The following reports are under development at one of the four ESP sites. If you would like to provide comments about the topic under development, serve as a peer reviewer for the draft report, or know the timeline for completion, please contact the ESP Coordinating Center.
To review the most up-to-date protocols, please visit the PROSPERO website. Protocol registration numbers for an individual project can be found along with the brief abstract for the project, below.
In recent years, use of anti-vascular endothelial growth factor (anti-VEGF) agents has substantially reduced the burden of disease related to retinal angiogenesis due to age-related macular degeneration, diabetic macular edema, and other conditions. However, there is uncertainty regarding the comparative clinical effectiveness and harms of these agents, and there is substantial difference among the agents in economic cost. Thus, this evidence synthesis will compare the clinical benefits, harms, and costs of these agents in treating retinal angiogenesis.
KQ1: What is the comparative clinical effectiveness of anti-vascular endothelial growth factor (VEGF) agents in adults with retinal angiogenesis?
KQ2: What are the comparative harms of anti-VEGF agents in adults with retinal angiogenesis?
KQ3: What is the comparative cost effectiveness of anti-VEGF agents in adults with retinal angiogenesis?
Population(s): Patients being treated with anti-VEGF agents for retinal angiogenesis due to one of the following conditions: diabetic macular edema, branch retinal vein occlusion, central retinal vein occlusion, neovascular age-related macular degeneration, vitreous hemorrhage, proliferative diabetic retinopathy, or neovascular glaucoma.
Interventions: Anti-VEGF injection therapy of Ranibizumab, Bevacizumab, or Aflibercept
Comparator: One anti-VEGF intervention versus another anti-VEGF intervention
Outcome(s): KQ1: Visual acuity, intermediate outcomes (eg, number of injections needed, proportion of patients requiring rescue/co-interventions, central macular thickness, or other Optical Coherence Tomography outcomes), functional status/quality of life, other measures of vision (eg, reading ability, reading speed, contrast sensitivity). KQ2: Infection, retinal detachment, glaucoma, ocular arterial occlusion, retinal atrophy, systemic adverse events, other reported harms. KQ3: Cost.
Timing: Short- and long-term outcomes
Setting: KQ1: Systematic reviews, meta-analyses, controlled clinical trials (randomized or non-randomized). KQs 2&3: Designs included for KQ1 plus observational studies (case control, cohort studies, and case series).
General Search Strategy
Search strategies will be developed in consultation with a research librarian and will include Ovid MEDLINE, PubMed, Elsevier Embase, Ovid EBM Reviews, and grey literature sources (including trial registries, regulatory agencies, conference proceedings, and Scientific Information Packet requests from pharmaceutical manufacturers). We will further review the bibliographies of relevant articles for additional studies.
Prevalence of and Interventions to Reduce Disparities in Vulnerable Populations within the VHA: A Map of the Evidence
Background/Objectives of Review
This topic was submitted to the ESP Coordinating Center by Uchenna S. Uchendu, MD, Executive Director, Office of Health Equity. We further refined the scope and key questions for this topic through a preliminary search of peer-reviewed literature, and in concert with internal partners and investigators, Dr. Uchendu, and a technical expert panel (TEP) comprised of both VA and non-VA experts.
KQ1: For what groups/populations, and in which clinical areas, are health and healthcare disparities prevalent within the VHA?
KQ2: What are the effects of interventions implemented within the VHA to reduce health disparities?
KQ3: What research projects have been funded by the VA Office of Research and Development (ORD) to address any of the components in the other key questions from 2010 to the present?
Interventions: KQ1: n/a. KQ2 and KQ3: Any interventions designed specifically or being specifically used to reduce disparities or to examine mediators associated with health disparities for Veterans
Comparator: Control group within the same group; comparison to other groups relevant to the population
Outcome(s): KQ1: Utilization of healthcare services; quality of healthcare services [1. Patient outcomes; 2. Intermediate/process of care measures; 3. Patient evaluations of care; 4. Direct observation (eg, communication patterns); 5. Other (eg, medication adherence, health education, etc)].
