Laboratory medicine best practices : developing an evidence- based review and evaluation process. Final technical report 2007: Phase I.

Clinical laboratory services play a vital role in the delivery of individual health care and public health in the United States. The U.S. Department of Health and Human Services\ue2\u20ac\u2122 (HHS) Centers for Medicare & Medicaid Services (CMS) certifies over 200,000 laboratories in the United States under the provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).1 These laboratories provide more than 1,000 laboratory tests for human conditions; about 500 of these tests are used daily.2The Centers for Disease Control and Prevention (CDC) is committed to organizing a national effort to promote the use of best practices in laboratory medicine. In response to the Institute of Medicine\ue2\u20ac\u2122s call to improve quality in medicine,3 CDC\ue2\u20ac\u2122s Division of Laboratory Systems (DLS) is supporting the development of a systematic, evidence-based process to identify best practices in laboratory medicine.This effort was undertaken in October 2006 when DLS convened the Laboratory Medicine Best Practices Workgroup, a multidisciplinary advisory panel including experts in laboratory and clinical medicine, health systems and policy research, performance measurement, and standard setting. The Workgroup was supported by a team from DLS and a contractor, Battelle Memorial Institute (Battelle). The goal of the effort is to develop a processfor making best practice recommendations that will assist professional organizations, government agencies, laboratory professionals, clinicians, and others who provide, use, regulate, or pay for laboratory services.The process focuses on improving laboratory medicine by identifying and evaluating best practices that achieve the following:\ue2\u20ac\ua2 Enhance the quality of laboratory services and patient outcomes.\ue2\u20ac\ua2 Reduce redundancy and waste.\ue2\u20ac\ua2 Enable laboratories to define opportunities for quality improvement.Suggested citation: Centers for Disease Control and Prevention. Laboratory Medicine Best Practices: Developing an Evidence- Based Review and Evaluation Process. Final Technical Report 2007: Phase I. Atlanta: U.S. Department of Health and Human Services; 2008.CS114578Contract No. 200-2001-00121, Task No. 001

Options for basing Dietary Reference Intakes (DRIs) on chronic disease endpoints: report from a joint US-/Canadian-sponsored working group.

Dietary Reference Intakes (DRIs) are used in Canada and the United States in planning and assessing diets of apparently healthy individuals and population groups. The approaches used to establish DRIs on the basis of classical nutrient deficiencies and/or toxicities have worked well. However, it has proved to be more challenging to base DRI values on chronic disease endpoints; deviations from the traditional framework were often required, and in some cases, DRI values were not established for intakes that affected chronic disease outcomes despite evidence that supported a relation. The increasing proportions of elderly citizens, the growing prevalence of chronic diseases, and the persistently high prevalence of overweight and obesity, which predispose to chronic disease, highlight the importance of understanding the impact of nutrition on chronic disease prevention and control. A multidisciplinary working group sponsored by the Canadian and US government DRI steering committees met from November 2014 to April 2016 to identify options for addressing key scientific challenges encountered in the use of chronic disease endpoints to establish reference values. The working group focused on 3 key questions: 1) What are the important evidentiary challenges for selecting and using chronic disease endpoints in future DRI reviews, 2) what intake-response models can future DRI committees consider when using chronic disease endpoints, and 3) what are the arguments for and against continuing to include chronic disease endpoints in future DRI reviews? This report outlines the range of options identified by the working group for answering these key questions, as well as the strengths and weaknesses of each option

