Establishment, value assignment, and characterization of new WHO reference reagents for six molecular forms of human chorionic gonadotropin

BACKGROUND: The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) established a Working Group to investigate means of improving the comparability of immunoassays for human chorionic gonadotropin (hCG), which was selected as a prototype glycoprotein analyte. The Working Group identified development of unambiguous nomenclature and production of new highly purified International Reference Reagents calibrated in substance concentrations as its primary objectives. METHODS: Preparations of intact hCG, nicked hCG, hCG beta-subunit, nicked hCG beta-subunit, hCG alpha-subunit, and hCG beta-core fragment were purified from a crude urinary hCG preparation, ampouled, lyophilized, and assigned values in substance concentrations (mol/L). Value assignment and accelerated degradation studies were carried out in accordance with WHO protocols for International Reference Reagents. RESULTS: The ampouled standards were assigned final values based on the recovery of immunoreactive material after reconstitution. The degradation studies showed that the standards were highly stable. CONCLUSIONS: The nomenclature of hCG-related molecules and immunoassays has been adopted by the IFCC, and the standards prepared and characterized by the Working Group have been formally adopted by the WHO as the First International Reference Reagents for six hCG-related molecules. These developments will enable better understanding of what assays for hCG measure and should ultimately help to improve the clinical application of these assays.     

Intra- and Interrater Reliability and Concurrent Validity of a New Tool for Assessment of Breast Cancer–Related Lymphedema of the Upper Extremity

Objective

The goal of this study was to develop and assess intra- and interrater reliability and validity of a clinical evaluation tool for breast cancer–related lymphedema, for use in the context of outcome evaluation in clinical trials.

Advanced nursing practice and Newton's three laws of motion

This article considers the reasons for the development of advanced practice roles among nurses and other healthcare professions. It explores the implications of financial constraints, consumer preferences and the development of new healthcare services on the reorganization of professional boundaries. It makes use of Sir Isaac Newton's three laws of motion to demonstrate how professional development in nursing has taken place in response to a number of external influences and demands. It also considers the significance of skill mix for the nursing profession, in particular the development and likely expansion of the physician assistant role. The application of different professionals and grades within a healthcare team or organization is central to the Government's Agenda for Change proposals and nurses have successfully adopted a number of roles traditionally performed by doctors. Nurses have demonstrated that they are capable of providing high quality care and contributing directly to positive patient outcome. Advanced nursing roles should not only reflect the changing nature of healthcare work, they should also be actively engaged in reconstructing healthcare boundaries.     

Revisiting an ancient treatment for transphincteric fistula-in-ano ‘There is nothing new under the sun’ Ecclesiastes 1v9

Objective

The history of treatments for fistula-in-ano can be traced back to ancient times. Current treatment of transphincteric fistulae is controversial, with many options available. We reviewed the history of treatment using cutting setons and present our series of transphincteric fistulae in the light of the series in the literature.

Design

Literature review and case series.

Setting

Hospital based coloproctology service

Participants

140 consecutive patients presenting with fistula-in-ano were included.

Main Outcome Measures

The literature pertaining to treatment of transphincteric fistula was reviewed, along with the outcome of various treatment methods for this condition. Data were collected for 140 consecutive patients presenting with fistula- in-ano were assessed for fistula healing, recurrence and complications.

Results

A total of 140 consecutive patients with fistula-in-ano were identified, of which 111 were cryptoglandular (79.3%). Eighty-one of these 111 were transphincteric (73.0%). At a median follow-up of 35 months (range, 2–83 months), 70 transphincteric fistulae had healed (86.4%), 10 were still undergoing treatment (12.3%) and one patient was lost to follow-up prior to treatment (1.2%). Two patients in this group required a stoma (2.5%), six patients developed recurrence (7.4%); three ‘true’ recurrences (3.7%). One (1.2%) developed a chronic fissure. There were no reported cases of incontinence.

Conclusions

The management of transphincteric fistula-in-ano is complex and controversial, for which no clear surgical procedure has gained acceptance as the gold standard. This study demonstrates that transphincteric fistulae can be successfully treated using cutting setons. A high healing rate (86.4%), low recurrence rate (7.4%) and a low complication rate (3.7%) are shown, which compares favourably with published rates over a long follow-up.     

The identification of higher forefoot temperatures associated with peripheral arterial disease in type 2 diabetes mellitus as detected by thermography

Aims

The purpose of this study was to investigate whether heat emitted from the feet of patients with type 2 diabetes (DM) and peripheral arterial disease (PAD) differed from those with type 2 diabetes without complications (DM).

A multilevel structural equation modeling analysis of vulnerabilities and resilience resources influencing affective adaptation to chronic pain

The processes of individual adaptation to chronic pain are complex and occur across multiple domains. We examined the social, cognitive, and affective context of daily pain adaptation in individuals with fibromyalgia and osteoarthritis. By using a sample of 260 women with fibromyalgia or osteoarthritis, we examined the contributions of pain catastrophizing, negative interpersonal events, and positive interpersonal events to daily negative and positive affect across 30 days of daily diary data. Individual differences and daily fluctuations in predictor variables were estimated simultaneously by utilizing multilevel structural equation modeling techniques. The relationships between pain and negative and positive affect were mediated by stable and day-to-day levels of pain catastrophizing as well as day-to-day positive interpersonal events, but not negative interpersonal events. There were significant and independent contributions of pain catastrophizing and positive interpersonal events to adaptation to pain and pain-related affective dysregulation. These effects occur both between persons and within a person’s everyday life