# Abstract

 

## Background It is important that potential study participants are appropriately informed and understand what is involved with their research participation. A few studies have examined study participants' understanding of the informed consent process and the adequacy of the information they received when agreeing to participate in a randomised controlled trial. Deficiencies in the consent process have been found. This topic remains an under researched area of acupuncture research. The aim of this study was to examine participants' understanding of their informed consent and the adequacy of the information presented when agreeing to participate in a randomised controlled trial of acupuncture. 

## Methods All women who participated in a randomised controlled trial over an 11 month period were invited to participate in a survey. An anonymous self-completion questionnaire was designed and covered participants' understanding of informed consent in the clinical trial, their views of the information provided, the opportunity to ask questions, the use of sham acupuncture, their recall of study visits and processes for withdrawal, and their reason for participating in the trial. 

## Results A response rate of 59 % was obtained. Over 90 % of subjects indicated there was plenty of opportunity to discuss the study prior to giving consent, and 89 % indicated that questions asked were answered to their satisfaction. The majority of women indicated the amount of information describing acupuncture was about right, however 24 % would have liked more. Information describing sham acupuncture was not considered adequate by 48 % of women, and 35 % would have liked more information, 30 % could not recall why, or were uncertain why a sham group was used. Participants indicated less understanding of the information relating to payment if they became ill due to study participation, risks and discomforts from the study interventions, which of the procedures were experimental and for how long they would be involved in the study. 

## Conclusion Trial participants' understanding of informed consent was overall satisfactory but highlighted some areas of deficiency. Future studies could consider use of supplementary material such as Q and A fact sheets. # Results A total of 353 questionnaires were sent out and responses were received from 210 participants giving a response rate of 59 %. Responses to the survey indicated representation across Australian States and Territories, and from our three overseas recruitment sites in New Zealand. The majority of women completing the survey were aged over 35 years, and the majority were highly educated (Table [1](#)). ::::table-wrap

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Demographic characteristics of study participants
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Demographics Survey population

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*n* = 210 %\
Age (year)\
\<35 74 35.2
35--44 120 57.1
Missing data 14 6.6
Place of residence\
New Zealand 69 32.8
South Australia 45 21.4
New South Wales 40 19.0
Victoria 36 17.1
Australian Capital Territory 11 5.2
Queensland 7 3.3
Missing 2 0.9
Education\
Did not finish high school 9 4.2
High School Certificate 22 10.4
Vocational training 42 20.0
University degree 121 57.6
Missing 16 7.6:::: All women indicated the primary reason for participating in the study was the they hoped acupuncture would improve their chance of having a baby. In addition 61 women (29 %) indicated the importance of undertaking research as a key reason for joining the trial. We sought women's views about the information they received and the opportunity to ask questions when considering their involvement in the study (Table [2](#)). Over 90 % indicated there was enough opportunity to discuss the study with the clinical staff before deciding to join the trial, and 89 % indicated that any questions they asked were answered to their satisfaction. The majority of women indicated the information describing acupuncture was about right, however 48 (24 %) would have liked more (Table [2](#)). Information describing sham acupuncture was not considered adequate by approximately half of the women, and 35 % would have liked more information. The role of educational status was examined in response these questions and we found women with tertiary education would have liked more information on acupuncture (*p* \< 0.009), no other associations were found. ::::table-wrap
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Views of information presented on the study
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Participation in the trial *N* = 210 %

