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We invite you to take part in anonline research study.
Help us find out whatoutcomes for pulmonarysarcoidosis are the mostimportant.
Who is this study for?Patients - who have experience of living withpulmonary sarcoidosis. Health professionals - who have experience oftreating pulmonary sarcoidosis. Researchers - who will use the core outcomesin their research). Industry representatives.
We would like to invite you to take part in theFSR SCOUT study.
Before you take part it is important for you tounderstand why the study is being done andwhat taking part will involve.
Please read this information sheet carefully.
Please get in touch if something is unclear orif you would like more information.
Contents What is an outcome?
Why are we doing this study?
What does taking part involve?
What happens at the end of the study?
Will I get paid for taking part?
Other information.
Contact information.
Link to the online survey.
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If you have any questionsand would like moreinformation about theFSR-SCOUT study pleasecontact Nicola Harman: [email protected]
Contact us
This survey focuses on pulmonary sarcoidosis. Future surveys, for other types of sarcoidosis,
will be conducted by the Foundation forSarcoidosis Research.
Participant information sheet verison 3.0 21-April-2020
Why are we doing this study?At the moment, different research studies, oftreatments for pulmonary sarcoidosis(sarcoidosis that involves the lungs), oftenmeasure different outcomes. This makes itdifficult to find out which treatments might bebest for patients as the results of differentstudies cannot be compared or combined. The FSR-SCOUT study needs your help to findout what outcomes are so important that theyshould always be measured in studies forpulmonary sarcoidosis. We call these the coreoutcomes. If all future studies for pulmonary sarcoidosismeasure these core outcomes, and measurethem in similar ways, the results of the studiescan be easily compared and combined. Thismay help new, effective treatments becomeavailable to patients more quickly.
Does it matter how an outcomeis measured?It is important to remember that in this studywe are interested in “what” outcomes should bemeasured. That means deciding whichoutcomes are the most meaningful to you whendeciding if a treatment for pulmonarysarcoidosis is working or not. There might be different ways to measure theseoutcomes or a new tool might need to bedeveloped. Deciding how each outcome shouldbe measured is important and will be decided inthe next stage of the study.
What is an outcome?When new treatments are developed andtested, researchers look at the effect those newtreatments have on patients by measuring an"outcome". For example, in a study testing a treatmentabout the common cold, an ‘outcome’ mightinclude ‘being able to breathe through your nosemore easily.’
An outcome is somethingthat is measured to helpdecide if a treatment is
working or not.
More information onoutcomes
You can watch a short [3 minute]video explaining what coreoutcomes are, why they areimportant and how patients andhealth professionals are involvedin developing them here: https://youtu.be/AlLc2yN0pII
What does taking part involve?The study will be run online and involves takingpart in two surveys. You can find out more about each survey andfuture steps on the next pages.
SCOUT PIS V3.0 21-4-2020
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Survey 1 will be open for around 6 weeks from the <date>. If you registerto take part but haven’t completed the survey, we will send you a reminderemail around two weeks after the survey opens and another a few daysbefore the survey closes.
Once the deadline for completing the survey has passed, we will analyseeveryone’s responses. This usually takes around 2 weeks. We will thenemail you an invitation and instructions on how to take part in the secondsurvey.
In the first survey, you will be shown a list ofoutcomes. For each outcome we want you to ratehow important you personally think it is to measurethat outcome in all future research of treatments forpulmonary sarcoidosis. At the end of the survey, you can also suggest otherimportant outcomes that you think are missing fromthe list.
SURVEY 120 - 30 minutes to complete
Survey 1 15-20 minutes to complete
SURVEY 230-40 minutes to complete
Week 2 reminder emailif not already completed
Reminder email if surveynot already completed
In the second survey, you will see the same list ofoutcomes from survey 1 with a reminder of your ownrating in round one. But this time, you will also see achart that shows you how the groups of people whotook part in the first survey rated that outcome. Now, when you rate the outcome, we’d like you tothink about how you and the other groups of peopletaking part in the first survey rated each outcome. This is a chance for you to consider the opinions ofothers and to reflect on your own previous ratings. We are trying to find out which outcomes patients,health professionals, researchers and industryrepresentatives can agree must always be measured.
