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Stopping rules for clinical trials incorporating clinical opinion.

A method is described of eliciting a 'range of equivalence', i.e. a range of differences between two treatments over which a group of clinical trial participants would have no clear preference for either treatment. This range of equivalence is then incorporated into a formal stopping rule for the trial using an extension of the group sequential design. Tables for the implementation of the design are presented. The method is discussed in the context of other sequential-trial designs.

Biometry↗

Patient behavior monitoring through self-reports.

This research examined the accuracy of data obtained by a self-observation and report technique (SORT) developed to record patients' ongoing everyday behaviors, where the behaviors occur, whether aid is provided, and if so, by whom. Over 2 consecutive weeks 10 persons with recent spinal cord injuries hospitalized at a major rehabilitation center reported their behaviors during 8 half-day periods. Assessments of reporting accuracy compared self-reports with data recorded by independent observers. Minute-by-minute comparisons of self-report and independent observations indicated moderate levels of agreement. Weekly measures of performance derived from the 2 kinds of records showed high agreement. Reporting accuracy was relatively unaffected by the amount of time between the occurrence of a behavior and its report and the personal importance of various behaviors to the patients. The SORT provides a dependable, flexible and cost-efficient means for assessing what patients do on a day-to-day basis and it offers many options for monitoring patients' functional performance in rehabilitation.

Adolescent↗

The stress of children's births: gender differences in the impact on alcoholics.

Previously reported gender differences regarding the role of discrete life change events in the onset of alcoholism are examined through a systematic evaluation of the histories of 586 alcoholics. Several methodological features of this research distinguish it from investigations reported in the past. The use of a structured, topically organized interview protocol eliminated possible biases introduced by gender differences in the tendency to attribute the onset of alcoholism to life change. The application of an actuarial analytic procedure allowed an examination of the temporal relationship between life change (births of children) and the onset of alcoholism and a restriction of the period of risk for the onset of alcoholism following discrete life change to two years. The focus on a single type of life change event, births of children, reflects an established concern with the role of gynecological events in the onset of alcoholism among women and allows of the general comparisons. Results indicate that, among those ever at risk of first experiencing alcohol-related problems during the two year period following the birth of a child, males show a statistically significantly higher percentage with the onset of alcoholism during this time period than do females. The birth of a first child was found to be most strongly related to the development of problem drinking. Among males, but not among females, the birth of a first child was also found to follow the onset of alcoholism by two years in a significant number of cases.

Alcoholism↗

[Medical research on patients' experiences--structured questionnaires result in worthless answers].

The patient's expectations, wishes, judgments, and opinions have recently become a topic of interest in medical research. This is partly due to the physician's increasing awareness of an inadequate impact of medical measures, be they preventive, informative, or even curative, on the patient and the general public. It may also be partly due to an increasing criticism on the part of the patient and the general public of the failure of the medical service to respond adequately to the information provided. Consequently, there has recently been increased interest in gaining knowledge about the social aspects of human life relevant to medicine. The measures for securing validity, however, are the traditional rules of reductionist methodology. The author argues that by exploring the domain of culturally constructed meaning with tools based on naturalistic epistemology, the knowledge obtained will be invalid.

Evaluation Studies as Topic↗