Interpretive Guidance Research Articles

Publication guidelines for human heart rate and heart rate variability studies in psychophysiology-Part 1: Physiological underpinnings and foundations of measurement.

This Committee Report provides methodological, interpretive, and reporting guidance for researchers who use measures of heart rate (HR) and heart rate variability (HRV) in psychophysiological research. We provide brief summaries of best practices in measuring HR and HRV via electrocardiographic and photoplethysmographic signals in laboratory, field (ambulatory), and brain-imaging contexts to address research questions incorporating measures of HR and HRV. The Report emphasizes evidence for the strengths and weaknesses of different recording and derivation methods for measures of HR and HRV. Along with this guidance, the Report reviews what is known about the origin of the heartbeat and its neural control, including factors that produce and influence HRV metrics. The Report concludes with checklists to guide authors in study design and analysis considerations, as well as guidance on the reporting of key methodological details and characteristics of the samples under study. It is expected that rigorous and transparent recording and reporting of HR and HRV measures will strengthen inferences across the many applications of these metrics in psychophysiology. The prior Committee Reports on HR and HRV are several decades old. Since their appearance, technologies for human cardiac and vascular monitoring in laboratory and daily life (i.e., ambulatory) contexts have greatly expanded. This Committee Report was prepared for the Society for Psychophysiological Research to provide updated methodological and interpretive guidance, as well as to summarize best practices for reporting HR and HRV studies in humans.

Covariate modeling in pharmacometrics: General points for consideration.

Modeling the relationships between covariates and pharmacometric model parameters is a central feature of pharmacometric analyses. The information obtained from covariate modeling may be used for dose selection, dose individualization, or the planning of clinical studies in different population subgroups. The pharmacometric literature has amassed a diverse, complex, and evolving collection of methodologies and interpretive guidance related to covariate modeling. With the number and complexity of technologies increasing, a need for an overview of the state of the art has emerged. In this article the International Society of Pharmacometrics (ISoP) Standards and Best Practices Committee presents perspectives on best practices for planning, executing, reporting, and interpreting covariate analyses to guide pharmacometrics decision making in academic, industry, and regulatory settings.

Gender, conflict and the environment: Surfacing connections in international humanitarian law

AbstractBoth gender and the environment have traditionally been positioned at the periphery of international humanitarian law (IHL). In recent decades, there has been important progress in moving both concerns closer to its centre; to date, however, an understanding of the intersection of gender and the environment in the legal regulation of armed conflict remains largely underdeveloped. Nevertheless, as the present article documents, there are important similarities in strategies pursued to advance both gender and the environment from the periphery to the mainstream of IHL, namely: first, a focus on sources of IHL, in particular concretizing arguably limited specific treaty content with interpretive guidance and implementation frameworks; second, a conceptual critique of prevailing definitions of “harm” in IHL; and third, advancing, through close empirical documentation and household-level analysis of conflict's effects, understandings of harm that capture so-called “second-round” effects of conflict. Recognizing these important affinities between gender and environment work in IHL, this article draws on these insights to propose a typology of gendered environmental harm in conflict. The article concludes with proposals for enhancing the legal and operational capture under IHL of the gender–conflict–environment nexus.

In Vitro Testing of Trichomonas vaginalis Drug Susceptibility: Evaluation of Minimal Lethal Concentrations for Metronidazole and Tinidazole That Correspond With Treatment Failure.

