Tamiflu prescribing by doctors in hospitals
| ISRCTN | ISRCTN18249297 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18249297 |
| Secondary identifying numbers | RHM 1280 |
- Submission date
- 27/10/2015
- Registration date
- 29/10/2015
- Last edited
- 10/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
There has been uncertainty over the effectiveness of drugs called neuraminidase inhibitors, such as oseltamivir (Tamiflu) for the treatment of influenza. Despite this their use is recommend by national guidelines providing certain conditions are met. Recently some studies run during the swine flu pandemic have been published and suggest large benefits from these drugs in unwell hospitalised patients with influenza. It is not known how often UK doctors prescribe neuraminidase inhibitors to patients with influenza or whether they use them in line with current guidelines. This questionnaire-based survey aims to find out how UK physicians are currently using these drugs in hospital and whether their practice is consistent with guidelines.
Who can participate?
Participants should be physicians based in a hospital in the UK that frequently manage patients that suffer from influenza and work in in infectious diseases, microbiology, respiratory medicine, acute medicine, emergency medicine or geriatric medicine. Recruitment of participants will be via relevant medical societies.
What does the study involve?
All participants are given access to an online questionnaire via a link sent out to them by the medical society that they belong to. They all have one month to complete the questionnaire and are sent a reminder after two weeks. Once all the questionnaires have been sent out and completed. Analysis is performed by the research team to investigate physicians neuraminidase inhibitor prescribing practices, whether these guidelines are consistent with current UK guidelines and why any differences may occur.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Southampton General Hospital (University Hospitals Southampton Foundation NHS trust) (UK)
When is the study starting and how long is it expected to run for?
July 2015 to September 2016
Who is funding the study?
University Hospitals Southampton Foundation NHS Trust (UK)
Who is the main contact?
Dr Tristan Clark
Contact information
Scientific
LF101, South Academic block, Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | On-line questionnaire-based survey of UK hospital physicians |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Neuraminidase inhibitor prescribing by physicians in the UK: a questionnaire-based survey of practice |
| Study objectives | Given the controversy relating to the efficacy of neuraminidase inhibitors, UK guideline discrepancies and the recent published evidence from observational studies of hospitalized adults, data regarding current NAI prescribing practices among UK hospital-based physicians is urgently needed. This questionnaire based survey of practise aims to address this need. Objectives: 1. To explore the neuraminidase inhibitor prescribing practices among UK hospital-based physicians using a questionnaire based survey of practice 2. To compare prescribing practise to current UK guidelines 3. To explore factors associated with deviation from guidelines |
| Ethics approval(s) | Faculty of Medicine Ethics committee, University of Southampton, 25/09/2015, ref: 17321. |
| Health condition(s) or problem(s) studied | Influenza |
| Intervention | The basis of this study is a online survey developed to explore current UK physician knowledge of existing neuraminidase inhibitor prescribing guidelines and self-reported prescribing practice for adults hospitalised with suspected influenza. The survey is electronic and uses the 'survey monkey' platform. The link is sent out via the listed professional societies to its physician members. The members have one month to respond following the initial email invitation and are sent a reminder after two weeks. One month after last society has sent it out we will close the survey and collate and analyse the results. The exact date of this will depend when the societies send it out which in turn depends on the speed at which it goes through their individual governance procedures. Analysis will be performed by the research team in conjunction with a medical statistician. Prism (GraphPad Software Inc; La Jolla, California) and SPSS (SPSS, Inc; Chicago, Illinois) will be used for statistical analysis. Demographic details (including place of work, speciality and seniority), influenza testing method and guideline awareness will be described using proportions. For guideline compliance, assessed using the scenarios provided, compliance will be described for PHE and NICE guidelines using proportions and compared using Chi squared and Fisher’s exact test. Factors associated with guideline compliance will be explored using univariate and multivariate analysis. Subgroup analysis will be by scenario and by speciality of respondent. |
| Intervention type | Other |
| Primary outcome measure | Self reported neuraminidase inhibitor prescribing practice and adherence to National guidelines. Collected and analysed one month after last surveys have been sent out. |
| Secondary outcome measures | Differences in practice between specialities. Collected and analysed one month after last surveys have been sent out. |
| Overall study start date | 01/07/2015 |
| Completion date | 30/09/2016 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1000 |
| Total final enrolment | 237 |
| Key inclusion criteria | 1. A hospital-based physician (consultant or specialist registrar grade or equivalent) 2. Working in the UK and managing patient with suspected influenza 3. Working in infectious diseases, microbiology, respiratory medicine, acute medicine, emergency medicine or geriatric medicine |
| Key exclusion criteria | Not meeting any of the inclusion criteria |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
"ROR" |
https://ror.org/0485axj58 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/10/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We plan to publish the results of the study sometime in the autumn 2016. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/07/2021 | 10/05/2021 | Yes | No |
Editorial Notes
10/05/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
