Evidence Synthesis Unit

HI-PIE’s Evidence Synthesis Unit is a collaboration of CLHSS and the Minnesota Evidence-Based Practice Center. It was created to address the need for rapid, high-quality evidence to inform clinical practice and guidelines.

We evaluate topic areas where evidence is emerging or where evidence gaps exist to inform and adapt clinical practice. Our skills and services include a range of reviews, such as systematic and scoping reviews and meta-analyses. Under appropriate circumstances, we perform rapid reviews that answer questions using a critical and rigorous but time-limited approach. 

The Evidence Synthesis Unit is led by Mary Butler, PhD, MBA and Josh Rhein, MD. Bronwyn Southwell, MD is the Integration Lead and Maya Peters, MPH is the project manager.

Infographic of Evidence Synthesis process

Work With Us

  1. The process for requesting an Evidence Synthesis review begins with filling out the CLHSS Services Request Form. In this form, we ask questions about the problem or decisional dilemma you are facing, how you will use the information, and when you need it. We review each submission to determine its suitability for an evidence review.

  2. If your request is suitable for a review, we then schedule a Problem Framing meeting to further clarify and define your research questions.

  3. After the Problem Framing meeting, your request is once more evaluated to determine if the scope of work fits within our Unit’s purview. If yes, a Scope of Work agreement is created, which defines the scope of work that the Evidence Synthesis Unit will undertake to fulfill your needs.

  4. Once the Scope of Work agreement has been approved, the work of synthesizing the evidence begins. Depending on the scope and complexity, project timelines will vary from weeks to months.

  5. After the evidence review has been completed, we will schedule a meeting to present our findings. You will be provided with final, archivable documents for your use.

Recent Evidence Synthesis Projects

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Recent Evidence Synthesis Projects

Bactisure & Irrisept Wound Lavage in Elective Arthroplasty

Project Purpose

Total joint arthroplasty (TJA) is among the most common surgeries performed in the United States. The goal of arthroplasty is to improve function and quality of life, generally in older adults. Periprosthetic joint infection (PJI) occurs in up to 2% of arthroplasty recipients overall and is one of the most serious adverse events related to TJA, often with long-term consequences.

Wound irrigation (lavage) is a surgical wound washout process used during arthroplasty procedures to remove debris from the operative wound and reduce microbial contamination that can lead to infection. In primary arthroplasty, the main goals of surgical lavage are to prevent surgical site infection (SSI) and microbial biofilm development and aid visualization of the operative area. 

The Evidence Synthesis unit conducted this rapid review in response to a request from a clinical working group interested in understanding two different wound lavage solutions and their comparative effectiveness in TJA, and revision arthroplasty in particular.

The two lavage options of interest were Bactisure® and Irrisept®. The Bactisure® Wound Lavage (BWL) system includes a 1000 ml bag of aqueous solution to remove debris from surgical wounds using pulsed (jet) lavage followed by saline, and is often used for revision arthroplasty surgeries. BWL was specifically designed to deconstruct and remove biofilm to make bacteria more susceptible to antibiotics. Irrisept®, a 0.05% chlorhexidine gluconate in sterile water jet lavage irrigation solution, has bactericidal and anti-biofilm properties and is used for lavage in orthopedic surgery, in addition to general surgery and urology.

Results Summary

  • We found a striking absence of randomized trials on the comparative effectiveness of surgical lavage solutions used during elective arthroplasty surgeries. Large cohort studies with a concurrent comparison group are also absent. 
  • Based on clinical studies to date, there is insufficient clinical evidence to determine the efficacy or comparative effectiveness of Bactisure™ or Irrisept® wound lavage for the prevention or treatment of infections associated with total joint arthroplasty of the hip, knee or shoulder. 
  • The literature suggests that there remain great uncertainties around which specific agent or combinations thereof best prevents prosthetic joint infections or removes biofilm.
  • Nonetheless, if Bactisure™ does have biofilm-busting capabilities that translate from in vitro to clinical settings, then Bactisure™ would likely be indicated for revision arthroplasty when infection (PJI) is present and known, provided the risk of adverse effects (e.g. cytotoxicity) is small. 
  • There are several limitations of this rapid review. Our searches focused on arthroplasty and specific irrigants, so we excluded evidence from other subspecialties, when identified.

Questions

Please contact Toyin Lamina, PhD, MPH: lamin019@umn.edu

Guidelines for Prescribing in Acute Sinusitis

Project Purpose

The Evidence Synthesis unit conducted this rapid review in response to a request from a clinical working group interested in understanding antibiotic treatment recommendations for acute sinusitis.

The working group was most familiar with the guidelines previously published by the Infectious Diseases Society of America (IDSA) and Institute for Clinical Systems Improvement (ICSI). However, both of these guidelines were outdated, and their recommendations conflicted with one another.

For this project, we assessed the quality of current (2018-present) clinical practice guidelines providing recommendations on antibiotic treatment for acute sinusitis.

