Meaningful Criteria Research Articles

Integration of Mechanistic–Empirical Pavement Design Guide Distresses with Local Performance Indices

The pavement management system (PMS) is the organizational entity within a state highway agency responsible for the condition of the pavement network. Visual distress surveys are typically combined into an index to provide an overall measure of performance. Decision makers use these familiar indices in a number of facets. A recent survey suggests every state highway agency has implemented or plans to implement the Mechanistic–Empirical Pavement Design Guide (MEPDG). As they do so, maintaining the role these local indices play is critical for upholding the system's continuity. However, using the MEPDG output directly in calculating performance indices becomes problematic because local distresses and MEPDG distresses are not always congruent. Therefore, there is a need to develop procedures for calculating local performance indices with locally calibrated MEPDG output. Doing so will allow interchangeable use of both while preserving the role of the local indices. The Nebraska Department of Roads (NDOR) PMS serves as a model case. NDOR employs three indices in network-level PMS analyses for flexible pavements. MEPDG flexible distress models were calibrated by using local agency data and input into the existing index functions. This paper explores how the current measures of network condition used in decision making can coexist with the new design methodology. This connection allows mechanistic–empirical analyses of fund allocation, needs estimations, performance modeling, planning, and remaining service life. In addition, local indices can provide much more meaningful failure criteria in the MEPDG to local designers. Practical methods for index calculations are introduced. Detailed guidance for local calibration is also presented.

Position Paper Number 3 for the Workshop “Towards Criteria of Sustainability and Social Meaningfulness in Development“: The emerging ecology of genetic, digital and cultural (including non-Western) information environments

Position Paper Number 3 for the Workshop “Towards Criteria of Sustainability and Social Meaningfulness in Development“: The emerging ecology of genetic, digital and cultural (including non-Western) information environments

Position Paper Number 3 for the Workshop “Towards Criteria of Sustainability and Social Meaningfulness in Development“: The emerging ecology of genetic, digital and cultural (including non-Western) information environments

Position Paper Number 3 for the Workshop “Towards Criteria of Sustainability and Social Meaningfulness in Development“: The emerging ecology of genetic, digital and cultural (including non-Western) information environments

Position Paper Number 2 for the Workshop “Towards Criteria of Sustainability and Social Meaningfulness in Development“: Critical Reflections on Modernization Theoretical Thinking and its Implications for ICTs in Development

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Position Paper Number 2 for the Workshop “Towards Criteria of Sustainability and Social Meaningfulness in Development“: Critical Reflections on Modernization Theoretical Thinking and its Implications for ICTs in Development

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Why ‘Clinical Pharmacology’ in Biomarkers in Medicine?

Lew Sheiner spent a 7‐month sabbatical stay in the company where I was working as a Clinical Pharmacologist 15 years ago. After this, he wrote a key paper entitled ‘Learning versus confirming in clinical drug development’ [1]. Lew foresaw that in the not‐too‐distant future, pharmaceu‐ tical companies would not only sell drugs with printed labeling but drugs with a software to guide the prescribers on the key elements to iden‐ tify the right drug, the right dose in the right patient with the right disease as guided by the right biomarkers! He already had in mind the concept of per‐ sonalized healthcare (PHC) and was already pro‐ moting the idea that PHC should be thought of at the same time as the target selection is defined. As always, Lew demonstrated his vision‐ ary skills... but we are not yet completely there! Very sadly, Lew died too early in 2004. In direct heritage with Lew Sheiner, the more recent paper from Lalonde et al. on model‐based drug development (MBDD) is highlighting the need for clinical pharmacologists to influence and lead drug‐development by using model‐ based drug development principles [2]. By sum‐ marizing MBDD in an excellent statement: “Models are essentially the knowledge reposi‐ tory for the data that are generated in clini‐ cal development programs”, Richard Lalonde underlines the possibilities for models to inte‐ grate knowledge on drug projects that could become drug products. However, we again have to realize that those data are mainly biomarkers. So, biomarkers are key to improving drug development but it is also important to ensure that they are appropriately used, in other words, that there is an integrated interpretation of what they mean. In this issue of Biomarkers in Medicine, several aspects of the challenges that biomarkers and integration by clinical pharmacology science are posing will be discussed. First, Dominic G Spinella (Biomarkers in clinical drug development: realizing the promise [3]) will review the variety of new technologies and approaches that have been attempted by the pharmaceutical industry, which were expected to bring ‘revolution’. But rather than revolu‐ tion, it was evolution and sometimes evolu‐ tion might be better than revolution. However, recently we have seen new positions such as ‘Translational Medicine Leaders’ joining our drug‐development teams. This is a big challenge for our clinical pharma cology colleagues but as described above by Richard Lalonde, they themselves evolved to become ‘knowledge inte‐ grators’ by developing their skills to be able to combine those new biomarkers into meaningful decision criteria markers. Clearly, the new early development teams now have more people on board, such as translational medicine leaders, biomarker and experimental medicine leaders and ... clinical pharmacologists!

