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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.
The VA Evidence Synthesis Program (ESP) Coordinating Center is responding to a request from the VA Offices of Enterprise Integration (OEI) and Planning and Performance Management (OPPM), which has established an Integrated Project Team (IPT) on Homelessness. The IPT has requested a review of known risk factors for homelessness experienced by US Veterans during the pre-service, in-service, and post-service periods. Findings from this report will inform cross-VA efforts to better understand and address homelessness among Veterans.
KQ1: Among Veterans and other adults, what factors during childhood and adolescence are associated with homelessness during adulthood?
KQ2: Among Veterans, what factors during in-service and post-service periods are associated with post-service homelessness?
Population(s):
KQ1: US Veterans (any service era) and other adults experiencing homelessness
KQ2: US Veterans (any service era) experiencing homelessness
Outcome(s): Homelessness (defined as meeting US Department of Housing and Urban Development criteria, use of any specialized VA homeless services, or documented ICD-9 clinical code suggesting homelessness)
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
Outcome(s): Perioperative complications (eg, infection, thromboembolism, prosthetic explantation, extended length of hospital stay, hospital readmission, mortality, etc)
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)
Outcome(s): Survival outcomes (eg, overall survival, disease-free survival)
Harms (Any; eg, treatment-related complications)
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
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
Toxicity
Quality of Life: Overall and cancer specific
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.
PROSPERO registration number: CRD42022343247
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).
No comparator.
Outcomes: Clinical Outcomes (all within 6 weeks)
Setting: Emergency department
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.
PROSPERO registration number: RD42022347945
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:
Comparator: KQ1: Any comparator (eg, usual care, active comparator, historical controls)
Outcome(s): KQ1:
Process outcomes:
Performance outcomes (eg, time required for supplement administration)
Patient outcomes:
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
KQ2:
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
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.
PROSPERO registration number: CRD42022347950
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
Interventions: Tissue-based, multigene expression classifiers, specifically:
*Tissue upon which testing is run can be from a diagnostic biopsy or prostatectomy
*Diagnostic test does not need to be run at the time of tissue acquisition
Comparator: Clinical feature-based prediction models (eg, AUA/NCCN, CAPRA-S)
Or no comparator for KQ1, KQ2a/b
*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
KQ2:
KQ3: Biochemical recurrence-free survival, metastasis-free survival, prostate cancer-specific mortality, overall survival, cost
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
Outcome(s):
Setting: Any inpatient or outpatient health care setting
PROSPERO registration number: CRD42022363787
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?
Population(s):
KQs 1 and 2:
KQ 2 (additional):
Interventions:
KQs 1 and 2:
Comparator:
KQ 1:
KQ 2:
Outcome(s):
KQ 1:
KQ 1.1:
KQ1 and 2:
KQ 1:
PROSPERO registration number: CRD42022377940
KQ1: Among adults with medically operable stage I non-small cell lung cancer, what are the benefits and harms of stereotactic beam radiotherapy (SBRT) compared to surgery?
KQ2: Do benefits and harms of SBRT compared to surgery differ by patient characteristics (age, comorbidities, performance status), tumor characteristics (size, location, stage), surgery characteristics (type of surgery (minimally invasive vs. open), type of resection (lobectomy, wedge resection, segmental resection, sleeve resection), SBRT characteristics (dose, fractionation)?
KQ3: What are the quantity and characteristics of evidence assessing the comparative effects of ablative therapies as monotherapy or combined with other ablative therapies versus surgical, radiotherapy or ablative therapies for patients with early stage I non-small cell lung cancer, by type of intervention, patient/tumor characteristics, study design, and outcomes?
Population(s):
Adults, 18 years or older, with medically operable (determined based on clinical factors; e.g. patient age, performance status, comorbidities, and cardiopulmonary function) stage I non-small cell lung cancer (KQ1/2)
Adults, 18 years or older, with medically operable or inoperable (determined based on clinical factors; includes patient age, performance status, comorbidities, and cardiopulmonary function) stage I non-small cell lung cancer (KQ3)
Interventions:
KQ1/2
KQ3
Non-surgical ablative treatment modalities
Comparator:
KQ1 and 2:
KQ3:
Outcome(s):
Benefits
Survival (Primary outcome)
Recurrence/Control (Secondary outcome)
Quality of Life (QOL) (Secondary outcome)
Harms
SBRT Toxicity (acute=within 90 days and late=>90days)
Surgery (Short term; <30days)
Surgery (Long term; >30days)
Ablative therapies (short term) (KQ3 Only)
Ablative therapies (long term) (KQ3 Only)
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.
KQ1: Among parents with a history of sexual assault, what are the effects of parenting skills training interventions on key parent, child, and family outcomes?
KQ2: Among parents with a history of serious mental illness, what are the effects of parenting skills training interventions on key parent, child, and family outcomes?
KQ3: Among parents with a history of military service, what are the effects of parenting skills training interventions on key parent, child, and family outcomes?
KQ4: What are intervention characteristics (eg, format, dose, content) of the identified effective parenting skills training interventions?
Population(s):
Community dwelling biological, adoptive, or parent figures/guardian (eg, grandparents as primary caregivers) aged 18 and over of children aged 2 to 17 with histories of
KQ1: Sexual assault (eg, Military Sexual Trauma) or
KQ2: Serious mental illness (SMI) as determined by meeting one of the following criteria:
KQ3: United States military service or other countries armed forces, including those now separated from service (ie, Veterans)
KQ 1-3: Any mixed populations comprised of conditions/exposures listed for K1 – K3 if meeting 75% or more of the overall study population.
Interventions:
Manualized/protocolized parenting skills training interventions that are appropriate for parent figures of any gender identity that are intended to prevent adverse child and family outcomes (eg, disruptive or aggressive behaviors; family conflict) or increase parenting capacity. A parenting skills training program must include modeling, homework, rehearsal/role play, or practice that actively promotes the acquisition of parenting skills (eg, effective communication; increasing use of effective discipline; promoting nurturing behaviors to support positive parent-child interactions; responding sensitively to child’s emotional needs). Parenting skills programs may include enhancements (eg, additional psychoeducation) that aim to address needs of specific parent groups (eg, SPMI, sexual trauma, military service) but must have a focus on acquisition of parenting skills to increase parenting capacity.
Qualifying programs can be delivered:
Comparator: Any comparator (eg, usual care, active comparator, historical controls)
Outcome(s):
KQ1 -KQ 3:
KQ4: Characteristics of effective parenting programs such as
Context:
We will conduct a primary search from inception to the current date of MEDLINE® (via Ovid®), Embase, PsycINFO (via Ovid®) and CINAHL from inception to September 7th 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.
