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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.
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?
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
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.
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])?
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)
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.
PROSPERO registration number: CRD42021239756
KQ1a) Among adults, what is the effect of synchronous virtual care (ie, phone and/or video) compared to in-person care (or phone vs video) for chronic management of congestive heart failure on key disease specific clinical outcomes and healthcare utilization (ie, hospital admission, hospital re-admission, ER visits)?
KQ1b) Does this effect differ by race/ethnicity, gender, age, and rural status?
KQ2a) Among adults, what is the effect of synchronous virtual care (ie, phone and/or video) compared to in-person care (or phone vs video) for chronic management of chronic obstructive pulmonary disorder on key disease specific clinical outcomes and healthcare utilization (ie, hospital admission, hospital re-admission, ER visits)?
KQ2b) Does this effect differ by race/ethnicity, gender, age, and rural status
KQ3a) Among adults, what is the effect of synchronous virtual care (ie, phone and/or video) compared to in-person care (or phone vs video) for chronic management of type 2 diabetes on key disease specific clinical outcomes and healthcare utilization (ie, hospital admission, hospital re-admission, ER visits)?
KQ3b) Does this effect differ by race/ethnicity, gender, age, and rural status
KQ4) Among patients receiving care, clinical team members, and clinics, what are the adverse effects of synchronous virtual care for chronic management of congestive heart failure, COPD, and Type 2 DM (ie, inappropriate treatment, increase in resource costs, provider burnout) as compared to in-person care (or phone vs video)?
Population(s): Adults (18 years and older) with the following chronic conditions:
1) congestive heart failure (CHF),
2) chronic obstructive pulmonary disorder (COPD),
3) type 2 diabetes (at least 75% if a mix of type 1 and type 2)
Clinicians/clinics conducting virtual care for chronic conditions if relevant to harms.
Interventions: Synchronous care delivered over at least two encounters in which some or all in-person care is supplanted by virtual care (ie, phone and/or video) and which is delivered remotely by a clinician with a scope of practice that includes independent prescribing, diagnosis, and/or chronic management (ie, physician, nurse practitioner, physician assistant, clinical pharmacist) of a patient who is not physically present in the same clinic (aka teleconsultation, video-conferencing) and which is administered within the context of longitudinal care provision (even if individual visits are for acute concerns).
Comparator: In-person care without any virtual care delivery or telephone if compared to video
Outcome(s): General clinical outcomes (eg, medication adherence, quality of life, depression)
CHF clinical outcomes (eg, NYHA class/symptoms)
COPD clinical outcomes (eg, exercise tolerance, dyspnea)
Type 2 DM clinical outcomes (eg, hemoglobin A1c)
Clinical utilization (ie, hospitalizations, hospital re-admissions, emergency room visits/urgent care)
Adverse effects (eg, hypoglycemic episodes, inappropriate treatment, provider burnout)
Setting: OECD countries; Any outpatient setting (ie, general medical or specialty care clinic)
We will conduct a primary search from inception to the current date of MEDLINE® (via Ovid®) 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 hand search previous systematic reviews conducted on this or a related topic for potential inclusion.
KQ1: For cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness-based therapy used to treat adults with chronic pain
a) What are the patient, provider, and system-level barriers and facilitators for treatment uptake?
b) What is the effect of implementation strategies to increase uptake of these treatments?
KQ2: For evidence-based psychotherapies and mindfulness-based interventions used in integrated delivery systems to treat adults with chronic mental health conditions:
a) What are the provider and system-level barriers and facilitators to treatment uptake?
b) What is the effect of implementation strategies to increase use of these treatments?
Population(s): Community-dwelling adults with chronic pain (KQ1) or chronic mental health conditions (KQ2)
Interventions: or KQ1:
For KQ2:
Comparator: Any (active or inactive)
Outcome(s): KQ1 – Pre-implementation studies: patient, provider, and system-level barriers and facilitators
KQ2 – Pre-implementation studies: Provider and system-level barriers and facilitators
KQ1&2 – Evaluations of implementation strategies:
Timing: Text
Setting: Outpatient (including clinics, home, and telehealth)
Keyword and subject headings for interventions (as specified below); chronic pain; Veterans or VA; integrated delivery systems; and implementation barriers, facilitators and strategies. Databases to be searched: MEDLINE, Embase, CINAHL, PsycINFO, Cochrane database, and AHRQ EPC reports.
PROSPERO registration number: CRD42021245263
KQ1: What is the comparative effectiveness or effectiveness of implementing continuous quality improvement (CQI) frameworks in terms of health care workers’ outcomes (eg, reaction, learning, behavior change, results, and sustainment of change)?
KQ2: What factors (including intervention, inner setting, outer setting, individuals involved, and process by which implementation is accomplished) contribute to the success or failure of these CQI frameworks?
