clinical significance, some were potentially dangerous, and some necessitated hospitalization (e.g., hypothermia, hematemesis, and respiratory depression).

Acute Disease↗
PubMed1995

Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers.

OBJECTIVE: A coalition conference of acute resuscitation researchers was held to discuss the feasibility of applying current federal research regulations regarding informed consent to the emergency setting. This article presents consensus recommendations for regulatory changes for consent in emergency research. PARTICIPANTS: Representatives from the Society for Academic Emergency Medicine and the American Heart Association identified several professional organizations as stakeholders in this issue, including research, clinical, bioethics, legal, and patient advocacy groups. The Office for Protection From Research Risks (OPRR), the Food And Drug Administration (FDA), and staff from specific legislative offices were also invited to observe. Forty-three participants attended, including representatives from 12 professional organizations, five medical institutions, and the FDA and OPRR. This was a closed meeting. Participants were self-funded or sponsored by their professional organizations. EVIDENCE: Before the meeting, a draft of a position statement was developed by the conference organizers based on the current literature and discussions with experts in the field. This draft, copies of the current federal research regulations, and supporting articles were distributed before the conference. CONSENSUS PROCESS: Participants rotated through moderated discussion sessions to comment on subsections of the draft. Following discussion, a working draft was developed and distributed to each participant and represented organizational board for final review. All comments were considered in the final version of the document. CONCLUSIONS: We believe there are circumstances when it is not feasible to obtain prospective or proxy consent for enrollment into an emergency research protocol. In these circumstances, patients are vulnerable, not only to research risks, but also to being denied potentially beneficial therapy when there is no known effective treatment for their life-threatening condition. We offer recommendations that should be met when the critical nature of the illness or injury or the need to apply an investigational therapy rapidly precludes prospective consent for participation in emergency research.

Consensus↗
PubMed1995

Effect of hypoxia or hyperbaric oxygen on cerebral edema following moderate fluid percussion or cortical impact injury in rats.

This study was designed to evaluate the production of cerebral edema [as measured by tissue specific gravity (SpG)] following moderate fluid percussion (FP) and cortical impact (CI) injury in rodents. To determine the effects of a secondary systemic insult, hypoxia (13% oxygen for 30 min) was added to some experimental groups immediately after head injury. To determine the effects of hyperbaric oxygen (HBO) on injured cortical tissue, additional animal groups were exposed to HBO (1.5 atm, for 60 min), beginning 4 h after head trauma. Both injury models produced equal amounts of tissue edema at the site of injury (mean SpG +/- SEM = 1.035 +/- 0.001), when measured 6 h posttrauma. There was no significant edema at the tissue sites immediately adjacent to the trauma sites. The addition of hypoxia to either injury system did not increase edema formation beyond that produced by injury alone. HBO reduced the water content of the trauma site in animals that had received FP, but not in animals receiving CI. We conclude that with the injury parameters used in this protocol, both FP and CI appear to produce focal cerebral edema at the site of trauma. Hypoxia does not worsen edema. HBO appears to reduce edema produced by FP, but not by CI.

Animals↗
PubMed1991

Experimental head trauma models: a clinical perspective.

The investigation of the biomechanics, biochemistry and functional changes occurring with significant head trauma is a very active and interesting area of scientific research by investigators of many disciplines. Using a variety of head trauma model systems, a tremendous amount of basic knowledge on what occurs to the injured brain has been accumulated over the last two to three decades. Ongoing research on the basic pathophysiology of head trauma as well as on the investigation of potentially useful therapeutic modalities is a current research trend. While a cross-disciplinary approach is necessary and useful in this rapidly expanding area of investigation, much of what is reported is technically difficult to understand and the clinical implications of the stated findings may not be clearly obvious. Some model systems are more suitable to study particular traumatic lesions that are others, and some systems have built-in limitations which must be acknowledged in data interpretation. This articles describes and evaluates some of the currently used head trauma model systems and reviews these systems from a clinician's standpoint.

Animals↗
PubMed1988

Comparison of sodium bicarbonate with dichloroacetate treatment of hyperlactatemia and lactic acidosis in the ischemic rat.

Serum lactic acidosis is characterized by a pH less than 7.25 and lactate greater than 5 mEq. Although sodium bicarbonate (NaHCO3) is standard treatment for this condition, clinical and experimental studies suggest that high doses of NaHCO3 may be ineffectual or even detrimental to brain, cardiovascular, and respiratory function, as well as survival. For this reason, low dose therapy with NaHCO3 has been recommended. Sodium dichloroacetate (NaDCA) has been used successfully to treat clinical and experimentally-induced lactic acidosis. The present study was designed to compare the effects of low dose NaHCO3 with NaDCA on blood pressure, blood chemistries and brain metabolites in rats with a low flow-induced (Type A, the most common type) lactic acidosis. Fasted male Wistar rats were subjected to cerebral ischemia and systemic hypotension for 30 min at which time, if the pH or HCO-3 fell to 7.2 or 10, respectively, the rat was treated with NaHCO3, NaDCA, or an equal volume of sterile water. Over the 30 min of recirculation that followed ischemia, treatment had no effect on blood pressure or glucose or on brain glucose or glycogen. NaHCO3 had no effect on lactate but appeared to stabilize pH and increase HCO3- more than in sham- or NaDCA-treated rats. Although NaDCA caused a greater increase in HCO3- than sham treatment, pH continued to decline. However, lactate decreased more in NaDCA- than in sham- or NaHCO3- treated rats. These results suggest that low dose NaHCO3 is not detrimental in this model; however, although NaHCO3 stabilized pH, it did not rapidly correct the acidosis. NaDCA at this dose had no effect on the acidosis but was effective in decreasing lactate. Since serum lactate has previously correlated with survival and since higher doses of NaDCA have corrected lactic acidosis in other studies, future evaluation of postischemic treatment with higher doses of NaDCA is warranted.

Acetates↗