Recruitment Methods. Identify and invite participants: Not applicable – retrospective medical record review Consent Please see attached waiver of consent application Reimbursements Not applicable Data Management Plan Data Collection Retrospective Medical Record Review Databases – SCHN eMR and Westmead Hospital eMR Variables/Outcome Measures Aim 1: Spirometry – Forced Expiratory Volume in One Second (FEV1), number of hospitalisations number of days on Intravenous antibiotics (IVAB), number of presentations to the Emergency Department Number of ICU admissions number of deaths lower airway microbiological results and nutritional outcomes – BMI z score and weight for length z score dependent on age Aim 2: Medical record review will take place for the 12 months prior to initiation of the hybrid method of care to measure adherence to the following standards of care as defined in the Australian CF Standards of Care Document. This list is subject to update with the release of more current standards of care. Each standard of care will be categorised into either a yes/no response for each participant depending on whether or not the standard was met in the 12 months prior to and 12 months post initiation of hybrid care. 4 reviews per year by CF Specialist Centre Sputum / Oropharyngeal sample collection for culture of common CF pathogens four times per year Sputum microbiology including AFB (Acid fast bacilli) once per year CXR and or/CT scan Abdominal ultrasound Comprehensive nutritional assessment by CF dietitian Fat soluble vitamins levels (A, E, D), full blood count, urea, electrolytes and creatinine, liver function tests, random or fasting blood glucose level (BSL), total IgE. Assessment for presence of CF related diabetes either by a formal oral glucose tolerance test or fasting and random blood glucose testing on a regular basis. Spirometry measurements at each visit’ Growth measurements Bone mineral density assessment using DEXA scanning every 1-2 years depending on previous results Comprehensive physiotherapy assessment including review of musculoskeletal system, urinary and faecal incontinence Review of airway clearance treatments including check of equipment, technique and cleaning/maintenance of equipment. Analysis of Data plan Analysis for Aim 1: The primary outcome will be change in % predicted FEV1. A two-way (centre and patient) random intercept linear mixed model will be used to compare changes in % predicted FEV1 for the period before and after introduction of hybrid out...
Recruitment Methods i. HOW, WHERE and WHEN will potential subjects be recruited? Potential subjects will be identified through existing genetic research studies at Children’s Hospital Boston, such as Xx. Xxxxx' studies on the molecular basis of neuromuscular disease and the Manton Center for Orphan Disease Research, or directly through one of the investigators. Potential participants will be contacted via phone, email or in person by an approved study staff member from the study in which they are already participating and/or by one of the investigators or research coordinators of this study. The method of contact will be chosen based on the participant’s previous interactions with the staff of the study in which they are already participating. The study staff member will explain the current project and get the family’s permission to be contacted to discuss it in further detail. Participants will then be contacted via phone, email or in person by one of the investigators, Xxxx Xxxxx and Xxxxx Xxxxxx, or research coordinator, Xxxxxx Xxxxx, to discuss the study in further detail. Participants may also self- refer themselves if they learn about the study. Recruitment will occur outside of hospital care. After establishing the potential participant’s interest in enrolling, copies of the consent form along with an informational letter and a medical record release form will be sent to the potential participants. A telephone call or in person interview will be scheduled to review the consent forms with the family and answer any questions. If assent is required, the research coordinator/genetic counselor will also speak with the child/adolescent directly to explain the study and ask questions as to gauge comprehension. This must be done in addition to obtaining parental permission from child/adolescent’s parent/guardian. Once consent is obtained, the study staff will coordinate obtaining a genomic data or a DNA sample from each family member by arranging for data, blood, saliva, or previously obtained tissue/DNA sample to be obtained. If needed, the research coordinator can help potential participants coordinate the blood draw with their local clinician’s office or at a clinically certified facility.
Recruitment Methods. Identifying potential participants will be through the Electronic Data Warehouse (XXX) and through the use of study flyers and recruitment materials. The XXX at Northwestern is updated daily. An algorithm can be set up based on the eligibility criteria of the trial to identify potential participants that have met enrollment criteria. Data gathered in the XXX request will include Name, contact information (address, email and/or phone), Date of Birth, MRN, hospitalization date(s), and if applicable, date that a HST or PSGG is ordered. The XXX request may exclude people based on the exclusion criteria. The use of the XXX will be used exclusively for recruitment purposes and no data from the warehouse will be added to the study data set for research analysis. The use of study flyers or advertisements will also be shared with potential study subjects who will be given contact information to follow up with the study team.
Recruitment Methods. Recruitment of volunteers will be accomplished by each participating site by face-to-face recruitment by the site research coordinator, or radiologist investigators. Site personnel may use appointment schedules to identify patients who may qualify for this study. Every effort will be made to recruit volunteers of ethnic minorities. Any member of the approved study team will ask the patient if she is interested in hearing about the clinical trial. If the patient is interested, she will be treated as a prospective subject. If the patient meets all the inclusion criteria, none of the exclusion criteria and wishes to continue participating in the study, she will be enrolled into the study. Following this, one of the licensed physicians (MD) or physician assistant (PA) involved in this study will approve and order the contrast-enhanced CBBCT radiographic exam, per NY State laws.
