Restrictive Guidelines Research Articles

Is best transfusion practice alone best clinical practice?

Is best transfusion practice alone best clinical practice?

Maximizing early treatment with biologics in patients with rheumatoid arthritis: the ultimate breakthrough in joints preservation

Rheumatoid arthritis (RA) is a chronic, systemic, progressive inflammatory disease that, if left untreated, can lead to irreversible joint damage and serious disability. In Central and Eastern Europe, RA treatment varies widely, partly due to economic factors, restrictive treatment guidelines, and access to practicing rheumatologists. The recent treatment paradigm shift of treating to target in RA with early, aggressive therapy has proven to be a successful strategy for achieving optimal clinical outcomes. Several clinical studies demonstrate that utilizing this strategy with anti-tumor necrosis factor biologics leads to improved clinical, radiographic, and functional outcomes. Patient education is also a critical component of the treating to target strategy, and the patient's version of the treat-to-target recommendations is an important tool for successful implementation. This review discusses the evidence for the treat-to-target approach and describes areas to improve the disparity of treatment between patients in Western European compared with Central and Eastern European countries.

The Gendered Individual in Funerary Papyri of the Ptolemaic and Roman Periods

In the magical texts provided to Egyptians to transition to the afterlife, the mythological precedent set by the rebirth of Osiris created gendered theological principles, which remained central to funerary beliefs throughout Egyptian history. At the point of mummification, the body of the deceased, male or female, temporarily took part in the Osirian rituals and was transformed. As restrictive guidelines for the use of texts started to fall away in the Third Intermediate period, and even more so in the Graeco-Roman period, there were many new, appropriate ways to connect a funerary text to a single person. This article addresses how ancient scribes accommodated allusions and adapted religious content to the text’s owner more extensively in later periods. Rather than the basic grammatical changes found in pharaonic sources, later scribes inserted gendered mythological references and biographical material as textual alterations to create personalized documents for either gender. They creatively pushed the boundaries of individualization as far as possible, but remained within the idealized context of funerary beliefs. Instead, they differentiated male or female gender roles to accentuate the character of the deceased only where appropriate without jeopardizing access to the next life.

Indications for Inferior Vena Cava Filter Placement: Do Physicians Comply with Guidelines?

PurposeInferior vena cava (IVC) filter placement has increased significantly over the past few decades, but indications for filter placement vary widely depending on which professional society recommendations are followed, and it is uncertain how compliant physicians are in adhering to guidelines. This study assessed documented indications for IVC filter placement and evaluated compliance with standards set by the American College of Chest Physicians (ACCP) and the Society of Interventional Radiology (SIR). Materials and MethodsA single-center, retrospective medical record review in a metropolitan, 652-bed, acute care, teaching hospital. Inpatient filter placement over a 26-month period was reviewed. The study measured compliance with established guidelines, relationship of medical specialty to filter placement, and evaluation of self-referral patterns among physicians. ResultsCompliance with established ACCP guidelines was poor regardless of whether the IVC filter insertion was performed by interventional radiology (IR; 43.5%), vascular surgery (VS; 39.9%), or interventional cardiology (IC; 33.3%) staff. Compliance with the less restrictive SIR guidelines was better (77.5%, 77.1%, and 80% for IR, VS, and IC, respectively). There was a greater degree of guideline compliance when filter placement was recommended by internal medicine (IM)–trained physicians than by non–IM-trained physicians: 46.3% of IR-placed filters requested by IM physicians met ACCP criteria whereas only 24.0% of filters recommended by non-IM specialties were compliant with criteria (P = .03). In the VS group, these compliance rates were 45.8% and 31.5%, respectively (P = .03). Among IR-placed filters, 84.0% of IM-recommended filter placements were compliant with SIR guidelines, versus only 48.0% of non–IM-recommended placements (P ≤ .001). In the VS group, these compliance rates were 87.8% and 69.6%, respectively (P ≤ .001). ConclusionsThere is poor physician compliance with guidelines for IVC filter placement. Most filter indications meeting SIR guidelines are for patients classified as “falls risks,” failures of anticoagulation, patients with limited cardiopulmonary reserve and patients non compliant with anticoagulation medications. This single-center study suggests a need for harmonization of current guidelines espoused by professional societies.

Donor exposure in neonatal blood transfusion - time to change strategy?

