Health Services Research & Development

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ESP 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.



Pharmacotherapy for Stimulant Use Disorders: A Systematic Review

PROSPERO registration number: CRD42018085667

Background/Objectives of Review

The review will be used by the Office of Mental Health Services to inform national VHA policy on VA substance use disorder (SUD) treatment. CESATE will also disseminate the findings to the field to help ensure medication-assisted SUD treatments available to Veterans include the latest evidence on effectiveness and harms. This review also has the potential to inform future SUD research priorities by identifying gaps in the literature.

Key Questions

KQ1: What are the benefits and harms of pharmacotherapy for cocaine use disorder (alone, or as an adjunct or follow-up to psychosocial treatment)?

KQ2: Are there known subpopulations for which different forms of pharmacotherapy is most/least effective for cocaine use disorder?

KQ3: What are the benefits and harms of pharmacotherapy for amphetamine/methamphetamine use disorder (alone, or as an adjunct or follow-up to psychosocial treatment)?

KQ4: Are there known subpopulations for which different forms of pharmacotherapy is most/least effective for amphetamine/methamphetamine use disorder?

PICOTS

Population(s): Included: Non-pregnant adults with cocaine or amphetamine/methamphetamine use disorder.

Excluded: subjects with psychotic spectrum disorder, bipolar disorder.

Interventions: Included: Pharmacotherapies identified as a potential treatment for cocaine or amphetamine/methamphetamine use disorder (common adjuncts may be med management; interpersonal therapy; contingency management (or motivational incentives); CBT (including matrix therapy, relapse prevention)

Excluded:treatment for temporary psychosis associated with stimulant overdose.

Comparator: Usual care, placebo, or other interventions (control groups should receive the same adjunctive treatments)

Outcome(s): Intermediate/Behavioral outcomes: Abstinence (UTS only; self-report only in addition to UTS); Also of interest when available: Longest Duration of Abstinence (LDA), and whether patients reach at least Three Consecutive Weeks (21 or more days) of abstinence. Reduction of cocaine use (eg, last 30 days, last 3 months, ASI included number of days of use, quantitative urine levels). Retention in treatment.

Health and other outcomes: Morbidity/mortality; Quality of Life; Legal/employment outcomes

Harms: Withdrawal due to AE, and severe AE (as reported in the trials)

General Search Strategy

Search strategies will be developed in consultation with a research librarian, and will be peer reviewed by a second research librarian using the instrument for Peer Review of Search Strategies (PRESS). We plan to conduct a primary review of the literature by systematically searching, reviewing, and analyzing the scientific evidence as it pertains to the research questions. To identify relevant articles, we will begin by searching Ovid MEDLINE, OvidPsycINFO, and Ovid EBM Reviews Cochrane Database of Systematic Reviews (CDSR, DARE, HTA, Cochrane CENTRAL, etc). We will search all available years of publication from database inception (1946 for Ovid MEDLINE) through November 2017. We will review the bibliographies of relevant articles and contact experts to identify additional studies. To identify in-progress or unpublished studies, we will search ClinicalTrials.gov, OpenTrials, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP).

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Strategies for Full System Scale/Spread

Key Questions

What strategies have been used to scale up and spread clinical and administrative practices across healthcare systems, with special attention paid to sites with poor performance or that may be hard to engage in improvement initiatives?

  1. What macro-organizational strategies (ie, at the whole organization or system level) have been used in spread and scale efforts?
    a. What macro-organizational strategies (ie, at the whole organization or system level) were used with sites with poor performance or that may be hard to engage in improvement initiatives?
  2. What micro-organizational strategies (ie, at the individual or group/team level) have been used in spread and scale efforts?
    b. What micro-organizational strategies (ie, at the individual or group/team level) have been used in spread and scale efforts with sites with poor performance or that may be hard to engage in improvement initiatives?

PICOTS

Population(s): Multi-site health care systems

Interventions: n/a

Comparator: n/a

Outcome(s): Uptake of practices across multiple sites within a health care system; ability to produce intended outcomes (eg, cost containment, access to care, coordination among care providers, patient outcomes, etc)

Context: Large health care systems in high-income countries improving clinical care or administrative performance.

General Search Strategy

We will procure literature from 3 main sources:

  1. A systematic search of PubMed and WorldCat databases using terms related to “learning health systems”.
  2. A systematic search of PubMed, WorldCat, Web of Science, and Business Source Complete databases using terms related to “scale and spread”.
  3. Publications in the ART database related to relevant QUERI projects. In addition to using ART database, articles were identified by experts or reference mined.

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Self-management Strategies for Epilepsy

Key Questions

KQ1: For adults with epilepsy, what are the effects of self-management programs on process, clinical outcomes and healthcare utilization?

KQ2:For adults with epilepsy, what are the most commonly employed components of self-management interventions evaluated in comparative studies?

(contingent KQ2b): Which epilepsy self-management intervention components are most effective?