LMBP Phase 3 Final Report

BACKGROUND AND PURPOSE: This report summarizes the third phase of an ongoing effort sponsored by the Division of Laboratory Science and Standards (DLSS), Centers for Disease Control and Prevention. The purpose is to develop new systematic evidence review and evaluation methods for identifying pre- and post-analytic laboratory medicine practices that are effective at improving healthcare quality.1 This effort began in 2006, when CDC convened the Laboratory Medicine Best Practices Workgroup (Workgroup), a multidisciplinary panel of experts in such fields as laboratory medicine, clinical medicine, health services research, and health care performance measurement. The Workgroup also includes two ex officio representatives from the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA).An outcome of Phase 1 (2006 \ue2\u20ac\u201c 2007) was to act on a Workgroup recommendation to enlarge the search for evidence to unpublished studies, including assessments performed for the purposes of quality assurance, process improvement and/or accreditation documentation. Phase 2 (2007-2008) involved a pilot test of further refined methods to obtain, review, and evaluate published and unpublished evidence, along with collecting observations via key informant interviews about organizational and implementation issues successfully addressed by other recommending bodies about the development and dissemination of guidelines and best practice recommendations. These evidence review methods were adapted from those established by the GRADE group, The Guide to Community Preventive Services (Community Guide), the Agency for Healthcare Research and Quality (AHRQ) (US Preventive Services Task Force (USPSTF), Evidence-based Practice Centers (EPCs), and Effective Healthcare Program), and others, and modified to better accommodate the non-controlled study designs typically found in quality improvement research.Phase 3 (2008-2010), the subject of this report, involved further development of methods for identifying evidence-based laboratory medicine quality improvement best practices, and validated these methods with reviews of practices associated with three topics: patient specimen identification, critical value reporting, and reducing blood culture contamination.Prepared for: Division of Laboratory Science and Standards, Laboratory Science, Policy and Practice Program Office. Office of Surveillance, Epidemiology, and Laboratory Sciences (OSELS), Centers for Disease Control and Prevention; prepared by the CDC Laboratory Medicine Best Practices Team.Contract No. W911NF-07-D-0001 / TCN 08319/DO 0567LMBP Yr3 FINAL Technical Report FINALW911NF-07-D-0001 / TCN 08319/DO 056

Standards for the development and methodology of the 2019 International Working Group on the Diabetic Foot guidelines

Diabetic foot disease is a source of major patient suffering and societal costs. Investing in evidence-based international guidelines on diabetic foot disease is likely among the most cost-effective forms of health care expenditure, provided the guidelines are outcome focused, evidence based, and properly implemented. The International Working Group on the Diabetic Foot (IWGDF) has published and updated international guidelines since 1999. The 2019 updates are based on formulating relevant clinical questions and outcomes, rigorous systematic reviews of the literature, and recommendations that are specific, and unambiguous along with their transparent rationale, all using the Grading of Recommendations Assessment Development and Evaluation (GRADE) framework. We herein describe the development of the 2019 IWGDF guidelines on the prevention and management of diabetic foot disease, which consists of six chapters, each prepared by a separate working group of international experts. These documents provide guidelines related to diabetic foot disease on prevention; offloading; peripheral artery disease; infection; wound healing interventions; and classification of diabetic foot ulcers. Based on these six chapters, the IWGDF Editorial Board also produced a set of practical guidelines. Each guideline underwent extensive review by the members of the IWGDF Editorial Board as well as independent international experts in each field. We believe that adoption and implementation of the 2019 IWGDF guidelines by health care providers, public health agencies, and policymakers will result in improved prevention and management of diabetic foot disease and a subsequent worldwide reduction in the patient and societal burden this disease causes

Optimising Management of Patients with Heart Failure with Preserved Ejection Fraction in Primary Care (OPTIMISE-HFpEF): rationale and protocol for a multi-method study.

