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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.




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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Tele-urgent Care for Low Acuity Conditions: A Systematic Review of a Complex Intervention

Key Questions

KQ1:

a.) Among adults, what are the effects of tele-urgent care for low acuity conditions on key clinical and health systems outcomes (ie, patient satisfaction, health care access, health care utilization, case resolution, cost, patient safety)?

b.) Does the impact of tele-urgent care for low acuity conditions differ by

1.) provider characteristics (ie, specialty, amount of telehealth experience, training) or

2.)mode of delivery (ie, telephone, video, web, short message service [SMS])?

KQ2:

a.) Among adults, what are the adverse effects (ie, inappropriate treatment, misdiagnosis, or delayed diagnosis; provider burnout) of tele-urgent care for low acuity conditions?

b.) Do the adverse effects of low acuity conditions differ by

1.) provider characteristics (ie, specialty, amount of telehealth experience, training) or

2.) mode of delivery (ie, telephone, video, web, short message service [SMS])?

PICOTS

Population(s): KQ1 & KQ2: Adults with low acuity but urgent conditions (≥18 years of age) and their families and caregivers.

KQ2 ONLY: Tele-urgent care providers (if included in harms)

Interventions: Tele-urgent care for low acuity conditions is defined as remotely delivered (eg, telephone, video conferencing) medical services indented to provide on-demand, initial treatment of illnesses or injuries of a less serious nature than those constituting emergencies (ie, urgent care, not routine primary care) and is initiated by a patient with a provider

Comparator: KQ1: Usual care/standard of care, waitlist control, other active comparator (eg, in-person care

KQ 2: No comparator required

Outcome(s): KQ1: Patient, provider, system outcomes (eg, patient satisfaction, health care access, health care utilization, case resolution, cost, and patient safety)

KQ 2: Key adverse effects associated with telehealth (eg, inappropriate treatment, misdiagnosis, delayed diagnosis, increase in resource costs; provider burnout)

General Search Strategy

We will conduct a primary search from inception to the current date of MEDLINE® (via Ovid®), EMBASE (via Elsevier), CINAHL Complete (via EBSCO). 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 hand search previous systematic reviews conducted on this or a related topic for potential inclusion.

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Staffing in Nursing Homes

PROSPERO registration number: CRD42021266319

Key Questions

KQ1: What are the effects of nurse staffing levels and staff mix on:

a) processes of care (eg, use of antipsychotics) in nursing homes?

b) resident outcomes (eg, falls) in nursing homes?

KQ2: Which nurse staffing levels and staff mix have demonstrated cost-effectiveness for improving resident outcomes in nursing homes?

PICOTS

Population(s): Individuals over 18 years of age living in nursing homes

Interventions: Staffing levels or mix (eg, staff to patient ratio, staffing roles [RN, LPN, nurse aides])

Comparator: Any (Alternative staffing levels or mix)

Outcome(s): Process Outcomes: Receipt of an antipsychotic, antianxiety, or hypnotic medication; Receipt and/or duration of urinary catheter; Citations for resident safety concerns

Resident Outcomes: Nursing home associated infections (eg, influenza, UTI, COVID-19); Pressure ulcers (new or worsened); Falls with major injury; Acute care episode (hospitalization, emergency room); Discharge to home or community; Functioning (ability to move independently, increase in needing help with daily activities); Pain severity; Quality of life; Mortality

Cost-Effectiveness: Cost per outcome; Cost per QALY

Setting: Nursing homes

General Search Strategy

We will search MEDLINE, CINAHL, Embase, and the grey literature (2001 to current), using key words and subject headings for nursing homes, long-term care, nurse schedules and staffing characteristics.

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Endoscopic Bariatric Therapies: A Systematic Review

Key Question

What is the efficacy of endoscopic bariatric interventions in achieving weight loss and comorbidity resolution compared to other endoscopic bariatric interventions, medical management, and surgical interventions?

