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PubMed2004

Consent documents for oncology trials: does anybody read these things?

This study was conducted to assess the readability and length of informed consent documents used in clinical trials in oncology. One hundred seven consent documents from clinical protocols open to accrual at the Emory University Winship Cancer Institute were quantitatively analyzed. These included trials sponsored or organized internally, by commercial interests, and by various cooperative groups. Each form was analyzed using the electronic text version of the consent document approved by the Emory University IRB. Readability software was used to determine the length of each document and 2 measures of readability: The Flesch Reading Ease Score and a grade-level readability estimate using the Gunning Fog Index. The mean length +/- SD was 2709 +/- 971 words or 10.8 +/- 3.8 pages. The mean +/- SD Flesch Reading Ease Score was 45.48 +/- 5.24. The mean +/- SD grade level using the Gunning Fog Index was 11.9 +/- 1.53. None of the consent documents were written at or below the 8th-grade reading level; 1.8% were at or below the 9th-grade level; 10.5% were below the 10th-grade level. Results were similar regardless of study sponsor. Consent documents for clinical trials in oncology are lengthy and complex to the point that is unlikely that most patients will be willing to read them or be able to understand the concepts they discuss. IRBs and cooperative group review committees are either unwilling or unable to enforce widely accepted readability standards for the consent document. We discuss the implications of this situation and suggest ways to improve it.

Clinical Trials as Topic↗
PubMed2003

Trial telemedicine system for supporting medical students on elective in the developing world.

RATIONALE AND OBJECTIVES: The authors sought to create a simple, versatile, and effective store-and-forward telemedicine system to facilitate consultation between medical students pursuing elective study at remote locations in the developing world and specialists at the central institution. MATERIALS AND METHODS: A trial telemedicine system was established between Gizo Hospital (Gizo, Solomon Islands) and Emory University Hospital (Atlanta, Ga). At Gizo Hospital, the system consisted of a commercially available digital camera and a locally available personal computer with a modem providing low-bandwidth (dial-up) Internet access. A visiting British medical student at Gizo Hospital used this equipment to relay digital photographs of patients, as well as the results of relevant tests, such as electrocardiograms, radiographs, and ultrasound images, to Emory University Hospital via the Internet for review by a specialist. RESULTS: The medical student, who had received minimal training (approximately 1 hour) in the use of this telemedicine system, used it successfully to perform eight referrals during the elective course period. Following the student's return home, his local preceptors at Gizo Hospital and a physician at Helena Goldie Hospital on New Georgia Island used the same system for more than 60 additional referrals. CONCLUSION: The telemedicine system is a low-cost, robust, and sustainable means of providing expert support to medical students and other health care providers in remote locations.

Developing Countries↗
PubMed1975

Leukoplakia revisited. A clinicopathologic study 3256 oral leukoplakias.

During a 13-year period, 3256 specimens clinically diagnosed as leukoplakia (('keratosis," "white patch") were submitted to the oral pathology laboratories of Indiana University School of Dentistry and Emory University School of Dentistry. These comprised 6.2% of the tissue specimens processed by these laboratories. The cases were analyzed as to age of occurrence, site of involvement, and pathologic findings. It was found that: leukoplakia occurs chiefly in the 5th, 6th, and 7th decades; about half of the lesions involved the mandibular mucosa, mandibular sulcus, and buccal mucosa; leukoplakia was slightly more common in men (54.2%). Microscopic study showed that 80.1% of the leukoplakias were varying combinations of hyperorthokeratosis, hyperparakeratosis, and acanthosis without evidence of epithelial dysplasia. Mild to moderate epithelial dysplasia was noted in 12.2% of specimens, and severe epithelial dysplasia or carcinoma in situ was found in 4.5%. Infiltrating squamous cell carcinoma was diagnosed in 3.1% of specimens submitted with a clinical diagnosis of leukoplakia. The risk of epithelial dysplasia, carcinoma in situ, or carcinoma varied between the anatomical locations of leukoplakia. The incidence of epithelial alteration, ranging from dysplasia to carcinoma, was 42.9% for lesions of the floor of the mouth, 24.2% for tongue lesions, and 24.0% for lip leukoplakias. The incidence of similar epithelial alterations in other sites varied from 18.8% for palatal lesions to 11.7% for leukoplakias of the retromolar area. The data suggest that there are regional differences in the incidence and character of leukoplakia in the United States. The Emory material, obtained almost exclusively from patients residing in the Southeastern United States, showed a proportionately higher total incidence, a lower male/female ratio, and a greater frequency of epithelial dysplasia, particularly in females, than the Indiana material, which came almost entirely from residents in the Northcentral United States.