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) is less well understood than heart failure with reduced ejection fraction (HFrEF), with greater diagnostic difficulty and management uncertainty. AIM: The primary aim is to develop an optimised programme that is informed by the needs and experiences of people with HFpEF and healthcare providers. This article presents the rationale and protocol for the Optimising Management of Patients with Heart Failure with Preserved Ejection Fraction in Primary Care (OPTIMISE-HFpEF) research programme. DESIGN & SETTING: This is a multi-method programme of research conducted in the UK. METHOD: OPTIMISE-HFpEF is a multi-site programme of research with three distinct work packages (WPs). WP1 is a systematic review of heart failure disease management programmes (HF-DMPs) tested in patients with HFpEF. WP2 has three components (a, b, c) that enable the characteristics, needs, and experiences of people with HFpEF, their carers, and healthcare providers to be understood. Qualitative enquiry (WP2a) with patients and providers will be conducted in three UK sites exploring patient and provider perspectives, with an additional qualitative component (WP2c) in one site to focus on transitions in care and carer perspectives. A longitudinal cohort study (WP2b), recruiting from four UK sites, will allow patients to be characterised and their illness trajectory observed across 1 year of follow-up. Finally, WP3 will synthesise the findings and conduct work to gain consensus on how best to identify and manage this patient group. RESULTS: Results from the four work packages will be synthesised to produce a summary of key learning points and possible solutions (optimised programme) which will be presented to a broad spectrum of stakeholders to gain consensus on a way forward. CONCLUSION: HFpEF is often described as the greatest unmet need in cardiology. The OPTIMISE-HFpEF programme aims to address this need in primary care, which is arguably the most appropriate setting for managing HFpEF.NIHR National School for Primary Care Researc

Acute kidney disease and renal recovery : consensus report of the Acute Disease Quality Initiative (ADQI) 16 Workgroup

Consensus definitions have been reached for both acute kidney injury (AKI) and chronic kidney disease (CKD) and these definitions are now routinely used in research and clinical practice. The KDIGO guideline defines AKI as an abrupt decrease in kidney function occurring over 7 days or less, whereas CKD is defined by the persistence of kidney disease for a period of > 90 days. AKI and CKD are increasingly recognized as related entities and in some instances probably represent a continuum of the disease process. For patients in whom pathophysiologic processes are ongoing, the term acute kidney disease (AKD) has been proposed to define the course of disease after AKI; however, definitions of AKD and strategies for the management of patients with AKD are not currently available. In this consensus statement, the Acute Disease Quality Initiative (ADQI) proposes definitions, staging criteria for AKD, and strategies for the management of affected patients. We also make recommendations for areas of future research, which aim to improve understanding of the underlying processes and improve outcomes for patients with AKD

Criteria for assessing high-priority drug-drug interactions for clinical decision support in electronic health records

Background: High override rates for drug-drug interaction (DDI) alerts in electronic health records (EHRs) result in the potentially dangerous consequence of providers ignoring clinically significant alerts. Lack of uniformity of criteria for determining the severity or validity of these interactions often results in discrepancies in how these are evaluated. The purpose of this study was to identify a set of criteria for assessing DDIs that should be used for the generation of clinical decision support (CDS) alerts in EHRs. Methods: We conducted a 20-year systematic literature review of MEDLINE and EMBASE to identify characteristics of high-priority DDIs. These criteria were validated by an expert panel consisting of medication knowledge base vendors, EHR vendors, in-house knowledge base developers from academic medical centers, and both federal and private agencies involved in the regulation of medication use. Results: Forty-four articles met the inclusion criteria for assessing characteristics of high-priority DDIs. The panel considered five criteria to be most important when assessing an interaction- Severity, Probability, Clinical Implications of the interaction, Patient characteristics, and the Evidence supporting the interaction. In addition, the panel identified barriers and considerations for being able to utilize these criteria in medication knowledge bases used by EHRs. Conclusions: A multi-dimensional approach is needed to understanding the importance of an interaction for inclusion in medication knowledge bases for the purpose of CDS alerting. The criteria identified in this study can serve as a first step towards a uniform approach in assessing which interactions are critical and warrant interruption of a provider’s workflow

Development of a Core Outcome Set for the research and assessment of inoperable malignant bowel obstruction

