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The Chronic Lung Disease Biomarker and Clinical Outcome Assessment Qualification Consortium (CBQC) evaluates the potential of biomarkers and outcome measures as drug development tools. Exercise endurance is an objective indicator of treatment benefit, closely related to daily physical function. Therefore, it is an ideal candidate for an outcome for drug development trials. Unfortunately, no exercise endurance measure is qualified by regulatory authorities for use in trials of chronic obstructive pulmonary disease (COPD) and no approved COPD therapies have claims of improving exercise endurance. Consequently, it has been challenging for developers to consider this outcome when designing clinical trials for new therapies. Endurance time during constant work rate cycle ergometry (CWRCE), performed on an electronically braked stationary cycle ergometer, provides an exercise endurance measure under standardized conditions. Baseline individualized work rate for each participant is set using an incremental test. During CWRCE the patient is encouraged to continue exercising for as long as possible. Although not required, physiological and sensory responses (e.g., pulmonary ventilation, heart rate, dyspnea ratings) are frequently collected to support interpretation of endurance time changes. Exercise tolerance limit is reached when the individual is limited by symptoms, unable to maintain pedaling cadence or unable to continue safely. At exercise cessation, exercise duration is recorded. An CWRCE endurance time increase from the pre-treatment baseline is proposed as a key efficacy endpoint in clinical trials. In COPD, improved exercise endurance has a direct relationship to the experience of physical functioning in daily life, which is a patient-centered, meaningful benefit.

IMPORTANCE: Most of the global morbidity and mortality in chronic obstructive pulmonary disease (COPD) occurs in low- and middle-income countries (LMICs), with significant economic effects. OBJECTIVE: To assess the discriminative accuracy of 3 instruments using questionnaires and peak expiratory flow (PEF) to screen for COPD in 3 LMIC settings. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional analysis of discriminative accuracy, conducted between January 2018 and March 2020 in semiurban Bhaktapur, Nepal; urban Lima, Peru; and rural Nakaseke, Uganda, using a random age- and sex-stratified sample of the population 40 years or older. EXPOSURES: Three screening tools, the COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE; range, 0-6; high risk indicated by a score of 5 or more or score 2-5 with low PEF [

This study tested the properties of a Spanish translation of CAPTURE (COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk) with selective use of peak expiratory flow (PEF).This study comprised analyses of data from the Spanish-speaking cohort of the cross-sectional, case-control study used to develop CAPTURE. Translation procedures included forward and backward translation, reconciliation, and cognitive interviewing to assure linguistic and cultural equivalence, yielding CAPTURE-S. Spanish-speaking participants were recruited through one center and designated as case subjects (clinically significant COPD: FEVThe study included 30 participants (17 case subjects and 13 control subjects). Their mean (± SD) age was 62.6 (11.49) years, and 33% were male. CAPTURE-S scores were significantly correlated with PEF (r = -0.78), the FEVCAPTURE-S with selective use of PEF seems to be useful for identifying Spanish-speaking patients in need of diagnostic evaluation for clinically significant COPD who may benefit from initiation of COPD treatment.ClinicalTrials.gov; No.: NCT01880177; URL: www.clinicaltrials.gov.

People with chronic obstructive pulmonary disease (COPD) experience deterioration in functional status, therefore improving functional status is a major goal of treatment. We reviewed interventions to improve functional status in people with COPD published from 1980 through September 1996. Randomized controlled clinical trials were reviewed to document outcomes in terms of functional capacity and functional performance for the following interventions: pharmacologic therapy including theophylline, inhaled bronchodilators, steroids, antianxiolytics and antidepressants; general exercise strategies including exercise training, exercise and comprehensive pulmonary rehabilitation, and upper extremity training; inspiratory muscle therapy including inspiratory muscle training and inspiratory muscle rest; nutritional therapy; oxygen therapy; and specialized nursing care. Improvements for functional capacity were documented in terms of strength of the inspiratory muscles and upper extremities, walking tests, and peak oxygen uptake. Most interventions were targeted to enhance functional capacity, and few were aimed at enhancing functional performance. Further research is needed to examine the relationship between functional capacity and functional performance and to design and test interventions to improve functional performance.

