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PubMed1985

Contracts to bear children.

In the surrogate mother procreation can be divorced both from sex as well as any anticipation of child rearing. Often the risks of surrogate motherhood are presented in terms of alternative family structures and economic exploitation of women. Such possibilities must invite critical reflection in order for there to be legal reform. Of paramount importance is the child's best interest and until the full psychological is the child's best interest and until the full psychological ramifications for the child, adoptive parents and natural mother are determined then the law's role must be ambivalent. In this impasse the minority view of the Warnock Report has much to commend itself.

Advisory Committees↗
PubMed2002

The roles and relationships of psychiatrists and other service providers in mental health services.

OBJECTIVE: A number of the problems facing psychiatry are identified as having common origins in unresolved issues about teamwork. The aim is to identify the issues and to formulate recommendations for dealing with these obstacles. METHOD: The Royal Australian and New Zealand College of Psychiatrists Professional Liaison Committee (Australia) of the Board of Professional and Community Relations convened a number of meetings and discussions, with external assistance from JW and TT. RESULTS: Much of contemporary mental health care is delivered either directly or indirectly by several persons, often working in teams. Teamwork and collaboration are central to good working relationships and service delivery. Effective teamwork and collaboration is supported by key elements including agreed goals, an agreed approach, effective communication styles, established ground rules, clear team roles, and competent leadership. The obstacles to effective teamwork and collaboration are discussed in terms of the following: ambiguity and conflict over roles; conflict and confusion over leadership; differing understandings of clinical responsibility and accountability; interprofessional misperceptions; and differing rewards between the professions. CONCLUSIONS: Developing an understanding of these issues opens the way to a series of recommendations in relation to education, professional organizations, and workplaces and government, which can be considered by a number of sectors and groups.

Continuity of Patient Care↗
PubMed2002

Sodium ferric gluconate complex in hemodialysis patients: adverse reactions compared to placebo and iron dextran.

BACKGROUND: Parenteral iron is often required by hemodialysis patients to maintain adequate iron stores. Until recently, the only available form of intravenous iron was iron dextran, which is associated with significant adverse reactions, including anaphylaxis and death. Sodium ferric gluconate complex (SFGC) was recently approved for use in the U.S. under FDA's priority drug review. This Phase IV study was designed to evaluate the safety of a single dose of intravenous SFGC as compared to placebo and a historical iron dextran control. METHODS: This multicenter, crossover, randomized, double blind, placebo-controlled prospective comparative study was performed in hemodialysis patients requiring at least 125 mg of elemental iron. The historical control was obtained from a meta-analysis of four publications examining outcomes in patients exposed to iron dextran. SFGC naïve patients were administered SFGC without a test dose, undiluted, at a rate of 125 mg over 10 minutes, and compared to placebo comprising bacteriostatic saline. RESULTS: A total of 2534 patients were enrolled. The incidence of drug intolerance (an adverse event precluding re-exposure) was significantly less [0.44%, confidence interval (CI) 0.21 to 0.71%] after SFGC as compared to the iron dextran control (2.47%, CI 1.87 to 3.07%, P < 0.0001), but higher than after placebo (0.1%, P = 0.02). There was no difference found between SFGC and placebo in serious adverse events. A single life-threatening event occurred after SFGC (0.04%, CI 0.00 to 0.22%), which was significantly less than following iron dextran (0.61%, CI 0.36 to 0.86%), P = 0.0001. CONCLUSION: SFGC is well tolerated when given by intravenous push without a test dose. SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran. The routine use of iron dextran in hemodialysis patients should be discontinued.

Adult↗
PubMed2003

Chronic use of sodium ferric gluconate complex in hemodialysis patients: safety of higher-dose (> or =250 mg) administration.

