Patient recruitment to a diabetic retinopathy screening trial through optimised patient information materials: an embedded study within a trial (SWAT)

Background: Printed participant information about trials is often technical, long and difficult to navigate. Optimisation and user testing can improve information materials, and may improve participant understanding and rates of recruitment. Methods: A study within a trial (SWAT) was undertaken within the ISDR trial. Potential participants in the ISDR trial were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing. Results: A total of 3,169 patients were randomised in the SWAT. Recruitment rates to the ISDR trial were 25.3% in the optimised information group and 26.1% in the standard information group (odds ratio 0.951; 95% CI 0.752 to 1.201; p=0.672). Clinic attendance rates were 71.6% in the optimised information group and 69.3% in the standard information group (OR 1.145; 95% CI 0.885 to 1.480; p=0.304). Conclusions: Optimisation of participant information through information design and user testing did not affect rate of recruitment to the host ISDR trial. Registration: ISRCTN ID ISRCTN87561257; registered on 08 May 2014.

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Optimised patient information materials and recruitment to a study of behavioural activation in older adults: an embedded study within a trial

F1000Research ◽

10.12688/f1000research.24051.1 ◽

2020 ◽

Vol 9 ◽

pp. 417 ◽

Cited By ~ 1

Author(s):

Peter Knapp ◽

Simon Gilbody ◽

Janet Holt ◽

Ada Keding ◽

Natasha Mitchell ◽

...

Keyword(s):

Information Design ◽

User Testing ◽

Study Within A Trial ◽

Information Group ◽

Standard Information ◽

Information Materials ◽

Randomised Controlled ◽

Participant Understanding ◽

To Receive ◽

Participant Information

Background: Printed participant information about randomised controlled trials is often long, technical and difficult to navigate. Improving information materials is possible through optimisation and user-testing, and may impact on participant understanding and rates of recruitment. Methods: A study within a trial (SWAT) was undertaken within the CASPER trial. Potential CASPER participants were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing. Results: A total of 11,531 patients were randomised in the SWAT. Rates of recruitment to the CASPER trial were 2.0% in the optimised information group and 1.9% in the standard information group (odds ratio 1.027; 95% CI 0.79 to 1.33; p=0.202). Conclusions: Participant information that had been optimised through information design and user testing did not result in any change to rate of recruitment to the host trial. Registration: ISRCTN ID ISRCTN02202951; registered on 3 June 2009.

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User testing digital, multimedia information to inform children, adolescents and their parents about healthcare trials

Journal of Child Health Care ◽

10.1177/1367493518807325 ◽

2018 ◽

Vol 23 (3) ◽

pp. 468-482 ◽

Cited By ~ 5

Author(s):

Rebecca Sheridan ◽

Jacqueline Martin-Kerry ◽

Ian Watt ◽

Steven Higgins ◽

Simon R Stones ◽

...

Keyword(s):

Multimedia Information ◽

Insulin Pump ◽

User Testing ◽

Promising Alternative ◽

Digital Multimedia ◽

Multimedia Resources ◽

Fit For Purpose ◽

Information Materials ◽

Information Comprehension ◽

Participant Information

Digital, multimedia information resources (MMIs) containing text, video, animation and pictures are a promising alternative to written participant information materials designed to inform children, adolescents and parents about healthcare trials, but little research has tested whether they are fit for purpose. This study employed a consecutive groups design and user testing questionnaire to assess whether participants were able to find and understand key information in multimedia resources. Two rounds of testing were completed. In each round, seven children aged 7–11 tested the MMI with a parent; six adolescents aged 12–17 and seven parents tested the MMI independently. After round 1, the resources were revised based on participant scores, behaviour and feedback. Round 1 identified problems with 2/10 information items (length of trial and use of insulin pump); only 3/20 participants could locate all information items without difficulty. After revisions, 14/20 participants scored a clear round. Information comprehension was high: 96% understood in round 1 and 99% in round 2. Participant feedback on the multimedia resources was positive, although presentation preferences varied. User testing was employed successfully with children, adolescents and parents to identify issues with, and improve, multimedia resources developed to inform potential healthcare trial participants.

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

BMC Medicine ◽

10.1186/s12916-021-02086-2 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Vichithranie W. Madurasinghe ◽

Peter Bower ◽

Sandra Eldridge ◽

David Collier ◽

Jonathan Graffy ◽

...

