New PROM for Crohn's Perianal Fistula Has Clinical, Research Potential

By Lisa Rapaport

January 06, 2021

(Reuters Health) - A draft patient-reported outcome measure (PROM) questionnaire for Crohn's perianal fistula may be useful for shaping both research and clinical practice, a recent study suggests.

Researchers developed a 28-item PROM questionnaire for Crohn's perianal fistula and tested it with 211 patients living with this condition. An evaluation of patients' responses to the questionnaire found the PROM, called the Crohn's Anal Fistula Quality of Life (CAF-QoL), had good stability (interclass correlation alpha 0.98) and internal consistency (Cronbach's alpha 0.88) as well as construct validity and good responsiveness.

"This new PROM lends itself to utility in clinical trial design for Crohn's perianal fistulas, enabling consistency in data sets collected in this condition," said lead study author Samuel Adegbola of Imperial College London in the UK.

"It also has the potential utility of assessment of disease impact in a clinic setting, to guide stratification of patients according to severity of disease impact and tailor appropriate management," Adegbola said by email.

There is currently heterogeneity and no gold standard in outcomes measurement for Crohn's perianal fistula patients, Adegbola and colleagues write in Gut. There is also currently no PROM for this condition.

The study team that developed the new PROM included a colorectal surgeon with fistula expertise, a gastroenterologist with IBD expertise, nurses with IBD expertise, researchers with experience in PROM design, and patients living with Crohn's perianal fistula.

The PROM includes 28 questions focused on three domains: symptoms from fistula like discharge and sore skin, the effects of current fistula treatment like medication side effects and surgical scars, and the impact of fistula on quality of life such as limitations with socializing, exercising, intimacy and work or school.

Higher scores on the PROM were positively associated with higher scores for depression and anxiety on the Hospital Anxiety and Depression Scale (HADS) as well as higher scores on the UK Inflammatory Bowel Disease Questionnaire, which are both tools currently used in clinical practice.

In addition, the PROM scores decreased significantly on reassessment for patients who experienced improving disease and increased significantly on reassessment for patients who experienced worsening disease.

One limitation of the study is the lack of assessment of other manifestations of perianal Crohn's disease that can be present in patients with perianal fistula, the study team notes.

In the short-term, the PROM developed for the study may have limited clinical utility and be more suited to use in clinical trials, said Dr. Nicole Lopez, an assistant professor in the division of colon and rectal surgery at UC San Diego Health, in California, who wasn't involved in the study.

"Generally, scales like this are most applicable for researchers in clinical trial settings because they help us make head to head comparisons between treatments," Dr. Lopez said by email. "If we ask patients to fill these forms out before clinic visits, the tool may also allow us to better evaluate clinical data retrospectively."

Because perianal fistulas are an important complication of Crohn's disease that have a tremendous impact on patients, more research is urgently needed to help clinicians better assess patients, said Dr. Jeremy Adler, director of the Pediatric Inflammatory Bowel Disease Program at the C.S. Mott Children's Hospital and Michigan Medicine at the University of Michigan in Ann Arbor.

"The CAF-QoL is an important tool that will help researchers have a focus on the patient experience beyond the simple outcome of fistula healing," Dr. Adler, who wasn't involved in the study, said by email.

Beyond this research application, the PROM developed in the study may help prompt clinicians to ask questions about symptoms they might otherwise overlook, Dr. Adler said.

"The CAF-QoL scale can serve as a prompt to clinicians to evaluate the symptoms that may be important to patients, and of which they may not be aware," Dr. Adler said.

SOURCE: https://bit.ly/3bePt06 Gut, online December 3, 2020.

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