There are 3 study data collection forms:
1. The Study Site Information form collects data about the PIVC policies and guidelines in effect at each site. This is a 4 page form, filled in once by the person responsible for the study at each site.
2. The Ward/Unit Screening Log will be filled in for every ward assessed on the day of the study. This will provide details on the prevalence of PIVCs among the inpatient population. Consent for the study will be documented on this form.
3. The Data Collection Form is completed on the day of the study for every consenting patient with a PIVC. Each PIVC will be assessed individually.
PIVC data will be collected at the patient’s bedside, on paper or via the on-line survey tool LimeSurvey.
Data collected on paper is then entered into the survey tool by each site, or scanned and emailed to the OMG study coordinator who will enter the data into LimeSurvey.
LimeSurvey is an online survey tool maintained and supported by Griffith University. This survey tool was successfully used during the pilot study at 15 hospital sites in 13 countries.
|Date of data collection|
The choice of date for the study is decided by the individual organisation, depending on staffing, workload and other local issues. We recommend that a group of assessors (nurse educator, clinical nurse specialist, vascular access clinician, etc.) be educated about the study and the data collection tools. Each assessor can then assess the PIVCs on 2 or 3 wards/units, rather than a 2 or 3 staff trying to collect data for the whole hospital.
It might be more feasible for a site to collect data over a week, rather than a single day.
We expect to collect data until 30 April 2015.
It may not be possible to obtain all the data on the form. If the data is not readily available (such as date and time of IV insertion), ask the patient, if feasible.
For benchmarking purposes, more data is better, but realistically this may not be possible.
One of the investigators has statistical qualifications and experience and will be analysing the data through the Stata statistical program.
No identifying data (name, address, date of birth, medical record number) will be collected.
The confidentiality of each hospital’s data will be clearly maintained. The prevalence and characteristics of PIVC data will be presented at aggregate levels, based on country and region of the world. All data will be stored on a password protected database, and hospital names will be coded to endure confidentiality.
Griffith University on-line survey program LimeSurvey will be used to enter and collect data. The survey program uses a unique token identifier system. The tokens have been allocated by the Study Coordinator as follows: Country code and number. E.g. AU0001, AU0002, AU0003, etc. Each unique code signifies Country, Region/State/Province, Hospital.
Each site will be notified what their own unique code is, but no hospital will have access to any other hospital’s coding details. Only the principal study investigators will have access to the list of codes. This information is password protected on a computer in the secure Centre for Health Practice Innovation at Griffith University.
Following the publication of the results of the study by country, hospital-specific data will be reported back to each study site. No hospital-specific data will be shared with other hospitals.
Every participating site must sign an Authorship Agreement form prior to receiving their study code. This agreement stipulates the following:
All information collected remains the intellectual property of the hospital. This information can be used to benchmark with other hospitals locally, nationally or internationally. After the main study is completed and the research results are published in a peer reviewed journal (all contributors will be acknowledged in the publication), opportunity will be available for individual hospitals or groups of hospitals to publish their own data and we encourage this collaboration.
A condition to being part of this study is that no publication is submitted to any journal or conference until the main study has been written and published in a peer reviewed journal. Every participating site will be acknowledged for their contribution to the study.
We can offer assistance with data analysis and manuscript preparation. If you decide to publish your local data independently we ask that you acknowledge the OMG PIVC team in any publication.
Acknowledgement addition to publication:
“We would like to acknowledge the One Million Global Peripheral Intravenous Catheter (OMG PIVC) study team for the original concept and study design (Evan Alexandrou, Gillian Ray-Barruel, Niall Higgins, Steven Frost, Peter Carr, Sheila Inwood, Frances Lin, Leonard Mermel and Claire Rickard)”.
|Data Storage and Security|
Stringent processes will be used to ensure that the data of organisations participating in the study are kept confidential.
On-line data entry will be entered in LimeSurvey, a secure on-line survey database housed at and supported by Griffith University. All survey tool connections are secured via SSL certificates provided by AusCERT, and all applications are hosted and secured according to Griffith Policy.
Paper data forms will be stored in a locked filing cabinet whose key will only be accessible by the principal researchers. Data received on paper forms will be entered into the LimeSurvey database by the study investigators for coding and statistical purposes.
Computer data will be stored on a secure computer located in the Research Room at the Griffith University School of Nursing and Midwifery, Brisbane, Australia, accessible only by the principal researchers.
|How long will the data be kept?|
Information will be stored for a mandatory period of seven years in accordance with the Griffith University research policy.
|How will data be disposed of?|
Code for the Responsible Conduct of Research, section 6: data is destroyed in accordance with Disposal Authorities issued by the Queensland State Archives:
Paper forms will be placed in a secure, locked confidential bin and then shredded.
Digital files will be erased from the archives by the university archiving management service (CARMS).