Adolescent↗
PubMed2004

Infections due to Scedosporium apiospermum and Scedosporium prolificans in transplant recipients: clinical characteristics and impact of antifungal agent therapy on outcome.

BACKGROUND: Unique characteristics, impact of therapy with antifungal agents, and outcome of infections with Scedosporium species were assessed in transplant recipients. METHODS: The patients comprised a total of 80 transplant recipients with Scedosporium infections, including 13 patients from our institutions (University of Pittsburgh Medical Center [Pittsburgh, PA], University of Maryland [Baltimore], Duke University Medical Center [Durham, NC], Emory University [Atlanta, GA], and Hospital Gregorio Maranon [Madrid, Spain]) and 67 reported in the literature. The transplant recipients were compared with 190 non-transplant recipients with scedosporiosis who were described in the literature. RESULTS: Overall, 69% of the infections in hematopoietic stem cell transplant (HSCT) recipients and 53% of the infections in organ transplant recipients were disseminated. HSCT recipients, compared with organ transplant recipients, were more likely to have infections caused by Scedosporium prolificans (P=.045), to have an earlier onset of infection (P=.007), to be neutropenic (P<.0001), and to have fungemia (P=.04). Time elapsed from transplantation to Scedosporium infection in transplant recipients has increased in recent years (P=.002). The mortality rate among transplant recipients with scedosporiosis was 58%. In a logistic regression model using amphotericin B as comparison treatment, voriconazole was associated with a trend towards better survival (odds ratio [OR], 10.40; P=.08). Presence of disseminated infection (OR, 0.20; P=.03) predicted lower survival, and receipt of adjunctive surgery as treatment (OR, 5.52; P=.02) independently predicted a better survival in this model. CONCLUSIONS: Scedosporium infections in transplant recipients were associated with a high rate of dissemination and a poor outcome overall. The use of newer triazole agents warrants consideration as a therapeutic modality for these infections.

Adolescent↗
PubMed2006

Role modeling humanistic behavior: learning bedside manner from the experts.

PURPOSE: Humanistic care is regarded as important by patients and professional accrediting agencies, but little is known about how attitudes and behaviors in this domain are taught in clinical settings. To answer this question, the authors studied how excellent clinical teachers impart the behaviors and attitudes consistent with humanistic care to their learners. METHOD: Using an observational, qualitative methodology, the authors studied 12 clinical faculty identified by the medical residents enrolled from 2003 to 2004 as excellent teachers of humanistic care on the inpatient medical services at four medical universities in the United States (University of Minnesota Medical School, Emory University, University of Rochester School of Medicine, and Baylor College of Medicine). Observations were conducted by the authors using standardized field notes. After each encounter, the authors debriefed patients, learners (residents and medical students), and the teaching physicians in semistructured interviews. RESULTS: Clinical teachers taught primarily by role modeling. Although they were highly aware of their significance as role models, they did not typically address the human dimensions of care overtly. Despite the common themes of role modeling identified, each clinical teacher exhibited unique teaching strategies. These clinical teachers identified self-reflection as the primary method by which they developed and refined their teaching strategies. CONCLUSIONS: Role modeling is the primary method by which excellent clinical teachers try to teach medical residents humanistic aspects of medical care. Although clinical teachers develop unique teaching styles and strategies, common themes are shared and could be used for the future development of clinical faculty.

