6:06181. The Medical Research Council Spine Stabilization Trial: surgical methods and costs of surgical stabilization as part of a randomized controlled trial

In a randomized, controlled trial, 62 patients (47 men and 15 women) with severe antisocial snoring, but no sleep apnea, were allocated to one of three surgical treatments. These were uvulopalato-pharyngoplasty, laser palatoplasty, and diathermy palatoplasty. Postoperative morbidity was measured on a visual analogue scale of severity of pain, dysphagia, and nasal regurgitation at 1, 2, and 7 days after the operation. Efficacy of each procedure was measured by asking the sleeping partner to record the severity of snoring before and after the operation, again on a visual analogue scale. Measurements were taken at 1, 3, and 6 months. There were no significant differences in early postoperative morbidity among the treatment groups. Diathermy palatoplasty is a new technique for the relief of snoring that is associated with low morbidity and requires little in the way of expensive equipment.

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Process evaluation of complex cardiovascular interventions: How to interpret the results of my trial?

European Journal of Cardiovascular Nursing ◽

10.1177/1474515120906561 ◽

2020 ◽

Vol 19 (3) ◽

pp. 269-274

Author(s):

Markus Saarijärvi ◽

Lars Wallin ◽

Ewa-Lena Bratt

Keyword(s):

Process Evaluation ◽

Chronic Conditions ◽

Research Council ◽

Medical Research Council ◽

Controlled Trial ◽

Complex Interventions ◽

Randomized Controlled ◽

Cardiovascular Interventions ◽

Cardiovascular Nursing ◽

Process Evaluations

Complex interventions of varying degrees of complexity are commonly used and evaluated in cardiovascular nursing and allied professions. Such interventions are increasingly tested using randomized trial designs. However, process evaluations are seldom used to better understand the results of these trials. Process evaluation aims to understand how complex interventions create change by evaluating implementation, mechanisms of impact, and the surrounding context when delivering an intervention. As such, this method can illuminate important mechanisms and clarify variation in results. In this article, process evaluation is described according to the Medical Research Council guidance and its use exemplified through a randomized controlled trial evaluating the effectiveness of a transition program for adolescents with chronic conditions.

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A Randomized Controlled Trial of Prenatal Nutritional Supplementation

PEDIATRICS ◽

10.1542/peds.65.4.835 ◽

1980 ◽

Vol 65 (4) ◽

pp. 835-836

Author(s):

Howard N. Jacobson

Keyword(s):

Randomized Controlled Trial ◽

Dietary Intake ◽

Study Design ◽

Research Council ◽

Maternal Nutrition ◽

Controlled Trial ◽

National Research Council ◽

Nutritional Supplement ◽

Nutritional Supplementation ◽

Randomized Controlled

This report is the long-awaited presentation of the results of the major study on the use of nutritional supplementation to improve the outcomes of pregnancy. In this study, a nutritional supplement refers to the provision of specified amounts of nutrients in a formula made up as a beverage. The formula would be used to aid in the quantification of the dietary intake of nutrients under study, in this case calories and protein. The expectation was that the supplements would be consumed in addition to the diet normally consumed and that they would not displace foods normally eaten. The study design was initially presented at a workshop on nutritional supplementation and the outcome of pregnancy and sponsored by the Committee on Maternal Nutrition, National Research Council, in November 1971.1

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