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.
Dual Antiplatelet Management in the Perioperative Period (protocol under development)
Parenting Skills Training (protocol under development)
Surgery vs Alternative Modalities for Treatment of Lung Cancer (protocol under development)
Guidance for Post-COVID Clinics (protocol under development)
Evidence Brief: Safety and Effectiveness of Telehealth-delivered Mental Health Care
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)?
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)
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).
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.
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.
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?
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
Evidence Brief: Psychedelic Medications for Mental Health and Substance Use Disorders
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?
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
Evidence Brief: Adjuvant Use of Molecularly Targeted Agents and Immune Checkpoint Inhibitors for Non-small Cell Lung Cancer
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?
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)
Hypofractionation Radiation Therapy for Definitive Treatment of Selected Cancers: A Comparative Effectiveness Review
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?
Population(s): Adults (18 years of age or older) with one of the identified cancers of interest
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)?
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).
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
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)
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.
KQ1a: What is the prevalence of adverse employment-related outcomes in adults with a history of COVID-19?
KQ1b: Do employment-related outcomes differ in adults with a history of COVID-19 compared to those with no COVID-19?
KQ2a: What is the prevalence of adverse post-secondary education-related outcomes in adults with a history of COVID-19?
KQ2b: Do post-secondary education-related outcomes differ in adults with a history of COVID-19 compared to those with no COVID-19?
KQ3a: What is the prevalence of need for residential long-term care services, rehabilitation services, in-home services, or family caregiver services in adults with a history of COVID-19?
KQ3b: Does need for residential long-term care services, rehabilitation services, in-home services, or family caregiver services differ in adults with a history of COVID-19 compared to those with no COVID-19?
Population(s): Inclusion: Adults (18 and older) with history of COVID-19 (hospitalized or community-based); minimum n≥100 with COVID-19
Exclusion: Children, no history of COVID-19; sample size <100 with COVID-19
Interventions: Inclusion: COVID-19 diagnosis (laboratory confirmed, clinician identified, or self-report); any severity
Exclusion: Not COVID-19, COVID-19 pandemic era
Comparator: Inclusion: None required; studies with a comparator group (ie, non-COVID individuals, individuals without long COVID, or outcomes data from pre/post COVID-19) are required to assess association
Exclusion: Not applicable
Outcome(s): KQ1: Days/weeks lost from work, decreased hours worked, % working “part time,” leaving workforce, unemployment, changing jobs, disability impacting ability to work
KQ2: Discontinue or delay educational enrollment, time to complete program of study, loss of internship opportunities, post-graduation job opportunities, unemployment post-graduation, post-graduation earnings, income below poverty level
KQ3: Receipt of residential long-term care services (ie, board and care homes, assisted living facilities, skilled nursing facility/nursing homes); rehabilitation services; in-home services; family caregiver services; length of stay
General Search Strategy
We will search MEDLINE, Embase, CINAHL, PsycINFO, ERIC, EconLit from 2020-current, limited to the English language.
We will also search for unpublished reports and other gray literature documents via Google and links from articles in newspapers and other popular press.
Neuroimaging and Neurophysiologic Biomarkers for Mental Health: An Evidence Map
What are the quantity, distribution, and characteristics of evidence assessing the accuracy and utility of neuroimaging and neurophysiologic biomarkers in the diagnosis and clinical management of the following conditions:
Posttraumatic stress disorder (PTSD)
Substance use disorder (SUD)
Traumatic brain injury (TBI)
Population(s): Adults ≥18 years of age with the following conditions:
Anxiety (including OCD, phobias, and panic disorders)
Posttraumatic stress disorder (PTSD)
Substance use disorder (SUD)
Traumatic brain injury (TBI)
Tests of interest: Magnetic resonance imaging (MRI)
Functional magnetic resonance imaging (fMRI)
Diffusion tensor imagine (DTI)
Perfusion weighted imaging (PWI)
Magnetic resonance spectroscopy (MRS)
Positron emission tomography (PET)
Single photon emission computed tomography (SPECT)
Arterial spin labeling (ASL)
Evoked potentials and electroencephalogram (EEG)
Paired pulse transcranial magnetic stimulation (ppTMS)
Outcome(s): Diagnostic accuracy compared with:
Validated structured clinical interviews (eg, MINI, SCID-5, WHO WMH-CIDI)
KQ1: What are the effects of automating the delivery of oral, enteral, or parenteral nutrition supplements to hospitalized patients on patient and process outcomes?
