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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: 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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Accelerated Diagnostic Protocols that Use High-sensitivity Troponin Assays to “Rule In” or “Rule Out” Myocardial Infarction

Key Questions

KQ1: Among adults presenting to the emergency department with suspected acute coronary syndrome, what are the effectiveness and comparative effectiveness of accelerated diagnostic protocols that use high sensitivity cardiac troponin assays on:

i) clinical outcomes (e.g., myocardial infarction, mortality, and major adverse cardiac events) within 6 weeks?

ii) health service use (e.g., duration of emergency department stay, duration of hospitalization, readmission) within 6 weeks?

KQ 1a: Does effectiveness differ as a function of patient characteristics (e.g., gender, chest pain duration, clinical risk score)? 

KQ1b: What is the comparative performance of accelerated diagnostic protocols that use 1-hour delta (change in) troponin versus protocols that use 2-hour delta troponin?

KQ2: What are the clinical and health service use outcomes among adults presenting to the emergency department with suspected acute coronary syndrome who have indeterminant (“grey” or “observational” zone) results of accelerated diagnostic protocols that use high sensitivity cardiac troponin assays?

KQ 2a: Do clinical and health service outcomes differ as a function of patient characteristics (e.g., gender, chest pain duration, clinical risk score)? 

PICOTS

Population(s): Adults ≥18 years of age presenting to the emergency department with suspected acute coronary syndrome

Exclude adults who present with ST-segment elevation myocardial infarction.

Exclude hospitalized patients (prior to symptom onset or ADP testing)

Interventions: Accelerated diagnostic protocols (ADP) that use high sensitivity cardiac troponin assays.

ADP must be explicitly defined and at a minimum incorporate clinical history.

Any specific protocol or hs-cTn assay, including both hs-cTnI and hs-cTnT.

ADP may start in emergency department or prior to arrival in emergency department (i.e., by emergency medical technicians)

Comparator: No use of ADP.

Use of alternative ADP (e.g., alternative components of ADP, alterative timing of hs-cTn tests, alternative assays, alternative thresholds).

No comparator.

  • Not alternative lab measures (e.g., copeptin)
  • Not: ADP with cTn (not hs) (e.g., point of care Tn)

Outcomes: Clinical Outcomes (all within 6 weeks)

  • Myocardial infarction (MI)
    • MI correct diagnosis
    • MI missed diagnosis
  • Mortality
    • Cardiac
    • All-cause
  • MACE (any definition)
  • Health Service Use Outcomes (any duration of follow-up, except as noted)
    • Delayed intervention (e.g., revascularization)
    • Duration of emergency department stay
    • Hospitalizations (full admission as opposed to emergency department observation)
    • Duration of hospitalization
    • Readmission to either emergency department or hospital (within 6 weeks)
    • Further cardiac testing (g., stress test, diagnostic angiography) (within 6 weeks)
  • Test performance in reference to above outcomes

Setting: Emergency department

General Search Strategy

PubMed (Medline), Embase, Cochrane (2008 – current), and clinicaltrials.gov using key words and subject headings for chest pain, accelerated diagnostic protocols, high-sensitivity cardiac troponin, and emergency department.

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