PICOTS

Population(s): Adults with obesity (BMI > 30 kg/m2)

Interventions: Intragastric balloons (gas-filled and fluid-filled), aspiration therapy, endoscopic gastroplasty, duodenal mucosal liner, duodenal resurfacing, endoscopic sleeve gastrectomy

Comparator: Surgical bariatric procedures, medical management, other endoscopic bariatric procedures

Outcome(s): Perioperative outcomes and adverse events

Primary outcomes: BMI, total and excess body weight loss

Secondary outcomes: Resolution of obesity-related co-morbidities such as DM, GERD, OSA<CHF, OA, NASH. Perioperative and long-term adverse events such as bleeding, nausea, vomiting, infection, 30-day readmission, mortality.

General Search Strategy

We conducted broad searches using terms such as “gastric balloon”, “gastroplasty” and “endoscopic sleeve.” We searched PubMed (1/1/14-12/31/2021), Cochrane (1/1/14-12/31/2021), and Embase (1/1/14-12/31/2021).

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Evidence Brief: Mental Health Impacts on Peri-implantitis or Dental Implant Failure

Key Question

KQ1: Among adults receiving dental implants, does presence and/or treatment of 1 or more comorbid mental health conditions (eg, PTSD, bipolar disorder, schizophrenia, depression, anxiety) increase risk of peri-implantitis or dental implant failure/loss?

PICOTS

Population(s): Adults receiving 1 or more dental implants

Interventions: Placement of 1 or more dental implants in patients with a comorbid mental health condition (eg, PTSD, bipolar disorder, schizophrenia, depression, anxiety)

Comparator: Placement of 1 or more dental implants in patients without a comorbid mental health condition

Outcome(s): Diagnosis of peri-implantitis within 5 years of implant placement; failure/loss of dental implants within 5 years of implant placement

Timing: Any

Setting: Any

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Evidence Brief: Intracameral Moxifloxacin for Preventing Endophthalmitis

Key Questions

KQ1: What are the benefits and harms of intracameral moxifloxacin use during cataract surgery to prevent postoperative endophthalmitis?

KQ2: How do benefits and harms of intracameral moxifloxacin use during cataract surgery vary based on administration method (eg, diluted vs undiluted) and use of co-interventions (eg, with vs without topical antibiotic eye drops)?

PICOTS

Population(s): Adults undergoing cataract surgery

Interventions: Intracameral moxifloxacin use during cataract surgery

Comparator: Care as usual (ie, no intracameral antibiotic use during cataract surgery)

Outcome(s): Incidence of postoperative endophthalmitis, harms (eg, corneal edema, severe inflammation, retinal toxicity/vasculitis), patient quality of life, patient use of co-interventions (eg, topical antibiotic eye drops)

Timing: Any

Setting: Any

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Evidence Brief: Doula Support for Veterans

Key Questions

KQ1: What are the benefits and harms of doula support programs to maternal and infant outcomes?

KQ2: What are the implementation characteristics of doula support programs shown to improve maternal and infant outcomes?

PICOTS

Population(s): Pregnant, birthing, or postpartum adults

Interventions: Doula support (ie, one-on-one emotional support during pregnancy, labor, and/or postpartum)

Comparator: No doula support (ie, pregnant, birthing, or postpartum adults not receiving doula support)

Outcome(s): KQ1: Maternal mortality and severe morbidity (as defined by Centers for Disease Control; excluding blood product transfusion); neonatal outcomes (eg, low birth weight, neonatal intensive care unit stay); and reduction in low-risk cesarean delivery (ie, nulliparous, term, singleton, vertex [NTSV] cesarean births)

KQ2: Implementation characteristics (eg, level of training, timing [ie, during pregnancy, birthing, or postpartum period])

Timing: Any

Setting: Any

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Evidence Brief: Specialty Care Staffing

Key Questions

KQ1: What staffing models for outpatient specialty care clinical support staff and clinicians are associated with increased staff productivity and improved patient outcomes?

KQ2: How do staffing models for outpatient specialty care clinical support staff and clinicians vary by program or contextual characteristics (eg, program type, rural or urban setting, etc)?

