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Research Article

Improving a trial participant information sheet through user testing in British South Asian women

[version 1; peer review: 1 approved with reservations]
PUBLISHED 16 Sep 2022
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This article is included in the Research on Research, Policy & Culture gateway.

Abstract

Background: People from ethnic minorities in the UK have higher rates of mental health problems and are less likely to take part in mental health research. Previous research indicates that participant information sheets (PIS) are complex, and this complexity may impair comprehension more significantly for ethnic minority participants. Improving the readability of patient information can be achieved through user testing. We aimed to improve the readability of a PIS through user testing in an ethnic minority group in an ongoing trial (ROSHNI-2).
Methods: An independent groups design was used to test the readability of the ROSHNI-2 PIS among South Asian women. There were two rounds of testing (n=31 women in total). South Asian women were asked to read the original PIS, then find and demonstrate an understanding of 19 key aspects of the trial. Based on the findings from the first round, the PIS was rewritten, redesigned, and retested.
Results: Using the original PIS, only 2 of the 19 (11%) questions were found and understood by at least 80% of participants. In the revised PIS, 6 of the 19 (32%) questions were found and understood by at least 80% of participants.
Conclusions: User testing and re-writing of a PIS resulted in a higher proportion of participants comprehending important information about a trial. This approach could improve participation in trials among ethnic minority communities.

Keywords

User Testing, Participant Information Sheets, South Asian, participation in research

Background

Informed consent for trials is often based on a written participant information sheet (PIS). Previous research indicates that PISs are often lengthy, complicated and with few navigation aids, resulting in poor comprehension which may have a negative impact on individual decisions and overall recruitment (Dresden & Levitt, 2001; Knapp et al., 2011; Terblanche & Burgess, 2010). Ethnic minority populations with low English proficiency may be disadvantaged in the informed consent process due to a lower level of understanding of study procedures (Hunt & de Voogd, 2007). Many British South Asians have English-reading skills, but for some these may be inadequate in order to comprehend concepts in the PIS such as randomisation and the need for written consent (Symonds et al., 2012).

Improving the performance of written information can be achieved through the user testing method. User testing is designed to highlight weaknesses in the layout and content of information, which is followed by making changes based on good practice in information design and writing to make it easier for readers to find and understand information (Dresden & Levitt, 2001). The user testing method not only indicates weaknesses in the PIS but can also confirm when changes have led to improved understanding (Knapp et al., 2009b).

Table 1 refers to previous studies utilizing user testing methods to improve trial PISs and other study information. A previous UK randomised trial on acute myeloid leukaemia aimed to test if a PIS developed through user testing improved readability compared to the original PIS. User tested PIS significantly altered its wording and layout, and 66% of participants who read the revised PIS were able to show understanding of all aspects of the trial, compared with 15% of those reading the original version. The results highlighted that performance-based user testing, expertise in writing for patients, and information design led to a significantly improved PIS (Knapp et al., 2011).

Table 1. Earlier studies utilizing user testing methodology.

StudiesYearSample size & participants in rounds of testingDesignHealth conditionPIS RevisionResults
Knapp, Raynor, Silcock, & Parkinson, 2009a2009General population n=20
Testing rounds = 2
First- round n=10
Second -round n=10
Independent group designIVFRewording and redesign of the PIS10% on original PIS, 50% on revised PIS showed understanding of all aspects of the trial
Knapp, Raynor, Silcock, & Parkinson, 2009c2009General population n=30
Testing round =2
First round on original PIS n=10
Second round on revised PIS n=20
Independent group designLeukaemiaRevised format, appearance, and wording of the PIS80% understood 6 of 21 questions on the original PIS, 100% understood 17 of 21 questions on revised PIS
Knapp, Raynor, Silcock, & Parkinson, 20112011General population n=50
Testing round =3
First and second round n=50
Third round on RCT n=123
n=62 tested the original PIS n=61 tested the revised PIS
Randomised controlled trialAcute Myeloid Leukaemia and MyelodysplasiaWording and layout revised PISRCT-15% participants on original PIS, 66 % participants on revised PIS understood all aspects
Cockayne et al., 20172017General population n=193
n= 62 tested the original PIS
n=68 tested the template PIS
n= 63 tested the user tested revised PIS
No round of testing info
A three-arm, embedded randomised trialPodiatryThe content, layout and style were revised.A total of 193 (2.8%) participants randomised into the REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63
Ponzio et al., 20182018General population n=60
n=30 tested the observation study PIS
n=30 tested the interventional PIS
Independent group designMultiple SclerosisNo revisions, user testing on observational and interventional studies82% on observational study PIS, 54% on intervention study PIS
Parker et al., 20182018General Population n=2262
n=1126 tested the original materials (control group)
n=1136 tested the revised materials (intervention group)
No round of testing info
SWAT designLung CancerPIB was
re-written and re-designed; formatting
15.6% from the control group enrolled and randomised to ECLS whereas 15.8% patients from the intervention group enrolled and randomised into ECLS
Sheridan et al., 20192019Children, Adolescents, and parents n=40
Testing rounds= 2
First-round on original MMI n=20
Second round of testing MMI n=20
Consecutive groups designType 1 diabetesRevisions to MMI included additional text, formatting and rearrangement of information85% participants scored a clear round for understanding on the original MMI.
95% participants scored a clear round for understanding on the revised MMI

