Research Design Service: East Midlands

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Top ten tips for developing and using progression criteria for internal pilot studies

  Created on Tuesday, 11 Feb 2020. Posted in Design Tips

From the BMJ Journals: Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies

1. A traffic light system of green (go), amber (amend) and red (stop) might be preferable to a simple stop/go approach when specifying progression criteria for internal pilot studies;

2. Pre-specified progression criteria agreed with funders need to strike a careful balance between being firm enough to promote ambition in the trial team yet being flexible enough to allow opportunities to remedy early problems;

3. Recruitment progression criteria should be based on rates per centre per unit time (eg, per month) that can be easily extrapolated, rather than specifying that an absolute number should be reached by a specific date, due to the unpredictability of opening sites;

4. When recruitment falls behind, it is essential to explore screening logs to determine whether insufficient participants were approached, insufficient participants passed eligibility criteria or insufficient eligible participants agreed to randomisation;

5. The assessment of intervention adherence, cross-over and outcome event rates should take into account the duration from randomisation to timing of primary outcomes if sufficient data are to be gleaned in time to inform progression;

6. When assessing missing data, it is important to explore the degree of missing data within key outcomes as well as the percentage of participants with missing data;

7. Trial teams should involve both their funders and their Trial Steering Committee in assessing their progression criteria;

8. Pilot study recruitment sites should be representative of sites that recruit into the main study;

9. Triallists may be able to take the opportunity to assess whether changes to existing technologies have occurred since the original study was planned, so that new technologies can be considered with funders, such as using an adaptive design;

10. Pilot studies need to be reported fully. An extension to CONSORT guidelines for pilot and feasibility studies is now available.

Young people's mental health and wellbeing research report

  Created on Monday, 10 Feb 2020. Posted in Literature | Mental Health | Young People

Over the past three years, Healthwatch England has heard from over 20,000 young people about their experiences of mental health support. To gain a deeper understanding of this issues, they brought together 47 young people, aged 16-25, to talk about what affects their mental health, their current experiences of care, and what services can do to better support them. The key findings are below but the full report is online.

What do young people want their mental health support to look like?

  1. Better education and communication, such as mental health awareness days in school and regular mental health check-ups every six months.
  2. More options for treatment and personalised care, such as more flexible appointment times and access to different types of therapies.

  3. Opportunities for peer support with others who have a mental health condition. 

NIHR Themed Review Better Health and Care for All

  Created on Monday, 10 Feb 2020. Posted in Literature

This review brings together NIHR-funded research for and about health and social care services for people with learning disabilities. Work is needed to improve care for these people, who experience poorer health and die earlier than the general population. Many of these deaths could be prevented by public health interventions or better access to high quality care. This review features 23 recent studies with important findings for those who commission, deliver, work in and use these services. These range from qualitative research on user experience to randomised trials of complex new services. Many of these studies involved people with learning disability and family carers in the research and in delivering some of the interventions.

This review looks primarily at studies of health and social care services targeted at people with lived experience of learning disabilities and their families. It excludes studies specifically concerned with autism because these may relate to separate pathways and services. Although there is a small number of studies on services for children, most are on services for adults. The NIHR has funded many studies on the effectiveness of individual interventions, from drugs to psychological therapies, but the focus of this review is on services for people with learning disabilities. These interventions are only included where the study is also about how this works in the context of health and social care services.

Participatory data gathering with Ketso

  Created on Monday, 03 Feb 2020. Posted in Toolkit/Database

This online toolkit looks at when and how in the research process participatory data gathering can be used, and explores key issues to consider when designing your research. Participatory data gathering can be a mutual learning experience, increasing the value to participants, as well as generating rich data. As well as core principles, the video introduces Ketso, a hands-on and visual toolkit, which makes participatory data gathering easier.

NIHR researchers develop new way to measure multimorbidity

  Created on Monday, 03 Feb 2020. Posted in Toolkit/Database

The new Cambridge Multimorbidity Score is a transparent, simple measure of multimorbidity that can predict different outcomes in people with multiple conditions. The score which includes 20 conditions could help people planning clinical services or allocating healthcare resources to respond to the needs of patients with multiple health conditions.

Updated Health economics guide for public health teams

  Created on Wednesday, 29 Jan 2020. Posted in Health Economics | Guidance

In this guide you will find links to tools and reports that can help you:

  • assess which interventions provide the best value for money, by calculating their costs, benefits and ROI
  • make the most of your budget by deciding how to split resources across different public health programmes
  • compare costs, savings and clinical outcomes

These evidence resources are relevant for local decision makers as well as national policymakers.

The cost-effectiveness of specific topic areas

PHE’s Health Economics team has produced a number of resources which can be used to estimate the value of investing in prevention and early diagnosis in your area. They pull together the best available evidence on costs, savings, and health benefits for specific topic areas in a single place, thus simplifying the process of commissioning cost-effective services.

Annual information on the health and care of people with learning disabilities from NHS Digital

  Created on Tuesday, 28 Jan 2020. Posted in Literature

Health and Care of People with Learning Disabilities, 2018-191 summarises data relating to 54% of patients in England on key health issues for people recorded by their GP as having a learning disability. It also includes comparative data about patients recorded by their GP as not having a learning disability, to show differences in health and care between the two groups.

For the first time, this publication contains a standardised mortality ratio, comparing mortality for those with a learning disability against those without.

Statistics about the prevalence of various health conditions, such as epilepsy and heart disease, are also included.

King's Fund dementia friendly environmental assessment tools

  Created on Wednesday, 22 Jan 2020. Posted in Dementia | Toolkit/Database

The King's Fund dementia friendly environmental assessment tools for wards, hospitals, care homes, housing and health centres were launched in 2014 and are now hosted by the Association for Dementia Studies. They are widely in use both nationally and internationally and are freely available to download at

CAHPR's Top Ten Tips series

  Created on Monday, 20 Jan 2020. Posted in Guidance

Council for Allied Health Professions Research (CAHPR) have created a brief summary advice on key topics for novice, ealry career and experienced researchers. Each guide has a top 10 tips sheet 

  • Becoming a Peer Reviewer
  • Capturing Research Impact
  • Enabling Research Activity
  • Engaging with your AHSN
  • Getting your Abstract Accepted
  • Getting Your Paper Published
  • NEW - Implementation for Impact
  • Medtech Development for AHPs
  • NEW - Navigating doctoral studies: overview
  • Patient and Public Involvement
  • Preparing a Scientific Poster
  • Running a Journal Club
  • Seeking Ethical Approval
  • Social Media
  • Statistics
  • Writing Service Improvement Case Studies

HTA - spending wisely when managing delays

  Created on Friday, 17 Jan 2020. Posted in Funding

The HTA vlog this month talks about dealing with delays in projects and how to manage funds wisely.

Trials sometimes face delays in start-up due to negotiating contracts, study drugs and placebos manufacture, data linkage agreements or in completing the feasibility stages of the project. These delays have a knock on effect for the completion date of trials that require a contract variation for extra time and money. Requests for extra funds however are not easily granted as they are viewed in competition with new funding proposals. Research teams need to make it as attractive as possible to funders to grant extensions. One way to do that is to show that you've been a good guardian of public funds and during the delay period you've built up an underspend which can be off set against the contract variation to complete the project.

Measures to build up an underspend could be suspending payments to those not working on the project during the delay period or redeploying trial staff until they are needed. It's always good to keep the sponsors and HTA secretariat informed about delays and your plans to mitigate costs. Although underspend needs to be returned on an annual basis to comply with the government's annual reconciliation rules the underspend returns will not affect the overall funding envelope agreed with the programme and can be used in the extension period.