Scientific and Legal Perspectives on Science Generated for Regulatory Activities

This article originated from a conference that asked “Should scientific work conducted for purposes of advocacy before regulatory agencies or courts be judged by the same standards as science conducted for other purposes?” In the article, which focuses on the regulatory advocacy context, we argue that it can be and should be. First, we describe a set of standards and practices currently being used to judge the quality of scientific research and testing and explain how these standards and practices assist in judging the quality of research and testing regardless of why the work was conducted. These standards and practices include the federal Information Quality Act, federal Good Laboratory Practice standards, peer review, disclosure of funding sources, and transparency in research policies. The more that scientific information meets these standards and practices, the more likely it is to be of high quality, reliable, reproducible, and credible. We then explore legal issues that may be implicated in any effort to create special rules for science conducted specifically for a regulatory proceeding. Federal administrative law does not provide a basis for treating information in a given proceeding differently depending on its source or the reason for which it was generated. To the contrary, this law positively assures that interested persons have the right to offer their technical expertise toward the solution of regulatory problems. Any proposal to subject scientific information generated for the purpose of a regulatory proceeding to more demanding standards than other scientific information considered in that proceeding would clash with this law and would face significant administrative complexities. In a closely related example, the U.S. Environmental Protection Agency considered but abandoned a program to implement standards aimed at “external” information

An evidence-based approach to the use of telehealth in long-term health conditions: development of an intervention and evaluation through pragmatic randomised controlled trials in patients with depression or raised cardiovascular risk

Background: Health services internationally are exploring the potential of telehealth to support the management of the growing number of people with long-term conditions (LTCs). Aim: To develop, implement and evaluate new care programmes for patients with LTCs, focusing on two common LTCs as exemplars: depression or high cardiovascular disease (CVD) risk. Methods Development: We synthesised quantitative and qualitative evidence on the effectiveness of telehealth for LTCs, conducted a qualitative study based on interviews with patients and staff and undertook a postal survey to explore which patients are interested in different forms of telehealth. Based on these studies we developed a conceptual model [TElehealth in CHronic disease (TECH) model] as a framework for the development and evaluation of the Healthlines Service for patients with LTCs. Implementation: The Healthlines Service consisted of regular telephone calls to participants from health information advisors, supporting them to make behaviour change and to use tailored online resources. Advisors sought to optimise participants’ medication and to improve adherence. Evaluation: The Healthlines Service was evaluated with linked pragmatic randomised controlled trials comparing the Healthlines Service plus usual care with usual care alone, with nested process and economic evaluations. Participants were adults with depression or raised CVD risk recruited from 43 general practices in three areas of England. The primary outcome was response to treatment and the secondary outcomes included anxiety (depression trial), individual risk factors (CVD risk trial), self-management skills, medication adherence, perceptions of support, access to health care and satisfaction with treatment. Trial results Depression trial: In total, 609 participants were randomised and the retention rate was 86%. Response to treatment [Patient Health Questionnaire 9-items (PHQ-9) reduction of ≥ 5 points and score of < 10 after 4 months] was higher in the intervention group (27%, 68/255) than in the control group (19%, 50/270) [odds ratio 1.7, 95% confidence interval (CI) 1.1 to 2.5; p = 0.02]. Anxiety also improved. Intervention participants reported better access to health support, greater satisfaction with treatment and small improvements in self-management, but not improved medication adherence. CVD risk trial: In total, 641 participants were randomised and the retention rate was 91%. Response to treatment (maintenance of/reduction in QRISK®2 score after 12 months) was higher in the intervention group (50%, 148/295) than in the control group (43%, 124/291), which does not exclude a null effect (odds ratio 1.3, 95% CI 1.0 to 1.9; p = 0.08). The intervention was associated with small improvements in blood pressure and weight, but not smoking or cholesterol. Intervention participants were more likely to adhere to medication, reported better access to health support and greater satisfaction with treatment, but few improvements in self-management. The Healthlines Service was likely to be cost-effective for CVD risk, particularly if the benefits are sustained, but not for depression. The intervention was implemented largely as planned, although initial delays and later disruption to delivery because of the closure of NHS Direct may have adversely affected participant engagement. Conclusion: The Healthlines Service, designed using an evidence-based conceptual model, provided modest health benefits and participants valued the better access to care and extra support provided. This service was cost-effective for CVD risk but not depression. These findings of small benefits at extra cost are consistent with previous pragmatic research on the implementation of comprehensive telehealth programmes for LTCs

Standards of ethical conduct for employees of the executive branch : final regulation issued by the U.S. Office of Government Ethics, codified in 5 C.F.R. part 2635 (1/1/97 edition), as amended at 62 FR 12531 (Mar. 17, 1997) and 62 FR 48746-48748 (Sept. 17, 1997).

"OGE, 9/17/97."Shipping list no.: 98-0279-P."Following document is an informal computer-generated version of the regulatory text of the ethical conduct standards rule, which became effective on February 3, 1993. This document incorporates all amendments to the Standards of Ethical Conduct through Septermber 17, 1997"--T.p. verso.Mode of access: Internet

Standards of ethical conduct for employees of the executive branch : final regulation issued by the U.S. Office of Government Ethics, codified in 5 C.F.R. part 2635.

"Official version ... published at 57 Federal Register 35006-35067 (August 7, 1992), with an effective date of February 3, 1993."Shipping list no.: 94-0351-P.Mode of access: Internet

Standards of ethical conduct for employees of the executive branch : final regulation issued by the U.S. Office of Government Ethics, codified in 5 C.F.R. part 2635 (1/1/02 edition), as amended at 67 FR 61761-61762 (Oct. 2, 2002).

Shipping list no.: 2003-0103-PMode of access: Internet

Public financial disclosure : a reviewer's reference /

Includes index.Shipping list no.: 96-0301-P.Mode of access: Internet

Standards of ethical conduct for employees of the executive branch : final regulation issued by the U.S. Office of Government Ethics, codified in 5 C.F.R. part 2635 (1/1/99 edition), as amended at 64 FR 2421-2422 (Jan. 14, 1999) and 64 FR 13063-13064 (Mar. 17, 1999).

"Document is an informal computer-generated version of the regulatory text of the ethical conduct standards rule, which became effective on February 3, 1993. This document incorporates all amendments to the Standards of Ethical Conduct through September 30, 1999"--Prelim. p."OGE 9/30/99."Mode of access: Internet