An independent group design study, which was a Phase 1 ‘first time in man’ trial for a CD28 super agonist antibody TGN1412 in six human volunteers, adopted a performance-based user testing method. The aim was to assess the readability of the phase 1 TGN412 PIS trial. The original PIS underperformed when compared to the revised PIS. On the original PIS, participants could not find information, and if the information was found it was not understood. The revised information performed much better with all 20 participants understanding answers to 17 of 21 questions. The revisions to the PIS included changes to format and wording (Knapp et al., 2009c).

Another study with an independent group design utilized the user testing performance method to test the PIS from the Phase 3 'Poor Responders' trial in vitro fertilisation. There were two rounds of testing the PIS with results from the first round of testing the original PIS showing that only two of the 20 members could find and show understanding of all question items. The first round of testing informed revisions to the original PIS which was re-written and re-designed. In the second round of testing the revised PIS showed much improvement, 10 out of the 20 members of the public, found and showed understanding of all questions (Knapp et al., 2009a).

In a similar TRECA (TRials Engagement in Children and Adolescents) study, multimedia templates to be used in healthcare trials recruiting children and adolescents were tested through the user testing method. An independent group design and the user testing method were used to assess whether children, adolescents, and their parents were able to find and understand key information about the Subcutaneous Insulin: Pumps or Injections (SCIPI) trial. SCIPI was a randomised controlled trial of continuous subcutaneous insulin infusion [CSII] compared to multiple daily injection regimens of insulin in children and young people at diagnosis of type I diabetes mellitus. The original information for the first round of testing showed that all questions were understood by 17 of 20 participants. The first round of testing informed revisions which included additional text, formatting, and rearrangement of information. The final revised information resulted in improvement with 19 of 20 participants understanding all of the questions (Sheridan et al., 2019).

A study within a trial (SWAT) was conducted in the Early CDT Lung Cancer Scotland (ECLS) trial which aimed to assess the effectiveness of a new test in reducing the incidence of patients with late-stage lung cancer at diagnosis compared with standard care. The primary outcome of the SWAT was to assess the number of patients recruited to ECLS using the optimised materials. In the ECLS trial potential participants randomly received either the original participant information including brochure and accompanying letter (the control group) or optimised versions of participant information materials which underwent changes through the user testing process. The optimised versions were re-written, and re-organised, with professional graphic design (the intervention group). The findings reported that optimised patient information materials made a slight difference in the recruitment levels in the ECLS trial. In total 15.6% (176 of 1126) of patients from the control group enrolled and randomised to ECLS whereas 15.8% (180 of 1136) of patients from the intervention group enrolled and randomised into ECLS (Parker et al., 2018).

A three-arm embedded randomised trial was conducted within the REducing Falls with ORthoses and a Multifaceted (REFORM) podiatry intervention cohort randomised controlled trial. The REFORM trial aimed to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in the UK and Irish settings. The three-arm embedded trial aimed to find out if the number of participants recruited, and randomised to the REFORM trial could be improved using both a modified user tested and a template-developed optimised PIS. Patients over the age of 65 randomly received either the original PIS (control) for the host trial or one of two optimised versions, a user-tested PIS or a template-developed PIS. The results showed that 6,900 patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; modified user-tested n = 63). The embedded trial showed limited evidence of the effectiveness of using optimised information materials on recruitment and retention rates in the REFORM study (Cockayne et al., 2017).

These findings were consistent: the original sheets which were initially approved by NHS research ethics committees were limited in scope for people to demonstrate locating and understanding important aspects of the trial-related information like safety, efficacy, consent, and practical details. In all the studies, the PISs had both their layout and wording significantly revised and user testing revealed improvements in PISs performance.

