Health Services Research & Development

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ESP Reports in Progress

  ESP Topic Nomination  ESP 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.

Comparing Antithrombotic Strategies after Bioprosthetic Aortic Valve Replacement: A Systematic Review

PROSPERO registration: CRD42017057064

Background/Objectives of Review

The proposed ESP evidence synthesis review will be used to inform future research within the VA. Specifically, the review would be used to design a VA-based randomized trial of VKA administration in patients after bAVR. Such a study would have the potential to inform clinical guidelines both within and outside of the VA.

Key Questions

KQ1: What are the comparative benefits of antithrombotic strategies for patients who have had bAVR?

KQ1A: Do the benefits differ according to thromboembolic risk profile?

KQ1B: Do the benefits differ according to concomitant procedure (eg, coronary artery bypass graft [CABG])?

KQ2: What are the comparative harms of antithrombotic strategies for patients who have had bAVR?

KQ2A: Do the harms differ according to thromboembolic risk profile?

KQ2B: Do the harms differ according to concomitant procedure (eg, coronary artery bypass graft [CABG])?

KQ3: What are the comparative benefits and harms of antithrombotic strategies for patients who have had transcatheter aortic valve replacement (TAVR)?

KQ3A: Do the benefits or harms differ according to thromboembolic risk profile?

KQ3B: Do the benefits or harms differ according to concomitant procedure (eg, percutaneous transluminal coronary angioplasty [PTCA] with stent)?

PICOTS

Population(s): Adult patients who have had bioprosthetic aortic valve replacement (bAVR; Key Questions 1 and 2) or transcatheter aortic valve replacement (TAVR) with stenting of aortic valves (Key Question 3).

Exclude: Patients receiving bAVRs no longer used in practice; patients with valve replacements in positions other than the aorta (eg, mitral valve, Ross procedure); pregnant women.

Interventions: Antithrombotic strategies/agents:

  • Vitamin K antagonist (VKA)
  • VKA plus acetylsalicylic acid (ASA; aspirin) or other antiplatelet agents
  • ASA or other antiplatelet agents
  • Dual antiplatelet therapy
  • Direct oral anticoagulants (DOACs)/novel oral anticoagulants (NOACs)

Comparator: Any of the above antithrombotic strategies (ie, one strategy vs another strategy), or no therapy.

Outcome(s): Primary outcomes:

  • Mortality
  • Thromboembolic events
  • Stroke
  • Major bleeding events

Secondary outcomes:

Benefits:

  • Myocardial infarction
  • Heart failure
  • Readmission rates
  • Need for valve reoperation (eg, valve thrombosis)
  • Length of stay
  • Need for change in antithrombotic strategy

Harms:

  • Other/minor bleeding
  • Readmission rates
  • Pericardial or pleural effusion (we will prioritize effusions requiring intervention)

Timing: Perioperative (defined as in-hospital or within 30 days) and long-term (defined as > 30 days to 1 year or longer) are of interest for each outcome.

General Search Strategy

Search strategies will be developed in consultation with a research librarian. 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, Elsevier EMBASE, and Ovid EBM Reviews Cochrane Database of Systematic Reviews. We will further review the bibliographies of relevant articles for additional studies. To identify in-progress or unpublished studies, we will search ClinicalTrials.gov, OpenTrials, and the WHO International Clinical Trials Registry Platform (ICTRP). We will also search the AHRQ Registry of Patient Registries to identify relevant registries of bAVR patients.

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Identification and Evaluation of Women's Telehealth

PROSPERO registration: CRD42017065965

Key Question

What is the quantity, distribution, and characteristics of evidence for the use of telehealth services designed specifically for women?

PICOTS

Population(s): Adult biological or transgender women only

Interventions: Eligible telehealth interventions must meet the following 4 criteria:

1.) Be for any of the following three conditions:

a.) women-specific conditions (eg, obstetrical, gynecological)

b.) the following conditions that predominantly affect women:

- migraines

- fibromyalgia

- breast cancer risk assessment (eg, risk assessment tools – Gail model, genetic counseling) and management decision-making for women at high risk for breast cancer (eg, counseling for pharmacoprophylactic treatment). Studies promoting breast cancer screening will be excluded.

- intimate partner or sexual violence, military sexual trauma or domestic violence

c.) gender non-specific conditions, but interventions designed specifically for women;

2.) Use technologies and tactics (eg, secure messaging, text messaging*, e-consultation, video-conferencing, interactive voice response) to deliver healthcare services for the purpose of diagnosis, consultation, treatment, and/or prevention (eg, tele-gynecology, tele-colposcopy, tele-mental health, tele-pharmacy, tele-care coordination, tele-primary care, tele-wellness);

3.) Involve transmission of clinical information via a telecommunication technology between patients and members of the medical/mental health care team** or provider-to-provider interactions who are at a distance;

4.) Includes bidirectional synchronous or asynchronous communication.

* Text messaging systems that are interactive based on a pre-determined algorithm are included even if there is not real-time human participation on the clinical end of the interaction.

** Team members can include those who are without formal medical training (eg, health coaches, nonskilled healthcare workers).

Comparator: Any (require an active or inactive control)

Outcome(s): As this is a mapping project, we will accept any outcomes reported by eligible studies. However, specific outcomes of interest and scope of outcomes accepted are listed under primary outcomes, below. There are no secondary outcomes in a mapping scenario.

Primary outcomes:

- Patient health outcomes (condition-specific): especially readiness/motivation to change, access to care (eg, no-show rates), patient satisfaction, treatment adherence, patient engagement

- Provider-level outcomes

- System-level outcomes

Setting: Any clinical setting in any country (will plan to assess for country and categorized according to low/middle/high income status).

General Search Strategy

We will search MEDLINE (via PubMed) and Embase. We anticipate using 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 a master librarian and will be informed by search strategies recommended by the Cochrane Effective Practice and Organization of Care Group.

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Comparative Effectiveness of Multifocal, Accommodative, and Monofocal Intraocular Lenses for Cataract Surgery and Lens Replacement

PROSPERO registration: CRD42017069949

Key Questions

KQ1: What is the effectiveness of multifocal or accommodative versus monofocal lenses with spectacle correction for distance vision in the setting of cataract surgery?

KQ2: What is the effectiveness of multifocal or accommodative versus monofocal lenses with spectacle correction for near vision in the setting of cataract surgery?

KQ3: What are the harms associated with multifocal or accommodative lenses versus monofocal replacement in the setting of cataract surgery?

KQ4: If feasible, what resources are required to best care for patients who choose multifocal or accommodative lens implants in the setting of cataract surgery?

PICOTS

Population(s): Patients undergoing cataract surgery with placement of intraocular lenses, adults only, children are excluded

Interventions: Placement of either multifocal or accommodative intraocular lenses

Comparator: Standard monofocal lenses. Studies using monovision comparisons are included.

Outcome(s): Vision quality of life; aberration; snellen quality; photopsia; patient goal; patient satisfaction/quality of life; spectacle independence; glare/halo; harms

Setting: Cataract surgery

General Search Strategy

A preliminary literature scan conducted by the ESP coordinating center identified multiple publications with data from primary research studies, as well as multiple systematic reviews. Publications included in these systematic reviews, as well as the primary research study publications, were eligible for inclusion. Hypothesis testing studies, including randomized controlled trials and observational studies that compared relevant outcomes across patients treated with different methods to achieve near and far vision, will be included.

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