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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).

OBJECTIVE: To describe physician understanding of patient preferences concerning cardiopulmonary resuscitation (CPR) and to assess the relationship of physician understanding of patient preferences with do not resuscitate (DNR) orders and in-hospital CPR. DESIGN: We evaluated physician understanding of patient CPR preference and the association of patient characteristics and physician-patient communication with physician understanding of patient CPR preferences. Among patients preferring to forgo CPR, we compared attempted resuscitations and time to receive a DNR order between patients whose preference was understood or misunderstood by their physician. PATIENTS/SETTING: Seriously ill hospitalized adult patients were enrolled in the Study to Understand Prognoses and Preferences for the Outcomes of Treatments. GENERAL RESULTS: Physicians understood 86% of patient preferences for CPR, but only 46% of patient preferences to forgo CPR. Younger patient age, higher physician-estimated quality of life, and higher physician prediction of 6-month survival were independently associated with both physician understanding when a patient preferred to receive CPR and physician misunderstanding when a patient preferred to forgo CPR. Physicians who spoke with patients about resuscitation and had longer physician-patient relationships understood patients' preferences to forgo CPR more often. Patients whose physicians understood their preference to forgo CPR more often received DNR orders, received them earlier, and were significantly less likely to undergo resuscitation. CONCLUSIONS: Physicians often misunderstand seriously ill, hospitalized patients' resuscitation preferences, especially preferences to forgo CPR. Factors associated with misunderstanding suggest that physicians infer patients' preferences without asking the patient. Patients who prefer to forgo CPR but whose wishes are not understood by their physician may receive unwanted treatment.

Objectives : To compare the outcomes for patients with one or more organ system failures treated in 1988 to 1990 with those outcomes from 1979 to 1982 ; to document risk factors for developing organ system failure ; and investigate the relationship of these factors to hospital survival. Design : Prospective, multicenter, inception cohort analysis. Setting : Sixty intensive care units (ICUs) at 53 U.S. hospitals. Patients : A total of 17,440 ICU admissions treated in 1988 to 1990 and 5,677 ICU admissions treated in 1979 to 1982. Interventions : None. Measurements and Main Results : At the time of organ system failure, patients were classified by demographic, physiologic, and diagnostic information. The type and number of organ system failures and physiologic responses were recorded for ≤7 days of ICU treatment, and all patients were followed for status at hospital discharge. Hospital survival and the prognostic value of assessing the number of organ system failures were compared with risk assessment, based on use of a prognostic scoring system that estimated the patient's probability of hospital mortality. The incidence of organ system failure (48%) among patients treated in 1988 to 1990 was similar (44%) to the occurrence rate in patients in 1979 to 1982 ; and an identical proportion (14%) developed multiple organ system failure. There was a significant (p < .0003) improvement in hospital mortality for patients with three or more organ system failures on day 4 or later of organ system failure. However, overall hospital mortality rates from multiple organ system failure were not different over this 8-yr period. The most important predictor of hospital mortality was the severity of physiologic disturbance on the initial day of failure. Discrimination of patients by risk of hospital mortality was better using the prognostic scoring system on day 1 of organ system failure (receiver operating characteristic curve = 0.88) than using a model based on the number of organ system failures (receiver operating characteristic curve = 0.68). Conclusions : Organ system failure remains a major contributor to death in patients in ICUs. The incidence and overall outcome have not significantly changed over the past 8 yrs, but there has been significant improvement in survival for patients with persistent severe organ system failure. A continuous measure of Individual patient severity of illness is a more sensitive and accurate method for describing patients and estimating outcome than counting the number of organ system failures.

OBJECTIVE: To describe the association between hospital resource utilization and physicians’ knowledge of patient preferences for cardiopulmonary resuscitation (CPR) among seriously ill hospitalized adult patients.

Background: Medical treatment decisions should be based on the preferences of informed patients or their proxies and on the expected outcomes of treatment. Because seriously ill patients are at ris...

Objective. —To examine the impact of illness on the families of seriously ill adults and to determine the correlates of adverse economic impact. Design. —Data were collected during the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment (SUPPORT), a prospective cohort study of outcomes, preferences, and decision making in seriously ill hospitalized adults and their families. Setting. —Five tertiary care hospitals in the United States. Participants. —The 2661 seriously ill patients in nine diagnostic categories who survived their index hospitalization and were discharged home were eligible for this analysis. Surrogate and/or patient interviews about the impact of illness on the family were obtained for 2129 (80%) of these patients (mean age, 62 years; 43% women; 6-month survival, 75%). Outcome Measures. —Surrogates and patients were surveyed to determine the frequency of adverse caregiving and economic burdens. Multivariable analyses were performed to determine correlates of loss of family savings. Results. —One third (34%) of patients required considerable caregiving assistance from a family member. In 20% of cases, a family member had to quit work or make another major life change to provide care for the patient. Loss of most or all of the family savings was reported by 31% of families, whereas 29% reported loss of the major source of income. Patient factors independently associated with loss of the family's savings on multivariable analysis included poor functional status (odds ratio [OR], 1.40; 95% confidence interval [CI], 1.10 to 1.78 for patients needing assistance with three or more activities of daily living), lower family income (OR, 1.74; 95% CI, 1.37 to 2.21 for those with annual incomes below $25 000), and young age (OR, 2.85; 95% CI, 2.13 to 3.82 for those younger than 45 years compared with those 65 years or older). Conclusions. —Many families of seriously ill patients experience severe caregiving and financial burdens. Families of younger, poorer, and more functionally dependent patients are most likely to report loss of most or all of the family's savings. (JAMA. 1994;272:1839-1844)