Introduction
Previous research has suggested orthodontic advertisements are poorly supported by evidence. The primary aim of this study was to identify the type and quality of evidence supporting advertisement claims in leading orthodontic journals.
Methods
A cross-sectional study was undertaken to assess all advertisements published between January 2015 and December 2017 in 6 major orthodontic journals. Only advertisements implying superior product performance in clinical practice or patient care were selected for further evaluation. Study variables were collected using a prespecified data collection form. In the presence of a supporting citation, the reference article was obtained, and the quality was assessed in duplicate. Associations between advertisement variables and quality of evidence were explored using contingency tables (Fisher exact test).
Results
A total of 1753 advertisements were identified. After the application of eligibility criteria, 124 were included in the final analysis. Advertisements promoting bracket systems predominated. Of these, 34.7% were supported by evidence, of which 10.5% (n = 13) included accessible references. Only 6 out of 13 studies involved orthodontic patients. Primarily expert opinion and observational study types were referenced. Less than 2% of advertisements were supported by high-value evidence. There was an association between the quality of evidence in advertisements and the product category ( P = 0.003).
Conclusions
There is a lack of both references and high-value evidence cited in orthodontic manufacturers’ advertisements. Without critical appraisal of references cited in advertisements, clinicians need to be cautious before implementing manufacturers’ recommendations in clinical practice. Efforts should be made to ensure appropriate high-value evidence is cited in advertisements to support manufacturers’ claims.
Highlights
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Journal advertisements are not peer-reviewed.
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The evidence supporting manufacturer products within is not assessed.
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About one-third of advertisements in 6 journals provided a reference to support claims.
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Only 10 were supported by accessible references with the evidence graded as low quality.
An evidence-based approach is regarded as the gold standard in the delivery of health care because it encourages safe, efficient, and cost-effective interventions . It is generally accepted within orthodontic practices that interventions should be supported wherever possible, by the highest levels of evidence. However, many clinicians still appear to rely on lower levels of evidence and are therefore vulnerable to claims made in orthodontic journal advertisements. A prescriptive belief in claims made in journal advertisements without a critical assessment of the underlying evidence supporting these products may put orthodontists at risk of not only letting down their patients but also the orthodontic specialty. Medical journals are a popular source of information for clinicians, and advertisements can provide an important source of information and education for health care providers, raising awareness regarding new products, services, and techniques. However, they are not the only source of product advertisements. Manufacturers are increasingly using social media platforms, opinion leaders, and direct marketing to consumers to promote the claimed benefits of their products. Indeed, studies have found that journal advertising can influence the behavior of clinicians; for example, pharmacists may be more likely to prescribe medications that have been featured in journal advertisements.
Because of their influence, it might be expected that advertisements should contain clear, accurate, and nonbiased information regarding the products that they advertise. , However, concerns have been expressed that although articles submitted to scientific journals are often subject to a stringent peer-review process before publication, the same level of scrutiny is not in place for advertisements. The World Health Organization specifies that advertisements within medical journals should contain references to the scientific literature when appropriate. However, an assessment of pharmaceutical advertisements within 5 major medical journals found that only 2% contained references. Furthermore, in both developing and developed countries, medical journal advertisements are frequently not supported by references, and when they are, these are often either sponsored, unobtainable, or low-quality evidence. , Regarding the latter, well-conducted randomized controlled trials are considered to be the most reliable form of scientific evidence for testing therapeutic interventions. However, only 22% of advertisements in the British Medical Journal cited randomized controlled trials.
Despite the presence of recommendations suggesting the use of appropriate advertising, studies have shown that inappropriate practice is still widespread. , Fundamentally, if a claim is to be made, then it should not be vague, ambiguous, or emotive; otherwise, such advertisements will invariably be less useful to clinicians. It has been found that within advertisements, 11% of references actually contradicted the original claims made within the advertisement and that 21% of references were completely irrelevant to the original claim made. , Furthermore, 70% of claims made worldwide in medical journal advertising have been classified as ambiguous.
In modern health care, in which an evidence-based approach is advocated, contemporary appraisal of the quality of evidence cited in orthodontic journal advertisements is important. The primary aim of this study was to identify the type and quality of evidence used to support advertisement claims made by manufacturers in 6 leading orthodontic journals. In addition, associations between advertisement variables and the quality of evidence were explored.
