(Poster 177) AUGS-PERFORM: Assessing Responsiveness to Change

Objectives: To assess responsiveness to change of the American Urogynecologic Society’s Prolapse pERFORmance Measure (AUGS-PERFORM), a novel 11-item patient-reported outcome (PRO) measure designed to assess several symptom domains that are relevant for assessing quality of care for pelvic organ prolapse (POP).

Methods: English-speaking women > 18 years old seeking evaluation of POP were eligible for this PRO validation study. We included those seeking treatment (e.g., pessary or surgery) and those who chose to observe their prolapse. After providing informed consent, baseline characteristics and POP-Q exam were collected. Participants electronically completed AUGS-PERFORM and several validated questionnaires at baseline and 3 months after treatment, or 3 months later for those that received no treatment. At 3-months, participants also completed the patient global impression of improvement (PGI-I). AUGS-PERFORM change scores were calculated by subtracting the 3 months (post) summary score from the baseline (pre) score. Because simple change scores do not account for baseline differences in symptoms, there can be misleading interpretations. Thus, baseline-adjusted change scores were also calculated. An ordinal regression model with actual pre and post scores was used to generate ‘estimated’ post scores. Baseline adjusted change score was calculated as estimated post score -- actual pre score. Baseline adjusted AUGS-PERFORM change scores were compared against PGI-I responses to assess responsiveness to change. As secondary outcomes we also assessed median baseline-adjusted change scores within the 5 individual domains (i.e., Awareness/Bulge, Physical Function, Urinary/Defecatory Symptoms, Sexual Function, Pain) against PGI-I response categories. We hypothesized that AUGS-PERFORM would be responsive, with a 7-point difference in summary score indicating a meaningful change in clinical status.

Results: We enrolled 172 participants; 135 underwent surgery, 17 received a pessary and 20 opted for observation. Table 1 shows AUGS-PERFORM scores at baseline and 3 months. Baseline AUGS-PERFORM scores were highest, indicating more symptom bother, in those opting for surgery. Change scores (simple and baseline-adjusted) were highest in surgical patients, though all 3 treatment groups had improved scores when baseline scores were considered. To assess for responsiveness to change, median baseline-adjusted AUGS-PERFORM change scores were compared against PGI-I response categories. These comparisons for summary and domain scores are shown in Table 2. If AUGS-PERFORM were responsive, we should see consistent trends where change scores are negative when participants perceive improvement, and positive when there is worsening. However, in our study population, this was not seen.

Conclusions: AUGS-PERFORM was not responsive in our study population, which was mainly comprised of patients with improvement in POP symptoms. The questionnaire needs to be studied in a broader population of patients where more patients are experiencing worsening of symptoms to fully assess the questionnaire's responsiveness to change.