BMJ  2004;328:742-743 (27 March), doi:10.1136/bmj.38035.705185.F6 (published 23 February 2004)

Paper

Does the type of competing interest statement affect readers' perceptions of the credibility of research? Randomised trial

¹ BMJ Editorial Office, BMA House, Tavistock Square, London WC1H 9JR, ² Medical Statistics Department, Education and Research Centre, Wythenshawe Hospital, Manchester M23 9LT, ³ General Surgery, North Staffordshire University Hospital, Stoke-on-Trent ST4 7LN

Introduction

Financial relationships among industry and academic institutions are diverse and common.¹ These interests can influence authors' conclusions² and readers' perceptions of published studies.³ We report the effects on reader perceptions of different statements of competing interests for two manuscripts.

Participants, methods, and results

We used computer generated random numbers from the British Medical Association's membership database (to select 900 BMJ readers). We randomised 450 to be sent a paper about the use of problem lists in letters between hospital doctors and general practitioners⁴ (problem lists paper) and 450 to be sent a paper indicating that the impact of pain from herpes zoster on patients' daily functioning may be substantial (herpes paper).⁵ We previously reported a study using the herpes paper,³ and we have incorporated the results from that study in this paper. For each of the papers, 150 readers received the paper with no competing interests declared, 150 with a financial statement, and 150 with a statement that the author was a recipient of funding for studentships and research grants.

The competing interest statements for each group were as follows. For both papers, when the type of competing interest was "none," the phrasing of the statement was "none declared."

For the herpes paper, when the type of competing interest was "financial," the statement read "The authors are employees of Tohen Research Laboratories, Tohen and Co, Inc, Connecticut, and potentially own stock and/or hold stock options in the company. When the type of competing interest was "grant," the statement read "KH is a recipient of funding for studentships and research grants from Tohen Laboratories Limited."

For the problem lists paper, when the type of competing interest was "financial," the statement read: "AT is an employee of Tohen Laboratories Limited, makers of medical management software and potentially owns stock or holds stock options within the company." When the type of competing interest was "grant," the statement read: "AT is a recipient of funding for studentships and research grants from Tohen Laboratories Limited, makers of medical management software."

Readers scored the studies in terms of interest, importance, relevance, validity, and believability on 5 point scales (for example, 1=extremely uninteresting to 5=extremely interesting). We estimated that 91 readers were needed in each group to achieve a power of 90% to detect a meaningful difference in scores between the groups of approximately 0.5 units (characterised by a variance of means of 0.047—for example, means of 3.3, 3.4, and 3.8), by using a one way analysis of variance with the conventional 5% significance level and assuming a common standard deviation of 1.0. We used an analysis of variance model to evaluate the impact of type of competing interest (none declared, financial, grants) on ratings of interest, importance, relevance, validity, and believability and to assess the influence of type of paper (herpes, problem lists) on this effect. To adjust for the possible confounding factors of age and sex of the reader we also included these in the statistical model. We included interaction terms to explore the inter-relations between the various factors.

We excluded 18 readers (unable to participate (8), incorrect address (9), lost (1)). Altogether 522/882 (59%) questionnaires were returned (230/440 (52%) herpes paper, 292/442 (66%) problem lists paper). Respondents were significantly older than non-respondents (mean age 45.1 (SD 16.0) years v 40.3 (SD 14.0) years, t(865) = 4.83; P<0.0001). Overall, importance, relevance, validity, and believability ratings were significantly lower in the "financial statement" group than in the "none declared" group (table). Validity ratings for the "financial statement" group were also significantly lower than for the "grants statement" group. We found significant differences in the ratings between papers for all five measures (P<0.001), with the problem lists paper scoring significantly higher (table A on bmj.com). We found a significant inter-relation between competing interest and paper for the two measures interest and believability (P=0.012 and P=0.007, respectively). For these measures the lower ratings for the "financial statement" group were more pronounced for the herpes paper. Ratings for all five measures increased significantly with age, and women reported significantly higher ratings than men.

View this table: [in this window] [in a new window]   Analysis of variance results: mean values (95% confidence intervals) and significance levels relating to competing interest

 

Comment

Both the type of competing interest and the contents of a study influence readers' perceptions of the credibility of published research. Qualitative research might tell us how. Our study has several weaknesses. The response rate was low. Readers were from one journal and told they were taking part in a study, which may have influenced responses. Respondents were significantly older than non-respondents, but age was not found to be significantly related to differences between the competing interest groups (there were no significant age-competing interest interactions). Journal editors should pursue the policy of declaring authors' competing interests so readers can make informed judgments about the credibility of research.

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Full details of the results for each paper and the interaction effects are on bmj.com

This article was posted on bmj.com on 23 February 2004: http://bmj.com/cgi/doi/10.1136/bmj.38035.705185.F6

We thank the authors of the original manuscripts for allowing us to use them and the readers for taking part in our study.

Contributors: SS, JM, SC, and RS designed the study. SC conducted the study with help from SS and HB. JM and SS performed the data analysis. All authors interpreted the results and wrote the manuscript. SS is guarantor.

Funding: BMJ Publishing Group's own research budget.

Competing interests: RS is the editor of the BMJ and responsible for devising its policy on competing interests. He is paid a fixed salary and will not be affected financially by the success or failure of the policy on competing interests. Because members of BMJ staff were involved in the conduct of this research and writing the paper, assessment and peer review were carried out entirely by external advisers. No member of BMJ staff has been involved in making the decision on the paper.

References

1. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003;289: 454-65.[Abstract/Free Full Text]
2. Barnes DE, Bero LA. Why review articles on the health effects of passive smoking reach different conclusions. JAMA 1998;279: 1566-70.[Abstract/Free Full Text]
3. Chaudhry S, Schroter S, Smith R, Morris J. Does declaration of competing interests affect reader perceptions: a randomised trial? BMJ 2002;325: 1391-2.[Free Full Text]
4. Lloyd BW, Barnett P. Use of problem lists in letters between hospital doctors and general practitioners. BMJ 1993;306: 247.
5. Coplan PM. Clinical relevance of zoster associated pain (ZAP) [electronic response to Helgasson et al. Prevalence of postherpetic neuralgia after a first episode of herpes zoster: prospective study with long term follow up]. BMJ 2000; bmj.com/cgi/eletters/321/7264/794#13902 (accessed 14 May 2002).

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