How should trial teams make decisions about the proportions and diversity of the ethnic groups in their trial?

Background: The benefits of randomised trials are not shared equally, and people from ethnic minority groups are a key constituency under-served by clinical research and clinical care. The STRIDE project aimed to give trialists practical information about how to decide which ethnic groups should be in their trials, and at what proportion.

Methods: We considered trials in six clinical areas: cancer, cardiovascular, diabetes, maternal health, mental health, and smoking cessation.

The financial impact of participant attrition from randomised trials: a case-study from the Occupational Therapist Intervention Study (OTIS).

Rationale: Loss to follow-up of participants can compromise the statistical validity of randomised trials. Moreover, it can have financial consequences for trial teams and funders. This study explores the Occupational Therapist Intervention Study (OTIS) where, despite a withdrawal rate of less than 10%, the trial team incurred opportunity costs related to participants who were initially recruited but subsequently decided to withdraw from the trial.

Bathing Adaptations in the Homes of Older Adults (BATH-OUT-2): study protocol for a randomised controlled trial, economic evaluation and process evaluation.

Background: The onset of disability in bathing is particularly important for older adults as it can be rapidly followed by disability in other daily activities; this may represent a judicious time point for intervention in order to improve health, well-being and associated quality of life. An important environmental and preventative intervention is housing adaptation, but there are often lengthy waiting times for statutory provision. In this randomised controlled trial (RCT), we aim to evaluate the effectiveness and cost-effectiveness of bathing adaptations compared to no adaptations and to explore the factors associated with routine and expedited implementation of bathing adaptations.

Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of 'studies within a trial' (SWATs).

Background: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content.

Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups-practical guidance to support better practice.

Randomised trials, especially those intended to directly inform clinical practice and policy, should be designed to reflect all those who could benefit from the intervention under test should it prove effective. This does not always happen. The UK National Institute for Health and Care Research (NIHR) INCLUDE project identified many groups in the UK that are under-served by trials, including ethnic minorities.

Bah humbug! Association between sending Christmas cards to trial participants and trial retention: randomised study within a trial conducted simultaneously across eight host trials.

Objectives: To determine the effectiveness of sending Christmas cards to participants in randomised controlled trials to increase retention rate at follow-ups, and to explore the feasibility of doing a study within a trial (SWAT) across multiple host trials simultaneously.

Design: Randomised SWAT conducted simultaneously across eight host trials.

Setting: Eight randomised controlled trials researching various areas including surgery and smoking cessation.

Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets.

Background: The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials.

Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS).

Background: Use of a person's name in a text message has been shown to be effective in instigating behaviour change. We evaluated the effectiveness of a personalised text message (including the recipient's name) versus a standardised text message for prompting a response from trial participants to complete and return postal follow-up questionnaires.

Methods: Using a randomised study within a trial (SWAT) embedded within the host GRASP (Getting it Right: Addressing Shoulder Pain) trial, participants who provided a mobile telephone number were randomised (1:1) by a central computer system to receive either (1) a personalised text message which included their name or (2) a standard text message.

Developing the INCLUDE Ethnicity Framework-a tool to help trialists design trials that better reflect the communities they serve.

Background: Ensuring that a trial is designed so that its participants reflect those who might benefit from the results, or be spared harms, is key to the potential benefits of the trial reaching all they should. This paper describes the process, facilitated by Trial Forge, that was used between July 2019 and October 2020 to develop the INCLUDE Ethnicity Framework, part of the wider INCLUDE initiative from the National Institute for Health Research to improve inclusion of under-served groups in clinical research studies.

Methods: Development of the Framework was done in seven phases: (1) outline, (2) initial draft, (3) stakeholder meeting, (4) modify draft, (5) Stakeholder feedback, (6) applying the Framework and (7) packaging.

A multicentre, randomized, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults.

Aims: A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients' quality of life and financial prospects. Robust evidence to guide treatment is currently lacking.

Patient and family co-developed participant information to improve recruitment rates, retention, and patient understanding in the Rehabilitation Strategies Following Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial: Protocol for a study within a trial (SWAT).