KQ3: What are the identified facilitators and barriers that impact the adoption of self-management programs for adults with epilepsy in large-scale health systems such as the VA?

PICOTS

Population(s): Adults (age ≥ 18 yo) with new or chronic epilepsy. Family members and/or caregivers of those with epilepsy.

Interventions: Self-management (SM), defined as interventions that aim to equip patients with skills to actively participate in and take responsibility for the management of epilepsy in order to function optimally through at least knowledge acquisition and a combination of 1 or more of the following: stimulation of independent sign/symptom monitoring, medication management, enhancing problem-solving and decision-making skills for epilepsy treatment management, safety promotion (eg, driving), and changing health behaviors (including stress management, sleep, substance use).

Comparator: Any, including usual care, attention control, active intervention

Outcome(s):

Clinical: Seizure Rate/frequency/Severity; Quality of Life (QOL); Social function/engagement (eg, days work missed, or validated measure); Psychological symptoms (ie, distress, depressive or anxiety symptoms); Safety outcomes (eg, motor vehicle accidents); Medication toxicity

Process: Epilepsy Self-efficacy and Epilepsy Self-management scales; Medication adherence; Disease knowledge

Utilization: Acute care or emergency department visits; Hospitalization; or Outpatient specialty visits for epilepsy

General Search Strategy

We will conduct a primary search from inception to the current date of MEDLINE® (via PubMed®), PsycINFO, 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 search the grey literature specifically by conducting a targeted search in clinicaltrials.gov and through hand-searches of the references from select high-quality systematic reviews and exemplar studies identified during the topic development process and as identified by our stakeholders.

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Guided Imagery, Biofeedback, and Hypnosis

Key Questions

  • KQ1: In which populations has guided imagery been examined, and what is the evidence of effectiveness and harms in each of these populations?
  • KQ2: In which populations has biofeedback been examined, and what is the evidence of effectiveness and harms in each of these populations?
  • KQ3:In which populations has hypnosis been examined, and what is the evidence of effectiveness and harms in each of these populations?

PICOTS

Population(s): Adults (18+) receiving an intervention of interest for any health condition. Children and adolescents are excluded. Exclude studies of healthy volunteers.

Intervention(s): Guided imagery (also “guided meditation,” “yoga nidra,” “mental practice,” “mental rehearsal,” “Katathym-imaginative Psychotherapy,” “autogenic training,” and “integrative restoration”). Studies of guided imagery as part of a complex or multicomponent intervention are excluded.

Biofeedback (also “neurofeedback,” and “neurotherapy”). Studies of biofeedback as part of a complex or multicomponent intervention are excluded.

Hypnosis (also “hypnotherapy”). Studies of hypnosis as part of a complex or multicomponent intervention are excluded.

Comparator: Systematic reviews and meta-analyses of RCTs comparing an intervention of interest to usual care, placebo, or another intervention

Outcome(s): Effect on diagnosis-related symptoms; harms

Setting(s): All health care settings

General Search Strategy

Search strategies will be developed in consultation with a research librarian, and will be peer reviewed by a second research librarian using the instrument for Peer Review of Search Strategies. We will conduct a review of the literature by systematically searching, reviewing, and analyzing the scientific evidence as it pertains to the research questions. To identify relevant systematic reviews/meta-analyses, we will begin by searching Ovid MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily and Ovid MEDLINE, Ovid PsycINFO, CINAHL, Epistomonikos, and Ovid EBM Reviews Cochrane Database of Systematic Reviews (CDSR, DARE, HTA, Cochrane CENTRAL, etc). We will search all available years of publication from database inception (1946 for Ovid MEDLINE®) through March 2018. To identify additional reviews, we will review the bibliographies of relevant reviews of reviews, search the review registry Prospero for completed reviews, and query subject matter experts.

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Adaptive Sports for Veterans with Disabilities

Background/Objectives of Review

This report will be used by the Veterans Health Administration national program offices for Physical Medicine and Rehabilitation Services (PM&RS), Prosthetic and Sensory Aids Services (PSAS), Recreation Therapy, and National Veterans Sports Programs and Special Events (NVPS&SE), as well as the offices under Rehabilitation and Prosthetic Services to determine the benefits and harms associated with participation in adaptive sports for Veterans with a disability and identify barriers to and facilitators of participation. This review will inform implementation efforts and enhance efforts to integrate all of the VHA’s national programs for rehabilitation and the Disabled Veterans Adaptive Sports Programs with the goal of advancing Veteran’s access to and the utilization of adaptive sports as part of their ongoing rehabilitation.

Key Questions

KQ 1: What is the effectiveness of participation in adaptive sports programs among individuals with amyotrophic lateral sclerosis (ALS), limb amputation, hearing loss or deafness, multiple sclerosis (MS), post-traumatic stress disorder (PTSD), spinal cord disorder, spinal cord injury (SCI), stroke/cerebrovascular accident (CVA), traumatic brain injury (TBI), or visual impairment or blindness?

