RATIONALE: Ambulatory oxygen improves acute exercise performance in people with chronic obstructive pulmonary disease (COPD). This improvement may not translate into symptomatic benefit for patients during activities of daily living. OBJECTIVES: We undertook a series of individual randomized controlled trials (N-of-1 RCTs) to measure the effect of oxygen in patients with COPD who do not meet criteria for mortality reduction with long-term oxygen therapy. METHODS: Twenty-seven patients completed blinded N-of-1 RCTs, each comprising three pairs of 2-week home treatment periods, with oxygen provided during one period of each pair and a placebo mixture during the other. MEASUREMENTS AND MAIN RESULTS: Patients completed the Chronic Respiratory Questionnaire (CRQ), the St. George's Respiratory Questionnaire, and a home five-minute-walk test at the end of each period. We defined a positive response as a CRQ dyspnea score greater (less dyspnea) on oxygen than placebo during all three pairs of treatment periods, with a difference >or= 0.5 inches for at least two treatment pairs. Oxygen significantly increased the five-minute-walk test (427 vs. 412 steps, p = 0.04). Two of 27 patients met the responder criteria. Among the whole group, neither the CRQ nor the St. George's Respiratory Questionnaire showed any statistical or clinical differences between oxygen and placebo. CONCLUSIONS: This study does not support the general application of long-term ambulatory oxygen therapy for patients with COPD who do not meet criteria for mortality reduction with long-term oxygen therapy. N-of-1 RCTs can identify patients who may benefit.
RCT Entities:
RATIONALE: Ambulatory oxygen improves acute exercise performance in people with chronic obstructive pulmonary disease (COPD). This improvement may not translate into symptomatic benefit for patients during activities of daily living. OBJECTIVES: We undertook a series of individual randomized controlled trials (N-of-1 RCTs) to measure the effect of oxygen in patients with COPD who do not meet criteria for mortality reduction with long-term oxygen therapy. METHODS: Twenty-seven patients completed blinded N-of-1 RCTs, each comprising three pairs of 2-week home treatment periods, with oxygen provided during one period of each pair and a placebo mixture during the other. MEASUREMENTS AND MAIN RESULTS:Patients completed the Chronic Respiratory Questionnaire (CRQ), the St. George's Respiratory Questionnaire, and a home five-minute-walk test at the end of each period. We defined a positive response as a CRQ dyspnea score greater (less dyspnea) on oxygen than placebo during all three pairs of treatment periods, with a difference >or= 0.5 inches for at least two treatment pairs. Oxygen significantly increased the five-minute-walk test (427 vs. 412 steps, p = 0.04). Two of 27 patients met the responder criteria. Among the whole group, neither the CRQ nor the St. George's Respiratory Questionnaire showed any statistical or clinical differences between oxygen and placebo. CONCLUSIONS: This study does not support the general application of long-term ambulatory oxygen therapy for patients with COPD who do not meet criteria for mortality reduction with long-term oxygen therapy. N-of-1 RCTs can identify patients who may benefit.
Authors: Darcy D Marciniuk; Donna Goodridge; Paul Hernandez; Graeme Rocker; Meyer Balter; Pat Bailey; Gord Ford; Jean Bourbeau; Denis E O'Donnell; Francois Maltais; Richard A Mularski; Andrew J Cave; Irvin Mayers; Vicki Kennedy; Thomas K Oliver; Candice Brown Journal: Can Respir J Date: 2011 Mar-Apr Impact factor: 2.409
Authors: Brian W Carlin; Kimberly S Wiles; Robert W McCoy; Toni Brennan; Dan Easley; Richard J Thomashow Journal: Chronic Obstr Pulm Dis Date: 2015-01-01
Authors: Amy P Abernethy; Christine F McDonald; Peter A Frith; Katherine Clark; James E Herndon; Jennifer Marcello; Iven H Young; Janet Bull; Andrew Wilcock; Sara Booth; Jane L Wheeler; James A Tulsky; Alan J Crockett; David C Currow Journal: Lancet Date: 2010-09-04 Impact factor: 79.321
Authors: Denis E O'Donnell; Shaw Aaron; Jean Bourbeau; Paul Hernandez; Darcy D Marciniuk; Meyer Balter; Gordon Ford; Andre Gervais; Rogers Goldstein; Rick Hodder; Alan Kaplan; Sean Keenan; Yves Lacasse; Francois Maltais; Jeremy Road; Graeme Rocker; Don Sin; Tasmin Sinuff; Nha Voduc Journal: Can Respir J Date: 2007-09 Impact factor: 2.409