<h3>Background</h3> Previous studies have recommended reserving 8 satellite packs (SP) for extremely low birth weight (ELBW) babies to reduce donor exposure (DE) from blood transfusions.1 However, concentration of transfusions at the beginning and end of neonatal care coupled with short shelf-life of blood result in wastage of SPs and unavoidable DE. Neonatal transfusion practice may have changed due to restrictive transfusion guidelines, micro-sampling methods and practice of delayed cord clamping. We currently reserve only 4 SPs for ELBW babies and strictly follow British Committee for Standards in Haematology 2004 guidelines for blood transfusion². <h3>Aims</h3> To ascertain the root cause of excess DE and SP wastage in multi-transfused ELBW babies and suggest an optimum contemporary strategy that would balance DE with SP wastage. <h3>Methods</h3> Transfusion data was collected for all inborn ELBW babies and those transferred-in within 96 hours of birth in 2010. Rates and determinants of DE were analysed. Projected SP wastage and DE rates were calculated for different SP strategies. <h3>Results</h3> Thirty-eight ELBW babies with a mean gestation of 25.5 weeks and birth weight of 712 grams were included. Eight babies were not transfused while 7 received only one transfusion. Therefore, 23 babies were included for DE and 30 for SP wastage analysis. The mean SP usage was 3.97/baby. The mean DE was 2.47 and mean SP wastage 4.7/baby. The mean age of the donor unit at allocation was 20.2 days (95% CI 18.4, 22). The mean interval between the first and last transfusion was 35 days. Reducing donor unit age to 14 days at allocation would have reduced one donor exposure in 11/23 babies (47.8%). Table 1 shows the effect of different projected SP strategies on DE and SP wastage. <h3>Conclusions</h3> Younger age of blood unit at allocation is the key to reduce DE. A 4-SP strategy appears appropriate for current transfusion practice for ELBW babies.

Tight Glycemic Control With Insulin in Hyperglycemic Preterm Babies: A Randomized Controlled Trial

The optimal treatment of neonatal hyperglycemia is unclear. The aim of this trial was to determine whether tight glycemic control with insulin improves growth in hyperglycemic preterm infants, without increasing the incidence of hypoglycemia. Randomized, controlled, nonblinded trial of 88 infants born at <30 weeks' gestation or <1500 g who developed hyperglycemia (2 consecutive blood glucose concentrations (BGC) >8.5 mmol/L, 4 hours apart) and were randomly assigned to tight glycemic control with insulin (target BGC 4-6 mmol/L, "tight" group) or standard practice (restrictive guidelines for starting insulin, target BGC 8-10 mmol/L, "control" group). The primary outcome was linear growth rate to 36 weeks' postmenstrual age. Eighty-eight infants were randomly assigned (tight group n = 43; control group n = 45). Infants in the tight group had a lesser lower leg growth rate (P < .05), but greater head circumference growth (P < .0005) and greater weight gain (P < .001) to 36 weeks' postmenstrual age than control infants. Tight group infants had lower daily BGC (median [interquartile range] 5.7 [4.8-6.7] vs 6.5 [5.1-8.2] mmol/L, P < .001) and greater incidence of hypoglycemia (BGC <2.6 mmol/L) (25/43 vs 12/45, P < .01) than controls. There were no significant differences in nutritional intake, or in the incidences of mortality or morbidity. Tight glycemic control with insulin in hyperglycemic preterm infants increases weight gain and head growth, but at the expense of reduced linear growth and increased risk of hypoglycemia. The balance of risks and benefits of insulin treatment in hyperglycemic preterm neonates remains uncertain.

Balancing Risk and Access: Underwriting Standards for Qualified Residential Mortgages

As policymakers develop underwriting guidelines for qualified residential mortgages (QRM) — which are exempt from risk retention requirements for privately securitized mortgages under the Dodd-Frank Wall Street Reform and Consumer Protection Act — both consumer and industry groups have raised concerns about the disproportionate impact that restrictive QRM guidelines may have on low-income, low-wealth, minority, and other households traditionally underserved by the mainstream mortgage market. In this study, we examine the way different QRM guidelines may affect access to mortgage credit and loan performance, with a special focus on historically underserved households. More narrowly, we estimate the additional impacts on defaults and access resulting from setting QRM underwriting guidelines over and above the proposed product restrictions for qualified mortgages (QM), which exclude loans with features associated with higher default rates. We find that the added benefits of reduced foreclosures resulting from restrictions beyond the QM product requirements do not necessarily outweigh the costs of reducing borrowers’ access to QRM mortgages. In particular, LTV requirements of 80 or 90 percent produce a smaller benefit when the resulting reductions in defaults are weighed against the number of borrowers excluded from the market. The results for debt-to-income (DTI) and borrower credit scores (FICO) similarly show that the most restrictive thresholds are less effective because they exclude a larger share of borrowers in relation to percent of defaults they prevent. In addition, we find that more stringent LTV, DTI, and FICO requirements could disproportionately deny low-income borrowers and borrowers of color access to QRM mortgages.