KQ2 and KQ3: Utilization of healthcare services; Quality of healthcare services [1. Patient outcomes; 2. Intermediate/process of care measures; 3. Patient evaluations of care; 4. Direct observation (eg, communication patterns); 5. Other (eg, medication adherence, health education, etc)]; Mediators [1. System level (eg, distribution of services); 2. Provider level (eg, racial bias); 3. Patient level (eg, trust); 4. Provider-patient level (eg, communication)]
Timing: No restrictions
Study design: Original research; systematic review; meta-analysis
General Search Strategy
We modified the search strategy developed for Saha et al's 2007 VA ESP review to include all populations for whom a disparity in the quality of or utilization of care might exist. To identify relevant articles, we searched MEDLINE, PubMed, PsycINFO, Embase, CINAHL, and the Cochrane Library (Ovid EBM Reviews: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews; Cochrane Health Technology Assessment, and Database of Abstracts of Reviews of Effects), Social Services Abstracts, and Sociological Abstracts. We conducted a primary review of the literature by systematically searching, reviewing, and analyzing the scientific evidence as it pertains to the key questions in the report. For KQs 1 and 2 (all populations), we searched relevant literature published since the search end date of Saha et al's VA ESP review (2006) through February 2016. For KQ 3 we searched the VA's Health Services Research and Development (HSR&D) Projects database to identify ongoing and recently completed VA research projects since 2010. We evaluated excluded studies and supplementary materials for Peterson et al's 2015 VA ESP evidence brief, and the bibliographies of included primary studies and relevant systematic or nonsystematic reviews that were identified in the course of our search, including Gierisch et al's 2014 ESP review on disparities on the quality of care for patients with mental illness, Spoont et al's 2011 VA ESP review examining ambulatory care in rural vs. urban populations, and Bean-Mayberry et al's 2010 VA ESP review examining women's health in the VA. To identify studies not published in peer-reviewed journals, we searched ClinicalTrials.gov and the VA HSR&D and ESP websites. To provide a broad overview of all health disparity research conducted within the VHA, we included studies included in previous VA ESP reports meeting inclusion and date criteria.
Among VA healthcare system users, 72% have one or more chronic medical conditions. The management of these conditions is time-consuming for primary care physicians. Thus patients are increasingly being asked to take an active role in self-management. Recently, health coaching has emerged as an intervention approach to enhance patients' compliance with chronic disease self-management, but there is no consensus on how to define health coaching other than that health coaching is collaborative, client-centered, and more likely focused on the whole person. The VA is considering health coaching as a strategy to optimize patient outcomes. This review has been commissioned to examine the effectiveness of health coaching on changes in health outcomes, health behaviors, and self-efficacy. It will also seek to identify key program elements. The key questions (KQs) for this systematic review (SR) are:
KQ1: Among adults, what is the effectiveness of health coaching on: a) clinical health outcomes (eg, blood pressure, HbA1c); b) patient health behavior (eg, smoking, physical activity, diet, medication adherence); and c) self-efficacy?
KQ1a: Among adults, does the impact of health coaching vary by: a) characteristics of the population (eg, type of chronic medical illnesses); b) dose of the intervention (eg, number and frequency of sessions, minutes of contact); c) mode of delivery (eg, individual visits vs group visits, face-to-face vs telephone); and d) types of individuals conducting coaching interventions (eg, peers, nurses, health educators, certified health coaches)?
Studies will be included if they self-identify primarily as coaching interventions (eg, health coaching, wellness coaching, peer coaching) and focus on improving outcomes related to a chronic medical condition or facilitating uptake of health behaviors, have more than one session or planned contact, and allow for two-way communication between coach and participant. To assess robustness of effects, we will also conduct analysis by intervention characteristics such as concordance of health coaching intervention with an a priori list of key elements developed in collaboration with our stakeholders and technical expert panel (TEP) members.
In two rounds of discussion and prioritization with our TEP and stakeholders, the following three elements have been decided on as key components of health coaching. We will code each of the included studies as concordant or discordant with each of these elements. Studies will be grouped and potentially analyzed by concordance status.
