Individuals with Down syndrome (DS) are predisposed to obstructive sleep apnoea (OSA) due to craniofacial features (eg, midface hypoplasia, glossoptosis) and studies have shown that the prevalence of OSA in this population is markedly increased compared with that of typically developing children. Adenotonsillectomy is considered the first-line treatment for childhood OSA. However, persistent OSA is common, thus many children with DS are referred for positive airway pressure (PAP) therapy initiation; PAP appears to be an important aspect of living with DS. PAP has been shown to be highly effective in the general population for treating OSA and improving OSA-associated neurobehavioural symptoms, such as quality of life, behaviour, mood, daytime sleepiness and school performance. However, PAP as a treatment for OSA has not been well-studied in children with DS. Therefore, we designed a multicentre randomised controlled trial recruiting children with DS and OSA at three academic institutions, aged 6–18 years, referred for PAP initiation to treat OSA.
86 participants will be randomised to a 6-month intensive behavioural intervention (INT) to improve PAP adherence versus standard clinical care and underwent standardised evaluations of quality of life, behaviour, attention, PAP adherence and healthcare utilisation at baseline, 6 months and 12 months.
This study has been approved by the institutional review board at Children’s Hospital of Philadelphia (IRB of record, IRB # 20–0 17 512). Cincinnati Children’s Medical Center and University of Miami delegated IRB review and approval responsibility to Children’s Hospital of Philadelphia through reliance agreements as mandated by National Institutes of Health (NIH). All participants will be minors; consent will be obtained from parents and assent from participants will be obtained when possible. The intervention tested in this trial is considered not greater than minimal risk, and no identifiable data will be reported. As required by the NIH, a data safety monitoring board (DSMB) has been formed, who will review and approve the protocol and any protocol changes prior to implementation. The study team will send biannual reports and hold a biannual meeting with the DSMB to review any safety and protocol concerns. Findings will be presented at national conferences pertinent to this topic and published in peer-reviewed medical journals. In addition, findings will be shared in the lay format with DS associations around the world and used for training of healthcare providers and trainees (R25HD118212). Further, data collected will be deposited in a repository (National Sleep Research Resource; sleepdata.org) after completion of the study to maximise use by scientific community.
We calculate positive predictive values (PPVs) of patients presenting with unexpected weight loss (UWL) being diagnosed with cancer within 6 months, using data from a population of Australian primary care patients to replicate results from a previous UK study.
A diagnostic accuracy study involving calculation of the PPV for any cancer using retrospective data from routinely collected electronic healthcare records. The index date is defined as the first recorded UWL presentation and the reference standard is cancer diagnosis within 6 months of the index date.
This study uses primary care data from the Patron primary care database, linked to hospital admissions data and the Victorian Cancer Registry. We include only patients who presented to their General Practitioners (GPs) at least once between 1 July 2007 and 1 February 2022.
Patients were included if they were at least 18 years of age at the index date, had no previous diagnosis of cancer or previous weight loss intervention, including being prescribed medications for weight loss. 13 306 patients out of a primary care population of 1 791 051 patients were identified that met the eligibility criteria.
When stratified by age, sex and smoking status, we found PPVs lower than those derived in a previous UK primary care study, though still above 3% for male non-smokers over 60, female smokers over 70 and all males over 70. Patients from ages 60–79 with at least one abnormal blood test result had PPVs consistently above 3%, while overall, patients with abnormal blood test results have PPVs of up to 35%.
We confirmed that many PPVs, while consistently below those derived in the UK study, are above clinically significant thresholds and increasing with age and the number of different abnormal blood test results.