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Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
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A new interactive evidence visualization on pelvic floor muscle training, or PFMT, is now available on the PCORI website. This visual evidence synthesis tool uses data from randomized controlled trials (RCTs) to assess the efficacy of PFMT to treat urinary incontinence (UI). This evidence visualization stemmed from a PCORI-funded 2018 AHRQ systematic review on nonsurgical treatments for urinary incontinence. Pelvic floor exercises were also highlighted as an effective nonsurgical treatment for UI in PCORI's 2019 Evidence Updates for Women and Clinicians.
When looking at the evidence visualization, users can select different filters on the left navigation pane and click on different visual elements within the maps to view the available evidence from clinical trials for many different PFMT interventions. In addition to collectively summarizing PFMT trials (on the Total RCTs tab), separate tabs use bubble plots to visually compare results from RCTs that assess PFMT versus usual care, different methods of PFMT, add-on treatments, and alternative treatments.
The PFMT evidence visualization is a pilot project that takes complex information from health studies and presents the data visually to make it easier to understand and use. Visual products are novel and may be of interest to a variety of people, including:
- Physicians who can identify evidence on treatments for their patients
- Researchers who can evaluate current gaps in the evidence base or determine where evidence from existing studies appears insufficient
- Patients who can identify treatments of interest, which they can bring to the attention of their clinician, and ask specific questions relating to their individual preferences and values
About Urinary Incontinence and PFMT
Millions of American women experience UI at some point in their lives. Causes of UI can include pregnancy or childbirth. Exercises for PFMT are used to strengthen the pelvic floor and treat UI. There are different ways to do PFMT. This evidence visualization presents the results from a systematic review of RCTs of PFMT for UI. Systematic reviews combine the results of many studies to help determine which treatments work best. The review focused on four questions:
- Does PFMT provide relief from UI when compared to usual or standard care?
- Do different methods of implementing PFMT provide different levels of relief from UI?
- Can PFMT plus add-on treatments provide more relief from UI than PFMT alone?
- Are alternative behavioral methods more effective than PFMT alone for relief of UI?
For each question, the review team looked at whether women’s UI symptoms improved or were cured and whether women’s quality of life improved.
The use of evidence visualizations to distill the results of a comprehensive synthesis, using an interactive web-based format, is a promising new development.
Observations from PFMT Evidence Visualization
The PFMT evidence visualization summarizes data from 68 trials reporting 89 treatment comparisons with data on 7,307 women experiencing UI. Many trials enrolled a mix of women at different ages, in different countries, and with different types of UI (stress, mixed, or urge). The main findings are:
- The use of PFMT can improve UI symptoms and lead to a decrease in number of UI episodes for women experiencing UI. The evidence appears to be stronger for younger women and women with stress UI, confirming the general clinical opinion that PFMT should be a first-line treatment for stress UI.
- Fully supervised PFMT yields greater reductions in UI events than partially supervised or unsupervised PFMT.
- For stress UI, adding exercise to PFMT reduces the frequency of UI events, but this result is based on only two studies, therefore adding exercise to PFMT is a ripe target for future research.
- Most other treatment comparisons did not lead to clear conclusions because of limited evidence for specific comparison and outcome combinations, such as small numbers of trials, low patient enrollment, and high variability among patients.
Conclusions, Implications, and Future Research
Traditionally, evidence-based medicine has not taken advantage of interactive tools to inform clinicians, researchers, and policymakers. The use of evidence visualizations to distill the results of a comprehensive synthesis, using an interactive web-based format, is a promising new development. The PFMT interactive web-based tool provides information at two levels: one that is more easily accessible using histograms and colored bubble plots and the second, which uses hover-overs and click-through features to highlight findings from individual studies and link to publications.
As we look to develop future evidence visualizations, a symphony of coordination must happen among scientists, clinical experts, data scientists, and web developers. Thoughtful conversations must occur to curate the data from clinical studies, distill the evidence, and present the data in a meaningful way for patients, clinicians, researchers, and policymakers. The end goal for these visual products is to facilitate evidence-informed decision making and support new research for clinicians and their patients. With the right planning, this data symphony will showcase the evidence in a visually meaningful way.
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