Patient interpretations of patient-reported outcome measures to assess bowel urgency: qualitative interviews in ulcerative colitis.

OBJECTIVES: Bowel urgency is an impactful core symptom of ulcerative colitis (UC). Patient-reported outcome (PRO) questionnaires have been developed and used to assess the patient experience of this important symptom. The objective of this paper is to present evidence from qualitative research conducted to support the use and interpretation of select PRO questionnaires to assess bowel urgency related to the UC patient experience. METHODS: Qualitative interviews were conducted with ten adults with a clinician-confirmed diagnosis of moderately to severely active UC. Interviews aimed to document patient interpretation of modified recall periods for the Urgency Numeric Rating Scale (Urgency NRS), two global assessments (i.e., the Patient Global Impression of Severity [PGIS] and Patient Global Impression of Change [PGIC]), and four items (Items 11, 16, 23, and 26) of the Inflammatory Bowel Disease Questionnaire (IBDQ), and explore the patient perspective of meaningful change on these questionnaires. RESULTS: Both modified Urgency NRS versions (with 7-day or 3-day recall period) were interpreted as intended by most patients (≥ 88.9%), and slightly more than half of patients (60.0%) reported that the 7-day recall period was more relevant to their bowel urgency experience. Patients reported thinking of bowel urgency (≥ 80.0%) or bowel urgency-related accidents (70.0% of patients) when interpreting the global assessments and IBDQ items. Most patients reported a 1- to 3-point change as the smallest meaningful improvement that would be meaningful on the Urgency NRS (similar to findings on other questionnaires). CONCLUSION: Adults with UC can understand and respond to the Urgency NRS with modified recall periods (i.e., 7-day or 3-day), interpret the conceptual content of the PGIS, PGIC, and select IBDQ items to be inclusive of bowel urgency and bowel urgency-related accidents, and select answers representing meaningful improvements on the Urgency NRS, PGIS, PGIC, and IBDQ item response scales. These results further contribute patient-centered data to existing UC and bowel urgency research.

State of the evidence: the connection between breast cancer and the environment.

A substantial body of scientific evidence indicates that exposures to common chemicals and radiation, alone and in combination, are contributing to the increase in breast cancer incidence observed over the past several decades. Key recurring themes in the growing scientific literature on breast cancer and environmental risk factors are: (a) the importance of understanding the effects of mixtures and interactions between various chemicals, radiation and other risk factors for the disease; and (b) the increasing evidence that timing of exposures matters, with exposures during early periods of development being particularly critical to later risk of developing breast cancer. A review of the scientific literature shows several classes of environmental factors have been implicated in an increased risk for breast cancer, including hormones and endocrine-disrupting compounds, organic chemicals and by-products of industrial and vehicular combustion, and both ionizing and non-ionizing radiation.

Policy and research recommendations emerging from the scientific evidence connecting environmental factors and breast cancer.

A substantial body of evidence links environmental exposures to increases in breast cancer incidence over the past decades. State and federal legislative initiatives that could help prevent breast cancer include: federal standards to achieve consistency in radiation-emitting medical and dental equipment; improved state quality assurance standards for radiation-emitting equipment; federal and state exposure limits for electromagnetic radiation; an overhaul of the federal Toxic Substances Control Act to reduce unsafe chemical exposures; strengthened premarket health and safety testing and regulation of pesticides; a federal ban on the manufacture, distribution and sale of consumer products containing bisphenol A and phthalates; and strengthened oversight and regulation of the cosmetics industry. We recommend public and private investment in research on low dose exposures, mixtures, and the timing of chemical exposures, as well as the development of health tracking and biomonitoring programs designed to link data from pollution surveillance systems with disease registries.