Guiding Principles This document presents official recommendations of the American Association for the Study of Liver Diseases (AASLD) on the treatment of chronic hepatitis B (CHB) virus (HBV) infection in adults and children. Unlike previous AASLD practice guidelines, this guideline was developed in compliance with the Institute of Medicine standards for trustworthy practice guidelines and use...

List of abbreviations 4 Introduction 5 The history and development of the new guideline ICH Topic Q8 5 The contents and requirements according to the new guideline 9 Comparison of the current guideline ICH Q8 with the previous guideline 15 Comparison of both guidelines – a summary 28 The term Design Space-Integration into ICH Q8, Q9 and Q10 29 Requirements of the new guideline for the innovatin...

BACKGROUND Clinical guidelines are considered important instruments to improve quality in health care. Since 1998 the Royal Dutch Society for Physical Therapy (KNGF) produced evidence-based clinical guidelines, based on a standardized program. New developments in the field of guideline research raised the need to evaluate and update the KNGF guideline program. Purpose of this study is to compar...

BACKGROUND The judgment and decision making process during guideline development is central for producing high-quality clinical practice guidelines, but the topic is relatively underexplored in the guideline research literature. We have studied the development process of national guidelines with a disease-prevention scope produced by the National board of Health and Welfare (NBHW) in Sweden. Th...

BACKGROUND The Dutch Healthcare Inspectorate supervises care providers in order to improve quality of care. Recently the inspectorate assessed and promoted the use of a guideline on smoking-cessation counselling in midwifery practices. The supervision programme consisted of an announcement of the enforcement deadline for the guideline and site visits. The purpose of our qualitative study was to...

BACKGROUND Many of the world's life threatening diseases (e.g. cancer, heart disease, stroke) could be prevented by eliminating life-style habits such as tobacco use, unhealthy diet, physical inactivity and excessive alcohol use. Incorporating evidence-based research on methods to change unhealthy lifestyle habits in clinical practice would be equally valuable. However gaps between guideline de...

BACKGROUND Continuous escalation in methodological and procedural rigor for evidence-based processes in guideline development is associated with increasing costs and production delays that threaten sustainability. While health research methodologists are appropriately responsible for promoting increasing rigor in guideline development, guideline sponsors are responsible for funding such process...

BACKGROUND Concerns regarding increasing microbial resistance to vancomycin have resulted in recommendations for a higher trough serum vancomycin concentration. This study aimed to assess the dosage guidelines targeting vancomycin trough concentrations of 15-20 mg/L. METHODS About 216 adult patients (age, >60 yr) were treated with intravenous vancomycin. The patients were divided into 2 group...

BACKGROUND There is international concern that conflicts of interest (COI) may bias clinical guideline development and render it untrustworthy. Guideline COI policies exist with the aim of reducing this bias but it is not known how such policies are interpreted and used by guideline producing organisations. This study sought to determine how conflicts of interest (COIs) are disclosed and manage...

BACKGROUND Clinical practice guidelines are an important element of evidence-based practice. Considering an often complicated body of evidence can be problematic for guideline developers, who in the past may have resorted to using levels of evidence of individual studies as a quasi-indicator for the strength of a recommendation. This paper reports on the production and trial of a methodology an...