The present study focused on researching British South Asian women and communication issues are a common barrier in this ethnic minority group (Brown et al., 2014; Symonds et al., 2012). To date, user testing methods have not been applied to a PIS designed for ethnic minority participants and the method can support the inclusion of ethnic minorities in health research. This study reports the application of user testing to the PIS in a trial evaluating a culturally adapted treatment for postnatal depression in British South Asian women (ROSHNI-2, ISRCTN1069).

Aim

The study aimed to test whether finding and understanding of key trial information could be improved using user testing methods.

Method

Study design

Randomised trials are rightly considered the most robust method of assessing health care interventions. However, they are often not possible due to practical and logistical barriers, such as the high cost of such research. A non-randomised independent between-groups design was chosen, with participants in each group seeing only one version of the PIS.

In a non-randomised between-groups design, each participant was exposed to only one version of the PIS. One group reviewed the original PIS, and the other group reviewed the revised PIS. The advantage is, considering the target population; those participants enter the study fresh and naïve regarding procedures, avoiding practice effects. Each participant can only be tested once, as the knowledge gained during the 1st round of testing would prevent a fair test of the 2nd round of information (Bellemare et al., 2018).

Participants

The ROSHNI-2 trial aimed to evaluate the clinical- and cost-effectiveness of a culturally adapted group psychological intervention (Positive Health Programme, PHP) in primary care for British South Asian women with postnatal depression compared with treatment as usual. The current study aimed to apply the user testing methodology to the ROSHNI-2 PIS to test whether a revised PIS makes it more likely that British South Asian women participants can find and understand key information.

Inclusion and exclusion criteria are shown in Table 2.

Table 2. Inclusion and exclusion criteria of ROSHNI-2 and user testing studies.

ROSHNI-2 inclusion criteria

  • South Asian women

  • Age 16 and above and living with their infants up to the age of 12 months (1- Year)

  • Meeting the criteria for DSM-V depression

Current study inclusion criteria

  • South Asian women

  • Age 18 and above

  • Able to converse in Urdu or English, to match the participants in the actual ROSHNI-2 trial

Exclusion criteria

  • Women with diagnosed physical or learning disability, post-partum or other psychosis, or who are actively suicidal (previous history of self-harm or suicide attempt)

Exclusion criteria

  • Women who took part in any readability testing study in the previous 6 months.

  • Women who took part in the ROSHNI-2 trial.

Sampling

A purposive sampling strategy was used to select participant characteristics matched to the ROSHNI-2 trial cohorts in terms of gender, age, and education. In addition, as the study did not use random allocation, the aim was to ensure that the participants’ characteristics were similar in the two independent groups.

Sample size

There was no formal sample size calculation for the study. Based on data from similar research using user testing methods (Table 1), a sample size of 20-40 participants was recommended (Knapp et al., 2009c), and the current research sought a sample size of thirty participants (15 in each group).

Recruitment

Initially, the recruitment process involved an introductory meeting with various community organisations and mosques in the Manchester area. The aim was to raise awareness and promote the research. Recruitment took place from one community organisation and two mosques.

Data collection

User testing was conducted on the ROSHNI-2 PIS. User testing data was collected by participants answering 19 key questions from the PIS. Table 3 shows the list of key questions. The testing of the original and revised PIS was undertaken in two languages (English or Urdu). In response to each question, the participants were asked to find where the answer was located, then give the answer (using their own words when possible). If participants were not able to locate the answer, it was recorded as not found and not understood (because real trial participants can only be informed by content they can find in the document).

Table 3. Key questions to be used for the user testing method.

Nature and purpose of the trial
Q4 What sort of patient is being offered interventional treatment?
Q14 What is this trial trying to find out?
Q15 How will it be decided which patients in the trial receive which treatment?
Q18 A patient could get 1 of 2 different treatments within the trial. What are the 2 different treatments?
Process and meaning of consent
Q2 Suppose you decided to take part in the trial but later changed your mind. Would you have to give a reason?
Q8 Suppose you take part and are harmed by the trial.
What can you do?
Q16 What happens to the information collected about you as part of the trial?
Trial procedure
Q1 If you need to contact the study team regarding your treatment, what number should you use?
Q3 Suppose you receive the intervention/treatment in the trial.
How and when would it be given to you?
Q7 What does the sheet say about the interview after the trial is completed? And what's the purpose of the interview?
Q10 During the trial you will receive follow up. When and why?
Q12 When you receive follow-ups, how far apart are these?
Q19 What do you need to do to take part in the trial?
Safety and confidentiality
Q5 What should you do if you want to make a complaint?
Q6 How can you be affected by taking part in this study? What should you do?
Q9 How is your information's confidentiality maintained?
Q11 What are the advantages and disadvantages of taking part in this study?
Q13 What does the information say about the location of delivering the intervention?
Q17 Who has checked and approved this study? And what does it mean?

