Seroadaptive Strategies of Vancouver Gay and Bisexual Men in a Treatment as Prevention Environment

British Columbia’s treatment as prevention policy has provided free access to highly active antiretroviral therapy (HAART) to all HIV-positive provincial residents since 1996. One outcome is an increase in HIV-positive gay and bisexual men (GBM) with suppressed viral loads. Previous cross-sectional analyses indicated that some Vancouver GBM now recognize condomless anal sex with men on HAART who report a suppressed viral load as a seroadaptive strategy. To test the hypothesis that this new strategy, termed viral load sorting (VLS), is recognized and used among by GBM in the Momentum Health Study, we analyzed longitudinal data for HIV-negative/unknown (n = 556) and HIV-positive (n = 218) serostatus participants. Analyses indicated that both groups reported VLS, and that serostatus and Treatment Optimism Scale scores were significant determinants in frequency and use. Results exemplify the medicalization of sex and Rogers’ Diffusion Of Preventative Innovations Model, and they have important implications for HIV research and GBM sexual decision-making.     

Applying a Treatment Effects Model to Investigate Public Amenity Effect on Physical Activity of the Elderly

The increasing elderly population puts significant health, economic, and social burdens on society. Physical activity is one of the most cost-effective ways to maintain the health of the elderly. This study adopts a treatment effects model to investigate the causal relationship between environment attributes and physical activity among the elderly, while taking endogeneity into account. The data were collected from 274 participants by face-to-face interviews in Taichung, Taiwan. Performing physical activity regularly in parks is the most important measure of the amount of physical activity by the elderly. Providing sufficient and accessible parks in metropolitan residential neighborhoods could be one of the most cost-effective ways to promote physical activity for the elderly living in midsize Asian cities.     

Treatment Choice With Trial Data: Statistical Decision Theory Should Supplant Hypothesis Testing

Abstract

A central objective of empirical research on treatment response is to inform treatment choice. Unfortunately, researchers commonly use concepts of statistical inference whose foundations are distant from the problem of treatment choice. It has been particularly common to use hypothesis tests to compare treatments. Wald’s development of statistical decision theory provides a coherent frequentist framework for use of sample data on treatment response to make treatment decisions. A body of recent research applies statistical decision theory to characterize uniformly satisfactory treatment choices, in the sense of maximum loss relative to optimal decisions (also known as maximum regret). This article describes the basic ideas and findings, which provide an appealing practical alternative to use of hypothesis tests. For simplicity, the article focuses on medical treatment with evidence from classical randomized clinical trials. The ideas apply generally, encompassing use of observational data and treatment choice in nonmedical contexts.     

Linking Decision Theory and Quantitative Microbial Risk Assessment: Tradeoffs Between Compliance and Efficacy for Waterborne Disease Interventions

Achieving health gains from the U.N. Sustainable Development Goals of universal coverage for water and sanitation will require interventions that can be widely adopted and maintained. Effectiveness—how an intervention performs based on actual use—as opposed to efficacy will therefore be central to evaluations of new and existing interventions. Incomplete compliance—when people do not always use the intervention and are therefore exposed to contamination—is thought to be responsible for the lower‐than‐expected risk reductions observed from water, sanitation, and hygiene interventions based on their efficacy at removing pathogens. We explicitly incorporated decision theory into a quantitative microbial risk assessment model. Specifically, we assume that the usability of household water treatment (HWT) devices (filters and chlorine) decreases as they become more efficacious due to issues such as taste or flow rates. Simulations were run to examine the tradeoff between device efficacy and usability. For most situations, HWT interventions that trade lower efficacy (i.e., remove less pathogens) for higher compliance (i.e., better usability) contribute substantial reductions in diarrheal disease risk compared to devices meeting current World Health Organization efficacy guidelines. Recommendations that take into account both the behavioral and microbiological properties of treatment devices are likely to be more effective at reducing the burden of diarrheal disease than current standards that only consider efficacy.     

