Health Services Research & Development

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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.




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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Gulf War Illness – A Systematic Review of Therapeutic Interventions and Management Strategies

Background/Objectives of Review

The Gulf War Research Program would use the findings of this evidence review to inform the planning for a state-of-the-art meeting on Gulf War Research and to provide guidance for ORD funding priorities in Gulf War research. The War Related Illness and Injury Study Center would utilize the summary to communicate to providers, patients, and other stakeholders about evidence-based treatments in its education and clinical care activities.

Key Questions

KQ1: Evidence on effectiveness/harms: What are the benefits and harms of pharmacological and non-pharmacological interventions and management strategies for Veterans with GWI?

KQ2: Evidence about subgroups: Do the effectiveness or harms of the interventions/strategies differ among subgroups of Veterans with GWI, such as female Veterans or cases defined by specific criteria, in comparison with Veterans with GWI overall?

KQ3: Emerging research: What interventions for GWI have been examined in

  1. a) noncomparative studies only?
  2. b) ongoing/unpublished trials or cohort studies?

PICOTS

Population(s): We will include studies of Veterans with GWI who were deployed to the Persian Gulf region between Aug 2, 1990 - Nov 1991. We will include studies of international veteran populations (but limit to English-language publications). We will include studies of civilian contractors present during the conflict, if available. We will also include studies of Veterans with GWI whose deployment status is unclear (eg, if diagnosis was made according to CDC/Fukuda 1998 criteria).

Interventions: Pharmacological and nonpharmacological interventions or management strategies for Gulf War Illness

Comparator: Comparators include another active intervention, placebo, or usual care.

Outcome(s): Outcomes of interest are the 3 symptom domains that occur in both the CDC and Kansas case definitions: cognitive function, fatigue, and pain.

Other outcomes of interest:

  • Additional symptom domains used in the Kansas case definition (sleep, mood, musculoskeletal, gastrointestinal, respiratory, dermatological)
  • Global outcomes (eg, QOL and measures of function)
  • PTSD
  • Adverse effects of treatment

General Search Strategy

We will 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 search Ovid MEDLINE, Ovid PsycINFO, Ovid EBM Reviews (Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials), CINAHL, and AMED: Allied and Complementary Medicine Database. 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.5 The search strategy will include terms to identify Veterans from the Gulf War era (eg, Desert Shield, Desert Storm, Kuwait War, Operation GRANBY) combined with past and present terms to identifying Gulf War Illness, (eg, chronic multisymptom illness, chronic fatigue, Gulf War Syndrome). An English language limit will be used, however no limits on publication status nor study design will be imposed. To identify in-progress or unpublished studies, we will search ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We will review the bibliographies of relevant articles and contact experts to identify additional studies.

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Models and Tools for Care Coordination Implementation

Background/Objectives of Review

The Coordinated Care and Integrated Case Management (CC&ICM) initiative has implemented several tools for identification and stratification of Veterans who may benefit from various levels of care coordination services. They are currently piloting these tools at 12 VHA sites, and have plans to evaluate these tools in the near future. CC&ICM would like to better understand the evidence on other tools to evaluate and guide implementation of care coordination models, and which types of models have been effective (and in which health care setting). Results from this review will be used by CC&ICM to help guide selection and implementation of VA care coordination models and tools.

Key Questions

For community-dwelling adults with ambulatory care sensitive conditions (at higher risk of having repeat hospitalization of emergency department [ED] visits):

KQ1: What are the key characteristics of care coordination models (of varying levels) that aim to reduce hospitalization or ED visits?

KQ2: What is the effect of implementing these care coordination models on hospitalizations, ED visits, and patient experience (eg, CAHPS)?

KQ3: What are the characteristics of settings in which effective models have been implemented?

KQ4: Among effective models, which approaches/tools have been used to:

  1. Measure patient trust or working alliance?
  2. Measure team integration?
  3. Improve communication between patients and providers?

PICOTS

Population(s): Community-dwelling adults, Veterans and non-Veterans

Interventions: Models of care coordination that involve outpatient care

Comparator: Any

Outcome(s): Hospitalization, ED visits, patient experience

Setting: Outpatient (including clinics, home and community settings)

General Search Strategy

MEDLINE, Embase, CINAHL, Cochrane Database, AHRQ Evidence-based Practice Center, and VA ESP reports

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Robot-assisted Procedures in General Surgery: Cholecystectomy, Inguinal and Ventral Hernia Repairs

Key Questions

KQ1: What is the clinical effectiveness of robotic-assisted surgery compared to open surgery or conventional laparoscopic surgery for cholecystectomy or hernia surgery?

KQ2: What is the cost-effectiveness of robotic-assisted surgery compared to open surgery or conventional laparoscopic surgery for cholecystectomy or hernia surgery?

PICOTS

Population(s): Adults undergoing general surgery including cholecystectomy for benign disease, inguinal hernias and ventral hernias (<10 cm, >=10 cm, complex repairs).

Interventions: Robotic-assisted surgery

Comparator: Open surgery or conventional laparoscopic surgery

Outcome(s): Cholecystectomy: Perioperative (length of stay, complications, estimated blood loss, operating room time); short term (readmission, reintervention, hernia occurrence, pain, narcotic use, return to work), long term (hernia occurrence, quality of life); and cost.

Inguinal and ventral hernia: Perioperative (length of stay, complications, estimated blood loss, operating room time); short term (readmission, reintervention, hernia recurrence, pain, narcotic use, return to work), long term (hernia recurrence, pain, quality of life); and cost.

General Search Strategy

We conducted broad searches using terms relating to “robotic surgery” or “cholecystectomy” or “incisional hernia surgery” or “inguinal hernia surgery”. For cholecystectomy, we searched PubMed, Cochrane, and Embase from inception through 8/21/19; For inguinal and incisional hernias, we search Medline, PubMed, Embase, and Cochrane from inception to 9/3/19.

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