The times taken to read the PIS (‘reading time’) and complete all 19 user testing questions (‘comprehension time’) were recorded. Pilot user testing assessments were conducted with two community members before the first round of testing and no changes made to the study.

Outcomes

The user testing explored participants' ability to find and understand 19 key points of information in the PIS (Table 3). The 19 items were drawn from the four categories of information from previous PIS user testing research (Knapp et al., 2011):

  • The nature and purpose of the trial (4 questions)

  • The process and meaning of consent (3 questions)

  • Trial procedures (6 questions)

  • Safety and confidentiality (6 questions)

Procedure for testing original, revised ROSHNI-2 PIS and interviews

The following procedures were in line with steps adopted in similar research (Knapp et al., 2011). Figure 1 shows the steps involved in the user testing of ROSHNI-2 original and revised PIS.

  • 1. Participants were posted the current study PIS 24 hours before testing so that they could read it carefully. Participants meeting the inclusion criteria were given the Urdu or English version of the ROSHNI-2 PIS (as appropriate) and were instructed to imagine taking part in the ROSHNI-2 trial.

  • 2. At the time of testing participants were given another chance to read the PIS with the reading time recorded. Participants were asked 19 user testing questions in turn and were asked to find the answer in the PIS and then, if found, to explain the answer. YM judged if the participant demonstrated understanding of the answers by cross-questioning participants when required.

  • 3. Firstly, testing of the original ROSHNI -2 PIS was performed on the first group of participants followed by testing on participants in the revised ROSHNI-2 PIS group. Testing of the revised ROSHNI-2 information sheet PIS proceeded in the same way as the original PIS.

e5ce7686-c0b2-4072-89c3-7fb52adb7a28_figure1.gif

Figure 1. User testing of ROSHNI-2 original and revised participant information sheet (PIS).

PIS

ROSHNI-2

The ROSHNI-2 PIS comprised three single-sided A4 pages. The revised ROSHNI-2 PIS retained its meaning but with a revised layout, appearance, structure, and wording which was informed by the results from the first round of testing. Refer to Figures 2 and 3 for example sections of the PIS.

e5ce7686-c0b2-4072-89c3-7fb52adb7a28_figure2.gif

Figure 2. Original ROSHNI-2 participant information sheet (PIS) section.

e5ce7686-c0b2-4072-89c3-7fb52adb7a28_figure3.gife5ce7686-c0b2-4072-89c3-7fb52adb7a28_figure4.gif

Figure 3. Revised ROSHNI-2 participant information sheet (PIS).

Revision of ROSHNI-2 original PIS

YM followed good practice guidelines for translating and adapting the ROSHNI-2 PIS (Hall et al., 2018). Figure 4 provides an overview of the steps involved in the adaption process.

e5ce7686-c0b2-4072-89c3-7fb52adb7a28_figure5.gif

Figure 4. Revision of ROSHNI-2 participant information sheet (PIS) based on seven steps.

Revisions to the Revised ROSHNI-2 PIS

Revisions to the ROSHNI-2 PIS included dividing the pages into two columns, adding a brief table of contents to the front page, and emphasising the contact details and placing them on both the first and last pages. The main text of the information sheet was divided into various headings and bullet points were used. Questions were reworded and the text was arranged into smaller sections with shortened sentences and paragraphs. The revisions included: use of lay language; replacing difficult or technical words with a lay alternative; and use of flow diagram to illustrate various stages of the trial. Colours were used for the section headings and the flow diagram. The flow diagram was used to illustrate various stages of the trial.

Translation of ROSHNI-2 PIS

For the translation of the ROSHNI 2 PIS, it was decided to select Urdu. It is native to South Asia, in particular the subcontinent, the national language for Pakistan and the official language of several Indian states and the Jammu and Kashmir areas, and is spoken in all by more than 145 million people. (Lewis et al., 2016). Within the UK Urdu is spoken by over 270,000 individuals, making it the 4th most spoken language. The majority of these individuals are from ethnic minorities, particularly of South Asian descent (Lewis et al., 2016).

