Implementation of Findings from PCORI's Major Research Investments -- Cycle 2 2021

This PFA seeks to fund meaningful implementation projects that promote the uptake of peer-reviewed findings from specific, high-priority PCORI initiatives—in the context of the body of related evidence—and make these findings more actionable and accessible to patients, clinicians, or other targeted decision makers and healthcare stakeholders at the point of care or in other decision settings.

Projects to Be Funded under this PFA

All proposed implementation projects are expected to:

• Incorporate active, multi-component strategies that will lead to uptake and integration of PCORI evidence into real-world practice settings. Activities may include, but should not focus on, development of tools and materials as part of these strategies.
• Target specific end-users with a clear interest in, and who can benefit from, using the evidence.
• Adapt findings as needed to facilitate uptake in the proposed settings and accomplish scale-up (to reach larger numbers) and/or scale-out (to reach broader audiences, including diverse populations and settings), as applicable.
• Demonstrate commitment and buy-in from proposed implementation sites—including frontline staff critical to the success of the project as well as leadership—such that they provide a supportive context and culture for undertaking the proposed project. In addition, projects should involve regional and national stakeholder organizations positioned to extend impact to broader venues.
• Be guided by an established conceptual model or framework, and where possible, by evidence regarding effective strategies for implementing evidence-based practices and interventions.
• Include a rigorous evaluation plan that documents
  • Successful execution of the implementation strategy
  • Impact of the implementation project on healthcare and health outcomes as feasible and appropriate within the project scope.

Evidence Eligible as the Focus of Implementation under this PFA:

Each release of this PFA will identify selected published, peer-reviewed patient-centered comparative clinical effectiveness research (CER) evidence as the focus for implementation. We anticipate that selected findings will emerge regularly from PCORI’s targeted funding initiatives and Pragmatic Clinical Studies, which address topics that have been identified as priority areas for PCORI research funding. In addition, PCORI may identify findings from PCORnet® Demonstration studies or from other selected PCORI-funded studies as the focus of implementation efforts under this PFA.

For the Cycle 2 2021 PFA, PCORI has identified the following three areas of eligible evidence, each of which is the focus of important PCORI-funded research. The goal of the proposed implementation projects under this PFA is to further awareness of this evidence and to promote its uptake in practice.

Nonsurgical treatment options can improve or eliminate symptoms for women with urinary incontinence (UI). (New Topic for Cycle 2 2021) Millions of women experience urinary incontinence; however, many women don’t seek treatment because they don’t realize that improvement is possible. A recent systematic review update on this topic found that several nonsurgical treatments for urinary incontinence can help. PCORI-funded Study: Nonsurgical Treatments for Urinary Incontinence in Women: A Systematic Review Update Several kinds of therapy and medicines can reduce or stop symptoms for people with posttraumatic stress disorder (PTSD). (Reissued from Cycle 3 2020 release of this PFA.) Findings from a recent systematic review update, which support the strength of evidence for specific treatment approaches for PTSD, underscore the potential for improving patient-centered outcomes through the implementation of effective treatment. PCORI-funded Study: Psychological and Pharmacological Treatments for Adults with Posttraumatic Stress Disorder (PTSD): A Systematic Review Update The use of narrow-spectrum versus broad-spectrum antibiotics to treat children’s acute respiratory tract infections (ARTIs). (Reissued from Cycle 1 2019 release of this PFA.) Current guidelines generally recommend the use of narrow-spectrum antibiotics, such as amoxicillin, as first-line treatment for ARTIs in children, subject to local conditions with respect to antibiotic resistance. A PCORI-funded study highlights the benefits of using narrow-spectrum antibiotics when possible. Consistent prescription of narrow-spectrum antibiotics as first-line treatment for these children has the potential to improve the quality of life for children, lowering the incidence of treatment-associated side effects, and for their caregivers. PCORI-funded Study: Comparing Broad- and Narrow-Spectrum Antibiotics for Children with Ear, Sinus, and Throat Infections

1. Nonsurgical treatment options can improve or eliminate symptoms for women with urinary incontinence (UI)

Recent estimates suggest that about half of adult women in the U.S. experience some level of urinary incontinence (UI). Prevalence and severity increase with age, with 44% of women age 60 or older reporting moderate-to-severe symptoms.^[1],[2] The burden of UI can be significant. Research links UI to declining mental health^[3] and depressive symptoms.^[4] UI can also be a risk factor for falls,^[5] nursing home admissions,^[6] and mortality.^[7] However, women often do not seek treatment for UI because they experience embarrassment, accept UI as a “normal” part of aging, or are not aware that alleviating symptoms is possible with treatment.

