Design of the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

The objectives of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial are to determine in screenees ages 55-74 at entry whether screening with flexible sigmoidoscopy (60-cm sigmoidoscope) can reduce mortality from colorectal cancer, whether screening with chest X-ray can reduce mortality from lung cancer, whether screening men with digital rectal examination (DRE) plus serum prostate-specific antigen (PSA) can reduce mortality from prostate cancer, and whether screening women with CA125 and transvaginal ultrasound (TVU) can reduce mortality from ovarian cancer. Secondary objectives are to assess screening variables other than mortality for each of the interventions including sensitivity, specificity, and positive predictive value; to assess incidence, stage, and survival of cancer cases; and to investigate biologic and/or prognostic characterizations of tumor tissue and biochemical products as intermediate endpoints. The design is a multicenter, two-armed, randomized trial with 37,000 females and 37,000 males in each of the two arms. In the intervention arm, the PSA and CA125 tests are performed at entry, then annually for 5 years. The DRE, TVU, and chest X-ray exams are performed at entry and then annually for 3 years. Sigmoidoscopy is performed at entry and then at the 5-year point. Participants in the control arm follow their usual medical care practices. Participants will be followed for at least 13 years from randomization to ascertain all cancers of the prostate, lung, colorectum, and ovary, as well as deaths from all causes. A pilot phase was undertaken to assess the randomization, screening, and data collection procedures of the trial and to estimate design parameters such as compliance and contamination levels. This paper describes eligibility, consent, and other design features of the trial, randomization and screening procedures, and an outline of the follow-up procedures. Sample-size calculations are reported, and a data analysis plan is presented.

Outcomes assessment in clinical settings: a consensus statement on principles and best practices in project management.

BACKGROUND: The focus of this article is on health-related outcomes particularly reducing symptoms and improving health status. Public policy, purchaser demand, quality assurance/quality improvement, clinical research, and the computerized medical record have all fed the increasing interest in outcomes. "Outcomes assessment" refers to the measurement, monitoring, and feedback of outcomes. In implementing outcomes assessment, the bulk of the work is concentrated in managing individual projects. From May 1992 through March 1993, under a grant from the Functional Outcomes Program of the New England Medical Center (Boston), the directors of five major health outcomes assessment programs held a series of meetings to share their experiences in implementation. Principles and recommended best practices for project management are provided here. Implementing an outcomes project: Making a commitment to begin includes identifying a condition or procedure to investigate, assembling a project team, and naming a coordinator. Designing a project entails defining its purpose and scope, developing the measurement instruments, and establishing a logistical protocol for data collection. Managing the data entails collecting the data, entering the data into a database, maintaining quality control over the data, and storing the data. Using the data entails analyzing the data, providing feedback and interpretation to clinicians, and linking outcomes to the clinical process. CASE STUDY: For a typical outcomes project--total hip replacement--the sequence of activities in the project and the staffing and resources needed are all described.

A randomized, controlled trial of an attending staff service in general internal medicine.

This study, a prospective, randomized trial comparing two inpatient staffing models, was undertaken to compare clinical and financial outcomes for general medicine inpatients assigned to resident (teaching) or staff (nonteaching) service. Key outcome measures included: 1) length of stay; 2) total charges; 3) laboratory, radiology, pharmacy, and supplies charges; 4) in-hospital mortality and mortality within 6 months of admission; and 5) 15-day readmission rate. The study took place at Henry Ford Hospital, a 937-bed urban teaching hospital in Detroit, Michigan; the subjects included all general internal medicine patients admitted to a single nursing unit of Henry Ford Hospital between October 1, 1987 and September 30, 1988. When the unit was fully staffed and operational, patients admitted to the Staff Service had a 1.7-day lower average length of stay than patients admitted to the Resident Service (P greater than 0.005), lower average total charges of $1,681 (P greater than 0.01), and significantly lower laboratory and pharmacy charges. No statistically significant differences in mortality rates or readmission rates were found. Even though personnel costs are invariably higher on an attending service, this staffing arrangement can be financially viable because of more efficient patterns of care. Shorter length of stay may be translated either into cost savings or increased revenues in order to offset higher salary costs. Teaching hospitals may wish to consider an attending service as one way to reduce house officer work loads, offer more opportunities for training in ambulatory settings, and adjust to a smaller pool of applicants for residency positions.

Determinants of breast self-examination after a benign biopsy.

Although breast self-examination (BSE) continues to be recommended as an adjunct to clinical screening techniques for the early detection of breast cancer, little is known about events that might negatively influence long-term adherence. The primary aim of this investigation was to determine if regularity of BSE would decline after a benign breast biopsy. Analyses are based on 655 women: 83 women who self-discovered the breast problem by BSE, 179 women in whom the problem was discovered by the health care system, and a control group of 393 women who had no history of breast problems. Frequency of BSE was assessed over two six-month periods and collapsed into three categories--nonpractitioner, irregular practitioner, and regular practitioner. Results indicated that the percentage of women in the self-discovered group who reported decreased regularity of BSE was over three times higher than that found in the control group. The largest percentage increase in BSE frequency was evidenced by the health care-discovered group. Logistic regressions revealed that the biopsy experience was a more powerful indicator of subsequent BSE practice than either sociodemographic characteristics or whether one engaged in other preventive health behaviors. The data provide substantial evidence that a benign biopsy can affect BSE practice, with the direction and magnitude of the change influenced by mode of discovery of the breast problem, perceived degree of confidence in ability to perform BSE, and level of practice before the biopsy. Postbiopsy educational strategies incorporating these findings and targeted at specific subgroups are outlined.

Progressive dialysis encephalopathy from dialysate aluminum.

Progressive dialysis encephalopathy was observed as a frequent complication (eight of 34 patients) in a small hemodialysis unit. After the water used for dialysis was deionized, no further cases of encephalopathy developed in 29 patients. In the absence of other apparent changes in therapy, this significant difference in incidence (P less than .005) is considered to be the result of reduction in unusually high water aluminum levels from 0.637 mg/liter to less than 0.001 mg/liter by use of a deionizer.