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Biomedical subjects

M A Dew

Publications and source records attributed to M A Dew.

111 records · Page 7Linked to original sources

Evaluation of an implantable ventricular assist system for humans with chronic refractory heart failure. Measuring quality of life.

The development of a multidimensional quality of life protocol to be used in a clinical trial of an LVAS was presented. The complexity of the new LVAS technology being evaluated added a unique dimension for HQL assessment. The rationale and procedures used in developing this protocol were described. Although we have elucidated the development of a protocol for a specific clinical trial, the principles and procedures employed are widely applicable. To summarize, these procedures are as follows: 1. Determine what quality of life domains are important to measure. This decision should be based upon the domains expected to be affected by treatment, those expected to change as a result of the natural course of the disease or condition, and those that may be affected by changes in the primary domains. 2. Once the domains are selected, identify specific measures for these domains. Where possible, the measures chosen should be standardized, well validated, and appropriate to the study population. Instrument length and mode of administration are additional considerations. 3. Consider any unique aspects of the study population or intervention and develop specific questions to address them. 4. Identify and measure important variables that may moderate or influence quality of life. 5. Test the protocol on an appropriate population for length, flow, and ease of administration. Copies of the complete HQL protocol are available by writing to: Dr. Nancy Avis, New England Research Institute, 9 Galen Street, Watertown, MA 02172.

Clinical Protocols↗

Life quality in the era of bridging to cardiac transplantation. Bridge patients in an outpatient setting.

This study provides an empirical evaluation of quality of life in the first two heart transplant candidates with mechanical circulatory support who were transferred (with support in place) to an outpatient setting to await transplantation. Their life quality in physical, emotional, and social domains following transfer was compared to: 1) their previous life quality while hospitalized, 2) life quality among a case series of five other candidates awaiting transplantation during the same time period, and 3) life quality among recent samples of heart recipients from our center and elsewhere. The transferred patients improved markedly in physical and emotional well being, with smaller gains in social functioning after leaving the hospital. They not only improved over their own earlier status while hospitalized, but showed life quality advantages over other hospitalized transplant candidates. Overall, they came to more closely resemble transplant recipients, rather than candidates, of similar age and indication for transplant. Outpatient care for selected mechanically supported heart transplant candidates provides an important potential option for the increasing numbers of patients requiring such support for extended time periods. The study yields critical data as fully implantable mechanical circulatory support devices for permanent heart replacement become a possibility.

Adolescent↗

Benzodiazepines and zolpidem for chronic insomnia: a meta-analysis of treatment efficacy.

OBJECTIVE: To evaluate the efficacy of benzodiazepines and zolpidem tartrate in chronic insomnia based on a quantitative review of literature. DATA SOURCES: Articles from 1966 to 1996 were identified using MEDLINE, by a manual review of relevant journals, and from bibliographies of identified articles. STUDY SELECTION: Studies using randomized, double-blind, placebo-controlled, parallel or crossover designs with benzodiazepines or zolpidem in adults younger than 65 years with chronic insomnia (modified Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for primary insomnia) were selected for review. Self-report and polysomnographic measures of sleep-onset latency, total sleep time, number of awakenings, and sleep quality were selected as outcomes. DATA EXTRACTION: Twenty-two studies met the selection criteria. A combined test of Pvalues was performed, pooling broadly from the 22 studies to determine whether medication was superior to placebo. A combined test of effect sizes was performed on the subset of studies that reported effect size information to determine the magnitude of medication effect. DATA SYNTHESIS: A homogeneous sample of studies summarized 1894 patients treated for a median duration of 7 days. The combined test of P values demonstrated that medication was superior to placebo in all 4 outcome measures. Treatment response was moderate in magnitude by the combined test of effect sizes. CONCLUSIONS: Benzodiazepines and zolpidem produced reliable improvements in commonly measured parameters of sleep in patients with chronic insomnia. Relative to the chronic and recurring course of insomnia, both the limited duration of treatments studied and the lack of follow-up data from controlled trials represent challenges for developing evidence-based guidelines for the use of hypnotics in the management of chronic insomnia.

Adult↗