Defining an age cut-off for older offenders: a systematic review of literature.

PURPOSE: In the literature, 65 years is commonly used as the age to designate an older person in the community. When studying older prisoners, there is much variation. The purpose of this paper is to investigate how researchers define older offenders and for what reasons. DESIGN/METHODOLOGY/APPROACH: The authors reviewed articles on health and well-being of older offenders to assess terminology used to describe this age group, the chosen age cut-offs distinguishing younger offenders from older offenders, the arguments provided to support this choice as well as the empirical base cited in this context. FINDINGS: The findings show that the age cut-off of 50 years and the term "older" were most frequently used by researchers in the field. The authors find eight main arguments given to underscore the use of specific age cut-offs delineating older offenders. They outline the reasoning provided for each argument and evaluate it for its use to define older offenders. ORIGINALITY/VALUE: With this review, it is hoped to stimulate the much-needed discussion advancing towards a uniform definition of the older offender. Such a uniform definition would make future research more comparable and ensure that there is no ambiguity when researchers state that the study population is "older offenders".

The utility of empirically assigning ancestry groups in cross-population genetic studies of addiction.

BACKGROUND AND OBJECTIVES: Given moderate heritability and significant heterogeneity among addiction phenotypes, successful genome-wide association studies (GWAS) are expected to need very large samples. As sample sizes grow, so can genetic diversity leading to challenges in analyzing these data. Methods for empirically assigning individuals to genetically informed ancestry groups are needed. METHODS: We describe a strategy for empirically assigning ancestry groups in ethnically diverse GWAS data including extensions of principal component analysis (PCA) and population matching through minimum Mahalanobis distance. We apply these methods to data from Spit for Science (S4S): the University Student Survey, a study following college students longitudinally that includes genetic and environmental data on substance use and mental health (n = 7,603). RESULTS: The genetic-based population assignments for S4S were 48.7% European, 22.5% African, 10.4% Americas, 9.2% East Asian, and 9.2% South Asian descent. Self-reported census categories "More than one race" and "Unknown"as well as "Hawaiian/Pacific Islander" and "American-Indian/Native Alaskan" were empirically assigned representing a +9% sample retention over conventional methods. Although there was high concordance between self-reported race and empirical population-match (+.924), there was reduction in variance for most ancestry PCs for genetic-based population assignments. CONCLUSIONS: We were able to create more genetically homogenous groups and reduce sample and marker loss through cross-ancestry meta-analysis, potentially increasing power to detect etiologically relevant variation. Our approach provides a framework for empirically assigning genetic ancestry groups which can be applied to other ethnically diverse genetic studies. SCIENTIFIC SIGNIFICANCE: Given the important public health impact and demonstrable gains in statistical power from studying diverse populations, empirically sound practices for genetic studies are needed. (Am J Addict 2017;26:494-501).

Justice, fairness, and membership in a class: conceptual confusions and moral puzzles in the regulation of human subjects research.

This essay examines conceptual difficulties with one of the ways in which justice has been understood and applied the ethical and regulatory review of human research. Justice requires the fair distribution of the benefits and burdens of research. Class membership is seen as justifying inclusion in higher hazard-no benefit research from which members of potentially vulnerable classes, such as children, typically would be excluded. I argue that class membership does not do the justificatory work it is thought to do and that the use of class membership to justify inclusion in higher hazard-no benefit research leads to unjustified discrimination of sick children and offers special protections to healthy children.

Who is the research subject in cluster randomized trials in health research?

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently.We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1) they are directly intervened upon by investigators; (2) they interact with investigators; (3) they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4) their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.

A proposed taxonomy of terms to guide the clinical trial recruitment process.