Through a research partnership with the Agency for Healthcare Research and Quality (AHRQ), PCORI supported a recent systematic review update on nonsurgical treatments for UI in women, which includes studies published through 2017. The review found strong or moderate evidence supporting nonsurgical treatments, including first-, second-, and third-line interventions. These findings align with treatment guidelines from professional societies such as the American College of Physicians, American College of Obstetricians and Gynecologists, and American Urological Association. Nonetheless, fewer than 25% of women with UI report receiving care for UI.^[8]

Under this PFA, PCORI seeks proposals for implementation projects that will promote the uptake of evidence-based UI care for women age 60 and over. The focus on this population reflects the disproportionate burden of UI in this age group.^[1] The uptake of evidence-based care for older women is supported by the Centers for Medicare & Medicaid Services’ inclusion of UI screening for women as a quality measure.^[9]

Further, under this PFA, applicants may propose projects that address other groups experiencing disproportionate burden associated with UI. Such groups may include, for example, subgroups of employed women who experience particular negative impacts of UI related to their occupation or the requirements of their workplace.^[10],[11] Or, they may address improvements in evidence-based care for UI among underserved demographic groups or women of lower socio-economic status for whom UI symptoms have been found to have greater impact on daily activities^[1] or who experience particular barriers to obtaining care.^[12]

This initiative extends a similar implementation effort recently undertaken by AHRQ, supporting projects that will increase the provision of evidence-based care for UI for adult women in primary care settings. [See AHRQ Funding Opportunity here]. To complement awards through AHRQ's initiative, PCORI encourages applications that focus on settings in addition to primary care, such as specialty practices (e.g., geriatrics), residential facilities, worksite medical clinics, or community-based wellness programs.

Please note: This PCORI implementation PFA is distinct from the Cycle 2 2021 targeted PFA to support comparative effectiveness research on nonsurgical options for women with UI. Applicants interested in applying for research funding can view this opportunity here.

PCORI-Funded Study: Nonsurgical Treatments for Urinary Incontinence in Women: A Systematic Review Update

Publication: Balk E, Adam GP, Kimmel H, Rofeberg V, Saeed I, Jeppson P, Trikalinos T. Nonsurgical Treatments for Urinary Incontinence in Women: A Systematic Review Update. Comparative Effectiveness Review No. 212. (Prepared by the Brown Evidence-based Practice Center under Contract No. 290-2015-00002-I for AHRQ and PCORI.) AHRQ Publication No. 18-EHC016-EF. PCORI Publication No. 2018-SR-03. Rockville, MD: Agency for Healthcare Research and Quality; August 2018. Posted final reports are located on the Effective Health Care Program search page.

See also: Pharmacologic and Nonpharmacologic Treatments for Urinary Incontinence in Women: A Systematic Review and Network Meta-analysis of Clinical Outcomes. Balk, E.M. et al. Ann Intern Med. 2019 Apr 2;170(7):465-479.

For additional reference, see PCORI Evidence Updates for Women and Clinicians, Evidence Map and Visualization, and the summary from a PCORI/AHRQ stakeholder workshop on this topic.

2. Several kinds of therapy and medicines can reduce or stop symptoms for people with posttraumatic stress disorder (PTSD)

Posttraumatic Stress Disorder (PTSD) affects about 6 percent of US adults.^[13] It is more common in certain groups, including women, younger people, and those who did not complete high school or who have lower incomes.^[14] PTSD can affect military personnel serving in combat, but it may also develop after many other types of traumatic events, including after a person experiences or witnesses intimate partner violence, sexual violence, other physical abuse or assault, or natural disasters. PTSD is also common among survivors of critical care illnesses, with one fifth of patients reporting PTSD symptoms within one year of their discharge from the intensive care unit (ICU)^[15],[16] adding to the current salience of this condition for the many patients recovering from COVID-19 who experienced serious illness.^[17] Experience from past disease outbreaks and pandemics suggests that caregivers of these patients, healthcare workers, first responders, and critical infrastructure personnel may also experience PTSD.^{[18],[19],[20]}

A recent update to a systematic review, supported by PCORI through a research partnership with AHRQ, summarizes evidence from nearly 200 studies on psychological and pharmacological treatments for people with PTSD. Findings indicate that cognitive behavioral therapy (CBT) can improve PTSD symptoms to the point where the PTSD diagnosis is no longer substantiated. Specifically, the review found that exposure therapy, a specific form of CBT, and a group of other treatments that included elements of CBT had high strength of evidence (SOE) of effectiveness for improving PTSD symptoms. Recent studies included in the systematic review update increased the strength of evidence supporting this finding. Although the harms of CBT were not well studied, they are likely minimal. Other forms of CBT (cognitive processing therapy, cognitive therapy, and narrative exposure therapy) and eye movement desensitization and reprocessing (EMDR) had moderate SOE for effectiveness of treating PTSD, as did three medications: fluoxetine, paroxetine and venlafaxine.^[21]

PTSD imposes a significant burden on people affected, and their families and caregivers. People affected by PTSD have high rates of psychiatric comorbidity and may have problems with work, family, and social functioning. They may suffer a range of adverse consequences over their life course, such as difficulties with educational attainment, work earnings, marriage attainment, and child rearing. Despite the extent of these health and other impacts, almost half (43 percent) of adults with PTSD do not get mental health treatment; among those who do, only 40 percent get minimally adequate treatment.^[22] Although studies have shown that about 92 percent of adults with lifetime PTSD eventually achieve remission, the median time to remission is 14 years.

