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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

National Academies Press (US).

Version: 2010

Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd edition

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

Dementia: A NICE-SCIE Guideline on Supporting People With Dementia and Their Carers in Health and Social Care

This guideline has been developed to advise on supporting people with dementia and their carers in health and social care. The guideline recommendations have been developed by a multidisciplinary team of health and social care professionals, a person with dementia, carers and guideline methodologists after careful consideration of the best available evidence. It is intended that the guideline will be useful to practitioners and service commissioners in providing and planning high-quality care for those with dementia while also emphasising the importance of the experience of care for people with dementia and carers.

NICE Clinical Guidelines - National Collaborating Centre for Mental Health (UK).

Version: 2007

Systematic review to identify and appraise outcome measures used to evaluate childhood obesity treatment interventions (CoOR): evidence of purpose, application, validity, reliability and sensitivity

The study found that the Childhood obesity Outcomes Review (CoOR) outcome measures framework provides clear guidance of recommended primary and secondary outcome measures, which will enhance comparability between treatment evaluations and ensure that appropriate measures are being used.

Health Technology Assessment - NIHR Journals Library.

Version: August 2014
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Stable Angina: Methods, Evidence & Guidance [Internet]

Angina is pain or constricting discomfort that typically occurs in the front of the chest (but may radiate to the neck, shoulders, jaw or arms) and is brought on by physical exertion or emotional stress. It is the main symptomatic manifestation of myocardial ischaemia and is usually caused by obstructive coronary artery disease restricting oxygen delivery to the cardiac myocytes. Other factors may exacerbate angina either by further restricting oxygen delivery (for example severe anaemia) or by increasing oxygen demand (for example left ventricular hypertrophy). Angina symptoms are associated with other cardiac disease such as aortic stenosis but the management of angina associated with non-coronary artery disease is outside the scope of this guideline.

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

Version: July 2011

Diabetes (Type 1 and Type 2) in Children and Young People: Diagnosis and Management

Diabetes is a long-term condition that can have a major impact on the life of a child or young person, as well as their family or carers. In addition to insulin therapy, diabetes management should include education, support and access to psychological services, as detailed here and in this guideline. Preparations should also be made for the transition from paediatric to adult services, which have a somewhat different model of care and evidence base.

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

Version: August 2015

Fertility: Assessment and Treatment for People with Fertility Problems

This guideline offers best practice advice on assisting people of reproductive age who have problems conceiving.

NICE Clinical Guidelines - National Collaborating Centre for Women’s and Children’s Health (UK).

Version: February 2013

Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Study found that implantable cardiac defibrillators reduced all-cause mortality in people at increased risk of sudden cardiac death as a result of previous ventricular arrhythmias or cardiac arrest, remote myocardial infarction or ischaemic/non-ischaemic heart failure and LVEF ≤ 35%. Cardiac resynchronisation therapy reduced all-cause mortality and improved other outcomes in people with heart failure as a result of left ventricular systolic dysfunction and cardiac dyssynchrony when compared with optimal pharmacological therapy. The devices were cost-effective at a willingness-to-pay threshold of £30,000 when compared with optimal pharmacological therapy.

Health Technology Assessment - NIHR Journals Library.

Version: August 2014
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Diabetes in Pregnancy: Management of Diabetes and Its Complications from Preconception to the Postnatal Period

Clinical guidelines have been defined as ‘systematically developed statements which assist clinicians and patients in making decisions about appropriate treatment for specific conditions’. This clinical guideline concerns the management of diabetes and its complications from preconception to the postnatal period. It has been developed with the aim of providing guidance on:

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

Version: February 2015

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

The Observational CER User's Guide serves as a resource for investigators and stakeholders when designing observational comparative effectiveness research (CER) studies, particularly those with findings that are intended to translate into decisions or actions. The User's Guide provides principles for designing research that will inform health care decisions of patients and other stakeholders. Furthermore, it serves as a reference for increasing the transparency of the methods used in a study and standardizing the review of protocols through checklists provided in every chapter.

Agency for Healthcare Research and Quality (US).

Version: January 2013

Neonatal Jaundice

Jaundice is one of the most common conditions requiring medical attention in newborn babies. Approximately 60% of term and 80% of preterm babies develop jaundice in the first week of life, and about 10% of breastfed babies are still jaundiced at 1 month of age. In most babies with jaundice thevre is no underlying disease, and this early jaundice (termed ‘physiological jaundice’) is generally harmless. However, there are pathological causes of jaundice in the newborn, which, although rare, need to be detected. Such pathological jaundice may co-exist with physiological jaundice.

