EVOLUTION
Evaluating a new rapid test for urinary tract infections in women
Background and trial aims
A urinary tract infection (UTI) is an infection that affects the bladder or waterworks. UTIs are very common and are often treated with antibiotics. However, not all UTIs are caused by bacteria, meaning antibiotics are not always needed. Taking antibiotics when they are not needed can cause side effects and can make antibiotics work less well in the future.
The EVOLUTION study is looking at a new, quick urine test known as the Sysmex-Astrego PA-100 system, that can be done in GP practices or pharmacies. The test can if bacteria are likely causing symptoms and which antibiotic is most likely to work, with results in around 45 minutes.
We want to see if using this new test, alongside usual NHS care, can help reduce unnecessary antibiotic use while still helping people get better safely.
WHO CAN PARTICIPATE
Adults registered at a participating GP practice or pharmacy can take part if they were assigned female at birth, are aged 18 or over, and have symptoms of a suspected urinary tract infection.
Text formatting
Formatting body text as bold or italic, should not be used as a substitute for subheadings, but may be helpful in limited amounts for picking out certain key details.
Click here to download the PHC website style guide.
Images and videos
You may need to be clever with how you arrange images and videos on the page, as Haiku has very limited functionality and full-width items may dominate too much of the page at maximum scale. This introductory section will usually have a width of '9' in Haiku, whereas images should ideally not be wider than '8' – and should perhaps therefore be shown further down the page. It is advisable to play around with dimensions options on the layout tab when inserting an item of media, and include empty columns where an indent or centring is necessary. See below for examples of well-formatted videos.
Embedded images must also contain alt text or a caption to ensure that the image can be electronically read. This can be entered when selecting an image for insertion.
However, graphics that primarily rely on text content (such as conference posters) should not be used anywhere on the page. This is not only because graphics are inaccessible for people with visual impairment (hence the need for alt text), but also because the website scales images with screen dimensions and browser window size, often rendering such windowed images illegible.
It is also advisable to provide a lead-in or title before videos clarifying how their content relates to the text, for reasons of accessibility and flow.
If you do not have any study images that you can use, you can source stock images for your page here.
White space
Unfortunately, the basic nature of Haiku tools means that it is very difficult to create a properly optimised page where everything is correctly scaled, and where sections follow on from one another without large empty gaps. Although correct scaling of media should be a primary consideration when designing your page, you will also need to keep an eye on how the length of different columns in the layout may also affect its appearance.
In this example page, I have minimised the amount of empty white space by expanding the main text column to full width after the sidebar ends. Where possible, you should counterweight media in one column with text or even other media in another; however, where it is too difficult to do this without disrupting flow, it is best simply to be neat. See the centred video below, and the two columns beneath that, for examples.
Who can participate?
This should be precise outline of the characteristics or medical history of participants being recruited.
If multiple different types of participants are being sought, this can be framed with ‘and/or’ statements, and may be best presented in a bullet pointed format.
It is also imperative to state how participants are being recruited (if not in this section, then in the subsequent one explaining how the trial will function); any action needed on the part of potential participants must be foregrounded as much as possible. If GPs will be inviting their patients, then say so – you will avoid unnecessary enquiries arriving in your trial inbox!
Furthermore, it is strongly advisable to state where the trial is recruiting. This can be kept in general terms in this section – i.e. "participating surgeries in the West Midlands CRN" rather than a written exhaustive list of all GP surgeries. If listing all participating surgeries is needed, this would best be done in an embedded Google Map further down the page, as shown below.
(Note that this section has been picked out in a "highlighted" blue box. Try to avoid overusing these in the main body to avoid making the page look too "busy" and clashing with the sidebar to the right.)
The trial logo should be included in high fidelity, preferably in a scalable vector file format. The file name should be "[STUDY] Logo". This tile can either be a "featured" tile or a "banner image" tile.
Trial status: "Set-up" / "Recruiting" / "Follow-up" / "Closing" / "Closed"
Trial duration: DD MMM YYYY - DD MMM YYYY
or
Expected end date: DD MMM YYYY
or (for platform trials)
End date of current recruitment phase: DD MMM YYYY
Contact Details
Email: suchandsuch@phc.ox.ac.uk (make sure the email link is live!)
Phone: 01865 000000
Participant Information Documents
Partner Organisations
What are the respective roles of any different teams and partner organisations? Provide links to their web pages!
e.g.
Primary Care Clinical Trials Unit – Lead and Primary Care Recruitment
Brighton and Sussex Clinical Trials Unit – Secondary Care Recruitment
What does the trial involve?
This section should outline what the participant should expect on enrolling into the study, including details such as location, number of appointments, details of trial groups if applicable (i.e. control and intervention), medication prescriptions, and duration of follow-up.
Again, this should not go to the same thorough lengths as the participant information sheet, but should nevertheless give a good impression to the interested reader about what the different stages of the trial entail.
An example of a video 'size-controlled' and centred using Haiku layout tools:
Practice Recruitment
This is an example of an optional section in which to expand on the number and location of participating primary care sites.
Lead-in text for the interactive map might read:
"A sample of approximately 40 GP practices will be recruited from within the West Midlands CRN to include different practice types according to list size, deprivation index, rural/urban location and practice type.
"The current list of GP practices participating in the FOUND study have been plotted on the map below:"
Press Releases
An example of another optional section, with links to press releases and news articles, and followed by a video with a title.
The staff sections below should be among the last items on the page, after all trial information but before the funding section.
At the very least they should include the Oxford trial team and Oxford co-investigators in two columns. As with images and videos, scaling can be somewhat problematic, so if only these two columns exist you will need to ensure that they are no more than '5' wide in Haiku Layout. (See the TOUCAN study for an example of a two-column layout.)
Also, to minimise white space, you may need to play around with the length of the list displayed – if there is only one investigator, as shown here, the Oxford trial team is best limited to a length of three.
Note also how the external co-investigators have been included using a table to imitate the team list format.
OXFORD TRIAL TEAM
-
Joy Rahman
Senior Clinical Trials Manager
-
Anne Smith
Clinical Trials Manager
-
Jenna Grabey
Clinical Data Manager
Oxford Co-Investigators
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Professor Michelle A Miller
Co Chief Investigator
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Professor Francesco Cappuccio
Co Chief Investigator
EXTERNAL CO-INVESTIGATORS
University of Bristol |
University of Warwick |
Funding Details
The 'Funding Details' section should include all of the information below, with the logos of funding sources arrayed to the left.
"The XXX trial is funded by [as an example] the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme."
REC: XX/XX/XXXX
IRAS: XXXXXX
Registration: ISRCTNXXXXXXXX
Related Publications
This section should contain only details of publications related to, or arising from, the clinical trial, and should include a link to the relevant online journal. Obviously, trials in early stages may not have any such publications and may dispense with this section until they do!
e.g.
A pilot study of a wearable apnoea detection device. BMJ Open 2014
Accuracy and usability of AcuPebble SA100 for automated diagnosis of obstructive sleep apnoea in the home environment setting: an evaluation study. BMJ Open 2021