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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.

PreviewTuberculosis, once on the decline, again poses a major health problem in the United States. Its incidence has increased since the 1980s because of the AIDS epidemic, so once again, diligence is required on the part of all healthcare personnel to control its spread. Dr Ravikrishnan identifies high-risk populations that should be screened and describes clinical and radiographic features of tuberculosis that help in its recognition.

Review of patients with active pulmonary tuberculosis over a three-year period showed an increased incidence of bronchogenic carcinoma (5%). There had been considerable delay in establishing diagnosis of coexistent carcinoma which was attributed to finding of acid-fast bacilli and relative ease of ascribing all findings to that cause. Suspicious roentgen signs are reviewed and the importance of sputum cytology is also stressed.

A 46-year-old man presented with swelling and pain in the right knee and a history of nonproductive cough and weight loss. Sporotrichum schenkii was cultured from synovium, synovial fluid, sputum, and bronchial washings. No other pathogens were cultured. Neither skin lesions nor history of exposure to S. schenckii was present, but 7 years before this admission the patient had been treated for suspected pulmonary tuberculosis despite negative mycobacteriology. The case is believed to represent systemic spread from chronic pulmonary sporotrichosis and supports the hypothesis that the lung may serve as a portal of entry in noncutaneous systemic sporotrichosis.

We studied 36 patients with gastrointestinal tuberculosis: 21 had peritonitis, 11 had enteritis, and four had both. Diagnostic criteria were (1) caseating granulomas or positive smear or culture from an abdominal specimen; (2) culture-proved pulmonary tuberculosis plus ascitic fluid containing protein, greater than 3.0 g/dL, and more than 50% lymphocytes, or granulomatous enterlitis on x-ray studies that resolved with antituberculous therapy. In only four of 15 patients with enteritis was the disease confined to the ileocecal region. Fourteen patients (40%) had complications: bowel obstruction in ten, perforation in six, and fistula in five. Five of these died. Two perforations and one death followed paracentesis and needle biopsy. Tuberculous peritonitis can be diagnosed without biopsy when lymphocytic exudative ascites responds to antituberculous chemotherapy given for concurrent culture-proved pulmonary tuberculosis. Patients with pulmonary tuberculosis and persistent abdominal complaints who have granulomatous enteritis should be considered to have tuberculous enteritis. Surgery is reserved for bowel obstruction, perforation, fistula, or a mass that does not resolve with drug therapy.

A case of pneumonia secondary to aspirated foreign body is presented. Xerotomography was useful in detecting abnormalities of the tracheobronchial tree and in demonstrating endobronchial foreign bodies.

Routine admission chest radiographs were abnormal in 35 (14%) of 242 patients hospitalized with an exacerbation of chronic obstructive pulmonary disease and resulted in management changes that were appropriate and clinically significant in only 11 cases (4.5%). Based on our analysis of clinical variables predictive of significant radiographic abnormalities and our assessment of clinically important findings, we propose the following indications for admission chest radiographs in patients with an acute exacerbation of chronic obstructive pulmonary disease: white blood cell count above 15 x 10(9)/L and polymorphonuclear leukocyte count above 8 x 10(9)/L, history of congestive heart failure, history of coronary artery disease, chest pain, or edema. In view of the low yield of clinically significant abnormalities, we believe that routine chest radiographs need not be performed in this patient population. The use of selective criteria could eliminate unnecessary studies while assuring recognition of important new radiographic abnormalities.

We report a case that illustrates an unusual manifestation of tuberculosis with massive atelectasis secondary to an endobronchial polypoid lesion. The rarity of this manifestation, coupled with the nonspecific findings on biopsy, delays recognition and therapy. Tuberculosis should be considered in the differential diagnosis of endobronchial mass lesions in the right clinical setting.

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.

• We report a case that illustrates an unusual manifestation of tuberculosis with massive atelectasis secondary to an endobronchial polypoid lesion. The rarity of this manifestation, coupled with the nonspecific findings on biopsy, delays recognition and therapy. Tuberculosis should be considered in the differential diagnosis of endobronchial mass lesions in the right clinical setting. (Arch Intern Med 140:1090-1091, 1980)