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Infusion of bypassing agents, such as recombinant activated FVII (rFVIIa) and plasma‐derived activated prothrombin complex concentrate (APCC), are suggested as alternative therapies to factor VIII (haemophilia A) or IX (haemophilia B) for individuals who no longer respond to these treatments because they develop inhibitory antibodies. The ultimate goal of treatment is to preserve the individual's joints, otherwise destroyed by recurrent bleeds. We therefore evaluated the effectiveness and safety of bypassing agents when used to prevent, as compared to treat, bleeds. We also compared different doses of bypassing agents in men with hemophilia A or B with inhibitors as a preventative (prophylactic) therapy.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: September 25, 2017

The aim of the present report was to assess the added benefit of simoctocog alfa compared with the appropriate comparator therapy (ACT) in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

Institute for Quality and Efficiency in Health Care (IQWiG).

Version: February 11, 2015

The aim of the present report is to assess the added benefit of turoctocog alfa compared with the appropriate comparator therapy (ACT) in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

Institute for Quality and Efficiency in Health Care (IQWiG).

Version: April 10, 2014

Background In accordance with §35a Social Code Book (SGB) V, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to assess the benefit of the drug efmoroctocog alfa. The assessment was based on a dossier compiled by the pharmaceutical company (hereinafter referred to as “the company”). The dossier was sent to IQWiG on 18 December 2015.

Institute for Quality and Efficiency in Health Care (IQWiG).

Version: March 30, 2016

Methods of assessing the need for systematic reviews to be updated have been published, but agreement among them is unclear.

Methods Research Reports - Agency for Healthcare Research and Quality (US).

Version: June 2011

This guideline contains recommendations about general principles of blood transfusion, and applies to a range of conditions and different settings. It does not include recommendations relating to specific conditions and provides guidance on:

NICE Guideline - National Clinical Guideline Centre (UK).

Version: November 2015

The study found that viscoelastic testing may be effective in reducing the numbers of cardiac surgery patients receiving red blood cell transfusion, platelet transfusion and fresh frozen plasma transfusion, compared with a management strategy based on standard laboratory tests.

Health Technology Assessment - NIHR Journals Library.

Version: July 2015

Sepsis is a syndrome characterised by a systemic inflammatory response to infection that leads to rapid acute organ failure and potentially rapid decline to death. Intravenous immunoglobulin (IVIG), a blood product derived from human donor blood, has been proposed as an adjuvant therapy for sepsis.

Health Technology Assessment - NIHR Journals Library.

Version: February 2012

The study found evidence to suggest that integrated continuous glucose monitoring insulin pump therapy systems are more clinically effective in patients with type 1 diabetes than stand-alone treatments. However, based on the evidence available, these integrated systems are unlikely to be cost-effective in comparison with stand-alone insulin delivery and monitoring. Further research on the clinical effectiveness and cost-effectiveness of these integrated systems in different populations is warranted.

Health Technology Assessment - NIHR Journals Library.

Version: February 2016

Sepsis is a syndrome characterised by a systemic inflammatory response to infection that leads to rapid acute organ failure and potentially rapid decline to death. Estimates of severe sepsis (sepsis associated with acute organ dysfunction) in UK adult critical-care units from the Intensive Care National Audit & Research Centre Case Mix Programme Database indicate an increasing incidence of severe sepsis in critical care (rising from 50 to 70 cases per 100,000 population per year over the last decade). This now represents approximately 31,000 patient episodes and 15,000 in-hospital deaths per year.

NIHR Health Technology Assessment programme: Executive Summaries - NIHR Journals Library.

Version: 2012

Despite the improved screening tests developed in recent years for infectious diseases for blood donors, there still remains a theoretical residual risk of transmission of transfusion-related viruses from single blood components. This mainly relates to donors in the window period of infection and the possible emergence of new pathogens. Octaplas is a virus-inactivated form of fresh frozen plasma (FFP) that, as a consequence of its means of preparation, reduces the risk of transfusion-related viral infections, thereby improving safety. The Canadian Blood Services, which is the distributor of all blood products for nine Canadian provinces and three territories, has been considering a broadening of its product coverage to include Octaplas as an alternative to FFP for certain indications. While several publications claim the in vitro equivalence of Octaplas and FFP in terms of clotting factor activities, the clinical effectiveness of this blood product in the treatment of various indications is not well understood or researched.