The ‘Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth-Weight Infants (ETTNO)’ Study: Background, Aims, and Study Protocol

Background: Infants with extremely low birth weight uniformly develop anemia of prematurity and frequently require red blood cell transfusions (RBCTs). Although RBCT is widely practiced, the indications remain controversial in the absence of conclusive data on the long-term effects of RBCT. Objectives: To summarize the current equipoise and to outline the study protocol of the ‘Effects of Transfusion Thresholds on Neurocognitive Outcome of extremely low birth-weight infants (ETTNO)’ study. Methods: Review of the literature and design of a large pragmatic randomized controlled trial of restrictive versus liberal RBCT guidelines enrolling 920 infants with birth weights of 400–999 g with long-term neurodevelopmental follow-up. Results and Conclusions: The results of ETTNO will provide definite data about the efficacy and safety of restrictive versus liberal RBCT guidelines in very preterm infants.

Incidence of Nephrogenic Systemic Fibrosis after Adoption of Restrictive Gadolinium-based Contrast Agent Guidelines

Incidence of Nephrogenic Systemic Fibrosis after Adoption of Restrictive Gadolinium-based Contrast Agent Guidelines

“Independent” Consultants' Role in the Executive Remuneration Design Process under Restrictive Guidelines

ABSTRACTManuscript Type: EmpiricalResearch Question/Issue: This study explores the remuneration consultant–client relationship in a non‐Anglo‐American context, focusing on what consultants do under heavy political remuneration guidance.Research Findings/Insights: A qualitative social constructivist approach was adopted, drawing on interviews with the CEO and “independent” chairman of the board of 23 Finnish state‐owned enterprises, as well as four leading consultants. The research context considerably differs from that of the US, since the State takes an active role in providing remuneration guidelines. Finland also represents a country with a high level of corporate governance and low level of corruption. Nonetheless, our results strongly support the managerial entrenchment perspective fraught with problems and filled with game playing, where “specialized” consultants and CEOs play the major roles, resulting in increased salary levels, slack, an emphasis on share‐based incentives, and public outrage. The effectiveness of these guidelines would be hard, even impossible, to understand, without proper analysis of human interaction related to it.Theoretical/Academic Implications: The study questions the definition of consultant independence based on external data. Second, routine practices commonly bypass rules, leading to the unintended consequence of forced change. Third, the structure of consultancy markets and long consultant–client relationships play an important role in the services offered by consultants.Practioner/Policy Implications: The findings show that restrictive remuneration guidelines can be ineffective and lead to standardized pay designs without providing competitive advantage. Shareholders should request greater transparency concerning remuneration design. The role of consultants should be considered proactively in the guidelines, even by limiting the length of the consultant–client relationship or increasing their transparency.

Exercise training improves exercise capacity in adult patients with a systemic right ventricle: a randomized clinical trial

To assess whether exercise training in adult patients with a systemic right ventricle (RV) improves exercise capacity and quality of life and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels. Multi-centre parallel randomized controlled trial. Patients with a systemic RV due to congenitally or surgically corrected transposition of the great arteries. Fifty-four adult patients with a systemic RV, were randomized using unmarked opaque envelopes to an intervention group (n = 28) with three training sessions per week for 10 consecutive weeks, and a control group (n = 26). Randomization was stratified by participating centre. At baseline, and follow-up, we determined maximal exercise capacity (V'O(2peak)), serum NT-proBNP levels, and quality of life by means of the SF-36, and the TAAQOL Congenital Heart Disease questionnaires. The final analysis was performed by linear regression, taking into account the stratified randomization. Forty-six patients were analysed (male 50%, age 32 ± 11 years, intervention group n = 24, control group n = 22). Analysis at 10 weeks showed a significant difference in V'O(2peak) (3.4 mL/kg/min, 95% CI: 0.2 to 6.7; P = 0.04) and resting systolic blood pressure (-7.6 mmHg, 95% CI: -14.0 to -1.3; P = 0.03) in favour of the exercise group. No significant changes were found in serum NT-proBNP levels or quality of life in the intervention group or in the control group nor between groups. None of the patients in the intervention group had to discontinue the training programme due to adverse events. In adult patients with a systemic RV exercise training improve exercise capacity. We recommend to revise restrictive guidelines, and to encourage patients to become physically active. ( The study was registered at http://trialregister.nl. Identifier: NTR1909.).