Regional reference variation provides ecologically meaningful protection criteria for northern World Heritage Site

Unprecedented rates of resource development and climate change at northern latitudes coupled with a lack of baseline information limits our ability to set ecologically meaningful criteria needed to protect these inherently sensitive ecosystems. We surveyed water and sediment chemistry, community composition of benthic algae and invertebrates and fish, and condition of a sentinel fish species, slimy sculpin (Cottus cognatus), in 2 rivers adjacent to metal mines and in 20 reference rivers in the headwaters of a World Heritage Site, the South Nahanni River Basin, NWT, Canada. The normal range (i.e., mean ± 2 standard deviations) of biological conditions in regional reference sites (grouped by community type) were used to set ecologically meaningful effect sizes. These effect sizes were used in noncentral hypotheses tests to assess the ecological condition of potentially impaired sites. Significant impairments at sites influenced by current and historical mining activity were indicative of mild enrichment (e.g., increased benthic abundance and sculpin condition) and bioaccumulation of metals (e.g., increased concentrations of Cu and Fe in muscle tissue of sculpin). Comparisons between our regional reference study and a concurrent upstream–downstream study showed that the sensitivity of biological endpoints was typically related to the impairment criteria used and not to the type of study design. Concentrations of metals such as Al, Cu, and Fe in river water at reference sites were above federal and regional guidelines, suggesting that these guidelines are not appropriate for the metal-rich headwaters of the South Nahanni River. The ephemerellid mayflies Drunella spinifera and Ephemerella maculata were present in 4 of our study sites; their occurrence had not previously been documented in the Yukon or Northwest Territories. Our results confirmed that the lack of baseline information on the physiochemical and biological composition of northern rivers is hampering our ability to evaluate changes in these understudied ecosystems. However, the use of noncentral hypotheses tests based on empirically derived effect sizes enabled us to develop ecologically meaningful protection criteria, maintain statistical rigor, and provide probabilities of impairment that can be used directly in risk assessment.

Incremental Advance or Seismic Shift? The Need to Raise the Bar of Efficacy for Drug Approval

Targeted agents have improved outcomes in many common solid tumors and are available for clinical practice in most countries. There are many more drugs in the developmental pipeline that have the potential to improve the treatment of some of the most deadly cancers. It is estimated that there are more than 350 antineoplastic agents in clinical development for cancer indications. This number is likely to increase in the future since the most important breakthroughs will most likely come from the development of targeted agents rather than from new cytotoxic chemotherapy. However, there is no question that both the costs of drug development and the price of approved biologics is very high. Table 1 summarizes the key efficacy results of the pivotal phase III registration trials on biologics for the treatment of solid tumors. Unlike imatinib that plays the role of a superstar in the first-line treatment of advanced gastrointestinal stromal tumors (GISTs), the data indicate that the benefit of approved biologics in the much more common solid tumors is much smaller. These agents appear more incremental than superstars. In fact, the median HR for PFS and OS in the pivotal phase III trials used for registration of new biologic agents approved for advanced colorectal, breast, pancreatic, non–small-cell lung cancer (NSCLC), renal cell carcinoma, and hepatocellular carcinoma are 0.57 and 0.73, respectively (Table 1). This translates into median PFS and OS gains of 2.7 and 2.0 months, respectively. The huge median benefit of cetuximab in head and neck cancer refers to the locally advanced setting (Table 1), not to the metastatic condition, common to the other trials in the Table. The enthusiasm for the demonstrated proof of principle in these diseases does not match the impact on patients. There are ambivalent positions on this problem. There is pressure for the rapid development and approval of drugs against diseases for which there are no or little effective therapies. In contrast, many of these new agents carry a very high price tag, especially considering the relatively modest gain in overall survival offered in the palliative setting. No matter how limited these gains are, the overall outcomes for patients have improved. One example of that improvement can be seen in colorectal cancer. Ten to 15 years ago there were only one or two active drugs, and now there are seven US Food and Drug Administration–approved drugs. Median survival has more than doubled, from 10 to 12 months in the era of fluorouracil plus leucovorin to 20 to 24 months now. This is the reason why many current studies designed to evaluate new agents in colorectal cancer (and most other solid tumors) are looking for incremental differences in efficacy, typically 0.75 to 0.80 HR for PFS. The question is whether we should continue to look for such a small, incremental , if we will not be able to afford the new, more expensive agents. This article describes the concept of the target for registration trials. That is, the difference that should be sought that will not only meet statistical measures of efficacy, but meet meaningful clinical criteria of efficacy. While there are many other equally important issues, such as the end point to be pursued, the relation between cost and pricing, the approval process, and the time from approval to market, consideration of those issues is beyond the scope of this report. In addition, we will focus on advanced stage solid tumors since the target for trials in the adjuvant setting of these diseases are based on completely different principles as a function of the treatment aims in this condition.