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Opportunity to ask question\
Yes plenty of time 191 91.0
No little opportunity 11 5.2
I can't remember 8 3.8
Questions answered to your satisfaction\
Yes completely 140 66.7
Yes mainly 49 23.3
No I wasn't happy with the answers 1 0.5
I didn't ask any questions 17 8.1
I can't remember 3 3.8
Information on acupuncture (*n* = 198)\
It was about right 142 71.7
I would have liked more 48 24.2
Information too detailed 4 2.0
I can't remember 4 2.0
Information on sham acupuncture (*n* = 198)\
It was about right 104 52.5
I would have liked more 70 35.4
I can't remember 20 10.1
Information too detailed 4 2.0:::: # Understanding of the patient information We asked about participants' understanding of the study based upon the written information they received and follow up verbal interaction with study staff (Table [3](#) Appendix 1, question 5). The majority of participants clearly understood what the study involved with overall mean scores of 4 in response to these questions. There were five areas in which participants indicated less understanding, these related to payment if they became ill due to their participation in the study, risks and discomforts from the study interventions, which of the procedures were experimental and for how long they would be involved in the study. In addition, over 75 % recalled they were required to attend for treatment on two occasions, and 50 % could accurately recall when they were required to complete questionnaires. ::::table-wrap
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Participants understanding of the study
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*n* = 199 Mean SD

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The fact that participation is voluntary 4.6 1.0
That your treatment involved research 4.5 1.0
What the researchers were trying to find out 4.3 1.0
Treatments and procedures you would undergo 4.3 1.0
How your participation may benefit future patients 4.3 1.0
Possible benefits from participating in the trial 4.2 1.1
Overall how well you understood the study when you signed the consent form 4.2 1.0
Who to contact if you have questions 4.3 1.1
Possible trial risks and discomforts 3.8 1.2
How long you would be in the trial 3.8 1.1
Which treatments were experimental 3.7 1.2
Alternatives to participation in the trial 3.6 1.4
Who will pay for treatment if you become ill/injured 3.0 1.5:::: We explored participants' understanding of selected areas relating to questions about the trial and the research terminology used in the patient information sheets through open-ended questions. Participant responses indicated some deficiencies. Over 82 % of responses indicated women could recall what a RCT meant. Responses were illustrated by the following quotations *"I will be selected at random to be in the real or sham acupuncture group to assess the effect of acupuncture on live birth rates"*. Many participants responded indicating their understanding of randomisation and blinding, for example, *"that the person is randomly picked to be in the sham or real acupuncture group", "I will be allocated to either a treatment or a control group, blind study means I won't be aware of which group I was allocated to"*. Some subjects responded by discussing the randomisation process, "*its like a name in a hat you get randomly drawn to have either real or placebo acupuncture",* and *" where a computer randomly selects which group you will be in"*. Incorrect responses reflected responses relating to blinding *" no one knows which group you are in", participants receive either sham or actual treatment without knowing which one"*, or general responses relating to the purpose of the study "*its a experiment used to test the effectiveness of something in this case the acupuncture meridians on the pregnancy success rates in IVF patients".* We asked why was sham acupuncture used? Thirty percent could not recall why or were uncertain, and 69 % provided an explanation. Many described it in terms of a non-specific effect relating it to the placebo effect, *"because it was the placebo treatment, you need to see whether the outcomes would be affected by receiving acupuncture or not", "to rule out the placebo effect, or to rule it in", "to see if it is all in the mind"*. Others indicated their understanding of the use of a control group, *" to determine if real acupuncture does actually cause more pregnancies", "as a control group to eliminate changes caused by bias or belief", "to see if specific points had results that can be compared against the sham results". "Sham acupuncture is used to control for the physiological and psychological effects".* Fifty nine percent of participants indicated they could not recall the process to withdraw from the study with an additional 16 % responding they were unclear. Of those indicating they understood the process for withdrawing, a small number mentioned they could withdraw any time, however the majority of participants responded to this question by explaining they were of aware of the process to contact the site research nurse or the trial co-ordinator to communicate their intention to withdraw. Recall of the potential risks and side effects was poor. Over 41 % could not describe any side effects or risks and a further 29 % were unsure. Twenty eight percent of women listed side effects, with the majority accurately recalling acupuncture side effects listed on the information sheet including slight discomfort, pain from needling, and the less frequently occurring events relation to feeling lighted heads, nausea, and dizziness. Five inaccurately recalled a risk of infection.


Extracted trial result:
Outcome: would have liked more information on acupuncture (binary)
Intervention: tertiary education
Comparator: other educations
Intervention group size: 121
Comparator group size: 89
Notes: Specific numbers were not given.