The only drugs approved by the US Food and Drug Administration for oral treatment of trichomoniasis belong to the 5-nitroimidazole group. Most individuals infected with Trichomonas vaginalis can be cured with a standard treatment of metronidazole or tinidazole, but it is estimated that more than 159,000 people fail treatment each year. Although a minimal lethal concentration (MLC) corresponding to treatment failure has been reported for metronidazole, the MLC for tinidazole associated with treatment failure has not been determined. We conducted a study using T. vaginalis isolates from women with reported treatment success or failure to determine these values. We measured MLCs of 47 isolates obtained from women who had failed metronidazole treatment, 33 isolates from women who had failed tinidazole treatment, and 48 isolates from women successfully cured with metronidazole. The cutoff was calculated as the 95th percentile of MLCs of susceptible isolates for each drug. Our data confirmed that the MLC previously associated with metronidazole treatment failure is ≥50 μg/mL and identified the MLC associated with tinidazole treatment failure as ≥6.3 μg/mL. For metronidazole, the agreement between laboratory result and treatment outcome was 93.7%; for tinidazole, this agreement was 88.9%. The T. vaginalis susceptibility assay is useful for determining whether 5-nitroimidazole treatment failure in persons with trichomoniasis can be attributed to drug resistance. These results are useful for establishing interpretive guidance of test results, and MLC levels can help guide appropriate patient treatment.

Distribution of property at the termination of de facto unions (marriages by cohabitation/repute) in some African countries

Abstract Many African countries have ratified the Convention on the Elimination of All Forms of Discrimination against Women (CEDAW). Article 16(1) of CEDAW provides for, inter alia, the right to equality in a marriage. The drafting history of Article 16 of CEDAW shows that the delegates agreed that the whole provision was applicable to women whether or not they were married. In its General Recommendation No. 29 on Marriage and Family Relations, the CEDAW Committee provides interpretive guidance for states on Article 16 and, inter alia, highlights the economic hardships that women face at the termination of de facto unions or relationships (marriages by cohabitation) and urged state parties to protect the economic rights of women in such relationships. African countries have approached the issue of de facto relationships in different ways. These approaches have also determined the manner in which the economic rights of parties to these relationships are protected. In some countries such as Malawi and Tanzania, legislation recognizes such unions. In Kenya, although these unions are not recognized by legislation, they are recognized by courts. Courts have also recognized some economic rights of parties therein. In Seychelles, a ‘hybrid’ approach has been followed in terms of which these rights are protected in both legislation and case law. In Uganda, South Africa, Zambia, Ghana, Zimbabwe, Lesotho, Swaziland, and Rwanda, de facto unions are neither recognized in legislation nor in case law. However, courts have invoked principles from other branches of law such as the law of equity (constructive trusts and proprietary estoppel), partnerships and the right to property to protect the economic rights of the parties in these unions. In this article, the author demonstrates the approaches taken by courts in countries where de facto unions are not recognized by legislation (Uganda, South Africa, Zambia, Ghana, Zimbabwe, Lesotho, Namibia, Eswatini (Swaziland), and Rwanda) to protect the economic rights of the parties when these relationships are terminated.

Reporting of Antimicrobial Resistance from Blood Cultures, an Antibacterial Resistance Leadership Group Survey Summary: Resistance Marker Reporting Practices from Positive Blood Cultures.

We assessed how laboratories use and handle reporting of results of rapid diagnostics performed on positive blood culture broths, with a focus on antimicrobial resistance (AMR) markers. A survey assembled by the Antibacterial Resistance Leadership Group Diagnostics Committee was circulated from December 2020 to May 2021. The survey was sent to local hospitals, shared on the ClinMicroNet and Division C listservs, and included in a College of American Pathologists proficiency testing survey. Ninety-six laboratories of various sizes across the United States (95%) and outside of the United States (5%) participated. Of the laboratories that had at least 1 rapid diagnostic in place (94%), significant heterogeneity in methods used and reporting practices was found across community (52%) and academic (40%) laboratories serving hospitals of various sizes. Respondents had implemented 1 to 6 different panels/platforms for a total of 31 permutations. Methods of reporting rapid organism identification and AMR results varied from listing all targets as "detected"/"not detected" (16-22%) without interpretive guidance, to interpreting results (23-42%), or providing therapeutic guidance comments to patient-facing healthcare teams (3-17%). Current approaches to reporting molecular AMR test results from positive blood culture vary significantly across clinical laboratories. Providing interpretative comments with therapeutic guidance alongside results reported may assist clinicians who are not well-versed in genetic mechanisms of AMR. However, this is currently not being done in all clinical laboratories. Standardized strategies for AMR gene result reporting are needed.

