Study Designs for Evaluation of Combination Treatment: Focus On Individual Patient Benefit

Combination treatment, i.e., the use of two or more drugs for the same condition, is frequent in medicine if monotherapy yields an insufficient therapeutic response. We here review and challenge clinical study designs and formats of reporting outcomes for the evaluation of the benefit/risk ratio of combination treatment over monotherapy. We demonstrate that benefits of combination treatment at the group level over-estimate the probability of benefit at the single patient level based on outcome simulations under almost any imaginable setting. Based on these findings we propose that studies testing combination treatment should always report on percentages of responders to monotherapy and combination treatment. We provide equations that allow calculation of the percentage of patients truly benefitting from combination (responders to both monotherapies) and that of patients exposed to risk of harm from adverse effects without a reasonable expectation of individual benefit. These considerations are explained based on real clinical data, mostly from the field of functional urology (male lower urinary tract symptoms).

儒家為什麼反對超人類主義？

LANGUAGE NOTE | Document text in Chinese; abstract also in English. The concept of human enhancement is a key to understanding transhumanism. According to Confucian ethics, the supervision of human enhancement technology is vital because we are facing the reasonable expectation of achieving “the unity of heaven and man.” (The idea of harmony between man and nature is not exclusive to Confucianism; it can be found in other schools of thought in the pre-Qin dynasty period, especially the philosophy of Taoism. However, the idea is uniquely expressed and developed in Confucianism.) Furthermore, human enhancement makes people unable to “settle in their place.” Therefore, Confucianism cannot accept it.

Documentary reality television's privacy problem

<p>Documentary reality television is hugely successful. The genre, which includes shows like Police Ten 7, Coastwatch and Border Patrol, consistently outperforms other television formats and fills free-to-air television schedules. In these shows ride-along film crews and body-worn cameras record agencies as they go about their tasks. Often these agencies are public authorities and their tasks are statutory functions. The purpose of this paper is to examine the genre’s privacy implications. It concludes that the genre is systemically unlawful. It is unlawful because it breaches the privacy rights of involuntary participants. The paper considers the privacy implications by examining the genre against the shared features of the publication tort and the Privacy Broadcasting Standard. Both of these consider that it is a breach of privacy to broadcast material subject to a reasonable expectation of privacy, where that broadcast is highly offensive unless there is an applicable defence. While the material broadcast represents the work of agencies, it also represents the personal stories of everyday people going about their lives. Often the moments captured are significant life events and intimate moments for those people. By agreeing to contribute to the genre, agencies agree to broadcast these life events without the active involvement of the participants. Research has also found that this is often occurring without informed consent. While the focus of this paper is on the private law implications of the genre, it identifies that some public authorities’ involvement in the genre may also be ultra vires. The paper finishes by considering why, if the genre is systemically unlawful, people are not suing. It considers that general issues with access to civil justice and the powers of the Broadcasting Standards Authority stand in the way of potential complainants. It finishes by considering some solutions that could improve the situation.</p>

Documentary reality television's privacy problem

<p>Documentary reality television is hugely successful. The genre, which includes shows like Police Ten 7, Coastwatch and Border Patrol, consistently outperforms other television formats and fills free-to-air television schedules. In these shows ride-along film crews and body-worn cameras record agencies as they go about their tasks. Often these agencies are public authorities and their tasks are statutory functions. The purpose of this paper is to examine the genre’s privacy implications. It concludes that the genre is systemically unlawful. It is unlawful because it breaches the privacy rights of involuntary participants. The paper considers the privacy implications by examining the genre against the shared features of the publication tort and the Privacy Broadcasting Standard. Both of these consider that it is a breach of privacy to broadcast material subject to a reasonable expectation of privacy, where that broadcast is highly offensive unless there is an applicable defence. While the material broadcast represents the work of agencies, it also represents the personal stories of everyday people going about their lives. Often the moments captured are significant life events and intimate moments for those people. By agreeing to contribute to the genre, agencies agree to broadcast these life events without the active involvement of the participants. Research has also found that this is often occurring without informed consent. While the focus of this paper is on the private law implications of the genre, it identifies that some public authorities’ involvement in the genre may also be ultra vires. The paper finishes by considering why, if the genre is systemically unlawful, people are not suing. It considers that general issues with access to civil justice and the powers of the Broadcasting Standards Authority stand in the way of potential complainants. It finishes by considering some solutions that could improve the situation.</p>

Applying and Developing the Intrusion into Seclusion Tort in New Zealand

<p>As new and intrusive ways of invading a person’s privacy become increasingly common, it is important that tort law has a satisfactory way of protecting a person from intrusion. The case of C v Holland in 2012 created such a protection mechanism, by importing the tort of intrusion into seclusion from the USA. Whereas the first tort of privacy introduced in New Zealand protects the publication of private facts, intrusion into seclusion prevents access to a person even if it does not result in dissemination of any personal information. This thesis explains why protecting the intrusion interest per se is important and uses Kirsty Hughes’ barriers theory, which suggests that privacy should only be protected when a desire for it is communicated or normatively appropriate, to help define the intrusion interest such that it is legally useful. It analyses the elements of an intrusion into seclusion action as suggested by Whata J in C v Holland, and recommends how they could be better constituted. The crux of the thesis though focuses on when a reasonable expectation of privacy is satisfied, a question that received limited attention in C v Holland. This section suggests that determining a reasonable expectation of privacy involves a detailed analysis of three suggested factors, modified from Richard Wilkins’ approach in the US search and seizure context. The thesis considers how the factors could be applied, both separately and holistically, to an intrusion into seclusion claim in New Zealand.</p>

