Health Services Research & Development

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ESP Reports in Progress

ESP ReportsESP Topic NominationESP Reports in Progress

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.




Gadolinium Agents for Patients with CKD

PROSPERO registration number: CRD42019135783

Background/Objectives of Review

The Nephrology Field Advisory Committee (FAC) provides independent advice to VA Specialty Care Services (SCS) on clinical policy and program development. The mission of the FAC is to provide National VA Renal program oversight, forward field concerns, assist in distributing information to the field, and serve as a resource to other VACO program offices.

This review will directly guide the FAC’s recommendations for development of national and local policies on Class 2 and Class 3 gadolinium use, the need for laboratory screening, and the need for informed consent prior to contrast administration for MRI scans.

Key Questions

KQ1: When exposed to macrocyclic or newer linear gadolinium-based contrast agents, what is the incidence of nephrogenic systemic fibrosis among:

  1. a) All patients?
  2. b) Patients with acute or chronic kidney disease?
  3. c) Patients with key risk factors for kidney disease (such as diabetes and hypertension)?

KQ2: When compared to older linear gadolinium-based agents, what is the relative risk of nephrogenic systemic fibrosis due to exposure to macrocyclic or newer linear gadolinium-based contrast agents among:

  1. a) All patients?
  2. b) Patients with acute or chronic kidney disease?
  3. c) Patients with key risk factors for kidney disease (such as diabetes and hypertension)?

PICOTS

Population(s): Adults, children, and autopsy

Interventions: ACR Class II gadolinium-based contrast agents: Gadoteridol (Prohance), Gadobenate dimeglumine, gadobenic acid (MultiHance),Gadobutrol (Gadavist, Gadovist, Gadograf), Gadoterate meglumine, Gadoteric acid (Dotarem, Clariscan, Artirem)

ACR Class III: Gadoxetate disodium (Eovist, Primovist)

We will also include Class I gadolinium agents when compared to Class II or III agents.

Comparator: Any or no comparators

Outcome(s): Nephrogenic systemic fibrosis (including “NSF” and nephrogenic fibrosing dermopathy (either confirmed or suspected cases; cases associated with multiple types of gadolinium agents or multiple doses also acceptable)

Setting: Gadolinium agents administered for any reason, outpatient or inpatient, in any country

General Search Strategy

We will conduct a primary search from inception to the current date of MEDLINE® (via PubMed®), Embase, Cochrane Register of Controlled Trials, and Web of Science. We will use a combination of MeSH keywords and selected free-text terms to search titles and abstracts. To ensure completeness, search strategies will be developed in consultation with an expert librarian. We will also hand search key references for relevant citations that may not be captured by our database search. Depending on the depth of the peer-reviewed literature, we may also search for case reports of NSF among patients exposed to newer gadolinium agents in the FDA (FAERS) database.

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Deprescribing for Older Veterans

PROSPERO registration number: CRD42019132420

Key Questions

KQ1: What are the effectiveness, comparative effectiveness, and harms of deprescribing interventions among adults age 65 and older?

KQ1a: What are the identified elements/components that contribute the most to the effectiveness of deprescribing interventions?

KQ1b: Do the effectiveness, comparative effectiveness, and harms of deprescribing interventions vary by patient population, provider factors, or setting?

KQ2: What are the identified facilitators and barriers that impact the implementation of deprescribing interventions within large-scale health systems such as the VA?

PICOTS

Population(s): Individuals age 65 years and older

Interventions: Deprescribing intervention

Comparator: Any (to include usual care or a different intervention)

Outcome(s): Patient-Centered Outcomes: quality of life, mortality, hospitalizations, acute care encounters, falls, delirium; functional status (physical and/or cognitive), adverse drug withdrawal events

Intermediate Outcomes: total number of medications discontinued, number of medications with dosage decreased, number of medications with schedule simplified, number of inappropriate medications discontinued, adherence to medications, types of medications, cost

Setting: Any health care setting

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End Stage Renal Disease and Depression: A Systematic Review

Key Questions

KQ1. What are the performance characteristics of screening tools for depression in patients with ESRD?

KQ2. What is the impact of screening for depression in patients with ESRD on intermediate and/or patient outcomes?

KQ3. What is the effectiveness of depression treatment in patients with ESRD?:

a. pharmacological treatment
b. non-pharmacological treatment
c. pharmacological and non-pharmacological treatments combined

KQ4. In patients with ESRD and depression, what are the potential harms of:

a. screening?
b. treatment?
      i. pharmacological
      ii. non-pharmacological

KQ5. Do the benefits or harms of screening differ by:

a. patient characteristics or other social determinants of health?
b. setting?
c. screening characteristics/process?
d. other (eg, patient engagement/receptivity to treatment, social
support)?
e. timing and type of follow-up?

KQ6. Do the benefits or harms of treatment differ by:

a. patient characteristics or other social determinants of health?
b. setting?
c. provider characteristics (eg, mental health, PCP, other)?
d. other (eg, patient engagement/receptivity to treatment, social
support)?
e. timing and type of follow-up?

PICOTS

Population(s): Adults with ESRD and known or suspected depression

Interventions: Depression screening, and pharmacological and non-pharmacological treatments for depression

Comparator: Other screening tools, placebo, other interventions, wait list controls

Outcome(s): Diagnostic test performance: sensitivity, specificity, positive predictive value, and negative predictive value

Therapeutic impact: timing, setting, or type of treatment.

