Clinical studies for systemic lupus erythematosus. From chaos to rigor.

Clinical study and treatment trials can assist in advancing knowledge of NP-SLE and improving patients' lives. They must be conducted systematically and with rigor, however, to justify their costs and meet their goals.

Barriers to automation in health care settings.

Health information systems have changed little since the 1970s, and most are incapable of meeting the information demands of either their organization or outside organizations. Through literature reviews, interviews with staff in three hospitals, and a vendor study, the staff of Kunitz and Associates, Inc. examined barriers to implementing automated systems in hospitals. These barriers were found to be technical, organizational, and operational in nature and to involve issues of communication within the health care environment and between information system vendors and health care staff. Resolving these issues is dependent upon efforts by both the health care and technical communities.

Validation of a symptoms questionnaire for benign prostatic hyperplasia.

We developed a questionnaire to assess the effect of finasteride on symptoms of benign prostatic hyperplasia (BPH) by modifying that of Boyarsky (1977). To validate the questionnaire, a cohort study was conducted in 2 groups of patients with BPH and 3 control groups without BPH. The BPH groups were: (1) 34 patients before TURP (transurethral resection of the prostate), average age 68 years; (2) 65 patients after TURP, average age 68 years; (3) 40 patients after other nonserious nonurological surgery, average age 50 years; (4) 14 healthy non-BPH volunteers, average age 58 years; and (5) 73 healthy non-BPH volunteers, average age 37 years. The questionnaire was administered once to all subjects, and a subset responded to a second administration. Mean total symptoms scores (TSS) from the initial questioning were 6.4, 3.2, 2.9, 2.6, and 1.6 for the 5 groups, respectively (pooled SD = 3.3); mean total troublesome symptoms scores (TTSS) were 4.8, 2.1, 1.4, 1.1, and 0.6, respectively (pooled SD = 2.2). All other groups were significantly less symptomatic and troubled than the pre-TURP group, and all surgical groups were significantly more so than the younger volunteer group. These data demonstrate the discriminant validity of the questionnaire. Corroborating prior data [Gregg et al., 1990], responsiveness was shown by the 3.7-point mean TSS improvement in response to TURP, which was significantly different from the near-zero changes in the other groups. Reproducibility was shown by kappa statistics being nearly all greater than 0.75 and an intraclass correlation coefficient of 0.64; construct validity and reliability were demonstrated by correlation (r = 0.7) with a general urination problems question; and internal consistency was documented by Cronbach's alpha values of approximately 0.6. We conclude that this questionnaire is a useful and validated tool for assessing BPH symptoms.

Reliability of the activities of daily living scale and its use in telephone interview.

Activities of daily living (ADL), a popular outcome assessment tool for studies of disabled populations, was evaluated for use in multicentered studies. The interobserver reliability of a modified Barthel Index of the ADL was evaluated on 18 stroke patients. Reliabilities between administrators of the ADL and between observers of the ADL administrations were r = .99 for total scores and r greater than .90 for most of the individual component items. The validity of ADL evaluation based on telephone interviews was demonstrated relative to ADL scores obtained on 72 patients in a direct test of their performance capabilities. The correlations between the performance-based ADL and the interview-based ADL were r greater than .97 for the total score and r greater than .85 for most of the individual items. The modified Barthel Index of the ADL is a reliable measure for assessing stable stroke patients, supporting its use in multicenter studies. In addition, the high validity observed in the telephone interview supports its use in longitudinal studies and large surveys where direct performance evaluation is not feasible or too costly.

The pilot Stroke Data Bank: definition, design, and data.

Four university centers collaborated to contribute 1158 patients with acute episodes of cerebrovascular disease to the pilot Stroke Data Bank, initiated by NINCDS in 1978. During the pilot project a standard set of data collection forms were developed and used at each of the collaborating centers. Data on clinical course, laboratory findings, therapy and outcome were gathered prospectively throughout the patient's hospitalization and at specified follow-up intervals. Using operational definitions of stroke sub-types, consecutive cases were systematically allocated to specific categories of brain and vascular pathology. The definitions were based on clinical criteria as well as on laboratory data, including computerized tomography (CT), and angiography findings. This paper describes the pilot Stroke Data Bank and presents the distribution of cases by diagnostic and demographic categories. It represents one of the largest series of prospectively collected stroke cases studied by CT (90% of the cases) and angiography (42%). Based upon the methods and processes of this pilot study, a main phase of the Stroke Data Bank has been established to address a number of questions pertaining to stroke classification, evolution, diagnosis, and prognosis.

The National Traumatic Coma Data Bank. Part 1: Design, purpose, goals, and results.

This paper describes the pilot phase of the National Traumatic Coma Data Bank, a cooperative effort of six clinical head-injury centers in the United States. Data were collected on 581 hospitalized patients with severe non-penetrating traumatic head injury. Severe head injury was defined on the basis of a Glasgow Coma Scale (GCS) score of 8 or less following nonsurgical resuscitation or deterioration to a GCS score of 8 or less within 48 hours after head injury. A common data collection protocol, definitions, and data collection instruments were developed and put into use by all centers commencing in June, 1979. Extensive information was collected on pre-hospital, emergency room, intensive care, and recovery phases of patient care. Data were obtained on all patients from the time of injury until the end of the pilot study. The pilot phase of the Data Bank provides data germane to questions of interest to neurosurgeons and to the lay public. Questions are as diverse as: what is the prognosis of severe brain injury; what is the impact of emergency care; and what is the role of rehabilitation in the recovery of the severely head-injured patient?