Results Summary

One high quality and current clinical practice guideline was identified in our review - the European Position on Rhinosinusitis and Nasal Polyps 2020 (EPOS2020). The AGREE-II tool was used to assess guideline quality.

A summary of the EPOS2020 guideline for treatment of acute sinusitis:

  • The EPOS2020 guideline included recommendations based on three distinct types of acute rhinosinusitis (ARS): acute viral rhinosinusitis, acute post-viral rhinosinusitis, and acute bacterial rhinosinusitis. 
  • Antibiotics were recommended for only adults diagnosed with acute bacterial rhinosinusitis. 
  • From limited evidence, it appears beta-lactams are effective and fluoroquinolone is not.
  • There was not enough data to make an antibiotic recommendation for children with acute bacterial rhinosinusitis.

We carried out further work to identify any randomized controlled trials using antibiotics to treat acute sinusitis published after the EPOS2020 publication (January 2019). Ten additional studies were identified and shared with the working group.

Questions

Please contact Toyin Lamina, PhD, MPH: lamin019@umn.edu

Mammography Screening in Average-Risk Women

Project Purpose

Breast cancer is the most common cancer in women in the United States, and mammography is a crucial part of a comprehensive breast cancer surveillance strategy. Mammography screening may be associated with reduced breast cancer mortality but can also cause harm.

The Evidence Synthesis unit conducted a rapid review in response to a request from a clinical working group interested in understanding the quality of clinical practice guidelines providing recommendations on the frequency and interval of mammography screening.

There are important differences in the mammography screening interval and frequency recommendations between guidelines, resulting in variations in practice by different providers and specialties within the organization. The requesting group desired to standardize practice as much as possible.

Results Summary

Seven different US-based clinical practice guidelines published from 2012 to 2022 were assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE-II) tool. 

  • The U.S. Preventive Services Task Force (USPSTF) 2016 guideline was investigated further because it was assessed to be a high quality guideline, and commonly utilized by the requesting organization.
  • The American College of Radiology (ACR) / Society of Breast Cancer Imaging (SBI) 2021 guideline was also investigated further. It was assessed to be of moderate quality, but was more current and also commonly utilized by the requesting organization.

The differences between the USPSTF 2016 and ACR/SBI 2021 guidelines were investigated:

  • ACR/SBI’s recommendation for screening is that it should begin at 40 and continue annually. 
  • USPSTF recommends using shared decision making for mammography screening for ages 40-49. They recommend biennial screening starting at 50.
  • Both groups insist on communication between women and their provider (shared-decision making).

In conclusion, It is difficult to uncover which guideline is superior between USPSTF and ACR/SBI due to the differences in guideline development processes and modeling assumptions. However, both USPSTF and ACR/SBI stress the importance of shared decision-making.

Questions

Please contact Toyin Lamina, PhD, MPH: lamin019@umn.edu

Rapid Review on the Impact of the SEP-1 Bundle on Patient Outcomes

Project Purpose

The Evidence Synthesis unit conducted this rapid review in response to a request from a clinical working group interested in understanding which aspects of the Severe Sepsis and Septic Shock Management Bundle (SEP-1) were most important for patient outcomes. 

SEP-1 mandates the administration of a bundle that carefully prescribes how patients with severe sepsis and septic shock must be treated in the early phases of care. The 1-hour bundle is composed of the following five elements: measuring the lactate level, obtaining blood culture prior to administration of antibiotics, administering broad-spectrum antibiotics, beginning rapid administration of 30 mL/kg crystalloid fluid for hypotension or lactate ≥4 mmol/L, and administering vasopressors if the patient is hypotensive during or after fluid resuscitation.

For this project, we developed a broad synopsis of the available literature through an evidence map on SEP-1 compliance, fluid resuscitation, and antibiotic administration in sepsis management. We then conducted a rapid review of the literature published over the last five years.

Results Summary

Our review produced several key points:

  • Recent evidence on sepsis patient management is limited, largely observational (non-randomized), and generally low quality.
  • The field needs high-quality RCT evidence to better inform patient care.
  • The evidence base for fluid resuscitation (volume) appears wide and includes several systematic reviews. 
  • No recent systematic reviews address the question of initial timing of fluid resuscitation, representing a research gap in this area.
  • An updated review on antibiotics de-escalation is needed, as the most recent one is more than five years old. 
  • Little to no research has directly addressed harms of antibiotic administration for patients at low risk of infection or suspected sepsis, representing another research gap in this area.
  • Key points: care bundles such as SEP-1 may improve survival; effects of fluid volume comparisons are mixed; early antibiotic administration (within 1 hour) showed no or equivocal benefit compared to later antibiotic initiation; antibiotic de-escalation showed no detrimental effect for mortality.

Questions?

Please contact Toyin Lamina, PhD, MPH: lamin019@umn.edu

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