Whilst the potential benefits of exercise rehabilitation in cancer survivorship are plentiful, recruitment to survivorship rehabilitation trials remains suboptimal. There is growing evidence that Public and Patient Involvement (PPI) initiatives can increase the rate of recruitment to research. This study within a trial (SWAT) will examine if participant information co-developed by patients and their families can lead to greater recruitment rates, retention and understanding of the Rehabilitation Strategies in Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial when compared to standard participant information.

Correction to: Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators.

An amendment to this paper has been published and can be accessed via the original article.

Including a pen and/or cover letter, containing social incentive text, had no effect on questionnaire response rate: a factorial randomised controlled Study within a Trial.

Postal questionnaires are frequently used in randomised controlled trials to collect outcome data on participants; however, poor response can introduce bias, affect generalisability and validity, and reduce statistical power. The objective of this study was to assess whether a pen and/or social incentive text cover letter sent with a postal follow-up questionnaire increased response rates in a trial. A two-by-two factorial randomised controlled trial was embedded within the OTIS host trial.

Study within a trial (SWAT) protocol. Investigating the effect of personalised versus non-personalised study invitations on recruitment: An embedded randomised controlled recruitment trial.

Introduction: Recruitment into clinical trials is a common challenge experienced by healthcare researchers. Currently, there is little evidence regarding strategies to improve recruitment into clinical trials. However, preliminary research suggests the personalisation of study invitation letters may increase recruitment rates.

Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators.

Background: Understanding why people take part in health research is critical to improve research efficiency and generalisability. The aim of this overview of systematic reviews was to identify psychosocial determinants of research participation and map them to psychological theory and empirical recruitment research, to identify effective strategies to increase research participation.

Methods: Qualitative and quantitative systematic reviews were systematically identified.

Timing of electronic reminders did not improve trial participant questionnaire response: a randomized trial and meta-analyses.

Objectives: The objective of this study was to assess whether timing of short messaging service (SMS) reminders improved postal questionnaire return rates from participants in a randomized controlled trial (RCT).

Study Design And Setting: A Study Within A Trial (SWAT) embedded in a multicenter RCT evaluating three treatments for the frozen shoulder. Participants who provided a mobile telephone number were randomized to either prenotification SMS on the day of the questionnaire mail-out or postnotification SMS 4 days after questionnaire mail-out for the 3-month follow-up.

Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed.

The evidence base available to trialists to support trial process decisions-e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants-is thin.

Outcome domains and outcome measures used in studies assessing the effectiveness of interventions to manage non-respiratory sleep disturbances in children with neurodisabilities: a systematic review.

Objectives: To assess whether a core outcome set is required for studies evaluating the effectiveness of interventions for non-respiratory sleep disturbances in children with neurodisabilities.

Design: Survey of outcome measures used in primary studies identified by a systematic review.

Data Sources: ASSIA, CENTRAL, Cochrane Database of Systematic Reviews, Conference Proceedings Citation Index, CINAHL, DARE, Embase, HMIC, MEDLINE, MEDLINE In-Process, PsycINFO, Science Citation Index, Social Care Online, Social Policy & Practice, ClinicalTrials.

Limited evidence exists on the effectiveness of education and training interventions on trial recruitment; a systematic review.

Objective: The objective of this study was to examine the effectiveness of education and training interventions on recruitment to randomized and non-randomized trials.

Study Design And Setting: A systematic review of the effectiveness of education and training interventions for recruiters to trials. The review included randomized and non-randomized controlled trials of any type of education and training intervention for recruiters to trials, within any health care field.

SWATted away: the challenging experience of setting up a programme of SWATs in paediatric trials.

Background: Randomised controlled trials are considered the best method for determining the effectiveness and safety of health interventions. Trials involving children are essential to ensure that treatments are safe and effective. However, many trials, in both adult and paediatric populations, do not achieve recruitment targets and/or maintain retention of participants, which can lead to a reduction in the internal and external validity of the results.

Oral melatonin for non-respiratory sleep disturbance in children with neurodisabilities: systematic review and meta-analyses.

Aim: To evaluate the effectiveness of pharmacological interventions for managing non-respiratory sleep disturbances in children with neurodisabilities.

Method: We performed a systematic review and meta-analyses of randomized controlled trials (RCTs). We searched 16 databases, grey literature, and reference lists of included papers up to February 2017.

Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis.

Objective: To investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.

Design: Systematic review and meta-analysis.

Data Sources: Ten electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.