Keyword(s):

Primary Outcome ◽

Meta Analysis ◽

Recruitment Strategies ◽

User Testing ◽

Research Teams ◽

Comprehensive Information ◽

Key Issues ◽

To Receive ◽

Trial Participants ◽

Participant Information

Abstract 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. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded ‘studies within a trial’ (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment. Methods Seven ‘host’ trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part. Results Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I2 = 0%). Conclusions Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies. Trial registration Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133)

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Dilemmas of nudging in public health: an ethical analysis of a Danish pamphlet

Health Promotion International ◽

10.1093/heapro/daaa146 ◽

2020 ◽

Author(s):

Jacob Busch ◽

Emilie Kirstine Madsen ◽

Antoinette Mary Fage-Butler ◽

Marianne Kjær ◽

Loni Ledderer

Keyword(s):

Public Health ◽

Ethical Issues ◽

Screening Programme ◽

Screening Program ◽

Ethical Analysis ◽

Choice Making ◽

The Face ◽

Information Materials ◽

The Individual ◽

To Receive

Summary Nudging has been discussed in the context of public health, and ethical issues raised by nudging in public health contexts have been highlighted. In this article, we first identify types of nudging approaches and techniques that have been used in screening programmes, and ethical issues that have been associated with nudging: paternalism, limited autonomy and manipulation. We then identify nudging techniques used in a pamphlet developed for the Danish National Screening Program for Colorectal Cancer. These include framing, default nudge, use of hassle bias, authority nudge and priming. The pamphlet and the very offering of a screening programme can in themselves be considered nudges. Whether nudging strategies are ethically problematic depend on whether they are categorized as educative- or non-educative nudges. Educative nudges seek to affect people’s choice making by engaging their reflective capabilities. Non-educative nudges work by circumventing people’s reflective capabilities. Information materials are, on the face of it, meant to engage citizens’ reflective capacities. Recipients are likely to receive information materials with this expectation, and thus not expect to be affected in other ways. Non-educative nudges may therefore be particularly problematic in the context of information on screening, also as participating in screening does not always benefit the individual.

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A DATA-DRIVEN APPROACH TO USER-EXPERIENCE-FOCUSED MODEL-BASED ROADMAPPING FOR NEW PRODUCT PLANNING

Proceedings of the Design Society ◽

10.1017/pds.2021.7 ◽

2021 ◽

Vol 1 ◽

pp. 61-70

Author(s):

Ilia Iuskevich ◽

Andreas-Makoto Hein ◽

Kahina Amokrane-Ferka ◽

Abdelkrim Doufene ◽

Marija Jankovic

Keyword(s):

New Product Development ◽

User Experience ◽

Planning Process ◽

New Product ◽

Data Driven ◽

User Needs ◽

User Testing ◽

Model Based ◽

Data Driven Approach ◽

To Receive

AbstractUser experience (UX) focused business needs to survive and plan its new product development (NPD) activities in a highly turbulent environment. The latter is a function of volatile UX and technology trends, competition, unpredictable events, and user needs uncertainty. To address this problem, the concept of design roadmapping has been proposed in the literature. It was argued that tools built on the idea of design roadmapping have to be very flexible and data-driven (i.e., be able to receive feedback from users in an iterative manner). At the same time, a model-based approach to roadmapping has emerged, promising to achieve such flexibility. In this work, we propose to incorporate design roadmapping to model-based roadmapping and integrate it with various user testing approaches into a single tool to support a flexible data-driven NPD planning process.

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User testing of consumer medicine information in Australia

Health Education Journal ◽

10.1177/0017896910376131 ◽

2010 ◽

Vol 70 (4) ◽

pp. 420-427 ◽

Cited By ~ 18

Author(s):

Eleanor Jay ◽

Parisa Aslani ◽

DK Raynor

Keyword(s):

Relevant Information ◽

Information Design ◽

The European Union ◽

Medicine Information ◽

User Testing ◽

Strong Argument ◽

Medicines Information ◽

Pharmaceutical Manufacturers ◽

The Creation ◽

The Individual

Background: Consumer Medicine Information (CMI) forms an important basis for the dissemination of medicines information worldwide. Methods: This article presents an overview of the design and development of Australian CMI, and discusses ‘user-testing’ as an iterative, formative process for CMI design. Findings: In Australia, legislation and templates guide the creation of CMI by pharmaceutical manufacturers using principles of written health information design, giving consideration to both content and structure. Following these principles to the letter, however, does not always assure the creation of a useable document. A suggested method to gauge the usability of CMI is ‘user-testing’. The process, based on observing individuals using the CMI to answer specific questions, aims to identify areas of weakness in the document allowing targeted improvement. Each question identifies whether (a) the individual can find the relevant information and (b) they can understand it. It is an iterative process designed to be performed repeatedly until it results in a highly-useable CMI. Crucially, the revisions of this information between rounds of testing need to be based on principles of good writing and information design. Other methods of analysing CMI do not actively engage the target audience while simultaneously testing the usability of both content and structure. Although developed in Australia, user testing is not routinely performed on Australian CMI. This is despite the fact that user testing is a legal requirement for leaflets for all new medicines across the European Union (EU). Conclusions: Given CMI’s role in empowering patients with information, it follows that every attempt should be made to ensure that they are consumer friendly and usable. There is a strong argument that user testing should be employed in writing medicine information.