KQ 1a: Does the effectiveness vary by frequency/duration of adaptive sport program participation?

KQ 1b: Do particular patient groups (ie, age range, gender, race, time since injury, time involved in adaptive sports, type and/or severity of disability) benefit more than others from adaptive sports participation?

KQ 2: What are the potential harms of participation in adaptive sports programs among individuals with amyotrophic lateral sclerosis (ALS), limb amputation, hearing loss or deafness, multiple sclerosis (MS), post-traumatic stress disorder (PTSD), spinal cord disorder, spinal cord injury (SCI), stroke/cerebrovascular accident (CVA), traumatic brain injury (TBI), or visual impairment or blindness?

KQ 3: What are the known facilitators of and barriers to the participation in adaptive sports programs among individuals with amyotrophic lateral sclerosis (ALS), limb amputation, hearing loss or deafness, multiple sclerosis (MS), post-traumatic stress disorder (PTSD), spinal cord disorder, spinal cord injury (SCI), stroke/cerebrovascular accident (CVA), traumatic brain injury (TBI), or visual impairment or blindness?

PICOTS

Population(s):Individuals age 18 and older with amyotrophic lateral sclerosis (ALS), limb amputation, hearing loss or deafness, multiple sclerosis (MS), post-traumatic stress disorder (PTSD), spinal cord disorder, spinal cord injury (SCI), stroke/cerebrovascular accident (CVA), traumatic brain injury (TBI), or visual impairment or blindness

Interventions: Adaptive sports programs defined for this review as organized programs at any level (eg, community-based, Paralympic) involving 1) a sport that has either been adapted or created specifically for persons with a disability and 2) a group of individuals working together under a coach or program director (eg, a swim program with a coach).

NOTE: We would include studies of Paralympic athletes who might be training on their own but with the intention of competing.

Comparator: Usual care (including community-based rehabilitation), other intervention, or no intervention; studies may be pre- to post-participation in an adaptive sports program, cross-sectional, or trials.

NOTE: We would not include comparisons of different training programs, different wheelchair designs/components, different prosthesis designs, etcetera.

Outcome(s):Effectiveness of adaptive sports among individuals with amyotrophic lateral sclerosis (ALS), limb amputation, hearing loss or deafness, multiple sclerosis (MS), post-traumatic stress disorder (PTSD), spinal cord disorder, spinal cord injury (SCI), stroke/cerebrovascular accident (CVA), traumatic brain injury (TBI), or visual impairment or blindness measured by:

  • health and wellness (eg, management of blood pressure, weight, diabetes [indicated by loss of diagnosis or reduction in medications], pressure sores); smoking cessation; alcohol control (indicated by loss of alcohol dependence)
  • daily functioning (eg, falls, activities of daily living, Bartel index, Functional Independence Measure [FIM])
  • self-esteem
  • perceived competence
  • community reintegration (engagement in other community activities, continuing participation in adaptive sport after the end of the adaptive sport program)
  • participation in social activities
  • employment status
  • mood
  • quality of life
  • health care utilization
  • participation in adaptive sports programs
  • improvement in physical health or PTSD scale scores

Harms of adaptive sports measured by:

  • physical injury
  • worsening of physical disability
  • worsening of physical health or PTSD scale scores
  • costs/burden (system, individual, societal)

Facilitators to adaptive sports

Barriers to adaptive sports

Setting: Community-based adaptive sports programs (to include adaptive sports programs that begin during inpatient rehabilitation and continue to an outpatient/community based phase).

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Cost-effectiveness of Leg Bypass vs Endovascular Therapy for Critical Limb Ischemia

Background/Objectives of Review

The proposed evidence review would be used to provide guidance to VHA vascular surgeons through communication pathways including the Vascular Surgery Specialty Advisory Board and the VISN Chief Surgical Consultants, Chiefs of Surgery, and Section Chiefs of Vascular Surgery at VHA facilities.

Key Questions

KQ1:   Among adults with CLI, what is the cost-effectiveness of leg bypass compared to endovascular procedures including balloon angioplasty, arterial stents, and atherectomy?

KQ2:   Does the cost-effectiveness of leg bypass compared to endovascular procedures for CLI vary by patient population, setting, or time (short vs long-term)?

PICOTS

Population(s): Patients with critical limb ischemia undergoing intervention

Interventions: Endovascular intervention

Comparator: Surgical intervention

Outcome(s): Cost-effectiveness, quality of life, major adverse limb events (MALE), mortality, complications / morbidity, physiologic measures (patency, ABI, flow, etc), utilization measures (length of stay, readmission, repeat procedure).

Setting: All patients will be undergoing intervention – whether as an inpatient or outpatient

General Search Strategy

We will procure literature from a systematic search of PubMed, Medline, and Embase databases using terms related to “limb ischemia”. We will include RCTs, cohort studies, and cost-effectiveness studies.

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