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

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 417 ◽  
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.

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

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 779
Author(s):  
Rebecca Sheridan ◽  
Peter Knapp ◽  
Peter Bower ◽  
Vichithranie Madurasinghe ◽  
Deborah M Broadbent ◽  
...  
Keyword(s):  
Information Design ◽  
User Testing ◽  
Diabetic Retinopathy Screening ◽  
Study Within A Trial ◽  
Information Group ◽  
Standard Information ◽  
Information Materials ◽  
Participant Understanding ◽  
To Receive ◽  
Participant Information

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.

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

2018 ◽  
Vol 23 (3) ◽  
pp. 468-482 ◽  
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.

scholarly journals The effectiveness of digital multimedia presentation of trial information on recruitment and retention of patients: Protocol for a study within a trial (SWAT).

2020 ◽  
Vol 3 ◽  
pp. 10
Author(s):  
Sinead Duane ◽  
Akke Vellinga ◽  
Valerie Smith ◽  
Marie Tierney ◽  
Claire Beecher ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Multimedia Presentation ◽  
Digital Information ◽  
Information Leaflet ◽  
Eligibility Criteria ◽  
Recruitment And Retention ◽  
Digital Multimedia ◽  
Study Within A Trial ◽  
Randomised Controlled ◽  
Participant Information

Background: Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials. One area in need of research is trial recruitment. Recruiting patients to trials is a major challenge facing trialists. Failure to meet recruitment targets can result in delays and underpowered studies. This SWAT evaluates the effectiveness of hand-held digital multimedia presentation of trial information and standard written patient information to potential participants on recruitment and retention to a host trial. Methods: This is the protocol for SWAT 15, a two-group, embedded parallel randomised controlled trial (RCT) (ISRCTN12838042) designed within a host trial - the SATIN trial (ISRCTN88111427), a RCT designed for implementation in the Irish primary care setting. The SWAT eligibility criteria was determined by the host trial. General practices who agree to participate in the host trial will provide women (participants) who are willing to consider participating in the host trial with either a multimedia digital information resource facilitated through a handheld tablet device, plus a written participant information leaflet (Intervention) or a written participant information leaflet (comparator). Outcomes are recruitment and retention to the host SATIN trial and participant’s quality of decision-making. Discussion: Although designed to be implemented in a host trial, the host trial, was suspended and therefore this SWAT was not implemented. The protocol and the lessons learnt whilst developing it offer guidance to researchers who wish to answer similar research questions in the future in a similar context or setting.   Trial registration: ISRCTN Registry ISRCTN12838042 (11/10/2017)

Effectiveness of brief patient information materials for promoting correct beliefs about imaging and inevitable consequences of low back pain: A randomised controlled trial

2021 ◽  
pp. 026921552110659
Author(s):  
Leandro M. Diniz ◽  
Crystian B. Oliveira ◽  
Gustavo C. Machado ◽  
Christopher G. Maher ◽  
Arianne P. Verhagen ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Patient Information ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Low Back ◽  
Information Materials ◽  
Randomised Controlled ◽  
To Receive

Objective To investigate what format for providing patient information (i.e. written summary, infographic or video animation) is most effective for promoting correct beliefs about imaging and inevitable consequences of low back pain (LBP). Design Randomised controlled trial. Setting/Patients One hundred and fifty-nine patients with non-specific LBP were recruited from outpatient physiotherapy clinics. Intervention Participants were randomised to receive patient information in one of three formats: video animation, infographic or written summary. Patients were allowed to read or watch the materials for up to 20 min. Measurements Outcome were assessed before and immediately after the intervention. The primary outcome was the Back Beliefs Questionnaire. The secondary outcome was beliefs about imaging for LBP assessed by two questions. Results All 159 patients completed the study. Our findings revealed no difference between groups for the Back Beliefs Questionnaire. Correct beliefs about imaging were more likely with the infographic than the video animation (Question 1- Odds Ratio [OR] = 3.9, 95% confidence interval [CI]: 1.7, 8.7; Question 2- OR = 6.8, 95%CI: 2.7, 17.2) and more likely with the written summary than the video animation (Question 1- OR = 3.3, 95%CI: 1.5, 7.4; Question 2- OR = 3.7, 95%CI: 1.6, 8.5). No difference between infographic and written summary formats were reported for the questions assessing LBP imaging beliefs. Conclusion The three materials were equally effective in improving patient's general beliefs about LBP care. However, the traditional written summary or infographic formats were more effective than the video animation format for improving beliefs about imaging for LBP.

