Responsiveness to Change and Minimally Important Differences of the Patient-Reported Outcomes Measurement Information System Gastrointestinal Symptoms Scales

Abstract

Background The NIH-sponsored Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal (GI) Symptoms scales were developed to assess patients’ GI symptoms in clinical settings. Aims To assess responsiveness to change and provide minimally important difference (MID) estimates for the PROMIS GI Symptoms scales. Methods A sample of 256 GI outpatients self-administered the eight PROMIS GI Symptoms scales (gastroesophageal reflux, disrupted swallowing, diarrhea, bowel incontinence/soilage, nausea and vomiting, constipation, belly pain, and gas/bloating/flatulence) at two visits. Patient self-reported and physician-reported assessments of the subjects’ overall GI condition were employed as change anchors. In addition, we prospectively assessed change at both visits using a GI-symptom anchor, the Gastrointestinal Symptom Rating Scale (GSRS). Responsiveness to change was assessed using F-statistics. The minimally changed group was those somewhat better or somewhat worse on the retrospective anchors and changing by one category on the modified GSRS (e.g., from slight to mild discomfort to moderate to moderately severe discomfort). Results Responsiveness to change was statistically significant for 6 of 8 PROMIS scales using the self-report GI anchor, 3 of 8 scales using the physician-reported anchor, and 5 of 5 scales using the corresponding GSRS scales as anchors. The MID estimates for scales for improvement and worsening were about 0.5–0.6 SD using the GSRS anchor and generally larger in magnitude than the change for the “about the same” group. Conclusions The responsiveness and MID estimates provided here for the PROMIS GI Symptoms scales can aid in scale score interpretation in clinical trials and observational studies.

Psychometric properties of the PROMIS short form measures in a U.S. cohort of 961 patients with chronic hepatitis C prescribed direct acting antiviral therapy

“…In particular, patients with MELD > 12 had higher (worse) scores on all symptoms compared to the other two groups, with mean differences ranging from 1.9 to 4.1. While the sample size of those with MELD > 12 was small (n = 37) and provided limited precision, the mean differences were comparable to established PROMIS minimally important differences reported in other medical populations . In the final known‐groups validity analysis, we found positive correlations between a greater number of comorbid health conditions and worse symptom scores, consistent with prior studies .…”

“…Higher scores indicate worse symptoms. Studies in other medical populations suggest that the minimally important difference within or between groups generally ranges from 2‐5 points …”

Cyclic vomiting syndrome: Pathophysiology, comorbidities, and future research directions

“…However, such instruments include recall time frames of up to several weeks and assume relatively stable, continuous symptoms and likely are inappropriate for CVS trials, which would require instruments that are responsive to brief, discrete episodes lasting hours to days separated by prolonged, asymptomatic inter‐episodic intervals. Recently developed questionnaires such as the Patient‐Reported Outcomes Measures Information System (PROMIS) in gastroenterology may also not have recall periods that are long enough to be meaningful for CVS studies . Similarly, quality‐of‐life instruments for CVS should address unique features of CVS including periodicity, variable intervals between episodes, and impact on activities of daily living.…”

“…System (PROMIS) in gastroenterology may also not have recall periods that are long enough to be meaningful for CVS studies. 42,43 Similarly, quality-of-life instruments for CVS should address unique features of CVS including periodicity, variable intervals between episodes, and impact on activities of daily living. Additionally, use of standardized psychological surveys in large CVS populations will enhance understanding of the impact of psychosocial dysfunction on CVS severity as has been done for other conditions with chronic nausea and vomiting such as gastroparesis.…”

Development and validation of a questionnaire for measuring drug-induced nausea

“…Although the PROMIS-GSS-nausea scale was used for measuring intensity of nausea in a variety of gastronitestinal diseases, showing high ability to discriminate between the subtle changes in the nausea intensity 15 , it was not previously used to measure drug-induced nausea. In our study, it showed necessary level of reliability for this purpose, but the DINS surpassed it by far with its high Cronbach's alpha around 0.9.…”