Patient Characteristics
All 87 patients were receiving renal dialysis in a hospital setting. 69% were male. The median age was 67 years.
Quantitative Findings
Patient understanding of trial and registry related terminology
Patients were asked to assess their understanding of terms/concepts related to RCTs (Table 1). The term registry, whether a ‘healthcare registry’ or a ‘kidney research registry’, was not well understood. 37.9% and 34.4% of patients reported a ‘poor/fair’ understanding of ‘healthcare registry’ and ‘kidney research registry’ respectively, with only 27% having a ‘very good/excellent’ understanding of each term. Over a third (36.8%) of patients had a ‘very good/excellent’ understanding of ‘clinical trials’. ‘Randomisation’ was poorly understood with 57.5% of patients reporting only ‘poor/fair’ understanding. Patients showed greatest understanding of ‘informed consent’ with more than 80% having a ‘good/very good/excellent’ understanding of its meaning.
Table 1 Patients’ self-reported understanding of key clinical trial and registry terms/concepts.
Research phrase
|
Self-reported percentage understanding (%)
|
Poor
|
Fair
|
Good
|
Very Good
|
Excellent
|
|
|
|
|
|
‘Healthcare Registry’ (n=87)
|
18.4%
|
19.5%
|
34.5%
|
20.7%
|
6.9%
|
‘Kidney Research Registry’
(n=87)
|
14.9%
|
19.5%
|
37.9%
|
23.0%
|
4.6%
|
‘Clinical Trial’ (n=87)
|
16.1%
|
14.9%
|
32.2%
|
27.6%
|
9.2%
|
‘Randomisation’ (n=87)
|
34.5%
|
23%
|
23%
|
14.9%
|
4.6%
|
‘Informed Consent’ (n=87)
|
6.9%
|
10.3%
|
36.8%
|
31.0%
|
14.9%
|
Patient’s openness to receiving information on a kidney randomised trial registry, from whom, and how.
91.7% of patients ‘strongly agree/agree’ to receive and 89.5% ‘strongly agree/agree’ to discuss information about potential participation in a kRTR during dialysis/during a regular clinic visit. <3% ‘disagree’ and 7% were ambivalent. 76% of patients ‘strongly agree/agree’ to being contacted by telephone outside of working hours by a researcher to discuss participating in a kRTR. 86% of patients ‘strongly agree/agree’ to receiving information by post with an option to discuss it at the next dialysis/clinic visit.
54.1% of patient’s preferred method of receiving information about the kRTR was receiving verbal information during their dialysis treatment with the option to consent to the kRTR after the discussion. 28.2% of patients preferred to receive information by post (consent at next visit to dialysis unit). The least popular methods to receive information were by email (9.4%) and by telephone (8.2%). Figure 2 represents patients’ preferences regarding whom they would like to receive and discuss information with about the kidney randomised trial registry. Consultants represent the largest group.
Patient data storage concerns
29.8% of patients ‘strongly agree/agree’ to having concerns about their medical data being stored in a kRTR. As a result, 24.1% of patients ‘strongly agree/agree’ to not wanting their data uploaded and stored in a kRTR as they considered their information private. Despite that, only 10.3% of patients were ‘not likely/very unlikely’ to consent to their medical information being uploaded and stored in a kRTR (Table 2).
Table 2: Patients views on their data being uploaded and stored in a kidney randomised trial registry (kRTR).
|
Strongly disagree (%)
|
Disagree
(%)
|
Neither agree nor disagree
(%)
|
Agree
(%)
|
Strongly agree
(%)
|
I would have concerns about my medical data being stored in a kidney randomised trial registry (n=87)
|
11.5
|
44.8
|
13.8
|
26.4
|
3.4
|
My medical information is private and I do not want it uploaded to a kidney randomised trial registry (n=87)
|
12.6
|
46
|
17.2
|
21.8
|
2.3
|
|
Very Unlikely (%)
|
Not Likely (%)
|
Neutral (%)
|
Likely (%)
|
Very Likely (%)
|
How likely would you be to consent to your medical information being uploaded and stored in a kidney randomised trial registry (n=87)
|
5.7
|
4.6
|
10.3
|
56.3
|
23
|
Patient perspectives on participation and healthcare/carer’s influence
In Section 2 of the questionnaire, patients read a short paragraph that explained in more detail the randomisation, the consent process, and the benefits of signing up to a kidney randomised trial registry (see Additional file 1). Researchers EM and AOK assisted with the explanations. Following this, 37.9% of patients were ‘very likely’, 42.5% were ‘likely’, 13.8% were ‘neutral’, 3.4% were ‘not likely’ and 2.3% ‘very unlikely’ to join the kRTR.