Material and methods
A cross-sectional retrospective study was undertaken. Advertisements published between January 2015 and December 2017 in the following orthodontic journals were assessed: American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), Australian Orthodontic Journal , Journal of Orthodontics , European Journal of Orthodontics , Journal of Clinical Orthodontics (JCO), and Journal of Orofacial Orthopedics (JOO). Because of an absence of relevant advertisements published in both The Angle Orthodontist and Orthodontics & Craniofacial Research journals, both were excluded from the study. The 6 scientific orthodontic journals were chosen as they all undertake a peer-review process, are internationally distributed and affiliated with national orthodontic societies. This is consistent with a previously reported methodology. The screening and selection of all advertisements were undertaken by a single investigator (O.H). Any discrepancies or ambiguous advertisements were discussed with another investigator (J.S) until a consensus was reached. Advertisements published in English, implying superior product performance on clinical practice or patient care, were only selected for further evaluation. Superior performance was defined as the suggestion of better, best, or more effective product performance within the narrative of the advertisement.
Advertisements were also assessed for supporting evidence and references. In the presence of a supporting study, the reference article was obtained by an electronic search via PubMed (Medline) and assessed in further detail. Attempts were also made to retrieve citations eluding to data on file by contacting the relevant company using the contact details provided within the advertisement. A study quality assessment of the supporting reference was undertaken. A previously validated and predetermined set of criteria were used to assess study quality, and these were then graded accordingly (A to C) ( Table I ). The quality of each reference was assessed independently by 2 investigators (O.H and J.S). Any disagreements were discussed until a consensus was obtained.
| Grade | Criteria |
|---|---|
| A (high-value of evidence) | All criteria should be met:
|
| B (moderate value of evidence) | All criteria should be met:
|
| C (low value of evidence) | One or more of the conditions below:
|
The following data variables were collected using a prespecified data collection form: publication year of the advertisement (2015, 2016, 2017), journal type (AJODO, Australian Orthodontic Journal , Journal of Orthodontics , European Journal of Orthodontics , JCO, and JOO); type of advertised product (appliances, bracket systems, orthodontic materials, mini-implants, software, oral hygiene aids); type of supporting evidence (published study, unpublished study, and anecdotal evidence); study type (systematic review with meta-analysis, randomized controlled trial, retrospective case-control, cohort, case series, case report, opinion, and in vitro) and quality of evidence of the supporting referenced study.
Statistical analysis
Descriptive statistics were calculated. Fisher’s exact test was used to examine associations between the variables (publication year of advertisement, journal type, type of advertised product) and level of evidence. A 2-tailed P value of 0.05 was considered statistically significant. All analyses were performed using Stata statistical software (version 15; StataCorp, College Station, Tex).
Results
A total of 128 print journal and supplement issues published within the 3-year period were identified. Handsearching of these issues yielded a total of 1753 advertisements. From this total, 57 were excluded because they were non-English, and 1323 were excluded because they did not imply a superior product performance in relation to clinical practice or patient care, leaving a remainder of 373 advertisements. After the exclusion of 249 duplicate advertisements, a total of 124 remained, which fulfilled the inclusion criteria ( Fig ).
From these 124 advertisements, 34.7% (n = 43) were supported by evidence, whereas 65.3% (n = 81) were not supported by any form of evidence. Of the 43 advertisements supported by evidence, 20 included references to strengthen the claims made by the advertisement; however, 7 out of the 20 citations were represented as data on file. All 7 of these data on file references were unobtainable, despite attempts to request the literature from the relevant companies. This resulted in the presence of only 13 advertisements with obtainable references to support the claims made. Only 6 out of the 13 studies involved orthodontic patients ( Table II ).
| Advertisement | Summary of claim(s) made by the advertisement | Patients included |
|---|---|---|
| 1. Colgate Duraphat | 33% reduction in DMFS and 46% reduction in DMFT scores | Nonorthodontic |
| 2. Listerine mouthwash | 500% less plaque at 6 mo compared with brushing alone | Nonorthodontic |
| 3. Listerine mouthwash | Destroys millions of germs preventing bad breath | Nonorthodontic |
| 4. Listerine mouthwash | Contains 4 essential oils which break down plaque biofilm | Nonorthodontic |
| 5. Reliance Pro Seal | Releases fluoride, durable, and prevents demineralization | Orthodontic |
| 6. Waterpik Water Flosser | 300% greater than string floss for cleaning around braces | Orthodontic |
| 7. Ormco Custom brackets | Reduces treatment time by 37% with 7 fewer appointments | Orthodontic |
| 8. Waterpik Water Flosser – Cordless Advance | Removes up to 99.9% of plaque and 500% more effective compared with brushing alone for plaque removal | Laboratory study |
| 9. Dynaflex CS3 springs | Up to 5 mm correction for treatment of patients with Class II/III malocclusion | Orthodontic |
| 10. Inspire ICE brackets | Esthetic, strong, safe, and easy to remove without fracture | Laboratory study |
| 11. Clarity Ceramic Brackets | Esthetic, predictable debonding, and greater comfort | Orthodontic |
| 12. TPO Mini-Positioner | Less chair-time, earlier braces removal, and superior finishes | Orthodontic |
| 13. Planmeca ProMax 3D | 77% reduction in radiation dose with no image degradation | Laboratory study |
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