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PubMed1998

Clinical trials comparing two treatment policies: which aspects of the treatment policies make a difference?

We discuss pragmatic clinical trials with survival endpoints in which subjects commonly change treatment during follow-up. Suppose that an intention-to-treat (ITT) analysis shows a significant difference between the randomized groups. We may want to ask questions about the reason for such a difference in outcome between randomized groups: for example, was the difference due to different policies for change to a third more beneficial regime? We address such questions using the semi-parametric accelerated life models of Robins, which exploit the randomization assumption fully and avoid direct comparisons of possibly differently selected subgroups. No assumption is made about the relationship of treatment actually prescribed to prognosis. A sensitivity analysis, using a range of plausible values for the causal effect of a covariate, estimates the contrasts between randomized groups that would have been observed if the covariate had universally been 0. The main technical problem is in dealing with censoring, for the method requires different degrees of recensoring for different values of the causal effect, and this can lead to estimates of low precision. The methods are applied to a randomized comparison of two anti-hypertensive treatments in which approximately half the subjects changed treatment during follow-up. Various time-dependent covariates, representing patterns of side-effects and treatments, are used in the model. We find that the observed difference in cardiovascular deaths between the randomized groups cannot be explained in this way by their different covariate patterns.

Adrenergic beta-Antagonists↗
PubMed1998

Frames of Reference: A Metaphor for Analyzing and Interpreting Attitudes of Environmental Policy Makers and Policy Influencers

/ The concept of frame of reference offers a potentially useful analytical metaphor in environmental management. This is illustrated by a case study in which attitudes of individuals involved in the management of trees in the New Zealand high country are classified into seven distinctive frames of reference. Some practical and theoretical implications of the use of the frame metaphor are explored, including its potential contribution to the emerg- ing field of communicative planning. KEY WORDS: Frames of reference; Environmental policy analysis; Metaphor; New Zealand high country

Journal Article↗
PubMed2003

Stigma, social risk, and health policy: public attitudes toward HIV surveillance policies and the social construction of illness.

Data from a 1999 national telephone survey with a probability sample of English-speaking US adults (N=1,335) were used to assess how support for HIV surveillance policies is related to AIDS stigma and negative attitudes toward groups disproportionately affected by the epidemic. Anonymous reporting of HIV results to the government was supported by a margin of approximately 2-to-l, but name-based reporting was opposed 3-to-l. Compared with other respondents, supporters of name-based surveillance expressed significantly more negative feelings toward people with AIDS, gay men, lesbians, and injecting drug users. More than one third of all respondents reported that concerns about AIDS stigma would affect their own decision to be tested for HIV in the future. Implications for understanding the social construction of illness and for implementing effective HIV surveillance programs are discussed.

AIDS Serodiagnosis↗
PubMed1999

Effect of management policy upon 120 Type 1 diabetic pregnancies: policy decisions in practice.

AIMS: To evaluate the outcome of two specific changes in the policy of managing pregnancy in Type 1 diabetes over a 5-year period. The need for change had been identified following an audit in the previous 5-year period: firstly, the need for intensive effort to improve the uptake of pre-pregnancy counselling; secondly, a modest relaxation of the targets for blood glucose control during labour to minimize the risk of maternal hypoglycaemia. METHODS: Data were collated from maternal and neonatal case notes from all women with Type 1 diabetes mellitus managed by Newcastle obstetric services between August 1989 and July 1994 (n = 80), comparing data with 40 such women looked after between November 1985 and July 1989. RESULTS: The age of the women, blood glucose control during pregnancy, gestation at delivery, and birth weight were similar in the 5-year period under study to those previously reported for the first study period. Mean blood glucose in labour for Period 2 was 5.5 +/- 0.6 mmol/l, exactly 1.0 mmol/l higher than the mean blood glucose achieved in labour for Period 1. As a consequence, only 22.5% women (18/80) experienced one or more episodes of blood glucose less than 3.0 mmol/l compared with 40.0% women in Period 1 (16/40) (P < 0.01). There was no effect of maternal blood glucose on neonatal blood glucose provided the former was within the range 4-8 mmol/l during labour. However, if maternal blood glucose was over 10 mmol/l, the infant's blood glucose was always low (1.3 +/- 0.8 vs. 2.5 +/- 1.5 P < 0.02). Macrosomia (over the 90th percentile for gestational age) was observed in 43.1% of infants in Period 1, and the mean birth weight was not different from Period 1. In the initial 5-year period 27.5% (11/40) women received specific pre-pregnancy care for their diabetes, compared with 21.3% (17/80) in Period 2 despite the intensive programme of education. There were six cases of congenital abnormality and two antepartum deaths (10% adverse outcome). CONCLUSIONS: The target range for blood glucose control in labour of 4-7 mmol/l minimizes maternal hypoglycaemia in labour and the data indicate that an upper limit of 8 mmol/l would not increase the risk of neonatal hypoglycaemia. Fresh thought is required about the matter of preventing congenital abnormalities by achieving better pre-pregnancy and peri-conception blood glucose control.

Adolescent↗
PubMed2005

Science, law, and politics in the Food and Drug Administration's genetically engineered foods policy: FDA's 1992 policy statement.

The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.

Allergens↗
PubMed2006

Policy makers ignoring science and scientists ignoring policy: the medical ethical challenges of heroin treatment.