KQ2: How is automating the delivery of oral, enteral, or parenteral nutrition supplements to hospitalized patients experienced by the staff involved in implementing and delivering it?
Population(s): KQ1: Hospitalized patients - including long-term care, skilled nursing facility residents and end of life patients - at risk of malnutrition (ie, who have difficulty eating or absorbing nutrients through GI tract)
KQ2: Hospital staff involved in automating the delivery oral, enteral, or parenteral nutrition supplements to patients (eg, nurses and nursing assistants, pharmacists, food service, registered dietitians)
Interventions: Automated nutrition delivery of oral, enteral, or parenteral nutrition supplements (ie, medical food supplements) that includes automated notifications to the hospital care team (eg, nurses and nursing assistants, physicians pharmacists, food service, registered dietitians) that nutrition supplements have been ordered/ prescribed and requires responses that the care team has administered nutrition supplements and/or how much the patient actually received (eg, electronic health record alerts, barcode scanning)
Automation is defined as the "creation of a process or application of a technology to deliver hospital-based nutrition to patients minimizing human intervention” (ie, hospital staff provide the thinking on the ordering side (inputs) and the delivery side (outputs) is automated to minimize human touch points).
Automation should include one or both of the following aspects of implementation:
Automation of documentation
Automation of ordering nutritional supplements, or
Automation of the delivery of nutrition supplements
Comparator: KQ1: Any comparator (eg, usual care, active comparator, historical controls)
supplements delivered, completion documentation (eg, documentation of supplement administration or reason for non-administration);
Patient-level harms among patients exposed to automated delivery of nutrition (eg, all-cause mortality, pressure injury, falls, organ damage, aspiration, refeeding syndrome (ie, consuming calories too quickly after starvation), failure to thrive diagnosis, medication-nutrition interactions
Primary purpose of evaluation is to explore the experiences and attitudes of hospital staff (eg, nursing, pharmacy, food service, dietetics) who interact with some aspect of implementing and delivering the automated delivery of nutrition
General Search Strategy
We will conduct a primary search from inception to the current date of MEDLINE (via Ovid), Embase, and CINAHL from inception to January 16, 2022. 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.
KQ1: Among individuals with localized prostate cancer who are considering first-line definitive treatment, does the addition of a tissue-based genomic test to existing clinical risk models impact risk classification
KQ2: Does tissue-based genomic testing impact the choice of treatment intensity or harms:
A. Among individuals with localized prostate cancer before first-line definitive treatment?
B. Among individuals who have undergone radical prostatectomy?
KQ3: Among patients with localized prostate cancer, what is the incremental prognostic effect of tissue-based genomic tests beyond existing prognostic clinical features on key clinical outcomes (eg, biochemical recurrence-free survival, metastases-free survival) following definitive treatment?
Population(s): KQ1, 2A: Patients with localized prostate cancer who are considering first-line definitive treatment (ie, active surveillance, surgical resection vs radiation, radiation with or without hormone treatment)
KQ2B: Patients who have localized prostate cancer who have undergone radical prostatectomy considering post-surgical treatment options (ie, observation alone, radiation with or without hormone treatment)
KQ3: Patients who have localized prostate cancer who have undergone definitive radiation or surgery
*Prediction models must include the following minimum core set of clinical features: PSA, Gleason score, and clinical tumor (T) stage
Outcome(s): KQ1: Changes in risk classification/reclassification, difference in classification, net reclassification index
Proportion choosing a specific treatment option (eg, active surveillance), change in management/treatment decision-making, addition of ADT to definitive radiation, receipt of adjuvant radiation with or without ADT (non-hypothetical changes in management or treatment)
Harms (eg, complications from unnecessary treatment)
We conducted a primary search from 2010 to the current date of MEDLINE (via Ovid), Embase, and Web of Science. We used a combination of MeSH keywords and selected free-text terms to search titles and abstracts. To ensure completeness, search strategies was developed in consultation with an expert medical librarian. We hand searched previous systematic reviews conducted on this or a related topic for potential inclusion.
