A cohort of 12 000 children in the Philippines who had enrolled in a 2000–2004 (current ages 16 to 20 years) Phase 3 11-valent pneumococcal conjugate vaccine for the prevention of radiographically confirmed pneumonia are now being asked to participate in a separate study (expected completion date September 2021) to assess the cohort’s current long-term audiometric and otologic status. This new study would allow assessments of the utility of the pneumococcal vaccine in conferring its protective effects on the long-term sequelae of otitis media (OM), if any. Lack of trained local healthcare providers in otolaryngology/audiology and testing equipment in Bohol, Philippines, necessitates the development of a distinct methodology that would lead to meaningful data analysis.
Reliable data collection and transfer are achieved by a US otolaryngologist/audiologist team training local nurses on all procedures in a didactic and hands-on process. An assortment of portable otolaryngologic and audiologic equipment suitable for field testing has been acquired, including an operating otoscope (Welch-Allyn), a video-otoscope (JedMed), a tympanometer with distortion product otoacoustic emission measurements (Path Sentiero) and a screening audiometer (HearScreen). Data will then be uploaded to a Research Electronic Data Capture database in the USA.
Tympanometric and audiologic data will be codified through separate conventional algorithms. A team of paediatric otolaryngology advanced practice providers (APPs) have been trained and validated in interpreting video otoscopy. The protocol for classification of diagnostic outcome variables based on video otoscopy and tympanometry has been developed and is being used by APPs to evaluate all otoscopy data.
The study was approved by the Research Institute of Tropical Medicine, Alabang, Manila, Philippines, and the institutional review board and the Colorado Multiple Institutional Review Board of the University of Colorado School of Medicine, Aurora, Colorado, USA.
Research results will be made available to children and their caregivers with abnormal audiologic outcomes, the funders and other researchers.
ISRCTN 62323832; Post-results.
To summarise the evidence on benefits and harms of prompt closure versus gradual weaning of external ventricular drainage (EVD) in patients with hydrocephalus following aneurysmal subarachnoid haemorrhage (aSAH) based on randomised clinical trials (RCTs) in humans.
RCTs comparing prompt closure versus gradual weaning of EVD in adult patients with hydrocephalus following aSAH were included.
Patients aged equal to or greater than 18 years with an EVD due to hydrocephalus following aSAH were eligible for inclusion.
Primary outcomes were all-cause mortality, any serious adverse event, rate of ventriculoperitoneal (VP) shunt placement and quality of life. Secondary outcomes were patients with shunt failure, hospital and neuro intensive care unit (NICU) length of stay (LOS) and complications related to treatment with an EVD. Data permitted report of rate of VP shunt placement, and hospital and NICU LOS.
Six studies were assessed in full text. One RCT with 81 patients was included. Rate of VP shunt placement was 63.4% in the rapid weaning group (ie, prompt closure of the EVD; 41 patients) and 62.5% in the gradual weaning group (40 patients; p=0.932). LOS in hospital and NICU was significantly shorter in the rapidly weaned group compared with the gradually weaned group (mean 19.1 vs 21.5 days in hospital (p=0.03); and mean 14.1 vs 16.9 days in NICU (p=0.0002)). Data were insufficient to conduct meta-analysis, trial sequential analysis or subgroup analysis of heterogeneity and sensitivity. One RCT is currently ongoing.
We found insufficient evidence to favour any of the two strategies for EVD discontinuation in patients with hydrocephalus following aSAH.
In Neuro Intensive Care Units (NICU) and neurosurgical units, patients with an external ventricular drain (EVD) due to hydrocephalus following aneurysmal subarachnoid haemorrhage (SAH) are commonly seen. Cessation of the EVD involves the dilemma of either closing the EVD directly, or gradually weaning it before removal. Development of increased intracranial pressure (ICP) and acute hydrocephalus with subsequent need of a permanent shunt has been associated with prompt closure of theEVD, whereas increased risk of infection with possible spreading to the brain and subsequent patient fatality is suspected in connection to a longer treatment as seen in gradual weaning. Sparse data exist on the recommendation of cessation strategy and patients are currently being treated on the basis of personal experience and expert opinion. The objective of this systematic review is to assess the available evidence from clinical trials on the effects of prompt closure versus gradual weaning of EVD treatment for hydrocephalus in adult patients with SAH.
We will search for randomised clinical trials in major international databases. Two authors will independently screen and select references for inclusion, extract data and assess the methodological quality of the included randomised clinical trials using the Cochrane risk of bias tool. Any disagreement will be resolved by consensus. We will analyse the extracted data using Review Manager and trial sequential analysis. To assess the quality of the evidence, we will create a ‘Summary of Findings’ table containing our primary and secondary outcomes using the GRADE assessment.
Results will be published widely according to the interest of the society. No possible impact, harm or ethical concerns are expected doing this protocol.