Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RHM 1280
Study information
Scientific title
Neuraminidase inhibitor prescribing by physicians in the UK: a questionnaire-based survey of practice
Acronym
Study hypothesis
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
Faculty of Medicine Ethics committee, University of Southampton, 25/09/2015, ref: 17321.
Study design
On-line questionnaire-based survey of UK hospital physicians
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
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 trial start date
01/07/2015
Overall trial end date
30/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
1000
Participant exclusion criteria
Not meeting any of the inclusion criteria
Recruitment start date
01/10/2015
Recruitment end date
30/09/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals Southampton Foundation NHS trust
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospitals Southampton Foundation NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We plan to publish the results of the study sometime in the autumn 2016.
Intention to publish date
01/10/2016
Participant level data
Not expected to be available
Basic results (scientific)
Publication list