PICOTS

Population(s): Outpatient specialty care programs (allergy/immunology, cardiology, critical care/pulmonary, dermatology, endocrinology/diabetes, gastroenterology, HIV/hepatitis, infectious disease, nephrology, neurology, oncology, optometry, pain management, rheumatology, sleep medicine),

Exclude: Surgical care, pediatrics

Interventions: Staffing models (ie, practices for adding/removing staff, expanding or reducing work hours, or altering allocation of clinic resources [eg, clinic room availability]) for outpatient specialty care program clinical support staff and clinicians (excluding administrative staff)

Comparator: Alternative staffing models (ie, implemented in comparable setting), pre/post implementation of staffing model, or no comparator

Outcome(s): Productivity outcomes (eg, efficiency, relative value units [RVUs], number of patients seen, number of procedures delivered, reduction in emergency department visits, staff satisfaction/wellbeing, cost-effectiveness, etc)

Patient-important outcomes (patient-centeredness/patient satisfaction, timeliness [eg, wait times for appointments], equity [eg, disparities in care], health outcomes [eg, HIV viral suppression])

Timing: Any

Setting: United States

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Interventions to Improve Long-term Adherence to Physical Rehabilitation among those with Hip or Knee Osteoarthritis or Chronic Low Back Pain

Key Question

Among adults with hip/knee osteoarthritis or chronic low back pain, do physical rehabilitation interventions supplemented with one or more adjunct components to promote adherence improve self-efficacy, adherence, or sustained functional improvements at ≥ 3 months after completing the rehabilitation intervention?

PICOTS

Population(s): Adults (age 18+ years) with: hip or knee osteoarthritis (self-reported diagnosis, clinical criteria, or radiographic evidence); chronic low back pain (lasting ≥ 12 weeks)

Interventions: Physical rehabilitation interventions (ie, active, structured physical activity or activities designed to reduce impairments and improve movement-related function that is delivered, supervised, and/or monitored by a health care professional or other trained individual) that have an adjunctive component(s) (embedded within initial PT) or are followed by component(s) (delivered after initial PT) designed to promote long-term adherence to the prescribed rehabilitation home practice including but not limited to the following approaches:

  • Feedback and monitoring (eg, use of activity monitors)
  • Social support (eg, peer coaches)
  • Incentives
  • Psychologically-informed interactions (eg, cognitive behavioral therapy, acceptance and commitment therapy, motivational interviewing)

Initial rehabilitation intervention must be delivered by trained individuals (in-person or virtual) with clearly stated profession including: PTs, kinesiotherapists, certified exercise physiologist, physiatrist (rehabilitation MD).

Adherence-focused sessions/component delivered after the initial PT course may be delivered by different professionals than initial rehabilitation intervention but still within the professions listed above or trained study team members.

Interventions may involve caregiver but primary target of intervention must be the patient.

Comparator: Same initial physical rehabilitation intervention without the adjunct component or same initial physical rehabilitation with attention control instead of adjunct component

Outcome(s): Any of the following if measured at 3 or more months after the end of the initial rehabilitation intervention:

  • Self-efficacy to engaging in home practice of PT outside of supervised PT
  • Adherence to prescribed rehabilitation home practice.

NOTE: if a study does not explicitly describe an intent to promote long-term adherence to rehabilitation home practice, it must measure adherence as an outcome.

  • Measures of physical function including but not limited to: (eg, WHO-DAS, FIM + FAM, 6-minute walk test)
  • Adverse events

Setting: Initial physical rehabilitation intervention: clinic or home-based

Adjunctive component: in-person, home-based, remotely delivered

General Search Strategy

We will conduct a primary search from inception to the current date of MEDLINE (via Ovid), CINAHL, and Embase. 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 medical librarian. We will identify exemplar articles for testing the integrity of the developed search strategy. All search strategies will be reviewed by a second medical librarian. We will hand-search previous systematic reviews conducted on this or a related topic to identify other potentially eligible studies.

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Videoconferencing of nonpharmacological interventions for chronic pain

Key Questions

KQ1: Among patients with chronic pain, what is the effect of videoconference-delivered psychologically informed behavioral interventions for non-pharmacological chronic pain on pain, functionality, quality of life, and patient engagement?