Applying and Developing the Intrusion into Seclusion Tort in New Zealand

<p>As new and intrusive ways of invading a person’s privacy become increasingly common, it is important that tort law has a satisfactory way of protecting a person from intrusion. The case of C v Holland in 2012 created such a protection mechanism, by importing the tort of intrusion into seclusion from the USA. Whereas the first tort of privacy introduced in New Zealand protects the publication of private facts, intrusion into seclusion prevents access to a person even if it does not result in dissemination of any personal information. This thesis explains why protecting the intrusion interest per se is important and uses Kirsty Hughes’ barriers theory, which suggests that privacy should only be protected when a desire for it is communicated or normatively appropriate, to help define the intrusion interest such that it is legally useful. It analyses the elements of an intrusion into seclusion action as suggested by Whata J in C v Holland, and recommends how they could be better constituted. The crux of the thesis though focuses on when a reasonable expectation of privacy is satisfied, a question that received limited attention in C v Holland. This section suggests that determining a reasonable expectation of privacy involves a detailed analysis of three suggested factors, modified from Richard Wilkins’ approach in the US search and seizure context. The thesis considers how the factors could be applied, both separately and holistically, to an intrusion into seclusion claim in New Zealand.</p>

The new intrusion tort: The news media exposed?

<p>In C v Holland, Whata J recognised that the tort of intrusion upon seclusion formed part of New Zealand’s common law. The tort protects against intentional intrusions into a person’s private space. This decision potentially exposes the news media to tortious liability when it engages in intrusive newsgathering practices. However, Whata J’s decision provides little guidance as to how the tort should be applied in later cases. In order to ascertain the meaning of the tort’s formulation, this essay draws upon the methods used, both in New Zealand and internationally, to prevent the news media from breaching individual privacy rights. It then suggests that the courts should replace the formulation with a one-step reasonable expectation of privacy test. It also argues that the legitimate public concern defence should be better tailored to the intrusion context. Finally, it briefly assesses how the intrusion tort should interact with the tort in Hosking v Runting. Ultimately, it concludes that, in future, the courts should reflect more carefully on the precise wording of the intrusion tort’s formulation so that it best vindicates the interests that it was designed to protect.</p>

The new intrusion tort: The news media exposed?

<p>In C v Holland, Whata J recognised that the tort of intrusion upon seclusion formed part of New Zealand’s common law. The tort protects against intentional intrusions into a person’s private space. This decision potentially exposes the news media to tortious liability when it engages in intrusive newsgathering practices. However, Whata J’s decision provides little guidance as to how the tort should be applied in later cases. In order to ascertain the meaning of the tort’s formulation, this essay draws upon the methods used, both in New Zealand and internationally, to prevent the news media from breaching individual privacy rights. It then suggests that the courts should replace the formulation with a one-step reasonable expectation of privacy test. It also argues that the legitimate public concern defence should be better tailored to the intrusion context. Finally, it briefly assesses how the intrusion tort should interact with the tort in Hosking v Runting. Ultimately, it concludes that, in future, the courts should reflect more carefully on the precise wording of the intrusion tort’s formulation so that it best vindicates the interests that it was designed to protect.</p>

Much ado about something: a response to “COVID-19: underpowered randomised trials, or no randomised trials?”

Non-pharmaceutical interventions (NPI) for infectious diseases such as COVID-19 are particularly challenging given the complexities of what is both practical and ethical to randomize. We are often faced with the difficult decision between having weak trials or not having a trial at all. In a recent article, Dr. Atle Fretheim argues that statistically underpowered studies are still valuable, particularly in conjunction with other similar studies in meta-analysis in the context of the DANMASK-19 trial, asking “Surely, some trial evidence must be better than no trial evidence?” However, informative trials are not always feasible, and feasible trials are not always informative. In some cases, even a well-conducted but weakly designed and/or underpowered trial such as DANMASK-19 may be uninformative or worse, both individually and in a body of literature. Meta-analysis, for example, can only resolve issues of statistical power if there is a reasonable expectation of compatible well-designed trials. Uninformative designs may also invite misinformation. Here, we make the case that—when considering informativeness, ethics, and opportunity costs in addition to statistical power—“nothing” is often the better choice.

Suitability of Earth Engine Evaporation Flux (EEFlux) Estimation of Evapotranspiration in Rainfed Crops

This study evaluated evapotranspiration (ET) estimated using the Earth Engine Evapotranspiration Flux (EEFlux), an automated version of the widely used Mapping Evapotranspiration at High Spatial Resolution with Internalized Calibration (METRIC) model, via comparison with ET measured using eddy covariance flux towers at two U.S. sites (St. John, WA, USA and Genesee, ID, USA) and for two years (2018 and 2019). Crops included spring wheat, winter pea, and winter wheat, all grown under rainfed conditions. The performance indices for daily EEFlux ET estimations combined for all sites and years dramatically improved when the cold pixel alfalfa reference ET fraction (ETrF) in METRIC was reduced from 1.05 (typically used for irrigated crops) to 0.85, with further improvement when the periods of early growth and canopy senescence were excluded. Large EEFlux ET overestimation during crop senescence was consistent in all sites and years. The seasonal absolute departure error was 51% (cold pixel ETrF = 1.05) and 23% (cold pixel ETrF = 0.85), the latter reduced to 12% when the early growth and canopy senescence periods were excluded. Departures of 10% are a reasonable expectation for methods of ET estimation, which EEFlux could achieve with more frequent satellite images, better daily weather data sources, automated adjustment of daily ETrF values during crop senescence, and a better understanding of the selection of adequate cold pixel ETrF values for rainfed crops.