58.8% of patients thought their dialysis doctors should be involved in conducting clinical trials while 41.2% felt their doctors should focus on patient treatment and let somebody else conduct the trials. When signing up to participate in a kRTR, 67.8% of patients would have discussed it with somebody. The majority would have discussed it with their spouse/partner (35%), their GP (15%), their child (13.3%), parent (6.7%) or friend (1.7%). 28.3% selected ‘other’ and the top preference was their consultant. 51.2% of patients felt it would be ‘important/very important’ for their GP to be involved in their decision to partake in a kRTR while 48.8% felt it was ‘of little importance/moderately important’. Regarding patients’ views on getting involved in other aspects of study processes, such as study design or conduct, 62.4% reported it was ‘important/very important’, while 11.8% said ‘moderately important’ and 25.9% of patients said it was ‘of little importance’. Finally, 94.7% of patients felt it was ‘important/very important’, to participate in medical research by means of a clinical trial to improve healthcare treatments for others.
Thematic Analysis
Of the 80.4% of patients who would be ‘likely/very likely’ to consent to participate in a kRTR, 87% provided at least one reason why. Reasons were not ranked.
Theme: Motivators for participation in a kidney randomised trial registry
Self-benefit
This emerged as a strong theme (n = 32). Patients would participate in a kRTR “to help myself”, “beneficial for myself”, “personal benefit”, “own self-interest/benefit”, “to improve my health, “to improve my own situation”, and for “better health”.
Within the theme of self-benefit, patients cited reasons orientated around learning: “to learn more about my condition”, “to understand my condition”, “like to know more about it” (n=1), “to learn better/improve quality of life” (n=4), “for further knowledge” and for “education”. Patients were also motivated to participate for benefits related to their own care process: “if it would help to get off dialysis”, “reduce dialysis hours”, “so treatments can be given to me correctly”, “knowing you are being looked after by experts in that field”, “to help my own care” and “open to better treatments because I have bad kidneys”, “to improve kidney care” , “to improve healthcare”.
Help research, science and medical advancement
This was an equally strong theme (n = 31). Patients said they would be likely to agree to participate in the kRTR for “research purposes”, because it would be “good for research”, “beneficial for research”, “to help research”, “bettering research” or making “medical discoveries”. Others said it was because “I love research”, “I believe in research”, it is “good for” and “helps science” and it would be “advancing medicine”. Others felt “more research is necessary” and that it is “essential every effort is made to improve the situation for people with kidney issues” or help “find a cure for kidney problems” and to “find answers to why they are sick”. Patients also felt it was an “important study”, they would participate because it was “for a good cause…if it is an advantage to the study” and because it is “valuable research”, it might “find new improved treatments”, and it would be “basically positive to clinical trials (to improve procedures)”.
Help others
Helping others was another dominant theme (n = 19), “to help others”, “to help someone else” “to help others on dialysis”, “helping others” “to improve someone else’s situation”, “to improve others health”, “for others benefit”, “benefit to other patients not in the trial” or “ultimately be beneficial to all”. Linked to this was the help/benefit of future generations of patients, e.g., “it will help those who come after me”, “to help people in the future”, “so others can benefit in future studies” and “very important for the future”. Three patients were willing to “help” in general and other patients were “eager to make a contribution”, “excited to participate in something new”, to “better things” and another believed that their participation would “save time for staff and patients”. One patient believed participation “would help” as “more information is always good”.
Why not do it?
Other patients (n=5) agreed to participate because they believed “there’s no harm in it”, they had “no reason not too” or they would “be interested” or because if they were “asked to participate”.
There were just two responses to why people would not participate in a kRTR so we were unable to theme them. Worth mentioning are the reasons cited: “have no interest, have “no complications so leave it”, “distance” and “inconvenient”.
Theme: Concerns of patients when being recruited to a kidney randomised trial registry
Risk (incl. data protection) and side effects
75.9% of patients (n=66) responded. Reasons were not ranked. Risks and side effects were important (30%; n=20). Ten patients wanted to know more “about the side effects” and “what level of danger there would be” and others wanted more information (n=8), for example “what is involved in a clinical trial”, “if trials went wrong what would happen”. One patient was concerned about being “a Guinea pig in the drug trials”. Concerns about the safety of patient medical information was also cited frequently: “who would be entitled to view the information” “how safe is my information” “what would they do with my information” and “who has access/who will see the data”. Other data and registry related concerns included “if the trial was open to review” and “has this method (of trial recruitment) been used in other areas of research and if so what are the results?”. Ten patients had “no concerns”, e.g., “doesn’t worry me” and “no questions I have total confidence in my consultant”.
Time and commitment
A key piece of information was time and commitment. This was listed by 27.2% (n=18): “how much time would it take”, “how long would it take”, “is there a time requirement”, and commitment - “time and place of meeting”, “where would you have to go”, “when would it be” and “when would it start and finish”.
Personal benefit
Personal benefit was also a key piece of information required (22.7%; n=15): “what is the benefit for me”, and would it be “beneficial to my kidneys”. Three patients wanted to know “if it will help other patients”, “what benefit would it be for my consultant”, “how would it help” and two patients wanted to make sure it would help research if they participated “make sure it is helping research” and “would participation help”.
Effect on current treatment
Effect on current treatment was another piece of information required (15%; n=10): “would my normal treatment be constrained”, patients wanted to know if it would interfere with “my medication”, “my dialysis” or the “times of my dialysis treatment” and “does it reduce dialysis time”.