KQ2: Among patients with chronic pain, what is the effect of videoconference-delivered therapeutic exercise and movement interventions for non-pharmacological chronic pain on pain, functionality, quality of life, and patient engagement?

PICOTS

Population(s): Community dwelling Adults (18 years +) with chronic (3+ months) non-cancer pain

Interventions: KQ1: Behavioral interventions encompassing at least one of the following approaches 1) psychological and behavioral therapies(eg, CBT/ACT, meditation, mindfulness) and or 2) self-management education and support approaches (eg, back school, pain education) as defined as tasks undertaken by patients to manage the symptoms, treatments, lifestyle changes, and physical and psychosocial consequences associated with chronic pain.

KQ2: Therapeutic exercise and movement interventions: Supervised exercise and movement therapies (ie, active, structured physical activity or activities designed to reduce impairments and improve movement-related function) delivered via videoconferencing.

All KQs: Synchronous videoconference care delivered over at least two encounters in which

a) all or the majority (ie, greater than 50%) of in-person non-pharmacological pain care is supplanted by virtual care;
b) which is delivered remotely by a provider of a patient who is not physically present in the same location;
c) which is administered within the context of longitudinal care provision (even if individual visits are for acute concerns); and
d) focused videoconferencing with an explicit focus on pain management.

*Interventions are not required to be exclusively virtual care provided by a provider as described above; rather may include the above with other asynchronous telehealth tools (eg, remote monitoring systems).

Comparator: In-person care without any videoconference delivery, telephone or combination of in-person and telephone

Outcome(s): Pain (eg, interference); Physical function (performance-based physical function & self-report); Quality of life; Patient engagement (eg, home practice, session completion rates, pt reported engagement)

Setting: Any outpatient setting (ie, general medical or specialty care clinic)

OECD Countries (Organization for Economic Co-operation and Development; Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Korea, Latvia, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States.)

General Search Strategy

We will conduct a primary search from inception to the current date of MEDLINE® (via Ovid®), Embase, CINAHL, and Cochrane Central Register of Controlled Trials. 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 medical librarian. We will hand search previous systematic reviews conducted on this or a related topic for potential inclusion.

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Diabetic Foot Risk

Key Questions

KQ1: Determine tools that assess the risk of (i) developing a diabetic foot ulcer (first ulcer or recurrent ulcer) or (ii) amputation in a patient with a diabetic foot ulcer. Additionally, ascertain how these tools compare with regards to:

  1. Prognostic accuracy
  2. Validation
  3. Usability (metrics include: time to conduct test/tool, training or certification need to conduct test, location of test performance [in office/outpatient], etc)

KQ2: Determine the effectiveness or comparative effectiveness of orthotic or pedorthic interventions to prevent diabetic foot ulcers.

KQ3: Determine the effectiveness or comparative effectiveness of orthotic or pedorthic interventions to treat diabetic foot ulcers.

PICOTS

Population(s): Individuals over 18 years of age with diabetes

Interventions: Foot ulcer risk assessment tools and orthotics/pedorthic interventions

Comparator: Any active comparator (eg, PAVE, other risk assessment tools) or no intervention (for tools and orthotics/pedorthics)

Outcome(s): KQ1: Prognostic accuracy for development of an ulcer (first or recurrent) or risk of amputation; Sensitivity, Specificity, Predictive Value, AUC, Calibration, Discrimination, Risk Reclassification; Usability (metrics include: time to conduct test/tool, training or certification needed to conduct test, location of test performance [in office/outpatient], etc); Validation

KQ2: Ulcer occurrence, amputation, cost, adherence, and harms

KQ3: Ulcer healing (complete vs partial), amputation, cost, adherence, and harms

General Search Strategy

We will search MEDLINE, Embase, Cochrane and the AHRQ database using key words and subject headings for diabetic foot, foot ulcers, risk assessment, and orthotics.

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Evidence Brief: Antithrombotic Treatments in COVID-19

Key Questions

KQ1a: Among adults with COVID-19, what is the incidence of venous and arterial thromboembolism?

