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Ann Am Thorac Soc. 2018 Jan;15(1):89-101. doi: 10.1513/AnnalsATS.201705-374SD.

The Long-Term Oxygen Treatment Trial for Chronic Obstructive Pulmonary Disease: Rationale, Design, and Lessons Learned.

Collaborators (169)

Bailey WC, Fuhlbrigge AL, Sampong E, Sloan K, Wagner A, Anderson S, Moy M, Okunbor O, Stoller JK, Marlow S, Meli Y, Rice R, Aboussouan LS, Castele R, Parambil J, Khatri S, Pande A, Zein J, Olbrych T, Alkins S, Jocko C, Rahaghi F, Barton J, Albert RK, Underwood J, Make B, Underwood J, MacIntyre N, Davies J, Stibolt T, Mularski R, Naleway A, Vertrees S, Casaburi R, Porszasz J, Walker P, Indelicato R, Specht L, Ellstrom K, Portillo J, Horak D, Tiep B, Barnett M, Diaz P, Drake J, Rittinger M, Compton R, Miller S, Panos RJ, Lach LA, Criner G, Grabianowski C, Cordova F, Desai P, Krachman S, Mamary J, Marchetti N, Satti A, Mumm E, Vega-Olivo M, Hua J, Tauch V, Criner LY, Jacobs M, Rising P, Simonelli P, Mitchell M, Lammi M, Romaine C, Lee H, Ianacone M, Scharf S, Bell-Farrell W, Mador MJ, Rahman A, Zaman M, Hill L, Platt A, Cooper JA, Harrington K, Dransfield M, Smith P, Davis D, Cooper JA, Smith P, Sriram P, Herring K, Gay S, Martinez F, Han M, Rysso K, Meldrum C, Ravikrishnan KP, Keena D, DeRidder J, Kring B, Anzueto A, Aguilera A, Houlihan T, Girgis R, Cannestra J, Sciurba F, Kelly B, Kanner R, Scholand MB, Villegas GM, Carle J, Au DH, Udris E, Curtis R, Au D, Feemster LC, Goodman R, Moss B, Reinke L, Udris E, Aitken M, Culver B, Yusen RD, Castro M, Mittler B, Heaghney J, Jacobs M, Joo M, Bracken N, Diamond E, Joseph MK, Soler X, Villa A, Layish D, Silverman E, Kelly R, Cossette D, Tonascia J, Belt P, Blackford A, Collison B, Dodge J, Donithan M, Ewing C, Jackson R, May KP, Meinert J, Piantadosi S, Reyes G, Shade D, Smith M, Sternberg AL, Van Natta M, Wilson L, Wagoner A, Wise R, Yates KP, Hakim R, Punturieri A, Bamdad J, Croxton T, Deshler J, McCord-Reynolds P, Stylianou M, Weinmann G, Bernard G, Anderson J, Lo B, Ries A, Stoloff S, Thomashow B, Tilley B, Weiss K.

Author information

1
1 Washington University School of Medicine, St. Louis, Missouri.
2
2 Temple University Hospital, Philadelphia, Pennsylvania.
3
3 Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.
4
4 University of Washington, Seattle, Washington.
5
5 Colorado Hospital, Aurora, Colorado.
6
6 Denver Health Medical Center, Denver, Colorado.
7
7 Harbor-UCLA Medical Center, Torrance, California.
8
8 Cleveland Clinic Foundation, Cleveland, Ohio.
9
9 University of Alabama at Birmingham, Birmingham, Alabama.
10
10 Ohio State University, Columbus, Ohio.
11
11 University of Michigan Hospital, Ann Arbor, Michigan.
12
12 University of Utah, Salt Lake City, Utah.
13
13 Duke University Medical Center, Durham, North Carolina.
14
14 Cornell Medical College, New York, New York.
15
15 Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
16
16 University of Pittsburgh, Pittsburgh, Pennsylvania.
17
17 Johns Hopkins School of Medicine, Baltimore, Maryland; and.
18
18 Kaiser Permanente Center for Health Research, Portland, Oregon.

Abstract

The Long-Term Oxygen Treatment Trial demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable chronic obstructive pulmonary disease and resting and/or exercise-induced moderate oxyhemoglobin desaturation, nor did it provide benefit for any other outcome measured in the trial. Nine months after initiation of patient screening, after randomization of 34 patients to treatment, a trial design amendment broadened the eligible population, expanded the primary outcome, and reduced the goal sample size. Within a few years, the protocol underwent minor modifications, and a second trial design amendment lowered the required sample size because of lower than expected treatment group crossover rates. After 5.5 years of recruitment, the trial met its amended sample size goal, and 1 year later, it achieved its follow-up goal. The process of publishing the trial results brought renewed scrutiny of the study design and the amendments. This article expands on the previously published design and methods information, provides the rationale for the amendments, and gives insight into the investigators' decisions about trial conduct. The story of the Long-Term Oxygen Treatment Trial may assist investigators in future trials, especially those that seek to assess the efficacy and safety of long-term oxygen therapy. Clinical trial registered with clinicaltrials.gov (NCT00692198).

KEYWORDS:

chronic obstructive pulmonary disease; hypoxemia; oxygen; randomized controlled trial; survival

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