Incidence of nephrogenic systemic fibrosis after adoption of restrictive gadolinium-based contrast agent guidelines

Incidence of nephrogenic systemic fibrosis after adoption of restrictive gadolinium-based contrast agent guidelines

Erythropoiesis-stimulating agents in cancer patients: reflections on safety

Chemotherapy-induced anemia (CIA) is a frequent problem in cancer patients with a negative impact on prognosis and quality of life. Erythropoiesis-stimulating agents (ESAs) have proven efficacy in improving hemoglobin levels and reducing red blood cell transfusion needs of these patients. In several randomized studies in settings other than CIA (such as patients not receiving any chemotherapy, or studies on preventive use of ESAs to keep high hemoglobin levels), safety signals that ESA therapy may result in worse cancer outcome were documented. We review the evidence for these safety concerns, the different hypotheses to explain effects on outcome, the implications of the more restrictive guidelines on ESA therapy on daily practice and possible alternative treatments to consider.

Incidence of Nephrogenic Systemic Fibrosis after Adoption of Restrictive Gadolinium-based Contrast Agent Guidelines

To retrospectively determine the incidence of nephrogenic systemic fibrosis (NSF) in a large academic medical center after the adoption of restrictive gadolinium-based contrast agent (GBCA) administration guidelines. For this retrospective HIPAA-compliant study, institutional review board approval was obtained and the requirement for informed consent was waived. Restrictive GBCA guidelines were adopted in May 2007. The guidelines (a) require a recent serum creatinine level measurement in any patient who is aged 60 years or older and/or at risk for renal disease, (b) limit the maximal weight-based GBCA dose administered to any patient with an estimated glomerular filtration rate (eGFR) lower than 60 mL/min/m(2) to 20 mL, and (c) prohibit the administration of any GBCA in patients who have an eGFR lower than 30 mL/min/m(2) and/or are undergoing chronic dialysis treatment (except in emergency situations). The electronic medical records were searched for all contrast material-enhanced magnetic resonance (MR) imaging examinations performed during the post-guidelines adoption period between January 2008 and March 2010 and the pre-guidelines adoption and transitional period between January 2002 and December 2007. Separate pathology records were searched for biopsy-confirmed cases of NSF during the same study periods. The incidences of NSF during the pre-guidelines adoption and transitional period and post-guidelines adoption period were compared by using the paired Z test. A total of 52,954 contrast-enhanced MR examinations were performed during the post-guidelines adoption period. Of these 52,954 examinations, 46,464 (88%) were performed in adult patients with an eGFR of 60 mL/min/m(2) or higher or presumed normal renal function and 6454 (12%) were performed in patients with an eGFR of 30-59 mL/min/m(2). Thirty-six patients with an eGFR lower than 30 mL/min/m(2) underwent contrast-enhanced MR imaging for emergent indications. Review of the pathology records for January 2008 to September 2010 revealed no new cases of NSF resulting from GBCA exposure. After restrictive guidelines regarding GBCA administration were instituted, no new cases of NSF were identified among 52,954 contrast-enhanced MR examinations, including those performed in patients with an eGFR lower than 60 mL/min/m(2).

Access to biologic treatment for rheumatoid arthritis in Central and Eastern European (CEE) countries.

SummaryBackgroundThe aim of this study was to assess and compare patients’ access to biologic anti-RA drugs in selected Central and Eastern European (CEE) countries and to analyze the determinants of differences between countries.Material/MethodsThis is a multi-country survey study, based on a combination of desk research and direct contact with national RA stakeholders. Data was collected using a pre-defined questionnaire. Affordability was measured using an affordability index, calculated comparing the index of health care expenditures to the price index, using Poland as an index of 1.ResultsThe percentage of patients on biologic treatment in 2009 was highest in Hungary (5% RA patients on biologic treatment), followed by Slovenia (4.5%), Slovakia (3.5%), Czech Republic (2.92%), Romania (2.2%), Estonia (1.8%), and Croatia, Serbia, Poland (below 1.5%). Infliximab, etanercept, adalimumab and rituximab were included in the reimbursement system in all countries, but abatacept and tocilizumab were included only in Slovakia. In Slovenia, public payer covered 75% of the price, and 25% is covered by supplementary health insurance; in Bulgaria public payer covered 50% of etanercept and adalimumab costs, and 75% of rituximab cost. In other countries, biologic drugs are reimbursed at 100%. Affordability index for biologic drugs was the lowest in Slovenia (0.4). In each country national guidelines define which patients are eligible for biologic treatment. Disease Activity Score (DAS28) of over 5.1 and failure of 2 or more disease-modifying anti-RA drugs, including methotrexate, are commonly used criteria.ConclusionsThe most important factors limiting access to biologic anti-RA treatment in the CEE region are macroeconomic conditions and restrictive treatment guidelines.

