Surveillance and Cost Analysis of Respiratory Syncytial Virus Infections in Arctic Communities in Canada

Regions: Inuvialuit Settlement Region, Gwich'in Settlement Area, Sahtu Settlement Area, Dehcho Region, North Slave Region, South Slave Region, Qikiqtaaluk Region

Tags: health, health care, hospitals, microbiology, respiratory

Principal Investigator: Benerji, Anna (1)
Licence Number: 14812
Organization: St. Michael's Hospital, University of Toronto
Licensed Year(s): 2010 2008 2008
Issued: Oct 18, 2010
Project Team: Dr. Michael Young

Objective(s): To identify the respiratory syncytial virus (RSV) and other respiratory viruses associated with lower respiratory tract infection (LRTI) admissions to regional and tertiary centres over a 18 month period for infants <1 year old living in the Canadian Arctic, and to stratify the RSV LRTI admissions into categories by location (town with a hospital verses rural) and age (<1 year, < 6 months).

Project Description: Primary Objectives: 1) To identify the respiratory syncytial virus (RSV) and other respiratory viruses associated with lower respiratory tract infection (LRTI) admissions to regional and tertiary centres over a 18 month period for infants <1 year old living in the Canadian Arctic 2) To stratify the RSV LRTI admissions into categories by location (town with a hospital verses rural) and age (<1 year, < 6 months) 3) To assess the costs associated with RSV admissions to the Canadian Arctic and calculate the number needed to treat (NNT), number of infections prevented, cost-efficacy and cost per hospitalization avoided for the stratified categories to identify communities that have the highest rates and expenditure associated with RSV. Secondary Objectives: To establish a baseline for rates of LRTI and RSV, to assess the impact of palivizumab (Synagis™) prophylaxis in communities of Inuit infants of all gestational ages who are less than 6 months (or at the highest age groups risk identified) at the start of the RSV as recommended by the Canadian Pediatric Society. The surveillance will occur for a year and a half period during which time, all infants less than 1 year of age at the time of admission who are admitted to the participating hospitals with a diagnosis of LRTI will be enrolled. The research nurses and/or site coordinator will monitor for all LRTI hospitalizations and ICU admissions during the surveillance period. The research nurse will identify those infants eligible in each community and obtain written informed consent (in English, French or Inuktitut as appropriate) for participation in the study. The following data will be collected for all participating infants: demographic information, location of residence, gestational age at birth, age at hospital entry, date of admission, date of discharge, ICU transfer and duration of stay at a tertiary centre, days of ventilation, serious complications and the number and frequency of doses of palivizumab received (if any). Each infant admitted will have nasopharyngeal aspirates collected and the first part of the specimen will processed with a rapid viral test for RSV (standard of care). In most regions the remaining specimens will be sent to a reference lab such as Provincial Laboratory for Public Health (Edmonton) or the Montreal Children's Hospital where they have enhanced testing for clinical purposes. Results of the reference laboratory testing will also be collected where applicable. After processing the specimen at the reference hospitals they will be frozen at -700 C and shipped to Regional Virology Laboratory at St. Joseph's Healthcare. If sites do not send the specimen to a reference laboratory the remainder of the specimen will be frozen at -70 0C at the local site and then would be sent in batches, once or twice, during the study to the Regional Virology Laboratory at St. Joseph's Healthcare, McMaster University, Hamilton, Ontario. St. Joseph's Healthcare will test all study samples using a multiplex polymerase chain reaction (PCR) testing for 20 common and emerging respiratory viruses and possible bacterial testing. Retrospective enrollment, in the form of chart review, will be allowed for missed patients due to emergency transfers to tertiary centers and inability of these patients to be enrolled prospectively. Also, retrospective enrolment will be allowed for sites with a gap in enrollment due to staffing problems experienced especially at northern sites understaffed with research and health personal. The results from microbiology testing done as a standard clinical practice will be used for these cases. For retrospective enrolled patients there will be no additional samples to be analyzed at Hamilton lab. Retrospectively enrolled patients will not have informed consent. All costs associated with the study will be covered by the study. The study team will hire and/or pay for a nurse or health care worker to collect data for the study in the hospital. This person would consent patients, collect the study information, and perform the shipping of the samples. This person will also perform retrospective chart review. The results of the study will be published in a peer-reviewed journal, and presented at national or international conferences. It is also very important, to inform the Inuit communities of the results of the intervention trial. The media may be contacted, but only after information is peer-reviewed. The fieldwork for this study will be conducted from October 15, 2010 to December 31, 2010.