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Investigating modifications to participant information materials to improve recruitment into a large randomized trial

Trials ◽

10.1186/s13063-019-3779-4 ◽

2019 ◽

Vol 20 (1) ◽

Author(s):

Richard Haynes ◽

◽

Fang Chen ◽

Elizabeth Wincott ◽

Rejive Dayanandan ◽

...

Keyword(s):

Focus Groups ◽

Randomized Trial ◽

Randomized Trials ◽

Trial Participation ◽

Efficacy And Safety ◽

Information Leaflet ◽

Potential Participant ◽

Information Materials ◽

Large Randomized Trial ◽

Participant Information

Abstract Background Large randomized trials are the best method to test the efficacy and safety of treatments expected to have moderate effects. We observed a significant decline in potential participants’ response to mailed invitations to participate in such trials over a 10-year period and investigated possible reasons behind this and potential modifications to the invitation process to mitigate it. Methods Participants who declined to participate in the HPS2-THRIVE trial were asked to give a reason. Formal focus groups were conducted to explore the reasons that potential participants might have for not participating. In addition, two embedded randomized comparisons around the timing of provision of the full participant information leaflet (PIL) and its style were conducted during recruitment into this large randomized trial. HPS2-THRIVE is registered at ClinicalTrials.gov (NCT00461630). Results The commonest reason given for declining invitations related to mobility and transportation (despite the offer of travel expenses). Both the focus groups and potential participants who declined their invitation indicated concern about side-effects of the treatment (as presented in the PIL) as a reason for declining the invitation. Neither delaying provision of the full PIL until the potential participant attended the trial clinic, nor modifying the style of the PIL improved the proportion of potential participants entering the trial: odds ratio (OR) 1.05 (95% confidence interval (CI) 0.94–1.17) and 1.10 (95% CI 0.94–1.28), respectively. However, modifying the style of the PIL did increase the proportion of participants attending screening appointments (OR 1.17, 95% CI 1.03–1.33). Conclusions Many reasons given for not participating in trials are not tractable to individual trials. However, modification of the PIL does show potential to modestly improve participation. If further trials could identify similar simple interventions that were beneficial, their net effects could substantially improve trial participation and facilitate recruitment into large trials.

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

10.21203/rs.3.rs-262194/v1 ◽

2021 ◽

Author(s):

Lucy Cureton ◽

Ioana Marian ◽

Vicki Barber ◽

Adwoa Parker ◽

David Torgerson ◽

...

Keyword(s):

Response Rate ◽

Text Message ◽

Mobile Telephone ◽

Questionnaire Response ◽

Randomised Study ◽

Study Within A Trial ◽

Standard Text ◽

To Receive ◽

Trial Participants

Abstract 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; 2) a standard text message. Text messages were sent by the trial office on the same day as the 6-month GRASP follow-up questionnaire. The primary outcome was questionnaire response rate, defined as the proportion of 6-month GRASP follow-up questionnaires returned by participants. Secondary outcomes included time to response, the proportion of participants sent a reminder follow-up questionnaire and cost.Results: Between March 2017 and May 2019 (recruitment period for GRASP trial), 618 participants were randomised to a personalised (n=309) or standard (n=309) text message and all were included in the analysis. The overall questionnaire response rate was 86.9% (n=537/618); 89.6% (n=277/309) of participants responded in the personalised text message group compared to 84.1% (n=260/309) in the standard text message group (Relative Risk (RR) 1.07; 95% CI 1.00 to 1.13). Participants randomised to receive the personalised text message were more likely to return their initial postal questionnaire than those who received the standard text message (n=185/309; 59.9% vs. n=160/309; 51.8%) (RR 1.16; 95% CI 1.00 to 1.33); this represents an absolute percentage difference between intervention groups of 8.1%. Post-hoc subgroup analysis showed that males under 65 years were the group most likely to return their initial questionnaire if they received a personalised text message. Conclusion: Overall, participants who received a personalised text message were more likely to return their questionnaire than those who received the standard text message.Trial Registration: GRASP Trial ISRCTN16539266; SWAT Repository ID 35.