Subjective evaluation of low-frequency impact sounds on floor-ceiling assemblies.

To investigate meaningful ratings and criteria for the acoustical performance of building partitions, it is necessary to understand the subjective judgments of listeners when hearing transmitted or radiated sounds. Impact sounds on floors caused by footstep noise (walking, running, etc.) are particularly bothersome and are not well characterized. A series of recordings of the sound radiated into the room below a floor-ceiling test assembly when an impact occurs on the topside of the assembly (floor surface) is ongoing. The primary impact sources considered are real adult walkers, and a heavy rubber ball, standardized in JIS A 1418-2. The binaural recordings are presented to listening test participants, who rate subjective attributes of the sounds such as annoyance. In this way the floor-ceiling test assembly is rated (and can be ranked) subjectively, and metrics derived from purely physical measurements can be assessed and interpreted. Preliminary results from measurements on a range of lightweight wood framed assemblies are discussed.

SENSORY PROPERTIES AFFECTING ACCEPTABILITY OF “BRESAOLA” FROM PODOLIAN YOUNG BULLS

ABSTRACT Three muscles (Semimembranosus, Quadriceps femoris, Adductor) from Podolian young bulls (aged 18 months) were processed into bresaolas, which were compared with commercial products, in terms of sensory profile and preference expressed by consumers. Slope analysis was conducted to study the preference drivers. The preference of homogeneous groups of consumers and the relationships with sensory properties of bresaola were investigated using partial least squares (PLS) regression analysis. The products differed for several sensory properties, such as sweetness, flavor intensity (P < 0.001), saltiness (P < 0.01), peppered, seasoned and tenderness (P < 0.05). The slope analysis showed that taste/flavor (k = 0.86) and appearance (k = 0.76) play an important role in orienting consumer preference, while texture (k = 0.54) is less important. No general trend was found for product liking. Conversely, PLS regression clustered the consumers in homogeneous groups: one preferred the commercial products characterized by sensory properties such as peppered, saltiness, seasoned and marbling, another one was more oriented toward properties such as sweetness, odor and chewiness, which characterized Podolian bresaolas.PRACTICAL APPLICATIONPartial least squares regression analysis clustered the consumers in homogeneous groups according to their liking: those preferring peppered, salty, seasoned and marbling bresaolas versus those oriented toward sweet and odorous products. In addition, the relationship between overall liking and attribute liking (appearance, taste/flavor and texture) was analyzed by linear regression analysis. This may be helpful in order to establish meaningful criteria for grading bresaolas and identify the particular attributes that move its acceptance (i.e., taste/flavor and appearance rather than texture).