Attitude↗
PubMed1992

Outcomes following cardiopulmonary resuscitation in an acute rehabilitation hospital. Clinical and ethical implications.

This retrospective study examines cases of cardiac arrest requiring cardiopulmonary resuscitation (CPR) in an acute rehabilitation hospital. All admissions to the Center for Rehabilitation Medicine at Emory University, a 56-bed facility, are reviewed. Seventeen cases of true cardiac arrest are identified for analysis of ultimate disposition over a 10-yr period. Only one patient (5.9%) survived CPR to discharge from the rehabilitation hospital, but he died subsequent to his transfer to the acute hospital. Though the sample size is small, it reflects the total population of patients eligible for CPR who suffered a cardiac arrest. We conclude that CPR is generally not successful in the elderly inpatient rehabilitation population. The growing clinical complexity of the rehabilitation patient demands that health-care providers and their patients more regularly address decision-making issues pertinent to CPR.

Age Factors↗
PubMed2002

Protected clinical teaching time and a bedside clinical evaluation instrument in an emergency medicine training program.

In a process that has evolved over the last four years, the Emory University Emergency Medicine Education Committee has developed an "academic attending" teaching shift incorporating a formatted lecture series with a clinical evaluation exercise (CEE). The program structures the approach to clinical teaching at the bedside, provides an objective clinical evaluation tool specific to emergency medicine residents, and provides targeted learning for medical students and residents rotating in the emergency department (ED). The CEE instrument was designed to be quick and efficient, satisfy requirements of assessment of the Accreditation Council for Graduate Medical Education (ACGME) general competencies, and incorporate the language of the "Model of the Clinical Practice of Emergency Medicine." The original program called for unstructured bedside teaching three days a week, by faculty freed from clinical duties, combined with a limited series of introductory emergency medicine lectures. The program proved more successful when concentrated in a once weekly structured educational program. The prepared, repeating lecture series has been expanded to include many of the most common ED presenting chief complaints and has significantly advanced a curriculum for medical students and visiting interns. A CEE was developed to evaluate and provide immediate feedback to residents on many of the core ACGME competencies. The CEE has been successfully used to structure the bedside educational encounter. This dedicated non-clinical "teaching" shift appears effective in meeting the educational goals of the authors' academic ED. This is a description of the program and its evolution; the program has not been formally evaluated.

Clinical Competence↗
PubMed2003

Comparison of automatic quantification software for the measurement of ventricular volume and ejection fraction in gated myocardial perfusion SPECT.

The aim of this study was to compare the performance of three different software packages for the calculation of ejection fraction (EF) and end diastolic volume (EDV) from gated myocardial single photon emission computed tomography studies. Two hundred patients undergoing gated stress myocardial perfusion scans were analysed retrospectively. Patients were grouped as follows: small heart (n=31), normal perfusion scan (n=71), and scan with perfusion defects (n=98). EF and EDV were calculated for each using QGS (Cedars Sinai, Los Angeles, CA), 4D-MSPECT (University of Michigan, Ann Arbor, MI), and ECT (Emory University, Atlanta, GA). Bland-Altman plots, repeated measures ANOVA, and linear regression analysis were used to compare methods. Correlation coefficients between the methods for both EF and EDV were high, greater than 0.9. However, Bland-Altman plots revealed a large standard deviation of the difference between methods, preventing the confident estimate of the value of one method from an observation of another. Despite good correlation, the variance between methods was high. These algorithms behave differently, produce widely variable results from one another, and should not be used interchangeably. It may prove prudent for laboratories to independently validate the software algorithm that is chosen against a 'gold standard' using their own population.

Adolescent↗
PubMed2001

Clinical pathways set to experience 'technological rebirth'.

The state of the art in case management care plans is automation. Larger hospital systems are at the beginning of a technological rebirth, and that includes acute care clinical pathways, according to case managers at New York University Medical Center in New York City and Emory University Hospital in Atlanta. Despite some minor glitches, and the perennial issue of getting physician support for pathways, the systems are up and running. Users are hopeful that pathway technology will continue to improve and someday be linked electronically to outcomes software.