CONTEXT: The successful conduct of clinical trials in palliative care is challenged by low accrual rates, high attrition of study patients during trials, difficulties managing comorbidity, and other factors. But what has been learned about improving the feasibility of palliative care research studies? OBJECTIVE: To develop standard terms to describe patient accrual, and using these terms, describe an approach to allow investigators to predict trial feasibility. METHODS: We proposed a standard language and definitions for specific elements of feasibility within clinical trial design and conduct. We then developed an approach to apply data generated from the use of these terms to allow researchers to predict feasibility at the design stage of a clinical trial's development. RESULTS: We developed a taxonomy and then retrospectively applied the approach to four trials selected from our library of completed studies, to provide preliminary validity evidence. The approach includes a framework to help predict the number of patients needed to be assessed to achieve a study's accrual targets, as part of ongoing operational oversight to monitor the conduct and feasibility of a clinical trial. CONCLUSION: Challenges to successful completion of palliative care trials are prevalent and serious. A taxonomy to characterize the eligible patient pool, and an approach by which feasibility is systematically investigated, hold the promise to enhance the effectiveness of scarce resources applied to palliative and end-of-life research.

The concentration-coverage curve: a tool for ecological studies.

BACKGROUND: A selective approach may be used in an ecological study where the aim is to choose a subset of units of analysis (UAs) and produce interpretations about a population of interest (PI) based solely on those UAs. The results for the PI will be reliable if that population is concentrated in the selected UAs and rare in other UAs. This article presents a graphical tool that helps determine whether these conditions are satisfied. DATA AND METHODS: Data on the Inuit and Métis ancestry populations from the 1996 Census of Canada are used for illustrative purposes. Based on a classification statistics table, a concentration-coverage curve can be created for a given PI. The shape of the curve indicates whether it is possible to choose a threshold that will yield both adequate concentration and adequate coverage of the PI. RESULTS: The concentration-coverage curve shows that, among Aboriginal peoples living in rural areas, the Inuit population is classifiable, but the Metis population is not. INTERPRETATION: This method can be applied to any ecological study focussing on the proportion of individuals sharing a single characteristic defined by a binary variable.

Using a fingerprint recognition system in a vaccine trial to avoid misclassification.

PROBLEM: The potential for misidentification of trial participants, leading to misclassification, is a threat to the integrity of randomized controlled trials. The correct identification of study subjects in large trials over prolonged periods is of vital importance to those conducting clinical trials. Currently used means of identifying study participants, such as identity cards and records of name, address, name of household head and demographic characteristics, require large numbers of well-trained personnel, and still leave room for uncertainty. APPROACH: We used fingerprint recognition technology for the identification of trial participants. This technology is already widely used in security and commercial contexts but not so far in clinical trials. LOCAL SETTING: A phase 2 cholera vaccine trial in SonLa, Viet Nam. RELEVANT CHANGES: An optical sensor was used to scan fingerprints. The fingerprint template of each participant was used to verify his or her identity during each of eight follow-up visits. LESSONS LEARNED: A system consisting of a laptop computer and sensor is small in size, requires minimal training and on average six seconds for scanning and recognition. All participants' identities were verified in the trial. Fingerprint recognition should become the standard technology for identification of participants in field trials. Fears exist, however, regarding the potential for invasion of privacy. It will therefore be necessary to convince not only trial participants but also investigators that templates of fingerprints stored in databases are less likely to be subject to abuse than currently used information databases.

Assessing decisional capacity for clinical research or treatment: a review of instruments.

OBJECTIVE: The need to evaluate decisional capacity among patients in treatment settings as well as subjects in clinical research settings has increasingly gained attention. Decisional capacity is generally conceptualized to include not only an understanding of disclosed information but also an appreciation of its significance, the ability to use the information in reasoning, and the ability to express a clear choice. The authors critically reviewed existing measures of decisional capacity for research and treatment. METHOD: Electronic medical and legal databases were searched for articles published from 1980 to 2004 describing structured assessments of adults' capacity to consent to clinical treatment or research protocols. The authors identified 23 decisional capacity assessment instruments and evaluated each in terms of format, content, administration features, and psychometric properties. RESULTS: Six instruments focused solely on understanding of disclosed information, and 11 tested for understanding, appreciation, reasoning, and expression of a choice. The instruments varied substantially in format, degree of standardization of disclosures, flexibility of item content, and scoring procedures. Reliability and validity also varied widely. All instruments have limitations, ranging from lack of supporting psychometric data to lack of generalizability across contexts. CONCLUSIONS: Of the instruments reviewed, the MacArthur Competence Assessment Tools for Clinical Research and for Treatment have the most empirical support, although other instruments may be equally or better suited to certain situations. Contextual factors are important but understudied. Capacity assessment tools should undergo further empirically based development and refinement as well as testing with a variety of populations.