KQ1b: Does the incidence of venous and arterial thromboembolism among adults with COVID 19 vary by patient characteristics (such as age, sex, race/ethnicity, pre-existing co-morbidities, pre-existing use of anticoagulation or antiplatelet medications, etc), COVID-19 disease severity, or degree of hypercoagulability?

KQ2a: Among adults with COVID-19, what are the benefits and harms of antithrombotic medications?

KQ2b: Do the benefits and harms of antithrombotic medications among adults with COVID-19 vary by medication type or dose, timing (eg, initiated at admission or later), patient characteristics, COVID-19 disease severity, or degree of hypercoagulability?

PICOTS

Population(s): Adults with COVID-19, stratified by:

  1. age, sex, race/ethnicity
  2. pre-existing co-morbidities
  3. pre-existing use of antithrombotic medications
  4. disease severity
  5. degree of hypercoagulability

Interventions: Use of antithrombotic medication (heparin, LMWH, fondaparinux, tPA, clopidogrel, antithrombin, etc)

Comparator: No antithrombotic medication or usual prophylactic dosing (heparin, LMWH, etc)

Outcome(s): Incidence of thromboembolism, mortality, mechanical ventilation, ICU admission and length of stay, hospital admission and length of stay

Timing: Any

Setting: Any

Study design: Any, excluding case reports and case series of <3 subjects

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Evidence Brief: Safety and Effectiveness of Telehealth-delivered Mental Health Care

Key Questions

KQ1: What is the safety and effectiveness of evidence-based mental health care when delivered via telehealth modalities to adults with post-traumatic stress disorder (PTSD), depression, anxiety, bipolar disorder, substance use disorder, suicidality, and/or serious mental illness (SMI)?

KQ2: Does the safety and/or effectiveness of evidence-based mental health care delivered via telehealth modalities vary according to the modality, format (ie, group vs individual), or presenting mental health condition (including patient risk/severity level)?

PICOTS

Population(s): Adults with symptoms or diagnosis of PTSD, depression, anxiety, bipolar disorder, substance use disorder, suicidality, and/or SMI

Interventions: Evidence-based (ie, recommended by applicable VA/DoD Clinical Practice Guidelines, or when unavailable, similar widely-adopted guidelines) mental health care delivered by a provider to a patient in a home or clinical setting with some aspect of care delivered by a telehealth modality (video teleconference, telephone, online portals, secure messaging, or integration of multiple modalities)

Comparator: Intervention delivered in person or via alternative telehealth modality

Outcome(s): Mental health condition symptomatology (eg, symptom reduction, functional improvement, quality of life)

Access and continuity of care (eg, wait times, patient retention/attrition, therapeutic alliance, missed appointments, involvement of family/partner)

Quality and implementation-related outcomes (eg, patient satisfaction, provider satisfaction, therapeutic alliance, cost-effectiveness)

Harms (Any)

Timing: Any

Setting: Patient home or clinical setting remotely located from mental health care provider

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Evidence Brief: Proton Beam Therapy for Treatment of Localized Prostate Cancer

Objective of Review

To synthesize available evidence on the benefits and harms of PBT for the treatment of localized prostate cancer.

Key Questions

KQ1: What are the benefits and harms of PBT compared to conventional external beam radiation therapy or brachytherapy for the treatment of early stage localized prostate cancer?

KQ1a: Do benefits or harms of PBT vary according to fractionation schedules, beam targeting modality (passive scattering vs pencil beam scanning), or patient characteristics (eg, symptom score, prostate size)?

KQ2: For patients with progression or recurrence of cancer in the prostate who were not previously treated with radiation therapy, what are the benefits and harms of PBT compared to conventional forms of radiation therapy?

PICOTS

Population(s): Adults with localized prostate cancer

Interventions: Proton beam irradiation therapy

Comparators: Radiotherapy using X-ray-based external beam modalities or brachytherapy

Outcomes: Benefits: Survival, quality of life, functional capacity, local tumor control, delivery of planned chemotherapy and radiation regimens

Harms: Urinary and rectal symptoms, secondary malignancies, soft tissue damage

Timing: Any

Setting: Any

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