How does a study get on to the reporting card?
The British Ophthalmological Surveillance Unit (BOSU) encourages anyone with a research interest to submit a proposal for a study to be included on the report card and if you have an idea it can be helpful to contact the unit for an informal discussion. The unit is always happy to offer advice and assistance to help with questionnaire design, or methodological issues. (firstname.lastname@example.org)
The first step is to submit a Phase I application (phase 1 form). This is a short outline proposal (up to two sides of A4), which should summarise the aims and objectives of the study and detail its suitability for inclusion on the card. The BOSU will review all phase 1 applications positively and even if the initial proposal is not suitable we will endeavour to help applicants amend their proposal to one that will fit in with our considerations:
- Rarity. The condition of interest must be rare enough to require ascertainment of cases on a national scale in order to generate sufficient numbers for study. This will usually be considered as an estimated annual UK population incidence of less than 350 cases.
- Case Identification. The study must be of a condition or complication that can be clearly defined and identified by reporting ophthalmologists.
- Quality of Proposal. It is expected that all studies will by the time they start, be of high quality in terms of clear and achievable objectives, robust methodology, and confidentiality of patient information. However, the BOSU is also committed to assisting potential investigators, especially those less experienced in research methodology, in improving potentially good studies.
- Public Health Importance or Scientific Importance: Proposals with clear implications of public health importance or of specific scientific interest to the ophthalmological community are prioritised.
All accepted phase 1 applications are then moved to Phase 2. This is in effect the full study protocol, and will include the full methodology, and provides copies of any questionnaires and covering letters that will be sent to reporting ophthalmologists. This application is also subject to a peer review process involving two ophthalmologists and an ophthalmic epidemiologist, who then report to the full steering committee for assessment. All questionnaires are assessed for size and content, BOSU also requires that a suitable piloting process has been undertaken.
To complete the second stage of the application process, applicants have to provide evidence that their study has sufficient funding arrangements, and has gained ethical permission from their local research ethics committee. However, because surveillance is nation-wide it is the individual researchers responsibility to obtain further ethical committee approval where required.
Once Phase 2 has been completed the applicant is then invited to attend a BOSU Steering Committee meeting to present the project to the committee for final acceptance. This allows the committee to meet the applicant and answer any outstanding queries that members may have.