Lyme disease: the next decade

Although Lyme disease remains a controversial illness, recent events have created an unprecedented opportunity to make progress against this serious tick-borne infection. Evidence presented during the legally mandated review of the restrictive Lyme guidelines of the Infectious Diseases Society of America (IDSA) has confirmed the potential for persistent infection with the Lyme spirochete, Borrelia burgdorferi, as well as the complicating role of tick-borne coinfections such as Babesia, Anaplasma, Ehrlichia, and Bartonella species associated with failure of short-course antibiotic therapy. Furthermore, renewed interest in the role of cell wall-deficient (CWD) forms in chronic bacterial infection and progress in understanding the molecular mechanisms of biofilms has focused attention on these processes in chronic Lyme disease. Recognition of the importance of CWD forms and biofilms in persistent B. burgdorferi infection should stimulate pharmaceutical research into new antimicrobial agents that target these mechanisms of chronic infection with the Lyme spirochete. Concurrent clinical implementation of proteomic screening offers a chance to correct significant deficiencies in Lyme testing. Advances in these areas have the potential to revolutionize the diagnosis and treatment of Lyme disease in the coming decade.

Aplicación de las guías de prevención secundaria de fractura osteoporótica y del índice FRAX en una cohorte de pacientes con fractura por fragilidad

Background and objectives There are different guidelines for secondary prevention of fractures related with osteoporosis. Our aim is to analyse the appliance of such guidelines in a sample of patients with fragility fracture Patients and methods Adult patients older than 50 years attended in the emergency department with a fragility fracture were invited to participate in a study for secondary prevention. Clinical data and densitometry for the FRAX index were recorded. Current guidelines were employed to calculate the number of patients who needed secondary prevention. Results With the appliance of current guidelines to 380 patients, 54-100% of women and 26-81% of men were candidates for treatment. For hip fractures the percentage was 81-100% and for forearm fractures 36-93%. FRAX index for hip fracture was ≥3% in 35% of patients. The National Institute for Health and Clinical Excellence and the National Osteoporosis Foundation 2009 were the most restrictive guidelines (54% and 57% respectively). On the other hand the National Guideline Clearinghouse (87%) and the National Osteoporosis Guideline Group (93%). Conclusion There are high differences in the percentage of patients who need treatment to prevent new fractures according to the guidelines. Fewer patients require treatment when the FRAX index is included in a guideline.

Perspective on prostate cancer screening

Cancer screening has become an obligatory appendix to all periodic and continuity care of adults. It is ritualistic and seldom questioned. It is discrete and modular and so easily audited for 'quality'. Its impact on actual health ranges from slightly helpful to slightly harmful, and even these conclusions are usually more than slightly speculative. While, in some cases, the existing data includes the probability of an occasional life saved, all screening programmes increase many-fold the lifetime chance of confronting a false alarm and thus becoming, for a time, a cancer patient.

The Lyme disease chronicles, continued: Chronic Lyme disease: in defense of the patient enterprise

The Lyme disease chronicles, continued: <i>Chronic Lyme disease: in defense of the patient enterprise</i>

Outcome for Gram-negative bacteraemia when following restrictive empirical antibiotic guidelines

Restrictions in prescribing broad spectrum antimicrobials have been part of a strategy to reduce Clostridium difficile cases in the UK in recent years. However, there has been little work on assessing the safety of alternative antimicrobial agents. We performed an uncontrolled prospective observational survey over a 1-year period to determine the effectiveness and safety of a new antimicrobial stewardship programme in a district hospital in the UK. In total, 227 Gram-negative bacteraemias (203 episodes) occurred in the study period. Guidelines were adequate in 194 of 203 (95%) episodes and 163 episodes (80.2%) received adequate therapy. Patients in the inadequate therapy group had >2-fold increased likelihood of death [odds ratio (OR) = 2.63, 95% confidence interval (CI) = 1.09-6.34] within 30 days and >6-fold increased risk of death (OR = 6.40, 95% CI = 2.22-18.45) within 1 week when compared to patients in the adequate therapy group. Failure to administer gentamicin was the principal reason for not following the guidelines (18 episodes). Eight of these 18 episodes were susceptible to cefuroxime and two of these patients died. Adherence to the guidelines was associated with a correct empirical antibiotic choice and reduced mortality. This study also demonstrates the importance of adopting guidelines based on local susceptibility patterns.