CADTH Optimal Use Report - Canadian Agency for Drugs and Technologies in Health.

Version: May 2011

Venous thromboembolism (VTE) is a condition in which a blood clot (a thrombus) forms in a vein and then dislodges to travel in the blood (an embolus). A venous thrombus most commonly occurs in the deep veins of the legs or pelvis; this is then called a deep vein thrombosis (DVT). Blood flow through the affected vein can be limited by the clot, and it can cause swelling and pain in the leg. If it dislodges and travels to the lungs, to the pulmonary arteries, it is called a pulmonary embolism (PE), which in some cases may be fatal. VTE as a term includes both DVT and PE. Major risk factors for VTE include a prior history of DVT, age over 60 years, surgery, obesity, prolonged travel, acute medical illness, cancer, immobility, thrombophilia (an abnormal tendency for the blood to clot) and pregnancy.

NICE Clinical Guidelines - National Clinical Guideline Centre (UK).

Version: June 2012

A systematic assessment of diagnostic and therapeutic devices in common use as blood management tools in cardiac surgery did not demonstrate clinical effectiveness or cost-effectiveness.

Programme Grants for Applied Research - NIHR Journals Library.

Version: September 2017

Expert-reviewed information summary about the treatment of childhood vascular tumors.

PDQ Cancer Information Summaries [Internet] - National Cancer Institute (US).

Version: January 26, 2018

Health Canada recently licensed Octaplas, which can now be considered as an alternative to standard fresh frozen plasma (FFP) for certain indications. Since, on average, 200,000 units of FFP are transfused annually in Canada, the widespread implementation of Octaplas may have significant public health and economic implications. This study investigates the cost-effectiveness position of Octaplas against standard FFP and its budgetary impact to the health care system.

CADTH Technology Report - Canadian Agency for Drugs and Technologies in Health.

Version: March 2011

Expert-reviewed information summary about the treatment of adult acute myeloid leukemia.

PDQ Cancer Information Summaries [Internet] - National Cancer Institute (US).

Version: February 7, 2018

This guideline reviews the evidence for the care of women who present with signs and symptoms of preterm labour and those who are scheduled to have a preterm birth. It also reviews how preterm birth can be optimally diagnosed in symptomatic women, given that many women thought to be in preterm labour when clinically assessed will not deliver preterm. Optimal diagnosis can facilitate transfer to a place where appropriate neonatal intensive care can be provided, a strategy known to improve rates of survival for the baby. Additional areas that will be covered by the guidance (such as information needs for women who presents with signs and symptoms of preterm labour) are outlined in the guideline scope.

NICE Guideline - National Collaborating Centre for Women's and Children's Health (UK).

Version: November 2015

Inadvertent perioperative hypothermia is a common but preventable complication of perioperative procedures, which is associated with poor outcomes for patients. Inadvertent perioperative hypothermia should be distinguished from the deliberate induction of hypothermia for medical reasons, which is not covered by this guideline.

NICE Clinical Guidelines - National Collaborating Centre for Nursing and Supportive Care (UK).

Version: April 2008

This User's Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care.

Agency for Healthcare Research and Quality (US).

Version: April 2014

This guideline covers the physical, emotional, social and spiritual elements of end of life care, and focuses on improving the child or young person’s quality of life and supporting their family and carers. There are, for instance, recommendations on managing distressing symptoms and providing care and bereavement support after death. Recommendations have also been made about how services should be delivered. The guideline is aimed at all providers of paediatric end of life care, whatever their level of practise, and also for children and young people with life-limiting conditions and their parents or carers.

NICE Guideline - National Guideline Alliance (UK).

Version: December 2016

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