Martin Villegas - Academia.edu (original) (raw)
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Texas Tech University Health Science Center
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Papers by Martin Villegas
Annals of the American Thoracic Society, Jan 31, 2017
The Long-term Oxygen Treatment Trial (LOTT) demonstrated that long-term supplemental oxygen did n... more The Long-term Oxygen Treatment Trial (LOTT) demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable COPD 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 had 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 manuscript expands o...
Annals of the American Thoracic Society, Jan 31, 2017
The Long-term Oxygen Treatment Trial (LOTT) demonstrated that long-term supplemental oxygen did n... more The Long-term Oxygen Treatment Trial (LOTT) demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable COPD 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 had 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 manuscript expands o...