Situación educativa de las niñas y adolescentes en los municipios de Ocotal, Somoto, Estelí y Distrito VI de Managua / Situation education of girls and adolescents in the municipalities of Ocotal, Somoto, Esteli and District VI of Managua

El documento presenta los resultados sobre la situación educacional de las niñas y adolescentes de los municipios de Ocotal, Somoto, Estelí y el Distrito VI de Managua, los resultados reflejan que la población femenina mayor de seis años requieren de una atención integral en todos los municipios por la situación economica y los altos niveles de pobreza sobre todo en el área rural y en las zonas suburbanas o asentamientos. Tambien presenta una critica al sistema educativo como causa de la falta de acceso y permanencia de niñas y adolescentes en la escuela como: Poco conocimiento de la demanda por sexo y limitaciones en la oferta educacional

Being a research participant: the nurse's ethical and legal rights.

Nurses and their patients/clients are increasingly being approached to participate in research projects conducted in the clinical setting. However, such research involving human participants raises many ethical and legal concerns. This article provides nurses with an overview of their rights when asked to participate in such research. The ethical and legal principles that must be respected when such research is being conducted are presented and questions to ask of the researcher suggested. The role of the nurse, as required by their professional duty of care, to protect patients' rights during research in the clinical setting is highlighted.

[Medical research and vulnerable subjects: unemployed people]. / Badania na ludziach i szczególnie wrazliwe grupy osób: bezrobotni.

Although the importance of medical research for the diagnosis and treatment of human diseases is unquestionable, the use of human subjects, however, still presents a complex ethical problem. Moral difficulties occur in particular when the medical research deals with vulnerable subjects. Vulnerable individuals are defined as those who experience diminished actual autonomy. Among the groups which should be considered as being vulnerable are usually listed the following: children, pregnant women, mentally or emotionally disabled, physically disabled, homeless, and institutionalized people. This study addresses key concerns that gave rise to the question of whether unemployed people had to be recognized as vulnerable subjects. The term "vulnerability" was clarified and it was assumed that the "vulnerability" of medical research subjects' had to be understood as a form of continuum from potential, through the circumstantial, temporal, episodic, permanent to inevitable vulnerability. The conclusion was drawn that unemployed people were, at least, potentially vulnerable subjects. Research involving unemployed people presents important moral challenges to researchers and should be undertaken very carefully, following special ethical guidelines.

Baseline recruitment and analyses of nonresponse of the Heinz Nixdorf Recall Study: identifiability of phone numbers as the major determinant of response.

The Heinz Nixdorf Recall Study is an ongoing population-based prospective cardiovascular cohort study of the Ruhr area in Germany. This paper focuses on the recruitment strategy and its response results including a comparison of participants of the baseline examination with nonparticipants. Random samples of the general population were drawn from residents' registration offices including men and women aged 45-74 years. We used a multimode contact approach including an invitational letter, a maximum of two reminder letters and phone calls for the recruitment of study subjects. Nonparticipants were asked to fill in a short questionnaire. We calculated proportions of response, contact, cooperation and recruitment efficacy to characterize the participation. Overall, 4487 eligible subjects participated in our study. Although the elderly (65-75 years) had the highest contact proportion, the cooperation proportion was the lowest among both men and women. The recruitment efficacy proportion was highest among subjects aged 55-64 years. The identifiability of the phone number of study subjects was an important determinant of response. The recruitment efficacy proportion among subjects without an identified phone number was 11.4% as compared to 65.3% among subjects with an identified phone number. The majority of subjects agreed to participate after one invitational letter only (52.6%). A second reminding letter contributed only very few participants to the study. Nonparticipants were more often current smokers than participants and less often belonged to the highest social class. Living in a regular relationship with a partner was more often reported among participants than nonparticipants.