In 35 daytime paired blood and cerebrospinal fluid (CSF) samples from 15 patients, melatonin levels in CSF were undetectable or detectable but not higher than blood levels. During pneumoencephalography in 6 patients, no significant elevation of blood melatonin levels was observed, whereas cortisol concentration increased.
Objectives: This study was designed to explore the prevalence and types of stipulations (such as clarifications or changes) required of investigators by the institutional review board (IRB) of one institution over a five year period. Design: Stipulations to research proposals (n = 124) were documented from the minutes of the IRB meetings. Setting: Community hospital. Participants: IRB submissions. Main measurements: Number and type of IRB stipulations. Results: Nineteen research submissions (15.3%) were approved without any stipulations. For the remainder, the majority of stipulations related to consent forms (74.2%). Conclusions: Consent forms appear to be at highest risk for IRB stipulations. Being aware of high risk areas before submission of research proposals may reduce the frequency of stipulations required of investigators.I nstitutional review boards (IRBs) have the responsibility to protect human subjects who are participating in research protocols. In this role, IRBs review research submissions and indicate in writing the changes (that is, the ''stipulations''), if any, which are required to undertake the research project. There is very little research on the prevalence or types of IRB stipulations required of investigators. In a British study, 1 Kent found that 24% of research submissions were approved without stipulations; stipulations were primarily related to requests for further information, design queries, changes in information sheets provided to participants, and changes in the consent procedure. Olsen and Mahrenholz 2 found that 46% of nursing protocols were approved without stipulations whereas 8% were not approved at all; stipulations related to the consent form (43%), the need for additional information (31%), and inadequate explanation to candidates of the potential benefits of participation (22%). In summary, available studies exploring the prevalence and types of IRB stipulations are few in number and limited with regard to the ability to generalise findings. The following pilot study was designed to audit, in a single US institution, the prevalence and types of stipulations required by an IRB.
METHODThe setting for the IRB is a 486 bed suburban Midwest hospital in the United States with several affiliated inpatient and outpatient facilities. This IRB is well established, including having the same chairperson for the past eight years. All reviews of research submissions by the IRB, both pharmacological and non-pharmacological, including all stipulations, are recorded in the minutes of the IRB meetings. During the study period of five years, the same staff assistant has recorded the minutes of these meetings.Following consultation with the IRB staff assistant to informally explore the most common types of IRB stipulations, we developed a data collection sheet to record stipulations. A single investigator then reviewed all of the IRB minutes over a five year period, noting all stipulations. Because of some unanticipated types of stipulations, we revised the data collection sheet midway thr...
Transsphenoidal microdissection has been proposed as a preferred means of treating Cushing's disease. This procedure allows the surgeon to remove a pituitary microadenoma and at the same time to preserve normal tissue. Two cases described here were treated by this method. An interesting and important observation was that neither patient appeared to be cured for 2 to 6 weeks after surgery, as assessed by dexamethasone suppression. Later, normal suppressibility occurred and the course of each patient was compatible with cure. Patients treated by this method should not be automatically retreated because of adrenocorticotropic hormone (ACTH) non-suppressibility in the early postoperative period.
A 29-year-old female patient exhibited a solitary neck mass, severe hypercalcemia, and multiple skeletal lytic lesions consistent with metastatic neoplastic disease. Fine-needle aspiration (FNA) cytology of the neck lesion indicated a follicular thyroid neoplasm. CT-guided bone biopsy was non-diagnostic. Subsequent 18F-FDG PET/CT examination demonstrated avid glucose uptake within the neck mass and diffuse bony lesions of variable metabolic activity. Repeat biopsy utilizing PET/CT guidance produced core tissue with classic histologic features of a brown tumor. Postoperative histology revealed an exclusively oncocytic parathyroid adenoma. Atypical radiotracer uptake of this rare functioning adenoma subtype is illustrated with discussion of improved procedural diagnostic yield utilizing PET/CT.
The problem-centered, learner-focused, small-group process (PLS) is used by faculty to train learners in evidence-based medicine (EBM). Few affordable and accessible courses exist to train faculty in the PLS process. The results of a novel course to train faculty in the PLS process are described. The course was a one-day workshop consisting of five small group sessions with two facilitators. The participants were seven clinicians and four medical librarians. The initial small-group session was a discussion of concepts and principles related to successful facilitation skills; the subsequent four small groups reinforced these concepts and principles with role-playing and case scenarios using different steps in the EBM process. The course, including the use of the PLS process, scored highly on participant evaluations. The authors conclude that the introductory course effectively taught the PLS process for use in EBM facilitation.
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