Information regarding participation
We would like to ask you to take part in SBU’s research study. Below you will find information about the study.
What is the project about?
In this project, relevant stakeholders will agree upon a Core Outcome Set for future treatment studies on provoked vestibulodynia. The goal of the project is to make recommendations regarding outcomes so that more studies measure those that are important for both healthcare staff and researchers as well as patients.
A Core Outcome Set is an agreed-upon standardised collection of outcomes which should be measured and reported, as a minimum, in all trials of a of a specific condition regardless of the type of treatment being studied. Examples of outcomes in this area are dyspareunia, sexual function, ability to carry out physical activities, quality of life, and level of function.
The Swedish Agency for Health Technology Assessment and Assessment of Social Service (SBU) is principal investigator (responsible for) for the project. The study has been approved by the Swedish ethical application board: (nr 2022-02091-01)
What does your participation involve?
SBU will summarise a list of the outcomes that are used in research in this area. All persons in the panel will receive two surveys, in which you are asked to rank how important you think the different outcomes are.
All participants will receive the surveys by e-mail. In the first survey, you will be asked to, from your perspective, rank how important you think the different outcomes are. It will also be possible to add important outcomes that are not listed.
Before the second survey, you will receive a compilation of the results from the first survey. Here, you will be able to see how both the entire panel and the different stakeholder groups (patients separately, healthcare staff separately, etc.) ranked the results on average. However, it will not be possible to see any individual ranking. Based on how others have ranked the results, you will have to consider whether you want to keep your original ranking or change it in the second survey.
The results from the two surveys will form the basis for a final prioritization that will take place during a consensus meeting later this year. Unfortunately, it will not be possible for everyone on the panel to attend the meeting. A separate request will therefore be made for attending that meeting later in the project. All participants who answered the questionnaires will, however, be given the opportunity to see and comment on the Core Outcome Set that is agreed upon in the meeting.
When the Core Outcome Set is agreed upon, SBU will write a report that will primarily be sent to the Swedish government but will also be disseminated to researchers and other relevant stakeholders (such as patients). The results will also be disseminated through a scientific article published in a relevant international journal aimed at researchers and clinicians in the field of sexual medicine.
We hope you find participating in this study interesting!
Possible risks associated with participation
All participants will receive two surveys, in which you are asked to rank how important you think the different outcomes are. Answering the surveys does not impose any risk. The prioritization of outcomes will be done by a panel consisting of persons who have experience (such as lived experience, research experience or clinical experience) with provoked vestibulodynia.
Before answering the surveys, participants need to register by filling out some personal information. To participate, you will need to provide us with contact information, country of residence, and your perspective in the project. You will be asked to choose from one of the following perspectives.
- Persons with ongoing or past experience of provoked vestibulodynia
- Relatives of those with ongoing or past experience of provoked vestibulodynia
- Healthcare staff
o Medical doctors (gynaecologist/ dermatologist/ general practitioner)
o Psychologists/other mental healthcare providers (sex therapists etc)
o Other relevant occupations
- Others (patient associations, research funders, systematic reviewers, HTA-personnel, decision-makers and industry).
This information is necessary in order to participate in the project.
We would also like to collect additional background information form the panel in order to analyse the representativeness of participants at a group level. This will be achieved by sending out an anonymous survey (which will be voluntary to fill in) asking for more background information, such as age and occupation but also information relevant to the condition such as sexual preferences and relationship status.
Registration to participate is not binding and participation can be suspended or withdrawn at any time during the project.
The personal information you provide will be handled confidentially and kept safe on SBU’s local servers with limited access. However, those that participate in the prioritisation meeting will have their name and perspective publicly available.
How will your information be handled?
When you register for participation, personal information about you will be collected and handled by SBU. Your information and your answers will be processed so that unauthorized persons cannot access them. The information you provide when registering will be stored on SBU's servers and only two project managers, an administrator and data Protection Officer at the SBU, will have access to the information.
If you register for the project, you will prioritize research outcomes in two consecutive surveys. This survey does not ask for any information about you, it is only a ranking of already known outcomes. The results of the surveys will be presented at group level based on the different perspectives that are represented.
The person responsible for your personal data is SBU (Christel Hellberg and Marie Österberg). According to the General Data Protection Regulation (GDPR), you have the right to access the information about you that is handled in the project free of charge, and if necessary, get any errors corrected. You can also request that information about you be deleted and that the processing of your personal data to be restricted. However, the right to delete and restrict the processing of personal data does not apply when the data is necessary for the research in question. If you want to receive more information, please contact Christel Hellberg, project manager at SBU Phone 08-412 32 79, e-mail Christel.Hellberg@sbu.se. The Data Protection Officer can be reached at email@example.com. If you are dissatisfied with how your personal data is processed, you have the right to submit a complaint to the Privacy Protection Authority, which is the supervisory authority.
More information about how SBU handles personal data can be found here.
The results from the project
All participants will receive information and be able to comment on the final set of outcomes that are to be included in the Core Outcome Set. When the project is finished, a report written in Swedish will be available on the SBU webpage. In addition, a scientific publication in English will be submitted.
There will be no financial compensation for taking part in the project.
Participation is voluntary
Registration to participate is not binding, and participation can be suspended or withdrawn at any time during the project. You do not need to state any reasons for cancelling your registration. If you chose to cancel your participation, please contact Christel Hellberg at Christel.Hellberg@sbu.se.
Who is responsible for the project?
Responsible for the project are Christel Hellberg and Marie Österberg at SBU.
If you have any questions or concerns, please feel free to contact us:
Registration to participate
Registration to participate is not binding, and participation can be suspended or withdrawn at any time during the project.
By registering, SBU will process your personal data. More information about SBU's personal data processing can be found here.