YM and WW were also bilingual, speaking both English and Urdu. The original ROSHNI-2 PIS was initially screened and reviewed in detail in the presence of WW, the technical wording about study concepts, definitions, processes, and methodology was marked and highlighted. A consensus was reached to adapt the marked terms in easy and understandable English language. WW and YM felt the terms used in the PISs did not conform to the British South Asian communities’ level of understanding of the research concepts.

A glossary of all the English terms and concepts was developed by YM, the technical terms and concepts were replaced by easy wording and explanations. The glossary of terms was based on explanations taken from other glossaries such as National Institute for Health Research (NIHR) dictionaries (Holosko & Thyer, 2014) and the wealth of expertise in translating and adapting for ethnic communities that WW has. To cater for the English-speaking lay British South Asian communities’ level of understanding, WW and YM decided to make changes to jargon and technical concepts. Therefore, specific language changes were applied to the English wording and terms.

Later, Urdu translation of information was carried out by YM and WW. YM translated the conceptual equivalent of a phrase, rather than a word-for-word translation, whilst considering the target audience. The language was kept simple, clear, and concise by avoiding long and complex sentences. Specialised terms and jargon were avoided. Back translation was carried out om the initial translation by MN. Later, two native speakers of the language provided feedback in developing the translated version and patient and public involvement (PPI) regarding formatting issues and language suitability was undertaken.

Data analysis

Comprehension was based on the participant's ability to find each of the 19 key questions in the information sheet and be able to convey an understanding of each of those points. The criterion of EU legislation on testing of medicine leaflet was used, which refers to questions found and understood by at least 80% of participants (Medicines and Healthcare products Regulatory Agency, 2005).

Stata statistical software was used to analyse the data (REF needed). Student t-tests were performed to test any difference in the reading and comprehension times for participants reading the original and revised PIS. Further chi-square tests were performed for found and understood data on individual questions on original and revised ROSHNI-2 PISs.

PPI

PPI was used at the stage of developing and translating the PIS for the ROSHNI-2 study. The PPI group gave suggestions to improve the layout and also suggested formatting preferences.

Ethical approval

The study received retrospective ethical approval following a review by the University of Manchester Research and Ethics Committee on 02 November 2018. All the participants provided written informed consent.

Results

Demographic data

The original ROSHNI-2 PIS was tested on group A with 15 British South Asian women, who had a mean age of 37 years and were Pakistani (n = 14) or Bangladeshi (n = 1). The majority of the women completed education at the graduate level and required English materials.

The revised ROSHNI-2 PIS was user tested on group B (16 Pakistani women with a mean age of 35 years). The majority completed education at the graduate level and required English materials.

Table 4 presents the demographic information relating to groups A, B and the ROSHNI-2 study. The groups were broadly similar in age, education, and use of English or Urdu versions of the PIS.

Table 4. Demographic information of current study and the ROSHNI-2 study.

Group A original participant information sheet (PIS)Group B revised PISROSHNI-2
Female, (n = 15) %Female, (n = 16) %Female, (n = 733) %
18-26 Yrs.(1) 7%(2) 13%-
27-35 Yrs.(6) 40%(8) 50%-
36-40 Yrs.(6) 40%(2) 13%-
41+ Yrs.(2) 13%(4) 24%-
Mean Yrs.37 years35 years31 years
Highest education attainment
1 = completed by 16 (GCSE level)(0) 0%(1) 6%(117) 16%
2 = by 18 or equivalent (A-level)(3) 20%(3) 19%(150) 20%
3 = Graduate level(8) 53%(11) 69%(221) 30%
4 = Post-graduate level(4) 26%(1) 6%(119) 16%
PIS language
Urdu(3) 20%(4) 25%-
English(12) 80%(12) 75%-
Ethnicity
Pakistan(14) 93%(16) 100%(396) 55%
Bangladeshi(1) 7%(0) 0%(127) 18%

Comprehension time and reading

Reading and comprehension times for the two groups are given in Table 5. Reading time was time taken to read the PIS whereas comprehension time was time taken to answer questions.

Table 5. Results from the t-test for comprehension & reading time of the original and the revised participant information sheet (PIS).

