Project Flashcards
NTOS is a rare condition- why is it worth investing in compared to something more common?
- 2-10 per 100,000 incidence- similar to TB in UK
- classed as a rare disease by DHSC ‘rare disease action plan’ which states we need to
- increase awareness among HCP
- increase access to specialist care
- improve co-ordination of care - high disability scores and low QoL
- 70% of pt current fail cons care and require more expensive options like surgery @ £9500 per op
- pts have symptoms for approx. 3 years before accessing specialist care
- NTOS clinicians and patients feel more research is needed into physio and NTOS
there is a novel and significant gap in the literature
What is / how will you define usual care for NTOS in your RCT?
- our impetus study team have published a survey of UK clinicians asking them their usual assessment and treatment modalities
- we know most clinicians state they don’t have treatment guidelines and they all favour more research into this topic
- we would take inspiration from other therapy RCT (UKFROST, GRASP, FIRST, OPTIMISE)
- we will define it by the consensus exercise
- capture usual care by using CRFs to capture Rx data
- from our UK survey it normally involves advice and education and ROM
Can you justify your sample size for your RCT / NGT phases?
Toton et al (2023) reviewed average sample sizes in pilot and feasibility studies between 2013-2020
Over 761 studies the mean was 30
- taking a pragmatic approach for timeframes / limitations of the fellowship
- currently at UHB we receive approx 12-14 NTOS referrals per month
- we also have EOI from other specialist centres in London , derby , Southampton and Wolverhampton
- NGT is recommended for guideline development when high quality evidence is lacking and advocated by NICE
Why have you chosen NGT over other consensus methods ?
Consensus group techniques recommended for guideline development when high quality evidence is lacking and are advocated by NICE
- this methodology has been used in similar studies and NIHR funded fellowships (OPTIMISE , COMBINE)
- my supervisory team have experience of implementing it and I have been part of projects before
I considered a Delphi but decided on NGT due to it being
- live
- moderator led
- idea generating and live discussion
I feel it’s the right method to currently answer my research question
You have stated you will do a pilot and feasibility RCT- what is the difference between them ?
Feasibility
Asks weather something can be done me should we proceed with it and if so how
Pilot
Same questions but also a specific design features
E.g part of the full study is conducted on a smaller scale
Impetus
Feasibility for recruitment , retention , delivery of RX
Why have you chosen to do a multi-site / specialist centres in your RCT when u state your aim is for non specialist physios to be able to use it ?
Correct
Global aim is to develop an intervention that can be used by non specialist centres, so NTOS pts have
- increased recognition
- better physio RX
- better outcomes
But
Currently to recruit patients and test feasibility we need specialist centres with higher volumes of patients
If successful we hope it could be rolled out nationwide / across Europe
How will you ensure your participants are as diverse as possible?
Diversity is important and shapes research
We know ethnic minorities participate in research less
Impetus
Recruit from 3 sites in diverse areas of the country
Birmingham , West Midlands , London
PIS/ facing material informed by PPIEgroup members and available in multiple languages
Physitrack is also available in 11 languages and models represent all demographics / disabilities
NIHR race equality group (REPAG)
If physio is ineffective- why don’t we research surgery instead if we know it works ?
The truth is we don’t know because of NTOS
- poor recognition
- chronicity
- heterogeneity of treatments which means we can’t compare
Surgery is not without risk and very costly (£9500 per surgery)
Most patients could potentially avoid surgery with quicker more effective physio Rx
AHP research is valuable -
cost patients, time, loss of earnings, NHS costs
Pilot project patient and clinicians feedback
What relevant research has already been completed in this area of proposed research ?
- Cochrane review 2014 (polvsen)
- low quality evidence & only 2 RCTs nil comparing conservative management
- Thompson 2013 development of CDC
Illig 2014 development of SVS reporting standards - balderman validation of CDC to PROMs
- x2 prospective studies (balderman 2018) and Peaser (2021)
- 2022 first RCT (STOPNTOS)
2022 European consensus project
2023 UK survey of NTOS clinicians - impetus team
How will your research build on the current evidence base and how will it be different ?
Will add to the evidence base for therapy which is currently lacking
Attempt to standardise therapy programmes which will allow more homogeneous comparisons
Can build on prospective studies ( balderman and pesser) which nicely use CDC
SR update from 2011
Scoping rv from 2022 mostly highlighted varying clinical practise and limited comparable outcomes
Currently 70% fail cons care
Physio is poorly understood with no RCT
There is scope to improve this
What impact will your project have ?
What similar projects have already been completed ?
Similar projects
-GRASP (shd pain)
-OPTIMISE (tennis elbow )
-FIRST (flexor tendon)
Impact
Address novel and sig gap in the literature
Clinicians and patients keen for more research
Develop clinical guidelines for NTOS
Support capacity building for treating
Improved accessibility for physio
Address elements of NOHR remit and NHS long term plan
Future scalability and commercialisation of digital components
What are the main limitations of the research project and how have you tired to mitigate them ?
Diagnosis of NTOS
Can be difficult but knowledge of available evidence base and use of CDC and it’s validation have been completed and the prospective studies have shown how to carry out a trial
Lack of other high quality research is why I have picked a consensus exercise to help develop the intervention
Have you made any changes to the research proposal since submission ?
NGT will use patient representatives not PPIE members
PPIE costing
? Have costed for travel to meetings and no dissemination costs
SoRCAT costs - were competed with UHB R&D and WM CRN but may need to be looked at
Kings fund course - I have missed VAT off but I have costed for accommodation that I likely don’t need
What type of mixed methods research will you use in phase 3 ?
Why have u chosen this method ?
There are 4
1. Explanatory- quant then qual
2. Exploratory - qual then quant
3. Parallel convergent- qual and quant concurrently
4 nested
I will use parallel so I can adapt to changes quickly
Mixed methods will generally provide pt with a stronger voice which is a positive but it does take more resources
I feel it’s the right method to currently answer my research question
What do you hope to gain from Doing a SR in phase 1?
Confirm up to date research on exercise for NTOS
Update current SR from 2014
List important features of potential physio treatments
Provide evidence summaries for phase 2
Confirm efficacy of physio interventions