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

Version: May 2010

The Prevention and Management of Pressure Ulcers in Primary and Secondary Care

Prevention of pressure ulcers usually involves an assessment to identify people most at risk of pressure ulcers, such as elderly, immobile people or those with spinal cord injury. Assessments are most commonly carried out using specific pressure area risk scores (for example, the Braden or Waterlow scales for predicting pressure sore risk or the, Glamorgan scale for paediatric pressure ulcers).

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

Version: April 2014

Antenatal Care: Routine Care for the Healthy Pregnant Woman

The original antenatal care guideline was published by NICE in 2003. Since then a number of important pieces of evidence have become available, particularly concerning gestational diabetes, haemoglobinopathy and ultrasound, so that the update was initiated. This update has also provided an opportunity to look at a number of aspects of antenatal care: the development of a method to assess women for whom additional care is necessary (the ‘antenatal assessment tool’), information giving to women, lifestyle (vitamin D supplementation, alcohol consumption), screening for the baby (use of ultrasound for gestational age assessment and screening for fetal abnormalities, methods for determining normal fetal growth, placenta praevia), and screening for the mother (haemoglobinopathy screening, gestational diabetes, pre-eclampsia and preterm labour, chlamydia).

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

Version: March 2008

Methods Guide for Medical Test Reviews [Internet]

Effectiveness and Comparative Effectiveness Reviews, systematic reviews of existing research on the effectiveness, comparative effectiveness, and comparative harms of different medical tests, are intended to provide relevant evidence to inform real-world health care decisions for patients, providers, and policymakers. In an effort to improve the transparency, consistency, and scientific rigor of the work of the Effective Health Care (EHC) Program, the Agency for Healthcare Research and Quality (AHRQ), the Scientific Resource Center, and the Evidence-based Practice Centers (EPCs), have developed this Methods Guide for Medical Test Reviews (also referred to as the Medical Test Methods Guide). We intend it to serve as a resource for the EPCs as well as for other investigators interested in conducting systematic reviews on medical tests. We hope it will be a practical guide both for those who prepare the systematic reviews and those who use them in clinical practice, research development, and in making policy decisions.

Agency for Healthcare Research and Quality (US).

Version: June 2012

Non-Pharmacological Interventions to Reduce the Risk of Diabetes in People with Impaired Glucose Regulation: A Systematic Review and Economic Evaluation

The prevalence of type 2 diabetes mellitus (T2DM) is increasing in the UK and worldwide. Before the onset of T2DM, there are two conditions characterised by blood glucose levels that are above normal but below the threshold for diabetes. If screening for T2DM in introduced, many people with impaired glucose tolerance (IGT) will be found and it is necessary to consider how they should be treated. The number would depend on what screening test was used and what cut-offs were chosen.

Health Technology Assessment - NIHR Journals Library.

Version: August 2012

Prostate Cancer, Nutrition, and Dietary Supplements (PDQ®): Health Professional Version

Expert-reviewed information summary about the use of nutrition and dietary supplements for reducing the risk of developing prostate cancer or for treating prostate cancer.

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

Version: January 19, 2017

Developing and evaluating a child-centred intervention for diabetes medicine management using mixed methods and a multicentre randomised controlled trial

Study found that there is a need to rethink context and the hierarchical relationships between children, young people, parents and diabetes professionals with regard to ‘partnership and participation’ in diabetes decision-making, self-care and self-management. Additional research, implementation strategies and service redesign are needed to translate – children’s diabetes information resources into optimal self-management knowledge and subsequent optimal diabetes self-management action.

Health Services and Delivery Research - NIHR Journals Library.

Version: March 2014

Generalised Anxiety Disorder in Adults: Management in Primary, Secondary and Community Care

This clinical guideline is an update of NICE’s previous guidance on generalised anxiety disorder. It was commissioned by NICE and developed by the National Collaborating Centre for Mental Health, and sets out clear evidence- and consensus-based recommendations for healthcare professionals on how to treat and manage generalised anxiety disorder in adults.

NICE Clinical Guidelines - National Collaborating Centre for Mental Health (UK).

Version: 2011

Systematic Reviews in PubMed

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