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

BMC Medicine ◽  
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)

scholarly journals Pre-notification and personalisation of text messages to increase questionnaire completion in a smoking cessation pregnancy RCT: an embedded randomised factorial trial

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 637
Author(s):  
Elizabeth Coleman ◽  
Rachel Whitemore ◽  
Laura Clark ◽  
Karen Daykin ◽  
Miranda Clark
Keyword(s):  
Smoking Cessation ◽  
Text Message ◽  
Text Messages ◽  
Completion Rate ◽  
Factorial Trial ◽  
Study Within A Trial ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
To Receive

Background:  Low completion rates of questionnaires in randomised controlled trials can compromise the reliability of the results, so ways to boost questionnaire completion are often implemented. Although there is evidence to suggest that sending a text message to participants increases completion, there is little evidence around the timing or personalisation of these text messages.  Methods:  A two-by-two factorial SWAT (study within a trial) was embedded within the MiQuit-3 trial, looking at smoking cessation within pregnant smokers. Participants who reached their 36-week gestational follow-up were randomised to receive a personalised or non-personalised text message, either one week or one day prior to their follow-up. Primary outcomes were completion rate of questionnaire via telephone. Secondary outcomes included: completion rate via any method, time to completion, and number of attempts to contact required.  Results  In total 194 participants were randomised into the SWAT to receive a text message that was personalised early(n=50), personalised late (n=47), non-personalised early(n=50), or non-personalised late(n=47). There was no evidence that timing of the text message (early: one week before; or late: one day before) had an effect on any of the outcomes. There was evidence that a personalised text message would result in fewer completions compared with a non-personalised text message when data was collected only via the telephone(adjusted OR 0.44, 95% CI 0.22–0.87, p=0.02). However, these results were not significant when looking at completion via any method (adjusted OR 0.61, 95% CI 0.30-1.24, p=0.17). There was no evidence to show that personalisation or not was better for any of the secondary outcomes.  Conclusion  Timing of the text message does not appear to influence the completion of questionnaires. Personalisation of a text message may be detrimental to questionnaire completion, if data is only collected via the telephone - however, more SWATs should be undertaken in this field.

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

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.

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

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.

Auricular Acupuncture for Pre-Exam Anxiety in Medical Students: A Prospective Observational Pilot Investigation

2016 ◽  
Vol 34 (2) ◽  
pp. 90-94 ◽  
Author(s):  
Catharina Klausenitz ◽  
Thomas Hesse ◽  
Henriette Hacker ◽  
Klaus Hahnenkamp ◽  
Taras Usichenko
Keyword(s):  
Medical Students ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Final Analysis ◽  
Auricular Acupuncture ◽  
Before And After ◽  
Pilot Investigation ◽  
Exam Anxiety ◽  
Randomised Controlled ◽  
To Receive

Objective Auricular acupuncture (AA) is effective for the treatment of preoperative anxiety. We aimed to study the feasibility and effects of AA on exam anxiety in a prospective observational pilot study. Methods Healthy medical students received bilateral AA using indwelling fixed needles at points MA-IC1, MA-TF1, MA-SC, MA-AH7, and MA-T on the day before an anatomy exam. The needles were removed after the exam. Anxiety levels were measured using the State-Trait-Anxiety Inventory (STAI) and a 100 mm visual analogue scale (VAS-100) before and after the AA intervention and once again immediately before the exam. The duration of sleep on the night before the exam was recorded and compared to that over the preceding 1 week and 6 months (all through students’ recollection). In addition, blood pressure, heart rate and the acceptability of AA to the students were recorded. Results Ten students (all female) were included in the final analysis. All tolerated the needles well and stated they would wish to receive AA again for exam anxiety in the future. Exam anxiety measured using both STAI and VAS-100 decreased by almost 20% after AA. Conclusions AA was well accepted, the outcome measurement was feasible, and the results have facilitated the calculation of the sample size for a subsequent randomised controlled trial.

Mucositis reduction with probiotics in children with cancer: a randomised-controlled feasibility study

2021 ◽  
pp. archdischild-2020-319968
Author(s):  
Hadeel Hassan ◽  
Sally Kinsey ◽  
Bob Phillips
Keyword(s):  
Direct Contact ◽  
Randomised Controlled Trials ◽  
Healthcare Professionals ◽  
Meta Analysis ◽  
Paediatric Oncology ◽  
Children With Cancer ◽  
Patient Diary ◽  
Registration Number ◽  
Randomised Controlled ◽  
To Receive

BackgroundA recent systematic review and meta-analysis identified a paucity of randomised-controlled trials (RCTs) investigating the use of probiotics to reduce or prevent mucositis and infection in children with cancer.ObjectiveThis study evaluated the feasibility of undertaking an RCT and investigated the efficacy of probiotics for reducing or preventing mucositis and infection in children with cancers.SettingThe Paediatric Oncology and Haematology department at Leeds Teaching Hospital, UK.PatientsChildren aged 1 year or older, receiving chemotherapies likely to cause mucositis.InterventionsParticipants were randomised to receive the probiotic or placebo on day 1–14 of a chemotherapy cycle. Participants were also required to complete a patient diary for 21 days.Main outcome measuresTo assess whether it is feasible to recruit children diagnosed with cancer who are at risk of developing mucositis to an adequately powered RCT.ResultsBetween May and November 2019, 34 out of 39 eligible participants were approached. Ten patients were recruited (4 probiotic and 6 placebo) of which 2 participants withdrew. Seven participants partially completed the diary but only two participants completed 80% or more. Eligible participants appeared to prefer giving informal verbal feedback when in direct contact with research and healthcare professionals.ConclusionThis study demonstrated that recruitment needs to be improved prior to undertaking an adequately powered RCT.Trial registration numberNCT03785938.

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