Academic Medical Centers↗
PubMedDate not supplied

Selecting and implementing a voice recognition system.

A single radiology department serves the three separate organizations that comprise Emory Healthcare in Atlanta--three separate hospitals, the Emory Clinic and the Emory University School of Medicine. In 1996, the chairman of Emory Healthcare issued a mandate to the radiology department to decrease its report turnaround time, provide better service and increase customer satisfaction. The area where the greatest effect could be made without involving the transcription area was the "exam complete to dictate" piece of the reporting process. A committee investigating voice recognition systems established an essential criteria for potential vendors--to be able to download patient scheduling and demographic information from the existing RIS to the new system. Second, the system had to be flexible and straightforward for doctors to learn. It must have a word processing package for easy report correction and editing, and a microphone that would rewind and correct dictation before recognition took place. To keep capital costs low for the pilot, the committee opted for server recognition rather than purchase the expensive workstations necessary for real-time recognition. A switch was made later to real-time recognition. PACS and voice recognition have proven to be highly complementary. Most importantly, the new system has had a tremendous impact on turnaround time in the "dictate to final" phase. Once in the 30-hour range, 65 percent of the reports are now turned around in less than 15 minutes, 80 percent in less than 30 minutes, and 90 percent in less than an hour.

Academic Medical Centers↗
PubMed1982

Pericardiectomy: current indications, concepts, and results in a university center.

During a 7 1/2-year period, 102 patients underwent pericardiectomy in the Emory University Affiliated Hospitals for a wide variety of pericardial disease. Seventy-six patients had predominantly effusive pericardial disease, and 26 patients had constrictive pericarditis. Nineteen cases of constrictive pericarditis developed in patients who had undergone previous open-heart operations. Hospital mortality at six weeks was 8.8%. The surgical approach was a left anterior thoracotomy in 72 patients; median sternotomy in 26 patients; and a subxiphoid approach in 4 patients. Only 2 patients required cardiopulmonary bypass. A detailed discussion of each subgroup of patients with pericardial disease requiring pericardiectomy is given.

Heart Neoplasms↗
PubMed2002

Thrombocytosis is associated with a significant increase in the cancer specific death rate after radical nephrectomy.

PURPOSE: We have previously reported that patients with advanced renal cell carcinoma and a normal platelet count of 400,000/mm. have a 64% increase in life expectancy compared with those with thrombocytosis. We determined whether thrombocytosis was predictive of death from renal cell carcinoma after radical nephrectomy was performed with curative intent for early stage disease. MATERIALS AND METHODS: We reviewed the records of 204 patients with renal cell carcinoma who underwent radical nephrectomy with curative intent between June 1993 and January 2000 at Emory University Hospital. Survival, pathological grade and stage were recorded from the Emory Winship Cancer Institute tumor registry. Platelet counts were recorded and any patient with at least 1 platelet count of greater than 400,000/mm. was classified with thrombocytosis. Those with a platelet count of 400,000/mm. were classified with a normal platelet count. RESULTS: There were 26 patients with thrombocytosis and 178 patients with persistently normal platelet counts. The overall and cancer specific death rate in the 26 patients with thrombocytosis was 50% and 42%, respectively. The overall mean time between nephrectomy and death was 12.1 months in this group. The overall and cancer specific death rate in the 178 patients with a normal platelet count was 15.2% and 7.3%, respectively. Mean time to death was 22.6 months in this group. Differences in the overall and cancer specific death rates were highly statistically significant as well as clinically significant. These differences remained significant after controlling for grade, stage and histological type of cancer. CONCLUSIONS: This study documents the association of thrombocytosis with decreased survival in patients with renal cell carcinoma. In those who undergo nephrectomy for early stage renal cell carcinoma with a perioperative platelet count of greater than 400,000/mm. the cancer specific death rate from renal cell carcinoma is greater than 5 times the rate in patients with a persistently normal platelet counts after radical nephrectomy. The platelet count appears to be a new and powerful independent prognosticator in patients with renal cell carcinoma who undergo radical nephrectomy for presumed localized disease.