Typologies of Culture

Cultural related business research requires robust frameworks for analysis and application of this complex phonomena. Business research has largely relied upon and applied Hofstede's dimensions to cultural problems. This study investigates and discusses plausible alternatives (Triandis, Trompenaars and Fiske) to Hofstede’s classification; identifies meaningful criteria to assess these classification, and; evaluate each classification against these criteria. The identified criteria are: simplicity; ability to transcend levels of analysis; lending itself to different research methods; providing richness in identifying themes, and; enabling a richer understanding cultural change. In addition to offering viable alternatives to Hofstede, this study suggests cultural researchers adopt a framework based on their research objectives; forwards criteria to shape and direct cultural research, and; provides researchers with a framework to develop more robust typologies

Research quality assessment in education: Impossible science, possible art?

For better or for worse, the assessment of research quality is one of the primary drivers of the behaviour of the academic community with all sorts of potential for distorting that behaviour. So, if you are going to assess research quality, how do you do it? This article explores some of the problems and possibilities, with particular reference to the UK Research Assessment Exercise and discussion around the proposed new Research Excellence Framework and the ongoing work of the Framework 7 European Education Research Quality Indicators project (EERQI). It begins by asking whether there are any meaningful generic criteria of quality which can be applied to research, and tension between such criteria and the diverse and sometimes contradictory requirements of educational research. It then looks at attempts to identify measurable indicators of quality, including consideration of the location of the publication, citation and download counts, and approaches based semantic analysis of machine readable text—but finds all these quasi ‘scientific’ attempts at quality assessment wanting (hence the ‘impossible science’). This is all the more the case because of their attachment to extrinsic correlates of quality rather than intrinsic characteristics of quality and hence the probability that the measures will induce behaviours not conducive to quality enhancement. Instead the article turns to a different approach. This is better expressed perhaps as quality ‘appreciation’, ‘discernment’ or even ‘connoisseurship’ and is rooted in the arts and humanities rather than in (quasi) science. It considers whether this might offer a better approximation to the kind of judgement involved in quality assessment of a piece of research writing than the sort of metrics approaches favoured in current discussion.

A new approach to combining clinical relevance and statistical significance for evaluation of quality of life changes in the individual patient

Objective Empirical investigation of formerly proposed criteria for relevant changes of health-related quality of life (QOL) regarding their use for monitoring changes in the individual patient. Suggestion of a new criterion trying to overcome the drawbacks of former criteria. Study Design and Setting QOL data were collected longitudinally in 160 cancer patients receiving chemotherapy at an oncological outpatient unit, giving rise to a total of 975 QOL assessments. QOL was measured using the European Organization on Research and Treatment of Cancer Quality of Life Core Questionnaire. Several formerly suggested criteria of relevant change (distribution based, anchor based) were compared in terms of both prevalence and statistical significance of the resulting relevant changes. Results When considering criteria of relevant change suggested in the literature, high proportions (average: 42.3–48.3%) of reputedly relevant changes were found. The majority of these changes (average: 55.8–62.2%) were statistically insignificant. Combination of an increased threshold for clinical relevance with the concept of statistical significance resulted in a more meaningful change criterion. Conclusion Formerly recommended thresholds of relevant change in QOL appear to be unduly low when focusing on the individual patient. A modified criterion is therefore suggested for this case. However, more research is needed for validation and refinement of the proposed criterion.

Sleep disordered breathing in children in a general population sample: prevalence and risk factors.

Assess the prevalence based on clinically meaningful criteria (i.e., blood pressure) and identify risk factors of sleep disordered breathing (SDB) in a representative sample of elementary school children. A random sample of the local elementary school children (K-5) were assessed using a two-phased strategy. In phase I a brief questionnaire was completed by a parent of each child in local elementary schools (N = 5,740), with a response rate of 78.5%. In phase II, randomly selected children and their parent spent a night in our sleep laboratory (N = 700) with a response rate of 70.0%. University sleep laboratory. Children enrolled in local elementary schools. None. Each child was assessed with a full polysomnogram and completed a history/physical examination including an electrocardiogram, otolaryngology examination, and pulmonary evaluation. The prevalence of moderate SDB (apnea-hypopnea index > or = 5) was 1.2%. The independent risk factors included nasal abnormalities and minority associated only with mild (1 < AHI < 5) SDB and snoring and waist circumference associated with all levels of SDB. Tonsil size, based on visual inspection, was not an independent risk factor. The prevalence of AHI > or = 5 was 1.2% in a representative sample of elementary school children. Risk factors for SDB included waist circumference, nasal abnormalities (e.g., chronic sinusitis/rhinitis), and minority. The strong linear relationship between waist circumference and BMI across all degrees of severity of SDB suggests that, as in adults, metabolic factors may be among the most important risk factors for SDB in children.