Rethinking direct participation in hostilities and continuous combat function in light of targeting members of terrorist non-State armed groups

AbstractEndless armed conflicts against terrorist groups put civilian populations at risk. Since France has been involved in the Sahel from 2013 onwards, transnational non-international armed conflicts (NIACs) of extended geographical and temporal scope against groups designated as terrorists are not a US exception anymore. NIACs against terrorist groups, conducted not only by the United States but also by France, persist and have been reconfigured around threat anticipation. How can anticipatory warfare be best constrained? This article argues that it can be best done through more constraining rules regulating target selection in NIACs and, in particular, by redefining the notion of continuous combat function (CCF). Many elements explored in this article indicate that the United States and France select targets that they pre-designate as terrorists, before these targets are engaged in hostilities. Instead of responding to the observed participation of these individuals in hostilities, strikes are based on contextual and behavioural elements ahead or outside of such moments. This paper argues that when war consists of threat anticipation, it becomes very extensive and particularly risky for civilians. Furthermore, recent State practice in the counterterrorism context reveals the pitfalls of the notions of direct participation in hostilities and CCF as defined in the 2009 International Committee of the Red Cross Interpretive Guidance. Outside this context, the interpretations proposed in the Interpretive Guidance might seem sufficient to constrain target selection processes and to protect civilian populations. However, when applied to armed conflicts that are driven by threat anticipation, the pitfalls of these interpretations emerge. I formulate a critique of these interpretations as being partly responsible for anticipatory warfare and propose an alternative theory for the CCF test.

P16.40: Physicians’ Opinions Regarding Low-Level Epstein-Barr Virus DNA Levels From PCR Testing

Introduction: Epstein Barr virus (EBV) DNA measurement supports diagnosis and management of EBV-associated complications in transplant recipients. Laboratory-developed EBV DNA tests can be variable between laboratories and relatively insensitive. The availability of more sensitive, consistent and accurate tests, with results that are traceable to the WHO International Standard and are reported IU/mL of plasma, raises questions regarding the clinical importance of results in lower titer ranges that are newly detectable. Commercially available EBV DNA tests now exhibit sensitivity and even linearity near or below 100 IU/mL in plasma. With the advancement of more sensitive diagnostics, the clinical significance of low-level EBV DNA test results should be considered, however, no clear clinical consensus is currently available to help interpret these results, and it is unclear what actions clinicians may take when presented with them. We undertook a survey of practicing adult and pediatric transplantation clinicians in order to characterize their likely therapeutic and diagnostic decisions in response to theoretical scenarios involving low-level EBV DNA test results. Methods: Fifty-one clinicians who manage transplant recipients in the US, UK and Australia responded to a questionnaire presenting two hypothetical clinical scenarios involving low-level EBV DNA test results in adult and pediatric transplant patients. Scenario 1 included a detectable DNA level that was below the limit of quantitation. Scenario 2 involved low-level DNA results (150 vs. 400 IU/mL of plasma) from two different laboratories. Results: Almost a quarter (24%) of clinicians would change treatment based on a single detectable EBV DNA result as presented in scenario 1 (Figure 1). Before changing treatment or ordering imaging studies in anticipation of possible core biopsy, the overwhelming majority would repeat EBV testing, mostly on a weekly basis. Most clinicians (59%) were likely to act based on the apparent increase in EBV DNA in scenario 2, with most intending to confirm the results through repeat testing to confirm the trend in viral load (Figure 2). Conclusions: Adequate use and uptake of diagnostic testing in clinical medicine is often suboptimal leading to misinterpretation by clinicians and unnecessary diagnostic errors. Our findings reveal the impact that low-level EBV DNA plasma results may have on potential patient management approaches. In addition, the survey also showed marked differences in how clinicians would interpret and act on these results. This highlights that, in our theoretical clinical scenarios, there is no clear consensus regarding these potential and diverse interventions based on the different diagnostic and therapeutic approaches triggered by low EBV DNA plasma levels. These observed differences underline the need for more interpretive guidance to support the wider availability of more accurate, sensitive and standardized EBV DNA level monitoring assays.