To synthesize available evidence on the accuracy of pulse oximeters among patients of different races/ethnicities and the impact of differential accuracy on treatment delivery and harms. Findings from this report will inform VA policies on the use of pulse oximeters in clinical care.
KQ1: Does detection of hypoxemia by pulse oximetry vary by patient race/ethnicity or skin pigmentation?
KQ2: If present, are racial/ethnic disparities in hypoxemia detection associated with differences in treatment delivery or harms?
Population(s): Adult inpatients or outpatients of different races/ethnicities (self-reported) or skin pigmentation (measured using chromaticity/phototype scales, spectroscopy, or other objective assessment)
Interventions: Concurrent (ie, within 10 minutes) measurement of oxygen saturation in arterial blood gas and by pulse oximetry
Comparator: Not applicable
KQ1: Accuracy to detect hypoxemia (eg, bias, precision, area under receiver operating characteristic curve), or frequency/risk of occult hypoxemia (defined as arterial oxygen saturation of ≤ 88% despite a pulse oximeter reading of > 88% or stricter criteria)
KQ2: Treatment delivery outcomes (eg, treatment eligibility recognition/timing, treatment dosing/timing, treatment discontinuation/ discharge) or harms (eg, organ dysfunction, mortality)
Setting: Any inpatient or outpatient health care setting
KQ1: What protocols have been described to reduce seclusion practices for adult patients in inpatient mental health units?
KQ 1.1: What are the described resource needs (such as personnel and space needs) of these protocols?
KQ2: What are the comparative effects of protocols to reduce seclusion practices on resource use, staff and unit practices, patient experiences, and staff experiences versus usual protocols?
KQs 1 and 2:
Adults with psychiatric conditions being treated in hospital inpatient units
Exclude patients who are:
KQ 2 (additional):
Frontline staff and other psychiatric unit and hospital personnel
KQs 1 and 2:
Psychiatric unit-level protocols to reduce seclusion practices
Protocols to be defined by research study or organization guidance as strategies recommended (or already employed) as an alternative to seclusion. Protocols need to include multiple components or a general overall policy to reduce seclusion (i.e., not a single strategy only)
Seclusion defined as use of involuntary time restricted to a space physically removed from other patients
Comparator group not required
Usual seclusion protocols (i.e., no protocol directly aimed at reducing or minimizing seclusion)
Examples comparison include:
Same unit pre-intervention (i.e., pre-post protocols to reduce seclusion)
Concurrent controls from other units that do not use protocols to reduce seclusion
Descriptions of protocols, with explicit callout of how these may differ from usual seclusion
Characteristics of psychiatric unit-level protocols to reduce seclusion practices
Characteristics of the psychiatric unit in which the protocols are designed to be employed
Characteristics of the organization or experts who developed the protocols
Brief summary of the methods used to develop the protocols
Center/unit/hospital resource use
Staffing needs and mix
Environment (home-like vs. clinical)
Programming (e.g., meaningful activities)
Security personnel needs
Space (e.g., rooms) requirements
Documentation needs (e.g., patient engaged in treatment planning and update of treatment plan)
Other direct medical use
Dollar (or other currency) costs
Hospital charges or payer costs
Patient costs (direct or indirect)
Other indirect costs/resources
General Search Strategy
KQ1 and 2:
PubMed (Medline), Embase, Cochrane Central Register of Controlled Trials (2008 – current), PsycINFO, CINAHL, Cairn.info, and clinicaltrials.gov using key words and subject headings for protocols to reduce seclusion practices and inpatient mental health.
In addition to the above, we will do extensive grey literature searching of relevant healthcare organizations and guideline developers who may have produced protocols on strategies to reduce seclusion practices. This will include using VA networks to solicit protocols from within and external to the VA system.