Statistical considerations in clinical trial design with event-free survival as the primary efficacy endpoint

In late-phase confirmatory clinical trials in the oncology field, time-to-event (TTE) endpoints are commonly used as primary endpoints for establishing the efficacy of investigational therapies. Among these TTE endpoints, overall survival (OS) is always considered as the gold standard. However, OS data can take years to mature, and its use for measurement of efficacy can be confounded by the use of post-treatment rescue therapies or supportive care. Therefore, to accelerate the development process and better characterize the treatment effect of new investigational therapies, other TTE endpoints such as progression-free survival and event-free survival (EFS) are applied as primary efficacy endpoints in some confirmatory trials, either as a surrogate for OS or as a direct measure of clinical benefits. For evaluating novel treatments for acute myeloid leukemia, EFS has been gradually recognized as a direct measure of clinical benefits. However, the application of an EFS endpoint is still controversial mainly due to the debate surrounding definition of treatment failure (TF) events. In this article, we investigate the EFS endpoint with the most conservative definition for the timing of TF, which is Day 1 since randomization. Specifically, the corresponding non-proportional hazard pattern of the EFS endpoint is investigated with both analytical and numerical approaches.     

Heterogeneity in treatment effects across diverse populations

Differences in patient characteristics, including age, sex, and race influence the safety and effectiveness of drugs, biologic products, and medical devices. Here we provide a summary of the topics discussed during the opening panel at the 2018 Johns Hopkins Center for Excellence in Regulatory Science and Innovation symposium on Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities. The goal of this session was to provide a brief overview of FDA-regulated therapeutics, including drugs, biologics and medical devices, and some of the major sources of heterogeneity of treatment effects (HTE) related to patient demographics, such as age, sex and race. The panel discussed the US Food and Drug Administration's role in reviewing and regulating drugs, devices, and biologic products and the challenges associated with ensuring that diverse patient populations benefit from these therapeutics. Ultimately, ensuring diverse demographic inclusion in clinical trials, and designing basic and clinical research studies to account for the intended patient population's age, sex, race, and genetic factors among other characteristics, will lead to better, safer therapies for diverse patient populations.     

Children's experiences with an intervention aimed to prevent further physical abuse

Although many children across cultures are victims of physical abuse, few treatment models target these children and their parents. In Sweden, Combined Parent–Child Cognitive Behavioural Therapy for families at risk for child physical abuse has been successfully used according to pretreatment and posttreatment studies. However, few studies have explored how physically abused children experience treatment. This study includes 20 physically abused children aged 9–17 who completed Combined Parent–Child Cognitive Behavioural Therapy. Children had a positive overall impression of the treatment and highlighted addressing the abuse, as well as processing their experiences as particularly essential. Children described a positive transformation in their family life as a result of treatment, including violence cessation and bonding among family members. Children experienced the intervention as inclusive and child‐friendly. The implications of the promising findings are discussed.     

How much is too much: Does the size of income support transfers affect labor supply?

Cash transfer programs pursue mainly protective objectives, but can also impact rural livelihoods by inducing investments in productive activities and changing household labor allocation. We adopt a continuous treatment approach to quantify how households’ labor supply responds to transfer size. We find a shift from paid labor to own farm labor and find that the transfer size is well within a level that would have disincentive effects on time spent on own farm activities. The switch from paid to own farm labor occurs at lower levels of transfers for labor-constrained households, and at higher levels for non-labor constrained households.     

基于违约鉴别能力组合赋权的小企业信用评级——基于小型工业企业样本数据的实证分析

信用评级是衡量债务违约的可能性,因此评级体系要有违约风险识别能力,能够将违约客户和非违约客户显著地区分开.通过逼近理想点的思路,构建多目标规划模型求解最优的组合权重,并对中国某区域性商业银行1 814笔小型工业企业贷款进行实证分析.本文的创新与特色一是以非违约企业的数据到正理想点的距离代数和最小为第一个目标函数,以违约企业的数据到负理想点的距离代数和最小为第二个目标函数,构建多目标非线性规划模型进行组合赋权,在满足了“非违约企业的评价得分越高、违约企业的评价得分越低”要求的目标下得到最优的组合赋权的权重系数,使赋权结果保证了评级模型能够将违约企业与非违约企业最大地区分开.改变了现有研究的组合赋权脱离评价目的的弊端,改变了现有研究中违约与非违约企业的评价得分存在大量重叠、对两类企业的区分能力低的弊端.二是通过检验“违约企业的信用得分是否显著小于非违约企业的信用得分”的J-T非参数检验,验证信用评价模型的合理性.改变现有研究忽略对信用评价模型的合理性进行验证的弊端.三是经过实证,发现本研究建立的组合赋权模型的违约鉴别能力(Z=5.546)要高于现有研究的两种常用组合赋权模型、即基于方差最大的组合赋权(Z=4.298)和基于偏差最小的组合赋权(Z=5.182)