Marital rape according to French law: Desire, need and consent

Summary Objective This article provides a critical analysis of a concept which will sound rather obvious: sexual relations are only acceptable when both parties consent to them; any form of forced sex is henceforth considered as rape, even when it takes place between two spouses. The author looks at how difficult it can be for the judge and the psychiatric expert to evaluate the plaintiff's consent or refusal, and – even more difficult – the defendant's perception of her consent or refusal. The subtleties of flirting and foreplay, the potential violence involved in sex, inexperience on the part of the lovers are today some of the frightening pitfalls that can lead to extremely severe sentences when charges are pressed. Indeed since a change in the law in France in 2006, spousal rape is now considered an aggravating circumstance and as such is more severely punished than the rape of a stranger. Method Based on 15 years experience of legal psychiatry and a review of more than 200 cases of rape, the author, a qualified psychiatrist and expert approved by the French Court of Appeal, qualified in clinical sexology, specialising in sexual delinquency, shares with us some of the results of his experience. Discussion An increasing percentage of cases of rape – currently 60% of the total – involve partners or ex-partners. This does not mean that there is more violence within couples today than in the past; but rather that the threshold of perception of violence has considerably dropped, and shows us that we should reconsider the relevance of currently used legal terms and concepts. Result The author, a psychiatrist and sexologist, approved as an expert by the French Court of Appeal, specializing in sexual delinquency, explains why he believes that “consent”, the evaluation of which is presented to the court by the psychiatric expert, is not a legally meaningful criterion since it cannot be proven and can easily be denied. He suggests that our legal terminology should be expanded so as to avoid lumping together under the same name “rape” very different situations ranging from an aggression in the street of a total stranger to sex forced by an egocentric spouse on a partner who no longer desires it.

Diagnosing Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is a common disease frequently encountered by surgical pathologists. Although the pathogenesis and clinical features of the disease have been studied for years, many unanswered questions remain. Typical clinical symptoms along with the endoscopic findings, pH monitoring, and biopsies, all support the diagnosis. However, these tests may yield conflicting findings, and at present there is no gold standard for the diagnosis of GERD. In patients with normal or nearly normal endoscopic findings (nonerosive reflux disease), the major diagnostic burden lies with the histology. The histologic diagnosis of GERD is based on a combination of findings, including basal cell hyperplasia, papilla elongation, inflammation, and dilatation of intercellular spaces. However, these features exhibit varying sensitivity and specificity, and minimal biopsy criteria for the diagnosis of reflux esophagitis have not been rigorously tested in well-characterized patient populations. However, given the high prevalence of GERD, pathologists face esophageal mucosal biopsies daily and must recognize the diagnostic strengths and limitations of histologic features of reflux esophagitis. Future studies and new techniques may improve the diagnostic strength of histology and establish meaningful minimal criteria for the diagnosis of reflux esophagitis.

Stereotypes About Stereotype Research

PAUL J. HANGESUniversity of MarylandJONATHAN C. ZIEGERTDrexel UniversityIn his commentary, Landy (2008) high-lighted the Ziegert and Hanges’ (2005) arti-cle and claimed that it was the only ImplicitAssociation Test (IAT) study that exploreda meaningful selection criterion. Whilehighlighting this article, Landy noted twoproblemswithit.First,itdidnotincludeindi-viduating information, and second, it usedan unrealistic manipulation to impose a dis-criminatory climate. In this article, werespond to Landy’s criticisms. We begin bydiscussing the generalizability of thestranger-to-stranger research design andidentify important real-world contexts inwhich raters have no individuating informa-tion. We then discuss whether the Ziegertand Hanges’ (2005) experimental climatemanipulation was unrealistic and discussthe factors that may exacerbate the negativeimpact of stereotypes in the real world.Generalizability of the Stranger-to-Stranger Laboratory ParadigmCommon, nontrivial, and critical organiza-tional practices exist in which individuatinginformation is not (and should not be) avail-able.Forexample, inreliable, valid,andfairselection interviews, evaluators are trainedtobasetheirratingsoninformationprovidedin the interview and nothing else. Ratings inassessment centers are designed to reflectthe behavior of applicants in the exercisesand not on anyadditional information. Sub-jective evaluations of applicants, includingevaluating resumes, letters of recommenda-tion, application information, responses toan in-basket exercise, writing samples, ormore general work samples, are all exam-ples of organizational practices that requireraters to focus on the provided material andnot on any additional individuating infor-mation. Indeed, the validity and fairness ofthese procedures are questioned and dis-puted when raters feel free to adjust theirratingstobeconsistentwithnontest-relevantinformation.These important organizational selectionprocedures are often performed by profes-sors, human resources specialists, andupper-level managers when they engage inthetaskofreviewingresumesandotherdoc-umentation to identify a subgroup of appli-cants to either directly admit into anorganization(e.g.,graduateschool)orinvitein for further evaluation (e.g., simulations,interviews,assessmentcenters).Wecontendthat the stranger-to-strangerlaboratorypara-digm can produce information directly rele-vanttoanyoftheseimportantorganizationalpractices. Indeed, Landy appears to agreewith this argument as he acknowledges that