Patient-centeredness: Was the coaching patient-centered (ie, were coaching strategies and processes tailored to the individual's specific needs, concerns, circumstances, what matters most to the patient, or readiness to change, or was the coaching instead applied uniformly, without regard to individual differences)?
Patient-determined goals: Did patients choose their own change goals and action steps as a target of the coaching, or were their goals preset or created by a professional?
Use of self-discovery process: Was a process of discovery or active learning (eg, Motivational Interviewing) to increase patient awareness through examining strengths, values, and assumptions included in the coaching process, or was the coaching instead instructional?
Population(s): Adults ( > 18 years of age) with a chronic medical condition medical condition
Interventions: RCTs (only) that self-identify primarily as health coaching interventions with more than one planned contact
Comparator: Any inactive or active control
Outcome(s): Major clinical health indicators that can be influenced by health behavior change, four specific health behaviors (smoking, diet change, physical activity, and medication adherence), and self-efficacy
Timing: Outcomes at > 6 months following initiation of the intervention
Setting: Outpatient general or specialty medical clinics or community settings that manage chronic medical conditions.
Other criteria: Date of publication (2000 or later) since health coaching is a relatively new modality; English-language publication in a peer-reviewed journal
Comparing Antithrombotic Strategies after Bioprosthetic Aortic Valve Replacement: A Systematic Review
Background/Objectives of Review
The proposed ESP evidence synthesis review will be used to inform future research within the VA. Specifically, the review would be used to design a VA-based randomized trial of VKA administration in patients after bAVR. Such a study would have the potential to inform clinical guidelines both within and outside of the VA.
KQ1: What are the comparative benefits of antithrombotic strategies for patients who have had bAVR?
KQ1A: Do the benefits differ according to thromboembolic risk profile?
KQ1B: Do the benefits differ according to concomitant procedure (eg, coronary artery bypass graft [CABG])?
KQ2: What are the comparative harms of antithrombotic strategies for patients who have had bAVR?
KQ2A: Do the harms differ according to thromboembolic risk profile?
KQ2B: Do the harms differ according to concomitant procedure (eg, coronary artery bypass graft [CABG])?
KQ3: What are the comparative benefits and harms of antithrombotic strategies for patients who have had transcatheter aortic valve replacement (TAVR)?
KQ3A: Do the benefits or harms differ according to thromboembolic risk profile?
KQ3B: Do the benefits or harms differ according to concomitant procedure (eg, percutaneous transluminal coronary angioplasty [PTCA] with stent)?
Population(s): Adult patients who have had bioprosthetic aortic valve replacement (bAVR; Key Questions 1 and 2) or transcatheter aortic valve replacement (TAVR) with stenting of aortic valves (Key Question 3).
Exclude: Patients receiving bAVRs no longer used in practice; patients with valve replacements in positions other than the aorta (eg, mitral valve, Ross procedure); pregnant women.
Interventions: Antithrombotic strategies/agents:
Vitamin K antagonist (VKA)
VKA plus acetylsalicylic acid (ASA; aspirin) or other antiplatelet agents
ASA or other antiplatelet agents
Dual antiplatelet therapy
Direct oral anticoagulants (DOACs)/novel oral anticoagulants (NOACs)
Comparator: Any of the above antithrombotic strategies (ie, one strategy vs another strategy), or no therapy.
Outcome(s): Primary outcomes:
Major bleeding events
Need for valve reoperation (eg, valve thrombosis)
Length of stay
Need for change in antithrombotic strategy
Pericardial or pleural effusion (we will prioritize effusions requiring intervention)
Timing: Perioperative (defined as in-hospital or within 30 days) and long-term (defined as > 30 days to 1 year or longer) are of interest for each outcome.
General Search Strategy
Search strategies will be developed in consultation with a research librarian. We plan to conduct a primary review of the literature by systematically searching, reviewing, and analyzing the scientific evidence as it pertains to the research questions. To identify relevant articles, we will begin by searching Ovid MEDLINE, Elsevier EMBASE, and Ovid EBM Reviews Cochrane Database of Systematic Reviews. We will further review the bibliographies of relevant articles for additional studies. To identify in-progress or unpublished studies, we will search ClinicalTrials.gov, OpenTrials, and the WHO International Clinical Trials Registry Platform (ICTRP). We will also search the AHRQ Registry of Patient Registries to identify relevant registries of bAVR patients.
