Saudi SPRINT SARI NEWS LETTER AUG 2016

Saudi Critical Care Society (SCCS)

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Contents
Invitation to participate: ............................................................................................................ 4
Participation: ............................................................................................................................... 4
Your participation is co-ordinated by: ...................................................................................... 5
For more information please contact the network coordinator: .................................................... 5
Message from the Chief Investigator:....................................................................................... 5
Project Management .................................................................................................................. 5
Study Document Translations ................................................................................................... 6
SPRINT-SARI Site Packs.............................................................................................................. 6
Site Packs include:....................................................................................................................... 6
Southern Hemisphere and Tropical region study periods ...................................................... 6
Saudi SPRINT SARI NEWS LETTER AUG 2016

SRPINT-SARI Website ................................................................................................................. 6

...................................................................................................................................................... 7
Resolving Data Entry Challenges for SPRINT-SARI ................................................................. 7
Denominator Sub-Study ............................................................................................................ 7
SPRINT-SARI EARL Sub-study (Ethical Administrative Regulatory and Logistic barriers) .. 8
What do you need to provide for the Sub-Study? .................................................................. 9
SPRINT-SARI Presentations ....................................................................................................... 9
SPRINT-SARI Generic Grant Application .................................................................................. 9
Feedback: ................................................................................................................................... 10
Global Co-ordinating Centre:................................................................................................... 10
SPRINT-SARI is endorsed by: ................................................................................................... 10

Saudi Critical Care Society (SCCS)

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Invitation to participate:
SPRINT-SARI (Short PeRiod IncideNce sTudy of Severe Acute Respiratory Infection) is an
international, multi-centre, prospective, short period incidence observational study of
patients in participating hospitals and intensive care units (ICUs) with SARI.
On behalf of the SPRINT-SARI Management Committee, The Saudi Critical Care
Society extends an invitation to participate in this landmark study. SPRINT-SARI represents
an important step in preparing the world to conduct time-critical observational research in
the event of a public health emergency. SPRINT-SARI is two things: a short period
incidence (observational) study that would occur once per year, for a maximum study
period of 7 days, and a process by which ethics approval is obtained to allow SPRINT-SARI
to be activated for a more extended time period in the event of a major outbreak of Severe
Acute Respiratory Infection (SARI

Participation:

Saudi SPRINT SARI NEWS LETTER AUG 2016

The study is being conducted on every continent, in 32 countries (including Saudi Arabia),
across 32 research and hospital networks, in over 240 ICUs and hospitals either
participated, ready to participate or preparing to participate in 2016 (figure 1).
The Northern hemisphere commenced the 5-to-7-day week enrolment period in January 2016. To
date 47 sites have contributed data with 296 individual participants enrolled into SPRINT-SARI

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Your participation is co-ordinated by:

For more information please contact the network coordinator:

Yaseen Arabi (Arabi@ngha.med.sa)

Message from the Chief Investigator:

The SPRINT SARI Management Committee comprises a representative from all participating
networks and takes over-arching responsibility for the studys strategic direction and is responsible
for approval of any changes to the protocol and CRF. The SPRINT SARI Working Group is a smaller
committee that takes operational responsibility for the study. The concept of SPRINT SARI was first
launched at an ISARIC meeting in Annecy in July 2012. I led the establishment of the study and a

Saudi SPRINT SARI NEWS LETTER AUG 2016

grant from the Australian National Health and Medical Research Council, which allowed Genevieve
ONeill to support the study as its Project Manager, was pivotal in getting SPRINT SARI up and
running. I was the initial chair of the Working Group and Id like to thank all the members of the
Working Group and Management Committee who have been instrumental in developing the
protocol, CRF, and recruiting so many networks and sites. In March this year, Srin Murthy took over
as the Working Group chair. Srin is based in Vancouver and is young and energetic and I know he
will provide fabulous leadership to the study. I will continue to be a member of the Working Group
and I look forward to assisting Srin drive the next stage of evolution of the study.
-Steve Webb

Project Management
SPRINT-SARI has a new full time Project Manager. Dr Maya George (bio here) has taken over the
central project management at Monash University. Dr George is available to answer any questions
you have regarding SPRINT-SARI via the SPRINT-SARI email address.
Central Program Manager: mnhs-sprint.sari@monash.edu

Saudi Critical Care Society (SCCS)

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Study Document Translations

The SPRINT-SARI Protocol is now available in Spanish, the CRF is now also available in Spanish and
French all translations are available on the study website (here).