Population(s): Health care workers
Interventions: Continuous Quality Improvement (CQI) frameworks (eg, Lean, Lean Six Sigma, Institute for Healthcare Improvement [IHI] Model for Change, and Clinical MicroSystems)
Comparator: Studies that directly compare one CQI framework to another when possible
Outcome(s): Health care workers’ outcomes (eg, reaction, learning, behavior change, results, and sustainment of change)
Timing: Text
Setting: Any healthcare setting
We will procure literature from these sources: PubMed, CINAHL, DARE, Cochrane
PROSPERO registration number: CRD42021266319
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?
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
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.
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?
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.
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).
KQ1: What is the prevalence of experienced IPV/SA among Veterans and spouses/ intimate partners of Veterans by type (physical, sexual, or psychological/ emotional), timing (lifetime or past-year), and sociodemographic characteristics (eg, gender identity)?
KQ2: What is the prevalence of past-year IPV/SA perpetration by Veterans by type (physical, sexual, or psychological/emotional) and gender identity?
KQ3: What are common recruitment strategies and data collection methods utilized in studies of IPV/SA prevalence among Veterans and spouses/intimate partners of Veterans?
Population(s): US Veterans and spouses/intimate partners of US Veterans
Interventions: Not applicable
Comparator: Not applicable
Outcome(s): KQ1: Prevalence (proportion) of Veterans or spouses/intimate partners of Veterans who have experienced IPV/SA (excluding non-partner SA)
KQ2: Prevalence (proportion) of Veterans who have perpetrated IPV/SA (excluding non-partner SA)
KQ3: Recruitment strategies and data collection methods
Timing: Any
Setting: Any
PROSPERO registration number: CRD42021273109
KQ1: Among adults with comorbid conditions, is response to treatment of a primary condition (eg, PTSD or TBI) impacted by the presence or severity of comorbidities (eg, anxiety, depression, bipolar disorder, substance use disorder, or chronic pain)?
KQ2: Among adults with comorbid conditions, does treatment of patients’ primary condition (eg, PTSD or TBI) lead to clinical improvement of comorbidities (eg, anxiety, depression, bipolar disorder, substance use disorder, or chronic pain)?
KQ3: Among adults with comorbid conditions, what is the effectiveness of integrated treatment of patients’ primary condition and comorbidity compared to nonintegrated treatment?
Population(s): Adults with PTSD comorbid with anxiety, depression, bipolar disorder, or TBI, or who are experiencing PTSD, anxiety, depression, bipolar disorder, or TBI comorbid with substance use disorder or chronic pain
Interventions: KQ1, KQ2: Treatment of primary condition (eg, PTSD or TBI). Treatments with demonstrated efficacy for the primary condition may be prioritized over developmental treatments with limited evidence of efficacy.
KQ3: Integrated treatment of primary condition and comorbidity
Comparator: KQ1: Treatment of primary condition in patients without comorbidity
KQ2: Any (eg, alternative treatment, placebo, treatment referral), or no comparator
KQ3: Nonintegrated treatment
Outcome(s): Clinical outcomes (eg, patient-reported symptoms, diagnostic status)
Timing: Any
Setting: Any
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?
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
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)?
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
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?
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
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)?
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
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?
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:
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:
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.
Setting: Initial physical rehabilitation intervention: clinic or home-based
Adjunctive component: in-person, home-based, remotely delivered
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.
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?
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.)
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.
KQ1: What implementation factors (organized by Consolidated Framework for Implementation Research (CFIR) constructs: intervention characteristics, outer setting, inner setting, characteristics of individuals, process) impact the benefits and harms of transition of care from emergency departments in one health system to outpatient care settings in another?
KQ1a: Does the implementation of transition of care interventions differ by patient characteristics (eg, clinical severity, demographics, level of emergency care utilization)?
Population(s): Adults discharged from the emergency department
Interventions: Interventions will be those that include “a set of actions designed to ensure the coordination and continuity of health care as patients transfer between different locations or different levels of care” (Coleman 2004). Interventions must involve the transition from the emergency department to outpatient care, and they must involve the transition from one health system to another. Interventions can take place before or after discharge and may include components that span settings.
Comparator: Usual care or other interventions
Outcome(s): Patient outcomes: Mortality, patient satisfaction
Intermediate outcomes: Over/inappropriate prescribing, duplicate tests or imaging, follow-up by primary care (# days), purpose tests/images ordered in ED are clear
Utilization: ED utilization (up to 1 year), inpatient admission (direct or via ED) within 30 days of last ED visit, ambulatory care sensitive hospitalizations within 30 days
Barriers and facilitators
Timing: Primarily ≤ 30 days. Up to 1 year for outcomes related to frequent utilization.
Setting: Emergency departments in the US, Canada, and Europe. We will include both integrated and non-integrated care settings.
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:
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.
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
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.
