Biomedical subjects

D Shortell

Publications and source records attributed to D Shortell.

3 recordsLinked to original sources

PubMed1989

Ensuring data quality in a multicenter clinical trial: remote site data entry, central coordination and feedback.

In an ongoing multicenter clinical trial, "Treatment Strategies in Schizophrenia," the five participating sites have the capacity to perform a variety of tasks or study functions independently. These tasks include (a) verification of diagnostic eligibility through the use of computerized decision algorithms; (b) assignment of patients to treatment based on prognostic indicators using a computerized randomization algorithm; (c) entry of data into a microcomputer using a clinical trial data management system that performs simple range and missing data item checks; and (d) regular transfer of all data to the central coordinating team. The clinical trial data management system employed allows for both independent site functioning and assurance of consistency across sites. The integration of a variety of software outside the main data management system provides the central coordinators with the tools to monitor critical data as it is collected, as well as the capacity to assess the flow, quality, and uniformity of the ongoing trial.

Clinical Trials as Topic↗

PubMed1984

The elderly patient and informed consent. Empirical findings.

Informed consent with the elderly patient and the competency of this patient population have been neglected issues in medicine and law. Particularly, the competency of the elderly patient has received little empirical investigation. The present study examines the capacity of geriatric patients to consent to research participation. Competency is investigated through the use of hypothetical consent information on three dimensions: comprehension of consent material, quality of reasoning about the decision to participate or not participate in research, and reasonable choice regarding participation. The results indicate that elderly patients' choices about those projects in which participation is "reasonable" do not differ, by and large, from younger patients. However, the elderly show significantly poorer comprehension of consent information. Thus, screening for competency and providing special instructions may become an important part of the research process when the elderly are participants.

Adult↗

PubMedDate not supplied

The design of a compliant composite crutch.

Ambulation by crutches takes up to twice the energy of normal gait and can lead to injuries of the hands and arms. The compliant composite forearm crutch described in this article seeks to address these problems. The new crutch is made of a single composite piece and has an S-curve in the main body to provide shock absorption and return of energy with the goal of reducing impact and repetitive injuries. It is lighter and, we expect, more durable than current crutches due to the lack of interfacing parts. The new forearm cuff design provides retention of the crutch on the arm without a pivot. The contoured forearm cuff with wrist supports and padding is intended to provide added comfort and support. These features are integrated into an aesthetic, high-tech-looking design in charcoal/black color. (See Figure 1) Initial testing with seven users yielded favorable response to function and appearance. Quantitative analysis has identified improvements needed for future iteration in design. These include 1) making the wrist supports more narrow and placed down one inch, 2) optimizing the stiffness of the top curve of the S-shape, and 3) testing the crutch for motion and energy requirements in use.

Biomechanical Phenomena↗