SPRINT-SARI Site Packs

Electronic site packs are available via the SPRINT-SARI Central Project Manager (email). These
documents are also available individually on the SPRINT-SARI website.

Site Packs include:

Protocol;
Case Record Form (by the Tier you are participating);
Completion Guidelines (data dictionary by the Tier you are participating);
Study Procedures Chart (by the Tier you are participating);
Database Terms of Submission document;
Electronic Case Record Form Data Entry Checklist (by the Tier you are participating);
Site Enrolment Log; and

Saudi SPRINT SARI NEWS LETTER AUG 2016

Central Database Cheat Sheet.

Southern Hemisphere and Tropical region study periods

The southern hemisphere study period commenced on the 1st July. Sites across the southern
hemisphere can now participate in SPRINT-SARI by enrolling participants into the study during a
pre-specified study week.
Site in Tropical Regions can participate at any time. Please notify the SPRINT-SARI Central Project
Manager via email if you will not be able to participate until after October 2016.
Recommendation
The SPRINT-SARI Management Committee strongly encourages all sites to participate ONLY at Tier
0 (RAPID CRF only) in 2016.

SRPINT-SARI Website
The SPRINT-SARI Website has a new TOOLBOX. The SPRINT-SARI Tool Box offers free access to
research tools and templates that have been shared by other groups, for you to adapt to suit your

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site and context. To share your own templates or tools, or to comment on the tools available in this
Tool Box, please email the SPRINT-SARI central Project Manager.

Resolving Data Entry Challenges for SPRINT-SARI

We have received a lot of valuable feedback on the initial version of the SPRINT-SARI study
documents and the data entry system. Thanks to all of you who have commented on how these
can be improved. The study documents, the online data management system, and all of the
feedback and challenges from the sites are currently being reviewed by the SPRINT-SARI working
group. As a part of our ongoing effort to evolve the quality of the study, we expect to have an
improved standard for your review at the start of 2017.
Some of the main areas of improvement identified through site feedback were:
Tier selection
Site/User registration:
Data export
Overlap in entries in Core and Rapid CRFs
Recording outcome/discharge after the study period
Time frame for data entry

Saudi SPRINT SARI NEWS LETTER AUG 2016

Inclusion criteria requires more clarity

Refining data variable nomenclature to avoid ambiguity

Meanwhile, we encourage feedback from networks and sites regarding issues in CRFs, study
protocol and the data management system that needs to be addressed in our upcoming revisions.
(Please email the SPRINT-SARI Central Project Manager)

Denominator Sub-Study
The objective of the SPRINT-SARI Denominator Study, is to collect aggregate information about
the participating hospitals, and the population that they serve, to develop and validate models that
allow extrapolation from data collected in SPRINT-SARI to the whole-of-population level. The
validation component is possible because in some regions all hospitals within a defined region are
participating in the study.
The significance of the study is that, while SPRINT SARI would be useful during an epidemic or

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pandemic to report the descriptive epidemiology of affected patients, the Denominator Study
would be useful in understanding the true population level burden of disease.

This sub-study will allow for model generation to determine the population-level burden of
hospitalized and critically ill patients with SARI, without the need to collect data at all hospitals.
Through the denominator study we aim to:
1. Develop models for extrapolation from local data to the whole-of-population level and
validate models in specific regions where all sites are participating in SPRINT SARI.
2. Extrapolate endemic SARI severe disease burden in participating locations and explore
relationships between estimated whole-of-population disease burden and factors such as
gross national income, geography and size;
The study will also enable SPRINT-SARI to achieve its secondary aims, specifically aims 1 and 8:
1. To understand the incidence of SARI; and
8. Explore the feasibility of extrapolating results obtained at participating sites to population
levels.

