Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld and a third was informally resolved after the advertiser agreed to amend or withdraw the advertising.
Ad description
A website and a tweet for Seating Matters Ltd, a company providing specialist chairs:
a. The website www.seatingmatters.com, seen in March 2018, stated "... Seating Matters collaborated with leading researchers at Ulster University to identify the importance of suitable seating provision in reducing the incidence of pressure ulcers and postural difficulties ... This is the first and only independent, large-scale randomised control trial to have been carried out on clinical therapeutic seating worldwide ... The staggering results have proven what we already believe, that the correct use of specialised seating can lead to: A significant reduction in pressure ulcer incidence by 88.3% ...".
b. The tweet on 16 November 2017 stated "Our clinical research proved an 88.3% reduction in pressure injury incidence ...".
Issue
Careflex Ltd challenged whether the following claims were misleading and could be substantiated:
1. "This is the first and only independent, large scale randomised control trial to have been carried out on clinical, therapeutic seating worldwide" in ad (a); and
2. "A significant reduction in pressure ulcer incidence by 88.3%" in ads (a) and (b).
Response
1. Seating Matters Ltd maintained that their study, which had been carried out by Ulster University, was to date, the only randomised controlled trial conducted into specialist seating anywhere in the world. They said their study was independent and had been peer reviewed.
2. They provided a copy of their study, which they believed substantiated the claim. They also provided a draft report which had been submitted to two publications for peer review.
Assessment
1. Upheld
The ASA noted that Seating Matters had not provided any explanation of the steps they had taken to demonstrate that to date there were no independent, large scale randomised controlled trials on clinical, therapeutic seating anywhere in the world.
Furthermore, we noted that their own study described itself as "a small-scale pilot study" and consisted of only 36 participants: 18 were in the intervention group and 18 were in the control group. We considered that the number of participants was not sufficient to be able to describe their study as "large scale".
For those reasons, we concluded that the claim that their study was "the first and only independent, large scale randomised control trial to have been carried out on clinical, therapeutic seating worldwide" had not been substantiated and was misleading.
On that point, ad (a) breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising), 3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation. (Substantiation) and 3.33 3.33 Marketing communications that include a comparison with an identifiable competitor must not mislead, or be likely to mislead, the consumer about either the advertised product or the competing product. (Comparisons with identifiable competitors).
2. Upheld
We had concerns with the methodology used in their study. As noted above, the pool of participants was small and consisted only of nursing home residents. It was therefore not necessarily the case that the results could be extrapolated to the general population. It was not clear from the study how participants had been assigned to their respective groups, although we noted that the draft report explained that they had been randomly assigned using computer-generated numbers. The study was not blinded, the measurement of pressure ulcers was purely observational and no statistical analysis had been carried out on the results. We understood that the study had not been peer reviewed but that one of the publications was in the process of doing that.
Furthermore, the study did not state that there had been an 88.3% reduction in pressure injury incidence in the intervention group. The draft report, submitted for publication, did refer to an 88.3% reduction in pressure incidence in the intervention group. However, because of the limitations with the study methodology, we considered that it was inadequate substantiation for the claim.
For those reasons, we concluded that the claim "a significant reduction in pressure ulcer incidence by 88.3%" in ads (a) and (b) had not been substantiated and was misleading.
On that point, ads (a) and (b) breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation),
3.11
3.11
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
(Exaggeration) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
Action
The ads must not appear again in their current form. We told Seating Matters Ltd not to claim in future that their study was the first and only independent, large scale randomised control trial to have been carried out on clinical, therapeutic seating worldwide or that it showed an 88.3% reduction in pressure injury incidence.