PET-CT in Clinical Adult Oncology: III. Gastrointestinal Malignancies.

Simple SummaryPositron emission tomography (PET), typically combined with computed tomography (CT), has become a critical advanced imaging technique in oncology. With PET-CT, a radioactive molecule (radiotracer) is injected in the bloodstream and localizes to sites of tumor because of specific cellular features of the tumor that accumulate the targeting radiotracer. The CT scan, performed at the same time, provides information to facilitate the characterization of radioactivity from deep or dense structures, and to provide detailed anatomic information. PET-CT has a variety of applications in oncology, including staging, therapeutic response assessment, restaging and surveillance. This series of six review articles provides an overview of the value, applications, and imaging interpretive strategies of PET-CT in the more common adult malignancies. The third report in this series provides a review of PET-CT imaging in gastrointestinal malignancies.PET-CT is an advanced imaging modality with many oncologic applications, including staging, assessment of response to therapy, restaging and longitudinal surveillance for recurrence. The goal of this series of six review articles is to provide practical information to providers and imaging professionals regarding the best use of PET-CT for specific oncologic indications, and the potential pitfalls and nuances that characterize these applications. In the third of these review articles, key tumor-specific clinical information and representative PET-CT images are provided to outline the role that PET-CT plays in the management of patients with gastrointestinal malignancies. The focus is on the use of 18F fluorodeoxyglucose (FDG), rather than on research radiopharmaceuticals under development. Many different types of gastrointestinal tumors exist, both pediatric and adult. A discussion of the role of FDG PET-CT for all of these is beyond the scope of this review. Rather, this article focuses on the most common adult gastrointestinal malignancies that may be encountered in clinical practice. The information provided here will provide information outlining the appropriate role of PET-CT in the clinical management of patients with gastrointestinal malignancies for healthcare professionals caring for adult cancer patients. It also addresses the nuances and provides interpretive guidance related to PET-CT for imaging providers, including radiologists, nuclear medicine physicians and their trainees.

Hemolysis Index and Potassium Reporting

In vitro hemolysis generates a spurious increase in potassium. Roche Diagnostics recently revised its recommended guidelines for potassium reporting on cobas analyzers. By dramatically reducing the allowable degree of hemolysis, these guidelines would increase specimen rejection rates. We attempted to balance the desire to avoid inaccurate results with the clinical implications of increased specimen rejection rates. We downloaded hemolytic indices (HI) for 80,795 specimens tested at our institution on cobas chemistry analyzers in 1 month and evaluated potential specimen rejection rates based on the new criteria. We also spiked nonhemolyzed samples with hemolyzed blood to assess the influence of HI values on potassium measurements. The new recommendations would lead to specimen rejection rates of 76% in the neonatal intensive care unit (NICU), 41% in the emergency department (ED), 16% in inpatient specimens, and 9% in outpatient samples. Our current criteria of reporting potassium concentrations in inpatient and outpatient specimens with HI ≤100 and in NICU and ED specimens with HI ≤300 and additional interpretive guidance for HI values between 100 and 300 reduce unnecessary specimen rejections to 3% in NICU, 2% in ED and inpatients, and less than 1% in outpatients without significantly increasing the number of clinically consequential incorrect results. The new recommendations would lead to unacceptably high specimen rejection rates. Laboratories should develop context-specific, evidence-based reporting criteria that minimize reporting of inaccurate results without disrupting delivery of care.

Facing the Challenges of Understanding and Managing Behavior and Psychiatric Issues

Facing the Challenges of Understanding and Managing Behavior and Psychiatric Issues

Replication of Quasi-Experimental Population Studies: Motivation and Guidance

Most quasi-experimental empirical analyses in accounting involve determining a set of sample selection criteria and then applying these criteria to obtain an exhaustive sample for analysis. By including all available observations, one might reasonably view such analyses as population studies. In this paper, I propose a structure and provide related interpretive guidance for conducting intentional, focused replications of population analyses defined by such sample selection criteria.

