Informed consent: patient information forms in chemotherapy trials

Documentation of informed consent by patients entering clinical trials is an ethical and legal necessity. Federal regulations and judicial opinions have led to increasingly lengthy, detailed "consent" forms, yet published studies demonstrate that patients remain confused about the nature and anticipated consequences of study entry. It has been suggested that more detail may even alarm or further confuse patients. Seventy-five women undergoing chemotherapy for advanced breast cancer participated in this study which assessed patient preference for long-, medium-, or short-form length, and whether form length preference correlated with patient characteristics or indicators of patient autonomy in decision-making or physician dependency. Patient preferences for information were not predicted by the patient autonomy or physician dependency scores or by age, marital status, or level of education. The majority of patients expressed a preference for more detailed information about their treatment, yet a majority of patients given detailed forms answered questions basic to the study design incorrectly, irrespective of educational level. The increased detail included in the long forms was not reported to increase stress compared to the short forms. Patient information forms are a principal tool for informing patients for consent but if they are to perform their desired function they must be designed more carefully and evaluated more thoroughly than in the past.     

Improving care through standardized treatment of spontaneous pneumothorax

PurposeThe objective of this quality improvement (QI) initiative was to implement a standardized clinical treatment protocol for patients presenting with primary spontaneous pneumothorax (PSP) in order to decrease hospital length of stay (LOS), diagnostic radiation exposure, and related cost.MethodsBaseline data from patients admitted with PSP from January 1, 2016 to July 31, 2018 were compared to data from patients managed using a newly developed evidence-based treatment pathway from August 1, 2018 to December 31, 2019. Standard QI methodology was used to track results.ResultsFifty-six episodes of PSP were observed during the baseline period and 40 episodes of PSP following initiation of the PSP protocol. The average LOS decreased from 4.5 days to 2.9 days. Patients underwent an average of 8.8 X-rays per admission preintervention versus 5.9 postintervention. The rate of CT scans decreased from 45% to 15% (p = 0.002). There was no significant difference in the rates of 30-day recurrence between the preintervention (13%) and postintervention (10%) groups (p = 0.7). Average admission costs per patient decreased by $1322 after adoption of the pathway.ConclusionsAdoption of a standardized treatment protocol for PSP led to a reduction in LOS, diagnostic imaging utilization, and cost without increasing clinical recurrence.Type of studyQuality improvement.Level of evidenceLevel III.     

Life underneath the VCA umbrella: Perspectives from the US Uterus Transplant Consortium

The parallel emergence of uterus transplantation (UTx) and other transplantation innovations including face and hand transplantation led to the categorization of the uterus as a vascular composite allograft (VCA). With >60 transplants and >20 births worldwide, UTx is transitioning rapidly from a research endeavor to an effective treatment option for women with uterine factor infertility. While it originally made sense to group the innovations under one umbrella, it is time to revisit the designation of UTx as a VCA. We describe how UTx needs unique policy, procedural codes, insurance contracts, and educational initiatives. We contend that separating UTx from VCAs may become necessary in the future to avoid hindering the growth and regulation of this field.     

Autistic Traits,Empathizing–Systemizing,and Gender Diversity

Archives of Sexual Behavior - Previous research indicates a link between autism and transgender and gender-diverse identities, though the association is not yet fully understood. The current study...     

A family exhibiting the cis-AB genotype

Studies on blood samples from a 30-year-old woman of Korean origin, her husband and children, showed the presence of the cis-AB genotype in the mother and one child. The cis-AB red cells showed abnormal reactions with both polyclonal and monoclonal anti-B reagents and an elevated level of H antigen. The serum contained weak anti-B that reacted with normal B antigen but not with that on cis-AB cells. Normal levels of A substance but reduced levels of B and H substances were present in the saliva. Conversely, the serum showed reduced A and normal B and H blood group transferase activity.     

Binding and specificity of major immunoglobulin classes of preformed human anti-pig heart antibodies

Preformed human anti-pig antibodies isolated from perfused pig hearts were used to analyze the binding of various immunoglobulin classes to cultured pig kidney cells. All anti-pig immunoglobulins (i.e., IgG, IgA, and IgM) were localized on the cell surface by the use of an indirect immunofluorescence technique. Anti-pig immunoglobulins also competed for the pig cell surface epitopes with Griffonia simplicifolia lectin (GS-I-B₄), which is specific for -galactosyl residues. This study provides further evidence that preformed human antibodies recognizing -glactosyl-containing epitopes (anti-gal antibodies) could be an important factor in hyperacute rejection of pig organs.     

Taurolin for the prevention of parenteral nutrition related infection: antimicrobial activity and long-term use

A case is described in which bis (1, 1 dioxoperhydro-1, 2, 4-thiadiazinyl-4-) methane (Taurolin) has saferly been administered on a long term basis to prevent recurrent sepsis in a patient receiving parenteral nutrition. A 26-year-old male with Crohn's disease receiving parenteral nutrition suffered repeated episodes of sepsis and developed an infected intra-atrial thrombus despite repeated courses of antimicrobial chemotherapy and surgical intervention. Continued parenteral nutrition was essential du5e to intestinal failure. Taurolin was administered in the parenteral feed, as a 0.3% solution, to prevent recrudescent and recurrent infection. This concentration was shown, in vitro, to be bactericidal to a variety of pathogenic organisms. No recurrence of sepsis, nor any evidence of side effects was observed throughout the 12 month period of Taurolin administration. After 12 months the taurolin was discontinued and within 2 weeks the patient was re-admitted with recurrent septicaemia. Following re-introduction of Taurolin the infection was controlled and the patient remains well. In our experience the addition of taurolin to the nutritive feeds of a patient at risk of sepsis is a safe and effective method of preventing recurrent sepsis.     

Applying critical pathways to neurosurgery patients at the University of Michigan Medical Center

Project Overview: In April 1990, The University of Michigan Hospitals began a major, multidisciplinary project to standardize care processes in order to increase efficiency and reduce costs while maintaining the quality of clinical care. A team of nurses began the project by developing critical pathways for two neurosurgery procedures--lumbar laminectomy and transphenoidal pituitary tumor resection. The pathways were reviewed by physicians and other staff from other disciplines and were implemented in January of 1991. Key Findings: Data from the first 14 months show a decrease in patients' average lengths of stay in both the intensive care unit (ICU) and routine care unit. Costs and variance data are being analyzed and further improvements to the pathways are being made. Eleven critical paths are now being used for neurosurgery patients. In retrospect, participants learned that physicians should be involved at the earliest stages of critical pathway development and in the process of implementation.     

Reconciling demands

How can hospitals keep a tight rein on their finances while satisfying changing demand? Kevin Richards explains how the hospital planning model helped Coventry HA.