Effectiveness of Interventions to Improve Emergent Department Efficiency
Background/Objectives of Review
The proposed evidence review would be used by the National Director of Emergency Medicine and the Emergency Medicine Field Advisory Committee (EMFAC) to prioritize national and local interventions to enhance access to emergency care and develop a research agenda around the delivery of emergency services within VHA. The results of an evidence review would also be used at an upcoming Field-Based Conference and meeting of the Emergency Medicine Field Advisory Committee to further refine the key questions that affect VHA emergency medicine.
In addition, the findings from this evidence review would be used to prioritize the performance measures monitored through the VA Emergency Medicine Management Tool (EMMT). The EMMT is a national data report which provides reporting on key performance measures for VA emergency medicine.
KQ1: What types of interventions have been evaluated to reduce ED crowding or other operational performance measures?
KQ2: Which interventions to reduce ED crowding or other operational performance measures have been the most effective and which are the most generalizable to the VHA population?
KQ3: What are the benefits and harms of interventions to reduce ED crowding or other operational performance measures to patients?
Population(s): Adult patients presenting to emergency departments (EDs)
Interventions: Any intervention designed to reduce ED overcrowding or improve other measures of ED operational performance
Comparator: Usual ED care
Outcome(s): Operational outcomes including ED length of stay, wait time, leaving without being seen, admissions data; clinical outcomes including mortality and harms; and cost or resource utilization of the intervention and ED.
General Search Strategy
A preliminary literature scan conducted by the ESP coordinating center identified multiple publications with data from primary research studies, as well as multiple systematic reviews. Publications included in these systematic reviews, as well as the primary research study publications, were eligible for inclusion. Studies to be included are hypothesis testing studies, including randomized controlled trials and observational studies that compared relevant outcomes across different ED interventions or organizational structure, either across institutions or within institution across time points. Studies of single conditions are excluded.
Impact of Family Caregiving on Care Recipients with Mental Illness or Cognitive Impairment
Background/Objectives of Review
The ESP report will be used by the VA Caregiver Support Program to refine and standardize its eligibility assessment process for patients requiring informal/family caregiver support and to identify future research needs to inform program practices and policies.
KQ1: For which patient groups (ie, patients with posttraumatic stress disorder (PTSD), traumatic brain injury (TBI), and polytrauma,) that receive family care has the impact on care recipient outcomes been assessed?
KQ2: What are the effects of programs/strategies to support or train family caregivers on care recipient (ie, patients with PTSD, TBI, polytrauma) and caregiver outcomes? Outcomes of interest include psychological symptoms, care recipient independence, function, quality-of-life indicators, physical health, health care utilization, economic status, and clinical eligibility for specific programs or services.
Population(s): Adults with conditions listed above AND functional cognitive, psychosocial or other impairments that limit ability to independently perform functions of daily life
Interventions: Programs to train family caregivers or support family caregiving (unpaid custodial or basic medical care) consisting of one or more of the following: caregiver training, day to day practical support or in-home respite care, financial assistance, education or information about the healthcare system or other resources, social or emotional support. Interventions may be delivered in person or by telephone; directed at caregiver or dyad.
Comparator: Any including: waitlist, usual care, attention control, active comparators
Outcome(s): Care recipient:
Functional status (physical, social, mental), disease-specific symptoms, health-related quality of life, healthcare utilization (outpatient, inpatient, institutional, total); adverse effects
Caregiver (if ONLY caregiver, ONLY KQ1):
Caregiver burden; depressive or anxiety symptoms; family functioning; household economic status (income, wealth); adverse effects
Setting: Community, home, clinic
General Search Strategy
Types of studies to be included: RCT and quasi-experimental (non-randomized controlled trials; controlled before-after studies (CBA); interrupted time series (ITS)