The strength of evidence for specific treatment approaches for PTSD, outlined in the recent systematic review update, underscores the potential for improving patient-centered outcomes through the implementation of effective treatment. This potential may be particularly great for non-military populations, among whom PTSD is often unrecognized or undertreated.^[23] Evidence suggests that undertreatment may be a particular concern for minority populations, who are also at higher risk for experiencing certain traumatic events but who have been found to seek treatment less often.^[24]

PCORI-funded Study: Psychological and Pharmacological Treatments for Adults with Posttraumatic Stress Disorder (PTSD): A Systematic Review Update

Publication: Hoffman V, Middleton JC, Feltner C, Gaynes BN, Weber RP, Bann C, Viswanathan M, Lohr KN, Baker C, Green J. Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder: A Systematic Review Update. Comparative Effectiveness Review No. 207. (Prepared by the RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center under Contract No. 290-2015-00011-I for AHRQ and PCORI.) AHRQ Publication No. 18-EHC011-EF. PCORI Publication No. 2018-SR-01. Rockville, MD: Agency for Healthcare Research and Quality; May 2018. Posted final reports are located on the Effective Health Care Program search page.

For additional reference, see PCORI Evidence Updates for Healthcare Consumers, and for Clinicians on this topic.

3. The use of narrow-spectrum versus broad-spectrum antibiotics to treat children’s acute respiratory tract infections (ARTIs)

Current guidelines generally recommend the use of narrow-spectrum antibiotics, such as amoxicillin, as first-line treatment for ARTIs in children, subject to local conditions with respect to antibiotic resistance. ^[25],[26] A recently published PCORI-funded study (PI: Jeffrey Gerber, MD, PhD) highlights the benefits of using narrow-spectrum antibiotics when possible. Gerber and colleagues looked at records for more than 30,000 children ages 6 months to 12 years taking narrow- or broad-spectrum antibiotics for ear, nose, or throat infections in 31 pediatric primary care practices in New Jersey and Pennsylvania. Their analysis found no difference in symptom resolution or treatment failure between children taking narrow versus those taking broad-spectrum antibiotics. However, the risk of side effects, including diarrhea, candidiasis, allergic reaction, and vomiting, was significantly lower for children taking narrow-spectrum antibiotics.^[27]

Available evidence suggests that approximately 80 percent of children’s diagnoses for common ARTIs should be treated with narrow-spectrum antibiotics, yet roughly half of children are still prescribed broad-spectrum antibiotics as first-line treatment.^[28],[29] In addition, studies have shown that there is significant variation in antibiotic prescribing behavior. For example, one study found that children seen at a high antibiotic use practice were four times as likely to receive a broad-spectrum antibiotic than a child visiting a low antibiotic use practice, as well as twice as likely to receive antibiotics overall.^[30]

Consistent prescription of narrow-spectrum antibiotics as first-line treatment has the potential to improve the quality of life for children, lowering the incidence of treatment-associated side effects, and for their caregivers. Inappropriate prescribing of broad-spectrum antibiotics can also contribute to antibiotic resistance, a growing problem that contributes to at least 2 million antibiotic-resistant infections each year. The problem of antibiotic resistance, as well as the larger goal of improving appropriate use of antibiotics, has been highlighted by the CDC as an important priority for improving patient safety and public health.^[31]

PCORI-funded Study: Comparing Broad- and Narrow-Spectrum Antibiotics for Children with Ear, Sinus, and Throat Infections (PI: Jeffrey Gerber)

Publication: Association of Broad- vs Narrow-Spectrum Antibiotics with Treatment Failure, Adverse Events, and Quality of Life in Children with Acute Respiratory Tract Infections. Gerber, J.S. et al. JAMA, 2017; 318(23): p. 2325-2336.

For additional reference, see PCORI Evidence Updates for Patients and Caregivers, and for Clinicians on this topic.

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Eligible Applicants:

This is an Open Competition funding opportunity that seeks to draw on the expertise, creativity, and capacity of a broad applicant pool, including implementation experts and diverse stakeholder partners. As such, PCORI does not require applicants to have been associated with the PCORI-funded studies described above, nor need they have received any previous PCORI funding.

Organizations: Private-sector research organizations, including any nonprofit or for-profit organization; public-sector research organizations, including any university or college hospital or healthcare system; any laboratory or manufacturer; or any unit of local, state, or federal government may submit applications. The Internal Revenue Service must recognize all US applicant organizations. Nondomestic components of organizations based in the US and foreign organizations may apply, as long as there is demonstrable benefit to the US healthcare system and US efforts in the area of patient-centered research. Organizations may submit multiple funding applications. Individuals may not apply.

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