Professional integrity in clinical research

In response to public concern over abuses in human medical experimentation, the dominant approach to the ethics of clinical research during the past 30 years has been regulation, particularly via institutional review board review and approval of scientific protocols and written consent forms. However, the effectiveness of regulatory mechanisms in ensuring the ethical conduct of clinical research is limited. Little attention has been devoted to the nature and role of professional integrity of physician investigators, a conscientious framework for guiding investigators in the socially important but morally complex activity of clinical research. Professional integrity is vital in forging an ethically sound relationship between investigators and patient volunteers, a relationship that differs in important ways from the patient-physician relationship in standard clinical practice. We examine critically 2 models of the moral identity of physician investigators, the investigator as clinician and the investigator as scientist; in neither of these 2 models can the physician investigator eliminate completely the moral conflicts posed by clinical research. The professional integrity of physician investigators depends on a coherent moral identity that is proper to the enterprise of clinical research. The roles of clinician and scientist must be integrated to manage conscientiously the ethical complexity, ambiguity, and tensions between the potentially competing loyalties of science and care of volunteer patients.     

Vortex-Antivortex Annihilation and Flux Turbulence in Layered Type-II Superconductors

New mechanism of turbulence instability of standing flux-antiflux front in layered superconductors is presented. We describe two assisting mechanisms destabilizing the standing vortex-antivortex front. There are anisotropy of the layered superconductors and the heat, released by the vortex-antivortex annihilation. We present the conditions of the front stability for various anisotropy and heating parameters. We predict that heat released by the vortex-antivortex annihilations enhances the turbulence instability in superconductors with small anisotropy. The characteristic size of the unstable pattern is estimated. The results are in a good agreement with recent experiments.     

Using information management to implement a clinical resource management program

BACKGROUND: This article provides a consultant's account of a 250-bed community hospital's experience in implementing the Clinical Resource Management (CRM) program, a four-stage process of using information to identify opportunities for improvement, developing an effective resource management team, implementing process improvement activities, and measuring the impact on outcomes of care. CASE STUDY EXAMPLE--CONGESTIVE HEART FAILURE: The chair of the departments of internal medicine and family practice selected congestive heart failure for in-depth study. A task force focused on treatment and patient disposition in the emergency room (ER), where most of the nonelective admissions originated. A set of standardized ER orders was developed that emphasized rapid and effective diuresis through the initiation of a progressive diuretic dosing schedule directly linked to patient response. LESSONS AND REFLECTIONS: Factors critical to the success of the CRM program included allocating adequate time to promote and sell the value and importance of the program, as well as securing the support of both information systems and physicians. The main barriers to success involved limitations in the information system infrastructure and delays attributable to committee review. Short-term results from the CRM program were encouraging, with average lengths of stay reduced by 0.5 days and average costs of care reduced by 12% for the ten diagnoses studied with no adverse results. Nonstudy diagnoses showed no notable improvement. CONCLUSIONS: Recognizing the growing importance of information management not only for clinical decision support but for accommodating all the necessary internal and external reporting requirements will require a significant commitment and investment in technology and personnel resources.     

Effect on normal vaginal flora of three intravaginal microbicidal agents potentially active against human immunodeficiency virus type 1

The effect on normal vaginal flora of three intravaginal microbicides potentially active against human immunodeficiency virus type 1 was examined. Volunteers received dextrin sulfate (D2S), nonoxynol-9 (N-9), or docusate sodium in separate placebo-controlled studies. High vaginal swabs were obtained for bacterial culture before and after microbicide application. D2S did not affect the vaginal flora. However, lactobacilli decreased by > or = 10(2) cfu/mL in 9 (56%) of 16 women given N-9 and in 5 (63%) of 8 women given docusate sodium. Women using N-9 were also significantly more likely to become colonized abnormally (usually with aerobic gram-negative rods) than were those using placebo, as were women using docusate sodium. Women with reduced lactobacilli were less likely to regain normal flora than were those whose lactobacilli were unaffected. However, coliform colonization occurred whether lactobacilli produced H2O2 or not. Continuous use of N-9 could induce susceptibility to urinary and gynecological infection. It is essential that potential microbicides are examined for activity against normal vaginal flora.     

Revision of cemented fixation and cement-bone interface strength.

Interfacial shear strength between poly(methyl methacrylate) (PMMA) bone cement and cancellous bone was measured in bone samples from human proximal femora. Samples were prepared with fresh cement-bone, fresh cement inside a mantle of existing cement and with fresh cement-revised bone surfaces. Push-out tests to measure shear strength caused failure only at bone-cement interfaces; revised bone interfaces were 30 per cent weaker (P < 0.02) than primary interfaces. The clinical relevance is that revision of cemented joint arthroplasties may necessitate removal of components with sound cement-bone fixation. The practice of removing all traces of PMMA cement may not yield the optimal fixation; adhesion of fresh cement to freshly prepared surfaces of the existing cement might also be considered where circumstances are favourable.     

Comment on Kiesler's "Public and Professional Myths…"

Contends that C. A. Kiesler (see record 1983-24077-001) has drawn too many inferences based on incomplete and inaccurate analyses in his article on public and professional myths about mental hospitalization. Specifically, the present authors differ with Kiesler's contention that mental hospitalization is increasing, his implicit assumption that episodes of mental disorder in general hospitals without psychiatric units are equivalent to those in general hospitals with such units, and his comparison of effects of hospitalization for mental illness vs alternate modes of care. (3 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Differential regulation of P53 and Bcl-2 expression by ultraviolet A and B

The induction of apoptosis by ultraviolet (UV) radiation and other DNA damaging agents plays a critical role in monitoring the accumulation of genetic damage and the suppression of tumor development. We hypothesize that UVA and UVB induce apoptosis by modulating balances between p53 and/or bcl-2 genes. Using MCF-7 cells that express both wild-type P53 and Bcl-2 proteins, we demonstrated that UVA and UVB induced apoptosis through regulating expression of apoptosis promoting or inhibiting genes. UVA induced immediate apoptosis and downregulated bcl-2 expression. Bcl-2 expression was reduced by approximately 40% at 4 h post-150 kJ UVA irradiation per m2 with a maximum downregulation (over 70%) at 24 h. The dose-response studies revealed that significant reduction of bcl-2 expression was observed at UVA doses ranging from 50 to 200 kJ per m2; however, p53 levels were not affected by UVA. In contrast, UVB exhibited a entirely different action than UVA in that UVB substantially induced p53 expression, but had no effect on bcl-2 expression. The induction of P53 by UVB was dose and time dependent with the maximum expression at 24 h post-2 and post-4 kJ UVB irradiation per m2. Down-regulation of bcl-2 and fragmentation of DNA induced by UVA occurred earlier (approximately at 4 h) than upregulation of p53 and DNA fragmentation by UVB (12-24 h). These results suggest that UVA and UVB cause cell damage through different mechanisms and that the balances between the expression of p53 and bcl-2 may play an important role in regulating the apoptosis induced by UV irradiation.