Catholics & Cultures: A Panoramic View in Search of Greater Understanding

While internet-based technologies can open up greater awareness of the world or create self-perpetuating echo-chambers, the Catholics & Cultures project aspires to do the former. Aiming to ‘widen the lens’ on the variety of Catholic communities and practices, the site delivers on this goal by introducing viewers to a vast array of articles, pictures and videos from around the world. The organization of the site by country and by certain key features of lived Catholicism offers some interpretive guidance. However, the project could be strengthened as a pedagogical resource if it were more extensively thematized and hosted reflections on potential heuristic tools for making sense of Catholicism’s rich diversity.

Targeting of Children in Non-International Armed Conflicts

Abstract Albeit the prohibition of recruitment and use in hostilities of children is an established norm of international law, recognized under both international humanitarian law and international human rights law, the problem still remains. The main actors responsible for this reality are non-state armed groups (NSAGs), which kept recruiting and involving children in various tasks, including direct participation in hostilities (DPH). This in turn generates a dilemma regarding targetability of such children: whether to extend the special protection afforded to them by international law from being recruited and/or used in hostilities for targeting purposes as well. Additionally, the difficulty to determine targeting rules in the context of non-international armed conflicts (NIACs), which led to controversies as to targetability of even adult members of NSAGs while they do not take a direct part in hostilities, exacerbates the dilemma. This piece, accepting persuasiveness of the proposal in the ICRC Interpretive Guidance that those members of armed groups who have continuous combat function (CCF) are targetable, in addition to civilians taking a direct part in hostilities, questions whether children with such function/role are targetable in the same manner as adults of the same position. It is argued here that though children can be targeted during their DPH or when they have CCF, there is support in the law that the notions of DPH and CCF should be applied to them differently than adults. The piece also analyzes if the same means and methods used to target adults could be lawful when employed against children.

Replication of Quasi-Experimental Population Studies: Motivation and Guidance

Most quasi-experimental empirical analyses in accounting involve determining a set of sample selection criteria and the then applying these criteria to obtain an exhaustive sample for analysis. By including all available observations, one might reasonably view such analyses as populations. In this article, I propose a structure and provide related interpretive guidance for conducting intentional focused replications of such such sample selection criteria defined population analyses.

Influence of various water quality parameters on passive sampler accumulation kinetics of different metal valencies in freshwater.

Stabilized liquid membrane devices (SLMDs) have been used for passive integrative sampling of metals in freshwater systems. Field measurements of metal accumulation on SLMDs can provide a time-weighted average mass of labile metals over the deployment period. We exposed SLMDs in the laboratory to 0.5μM solutions of silver, zinc, or aluminum as nitrate salts at three levels of water hardness, measuring metal accumulation every 4days for 32days. We saw linear accumulation in all experimental treatments, except for silver in high hardness (345.9mg/L as CaCO3). The time-accumulation relationships indicated that metal sorption rates vary across valency with the lower valency metals generally accumulating at greater rates. Water hardness also affected accumulation rates and accumulated mass with greater rates as hardness increased for zinc and aluminum. The accumulated zinc mass at 32days in soft water was 78% of the mass in hard water for zinc, and accumulated aluminum mass was 29% of the mass in hard water. Factors such as oleate formation on the SLMD surface and solution chemistry, including pH and chemical speciation, were evaluated in explaining our results. Our work supports that SLMDs have utility for sampling metals in freshwater over extended time periods, which may be beneficial when there is limited access to sites; it also provide important interpretive guidance for the use of SLMDs.