Aged↗
PubMed2000

Diurnal stability of refraction after implantation with intracorneal ring segments.

PURPOSE: To investigate diurnal changes in visual acuity and refraction in myopic eyes implanted with intracorneal ring segments (ICRS). SETTING: University of California San Diego Shiley Eye Center, La Jolla, California, and Emory University Vision Correction Center, Atlanta, Georgia, USA. METHODS: This prospective study involved 2 groups of patients who had ICRS (Intacs) implantation and a follow-up of at least 6 months. The first group included 102 eyes of 51 bilaterally treated patients; the second group, 32 eyes of 16 unilaterally treated patients. Examinations including visual acuity, manifest refraction, and videokeratography were done in the morning and evening at least 9 hours apart on a single day. Refractive changes were analyzed by power vectors; multivariate statistics were used to determine the significance of change in any component of the spectacle prescription. RESULTS: In the bilateral treatment group, 97 eyes (95%) were within 1 line of spectacle-corrected visual acuity from morning to evening. The mean change in manifest refraction was -0.14 +0.08 x 4 and in spherical equivalent, -0.10 diopters (D) (sigma = 0.3; range -0.750 to +0.875 D). Ninety-six eyes (94%) had a change in refraction within 0.50 D of spherical equivalent. There was no significant change in corneal power (P =.20). In the unilateral treatment group, there was no significant difference between treated and untreated eyes in changes in spectacle-corrected visual acuity, manifest refraction, or corneal power and toricity (P.05). CONCLUSION: No clinically significant diurnal variation in visual acuity or manifest refraction was observed after ICRS implantation or in untreated paired eyes. Moreover, the data suggest less diurnal change in visual acuity and refraction after ICRS implantation.

Circadian Rhythm↗
PubMed1994

Will Camp Sealy: surgical innovator, scholar, exceptional teacher, and true Georgian.

Will Camp Sealy, MD, Professor Emeritus of Surgery, Duke University 1984 and Mercer University 1992, was born in Roberta, Georgia, in 1912. A 1936 medical graduate of Emory University, he was in surgical residency training at Duke University from 1936 to 1942. During the next 4 years as an army surgeon in World War II, he was promoted to lieutenant colonel and, in the European theater, made chief of surgery of the 121st General Hospital and later the 128th Evacuation Hospital. After the war, he rejoined the surgical faculty at Duke. In 1950, he became chairman of the division of thoracic and cardiovascular surgery, where in the ensuing years he made a number of important initial observations and significant contributions. Among these were studies on the serious paradoxical hypertension that may follow repair of coarctation of the aorta, and on the combined use of hypothermia and perfusion for open heart surgical procedures. In more recent years, his initiation and landmark studies of the surgical treatment of certain cardiac arrhythmias have gained him worldwide recognition and opened one of the last frontiers of cardiac surgery.

Georgia↗
PubMed1996

Pathology of microsporidiosis: emerging parasitic infections in patients with acquired immunodeficiency syndrome.