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Can patient decision aids reduce decisional conflict in a de-escalation of breast radiotherapy clinical trial? The PRIMETIME Study Within a Trial implemented using a cluster stepped-wedge trial design

Trials ◽

10.1186/s13063-021-05345-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Indrani S. Bhattacharya ◽

Joanne S. Haviland ◽

Lesley Turner ◽

Hilary Stobart ◽

Ada Balasopoulou ◽

...

Keyword(s):

Breast Cancer ◽

Patient Information ◽

Trial Design ◽

Decision Aids ◽

Decisional Conflict ◽

Stepped Wedge ◽

Patient Decision ◽

Study Within A Trial ◽

Information Group ◽

Stepped Wedge Trial

Abstract Background For patients with early breast cancer considered at very-low risk of local relapse, risks of radiotherapy may outweigh the benefits. Decisions regarding treatment omission can lead to patient uncertainty (decisional conflict), which may be lessened with patient decision aids (PDA). PRIMETIME (ISRCTN 41579286) is a UK-led biomarker-directed study evaluating omission of adjuvant radiotherapy in breast cancer; an embedded Study Within A Trial (SWAT) investigated whether PDA reduces decisional conflict using a cluster stepped-wedge trial design. Methods PDA diagrams and a video explaining risks and benefits of radiotherapy were developed in close collaboration between patient advocates and PRIMETIME trialists. The SWAT used a cluster stepped-wedge trial design, where each cluster represented the radiotherapy centre and referring peripheral centres. All clusters began in the standard information group (patient information and diagrams) and were randomised to cross-over to the enhanced information group (standard information plus video) at 2, 4 or 6 months. Primary endpoint was the decisional conflict scale (0–100, higher scores indicating greater conflict) which was assessed on an individual participant level. Multilevel mixed effects models used a random effect for cluster and a fixed effect for each step to adjust for calendar time and clustering. Robust standard errors were also adjusted for the clustering effect. Results Five hundred twenty-one evaluable questionnaires were returned from 809 eligible patients (64%) in 24 clusters between April 2018 and October 2019. Mean decisional conflict scores in the standard group (N = 184) were 10.88 (SD 11.82) and 8.99 (SD 11.82) in the enhanced group (N = 337), with no statistically significant difference [mean difference − 1.78, 95%CI − 3.82–0.25, p = 0.09]. Compliance with patient information and diagrams was high in both groups although in the enhanced group only 121/337 (36%) reported watching the video. Conclusion The low levels of decisional conflict in PRIMETIME are reassuring and may reflect the high-quality information provision, such that not everyone required the video. This reinforces the importance of working with patients as partners in clinical trials especially in the development of patient-centred information and decision aids.

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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)

HRB Open Research ◽

10.12688/hrbopenres.12950.1 ◽

2019 ◽

Vol 2 ◽

pp. 27 ◽

Cited By ~ 1

Author(s):

Linda O'Neill ◽

Peter Knapp ◽

Suzanne L. Doyle ◽

Emer Guinan ◽

Adwoa Parker ◽

...

Keyword(s):

Focus Group ◽

Cancer Survivorship ◽

Retention Rates ◽

Patient Understanding ◽

Phase Ib ◽

Recruitment And Retention ◽

Exercise Rehabilitation ◽

Link Type ◽

Study Within A Trial ◽

Participant Information

Background: 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. Methods: This SWAT will be carried out over two phases. Phase I will utilise qualitative methods to develop (Phase Ia) and refine (Phase Ib) the new participant information. Phase Ia will recruit up to 20 survivors of upper gastrointestinal or hepatopancreaticobiliary cancer, or their family members, to take part in a focus group or interview to develop the new participant information. Focus groups/interviews will be recorded, transcribed verbatim and analysed thematically. In Phase Ib, participants will return for a second focus group/interview to refine the participant information. Once finalised, the participant information will be submitted to ethics for approval. In Phase II, potential participants for the ReStOre II trial will be randomly assigned to receive either the standard or patient and family co-developed participant information. The two forms of participant information will be compared by recruitment and retention rates, and participant understanding of the trial (Decision-Making Questionnaire). Discussion: We anticipate that engaging with patients and their families to develop participant information will help to increase patient understanding of the ReStOre II trial and therefore recruitment and retention rates. The results of this SWAT will indicate the usefulness of this strategy for optimising recruitment to exercise rehabilitation trials in cancer survivorship. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT-100). ReStOre II: ClinicalTrials.gov (NCT03958019).

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