HTA update: Multi-morbidity or rather multiple long-term conditions!
Created on Tuesday, 12 Nov 2019.
This month's update from HTA addresses who should be included in clinical trials in relation to multi-morbidity.
Multiple long-term conditions are not easy to research as the understanding of disease clustering whether genetic, early risk factors or attributes of age, poverty and geography is still at an early stage, but what we can do is be more vigilant as to who we include in clinical trials. Unless there are very good reasons to exclude people then researchers should strive to include those who are often in the past been excluded from trails such as those with multiple long-term conditions.
It’s recognised that being more inclusive might result in slightly larger sample sizes and data from efficacy studies might not be the best on which to base planned sample size calculations but we need to try and base our clinical trial plans on as much real world NHS data as possible.
Also including lots of different people in clinical trials risks diluting the ability to detect changes, as some groups are less likely to benefit from the intervention or they may have much poorer follow up data, but we must do what we can to achieve a reasonable balance.
HTA will be looking carefully at exclusion criteria in applications. Study populations should be a sensible balance between feasibility, cost and the ability to generalise to the wider NHS population.
NIHR Guidance update for applicants on Equality, Diversity and Inclusion for study participants
Created on Monday, 04 Nov 2019.
Guidance for applicants on Equality, Diversity and Inclusion for study participants: Every person eligible to take part in research should be offered the same opportunity of taking part in that research regardless of:
Gender including gender reassignment
Being pregnant or on maternity leave
Disability including diminished mental capacity
Ethnicity, religion or belief
Access to healthcare
Applicants should demonstrate how these factors have been considered and addressed in their proposal, including steps taken to ensure the research sample is representative of the population the study is targeted at.
Hundreds of practice nurses across the country have been taught how social media can improve health thanks to the success of one of NHS Digital’s Widening Digital Participation projects
Created on Friday, 01 Nov 2019.
Following a pilot using Facebook to promote breast screening, one area saw a 12.9% increase in the take-up of screening services and moved from 58th in the country for uptake to 11th. The same techniques are now being used to encourage patients to go for other cancer screening tests. Around 350 general practice nurses and other practice staff have so far been trained as “digital health champions”, including learning how social media can help promote practice services.
Guidance on whether an intervention is ready for HTA evaluation
RDS EM newsletter with an editorial from Caroline Nicholson one of the NIHR Training Advocates. The issue also features the Adult Social Care Outcomes Framework and the new Essence toolkit with case studies looking at intervention, cost effectiveness and the nature of evidence in adult social care.
The Adult Social Care Outcomes Toolkit (ASCOT) is a novel method for determining the impact of services. ASCOT tools measure the domains of quality of life more affected by social care - key outcome is social care-related quality of life (SCRQoL).
In order to use ASCOT tools you have to register and obtain a licence.
Adult Social Care Outcomes Framework (ASCOF)
Created on Wednesday, 09 Oct 2019.
The Adult Social Care Outcomes Framework (ASCOF) measures how well care and support services achieve the outcomes that matter most to people. The measures are grouped into four domains which are typically reviewed in terms of movement over time. Data is provided at council, regional and national level.
The toolkit aims to help those planning and shaping services and treatments for adult people with social care needs and their carers make informed decisions about which services and treatments to provide and how much they cost.
The toolkit is available here and is a collection of case studies looking at intervention, effectiveness, cost-effectiveness and the nature of evidence
Guidance on how to develop complex interventions to improve health and healthcare
Created on Monday, 07 Oct 2019.
This guidance on intervention development presents a set of principles and actions for future developers to consider throughout the development process. There is insufficient research evidence to recommend that a particular published approach or set of actions is essential to produce a successful intervention. Some aspects of the guidance may not be relevant to some interventions or contexts, and not all developers are fortunate enough to have a large amount of resource available to them, so a flexible approach to using the guidance is required. The best way to use the guidance is to consider each action by addressing its relevance to a specific intervention in a specific context, both at the start and throughout the development process.
Bias in clinical trials
Created on Monday, 07 Oct 2019.
If you are aware of a significant potential for bias when designing a study, to address an important question to the NHS, then name it. Demonstrate in your application that you recognise the bias and come up with ideas on how to tackle it! The funding committee will otherwise identify it and it will be seen as a fault that has been overlooked and confidence in your team will be lost.
When answering a commissioned brief look out for the phrase 'applicants to define', it's a recognition that bias if a strong possibility and provides applicants with the opportunity to demonstrate creatinve solutions to address it.
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