Saudi SPRINT SARI NEWS LETTER AUG 2016

Monash University Human Research Ethics Committee (MUHREC) has given approval to conduct
this Sub-Study. Networks and Sites will be contacted soon with information on how to participate.

SPRINT-SARI EARL Sub-study (Ethical Administrative Regulatory and Logistic barriers)

This sub-study (SPRINT-SARI-EARL) aims to follow and describe the application of SPRINTSARI for
all applicable EARL approvals in each participating region / nation. The results of the EARL substudy will be incorporated into the next Protocol and CRF update to ensure we make the SPRINTSARI EARL process as easy as possible for sites.
If you have submitted a SPRINT-SARI Ethics Committee / IRB / REB application for SPRINT-SARI,
please follow this link where they will find further explanation of the sub-study and a very short
questionnaire to complete http://prepare.ucd.ie/surveys/ index.php/985735. Once you have filled in
the short questionnaire you will be sent an Ethics Tracker to complete detailing your experience
applying for ethics approval and any barriers you faced.

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What do you need to provide for the Sub-Study?

1. Type of IRB/ Ethics Committee to which the application has been submitted (Local/single
Centre/ regional/ National);
2. Dates of application submission, responses, and approval;
3. Details of documents submitted with the application;
4. Number and type of issues raised by the IRB/Ethics committee;
5. Details of your responses to ethics committees concerns; and
6. Your overall satisfaction with the IRB/Ethics committee process.
For more information on SPRINT-SARI EARL, please visit the SPRINT-SARI website or contact:
Prasanth Sukumar: email, prasanth.sukumar@ucd.ie

SPRINT-SARI Presentations
SPRINT-SARI will be presenting at the Options IX conference being held at Chicago U.S.A from 2428 Aug 2016. The presentation will acknowledge individual site contribution through group
authorship as SPRINT-SARI Investigators. If you would like to receive a copy of the abstract or
would like to opt-out from contributing your site data please email the SPRINT-SARI Chief
Investigator

SPRINT-SARI Generic Grant Application

Saudi SPRINT SARI NEWS LETTER AUG 2016

The SPRINT-SARI working group has been applying to small funding opportunities to help support
the ongoing central coordination of the study.
SPRINT-SARI funding opportunities come up frequently but due to the nature of SPRINT-SARI it
difficult to secure funding centrally for all sites and networks. As a result, the SPRINT-SARI working
group is in the process of drafting a generic grant application. This generic grant application
consistence of modules which can be re-shaped to meet specific grant application requirements. It
is the objective of the SPRINT-SARI Management Committee to secure more stable and sustainable
funding with the desire for per patient payment in low and middle income countries. The generic
grant application will provide a template for Networks / Local Groups to re-shape the draft to
enable them to apply for local funding opportunities to support their site participation and
coordination.

For more information, visit the SPRINT-SARI Website

Or contact the Central Project Manager email.

Saudi Critical Care Society (SCCS)

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Feedback:
The SPRINT-SARI Working Group is asking all site and Networks to provide us with feedback on
ways we can improve the Case Record Form, Protocol and Central Database. If you have any
feedback, please contact the SPRINT-SARI Central Project Manager via email by 1st October 2016.

Global Co-ordinating Centre:

The Australian and New Zealand Intensive Care Research Centre (ANZIC-RC)
website
Central Program Manager: email mnhs-sprint.sari@monash.edu

SPRINT-SARI is endorsed by:

The International Forum of Acute Care Trialists (InFACT), the International Severe Acute Respiratory
Saudi SPRINT SARI NEWS LETTER AUG 2016

and emerging Infection Consortium (ISARIC), the Platform for European Preparedness Against (Re-)
emerging Epidemics (PREPARE), and the European Society of Intensive Care Medicine (ESICM).

Copyright *2016*
*SPRINT-SARI*, All rights reserved.

Saudi Critical Care Society (SCCS)

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