Methods for Equivalence and Noninferiority Testing

Classical hypothesis testing focuses on testing whether treatments have differential effects on outcome. However, sometimes clinicians may be more interested in determining whether treatments are equivalent or whether one has noninferior outcomes. We review the hypotheses for these noninferiority and equivalence research questions, consider power and sample size issues, and discuss how to perform such a test for both binary and survival outcomes. The methods are illustrated on 2 recent studies in hematopoietic cell transplantation.

SEMIPERFECT IPRI-RINGS AND RIGHT BEZOUT RINGS

We present a survey of some results on ipri-rings and right Bezout rings. All these rings are generalizations of principal ideal rings. From the general point of view, decomposition theorems are proved for semiperfect ipri-rings and right Bezout rings.

Comparison of treatment of incomplete abortion with misoprostol by physicians and midwives at district level in Uganda : a randomised controlled equivalence trial

BACKGROUND: Misoprostol is established for the treatment of incomplete abortion but has not been systematically assessed when provided by midwives at district level in a low-resource setting. We investigated the effectiveness and safety of midwives diagnosing and treating incomplete abortion with misoprostol, compared with physicians. METHODS: We did a multicentre randomised controlled equivalence trial at district level at six facilities in Uganda. Eligibility criteria were women with signs of incomplete abortion. We randomly allocated women with first-trimester incomplete abortion to clinical assessment and treatment with misoprostol either by a physician or a midwife. The randomisation (1:1) was done in blocks of 12 and was stratified for study site. Primary outcome was complete abortion not needing surgical intervention within 14-28 days after initial treatment. The study was not masked. Analysis of the primary outcome was done on the per-protocol population with a generalised linear-mixed effects model. The predefined equivalence range was -4% to 4%. The trial was registered at ClinicalTrials.gov, number NCT01844024. FINDINGS: From April 30, 2013, to July 21, 2014, 1108 women were assessed for eligibility. 1010 women were randomly assigned to each group (506 to midwife group and 504 to physician group). 955 women (472 in the midwife group and 483 in the physician group) were included in the per-protocol analysis. 452 (95·8%) of women in the midwife group had complete abortion and 467 (96·7%) in the physician group. The model-based risk difference for midwife versus physician group was -0·8% (95% CI -2·9 to 1·4), falling within the predefined equivalence range (-4% to 4%). The overall proportion of women with incomplete abortion was 3·8% (36/955), similarly distributed between the two groups (4·2% [20/472] in the midwife group, 3·3% [16/483] in the physician group). No serious adverse events were recorded. INTERPRETATION: Diagnosis and treatment of incomplete abortion with misoprostol by midwives is equally safe and effective as when provided by physicians, in a low-resource setting. Scaling up midwives' involvement in treatment of incomplete abortion with misoprostol at district level would increase access to safe post-abortion care. FUNDING: The Swedish Research Council, Karolinska Institutet, and Dalarna University.

Women's acceptability of misoprostol treatment for incomplete abortion by midwives and physicians : secondary outcome analysis from a randomized controlled equivalence trial at district level in Uganda

OBJECTIVE: This study aimed to assess women´s acceptability of diagnosis and treatment of incomplete abortion with misoprostol by midwives, compared with physicians. METHODS: This was an analysis of secondary outcomes from a multi-centre randomized controlled equivalence trial at district level in Uganda. Women with first trimester incomplete abortion were randomly allocated to clinical assessment and treatment with misoprostol by a physician or a midwife. The randomisation (1:1) was done in blocks of 12 and stratified for health care facility. Acceptability was measured in expectations and satisfaction at a follow up visit 14-28 days following treatment. Analysis of women's overall acceptability was done using a generalized linear mixed-effects model with an equivalence range of -4% to 4%. The study was not masked. The trial is registered at ClinicalTrials.org, NCT 01844024. RESULTS: From April 2013 to June 2014, 1108 women were assessed for eligibility of which 1010 were randomized (506 to midwife and 504 to physician). 953 women were successfully followed up and included in the acceptability analysis. 95% (904) of the participants found the treatment satisfactory and overall acceptability was found to be equivalent between the two study groups. Treatment failure, not feeling calm and safe following treatment, experiencing severe abdominal pain or heavy bleeding following treatment, were significantly associated with non-satisfaction. No serious adverse events were recorded. CONCLUSIONS: Treatment of incomplete abortion with misoprostol by midwives and physician was highly, and equally, acceptable to women. TRIAL REGISTRATION: ClinicalTrials.gov NCT01844024.

"I will start treatment when I think the time is right":HIV-positive gay men talk about their decision not to access antiretroviral therapy.

