Comprehensive assessment of patients with irritable bowel syndrome with constipation and chronic idiopathic constipation using deterministically linked administrative claims and patient-reported data: the Chronic Constipation and IBS-C Treatment and Outcomes Real-World Research Platform (CONTOR).

AIMS: To characterize a US population of patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) using CONTOR, a real-world longitudinal research platform that deterministically linked administrative claims data with patient-reported outcomes data among patients with these conditions. METHODS: Patients with IBS-C or CIC were identified using diagnosis and treatment codes from administrative claims. Potential respondents received a mailed survey followed by 12 monthly online follow-up surveys and 2 mailed diaries. Surveys collected symptom severity, treatment use, quality of life, productivity, and condition/treatment history. Comorbidities and healthcare costs/utilization were captured from claims data. Diaries collected symptoms, treatments, and clinical outcomes at baseline and 12 months. Data were linked to create a patient-centric research platform. RESULTS: Baseline surveys were returned by 2,052 respondents (16.8% response rate) and retention rates throughout the study were high (64.8%-70.8%). Most participants reported burdensome symptoms despite having complex treatment histories that included multiple treatments over many years. More than half (55.3%) were dissatisfied with their treatment regimen; however, a higher proportion of those treated with prescription medications were satisfied. LIMITATIONS: The study sample may have been biased by patients with difficult-to-treat symptoms as a result of prior authorization processes for IBS-C/CIC prescriptions. Results may not be generalizable to uninsured or older populations because all participants had commercial insurance coverage. CONCLUSIONS: By combining administrative claims and patient-reported data over time, CONTOR afforded a deeper understanding of the IBS-C/CIC patient experience than could be achieved with 1 data source alone; for example, participants self-reported burdensome symptoms and treatment dissatisfaction despite making few treatment changes, highlighting an opportunity to improve patient management. This patient-centric approach to understanding real-world experience and management of a chronic condition could be leveraged for other conditions in which the patient experience is not adequately captured by standardized data sources.

A clinical study of COPD severity assessment by primary care physicians and their patients compared with spirometry.

PURPOSE: Primary care physicians often do not use spirometry to confirm the diagnosis of chronic obstructive pulmonary disease. This project was designed to see how well physicians' impressions about their patients' chronic obstructive pulmonary disease severity correlate with the severity of airflow obstruction measured by spirometry and to assess whether spirometry results subsequently changed the physicians' opinions about chronic obstructive pulmonary disease severity and treatment. METHODS: We performed a multicenter, cross-sectional, observational study conducted in 83 primary care clinics from across the United States. A total of 899 patients with a clinical diagnosis of chronic obstructive pulmonary disease completed a questionnaire and spirometry testing. Physicians completed a questionnaire and case report forms. Concordance among physician ratings, patient ratings, and spirometry results was evaluated. RESULTS: Physicians' chronic obstructive pulmonary disease severity ratings before spirometry were accurate for only 30% of patients with evaluable spirometry results, and disease severity in 41% of patients was underestimated. Physicians also underestimated severity compared with patients' self-assessment among 42% of those with evaluable results. After spirometry, physicians changed their opinions on the severity for 30% of patients and recommended treatment changes for 37%. Only 75% of patients performed at least 1 high-quality spirometry test; however, the physicians' opinions and treatment decisions were similar regardless of suboptimal test results. CONCLUSIONS: Without performing spirometry, physicians are likely to underestimate their patients' chronic obstructive pulmonary disease severity or inadequately characterize their patients' lung disease. Spirometry changed the physicians' clinical impressions and treatments for approximately one third of these patients; thus, spirometry is a valuable tool for chronic obstructive pulmonary disease management in primary care.