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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).

Purpose The aims were to determine if the maximum standardized uptake value (SUVmax) of the primary tumor as determined by preoperative 18F-fluoro-2-deoxyglucose (18F-FDG) positron emission tomography (PET) is an independent predictor of overall survival and to assess its prognostic value after stratification according to pathological staging. Methods A retrospective clinicopathologic review of 363 patients who had a preoperative 18F-FDG PET done before undergoing attempted curative resection for early-stage (I & II) non-small cell lung cancer (NSCLC) was performed. Patients who had received any adjuvant or neoadjuvant chemotherapy or radiation therapy were excluded. The primary outcome measure was duration of overall survival. Receiver-operating characteristic (ROC) curves were plotted to find out the optimal cutoff values of SUVmax yielding the maximal sensitivity plus specificity for predicting the overall survival. Survival curves stratified by median SUVmax and optimal cutoff SUVmax were estimated by the Kaplan-Meier method and statistical differences were assessed using the log-rank test. Multivariate proportional hazards (Cox) regression analyses were applied to test the SUVmax’s independency of other prognostic factors for the prediction of overall survival. Results The median duration of follow-up was 981 days (2.7 years). The median SUVmax was 5.9 for all subjects, 4.5 for stage IA, 8.4 for stage IB, and 10.9 for stage IIB. The optimal cutoff SUVmax was 8.2 for all subjects. No optimal cutoff could be established for specific stages. In univariate analyses, each doubling of SUVmax [i.e., each log (base 2) unit increase in SUVmax] was associated with a 1.28-fold [95% confidence interval (CI): 1.03–1.59, p = 0.029] increase in hazard of death. Univariate analyses did not show any significant difference in survival by SUVmax when data were stratified according to pathological stage (p = 0.119, p = 0.818, and p = 0.882 for stages IA, IB, and IIB, respectively). Multivariate analyses demonstrated that SUVmax was not an independent predictor of overall survival (p > 0.05). Conclusion Each doubling of SUVmax as determined by preoperative PET is associated with a 1.28-fold increase in hazard of death in early-stage (I & II) NSCLC. Preoperative SUVmax is not an independent predictor of overall survival.

Gallium-67 citrate scans were obtained in 11 patients considered at risk for extrapulmonary tuberculosis. Radiographic and bacteriologic studies were performed routinely and tissue biopsy selectively. Of five patients with proven extrapulmonary tuberculosis, there were three with renal tuberculosis, one with Pott's disease, and one with peritoneal tuberculosis. The Ga-67 scan correctly predicted presence or absence of active extrapulmonary foci in all 11 patients. Follow-up scans correlated well with clinical response to therapy. The diagnosis of extrapulmonary tuberculosis is often overlooked because of nonspecific symptoms and frequent lack of concurrent lung involvement. Scanning with Ga-67 citrate offers a reliable and simple means of screening patients at risk and of monitoring response to treatment.