In a qualitative study, 20 HIV-infected Australian gay men were interviewed about their decision not to access antiretroviral drug therapy. The main reasons given for the decision were fear of side effects; fear of long-term damage to body organs; the inconvenience of the treatment regimens; belief that the regimen's demands would be a threat to morale; and belief that there was no reason to start therapy in the absence of AIDS-related symptoms. Actions taken by the men to monitor and maintain their health included seeing a doctor regularly; having regular T-cell and viral load tests; and trying to maintain a positive outlook by not letting HIV/AIDS 'take over' their lives. Almost half the men considered they had been subjected to unreasonable pressure to access therapy and there was considerable pride at having resisted this pressure. The findings suggest that the men disagreed with the biomedical model for managing HIV/AIDS only on the question of if and when to access therapy. They also suggest that underlying the men's dissent from the biomedical model was a different mode of thinking than is required by the model: while the model demands thinking that is abstract, the men focused strongly on factors close to the 'here and now' of immediate experience. The practical implications of the findings are explored.

Expanding criminal sanctions for corporate crimes-deprivation of right to work and cancellation of education qualifications

Fines are the standard sanctions employed by most Western countries when a corporation has been convicted of a crime. However, some offences committed by corporations are too serious to be dealt with by way of a fine. There is a need to consider other sanctions that can be invoked in order to deter corporate crime. In this article, it is suggested that the focus should be on criminal sanctions against the natural persons who can potentially commit crimes on behalf of a corporation. New sentencing options against those who can potentially commit crimes on behalf of a corporation should include the annulment or suspension of an offender's academic  qualifications and the making of orders preventing an offender from working or being enrolled in an educational or vocational pursuit.

The right to convert exploration licences to mining leases in Australia: a proposed national uniform model

In this article, the authors raise an important proposal for reform to Australia's mining legislation: a nationally-consistent model providing exploration licence holders with a legislative right to be granted a mining lease. This proposed national model will be designed to reflect the present Western Australian system - Western Australia being the only jurisdiction to provide exploration licence holders with the express right to be granted a mining lease on application. The authors believe that the Western Australian system should provide the basis for a national legislative model, given that it is designed to balance appropriately the interests of companies wanting a right to mine to recoup the costs involved in exploring for minerals, and the interests of the public in ensuring that exploration and mining is conducted
reasonably.

The right to privacy and corporations

Traditionally the right of privacy has not been recognised at common law. However, recently the High Court has indicated that it may be willing to develop a new tort of invasion of privacy. Several of the justices have stated that the new action would only relate to natural persons, not corporations. This is because the principles said to underpin the right to privacy, autonomy and dignity, are supposedly inapposite to corporations. This article argues that this reasoning is flawed. Neither the right to autonomy nor dignity is capable of underpinning the right to privacy. Hence, no sustainable basis has so far been advanced for restricting the availability of any future tort of invasion of privacy to individuals. This article also questions whether a separate tort is needed in view of the protection already provided to the privacy interests of individuals and corporations under the equitable doctrine of confidence.

RE Kevin and the right of transsexual persons to marry in Australia

This article considers the decision of the Family Court of Australia in Re Kevin (Validity of Marriage of a Transsexual) [2001] FamCA 1074, which was upheld by the Full Court of the Family Court of Australia in February 2003. Re Kevin was the first case in Australia to deal directly with the question of whether a transsexual person could marry under Australian law. In the past, Australia had adhered to the judgement of Ormrod J in Corbett v Corbett [1971] P. 83, which set the benchmark for what is ‘male’ and what is ‘female’ under the common law. Prior to Re Kevin the question of what is a man and what is a woman for the purposes of marriage in Australia mirrored the strict biological test established in Corbett. In other words, the Australian courts relied upon biological factors, as espoused by Ormrod J, when determining a person's true sex. In Re Kevin, Chisholm J examined in detail what it is to be a man or woman, but unlike Ormrod J considered ‘brain sex’ to have a significant impact on a person's view of their own innate sexual identity. The Full Court of the Family Court agreed with the powerful and well-reasoned judgement of Chisholm J at first instance.

Non-equivalence of direct and indirect measures of unrealistic optimism

Individuals typically believe that they are less likely than the average person to experience negative events. Such “unrealistic optimism” (UO) has been assessed in two ways: directly (via a single question, requiring comparison of own risk to that of the average person) and indirectly (via separate questions about own risk and that of the average person). The study examined the equivalence of the direct and indirect measures of female students' UO for unwanted pregnancy. Participants (N = 120) answered questions about their own risk, that of the average female student, and their own risk relative to that of the average female student; responses and response times were recorded. There was only a moderate association between direct- and indirect-UO. Direct-UO was strongly associated with estimate of own risk, but only moderately associated with estimate of the average student's risk. Response times for the comparative risk and own risk questions did not differ, but participants took significantly longer to answer the question about average student's risk. The results suggest that the two measures of UO are not equivalent, but, rather, that individuals answering a comparative risk question focus mainly on their own risk, at the expense of that of the average person.

A few good men: psychoanalysis, Abu ghraib and (the) American right

This essay proffers a psychoanalytic reading of the events of Abu Ghraib as deeply symptomatic of changes in American foreign policy and political culture. The paper examines the Lacanian understanding of group formation developed by Slavoj Zizek in his work on politics and culture (in Part I), and then applies this understanding to the Abu Ghraib scandal (Part II). In Part III, implications of the analysis are elaborated, in terms of Zizek's contention that the contemporary "permissive society" engenders in subjects the desire for new forms of mastery or "moral clarity".