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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.




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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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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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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VA vs Non-VA Quality of Care

Key Question

To identify and compare and contrast all studies that make conclusions about the quality of care provided in VA Medical Centers and outpatient clinics compared with care provided in other health systems (ie, the general population).

PICOTS

Population(s): Patients receiving care from VA or no-VA providers, in the following hierarchy: Veterans receiving care in VA and Veterans receiving care in the community as part of the CHOICE or MISSION Act; Veterans receiving care in VA and Veterans receiving care in the community not as part of CHOICE or MISSION; Veterans receiving care in VA and general population patients receiving care in the community

Interventions: Care received from VA

Comparator: Community care

Outcome(s): Quality in any of the IOM domains: clinical quality, safety, efficiency, access, patient experience, equity

General Search Strategy

We will procure literature from these sources: Operational Partner recommendations, PubMed.

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Evidence Brief: Orthopedic Surgery Complication Risk Associated with Tobacco Smoking, Smoking Cessation, and Use of Nicotine Replacement Therapies

Objective of Review

To synthesize available evidence on comparative postoperative complication risk associated with tobacco smoking, smoking cessation/reduction, and use of nicotine replacement therapies prior to elective orthopedic surgery.

Key Questions

KQ1: What is the comparative postoperative complication risk/risk reduction associated with continued tobacco smoking, smoking cessation/reduction, and use of nicotine replacement therapies prior to elective orthopedic surgery?

KQ1a: Does comparative complication risk/risk reduction vary by patient age, sex, race/ethnicity, or preexisting comorbidities?

KQ1b: Does complication risk/risk reduction vary by duration of smoking cessation/reduction or use of nicotine replacement therapies prior to elective orthopedic surgery?

PICOTS

Population(s): Adults undergoing elective orthopedic surgery

Interventions: Continued tobacco smoking, smoking cessation/reduction, or use of nicotine replacement therapies prior to elective orthopedic surgery

Comparator: Alternative intervention conditions, or non-smoking status

Outcome(s): Perioperative complications (eg, infection, thromboembolism, prosthetic explantation, extended length of hospital stay, hospital readmission, mortality, etc)

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Evidence Brief: Psychedelic Medications for Mental Health and Substance Use Disorders

Key Questions

KQ1: What are the benefits and harms of psychedelic medications as primary or adjunct treatment for mental health and substance use disorders?

KQ1a: Do benefits or harms of psychedelic medications vary based on patient characteristics (eg, race/ethnicity, gender identity, age, comorbid mental health or substance use disorders, index trauma type), disorder type, or disorder severity?

PICOTS

Population(s): Adults with mental health and/or substance use disorders (eg, depression, anxiety, PTSD). Studies among patients whose mental health and/or substance use disorders are secondary to other health conditions (eg, terminal cancer, end-stage renal disease) will be ineligible.

Interventions: Psychedelic medications (eg, ayahuasca/DMT, LSD, MDMA, psilocybin; excluding cannabinoids) used as a primary treatment or as an adjunct to psychotherapy or another treatment (ie, psychedelic-assisted therapy)

Comparator: Any (eg, placebo, treatment as usual)

Outcome(s): Disorder symptoms

Quality of life/functioning

Harms (eg, treatment-emergent adverse events)

Setting: Any, but we may prioritize articles using a best-evidence approach to accommodate project timeline

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Evidence Brief: Adjuvant Use of Molecularly Targeted Agents and Immune Checkpoint Inhibitors for Non-small Cell Lung Cancer

Key Questions

KQ1: Among adults with stage I-III NSCLC, what are the benefits and harms of adjuvant or neoadjuvant use of molecularly targeted agents or ICIs (with or without chemotherapy-based adjuvant therapy)?

KQ21a: Do benefits or harms vary by patient characteristics (eg, age, comorbidities) or disease stage?

PICOTS

Population(s): Adults with stage I-III NSCLC with surgically resected tumor(s) or planned surgical resection

Interventions: Adjuvant or neoadjuvant use of molecularly targeted agents (EGFR tyrosine kinase inhibitors including gefitinib, erolotinib, afatinib, and osimertinib) or ICIs (anti-PD-1 or anti-PD-L1 antibodies including atezolizumab, durvalumab, nivolumab, pembrolizumab, and cemiplimab) with or without chemotherapy-based adjuvant therapy

Comparator: Surgical resection without adjuvant or neoadjuvant use of molecularly targeted agents or ICIs (eg, chemotherapy-based adjuvant therapy only, placebo intervention only)

Outcome(s): Survival outcomes (eg, overall survival, disease-free survival)

Harms (Any; eg, treatment-related complications)

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Hypofractionation Radiation Therapy for Definitive Treatment of Selected Cancers: A Comparative Effectiveness Review

Key Questions

KQ1: What are the comparative efficacy and harms of hypofractionated vs. conventional radiation therapy in definitive treatment of adults with breast, prostate, lung, rectal, head and neck, bladder, pancreas, melanoma, or non-melanoma skin cancer?

KQ2: In the treatment of adults with the above types of cancer, do efficacy and harms of hypofractionation strategies vary by cancer stage, prostate cancer NCCN risk stratification, and other patient characteristics?

PICOTS

Population(s): Adults (18 years of age or older) with one of the identified cancers of interest

Interventions: Hypofractionation: [>220 cGy (2.2 Gy)]

Moderate hypofractionation

Ultrahypofractionation/extreme hypofractionation/stereotactic body radiation therapy (SBRT)/Stereotactic ablative body radiation therapy (SABR)/CyberKnife)

Comparator: Standard of care radiation therapy

Outcome(s): Survival

  • Overall
  • Disease-specific
  • Metastasis-free
  • Biochemical recurrence-free (prostate)
  • Disease free/local-recurrence free (non-prostate)

Toxicity

  • Overall (Any) AEs of Common Terminology Criteria for Adverse Events: Grade 2-5
  • Specific AE of Common Terminology Criteria for Adverse Events: Grade 2-5

Quality of Life: Overall and cancer specific

General Search Strategy

We will search Embase and Medline. Searches will be limited to English language. There will be no limits for geographical origin or time period.

We will supplement our bibliographic database searches with citation searching of relevant systematic reviews identified via the Cochrane and AHRQ databases.

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