Your opinion in both survey 1 and 2 is extremely important in developingthe core outcome set. It is very important that you complete both surveys.
Survey 2 20-30 minutes to complete
SCOUT PIS V3.0 21-4-2020
What happens after the surveys have been completed?
After the second survey has ended, we willcombine the information from the two surveysand analyse the results. Once we have done this,we will invite a group of patients, healthcareprofessionals, researchers and industryrepresentatives to a face to face meeting todiscuss the results and agree the final coreoutcomes. Unfortunately not everyone who completes thesurvey will be able to attend the face to facemeeting. However, it you would like to beconsidered for a place you can tell us at the endof the second survey. Further information aboutwhat the face to face meeting involves will besent to those interested in taking part.
Face to face meeting
Sharing the results of the study The results will be analysed and published in amedical journal at the end of the study. We willalso share a summary with relevant patient andprofessional organisations. You will not be identified in the publication unlessyou have told us at the end of the secondsurvey that you would like to be acknowledgedfor your contribution. If this is the case, yourname will be included in a specificacknowledgements section of the publication.We will not present your individual thoughts onoutcomes in the publication; rather all results willbe presented according to the different groupsthat took part (i.e. patients, healthcareprofessionals and researchers). When you register to take part, you will be ableto tell us if you would like to be sent the resultsof the study. These will be sent by email whenthe results have been published. This cansometimes be several months after you havetaken part.
After this stage of project, to decide the coreoutcomes, has been completed a second stage willdecide how best to measure each of the coreoutcomes recommended for use in researchstudies. Taking part in the online surveys now doesnot mean that you have to take part in futureproject stages. However, when you register to takepart you can tell us if you would like to be kept up todate, by email, with opportunities to take part in thefuture.
Next steps
Online survey 1 and 2 to decide whatoutcomes are the most important to
measure in future research.
Publication of the agreed core outcomes ina medical journal and summary sent to
study participants.
Second phase of the project - decidinghow each of the core outcomes should be
measured.
Face to face consensus meeting to reviewthe results of the surveys and agree the
core outcomes.
SCOUT PIS V3.0 21-4-2020
If you are unhappy, or if there is a problem,please let us know by contacting the studycoordinator, Nicola Harman ([email protected])and we will try to help. If you remain unhappy or have a complaint thatyou feel you cannot come to us with then youshould contact the University of LiverpoolResearch Ethics and Integrity Office [email protected]. When contacting the Research Ethics andIntegrity Office, please provide details of thename of the study (FSR-SCOUT, Sarcoidosisclinical outcomes task force), the ID number(5211 ) and the details of the complaint you wishto make.
What if there is a problem?
Yes. Your responses to the survey andcontributions at the face to face consensusmeeting will be labelled with a number ratherthan your name, to maintain confidentiality, andwill only be looked at by members of the studyteam. Your email will only be used to contact youabout this study. Your responses to the surveys will be stored on asecure server at the University of Liverpool forten years after the study ends.
Will my participation be keptconfidential?
Other important information
There is no payment for taking part in the onlinesurvey. If you are invited to take part in the faceto face meeting at the end of the study, we willcover your travel expenses to attend.
Will I get paid for taking part?
We do not expect there to be any major risks,although occasionally some patients can find itupsetting thinking about outcomes related totheir condition. If you do feel uncomfortablecompleting any part of the questionnaire orduring the consensus meeting you can stoptaking part at any time and, if you would like to,provide feedback on any areas of concern.
Are there any risks in takingpart?
Ready to take part?If you are ready to take part please visit the link
below to register and complete survey 1.
https://delphimanager.liv.ac.uk/SCOUT/
If you have any questions, would like more
information about the FSR- SCOUT study or
have a question about how to complete the
Delphi survey please contact
Nicola Harman
[email protected] can expect to recieve a reply within one working day.
SCOUT PIS V3.0 21-4-2020