GroupMean(95% CI)t statistics P-value)
A - Original participant PIS reading22.219.7-24.80.006 (3.00)
B - Revised PIS reading18.417.2-19.6
A - Original PIS comprehension31.428.2-34.60.04 (2.21)
B - Revised PIS comprehension27.725.9-29.5

Overall, the time taken to read and comprehend 19 questions was less in the revised PIS when compared to the original PIS. There was a significant difference in reading time between the original PIS and the revised PIS (mean difference 3.84; t (29) 3.00 = 0.006; p < 0.05). Furthermore, there was a significant difference in comprehension time between the original PIS and the revised PIS (mean difference 3.70; t (29) 2.21 = 0.04; p < 0.05).

In the original PIS, questions under the categories of nature and purpose, trial procedure and safety and confidentiality had significant problems. Among the 19 questions, 2 questions (Q2, Q5) were understood by 80% of participants while 5 questions (Q4, Q8, Q16, Q1, Q9) were understood by 53-73% of participants. The rest of the questions were understood by fewer than 53% of the participants. Table 6 shows the results from the original and revised PISs.

Table 6. User testing found and understood results of the original and revised ROSHNI-2 participant information sheets (PISs).

QuestionGroup A original PIS n=15Group B revised PIS n=16% differenceChi-square test P-value
Nature and purpose of the trial
Q4 What sort of patient is being offered interventional treatment?
Found & understood67%75%8%0.27 (0.609)
Q14 What is this trial trying to find out?
Found & understood27%75%48%7.24 (.007)
Q15 How will it be decided which patients in the trial receive which treatment?
Found & understood20%37%17%1.15 (0.283)
Q18 A patient could get 1 of 2 different treatments within the trial. What are the 2 different treatments?
Found & understood33%50%17%0.88 (0.347)
Process and meaning of consent
Q2 Suppose you decided to take part in the trial but later changed your mind. Would you have to give a reason?
Found & understood100%100%0%n/a
Q8 Suppose you take part and are harmed by the trial. What can you do?
Found & understood66%94%28%3.68 (0.056)
Q16 What happens to the information collected about you as part of the trial?
Found & understood53%68%15%0.78 (0.379)
Trial procedure
Q1 If you need to contact the study team regarding your treatment, what number should you use?
Found & understood73%87%14%1.00 (0.318)
Q3 Suppose you receive the intervention/treatment in the trial. How and when would it be given to you?
Found & understood20%68%48%7.43 (0.006)
Q7 What does the sheet say about the interview after the trial is completed? And what's the purpose of the interview?
Found & understood27%62%35%4.01 (0.045)
Q10 During the trial you will receive follow up. When and Why?
Found & understood20%68%48%7.43 (0.006)
Q12 When you receive follow-ups, how far apart are these?
Found & understood13%69%56%9.76 (0.002)
Q19 What do you do to take part in the trial?
Found & understood20%68%48%7.43 (0.006)
Safety and confidentiality
Q5 What should you do if you want to make a complaint?
Found & understood80%87%7%0.005 (0.945)
Q6 How can you be affected by taking part in this study? What should you do?
Found & understood40%69%29%2.58 (0.108)
Q9 How is your information's confidentiality maintained?
Found & understood53%75%22%1.59 (0.208)
Q11 What are the advantages and disadvantages of taking part in this study?
Found & understood53%88%35%4.39 (0.036)
Q13 What does the information say about the location of delivering the intervention?
Found & understood33%56%23%1.64 (0.200)
Q17 Who has checked and approved this study? And What does it mean?
Found & understood20%81%61%11.63 (0.001)

Based on the findings from the checklist questions, testing, locating, and understanding answers to the questions, the time taken to answer questions, and participants' evaluative comments all indicated that the ROSHNI-2 original PIS was not performing well. Participants were not able to understand the content of the sheet and follow the information accurately.

The revised ROSHNI-2 PIS showed improvement. Questions under the categories of nature and purpose, trial procedure questions, and safety and confidentiality questions showed significant improvement. Among the 19 questions, nine (Q14, Q8, Q3, Q7, Q10, Q12, Q19, Q11, Q17) showed significant improvement at p < 0.05 (Table 6).

Discussion

Summary of the findings

User testing of the original ROSHNI-2 trial PIS showed that it underperformed. Participants found it hard to find information, and even when information was found, it was not always understood. Overall, there was a lack of understanding about important aspects of the trial, including what is the trial trying to find out, what are the two different treatments, how will it be decided which patient in the trial receives which treatment, the number of follow-up visits and locating the emergency contact number. The findings are in line with previous user testing studies of trial information sheets (Table 1).

