Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000167662
Ethics application status
Approved
Date submitted
5/02/2014
Date registered
11/02/2014
Date last updated
2/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
What is the optimum way to approach external clinical vignette reviewers for the National Institute for Health Research's Health Technology Assessment (NIHR HTA) programme?: a factorial Randomised Controlled Trial
Scientific title
How do different approaches to obtaining information from clinical experts affect the quality of advice received in the NIHR HTA programme?
Secondary ID [1] 284038 0
nil known
Universal Trial Number (UTN)
U1111-1153-0628
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Engagement of clinical experts with the research prioritisation process 291092 0
Condition category
Condition code
Other 291435 291435 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Public Health 291436 291436 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clinical experts who have agreed to provide advise to the NIHR HTA programme's vignette process (used to help prioritise questions for pragmatic clinical research) will be sent either a short (1 page- the intervention)) or long (up to 10 page - usual control) paper, and asked to provide advice on it using either a structured form (control) or free text (intervention) to reply.

As a 2x2 factorial study the randomisations are short v long paper; and structured form v free text

It is anticipated that the control group options (long paper and structured form) will take less than an hour to complete, with the intervention options (short paper and free text) shortening the required time for the participant.
Intervention code [1] 288730 0
Other interventions
Comparator / control treatment
Usual practice - the long paper and a structured form.

The papers sets out a research question in Population-Intervention-Control-Outcome format, and provides epidemiological and clinical information about the question - such as prevalence or incidence of a disease, costs of the interventions to be studied, and a summary of previous and current research.

The structured form asks "How important do you think this research question is to the NHS", "2. Does the proposed research address the uncertainty and need for research described? If not – What would be a better question/proposed type of research required to get an answer?", "Is this the right target group and setting?", "Is the study design appropriate?", "Are you aware of any relevant published research?", "Are you aware of any relevant research in progress", "Do you have any other comments that you think are important?"

It is anticipated that the control group options (long paper and structured form) will take less than an hour to complete.
Control group
Active

Outcomes
Primary outcome [1] 291420 0
Usefulness of response, assessed using a 5 point Likert scale, by the writing teams who will use the materials provided by the expert.
Timepoint [1] 291420 0
On receiving the response from the expert
Secondary outcome [1] 306729 0
proportion of experts approached who complete and return the requested work within agreed timescales
Timepoint [1] 306729 0
at end of agreed timescale (will vary with each expert, but is agreed prospectively)

Eligibility
Key inclusion criteria
Vignettes - all vignettes prepared during the Autumn 2013 and Spring 2014 prioritisation rounds of the NIHR HTA Programme

Experts - all clinical experts included to comment on the prepared vignettes
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Vignettes
- those which ask a methodological, rather than clinical question
- vignettes where the responsible CA does not want external experts
- Vignettes which have been through previous external review, other than as a
panel topic

Experts
- Non-clinical experts, eg PPI advisors, methodologists. Clinical-Academics count as clinical experts. The final decision as to whether an advisor is 'clinical' rests with the Steering Group responsible for the vignette, who may take advice from the relevant CA
- People who have provided advice on the panel topic from which the vignette was derived
- Current and previous members of HTA prioritisation and TIDE panels

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants assessed for eligibility by a researcher, in order of their accepting work for the programme. The order is determined by the time stamp of receipt of their email indicating acceptance.

If the researcher can't decide on eligibility the decision is made by the chief investigator.

Once the eligibility decision is made, group allocation is made by an administrator, using a regenerated randomisation schedule. The researcher and chief investigator do not have access to the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permuted block allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Regression using variables such as: type of material sent, mode of response, clinical area of topic, to determine which combination of approaches produces the most useful responses.

The number of participants was determined pragmatically, based on how many could be recruited in the time available.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/01/2014
Actual
16/01/2014
Date of last participant enrolment
Anticipated
30/05/2014
Actual
9/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
460
Recruitment outside Australia
Country [1] 5806 0
United Kingdom
State/province [1] 5806 0

Funding & Sponsors
Funding source category [1] 288666 0
University
Name [1] 288666 0
NIHR Evaluations, Trials and Studies Coordinating Centre
Country [1] 288666 0
United Kingdom
Primary sponsor type
University
Name
Faculty of Medicine, University of Southampton
Address
Building 85
Life Sciences Building
Highfield Campus
Southampton
SO171BJ
Country
United Kingdom
Secondary sponsor category [1] 287374 0
None
Name [1] 287374 0
Address [1] 287374 0
Country [1] 287374 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290516 0
Faculty of Medicine Ethics Committee, University of Southampton
Ethics committee address [1] 290516 0
Ethics committee country [1] 290516 0
United Kingdom
Date submitted for ethics approval [1] 290516 0
14/11/2013
Approval date [1] 290516 0
12/12/2013
Ethics approval number [1] 290516 0
8192

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46050 0
Dr Andrew Cook
Address 46050 0
Wessex Institute, University of Southampton
Alpha House
Enterprise Road
Southampton
SO16 7NS
Country 46050 0
United Kingdom
Phone 46050 0
+44(0)23 8059 5586
Fax 46050 0
Email 46050 0
andrewc@soton.ac.uk
Contact person for public queries
Name 46051 0
Andrew Cook
Address 46051 0
Wessex Institute, University of Southampton
Alpha House
Enterprise Road
Southampton
SO16 7NS
Country 46051 0
United Kingdom
Phone 46051 0
+44(0)23 8059 5586
Fax 46051 0
Email 46051 0
andrewc@soton.ac.uk
Contact person for scientific queries
Name 46052 0
Andrew Cook
Address 46052 0
Wessex Institute, University of Southampton
Alpha House
Enterprise Road
Southampton
SO16 7NS
Country 46052 0
United Kingdom
Phone 46052 0
+44(0)23 8059 5586
Fax 46052 0
Email 46052 0
andrewc@soton.ac.uk

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.