OBJECTIVE: Microsporidiosis is a group of rapidly emerging protozoan infections that have thus far been reported predominantly from severely immunosuppressed persons with the acquired immunodeficiency syndrome (AIDS). The four genera that have been identified in AIDS patients (Enterocytozoon, Encephalitozoon, Septata, and Pleistophora) are an increasingly common source of both localized and disseminated infections. However, the clinical and pathologic features of these agents are being described with such rapidity that many pathologists are unaware of the histologic, immunologic, and molecular methods for diagnosing these infections. This article summarizes the clinical and morphologic spectrum of the microsporidian species that infect patients with AIDS. Additionally, the role of ultrastructural, immunologic, tissue culture, and molecular techniques for the diagnosis of microsporidian infections are discussed. DATA SOURCES: Clinical and pathologic findings were obtained from patients with AIDS who were evaluated for microsporidian infections at the Grady Memorial Hospital in Atlanta. Selected laboratory studies were performed at the Division of Parasitic Diseases of the Centers for Disease Control and Prevention and at the Department of Physiology at Morehouse University. Additionally, some cases were sent for consultation to the Infectious Disease Pathology service at Emory University. These data were combined with the published studies of microsporidian infection from the medical literature. DATA SYNTHESIS: The pathologic appearance of microsporidian infections in each major organ system (ocular, respiratory, genitourinary, gastrointestinal) is illustrated using routine and special histochemistry and immunofluorescence. The differential diagnostic features of the four genera of microsporidia infecting AIDS patients are illustrated using transmission and scanning electron micrographs from biopsy, autopsy, and tissue culture materials. Cytologic evaluation of body tissues is emphasized as a sensitive method for microsporidian diagnosis. CONCLUSIONS: Microsporidian infections can be expected to remain an increasingly important cause of morbidity and mortality in patients with AIDS. It is important that pathologists and microbiologists become acquainted with the clinicopathologic spectrum of these emerging protozoal infections, ensuring timely diagnosis and subsequent treatment.

Acquired Immunodeficiency Syndrome↗
PubMed1983

Metastatic malignant melanoma of unknown primary origin: a study of 30 cases.

Thirty patients with metastatic malignant melanoma of unknown primary origin treated at Emory University Clinic between 1940 and 1975 are presented. This group represents the 4.4% of all melanomas treated during the same period of time at Emory. Nineteen (63.3%) patients had nodal metastases only, and they were handled by radical lymphadenectomy of the involved area. The remaining 11 patients presented with lung or widespread subcutaneous metastatic disease and treated with biopsy and radiotherapy or chemotherapy. The former group experienced 28.6% five- and ten-year actuarial survival while patients with lung metastases succumbed within four months after diagnosis. Spontaneous regression of a typical melanoma skin lesion has been reported in three patients prior to development of metastatic disease.

Adult↗
PubMed1998

Acute occlusion of the abdominal aorta.

BACKGROUND: Acute aortic occlusion most commonly results from aortic saddle embolus or thrombosis of an atherosclerotic abdominal aorta. The purpose of this study was to review the experience at a university hospital to better define the diagnosis and management of this uncommon process. METHODS: A retrospective chart review was performed from patients admitted to Emory University Hospital with acute occlusion of the abdominal aorta from 1985 through 1997. RESULTS: Thirty-three patients were identified. In group EMB (n = 16), occlusion was due to saddle embolus. In group IST (n = 17), occlusion was attributed to in situ thrombosis of a severely diseased aorta. Operative procedures performed included transfemoral embolectomy (15), aorto-bifemoral bypass (9), axillobifemoral bypass (5), fasciotomy (3), and thrombolysis (1). The in-hospital mortality rate was 21% (31% EMB, 12% IST), and morbidity was significant and included mesenteric ischemia (6%), bleeding complications (9%), subsequent amputation (12%), renal failure (15%), recurrent embolization or thrombosis (21%), and cardiac complications (42%). CONCLUSIONS: Acute aortic occlusion has tremendous morbidity and mortality even with optimal surgical care.

Acute Disease↗
PubMedDate not supplied

Enhancing quality critical care education: establishing a consortium.

The demand for expanded knowledge and accountability in critical care nursing has increased the need for qualified critical care nurses and is tempered by requirements that their preparation be cost-effective. The Emory University School of Nursing (EUSN) has pioneered in meeting this challenge. Since June 1988, a Critical Care Consortium consisting of the EUSN and Emory-affiliated hospitals has been operational, providing uniform critical care education to multiple hospital nursing staffs. Instructional resources are being economically utilized, eliminating duplication of efforts. This collaboration between academic and service settings enhances productivity, quality patient care, professional growth, and promotes significantly greater interinstitutional cohesiveness.

Critical Care↗