Dermatophytenspezies

Taxonomy is an artificial system to classify living organisms. For this purpose, different concepts of how to define a species can be used. In recent years, DNA analysis has especially helped to better understand the phylogenetic relations of dermatophytes and thus influenced the distinction of dermatophyte species. In some cases species previously considered separate were made synonymous. It may be necessary to discriminate different varieties within a particular species if this is required by their typical morphologic, physiologic or epidemiological characteristics. Trichophyton eboreum with its perfect state Arthroderma olidum was recently described as a new species. The taxonomic order of dermatophytes must continuously be updated by integrating new findings; at the same time, meaningful and proven criteria should be retained.

Inventory, differentiation, and proportional diversity: a consistent terminology for quantifying species diversity

Almost half a century after Whittaker (Ecol Monogr 30:279-338, 1960) proposed his influential diversity concept, it is time for a critical reappraisal. Although the terms alpha, beta and gamma diversity introduced by Whittaker have become general textbook knowledge, the concept suffers from several drawbacks. First, alpha and gamma diversity share the same characteristics and are differentiated only by the scale at which they are applied. However, as scale is relative--depending on the organism(s) or ecosystems investigated--this is not a meaningful ecological criterion. Alpha and gamma diversity can instead be grouped together under the term "inventory diversity." Out of the three levels proposed by Whittaker, beta diversity is the one which receives the most contradictory comments regarding its usefulness ("key concept" vs. "abstruse concept"). Obviously beta diversity means different things to different people. Apart from the large variety of methods used to investigate it, the main reason for this may be different underlying data characteristics. A literature review reveals that the multitude of measures used to assess beta diversity can be sorted into two conceptually different groups. The first group directly takes species distinction into account and compares the similarity of sites (similarity indices, slope of the distance decay relationship, length of the ordination axis, and sum of squares of a species matrix). The second group relates species richness (or other summary diversity measures) of two (or more) different scales to each other (additive and multiplicative partitioning). Due to that important distinction, we suggest that beta diversity should be split into two levels, "differentiation diversity" (first group) and "proportional diversity" (second group). Thus, we propose to use the terms "inventory diversity" for within-sample diversity, "differentiation diversity" for compositional similarity between samples, and "proportional diversity" for the comparison of inventory diversity across spatial and temporal scales.

Clinically meaningful differences of the Ashworth Scale in patients with chronic post-stroke upper limb spasticity treated with botulinum neurotoxin type A (botox ®)

We describe the clinical importance of changes in Ashworth Scale (AS) scores in chronic post-stroke spasticity patients. Data from 3 clinical trials including 442 patients were pooled and analyzed. Changes from baseline in the AS were compared to the Physician Global Assessment score (PGAS). Receiver Operator Curve (ROC) analyses with wrist flexor AS change from baseline as the independent variable and PGAS as the dependent variable were performed to estimate clinically meaningful changes in spasticity using the criteria for clinical meaningfulness of PGAS ⩾1 (mild improvement or better) and PGAS ⩾2 (moderate improvement or better). Pearson correlation for the change in wrist AS and PGAS was −0.44 (p=0, t=26.5), with correlations of −0.45 and −0.22 noted for the finger and elbow (p Study supported by: Allergan, Irvine, CA