Furthermore, the study identified other issues such as the complexity of the structure and organisation of the original information, and the coherence of the information presented. The use of scientific terms and presentation of information in lengthy paragraphs led to less engagement and poor understanding of the study concepts. Also, findings reported that the original PIS had excessive wording with no apparent sequence in the flow of information.

Also, in the revised sheet, participant results reported that locating and understanding information was easier, and it was found that the time taken to read the sheet and then complete the checklist questionnaire was much shorter. The results emphasised the use of non-scientific language, improved structure, and better presentation of the PIS. These findings reinforce the existing view to consider language aspect as members of minority groups find difficulty in distinguishing clinical treatment from research (Dein, 2006).

Strengths and limitations

This is the first study to test understanding of a mental health trial PIS in ethnic minorities. Earlier research in this area utilised user testing on physical health conditions in the general population (Knapp et al., 2009a, 2009c, 2011).

As the current study was not recruiting participants for the ROSHNI-2 trial, several aspects of the study significantly differed from the actual recruitment situation. The participants were members of the public asked to imagine taking part in the ROSHNI-2 trial. They read the PIS at home before the testing appointment, and the user testing interviews took place in a quiet interview room rather than a busy clinic. Though these factors may have, to some extent, facilitated participants in their reading and understanding, it is unlikely to have biased the comparison of the original and revised PIS (Knapp et al., 2011). The demographic characteristics of the current study broadly matched the demographic characteristics of the ROSHNI-2 participants.

Although the analysis highlighted improvements in participants’ comprehension levels in the revised PIS, participants were not randomised. In relation to differences between groups A and B, education levels showed differences, with more participants at the graduate level in group B when compared to group A. Also, there were more postgraduate level participants in group A when compared to group B. It’s important to highlight that despite both groups being at least A-level educated, they also struggled to understand, showing a modest difference in improvement. Furthermore, there may have been other group differences that the study did not measure which also might have contributed to the difference in comprehension level found in the revised PIS.

There are reports that ethnic minority patients have considerable trust in their GPs and prefer to receive study-related information from them (Symonds et al., 2012) or other clinicians (D K Raynor et al., 2007). In contrast to an actual trial, where there is a recruiting clinician who assists participants with spoken and written information, in this study participants were asked to show an understanding of the ROSHNI-2 trial from the PIS alone. It is unclear whether the presence of a clinician would have impacted on the understanding of the PIS; this should be investigated in further research (Knapp et al., 2011).

The user testing method was tested in a study sample with a majority of participants at a graduate level, with a few at the high school level, while none of the participants had any formal research experience. Participants' level of education must have contributed to some level of understating the concepts, however overall understanding within this group was poor and therefore there is a need to assess this method with an ethnic minority sample where literacy in English is an issue.

Furthermore, the sample mainly comprised of Pakistani women, with only one participant from a Bangladeshi background. Future research requires testing the method in a more diverse British South Asian ethnic population.

At the time of testing participants, YM judged if the participant demonstrated understanding of the answers by cross-questioning participants. As YM was the only researcher collecting data and was not blinded to study aims, therefore there could be an aspect of bias influencing the data collection process.

Reporting the results of the individual items meant multiple statistical tests, which needs to be taken into account when interpreting p values, as multiple comparisons increase the likelihood that an individual value will be outside a 95% confidence limit or that the p-value for a single comparison will be less than 0.05 (Feise, 2002).

The user testing results from the participants showed that some questions improved more than others between the original and revised PISs. The questions linked to the nature of the trial, the process of taking part in the trial, management of treatment, and follow-up-based questions showed significant improvement. However, changes made did not affect user testing performance in some questions. Questions linked to interventions, and management of information did not show significant improvements, and further research is needed to seek greater understanding of these concepts.

A point to highlight is that user testing was used in this study as both a developmental tool and then an outcome measure with a small number of participants. Its use aimed to indicate problems with information, and it gives an indicator of when those problems have been fixed. In the current study, sample sizes of 15 per group are small and there can be a chance of Type 2 error.

Comparing the findings to the existing literature

The present finding confirms that the revision of the sheet by user testing with lay participants, through rewording, redesigning, and restructuring while retaining the meaning showed much-improved performance in almost all areas of the sheet. The results confirm the pattern reported in the studies reported in Table 1.

