Design and Implementation of a Controlled Clinical Trial to Evaluate the Effectiveness and Efficiency of Routine Opt-out Rapid Human Immunodeficiency Virus Screening in the Emergency Department

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.     

Patient-reported outcomes in the Translational Breast Cancer Research Consortium

Members of the Translational Breast Cancer Research Consortium conducted an expert-driven literature review to identify a list of domains and to evaluate potential measures of these domains for inclusion in a list of preferred measures. Measures were included if they were easily available, free of charge, and had acceptable psychometrics based on published peer-reviewed analyses. A total of 22 domains and 52 measures were identified during the selection process. Taken together, these measures form a reliable and validated list of measurement tools that are easily available and used in multiple cancer trials to assess patient-reported outcomes in relevant patients.     

Parvovirus B19 infection and Diamond-Blackfan anaemia

It is the purpose of the study to report the frequency of parvovirus in children with a diagnosis of Diamond-Blackfan anaemia and to discuss the possible aetiological role of parvovirus in Diamond-Blackfan anaemia. We found parvovirus DNA in 3 of 11 bone marrow smears. Giant pronormoblasts showed low sensitivity (33%) and poor specificity (75%). The presence of giant pronormoblasts was associated with a very high myeloid: erythroid ratio, and may not be specific for parvovirus infection, but a feature of severely suppressed erythropoiesis. The three parvovirus-positive patients were the only children who experienced a remission, and who are free of medication. The seven surviving parvovirus-negative patients are all currently on steroid treatment.     

Protein restriction in chronic renal failure

The aim of the study was to investigate the effect of a protein restricted diet on renal function and growth of children with chronic renal failure. In a multicentre prospective study 56 children (aged 2-18 years) with chronic renal failure were randomly assigned to the protein restricted (0.8-1.1 g/kg/day) or the control group. All children were followed up by the same paediatrician and dietitian. After a follow up period of three years there was no significant difference in glomerular filtration rate between children on a protein restricted diet and children of the control group. There was no significant difference in weight with respect to height and height SD score between the protein restricted and the control group. Compliance with the protein restricted diet, as indicated by the prospective diet diaries and the serum urea:creatinine ratio, was good. This study shows that children with chronic renal failure do not benefit from a protein restricted diet.     

Life Satisfaction and Subsequent Physical,Behavioral, and Psychosocial Health in Older Adults

Policy Points

• Several intergovernmental organizations (Organisation for Economic Co‐operation and Development, World Health Organization, United Nations) are urging countries to use well‐being indicators (e.g., life satisfaction) in addition to traditional economic indicators when making important policy decisions.
• As the number of governments implementing this new approach grows, so does the need to continue evaluating the health and well‐being outcomes we might observe from policies aimed at improving life satisfaction.
• The results of this study suggest that life satisfaction is a valuable target for policies aiming to enhance several indicators of psychosocial well‐being, health behaviors, and physical health outcomes.

ContextSeveral intergovernmental organizations (Organisation for Economic Co‐operation and Development, World Health Organization, United Nations) are urging countries to use well‐being indicators (e.g., life satisfaction) in addition to traditional economic indicators when making important policy decisions. As the number of governments implementing this new approach grows, so does the need to continue evaluating the health and well‐being outcomes we might observe from policies aimed at improving life satisfaction.MethodsWe evaluated whether positive change in life satisfaction (between t₀;2006/2008 and t₁;2010/2012) was associated with better outcomes on 35 indicators of physical, behavioral, and psychosocial health and well‐being (in t₂;2014/2016). Data were from 12,998 participants in the University of Michigan''s Health and Retirement Study—a prospective and nationally representative cohort of US adults over age 50.FindingsParticipants with the highest (versus lowest) life satisfaction had better subsequent outcomes on some physical health indicators (lower risk of pain, physical functioning limitations, and mortality; lower number of chronic conditions; and higher self‐rated health) and health behaviors (lower risk of sleep problems and more frequent physical activity), and nearly all psychosocial indicators (higher positive affect, optimism, purpose in life, mastery, health mastery, financial mastery, and likelihood of living with spouse/partner; and lower depression, depressive symptoms, hopelessness, negative affect, perceived constraints, and loneliness) over the 4‐year follow‐up period. However, life satisfaction was not subsequently associated with many specific health conditions (i.e., diabetes, hypertension, stroke, cancer, heart disease, lung disease, arthritis, overweight/obesity, or cognitive impairment), other health behaviors (i.e., binge drinking or smoking), or frequency of contact with children, family, or friends.ConclusionsThese results suggest that life satisfaction is a valuable target for policies aiming to enhance several indicators of psychosocial well‐being, health behaviors, and physical health outcomes.     

Parastomal evisceration as an extremely rare complication of a common procedure

The creation of an abdominal stoma is a common procedure performed as part of the treatment for many conditions. Common complications include poor stoma siting, high output, skin irritation, ischaemia, retraction, parastomal hernia and prolapse. An extremely rare stoma complication is parastomal evisceration. We present a case of a 48-year-old woman who presented to us with parastomal evisceration as a late complication of a transverse colostomy. It is the second case reported as acomplication of this procedure but the first that occurred after such a long postoperative period (almost 18 months).