BACKGROUND: Almost all hemodialysis (HD) patients require intravenous iron therapy to correct their anemia and maintain their iron stores. Sodium ferric gluconate complex (SFGC) is approved by the Food and Drug Administration (FDA) for treatment of iron deficiency anemia in HD patients at individual doses up to 125 mg over 10 minutes (12.5 mg/min) and has been shown to have a superior safety profile compared with iron-dextran. Higher individual doses of SFGC would permit more rapid repletion of iron stores and greater flexibility in maintenance iron therapy as well as simplify treatment of peritoneal dialysis patients and chronic kidney disease patients. METHODS: The authors reviewed the safety and tolerability of higher-dose SFGC infusions (> or =250 mg) in 144 HD patients who were previously tolerant to a single 125-mg dose of SFGC. These 144 patients received a total of 590 doses of > or =250 mg of SFGC; 571 doses were 250 mg SFGC, and most of these were infused over 1 hour, an infusion rate of 4.17 mg/min. The other 19 doses were 312.5 mg (n = 1), 375 mg (n = 14), and 500 mg (n = 4). Infusion rates varied from 1.22 mg/min to 25.0 mg/min. RESULTS: Only one patient was considered intolerant to higher-dosing SFGC after having pruritus after a second 250-mg dose of SFGC. Three patients had nonserious events that did not preclude further dosing of SFGC. CONCLUSION: Administration of 250 mg SFGC over 1 hour is safe and well tolerated. Individual doses of 375 mg and 500 mg SFGC also were well tolerated, but further research and experience are needed to confirm the safety and tolerance of these doses.

Anemia, Iron-Deficiency↗
PubMed2004

Sodium ferric gluconate complex in haemodialysis patients: a prospective evaluation of long-term safety.

BACKGROUND: A previous single dose placebo-controlled double-blinded trial showed an extremely low (0.4%) intolerance rate of sodium ferric gluconate complex (SFGC) in SFGC-naive haemodialysis patients. No large prospective trials have assessed the safety of SFGC during repeated exposure in the outpatient haemodialysis setting. METHODS: Chronic haemodialysis patients completing the single-dose trial of SFGC were eligible to participate in this prospective, multicentre, open-label, long-term evaluation of SFGC, designed to record adverse events occurring up to 72 h post-dose. Patients received as many as 20 ampules (1250 mg total) of SFGC at an investigator-determined dose and rate over a 9 month evaluation period. RESULTS: Among 1412 enrolled patients at 54 centres, 1321 received 13,151 infusions of SFGC. Most doses (94.8%) were < or =125 mg and the majority were given over 10 min. Infusion rates ranged from <5 to 125 mg/min. There were no life-threatening events. Fifty-one patients (3.9%) experienced an adverse event, possibly related to SFGC. Of these, one experienced a serious event (hypotension). Five patients (0.4%) experienced an event that precluded SFGC readministration: pruritus (three), vasodilatation (one) and loss of taste (one). Among 372 patients (28.2%) receiving angiotensin-converting enzyme inhibitor (ACEI) therapy, adverse events were neither more common nor more severe than in the other patients. CONCLUSIONS: Repeated doses of SFGC are very well tolerated in haemodialysis patients. No life-threatening events were observed in over 13,000 doses administered. Administration of SFGC to patients using ACEI is safe and does not increase the incidence or severity of adverse events to SFGC.

Aged↗
PubMed2000

Has clinical practice been changed by the Human Fertilisation and Embryology Act 1990?

The birth in 1978 of the first baby to be conceived through in vitro fertilization caused both wonder and controversy. Concerns that this technology would be abused led the Government of the United Kingdom to appoint a Committee of Enquiry into human fertilization and embryology, which led to the publication in 1984 of what has become known as the Warnock Report. This made recommendations on the creation of human embryos in vitro, the storage of human eggs, sperm and embryos, and research on human embryos. This report led eventually to the passing by Parliament of the Human Fertilisation and Embryology Act 1990 and the creation of the Human Fertilisation and Embryology Authority, which since 1991 has licensed and regulated all centres and practitioners of assisted reproductive technology. The effects of these regulations are considered in this article. Clinical practice has been affected by the Act, but it has generally led to higher standards of clinical and laboratory practice, improved patient information and care, and improved ethical standards.

Journal Article↗
PubMedDate not supplied

Sharing best practice: developing a Web-based database.

