Naturopathic Approaches to Ulcerative Colitis

There are over 30 patient reported outcomes (PRO) instruments in use for patients with IBD.14 The oldest and most widely used is the Patient-Modified Simple Clinical Colitis Activity Index [P-SCCAI], a validated, non-proprietary patient-reported outcome measure for ulcerative colitis. The P-SCCAI is a patient-worded version of the Simple Clinical Colitis Activity Index and includes six symptom domains: stool frequency (day and night), urgency, rectal bleeding, general well-being, and extra-intestinal manifestations. Total scores range from 0-19, with ≥5 commonly used to define active disease.

PROMIS-29 The Patient Reported Outcomes Measurement Information System (PROMIS) provides a standardized, reliable, and valid measure of health status. The profile is a collection of self-report short forms containing items from seven PROMIS domains (Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity). The PROMIS-29 Profile consists of four questions per domain rated on a 5-point rating scale along with a 1 question Pain Intensity section rated on an 11-point scale. A raw score ranges from 29 to 150, and can be converted into T-scores which are referenced to mean score levels in the general U.S. population. Lower PROMIS scores have been shown to predict reduced health related quality of life for multiple chronic conditions. We will measure average change in each participant's PROMIS - 29 score from week zero to week twelve and twenty four.

The clinician's interpersonal practice will be assessed using the Consultation and Relational Empathy (CARE) Measure, a validated 10-item patient-reported instrument that evaluates practitioner empathy during the clinical encounter. Each item is scored from 1 to 5, yielding a total score range of 10 to 50, with higher scores indicating greater perceived clinician empathy. The CARE Measure has demonstrated validity and reliability in multiple health care settings and has also been used to assess interpersonal aspects of care in integrative medicine contexts. Outcome assessment will occur over 6 months.

The 5-item Empowerment scale will be employed to evaluate the patient experiences of the clinical consultation with regards to the degree to which the practitioner encourages patient empowerment. Each item is scored on a Likert scale from 1 to 5, yielding a total score range of 5 to 25, with higher scores indicating greater patient empowerment. Outcome assessment will occur over 6 months.

The Patient-Centered Care-Perceived Provider Support-Empowerment Scale is a trifecta of validated instruments developed to assess patients' perceptions of provider support, patient-centered care, and empowerment as they relate to health outcomes. These questionnaires aim at measuring the impact of the therapeutic relationship, the philosophy of healing, and CIH-specific techniques on treatment effects. Each component instrument will be scored according to its validated scoring system, with item responses rated on Likert scales (e.g., 1 to 4 or 1 to 5). For all included measures, higher scores indicate greater perceived patient-centeredness, provider support, and patient empowerment. Outcome assessment will occur over 6 months.

Prescribed treatments (e.g. diets, supplements, medications, lifestyle changes), including doses and frequencies with be extracted from chart notes.

Total number of adverse events and serious adverse events (using NIH's Common Terminology Criteria for Adverse Events version 4.0). This will be measured by practitioner report using chart abstraction. Practitioners will be trained on grading and documenting adverse events, as well as using standardized AE forms, before subjects are enrolled.