Intermediate and Patient outcomes: depressive symptoms, mortality, suicide attempts or completion, hospitalization, ED/urgent care utilization, patient satisfaction, adherence to dialysis, medication, or treatment, pain medication reduction, BP/metabolic control, quality of life, other outcomes (eg, employment)

Adverse effects or unintended consequences

Setting: All US and international settings (VHA, hospital community, community mental health, ED, urgent care, other community)

General Search Strategy

Search strategies will be developed in consultation with a research librarian, and will be peer reviewed by a second research librarian using the instrument for Peer Review of Search Strategies (PRESS). We will conduct a review of the literature by systematically searching, reviewing, and analyzing the scientific evidence as it pertains to the research questions. To identify relevant trials, we will search Ovid MEDLINE, PsycINFO, Elsevier EMBASE, and Ovid EBM Reviews Cochrane Database of Systematic Reviews (CDSR, DARE, HTA, Cochrane CENTRAL, etc). We will search all available years of publication from database inception (1946 for Ovid MEDLINE®) through April 2019. We will review the bibliographies of relevant articles and contact experts to identify additional studies. To identify in-progress or unpublished studies, we will search the VHA HSR&D website, ClinicalTrials.gov, OpenTrials, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP).

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Orthobiologic Products in Foot and Ankle Arthrodesis Sites

Key Questions

KQ1: What are the effectiveness and harms of adding orthobiologics compared to no orthobiologics when performing primary foot/ankle arthrodesis surgery?

KQ1a: Do effectiveness and harms vary by patient age, gender, smoking status, obesity, diabetes, bone quality, arthrodesis site, or use of medications that may impede healing (eg, immunosuppressives)?

KQ2: What is the cost and/or cost-effectiveness (as reported in the literature) of adding orthobiologics compared to no orthobiologics when performing primary foot/ankle arthrodesis surgery?

PICOTS

Population(s): Adults undergoing primary foot/ankle arthrodesis surgery (forefoot to ankle)

Interventions: Non-structural autogenous orthobiologics (autogenous bone graft, bone marrow aspirate, plasma products); synthetic products

Comparator: Primary foot/ankle arthrodesis surgery without orthobiologic products

Outcome(s): Patient-centered Outcomes: wound healing, need for reoperation/reintervention, pain, clinically meaningful differences in functional outcome or quality of life scale scores (eg, American Orthopedic Foot and Ankle Society [AOFAS], Mazur)

Intermediate Outcomes: radiographic fusion, mean time to union

Costs, Cost Effectiveness, Resource Utilization: patient costs, facility costs

Harms: post-operative complications (eg, scar pain, wound dehiscence, wound complications, neuritis, infection, amputation, malalignment, lateral impingement, mortality, venous thromboembolism); donor site morbidity (eg, hematoma formation, infection, chronic pain, neurological deficits, iatrogenic fractures)

Setting: Any health care setting

General Search Strategy

Databases: MEDLINE, EMBASE, and Cochrane Library from 2000 to present

The search strategy includes Medical Subject Headings (eg, Autografts; Bone Transplantation; Transplantation, Autologous; Bone Marrow Transplantation; Platelet-Derived Growth Factor, Foot Bones; Foot Joints; Ankle Joint; Arthrodesis) and title/abstract words for orthobiologic products and foot and ankle arthrodesis.

We will also search Clinicaltrials.gov for recently completed and/or on-going trials and reference lists from relevant systematic reviews for references missed by our database searches.

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Screening for Male Osteoporosis

Key Questions

KQ1: Among males, is there a clinical risk tool (eg, FRAX) that identify patients at highest risk of osteoporosis or major osteoporotic fracture?

KQ2: Among male Veterans, is there a combination of risk factors that identify patients at highest risk of osteoporosis or major osteoporotic fracture?

KQ3: What systems level interventions improve uptake of osteoporosis screening?

PICOTS

Populations:
KQ 1: Adult men, KQ 2: Adult male Veterans, KQ 3: Health care providers, adult patients, health system administrators and/or staff.

In studies that recruit populations with and without facture histories, 80% of recruited study population should have no prior identified low-trauma fracture.

For studies with mixed populations of men and women, we will include them if they conduct a subgroup analysis of men only.

Interventions:
KQ 1: Clinical risk assessment or fracture risk predations tools (eg, FRAX, GARVAN FRC, Q fracture, fracture risk calculator, Osteoporosis Screening tool [OST], male osteoporosis screening tool [MOST], Male Osteoporosis Risk Estimation Score [MORES]); combination of assessment tools and screening tests (eg, dual-energy x-ray absorptiometry-DXA)

KQ 2: Risk factor for osteoporosis (eg, medication use, smoking, body mass index) and clinical risk assessment or fracture risk predations tools.

KQ 3: System-level approaches targeting provider behaviors or systems operations to optimize uptake of osteoporosis screening (eg, clinical reminder systems; bone health clinics; provider education; tailored and/or bi-directional patient education such as IVR assessing individual risk scores; remote consultation; nurse/physician/pharmacist led interventions; clinician incentives, academic detailing; patient self-referral system)

Comparators:
KQ 1 & KQ 2: other risk assessment tools, bone mineral density testing via validated approach (eg, dual-energy x-ray absorptiometry-DXA)

KQ 3: usual care, other system-level approached, patient-focused interventions

Outcomes:
KQ 1 & KQ 2: fracture rates; bone mineral density

KQ 3: fracture rates, screening rates

Setting: Outpatient general medical settings (eg, geriatrics, family medicine, general internal medicine, integrative medicine, urgent care, emergency departments) or inpatient health care settings

General Search Strategy

We will conduct a primary search from inception to the current date of MEDLINE® (via PubMed®), Embase, and CINAHL. We will use a combination of MeSH keywords and selected free-text terms to search titles and abstracts. To ensure completeness, search strategies will be developed in consultation with an expert librarian. We will also hand search key references for relevant citations that may not be captured by our database search.

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