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OBJECTIVES: The literature reports mixed results regarding the efficacy of intraoral topical anesthetics. Only a few studies have been performed in children. Some non-placebo controlled studies have been carried out to compare the efficacy in reducing children's injection pain between different topical anesthetics METHODS: In a randomized, double blind, placebo controlled study with split-mouth design 104 children were enrolled to evaluate the efficacy of four topical anesthetics (Gingicain Spray, Gingicaine Topical Anesthetic, Legecain-Solution, EMLA Crème) when used prior to buccal injections within the conservative treatment of carious upper primary molars. The heart rate change and a Face Pain Scale were used as primary variables. The Visual Analog Scale, the modified Children's Hospital Pain Scale and the Sound-Eyes-Motor Scale were also evaluated. RESULTS: There was no significant difference between the placebo and any corresponding topical anesthetic with regard to the primary variables (HRC and FPS). A significant difference was found in favour of Gingicain Spray and Gingicaine Topical Anesthetic according to secondary variables (VAS, S(E)MS). CONCLUSION: While the secondary variables point to a benefit of the topical anesthetics Gingicain Spray and Gingicaine Topical Anesthetic compared to placebo, the results of the primary variables showed no differences in effectiveness of topical anesthetics and their corresponding placebos.
OBJECTIVES: To study aspects of management and views about hyperlipidaemia and its treatment amongst different categories of physicians. DESIGN: A postal questionnaire was sent to selected physicians. Reminders were used. SETTING: The study included physicians in primary health care (PHCPs), occupational health care (OHCPs), and in departments of internal medicine in hospitals (IMPHs). SUBJECTS: All 146 PHCPs in the south-western region of Stockholm, 147 OHCPs, randomly selected from the directory of occupational health care offices, and all 157 IMPHs in six hospitals, in the greater Stockholm area, were offered the questionnaire. MAIN OUTCOME MEASURES: Differences in views, attitudes and treatment policy amongst different categories of physicians. RESULTS: Response rate was 70% (61-81%). Intervention was initiated by the OHCPs at lower levels of cholesterol than by the other two groups, with diet (P < 0.001) and with drug intervention as primary (P < 0.01) and secondary prevention (P < 0.005). When other cardiovascular risk factors were present, intervention was started earlier by the OHCPs only in comparison with the PHCPs (P < 0.01). Knowledge of one's own cholesterol level was more common amongst the OHCPs than in the other two groups (P < 0.001). Patient follow-up was the same in all groups. CONCLUSIONS: Disagreement amongst physicians about hyperlipidaemia leads to conflicting information being given to patients. It is important to be aware of these differences when trying to reach a consensus on this topic. Corresponding knowledge and attitudes amongst members of the public should also be studied.
BACKGROUND: There is little information about the prevalence of research integrity problems in the scientific literature. We sought to determine how frequently authors of published pharmaceutical clinical trials reported fabrication of data or misrepresentation of research. METHODS: We conducted a mail survey of 549 authors who had published reports of pharmaceutical clinical trials from 1998 to 2001 that appeared in the Cochrane Database of Systematic Reviews. We asked authors about fabricated data or misrepresentations of research in three contexts: the target study (the report from which their name was obtained), another study they had participated in, or a study that they personally knew about. RESULTS: We received replies from 64% of authors with valid addresses. Two authors (1%) reported that the target article misrepresented the research. Almost 5% reported fabrication or misrepresentation in a study they had participated in the last 10 years, and 17% of authors personally know about a case of fabrication or misrepresentation in the last 10 years from a source other than published accounts of research misconduct. CONCLUSIONS: Fraud and misrepresentation in clinical trials appear to be rare on a per-published report basis. However, they occur sufficiently frequently that scientists have a significant chance of participating in a project affected by fraud or misrepresentation during their research careers. These rates of exposure justify vigorous efforts to prevent research misconduct.