A decade of research in Switzerland, The Netherlands, Germany, and Spain now constitutes a massive body of work supporting the use of heroin treatment for the most difficult patients addicted to opiates. These trials concur on this method's safety and efficacy and are now serving as a prelude to the institution of heroin treatment in clinical practice throughout Europe. While the different sampling and research protocols for heroin treatment in these studies were important to the academic claims about specific results and conclusions that could be drawn from each study, the overall outcomes were quite clear--and uniformly positive. They all find that the use of prescribed pharmaceutical heroin does exactly what it is intended to do: it reaches a treatment refractory group of addicts by engaging them in a positive healthcare relationship with a physician, it reduces their criminal activity, improves their health status, and increases their social tenure through more stable housing, employment, and contact with family. The Canadian trial (NAOMI), now underway for over a year, but not yet completed, now faces a dilemma about what to do with its patients who have successfully completed 12 months of heroin and must be withdrawn from heroin and transferred to other treatments in accordance with the research protocol approved by Government of Canada, federal granting body and host institutions. The problem is that the principal criterion for acceptance to NAOMI was their history of repeated failure in these very same treatment programs to which they will now be referred. The existence of the results from abroad (some of which were not yet available when NAOMI was designed and initiated) now raises a very important question for Canada: is it ethical to continue to prohibit the medical use of heroin treatment that has already been shown to be feasible and effective in numerous medical studies throughout the world? And while this is being worked out, is it acceptable to require patients who have been successfully treated with heroin in Canada, to be forced to move back to less effective treatments (treatments that failed to be efficacious in the past)? This essay discusses this dilemma and places it in the broader context of ethics, science, and health policy. It makes the case for continuation of the current successful patients in heroin treatment and the institution of heroin treatment to all Canadian patients living with active addictions who qualify.

Journal Article↗
PubMed1997

Medicare program; revisions to payment policies and adjustments to the relative value units under the physician fee schedule, other Part B payment policies, and establishment of the clinical psychologist fee schedule for calendar year 1998--HCFA. Final rule with comment period.

This final rule makes several policy changes affecting Medicare Part B payment. The changes relate to physician services, including geographic practice cost index changes, clinical psychologist services, physician supervision of diagnostic tests, establishment of independent diagnostic testing facilities, the methodology used to develop reasonable compensation equivalent limits, payment to participating and nonparticipating suppliers, global surgical services, caloric vestibular testing, and clinical consultations. This rule also implements provisions in the Balanced Budget Act of 1997 relating to practice expense relative value units, screening mammography, colorectal cancer screening, screening pelvic examinations, and EKG transportation. In addition, we are finalizing the 1997 interim work relative value units and are issuing interim work relative value units for new and revised codes for 1998.

Aged↗
PubMed1999

[Optimizing the antibiotics policy in the Netherlands. IV. SWAB- guidelines for antimicrobial therapy of adults with sepsis in hospitals. Foundation Antibiotics Policy Work Group].

The Stichting Werkgroep Antibioticabeleid (SWAB, Foundation Antibiotic Policy Team) issued guidelines for empirical antimicrobial therapy in the hospital of sepsis in adults. A distinction is made between sepsis in patients with and patients without neutropenia. Patients without neutropenia are subdivided according to the setting where they contracted sepsis: at home, in the hospital or in the intensive-care unit. Because of the diversity in antibiotic spectrum of the different classes of cephalosporins, they can be used in all the categories of sepsis. The use of antibiotics with a very broad spectrum, like carbapenems and piperacillin-tazobactam, or antibiotics which can be applied in infections with microorganisms difficult to treat, like quinolones and glycopeptides, is limited in the empirical treatment of sepsis in order to combat development of resistance. It is crucial to streamline antibiotic therapy as soon as the causative agent of the sepsis is known; this includes choosing an antibiotic with the narrowest possible spectrum.

Adult↗
PubMed2000

[Optimizing antibiotics policy in the Netherlands. V. SWAB guidelines for perioperative antibiotic prophylaxis. Foundation Antibiotics Policy Team].

The Stichting Werkgroep Antibioticabeleid (SWAB, Foundation Antibiotics Policy Team) has issued guidelines for perioperative antibiotic prophylaxis in Dutch hospitals. Antibiotic prophylaxis is generally recommended for surgical procedures with relatively high postoperative infection rates and those in which consequences of infection are really serious. Studies have revealed that prophylaxis given within two hours before incision is most effective. Short-term, preferably single-dose prophylaxis, is as effective as multiple-dose prophylaxis in most procedures. For reasons of cost effectiveness and prevention of induction of resistance, single-dose prophylaxis is recommended. The antimicrobial agent of choice for perioperative prophylaxis should not be widely used as a therapeutic agent, should be selectively active against micro-organisms most frequently isolated from surgical site infections, and should have a plasma-half-life that makes single-dosing possible for most operations. Therefore cefazoline is an agent that is widely used for perioperative prophylaxis.

Antibiotic Prophylaxis↗
PubMed2005

A voluntary privacy standard for health services and policy research: legal, ethical and social policy issues in the Canadian context.

In this review, the authors describe how one group of Canadian researchers has begun to address current privacy protection challenges with the end goal of developing a Canadian national standard for privacy protection specific to health services and policy research (HSPR). They provide a concise description of some of the key messages and issues that resulted from a recent series of HSPR workshops and describe some of the workshop outcomes in terms of their legal, ethical and social/policy significance. The review ends with a brief description of some future directions for research and development in this area.

Biomedical Research↗