In terms of design, three studies used a stronger design (a randomised control trial [RCT] and a SWAT) whereas all other studies employed an independent group design and SWAT design (Knapp et al., 2011; Cockayne et al., 2017; Parker et al., 2018). In non-trials, there is a risk of participant variability (individual differences between groups) affecting the results, rather than solely manipulation of the independent variable. The sample size of the current study was lower compared to those conducted previously. Comparing the outcomes of the studies is difficult, as each study reported outcomes differently, although the general direction of the effect was consistent with a higher proportion of respondents answering questions correctly after user testing. As well as providing support for the general use of user testing, the current study is the first to evaluate user testing in a mental health setting, as the other studies recruited from a variety of physical health conditions.

Previously studies have reported that a shorter PIS led to a greater understanding (Knapp et al., 2011). However, the present study highlights that restructuring and changing the layout of information contributed to more effective engagement with the PIS.

Studies on the design of written medicine information have emphasised a need to involve users' perspectives in producing information for public usage (Lentz & De Jong, 1997; Raynor & Dickinson, 2009). The involvement of ethnic minorities in the development of trial materials may result in significant improvements to the information sheets, leading to better understanding and increased ethnic minority participation in trials. The present study supports involving users in the process of optimising and amending PISs. The study highlighted the problem areas that ethnic minority participants face when trying to read and understand trial-related information. User testing can help assure that the PIS can meet the needs of ethnic minority communities in understanding study-related information.

Policy and ethics implications

Modern research ethics committees often request highly detailed PISs, which may perversely reduce the quality of the consent decision by discouraging thorough reading and reducing assimilation of information. The current findings support this observation (Shukla et al., 2012).

It has been observed that in PISs there is more emphasis on the legal issues as compared to the communication aspect, as a result of this the length and complexity of the information sheets has increased (Fortun et al., 2008). Principal investigators and research ethics committees must balance legal and comprehensibility issues. In our study the most criticised aspect of the sheet was the structure of the information presented, and the complexity of the information presented. Other investigators have found that attempts to simplify PISs are rejected because of concerns of how text alterations might affect the legality of the statements (Koops & Lindley, 2002). The research ethics committee may review the standardised procedure for reviewing sheets, and this has implications for ethnic minority participant recruitment. Principal investigators and research ethics committees must consider other aspects to improve the readability and comprehensibility aspects of the information sheets without compromising on the length and legal aspects (Cockayne et al., 2015; Knapp et al., 2011).

Future work and implication

User testing methods may contribute to the recruitment of ethnic minority patients and the smooth running of the trial, with participants having a more complete understanding of the study (Hanley et al., 2001). Finally, it was not possible to evaluate the impact of revised ROSHNI-2 information sheets on the recruitment rate. However, the effect on actual trial participants is an important question. Further testing would require a study comparing the original and revised PIS with the random allocation of participants to test the effectiveness of the revised version on recruitment rates (Cockayne et al., 2015; Knapp et al., 2009b).

The Health Research Authority (HRA) in the UK has guidance on drafting PISs, the study highlights room for improvement in the guidelines, specifically addressing the needs of ethnic minority participants (Raynor et al., 2007).

Conclusion

User testing can allow information for patients to be evaluated and revised in a structured way. When the process is combined with expertise in writing for patients and information design, this may result in a greater proportion of ethnic minority participants being able to understand all the necessary information and thus the extent to which ethnic minorities can give valid consent (Cockayne et al., 2015; Knapp et al., 2011). The user testing methodology may be a useful tool to improve ethnic minority recruitment in trials, although this remains to be formally tested.

Data availability

Figshare: Improving a trial participant information sheet through user testing in British South Asian women. https://doi.org/10.48420/20803078.v1

This project contains the following underlying data:

  • Spreadsheet 1 - Original Roshini Information Sheet.csv

  • Spreadsheet 2 - Revised Roshini Information Sheet.csv

Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).

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Masood Y, Bower P, Knapp P et al. Improving a trial participant information sheet through user testing in British South Asian women [version 1; peer review: 1 approved with reservations]. F1000Research 2022, 11:1064 (https://doi.org/10.12688/f1000research.123499.1)
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Reviewer Report 23 Mar 2024
William J Cragg, University of Leeds, Leeds, England, UK 
Approved with Reservations
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Thanks for the opportunity to read this interesting paper. I think it is a useful idea to apply this same 'user testing' method to the challenge of improving diversity of clinical trial recruitment. I have a few major/general and a ... Continue reading
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J Cragg W. Reviewer Report For: Improving a trial participant information sheet through user testing in British South Asian women [version 1; peer review: 1 approved with reservations]. F1000Research 2022, 11:1064 (https://doi.org/10.5256/f1000research.135610.r250974)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

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Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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