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Recruiting participants for large prevention trials is time consuming and costly. In order to test various recruitment techniques, we conducted two studies of response rates to recruitment mailings for the Women's Health Trial. The potential participants, 50- to 79-year-old women, were requested to return an enclosed postcard to learn more about the trial. In the first study, we sent at random either a short or a long message to a group of University of Miami personnel (N = 862) and a Dade County cohort (N = 2964). More university women responded to the short message than to the long message (22.4% vs 16.4%, p = 0.024). Similarly, more of the Dade County cohort replied to the short message than to the long one (12.1% vs 9.6%, p = 0.027). The long message listed details of the intervention (e.g., modifying recipes) that some women may have used to decide they were not interested in participating. In the second study, we examined response rates to two different ways of addressing the mailing, i.e., handwritten envelopes and machine-printed labels; we also evaluated three methods for delivering the short message: (1) formal invitation, (2) business letter with an inside name and address of the recipient, and (3) business letter without the recipient's name and address. Response rates were similar between the methods of addressing envelopes and among the three vehicles for the message, suggesting that the least costly method of mailing should be used.
More than 400 community-dwelling older adults were recruited into a clinical trial which compared the effectiveness of diagnosis and treatment through geriatric assessment with that provided through usual community physician care. Six recruitment methods were utilized: referrals, solicitations, presentations, media, mailings, and fliers. Each method is described and its results reported in terms of numbers recruited, yield, and cost per participant. The most efficient method was referrals; the method producing the largest number was presentations; the least effective method was fliers. Problems and solutions are discussed, and guidelines for recruiting older adults are suggested. These guidelines include: monitoring with accompanying adaptation, targeting the groups most likely to benefit, providing incentives, and reducing uncertainty among potential participants.
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PURPOSE: This study explores the ethical issues contained in warning letters issued to clinical researchers by the Food and Drug Administration (FDA) in the USA. METHODS: The online FDA Warning Letter Index was reviewed for letters issued to drug and device researchers in the USA and Canada under the violation subject "Clinical Investigator" for the period February 2002 through February 2004. The resultant letters were evaluated for the presence of 7 research ethics themes: deviation from investigational plan; informed consent; adverse event reporting; study reporting; study supervision; institutional review-board approval; and misconduct. RESULTS: Thirty-six FDA warning letters addressing violations of 58 protocols were issued to researchers during the 25 months studied. Researchers performing pulmonary medicine studies received the most warning letters (12), followed by oncology (10) and cardiology (9) researchers. The most common regulatory violations were deviation from the research plan, a flawed or nonexistent consent process, and failure to report or late reporting of adverse events. Three warning letters (8%) mentioned study misconduct, including data fabrication. CONCLUSIONS: Warning letters are informative about good practice, ethics and participant protection in research. As distressing as the content in an FDA warning letter may be to investigators receiving it, that information can become an educational tool for all members of the research team. These letters are also informative as to what the FDA is looking for when they audit clinical trials.
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PURPOSE: This study explores the ethical issues contained in warning letters (WLs) issued to institutional review boards (IRBs) by the United States Food and Drug Administration (FDA). METHODS: The online FDA Warning Letter Index was reviewed for letters issued to IRBs in the United States under the violation categories "Institutional Review Board" and "IRB" for the period January 1997 through July 2004. The resultant letters were evaluated for violations in 4 regulatory themes: having and following written procedures for research review; documentation of research review; IRB membership and conflict of interest; and informed consent. RESULTS: Fifty-two (52) FDA WLs were issued to IRBs during this period. Hospital/medical centre IRBs received the most letters (n = 34), followed by university IRBs (n = 9) and private IRBs (n = 9). The most common regulatory violations were failure to have and follow adequate written procedures about how the review of research is conducted (50 WLs); failure to prepare and maintain adequate documentation of IRB activities (47 WLs); and failure to provide adequate continuing review of approved studies (36 WLs). Nineteen WLs were issued for consent form issues. CONCLUSIONS: Warning letters are informative with regard to clinical research regulations and research subject protection. The content of these letters consistently indicates weaknesses in review and documentation activities of audited IRBs, potentially signalling similar issues among IRBs across the United States. Our findings, in a setting of overburdened IRBs who, in general, passively monitor studies, raise concerns about study oversight and optimal protection of research subjects.
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