Fifty years of criteria development for selecting wetlands of international importance

The Ramsar Convention’s criteria for the identification of wetlands of international importance (Ramsar sites) and its associated guidance have been widely influential, not only in the selection of Ramsar sites, but also in the development of similar criteria to identify internationally or nationally protected areas for biodiversity through other processes. Over 50 years there has been a conceptual broadening of the scope of the criteria from an initial focus on waterbirds, as well as progressive development of interpretive guidance, allowing meaning and interpretation to develop to support criteria that have been unchanged since 2005. However, establishing criteria based on the provision of cultural or socioeconomic ecosystem services for humans, although regularly discussed at recent conferences of parties, remain unresolved, with opposing views among contracting parties. A pragmatic way forward may be to establish a status ‘badge’ or attribute that acknowledges the value of a Ramsar site to human communities, distinct from the site selection criteria. Allowing parties themselves to ‘award’ this status to appropriate sites would give flexibility for differential national uptake, perhaps being more frequently applied by some parties than others.

Why Questionable Assessment Practices Remain Popular in School Psychology: Instructional Materials as Pedagogic Vehicles

Surveys reveal that many school psychologists continue to employ cognitive profile analysis despite the long-standing history of negative research results from this class of practice. This begets the question: why do questionable assessment practices persist in school psychology? To provide insight on this dilemma, this article presents the results of a content analyses of available interpretive resources in the clinical assessment literature that may shed insight on this issue. Although previous reviews have evaluated the content of individual assessment courses, this is the first systematic review of pedagogical resources frequently adopted in reading lists by course instructors. The interpretive guidance offered across tests within these texts was largely homogenous emphasizing the primary interpretation of subscale scores, de-emphasizing interpretation of global composites (i.e., FSIQ), and advocating for the use of some variant of profile analysis to interpret scores and score profiles. Implications for advancing evidence-based assessment in school psychology training and guarding against unwarranted unsupported claims in clinical assessment is discussed.

In or out? – the CFTC explains when virtual currencies come within its jurisdiction

Purpose To summarize and explain the U.S. Commodity Futures Trading Commission’s (CFTC’s) guidance regarding whether cryptocurrency is subject to CFTC jurisdiction. Design/methodology/approach The article reviews the CFTC’s March 24, 2020 final interpretive guidance, summarizes the history of the agency’s jurisdiction over leveraged, margined or financed retail transactions, and relates it to the CFTC’s guidance and judicial decisions regarding cryptocurrency. Findings We found that the CFTC, in carrying out its leadership role related to developments in the fintech industry, had provided clarity about its jurisdiction over cryptocurrency. The CFTC defines virtual currency as a “commodity,” even if intangible, and finds that many transactions in virtual currency satisfy the exception to the CFTC’s jurisdiction over leveraged retail commodity transactions because “delivery” can be said to occur within 28 days. Originality/value The article provides a useful summary of an important pronouncement from the CFTC in a manner that is readily understandable and relatable to industry participants and legal practitioners in this field.

Scientific Purpose and Human Rights: Evaluating General Comment No 25 in Light of Major Discussions in the Travaux Préparatoires of the Universal Declaration of Human Rights and International Covenant on Economic, Social, and Cultural Rights

ABSTRACT Science and technology play increasingly dominant roles in the lives of individuals around the world, and the extent to which scientific advancements can both support and frustrate the realisation of human rights is becoming more and more evident. General Comment No 25 on the Right to Science, issued by the Committee on Economic, Social, and Cultural Rights in April 2020, suggests that science ought to serve human rights and peace as a priority over all other uses. This suggestion, that science ought to serve a purpose, directly challenges extensive debates held around the drafting tables of the 1940s, 1950s, and 1960s as the Universal Declaration of Human Rights and International Covenant on Economic, Social, and Cultural Rights were being developed. Proposals to include a scientific purpose in these foundational human rights instruments were rejected multiple times for reasons which remain valid to this day. This article evaluates the proposed scientific purpose in General Comment No 25 in light of the discussions recorded in the travaux préparatoires to determine the extent to which the new interpretive guidance will help or hinder the future development and realisation of the right to science.