The workplace is a key environment to impact employees, families, and communities to prevent further opioid and substance misuse, addiction, and overdose. However, it is often overlooked as an ideal location to launch a prevention intervention or support strategy. Employees in recovery, seeking treatment, and dealing with mental distress require employer support. Supports should consider the diversity of the work force and be culturally appropriate. Several data sources, tools, and other resources exist to aid employers in supporting their employees and addressing the opioid epidemic; a few from the National Safety Council are discussed. As well as suitable strategies to strengthen workplace prevention interventions and treatment access, in light of the opioid epidemic, coronavirus pandemic, and workplace disparities.
Background
Cleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, hearing, dental development, and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. The Timing Of Primary Surgery for cleft palate (TOPS) trial aims to determine whether, in infants with cleft palate, it is better to perform primary surgery at age 6 or 12 months (corrected for gestational age).
Methods/design
The TOPS trial is an international, two-arm, parallel group, randomised controlled trial. The primary outcome is insufficient velopharyngeal function at 5 years of age. Secondary outcomes, measured at 12 months, 3 years, and 5 years of age, include measures of speech development, safety of the procedure, hearing level, middle ear function, dentofacial development, and growth. The analysis approaches for primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The TOPS protocol has been published previously.
Discussion
This paper provides details of the planned statistical analyses for the TOPS trial and will reduce the risk of outcome reporting bias and data-driven results.
Trial registration
ClinicalTrials.gov NCT00993551. Registered on 9 October 2009.
Inter-rater reliability in classification of canonical babbling status based on canonical babbling ratio in infants with isolated cleft palate randomised to Timing of Primary Surgery for Cleft Palate (TOPS). Clinical LInguistics and Phonetics, 1-22.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.