Although exacerbations are an important problem in chronic obstructive pulmonary disease (COPD) and a target of intervention, there is no valid, standardized tool for assessing their frequency, severity, and duration.This study tested the properties of the Exacerbations of Chronic Pulmonary Disease Tool (EXACT), a new patient-reported outcome diary.A prospective, two-group, observational study was conducted in patients with COPD. The acute group (n = 222) was enrolled during a clinic visit for exacerbation with follow-up visits on Days 10, 29, and 60. The stable group (n = 188), recruited by telephone or during routine visits, was exacerbation free for at least 60 days.Acute patients completed the diary on Days 1-29 and 60-67; stable patients for 7 days. All patients provided stable-state spirometry and completed the St. George Respiratory Questionnaire-COPD (SGRQ-C). Acute patient assessments included clinician and patient global ratings of exacerbation severity and recovery. Mean age of the sample (n = 410) was 65 (± 10) years; 48% were male; stable FEV₁ was 51% predicted (± 20). Internal consistency (Pearson separation index) for the EXACT was 0.92, 1-week reproducibility (stable patients; intraclass correlation) was 0.77. EXACT scores correlated with SGRQ-C (r = 0.64; P0.0001) and differentiated acute and stable patients (P0.0001). In acute patients, scores improved over time (P0.0001) and differentiated between degrees of clinician-rated exacerbation severity (P0.05). EXACT change scores differentiated responders and nonresponders on Day 10, as judged by clinicians or patients (P0.0001).Results suggest the EXACT is reliable, valid, and sensitive to change with exacerbation recovery.

Background: The Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UCPRO/SS) measure was recently developed to evaluate symptom outcomes in clinical trials of ulcerative colitis (UC). Aim: To examine the structure, reliability and validity of the UCPRO/SS. Methods: An observational study was conducted in adults with UC and included three clinic visits: Day 1 (Visit 1), Day 7 (Visit 2), and Day 28 (Visit 3). Subjects completed the UC-PRO/SS on a daily basis using an electronic device. Descriptive statistics, factor analysis, and Rasch analysis were conducted to determine final structure. Test-retest reliability was assessed among stable subjects, defined as those with "no change" on patient-reported global rating of change in UC severity from Visit 2 to Visit 3, using paired t-test and intraclass correlation coefficients (ICCs). Cronbach's coefficient alpha was used to assess internal consistency. Construct validity was examined based on correlations with the Inflammatory Bowel Disease Questionnaire (IBDQ), Partial Mayo Score, and other ancillary measures. Known-groups validity was evaluated by comparing UC-PRO/SS domain scores by groups defined by the Partial Mayo Score, Patient Global Rating of Disease Severity, and Clinician Global Rating of Disease Severity using ANCOVA models adjusted for age and gender. Results: Of the 200 participants, 117 (59%) were female; mean (SD) age was 46 (14.6) years. The 14-item UC-PRO/SS includes three domains: Bowel Movement (BM) Signs and Symptoms, Abdominal Symptoms, and Systemic Symptoms. Alpha coefficients ranged from 0.66 to 0.80. No significant differences were observed in UC-PRO/SS domain scores between visits for stable subjects, with ICC values of 0.71-0.81. The BM Signs and Symptoms scale was strongly correlated to the Partial Mayo Score (0.79) and moderately to strongly correlated with the IBDQ (0.51 to 0.73). Moderate correlations (0.45-0.65) were observed between Abdominal Symptoms and Partial Mayo Score, IBDQ, and BPI Worst Pain. Similar correlations were observed for Systemic Symptoms. Findings indicate that UC-PRO/SS domain scores were significantly different (p