BackgroundMalignant bowel obstruction is experienced by 15% of people with advanced cancer, preventing them from eating and drinking and causing pain, nausea and vomiting. Surgery is not always appropriate. Management options include tube or stent drainage of intestinal contents and symptom control using medication. Published literature describing palliative interventions uses a broad range of outcome measures, few of which are patient-relevant. This hinders evidence synthesis, and fails to consider the perspectives of people undergoing treatment.AimsTo develop a Core Outcome Set for the assessment of inoperable malignant bowel obstruction with clinician, patient and caregiver involvement, using COMET methodology (Core Outcome Measures in Effectiveness Trials).MethodsA systematic review of clinical trials and observational studies, a rapid review of the qualitative literature and in-depth patient and clinician interviews were conducted to identify a comprehensive list of outcomes. Outcomes were compared and consolidated by the study Steering Group and Patient and Public Involvement contributors, and presented to an international clinical Expert Panel for review. Outcomes from the finalised list were rated for importance in a three-round international Delphi process: results of two survey rounds were circulated to respondents, and two separate consensus meetings were conducted with clinicians and with patients and caregivers via virtual conferencing, using live polling to reach agreement on a Core Outcome Set.Results130 unique outcomes were identified. Following the independent Expert Panel review, 82 outcomes were taken into round 1 of the Delphi survey; 24 outcomes reached criteria for critical importance across all stakeholder groups and none reached criteria for dropping. All outcomes rated critically important were taken forward for re-rating in round 2 and all other outcomes dropped. In round 2, all outcomes were voted critically important by at least one stakeholder group. Round 2 outcomes were presented again at online consensus meetings, categorised as high ranking (n = 9), middle ranking (n = 7) or low ranking (n = 8). Stakeholders reached agreement on 16 core outcomes across four key domains: Symptom control, Life impact, Treatment outcomes, and Communication and patient preferences.ConclusionUse of this Core Outcome Set can help to address current challenges in making sense of the evidence around treatment for inoperable malignant bowel obstruction to date, and underpin a more robust future approach. Clearer communication and an honest understanding between all stakeholders will help to provide a basis for responsible decision-making in this distressing situation in clinical practice

Assessing effective teacher behaviors in athletic training clinical education

"The present study assessed the use of effective teacher behaviors in athletic training clinical education. Research involved development and use of: 1) the 20-question Survey of Effective Clinical Educator Behaviors (SECEB) to assess student and instructor perceptions of clinical instructor use of effective teaching behaviors; and 2) the Observational Record of Clinical Educator Behaviors (ORCEB) interval recording instrument to objectively measure instructor's demonstrated behaviors in the clinical setting. The SECEB was distributed to twelve Commission on Accreditation of Allied Health Education Programs (CAAHEP)-accredited athletic training education programs in the National Athletic Trainers' Association (NATA) District 3. Subjects (n=186) representing ten of those schools returned usable data. SECEB item statements were grouped into four subcategories of effective teaching behaviors (Information, Evaluation, Critical Thinking, and Physical Presence), and were ranked on a scale from 'Never (1)' to 'Very Often (5)'. While educators rated themselves and their perceived ideal, students evaluated their current and an ideal clinical instructor. Cronbach's alpha for all items showed excellent internal consistency (α=.858). Results found that students (4.56±.33) and clinical instructors (4.56±.24) had nearly identical perceptions of an ideal instructor's behavior, but that students consistently rated current instructors higher (4.09±.52) than the instructors rated themselves (3.93±.36). In addition to the survey data, four approved clinical instructors (ACIs) were observed using the ORCEB as they interacted with patients and students for five 30-minute sessions. Inter-rater and intra-rater reliabilities as determined by simple correlation of behavior frequencies between two independent coders were r=.964 and r=.974, respectively. The ORCEB was used to assess clinical instructor demonstration of twelve target behaviors. Results indicate that instructors use only 24% of each clinical education session for teaching/learning behaviors; of the remaining time, 32% was devoted to patient care without student interaction, 35% to behaviors unrelated to clinical education, and 9% in downtime when no students or patients were present. Furthermore, student ranking of these instructors based upon their SECEB scores was identical to that created by ORCEB behavior percentages, indicating that students' perceptions of their instructor's behavior are accurate."--Abstract from author supplied metadata