This article reports on the development of a web-based interactive database that was designed to facilitate the dissemination of practice development, research and audit projects across a large NHS trust. A multidisciplinary team worked collaboratively to design the database in order to ensure that it incorporated features which made it easy for the end user. Concise structured information on each project was recorded and search facilities incorporated to facilitate access to information. Hyperlinks to other web pages on the Internet and the Trust intranet were created and full reports/publications of projects were included for those who wanted more information. The subsequent implementation across the organization involved promoting the database, helping practitioners develop skills to access information, setting up quality review procedures for projects and evaluating its use. The development of the database has highlighted that time, the availability of computers in clinical areas and skills development are important considerations when taking forward information technology (IT) initiatives.

Benchmarking↗
PubMed1984

What is extraordinary life support?

These discussions are selected from the weekly staff conferences in the Department of Medicine, University of California, San Francisco. Taken from transcriptions, they are prepared by Drs Homer A. Boushey, Associate Professor of Medicine, and David G. Warnock, Associate Professor of Medicine, under the direction of Dr Lloyd H. Smith, Jr, Professor of Medicine. Requests for reprints should be sent to the Department of Medicine, University of California, San Francisco, School of Medicine, San Francisco, CA 94143.

Aged↗
PubMed2000

In vitro antifungal susceptibility methods and clinical implications of antifungal resistance.

As new antifungal agents are introduced for the treatment of infections caused by yeasts and filamentous fungi (moulds), it is important that reliable methods are available for the in vitro testing of both new and established agents. The ultimate goal of in vitro testing is the prediction of the clinical outcome of therapy. The use of the M27-A procedures that were developed by the US National Committee for Clinical Laboratory Standards (NCCLS) has led to increased interlaboratory agreement of minimum inhibitory concentrations (MICs) for yeasts and has facilitated the establishment of interpretive breakpoints for fluconazole and itraconazole. The clinical relevance and limitations of these breakpoints are discussed elsewhere. The focus of this paper is to review the advantages and disadvantages of the available methods for antifungal susceptibility testing of yeasts and moulds as well as the clinical implications of in vitro antifungal resistance.

Antifungal Agents↗
PubMed2004

In vitro susceptibilities of bloodstream isolates of Candida species to six antifungal agents: results from a population-based active surveillance programme, Barcelona, Spain, 2002-2003.

OBJECTIVES: The antifungal drug susceptibilities of 351 isolates of Candida species, obtained through active laboratory-based surveillance in the period January 2002-December 2003, were determined (Candida albicans 51%, Candida parapsilosis 23%, Candida tropicalis 10%, Candida glabrata 9%, Candida krusei 4%). METHODS: The MICs of amphotericin B, flucytosine, fluconazole, itraconazole, voriconazole and caspofungin were established by means of the broth microdilution reference procedure of the European Committee on Antibiotic Susceptibility Testing. RESULTS AND CONCLUSIONS: Amphotericin B and flucytosine were active in vitro against all strains. A total of 24 isolates (6.8%) showed decreased susceptibility to fluconazole (MIC > or = 16 mg/L) and 43 (12.3%) showed decreased susceptibility to itraconazole (MIC > or = 0.25 mg/L). Voriconazole and caspofungin were active in vitro against the majority of isolates, even those that were resistant to fluconazole.

Antifungal Agents↗
PubMed1998

Surgical research in Canada: synopsis of a consensus conference.

Canadian surgical research requires careful nurturing if it is to flourish in tomorrow's environment. A consensus conference organized by the Research Development Committee of the Canadian Association of Surgical Chairs has addressed a number of issues to promote Canadian surgical research. This synopsis is a summary of the proceedings of that conference. It reflects on the meaning of surgical science, elements of establishing a successful research program, leadership in surgical science, identification of talented trainees, and the means to make the most of opportunities for funding. The information contained in the synopsis should not only assist departments of surgery and surgical specialty societies but should challenge them to set goals and innovative approaches to plan for strong surgical research in a changing environment.

Canada↗